benzylpenicilin dng pha thuc tim

Benzylpenicillini pro injectione

 

Benzylpenicilin dng pha thuc tim l bt kt tinh v khun ca benzylpenicilin kali hoc benzylpenicilin natri ng trong ng thu tinh hn kn hoc l thu tinh nt kn. Ch pha vi nc v khun tim ngay trc khi dng.

Ch phm phi t cc yu cu quy nh trong chuyn lun chung v Thuc tim , thuc tim truyn (Ph lc 1.19) v cc yu cu sau y:

Hm lng benzylpenicilin kali, C16 H17N2KO4S, hoc benzylpenicilin natri C16 H17N2NaO4S, phi t 95,0 n 105,0% so vi hm lng ghi trn nhn.

 

Tnh cht

Bt kt tinh trng, v hi ng, hi c mi c bit.

 

nh tnh

A. Ph hp th hng ngoi (Ph lc 4.2) ca ch phm phi tng ng vi ph ca benzylpenicilin kali (C) hoc benzylpenicilin natri (C).

B. C phn ng c trng ca ion kali hoc natri (Ph lc 8.1) v phn ng ca benzylpenicilin (Ph lc 8.2).

 

Gii hn acid kim

Dung dch 10% ch phm trong nc c pH t 5,5 n 7,5 (Ph lc 6.2).

 

trong v mu sc dung dch

Thm nc vo 5 l hoc ng tim (tu theo cch ng gi) to dung dch cha 60 mg/ml (theo lng ghi trn nhn), dung dch thu c phi trong v khng mu.

 

Mt khi lng do lm kh

Khng c ln hn 1,0% (Ph lc 9.6). Dng 1 g ch phm, sy 105OC n khi lng khng i.

 

Cht gy st

Ch phm phi p ng yu cu v th cht gy st (Ph lc 13.4). Tim 1 ml dung dch c cha 1,5 mg ch phm pha trong nc pha thuc tim cho 1 kg th th nghim.

 

v khun

Ch phm phi t v khun (Ph lc 13.7). Dng 120 mg ch phm, lm mt hot tnh bng penicilinase ri th, hoc th theo phng php mng lc.

 

nh lng

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

Pha ng A: Hn hp 10 th tch dung dch kali dihydrophosphat 6,8% (TT) c iu chnh ti pH 3,5 vi dung dch acid phosphoric 50% (TT) v 30 th tch methanol (TT) v 60 th tch nc.

Pha ng B: Hn hp 10 th tch dung dch kali dihydrophosphat 6,8% (TT) c iu chnh ti pH 3,5 vi dung dch acid phosphoric 50% (TT) v 50 th tch methanol (TT) v 40 th tch nc.

Pha ng: Hn hp pha ng A v pha ng B (70 : 30).

Dung dch chun: Dung dch cha benzylpenicilin natri chun hoc benzylpenicilin kali chun, nng 0,10% trong nc.

Dung dch phn gii: Cha benzylpenicilin natri chun ( hoc benzylpenicilin kali chun) 0,020% v acid phenylacetic chun 0,020% trong nc.

Dung dch th: Cn nhanh thuc trong tng n v ch phm ca 10 n v ch phm (l), trn u. Cn chnh xc mt lng ch phm tng ng khong 80 mg benzylpenicilin pha trong 20,0 ml nc, lc. Pha long 1 th tch dch lc vi nc thnh 4 th tch.

iu kin sc k:

Ct thp khng g (25 cm 4,6 mm) cha pha tnh C (5mm) (Hypersil ODS l thch hp).

Detector hp th t ngoi t bc sng 225 nm.

Tc dng: 1,0 ml/pht.

Th tch tim: 20 ml.

Cch tin hnh:

Tim 20 ml dung dch phn gii, h s phn gii gia 2 pic chnh thu c phi khng nh hn 6,0. Nu cn, iu chnh t l ca pha ng A v pha ng B t yu cu trn.

Tim ring bit dung dch th v dung dch chun.

Tnh ton hm lng benzylpenicilin trong mt n v ch phm da din tch pic chnh thu c t sc k ca dung dch th, dung dch chun v nng hm lng mui benzylpenicilin trong dung dch chun.

Hot lc l thuyt ca 1 mg benzylpeniciln natri l 1670 n v .

Hot lc l thuyt ca 1 mg benzylpeniciln kali l 1600 n v.

 

Bo qun

ni kh mt, nhit khng qu 30oC.

 

Loại thuốc

Khng sinh.

 

Hm lng thng dng

0,125 g; 0,312 g ; 0,625 g. hoc

200.000 n v, 500.000 n v v 1.000.000 n v.