西尼地平片晶型及溶出度研究.pdfVIP

西尼地平片晶型及溶出度研究 石云峰 1 1,2 1,2 1 2 1 1 ，王建 ，杨伟峰 ，曾红霞 ，许梦佳 ，李煜 ，艾婕 (1.浙江省食品药品检验研究院，杭州 310052 ；2. 浙江工业大学化工学院，杭州 310014)  摘要：目的 考察西尼地平片国内仿制药和原研药晶型和体外溶出情况。方法 制备西尼地平 2 种晶型，采用激光共聚 焦显微拉曼光谱仪测定 2 种晶型、原研药、仿制药的拉曼图谱，确定国内仿制药和原研药的晶型情况，并建立具有区分 力的溶出度方法。结果 国内 A 、B 2 家企业产品为 α 晶型，原研药和国内 C 企业产品为无定型，所建立的溶出度方法 (0.5%SDS 的 pH 6.8 磷酸盐缓冲液为溶出介质，体积为 900 mL ，转速为 75 r·min1)可以有效区分国内仿制药和原研药。 结论 国内仿制药和原研药晶型与体外溶出存在一定差异。 关键词：西尼地平片；晶型；溶出度；激光共聚焦显微拉曼光谱；制剂工艺 中图分类号：R944.4 文献标志码：B 文章编号：1007-7693(2016)12-1539-05 DOI: 10.13748/ki.issn1007-7693.2016.12.012 Study of the Polymorphs and Dissolution of Cilnidipine Tablets SHI Yunfeng1 1,2 1,2 1 2 1 1 , WANG Jian , YANG Weifeng , ZENG Hongxia , XU Mengjia , LI Yu , AI Jie (1.Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China; 2.College of Chemical Engineering and Materials Science, Zhejiang University of Technology, Hangzhou 310014, China) ABSTRACT: OBJECTIVE To investigate the difference of generic drugs and the original drug by researching the polymorphs and dissolution. METHODS Reference Raman spectra of the 2 crystal forms of cilnidipine were established; then the polymorphs of the cilnidipine tablets from different manufacturers were analyzed, and a dissolution method was established to distinguish the different samples. RESULTS The polymorph of samples from manufacture A and manufacture B were polymorph . The polymorph of samples from manufacture C and original drug were amorphous form. The dissolution method (0.5% SDS pH 6.8 phosphate buffer, 900 mL, 75 r·min1) was established and could distinguish the different samples. CONCLUSION There exist certain d