健脑补肾丸质量标准研究

Study on Quality Control of Jiannao Bushen Pill

目的:建立中成药健脑补肾丸的质量标准。方法:采用薄层色谱法对成药中甘草、山药进行定性鉴别;采用HPLC法对牛蒡子中牛蒡苷进行含量测定。结果:建立了甘草、山药的薄层色谱法鉴别方法,在所确定实验条件下,供试品色谱与对照药材色谱相应位置上,具有相同颜色斑点,阴性液无干扰;建立了HPLC法测定牛蒡子中牛蒡苷的实验条件,各项方法学考察结果均符合有关规定,并规定了成药中牛蒡苷含量不少于10.10μg/g。结论:本实验确定的实验方法简便快速,结果准确,重现性好,可作为该制剂的质量控制方法。

Objective： To study the quality standard for Jiannao Bushen Pill. Methods： To identify Rehmannia,Scrophulariaceae in Jiannao Bushen Pill by TLC and to determine the Gastrodin by HPLC. Result： The methods to identify Rehmannia Scrophulariaceae aucklandiae in Jiannao Bushen Pill by TLC were established and under the determined experimental condition,the sample and the reference had the same color spots on the corresponding position and the negative fluid without interference. The experimental condition to determine the Gastrodin by HPLC was established. Various methodological study results were consistent with the requirements and the gastrodin content was not less than 10. 10 μg /g. Conclusion： This method was sensitive,quick and accurate for the quality control of this preparation.