Tobramycin

Tobramycinum

 

C18H37N5O9 P.t.l: 467,5

Tobramycin la 4-O-(3-Amino-3-deoxy-a-D-glucopyranosyl)-2-deoxy-6-O-(2,6-diamino-2,3-6-trideoxy-a-D-ribo-hexopyranosyl)-L-streptamin, đc ieu che t Streptomyces tenebrarius hoac bang cac phng phap khac, hoat lc khong c t hn 930 I.U / mg, tnh theo che pham a lam kho va khong cha 2-methyl-1-propanol.

Tnh chat 

Bot trang hoac gan nh trang. De tan trong nc, rat kho tan trong ethanol 96%, thc te khong tan trong ether.

nh tnh

A. Sac ky lp mong (Phu luc 5.4)

Ban mong: Silica gel (TT).

Dung moi trien khai: Methylen clorid - amoniac am ac - methanol (17 : 33 : 50).

Dung dch th: Hoa tan 20 mg che pham trong nc va pha loang thanh 5,0 ml vi cung dung moi.

Dung dch oi chieu (1): Hoa tan 20,0 mg tobramycin chuan (C) trong nc va pha loang thanh 5,0 ml vi cung dung moi.

Dung dch oi chieu (2): Hoa tan 4,0 mg neomycin sulfat chuan (C) va 4,0 mg kanamycin monosulfat chuan (C) trong 1 ml dung dch oi chieu (1).

Cach tien hanh:

Cham rieng re 5 l cac dung dch tren len ban mong. Trien khai sac ky en khi dung moi i c c khoang 15 cm. Lam kho bang khong kh nong. Phun thuoc th phat hien bang hon hp ong the tch cua dung dch 1,3-dihydroxynaphtalen 0,2% trong ethanol 96% (TT) va dung dch acid sulfuric 46,0%. Say ban mong 105 oC trong 5 - 10 phut.

Tren sac ky o, vet chnh thu c t dung dch th phai tng ng ve v tr, mau sac va kch thc so vi vet chnh thu c t dung dch oi chieu (1). Phep th ch co gia tr khi sac ky o thu c t dung dch oi chieu (2) co 3 vet chnh tach nhau ro rang.

B. Hoa tan khoang 5 mg che pham trong 5 ml nc. Them tiep 5 ml dung dch ninhydrin 0,1% pha trong ethanol 96% (TT), va un trong cach thuy 3 phut. Mau xanh tm xuat hien.

pH

T 9,0 en 10,0 (Phu luc 6.2).

Hoa tan 1,0 g che pham trong 10 ml nc khong co carbon dioxyd (TT).

Goc quay cc rieng

T +138 en +148 (tnh theo chat a lam khan khong co 2-methyl-1-propanol) (Phu luc 6.4)

Hoa tan 1,0 g che pham trong nc va pha loang thanh 25,0 ml vi cung dung moi.

Tap chat lien quan

Tien hanh theo phng phap sac ky lp mong (Phu luc 5.4)

Ban mong: Silica gel (TT).

Dung moi trien khai: Amoniac am ac - 2-butanon - ethanol 95% (1 : 1 : 1)

Dung dch th : Dung dch 0,80% (kl/tt) che pham trong dung dch amoniac 0,02 M.

Dung dch oi chieu: Dung dch 0,008% (kl/tt) che pham trong dung dch amoniac 0,02 M.

Cach tien hanh: Cham rieng biet 5 l moi dung dc. Trien khai sac ky en khi dung moi i c 12 cm. Lay ban mong ra va e kho ngoai khong kh, lam nong en 110 oC trong 10 phut. Phun ban mong khi con nong vi dung dch c pha ngay trc khi dung, bang cach pha loang dung dch natri hypoclorid (3% clor) vi nc e c dung dch cha 0,5% clor (kl/tt). Lam kho ban mong trong luong khong kh lanh va kho cho en khi phan dien tch c phun thuoc th pha di vach cham sac ky ch cho mau xanh rat nhat vi 1 giot dung dch ho tinh bot co kali iodid (TT); tranh e lau ngoai khong kh lanh. Phun ban mong vi dung dch ho tinh bot co kali iodid (TT). Bat c vet phu nao xuat hien tren sac ky o cua dung dch th khong c am mau hn vet thu c cua dung dch th oi chieu.

2-Methyl-1-propanol

Khong c qua 1,0% (kl/kl) (Phu luc 10.14, he B).

Nc

Khong c qua 8,0 % (Phu luc 10.3).

Dung 0,30 g che pham.

Tro sulfat

Khong qua 0,3 % (Phu luc 9.9; Phng phap 2).

Dung 1,0 g che pham.

o vo khuan

Neu dung cho san xuat thuoc tiem hoac thuoc nho mat dang phan lieu, khong co them giai oan tiet trung thch hp trong qui trnh san xuat, che pham phai at ch tieu nay (Phu luc 13.7).

Noi oc to vi khuan

Khong c qua 2,0 I.U /mg.

Neu dung cho san xuat dang pha tiem theo qui trnh khong co them giai oan thch hp e loai bo noi oc to vi khuan, che pham phai at ch tieu nay (Phu luc 13.2).

nh lng

nh lng theo phng phap xac nh hoat lc khang sinh bang phng phap th vi sinh vat (Phu luc 13.9).

Bao quan

Neu che pham a c tiet khuan, phai bao quan trong lo kn a c tiet khuan.

Nhan

San pham at gii han vo khuan.

San pham at gii han noi oc to vi khuan.