基于微量量热法的清开灵注射液质量一致性和稳定性初步研究.docVIP

基于微量量热法的清开灵注射液质量一致性和稳定性初步研究 武彦舒1,2，张 倩1,2，金 城1，鄢 丹1，肖小河1*，杜晓曦*，王 建2 nvestigation of consistency and stability of Qingkailing Injection based on/by microcalorimetry WU Yan-shu1,2，ZHANG Qian1,2，JIN Cheng1，YAN Dan1，JIAO Yi3， XIAO Xiao-he1*，DU Xiao-xi4*，WANG Jian2 (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. Pharmacy College, Hunan University of TCM, Changsha 410002, China; 4. Centre for Drug Evaluation, SFDA, Beijing 100038, China) [Abstract] Objective: To investigate the bioactivity finger print of Qingkailing Injection on staphylococcus aureus, and to search new method for evaluating bioactivity of Qingkailing Injection. Methods: The bioactivity finger prints of different Qingkailing Injection on staphylococcus aureus were determined by microcalorimetry, analyzed qualitatively and quantitively. An expired sample was also distinguished. Results: The similarity and thermomechanical parameters were something deffrence of Qingkailing Injection from different factories and different batches. 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 provided for investigating consistency and stability of traditional Chinese medicine injection. [Key words] Microcalorimetry; Qingkailing Injection; staphylococcus aureus; bioactivity finger print; consistency; stability 清开灵注射液组方源于中医治疗急性热病传统处方“温病三宝”中的安宫牛黄丸。由胆酸、猪去氧胆酸、水牛角（粉）、黄芩苷、珍珠母（粉）、栀子、板蓝根、金银花等组成。1992年始清开灵注射液被政府医药管理部门指定为全国中医医院急诊（科）室必备的中成药，具有清热解毒、化痰通络、醒神开窍的作用，用于热病神昏，中风偏瘫，神志不清等症。 清开灵注射液生产厂家众多，水平参差不齐，质量高低不一，加之其组方、生产工艺复杂，使得目前的质控方法都难以有效保证清开灵注射液的质量。2006年，SFDA已针对中药注射液的活性评价做了相关规定[1]。中药质量生物控制已成为中药质量控制研究发展的趋势[2]。但是目前这方面的研究相对薄弱，有关方面的报道更是少之又少。 结合前期研究[3,4]，我们提出从质量一致性、稳定性出发，以清开灵注射液的抑菌活性为着眼点，采用微量量热法，以生物热活性指纹图谱及热动力学参数定性定量的表征清开灵注射液的质量，为从活性角度评价清开灵注射液进行了有益尝试，亦为保障清开灵注射液的安全使用提供参考。 1 实验仪器及材料 1.1 实验仪器 实验仪器采用瑞典T