摘要
目的:建立测定替硝唑阴道泡腾片溶出度的方法。方法:采用流通池法,分别以水和柠檬酸-磷酸二氢钠缓冲液(pH 4.0)为溶出介质,在流通池内以层流方式流动,温度为37℃,以紫外-可见分光光度法在315 nm波长处测定吸光度;对2 ml/min与3 ml/min流速情况下的溶出曲线进行非模型依赖相似因子比较,并采用威布尔分布模型提取溶出参数进行统计学分析。结果:参比制剂与研发制剂在20 min内的累积溶出百分率均大于75%,溶出曲线相似因子f2均大于50,参比制剂与研发制剂威布尔参数间差异无统计学意义(P>0.05)。结论:该方法简单、快速,可用于替硝唑阴道泡腾片溶出度的测定。
OBJECTIVE： To establish a method to determine the dissolution of Tinidazole vaginal effervescent tablets. METH- ODS： The flow-through cell method was adopted, using water and citric acid-sodium dihydrogen phosphate buffer solution （pH 4.0） as the dissolution medium separately with laminar flow mode in the flow cell at 37 ~C. The absorption was measured with UV spectrophotometry at 315 nm. A similarity factor method was used to compare the similarity of dissolution curves at the flow rates of 2 ml/min and 3 ml/min. The Weibull distribution model was used to extract dissolution parameters and statistical analysis. RE- SULTS： The cumulative dissolution percentages of test and reference preparations were more than 75% within 20 min. The f2 similarity factor of dissolution curves were greater than 50 and there was no significant difference between the Weibull parameters （P〉 0.05）. CONCLUSIONS： The established method is simple, fast and can be used for the dissolution determination of Tinidazole vaginal effervescent tablets.
出处
《中国药房》
CAS
CSCD
2014年第32期3059-3063,共5页
China Pharmacy
关键词
替硝唑阴道泡腾片
流通池法
溶出曲线
相似因子
威布尔参数
Tinidazole vaginal effervescent tablets
Flow-through cell method
Dissolution curves
Similarity factor
Weibull parameters
