胆黄润肠丸的质量标准提高研究  

Study on Quality Standard Improvement for DanHuang RunChang Pills

作　　者：黄玮[1] 华丰 刘产明[1] 朱月琴 HUANG Wei;HUA Feng;LIU Chan-ming;ZHU Yue-qin(Changzhou Affiliated Hospital,Nanjing Unversity of Chinese Medicine,Jiangsu Province,Changzhou 213003,China)

机构地区：[1]南京中医药大学附属常州市中医医院,江苏常州213003

出　　处：《海峡药学》2023年第1期41-44,共4页Strait Pharmaceutical Journal

基　　金：江苏省中医药局科技发展计划项目(YB2020054);江苏省研究生科研与实践创新计划项目(SJCX22_0870)。

摘　　要：目的提高胆黄润肠丸的质量标准。方法用薄层色谱法(TLC)鉴别丸剂中的大黄和猪胆膏,用高效液相色谱法(HPLC)测定丸剂中的芦荟大黄素、大黄酸、大黄素、大黄酚和大黄素甲醚的含量。结果TLC图谱中特征斑点清晰无干扰。HPLC测定中,芦荟大黄素在0.0176~0.308 mg·mL^(-1)(r=0.9999)、大黄酸在0.0172~0.301 mg·mL^(-1)(r=0.9999),大黄素在0.0166~0.290 mg·mL^(-1)(r=0.9999)、大黄酚在0.0180~0.315 mg·mL^(-1)(r=0.9998)、大黄素甲醚在0.0160~0.280 mg·mL^(-1)(r=0.9997)范围内,与峰面积有良好的线性关系,平均加样回收率分别为99.06%(RSD=1.58%)、101.18%(RSD=1.30%)、98.97%(RSD=1.92%)、99.92%(RSD=1.92%)、100.05%(RSD=1.64%)。结论该方法操作简便、稳定可行,可用于胆黄润肠丸的质量控制。OBJECTIVE To improve the quality standard of DanHuang RunChang pills.METHODS Thin-layer chromatography(TLC)method was used to identify Rhei Radix et Rhizoma and Suis Fellis Pulivis in Pills.High performance liquid chromatography(HPLC)method was used to determine the contents of aloe-emodin,rhein,emodin,chrysophanol and physcion in Pills.RESULTS The characteristic spots in TLC spectrum were clear without interference.In HPLC determination,aloe-emodin was 0.0176-0.308 mg·mL^(-1)(r=0.9999),rhein was 0.0172-0.301 mg·mL^(-1)(r=0.9999),emodin was 0.0166-0.290 mg·mL^(-1)(r=0.9999),chrysophanol was 0.0180-0.315 mg·mL^(-1)(r=0.9998),and physcion was 0.0160-0.280 mg·mL^(-1)(r=0.9997),which had a good linear relationship with the peak area.The average recoveries were 99.06%(RSD=1.58%),101.18%(RSD=1.30%),98.97%(RSD=1.92%),99.92%(RSD=1.92%),100.05%(RSD=1.64%).CONCLUSION The method is simple,stable and feasible,and can be used for the quality control of DanHuang RunChang pills.

关 键 词：胆黄润肠丸 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R927[医药卫生—药学]