李园园,罗明和,石三军,明月,等.金丝桃苷胶囊的制备及质量标准研究[J].,2018,5(9):12-15.
金丝桃苷胶囊的制备及质量标准研究
Studies on preparation of hyperin capsules and quality standard
投稿时间:2018-06-25  最后修改时间:2018-08-20
DOI:10.12095/j.issn.2095-6894.2018.09.003
中文关键词:  金丝桃苷胶囊;HPLC;质量标准
英文关键词:Hyperin capsules; HPLC; Quality standard
基金项目:重庆市基础科学与前沿技术研究重点项目:保肝新药金丝桃苷胶囊的研究与开发(CSTC2015jcyjBX0018);第三军医大学科技成果转化项目(2015XZH19)
作者单位E-mail
李园园 陆军军医大学第三附属医院(野战外科研究所) 药剂科 419914836@qq.com 
罗明和 陆军军医大学第三附属医院(野战外科研究所) 药剂科  
石三军 陆军军医大学第三附属医院(野战外科研究所) 药剂科  
明月 陆军军医大学第三附属医院(野战外科研究所) 药剂科 343951956@qq.com 
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中文摘要:
      【摘 要】目的:优化金丝桃苷胶囊的制备工艺,并建立其质量标准。方法:采用研磨法以PEG6000 为载体材料制备金丝桃苷固   体分散体,将其与不同辅料按照不同比例混合制粒填充胶囊。采用高效液相色谱法(HPLC)对胶囊中金丝桃苷的含量进行测定。   结果:选择将金丝桃苷PEG6000 固体分散体与微晶纤维素按7 ∶ 8 混合制粒填充胶囊,制备工艺简便易行。金丝桃苷质量浓度   在1.5~25 μg/ mL 范围内与峰面积呈良好的线性关系,r =0.9993,平均加样回收率为98.7%,RSD 值为0.4% (n = 6)。结论:该实   验成功制备了金丝桃苷胶囊,并建立了HPLC 检测金丝桃苷含量的质量标准。
英文摘要:
      【Abstract】Objective: To optimize preparation of hyperin capsule and establish the quality standards. Methods:The solid dispersion of   hyperoside was prepared by grinding method and using PEG6000 as a carrier material, and then and mixed proportionally with different ex?   cipients to fill capsules. The content of hyperoside in the capsule was determined by high performance liquid chromatography (HPLC).   Results: The preparation process of mixing the hypericin PEG6000 solid dispersion with the microcrystalline cellulose by 7 ∶ 8 is simple   and easy. The concentration of hyperin in the range of 1.5-25 μg/ mL showed a good linear relationship with the peak area, r = 0.9993.   The average recovery rate was 98.6%, and the RSD was 0.44% (n = 6). Conclusion: In this experiment, hypericin capsules were suc?   cessfully prepared and the quality standard for the determination of hyperoside content by HPLC was established.
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