开喉剑喷雾剂的质量控制

目的：建立开喉剑喷雾剂的质量控制标准。方法：用薄层色谱法定性鉴别制剂中的八爪金龙；采用高效液相色谱法测定制剂中苦参碱的含量，色谱柱：Agilent ZORBAX NH2（250mm×4.6mm，5μm），流动相：乙腈-异丙醇-3%磷酸溶液（82∶4.5∶13.5），检测波长：220nm，流速：1.0mL·min-1，柱温：30℃。结果：薄层色谱斑点清晰，分离度好，阴性无干扰；苦参碱的线性范围分别为0.25872～2.58720μg（r=0.9999），平均加样回收率（n=6）分别为102.51%，RSD分别为1.43%。结论：定性定量分析方法快速、准确、专属性强，本法更好地控制开喉剑喷雾剂的质量。

Quality Control of KaihoujianSpray

Objective:To establish quality standard ofKaihoujian Spray.Methods:Bazhuajinlongin preparation was identified by Thin layer chromatography(TLC).The conent of matrine was determined by High efficiency liquid chromatography(HPLC). Agilent ZORBAX NH2 Column (250mm ×4.6mm,5μm)was used as chromatographic column, acetonitrile- isopropanol-3% phosphoric acidsolution (82∶4.5∶13.5)as mobile phase, at detection wavelength of 220nm,flow rate at 1.0mL·min-1, and column temperatures at 30℃.Results:The TLC spots were clear and well-separated. Linear ranges of matrine was 0.25872~2.58720μg (r=0.9999), average recovery rates (n=6) was 102.51%, and RSD values was 1.43%.Conclusion:Thequalitative analysis andquantitative analysis method of Kaihoujian Spray was simple, accurate, reproducible and could be used as quality standard of Kaihoujian Spray.