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目的:考察不同厂家肝速康胶囊中的齐墩果酸在两种不同介质中的溶出行为,为评价药品质量提供依据。方法:参照日本《医疗用药品品质情报集》中的溶出度试验条件,并根据肝速康胶囊处方成分的理化性质对溶出介质进行筛选,采用《中国药典》2010年版二部附录XC第一法装置,分别测定3个厂家7个不同批号的肝速康胶囊在p H 6.8磷酸盐缓冲液(含0.25%十二烷基硫酸钠)和水(含0.25%十二烷基硫酸钠)中的溶出曲线;用HPLC-ELSD法对齐墩果酸的溶出度进行测定。结果:齐墩果酸在2.0~40.0 mg·ml-1浓度范围内呈良好线性关系,在两种不同溶出介质中齐墩果酸的回收率均在98%以上且溶出均一性良好;7个不同批号肝速康胶囊主要成分齐墩果酸水中的溶出曲线基本一致,p H 6.8磷酸盐缓冲液中溶出曲线则有较大差异。结论:作为肝速康胶囊的溶出介质,p H6.8磷酸盐缓冲液比水更能体现肝速康胶囊不同来源和不同批次间的溶出差异;该方法简便、准确,重复性好,可用于该胶囊的溶出度测定。
OBJECTIVE: To investigate the dissolution behavior of oleanolic acid in two different media from different manufacturers of Gansukang capsule, and to provide a basis for evaluating the quality of the drug. Methods: According to the dissolution test conditions in the Japanese medical quality intelligence set, according to the physicochemical properties of the prescription ingredients of Gosu Kang Capsule, the dissolution medium was screened by using the Chinese Pharmacopoeia 2010 edition two appendix XC first method Device, were measured in three manufacturers of seven different batches of Gan Sukang capsules p H 6.8 phosphate buffer (containing 0.25% sodium lauryl sulfate) and water (containing 0.25% sodium lauryl sulfate) in Dissolution curve; Determination of oleanolic acid dissolution by HPLC-ELSD method. Results: Oleanolic acid showed good linearity in the concentration range of 2.0-40.0 mg · ml-1. The recoveries of oleanolic acid were both above 98% in two different dissolution media with good dissolution uniformity. Seven Dissolution curves of the main components of oleic acid in different batches of Hekukang Capsule were basically the same, and the dissolution curves in p H 6.8 phosphate buffer were quite different. CONCLUSION: As the dissolution medium of Goksukang Capsule, p H6.8 phosphate buffer can reflect the difference of dissolution between different sources and different batches of Gansukang Capsules better than water. The method is simple, accurate and reproducible Determination of the dissolution of the capsule.