军队医院制剂复方降压灵片的质量标准研究

Quality Standard for Compound Hypotensive Tablets Made by Military Hospitals

目的建立复方降压灵片的质量标准。方法采用显微鉴别法和薄层色谱法对复方降压灵片方中主要成分川芎和山楂进行鉴别;采用高效液相色谱法测定氨苯蝶啶的含量。结果川芎和山楂显微鉴别特征明显;薄层色谱鉴别川芎和山楂专属性较强;氨苯蝶啶浓度在0.033~0.263 mg·ml^(-1)范围内与峰面积有良好的线性关系(r=0.9995);加样回收率试验中氨苯蝶啶的平均回收率为99.64%,RSD为1.21%(n=9)。结论该法简单易行,科学性、准确性较好,可作为复方降压灵片的质量控制标准。

Objective To establish a quality standard for evaluation of compound hypotensive tablets.Methods Microscopic identification and thin layer chromatography methods were used to identify Chuanxiong Rhizoma and Crataegi Fructus in compound hypotensive tablets.The high performance liquid chromatography method was adopted to determine the content of Triamterene.Results Microscopic identification revealed distinct characteristics of Chuanxiong Rhizoma and Crataegi Fructus while thin layer chromatography confirmed their strong specificities.The content of Triamterene ranged from 0.033 to 0.263 mg·ml-1.There was a fine linear relationship between the sample input and the peak area(r=0.9995).The average recovery of Triamterene was 99.64%with an RSD of 1.21%(n=9).Conclusion This method is simple,well-conceived and accurate,which is expected to provide data for formulating a quality standard for compound hypotensive tablets.