扶正养血颗粒的制备及质量标准研究

Preparation Method and Quality Standard of Fuzheng Yangxue Granula

目的:制备扶正养血颗粒并建立其质量控制标准,有效控制其质量。方法:按处方和颗粒剂的工艺要求制备扶正养血颗粒。依据《中国药典》通则规定,制定质量控制标准,对其粒度、水分、溶化性、装量差异和微生物限度进行检查,用薄层色谱法(TLC)对该处方中的当归进行定性鉴别,采用高效液相色谱法(HPLC)对处方中当归的主要成分阿魏酸进行定量测定。结果:各项检查均符合颗粒剂要求,TLC色谱中特征斑点清晰;HPLC法测定灵敏度高,阿魏酸的进样量在0.029 2~0.292 0μg范围内与峰面积值呈良好的线性关系(r2=0.999 6),阴性对照无干扰。结论:扶正养血颗粒的制备工艺简单,制定的质量标准中鉴别专属性强,含量测定方法准确可靠,可作为该制剂的质量控制方法。

Objective： To prepare and establish the quality standard of Fuzheng Yangxue granula,and control the quality effectivelly.Methods： The Fuzheng Yangxue granula was prepared according to the pharmaceutical granulation technology. The quality control methods of Fuzheng Yangxue granula on items of particle size,water content,solubility,weight and microbial Limit were according to the Chinese Pharmacopoeia. The angelica was identified by TLC,and the content of ferulic acid in Fuzheng Yangxue granula was measured by HPLC. Results： The results of TLC showed a clear spots,and the results of HPLC showed a good linear relationship with the range of 0. 029,2 to 0. 292,0 μg（ r2= 0. 999,6）. Conclusion： Our present study demonstrates a simple and reliable method for preparation and quality control of Fuzheng Yangxue granula.