乳腺康颗粒的制备工艺研究

Preparation process of Ruxiankang granules

目的优选乳腺康颗粒的最佳提取工艺和成型工艺条件。方法通过正交试验设计,使用高效液相色谱法(HPLC)以干浸膏得率和芍药苷、阿魏酸、丹酚酸B的含量为评价指标,考察提取次数、加水量和提取时间3个因素对乳腺康颗粒提取工艺的影响,确定最佳提取工艺。采用响应面优化试验法,以颗粒的成型率、休止角、吸湿率和溶化率为考察指标,确定最佳成型工艺。结果乳腺康颗粒最佳的提取工艺为提取2次,第一次用12倍量水提取1.5 h,第二次用10倍量水提取1 h;最佳成型工艺:选择β-环糊精为辅料,辅料与药粉比例为1.8∶1,85%乙醇作为湿润剂,乙醇加入量为药辅总量的36%。结论本研究可为乳腺康颗粒进一步的研究提供科学依据,并为后续的生产工作提供理论参考。

Objective To optimize the extraction and molding conditions of Ruxiankang granules.Methods Through orthogonal experimental design,high performance liquid chromatography(HPLC)was used to evaluate the yield of dry extract and the contents of paeoniflorin,ferulic acid and salvianolic acid B.The effects of extraction times,water amount and extraction time on the extraction process of Ruxiankang granules were determined,as well as the optimal extraction process.The response surface optimization test was used to determine the best forming process with the forming rate,resting angle,moisture absorption rate and dissolubility of the granules as the indexes.Results The optimal process of Ruxiankang granules was 2 extractions times,the first time was extracted with 12 times water for 1.5 h,the second time was 10 times of water for 1 h.The optimum molding process was as follows:β-cyclodextrin was selected as the excipient,the ratio of excipient to powder was 1.8∶1,85%ethanol as the wetting agent,and the amount of ethanol addition was 36%of the total amount of adjuvant.Conclusion This paper provides scientific basis for the further study of Ruxiankang granules and theoretical reference for the subsequent production.