Nang piracetam

Capsulae Piracetami

 

L nang cng c cha piracetam.

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 piracetam, C6H10N2O2, t 93,0 n 107,0% so vi hm lng ghi trn nhn.

 

Tnh cht

Nang cng, bt thuc trong nang mu trng ng.

 

nh tnh

A. Trong phn nh lng, pic chnh trn sc k thu c ca dung dch th phi c thi gian lu tng ng vi thi gian lu ca pic piracetam trong dung dch chun.

B. Ly mt lng bt ch phm nghin mn tng ng khong 0,5 g piracetam lc k vi 10 ml nc, lc. Ly 2 ml dch lc thm 1 git dung dch kali permanganat 5,0% (TT). Sau thm dung dch natri hydroxyd 10,0% (TT) s c mu tm chuyn sang xanh da tri v cui cng l mu xanh l cy.

 

nh lng

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

Pha ng: Methanol - nc (10 : 90 ).

Dung dch th: Cn thuc trong 20 nang, tnh khi lng trung bnh ca thuc trong mt nang, trn u ri nghin thnh bt mn. Cn chnh xc mt lng bt ch phm tng ng khong 0,1 g piracetam ho tan trong pha ng va 100 ml, lc k v lc. Ly chnh xc 5,0 ml dch lc pha long n 50,0 ml bng pha ng, trn u.

Dung dch chun: Cn chnh xc khong 100 mg piracetam chun vo bnh nh mc 100 ml, thm 60 ml pha ng, lc siu m ho tan, thm pha ng n nh mc, lc u. Pha long 5,0 ml dung dch trn thnh 50,0 ml bng pha ng, lc u.

iu kin sc k:

Ct thp khng g (25 cm 4,6 mm) c nhi pha tnh C 5mm).

Detector quang ph t ngoi t bc sng 210 nm.

Tc dng: 1,5 ml/ pht.

Th tch tim: 10 m l.

Cch tin hnh:

Kim tra kh nng thch hp ca h thng sc k: Tin hnh sc k vi dung dch chun. Hiu sut ca ct i vi pic piracetam khng c nh hn 2000 a l thuyt.

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

Tnh hm lng piracetam, C6H10N2O2, trong nang da vo din tch pic trn sc k ca dung dch chun, dung dch th v hm lng C6H10N2O2 ca piracetam chun.

 

Bo qun

Trong ng kn, trnh nh sng.

 

Hm lng thng dng

200 mg v 400 mg.