镇惊泻火颗粒的制备工艺研究  

Study on the Preparation Process of Zhenjing Xiehuo Granules

作　　者：奚之骏[1] 许丽雯[1] 史秀峰[1] 祁雯[1] 陶建生[2] 袁灿兴[3] 

机构地区：[1]上海中医药大学附属龙华医院药剂科,上海200032 [2]上海中医药大学药物安全评价中心 [3]上海中医药大学附属龙华医院脑病科

出　　处：《中国药师》2015年第12期2058-2061,2094,共5页China Pharmacist

基　　金：上海市卫生局中药新药及院内制剂研发项目(编号:2010YD13A)

摘　　要：目的:研究镇惊泻火颗粒的制备工艺。方法:采用正交试验,以干浸膏得率、甘草苷和丹酚酸B的含量为指标对镇惊泻火颗粒的提取、纯化工艺进行研究;以合格颗粒得率为指标,对颗粒的成型工艺进行研究,优选制剂的制备工艺。结果:铁落先煎60 min,其余各药加8倍量水浸泡90 min加入先煎铁落液煎煮提取90 min洪3次。合并浓缩至相对密度1.3左右(60℃热测)加蒸馏水至稀释比为1:2(V/V),加乙醇至含醇量50%24 h后滤过。滤液回收乙醇后浓缩至相对密度1.3(60℃热测),60℃下干燥粉碎得干浸膏。以淀粉作稀释剂,干浸膏与辅料比例1:0.8,90%乙醇为润湿剂制软材,过20目筛制粒,60℃干燥3h,烘干,整粒,即得。结论:优选的镇惊泻火颗粒制备工艺稳定可行。Objective： To investigate the preparation procedure of Zhenjing Xiehuo granules. Methods： Using the dry extract yielding rate and the contents of liquiritin and salvianolic acid B as the indices, an orthagonal test was adopted to choose the best ex- traction and purification technology. Using the qualified ratio of granules as the index, an orthogonal test was adopted to choose the best preparation process of the granules. Results： The optimized preparation conditions were as follows ： Pulvis ferri was decocted first for 60 rain. The other medicines were dipped in 8-fold amount of water for 90 min, and then added into pulvis ferri extracts and decocted for 3 times with 90 .min for each time. The extracts were collected and concentrated till the relative density was 1.3 （ measured at 60℃ ）, water was added with the dilution ratio of 1 ： 2, ethanol was added till the percentage of ethanol was 50% , and then the mixed liquid was filtered after 24 hours. After ethanol was recycled from the filtrate, the filtrate was concentrated till the relative density was 1.3 （ measured at 60℃ ）, and then dried at 60℃. Starch as the diluent, the ratio of extract to excipient was 1 ： 0.8, and the wet granules were prepared with 90% ethanol as the wetting agent, dried 3 hours at 60℃ followed by size stabilization to obtain the products. Con- dusion： The optimized preparation procedure of Zhenjing Xiehuo granules is stable and feasible.

关 键 词：镇惊泻火颗粒 提取工艺 醇沉工艺 颗粒制备工艺 

分 类 号：R283[医药卫生—中药学]