| 引用本文: | 石云峰,王建,杨伟峰,曾红霞,许梦佳,李煜,艾婕.西尼地平片晶型及溶出度研究[J].中国现代应用药学,2016,33(12):1539-1543. |
| SHI Yunfeng,WANG Jian,YANG Weifeng,ZENG Hongxia,XU Mengjia,LI Yu,AI Jie.Study of the Polymorphs and Dissolution of Cilnidipine Tablets[J].Chin J Mod Appl Pharm(中国现代应用药学),2016,33(12):1539-1543. |
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| 西尼地平片晶型及溶出度研究 |
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石云峰1, 王建1,2, 杨伟峰1,2, 曾红霞1, 许梦佳2, 李煜1, 艾婕1
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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
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| 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 |
| DOI：10.13748/j.cnki.issn1007-7693.2016.12.012 |
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| 基金项目:浙江省科技计划项目（2015C37056） |
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| Study of the Polymorphs and Dissolution of Cilnidipine Tablets |
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SHI Yunfeng1, WANG Jian1,2, YANG Weifeng1,2, ZENG Hongxia1, XU Mengjia2, LI Yu1, AI Jie1
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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
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| 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 α. 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 differences between generic drugs and the original drug in terms of dissolution and the polymorphs. |
| Key words: cilnidipine tablets polymorphs dissolution laser confocal micro-Raman spectra preparation process |
