蓝翘解毒口服液质量标准的改进  

Study on the quality standard improve of Lanqiao Jiedu Oral Liquid

作　　者：巩伟[1] 李兴东[1] 孙旭[1] 赵庆华[1] 张欣欣[1] 张琨[1] 赵梅[1] 

机构地区：[1]济南军区联勤部药品仪器检验所,山东济南250022

出　　处：《中国医药导报》2015年第3期95-99,共5页China Medical Herald

基　　金：军队医疗机构制剂标准提高科研专项课题(编号14ZJZ01-2)

摘　　要：目的对蓝翘解毒口服液的质量标准进行改进。方法采用薄层色谱法（TLC）鉴别制剂中的板蓝根,气相色谱法（GC）鉴别制剂中的广藿香,高效液相色谱法（HPLC）测定制剂中连翘苷的含量。结果 TLC法鉴别供试品色谱中,在与对照药材色谱和对照品色谱相应的位置上显相同颜色的斑点;GC法检测供试品色谱中呈现与对照品色谱峰保留时间相同的色谱峰;HPLC法含量测定中连翘苷在9.387～300.4μg/m L质量浓度范围内线性关系良好（r=0.9999,n=6）,加样回收率为99.62%,RSD为1.21%（n=9）。结论本研究建立的方法结果准确,稳定性好,专属性强,改进后的质量标准可用于蓝翘解毒口服液的质量控制。Objective To improve the quality standard of Lanqiao Jiedu Oral Liquid. Methods Isatidis radix in the prescription was identified by TLC, while Pogostemonis herba in the prescription was identified by GC. The content of Phillyrin, which derived from Forsythiae fructus, was determined by HPLC. Results The spots in the chromatogram obtained with test solution correspond in position and colour to the spots obtained with the reference drug solution and the reference solution in the TLC test. The retention time of the peaks obtained with the test solution and the reference solution was concordant with each other in the GC test. Phillyrin showed a good linear relationship at 9.387-300.4 μg/m L（r = 0.9999, n = 6） with average recovery of 99.62%（RSD = 1.21%, n = 9）. Conclusion TLC has obvious characteristics with the spots clear and well-separated for Isatidis radix identification. GC has highly sensitive and good specificity for Pogostemonis herba identification. The HPLC method is easy and simple to operate, accurate and stable in results with good specificity. Above all, the improved quality standard is applicable for the quality control of Lanqiao Jiedu Oral Liquid.

关 键 词：蓝翘解毒口服液 薄层色谱法 气相色谱法 高效液相色谱法 板蓝根 广藿香 连翘苷 

分 类 号：R927.2[医药卫生—药学]