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p H 6.8磷酸盐缓冲液为溶出介质,体积为900 m L,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。
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 a. The polymorph of samples from manufacture C and original drug were amorphous form. The dissolution method（0.5% SDS p H 6.8 phosphate buffer, 900 m L, 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.
作者
石云峰
王建
杨伟峰
曾红霞
许梦佳
李煜
艾婕
SHI Yunfeng WANG Jian YANG Weifeng ZENG Hongxia XU Mengjia LI Yu AI Jie(Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China College of Chemical Engineering and Materials Science, Zhejiang University of Technology, Hangzhou 310014, China)
出处
《中国现代应用药学》
CAS
CSCD
2016年第12期1539-1543,共5页
Chinese Journal of Modern Applied Pharmacy
基金
浙江省科技计划项目(2015C37056)
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
cilnidipine tablets
polymorphs
dissolution
laser confocal micro-Raman spectra
preparation process
