BN DCH (KHNG CHNH THC)

TI LIU GACP-EU
V 3 CHUYN LUN
TRONG DC IN CHU U 8.0

Ngi dch:
Ngi dch
Mai Th Luyn
Nguyn M Chn
(Hiu nh)
Cc chuyn lun Dc in Chu u 8.0
Chuyn lun ng Quy (Angelica Nguyn M Chn
sinensis)
Chuyn lun thn r (c) Ngh
Phm Minh t
(Cucurma longae)
Chuyn lun L Bc H (Mentha
Nguyn Hi An
piperita)
Tn ti liu
GACP-EU

n v
Lp O1K66
Lp N2K66

Lp N2K66
Lp M2K67
Lp N1K66

Ti liu nm trong ti: Nghin cu mt s quy nh ca EU i vi vic

nhp khu dc liu, thc phm chc nng, thuc v nguyn liu lm thuc c
ngun gc dc liu trong ti khoa hc - cng ngh cp trng doTin s
Xun Thng v Thc s Mai Xun Bch thc hin.
Thuc n v:
B mn Qun l v Kinh t Dc
Trng i hc Dc H Ni

Ch :
Phn dch ny c thc hin nhm h tr cc doanh ngip trong vic tiu chun
ha ngun dc liu t tiu chun EU v phc v qu trnh nghin cu khoa
hc. Mc d nhm dch thut c gng ht sc c mt ti liu chnh xc, tuy
nhin do kinh nghim v iu kin ti chnh cn hn hp nn vn cn nhiu thiu
st. Chng ti khng chu trch nhim v mt php l v cc hu qu kinh t khi
cc c nhn, t chc s dng ti liu ny tham kho, trch dn...
Ngun s dng: Free
2

C quan Qun l Dc chu u

nh gi thuc s dng trn ngi

London, ngy 20 thng 2 nm 2006

Doc.ref. EMEA/HMPC/246816/2005

HI NG CC CH PHM C NGUN GC DC LIU

(Committee on Herbal Medicinal Products- HMPC)

HNG DN THC HNH TT TRNG TRT V THU HI (GACP)

DNH CHO NGUYN LIU BAN U C NGUN GC DC LIU

THNG QUA BI HI NG CC CH PHM C

NGUN GC DC LIU (HMPC), CNG B LY
KIN THO LUN
KT THC THO LUN (HN CHT LY KIN)
C NG BI NHM D THO CHT LNG
HMPC
THNG QUA BI HMPC
CHNH THC C HIU LC

Thng 7/2005

Ngy
30/10/2005
Thng 1/2006
Ngy
12/1/2006
Ngy 1/8/2006

Ch : Cc quan im trc y ca y ban chuyn nhim v cc ch phm c

ngun gc dc liu xem xt GACP c a vo trong Hng dn ca
Hi ng cc ch phm c ngun gc dc liu (HMPC). Ch c nhng thay i
nh c a ra trong ni dung cho ph hp vi tham vn cng chng.

BN DCH
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 70 51
E- mail: mail@emea.eu.int http://www.emea.eu.int
EMEA 2006 Reproduction and/or distribution of this document is authorised
for non commercial purposes only pdovided the EMEA is acknowledged

HNG DN THC HNH TT TRNG TRT V THU HI

DNH CHO NGUYN LIU BAN U C NGUN GC DC LIU
(GACP)

Mc lc
1. GII THIU ..................................................................................................... 7
2. TNG QUT .................................................................................................... 7
3. M BO CHT LNG ............................................................................. 9
4. NHN LC V O TO NHN LC ...................................................... 9
5. C S VT CHT ........................................................................................ 10
6. THIT B ......................................................................................................... 11
7. GHI CHP TI LIU .................................................................................... 12
8. GING V VT LIU NHN GING ...................................................... 13
9. TRNG TRT................................................................................................ 13
10.

THU HI. ..................................................................................................... 15

11.

THU HOCH............................................................................................... 15

12.

S CH ........................................................................................................ 16

13.

NG GI................................................................................................... 17

14.

BO QUN V PHN PHI ................................................................... 18

Ch thch: ................................................................................................................ 19

1. GII THIU
m bo c cht lng thch hp v thng nht ca cc tho dc/dc
liu1 cn thit phi a ra quy trnh Thc hnh tt trng trt v thu hi dnh cho
nguyn liu ban u v tho dc (GACP). Khi nim thc hnh tt sn xut
(GMP) dnh cho sn xut, gia cng, ng gi, vo kho ca Cc thnh phn dc
phm c hot tnh (Active Pharmaceutical Ingredient- APIs) cng c p dng
cho cy thuc/dc liu.
Vi ch phm t dc liu2, sn phm v qu trnh s ch tho dc/dc liu
c nh hng trc tip n cht lng ca API. Do s phc tp vn c ca tho
dc/dc liu mc t nhin v hn ch ca k thut phn tch trong vic m t
mt cch hon chnh cc thnh phn hot cht bng phng php ha hc v
sinh hc, c cht lng n nh ca nguyn liu ban u c ngun gc tho
dc i hi mt h thng m bo cht lng tng xng cho qu trnh thu hi
v/hoc trng trt, thu hoch qu trnh s ch.
Thu hi trong mi trng t nhin, c th gp nhiu vn c bit, nht l lin
quan ti vic nhm ln gia cc loi tng t nhau, s ph hy mi trng, thiu
kim sot v cht lng nhn lc km.
2. TNG QUT
2.1.

Ti liu ny nhm hng dn cch trng, thu hi v s ch cc cy

tho dc/ dc liu c s dng cho mc ch iu tr . N cp
n cc vn c th lin quan n sn xut nng nghip v thu hi
tho dc/dc liu trong t nhin. Nhng hng dn ny phi c
c cng

1. Dc liu (herbal subtances): tng t thut ng herbal drug c nh

ngha trong dc in chu u. Xem ch thch cui ti liu.
2. Cc ch phm t dc liu (herbal preparations): tng t thut ng
herbal drug preparation c nh ngha trong dc in chu u. Xem
ch thch cui ti liu.
vi hng dn GMP dnh cho cc thnh phn dc phm c hot tnh
v nn p dng cho tt c phng php sn xut bao gm c sn xut
hu c, ph hp vi quy nh ca khu vc v/hoc quc gia.
2.2.

Mc ch chnh l m bo an ton ca ngi tiu dng bng cch

thit lp cc tiu chun cht lng ph hp cho cc tho dc /dc
liu. Cc tiu chun c bit quan trng l nhng tho dc/dc liu
phi:
c sn xut hp v sinh, nhm gim s lng vi sinh vt
xung mc ti thiu.
c x l vi mt cch cn thn tho dc/dc liu khng
b nh hng xu trong qu trnh trng trt, thu hi, ch bin v
bo qun.
Trong qu trnh sn xut tho dc/ dc liu v ch phm tho dc
b phi nhim vi mt s lng ln cc vi sinh vt v cc cht gy
nhim. Hng dn ny a ra mt s khuyn co dnh cho cc nh sn
xut gim s nhim n mc ti thiu.

2.3.

Nhng lu v khuyn co trong hng dn ny hng ti tt c cc

thnh vin tham gia, t cc ngi trng ban u, ti cc nh phn phi
v cc nh my ch bin.
V vy, ngi trng, phn phi v ch bin cc tho dc/dc liu
cn tun th nhng lu ny, a ra tt c cc ti liu c lin quan n
8

cc hot ng trong cng l m v yu cu cc i tc ca h cng lm

tng t, tr khi c iu chnh mt cch hp l.
Ngi trng v thu hi tho dc/dc liu phi m bo trnh c
thit hi cho mi trng sng hoang d. Tn trng cng c CITES
(Cng c v bun bn quc t cc loi hoang d c nguy c tuyt
chng ca Wild Fauna and Flora).
3. M BO CHT LNG
Tha thun gia ngi sn xut v ngi mua v cht lng nh: gii hn
nhim vi sinh vt, ha hc, d lng kim loi nng .. v.v, phi c da trn
cng nhn v yu cu k thut ca khu vc v/hoc ca quc gia v phi c
quy nh trong vn bn.
4. NHN LC V O TO NHN LC
4.1.

Tt c cc th tc v qu s ch phi ph hp hon ton vi hng dn

ca khu vc v/hoc quc gia v v sinh an ton thc phm, cng nhn
c giao vic x l tho dc/dc liu yu cu phi tun th quy
nh v v sinh c nhn mt cch nghim ngt (k c cc cng nhn
lm vic trn cnh ng) v c o to y v trch nhim
trong v sinh.

4.2.

Cc phc li ca cc cng nhn tham gia vo trng v ch bin phi

c m bo.

4.3.

Cng nhn phi c bo v khi tip xc vi thuc c hoc thuc c

kh nng gy d ng bng qun o bo v .

4.4.

i vi ngi mc bnh truyn nhim ly qua thc n , bao gm c

tiu chy, hoc cc bnh ly truyn tng t, khng c vo vng m
h s tip xc vi tho dc/ dc liu, theo quy nh ca khu vc
v/hoc ca quc gia.
9

4.5.

Ngi c vt thng h, vim v nhim trng da khng c vo

khu vc din ra quy trnh x l cy thuc hoc cn phi mc qun o
bo h/gng tay ph hp cho n khi hi phc vt thng hon ton.

4.6.

Nhn vin phi c o to thch hp v thc vt hc trc khi thc

hin nhim v i hi cc kin thc ny.

4.7.

Ngi thu hi phi c kin thc v cy trng h phi thu hi . Bao

gm cc yu cu v nhn dng, cc c trng v mi trng sng .
Nhng ngi thu hi phi phn bit s khc nhau gia cc loi dc
thu hi v cc loi tng t ngoi t nhin v/hoc cc loi tng t
v hnh thi trnh bt k ri ro cho sc khe cng ng. Ngi thu
hi nn c kin thc v thi im tt nht thu hoch v k thut
thu hoch v tm quan trng ca vic s ch m bo cht lng tt
nht c th.

4.8.

Nu ngi thu hi khng c kin thc cn thit, gim st vin a

phng cn m bo vic o to, gim st v cung cp ti liu.

4.9.

Nn o to tt c cc cng nhn x l tho dc/dc liu v tt c

nhng ngi tham gia canh tc k thut canh tc thch hp bao gm c
vic s dng hp l thuc dit c v thuc tr su.

4.10. Nhng ngi thu hi tho dc/dc liu cn phi c hng dn

v tt c cc vn c lin quan n bo v mi trng v bo tn cc
loi thc vt. Bao gm thng tin v cc quy nh lin quan n cc loi
c bo v.
5. C S VT CHT
5.1.

Nh xng c s dng trong ch bin cy thuc sau khi thu hoch

phi sch s, thng kh v phi cha tng c s dng lm ni chn
nui gia sc.
10

5.2.

Nh xng phi bo v c dc liu/tho dc thu hoch mt

cch thch hp, trnh s ph hoi ca cc loi chim, cn trng, ng
vt gm nhm v cc vt nui. Tt c kho cha v khu vc ch bin,
cc bin php kim sot cn trng c hi nh dng b v dng my
in git cn trng phi c vn hnh v kim tra bi i ng
nhn vin chuyn nghip c trnh hoc cc nh u thu.

5.3.

Cc tho dc/dc liu ng gi c khuyn co phi bo qun:

Trong cc nh xng bng btng hoc tng t d dng lm
sch sn nh,
Trn cc tm pallet,
Khong cch va ti cc bc tng,
Cc dc liu khc nhau phi c tch ra trnh nhim cho.
Cc sn phm hu c phi c bo qun ring.

5.4.

Cc nh xng dng ch bin phi c c s vt cht thay i

thng xuyn cng nh nh v sinh c khu ra tay, theo quy nh khu
vc v/hoc quc gia.

6. THIT B
Thit b s dng trong trng trt v ch bin thc vt nn :
6.1.

c ra sch, thng xuyn bo dng v bi trn m bo hot

ng tt v c c gii ha. Hn na, my mc c s dng trong
vic bn phn v thuc tr su phi thng xuyn c chun ha.

6.2.

Nhng b phn my c tip xc trc tip vi cy thuc / dc liu,

phi c lm sch sau khi s dng m bo rng d lng cn st
li khng gy nhim cho v sau.

11

6.3.

Cc thit b phi c lm t cc vt liu thch hp ngn nga

nhim cho tho dc/dc liu vi ha cht v cc cht khng mong
mun khc.

7. GHI CHP TI LIU

7.1.

Tt c cc quy trnh v cc yu t c th nh hng n cht lng ca

sn phm phi c ghi chp li.

7.2.

iu kin hon cnh bt thng trong sut thi k tng trng c th

nh hng ti thnh phn ha cht ca tho dc/dc liu nh iu
kin thi tit khc nghit v su bnh, c bit l trong thi k thu
hoch phi c ghi chp li.

7.3.

i vi tho dc/dc liu c gieo trng , tt c cc bc x l

phi c ghi chp li bao gm cc v tr trng trt. Bo co tng
trnh v ma v u tin v cc sn phm thuc bo v thc vt c
s dng trong sut qu trnh bi tt c nhng ngi trng.

7.4.

i vi tho dc/dc liu c canh tc, cn phi ghi chp v loi,

s lng v ngy thu hoch cng nh cc ha cht v cc cht khc
c s dng trong qu trnh sn xut nh phn bn, thuc tr su,
thuc dit c v cc cht kch thch tng trng.

7.5.

Vic s dng cc tc nhn ty trng phi c ghi chp.

7.6.

V tr a l ca khu vc thu hi v thi gian thu hoch nn c m t

l chnh xc nht c th.

7.7.

Cc l nguyn liu tho dc cn c ghi chp sao cho c th truy tm

li ngun gc ca chng mt cch r rng v khng b nhm ln. Do
vic dn nhn v m vch nn c thc hin mt cch n gin
nht c th. Tho dc/dc liu c thu hi v canh tc v tr khc
nhau nn c s l khc nhau.
12

7.8.

Cc l trng cc khu vc a l khc nhau ch c trn nu n m

bo rng hn hp s ng nht. Qu trnh nh vy cn c ghi chp
li.

7.9.

Tt c cc tha thun (hng dn sn xut, hp ng .v.v..) gia nh

sn xut hoc ngi thu hi v ngi mua phi c lp thnh vn bn.
m bo vic trng trt, thu hoch v ch bin c thc hin theo
cc tha thun ny. Mi thng tin ti thiu trong ti liu hng dn
nn bao gm v tr a l, nc xut x v sn xut c trch nhim.

7.10. Cc kt qu ca vic kim tra s sch phi c ghi trong bo co kim

tra s sch (bn sao ca tt c cc ti liu, bo co kim ton, bo co
phn tch) c lu tr ti thiu 10 nm.
8. GING V VT LIU NHN GING
8.1.

Ht ging nn s dng t cy thc vt c xc nh chnh xc v

chi, loi, ging/cy trng v ngun gc cng phi c theo di. Cc
k thut cng c p dng nhn ging v tnh cy thuc. Ht
ging v/hoc b phn sinh dng dng nhn ging ca cy thuc
c s dng trong sn xut hu c phi c chng nhn v l hu
c. Cc nguyn liu ban u cn phi m bo sch su bnh m
bo thc vt tng trng mt khe mnh. Nu c th, nn s dng loi
c kh nng khng t nhin hoc chu c bnh tt nht.

8.2.

S c mt ca cc loi, ging hoc cc b phn thc vt khc nhau

phi c kim sot trong ton b qu trnh sn xut, trnh s pha trn.
Vic s dng ht ging hoc cy ging bin i gen phi tun theo quy
nh ca khu vc v/hoc ca quc gia.

9. TRNG TRT.
9.1.

t trng v phn bn
13

9.1.1. Cy thuc khng nn trng trn t b nhim bn thi, kim loi

nng, ph thi, cht bo v thc vt, ho cht .vv Bt k ha
cht no c s dng trong qu trnh sinh trng hay bo v
cy trng nn c hn ch mc ti thiu.
9.1.2. Phn chung khi s dng phi c k lng v khng s
dng phn ngi.
9.1.3. Tt c cc loi phn bn khc nn s dng mt cch tit kim
v ph hp vi nhu cu ca cc loi c th. Phn bn nn c
s dng mt cch hp l gim thiu s ra tri.
9.2.

Ti tiu
9.2.1. Vic cn c kim sot v ti theo nhu cu ca cy.
9.2.2. Nc dng cho vic ti tiu cn tun th cc tiu chun cht
lng ca khu vc /quc gia.

9.3.

S lun canh ma v v bo v thc vt.

9.3.1. t trng nn c iu chnh ph hp vi yu cu v s
pht trin ca cy.
9.3.2. Thuc tr su v thuc dit c nn trnh s dng cng t cng
tt. Khi phi s dng cc sn phm bo v thc vt cn thit th
nn s dng mc ti thiu c hiu qu ph hp vi cc
khuyn co t nh sn xut v nh chc trch. Vic p dng ny
nn c thc hin ch bi i ng nhn vin c trnh s
dng thit b c ph duyt. Khong thi gian ti thiu gia
cc ln s dng nh vy v thi gian thu hoch phi c quy
nh bi ngi mua hoc ph hp vi cc khuyn co t cc nh
sn xut sn phm bo v thc vt. Quy nh ca khu vc v
/hoc quc gia v gii hn d lng ti a trong Dc in
14

Chu u, Ch th Chu u, Codex Alimentarius vv nn c

tun th.
10.THU HI.
10.1. Chn ra cc c nhn xc nh v xc minh dc liu/dc liu c
thu hi v gim st ngi thu hi. (Xem 4.7 v 4.8)
10.2. Vic thu hi phi c tin hnh theo ng quy nh ca lut bo tn
cc loi hin hnh khu vc v/hoc quc gia. Phng php thu hi
phi khng c ph hy mi trng sinh trng, m bo cc iu
kin ti u cho s ti sinh ca cc tho dc/dc liu c thu hoch.
10.3. Khng c thu hi cc loi tho dc / dc liu c lit k trong
danh sch c nguy c (Cng c CITES, Cng c v bun bn quc
t cc loi hoang d Fauna and Flora), tr khi c s y quyn ca c
quan c thm quyn lin quan (Xem 4.10)
10.4. Cc khuyn co trong phn 3, 5, 6, 7, 11, 12, 13 v 14 phi c tun
theo.
11.THU HOCH.
11.1. Cc tho dc/dc liu nn c thu hoch khi n c cht lng tt
nht cho mc ch s dng.
11.2. Cc cy hoc b phn ca cy b h hi cn phi c loi b hoc gii
hn theo quy nh ca Chuyn lun lin quan trong dc in.
11.3. Cc tho dc/dc liu nn c thu hoch di iu kin tt nht c
th trnh t t, sng, ma, m khng kh cao. Nu thu hoch
xy ra trong iu kin m t c th nh hng xu n tho
dc/dc liu do m tng ln lm mt tc dng hot cht.
11.4. Cc thit b ct hoc thu hoch phi c iu chnh sao cho nhim
t t c gim n mc ti thiu.
15

11.5. Cc tho dc / dc liu c thu hoch khng nn tip xc trc tip

vi t. N phi c thu hi kp thi v vn chuyn trong iu kin
kh sch.
11.6. Trong sut thi gian thu hoch, cn chm sc m bo rng khng
c c di c hi ln vo vi tho dc/dc liu thu hoch
11.7. Tt c thng cha c s dng trong qu trnh thu hoch phi c
gi sch s v khng b nhim cht bn t cc v thu hoch trc .
Thng cha khng c s dng phi c gi trong iu kin kh,
khng c cn trng v khng b nh hng bi chut/ng vt gm
nhm, gia sc v vt nui.
11.8. S h hao do tc ng ca my mc c kh v tc ng nn p ln tho
dc/dc liu thu hoch c th dn n nhng thay i khng
mong mun v cht lng cn phi c hn ch. Trong , phi ch
n:
Gii hn ca bao ti,
S xp chng cc bao ti.
11.9. Vic thu hoch tho dc ti/dc liu phi c thc hin mt cch
nhanh chng nht c th v cc c s ch bin ngn s gim cht
lng.
11.10. Cc v thu hoch phi c bo v khi su bnh, chut / ng vt
gm nhm, gia sc . Bt k bin php kim sot dch hi no cng phi
c ghi chp.
12.S CH
12.1. Quy trnh s ch bao gm ra, ct trc khi lm kh, st khun, lm
lnh, chng ct, sy Trng hp p dng tt c cc quy trnh ny

16

phi tun th quy nh quc gia/ khu vc v cn c thc hin ngay

sau khi thu hoch nu c th
12.2. Khi n cc c s ch bin, cc cy thuc/dc liu thu hoch
phi c ra khi bao ti v ti ra. Trc khi ch bin, cc nguyn
liu khng nn tip xc trc tip vi nh nng mt tri, tr trng hp
c yu cu c th, v phi c bo v khi ma, cn trng ph hoi,
v.v..
12.3. Trong trng hp lm kh bi khng kh t nhin, cc tho dc/dc
liu phi c tri ln thnh lp mng. m bo khng kh lu
thng y , cc khung lm kh phi c t mt khong cch
thch hp t mt t. Trnh sy trc tip trn mt t hoc tip xc trc
tip vi nh sng mt tri, tr khi c yu cu c th. Cn sy kh ng
u cc tho dc /dc liu trnh s hnh thnh nm mc.
12.4. Tr trng hp lm kh ngoi khng kh , cc iu kin sy nh nhit
, thi gian, s lu thng khng kh ..vv phi c tnh ton, la chn
i vi cc thnh phn khc nhau ca thc vt nh r, l hoc hoa v
bn cht ca thnh phn hot tnh ca n, chng hn nh cc loi tinh
du. iu kin c th phi c ghi li mt cch chi tit.
12.5. Tt c nguyn vt liu phi c kim tra v nu cn thit phi sng
lc loi b cc sn phm khng t tiu chun v cc b phn ngoi
lai. Sng phi lun c gi sch s v nn c s dng thng
xuyn.
12.6. nh du r rng cc thng ng cht thi, cht thi v lm sch
hng ngy.
13.NG GI.

17

13.1. bo v cc sn phm v lm gim nguy c ca s tn cng gy hi,

khuyn khch ng gi bao b sm.
13.2. Sau qu trnh theo di bng vic kim sot quy trnh bn trong , cc
sn phm phi c ng gi trong cc bao ti, ti, hp mi sch s v
kh ro, c a chung. Cc nhn hiu phi r rng, c nh vnh vn
v c lm t vt liu khng c. Thng tin phi ph hp vi quy
nh khu vc v/ hoc quc gia.
13.3. Vt liu ng gi m ti s dng c nn lau chi sch s v lm
kh ng cch trc khi s dng.
13.4. Vt liu ng gi phi c bo qun ni sch s v kh, khng c
cn trng v khng tip xc vi gia sc v vt nui. m bo rng
khng c s nhim bn ca sn phm do vic s dng cc vt liu ng
gi, c bit l cc trng hp dng ti si.
14.BO QUN V PHN PHI
14.1. ng gi tho dc kh / dc liu, bao gm tinh du, nn c c
bo qun mt ni kh, trong hn ch vic dao ng nhit hng
ngy.
Sn phm ti phi c bo qun t 1C ti 5C trong khi cc sn
phm ng lnh nn c lu tr di -18C (hoc di -20C lu
tr lu di).
14.2. Trong trng hp vn chuyn s lng ln, iu quan trng l phi
m bo cc iu kin kh. Hn na, gim nguy c hnh thnh nm
mc hoc ln men th khuyn khch s dng nhng container c thng
kh. C th thay th bng cc phng tin vn ti thng thong v
cc phng tin c thng kh khc. Vn chuyn tinh du phi tun th

18

quy nh, nhng quy nh ca khu vc v/ hoc quc gia v giao thng
vn ti phi c tn trng.
14.3. Kh trng chng li s tn cng gy hi nn c thc hin ch trong
trng hp cn thit v phi c thc hin bi nhn vin c cp
php. Ch c cc ha cht c ng k mi c s dng. Bt k
thuc kh trng no phi c bo co trong cc ghi chp
14.4. i vi kh trng kho cha , ch cc cht c cho php theo quy
nh ca khu vc v/ hoc quc gia mi c s dng.
14.5. Khi bo qun iu kin ng lnh hoc hi nc bo ha c s
dng kim sot su bnh , m ca vt liu phi c kim sot
sau khi s dng.

Ch thch:
Dc liu (herbal subtances): Ton b, mnh c lm v hoc mnh ct ca
thc vt, cc b phn ca thc vt, to, nm, a y trng thi cha qua ch
bin, thng dng kh nhng i khi dng ti. Cc cht tit khng c s
dng vi mc ch iu tr c th no cng c xem xt l dc liu. Dc liu
c nh ngha chnh xc bi phn ca cy c s dng v tn khoa hc theo
h thng tn kp (chi, loi, th v tn tc gi)
Ch phm t tho dc (Herbal preparations): l cc ch phm thu c t
dc liu c s dng vi mc ch iu tr qua cc qu trnh nh: chit xut,
chng ct, p, ct phn on, tinh ch, c cn hoc ln men. Cc ch phm ny

19

bao gm bt dc liu/dc liu nghin nh, cn thuc, cao, tinh du, nc p

qu v cc cht tit tng hp.

20

Phn II. Mt s chuyn lun Dc in Chu u 8.0

Chuyn lun: R NG QUY (Angelica sinensis root)
Angelicae sinesis radix
NH NGHA
Mt phn hay ton b r phi-sy kh, c loi b r con ca cy ng
quy (Angelica sinensis (Oliv.) Diels) c thu hi vo cui ma thu.
Hm lng: Ti thiu 0,050% acid trans-ferulic (C10H10O4, KLPT 194,2) (dc
liu kh)
NH TNH
A. R cc, phn nhnh sm thnh 10 (hoc nhiu hn) r chnh hnh nn, di
khong 15-25 cm. Vng trn ca r c ng knh 1,5-4 cm, chp r t,
trn vn gi c mu vng-xanh ca gc v cung l. B mt ngoi mu
nu vng sng hoc nu sm, sn si, c np nhn dc, vn cn so ca r
ph li, v c cc vt nm ngang ging nh l r. R nhnh c phn
trn mp (ng knh 0,3-1cm) v phn di mnh hn. Chng thng
xon li v c vi vt so ca r ph. Kt cu b. Mt ct ngang cho thy
v dy, mu vng trng hoc vng nu vi mt s vt nt v nhiu im
mu nu ca ng tit tinh du. Tng phn sinh c hnh nhn mu vngnu. Cht g mu sng.
R khi ct s thnh cc mnh di dy 1,5-2mm, rng 1,5-4 cm nh v
di 10-15cm.

21

B. Vi phu (2.8.23). Bt mu vng trng. Soi di knh hin vi s dng dung

dch chloral hydrat R. Bt c cc c im sau: C cc mch g dng
mch mng hoc mch bc thang c ng knh ln ti 80 m, n l
hoc theo nhm 2-3 mch i km vi cc t bo ha g c thnh dy;
nhiu mnh m mm vi cc t bo hnh trng; cc mnh lie mu cam,
gm nhiu lp t bo chng ln nhau, hnh gn ch nht nhn t trn b
mt; nhiu tinh th canxi oxalate hnh lng tr rt nh, c th nhn thy
di nh sng phn cc, trong lie; cc ng tit tinh du him nhn thy,
thng b v, c mu vng cam bn trong, ng knh ln n 170 m.
Soi di knh hin vi s dng dung dch glycerol R 50% v/v: C cc ht
tinh bt nh, n l, hnh trn hoc hnh trng, thng trong cc t bo
m mm.
C. Kim tra sc k thu c khi th vi cc loi lm thuc khc ca
Angelica, Levisticum v ligusticum.
Kt qu A: Xem trnh t cc vt trn sc k thu c vi dung dch
th v dung dch i chiu di y. Ngoi ra, cc vt hunh quang m
khc c th c mt trn sc k thu c vi dung dch th.
Sc k
(Z)-Ligustilide: Mt vt hunh Mt vt hunh quang mu xanh l
quang mu xanh l
_________

r rt ((Z)-Ligustilide)
__________

22

Osthole: mt vt hunh quang mu

xanh dng
Imperatorin: Mt vt hunh quang
mu trng nh
___________

__________

Dung dch i chiu

Dung dch th

Kt qu B: Xem trnh t cc vng th hin trn sc k thu c vi

dung dch th v dung dch i chiu di y. Ngoi ra, cc vt ti m
nht khc c th th hin trn sc k thu c dung dch th
Sc k
(Z)-Ligustilide:

Mt

quang mu xanh dng

vt

hunh Mt vt hunh quang mu xanh

dng r rt ((Z)-Ligustilide)
Mt vt m ti

________
Osthole: Mt vt ti

_________
Mt vt m ti

Imperatorin: Mt vt ti

23

________

Dung dch i chiu

_________

Dung dch th

CCH TH
Cc loi dng lm thuc khc ca Angelica, Levisticum v Ligusticum.
Sc k bn mng (2.2.27)
Dung dch th: Cho 1 g bt dc liu (355) (2.9.12) vo 4mL heptan R,
y li v siu m ( ph v t bo) trong 5 pht. Cho vo my li tm v
ly phn dch pha trn.
Dung dch i chiu: Ha tan 1 mg (Z)-ligustilide R, 1 mg imperatorin R
v 1 mg osthole R trong 10 mL methanol R.
Bn mng: TCL silica gel F254 bn mng R (2-10 m).
Pha ng: acid acetic bng R, ethyl acetate R, toluene R (1:10:90 v/v/v).
Chm sc k: 4L vt chm c ng knh khng c qu 8mm.
Chy sc k: 6 cm.
kh: trong khng kh
Pht hin A: Kim tra di nh sng UV bc sng 365 nm.

24

Kt qu A: Sc k thu c ca mu chun khng c vt hunh quang

mu xanh dng r ti/di v tr tng ng vi vt osthole tng ng
sc k thu c vi dung dch i chiu.
Pht hin B: Kim tra di nh sng UV bc sng 254nm.
Kt qu B: Sc k thu c vi dung dch th khng c vt ti ti/di
v tr tng ng vi vt imperatorin sc k thu c ca dung dch
i chiu.
Mt khi lng do lm kh (2.2.32): Ti a 12,0 %, xc nh vi 1,000
g bt dc liu (355) (2.9.12) bng cch sy trong t sy 105oC trong
2h.
Tng lng tro (2.4.16): ti a 7%
Tro khng tan trong dung dch acid hydrochloric (2.8.1): ti a 2%.

NH LNG
Sc k lng (2.2.29).
Dung dch th: Phn tn 0,200 g bt dc liu (355) (2.9.12) vo 20,0 mL
dung dch methanol R 70% v/v trong bnh nn, y nt cht v em cn.
Lm nng vi mt bnh hi lu ngng t trong 30 pht, lm ngui v em
cn li. B lng dung mi mt i vi dung dch methanol R 70% v/v,
trn u v yn. Lc dch ni pha trn qua mt mng lc (kch thc
l lc 0,45 m); s dng dch lc.

25

Dung dch i chiu (a). Trong mt bnh nh mc thy tinh mu nu,

ha tan 10,0 mg ferulic acid CRS trong methanol R 70% v/v v pha long
vi cng dung mi.
Dung dch i chiu (b): chun b acid cis-ferulic ti ch, ly 2 mL ca
dung dch i chiu (a) vo mt l nh trong sut v trc nh sng t
ngoi bc song 254 nm trong 60 pht.
Ct:
- Kch thc: l= 0.150 m, = 2,0 mm
- Pha tnh: Octadecylsilyl silica gel R dng cho sc k (4m)
- Nhit : 35oC
Pha ng: acetonitrile R, dung dch acid phosphoric R 0,085 % (17:83
v/v)
Tc dng: 0,23 mL/pht
Pht hin: my quang ph 316 nm.
Tim mu: 10 L.
Thi gian lu: acid trans-ferulic = khong 13 pht; acid cis-ferulic =
khong 14 pht.
H thng ph hp: dung dch i chiu (b):
- phn gii: ti thiu 1,3 gia cc pic ca acid trans-ferulic v acid
cis-ferulic.
26

Tnh hm lng phn trm ca acid trans-ferulic s dng cng thc sau:

A1

= din tch pic ca acid trans-ferulic trn sc k thu c

vi dung dch th

A2

= din tch pic ca acid trans-ferulic trn sc k thu c

ca dung dch i chiu.

m1

= khi lng dc liu dng chun b dung dch th, n

v gam;

m2

= Khi lng acid ferulic CRS c s dng chun b

dung dch i chiu (a), n v gam;

= Phn trm hm lng ca acid trans-ferulic trong acid

ferulic CRS.

27

Chuyn lun: THN R CY NGH (Cucurma longae root)

NH NGHA:
Thn r cy ngh ch bin (bng cch luc hoc hp), vi r v b mt bn ngoi
b loi b.
Hm lng: ti thiu 25 ml tinh du trn 1kg dc liu nguyn.
Cinnamoyl (dn xut methane), (C21H20O6; Mr 368.4) ti thiu 2,0 phn trm
trn 1kg dc liu nguyn.
TNH CHT:
Mi cay.
NH TNH:
A. Thn r l hnh trng, thun di hnh trng hay hnh tr, phn nhnh nhanh,
di ti 6 cm v dy 15 mm. Thn r chnh c nhng vt so t cnh. B mt thn
r x x, c m nu vng. Thn r mu vng hoc mu nu xm, c vn ng
tm nhn , khng x.
B. Kim tra di knh hin vi. Bt c mu vng cam. Kim tra di knh hin vi
s dng chloral hydrat bt nguyn liu cho thy: cc mnh dc liu gm mt
s t bo tit c cha mt lng tinh du mu nu vng [G]; mt li hoc r [B,
D]; 1 vi lp biu b (xem b mt [F]), vi cc t bo c thnh hi dy ln [Fa]
v nhng vt so ca lng tit [Fb]; thng xut hin v khc khuu, vch dy,
cc lng tit n bo, b phn mnh [E] hoc gn vo mnh v ca lp biu b
[J]; mnh him ca nt chai (Xem b mt [A], xem bn [H]), i khi c bao
ph bi biu b [Ha]. Kim tra di knh hin vi s dng 50 %/ glycerol R. Trn
bt quan st c cc ht tinh bt ri rc hoc c trong cc t bo nhu m, thng
dng gel v ng thnh khi bt nho tinh bt; i lc c ht tinh bt hnh trng
khng, thng b bin dng nh [C] cng xut hin.

28

Hnh 1. Mt s c im ca bt ngh
C. Sc k bn mng:
Kim tra sc k c trong th nghim vi thn r ngh.
Kt qu A:
C cc vng ti trn sc k thu c vi dung dch i chiu v dung dch th.
Cc vng m nht khc c th c hin din trong sc k thu c vi cc
phng php th nghim khc.
Phn trn

29

Curcuminoids: mu xanh hunh quang Mt vng hunh quang mu xanh lc

(curcuminoids)
Curcuminoids: mu xanh hunh quang 2 vng hunh quang mu xanh lc
(curcuminoids)
Dung dch i chiu

Dung dch th

Kt qu B:
C cc vng ti trn sc k thu c vi dung dch i chiu v dung dch th.
Cc vng m nht khc c th c hin din trong sc k thu c vi cc
phng php th nghim khc.
Phn trn
Mt vng mu hng nht.
Mt vng mu m.
Thymol: mt vng ti

Mt vng hng .
Curcuminoids: mt vng nu.

Curcuminoids: 2 vng mu vng

Curcuminoids: 2 vng mu vng.

Dung dch i chiu

Dung dch th

KIM TRA:
Sc k lp mng:
Dung dch th. cho 1 g ca bt tho dc ti thm 10mL ethanol (96 %) lc
u, yn trong 30 pht cui cng lc mnh v lc; s dng dch lc.
Dung dch i chiu: Ha tan 20mg curcuminoids R v 10 mg thymol R trong10
ml ethanol (96 %) .

30

Bn mng TLC silica gel GF254 plate R. (5-40 m) [ hoc TLC silica gel F254
plate R (2-10 m)].
Pha ng: axit axetic, toluene (20:80V/V).
Dung dch chm sc k: 10 l [ hoc 3L].
Trin khai: 10 cm hoc 6 cm.
Lm kh: trong khng kh.
Detector:
A: UV = 365 nm.
B: phun bng dung dch anisaldehyde v 100-105 C trong 10 pht; kim
tra di nh sng t ngoi UV = 365 nm.
Kt qu B: sc k ca dung dch th cho thy khng c vng ti ngay pha
trn vng vc do thymol trong sc k ca dung dch i chiu.
Nc: ti a 120 mL / kg, xc nh trn 15,0g bt tho dc.
Tro: 7%.
NH LNG:
Tinh du: Dng 2,5 g bt tho dc ti cho vo bnh cu (2L), thm 400 ml.
Nc v 0,5 ml xylen R trong ng thu tinh du. Chng ct tc 2 ml/pht
trong 3 h.
Dicinnamoyl dn xut. methane. Ha tan 0.500g bt tho dc trong 30ml
ethanol.
(96 %) trong 100 mL bnh y trn. un hi lu trong 2,5 h. Lm lnh v lc
vo bnh nh mc 100 mL bnh, ra bnh y trn v cc b lc vi ethanol (96
%) cho cng vo bnh nh mc trn . Sau thm va 100,0 ml vi cng

31

dung mi. Pha long 1,0 ml dung dch thnh 50,0 ml vi ethanol (96%). o
hp th ti 425nm. S dng ethanol (96%) l mu trng.
Tnh hm lng phn trm ca methane dn xut dicinnamoyl , ging nh
curcumin, bng cch s dng biu thc sau y :

A 5000
1607 m
hp th c th ca curcumin l 1607.
A = hp th 425 nm;
m = khi lng ca cc loi thuc tho dc c kim tra, tnh bng gam.

32

Chuyn lun: L BC H
Mentha piperita leaf

NH NGHA
L nguyn hay ct nh ca loi Mentha piperita L.
Hm lng: hm lng tinh du ti thiu 12 mL/kg vi l nguyn hoc 9 mL/kg
vi l ct nh.
TNH CHT
Mi thm c bit.
L mu xanh hoc xanh nu c khi c gn l mu tm sm. Cung l mu xanh
hoc mu tm sm.
NH TNH
A. L nguyn vn, vn hoc ct nh, l kh thng nhn nheo; l nguyn di
3-9 cm, rng 1-3 cm, phin l hnh ovan hoc hnh ngn gio, nh l
nhn, mp l c rng ca r v gc l khng i xng. Gn l hnh lng
chim, l r mt di l, gc gia gn chnh v gn ph khong 45 0. Mt
di c lng mn che ch v lng tit quan st di knh hin vi (6x) l
nhng im mu vng ti. Cung l c rnh, di 0,5-1 cm, ng knh
1mm.

33

Hnh 1. Mt s c im bt l bc h
B. Nghin thnh bt, bt c mu xanh lc hi nu. Soi di knh hin vi,
dng dung dch Cloral hydrat R c th quan st thy nhng c im sau:
cc mnh t bo biu b, lng tit v l kh trn b mt quan st [B,H]. Cc
t bo biu ngon ngoo[Ha] v lp biu b vn qua gn l (B) kt hp m
du [Hb]. L kh [C] vi kh khng kiu trc bo( diacytic) [Ca]; lng che
ch thng phn mnh, thun di, lng n tnh vi 3-8 t bo biu b c
vn [A, E]; lng che ch c 2 loi: a) cung n bo vi u n bo,
trn, nh vi ng knh 15-25 mcm, trn b mt quan st [Ba, Cb] hoc
ti cc mt ct ngang [D], b) cung n bo c m rng u hnh bu dc
ng knh 55-70 mcm gm pf 8 t bo ta ra, trong quan im ca b
mt [Bb] hoc ti cc mt ct ngang [Ga]; mng gn mp l [F] vi cc
t bo isodiametric m vch t bo li ra bn ngoi l cc t bo thng hay
c ht [Fa] v lng che ch ngn, hnh nn, gm 1 hoc 2 t bo [Fb];

34

mnh cha dip lc phin l, trong phn ct ngang [G], vi mt lp t

bo m giu [Gc] v 4-6 lp nhu m xp [Gb]. C th quan st thy tinh
th menthol mu vng di lp biu b.

C. Sc k lp mng:
Dung dch th: Cho 0,2g bt dc liu vo 2 ml dung dch Methylen chlorid R,
siu m trong vi pht v lc ly dch lc. C dich lc nhit 40 0C sau
ha tan cn vo 0,1 ml toluene.
Dung dch i chiu: Ha tan 50 mg menthol R, 20 l cineol R, 10 g thymol R
v 10 l menthyl acetate L trong toluene v pha long thnh 10,0 ml vi dung
mi.
Dung mi pha ng: Ethyl acetat R, toluene R (t l 5:95 v/v)
Bn mng: TLC silica gel GF254 R.
Dung dch chm sc k: 10 l dung dch i chiu v 20 l dung dch th.
Chy sc k: trin khai sc k n khi dung mi i c 15cm
Lm kh: trong khng kh cho n khi dung mi bay hi hon ton.
Pht hin A: soi di n UV bc sng 254 nm.
Kt qu A:
C cc vt ti trn sc k ca dung dch i chiu v dung dch th, Trn sc
k ca dung dch th c th xut hin cc vt ti yu khc.
u trn ca bn mng

Thymol: 1 vt ti
Vng ti c th c (carvone, pulegone)

35

Dung dch i chiu

Dung dch th

Pht hin B
Phun bn mng vi anisaldehyde gii php R v quan st di nh sng ban
ngy say khi sy 5-10 pht 100-105 oC.
Kt qu B
C cc vt mu trn sc k ca dung dch i chiu v dung dch th. Trn
sc k ca dung dch th c th xut hin cc vt mu yu khc.
Pha trn bn mng
1 vng m (gn trc dung mi)
(hydrocarbons)

Methyl acetate: 1 vng xanh tm

1 vng xanh tm (methyl acetate)

1 vng xanh (mentone)

Thymol: 1 vung mu hng

Cineole: 1 vng xanh tm hoc hng

nh sng mu hng, khu xm xanh c

th c mt (carvone, pulegone,
isomenthone).
1 vng xanh tm hoc nu (cineile)

Menthol: 1 vng ti m mu xanh 1 vng ti m mu xanh hoc tm

hoc tm
(menthol).

36

Dung dch i chiu

Dung dch th

Tp cht: khng qu 5% cnh, thn, ton b cc mnh khng ln hn 1,5 mm,

khng qu 2% cc tp cht l, ti a 8% cc tp cht bn Puccina menthae.
Tin hnh th vi 10g dc liu kh.
m: khng qu 110 mL / kg, xc nh trn 20,0 g.
Tro ton phn: ti a 15,0 %.
Tro khng tan trong HCl: ti a 1,5%.

NH LNG
Tin hnh xc nh hm lng tinh du trong dc liu. S dng 20,0 g dc
liu ct nh trong bnh nh mc 500 ml, cho 200ml nc vo 0,5 ml Xylen
trong bnh hng. iu chnh tc nh git khong 3-4ml/pht trong vng 2
gi.

37