大黄排毒胶囊的制备及质量标准研究  

Study on Preparation and Quality Standard of Dahuang Paidu Capsules

作　　者：郑江萍[1] 甘春英[1] 黄良永[1] 

机构地区：[1]湖北医药学院附属太和医院,湖北十堰442000

出　　处：《儿科药学杂志》2015年第1期47-51,共5页Journal of Pediatric Pharmacy

摘　　要：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 Dahuang Paidu capsules and establish its quality standard. Methods： The content of aloe-emodin, rhein, emodin, chrysophanol in Dahuang Paidn capsules were identified and determined by HPLC. Rhaponticin was used to a reference substance identify Rheum officinale by TCL. Results： The characteristic TLC spots of Rhaponticin were not detected in Dahuang Paidu capsules. The peaks of the four components were segregated effectively, the linear ranges of aloe-emodin, rhein, emodin, chrysophanol were 1.07 ~ 21.36 μg/mL, 3.93 ~ 78.50 μg/mL, 0. 85 - 16. 92μg/mL, 6.95 -69. 50 μg/mL, average recovery rate of aloe-emodin, rhein, emodin, chrysophanol were 102. 73% , 100. 86% , 98. 16% , 100.07% , RSD was 0. 16% , 0. 14% , 0. 13% , 0. 64%. Quality of Dahuang Paidu capsules was stable, and its properties, moisture content, disintegration degree, the total content of four components were conformed to the prescribed standards. Conclusion： This method is simple and reliable, and it can be used for the quality control of accurate, reproducible, and can be used quality control of Dahuang Paidu capsules.

关 键 词：大黄排毒胶囊 薄层色谱法 高效液相色谱法 制备 质量标准 

分 类 号：R927.2[医药卫生—药学]