调胃承气颗粒的成型辅料优选

目的:筛选调胃承气颗粒的辅料种类及配比,解决其成型性、溶化性及吸湿性等问题,为该制剂的临床推广与开发提供参考。方法:以颗粒的外观、粒度、水分、溶化性、吸湿性等为质量评价指标,通过单因素试验筛选调胃承气颗粒的辅料品种、配比及用量,并对成型颗粒进行质量验证和临界相对湿度、休止角考察。结果:最佳成型辅料为乳糖和甘露醇混合物,以浸膏-乳糖-甘露醇(1∶3∶1)配比混合制粒,制得的颗粒大小均匀,成型性、溶解性、流动性均好,且不易吸湿。临界相对湿度69%,休止角40度。结论:优选的辅料可显著地提高该制剂的稳定性,且工艺科学合理、简便可行。

Optimization of Molding Materials for Tiaowei Chengqi Granules

Objective: To screen optimal shaping and matching excipients of Tiaowei Chengqi granules for solving moldability,dissolvability, hygroscopicity and other issues. Method: With appearance,particle size,moisture content,dissolvability and hygroscopicity of granules as indexes,single factor tests were adopted to screen kinds,ratio and amounts of excipients,then quality verification,critical relative humidity and angle of repose were investigated. Result: Optimum molding materials was mixture of lactose and mannitol,ratio of extract-lactose-mannitol (1 : 3 : 1) for granulating,these prepared granules had uniform particle size,good properties and were not easy to moisture absorption.Critical relative humidity was 69% and angle of repose was less than 40°. Conclusion: These optimized excipients can significantly improve stability of Tiaowei Chengqi granules,and this molding process is scientific and rational.