不同企业维生素E烟酸酯胶囊溶出曲线相似性研究  

Study on similarity of dissolution curves of Vitamin E Nicotinate Capsules from different manufacturers

作　　者：王文心 候爱荣 聂延君 牛冲 徐玉文 WANG Wenxin;HOU Airong;NIE Yanjun;NIU Chong;XU Yuwen(Shandong Institute for Food and Drug Control,Jinan 250101,China;Yantai Food and Drug Testing Center, Yantai 264003, China)

机构地区：[1]山东省食品药品检验研究院,山东济南250101 [2]烟台市食品药品检验检测中心,山东烟台264003

出　　处：《药学研究》2018年第4期217-220,共4页Journal of Pharmaceutical Research

摘　　要：目的考察国内不同企业维生素E烟酸酯胶囊的溶出曲线,比较与原研制剂的相似性,为该品种的一致性评价提供参考。方法采用高效液相色谱(HPLC)法测定维生素E烟酸酯胶囊在水(0.2%SDS)、pH 1.2盐酸溶液(0.2%SDS)、pH 4.0醋酸盐缓冲液(0.2%SDS)、pH 6.8枸橼酸缓冲液(0.2%SDS)4种溶出介质中的溶出曲线,采用f_2因子法进行一致性评价,进一步分析影响样品溶出度的关键因素。结果 4家企业的样品在4种介质中的溶出行为与参比制剂均不一致,溶散粒径和处方工艺是影响该品种溶出的最关键因素。结论建议相关生产企业进一步优化和改进处方工艺,以提高产品的内在质量。Objective To investigate the dissolution curves of Vitamin E Nicotinate capsules from different companies in China,and compare the similarities with the original preparations to provide a reference for the generic pharmaceutical evaluation consistency.Methods The dissolution process of Vitamin E Nicotinate Capsules were monitored in the following repective medium： water（ contains 0.2%SDS）,hydrochloric acid solution with pH 1.2（ contains 0.2%SDS）,acetate buffer with pH 4.5（ contains 0.2%SDS）,citrate buffer with pH 6.8（ contains 0.2% SDS）. The dissolution curves were determined by HPLC.The evaluation used the f2 factor method to further analyze the key factors affecting sample dissolution profiles.Results The dissolution behaviors of the samples from four different companies inconsistent with the reference preparations in either dissolution medium.The dissolving particle size and the formulation process were the most critical factors affecting the dissolution of this product. Conclusion It was recommended that relevant manufacturers should further optimize and improve the prescription process in order to improve the intrinsic quality of the product.

关 键 词：维生素E烟酸酯胶囊 溶出曲线 F2因子 仿制药一致性评价 

分 类 号：R927.1[医药卫生—药学]