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尼莫地平自微乳化颗粒的研制及质量评价

Preparation and Quality Evaluation of Nimodipine Solid Self-microemulsifying Granules

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【作者】 王姿媛; 欧丽红; 何泽民; 蔡晓虹; 崔升淼;

【Author】 Wang Ziyuan~1,Ou Li hong~2,He Zemin~3,Cai Xiaohong~1,Cui Shengmiao~2(1.The First Affiliated Hospital,Guangzhou University of Chinese Medicine,Guangzhou 510405,China;2.Guangdong Pharmaceutical University;3.Gangdong Kangyu Pharmaceutical Co. Ltd.)

【机构】 广州中医药大学第一附属医院; 广东药学院; 广东康裕医药有限公司;

【摘要】 目的:制备尼莫地平固体自微乳化颗粒,并对其进行质量评价。方法:通过综合考察不同处方比例的成型率、重分散性及体外溶出度,筛选尼莫地平固体自微乳化颗粒的最佳处方,并对最佳处方的粒径、Zeta电位、溶出度进行考察,同时用差示扫描量热法(DSC)、X-衍射考察尼莫地平在制剂存在状态。结果:最佳处方为尼莫地平-油酸乙酯-Tween 80-PEG400-糊精-乳糖-甘露醇的质量比为0.03:0.2:0.55:0.25:1:1:2,其自微乳化后平均粒径(28.8±0.71)nm,30 min溶出度达80.7%。结论:尼莫地平固体自微乳化颗粒制备简单,质量稳定,可提高药物溶出度。

【Abstract】 Objective:To prepare nimodipine solid self - microemulsifying drug delivery system(SMEDDS) and evaluate the quality.Method:The optima]formula of nimodipine solid SMEDDS was screened by comprehensive investigation on the forming ratio of different proportion,re-dispersion and in vitro dissolution.The particle size,Zeta potential and dissolution were studied.The existing situation of nimodipine in the SMEDDS was also studied by DSC and X-diffraction.Result;The optimal formula was as follows;the ratio of nimodipine-ethyl oleate-Tween80-PEG400-dextrin-laclose-mannilol was 0.03:0.2:0.55:0.25:1:1:2.The average particle size was(28.8±0.707) nm after redispersed,and the dissolution was 80.7%in 30 min.Conclusion;Nimodipine solid SMEDDS is easy to prepare and the quality is stable with improved dissolution.

【基金】 广东省科技计划项目(编号:2012B031800196);广东省医学利研基金(编号:A2012218)
  • 【分类号】R944.9
  • 【被引频次】2
  • 【下载频次】152
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