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目的:比较国内盐酸特拉唑嗪片及胶囊的溶出情况,为临床用药提供参考。方法:分别考察各企业产品在p H 1.0盐酸溶液、p H4.5磷酸盐缓冲液、p H 6.8磷酸盐缓冲液及水4种溶出介质中的体外溶出行为;溶出方法采用桨法,转速为50 r·min-1,溶出度测定方法为高效液相色谱法;采用相似因子法进行各企业产品间溶出行为的比较。结果:国内片剂生产企业的产品与参比制剂的相似较高,胶囊剂产品溶出行为差异较大。结论:部分企业的规格计算方式与参比制剂不一致是造成受试制剂与参比制剂不相似的重要原因,临床用药时应加以注意。
OBJECTIVE: To compare the dissolution of terazosin hydrochloride tablets and capsules in China and provide references for clinical use. Methods: The in vitro dissolution behavior of each product in four dissolution media of p H 1.0 hydrochloric acid, p H 4.5 phosphate buffer, p H 6.8 phosphate buffer and water was investigated respectively. The dissolution method was paddle method, 50 r · min-1. The dissolution was determined by high performance liquid chromatography (HPLC). The similarity factor method was used to compare the dissolution behavior among different enterprises. Results: The products of domestic tablet manufacturers are similar to the reference preparations, and the dissolution behavior of capsule products is quite different. Conclusion: The inconsistency between the specifications of some enterprises and the reference preparations is an important reason for the dissimilarity between the tested preparations and the reference preparations. Attention should be paid to clinical treatment.