乙酰螺旋霉素片鉴别方法探讨

Discussion on Identification Tests for Acetylspiramycin Tablets

目的:对乙酰螺旋霉素片鉴别方法进行探讨。方法:分别考察了乙酰螺旋霉素片鉴别项下紫外分光光度法、高效液相色谱法、薄层色谱法。结果:高效液相色谱法(2)可以代替薄层色谱法(3)鉴别而不能代替紫外分光光度法(1)测定最大吸收。结论:《中国药典2000年版二部》乙酰螺旋霉素片鉴别项下“以上(1)、(2)两项可选做一项”有误,根据原料药鉴别及本文试验结果应改为“以上(2)、(3)两项可选做一项”。

Objective:To discuss on identification tests for acetylspiramycin tablets. Method:To examine identification tests for acetylspiramycin tablets-(1) Ultraviolet Spectrophotometry(2)High performance liquid chromatography (3 )Thin-layer chro-matography. Result:Test(2)High performance liquid chromatography can take the place of the test(3) Thin-layer chromatography,but not the testCDUltraviolet Spectrophotometry. Conclusion:Under identification of acetylspiramycin tablets in Pharmacopoeia of People's Republic of China (2000 edition)test(Dor test(2)used alternatively is mistake,test(2)or test(3) may be used alternatively.