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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。
OBJECTIVE: To screen the types and proportions of adjuvants of Tiaowei Chengqi Granules and to solve the problems of their formability, dissolvability and hygroscopicity, and to provide references for the clinical promotion and development of the preparation. Methods: The quality, the particle size, the moisture, the solubility and the hygroscopicity of the granules were taken as the quality evaluation indexes. Through the single factor test, the varieties, proportioning and dosage of adjuvants of Tiawei Chengqi granules were screened, and the quality of the granules was verified and the critical Relative humidity, angle of repose inspection. Results: The best forming excipients were mixture of lactose and mannitol. The granules were mixed and granulated by the ratio of extract - lactose - mannitol (1: 3: 1), and the obtained granules were uniform in size, formability, solubility and fluidity Good, not easy to absorb moisture The critical relative humidity of 69%, angle of repose <40 degrees. Conclusion: The preferred adjuvant can significantly improve the stability of the preparation, and the process is scientific and reasonable, simple and feasible.