黄芩素滴丸的质量标准研究

Study on Quality Standards of Baicalein Dropping Pills

目的:建立黄芩素滴丸的质量标准。方法:采用薄层色谱(TLC)法定性鉴别黄芩素滴丸中的黄芩苷;采用高效液相色谱法测定制剂中黄芩苷的含量。同时按照2010年版《中国药典》对滴丸剂的常规要求进行检验。结果:TLC图中,供试品在与对照品色谱相应的位置上显相同颜色的斑点,阴性对照无干扰。黄芩苷的进样量在0.51975～1.55925μg范围内与其峰面积积分值呈良好的线性关系;精密度、重复性、稳定性试验的RSD均<2%;平均加样回收率为97.61%,RSD=1.10%(n=6)。重量差异和微生物限度检查、崩解时限均符合2010年版《中国药典》要求。结论:所建标准可用于黄芩素滴丸的质量控制。

OBJECTIVE ： To establish the quality standards of Baicalein dropping pills. METHODS ： Baicalin of Baicalein drop-ping pills was identified qualitatively by TLC;the content of baicalin was determined by HPLC. At the same time, the preparation was detected according to the general requirements of dropping pills in 2010 edition Chinese Pharmacopoeia. RESULTS： The chro- matographic spots of samples showed the same colors in the same position with control agents by TLC, without interference from negative control agents. The linear range of baicalein were 0.519 75-1.559 25μg; RSDs of precision, repeatability and stability were less than 2% ; average recovery was 97.61% （RSD=1.10% ,n=6） ; the weight variation, microbial limit tests and disintegra-tion time were all fitted with the requirements of 2010 edition Chinese Pharmacopoeia. CONCLUSIONS： The standard can be used for aualit-v control of Baicalein dronnine hills.