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T 2 M1 K65

1. Kim tra tinh cht v t ly cua thuc m va ta dc


1.1. Kim tra ng nht cua thuc m
1.2. Xac inh im nho giot
1.3. Xac inh im ng c
1.4. Xac inh chi s nc
2. Kim tra tinh cht lu bin cua thuc m
2.1. Xac inh nht
2.2. Xac inh th cht
3. Xac inh kha nng giai phong hoat cht
3.1. Phng phap khuych tan gel
3.2. Phng phap khuych tan qua mang
4. Cac chi tiu khac
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1. Kim tra tinh cht vt ly cua thuc m va ta dc


1.1 Kim tra ng nht cua thuc m
Muc ich : Kim tra s phn tn ng u ca dc cht trong
t dc , nht la nhng ch phm c cu trc kiu hn dch.
Cach th:
B1 : Ly 4 n v ng gi (1 v= 0,02-0,03g) tri
u trn phin knh
B2 : y phin knh th 2 ln va p mnh => to
thanh vt c K khong 2 cm
B3: Quan st vt thu c bng mt thng (cch
mt khong 30 cm), 3 trong 4 tiu bn khng c
nhn thy cc tiu phn.
Nu c cc tiu phn nhn thy trong phn ln s
cc vt th lam li B1 vi 8 n v ng gi
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1. Kim tra tinh cht vt ly cua thuc m va ta dc


1.2 Xac inh im nho giot:
DVN quy inh: Thuc m khng c chay lng nhit
370C xac inh im nh git la cn thit.
Gi nhit ma o nguyn liu tr thanh lng, chay thanh
git (trong mt iu kin nht inh) la im nh git .

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1. Kim tra tinh cht vt ly cua thuc m va ta dc


1.3.Xac inh im ng c
Dng c dng xc nh la mt bnh
thy tinh c 2 thanh, gia 2 thanh la
khong trng.

Trong mt s trng hp nhit ha thp xung di


im ng c sau o lai tng ln mt cach t ngt. Gia
tri cao nht cua s tng nhit la im ng dc cua
nguyn liu
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1. Kim tra tinh cht vt ly cua thuc m va ta dc


1.4. Xac inh chi s nc:
Chi s nc la lng nc ti a biu th bng gam ma
100 gam t dc khan nc nhit thng c kh nng
ht c.

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2. Kim tra tnh cht lu bin ca thuc m


Lu bin la nghin cu s chy ca vt cht: ch yu la cc cht
lng, mm.

2.1 Xac inh nht


nht : TCVL quan trng, c xem la ma st ni ti ca
cht lng, cn tr s chy ca cht lng, c nh hng n
sinh kh dng, bm dnh, kh nng chy ra khi ng ca
thuc m.
Nguyn tc:
o thi gian chay (s)cua 1 th tich cht lng chay qua mao
quan cua nht k chun di tac dng cua trng lc va so
sanh vi cac cht chun bit trc nht.

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2. Kim tra tnh cht lu bin ca thuc m


2.1 Xac inh nht
Vic xc nh nht ca cht lng
khng Niutn phi c tin hanh
bng cc nht k c bit nh nht
k quay, nht k kiu Hppler ci
tin.
nht c tnh theo cng thc:
= k.p.t

(n v cps)

P=g/cm2
t= thi gian
k= hng s dng c
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2. Kim tra tnh cht lu bin ca thuc m


2.2 Xac inh th cht
Xac inh th cht bng may o xuyn su.
Nguyn tc: dng 1 vt rn hnh chp c trng lng xc nh
xuyn thng vao khi thuc m.
xuyn su c biu th bng 1/10m

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2.Kim tra tnh cht lu bin ca thuc m


2.2 Xac inh th cht
Xac inh dan mng cua thuc m

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2. Kim tra tnh cht lu bin ca thuc m


2.2 Xac inh th cht
Xc nh dnh ca thuc m
bm dnh gip thuc c th hp thu khi ra tri do mt phn
c gi li lp sng.
biu th bng thi gian trt trn khi thuc m ca mt tm
knh
B phn ch yu l hai tm knh,tm di c nh,tm trn
c ni vi 1 chic quang treo a cn chuyn ng qua 1
rng rc t 1 gram thuc m gia 2 tm knh.t trn tm knh
mt qu cn 1kg, trong 5 pht.sau t ln a cn mt qu
cn c trng lng nht nh.o thi gian trt ca tm knh ln
trn khi thuc m,nu thi gian cng ngn th dnh ca khi
thuc m cng nh
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3. Xc nh kh nng gii phng hot cht


Kh nng gii phng dc cht ra khi t dc l mt
trong nhng yu t quyt nh mc v tc hp thu
thuc qua da
Ph thuc vo nhiu yu t, ng k nht l bn cht ca
dc cht, t dc, cc cht ph v phng php ch
to (quy trnh sn xut).
nh gi kh nng gii phng dc cht ra khi t
dc khc nhau, ngi ta thng s dng phng php
khuych tn qua gel hoc qua mng.
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3. Xc nh kh nng gii phng hot cht


3.1 Phng phap khuych tan gel:
u im:
Cch lam n gin, nhanh chng.
Nhc im: Ch p dng c vi cc dc cht to mau hoc
phc mau vi cc thuc th tan c trong mi
trng khuych tn.

FeCl3 +

mau xanh xm

nh

gi mc va tc gii phng (mt cch tng


i) ca acid salicylic ra khi ch phm cha acid salicylic
nh thuc m benzosali..
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3. Xc nh kh nng gii phng hot cht


3.2. Phng php khuych tn qua mng:
: Ap dng rng ri vi nhiu DC, SD nh gi mt cch kh
nh lng mc v tc gii phng ca dc cht ra khi cc
ct t dc khc nhau tip tc nghin cu in vivo v thit k
cc cng thc c tc dng iu tr ng vi mc tiu mong mun .
N: phc tap
Mang dung cho phng php nay co th la:
Mng nhn to: celophan, silicon, dn cht cenllulose,...
Mng t nhin: da ng vt ( nguyn hoc loi bt sng):
chut, th, ngi cht...
xc nh lng DC c GP trong tng khong t/g, thng
dng nhng pp quang ph hoc HPLC. T cc kq, v th biu
din s tng quan gia lng dc cht gii phng theo t/g.
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4. Nhng chi tiu khac.


ng u khi lng
nhim khun
Th v khun
Cac phn t kim loi
Gii hn kich thc cac phn t

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1. Gii thiu
2. Phng php tin hanh

NI
DUNG

3. Kt qu va nh gi
4. Kt lun

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1. Gii thiu
Tretinoin ( retinoic acid) c s dng iu tr cc bnh vy nn, vy c,
mn trng c thng thng, u v cc bnh ngoi da khc, vi nhiu loi bo
ch khc nhau nh dung dch, sa, thuc m v cc loi kem.
Vi cc dng bo ch ny,
kh nng duy tr tc dng
km s dng cc t dc
to gel. Carpobol c s
dng v kh nng n nh
cao, tng thch v c tnh
thp.
Tng kh nng thm qua da s dng cc cht gy tng thm: mui
mt, cht din hot, glycol v dn xut
Kho st s nh hng ca mi trng hp th, nhit , pH, nng
thuc v cc tc ng ca cht tng cng thm thu ti s
khuch tn thuc trong cc loi gel carbopol tretinoin.
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2. Phng php tin hnh


2.1. Nguyn liu
Nguyn liu

Ni cung cp

Tretinoin

Taegeug Pharm, Ltd (Hn Quc)

Carbopol 934

BF Goodrich (M)

Polyoxyethylene 2Sigma Chemical (M)


stearyl ether,
Polyoxyethylene 2oleyl ether,
Polyoxyethylene 2lauryl ether, tetraethylene
glycol (TEG), v
diethylene glycol (DEG)
Acetonitrile, alcol ethylic
tuyt i

J.T. Baker Inc (M).


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2. Phng php tin hnh


2.2. Chun b h gel carbopol cha tretinoin
(2 g) bt carbopol, thm t t vo nc ng thi khuy lin tc,
thm mt vi git Tris (2-Amino-2-hydroxymethyl-propan-1 ,3-diol)
vo iu chnh pH ca carbopol gel
0,025 g Tretinoin c ha tan trong 30 ml dung dch diethylene
glycol methyl ether (DGME) ri thm tip vo lng gel carbopol
trn, khuy u, thm nc va 100ml.
gim thiu s chuyn ha ca tretinoin, tt c quy trnh trn phi
c thc hin trong iu kin ti

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2. Phng php tin hnh


2.3. Phng php HPLC xc nh Tretinoin

Ct

- Bondapak C18 (3.9 300mm)

Pha ng

acetonitrile : alcol ethylic : acid acetic : nc


( 85:85:1:15 )

Detector

UV; = 348nm

Th tch tim

10 l

Tc dng

1ml/pht

Pic tretinoin xut hin ti ts = 6 pht v DGME xp x 2,7 pht

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2. Phng php tin hnh


2.4. Nghin cu s khuch tn ca tretinoin t gel carbopol
Thit b
Khay ng mu (IMMERSION CELL) 4 phn
Vng bo v: Bo v v gi c nh mng kho
st
Ming m bo v v gi c nh mng kho st
Mng cellulose tng hp
Thn khay: Cha dc cht
Bnh cha dung mi: l 1 bnh c bit
dung tch 200ml y phng. Ko s dng
loi y cu nh bnh thng trnh
phn dung mi di y ko c tun
hon
B iu nhit: S dng nc ct iu
nhit

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2. Phng php tin hnh


2.4. Nghin cu s khuch tn ca tretinoin t gel carbopol
Tin hanh
Mng cellulose tng hp c gn vo khay ng mu
Gel carbopol chun b c cha tretinoin c t tip xc vi mng
cellulose tng hp, trn ph 1 lp mng parafin ngn chn s bay hi
ca dung mi
t ming m v vng bo v ln trn
Th khay vo bnh cha dung mi ( rng)
Thm dung mi c iu nhit v ui kh
Bt cnh khuy
nh k ht dch theo thi gian nh v ngay lp tc b sung th tch
duy tr diu kin ban u ca th nghim.
nh lng dch va ht bng HPLC( lm 3 ln, ly kt qu trung bnh)
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iu kin kho st
Nng DGME dao ng trong khong 0-50 ( v / v) %
nh hng ca nng thuc c gii phng t gel c
nghin cu theo cc nng 0.005 , 0.01 , 0.025 v 0.05% ( w /
w), vi nng DGME 40%
nh hng ca nhit trn tc gii phng thuc c thc
hin ti cc nhit 28 , 32, 37, 42 0C, vi nng DGME 40%

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2.5. Nghin cu in vitro s thm qua da


Chun b da
chut c
git chut bng
cch hy ty sng
c
ct b lng phn
bng , ct mt
ming da bng hnh
vung,
sau
khi
rch, loi b cht
bo dnh cht v
cc mnh ni tng
khc trong da

Phn tch d liu


Lng thuc thm
t gel carbopol qua
da chut c xc
nh bi phng
php HPLC, lm 3
ln, ly kt qu trung
bnh
Tc dng ca cc
yu t tng thm
c xc nh bng
cch so snh thng
lng ca tretinoin
khi c v khng c
cht tng thm
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3. Kt qu v nh gi
3.1. nh hng cua DGME n s giai phong cua thuc.

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3. Kt qu v nh gi
3.1. nh hng cua DGME n s giai phong cua thuc.
T th nghim cho thy, lng tch ly ca tretinoin khi gii
phng vi thi gian quan h tuyn tnh vi nhau

< 40% DGME


Kh nng gii
phng ca
tretinoin thp

40% DGME
Kh nng gii
phng ca
tretinoin cao

>40%DGME
Kh nng
gii phng
tng khng
ng k.

S dng 40% DGME lam tng kh nng gii phong


ca tretinoin
.

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3. Kt qu v nh gi
3.2 Tac ng cua pH cua carbopol gel n s giai phong thuc.
Nghin cu s thay i
ca pH 5-8 thy kh nng
gii phng dc cht tng
khi pH ca carbopol gels
tng, c bit s trng n
va kt dnh ca carbopol
gels tng cao khi c
trung ha bi cc cht c
tnh
kim:
trimethanolamin.
KOH,
NaOH.

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3. Kt qu v nh gi
3.3 nh hng cua nng tretinoin ti s GP cua thuc.
.

Nng ca tretinoin i
vi s gii phng thuc
qua mng cellulose tng
hp c s dng 40%
DGME, 2% carbopol gel
vi nng : 0.005%;
0.01%; 0.025%; 0.05%
nng tretinoin cng
cao th kh nng gii phng
thuc cng cao.

Tuy nhin nng cua tretinoin vt qua 0.05% th lai gy ra tac


dng khng mong mun: lng cn, gy au va bng rat.
Ngi ta thng chn nng 0.025% la ph hp.
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3. Kt qu v nh gi
3.4 anh hng cua nhit n s giai phong thuc
Nhit tng th kh nng gii
phng thuc cng tng. Nhng
thng cc th nghim v tnh
thm ca thuc c tin hnh
nhit 37 C l nhit ca
da.
Nng lng hot ha (Ea) tnh
theo dc ca thi: ti nng
0,025% l 14,96 kcal/mol;
0,05% l 14,55 kcal/mol. Nh
vy s gii phng thuc t h
gel lin quan n nng lng.

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3. Kt qu v nh gi
3.5. Tinh thm cua tretinoin t dang gel khi cha cac cht
gy thm khac nhau qua da chut
Khi nghin cu kha nng thm
cua tretinoin qua da chut khi co
mt cht gy thm va khng: vi
cht gy thm: cac glycols, cht
din hoat khng ion hoa th kha
nng thm qua da tt hn. c
bit la polyoxyethylene 2-oleyl
ether.
Kha nng tng thm tng do lam
lng lp sng cua da va giam ti l
lipid.
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4. Kt lun
Qu trnh gii phng tretinoin t gel carbopol b nh hng
bi:
pH ca gel carbopol, gii phng tt nht pH 8.
nng thuc tng dn n s gii phng thuc t gel
tng, cho thy s ph thuc vo nng .
S tng ca nhit lm cho vic gii phng thuc tng
ln, ty thuc vo nng lng kch hot ca s thm thu.
Mt trong nhng cht tng thm c s dng nh glycol
v cc cht din hot khng ion ha , polyoxyethylene 2 oleyl ether cho hiu qu tng cng tt nht.
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