新工艺清开灵注射液药效学和安全性研究
清开灵注射液,,清开灵注射液；抗菌；抗炎；解热；膜过滤系统,热原,1试验材料,2方法,3结果,4讨论,参考文献：
摘要:目的 通过对新、旧工艺清开灵注射液进行相关药效学对比试验，了解经工艺改革后新工艺的药理活性是否优于旧工艺。方法 分别采用体外抗菌法，干酵母致大鼠发热模型，大鼠CMCNa囊内白细胞聚集模型，二甲苯致小鼠耳廓肿胀模型，观察新、旧工艺的抑菌杀菌活性、抗炎解热疗效及对单核巨噬细胞系统吞噬功能的影响。用热原检查法来考察其安全性。结果 新、旧工艺解热、抗炎作用强度相似，其差异无统计学意义。新工艺的抑菌杀菌活性略强，另外新工艺对CMCNa诱导的炎症中期的细胞移行有明显抑制作用；热原检查显示合格率明显高于旧工艺。结论 新工艺的总体抗菌抗炎效果优于旧工艺，其余药效作用与旧工艺相当；热原的降低将大大减少不良反应的发生率。关键词:清开灵注射液；抗菌；抗炎；解热；膜过滤系统 热原
The main pharmacodynamic and reliability of Qingkailing injection prepared with new procedure
SITU Shaojin, ZHOU Weifen, WANG Sha, YANG Que
(1.Guangzhou Mingxing Pharmaceutical Co., Ltd., Guangzhou, 510250，China; 2. Pharmacological Laboratory, Pharmaceutical Industrial Research Institute of Guangzhou, Guangzhou 510250,China)
Abstract: Objective To study and compare the variations of the Qingkailing injection prepared with the new procedure with injection prepared with the original procedure. And inspect the reliability of Qingkailing injection by determining pyrogen. Methods in vitro antibacterial assay, fever in rats induced by dried yeast, leucocyte aggregation in bursa of rats induced by CMCNa, swelling of auricle in mice induced by dimethylbenzene, and competence of clearing up carbon in mice were conducted to investigate the effect of new procedure on the bacteriostatic and antibiotic activities, antiinflammatory and antipyretic efficacies, and effects on the cytophagocytosis of mononuclear phagocyte system. Results Compared with the injection prepared with original procedures, Qingkailing injection prepared with new procedure is similar in antipyretic, antiinflammatory effects, and the difference has no statistical significance. The antibiotic and bacteriostatic activity of the injection prepared with the new procedure is slightly stronger than that prepared with the original procedure. The injection prepared with new procedures has obvious inhibitory effect on cell migration in metaphase of inflammation induced by CMCNa in rats. The qualification rate of injection prepared with the new procedures is markedly higher than that prepared with the original procedure. Conclusions The injection prepared with the new procedure surpasses the injection prepared with the original procedure in antibacterial and antiinflammatory actions, and similar with each other in other characters with no statistical significance. And the reduction of pyrogen in injection prepared with new procedure will enormously decrease the incidence of adverse reactions. ......
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