桂枝茯苓胶囊质量标准提升对制剂主要药效影响研究.docVIP

桂枝茯苓胶囊质量标准提升对制剂主要药效影响研究 　　[摘要]比较生产质控过程优化及质量标准提高后，桂枝茯苓胶囊在抗痛经、盆腔炎和子宫肌瘤3个方面的主要药效作用以及均一性的差异。选取2011年12个批次桂枝茯苓胶囊（质量标准提升前制剂）、2012―2014年每年12个批次桂枝茯苓胶囊（质量标准提升后制剂），利用缩宫素致大鼠痛经模型、混合菌液致大鼠慢性盆腔炎模型、雌孕激素负荷致大鼠子宫肌瘤模型，研究质量标准提升前后多批次的桂枝茯苓胶囊抗痛经、盆腔炎和子宫肌瘤的药效作用。2011―2014各批次桂枝茯苓胶囊，在痛经的主要药效模型上的研究表明各批次均可不同程度减少痛经大鼠的扭体次数，延长扭体潜伏期，降低子宫组织中ET1及PGF2α的含量，与模型组比较，均具有显著性差异；慢性盆腔炎模型主要药效显示，各批次均可不同程度降低盆腔炎大鼠子宫TNFα、促进IL2分泌；子宫肌瘤模型主要药效显示，各批次均可不同程度降低子宫肌瘤大鼠的子宫质量，抑制子宫平滑肌过度增殖，降低血清中E2和P水平。2012―2014年各批次桂枝茯苓胶囊在治疗痛经、盆腔炎、子宫肌瘤方面的药效学指标（减少痛经模型大鼠的扭体次数，延长扭体潜伏期，降低子宫组织中ET1及PGF2α的含量；降低盆腔炎大鼠子宫TNFα、促进IL2分泌；降低子宫肌瘤大鼠血清中E2和P水平）优于2011年桂枝茯苓胶囊，且具有显著性差异。2011年个批次桂枝茯苓胶囊的药效学指标存在显著性的组间差异，2012―2014年桂枝茯苓胶囊的药效学指标组间比较无显著差异。该研究表明，生产质控过程优化及提高质量标准后，桂枝茯苓胶囊抗痛经、抗盆腔炎、抗子宫肌瘤的药效显著性增强，且产品均一性显著提升。 　　[关键词]桂枝茯苓胶囊；质量标准提升；痛经；盆腔炎；子宫肌瘤 　　[Abstract]In 2012， the preparation process and quality standard for Guizhi Fuling capsule were improved To compare the effects and differences of capsules before（2011） and after（2012―2014） the improvement， evaluation models for intrinsic dysmenorrhea， pelvic inflammation and hysteromyoma were applied in rats Models were induced by oxytocin， liqiud bacteria mixture and estrogen loading， respectively The capsules（12 batchs/year， 48 bathcs in all）， sampled randomly in 2011―2014， the effects were assessed using the three models In antidysmenorrhea models， remarked reduction of writhing frequency， ET1 and PGF2α content in uterus could be detected， as well as extension of writhing latency In pelvic inflammation rats， depression of TNFα and raise of IL2 were induced by earh batch of capsules In hysteromyoma model， uterine weight and smooth muscle proliferation， including E2 and P level in plasma， were lowered obviously by all batchs of capsules Secondly， Guizhi Fuling capsules produced in 2012―2014 revealed better effectiveness than the ones manufactured in 2011 Moreover， pharmacodynamics indexes of the samples made in 2011 differed significantly between groups， which could not be observed in the ones of 2012―2014 After the preparatio