通脉化瘀胶囊制备工艺及质量标准研究

Preparation technology and quality standard research of Tongmai Huayu Capsules

目的优选通脉化瘀胶囊制备工艺,确定质量标准。方法单因素考察确定最优制备工艺,显微鉴别、薄层鉴别、HPLC方法含量测定以及检查项目确定质量标准。结果以药材总量的0.56~0.60倍水为粘合剂湿法制粒后填充胶囊,通过显微鉴别可清晰看到全蝎刚毛、降香纤维、土鳖虫体壁碎片、红花花粉粒、肉桂纤维及大黄草酸钙簇晶;三七及降香药材TLC鉴别斑点清晰,专属性强,无干扰;HPLC方法测定羟基红花黄色素A含量应不低于1.0 mg/g。结论优化的制备工艺稳定可行;全蝎、降香、土鳖虫、红花、肉桂、大黄显微鉴别特征明显易观察,三七及降香药材TLC鉴别可作为通脉化瘀胶囊定性鉴别的有效方法;HPLC方法测定羟基红花黄色素A含量可作为质量控制检测指标。

Objective Optimizing the preparation process and determining the quality standards of Tongmai Huayu Capsules.Methods We use the method of single factor investigation to determine the optimal preparation process,as well as microscopic identification,TLC,HPLC method to determine the content,and inspect items to determine quality standards.Results Filling the capsules after wet granulation,which is employed with water that is 0.56~0.60 times the total amount of medicinal materials as the binder.Through microscopic identification,Scorpion seta,Dalbergia odorifera fibre,fragments of Eupolyphaga sinensis'body wall,Safflower pollen grains,Cinnamon fibre and Clustered crystal of rheum officinale calcium oxalate are clearly visible.Through TLC identification,it can be seen that Panax notoginseng and Dalbergia odorifera are clearly spotted,exclusive,and there is no interference.Determined by HPLC method,the content of Hydroxysafflor yellow A is not less than 1.0 mg/g.Conclusion The optimized process is stable and advisable.Under microscopic identification,features of Scorpion,Dalbergia odorifera,Eupolyphaga sinensis,Safflower,Cinnamonare and rheum officinale,are clearly easy to observe.The TCL identification of Panax notoginseng and Dalbergia odorifera can be used as an effective method for qualitative identification of Tongmai Huayu capsules.The HPLC determination of the content of Hydroxysafflor yellow A can be used as a quality control detection indicator.