化瘀生新合剂制备工艺优化

Preparation Process for Huayu Shengxin Mixture

目的:优化化瘀生新合剂的制备工艺,为制剂提供稳定可靠的生产参数。方法:采用单因素筛选法考察挥发油提取工艺;以固形物质量及毛蕊异黄酮葡萄糖苷含量为考察指标,采用正交设计法对水提工艺的提取时间、加水量、提取次数进行优选;以毛蕊异黄酮葡萄糖苷含量保留率为指标,考察浓缩工艺;再考察抑菌剂、矫味剂等对成型工艺的影响。结果:挥发油提取工艺为加水8倍量,回流提取6 h;水提工艺为提取2次,加水8倍量,每次提取1 h,综合评分达到97.96;减压浓缩较常压浓缩指标成分保留率高;蔗糖用量2.8%、苯甲酸钠0.3%时成型工艺达到最优。结论:所选工艺科学、合理、稳定,适合工业化生产。

Objective:To optimize preparation process for Huayu Shengxin Mixture.Methods:The single factor screening method was used to investigate extraction process of volatile oil.With solid total mass,contents of calycosin-7-glucoside as evaluation indices,water addition,extraction time and extraction times as influencing factors,the aqueous extraction process was optimized by orthogonal test.With the contents and retention rates contents of calycosin-7-glucoside as evaluation indices,the effects of normal pressure and decompression on the concentration process were investigated.And the effects of taste masking agent(sucrose)and bacteriostatic agent(sodium benzoate)amounts on the forming process were studied as wel1.Results:The optimal preparation process was as follows:the volatile oil in the prescription were extracted 6 h with 8-fold amount of water;the medicinal materials in the prescription were extracted 2 times with 8-fold amount of water with 1 h for each time,the comprehensive score was 97.96.The contents and retention rates of calycosin-7-glucoside at decompression pressure concentration were higher than those at normal concentration.The optimal forming process was obtained at sucrose and sodium benzoate amounts of 2.8%and 0.3%,respectively.Conclusion:The selected preparation process is scientific,reasonable and stable,and suitable for the industrial production of Huayu Shengxin Mixture.