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目的建立补肺胶囊的质量控制方法。方法采用TLC法鉴别方中补骨脂、陈皮及肉苁蓉;采用HPLC测定补肺胶囊中补骨脂素、异补骨脂素。色谱柱为Hypersil ODS(5μm,250mm×4.6mm),甲醇-水为流动相,检测器为VWD检测器。结果薄层色谱鉴别方法专属性强,斑点清晰,且阴性无干扰;补骨脂素线性范围0.00067881~0.0034092 g·L-1,r=0.999 79。异补骨脂素线性范围为0.0008014~0.0040249 g·L-1,r=0.99974。结论实验方法结果准确、重复性好,可有效控制该制剂的质量。
Objective To establish a method for quality control of Bufei Capsule. Methods TLC method was used to identify psoralen, Citrus rehmanniae and Cistanche tuberculosis. The psoralen and isopsoralen of Bufei capsule were determined by HPLC. The column was Hypersil ODS (5μm, 250mm × 4.6mm), methanol-water as mobile phase and the detector as VWD detector. Results The TLC identification method was characterized by specificity, clear spots and no negative interference. The linear range of psoralen was 0.00067881 ~ 0.0034092 g · L-1, r = 0.999 79. Isopsoralen linear range of 0.0008014 ~ 0.0040249 g · L-1, r = 0.99974. Conclusion The experimental method is accurate and reproducible, which can effectively control the quality of the preparation.