一种治疗膝骨关节炎的中药复方制剂有效成分含量测定  

Determination of Two Active Ingredients in Traditional Chinese Medicine Compound Prescription in Treatment of Knee Osteoarthritis

作　　者：包子威 雷静文[2] 程岚[1] 张纯刚 Bao Ziwei;Lei Jingwen;Cheng Lan;Zhang Chungang(College of Pharmacy,Liaoning University of Traditional Chinese Medicine,Dalian 116620,China;Department of Pharmacy,Changzhi Medical College,Changzhi 046000,China;Qimeng Co.,Ltd.,Chifeng 024330,China)

机构地区：[1]辽宁中医药大学药学院,辽宁大连116620 [2]长治医学院药学系,山西长治046000 [3]祈蒙股份有限公司,内蒙古赤峰024330

出　　处：《亚太传统医药》2023年第3期18-24,共7页Asia-Pacific Traditional Medicine

基　　金：内蒙古自治区科技重大专项(2021ZD0017);国家重点研发计划(2018YFC1706903);中医脏象理论及应用国家教育部重点实验室一般项目(zyzx1809);辽宁省科学计划-自然基金指导计划(2019-ZD-0968);沈阳市中青年科技创新人才项目(RC200204)。

摘　　要：目的:建立以青藤碱、芍药苷为指标成分的含量测定方法,为其复方制剂的开发提供参考。方法:采用高效液相色谱法测定饮片、中药复方水煎液中青藤碱和芍药苷含量,并计算其转移率。结果:青藤碱、芍药苷检测质量浓度线性范围分别为0.18~22.5μg/mL(R2=0.9999)、0.24~60.0μg/mL(R2=1);青藤碱与芍药苷精密度、重复性及其他方法学研究符合要求;平均加样回收率分别为99.12%、102.15%(RSD分别为1.41%、1.76%,n=6);3批饮片中青藤碱含量为2.45%~2.49%、转移率为58.38%~60.16%;芍药苷的含量为2.69%~2.72%;转移率为57.17%~60.30%。结论:所建立的含量测定方法便捷、灵敏、准确,为该方的质量控制、药效物质基础研究及其制剂的质量评价体系建立提供参考。Objective:To establish the method for the determination of sinomenine and paeoniflorin, provide reference for the development of Chinese medicine compound prescription. Methods:The contents of sinomenine and paeoniflorin in decoction pieces and Chinese herbal compound decoction were determined by high performance liquid chromatography, and their transfer rates were calculated. Results:The linear range of sinomenine and paeoniflorin were 0.18~22.5μg/mL(R~2=0.999 9),0.24~60.0μg/mL(R~2=1) respectively. And beyond that, the precision, repeatability tests, and other methodological study of sinomenine and paeoniflorin all met the requirements. Average recoveries were 99.12%,102.15%(RSD=1.41%,1.76%,n=6). The content of sinomenine in 3 batches of decoction pieces was 2.45%~2.49%,with the transfer rate of 58.38%~60.16%. The content of paeoniflorin was 2.69%~2.72%,with the transfer rate of 57.17%~60.30%. Conclusion:The established method for content determination is convenient, sensitive and accurate, which providing a reference for the quality control, the study on substance standard reference and establishment of quality evaluation system of compound prescription.

关 键 词：中药复方 高效液相色谱法 青藤碱 芍药苷 

分 类 号：R284[医药卫生—中药学]