清开灵注射液生物热活性指纹图谱的初步研究.pdf
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清开灵注射液生物热活性指纹图谱的初步研究
1,2 1,2 1 1 3 1* 4 2
武彦舒 ,张倩 ,金城 ,鄢丹 ,刘义 ,肖小河 ,杜晓曦 ,王建 (1.解放军 302 医院全军中药研究所,北京 100039 ;
2.成都中医药大学药学院,成都 611137 ;3.武汉大学化学与分子科学学院,武汉 430072 ;4. 国家食品药品监督管理局药品审评中心,北京 100038 )
摘要:目的 研究清开灵注射液作用于金黄色葡萄球菌的生物热活性指纹图谱,探索清开灵注射液质量的生物活性评价新方
法。方法 采用微量量热法,在合适测试浓度下,分别测定各清开灵注射液样品生物热活性指纹图谱,并进行定性、定量分
析。结果 不同厂家及同厂家不同批次清开灵注射液样品的生物热活性指纹图谱相似度及热动力学参数存在不同程度差异,
一个过期样品亦可被区分。结论 该方法简便可靠,可为清开灵注射液的质量控制提供参考,为从活性角度研究中药注射液
的质量一致性和稳定性提供了一种很好的思路。
关键词:微量量热法;清开灵注射液;金黄色葡萄球菌;生物热活性指纹图谱;一致性;稳定性
中图分类号:R927.1 文献标识码:A 文章编号:1001-2494(2009)06-0471-04
Investigation on the Bioactivity Fingerprint of Qingkailing Injection by Microcalorimetry
WU Yan-shu1,2 1,2 1 1 3 1* 4 2
, ZHANG Qian , JIN Cheng , YAN Dan , LIU Yi , XIAO Xiao-he ,DU Xiao-xi , WANG Jian (1.
PLA Institute of Chinese Materia Medica, 302 Hospital of PLA,Beijing 100039, China ;2. Pharmacy College, Chengdu University of
TCM, Chengdu 610075, China ;3. College of Chemistry and Molecule Science, Wuhan University, Wuhan 430072, China ;4. Center
for Drug Evaluation, SFDA, Beijing 100038, China)
ABSTRACT :OBJECTIVE To investigate the bioactivity fingerprint of Qingkailing Injection on staphylococcus aureus, and to
search new method for evaluating bioactivity of Qingkailing Injection. METHODS The bioactivity fingerprints of different
Qingkailing Injection on staphylococcus aureus were determined by microcalorimetry, analyzed qualitatively and quantitively.
RESULTS The similarity and thermomechanical parameters were different between different factories and different batches. An
expired sample was distinguished. CONCLUSION The result showed that this method is single, practicable, and reliable as a
reference method for the quality control of Qingkailing Injection. A new direction was prov
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