头孢泊肟酯片体外溶出曲线研究

Study on Dissolution Curves of Cefpodoxime Proxetil Tablets in Vitro

关键词:  头孢泊肟酯片  参比制剂  溶出曲线  一致性评价

Key words:  cefpodoxime proxetil tablets  reference preparations  dissolution curves  consistency evaluation

摘要:

建立头孢泊肟酯片溶出度测定方法，通过比较自制头孢泊肟酯片与参比制剂的溶出曲线，评价两种制剂体外溶出行为是否一致。测定自制制剂及参比制剂在盐酸溶液(pH=1.5)、甘氨酸-氯化钠-盐酸溶液(pH=3.0)、醋酸盐缓冲液(pH=4.0)、磷酸盐缓冲液(pH=6.8)的溶出曲线，并通过计算相似因子(f2)评价溶出曲线的相似性。在4种溶出介质中，3批自制制剂与参比制剂溶出曲线均相似。本研究建立的溶出试验方法能有效控制自制头孢泊肟酯片的质量，自制制剂与参比制剂体外溶出行为基本一致。

Abstract:

A dissolution test assay for cefpodoxime proxetil tablets was established to evaluate the consistency of in vitro dissolution behaviors of self-developed cefpodoxime proxetil tablets and reference preparations by comparing the dissolution curves of the two preparations. The dissolution curves of self-developed preparations and reference preparations in hydrochloric acid solution (pH=1.5), glycine-sodium chloride-hydrochloric acid solution (pH=3.0), acetate buffer (pH=4.0) and phosphate buffer (pH=6.8) were determined and the similarity of dissolution curves was evaluated by calculating similarity factor (f2). Results show that the dissolution curves of three batches of self-developed preparations and reference preparations were similar in all four dissolution media. In conclusion, the dissolution test method established in this study can effectively control the quality of self-developed cefpodoxime proxetil tablets. The in vitro dissolution behaviors of self-developed cefpodoxime proxetil tablets were basically consistent with that of reference preparations.