盐酸洛美沙星胶囊和片剂的体外溶出度

Dissolution of Lomefloxacin hydrochloride in capsules and tablets

目的 对盐酸洛美沙星胶囊和片剂进行溶出度测定 ,以考察其质量。方法 采用转篮法 ,以 0 1mol·L- 1 盐酸为溶出介质 ,检测波长 2 87nm ,研究洛美沙星胶囊和片剂的溶出度。结果 根据Weibull分布模型 ,计算出溶出参数T0 5、Td、T0 8和m。结论 各厂家的产品在 30min时 ,累积溶出量均大于 80 % ,符合规定。不同厂家的胶囊溶出度无显著性差异 (P >0 0 5 ) ,而不同厂家的片剂溶出度有极显著差异 (P <0 0 1)。建议对每批产品进行溶出度检查 ,控制其质量 。

OBJECTIVE To determine the dissolution of Lomefloxacin hydrochloride capsules and tablets in order to test the quality of them.METHODS The rotatory basket method was adopted(Chinese pharmacopoeia 2000 edition).The release characteristics of the capsules and tablets were evaluated in 0.1 mol·L -1 HCl,and 287nm was selected as the determination wavelength,to study the dissolution of Lomefloxacin hydrochloride capsules and tablets in vitro .RESULTS The dissolution parameters of T 0.5 , T d, T 0.8 and m were obtained according to Weibull distribution.CONCLUSION The accumulative dissolving quantities of all preparations exceeded 80% in 30 minutes.The dissolution of capsules from different factories have no significant difference( P >0 05),but the dissolution of tablets from different factories was markedly different( P <0 01) It's suggested that dissolulility of products should be tested to control the quality and ensure clinic efficacy.