Ding Yue, Cao Ze-yui, Ke Zhi-peng, Su Zhen-zhen, Cao Liang, Li Na, Zhang Chen-feng, Wang Tuan-jie, Ding Gang, Wang Zhen-zhong, Xiao Wei
Zhongguo Zhong Yao Za Zhi. 2015 Oct;40(19):3786-93.
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 ot 2012-2014. After tne preparation process and quality standard improvement, the effectiveness and homogeneity of Guizhi Fuling capsules were enhanced.
2012年，对桂枝茯苓胶囊的制备工艺和质量标准进行了改进。为比较改进前（2011年）和改进后（2012 - 2014年）胶囊的效果及差异，在大鼠身上应用了原发性痛经、盆腔炎和子宫肌瘤的评价模型。模型分别由催产素、液体细菌混合物和雌激素负荷诱导产生。在2011 - 2014年随机抽取胶囊（每年12批，共48批），使用这三种模型评估其效果。在抗痛经模型中，可检测到扭体频率显著降低、子宫中ET - 1和PGF2α含量降低以及扭体潜伏期延长。在盆腔炎大鼠中，每批胶囊都能诱导TNF - α降低和IL - 2升高。在子宫肌瘤模型中，所有批次的胶囊都能明显降低子宫重量和平滑肌增殖，包括血浆中的E2和P水平。其次，2012 - 2014年生产的桂枝茯苓胶囊显示出比2011年生产的胶囊更好的效果。此外，2011年制备的样品的药效学指标在组间差异显著，而在2012 - 2014年制备的样品中未观察到这种情况。经过制备工艺和质量标准改进后，桂枝茯苓胶囊的有效性和均一性得到了提高。
