摘要
目的改变吉他霉素片溶出度试验条件,使溶出度检查和人体生理特点更接近,有利于区分不同厂家药品的质量高低。方法采用降低转速及改变溶出介质的方法检查吉他霉素片的溶出度。结果改进方法容易区分药片质量的优劣。结论建议吉他霉素片溶出度检查条件改成:以盐酸溶液(5.6→1000)900mL为溶出介质,转速为每min50转的方法进行检查;溶出介质配制简单,使用试剂少,对环境的污染小。
Objective To change experimental condition of dissolution of Kitasamycin Tablets,make the human physiological characteristics more closely,and distinguish different manufacturers the quality of the drugs. Methods Adopting schedule method to compare with reducing revolutions and changing dissolution medium. Results There was no difference of the two methods in the dissolution of drugs of good quality,but there was significant difference in the dissolution of drugs of bad quality. Conclusion The second method was proposed to determine the dissolution of Kitasamycin Tablets,taking the hydrochloric acid solution (5.6-1000)900mL as dissolution medium,rotate speed is 50rpm,dissolution medium is simple and fewer reagent consumption with lower pollution.
出处
《中国药事》
CAS
2010年第9期889-891,共3页
Chinese Pharmaceutical Affairs
关键词
吉他霉素片
溶出度
转速
溶出介质
Kitasamycin Tablets
dissolution
rotate speed
dissolution medium