阿魏酸哌嗪片的溶出曲线考察

目的：建立阿魏酸哌嗪片溶出度曲线测定方法，比较4家生产企业阿魏酸哌嗪片在4种不同溶出介质中的溶出行为差异，为药品质量控制与仿制药一致性评价提供参考。方法：以pH 1.2盐酸溶液、醋酸盐缓冲液（pH 4.0）、磷酸盐缓冲液（pH 6.8）和水为溶出介质，分别考察4家企业12批阿魏酸哌嗪片的溶出曲线，采用f2相似因子法评价溶出曲线的相似性。结果：所有批次样品在pH 1.2盐酸溶液中溶出量均低于15%，3家企业9批次样品在pH 6.8磷酸盐缓冲液和水中的溶出行为相似（f2>50），pH 4.0醋酸盐缓冲液对阿魏酸哌嗪片有较好区分力。结论：建立的测定方法专属性强、灵敏度高、准确可靠，可用于阿魏酸哌嗪片溶出曲线测定，为其质量控制提供参考。

Study of Dissolution Profiles of Piperazine Ferulate Tablets

Objective: To study the dissolution profiles of piperazine ferulate tablets in different dissolution media so as to evaluate drug quality and generic drug quality consistency. Methods: The dissolution of 12 batches of piperazine ferulate tablets from 4 manufactures were determined in dissolution media of pH 1.2 hydrochloric acid, pH 4.0 acetate buffer, pH 6.8 phosphate buffer and water, respectively. The consistency of dissolution curves were evaluated by calculating the similarity factor (f2). Results: The accumulated dissolutions were less than 15% in pH 1.2 hydrochloric acid for all the 12 batches of products from 4 manufactures. The dissolution behavior of 9 batches of products in pH 6.8 phosphate buffer and water had high similarity (f2>50). The dissolution profiles were significantly different in dissolution media of pH 4.0 acetate buffer. Conclusions: The established dissolution curve testing method is specific, sensitive and reliable, which can be used for the determination of dissolution and provide reference for the consistency evaluation for piperazine ferulate tablets.