豨莶风湿片质量研究

Quality standard for Herba siegesbeckiae rheumatism tablets

目的豨莶风湿片是由豨莶草、桑寄生、桑枝、威灵仙、防己、槐枝提取制成的口服片剂。为了控制其药品的质量,对其组方成分进行定性和定量控制。方法薄层色谱法、高效液相色谱法。结果桑寄生、威灵仙、防己的薄层色谱鉴别方法质量可控,阴性无干扰。豨莶草中奇壬醇的高效液相色谱含量测定方法经方法学验证,奇壬醇在4.0~40.0μg/mL范围内线性关系良好,其回归方程为Y=91.585X-12.845（r=0.999 7）。结论本方法能够有效地控制产品质量,可作为豨莶风湿片质量控制和考察制备工艺稳定性的指标。

Objective The oral tablets,Herba siegesbeckiae rheumatism tablets are made by extracting the Herba siegesbeckiae,Loranthaceae,Mulberry,Clematis,Menispermaceae and Cassia sticks.To control the drugs quality,the identification and determination of the ingredients were made.Methods TLC and HPLC were applied in this study.Results Loranthaceae,Menispermaceae and Cassia sticks in Herba siegesbeckiae rheumatism tablets were identified by TLC,which the quality was controllable,negative and non-interference.The HPLC method for the content determination of odd nonanol in Herba siegesbeckiae was verified by methods validation.There was a good linear relationship between the peak area and the concentration of odd nonano in the range of 4.0~40.0μg/mL.The regression equation： Y=91.585X-12.845（r=0.999 7）.Conculsion This method can effectively control the product quality.It can serve as indicators of Herba siegesbeckiae rheumatism tablets to control product quality and to examine the process stabilization of preparation.