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[摘要]
目的 优选麻杏止咳平喘颗粒剂的成型工艺。方法 考察不同辅料糊精、糖粉、可溶性淀粉用量对浸膏粉吸湿性的影响,用正交试验法优选制粒工艺条件,考察颗粒的流动性与吸湿性,以成型率、溶解性及吸湿率为指标,筛选处方中加入辅料的品种、配比及最佳成型工艺。结果 以糖粉加糊精作辅料的颗粒优于以糊精或糖粉或可溶性淀粉作辅料的颗粒,最佳工艺条件为主药-辅料(1:2)、辅料配比为糊精-糖粉(1:1),以80%乙醇为润湿剂,润湿剂的用量占主药的14%。结论 该颗粒剂所选辅料合理,成型制备工艺可行,本研究为麻杏止咳平喘颗粒制粒工艺条件的确定及生产环境的控制提供了科学的实验依据。
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[Abstract]
Objective To optimize the processing conditions of Maxing Antitussive and Antiasthmatic Grannule(MAAG).Methods The influence of different excipients including lactose, soluble amylum, and dextrine, and usage amount of soluble amylum to hygroscopicity of powdered extract was investigated;Processing conditions were optimized by orthogonal test, flowability, and hygroscopicity were investigated.Taking forming rate, solubility, and absorption rate as indexes, the materials added prescription varieties, ratio, and optimum molding process were screened.Results The particles sugar plus dextrin as excipients were superior to dextrin or sugar or soluble starch as excipient particles;The optimized conditions were obtained with:main drug-accessories(1:2), accessories for the dextrin-powdered sugar(1:1), with 80% ethanol as wetting agent which accounted for 14% of the main drug.Conclusion The selected accessories in MAAG is reasonable and forming process is feasible.This research provides the basis for the establishment of forming technique and control of production environment of MAAG.
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