......

B Y T
TRNG I HC Dc H NI

... ............... IB!

NGUYN TH THANH THO

GP PHN KHO ST, NH GI NNG Lc

SN XUT CA CC C S SN XUT Dc
PHM TI VIT NAM THNG QUA DANH MC
THUC C CP S NG K Lu HNH
(KHO LUN TT NGHIP D c s KHO 1998 - 2003)

Ngi hng dn:

PGS. TS. Nguyn Th Thi Hng
TS. L Ngc Phan
Ni thc hin
B mn Qun L & Kinh T Dc
Thi gian thc hin: Thng 3 - 5/2003

.................................. .....................

H Ni 05/2003

M'i c m t t
(Vi lny lt t Lu &a a & knh vii, ti ehi i li em i eiiti thnh
l i:

/r/

- Qf. QIxjaujjl 7

&h Tir Qvn mn Q/ii JCKlnh 7'

^DutUi, *ny tii he ^Due 7/5 Qli. QIu tlt t true tit hn dn ng

oin tan tih ehi ba eh& ii tvny sui thi gian lm. Uh lun

&< M, OtiMi (J)kunr ^ph tng tn a tn en I ne. <T)$l QlaiL,

n u i n h i t tn h p (t t i tvig th i g ia n th u th A ft th im tit tng, ent t,

^Dutte ()il Qlawt.

& i en di i LI ein Oil eitn th n h t i:

@e th gio-, ea e k} ikut men tvii h& mn Qun DCnh

OT

^a nki tnh i$L t, n gfi ldht ifr iu kin tkun Ji ehfr ti

tin thnh Uh lun tt nhfi.

(Ban iti hu, ng l nh tvi en toi h ea tl c- ifr trmi

rutu tao i kii fjiLft (T ti tt'iuj Mt qu trnh h< t)ft MU lun ti

iriiti.
@11i en ti xin i li iiit a ti cha me L anh ehi thn ii, nhng, ni
lun lun th tt e nui tlii , uq on ti, tiQL ti ttiii thnh tvn. eue.
itg tui Uinhljft.

Q.'hn. 0 5 nnt 2 0 0 3
Sinh aM

OliyL Qfhi &hanh &hfr

MC LC

trang
Li cm n
t vn

PHN 1-TNG QUAN

l.l.Cc loi hnh doanh nghip tham gia sn xut thuc VN

1.1.1 .Phn loi theo hnh thc s hu

1.1.2.Phn loi theo quy m

1.2.Cng tc qun l v ng k thuc Vit Nam

1.2.1 .Mt s vn bn lin quan n qun l v ng k thuc

1.2.2.Mc ch ca vic cp s ng k

1.2.3.H s xin cp s ng k

1.2.4.X l vi phm

1.3.Cc dng bo ch sn xut c trong nc

1.3.1.Vin nn

1.3.2.Vin nang

1.3.3.Vin bao

1.3.4.Thuc tim, dch truyn

1.3.5.Vin hon

1.3.6.Cc dng bo ch khc

1.4.Tnh hnh sn xut thuc trong nc nhng nm gn y

10

1.4.1 .C cu ca cc doanh nghip tham gia sn xut thuc

10

1.4.2.Tnh hnh thc hin xy dng c s s x theo tiu chun GMP

10

1.4.3.Cng tc m bo cht lng thuc

13

1.4.4.Nhng tn ti ca ngnh sn xut dc phm trong nc

15

1.4.5.Phng hng pht trin ca ngnh cng nghip s x dc phm VN

16

PHN 2-l TNG V PHNG PHP NGHIN c u

18

2.1.Phng php nghin cu

18

2.2.

18

tng nghin cu

PHN 3-NI DNG V KT QU

19

3.1.S lng thuc sn xut trong nc c cp s ng k lu hnh

19

3.1.1 .S lng thuc sn xut trong nc c cp s ng k lu hnh

19

3.1.2.Thuc mi ca cc c s s x trong nc c cp SDK lu hnh

20

3.2.S lng tng dng bo ch s x trong nc c cp SDK

20

3.3.Phn b s lng s ng k theo loi hnh doanh nghip

24

3.3.1.Phn b s lng s n k theo loi hnh doanh nghip

24

3.3.2.C cu ca cc c s s x c di 25 SDK

26

3.3.3.C cu ca cc c s s x c t 25 n 99 SDK

27

3.3.4.C cu ca cc c s s x c t 100 SDK tr ln

28

3.4.Tnh hnh s x ca cc DN trc thuc tng cng ty Dc VN

30

3.5.KM0 st, nh gi nng lc sn xut thng qua

34

danh mc thuc ca 10 c s s x c nhiu SDK nht

3.6.Mt s dng bo ch mi, hin i, cng ngh cao

36

sn xut trong nc
3.7.Nguyn liu lm thuc sn xut c trong nc

36

3.8.Tui

42

th ca thuc sn xut trong nc

3.9.Tiu chun cht lng ca cc thuc sn xut trong nc

44

PHN 4-KT LUN V XUT

46

4.1.Kt lun

46

4.2. xut

48

Ti liu tham kho

CC CH V IT TT

BYT

c ssx
CT
DNNN
DNPNN
D&TTBYT
DN
DM
TNHH
TW
TCCL
SDK
VN
XNDP

B y t
C s sn xut
Cng ty
Doanh nghip nh nc
Doanh nghip phi nh nc
Dc v trang thit b y t
Doanh nghip
Danh mc
Trch nhim hu hn
Trung ng
Tiu chun cht lng
S ng k
Vit Nam
X nghip dc phm

T VN

Thuc l mt loi hng ho ng vai tr quan trng trong cng tc

chm sc v bo v sc kho ca nhn dn,Vit Nam l mt nc ng dn
nn nhu cu s dng thuc l rt ln. Hin nay, thuc nhp khu vn ng
vai tr quan trng v chim mt t l kh ln trong s dng thuc Vit
nam, nhng thuc nhp khu thng cgi thnh cao, phn ln ngi dn
khng iu kin chi tr. V vy, con ng duy nht m bo nhu
cu thuc l pht huy ni lc, pht trin sn xut thuc trong nc. Nhng
sn xut dc phm trong nc hin nay vn cha p ng c vi nhu cu
thuc s dng cho vic chm sc y bo v sc kho ca nhn dn. Tnh n
ht nm 2002 sn xut trong nc mi ch cung cp c 38,10% tng gi tr
tiu dng thuc trong nc [6] .Vi nng lc sn xut thuc nh hin nay v
nu vi tc tng trng cao l t 15% n 20% trong mt nm, th n
nm 2005 doanh s sn xut ton ngnh t khong t 310 n 380 triu
USD, ch p ng c 1/2 tim nng th trng trong nc ( l cha tnh
n phn sn xut xut khu) [21].
Pht trin sn xut trong nc chnh l c s bn vng v lu di cho
vic to ngun cung ng thuc tt nht. V vy, b y t c nhiu chnh
sch u tin, h tr sn xut dc phm trong nc. hng dn v
khuyn khch cc c s sn xut dc phm trong nc pht trin sn xut
c h thng v hiu qu, b y t ra l trnh xy dng v thc hin tiu
chun thc hnh sn xut thuc tt (GMP) v tiu chun thc hnh th
nghim thuc tt (GLP). Xy dng c mt h thng cc c s sn xut t
tiu chn GMP mt cch ng b, theo tiu chun quc t chnh l yu t
quyt nh sng cn i vi ngnh cng nghip Dc ca nc ta hin nay,
c bit l thi im hi nhp AFTA ang n cn k. xy dng c
mt cch hiu qu h thng cc c s sn xut t tiu chun GMP th trc

ht phi tin hnh nh gi thc trng sn xut dc phm trong nc, t

c hng pht trin c th v ph hp vi giai on pht trin hin nay.
gp phn vo vic thc hin cng vic ny, chng ti thc hin ti:

"GP PHN KHO ST, NH GI NNG L c SN XUT

CA CC C S SN XUT DC PHM t i v i t n a m
THNG QUA DANH MC THUC NG K LU HNH.
Vi khun kh ca mt kho lun tt nghip c nhiu hn ch v thi gian
v iu kin nghin cu, nn chng ti s dng phng php nghin cu
gin tip: thng qua danh mc thuc c cp s ng k lu hnh qua mt
s nm s b kho st, nh gi nng lc sn xut ca cc c s sn xut
trong nc.Vi cc mc tiu, yu cu c th sau:
-

Phn tch, tm hiu danh mc thuc c cp s ng k trong nc n

ht ngy 31 thng 12 nm 2002 v cc mc:c s sn xut, hot cht,

dng bo ch, tiu chun, hn dng v nm c cp s ng k.
Thng qua phn tch danh mc thuc c cp s ng k trong nc
nhm s b kho st nh gi nng lc sn xut ca cc c s sn xut
dc phm trong nc.
-T nhng kt qu , a ra nhng nhn xt v ng gp mt s kin
cho vic pht trin sn xut dc phm trong nc t hiu qu tt hn.

PHN 1
TNG QUAN
1.1.CC LOI HNH DOANH NGHIP THAM GIA SN XUT
THUC TI VIT NAM:
Thuc l mt loi hng ho c bit nn vic sn xut, phn phi, xut
nhp khu thuc c qun l rt cht ch. Trc nm 1986 ngnh Dc
nh nc gi vai tr duy nht trong vic m bo thuc cho cng tc chm
sc v bo v sc kho nhn dn. Sau nm 1986, nn kinh t nc ta
chuyn sang hot ng theo c ch th trng c s qun l ca nh nc.
thch ng vi tnh hnh mi, ngnh Dc c nhng thay i ph hp
v t c nhng tin b vt bc. Ring v mt s x thuc, cc DNNN
khng cn l nhng DN duy nht c php s x thuc m ngy cng c
nhiu loi hnh DN tham gia vo s x dc phm, p ng ngy cng tt hn
nhu cu v thuc ca nhn dn c v s lng v cht lng thuc.
1.1.1.Phn loi theo hnh thc s hu: [18], C 2 loi hnh DN chnh:
* Doanh nghip nh nc:
Hin nay DNNN vn gi vai tr ch o trong s x Dc phm. Do c nh
nc u t vn, khoa hc k thut nn cc DNNN thng c nng lc s x
cao, hin nay cc DN tham gia s x thuc gm:
- Cng ty, x nghip Dc phm trung ng.
- Cng ty, x nghip Dc phm trc thuc cc b, ngnh.
- Cng ty, x nghip Dc phm tnh, thnh ph.
- Cng ty, x nghip Dc phm qun, huyn.
- Cc vin nghin cu, trng i hc.
- Cc DN khc.

*Doanh Nghip Phi Nh Nc:

Vai tr ca cc DNPNN trong lnh vc s x dc phm ngy cng c
nng cao. y thng l nhng DN va v nh, d thch nghi v c nhng
thay i hp l vi c ch th trng, hin nay cc DNPNN tham gia s x
thuc gm:
- Cng ty c phn Dc phm.
- Cng ty THHH Dc phm.
- Cng ty, X nghip lin doanh vi nc ngoi.
- Cng ty, X nghip 100% vn nc ngoi.
- c s s x , nh thuc, t hp s x thuc.
- Cc DN khc.
1.1.2.Phn lo theo quy m: [18]
Cch phn loi ny da trn vn iu l v s lao ng trung bnh hng
nm:
* Cc DN ln: L nhng DN c vn iu l ln hn 5 t ng v c s lao
ng bnh qun hng nm hn 200 ngi.
* Cc DN va v nh: L nhng DN c vn iu l nh hn 5 t ng v
c s lao ng bnh qun hng nm t hn 200 ngi.
Cn c vo quy m s x ca cc DN Dc tng ng vi s lng thuc
c cp SDK ca DN , v thun tin cho vic nghin cu, trong kho
lun ny nghin cu cc c s s x trong nc theo cc nhm sau:
- nhng DN c t 100 thuc c cp SDK tr ln
- nhng DN c t 25 dn 99 thuc c cp SDK
- nhng DN c di 25 thuc c cp SDK.
Phn nhm cc c s s x nh trn phn nh ng nng lc s x ca a s
cc DN, nhng c bit c nhng DN c t SDK nhng s x vi s lng ln
hoc ngc li c nhng DN lm th tc xin ng k nhng li khng sx.
Mt khc, DM thuc c cp SDK v DM thuc ang lu hnh trn th

trng cng c nhng s khc bit nh do nhng nguyn nhn v thi v,

v th trng, v trnh my mc cng ngh...
1.2.CNG TC QUN L V NG K THUC VIT NAM:
1.2.1.Mt s vn bn php quy lin quan n qun l v ng k
thuc: [8], [9], [15], [19].
- Ngy 11/7/1989 hi ng nh nc ban hnh lut bo v sc kho nhn
dn, trong iu 38 c ghi r:"BYT thng nht qun l sx , lu thng, xut
nhp khu thuc v nguyn liu lm thuc, t chc bn v cung cp thuc
thit yu trong phng v cha bnh cho nhn dn".
- Ngy 15/9/1989 BYT ban hnh quy ch ng k thuc sx trong nc,
trong c quy nh mt s thuc ng k ti cc s y t.
- Ngy 31/8/1992 BYT c vn bn s 5517/QLD quy nh c nc ch c
mt hi ng xt duyt cp SDK lu hnh thuc c nc, khng cn khi
nim thuc ch lu hnh trong mt khu vc nh trc na.
- Quyt nh s 3121/2001Q-BYT, ngy 18/7/2001 ca BYT quy nh:
"Tt c cc thuc v nguyn liu lm thuc (gi chung l thuc) mun sn
xut v lu hnh ti VN u phi ng k v c BYT cp SDK"
1.2.2.Mc ch ca vic cp SDK: [8], [19], [15].
- Tng cng cng tc qun l nh nc v thuc. Tt c cc thuc sx, lu
hnh trn lnh th VN c c quan qun l nh nc xt duyt phi
m bo hiu lc, an ton cho ngi tiu dng.
- Thng bo chnh thc v cng khai cc thuc c lu hnh trong c nc
cc n v mua bn bit v ch mua bn cc thuc c lu hnh hp
php, ngn chn vic mua bn tri php, t ngn chn thuc gi, thuc
khng m bo cht lng, thuc vi phm quyn s hu cng nghip.

1.2.3. H s xin cp SDK: [8], [19]., [15].

Theo quyt nh s 3121/Q-BYT, ngy 18/7/2001ca BYT quy nh
cc n v mun xin cp SDK sn xut, lu hnh thuc phi gi n BYT
h s k thut sau:
* n xin ng k thuc (theo mu ca BYT).
* Bn thuyt minh gii thiu qu trnh v kt qu nghin cu.
*Cc ti liu nghin cu.
*Tiu chun cht lng v phng php kim nghim.
* Chng ch xc nhn cht lng ca c quan kim tra cht lng.
*Mu thuc.
*Quy trnh sx .
*L ph.
1.2.4. X l vi phm: [8], [15].
Thuc c cp SDK trong thi gian cn hiu lc s b nh ch sx ,
nh ch lu hnh, thu hi v s trong cc trng hp sau:
- Thuc lu hnh trn th trng khng ng vi h s ng k ti BYT
(tn, nhn, TCCL, quy trnh sx , quy cch ng gi, hm lng...).
- Cc l thuc khng t yu cu v cht lng.
BYT c th rt SDK tm thi hay chnh thc cc mt hng hoc thu hi
giy php s x tu theo mc vi phm.
1.3.CC DNG BO CH SN XUT C TI VIT NAM:
[2], [3], [12], [13], [14].
Cng vi xu th y mnh nghin cu v cc hot cht thuc mi, qu
trnh nghin cu v pht trin cc dng bo ch mi, k thut s x hin i,
c sinh kh dng cao v c cht lng tt ang din ra rt mnh m v hiu
qu ti Vit Nam. C nhiu dng bo ch mc trung bnh tin tin so vi
th gii c nghin cu v a vo s x nh: vin si, vin bao tan trong

rut, vin nang vi ht, vin tc dng ko di, thuc xt c van nh liu, vin
n, vin nang mm...
Tuy nhin vn cn ph bin nhiu dng bo ch n gin nh: cao lng,
thuc nc, thuc bt, hon...
a s cc dng bo ch hin i nh: h tr liu qua da, thuc gii phng
nh gi, xi r kh, thuc tc dng ti ch.. .th trong nc cha sx c.
1.3.1.Vin Nn:
Vin nn l mt loi thuc rn c iu ch bng cch nn mt hay
nhiu loi dc cht (c thm hoc khng c thm t dc), thng c
hnh tr dt, mi vin l mt n v liu.
u im ca vin nn: chia liu tng i chnh xc, dc cht n nh,
tui th di hn dng thuc lng, din s dng rng (c th nut, nhai,
ngm, cy, t, pha thnh dung dch, hn dch hoc ch thnh dng tc
dng ko di).
Nhc im: nh hng n ho tan ca dc cht, sinh kh dng
ca vin nn thng thay i tht thng.
Nhm t dc dng trong sx vin nn gm: t dc n, t dc r, t
dc dnh, t dc trn, t dc mu, t dc bao...
Cc loai my s dung trong sn xut vin nn: My dp vin (my tm
sai, my quay trn), thit b to ht tng si, my trn bt, my sy, my
st ht, my p v...
Hin nay, dng vin nn vn l dng bo ch c sx nhiu nht trong
nc
+ Vin nn si:
i vi vin nn si, ngoi dc cht, iu quan trng nht l phi to ra
c h t dc sinh kh C02. H t dc ny gm mt acid hu c yu
(thng l acid citric hay acid tartric) v Natri hydrocarbonat (NaHC03).
Khi gp nc, h t dc s c phn ng sinh kh C 02 bay ln lm r vin

thuc v gip gii phng hot cht mt cch nhanh chng. Trong sn xut
vin nn si ngoi cc yu cu chung ca vin nn cn i hi yu cu cht
ch v m phng, trong qu trnh sx phi gi m phng sx lun
lun nh hn 25%. m bo cht lng thuc, sau khi sx qu trnh bo
qun cng phi trnh m, nn thng vin nn si c ng gi trong cc
v bc hay tuyp nha c u hn kn.
Vi nm tr li y vin nn si c sx ngy cng nhiu do vin tc
dng nhanh, c sinh kh dng cao v d s dng. Dng vin nn si thng
c sx vi cc dc cht cn c tc dng nhanh nh thuc gim au,
thuc an thn hay cc Vitamin...
1.3.2.Vin nang
Vin nang gm hai loi:
Nang cng: Cn gi l vin nhng gm hai na v nang, y v np lng
kht vo nhau.
Nang mm (softgel): v nng mm v do dai do nang c sn xut bng
hn hp gelatin v glycerin.
u im: Thuc ng vo nang c bo v, che du mi v nn d ung,
tnh sinh kh dng cao.
Nhm t dc s dung trong sx vin nang cng ging nh nhm t dc
s dng trong sx vin nn nhng thng sn xut vin nang s dng t t
dc hn sx vin nn.
Cc loai mv s dung trong sn xut vin nang: My ch to v nang
(my p khun, ch to bng phng php nh git...), my ng thuc vo
nang (my ng c hc hay my ng nang t ng...).
Nang mm l mt dng bo ch c k thut sx trung bnh tin tin v
ang c pht trin sn xut kh mnh trong nc, c nhiu dy truyn
sn xut vin nang mm c BYT cng nhn t tiu chun GMP.

1.3.3. Vin bao:

+ Vin bao phim:
K thut bao phim l to mt mng mng ng nht c cu trc polymer
bn vng ph ln b mt nhn bao.
u im: Nhn bao chu c m v nhit, v bao bn vng, nhn
bao c th l vin nn, tinh th, cm, bt v c bit c th kim sot c
s gii phng ca dc cht ra khi dng thuc.
Nhc im: Trong s x c s dng dung mi hu c nn gi thnh cao,
gy nhim mi trng.
T dc dng bao phim: tu theo mc ch chn t dc bao:
+Phim bao bo v: dng cc cht tan nhanh trong mi trng dch v c
PH<5, loi phim ny dng che du mi v, bo v dc cht. Thng hay
s dng cc t dc bao sau: HPMC, EC, MHEC, NaCMC, PVP, PEG v
Eudragit E100(aminoalkyl methacrylat copolymers).
+Phim bao tan trong rut: phim phi khng tan trong d dy m n t
trng (c PH>5) phim mi bt u tan r v gii phng dc cht, do
nguyn liu bao phim phi m bo khng dch v, thm dch rut, khng
c, d bao v bn vng. Thng hay s dng cc t dc bao sau: CAP,
HPMCP, Eudragit L100/S100, Eudragit L30D (methacrylic acid copolymers).
+Phim bao gii phng thuc chm: thuc c bao phim s gii phng
dc cht trong h tiu ho, nn loi phim bao s dng l loi khng b nh
hng bi PH mi trng v khng tan trong dch tiu ho. Phim bao ch
trng n nc thm qua ho tan dc cht v to ra s chnh lch p
sut y thuc ra khi dng thuc, do c th kim sot c s gii
phng dc cht. Thng bao vin nh, cm, tinh th, sau khi bao cc ht
c dp thnh vin hoc ng vo nang cng. Thng hay s dng t dc
bao l Eudragit RL100/RS100, Eudragit NE30D (Methacrylic ester
copolymers).

Mt s thit b bao phim: ni bao ng c in, ni Pelegrini, ni

strunck, ni accela costa, ni hi-coater, ni adria-coater.
Hin nay, trong nc mi ch sx c dng phim bao bo v v phim
bao tan trong rut, dng phim bao gii phng thuc chm c sn xut c
nhng mi ch dng mc nghin cu, thm d.
+ Vin bao ng:
Bao ng l phng php bao c truyn p dng cho quy m sx ln.
Vin s dng bao ng l vin trn hay vin nn.
Qu trnh bao gm 4 bc: bao nn, bao nhn, bao mu, bao bng c
tin hnh trong ni bao ng, sX vin bao ng c u im l d lm,
nguyn liu d kim nhng li c nhc im l v bao d v, kh bo
qun v v bao dy c th nh hng n r ca vin.
1.3.4.Thuc tim, dch truyn:
Thuc tim l dng thuc lng, v khun dng tim vo cc m ca
c th theo nhiu ng tim khc nhau, ngoi ra n cn c th l bt v
trng.
Ngoi hot cht v dung mi, trong mt s cc cng thc thuc tim,
ngi ta cn thm cc cht ph (cc cht ny phi t tinh khit dng
pha tim) bao gm: cht lm tng tan, cht chng xi ho, cht st
khun, cht iu chnh v n nh PH, cht ng trng, cht ph c tc
dng gim au, cht ph c tc dng ko di tc dng ca thuc...
Yu cu, i hi cao nht i vi sn xut thuc tim l phi m bo
c v khun ca thuc tim. V vy cc c s s x thuc tim phi c
xy dng theo nguyn tc mt chiu v tt nht l m bo c tiu chun
ca GMP cho dy truyn sn xut thuc tim.
My mc, thit b s dng trong sn xut thuc tim: thit b ct ng,
thit b ra ng, thit b sy ng, thit b ng ng, thit b lc (mng lc
thng c kch thc l lc t 0,22 n 0,45

|Lim

m bo lc loi

khun), thit b hn ng, thit b tit khun...Vi cc my s x thuc tim

truyn hin i, c th c mt dn my ng b t cng on ra ng n
hn kn u ng trong iu kin Ytrng.
Hin nay cc c s s x ang phn u xy dng dy truyn s x thuc tim
t tiu chun GMP ASEAN, v BYT quy nh n 31/12/2001 c s s x
no khng t tiu chun GMP th s khng c quyn tip tc s x thuc
tim v dch truyn. Ngoi cng ty TNHH BBraun chuyn v s x dch
truyn, trong nc cn c mt s c s s x cng kh mnh v thuc tim
truyn nh: CT Dc v TTBYT Bnh nh, XNDP TW 1, XNDP TW2...
1.3.5.Vin hon:
Vin hon hay cn gi l thuc vin trn, gm 2 loi l hon cng v
hon mm. s x vin hon c u im l cng ngh, my mc thit b s x
n gin, d lm nhng c nhiu nhc im nh kh m bo v sinh, kh
tiu chun ho v mt cht lng v thi gian tan r ca vin hon lu hn
vin nn.
Cc loi t dc dng trong s x vin hon l: t dc n, t dc r, t
dc ht, t dc dnh, t dc mu, t dc bao bng...
Dc cht v t dc c sx thnh vin hon trong ni bao vin .
Do d s x v my mc n gin nn hu ht cc c s s x trong nc u
s x dng bo ch ny, k c nhng c s s x ln. Nhng ni chung s x dng
vin hon ch yu vn l cc c s s x nh, s x thuc ng dc.
1.3.6.Cc dng bo ch khc:
Ngoi cc dng bo ch trn hin nay cc c s s x trong nc cn s x c
nhng dng bo ch sau:
-Vin ngm

- Vin n

- Thuc xt

- Hn dch ung, dng ngoi

- Thuc m, kem, gel

- Bt thuc, cm thuc

- Dung dch thuc

- Cao lng

- Siro, potio

- Cao mm

- Cao xoa

- Cao dn

- Tr thuc

- Thuc thang

- Thuc git

- Vin t

1.4.TNH HNH SN XUT THUC TRONG NC NHNG NM

GN Y:
1.4.1.C cu ca cc doanh nghip tham gia sn xut thuc:
Trc khi c ngh nh 388/HBT v vic sp xp li cc DNNN, ngnh
cng nghip Dc ang c mt h thng cc XNDP nhng nhiu DN trong
s hot ng khng c hiu qu [28]. Sau khi c s sp xp li v c
nhng thay i mi thch ng vi c ch th trng, c cu cc DN tham
gia s x thuc tr nn hp l hn vi nhiu loi hnh DN. Trong s cc
DNNN hn 20 DN sn xut, kinh doanh thuc c quy m ln tp hp thnh
tng cng ty Dc VN. Nm 2002, tng cng ty Dc VN c tng doanh
thu s x t 1343,69 t ng, chim 35,55% tng doanh thu sn xut ton
ngnh [22]. Cc DN a phng chim hn 80% s DNNN nhng doanh s
s x ch chim khong 50% [28]. Nm 2002 c 19 DN lin doanh i vo
hot ng s x chim 14,70% sn lng s x v 22,52% tng doanh thu
s x trong nc [6] . Cc DN c phn dc phm (ch yu l nhng DN
c c phn ho t nhng DNNN), mt s DN t nhn v cng ty TNHH
Dc phm ang c nhng bc i nng ng v c nhiu ng gp tch
cc cho s x dc phm trong nc. S cn li l cc c s s x nh l chim t
l cao v s lng nhng khng nh hng nhiu n sX thuc trong nc
do nng lc s x cn hn ch.
1.4.2.Tnh hnh thc hin xy dng cssx theo tiu chun GMP:
Sau khi BYT ra l trnh xy dng v thc hin tiu chun thc hnh

sx thuc tt (GMP) hng dn v c k hoch khuyn khch, u t cho

10

cc c s s x trong nc, c nhiu c s s x thc hin c hiu qu vic xy

dng cc dy truyn s x t tiu chun GMP. Kt qu c th nh sau:
- Nm 1996 BYT cp giy chng nhn t tiu chun GMP ASEAN cho 3
CSSX: Sanofi Pharma Vit Nam, CT Dc Phm ng Thp v XN lin
hp Dc Hu Giang [1].
- Nm 1998 BYT cp giy chng nhn t tiu chun GMP ASEAN cho 8
CSSX: 3 c s c cp giy chng nhn nm 96 v XN Dc Phm v
Sinh Hc Y T (Mebipha), cng ty TNHH Hisamitsu Vit Nam, cng ty
TNHH Novartis Vit Nam, cng ty TNHH Rhoto metholatum Vit Nam,
cng ty TNHH Phone poulenc Rorer, ring cng ty Dc phm ng Thp
a dy truyn s x khng sinh nhm Betalactam t tiu chun GMP i
vo hot ng [1].
- Nm 2000: c 18 c s c BYT cp chng nhn t tiu chun GMP
Asean, trong c 7 c s u t nc ngoi, 7 c s ca trung ng, 3 c
s ca tnh v 1 cng ty TNHH [4].
- Nm 2001: c 26 c s c BYT cp giy chng nhn t tiu chun
GMP [5].
-Nm 2002: BYT cp chng nhn t tiu chun GMP ASEAN cho 31 c
s (tng 8 c s so vi nm 2001). Trong min Bc c 8 c s, min
Trung c 2 c s, min Nam c 21 c s (ring thnh ph H Ch Minh
c 12 c s t tiu chun GMP), 5 c s c cp chng nhn mi l:
cng ty Dc & VTYT Tin Giang, cng ty Dc & VTYT Thanh Ho,
Cng ty CPDP Dc liu Pharmadic, cng ty TNHH Ranbaxy Vit Nam,
cng ty TNHH Thainakom patana Vit Nam v 3 n v s x c cng
nhn b xung t GMP i vi mt s dy truyn mi l: dy truyn vin
nang mm ca cng ty CPDP Nam H, dy truyn thuc bt tim nhm
Beta lactam ca XNDP TW 24, dy truyn thuc dng ngoi ca cng ty
TNHH- MST [6].

11

C th, danh sch cc c s s x t tiu chun GMP tnh n ht

31/12/2002, gm: [1], [4], [5], [6], [24], [25],
l.Sanofi Pharma VN.
2.Cng ty TNHH Ranbaxy VN.
3.

Cng ty TNHH Hisamitsu VN.

4. Cng ty TNHH Novatis VN.

5. Cng ty TNHH Rhoto metholatum VN.
6. Cng ty TNHHJhone-poulenc Rorer VN.
7. Cng ty TNHH Thai nakom Patana VN.
8.Cng ty Dc phm BBraun H Ni.
9.XN lin hp Dc Hu Giang
10.Cng ty Dc phm ng Thp.
1l.XN Dc phm v sinh hc y t (Mebipha).
12.Cng ty c phn Dc phm Nam H.
13.

Cng ty c phn Dc phm Dc liu Pharmadic.

14. Cng ty Dc phm H Ty.

15. Cng ty c phn Dc phm v trang thit b y t GTVT Traphaco.
l.Cng ty TNHH MST.
17.XN Dc phm TW 24 (cng ty c phn ho dc phm Mekophar).
18.XN Dc phm TW 26.
19.XN Dc phm TW 1.
20.Cng ty Dc & VTYT Tin Giang.
21.Cng ty Dc & VTYT Thanh Ho.
22.Cng ty Dc & TBYT Bnh nh.
23.Cng ty CPDP Dc liu Mekng.
24.Cng ty Dc & VTYT Tr Vinh.
25.Cng ty Dc & VTYT Vnh Phc.
26.Cng ty Dc liu TW 1.

12

27.Cng ty c phn Dc Phm Imexpharm.

28.XN Dc phm TW 25.
29.Cng ty pht trin k ngh Dc TW.
30.XN Dc phm TW 5.
31.

Cng ty Dc phm TW Hu.

Theo quyt nh ca BYT n cui nm 2002 c s s x no khng t tiu

chun GMP s khng c tip tc s x thuc khng sinh nhm Betalactam,

thuc tim v dch truyn.
Theo cng vn s 1044/QLD-K th n nm 2005 cc c ssx nu
khng t tiu chun GMP v thuc tn dc th s khng c cp SDK v
tip tc s x thuc tn dc v TCCL phi c kim nghim t theo
DVNIII mi c cp SDK [4].
Nhn thc c tm quan trng sng cn ca vic xy dng c s s x t
theo tiu chun GMP, cc DN ang tp trung u t c v my mc, nh
xng, ngun nguyn liu v nhn lc, kh nng qun l xy dng cssx
t theo tiu chun GMP ASEAN, qu trnh ny ang din ra mnh m v
rt hiu qu.
1.4.3.Cng tc qun l cht lng thuc: [6], [16]
Thuc l nhng sn phm s dng cho ngi nhm mc ch phng,
cha bnh. Thuc l mt loi hng ho c bit do nguyn tc chung l
tt c cc thuc u phi kim nghim xc nh cht lng, nu t tiu
chun quy nh mi a vo s dng.
H thng kim tra cht lng thuc c t chc cht ch t trung ng
n a phng [6],[16]
- C quan kim tra cht lng thuc cp nh nc gm Vin Kim
Nghim, Phn Vin Kim Nghim v cc trung tm kim nghim cc
tnh, thnh ph (hin nay c 61 trung tm kim nghim, trm kim nghim
t cc tnh, thnh).

13

- Phng kim tra cht lng thuc ca cc n v sx, kinh doanh Dc

phm: trc tip tham gia vo cng tc m bo cht lng thuc sx , kinh
doanh ca n v .
H thng m bo cht lng c pht trin v hon thin t giai on
s x n giai on sau sx , n ht 31/12/2002 c 31 c s s x t GMP, 10

c s s x t GSP v 16 c s s x t GLP.
Do c tng cng v ngun nhn lc v nhiu my mc, thit b phn
tch hin i nh my sc k lng hiu nng cao HPLC, my UV/VIS, my
xt nghim sinh ho... nn h thng m bo cht lng thuc trong nc
c cng nhn t c cc tiu chun:
-Vin Kim Nghim p dng h thng cht lng ISO v cui nm
2001 c VILAS cp chng nhn t tiu chun quc t ISO/IEC 17025
v nng lc phng th nghim v hiu chun
- Phn Vin Kim Nghim c BYT cp chng nhn t tiu chun
GLP v cui nm 2002 c cp chng nhn t tiu chun ISO/IEC 17025
-

C 15 phng kim tra cht lng thuc ca cc cssx thuc c cp

chng nhn t tiu chun GLP, phng m bo cht lng thuc ca XN

lin hp Dc Hu Giang c cp chng ch ISO/IEC 17025.
Tt c cc thuc v nguyn liu lm thuc phi c kim tra t theo
cc TCCL ng k ti c quan qun l v thuc trc khi c a vo
lu thng. Hin nay cc nh s x c th cn c vo cc cp tiu chun cht
lng sau: tiu chun c s (TC), tiu chun nh nc (DVN), tiu chun
ngnh (TCN), cc tiu chun khc (Dc in Anh (BP), Dc in M
(USP), Dc in Php, Dc in Trung Quc...).
H thng m bo cht lng thuc thc hin qu trnh ly mu, phn
tch, kim tra cht lng thuc, t pht hin ra cc thuc gi, thuc km
cht lng lu hnh trn th trng v m bo cho qu trnh s x to ra cc
sn phm t theo tiu chun cht lng quy nh.

14

Chnh h thng m bo cht lng mang tiu chun quc t, ng b

v thng nht l yu t to uy tn v nim tin ni ngi s dng thuc. Do
chng ta phi xy dng c mt h thng m bo cht lng thuc
theo tiu chun quc t thc th.
1.4.4.Nhng tn ti ca ngnh cng nghip s x dc phm trong nc:
Pht trin s x thuc trong nc chnh l c s bn vng lu di cho vic
to ngun cung ng thuc tt nht, nhng hin nay cc thuc s x c
trong nc khng hoc cha p ng c vi chnh nhu cu thuc s
dng phng v cha bnh trong nc. n c ngay vi thuc thit yu,
tnh n ht ngy 10/3/2003 c 383 hot cht trong danh mc thuc thit
yu, trong nc s x c 152 hot cht c trong DM thuc thit yu
chim 56,3%, vn cn 118 hot cht tng ng vi 43,7% tng s hot
cht trong danh mc thuc thit yu cha s x c trong nc [28]. Theo
d on, n nm 2005 kh nng s x trong nc ch p ng c 50% v
n nm 2010 s x trong nc phn u cung cp c 60% tim nng th
trng trong nc [6]. Nhng hn ch ca ngnh cng nghip s x thuc
trong nc l do:
- S lng cc DN tham gia s x thuc tuy nhiu nhng quy m nh, trang
thit b lc hu nhng vn khng hot ng ht cng sut, hiu qu hot
ng thp, s c s s x nguyn liu lm thuc qu t [28].
- C cu ca cc thuc c

sx trong nc cha hp l, mt hng c nhiu

s trng lp: trong hn 7 nghn thuc c cp SDK th ch c 384 hot

cht c s dng. Mt khc, hot cht thuc ca cc sn phm s x trong
nc cn n iu, ch yu l cc thuc thuc nhm khng sinh, vitamin v
thuc cm st [1].
- Trnh cng ngh

sx ni chung cn mc thp, mc d gn y nhiu

DN u t thit b nh xng t tiu chun GMP. Trong nc s x

c cc dng bo ch trung bnh tin tin nh vin nang mm, thuc xt,

15

vin bao tan trong rut...nhng cc dng bo ch n gin vn chim mt t

l kh ln [28].
- H thng m bo cht lng thuc c u t pht trin nn phn ln
cc DN sx , kinh doanh thuc u c th kim tra cht lng thuc ngay ti
c s theo tiu chun m c s ng k. Tuy vy mt s c s s x cha
nng lc k thut kim nghim ton b tiu ch cht lng trong tiu chuncht lng sn phm ca mnh, phi hp ng kim nghim cc thuc do c
s s x ti cc n v khc, iu ny c th dn n vic kim tra cht lng
thuc trong qu trnh s x khng c thng xuyn v kp thi [6].
1.4.5.Phng hng pht trin ca ngnh sn xut dc phm VN:
Kt qu ca khi
Bng 1.1:

sx thuc trong nhng nm gn y th hin bng 1.1

TNG DOANH THU KHI

sx THUC TRONG NM NM GAN y : [26]

Nm

1997

1998

1999

2000

2001

2002

Doanh thu SX(t ng)

1385

1578

1823

2280

2760

3289

t l tng trng%

+11.0 +11.4 +11.6 +12.5 +12.1 +19

Nh vy tng doanh thu khi sx tng qua cc nm v tng mnh vo nm

2002, t trng thuc

sx trong

nc so vi tng s lng thuc s dng

trong nc cng tng, t 25% nm 98 tng ln 28% nm 99, 35% nm

2000 v 2001 , v n nm 2002 con s ny l 38,3% [28], [6]. T nhng
thnh qu v thc trng ca sx trong nc, BYT ra phng hng
pht trin ca ngnh cng nghip sx dc phm VN vi nhng mc tiu:
*Muc tiu cu th nm 2003: [6]
- Khuyn khch cc c s s x tng cng u t cng ngh hin i, i mi
trang thit b v i mi qun l, cc DN cn dnh t l thch ng (khong
3% n 5% doanh thu) cho qu nghin cu v pht trin cc hot cht
thuc mi, cc dng bo ch mi. T chc hi ngh chuyn v
hng dn v thng tin kp thi, trnh trng lp gia cc cssx.

16

sx,

- Khuyn khch cc DN thc hin GMP, ISO m bo l trnh ra, gi

vng mc tng trng sx , kinh doanh hn 15%. Phn u n cui nm
2003 c nc c t 40 n 45 c s s x dc phm t tiu chun GMP.
- Tip tc hin i ho cc c quan kim nghim trung ng, quy hoch
trung tm kim nghim, hon thin cc cng tc qun l phng th nghim
theo yu cu ISO v GLP.
*Muc tiu cu th n nm 2005: [4]
- Quy hoch v t chc li ngnh cng nghip Dc, tng cng u t
cng ngh hin i, i mi trang thit b v i mi qun l. Phn u n
nm 2005 s x Dc phm trong nc m bo c 50% nhu cu phng
bnh v cha bnh, s x mt s nguyn liu lm thuc c th mnh, c bit
l t dc liu. Tin thuc bnh qun u ngi t 8 n 10
USD/ngi/nm
- To iu kin v khuyn khch thnh lp cc c s dch v kim nghim
hin i ngoi h thng kim nghim nh nc, nng cao nng lc ca Vin
Kim Nghim, Phn Vin Kim Nghim. Tng cng cng tc kim tra,
gim st, nng cao trch nhim t kim tra ca cc DN, m bo cht lng
thuc phc v nhu cu chm sc, bo v sc kho nhn dn.
* Muc tiu cu th n nm 2010: n i
- u t cng ngh hin i, i mi thit b v i mi qun l ngnh
cng nghip dc tng bc p ng ngun nguyn liu lm thuc. n ht
2010 tt c cc c s s x , kinh doanh, nghin cu v kim nghim dc phm
u t tiu chun thc hnh tt GP (good practice ).
- Xy dng c s s x khng sinh v ho dc, s x cc nguyn liu lm
thuc c th mnh c bit l t dc liu.
- m bo s x trong nc cung cp c 60% nhu cu thuc phng v
cha bnh. Mc tiu dng t 12 n 25 USD/ngi/nm.

J7

PHN 2
PHNG PHP V I TNG NGHIN c u
2.1.PHNG PHP NGHIN CU:
2.1.1.Phng php nghin cu gin tip:
Thng qua phn tch, nh gi DM thuc c cp SDK ca cc c s s x
trong nc s b kho st, nh gi nng lc s x ca cc c s s x .
2.1.2.Phng php hi cu:
Hi cu li DM cc thuc c cp SDK t nm 1997 n nm 2002, t
tin hnh tng hp, phn tch, nh gi.
2.1.3.Phng php tng hp v phn tch:
+ Tng hp s liu thng k c v danh mc thuc c cp SDK ti VN
t nm 1997 n ht nm 2002.
+ Phn tch, nh gi c cu DM thuc c cp SDK v cc mc: hot
cht, dng bo ch, tui th, TCCL, nm c cp SDK v c s s x .
2.2. I TNG NGHIN CU:
- Nghin cu h s ng k thuc
- Nghin cu DM thuc ng k lu hnh v cc DM thuc ng k b
sung
- Nghin cu bo co tng kt cng tc Dc cc nm 1997, 1998, 1999,
2000,2001,2002 ca Cc Qun l Dc-BYT.

18

PHN 3
NI DUNG V KT QU NGHIN c u
3.1.S LNG THUC SN XUT TRONG NC

c CP

S NG K LU HNH:
3.1.1.S lng thuc

sx trong nc c cp SDK qua mt s nm:

Tt c cc thuc v nguyn liu lm thuc mun c s x v lu hnh

ti VN u phi ng k v c BYT cp SDK. V vy, s lng thuc
c cp SDK hng nm s phn nh nng lc s x trong nc qua cc nm.
Bng 3.1: s LNG THUC sx TRONG NC C CP SDK QUA MT s NM:
nm

Thuc c cp SDK
S lng
Tng lin
hon %

1997
1998

749
849

1999
2000
2001
2002

1489
1510
1370
1227

S lng

100

175
310
337
346
365
384

113,35
175,38
101,41
90,73
89,56

Hot cht s dng

Tng lin
SL hot
hon %
cht/SK lu
hnh
100
1/23
177,14
1/11
108,71
1/14
102,67
1/16
122,90
1/17
1/18,7
129,30

Slng1600
1400

1227

1200
1000

800
600
400
200

'AQ

!4()

333-

310
175
*\
1997

lVi
1998

346

384

65_

E H
1999

2000

2001

2002 Nm

Slng SDK SL hot cht s dng

HNH 3.1:THUC s x TRONG NC C CP SDK V HOT CHT s DNG

19

Nhn xt: Ni chung s lng thuc c cp SDK c xu hng tng,

c bit tng nhanh vo nm 99 v 2000, tng ng vi khong thi gian
nc ta vc dy thot khi cuc khng hong kinh t ng Nam , y
cng l khong thi gian pht trin mnh v s lng ca cc cssx, do
s lng thuc c cp SDK v a ra th trng tng nhanh. Nm 94
c 3468 SDK, nm 2001 c 6876 SDK v n nm 2002 tng ln 7194
SDK. S lng cc hot cht s dng cng tng qua cc nm, tuy nhin t l
s lng hot cht s dng/SK lu hnh gim cho thy t l trng lp hot
cht thuc gia cc thuc c cp SDK c xu hng gia tng. T l trng
lp hot cht rt cao, c bit l mt s hot cht nh: Paracetamol c 380
SDK, Clopheniramin c 191 SDK, Vitamin

c c

161 SDK, Terpin hydrat -

c 125 SDK...
Tc tng trng s lng thuc nh vy l kh nhanh, nhng nu so
snh vi cc nc khc trong khu vc th vn cn thp. Nm 89 Thi Lan
c 30000 SDK, nm 93 Philipin c 18000 SDK lu hnh. Nh vy,
mc d c tc pht trin kh nhanh v s lng thuc c cp SDK
nhng cc cssx trong nc vn phi tip tc u t theo c 2 hng l pht
trin cc dng bo ch mi hin i v nghin cu thm cc hot cht thuc
mi.
S lng thuc c cp SDK tng nhanh nhng c mt t l kh ln
trong l cc thuc ng k li (thuc c SDK nhng sp ht hn lu
hnh phi lm cc th tc ng k tip tc), s cn li l cc thuc mi.
3.1.2.Thuc mi ca cc

cssx c cp SDK hng nm:

T l thuc mi c cp SDK hng nm phn nh kh nng nghin cu

v pht trin sn phm mi ca cc

cssx, s liu c khi qut ti bng

3.2:

20

Bng 3.2: s

Nm
97
98
99
2000
2001
2002
Tng

LNG THUC MI CA CC cssx TRONG NC c CP SDK Lu HNH:

Thuc ng k mi
S lng
Tng lin hon
%
451
100
462
102,44
628
135,93
721
114,89
755
104,72
879
116,42
3896

Hot cht mi s dng

S lng
T l so thuc
K mi %
29
6,43
135
29,22
27
4,30
9
1,25
19
2,52
19
2,16
238

S lng thuc sx trong nc c cp SDK v s lng thuc ng k

mi hng nm tng u qua cc nm, c th hin hnh 3.2

Hnh 3.2: s LNG THUC C CP SDK V SDK MI HNG NM

Nhn xt: Cc thuc ng k mi tng nhanh qua cc nm, trn th ta
thy mc d s lng thuc c cp SDK nm 2001, 2002 c hi gim so
vi nm 2000 nhng s lng thuc ng k mi vn tng u. iu ny
th hin cc DN tham gia s x thuc ch nhiu hn n nghin cu v
pht trin sn phm mi. T l cc thuc ng k mi tng mnh nht l
nm 99 (tng 135,93% so vi nm 98) v tng thp nht l nm 98 (ch tng
102,44% so vi nm 97).

21

Tuy s lng thuc ng k mi tng mnh nhng s lng cc hot

cht mi c s dng trong sx cc thuc ng k mi ch chim t l nh
qua cc nm. Nh vy, c th thy phn ln thuc c cp SDK mi vn
c hot cht c trng lp vi cc thuc c cp SDK trc ca cc
CSSXkhc.
Vic gia tng s lng thuc ng k lu hnh s to ra mt p lc cnh
tranh gia cc cssx , kinh doanh thuc. Kt qu l cht lng thuc s
ngy cng tt hn, gi thuc s c xu hng r hn, tt c iu ny s c li
cho ngi dng.Tuy nhin vic gia tng mnh s lng thuc m khng
tng nhiu v hot cht thuc mi s to ra s trng lp, gy ra nhng lng
tng, kh khn nht nh cho ngi s dng khi la chn thuc.
3.2.S LNG TNG DNG BO CH SN XUT TRONG
NC C CP S NG K LU HNH:
Bng 3.3: s LNG TNG DNG BO CH QUA CC NM
^ \N m

1997

1998

1999

2000

2001

2002

Dng

SL IL% SL TL%

SL

TL%

SL

TL%

SL

TL%

Vin nn

185 24,70 204 24,03

342

22,97

286

18,94

260

18,98 250 20,37

Vin nang

81 10,81 131 15,43

246

16,52

182

12,05

165

12,04 192

15,65

Vin bao phim

36

4,81

46

5,42

110

7,39

167

11,06

123

8,98

175

14,26

Vin bao ng 37

4,94

47

5,54

78

5,24

73

4,83

61

4,53

33

2,69

Thuc tim

84 10,95 68

7,30

71

4,67

91

5,99

46

3,36

52

4,24

Vin hon

21

2,80

25

2,94

75

5,04

84

5,56

76

5,55

36

2,93

M, kem, gel

36

4,81

36

4,24

58

4,00

71

4,70

42

3,07

62

5,05

Dng BC mi

16

2,14

15

2,94

39

2,62

40

2,65

71

5,18

70

5,70

Cm, bt thuc

46

6,14

42

4,95

83

5,57

74

4,90

72

5,21

75

6,11

16,12

250

16,56 197 14,38 211 14,20

146

9,87

189

12,52

257

18,76

51

4,16

1489

100

1510

100

1370

100

1227

100

Thuc nc,DD 138 18,43 432

Dng khc

200 26,70

Tng

749

15,55 240

195 22,97

100 849

100

SL

TL%

(Dng bo ch mi gm: thuc tim ng kh, vin tc dng ko di, vin

nang vi ht, vin n, t, vin nn si, thuc xt, vin bao tan trong mt)

22

H n h 3 .3 : T L CC DNG BO CH QUA CC NM

Nhn xt: Ngnh cng nghip dc VN ang pht trin v pht trin
ngy mt mnh m, do nng lc s x ca cc DN trong nc tp trung
ch yu cc dng bo ch c k thut s x trung bnh n trung bnh tin
tin nh: vin nn, thuc cm, bt, vin nang, vin bao phim, thuc tim...
Cc dng bo ch c k thut mc trung bnh: vin nn, thuc m,
kem, gel, dng cm, bt thuc c xu hng n nh qua cc nm, dng vin
nn thng chim khong 21,5%, dng thuc m, kem, gel chim khong
4% , dng cm, bt chim khong 5,5% trong tng s cc thuc s x trong
nc.
T l dng vin bao phim v vin nang trong tng s cc dng bo ch c
xu hng tng nh, (t l dng vin bao phim tng t 4,81% nm 97 ln
14,26% nm 2002, t l dng vin nang tng t 10,81% nm 97 ln 15,65%
nm 2002.
Ngc li t l dng thuc tim trong tng s cc dng bo ch c xu
hng gim ( t 10,95% nm 97 xung 4,24% nm 2002). Cc con s ny
phn nh tnh hnh s x thuc trong nc, cc dng bo ch trung bnh, s x
n gin, sinh kh dng khng cao nh: vin hon, vin nn, vin bao
ng...khng cn c ch trng u t pht trin nh trc m ch duy tr
s x vi my mc, phng tin sn c. Cn cc dng bo ch tng i mi
nh vin nang mm, vin bao phim th c cc c s s x u t my mc,

23

thit b nhiu hn. Ring dng thuc tim c xu hng gim nh v thc
hin cc vn bn qun l ca BYT ch c cc c s c my mc, thit b
hin i, c nh xng t cc yu cu

sx thuc tim

mi dc tip tc

cp SDK, theo BYT quy nh, n cui 2002 nu c s s x no khng t tiu

chun GMP th khng c tip tc sx thuc tim truyn.
Cc dng bo ch n gin nh, thuc nc, vin hon, vin bao ng
cng c t l hi gim qua cc nm: t l dng vin bao ng gim t
4,94% nm 97 xung cn 2,69% nm 2002, dng thuc nc, dung dch
gim t 18,43% nm 97 xung 14,20% nm 2002, tuy nhin cc dng bo
ch n gin vn chim t l kh cao trong tng s cc dng bo ch s x
trong nc. Cc dng thuc ny cng vi cc dng thuc khc nh cao
lng, vin t, thuc thang...thng do cc c ssx nh l, t my mc hin i

sx.
Cc dng thuc c k thut bo ch mi, hin i bt u xut hin
trong DM thuc ng k v c xu hng tng nhanh, c bit tng mnh
vo nm 2001, 2002( tng t 2% ln 5%), tuy nhin t l ny cn qu thp.
Trong nhng nm ti cc

cssx phi u t nhiu hn cho nghin cu v

pht trin sn phm mi, hin i, c cht lng cao thuc VN khng
nhng ng vng th trng trong nc m cn tham gia vo th trng
khu vc khi VN hi nhp vo AFTA.
*Nh vy, ngnh

sx trong nc ang c nhng bc i kh mnh m v

vng chc, vi cc thay i hp l thch ng vi c ch th trng l

gim dn cc dng bo ch c, lc hu, gi n nh cc dng bo ch c k
thut s x trung bnh to ngun vn u t cho pht trin cc dng bo
ch c k thut s x trung bnh tin tin v cc dng bo ch hin i, c
cng ngh cao hay s dng cc t dc mi.
3.3. PHN B S LNG SDK THEO LOI HNH DOANH NGHIP
3.3.1. Phn b s lng SDK theo loi hnh doanh nghip:

24

S thuc c cp SDK ca mt c ssx phn nh quy m, trnh khoa

hc k thut v nng lc sx ca c s .
Bng 3.4 : PHN B s

LNG SDK THEO LOI HNH DOANH NGHIP:

(Tnh n ht 2002)
S lng
SDK

Tng s c s s x

DNNN

DNPNN

t l so

T l so

T l so

lng

tng %

lng

tng %

lng

tng %

1-24

224

76,71

42

18,75

182

81,25

25-99

44

15,07

28

63,64

16

36,36

>100

24

8,22

19

79,17

20,83

Tng

292

100

85

203

cssx c 1-24 SDK DCSSX c 25-99 SDK mcssx c t 100 SDK tr ln

H n h 3 .4 :t l

cc n h m c s s x t h e o s l n g t h u c c cp

SDK

Nhn xt: T nm 97 n nm 2002 s thuc ca cc c s s x rt chnh

lch, c s t nht c 1 SDK v c s nhiu nht c 231 SDK. Phn ln cc
c s s x dc phm trong nc vn l cc c s s x va v nh, s lng thuc

ng k t. C 76,71%s c s s x c di 25 SDK v ch c 8,22%s c s s x

c t 100 SDK tr ln. Trong s cc

cssx c nhiu SDK th cc DNNN

25

chim t l cao v ngc li trong s cc c ssx c t SDK th cc DNPNN

li chim ch yu.
3.3.2.C cu ca cc c s sn xut c di 25 SDK:
Cc c s s x c di 25 SDK chim ti hn 76% s cc c ssx thuc,
nhng nng lc sx ca cc c s ny cn yu.
Bng 3.5: c

CU CA CC c s s x C DI 25 SDK

S lng Tng s c s s x
SDK
S
t l so tng
1-5
6-10
11-15
16-20
21-24
Tng

lng

138
45
20

61,61
20,09
8,93
4,46

1
11
224

4,91

DNNN

DNPNN

S
lng

T l so tng

T l so

lng

tng %

21
7
5
5
4
42

15,22
15,56
25,00
50,00

117
38
15
5
7
182

84,78
84,44
75,00
50,00
63,64

36,36

E3DNNN DDNPNN
Hnh 3.5: c

CU CA CC c s s x C DI 25 SDK

Nhn xt: Trong c cu ca cc c ssx c di 25 SDK th DNPNN

chim t l ch yu, c 182 DNPNN chim 81,25%, cc DNNN c 42 DN

26

chim 18,75% tng s cc c ssx c di 25 SDK. Cc DN c t 5 SDK tr

xung chim t l cao nht, chim 61,61% v 84,75% trong s ny l cc
DNPNN. c bit c 55 c s ch c 1 SDK chim 18,84% tng s cc
c s s x trong nc. Nhng con s ny phn nh r nng lc s x ca cc
DNPNN, ngoi mt s c s c nng lc s x ln (phn ln l cc DN c
c phn ho t cc DNNN v cc DN lin doanh vi nc ngoi) cn li
phn ln l cc s s c quy m s x nh, mt hng thng l cc dng bo
ch n gin, phn nhiu l cc sn phm ng dc.Tnh n ht nm
2002 trong s 162 c s s x nh, t hp s x thuc, nh thuc th ch c 9 c s
c my mc s x loi trung bnh nh my dp vin (3 c s), my ng nang
(4 c s) v ni bao ng (2 c s). Hn na nhng my mc ny cng ch
l my mua li qua s dng, khng phi l my mi. Nh vy nng lc
s x ca cc c s s x nh cn rt hn ch, ch c th s x c nhng dng bo
ch n gin. Cc c s s x nh trong nc s lng nhiu nhng manh mn,
kh khn cho vic pht trin mt cch c h thng. Nhng DN nh c u
th l c tnh nng ng cao, d c nhng thay i thch ng vi c ch
th trng, nhng do thiu vn, nhn lc, cng ngh nn trong nhng nm
ti nu khng c s h tr ca nh nc th kh c th c c mt bc
pht trin nhy vt cho nhm ny.
3.3.3. C cu ca cc cssx c t 25 n 99 SDK:
C khong 15% trong tng s cc cssx thuc trong nc c t 25 n
99 SDK, y l nhng DN c n cha nhiu tim nng pht trin.
Bng 3.6: c CU CA CC c s s x C T25 N 99SDK
S lng Tng s cssx
SDK
S lng T l so

DNNN
S lng

tng %
25-49
50-74
75-99

24
12
8

Tng

44

54,55
27,27
18,18

T l so

DNPNN
S lng

T l so
tng %

9
5
2

37,50
41,76
25,00

tng %

15
7
6
28

27

62,50
58,33
75,00

16

Nhn xt: Trong nhm cc c s s x c t 25 n 99 SDK cc DNNN

chim t l cao hn (28 DN hay 63,64%) v cc DNPNN chim t hn (16
DN hay 33,33%) . Hu ht cc DNNN trong nhm ny l cc cng ty,
XNDP tnh, thnh ph hay trc thuc cc b, ngnh. Cc DNPNN trong
nhm ny thng l cc cng ty lin doanh vi nc ngoi, cng ty c
phn, cng ty TNHH. y l nhm tim n nhiu kh nng pht trin, nh
nc cn c nhng h tr v c nhng chnh sch u i nht nh gip
cc c s m rng v pht trin, nng cao nng lc sx dc phm. Mt s
DN thuc nhm ny nu c pht trin ng hng s c nhng bc
nhy vt v gia nhp nhm cc DN ln sx dc phm VN.
3.3.4.C cu ca cc cssx c t 100 SDK tr ln:
Cc c s s x c t 100 SDK tr ln khng nhiu nhng c vai tr quan
trng, sng cn, chi phi c lnh vc sx dc phm trong nc.
Bng 3.7: c CU CA CC cssx C T 100SDK TR LN
S lng
SDK
100-149
150-199
>=200
Tng

Tng s cssx
S
T l so
lng
tng %
15
62,50
7
29,17
2
8,33
24

DNNN
S
T l so
lng
tng %
11
73,33
6
85,71
2
100
19

DNPNN
S
T l so
lng
tng %
4
26,67
1
14,29
0
0
5

79.17%

Hnh 3.6: c CU CC cssx C T 100SDK TR

28

LN

Nhn xt: C 24 c s s x c t 100 SDK tr ln, chim 8,22% trong tng

s c s s x dc phm. Cc c s ny ch yu l cc DNNN, l cc DN c
quy m ln, chim t trng cao v s thuc ng k v s lng thuc cung
ng cho th trng, ch ring 24 c s ny c 4311 SDK lu hnh chim
47,41% tng s thuc c cp SDK, nh vy nng lc s x trong nc
ang tp trung ch yu cc DNNN. C 5 DNNQD c t 100 SDK tr ln,
trong c 2 c s l DNNN c phn ho. Trong s 24 DN ny c 18 DN
c my mc, nh xng, thit b t tiu chun GMP.

Danh sch cc c s s x c t 100 SDK tr ln:

- X nghip lin hp dc Hu Giang
-XNDPTW5

- Cng ty D &TTBYT Bnh nh

- CT CPDP Dc Liu Mekng
-XNDPTW2
-XNDPTW25
- CT pht trin k ngh dc TW
- CTDP H Ty
-XNDPTW1
- XNDP & sinh hc y t thnh ph HCM
- CT dc liu TW1
- XNDPTW 24
- CT CPDP Nam H
- CT xut nhp khu y t ng Thp
- CT CPDP dc liu Pharmadic
- XNDPTW 26
- CT CPDP & TBYT giao thng vn ti Traphaco
- CT D &VTYT Tr Vinh
-C TD & V TY T Cu Long
- XNDP H Ni

29

- XNDPTW 7
-CTCPDPHTy
-C ID PTW H ue
- XNDP 150 B quc phng
3.4.HOT NG SN XUT CA CC DOANH NGHIP TRC
THUC TNG CNG TY Dc VIT NAM:
Tng cng ty Dc VN c thnh lp theo quyt nh s 90/TTG ca
th tng chnh ph trn c s chuyn t lin hip cc x nghip VN. K t
khi c thnh lp cc DN trc thuc tng cng ty lun t mc tng
trng

sx, kinh

doanh trn cao, ring

khi sx

nm

2002 c mc

tng

trng t trn 18%. Cc n v thnh vin ca tng cng ty c tng

cng u t mt cch c h thng, quy c v hiu qu, chi ph u t cho
cc d n xy dng c s vt cht nm 2002 c trnh by bng di
y:
Bng 3.8: CHI PH U TXY DNG c
TT n v

s VT CHT CA TN G CNG TY NM 2002

D n

Tng vn
(t ng)

Tng CT Dc VN

Phng th nghim trng im GLP

6,76

XNDPTW25

dy truyn thuc tim t GMP

12,6

XNDPTW1

Nh my bo ch t GMP

324

XNDPTW5

Nh my bo ch t GMP

38,8

XNDPTW2

dy truyn thuc vin betalactam t 12

GMP

CT pht trin k dy truyn thuc tim t GMP

10

ngh Dc TW
7

Cng ty Dc TW Dy truyn thuc vin non-betalactam 6

Hu

t GMP

Cng ty Dc Phm Dy truyn thuc vin, thuc bt tim 4,95

TW3

t GMP

30

u t ng hng v hiu qu, tnh n ht nm 2002 c 10 DN

trc thuc tng cng ty xy dng v a vo sx thnh cng cc dy truyn
hay nh my t tiu chun GMP, th hin bng 3.9.
Bng 3.9: CC c s s x T TIU CHUN GMP CA CNG TY DC VN
TT

n v

XNDPTW1

Dy truyn, nh my t tiu chun GMP, GLP

Dy truyn thuc bt tim betalactam
Dy truyn thuc vin betalactam
Dy truyn thuc vin non_betalactam

XNDPTW24

Dy truyn thuc sx dch truyn

Dy truyn thuc vin betalactam

XNDPTW25

Dy truyn thuc vin betalactam

Dy truyn thuc vin non-betalactam

XNDPTW26

Nh my t tiu chun GMP

Phng kim tra cht lng t tiu chun GLP

CT Dc Liu TW1

CTDPTW Hu

Dy truyn thuc m, thuc nc

CT pht trin k
ngh Dc TW

Dy truyn thuc vin betalactam

Dy truyn thuc vin non-betalactam
Phng th nghim t GLP

XNDPTW5

CTCP Imexpharm

10

CT lin doanh
Sanofi Synthelabo
VN

Dy truyn sx thuc vin chng st rt

Nh my t tiu chun GMP

Phng th nghim t tiu chun GLP
Dy truyn thuc vin non-betalactam
Dy truyn thuc vin betalactam
Phng th nghim t GLP
Nh my t tiu chun GMP:
- Dy truyn thuc vin betalactam
- Dy truyn thuc vin non-betalactam
- Dy truyn thuc tim, thuc nc
- Phng th nghim t GLP

31

c u t v h tr v nhiu mt cc n v thnh vin c nhiu n v

pht trin sx , kinh doanh c hiu qu.
Bng 3.10: 5 DN TRC THUC TNG CNG TY C DOANH THU CAO NHT NM 2002
TT

n v

CTCPDP Mekophar

Doanh thu (t
ng)(2002)
261,09

Tc tng trng
(%) so VI 2001
27,8

195,79

22,2

c r lin doanh Sanofi

Synthelabo VN
CTCPDP Imexpharm

158,18

40,7

XNDPTW1

126,68

16,2

CT pht trin k ngh Dc

TW

126,24

19,8

Cng ty CP DP Imexpharm khai thc tt c s vt cht c u t,

y mnh hp tc s x nhng quyn vi cc cng ty dc uy tn quc t,
tip tc xp xp v i mi qun l, tng nhanh lng hng sx . Nm 2002
CTCPDP Imexpharm dn u v tng trng s x v kinh doanh ca ton
tng cng ty, doanh thu s x t 158,18 t, tc tng trng t 40,7%.
Cc DN trc thuc tng cng ty a nhiu dy truyn s x cc dng
bo ch mi, hin i vo hot ng:
- Dy truyn chit xut dc liu theo cng ngh mi ca XNDPTW26
- Dy truyn vin si bt ca XNDPTW26
- Cng ngh sx vin nang mm p khun ca XNDPTW26
- Dy truyn

sx thuc mt, gel bi ngoi da ca XNDPTW Hu

- Dy truyn

sx vi nang ca XNDPTW1, XNDPTW7

Tng doanh thu khi s x ca tng cng ty tng u qua cc nm.

32

Bng3.11

-.TNG d o a n h t h u k h i s x c a t n g c n g t y q u a c c n m

nm

doanh thu (t ng)

Tng lin hon %

tng so vi nm
97(%)

1997

556

100

100

1998

675

121,40

121,40

1999

716

106,07

128,78

2000

811

113,27

145,86

2001

1101,4

135,81

198,09

2002

1343,2

121,95

241,58

Hnh 3.7 : DOANH THU KHI s x CA TNG CNG TY QUA CC NM

Nhn xt: tng doanh thu khi s x ca cc DN trc truc tng cng ty
Dc VN tng mnh qua cc nm, nm 97 tng doanh thu khi s x l 556 t
ng tng ln 1343.2 t ng nm 2002. Khi s x ca cng ty gp mt
phn ng k vo pht trin sx , kinh doanh ca cng ty ni ring v pht
trin s x trong nc ni chung.Bn cnh nhng thnh cng t c, vn
cn nhng tn ti cn khc phc:

33

- Tnh trng chm u t, i mi cng ngh ca mt s doanh nghip pha

Bc cha c khc phc, v d nh XN Ho Dc, XNDPTW2... cn phi
c bin php ch ng ca doanh nghip v s h tr trc tip ca tng
cng ty thc y trin khai khn trng cng tc u t
- Mt s n v cha quan tm ng mc cng tc nghin cu khoa hc,
pht trin mt hng mi, i mi c cu sn phm ph hp vi yu cu iu
tr v th hiu khch hng.

3.5. KHO ST, NH GI NNG Lc SN XUT THNG QUA

DANH MC THUC CA 10 cssx C NHIU SDK NHT:
Bng 3.12: DANH MC THUC V DNG BO CH CA 10cssx C NHIU SDK NHT
c ssx

XNDP TW5

CT D&
TBYT Bnh
nh

SL

T l

SL

T l

SL

T l

SL

T l

SL

T l

Vin nang

43

18,61

20

9,30

29

16,57

48

28,24

25

15,34

Vin bao phim

23

9,96

23

10,70

16

9,14

35

20,59

12

7,36

Vin bao ng

18

7,79

14

6,51

10

5,71

15

8,82

4,29

Thuc tim

0,87

16

7,44

50

28,57

30

18,41

Vin nn

61

26,41

50

23,26

25

14,29

47

27,65

51

31,13

Vin si

2,60

0,57

Vin bao tan

trong rut
Thuc n,t

1,3

1,86

1,84

0,61

Thuc xt

0,47

0,57

Vin ngm

1,73

1,40

1,14

0,59

1,23

Dng khc

71

30,74

84

39,07

41

23,43

24

14,12

31

19,02

Tng

231

100

215

100

175

100

170

100

163

100

dng BC

34

CTCPDP
dc liu
Mekong

XNDPTW
25

XN lin hp
dc Hu
Giang

c ssx
dng BC

Vin nang
Vin bao phim
Vin bao ng
Thuc tim
Vin nn
Vin si
Vin bao tan
trong rut
Thuc n,t
Thuc xt
Vin ngm
Dng khc
Tng

XNDPTW25

CT pht
trin
k ngh dc
TW

CTDP H
Ty

XNDPTW1

SL

T l

SL

T l

SL

T l

SL

T l

SL

27

16,77

32

19,88

35

22,88

21

14,00

22

27

16,77

17

10,56

11

7,19

13

8,67

14

12

7,45

3,11

1,31

3,33

4,35

24

14,91

10

6,54

51

34,00

23

14,29

44

27,33

42

27,45

44

29,33

55

1,24

2,00

1,24

10

0,62

3,27

0,67

1,24

1,24

2,61

0,67

60

37,27

35

21,74

53

34,64

11

7,33

39

161

100

161

100

153

100

150

100

46

CT Dc liu
TW1

Danh mc thuc v dng bo ch ca 10 c ssx c nhiu SDK nht rt a

dng v y , ring 10 c s ny c 1725 SDK chim 24% tng s
thuc c cp SDK lu hnh. y chnh l nhng DN cung cp mt s
lng ln thuc cho th trng trong nc nn DM thuc sx ca cc DN
ny khng nhng phi ph hp vi m hnh bnh tt ca VN m cn phi
ph hp vi kh nng chi tr ca i a s ngi dn. Do , cc dng bo
ch c sx chim t l ln l nhng dng thuc n gin n trung bnh

35

T l
15,07
9,59
2,05
0
37,67
0,69
1,37
6,85
0
0
26,71
100

kh nh vin nn, vin nang, vin bao phim, vin bao ng, thuc tim vi
gi thnh s x r c th sx vi s lng ln. Cc DN ln u c DM thuc
a dng v mt bo ch, nhng mi DM cng c nhng th mnh ring, v
d nh cng ty D & TTBYT Bnh nh, XNDPTW1 mnh v thuc tim,
CTCPDP Dc liu Mekong v XNLHD Hu Giang mnh v vin nang
mm...
Nhiu dng bo ch mi, tin tin cng c cc DN nghin cu v a
ra th trng nh: thuc bt tim ng kh ca cng ty D & TTBYT Bnh
nh, vin nang vi ht ca XNDPTW1, vin bao tan trong rut ca XNLHD
Hu Giang, XNDPTW5...Tuy nhin nghin cu v

sx cc

dng bo ch

mi cng c th gp nhng ri ro tht bi v khng thu hi c vn u t

khng l cho my mc, thit b, cng ngh

sx, nn

c nhng DN ln

khng chn cch ny. V d CTCPDP Dc liu Mkng hu nh ch tp

trung

sx bn dng bo ch chnh l: vin nang, vin nn, vin bao phim,

vin bao ng, ring bn dng ny c 145 SDK chim 85% s lng
thuc c cp SDK ca cng ty, v cng ty khng u t nhiu cho nghin
cu, sx cc dng bo ch mi, k thut sx hin i.
Trong s 10 c s s x c nhiu SDK nht c 8 c s t tiu chun
GMP. y l nhng DN ng vai tr quan trng i vi

sx dc phm

trong nc, v cng l nhng DN i tin phong trong nghin cu, s x cc

dng thuc mi. Vi DM thuc y v s lng, a dng v hot cht v
phong ph v dng bo ch, nhng c s sx dc phm ln trong nc c
vai tr quan trng gip n nh v iu tit th trng thuc trong nc.

36

3.6.MT S DNG BO CH MI, HIN I, CNG NGH CAO

sx C TRONG NC:
Bng 3.13: s

LNG THUC NG K MI CA CC DNG BO CH MI QUA CC NM

Nm
2002

1997

1998

1999

2000

2001

Thuc tim truyn

84

68

71

91

45

52

Vin bao tan trong rut

19

10

Vin si

22

29

Thuc xt

Vin nang vi ht

Vin tc dng ko di

0
2

Bt tim ng kh

Thuc n, t

Tng

90

86

88

121

97

S lng

Hnh 3.8 : s

LNG CC DNG BO CH MI QUA CC NM

37

100

Tnh n ht 31/12/2002 c 412 SDK thuc tim truyn, nhng c nhiu s

trng lp v hot cht gia cc c s sx, hot cht s dng sx thuc
tim truyn ch yu l khng sinh, nc ct pha tim, thuc gim au,

vitamin...V c cu ca cc c s s x thuc tim truyn th c nc c khong

30 c s, trong c 20 DN nh nc chim 66,67% v 10 DN phi nh
nc chim 33,33%. Sn xut thuc tim i hi phi c h thng thit b,
my mc, nh xng c u t t cc tiu chun cho nh my sn xut
thuc tim m bo tnh v khun cho sn phm, T nm 2003 c th
cc c ssx c php tip tc s x thuc tim truyn s gim xung v BYT
c quyt nh n cui 2002 cc c ssx khng t tiu chun GMP s
khng c tip tc sx thuc tim truyn.

Vin nn si sx trong nc c s lng ng k tng mnh v u qua

cc nm. Mt trong nhng

cssx

c nhiu SDK dng vin nn si l

CTCPDP Nam H, c 15/70 SDK chim 21,43%, ngoi ra cng ngh s x

vin si bt ca XNDPTW26 t tiu chun ngang hng vi cc hng
ni ting trn th gii. Hot cht thng c s dng l Paracetamol,
vitamin c v mt s hot cht khc.
Cc dng bo ch hin i, nh vin nang vi ht, vin tc dng ko di,
bt tim ng kh ch mi xut hin v cn ang dng mc th nghim,
thm d cha c pht trin mnh. Cc DN tham gia s x nhng dng bo
ch ny u l nhng DN ln trong nc v DN lin doanh vi nc ngoi.
y ch l nhng dng bo ch c k thut sn xut mc tmg bnh tin
tin so vi th gii, cn nhng dng bo ch c cng ngh cao nh cc dng
thuc gii phng nh gi, cc dng thuc tc dng ti ch ... hay cc dng
thuc i hi chnh xc cao nh cc thuc c cha hot cht l cc
hormon, cc cht c...dng tim th trong nc cha sn xut c.

38

3.7. NGUYN LIU LM THUC s x

c TI VN:

Bng 3.14: CC NGUYN LIU LM THUC c CP SDK Lu HNH

TT

Tn nguyn liu

cssx

TCCL

Tui th
(thng)

Magnesi lactat

XN Ho Dc

TC

36

Magnesi

XN Ho Dc

DVN

60

Magnesi sulfat

XN Ho Dc

DVN

36

Magnesi trisilicat

XN Ho Dc

D VN

60

Calci Carbonat

XN Ho Dc

D VN

60

Magnesi Carbonat base

XN Ho Dc

TC

60

Calci Hydro Phosphat

XN Ho Dc

TC

36

Nang gelatin rng s 0 CT D&VTYT Cu Long

TC

36

Nang gelatin rng s 1 CT D&VTYT Cu Long

TC

36

10 Nang gelatin rng s 2 CT D&VTYT Cu Long

TC

36

11 Nang gelatin rng s 3 CT D&VTYT Cu Long

TC

36

12 Nang gelatin rng s 4 CTD&VTYT Cu Long

13
Chitosan
CT Dc Liu TW1

TC

36

TCN

36

14

Chitosan

XNDPTW26

TC

60

15

Dilutap

XNDPTW5

TC

60

16

Calci Clorid

XN Ho Dc

TC

36

17

Morphin hydroclorid

XN Ho Dc

D VN

36

18

Nacortin

XN Ho Dc

D VN

36

19

Berberin hydroclorid

XN Ho Dc

DVN

60

20

Calci Bromid

XN Ho Dc

TC

24

21

Diethyl phtalat

XN Ho Dc

DVN

36

22

Kali Clorid

XN Ho Dc

DVN

36

23

Natri Clorid

XN Ho Dc

DVN

60

24

Methyl Salicylat

XN Ho Dc

DVN

36

25

Phtalin Sulfathiazon

XN Ho Dc

DVN

60

39

26

st(2) Oxalat

XN Ho Dc

TC

60

27

Terpin hydrat

XN Ho Dc

DVN

48

28

Natri hydro Carbonat

XN Ho Dc

DVN

36

29

Pluriamin

Vin cng ngh sinh hc

TC

24

30

Artesunat (tim)

TT KHCN-H Dc

DVN

36

DVN

36

HN
31

Artesunat

TT KHCN-H Dc
HN

32

Artesunat

CT TNHH Sao Kim

TCN

36

33

Artesunat

CT Dc Liu TW1

TCN

36

34

Artemisinin

CT Dc Liu TW1

TCN

36

35

Diethyl phtalat

CT Dc Liu TW1

DVN

24

36

Ethnol 96

XNDPTW26

DVN

48

37

Terpin hydrat

XNDPTW24

DVN

36

38

Alpha Terpineol

XNDPTW2

TC

36

39

Eucaliptol

XNDPTW2

DVN

36

40

menthol crystal

XNDPTW2

DVN

24

41

Rotundin sulphat

Hc vin qun y

TC

24

42

Rotundin

XNDPTW2

DTQ

36

43

Rutin

XNDPTW2

DVN

36

44

Ampicillin trihydrat

LD Wopyung-

TC

36

TC

36

TC

36

TC

36

Mekophar
45

Ampicillin trihydrat

LD WopyungMekophar

46

Amoxicillin trihydrat

LD WopyungMekophar

47

Amoxicillin trihydrat

LD WopyungMekophar

40

Trong s 47 SDK l nguyn liu th c 15 SDK l t dc chim

31,91% v 32 SDK l hot cht thuc chim 68,09%. Do c s trng lp
nn c 32 SDK nguyn liu l hot cht thuc nhng trn thc t ch c 24
hot cht c

sx trong nc, cc nguyn liu l hot cht thuc sx

c trong nc gm:
- Calci clorid

- Nacortin

- Morphin hydroclorid

-Calci bromid

- Berberin hydroclorid

- Kali clorid

- Diethylphtalat

- Natri clorid

- Methyl salicylat

- St phtalat

- Phtalin sulphathiazon

- Terpin hydrat

- Natrihydro carbonat

- Artesunat

- Artemisinin

- Ethanol

- Pluriamin

- Eucalyptol

- Alpha terpineol

- Rotundin

- Melthol

- Ampicilli trihydrat

- Rutin

- Amoxicillin trihydrat

Nh vy cc

cssx

trong nc mi ch s x c 24/384 hot cht

ang s dng trong nc, chim 6,25%, cn 360 hot cht chim
93,75% tng s hot cht ang s dng
nhp khu. Ngun nguyn liu dng

sx thuc trong nc vn phi

sx thuc trong nc phi ph thuc

qu nhiu vo nhp khu chnh l mt nguyn nhn quan trng dn ti hin

tng gi thuc khng n nh thi gian gn y.
B ng 3 .1 5 : c CU CA CC cssx THAM GIA VO s x NGUYN LIU LM THUC

Tng
n v

DNNN

SL

DNPNN

SL T l % SL T l %

Vin nghin cu
SL

T l %

t l%

cssx

13

SDK nguyn liu

47

100
100

61,15

18,53

23,08

38

80,85

10,64

8,51

41

Cc DNNN ng vai tr ch yu trong s x nguyn liu lm thuc, chim

61,15% s c s s x nguyn liu v c 38 SDK tng ng vi 80,85% .
Tui th ca nguyn liu lm thuc s x trong nc u t 24 thng tr
ln, c 12 SDK c tui th t 48 thng tr ln chim 12,77%. Hu ht cc
nguyn liu u c s dng s x thuc trong nc nn tui th ca cc
nguyn liu u mc an ton tuy c hi thp. Ring i vi cc nguyn
liu s x c tham gia xut khu nh Artesunat, Amoxicillin, Ampicillin c
tui th 36 thng l cn thp v l mt tr ngi cho xut khu nguyn liu,
c bit l xut khu sang cc th trng kh tnh nh th trng Chu u.
+ Hu ht cc nguyn liu u c s x theo phng php chit, tch
hot cht t cc ngun nguyn liu c sn trong nc, v d:
- Rutin chit t hoa ho.
- Rotundin chit t c bnh vi.
- Artemisinin, Artesunat chit t thanh hao hoa vng.
- Pluriamin chit t nhng tm.
- Berberin chit t Hong ng.
- Morphin chit t cy thuc phin.
- Menthol chit t cy Bc H.
- Terpineol, Eukalyptol chit t mt s cy thuc h Eukalyptus.
+ Ch c mt s t hot cht c s x theo cng ngh ho dc hay vi sinh
nh: DEP, Ampicillin, Amoxicillin, Phtalin sulphathiazon...SX thuc theo
cng ngh ho dc hoc vi sinh i hi u t vn, my mc, cng ngh
rt ln v s hp tc ca nhiu ngnh nn hin nay cc c s s x trong nc

vn cha c kh nng thc hin.

Mc d trong mc tiu c th n nm 2010 ra l :"Xy dng cc

c s s x khng sinh v ho dc, s x cc nguyn liu lm thuc c th mnh

c bit l t dc liu" nhng cn thy rng, vic u t cho mt nh my
mi s x nguyn liu t tiu chun GMP cng i hi yu cu khng t tn

42

km so vi nh my sx thnh phm. Trong khi ngun ti chnh u t cho

sx trong nc cha tht di do th phn ln cc nh my sx VN hin

nay vn c th thc hin vic nng cp tng dy truyn n l hin c. V
vy, vic xy dng cc nh my sx nguyn liu lm thuc l cn thit
nhng mc u tin phi t sau vic cng c v hon thin cc nh my

sx thnh phm t tiu chun GMP.

3.8.TUI TH CA THUC s x TRONG NC:
Tui th ca thuc c quyt nh bi cc yu t: ngun nguyn liu,
trnh my mc, cng ngh, quy trnh SX...V vy tui th ca thuc sx
trong nc gin tip phn nh mt phn nng lc sx trong nc.
Bng 3.16: TUI TH CA CC THUC sx TRONG NC
TT
1
2
3

Tui th (thng)
4
5
6

S lng

T l

3
8

0,04
0,11
0,75

4
5
6
7

9
10
12
14

54
18
2
721
2

15

0,25
0,03
10,02
0,03
0,06

16

10
11
12
13
14
16

18
20
24
26
30

2
768
13
4721
2
38

0,03
10,68
0,18
65,62
0,03
0,53

36

708

9,84

17

48

48

0,67

18

60

48

0,67

19

Tng

7194

100

43

& Tui th 12 thng

ft;Tui th 18 thng

Tui th 36 thng

Tui th 48 v 60 thng ETui th khc

Tui th 24 thng

H n h 3 .9 : TUI TH CA CC THUC s x TRONG NC

Nhn xt: Tui th ca cc thuc s x trong nc tng i ngn, nhng

thuc c hn dng di 36 thng chim 98,66%, ch yu l 24 thng
(chim 65,62%), v sau l 18 thng, 12 thng v 36 thng ( u chim
khong 10%), vn cn nhng thuc c tui th 4, 5, 6, 9 hay 10 thng. Ch

c 96 SDK c tui th 48 v 60 thng, chim 1,34%.

Bng 3.17 : c

CU CC c s s x C THUC C TUI TH 48 V 60 THNG

TT

Tng

DNNN

DNPNN

SL

T l %

SL

T l %

SL

T l %

S lng cssx

26

100

14

53,85

12

46,15

S lng SDK

96

100

51

53,13

45

46,87

T l cc DNNN v DNPNN c thuc c tui th 48 v 60 thng chnh

lch nhau khng nhiu: DNNN chim 53,85% v DNPNN chim 46,15%.
S lng SDK c tui th 48 v 60 thng ca cc DN ny cng tng
ng nh vy. iu ng ni y l trong s s 14 DNPNN th c 9 DN
lin doanh vi nc ngoi v 3 DN c phn ho t DN nh nc v 2 CT

TNHH, khng c cc cssx nh, cc cssx thuc ng dc. Trong s 26

DN ny c 20 DN t tiu chun GMP, nh vy, c th khng nh rng

sx thuc theo tiu chun GMP l phng php tt nht loi tr cc tc

nhn nh hng n cht lng thuc, ko di tui th ca thuc.

44

Cc thuc

sx trong nc c tui th di chim khng nhiu, ch yu

vn l nhng thuc c tui th ngn. Nguyn nhn l do ngun nguyn liu

nhp khu rt kh kim sot cht ch, my mc thit b
cn lc hu, quy trnh

sx ca nhiu cssx

sx cn nhiu khu khng hp l lm gim tui th

ca thuc v phng php lo ho cp tc thng c s dng trong nc

xc nh tui th ca thuc ch c chnh xc tng i.

2.10.TIU CHUN CHT LNG CA CC THUC SN XT

TRONG NC:
Bng 3.18: PHN LOI CP TIU CHUN CA THUC s x TRONG NC
TT
TCCL
S lng
T l %
1

DVN

734

10,20

BP

24

0,34

SP

0,10

DTQ

0,04

TCN

101

1,40

TC

6325

87,92

Tng

7194

100

87.22%

1.27% J 39%

TClDVNBTCNQTCkhc
Hnh 3.10: TIU CHUN CHT LNG CA THUC s x TRONG NC

45

Nhn xt: Tiu chun cht lng l cn c da vo nh gi cht

lng thuc. Nu s lng cc hot cht v cc dng bo ch th hin quy

m v chiu di v chiu rng ca c s s x th cht lng thuc phn nh quy

m v chiu su ca c s s x . Mc d c DVN v mi y l DVNIII
lm quy chun thng nht v cht lng cho cc thuc s x trong nc
nhng ch c 10,06% thuc Sx trong nc t theo tiu chun DVN v c
87,92% l cc thuc s x theo tiu chun c s. i vi cc nh s x dc
phm nc ngoi, do c h thng kim tra cht lng mang tiu chun quc
t, ng b v thng nht trn ton th gii nn cc ch tiu c quy nh
trong tiu chun cht lng sn phm ca cc nh s x Dc phm nc
ngoi nhiu khi cn cht ch hn cc tiu chun quy nh trong dc in.
i vi cc c s s x trong nc, ngoi 15 c s c phng kim tra cht lng

t tiu chun GLP v 31 c ssx t tiu chun GMP , s cc c s cn li

hu ht l c my mc thit b cn lc hu, h thng cc phng kim tra
cht lng thuc cn thiu v yu nn phn ln cc c s s x trong nc
thng quy nh cc ch tiu trong tiu chun cht lng sn phm thp hn
DVN. Nhiu c s s x cha c phng kim tra cht lng thuc kh nng
kim tra ht cc ch tiu ng k vi BYT. H thng my mc, nh
xng c, khng m bo v quy trnh s x cn nhiu giai on khng hp
l l nhng nguyn nhn chnh lm gim cht lng thuc s x trong nc.
Trn thc t VN vn b coi l mt trong nhng th trng c cht lng
thuc cha cao, uy tn v cht lng thuc ca VN trong khu vc cn hn
ch v ang khin chng ta gp khng t kh khn khi thm nhp th
trng khu vc, mc d nhiu

cssx t chng ch GMP ASEAN.

Do

, gip thuc mang thng hiu VN thm nhp tt vo cc khi th

trng bn ngoi cn phi lm tt vic xy dng v hon thin h thng
kim tra v m bo cht lng thuc t trung ng ti cc cssx thuc.

46

PHN 4
KT LUN V XUT
4.1.KT LUN:
Sau khi kho st,phn tch mt s ch tiu trong danh mc thuc c
cp s ng k nhm s b nh gi nng lc sn xut ca cc c s sn
xut trong nc, kt qu nghin cu cho thy:
4.1.1.Nng lc sn xut ca cc c s sn xut dc phm trong nc
tng qua cc nm th hin qua s gia tng v s lng thuc c cp s
ng k lu hnh, tuy nhin u t cho nghin cu v pht trin sn phm
mi cn yu, t l trng lp gia cc hot cht thuc cn cao.
4.1.2.Nng lc sn xut ca cc c s sn xut thuc trong nc cn
thp, tp trung ch yu cc dng bo ch c k thut sn xut t n gin
n trung bnh. Cc dng bo ch trung bnh nh vin nn, thuc m, kem,
g e l, dng cm, bt thuc c xu hng n nh qua cc nm, cc dng bo
ch c k thut sn xut trung bnh tin tin c xu hng tng nh, thuc
tim truyn v dng bo ch n gin nh vin bao ng, thuc nc, vin
hon... c s lng s ng k mi gim nh. sn xut c cc dng
bo ch hin i, i hi cng ngh cao, s lng tng mnh nm 2001 v
2002 nhng t l vn cn thp so vi tng s lng thuc ng k.
4.1.3.Nhm cc c s sn xut nh, c t s ng k, nng lc sn xut
yu nh cc c s sn xut c nhn, t hp sn xut ng nam dc...vn
chim t l ch yu trong s cc c s sn xut dc phm Vit Nam, cc
c s c di 25 s ng k chim 76,71 % trong tng s cc c s sn xut
dc phm trong nc. Nng lc sn xut trong nc tp trung ch yu
nhm cc doanh nghip ln do sn phm ca cc c s ny c sn xut
vi s lng ln, hu nh chim lnh th trng ton quc. Nhng cc
doanh nghip ln cn chim t trng nh, cc c s sn xut c t 100 s

47

ng k tr ln chim 8,22% trong tng s cc c s sn xut dc phm

trong nc. Trong cc doanh nghip c nhiu s ng k th cc doanh
nghip nh nc chim t l cao v ngc li, nh vy hin nay nng lc
sn xut trong nc vn tp trung ch yu cc doanh nghip nh nc.
4.1.4. Nng lc sn xut ca 10 doanh nghip c nhiu s ng k nht
tp trung ch yu cc dng bo ch c k thut sn xut t n gin n
trung bnh tin tin, c bit cc dng bo ch trung bnh kh nh vin
nang, vin bao phim, thuc tim c t l cao hn hn so vi t l chung ca
cc c s sn xut trong nc v dng . Cc doanh nghip ny cng l
nhng doanh nghip i tin phong trong nghin cu v sn xut cc dng
bo ch mi, c k thut sn xut cao, v c cht lng tt.
4.1.5.Cc doanh nghip trc thuc tng cng ty dc Vit Nam c
u t c h thng cho my mc, thit b, nh xng...n ht 2002
c 10 doanh nghip trc thuc tng cng ty c nh my hay dy truyn sn
xut t tiu chun GMP, c nhiu dy truyn sn xut cc dng bo ch
mi c a vo sn xut. Tc tng trng ca khi sn xut trc
thuc tng cng ty lun t trn 15%, c bit nm 2002 t 18%.Tng
doanh thu khi sn xut ca tng cng ty tng u qua cc nm.
4.1.6.Cc c s sn xut dc phm trong nc c kh nng nghin
cu v sn xut nhiu dng bo ch mi, hin i, cng ngh cao nh: vin
bao tan trong rut, vin nang vi ht, bt tim ng kh, vin si bt, vin
tc dng chm...Tuy nhin, cc dng bo ch mi vn cha dc pht trin
mnh, mi dng mc thm d v gii thiu. C nng lc sn xut
nhng dng bo ch mi ny ch yu l cc doanh nghip ln trong nc v
cc doanh nghip lin doanh vi nc ngoi.
4.1.7.

Nng lc sn xut nguyn liu dng sn xut thuc trong nc

cn yu, s lng nguyn liu sn xut c cn t (ch sn xut c

24/384 hot cht thuc ang s dng sn xut trong nc, chim 6,57%).

48

Ch yu vn l cc nguyn liu sn xut bng phng php chit, tch hot

cht t cc ngun dc liu sn c trong nc, hu nh cha xy dng c
cc dy truyn sn xut nguyn liu lm thuc bng phng php ho hc
hay vi sinh cc. Cc c s tham gia sn xut nguyn liu gm: cc doanh
nghip ln, c nng lc sn xut cao, v cc vin nghin cu, trng i
hc.
4.1.8.Tui th ca cc thuc sn xut trong nc cn tng i ngn,
ch yu l 24 thng, chim 65,62% sau l 12, 18, 36 thng u chim
khong 10%, vn cn cc thuc c tui th di 12 thng.

4.1.9.Cht lng thuc sn xut trong nc hin nay cha cao: thuc sn
xut cn c theo tiu chun c s chim khong 88%, cc thuc sn xut
theo dc in Vit Nam chim khong 10% tng s thuc ng k. Vn
cn nhiu yu t v nguyn liu, my mc, nh xng, nhn lc... lm gim
cht lng thuc sn xut trong nc.

4.2. XUT:
Cng nghip sn xut dc phm trong nc ang c nhng bc i ng
hng v ang c nhng bc pht trin mnh m, gp phn nng cao
hiu qu v thc y sn xut dc phm trong nc pht trin tt hn cn
phi lm tt hn mt s vic sau:
- Nh nc cn c chnh sch khuyn khch pht trin ngnh sn xut dc
phm trong nc, h tr v vn v khoa hc k thut, y mnh xy dng
cc c s sn xut t tiu chun GMP v cc phng kim tra cht lng
t tiu chun GLP, nng cao cht lng thuc sn xut trong nc.
- Khuyn khch cc doanh nghip ln sn xut thuc trong nc, tng
cng u t cho nhng c s sn xut c quy m va to iu kin cho
nhng doanh nghip ny ra nhp nhm cc c s sn xut c quy m ln.
Qun l cht ch cc c s sn xut nh sn xut thuc bng cch t ra

49

cc yu cu cn thit v my mc, nh xng, nhn lc, h thng m bo

cht lng thuc...
- Tng cng xy dng cc phng kim nghim t tiu chun ISO, GLP
quc t lm cng tc dch v, kim tra cht lng thuc cho nhng c s
sn xut cha c phng kim tra cht lng t tiu chun theo quy nh.
- Tng cng u t, xy dng mi cc nh my sn xut nguyn liu lm

thuc, xy dng cc dy truyn sn xut nguyn liu bng phng php ho

dc v vi sinh, pht trin v hon thin cc c s sn xut chit xut dc
liu lm nguyn liu sn xut thuc. Phn u m bo c v nguyn
liu cho sn xut trong nc v c s lng v cht lng, hn ch dn vic
nhp khu nguyn liu h thp chi ph sn xut.
- Cc c s sn xut cn u t nhiu hn cho qu nghin cu v pht trin
pht trin danh mc thuc c v chiu di v chiu su. Phn u trong
nhng nm ti nghin cu v sn xut thnh cng cc dng bo ch mi,
hin i, cng ngh cao c sinh kh dng cao, cht lng tt nh: thuc
tim hn dch, bt tim ng kh, xi r kh, dng kh dung, vin tc dng
ko di, h tr liu qua da...
- u t nng cp my mc, nh xng, xy dng cc quy trnh thao tc
chun (SOP) nng cao cht lng thuc, ko di tui th ca thuc.
ng thi hn ch cp s ng k cho nhng thuc c tui th ngn, c
bit l nhng thuc c tui th di 12 thng.
- Tng cng cng tc nghin cu khoa hc trong ngnh dc, tng cng
hp tc gia cc c s sn xut v cc vin nghin cu, cc trng i hc,
gn lin gia nghin cu vi sn xut,gp phn thc y ngnh cng nghip
sn xut thuc trong nc.

50

TI LIU THAM KHO

1.BYT-Cc Qun L Dc (2002), Bc i ca ngnh Dc Vit Nam

trong nhng nm i mi, NXB Y HC, pp: 29-34, 57-60, 93-100.
2.BYT-Cc Qun L Dc (2002), Danh mc cc thuc c cp SDK
lu hnh VN t 1996 n 2001, NXB Y HC, tp 1: Cc thuc s x trong
nc.
3.BYT-Cc Qun L Dc (2003), Danh mc b sung cc thuc c
cp SDK lu hnh Vit Nam n ht 2002, NXB Y HC, tp 1: Cc thuc
s x trong nc.
4.

BYT-Cc Qun L Dc (2001), Hi ngh tng kt cng tc Dc nm

2000, k hoch cng tc Dc nm 2001 v giai on 2001-2005, NXB Y

HC.
5.BYT-Cc Qun L Dc (2002), Hi ngh tng kt cng tc dc nm
2001, k hoch cng tc dc nm 2002 v d tho lut Dc Vit Nam,

NXBYHC.
6.BYT-

Cc Qun L Dc (2003), Hi ngh tng kt cng tc dc nm

2002, k hoch cng tc dc nm 2003 v d tho lut Dc Vit Nam,

NXB Y HC.
7.BYT (2002), Nin gim thng k y t nm 2001, NXB Y HC.
8.BYT- Cc Qun L Dc (2001), Qu ch ng k thuc s 312112001,

NXBYHC.

9.B mn

Qun

Kinh

T Dc (2002), Gio trnh

Php Ch Hnh Ngh Dc, trng i Hc Dc HN.

10. B mn Qun L v Kinh T Dc (2001), Gio trnh Kinh T Dc,
trng i Hc Dc HN.
11.B mn Qun L v Kinh T Dc (2002), Gio trnh Dc X Hi
Hc, trng i Hc Dc HN.
12.B mn cng nghip Dc (1999), Gio trnh K thut s x thuc,
HDHN.
13.B mn bo ch (2002), K thut bo ch v sinh dc hc cc dng
//mc,HDHN, tp 1.
14.B mn bo ch (2002), gio trnh K thut bo ch v sinh dc hc
cc dng thuc, HDHN, tp 2.
15.Nguyn Th Thi Hng (2002), Bi ging Quy ch ng k thuc, php
ch hnh ngh dc, B mn QLKTD, HDHN,pp:45-75.
l.Nguyn Th Thi Hng (2002), Bi ging Qu ch qun l cht lng
thuc, php ch hnh ngh dc, B mn QLKTD, HDHN, pp: 103-120.
17.Phm Th Vn Hnh (1995), S b phn tch nh gi c cu danh mc
thuc s x trong nc t 1989 n 1994, Lun vn tt nghip Dc s i hc,
trng HDHN.
18.L

Vit Hng (2001), Doanh nghip, lut doanh nghip, gio trnh kinh

t Dc, B mn QLKTD, HDHN, pp:34-57.

19.L Vit Hng (2002), Mt s vn lin quan trong qun l v nng cao
cht lng thuc, TCDH s 291.
20.Nguyn vn Long {2002),Chuyn GMP
21.Nguyn Xun Sn (2003), Mt s suy ngh v hng pht trin ca
ngnh Dc VN giai on 2002 - 2010, TCDH s 321, pp:3-6.

22.Nguyn Xun Son (2003), Mt s kin bn lun cng cc nh SXdc

phm Vit Nam trong giai on hi nhp, TCDH s 322, pp:9-12.
23.Nguyn Trng Thnh (2002), S b kho st nh gi tnh thch ng
ca DM thuc c cp SDK lu hnh vi m hnh bnh tt ca VN, lun
vn tt nghip Dc s i hc, trng HDHN, pp:3-7.
24.Tng cng ty Dc VN (2003), Bo co cng tc tng kt 2002, trin
khai k hoch 2003.
25.Tng cng ty Dc VN (2001), Tng kt hot ng SXKD t 1996 n
2000 .

26.L

Vn Truyn (2003), Nm bt thi c, vt qua thch thc, cng

nghip Dc VN phn u m bo 60% mc tiu dng thuc vo nm

2010, TCDH, s 4/2003, pp:5-9.

27.L Vn Truyn (2003), Mt s vn v sx thuc thit yu VN,

TCDH, s 323, pp: 2-5.
28.Nguyn Vn Yn (2002), Lun n th s Dc hc, pp:28-82.