■为建立六味能消丸的质量标准,优化质量控制方法,为六味能消丸的质量控制提供参考。
■Chebula,干姜,通过薄层色谱法(TLC)分析了不同批号的六味能消丸中的藏酒根。然后,用高效液相色谱法测定制剂中大黄酚的含量。此外,一系列的方法学验证,包括对线性关系的调查,精度,稳定性,以及重现性和样品回收率测试,进行了验证结果的可靠性。
■TLC鉴定方法易于执行,并显示出高特异性,清晰的斑点,良好的分离效果。此外,阴性对照显示无干扰。HPLC法显示了较高的准确度。方法学验证结果表明,大黄酚在0.06~0.80μg范围内,峰面积呈良好的线性关系(r2=1.0),具有良好的精度(相对标准偏差低于2.0%),良好的稳定性和重现性(相对标准偏差低于1.0%),平均回收率为100.8%。
■TLC和HPLC易于执行,显示高精度和重现性。建立的质量标准是科学的,合理,稳定,可行,为六味能消丸的质量控制提供参考。
UNASSIGNED: To establish quality standards for Liuwei Nengxiao pills, to optimize the quality control method, and to provide references for the quality control of Liuwei Nengxiao pills.
UNASSIGNED: Chebula, dried ginger, and Tibetan liqueur root in Liuwei Nengxiao pills of different batch numbers were analyzed by thin layer chromatography (TLC). Then, the content of chrysophanol in the preparation was determined by high performance liquid chromatography (HPLC). Furthermore, a series of methodological validation, including the investigation of the linear relationship, precision, stability, and reproducibility and sample recovery test, were performed to verify the reliability of the results.
UNASSIGNED: The TLC identification method was easy to perform and demonstrated high specificity, clear spots, and good separation effect. In addition, the negative controls showed no interference. The HPLC method showed high accuracy. The results of methodological validation showed that the peak area of chrysophanol had a good linear relationship (r2=1.0) in the range of 0.06-0.80 μg, presenting good precision (with the relative standard deviation being lower than 2.0%), good stability and reproducibility (with the relative standard deviation being lower than 1.0%), and an average recovery rate of 100.8%.
UNASSIGNED: TLC and HPLC are easy to perform, showing high accuracy and reproducibility. The quality standards established are scientific, reasonable, stable, and feasible, providing references for the quality control of Liuwei Nengxiao pills.