一测多评法测定热毒宁注射液中9种成分  

Determination of nine components in Reduning Injection by quantitative analysis of multi-components with a single-marker

作　　者：张亚非[1] 王雪[2,3] 毕宇安[2,3] 王振中[2,3] 萧伟[2,3] 李萍[1] 

机构地区：[1]中国药科大学中药学院,江苏南京210009 [2]江苏康缘药业股份有限公司,江苏连云港222001 [3]中药制药过程新技术国家重点实验室,江苏连云港222001

出　　处：《中草药》2013年第22期3162-3169,共8页Chinese Traditional and Herbal Drugs

基　　金：国家"重大新药创制"--现代中药创新集群与数字制药技术平台(2013ZX09402203);国家"重大新药创制"--大品种药物IV期临床试验及新药临床试验审评研究技术平台--热毒宁注射液IV期临床试验研究(2011ZX09304)

摘　　要：目的建立一测多评(QAMS)法测定热毒宁注射液中9种成分的分析方法,并与外标法进行比较,评价QAMS法用于热毒宁注射液质量控制的技术适应性和应用可行性。方法以热毒宁注射液为研究对象,以绿原酸、异绿原酸A和栀子苷为内参物,建立绿原酸与新绿原酸、隐绿原酸、咖啡酸间的相对校正因子(f),异绿原酸A与异绿原酸B、异绿原酸C间的f,栀子苷与断氧化马钱子苷间的f,比较该方法与外标法测定结果的差异,并对该方法进行再验证。结果热毒宁注射液中各成分的f分别为f绿原酸/新绿原酸=0.965、f绿原酸/隐绿原酸=0.991、f绿原酸/咖啡酸=0.555、f异绿原酸A/异绿原酸B=1.283、f异绿原酸A/异绿原酸C=1.129、f栀子苷/断氧化马钱子苷=1.030。QAMS法的计算结果与外标法的实测结果无显著性差异,再验证结果也无显著性差异,实验所得的f可信。结论 QAMS可以作为一种简便准确的质量评价模式用于热毒宁注射液多种成分的定量测定。Objective To establish a quantitative analysis of multi-components with a single-marker （QAMS） method for the determination of the nine components in Reduning Injection （RI）, comparing with the external standard method, and to evaluate the adaptation and application of QAMS method in the quality control of RI. Methods Chlorogenic acid, isochlorogenic acid A, and gardenoside were used as the internal reference substances. The relative correlation factors （f） ofneochlorogenic acid, cryptochlorogenic acid, and caffeic acid to chlorogenic acid, isochlorogenic acid B and isochlorogenic acid C to isochlorogenic acid A, and secoxyloganin to gardenoside were calculated and established. The results were compared with those obtained by the external standard method. Results Within the linear ranges, thefvalues of chlorogenic acid to neochlorogenic acid, cryptochlorogenic acid, and caffeic acid were 0.965, 0.991, and 0.555, respectively; isochlorogenic acid A to isochlorogenic acid B and isochlorogenic acid C were 1.283 and 1.129, respectively; jasminoidin to secoxyloganin was 1.030. The two methods did not show the significant difference in assay results. Conclusion The QAMS method is feasible and credible, and could be used to determine the multiple components in RI.

关 键 词：一测多评 相对校正因子 热毒宁注射液 高效液相色谱 绿原酸 咖啡酸 栀子苷 断氧化马钱子苷 

分 类 号：R286.02[医药卫生—中药学]