不同介质中头孢地尼干混悬剂溶出曲线相似性比较的研究

目的：评价自制头孢地尼干混悬剂与市售原研品头孢地尼胶囊体外溶出行为的相似性,同时为难溶性药物制剂质量判断提供参考.方法：分别考查自制试验制剂头孢地尼干混悬和参比制剂头孢地尼胶囊在纯水、pH 1.2人工胃液、pH 4.0与pH 6.8磷酸盐缓冲液4种溶出介质中的体外溶出行为,以紫外-可见分光光度法进行测定,并采用f2相似因子法评价受试制剂和市售参比制剂溶出曲线的相似性.结果：在4种介质中,自制样品与参比制剂相似因子f2均大于50.结论：在这4种介质中,自制试验制剂与参比制剂溶出行为相似,说明受试制剂的处方工艺合理.

Similarity comparison of the dissolution curve of cefdinir in various dissolution media

Objective ： To compare the dissolution curves similarity of two cefdinir products in various dissolution media with dif- ferent properties, of which one is suspension （ the test formulation ）, the other one is capsule （ the reference formulation）, and to provide the reference for insoluble drug quality evaluation. Methods ： The oar method for dissolution test in Japenese pharmacopoeia was consulted. To determine the rate of dissolution of the test and reference formulations, four dissolution media were selected, inclu- ding water, pH 1.2 artificial gastric juice, pH 4.0 and pH 6.8 phosphate buffer. Similartity factor f2 was used to compare the disso- lution profiles between the test and reference formulations. Results： The similarity factors f2 in various conditions were over 50. Conclusion： The dissolution curve of two products in various dissolution media was in good comparability.