银连口服液质量标准研究

目的建立银连口服液的质量标准。方法以薄层色谱(TLC)法鉴别方中黄芩、黄连、连翘;以高效液相色谱(HPLC)法测定黄芩苷的含量色谱柱为Nova-Pak C18(150mm×4.6mm,4μm),流动相为甲醇-0.3%磷酸溶液(40∶60),检测波长为276nm,流速为1.0mL.min-1。结果TCL色谱中能明显检出黄芩、黄连、连翘。黄芩苷的检测浓度线性范围为1.68~16.8μg.mL-1(r=0.9998);平均加样回收率为99.06%(RSD=0.79%)。结论所建标准准确、可靠,可用于控制银连口服液的质量。

Study on Quality Standards for Yinlian Oral Solution

OBJECTIVE: To establish the quality standards for Yinlian oral solution. METHODS: TLC was adopted to identify Radix Scutellariae, Rhizoma Coptidis, Fructus Forsythiae in Yinlian oral solution. HPLC was applied to determine the content of Baicalin in Yinlian oral solution, using Nova- Pak C18( 150mm× 4. 6mm, 4μ m) as column, the mixture of methanol- 0. 3% phosphoric acid ( 40∶ 60) as mobile phase, with flow rate set at 1. 0mL· min- 1 and detection wavelength at 276 nm. RESULTS: Radix Scutellariae, Rhizoma Coptidis and Fructus Forsythiae were clearly detected with TLC. The content of baicalin showed a good linear relationship at a range of 1. 68～ 16. 8μ g· mL- 1( r=0. 999 8) . The average recovery was 99. 06% ( RSD=0. 79% ) . CONCLUSIONS: The standard is accurate, reliable, and can be used for quality control of Yinlian oral solution.