基于多成分质量控制的柴芍疏肝调神胶囊制备工艺研究

Preparation technology and quality control of Chaishao Shugan Tiaoshen Capsules based on multi-index quantification

目的 以经典名方四逆散为基础加减得柴芍疏肝调神方,将其制备为柴芍疏肝调神胶囊(Chaishao Shugan Tiaoshen Capsules,CSTC),对其进行制备工艺优化和多成分质量控制研究。方法 采用水提醇沉、湿法制粒、填充制备成CSTC。选取6种指标成分辛弗林、栀子苷、芍药苷、甘草苷、柚皮苷和甘草酸铵的含量,以其综合评分为指标,严格考察料液比、提取次数、提取时间、药液相对密度、醇沉浓度、醇沉时间对水提醇沉精制工艺的影响。另以休止角、堆密度、成型率、吸湿率的综合得分为条件,筛选辅料种类、辅料比、药辅比、95%乙醇用量对成型工艺的影响。结果 得到CSTC剂的最佳制备工艺为料液比1∶12,提取次数2次,提取时间69 min,药液相对密度1.15(50℃),醇沉乙醇体积分数为60%,醇沉时间36 h,辅料为糊精+微晶纤维素(3∶2),药辅比(1∶1),95%乙醇用量占药辅量的23%。结论 优选的制备工艺,科学合理,可行性高,可以为CSTC及相关中药制剂的开发提供参考,为其质量控制评价提供依据。

Objective To prepare Chaishao Shugan Tiaoshen Capsules(柴芍疏肝调神胶囊,CSTC) from Chaishao Shugan Tiaoshen prescription based on the classic famous prescription Sini Powder(四逆散),and carry out the quality control analysis by optimizing the preparation process and evaluating the multi-component.Methods The CSTC were prepared by water extraction and alcohol precipitation,wet granulation and filling.According to the fingerprints of six index components synephrine,geniposide,paeoniflorin,liquiritin,naringin and ammonium glycyrrhizinate,and the comprehensive scores were analyzed to investigate the effects of the ratio of solid to liquid,extraction times,and extraction time,the relative density of liquid medicine,alcohol precipitation concentration and alcohol precipitation time on the refining process of water extraction and alcohol precipitation.In addition,based on the comprehensive score of angle of repose,bulk density,molding rate,moisture absorption rate to screen the effect of excipient types,excipient ratio,drug adjuvant ratio,and 95% ethanol dosage on the molding process.Results The optimal preparation process of CSTC was the ratio of solid to liquid of 1:12,extraction times of two times,extraction time of 69 min,relative density of medicinal liquid of 1.15 g/mL(50 ℃),alcohol precipitation concentration of 60%,alcohol precipitation time of 36 h,the excipient of dextrin + microcrystalline cellulose(3:2),the ratio of drug adjuvant of 1:1,and the amount of 95% ethanol accounting for 23% of the amount of drug adjuvant.Conclusion The optimal preparation process is scientific,reasonable and highly feasible in this experiment,and can provide a reference for the development of CSTC and related traditional Chinese medicine preparations,which can provide the theoretical guidance for the quality evaluation of CSTC.