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退热止痛散解热镇痛活性部位软胶囊制备工艺与质量控制研究

The soft capsule preparation process and quality control of the antipyretic and analgesic active fractions extracted from Antipyretic Analgesics Powder
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摘要 目的对退热止痛散解热镇痛活性部位软胶囊制备工艺进行考察并对其质量进行控制。方法以流动性、均匀性和沉降体积比等为考察指标筛选囊内物基质和湿润剂的种类与用量,确定囊内物处方和成型工艺,并通过性状、鉴别、检查和主要成分的含量测定来控制该软胶囊剂的质量。结果囊内物最佳处方为:大豆油和活性部位包合物按1.5∶1比例混合,并加入1%的大豆磷脂作为湿润剂。结论该工艺可行,制得的软胶囊剂质量稳定,符合药用要求。 Objective To investigate the soft capsule preparation process of the antipyretic and analgesic active fractions extracted from Antipyretic Analgesics Powder and to control its quality. Methods As the liquidity, uniformity and sedimentation volume were examining index, screening the type and dosage of pouch matrix and wetting agents to determine the pouch prescription and molding process. And to control the quality of the soft capsule by the character, identification, examination and content determination of main components. Results The optimum prescription of pouch material is soybean oil and active site clathrate were mixed according to 1.5 : 1 ratio, and adding 1% soybean phospholipid as wetting agents. Conclusion The technology is feasible and the soft capsule has stable quality, conforming to the requirements for medicinal.
出处 《时珍国医国药》 CAS CSCD 北大核心 2015年第9期2162-2164,共3页 Lishizhen Medicine and Materia Medica Research
基金 广东省建设中医药强省重点课题(No.3060010)
关键词 退热止痛散 活性部位 软胶囊 制备工艺 质量控制 Antipyretic Analgesics Powder Active fractions Soft capsule Preparation process Quality control
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