苦橘咳喘合剂的质量标准

Quality standard for Kujukechuan mistura

目的：确定苦橘咳喘合剂的质量标准。方法：采用薄层色谱法对制剂中的麻黄、橘红进行定性鉴别。采用高效液相色谱法测定苦杏仁中苦杏仁苷的含量,采用：Hypersil ODS（Waters eXTerra色谱柱（4.6 mm×250 mm,5μm）,流动相为乙腈-0.1%磷酸溶液（6∶94）,流速为1.0mL·min^-1,检测波长为207 nm,柱温为26℃。结果：薄层鉴别的色谱斑点清晰,且阴性对照无干扰。高效液相苦杏仁苷进样浓度在2.00~32.00μg·mL^-1范围内呈良好的线性关系,平均回收率达到99.4%以上。结论：本法简便、可靠、专属性强,可以作为苦橘咳喘合剂的质量控制标准。

OBJECTIVE To formulate a quality standard for Kuiukechuan Mistura. METHODS TLC method was estab- lished for ephedra herba, cirri exocarpium rubrum, and HPLC method was established for determination of laetrile in Kujuke- chuan Mistura. Hypersil ODS （Waters eXTerra） （4. 6 min× 150 mm, 5 μm） column was used with acetonitrile-0. 1% phos- phoric acid （6：94） as the mobile phase at flow rate of 1.0 mL·min^-1. The detection wavelength was 207 nm. RFNULTS TLC chromatographic spots were clear, and negative control had no interference. The linear range of Laetrile was 2. 00-32.00 μg·h·mL^-1 , and the average recovery was over 99. 4%. CONCLUSION The method is simple, reliable, with strong exclusive fea- ture, and suitable for quality control of Kujukechuan Mistura.