布洛芬滴丸的成型工艺及体外溶出度研究

发布时间：2018-07-20 14:03

【摘要】：目的:研究布洛芬滴丸的成型工艺并测定其体外溶出度。方法:在单因素试验的基础上,采用响应面法,以圆整度、载药率、丸重差异为评价指标,筛选成型工艺中的药物与基质质量比、药液温度、制冷温度;同时进行验证试验,考察最优工艺所制滴丸的体外溶出度并与市售片剂进行比较。结果:布洛芬滴丸的最优成型工艺为药物与基质质量比1∶6,药液温度83℃,制冷温度7.3℃。验证试验中自制滴丸的圆整度为0.945 9、载药率为99.82%、丸重差异为0.040 28,含药量约为30 mg/丸;综合评分的实际值为0.972 5,与理论值(0.980 0)的偏差值为0.771 2%,RSD1.5%(n=3)。所制滴丸5 min溶出度为25.36%,30 min累积溶出度达到90.12%,与市售布洛芬片剂体外释药行为相似(f_2=54.91),符合一级药动学方程。结论:该成型工艺方法简单、稳定可行;以优化成型工艺所制滴丸可快速释药且重复性好。
[Abstract]:Objective: to study the molding technology of ibuprofen drop pills and determine its dissolution in vitro. Methods: on the basis of single factor test, response surface method was used to select the mass ratio of drug to matrix, liquid temperature, refrigeration temperature and validation test, taking roundness, drug loading rate and pill weight difference as evaluation indexes. The dissolution of the dropping pills prepared by the optimal technology was investigated and compared with the commercial tablets. Results: the optimum molding technology of ibuprofen drop pills was as follows: the mass ratio of drug to matrix was 1: 6, the liquid temperature was 83 鈩，

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