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本文以建立泻下中药质量的生物控制方法为实例,针对中药质量易受多种因素影响,样本总体波动范围大的特点,比较了不同生物检定数学模型的适用性,建议中药质量生物控制方法首选准确度相对较高的量反应平行线法,若供试品不能通过可靠性检验,可按质反应平行线法检测。对准确性要求不太高时,也可首选质反应平行线法,操作相对更简单。根据生物检定对参照物质和待测样品同质性的要求,建议采用对照药材提取物作为中药质量生物控制的标准物质,并采用化学参照物进行效价赋值,为效价传递及法定标准物质的建立提供参考。实际检测不同品种大黄药材及其复方制剂的致泻效价,取得较好结果,表明本文建立的生物检定方法及参照物质可用于泻下类中药的质量控制。
In this paper, we set up a biological control method of diarrhea quality of Chinese medicine as an example, in view of the quality of traditional Chinese medicine is susceptible to many factors, the overall sample range of fluctuations in the characteristics of different bioassay compared mathematical applicability of the proposed biological control of traditional Chinese medicine preferred Relatively high accuracy of quantitative reaction parallel line method, if the test can not pass the reliability test, according to the parallel reaction of mass reaction method. Accuracy requirements are not too high, but also the preferred method of parallel reaction of qualitative response, the operation is relatively simple. According to the requirement of bioassay for the homogeneity of the reference substance and the sample to be tested, it is suggested that the reference medicinal herb extract be used as the standard substance for quality control of Chinese traditional medicine, and the chemical reference value should be used for the titer assignment to the titer and the legal standard substance Establish a reference. The actual detection of different varieties of rhubarb herbs and their compounds induced diarrhea valence, and achieved good results, indicating that the bioassay established in this article and the reference substance can be used for diarrhea medicine quality control.