固环胶囊制备工艺的优选

Research on Preparation Process of Guhuan Capsules

目的 :优选固环胶囊制备工艺。方法 :以黄芩甙和小檗碱收率为指标 ,应用正交设计试验优选固环胶囊提取工艺。结果 :三七粉碎为 12 0目细粉入药 ;影响乙醇渗漉提取的主次因素 :A >B >C(A为乙醇加入量 ;B为乙醇浓度 ;C为渗漉时间 ) ,优选的提取工艺条件 :加入 5倍于药材量的乙醇 ,乙醇浓度为 6 0 % ,渗漉 48h ;影响加水煎煮的主次因素 :A >C >B >D(A为加水量 ;B为乙醇在药材浸膏中的浓度 ;C为煎煮时间 ;D为煎煮次数 ) ,优选的提取工艺条件 :加水量为药材量的 12倍 ,每次煎煮 1.5h ,煎煮 2次 ,合并滤液 ,浓缩成相对密度为 1.2 0 (85℃测定 )的药材浸膏 ,缓缓加入乙醇 ,使浸膏中乙醇浓度达到 80 %。结论 :优选的制备工艺稳定可行。

Objective: To optimize the preparation process of Guhuan Capsules. Methods: The optimum extraction conditions were studied by the orthogonal test in baicalin & berberine as markers. Results: Radix Notogiseng was crushed to powder (120 mesh) and added directly into capsules. The factors influencing the alcohol percolation were as follows: A>B>C (A: the amount of alcohol added. B: the alcohol concentration. C: the percolation time). The optimum percolation condition obtained was: adding 5 fold of alcohol which concentration was 60%, and percolating for 48 hours. The factors influencing decoctation were as follows: A>C>B>D (A:the amount of water added. B: the alcohol concentration in the fluidextract of herbs. C: decoction time, D: decoction times). The optimum decoction condition obtained was: adding water (12 times as much as medicine), decocting twice 1.5 hours each time, merging the filtrate, concentrating the merged filtrate into extract with a relative density of 1.20 (measured at 85℃), then adding alcohol slowly, and making the concentration of alcohol in the fluidextract come to 80%. Conclusion: The optimized process is stable and feasible.