Vin nn penicilin V kali

Tabellae Phenoxymethylpenicillini Kalii

 

L vin nn cha phenoxymethylpenicilin kali.

Ch phm phi p ng cc yu cu trong chuyn lun Thuc vin nn (Ph lc 1.20) v cc yu cu sau:

Hm lng phenoxymethylpenicilin, C16H18N2O5S, t 90,0 n 120,0% so vi hm lng ghi trn nhn.

 

Tnh cht

Vin mu trng hoc trng ng, khng mi hoc c mi c bit ca penicilin.

 

nh tnh

A. Lc k mt lng bt vin tng ng vi khong 80 mg phenoxymethylpenicilin vi khong 200 ml nc trong bnh nh mc 250 ml, thm nc đến nh mc, trn u, lc. Ph hp th (Ph lc 4.1) ca dch lc thu c phi c cc i cc bc sng 268 nm v 274 nm, cc tiu bc sng 272 nm.

B. Trong phn nh lng, thi gian lu ca pic chnh trn sc k ca dung dch th phi tng ng vi thi gian lu ca pic phenoxymethylpenicilin trn sc k ca dung dch chun.

C. t 0,5 g bt vin ri nung n cn tro mu trng. ngui, thm vo cn 5 ml dung dch acid acetic 2 M (TT). un si, ngui, lc. Dch lc phi cho phn ng B ca ion kali (Ph lc 8.1).

 

Mt khi lng do lm kh

Khng c qu 1,5% (Ph lc 9.6).

(Dng 100 mg bt vin nghin mn, sy 3 gi di p sut gim 60 OC).

 

ho tan (Ph lc 11.4).

Thit b: Kiu cnh khuy.

Mi trng ho tan: 900 ml dung dch m phosphat pH 6,0 (TT).

Tc quay: 50 vng/pht.

Thi gian: 45 pht.

Cch tin hnh: Lấy một phần dung dịch mi trường sau khi ha tan, lọc, bỏ 20 ml dịch lọc đầu. Pha long vi mi trng ho tan c dung dch c nng thch hp ( nu cn). o hp th (Ph lc 4.1) ca dung dch cc i 268 nm, trong cc o dy 1 cm, mu trng l trng mi ha tan. So snh vi dung dch phenoxymethylpenicilin kali chun c nng tng ng pha trong mi trng ho tan. Tnh lng phenoxymethylpenicilin, C16H18N2O5S, c ho tan trong vin da vo cc hp th o c v hm lng C16H18N2O5S trong mu chun.

Yu cu: Khng c t hn 75,0% lng phenoxymethylpenicilin, C16H18N2O5S, so vi lng ghi trn nhn c ho tan trong 45 pht.

 

nh lng

Tin hnh bng phng php sc k lng (Ph lc 5.3)

Pha ng: Hn hp nc - acetonitril - acid acetic bng (650 : 350: 5,75).

Dung dch phn gii: Dung dch c cha 2,5 mg benzylpenicilin kali v 2,5 mg phenoxymethylpenicilin kali trong 1 ml, pha trong pha ng.

Dung dch chun: Dung dch phenoxymethylpenicilin kali c nng khong 2,5 mg/1 ml, pha trong pha ng.

Dung dch th: Cn 20 vin, tnh khi lng trung bnh vin ri nghin thnh bt mn. Cn chnh xc mt lng bt vin tng ng khong 400.000 n v phenoxymethylpenicilin ho trong pha ng va 100,0 ml, lc k trong 5 pht, lc qua mng lc 0,5 mm.

iu kin sc k:

Ct thp khng g (30 cm 4 mm), c nhi pha tnh C (3 n 10 mm).

Detector quang ph hp th t ngoi bc sng 254 nm.

Tc dng: 1,0 ml/pht.

Th tch tim: 10 ml.

Cch tin hnh:

Tin hnh sc k vi dung dch phn gii, thi gian lu tng i ca pic benzylpenicilin khong 0,8 v ca pic phenoxymethylpenicilin l 1,0. Hiu sut ca ct i vi phenoxymethylpenicilin khng c t hn 1800 a l thuyt v h s phn gii gia pic benzylpenicilin v pic phenoxymethylpenicilin khng c t hn 3,0.

Tin hnh sc k vi dung dch chun, lch chun tng i ca din tch pic phenoxymethylpenicilin trn sc k thu c trong 6 ln tim lp li khng c ln hn 1,0%. C th iu chnh thnh phn pha ng t iu kin trn.

Tin hnh sc k ln lt vi dung dch chun v dung dch th .

Tnh hm lng phenoxymethylpenicilin, C16H18N2O5S, trong vin da vo din tch pic trn sc k ca dung dch th, dung dch chun v hm lng C16H18N2O5S trong phenoxymethylpenicilin kali chun.

Hot lc l thuyt ca phenoxymethylpenicilin l 1695 I.U trong 1 mg.

Hot lc l thuyt ca phenoxymethylpenicilin kali l 1530 I.U trong 1mg.

 

Bo qun

Trnh m v nh sng, nhit khng qu 30 OC.

 

Loi thuc

Khng sinh

 

Hm lng thng dng

200.000 n v (IU); 400.000 n v (IU).