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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
【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.
【Key words】 Nimodipine; Solid self-microemulsifying drug delivery system; Quality evaluation;
- 【文献出处】 中国药师 ,China Pharmacist , 编辑部邮箱 ,2013年06期
- 【分类号】R944.9
- 【被引频次】2
- 【下载频次】152