消坚止血颗粒剂的质量标准研究

Research into Quality Standards for Xiaojianzhixue Granule

目的 研究消坚止血颗粒的定性、定量方法及制剂常规标准。方法 采用TLC法鉴别处方主要药味 ,采用比色法对制剂中总蒽醌、总黄酮定量分析 ,并进行制剂常规检测。结果 TLC法显示 ,益母草、仙鹤草、大黄、川牛膝、莪术等样品色谱与对照品色谱在相应位置上显现相同斑点 ;样品中总蒽醌和总黄酮含量分别不低于 0 .5mg/g和 15mg/g。结论 定性、定量方法简便易行 ,结果可靠 ,可作为该制剂的质量控制标准。

OBJECTIVE To investigate into the quality and quantity determination method and the routine standards of Xiaojianzhixue Granule.METHODS TLC method was used to identify the main ingredients of the prescription and colorimetry was used to make quality determination of total anthraquinone and total flavone in the preparation, and carry out routine examination.RESULTS TLC method revealed that sample chromatograms like Herba Leonuri, Herba Agrimoniae, Radix et Rhizoma, Radix Cyathulae and Rhizoma Zedoariae showed the same patches with the control chromatogram at the corresponding locations, and the total anthraquinone and total flavone contents were not lower than 0.5 mg/g and 15 mg/g respectively.CONCLUSION The quality and quantity determination method is simple and convenient with reliable results, and therefore can serve as quality control standard for the preparation.