论文部分内容阅读
目的:建立结肠宁灌肠剂质量标准。方法:采用TLC法对蒲黄、丁香蓼进行鉴别;用HPLC法测定没食子酸的含量,色谱柱为Agilent TC-C_(18)(250mm×4.6mm,5μm),流动相为甲醇-0.1%磷酸溶液(5:95),柱温:35℃,流速:0.8ml·min~(-1),检测波长为273nm。结果:TLC色谱斑点清晰;没食子酸在4.985～1994.0ng范围内线性关系良好(r=0.9999),平均回收率为99.7%(RSD=2.2%,n=9)。结论:本法简便、可靠、准确,可用于该制剂的质量控制。
Objective: To establish the quality standard of colonic enema. Methods: The contents of gallic acid were determined by TLC. The content of gallic acid was determined by HPLC. Agilent TC-C 18 column (250 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase was methanol-0.1% phosphoric acid Solution (5:95). The column temperature was 35 ℃, the flow rate was 0.8ml · min -1 and the detection wavelength was 273nm. Results: TLC chromatogram spots were clear. Gallic acid had good linearity (r = 0.9999) in the range of 4.985 ~ 1994.0ng with an average recovery of 99.7% (RSD = 2.2%, n = 9). Conclusion: This method is simple, reliable and accurate and can be used for the quality control of the preparation.