维药金锁昆都尔片的质量标准研究

Study on the Quality Standard of Uighur Medicine Jin Suo Kun Du Er Tablets

目的建立金锁昆都尔片的质量标准。方法采用薄层色谱法鉴别香附、乳香和胡椒,采用高效液相色谱法测定木香含量。结果定性鉴别中分离度好、专属性强,阴性对照无干扰,木香烃内酯在0.03～0.07mg/mL范围内呈良好线性关系(r=0.999 5),平均回收率为99.31%,RSD为0.62%;去氢木香内酯在0.06～0.14mg/mL范围内呈良好线性关系(r=1),平均回收率为99.33%,RSD为0.70%。结论所建立的方法准确、可靠、专属性强,可以用于该制剂的质量控制。

Objective To establish the quality standard of Jin Suo Kun Du Er tablets. Methods Cyperus tuber, Olibanum and Pepper were identified respectively by TLC, the content of Costustoot was determined by HPLC. Results The characteristic identification by TLC was distinct and highly specific.Costunolide were linear between 0.03-0.07mg/mL（r=0.999 5）,the average recovery was 99.31% with RSD of 0.62%. Dehydrocostus lactone were linear between 0.06-0.14mg/mL（r=l）,the average recovery was 99.33% with RSD of 0.69%. Conclusion The method is reliable, accurate and specific, and it can be used for quality control of this preparation.