清咽含片的研制

【作者】 赵海霞；

【导师】 田景振；

【作者基本信息】 山东中医药大学 ， 中药学， 2001， 硕士

【摘要】 目的：研制中药复方制剂清咽含片。方法：采用正交试验设计，以总糖和氧化苦参碱为指标，优选山豆根等药材的水提取工艺；以绿原酸为指标，拟定金银花、板蓝根的醇提条件；用均匀设计法，优选精制工艺；采用正交设计，筛选辅料配比，制备清咽含片；采用HPLC测定氧化苦参碱与绿原酸含量，制定质量标准。对药效及安全性进行考察。结果：最佳提取精制工艺为：水提部分以12倍量水煎煮2次，每次1小时，浓缩至5倍量，按1A0.5B加入BD澄清剂，搅拌，静置。醇提部分以10倍量75％乙醇提取2次，每次1小时。按处方量3％蛋白糖、20％甘露醇、3％薄荷脑比例配料制粒。氧化苦参碱平均回收率为99.29％，RSD=2.37％（n=5）；绿原酸平均回收率为99.44％，RSD=1.81％（n=5）。清咽含片有抗炎、解热、抑菌等作用，且安全无毒。结论：工艺及质量控制方法简便可行，稳定可靠，药效学实验及安全性评价为临床提供了实验基础。更多还原

【Abstract】 Preparation and Evaluation of Qingyan TabletsAuthor:Zhao HaixiaInstructor:Prof. Tian JingzhenAddress:The affiliated hospital of Shan Dong TCM universityAbstract:Objective: To study the compound Chinese medicinc QingyanTablets.Methods:Withtheorthogonaltest ,regardingomni-phlysaccharide and Oxymatrine as index, to well choose the water extraction technology of Radix Sophorae tonkinensis and other herbs; regarding Cholorogenic acid as index, to establish the alcohol-extraction conditions of Flos lonicerae and Radix isatidis; with the uniformdesign, to well choose clarification technology ; with the orthogonal design , to choose the proportion of affiliated materials and make Qingyan tablets; to establish the quality standard and test on pharmacology and toxicology . Result: The best water-extraction conditionis: boiled twice with l2times water, 1 hour for each time, condensing the boiled liquid to 1:5, adding BD clarification dose of lAO.5B, stirring and laying up. The best alcohol-extraction condition is refluxing and extracting twice with 10 times alcohol of 75%, 1 hour for each time. The average retriving rate of Oxymatrine is99.29%, RSD~2. 37%(n5), the average retriving rate of Cholorogenic acid is 99.44%, RSD~l.8l%(n%). The Qingyan tablets have the effect of anti-nflammation, releasing heat, restraining bacteria and so on, without ~poision. Conclusion: The well梒hosen technology is simple, stable and feasible; the quality of Qingyan Tablets can be controlled by the established containation testing method. The pharmacology testing offerred a foundation to clinical use.更多还原