Vin nn penicilin V

Tabellae Phenoxymethylpenicillini

 

L vin nn cha phenoxymethylpenicilin.

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 80 mg phenoxymethylpenicilin vi 5 ml methanol (TT) trong bnh nh mc 250 ml, thm nc n nh mc, trn u, lc. Ph hp th nh sng (Ph lc 4.1) ca dch lc phi c cc 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 penicilin V trn sc k ca dung dch chun.

 

Nc

Khng qu 3,0% (Ph lc 10.3).

 

ho tan (Ph lc 11.4).

Thit b: Kiu cnh khuy.

Mi trng ho tan: 900 ml nc.

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 dch lc thu c 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 phenoxymethylpenicilin kali 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 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 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 30OC.

 

Loi thuc

Khng sinh

 

Hm lng thng dng

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