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目的:制备大黄排毒胶囊并建立其质量控制标准。方法:采用高效液相色谱(HPLC)法对大黄的主要成分芦荟大黄素、大黄酸、大黄素、大黄酚进行定性、定量分析;采用薄层色谱法(TLC)用土大黄苷对照品进行大黄的真伪检查。结果:TLC中样品在土大黄苷对照品斑点相应位置无持久的亮紫色斑点;HPLC法测定制剂中芦荟大黄素、大黄酸、大黄素、大黄酚4种成分的含量,4种成分与其他成分分离良好;芦荟大黄素、大黄酸、大黄素、大黄酚浓度分别在1.07~21.36μg/m L、3.93~78.50μg/m L、0.85~16.92μg/m L、6.95~69.50μg/m L浓度范围内与峰面积有良好的线性关系,平均回收率分别为102.73%、100.86%、98.16%、100.07%,RSD分别为0.16%、0.14%、0.13%、0.64%。大黄排毒胶囊的质量稳定,其性状、水分、装量差异、崩解时限及芦荟大黄素、大黄酸、大黄素、大黄酚4种成分的总量等检验指标符合质量标准。结论:本制备工艺简单可行,所建立的质量标准可用于该制剂的质量控制。
Objective: To prepare rhubarb detox capsules and establish its quality control standards. Methods: The main constituents of rhubarb were identified as emodin, rhein, emodin and chrysophanol by high performance liquid chromatography (HPLC). The content of rhubarb was determined by thin layer chromatography (TLC) Authenticity check. Results: TLC samples showed no persistent bright purple spots on the corresponding spots of emodin glycosides. The contents of four components of aloe-emodin, rhein, emodin and chrysophanol in the preparations were determined by HPLC. The contents of four components and other components The concentrations of aloe-emodin, rhein, emodin and chrysophanol were 1.07 ~ 21.36μg / mL, 3.93 ~ 78.50μg / mL, 0.85 ~ 16.92μg / mL and 6.95 ~ 69.50μg / mL respectively The average recovery was 102.73%, 100.86%, 98.16% and 100.07%, respectively. The RSDs were 0.16%, 0.14%, 0.13% and 0.64%, respectively. The quality of rhubarb detoxification capsule is stable, and the test indexes such as traits, moisture, loading difference, disintegration time and the total amount of four components of aloe-emodin, rhein, emodin and chrysophanol meet the quality standards. Conclusion: The preparation process is simple and feasible, and the established quality standards can be used for the quality control of the preparation.