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卡那霉素中卡那霉素 B(以下简称卡 B)的检查,药典(中国药典1977年版,附录61页)规定,系将样品熔封于安瓿内,在水浴中水解,操作手续较复杂。我们改用容量瓶代替安瓿水解,并进行了对比,测得结果与药典法相近。操作方法:将精密称定的样品置25ml 的容量瓶内,加水5ml 溶解,加盐酸5ml,混匀,盖上磨口玻璃塞,用粘布包紧后,直立水浴中央,水解60分钟。通过8组数据比较,样品中卡 B 测定值的均值,安瓿组和容量瓶组分别为0.7500和0.7425,平均偏差约为1%左右,符合微生物测定法的要求(卡 B 估计值为0.8%)。
Kanamycin kanamycin B (hereinafter referred to as card B) examination, Pharmacopoeia (Chinese Pharmacopoeia 1977 edition, Appendix 61) provides that the sample is fused in ampoules, hydrolyzed in a water bath, the procedure is more complicated . We use instead of ampoule volumetric flask ampoule hydrolysis, and compared the measured results and pharmacopoeia similar. Operation method: accurately weighed sample set 25ml volumetric flask, add water 5ml dissolved, add hydrochloric acid 5ml, mix well, cover with a glass stopper, with a cloth wrapped tight, upright water bath, hydrolysis 60 minutes. According to the comparison of 8 groups of data, the mean value of the measured value of the card B in the sample is 0.7500 and 0.7425 for the ampoule group and the volumetric flask group respectively, and the average deviation is about 1%, which meets the requirement of the microbial assay (card B is estimated to be 0.8%). .