复方牛蒡子含片质量标准研究

Quality Standard of Compound Niubangzi Buccal Tablets

目的:建立复方牛蒡子含片的质量标准。方法:采用薄层色谱(TLC)法对方中金银花、牡丹皮进行定性鉴别;采用高效液相色谱法对制剂中牛蒡子苷进行含量测定。结果:TLC斑点清晰、分离度好、专属性强。牛蒡子苷的进样量在0.586～5.274μg范围内与峰面积积分值呈良好线性关系(r=0.9999);平均回收率为98.94%,RSD=1.68%(n=9)。结论:所建标准可用于复方牛蒡子含片的质量控制。

OBJECTIVE： To establish the quality standard of Compound niubangzi buccal tablets. METHODS：Lonicerae japonica and Paeonia suffruticosa in the formulation were identified by TLC, and the content of arctiin in the tablets was determined by HPLC. RESULTS： The TLC spots were clear, well- isolated and distinctive. The linear range of arctiin was 0. 586-5.274 μg（ r = 0. 999 9） and its average recovery was 98.94% （RSD = 1.68%, n = 9）.CONCLUSION： The established quality standard can be used for the quality control of Compound niubangzi buccal tablets.