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目的:建立脑瘤克胶囊的质量标准。方法:采用TLC法鉴别成方制剂中姜半夏、莪术、石菖蒲、猪苓;采用HPLC法对吉马酮含量进行定量测定。色谱柱为Agilent HC-C18(2)柱(150 mm×4.6 mm,5μm),流动相为乙腈-水(50∶50),流速为1.0 ml·min-1;检测波长为216 nm,柱温为30℃,进样量为5μl。结果:TLC斑点清晰,分离度良好,阴性对照无干扰;吉马酮线性范围为7.824~78.240μg·ml-1(r=0.999 9),平均加样回收率为100.31%,RSD=2.09%(n=9)。结论:该法简便、灵敏、重复性好,所建标准可用于脑瘤克胶囊的质量控制。
Objective: To establish the quality standard of brain tumor capsule. Methods: TLC preparations were identified in the preparation of ginger Pinellia, Curcuma, Acorus calamus, Polyporus; HPLC method for the quantitative determination of the content of gemcitabine. The column was Agilent HC-C18 (2) column (150 mm × 4.6 mm, 5 μm) with a mobile phase of acetonitrile-water (50:50) at a flow rate of 1.0 ml · min- 30 ℃, the injection volume of 5μl. Results: The spots of TLC were clear and the resolution was good. There was no interference in the negative control. The linear range of germacrone was 7.824 ~ 78.240μg · ml-1 (r = 0.999 9). The average recoveries were 100.31% and RSD = 2.09% n = 9). Conclusion: The method is simple, sensitive and reproducible. The established standard can be used for the quality control of Naoyu capsule.