清热化痰通腑外用制剂的质量标准研究  

Study on the Quality Standard for Qingre Huatan Tongfu External Preparation

作　　者：郑棵林 周思茹 陆华[1] 何成章[1] 秦银燕 雷宇[1] 黄春喜[1] ZHENG Kelin;ZHOU Siru;LU Hua;HE Chengzhang;QIN Yinyan;LEI Yu;HUANG Chunxi(The First Affiliated Hospital of Guangxi Medical University,Nanning 530000,China)

机构地区：[1]广西医科大学第一附属医院,广西南宁530000

出　　处：《中国民族民间医药》2025年第8期51-55,共5页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：广西中医药适宜技术开发与推广项目[GZSY22-63]。

摘　　要：目的:建立清热化痰通腑外用制剂的质量标准。方法:采用薄层色谱方法对清热化痰通腑外用制剂中的大黄、枳实、黄芩、石菖蒲进行定性鉴别;采用高效液相色谱法对制剂中大黄素、大黄酸、大黄酚进行含量测定,流动相采用甲醇-0.1%磷酸水溶液(70∶30);流速为1.0 mL·min^(-1);检测波长为227 nm;柱温为30℃;进样量为10μL。结果:薄层色谱法能定性检出大黄、枳实、黄芩、石菖蒲,斑点清晰,分离度好且阴性对照无干扰;大黄酸、大黄素、大黄酚分别在1.13~22.08μg·mL^(-1)(r=0.9999)、1.00~9.99μg·mL^(-1)(r=0.9999)、1.08~10.81μg·mL^(-1)(r=0.9999)范围内与峰面积均呈现良好的线性关系,平均回收率分别为102.61%(RSD=1.37%)、100.26%(RSD=2.16%)、102.32%(RSD=1.06%)。结论:所建立的定性、定量检测方法简便快速,结果准确,专属性强,可用于清热化痰通腑外用制剂的质量控制。Objective To establish the quality standard for Qingre Huatan Tongfu external preparation.Methods TLC was used to identify Radix et Rhizoma Rhei,Fructus aurantii immaturus,Radix Scutellariae and Rhizoma Acori Tatarinowii in the preparation;the contents of rhein,emodin and chrysophanic in Qingre Huatan Tongfu external preparation were determined by HPLC.Mobile phase was methanol-0.1%phosphoric acid solution(70∶30),the flow rate was 1.0 mL·min^(-1),the detection wavelengths were 227 nm,the column temperature was 30℃,and the volume injection was 10μL.Result TLC spots were clear and well-separated without negative interference;the calibration curves of rhein,emodin and chrysophanic were linear over the range of 1.13-22.08μg·mL^(-1)(r=0.9999),1.00-9.99μg·mL^(-1)(r=0.9999)and 1.08^(-1)0.81μg·mL^(-1)(r=0.9999).The average recoveries were 102.61%,100.26%and 102.32%with the RSDs of 1.37%,2.16%and 1.06%,respectively(n=6).Conclusion The method is fast and accurate with good specificity,and can be used for the quality control of Qingre Huatan Tongfu external preparation.

关 键 词：清热化痰通腑外用制剂 大黄素 薄层色谱 高效液相色谱 质量标准 

分 类 号：R286.0[医药卫生—中药学]