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[摘要]
目的:研究桂枝茯苓软胶囊的制备及其质量控制方法。方法:鉴别采用薄层色谱法,含量测定采用高效液相色谱法,色谱柱Shim-PackVP-ODS(150mm×4.6mm),流动相:乙腈-水-冰乙酸(42∶58∶0.8),检测波长:273nm;柱温:40℃;流速:1mL/min。结果:桂枝茯苓软胶囊中丹皮酚 A=10794.70C+9783.24,在0.1456μg-1.7472μg范围内线性关系良好(R=0.9999)。结论:桂枝茯苓软胶囊制备工艺简单,质量控制方法可靠,重现性好。
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[Abstract]
This paper describes the technique of preparing Guizhi Fuling Capsula and associated quality control process. In the study, both TLC and HPLC techniques were used to identify and assay target elements. An analytical column of Shim-Pack VP-ODS (150mm×4.6mm) was also used. A mobile phase of Acetonitrile-water-glacial acetic acid was set at 42:58:0.8, with a detective wavelength at 273nm, column temperature 40oC, and the flow rate 1mL/min. Test results show that the calibration curve of paeonol in Guizhi Fuling capsula, derived from the technique, is A=10794.70C+9783.24, r=0.9999, in the range of 0.1456μg -1.7472 μg. It is concluded that the technique of preparing Guizhi Fuling capsula is simple, and associated quality control process is reliable with fine reproducibility.
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