经典恒温法在九味化斑丸稳定性研究中的应用  

Application of the classical constant-temperature method in the stability study of the Jiuwei Huabanwan pill(JWHBW)

作　　者：隋银海 郝磊 霍志鹏 何毅[2,3] Sui Yinhai;Hao Lei;Huo Zhipeng;He Yi(School of Chinese Materia Medica,Tianjin University of Traditional Chinese Medicine,Tianjin 301617;Development Center of Modern Chinese Medicine,Research Institute of Tasly Holding Group Co Ltd,Tianjin 300410;National Key Laboratory of Chinese Medicine Modernization,Tianjin 300410)

机构地区：[1]天津中医药大学中药学院,天津301617 [2]天士力控股集团有限公司研究院现代中药开发中心,天津300410 [3]现代中药创制全国重点实验室,天津300410

出　　处：《天津药学》2023年第6期1-6,共6页Tianjin Pharmacy

摘　　要：目的:建立HPLC法测定九味化斑丸(JWHBW)中绿原酸和芍药苷含量的方法,并以绿原酸和芍药苷含量为指标预测JWHBW有效期。方法:绿原酸:色谱柱为Ultimate■Plus C18(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%甲酸水溶液(8∶92),检测波长326 nm;芍药苷:色谱柱为Zafex Acutfex PA-C_(18)(250 mm×4.6 mm,5μm),流动相为甲醇-0.05 mol/L磷酸二氢钾水溶液(22∶78),检测波长230 nm;通过经典恒温试验预测JWHBW有效期。结果:①绿原酸和芍药苷线性范围分别为0.0036~0.1152 mg/ml和0.0250~0.8013 mg/ml,平均回收率分别为100.99%和100.35%,RSD分别为0.93%和1.57%(n=6)。②25℃时绿原酸和芍药苷的分解速度常数k分别为1.78×10^(-5)和8.40×10^(-5),以有效期较短的芍药苷为指标,制剂有效期为3.44年。结论:本研究所建立的方法适用于JWHBW中绿原酸和芍药苷的测定,通过预测有效期能够为产品的质量控制提供数据支持。Objective:To establish a method for the determination of chlorogenic acid and paeoniflorin in Jiufei Huabanwan(JWHBW)by high-performance liquid chromatography(HPLC)and to predict the expiration date of JWHBW using chlorogenic acid and paeoniflorin content as indicators.Methods:Chlorogenic acid:the column was Ultimate■Plus C_(18)(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.1%formic acid aqueous solution(8∶92),and the detection wavelength was 326 nm;paeoniflorin:the column was Zafex Acutfex PA-C18(250 mm×4.6 mm,5μm),the mobile phase was methanol-0.05 mol/L potassium dihydrogen phosphate aqueous solution(22∶78),and the detection wavelength was 230 nm.The JWHBW validity period was predicted using a classical thermostat test.Results:①The linear ranges of chlorogenic acid and paeoniflorin were 0.0036~0.1152 mg/mland 0.0250~0.8013 mg/ml,respectively,with average recoveries of 100.99%and 100.35%,RSDs of 0.93%and 1.57%,respectively(n=6).②The decomposition rate constants k of chlorogenic acid and paeoniflorin at 25℃were 1.78×10^(-5)and 8.40×10^(-5),respectively.Using the validity period of paeoniflorin as an index,the validity period of the preparation was 3.44 years.Conclusion:The method established in this study is simple,accurate,and reliable,is suitable for the determination of chlorogenic acid and paeoniflorin in JWHBW,and can provide data support for the quality control of the product by predicting the validity period.

关 键 词：经典恒温法 九味化斑 丸绿原酸 芍药苷 高效液相色谱法 有效期 

分 类 号：R283[医药卫生—中药学]