银冬利咽口服液的质量控制研究  

Study on quality control of Yindong-liyan oral solution

作　　者：陈蔚琳[1] 漏德宝 

机构地区：[1]上海市第八人民医院药剂科,上海200235

出　　处：《药学服务与研究》2007年第2期120-123,共4页Pharmaceutical Care and Research

摘　　要：目的:建立银冬利咽口服液的质量控制方法。方法:用薄层色谱法鉴别银冬利咽口服液中射干、玄参和山豆根;用HPLC法测定银冬利咽口服液中绿原酸的含量,色谱条件:Nova-Pak C_(18)色谱柱(150 mm×4．6 mm,4μm);流动相为甲醇-1．2％乙酸(23:77);检测波长:327 nm;流速:1．0 mL/min。结果:薄层色谱中,在对照品和样品的相应位置处能明显检出射干、玄参和山豆根的特征斑点。HPLC中,绿原酸的线性范围为6．688～66．880μg/mL,将峰面积(A)与浓度(c)进行线性回归,得回归方程A=54959．21 c-96350．88(r=0．9999)。平均加样回收率为98．66％,RSD为1．66％(n=6)。结论:此方法简便、灵敏、准确,可用于银冬利咽口服液的质量控制。Objective： To establish the methods for quality control of Yindong-liyan oral solution. Methods： Rhizoma Belamcandae, Radix Scrophulariae and Radix Et Rhizoma Sophorae Tonkinensis in Yindong-liyan oral solution were identified by TLC method. The content of chlorogenic acid in the solution was determined by HPLC method. Nova-Pak C18 column （150 mm×4.6 mm, 4 μm） was used with the mixture of methanol-1.2% acetic acid （23 ： 77） as the mobile phase. The flow rate was 1.0 mL/min and the detection was carried out at 327 nm. Results： Rhizoma Belamcandae, Radix Scrophulariae, Radix Et Rhizoma Sophorae Tonkinensis in Yindong-liyan oral solution could be detected by TLC method. The spots appeared separately in thin-layer chromatograms at the corresponding positions of the control and sample solutions. The chlorogenic acid showed a good linear relationship at the range of 6. 688-66. 880 μg/mL, and the regression equation was A = 54 959.21 c- 96 350.88 （r=0. 999 9）. The average recovery was 98.66%, and the RSD was 1.66%（n=6）. Conclusion： The methods are simple,sensitive and accurate, and can be used for quality control of Yindong-liyan oral solution.

关 键 词：银冬利咽口服液 质量控制 绿原酸 色谱法 薄层 色谱法 高压液相 

分 类 号：R943.3[医药卫生—药剂学]