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自制和原研地氯雷他定片溶出曲线的比较和评价does的用法
摘要 目的：比较自制和原研地氯雷他定片剂的溶出行为。方法：根据普通口服固体制剂溶出曲线测定与比较指导原则，采用浆法，高效液相色谱法检测自制和原研片剂分别在pH 1.0、pH 4.5、pH 6.8的缓冲液和水中的溶出度，f2相似因子法比较溶出曲线的相似程度，初步评价其体外释放行为的一致性。结果：主成分的溶液稳定性良好，自制片剂和原研片剂在不同介质中的溶出曲线均相似，四组f2因子都大于50，符合评价要求。结论：自制片剂和原研片剂的体外释放度一致。
huxley
昨梦录翻译ABSTRACT Objective： To compare and evaluate the dissolution behaviors between home-made desloratadine tablet and its reference listed drug. Methods： The dissolution of desloratadine tablets was analyzed by an HPLC method according to guiding principles of determination and comparison on dissolution profile of general oral solid preparation. The dissolution of both drugs was determined in buffer solutions at pH 1.0， pH 4.5， pH 6.8 and water， respectively. The degree of similarity of the dissolution curve was compared by similarity factor f2 and then the consistency of the in vitro relea behavior was initially eval
uated. Results： The solutions containing main components were stable， and the dissolution profiles of both drugs were similar in various types of media （f2 factors>50）. The f2 factors were all met the quoted requirements. Conclusion： The in vitro relea behavior of both drugs is consistent.
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