不同厂家肝速康胶囊在两种溶出介质中的溶出曲线比较  

Comparative Studies on Dissolution of Gansukang Capsules from Different Manufacturers in Two Dissolution Media

作　　者：王蕾 

机构地区：[1]盐城市药品检验所,江苏盐城224002

出　　处：《中国药师》2015年第11期1888-1892,共5页China Pharmacist

摘　　要：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pH 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,pH 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,pH6.8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 dissdution behavior of Gansukang capsules from different manufactures in two different dissdution media and to provide theoretical basis for evaluating the quality of medicine. Methods：According to the dissolution test con-ditions in Japan’ s “quality of medical drugs information set” and the physicochemical properties of Gansukang capsules, two dissolu-tion media were chosen. The dissolution behavior of Gansukang capsules from 3 manufacturers in pH 6. 8 phosphate buffer （containing 0. 25% sodium lauryl sulfate） and water （containing 0. 25% sodium lauryl sulfate） was determined by the method I in Appendix XC of Chinese Pharmacopoeia Volume II （2010 edition）, and the dissolution rate was determined by HPLC-ELSD. Results：The assay dis-played a good linearity over the concentration range of 2. 0-40. 0 mg·ml-1 for oleanolic acid, the recovery of oleanolic acid in pH 6. 8 phosphate buffer and water was above 98%, and Gansukang capsules had the similar property in the two media. The dissolution behav-ior of Gansukang capsules from 3 manufacturers in water was similar to each other, while in pH 6. 8 phosphate buffer, that was signifi-cantly different. Conclusion：As for the dissolution medium for Gansukang capsule, pH 6. 8 phosphate buffer can reflect more differ-ences in the dissolution of products with different batches and from different manufacturers than water. The method is simple, accurate and reproducible in the dissolution determination of the capsules.

关 键 词：肝速康胶囊 齐墩果酸 高效液相色谱-蒸发光散射检测器联用法 溶出度 

分 类 号：R927.1[医药卫生—药学]