BI 1: HN DCH IBUPROFEN

Cng thc:
Ibuprofen ---
Saccharose 40%
Sorbitol lng 8% (kl/tt)
Glycerol 1,5% (kl/tt)
Gm xanthan 0,25%
Acid citric 0,125%
Cht bo qun 0,125%
Vanillin 0,0125%
Tween 80 0,125% (kl/tt)
Nc tinh khit v ---
1. L thuyt
1.1 Cng thc 1 n v phn liu 5ml cha 200mg ibuprofen
Thnh phn 5 ml sn phm c cha
Ibuprofen 200 mg
Saccharose 2000 mg
Sorbitol lng 400 mg
Glycerol 75 mg
Gm xanthan 12,5 mg
Acid citric 6,25 mg
Natri benzoat 6,25 mg
Vanillin 0,625 mg
Tween 80 6,25 mg
Nc tinh khit v 5 ml
1.2 Tnh cht, vai tr ca tng cht trong cng thc [3]
a. Ibuprofen
- Bt kt tinh trng hay tinh th khng mu.
- Khng tan trong nc, d tan trong aceton, dicloromethan, methanol, ether, tan trong cc
dung dch hydroxyd kim long v carbonat kim
- L hot cht chnh, c tc dng gim au, khng vim NSAIDs.
b. Saccharose
- L cht rn mu trng, c v ngt
- D tan trong nc l 1: 0,5
- C tc dng to v ngt v tng nht ca cht dn.
c. Sorbitol
- Bt kt tinh mu trng, khng mi, c v ngt
- Rt d tan trong nc (1:0,5), thc t khng tan trong ethanol 96%
- Cht lm tng nht, chng kt tinh ng trn np chai.
d. Glycerol
- Cht lng snh, khng mu, khng mi, v nng v ngt, d = 1,26
- Cht ht m, lm du v, lm ngt, tng nht.
e. Gm xanthan
- Bt trng hay trng ng
- D tan trong nc to dung dch keo nht c
- Tc nhn gy treo, gip n nh hn dch.
f. Acid citric
- Bt kt tinh trng hay tinh th, dng ht khng mu
- Rt d tan trong nc, ethanol 96 %, hi tan trong ether, d = 1,665
- Cht iu chnh pH.
1
 g. Natri benzoat
- Bt kt tinh hay tinh th mu trng, hi ht m
- D tan trong nc (1:18), hi tan trong ethanol 90%, d = 1,497
- Cht bo qun.
h. Vanilin
- Bt tinh th hnh kim, mu trng hay vng nht
- Kh tan trong nc, d tan trong ethanol 96% v methanol, tan trong cc dung dch kim
hydroxyd long
- Cht to mi thch hp dng cho ng ung.
i. Tween 80
- Cht lng nh du, c mu vng hoc h phch, mi nh, v nng hi ng, tan c trong
nc, HLB = 15
- Cht gy thm.
j. Nc tinh khit
- Cht lng trong sut, khng mu, khng mi, khng v
- Pha lin tc, cht dn.
1.3 Cht bo qun
Chn cht bo qun l Natri benzoat v:
- Cng thc trn l dng thuc hn dch gm 2 pha: pha ni l ibuprofen l cht rn khng tan v
c phn tn ng nht trong pha ngoi l nc. Natri benzoat d tan trong nc nn dng
lm cht bo qun trong pha nc.
- Khng chn Nipagin lm cht bo qun trong cng thc v Nipagin km tan trong nc cn c
cn ha tan, v Nipagin cng c tng k vi Tween 80 (Tween 80 hp ph Nipagin) nn
lm gim hot tnh khng khun ca Nipagin.
Natri benzoat d tan trong nc, c tng k vi acid citric to kt ta acid benzoic nhng c th khc
phc c bng cch pha ch ring.
1.4 Cng thc hon chnh v cch iu ch 1 n v sn phm
a. Cng thc hon chnh 1 n v sn phm
Thnh phn 80 ml thnh phm
Ibuprofen 3,2 g
Saccharose 32 g
Sorbitol lng 6,4 g
Glycerol 1,2 g
Gm xanthan 0,2 g
Acid citric 0,1 g
Natri benzoat 0,1 g
Vanillin 10% 0,1 g
Tween 80 0,1 g
Nc tinh khit v 80 ml
b. Cch iu ch 1 n v sn phm [1]
p dng phng php phn tn c hc, gm 3 giai on:
Nghin kh: nghin 3,2 g Ibuprofen n mn thch hp v vt gn trong ci
Nghin t: cn 0,1 g Tween 80 trn mt knh ng h c lt giy cho vo ci, thm 2 ml
nc ct trng mt knh ng h cho vo ci, nghin k thu c khi nho.
Phn tn khi nho vo cht dn:
Cho 0,2 g gm xanthan v 1,2 g glycerol vo becher, trn k. Thm 20 ml nc tinh
khit, khuy k, ngm trong 15 pht cho gm n hon ton (becher 1)
Ha tan 0,1 g bt vanillin 10% v 0,1 g acid citric vo 10ml nc (becher 2)

2
 Ln lt ha tan 0,1 g natri benzoat, 32 g saccharose vo 30 ml nc, cch thy nh
cho tan hon ton, sau cho becher 1 vo, un cch thy cho n khi tan hon
ton thu c hn hp cht dn (becher 3).
Cho hn hp becher 3 vo khi bt nho trong ci, cho 6,4 g sorbitol lng vo, ly
chy phn tn u. Cho ton b becher 2 vo, trng dng c bng 1 t nc, phn
tn u thnh hn dch ng nht.
Chuyn sang chai nh du th tch 80 ml, trng dng c v b sung nc va
80 ml.
ng np, dn nhn lc k trc khi dng.
1.5 Nhn sn phm

TRNG I HC Y DC TP.HCM
KHOA DC - B MN BO CH
41- 43 inh Tin Hong, P. Bn Ngh, Q.1, TP.HCM

HN DCH IBUPROFEN 200mg/5ml

Chai 80 ml
Ibuprofen .................................................. 3,2 g
T dc (v) ........................................... 80 m1
Ch nh: H st v gim au khi mc rng.
Cch dng: Xem t HDSD
S ng k: 01/2017 NSX: 15/01/2017
HSD: 15/01/2019 Bo qun: Xem t HDSD
LC TRC KHI DNG

1.6 Mi lin quan gia t dc trong cng thc v cc ch tiu kim nghim [2]
STT Ch tiu kim nghim Thnh phn lin quan Tiu chun k thut
1 nh tnh Ibuprofen C/khng
2 ha tan Ibuprofen >80% so vi ghi trn nhn, trong
thi gian ha tan l 60 pht.
2 ng u v phn liu Glycerol Chuyn lun chung
3 Sai s th tch Glycerol Chuyn lun chung
4 pH Acid citric 3,6 4,6
5 Gii hn 4- isobutyl Ibuprofen < 0,25 %
acetophenon
6 Gii hn dung mi d Glycerol, Tween 80, Ethylene glycol: 620 ppm
gm xanthan 2 propanol: < 5000 ppm
7 Hm lng ibuprofen Ibuprofen 180 220 mg/ 5ml

1.7 Cng thc Ibuprofen trn th trng [4]

Nurofen for Children Suspension
Thnh phn Cng thc thc tp
Ibuprofen 100mg/5ml
Hot cht chnh Ibuprofen Ibuprofen
Cht lm ngt Saccharose Syrup maltitol
Sodium saccharine
Cht n nh Sorbitol lng
Cht to nht Glycerol Glycerol
Cht gy treo Gm xanthan Gm xanthan
Cht iu chnh pH Acid citric Acid citric, Sodium citrate

3
 Cht to mi Vanillin 10% Hng cam
Cht bo qun Natri benzoate Domiphen bromide
Cht gy thm Tween 80 Tween 80
Cht dn Nc tinh khit Nc tinh khit
Cht khc Sodium chloride
2. Thc hnh
2.1 nh gi vai tr ca gm xanthan trong cng thc
- Tin hnh iu ch hn dch trn vi 2 cng thc: cng thc 1 c gm xanthan, cng thc 2
khng c gm xanthan.
- nh gi sn phm thu c da trn cc tiu ch:
Cm quan v yu cu chung: Hn dch khi yn th dc cht rn phn tn c th
tch ring nhng phi tr li trng thi phn tn ng nht trong cht dn khi lc nh
trong 1 - 2 pht v gi nguyn trng thi trong vi pht.
Phn b kch thc tiu phn trong hn dch.
nht hn dch.
Tc sa lng: Kho st tc sa lng ca hai cng thc trn.
Lc u hn dch, l y mt lng hn dich
cho vao ng ong 100 ml. Xc nh h s
lng ca cc tiu phn sau khong thi gian xc nh.
H s lng F c xc nh nh sau:
Vu
F=
Vo
Vu : th tch cht lng
Vo : th tch hn dch ban u
lng% = F x 100
F cng ln, hn dch c xem cng tt.
Kh nng phn tn li sau khi sa lng (Stanko Decay)
Cho hn dch kt lng vo ng ong 100 ml v cho quay 360o vi tc 20 vng/
pht. Th nghim kt thc khi khng cn thy cn lng di y ng ong. Ghi nhn
s vng quay. S vng quay cng t, hn dch cng tt.
2.2 Dng sorbitol thay th cho sorbitol lng
- Lng Sorbitol lng 70% dng trong cng thc: 6,4 g
- Vy lng Sorbitol rn cn dng l: 6,4 x 70 / 100 = 4,48 g
- V sorbitol rn rt d tan trong nc (1:0,5), nn ta s ha tan 4.48g sorbitol vo becher 3
(trong mc 1.4)

Ti liu tham kho

[1]. L Th Thu Vn, Nh tng v hn dch, Bo Ch v Sinh dc hc tp 2, NXB Y hc, 2014,
trang 27-40.
[2]. USP35-NF30, Ibuprofen Oral Suspension, trang 3471.
[3]. Raymond C. Rowe, Handbook of Pharmceutical Excipients 6th edition.
[4]. eMC, Nurofen for Children Suspension 100mg/5ml, Reckitt Benckiser Healthcare (UK) Ltd
(https://www.medicines.org.uk/emc/medicine/20102)

4
 BI 2: THUC M DICLOFENAC 1%
Cng thc
Diclofenac (Diclofenac diethylamin) 1g
Cetostearyl alcohol g
Sp ong g
Du paraffin g
Propylenglycol 15g
Tween 80 g
Nipagin M 0,2g
Nc ct v 100g

1. Tnh cht v vai tr ca tng cht trong cng thc [1], [2]
Cht Tnh cht
- Thuc nhm NSAID dn cht arylacetic.
- Bt tinh th mu trng hoc hi vng, d
tan trong methanol, tan trong propylen-
Diclofenac
glycol v ethanol, t tan trong nc v
diethylamin
aceton, thc t khng tan trong ether,
chloroform v NaOH, d thm qua da.
- Nhit nng chy khong 154oC.
- Ch yu l cetyl alcol (20-35%) v
strearyl alcol (50-70%). Th cht rn dng
ha t hay vay, cng nhu sp, mu tr ng hoc
hi vng, mi nhe c trung, vi nha t. Bn
Cetostearyl vng, kh nng nh ha yu to kiu nh
alcohol tng N/D.
- Tan trong eter, ethanol 95%, du thc
vt. Khng tan trong nc, khi un chy
c th hn ha vi du bo, parafin.
- Nhit nng chy: 49-56oC.
- Dng mnh, phin mu trng hoc vng
nht hoc cc ht mn hn c, khng v.
- Tan trong cloroform, ether, t tan trong
Sp ong
ethanol 95%, khng tan trong nc. Ha
tan hon ton trong du bo v tinh du.
- Nhit nng chy: 61 66oC.
- L hn hp cc hydrocarbon no th lng,
trong m, snh, khng mu, khng mi,
khng v. Bn vng, tr v mt ha hc,
khng b nm mc vi khun tc dng. T
Du
trng 0,830,89g/cm3.
paraffin
- Tan trong chloroform, ether, du. Khng
tan trong aceton, ethanol 95% v nc,
ng tan vi mi t l du bo (tr thu
du) v cc tinh du.
- Cht lng snh, trong sut, khng mu,
khng c mi r, v ngt, hi cht ging
glycerin nng hn nc. T trng
Propylen
1,038g/cm3
glycol
- Tan trong nc, acetone, chloroform,
ethanol 95%, glycerin, ha tan trong eter
theo t l (1:6), khng th trn ln vi du
5
Vai tr
- Hot cht chnh.
- Tc dng dc l: gim au,
khng vim.
- Thnh phn ca pha du.
- Cht nh ha n nh, phi hp
vi cc cht nh ha mnh kiu
D/N (Tween 80) lm tng rt mnh
kh nng nh ha, ht nc ca
nhiu t dc (Tween 80).
- Ngoi ra, cn c tc dng lm du
da, mm da.
- Thnh phn ca pha du.
- Phi hp vi du paraffin iu
chnh th cht, lm tng cng,
chy ca thuc m.
- Gip tng kh nng nh ha ca
t dc nh tng (Tween 80).
- Thnh phn ca pha du
- Cht iu chnh th cht, phi
hp lm gim cng ca thuc
m.
- Lm tng du trong cc t dc
nh tng.
- Thnh phn ca pha nc.
- Dung mi ha tan diclofenac
diethylamin.
- L cht gi m, tng kh nng
thm ca hot cht do lm gim
tnh i khng lp sng v tng
qu trnh hydrat ha ca da.
 khong hoc cc loi du c nh nhng
ha tan c 1 s tinh du.
- Cht lng trong dng du mu vng hoc - Cht nh ha c bn cht l cht
vng nu, v ng. T trng tng i din hot.
khong 1,08g/cm3. nht khong 400 - Gim sc cng lin b mt gip
Tween 80 mPas 25oC, HLB = 15. hnh thnh v n nh nh tng,
- Hn ha vi nc, ethanol, ethyl acetat tng tnh thm ca hot cht.
v vi methanol, thc t khng tan trong
cc du bo v parafin lng.
- Dng bt kt tinh trng, khng mi, - Cht bo qun, ngn s pht trin
khng v. ca vi khun, nm mc.
Nipagin
- Rt t tan trong nc, d tan trong
ethanol 96% v trong methanol.
- Cht lng, trong sut, khng mu, - Pha ngoi.
Nc ct khng mi, khng v. L nc ung c
lm tinh khit bng phng php ct.

2. Thit lp cng thc kho st nh hng ca t l cetostearyl alcohol: sp ong: du paraffin n

dn mng v bn vt l ca thuc m.
Thuc m Diclofenac 1% dng dng diclofenac natri (M = 318,1) l 1g. Vy lng diclofenac
diethylamin (M = 369,3) l:
MDiclofenac natri = 318,1 nDiclofenac natri = 1/318,1 = 3,14.10-3 (mol)
mDiclofenac diethylamin = 3,14*10-3 x 369,3 = 1,16 g
a. Cng thc 1: T l 1,4 : 0,1 : 2,3
Gi x, y, z ln lt l lng cetostearyl alcohol, sp ong v du parafin.
T l cetostearyl alcohol: sp ong: du parafin = 1,4 : 0,1 : 2,3
x 1,4
= x = 14y (1)
y 0,1
y 0,1
= z= 23y (2)
z 2,3
Pha du chim 25% (kl/kl) trong cng thc: x + y + z = 25g (3)
(1), (2), (3) x = 9,2g y = 0,7g z = 15,1g
b. Cng thc 2: T l 0,9 : 0,6 : 2,3
Gi a, b, c ln lt l lng cetostearyl alcohol, sp ong v du parafin.
T l cetostearyl alcohol: sp ong: du parafin = 0,9 : 0,6 : 2,3
a 0,9
= a = 1,5b (4)
b 0,6
b 0,6 2,3
= c= b (5)
c 2,3 0,6
Pha du chim 25% (kl/kl) trong cng thc: a + b + c = 25g (6)
(4), (5), (6) a = 5,9g b = 3,9g c = 15,2g
Thnh phn Cng thc 1 Cng thc 2
Diclofenac diethylamin 1,16g 1,16g
Cetostearyl alcohol 9,2g 5,9g
Sp ong 0,7g 3,9g
Du parafin 15,1g 15,2g
Propylenglycol 15g 15g
Tween 80 1g 1g
Nipagin 0,2g 0,2g
Nc ct 57,64g 57,64g

6
3. ngh cch iu ch 100g thnh phm [1]
- Phng php: trn u nh ha
- S iu ch:

Ha tan: Cetostearyl alcohol, Ho tan: Tween 80, Propyleneglycol,

Sp ong, Du parafin Nipagin, Diclofenac diethylamin, Nc ct

Pha d (65-70oC) Pha nc (70-75oC)

Trn u nh ho

ng nht ho

X l tup Kim tra bn thnh phm

V tup

Kim nghim thnh phm

ng gi

- Nguyn tc: iu ch pha Nc ring, pha Du ring, phi hp hot cht v t dc ng thi vo
tng pha ty theo tnh cht. Duy tr nhit pha Du 6570oC, pha Nc cao hn pha Du 5oC.
Khuy trn n khi thu c hn hp ng nht.
- Cc bc thc hin:
Pha Du: cn ln lt cc cht: Cetostearyl alcohol, Sp ong, Du parafin, khuy u. un chy
lng khi t dc pha Du khong 65-70oC .
Pha Nc: cn ln lt cc cht Tween 80, Propylenglycol, Nipagin v cui cng l Diclofenac
diethyllamin, khuy n tan hon ton, thm nc ct vo, khuy u. un v duy tr hn hp
nhit 70-75oC.
Phi hp hai pha Nc vo pha Du: phi hp t t pha Du vo pha Nc, khuy trn lin tc
cho n khi ngui, to hn hp ng nht.
ng chai thnh phm, nt kn v dn nhn. Chai ng thnh phm nn l chai kim loi nh Al
trng verni, ng y, nt kn.
+ Dn nhn.

7
 TRNG I HC Y DC TP.HCM
KHOA DC - B MN BO CH
41- 43 inh Tin Hong, P. Bn Ngh, Q.1, TP.HCM
Kem bi da
DICLOFENAC 1%
Tup 100g

Cng thc: Diclofenac diethylamin 1,16g

T dc v 100g
Cng dng: Gim au, khng vim Ngy pha ch: 15/01/2017
Cch dng: Xem HDSD HSD: 3 nm t ngy sn xut
Liu dng: Xem HDSD KBQ: ni mt, trnh nh sng

4. Cch tin hnh nh gi dn mng v bn vt l ca ch phm [1]

4.1. dn mng:
o din tch dn mng di tc dng ca mt khi lng xc nh
Tin hnh: t ln tm knh mt lng thuc m nht nh, ng knh nht nh. t tm knh
thc hai ln, c ng knh ban u khi thuc m tn ra. t ln tm knh qu cn c khi
lng xc nh, c ng knh tn ra ca khi thuc m v so snh vi kt qu vi thuc m
i chng.

4.2. bn vt l:
nh gi s bn vng ca thuc bng cm quan: thay i hnh thc bn ngoi, s tch lp ca
thuc m khi tc ng ln thuc nhng yu t: nhit cao, thp, s ly tm.
Phng php: lo ha cp tc: thuc m c theo di s thay i cht lng trong 6 chu k gia
gim nhit , 1 chu k: 4oC/ 24h, 50oC/ 24h, nhit phng/6h. Sau mi chu k thuc m c
kim tra cc ch tiu cht lng theo yu cu. t khi khng c s thay i no qua 6 k.

5. Ti liu tham kho

[1]. Hunh Vn Ha, K thut iu ch thuc mm dng ngoi, Bo ch v sinh dc hc tp II
2014
[2]. B Y t, Chuyn lun Cetostearyl alcol; Tween 80; Sp ong, Dc in Vit Nam IV, 2009.

8
 BI 3: THUC N PARACETAMOL
Cng thc
Paracetamol 150 mg
T dc v 1 vin
T dc bao gm PEG 4000: PEG 400, t l 90:10
Yu cu thuc n
iu ch 24 vin thuc n paracetamol
t ch tiu v cm quan
t ch tiu r
t ch tiu ng u khi lng.

1. Trnh t ni dung cn thc hin t yu cu trn

Gm 3 ni dung nh sau:
Xc nh h s thay th E.
Tnh ton v thit lp cng thc iu ch 24 vin thuc n.
nh gi v cm quan, r v ng u khi lng.
2. Cch tin hnh cc ni dung
a. Xc nh h s thay th E
Trng hp cha bit h s thay th, c th tnh nh sau:
x (y p)
F=
p
x: khi lng 12 vin t dc nguyn cht
y: khi lng 12 vin c p (gam) dc cht + t dc.
p: l lng dc cht trong 12 vin.
T F, c th tnh ra E:
1
E=
F
Cng thc 1: iu ch 12 vin t dc
Cho khi lng mi vin thuc n l 3g.
iu ch 12 vin cn t nht 36g, vy iu ch 40g.
T l t dc PEG 4000: PEG 400 l 9:1, vy cn 36g PEG 4000 v 4g PEG 400.
Trn t dc, un chy v khun thu 12 vin. Cn 12 vin t dc, xc nh x.
Cng thc 2: iu ch 12 vin dc cht + t dc.
Vin cn iu ch gm 3 thnh phn (paracetamol, PEG 4000, PEG 400), tng lng cn iu
ch cng l 40g.
Thit k paracetamol 10%, cn 4g paracetamol.
PEG 4000: PEG 400 l 9:1, vy cn 32,4g PEG 4000 v 3,6g PEG 400.
Trn 3 thnh phn, un chy v khun thu 12 vin.
Cn 12 vin dc cht + t dc, xc nh y.
Gi tr p c tnh da vo lng y cn c: p = 10% y
Th cc gi tr x, y, p vo cng thc, tm c F v E.
b. Thit lp cng thc 24 vin thuc n
Cng thc 1 vin thuc n paracetamol:
Paracetamol 150mg
T dc v 3g
Liu nh vy iu ch 24 vin thuc n.
H s E tm c bc 1. Th vo cng thc
nb
X=na
E
E: h s thay th thun
9
 n: s lng vin cn iu ch
a: khi lng 1 vin
b: lng dc cht cho 1 vin
Trong , theo yu cu ta c:
n = 24 (iu ch 24 vin)
a l khi lng trung bnh ca 1 vin t dc (c c khi tm h s thay th, l lng cn x/n).
b = 0,15 (l lng hot cht c trong 1 vin).
Tm c X, l lng t dc PEG 4000 v PEG 400.
PEG 4000 = 90% X
PEG 400 = 10% X
Paracetamol = 0,15 24 = 3,6g
Cng thc 24 vin thuc n paracetamol l:
Paracetamol 3,6g
PEG 4000 0,9X
PEG 400 0,1X
c. nh gi cc ch tiu
Ch tiu cm quan [1]
B mt vin phi mn, lng, khng c vt nt do lm lnh qu nhanh hoc do lc khun qu
sm hay qu mun. Khng c c nhng m trng hoc s kt tinh dc cht trn b mt vin. Khi
ct dc v ct ngang vin thuc v quan st, mt ct phi thun nht, khng c hin tng ng cc
hay lng ng dc cht.
Ch tiu r [2]
t mt vin ln a di ca b phn kim loi, a b phn ny vo ng bao v gn cht vo
thnh ng. t thit b th vo mt bn cha t nht 4 lt nc m (36 37oC ) c gn dng c khuy
chm v gi thit b th v tr thng ng, ngp 90 mm so vi mt nc. Xoay ngc thit b th 10
pht mt ln, trnh khng nh ln khi mt nc.
Lp li ton b th nghim vi hai vin khc.
Thuc c coi l r, khi p ng mt trong nhng yu cu sau:
Tan hon ton.
Phn tch ra cc thnh phn to thnh, ri tp trung trn b mt (cc cht m nng chy), chm
xung y (bt khng tan) hay ho tan trong nc (cc thnh phn ho tan), hoc c th phn
tn theo mt hay vi cch nu trn.
Tr nn mm, c th bin dng ng k, khng nht thit b phn tch hon ton ra cc thnh
phn to thnh, nhng khng c nhn rn chu c sc p ca a thu tinh.
Thi gian r khng qu 30 pht i vi cc thuc n c t dc thn m v khng qu 60 pht i
vi thuc n tan trong nc.
Ch tiu ng u khi lng [2]
Cn ring bit 20 n v ly ngu nhin, tnh khi lng trung bnh. Khng c c qu hai
n v c khi lng vt qu 5% so vi khi lng trung bnh v khng c c n v no c khi
lng vt gp i gii hn .
3. Tnh cht ca 2 loi PEG [3]
Tnh cht PEG 400 PEG 4000
Cng thc phn t m = 8,7 m = 69 84
HOCH2(CH2OCH2)mCH2OH
Trong lng phn t (g/mol) 380 420 3 000 3 700
T trng (g/cm3) 1,120 1,080
Th cht ( 25 C)
o
Cht lng nht, trong sut, Cht rn mu trng, th cht gn
khng mu ging sp hoc parafin
im nng chy/ ng c 48 53 59
(oC)
im bc chy (oC) 238

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 pH (dung dch 5% kl/tt) 4,0 7,0
nht ng lc hc
cP (mPa.s) 105 130 110 170
nht ng hc
cSt 25oC (mm2/s) 94 116 (90,0) 102 158 (180)
Ch s hydroxyl 264 300 25 32
Sc cng b mt (mN/m) 44 55 (dd nc 10% kl/tt)
Hm m ( m %) Rt ht m Khng ht m
tan Hn ha vi nc, tan trong Tan trong aceton, DCM, ethanol
acetone, cn, benzen, glycerin 95%, methanol.
v cc glycol. t tan trong hydrocarbon no v
t tan trong hydrocarbon bo. ether. Khng tan trong cht bo,
du khong.

4. Cch iu ch thuc n paracetamol

Thuc n paracetamol c iu ch bng phng php un chy khun.
Nguyn tc: Dc cht c ha tan hoc phn tn trong t dc c un chy, sau vo
khun c th tch nht nh nhit thch hp.
Tin hnh qua 2 giai on:
Chun b dng c v nguyn liu.
Phi hp dc cht vo t dc v khun.
a. Chun b dng c v nguyn liu [1]
Ra sch khun.
Tit trng khun.
Bi trn khun (nu cn) bng du parafin.
vo t lnh lm lnh khun.
Cn nguyn liu theo cng thc tnh.
b. Phi hp dc cht vo t dc v khun.[1]
Phng php phi hp paracetamol vo t dc l phng php ha tan (do paracetamol c kh nng
tan hon ton trong hn hp PEG 4000 v PEG 400).
Trn hn hp PEG 4000 v PEG 400 cn vo 1 chn s. un chy hn hp nhit thch
hp v khuy u cho n khi hn hp t dc ng nht.
Cho Paracetamol vo, va un va khuy cho tan hon ton, dung dch trong sut.
ngui n gn nhit ng c khong 60oC (lun khuy trnh lng ng). Tin hnh
khun, nhanh v lin tc, y v cao hn b mt khun 1 - 2 mm
Lm lnh khun thuc ngay thuc ng rn hon ton.
Dng dao ct b phn tha.
Tho khun, ly vin ra, gi vin trong giy chng m, dn nhn.

5. So snh thuc n thc tp vi 2 thuc n paracetamol c trn th trng v t dc v cu

trc ha l.
Thuc Thuc n thc tp Alvedon Suppositories Efferalgan Suppositories
125 mg [4] 150mg [5]
Nh sn Intrapharm Laboratories Bristol-Myers Squibb, Php.
xut Limited, UK
T dc PEG 4000 & 400 Witepsol H12 Triglycerid
Cu trc Dung dch Hn dch Hn dch
ha l

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6. Ti liu tham kho
[1]. Trnh Th Thu Loan, Thuc t, Bo ch v sinh dc hc tp 2, NXB Y hc, 2014, trang 99
116.
[2]. B Y t, Ph lc 11.3; 11.5, Dc in Vit Nam IV, NXB Y hc, 2009.
[3]. D. Wallick, Polyethylene glycol, Handbook of Pharmaceutical Excipients 6th Edition, p.517
522.
[4]. eMC, Alvedon Suppositories 125 mg (https://www.medicines.org.uk/emc/medicine/29892).
[5]. Bristol-Myers Squibb, Efferalgan 150mg Suppositories (http://www.bms.com/products/Pages
/home.aspx)

K HOCH THC HIN

Bui 1 Hn dch Ibuprofen
Kho st cng thc
iu ch hn dch bng phng php phn tn c hc
Bui 2 Thuc m diclofenac 1%
Kho st cc t l t dc ph hp
iu ch thuc m bng phng php trn u nh ha
Bui 3 Thuc n Paracetamol
Xc nh h s thay th
Tin hnh iu ch 24 vin.
Bui 4 nh gi cc ch tiu ca 3 thuc
- Hn dch Ibuprofen
- Thuc m diclofenac 1%
- Thuc n Paracetamol

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