硝苯地平缓释滴丸的制备及其质量评价  

Preparation and quality evaluation of nifedipine sustained-release dropping pills

作　　者：杜丽 陈林林 杜艳[2] DU Li;CHEN Linlin;DU Yan(Department of Pharmacy,Shanxi Cancer Hospital,Taiyuan 030013,China;Department of Pharmaceutics,School of Pharmacy,Shanxi Medical University)

机构地区：[1]山西省肿瘤医院药学部,太原030013 [2]山西医科大学药学院药剂教研室

出　　处：《山西医科大学学报》2022年第1期106-111,共6页Journal of Shanxi Medical University

摘　　要：目的制备硝苯地平缓释滴丸,并对其进行质量评价。方法采用单因素试验设计法对硝苯地平缓释滴丸的处方工艺进行筛选,确定缓释载体材料种类(硬脂酸、十八醇)及用量(6%,9%,12%)、载药量(25%,35%,45%)及PEG4000与PEG6000比例(1∶1,1∶2)对硝苯地平滴丸体外释放度的影响。按照药典方法检测质量差异限度,并进行稳定性试验。结果硝苯地平滴丸的最佳处方工艺为:硬脂酸用量9%,PEG4000∶PEG6000为1∶2,载药量为25%。硝苯地平滴丸体外12 h内持续释放药物,其释药机制经拟合为一级方程,In(1-Q)=-K_(t)。硝苯地平滴丸的质量差异限度符合药典要求,在高温(40℃)、高湿(90%±5%)条件下稳定性良好,对光照敏感。结论硝苯地平缓释滴丸能够缓慢释放,制备工艺合理,滴丸质量合格。Objective To prepare nifedipine sustained-release dropping pill and evaluate its quality.Methods The optimized formulation was screened by single factor experiments.The effects of the type of control-released carrier materials(stearic acid and octadecanol),the amount(6%,9%,12%),the drug loading(25%,35%,45%),and PEG-4000/PEG-6000 ratio(1∶1,1∶2)on the release rate of nifedipine sustained-release dropping pills were investigated.The limit of weight difference was detected by methods in Chinese Pharmacopoeia,and the stability test was performed.Results When the dosage of stearic acid was 9%,the mass ratio of PEG-4000/PEG-6000 was 1∶2,and the loading of drug was 25%,the formulation was the best.Nifedipine dropping pills sustained drug release for 12 h in vitro,and its drug release mechanism was fitted into a first-order equation,In(1-Q)=-K_(t).The weight difference limit met the requirements of Chinese Pharmacopoeia.The dropping pills had good stability under high temperature(40℃)and high humi-dity(90%±5%),but they were sensitive to light.Conclusion Nifedipine sustained-release dropping pill can be released slowly,its preparation process is reasonable,and the quality of dropping pills is qualified.

关 键 词：硝苯地平 缓释滴丸 体外释放度 质量评价 

分 类 号：R92[医药卫生—药学]