I HC Y DC THNH PH H CH MINH

KHOA DC

B MN BO CH

CNG THC TP
BO CH 2

Tn bi thc tp: Cm pha hn dch Vin nang Vin nn

t thc tp: 1

Nhm thc tp: 4

Bui thc tp: sng th 2

Bn thc tp: 3 Tiu nhm: 5

Lp: Dc 2013 Nin kho: 2016 2017

3/2017
 CNG THC TP BO CH 2
CM PHA HN DCH, VIN NANG, VIN NN

Danh sch sinh vin Tiu nhm 5 Nhm 4

STT H tn sinh vin

1 Trn Gia Lc

2 Nguyn Duy Long

3 ng Th Thu Linh

4 Trn Th Thu Linh

5 inh Th Nh Mai

1
1
1
 MC LC

NGUYN LIU CHUNG 3

VIN NANG PARACEATMOL 6

I. XY DNG CNG THC ......................................................................................... 6

II. CCH XC NH TH TCH NG NANG ............................................................ 8

III. QUI TRNH IU CH ............................................................................................... 8

IV. CC CH TIU C BN NH GI NHANH VIN NANG ................................ 11

CM PHA HN DCH PARACETAMOL 12

I. XY DNG CNG THC ......................................................................................... 12

II. CCH IU CH ........................................................................................................ 14

III. CH TIU NH GI CNG THC ........................................................................ 16

VIN NN PARACETAMOL 17

I. XY DNG CNG THC ......................................................................................... 17

II. QUI TRNH IU CH ............................................................................................... 18

III. CC CH TIU NH GI CM BN THNH PHM ........................................ 21

IV. CC CH TIU KIM TRA NHANH VIN NN .................................................... 22

TI LIU THAM KHO 23

K HOCH THC TP 24

2
 NGUYN LIU CHUNG

I. HOT CHT PARACETAMOL [2, 5, 6]

Cng thc phn t: C8H9NO2

Phn t lng: 151,2.

Cu to ho hc:

Gm nhn benzen, 1 nhm hydroxyl (tnh acid yu, d b oxy ho) v 1 nhm acetamid (d
b thu phn trong acid hay base).

Sn phm thu phn l 4aminophenol, 1 tp cht lin quan c kim nghim.

Tnh cht: bt kt tinh trng, khng mi, v ng.

tan: hi tan trong nc; rt kh tan trong cloroform, ether, methyl clorid;
d tan trong ethanol 96%, dung dch kim.

Dung dch bo ha c pH 5,5 6,5, pKa = 9,38.

n nh:

Paracetamol n nh trong nc. Khong pH n nh l 5 7.

Acid, base, nh sng, nhit hay cc cht oxi ho lm thc y phn ng thu phn amid
ca dc cht.

II. DUNG MI V CC T DC [1, 4]

1. Dung mi

Ethanol 70%
Vai tr: dung mi pha t dc dnh (dung dch PVP), ho tan t dc mu.
Tng k: gy ta mui hu c v gm t dung dch hoc hn dch;
khng tng hp vi cc vt liu, bao b nhm.

Nc ct
Vai tr: dung mi pha t dc dnh (h tinh bt).
Tng k: thu phn mt s dc cht, t dc.

3
2. Cc t dc

T dc Vai tr, chc nng Nng / t l thng dng Tng k cn lu

Lactose T dc n Phn ng vi cc amin bc I, II

ng saccharose T dc n C khi ng ln vt kim loi, tng k vi mt s

xay mn dc cht
Cht gy treo, tng nht
Thu phn trong acid to ng nghch chuyn
Cht to ngt (iu v)
(dextrose, fructose)
Tng k vi np nhm

Bt PVP T dc dnh T dc dnh: 0,5 5% To phc hp vi mt s cht bo qun

(thimerosal)
T dc r

Tinh bt
T dc n Cht oxi ho mnh
Hm lng amylose
T dc dnh T dc dnh: 3 20%
Bp: 24 28% (thng 5 10%)
M (sn): 17 20%
T dc r T dc r: 3 25% (thng 15%)

Cht din hot cation, mt s polymer, cht bo

Gm xanthan Cht gy treo, tng nht 0,05 0,5%
qun, cht oxy ha mnh,

Natri carboxymethyl T dc dnh T dc dnh: 1 6% Acid mnh, mui kim loi (st, nhm, thy ngn,
cellulose km), gm xanthan
T dc r
C th to ta pH < 2 hoc khi trn vi ethanol
Cht gy treo, tng nht Cht gy treo: 0,1 5%
95%

4
Natri croscarmellose T dc siu r Vin nn: 0,5 5,0% Acid mnh, mui kim loi (st, nhm, thy
ngn, km)
Vin nang: 10 25%
Hiu qu r c th gim khi phi hp vi t
dc ho nc (sorbitol), qu trnh xt ht
t, dp trc tip

Natri starch glycolat T dc r 2 8% Acid ascorbic

(ti u 4%, c khi 2% l )

Avicel PH101 T dc n, dnh, r, trn T dc n/dnh: 20 90% Cht oxi ho mnh

(antiadherent)
T dc r: 5 15%
T dc trn: 5 20%

Aerosil T dc trn (glidant) 0,1 1% Ch phm cha diethylstilbestrol

Magie stearat T dc trn (lubricant) 0,25 5% Acid hay kim mnh, mui st, cht oxi ho
mnh, a s cc mui alkaloid

Talc T dc trn (glidant, lubricant) 1 10% Hp cht amoni bc IV

Dung dch mu To cm quan hp dn, d phn bit Cht oxi ho mnh

(cam, )
Mu cam: Sunset Yellow,
D&C Orange,
Mu : Erythrosine, Red 2G,
Carmin,

Dung dch mi To hng, che mi kh chu 0,5%

(cam, du)
Thng l cc tinh du

5
 VIN NANG PARACETAMOL

CNG THC
Cng thc ca 1 vin nang Paracetamol 250 mg
Paracetamol 250 mg
T dc dnh v
Talc 1%
V nang s 1

I. XY DNG CNG THC

C 2 cch iu ch vin nang cng:

ng bt thuc trc tip vo nang
To cm ri ng vo nang
Cng thc trn dng t dc dnh, nn cch thc hin l to cm ri ng nang.

T dc trn: bt talc, gip ci thin trn chy, d ng thuc vo nang.

T dc dnh: to cm, tng t trng khi thuc, t tng trn chy.

T dc dnh dc dng c th l dung dch PVP 10% hoc h tinh bt 10%.
Nh vy, tiu nhm s xy dng v iu ch 2 cng thc.

1. T dc dnh l dung dch PVP 10%

Dung mi pha PVP: ethanol 70%.

Nng dung dch PVP: 10% (kl/tt).

Chn ethanol 70% v:

D ho tan PVP, d bay hi sau khi sy
cn qu cao s bay hi nhanh, lm hn hp bt chng kh

PVP trong cm bn thnh phm thng chim 0,5 5% (kl/kl).

Tiu nhm ngh hm lng PVP trong cm l 2%.

hm lng paracetamol trong cm l 98%.

Khi lng cm bn thnh phm trong 1 vin nang l:

100
250 255,1 (mg)
98

Lng t dc PVP cn dng l: 255,1 250 = 5,1 (mg)

6
 5,1 100
Nn dung dch PVP 10% (kl/tt) cn ly: 0,051 (ml)
1000 10

Do bt talc chim 1% trong cng thc (tc l cm bn thnh phm chim 99%),
1
nn lng bt talc dng cho 1 vin nang l: 255,1 2,58 (mg)
99

Vy cng thc hon chnh vi dung dch PVP 10% l

300 vin nang

Thnh phn 1 vin nang 300 vin nang
(hao ht 10%)

Paracetamol 250 mg 75 g 82,5 g

Dung dch PVP 10% (kl/tt) 0,051 ml 15,3 ml 16,8 ml
Talc 2,58 mg 0,77 g 0,85 g

2. T dc dnh l h tinh bt 10%

Dung mi pha: nc ct.

Nng h tinh bt: 10% (kl/kl).

H tinh bt dng lm t dc dnh thng chim 3 20% (kl/kl) cm bn thnh phm.

Tiu nhm ngh hm lng h tinh bt trong cm l 5%.

hm lng paracetamol trong cm l 95%.

Khi lng cm bn thnh phm trong 1 vin nang l:

100
250 263, 2 (mg)
95

Lng h tinh bt 10% (kl/kl) cn dng l: 263,2 250 = 13,2 (mg)

Do bt talc chim 1% trong cng thc (tc l cm bn thnh phm chim 99%),
1
nn lng bt talc dng cho 1 vin nang l: 263, 2 2,7 (mg)
99

Vy cng thc hon chnh vi dung dch PVP 10% l

300 vin nang

Thnh phn 1 vin nang 300 vin nang
(hao ht 10%)

Paracetamol 250 mg 75 g 82,5 g

H tinh bt 10% (kl/kl) 13,2 mg 3,96 g 4,36 g
Talc 2,7 mg 0,81 g 0,89 g

7
II. CCH XC NH TH TCH NG NANG

o t trng biu kin d ca ht thuc:

Khi lng ca ht (g)
T trng biu kin =
Th tch biu kin ca ht (ml)
Cch lm:
Cn 50 g ht, nh nhng vo ng ong 100 ml.
Cm ng ong gi ln cao khong 2,5 cm, ng ri theo chiu thng ng xung mt mt
g nhn 3 ln, mi ln cch nhau 2 giy.
c th tch v tnh t trng biu kin.

m
T t trng biu kin, tnh c th tch ca khi thuc l: V (ml)
d

Th tch khi thuc V Hng lm

V < 0,48 ml Thm t dc n (lactose hoc tinh bt)

Lng t dc n thm vo chim th tch:
0,48 V (ml)
T trng thc ca t dc n:
Lactose khan: 1,589 g/ml
Tinh bt bp: 1,478 g/ml

V = 0,48 ml Tin hnh ng nang

V > 0,48 ml Cn nn ht

III. QUI TRNH IU CH

Dng c, thit b d kin

Cn in t, bp in

Ry, phu o gc chy, thc o

B ci chy; ng ong 100 ml; becher 50 ml, 250 ml; a thy tinh

My xt sa ht, my ng nang th cng, t sy

My o r, cn o m bng hng ngoi

8
1. To cm paracetamol

Phng php: xt ht t.

Cch thc hin:

Cn lng paracetamol tng ng mi cng thc, ri nghin trong ci c lt khn.

Pha t dc dnh:
Dung dch PVP 10% (kl/tt):
Bt PVP 2g
Ethanol 70% v 20 ml
nh du vch th tch 20 ml trn becher (bng 20 ml ethanol 70%).
Cn 2 g bt PVP, cho vo becher trn. B sung th tch va n vch 20 ml bng
ethanol 70%, khuy u cho tan ht.

H tinh bt 10% (kl/kl):

Cn 5 g tinh bt bp, cho vo becher 250 ml kh, sch.
Thm 45 g nc ct vo becher ny, khuy u cho trng n.
t becher trn bp in, khuy t t, hn hp s chuyn sang th h st, trong.

To khi bt m:
Lm m bt paracetamol bng lng t dc dnh va , trn u.
Ghi nhn lng t dc dnh dng.
khi bt m n nh trong 30 45 pht.

Xt ht: bng my qua ry 2 mm, thu cm t.

o
Sy ht: nhit 40 70 C, trong 1 2 gi, n khi hm m 5%.

Sa ht: bng my qua ry 1 mm. Nu si cm kh v c t ht nh, ri th gi, xay nghin trc

khi ry. Nu si cm kh v c nhiu ht cm nh, ri th ry ly ht nh trc.

Ry phn on: qua 2 b ry 0,71 0,355 mm xp chng ln nhau. Cho ton b cm ln ry trn
cng, y np, lc trong 5 pht. Cn lng cm thu c tng phn on.

Vi mi phn on, tnh ton lng bt talc thc t cn thm vo v trn u.

o t trng biu kin ca tng phn on, v t trng biu kin ca cm ton phn (trn chung cc
phn on vi nhau).

Chn cm ton phn hoc phn on cm c c ht thch hp nht ng nang.

2. ng nang

Do tnh cht thc tp, quy m nh (300 vin nang), nn tin hnh bng my ng nang th cng.

Sau khi ng nang, lau nang, nh bng, ng gi, kim tra thnh phm.

9
 S qui trnh iu ch vin nang Paracetamol

Chun b nguyn liu Cn, nghin Paracetamol

Pha t dc dnh

To khi bt m Trn vi t dc dnh va , trn u

yn 30 45 pht

Xt ht Xt ht qua ry 2 mm

o
Sy ht Sy 40 70 C, n khi m 5%

Sa ht Sa ht qua ry 1 mm

Ry phn on Ry 0,71 0,355 mm

Trn hon tt Tnh ton, thm talc vo mi phn on

o t trng biu kin, gc chy, chn phn on

ng nang thuc ng nang bng my th cng

ng gi

Kim nghim Kim ng u khi lng, r

10
IV. CC CH TIU C BN NH GI NHANH VIN NANG [2]
C 2 ch tiu c bn nh gi nhanh cht lng ca vin thuc nang.

1. ng u khi lng (Ph lc 11.3 DVN IV)

Cch thc hin: tin hnh vi 20 vin nang ngu nhin.

Vi mi vin nang:

Cn khi lng ca nang.

Tho ri 2 na v nang, dng bng lau sch v v cn khi lng ca v.

Tnh: Khi lng thuc trong nang = Khi lng nang thuc Khi lng v nang.

Tnh khi lng trung bnh ca thuc trong nang.

nh gi: (khi lng trung bnh vin nh hn 300 mg)

Khng c qu 02 vin nang c khi lng nm ngoi gii hn chnh lch 10% so vi khi lng
trung bnh.

Khng c c vin nang no c khi lng vt gp i gii hn .

2. r (Ph lc 1.13, 11.6 DVN IV)

Cch thc hin: dng my o r

Mi trng th: nc.

Nu th trong mi trng nc khng t, thay nc bng dung dch HCl 0,1 N hoc dung dch
d dy gi (TT).

Ly 6 vin nang, cho vo mi ng th 1 vin.

Treo gi ng th trong cc c cha nc. Nu nang ni trn mt nc, c th dng a ln.

Vn hnh my trong 30 pht.

Ly gi ng th ra khi cht lng, nh gi kt qu.

nh gi:

Mu th t yu cu nu tt c 6 vin u r khng qu 30 pht.

Thuc c coi l r khi p ng 1 trong cc yu cu sau:

Khng cn cn trn mt li.
Nu cn cn, l khi mm khng c mng nhn thy r, khng c nhn kh.
Ch cn nhng mnh v nang trn mt li. Nu s dng a, cc mnh v nang c th dnh
vo mt di ca a.

11
 CM PHA HN DCH PARACETAMOL

CNG THC
Cng thc 1 n v ng gi (1 g):
Paracetamol 150 mg
Cht iu mu, mi v
Dung dch PVP 10% v
Aerosil 5 mg
T dc X v
ng saccharose v 1g

I. XY DNG CNG THC

1. Vai tr ca cc cht trong cng thc

Cm pha hn dch Paracetamol dng cho tr em, cn p ng cc tiu ch [1]:

Cm phi kh, ti, ng nht, chy tt, khng b dnh hay v vn.
Cn t dc n, dnh, trn to cm.

D phn tn dc cht to thnh hn dch bng cch lc, hn dch phi n nh.
Cn cht gy treo.

Che lp v ng ca dc cht, d ung, mi thm, mu sc hp dn.

Cn cht lm ngt, cht mu, t dc mi.

Trong cng thc trn, t dc X cn thiu chnh l cht gy treo.

Tiu nhm ngh cht gy treo Na CMC.

Cht mu, mi gm c:

Mu cam: Sunset Yellow (E110), D&C Orange,

Mu : Erythrosine, Carmin (E120),

Tinh du hng cam

Tinh du hng du ty

Tiu nhm chn mu cam Sunset Yellow (E110), tinh du hng cam.

12
 Thnh phn Vai tr

Paracetamol Dc cht

Dung dch PVP 10% T dc dnh

Aerosil T dc trn

Na CMC Cht gy treo, n nh

ng saccharose T dc n, lm ngt, tng nht

Dung dch mu E110 Cht mu

Tinh du hng cam iu hng

2. Tnh ton lng t dc, hon thnh cng thc

Lng dng PVP lm t dc dnh trong cm thng l 0,5 5%.

Tiu nhm ngh lng PVP l 5% trong 1 n v ng gi, tc l:

5
1 0,05 (g)
100

Nu pha dung dch PVP 10% (kl/tt) bng ethanol 70%, th th tch ethanol cn ly l:
100
0, 05 0,5 (ml)
10

Lng dng Na CMC lm cht gy treo thng chim 0,1 5%.

Tiu nhm ngh lng Na CMC l 5% trong 1 n v ng gi, tc l:

5
1 0,05 (g)
100

Cng thc hon chnh

Thnh phn 1 n v 100 n v

Paracetamol 150 mg 15 g

Dung dch PVP 10% (kl/tt) 0,5 ml 50 ml

Aerosil 5 mg 0,5 g

Na CMC 50 mg 5g

Tinh du hng cam v v

Dung dch mu E110 v v

ng saccharose v 1 g v 100 g

13
II. CCH IU CH

Dng c, thit b d kin

Cn in t
Ry
B ci chy; ng ong 50 ml; becher 100 ml, 250 ml; a thy tinh
My xt sa ht, t sy
Cn o m bng hng ngoi

Phng php: xt ht t

1. Nghin v trn bt kp

Nghin bt n:
Tit trng ci chy, nghin ring tng cht (bt no c t trng nng hn th nghin mn hn,
bt no c khi lng ln hn th nghin trc).
Ry qua ry 1 mm (ch khng cho qu nhiu bt ln ry, lc ry va phi, khng ch xt
mnh).

Cn cc nguyn liu theo cng thc.

Trn bt kp: cho ln lt v trn u bt theo nguyn tc ng lng (bt c khi lng nh cho
vo trn trc, theo th t Na CMC, paracetamol, ng saccharose xay mn).

2. Trn hn hp bt vi t dc dnh lng

Pha dung dch PVP 10% (kl/tt):

Bt PVP 5g
Ethanol 70% v 50 ml
Cn 5 g bt PVP cho vo becher 250 ml kh sch, thm khong 30 ml ethanol 70%, khuy
u cho tan ht. Thm cht mu vo, khuy u.
Chuyn dung dch vo ng ong, thm ethanol 70% va 50 ml.

To khi bt m:
Cho t t dung dch PVP 10% va pha vo ci, va cho va trn u n khi khi bt
m v kt dnh nhau (bp ht khi nho thnh cc trn, ngng bp th khi nho khng b
b hay v vn).
Ghi nhn th tch dung dch PVP 10% dng.

3. Xt ht
Xt ht th cng qua ry 2 mm: dng chy p theo phng thng ng, va p va xoay u chy.

4. Sy ht
Tri u cm ra khay (c lt giy) thnh lp mng.
o
Sy cm nhit 50 70 C n khi m 5%.

14
5. Sa ht
Sa ht th cng qua ry 1 mm

6. Trn hon tt, ng gi, kim tra

Tri cm u trn khay, phun tinh du hng cam vo cm, trn s, phun li tinh du, ri em sy
o
nh 50 70 C trong 5 pht.

Sau cn lng cm, tnh ton li lng aerosil thc t cn dng. Trn aerosil vi cm trong bao
nilon.

ng gi, kim tra thnh phm.

S qui trnh iu ch cm pha hn dch Paracetamol

Nghin v trn bt kp Nghin bt n, cn nguyn liu, ry 1 mm

Trn bt kp theo th t:
Na CMC, paracetamol, saccharose

To khi bt m Pha dung dch PVP 10% (kl/tt), thm cht mu

Trn u bt kp vi t dc dnh va

Xt ht Xt ht qua ry 2 mm

o
Sy ht Sy 50 70 C, n khi m 5%

Sa ht Sa ht qua ry 1 mm

Trn hon tt Tri cm ln khay, phun tinh du, trn s, phun tinh du li,
o
sy nh 50 70 C trong 5 pht
Thm aerosil vo cm, trn u trong nilon

ng gi

Kim nghim

15
III. CH TIU NH GI CNG THC

nh gi vai tr ca cht gy treo la chn, c 2 ch tiu sau

1. Kh nng phn tn

Ly 2 g cm thnh phm cho vo khong 20 ml nc, khuy nh.

Xc nh thi gian hn dch c phn tn hon ton sau khi khuy.

2. lng

Cho 2 g cm vo 20 ml nc, khuy u, ri chuyn sang ng ong, dng nc trng v b sung

va 25 ml, xc nh th tch hn dch ban u V0 trong ng ong.

Sau 15 pht, c th tch phn lng V.

V
Tnh h s lng: F
V0

lng % = F x 100.

lng cng ln, hn dch c xem cng bn.

16
 VIN NN PARACETAMOL

CNG THC
Cng thc 1 vin nn Paracetamol 325 mg:
Paracetamol 325 mg
Avicel PH101 20 mg
T dc n 20 mg
Tinh bt m (pha h) 10 mg
Natri starch glycolat 22 mg
Aerosil 0,5 mg
Magie stearat 2,5 mg

I. XY DNG CNG THC

Paracetamol l dc cht t tan, ti xp, kh lin kt, nn cn thm t dc n t n hi, dnh tt
d nn v xt ht hn, v d cc dn cht ca cellulose [3].
Cellulose vi tinh th (Avicel) vi hm lng 5 15% cho thy c li trong qu trnh xt ht t v
sy kh, gim tnh cng b mt v vt m trn vin thuc [7].
V vy, tiu nhm ngh chn t dc n Avicel PH101 v tnh a nng ca n, ng thi n
gin ho cng thc, trnh thm cht mi.

Bng nc ct, tinh bt m c pha thnh h tinh bt 10% (kl/kl).

Vy, lng h tinh bt 10% cho 1 vin l 100 mg.
lng nc ct cn dng cho 1 vin l 90 mg.

Vy cng thc hon chnh l:

Hm lng % 1 vin 500 vin 500 vin

Thnh phn
trong 1 vin (mg) (g) (g, hao ht 20%)

Paracetamol 81,25 325 162,5 195

Avicel PH101 10 40 20 24

H tinh bt 10% (kl/kl) 2,5 100 50 60

Natri starch glycolat 5,5 22 11 13,2

Aerosil 0,125 0,5 0,25 0,3

Magie stearat 0,625 2,5 1,25 1,5

TNG 100 400 400 480

17
Vai tr ca cc cht trong cng thc

Thnh phn Vai tr

Paracetamol Dc cht

Avicel PH101 T dc n, dnh

H tinh bt 10% (kl/kl) T dc dnh

Natri starch glycolat T dc r

Aerosil T dc trn

Magie stearat T dc trn

II. QUI TRNH IU CH

Dng c, thit b d kin

Cn in t

Ry, phu o gc chy, thc o

B ci chy; becher 100 ml, 250 ml; a thy tinh

My xt sa ht, t sy

Cn o m bng hng ngoi, my o r, my th mi mn, my o cng

Phng php: xt ht t.

1. Chun b nguyn liu

Nghin bt n, ring tng nguyn liu (bt no c t trng nng hn th nghin mn hn, bt no
c khi lng ln th nghin trc), ry qua ry 1 mm. Cn nguyn liu theo cng thc.

Pha t dc dnh:
Tinh bt m 6g
Nc ct 54 g
Cn 6 g tinh bt, nghin nh, cho vo becher 100 ml.
Thm 54 g nc ct (54 ml), ngm khong 15 pht tinh bt trng n.
t becher trn bp in, khuy t t, hn hp s chuyn sang th h st, trong.

2. Trn bt kp

Cc nghin cu (Shotton and Leonard, 1972; Rubenstein and Bodey, 1974) ngh t dc r
ngoi chim 20 50% s cho kt qu tt nht [8].
Tiu nhm ngh t l natri starch glycolat r ngoi : r ni l 5 : 5.
(6,6 g natri starch glycolat r ngoi : 6,6 g natri starch glycolat r ni)

18
 Trn 6,6 g natri starch glycolat, 24 g Avicel PH101, 195 g paracetamol trong ci theo nguyn tc
trn bt kp.
(cht c lng bt nh cho trc, thm dn cht c lng ln hn; bt nng trn trc, bt nh
trn sau trnh bay bi)

3. Xt ht t

Thm h tinh bt 10% vo khi bt va lm m v kt dnh, trn u.

Xt ht qua my xt vi ry 2 mm.

4. Sy ht
o
Sy kh cm 50 70 C n khi t m 5%.

5. Sa ht

Sa ht qua my sa vi ry 1 mm.

6. Trn hon tt

Thm 6,6 g natri starch glycolat vo cm, trn u.

Trn cm tip vi 0,3 g aerosil, 1,5 g magie stearat.

7. Dp vin

Tin hnh dp vin trn my dp vin tm sai.

8. ng gi, kim nghim

Chn vin, ng gi, kim nghim thnh phm.

19
 Qui trnh iu ch vin nn Paracetamol

Chun b nguyn liu Nghin bt n, ry qua ry 1 mm, cn nguyn liu

Pha 60 g h tinh bt 10% (kl/kl)

Trn bt kp Trn u 6,6 g natri starch glycolat, 24 g Avicel PH101,

195 g paracetamol theo nguyn tc trn bt kp

Xt ht t Thm h tinh bt 10% va , trn u

Xt ht qua ry 2 mm

o
Sy ht Sy 50 70 C, n khi m 5%

Sa ht Sa ht qua ry 1 mm

Trn hon tt Thm 6,6 g natri starch glycolat, trn u

Thm 0,3 g aerosil, 1,5 g magie stearat, trn u
Kim m, chy, phn b c ht

Dp vin Dp vin bng my dp tm sai

ng gi

Kim nghim Kim ng u khi lng, r, cng, mi mn

20
III. CC CH TIU NH GI CM BN THNH PHM [1]

1. m

Phng php: xc nh mt khi lng do lm kh

Cch thc hin: dng cn o m bng hng ngoi (cn sy m).

M np cn, t a cn vo tay cm a cn, ri t c hai vo bung mu.

Tri mu thnh 1 lp mng u trn a cn, khong 3 g mu.

y np cn, tin hnh sy. Khi my dng, c kt qu m.

nh gi: m cm khng qu 5,0%.

2. chy

Tc chy
L khi lng ht thuc trong 1 giy, chy qua mt phu c chui c ng knh trong 10 mm,
gc nghing, chui phu c tiu chun ha v gn vi dng c, thit b rung lc trong iu kin quy
nh. Lng ht cho mi ln th l 50 100 g.
Khi lng ca ht (g)
Tc chy ca ht =
Thi gian chy ht khi ht (giy)
Gc chy
Cn 50 g ht, cho chy qua phu c kch thc xc nh, o cao h v ng knh d ca khi
bt.
2h
Tnh gc chy , bit: tan
d

Gc chy nh gi
o
> 65 Bt dnh, khng chy
o
= 25 30 Bt chy tt

< 25 Bt khng dnh, chy rt tt

3. Phn b c ht

Tin hnh ry bng tay hoc dng my ry vi b ry chun thng c 12 c, t 45 2000 m.

Cn mt lng ht, t ln c ry ln nht v lc quay trn theo chiu nm ngang trong t nht 20
pht, cho ti khi ht phn chia hon ton hoc theo ch dn nu dng my ry.

Cn s ht cn li trn cc mt ry v phn ht trong hp hng.

Tnh t l % khi lng ht mi c ry so vi tng lng, v biu th hin ng cong phn

b c ht.

ng cong c hnh chung hp th cm c c ht kh ng nht.

21
IV. CC CH TIU KIM TRA NHANH VIN NN

1. ng u khi lng (Ph lc 11.3 DVN IV) [2]

Cch thc hin: cn ring bit 20 vin nn ngu nhin, tnh khi lng trung bnh.

nh gi: (khi lng trung bnh bng hoc ln hn 250 mg)

Khng c qu 02 vin thuc c khi lng nm ngoi gii hn chnh lch 5% so vi khi lng
trung bnh.

Khng c c vin thuc no c khi lng vt gp i gii hn .

2. r (Ph lc 1.20, 11.6 DVN IV) [2]

Cch thc hin: dng my o r

Ly 6 vin nn, cho vo mi ng th 1 vin.

Treo gi ng th trong cc c cha nc. Vn hnh my trong vng 15 pht.

Ly gi ng th ra khi cht lng, nh gi kt qu.

nh gi: mu th t yu cu nu tt c 6 vin u r khng qu 15 pht.

3. mi mn [1]

mi mn ca vin nn l t l % khi lng b mt i do b v, b bo mn sau qu trnh th

nghim.
Thng s ny cho bit bn chu va p, c bit l bn b mt ca vin chng li s bo
mn ca my.

Tin hnh: cn 20 vin nn, cho vo my th mi mn, quay vi tc 25 vng/pht trong 4

pht. Cn vin sau th nghim, tnh kt qu.

nh gi: mi mn ca vin nn thng thng phi 3%.

4. cng [1]

cng l lc ti thiu lm v vin theo hng chu lc km nht (ng knh).

Tin hnh: t vin thng ng hoc nm ngang trn e c nh, pha trn vin tip xc mi e.
Cho my nn mi e vo vin vi lc ln dn, n khi v. My dng v t ghi gi tr lc lm v vin.

Dc in khng qui nh c th, m do nh sn xut n nh.

2
Gi tr tham kho: 4 kf/cm .

22
 TI LIU THAM KHO

Ti liu ting Vit

1. Hunh Vn Ho, L Th Thu Vn, Bo ch v Sinh dc hc Tp 2, NXB Y hc, 2014, Hn dch

Nh tng, Thuc bt Thuc cm, Thuc vin nn, vin bao v vin trn, Vin nang Vi nang, tr.
2740, 117135, 147190, 225252.

2. B Y T, Dc in Vit Nam IV, NXB Y hc, 2009, Paracetamol, Nang Paracetamol, Hn dch
thuc, Thuc cm, Thuc nang, Thuc vin nn, Xc nh mt khi lng do lm kh, Php th
ng u khi lng, Php th r ca vin nn v vin nang, tr. 462, 464, PL-12, PL-14, PL-20,
PL-29, PL-182, PL-221, PL-222.

3. V Xun Minh, Vin nn, K thut bo ch v Sinh dc hc cc dng thuc Tp 2, NXB Y hc,
2004, tr. 189.

Ti liu ting Anh

4. Raymond C. Rowe, Paul J. Sheskey, and Marian E. Quinn, Handbook of Pharmaceutical Excipients,
th
6 ed., Pharmaceutical Press and the American Pharmacist Association, 2009, Alcohol,
Carboxymethylcellulose sodium, Cellulose microcrystalline, Colloidal silicon dioxide,
Croscarmellose sodium, Lactose anhydrous, Lactose monohydrate, Magnesium stearate, Povidone,
Sodium starch glycolate, Starch, Sucrose, Talc, Water, Xanthan gum, p. 17, 118, 129, 185, 206, 359,
364, 404, 581, 663, 685, 703, 728, 766, 782.
th
5. Lewis, R.J. Sr., Paracetamol, Hawley's Condensed Chemical Dictionary, 15 ed., John Wiley & Sons
Inc., 2007, p. 11.

6. Kenneth A. Connors,Gordon L. Amidon,Valentino J. Stella, Acetaminophen, Chemical Stability of

nd
Pharmaceuticals: A Handbook for Pharmacists, 2 ed., John Wiley & Sons Inc., 1986, p. 163.
st
7. Linda A. Felton, Oral solid dosage form, Remington Essentials of Pharmaceutics, 1 ed.,
Pharmaceutical Press, 2012, p. 583.
nd
8. Mark Gibson, Oral solid dosage form, Pharmaceutical Preformulation and Formulation, 2 ed.,
Informa Healthcare USA Inc., 2009, p. 398.

23
 K HOCH THC TP

Tun Ni dung thc tp

Tun 1 Sa cng
Cn, nghin nguyn liu
Cm pha hn dch: iu ch n giai on sy

Tun 2 Cm pha hn dch: hon tt thnh phm

Vin nang: iu ch cm n giai on sy
Vin nn: iu ch cm n giai on sy

Tun 3 Cm pha hn dch: kim nghim thnh phm

Vin nang: xc nh t trng biu kin, tnh th tch ng nang, ng
nang
Vin nn: sa ht, kim bn thnh phm, trn hon tt, dp vin

Tun 4 Vin nang: kim nghim thnh phm

Vin nn: kim nghim thnh phm
Tng kt

24