THUC BT ACETYLCYSTEIN Pulveres Acetylcysteinum L thuc bt cha acetylcystein. Ch phm phi p ng cc yu cu trong chuyn lun Thuc bt (Ph lc 1.

.7) v cc yu cu sau y: Hm lng acetylcystein, C5H9NO3S t 95,0 n 105,0% so vi hm lng ghi trn nhn. Tnh cht Bt mu trng, c v ngt. nh tnh A. Trong phn nh lng, trn sc k ca dung dch th phi cho pic chnh c thi gian lu tng ng vi thi gian lu ca pic acetylcystein trn sc k ca dung dch chun. B. Ha tan mt lng ch phm cha khong 1,0 g acetylcystein trong 20 ml nc. Lc k, lc. Ly 1 ml dch lc, thm 0,1 ml dung dch natri nitroprussiat 5% (TT) v 0,1 ml dung dch amoniac m c (TT) s xut hin mu tm m. Mt khi lng do lm kh Khng c qu 5,0% (Ph lc 9.6) (1,000g; 75oC; 4 gi trong t sy chn khng) mn Thuc bt phi t yu cu Bt rt mn (Ph lc 3.5). nh lng Phng php sc k lng (Ph lc 5.3). Pha ng: Ha tan 6,8 g kali dihydrophosphat (TT) trong 1000 ml nc, iu chnh dung dch ti pH 3,0 bng dung dch acid phosphoric m c (TT), lc. Dung dch th: Cn 10 gi, tnh khi lng trung bnh ca bt thuc trong gi, nghin thnh bt mn. Cn chnh xc mt lng bt tng ng khong 0,1 g acetylcystein vo bnh nh mc 100 ml, pha long vi dung dch natri bisulfit (1/2000) (TT) n nh mc, lc u. Ht 10 ml dung dch ny vo bnh nh mc 100 ml, pha long vi dung dch natri bisulfit (1/2000) (TT) n nh mc, lc u. Dung dch chun: Cn chnh xc khong 0,1 g acetylcystein chun vo bnh nh mc 100 ml, ha tan bng dung dch natri bisulfit (1/2000) (TT), pha long cng dung mi n nh mc, lc u. Ht 10 ml dung dch ny vo bnh nh mc 100 ml, pha long vi dung dch natri bisulfit (1/2000) (TT), n nh mc, lc u. iu kin sc k: Ct thp khng g (25 cm x 4 mm) nhi pha tnh C (5 m). Detector quang ph t ngoi bc sng: 214 nm. Th tch tim: 20 l. Tc dng: 1,5 ml/pht. Cch tin hnh : Kim tra kh nng thch hp ca h thng sc k: Tin hnh sc k vi dung dch chun, lch chun tng i ca cc din tch p ng t 6 ln tim lp li khng c ln hn 2,0 %. Tin hnh sc k ln lt vi dung dch chun v dung dch th. Tnh hm lng acetylcystein, C5H9NO3S, c trong nang da vo din tch pic thu c trn sc k ca dung dch th, dung dch chun v hm lng C5H9NO3S ca acetylcystein chun. Bo qun Trong bao b kn, ni kh mt, trnh nh sng.

Loi thuc Thuc iu ha s tit dch ca ph qun. Hm lng thng dng Thuc gi 200mg.