西尼地平片晶型及溶出度研究

    Study of the Polymorphs and Dissolution of Cilnidipine Tablets

    • 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。

       

      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.

       

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