NGHIN CU N NH THUC TIM VITAMIN C

1. CC L THUC KIM TRA

S l sn xut 270717: sn xut vo ngy 06/07/17.
S l sn xut 052171: sn xut vo ngy 31/05/17.

2. PHNG PHP KHO ST: Lo ha cp tc.

Nghin cu c thc hin trn 2 l trong nhng iu kin bo qun sau:
- p sut kh quyn
- Cc nhit : . nhit phng ( 25 oC 2 oC).
. 40 oC ( 25 oC 2 oC).
. 50 oC ( 25 oC 2 oC).
. 60 oC ( 25 oC 2 oC).
- Thi gian ko di th nghim: 1,3 v 6 thng.

3. CC TNH CHT C KHO ST.

3.1 Tnh cht vt l.
- Cm quan.
- trong.
- Mu sc.
- ng u th tch.
3.2 Tnh cht ha hc.
- nh tnh.
- Acid Oxalic.
- nh lng.
3.3 Tnh cht v bao gi: vic ng gi tng t nh c ngh cho bit dc
ny.

4. CHN PHNG PHP NH GI.

4.1 M t phng php th nghim.
- Cc tnh cht vt l:
. trong: theo DVN IV , PL-138, mc 8.9 Xc nh gii hn tiu phn, trng
hp B Vt th nhn thy bng mt thng.
 . Mu sc: Nu cn, pha long mt th tch ch phm ( ly chnh xc) vi nc thu
c dung dch c nng 50 mg acid ascorbic/ ml. o hp thu ca dung dch ny
bc sng 420 nm (Ph lc 4.1), trong cc o dy 1 cm, dng nc lm mu trng. hp
th o c khng qu 0,06.
. ng u th tch: Theo DVN IV , Ph lc 1.19, Cc dng thuc tim, thuc
tim truyn.
Phng php 1 trng hp thuc tim c th tch khng ln hn 5 ml. Ly 6 ng: 5
ng th, 1 ng trng bm tim. Kim tra bng cm quan 5 ng th phi cha th tch
thuc tim gn bng nhau. Dng bm tim kh sch c gn kim tim thch hp, c dung
tch khng ln hn 2,5 ln th tch cn o. Ly thuc vo bm tim sao cho trong bm
tim khng c bt kh v trong kim tim vn cha u thuc tim. Ln lt ly ht thuc
trong tng ng o theo cch . Kt qu th tch trung bnh ca 5 ng phi t 100
115% ca th tch ghi trn nhn.

- Cc tnh cht ha hc:

. nh tnh: A. Phn ng ha hc
Ly mt lng ch phm cha khong 50 mg acid ascorbic, thm 0,2 ml dung dch
acid nitric 2M (TT) v 0,2 ml dung dch bc nitrat 2% (TT). Xut hin ta mu xm en.
B.Phng php sc k lp mng (Ph lc 5.4).
Bn mng : Silica gel F254
Dung mi khai trin: Ethanol 96% - nc (120 : 20)
Dung dch th: Pha long ch phm, nu cn, vi nc thu c dung dch c nng
acid ascorbic 0,5%.
Dung dch i chiu: Dung dch acid ascorbic chun 0,5%.
Cch tin hnh: Chm ring bit ln bn mng 2 l mi dung dch trn. Trin khai sc
k ti khi dung mi i c khong 15 cm. Ly bn mng kh ngoi khng kh v
quan st di nh sng t ngoi bc sng 254 nm.
Vt chnh trong sc k ca dung dch th phi tng ng v v tr v mu sc vi vt
chnh trong sc k ca dung dch i chiu.
. Acid Oxalic: Khng qu 0,3%
Dung dch th: Ly chnh xc mt th tch ch phm c cha 250 mg acid
ascorbic, nu cn, pha long vi nc va 5 ml, trung ha bng dung dch natri
hydroxyd 10% (TT), thm 1 ml dung dch acid acetic 2M (TT ) v 0,5 ml dung dch calci
clorid 10% (TT). yn trong 1 gi.
Dung dch i chiu: Ha tan 70 mg acid oxalic (TT) trong 500 ml nc. Ly 5 ml
dungdch thu c, thm 1 ml dung dch acid acetic 2M (TT) v 0,5 ml dung dch
calciclorid 10% (TT). yn trong 1 gi.
Pha ch dung dch th v dung dch i chiu trong cng thi gian v cng iu kin.
Dung dch th khng c c hn dung dch i chiu.
Ly chnh xc mt th tch ch phm tng ng vi khong 0,20 - 0,25 g acid
ascorbic, thm 0.25 ml dung dch formaldehyd 1 % (TT), 4 ml dung dch acid hydrocloric
2% (TT), 0,5 ml dung dch kali iodid 10% (TT) v 2 ml dung dch h tinh bt (TT). nh
lng bng dung dch kali iodat 0,1N (C) cho n khi xut hin mu lam bn vng. 1 ml
dung dch kali iodat 0,1 N (C) tng ng vi 8,806 mg C6H8O6.
4.2 nh lng.
Nguyn tc: Axit ascorbic c xc nh da trn phn ng oxi ha n bng iot (trong
KI d) theo phng php chun trc tip vi cht ch th h tinh bt.
Thuc th: dung dch h tinh bt.
Tin hnh: Cho vo bnh nn ln lt: chnh xc mt th tch ch phm tng ng vi
khong 0,20 - 0,25 g acid ascorbic tng ng 5 ml ch phm, thm 0.25 ml dung dch
formaldehyd 1 % (TT), 4 ml dung dch acid hydrocloric 2% (TT), 0,5 ml dung dch kali
iodid 10% (TT) v 2 ml dung dch h tinh bt (TT). nh lng bng dung dch kali iodat
0,1N (C) cho n khi xut hin mu lam bn vng.
1 ml dung dch kali iodat 0,1 N (C) tng ng vi 8,806 mg C6H8O6.
Tnh ton kt qu:
Gi V (ml) l th tch kali iodat 0,1N (C) dng nh lng.

V 8,0806 2 100
Hm lng acid ascorbic trong mt n v ch phm 2 ml l: (%)
100 5
5. KT QUT TH NGHIM.
c trnh by nh sau
THUC TIM VITAMIN C 100 mg/2 ml
L 052171 Sn xut: 31/05/17 Hn dng: 01/05/19

Bo qun iu kin 40 oC ( 25 oC 2 oC).

Thi
im
phn Cm nh Mu ng Acid nh
tch quan tnh trong sc u th oxalic lng
nhit tch
phng.
T1, sau
1 thng
T3, sau
3 thng
T4, sau
4 thng

Bo qun nhit 50 oC ( 25 oC 2 oC).

Thi
im
phn Cm nh Mu ng Acid nh
tch quan tnh trong sc u th oxalic lng
nhit tch
phng.
T1, sau
1 thng
T3, sau
3 thng
T4, sau
4 thng
Bo qun nhit 60 oC ( 25 oC 2 oC).
Thi
im
phn Cm nh Mu ng Acid nh
tch quan tnh trong sc u th oxalic lng
nhit tch
phng.
T1, sau
1 thng
T3, sau
3 thng
T4, sau
4 thng