基于微量量热法表征的茵栀黄注射液质量波动评价方法研究  

Quality fluctuation of Yinzhihuang Injection by microcalorimetry

作　　者：张萍[1,2] 任永申[1,3] 鄢丹[1] 段慧娟[1] 李正明[1] 肖小河[1] 

机构地区：[1]解放军中药研究所解放军第三○二医院,北京100039 [2]军医进修学院研究生队,北京100853 [3]成都中医药大学药学院,四川成都610075

出　　处：《中成药》2011年第6期980-984,共5页Chinese Traditional Patent Medicine

基　　金：国家自然科学基金(30701109);国家“重大新药创制”科技重大专项资助项目(2009ZX09502-003,2009ZX09308-005,2009ZX09502-022)

摘　　要：目的研究茵栀黄注射液(茵陈,桅子,黄芩和金银花)对金黄色葡萄球菌生长代谢的影响,探索该注射液质量一致性和稳定的生物活性评价方法。方法采用微量量热法,测定金黄色葡萄球菌在7个批次茵栀黄注射液作用下的生长代谢热谱曲线和热动力学参数,结合主成分分析和聚类分析,评价该注射液的抗菌作用。结果主成分分析结果显示第一指数生长期的生长速率常数k1(0.036 24～0.017 42 min-1,贡献度52.5%)和整个生长过程的产热量Q(11.64～9.84 J,贡献度24.75%),可以较好地反应各批注射液的抗菌作用差异及内在质量稳定性,聚类分析结果显示其顺序为S5>S7>S3>S6>S4>S2>S1。结论不同批次的茵栀黄注射液抗菌活性具有一定的稳定性;微量量热法可以灵敏地区分不同批次产品抑菌活性的差异,为评价注射液产品的质量波动性提供了一种新的方法和模式参考。AIM To study the effect of Yinzhihuang Injection（Artemisiae scopariae Herba,Gardeniae Fructus,Scutellariae Radix,Lonicerae japonicae Flos）（YZHI） on the growth of Staphylococcus aureus（S.aureus） for eva-luation of the quality consistency and stability of this injection.METHODS To measure the thermogenic curves and some biothermokinetic growth parameters of S.aureus affected by adding seven batches of YZHI to S.aureus by microcalorimety.Coupled with principal component analysis and cluster analysis,the antibacterial effect of these injections was investigated.RESULTS The principal component analysis showed the antibacterial effect and qua-lity stability of YZHI could be well discriminated by biothermokinetics parameters k1（constant of first exponential growth phase,0.036 24-0.017 42 min-1,dedication was 52.5%） and Q（thermogenesis of whole growth cycle,11.64-9.84 J,dedication was 24.75%）.The cluster analysis showed the order of antibacterial effect and intrinsic quality stability were S5 S7 S3 S6 S4 S2 S1.CONCLUSION There is limited stability of antibacterial activity of different batches of YZHI,and the antibacterial activity fluctuation could be sensitively detected by microcalorimetry,which could be adopted as a novel method and mode for evaluating the quality fluctuation of YZHI.

关 键 词：茵栀黄注射液 微量量热法 金黄色葡萄球菌 抑菌活性 质量波动性 

分 类 号：R927.11[医药卫生—药学]