中国中药杂志

2015, v.40(19) 3786-3793

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桂枝茯苓胶囊质量标准提升对制剂主要药效影响的研究
Monitor on influence of quality standard improvement upon Guizhi Fuling capsules efficacy

丁玥;曹泽彧;柯志鹏;苏真真;曹亮;李娜;章晨峰;王团结;丁岗;王振中;萧伟;
DING Yue;CAO Ze-yu;KE Zhi-peng;SU Zhen-zhen;CAO Liang;LI Na;ZHANG Chen-feng;WANG Tuan-jie;DING Gang;WANG Zhen-zhong;XIAO Wei;Jiangsu Kanion Pharmarceutical Co.,Ltd.;State Key Laboratory of Pharmaceutical Process New-tech for Chinese Medicine;

摘要(Abstract):

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ET-1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TNF-α、促进IL-2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ET-1及PGF2α的含量;降低盆腔炎大鼠子宫TNF-α、促进IL-2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。
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 anti-dysmenorrhea models,remarked reduction of writhing frequency,ET-1 and PGF2α content in uterus could be detected,as well as extension of writhing latency. In pelvic inflammation rats,depression of TNF-α and raise of IL-2 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 preparation process and quality standard improvement,the effectiveness and homogeneity of Guizhi Fuling capsules were enhanced.

关键词(KeyWords): 桂枝茯苓胶囊;质量标准提升;痛经;盆腔炎;子宫肌瘤
Guizhi Fuling capsule;quality standard improvement;dysmenorrheal;pelvic inflammation;hysteromyoma

Abstract:

Keywords:

基金项目(Foundation): 国家“重大新药创制”科技重大专项(2013ZX09402203)

作者(Author): 丁玥;曹泽彧;柯志鹏;苏真真;曹亮;李娜;章晨峰;王团结;丁岗;王振中;萧伟;
DING Yue;CAO Ze-yu;KE Zhi-peng;SU Zhen-zhen;CAO Liang;LI Na;ZHANG Chen-feng;WANG Tuan-jie;DING Gang;WANG Zhen-zhong;XIAO Wei;Jiangsu Kanion Pharmarceutical Co.,Ltd.;State Key Laboratory of Pharmaceutical Process New-tech for Chinese Medicine;

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