Nang ampicilin

Capsulae Ampicillini

 

L nang cng c cha ampicilin khan hoc ampicilin trihydrat.

Ch phm phi p ng cc yu cu trong chuyn lun Thuc nang (Ph lc 1.13) v cc yu cu sau y:

Hm lng ampicilin, C16H19N3O4S, t 90,0 n 110,0% so vi hm lng ghi trn nhn (tnh theo ch phm khan).

 

Tnh cht

Nang cng, bt thuc trong nang mu trng ng, khng mi hay gn nh khng mi.

 

nh tnh

A. Ly mt lng bt vin nghin mn tng ng khong 10 mg ampicilin, thm 10 ml nc, lc k, lc. Thm vo dch lc 2 ml thuc th Fehling (TT), xut hin ngay mu tm .

B. Phng php sc k lp mng (Ph lc 5.4)

Bn mng: Silica gel GF254 hot ho 100 0C trong 1 gi.

Dung mi khai trin: Aceton - dung dch amoni acetat 15,4%(TT) c iu chnh ti pH 5,0 bng acid acetic bng (TT) (10 : 90).

Dung dch th: Lc mt lng bt vin tng ng 125 mg ampicilin trong 50 ml trong dung dch natri hydrocarbonat 4,2% (TT).

Dung dch i chiu (1): Dung dch ampicilin trihydrat chun 0,25% pha trong dung dch natri hydrocarbonat 4,2% (TT).

Dung dch i chiu (2): Dung dch cha 0,25% ampicilin trihydrat chun v 0,25% amoxicilin trihydrat chun, pha trong dung dch natri hydrocarbonat 4,2% (TT).

Cch tin hnh: Chm ring bit 2 ml mi dung dch trn ln bn mng. Trin khai sc k n khi dung mi i c khong 15 cm, ly bn mng ra, kh ngoi khng kh, t bn mng vo bnh c hi iod n khi xut hin cc vt, quan st di nh sng ban ngy. Trn sc k thu c, vt chnh ca dung dch th v dung dch i chiu (1) phi ging nhau v v tr, mu sc v hnh dng. Php th ch c gi tr khi dung dch i chiu (2) cho 2 vt tch bit nhau r rng.

ho tan ( Ph lc 11.4 )

Thit b: Kiu gi quay.

Tc quay: 100 vng/pht.

Mi trng ho tan: 900 ml nc.

Thi gian: 60 pht.

Cch tin hnh:

Thc hin bng phng php sc k lng ( Ph lc 5.3).

Pha ng, dung dch chun v iu kin sc k thc hin nh trong phn nh lng.

Dung dch th: Ly mt phn dung dch mi trng sau khi ha tan, lc, b 20 ml dch lc u. Ly chnh xc mt th tch dch lc, pha trong pha ng A c nng ampicilin chnh xc khong 0,006%.

Yu cu: Khng c t hn 80,0% lng ampicilin, C16H19N3O4S, so vi lng ghi trn nhn c ho tan trong 60 pht.

 

Mt khi lng do lm kh

Cn chnh xc khong 100 mg bt thuc, sy trong chn khng di p sut 5 mmHg 60OC trong 3 gi.

Lng mt i phi t 10,0 n 15,0% khi ch phm cha ampicilin trihydrat. Lng mt i khng c ln hn 4% khi ch phm cha ampicilin khan

 

nh lng

Bng phng php sc k lng (Ph lc 5.3),

Pha ng A: Hn hp gm 1 th tch dung dch acid acetic 10% (TT), 100 th tch dung dch kali dihydrophosphat 0,2 M (TT), 100 th tch acetonitril (TT) v nc va 2000 ml.

Pha ng B: Hn hp gm 1 th tch dung dch acid acetic 10% (TT), 100 th tch dung dch kali dihydrophosphat 0,2 M (TT), 800 th tch acetonitril (TT) v nc va 2000 ml.

Pha ng: L hn hp gm 85 th tch pha ng A v 15 th tch pha ng B.

Dung dch chun: Dung dch ampicilin chun 0,006% trong pha ng A.

Dung dch phn gii: Dung dch cha 0,025% ampicilin chun v 0,002% cephradin chun, pha trong pha ng A.

Dung dch th: Cn thuc trong 20 nang, tnh khi lng trung bnh, trn u v nghin thnh bt mn. Cn chnh xc mt lng bt tng ng vi 60 mg ampicilin, lc trong 15 pht vi 80 ml pha ng A ri thm pha ng A n va th tch 100,0 ml. Lc, ly 5,0 ml dch lc pha long thnh 50,0 ml bng pha ng A.

iu kin sc k:

Ct thp khng g (25 cm 4,6 mm), c nhi pha tnh C (5mm) (ct Nucleosil C18 l thch hp ).

Detector hp th t ngoi t bc sng 254 nm.

Tc dng: 1,0 ml/pht.

Th tch tim: 50 ml.

Cch tin hnh:

Kim tra kh nng thch hp ca h thng sc k: Tim dung dch phn gii, phn gii gia pic ampicilin v pic cephradin phi khng nh hn 3,0; c th iu chnh thnh phn pha ng t yu cu trn.

Tim ln lt dung dch th v dung dch chun .

Tnh hm lng ampicilin, C16H19N3O4S , trong vin t din tch pic trn sc k ca dung dch chun v dung dch th, v hm lng C16H19N3O4S trong ampicilin chun.

 

Bo qun

ni mt, trong ng kn, trnh nh sng.

 

Loi thuc

Khng sinh nhm beta - lactam

 

Hm lng thng dng

250 mg, 500 mg, tnh theo ampicilin khan.