消风颗粒质量标准研究

Quality Standard of Xiaofeng Granules

目的:建立消风颗粒的质量标准。方法:采用薄层色谱(TLC)法对制剂中地骨皮、荆芥、甘草、地黄进行定性鉴别;用高效液相色谱法对制剂中盐酸去氯羟嗪进行含量测定。结果:所鉴别的药材TLC特征明显,在与对照药材相应的位置上显相同颜色的斑点,阴性对照无干扰。盐酸去氯羟嗪检测浓度在2.45～78.4μg.mL-1范围内与峰面积积分值呈良好的线性关系(r=0.9999);平均回收率为99.11%,RSD=1.30%(n=6)。结论:所建标准可用于消风颗粒的质量控制。

OBJECTIVE： To establish the quality standard of Xiaofeng granules. METHODS： Rehmannia glutinosa, Schizonepetae tenuifolia, Radix et Rhizoma Glycyrrhizae, Rehmanniae glutinosa in the formulation were identified by TLC, and the content of decloxizine hydrochloride in Xiaofeng granules was determined by HPLC. RESULTS： The TLC charac- teristics were distinctive. At the corresponding position, the sample and its reference substance showed identical color of TLC spots, and there was no interference from negative control. The linear range of decloxizine hydrochloride was 2.45--78.4 μg ·mL^- l（r = 0.999 9） and its average recovery was 99.11% （RSD = 1.30%, n = 6） .CONCLUSION： The established quality standard can be used for the quality control of Xiaofeng granules.