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目的:以黄连解毒汤为例,基于中药复方药物动力学原理优化中药复方制备工艺。方法:大鼠分别灌胃给予不同制备工艺所得黄连解毒汤全方提取物Ⅰ,Ⅱ,Ⅲ,Ⅳ,于不同时间点采集血浆样品,以黄连解毒汤全方中含量较高的栀子苷为检测指标,采用HPLC测定不同时间点的血药浓度,绘制药-时曲线,应用DAS 2.0软件拟合药动学参数。结果:不同制备工艺所得黄连解毒汤全方提取物中栀子苷的药动学特征相差较大。全方水提取沉淀物组的药-时曲线下面积(AUC)最小且消除最快;全方水提去沉淀物组的AUC(0～∞)与全方水提物组及全方水提醇沉精制物组的AUC(0～∞)相比存在显著性差异(P<0.05);全方水提醇沉精制物组中栀子苷的药-时曲线呈现平缓的趋势;全方水提物组的最大血药浓度(Cmax)最大,但是消除较全方水提醇沉精制物组快。结论:通过不同工艺产物中栀子苷的药代动力学特征的比较,提示中药复方的制备工艺可根据临床给药剂型、给药时间间隔的需求而采用不同的制备工艺,为初步评价中药复方全方的制备工艺研究提供了一种新思路。
Objective: Taking Huanglian Jiedu Decoction as an example, the preparation process of traditional Chinese medicine was optimized based on the pharmacokinetic principle of traditional Chinese medicine. Methods: The rats were treated with different preparation process Huanglian Jiedu Decoction extract all the way to Ⅰ, Ⅱ, Ⅲ, Ⅳ, at different time points to collect plasma samples, with the content of Huanglian Jiedu Decoction in the higher content of geniposide as detection index, using HPLC determination of plasma concentrations at different time points, draw the drug - time curve, the use of DAS 2.0 software to fit pharmacokinetic parameters. Results: The pharmacokinetics characteristics of geniposide in Huanglian Jiedu Decoction extract obtained by different preparation methods varied greatly. The area under the curve (AUC) and the elimination area (AUC) of the whole water extraction sediment group were the smallest and the fastest ones were eliminated. The AUC (0 ~ ∞) and the whole water extract group The AUC (0 ~ ∞) of alcohol precipitation group had a significant difference (P <0.05); the drug-time curve of geniposide showed a gentle trend in the water-alcohol precipitation refined group; The maximal plasma concentration (Cmax) of the extract group was the highest, but the elimination group was faster than that of the ethanol-soluble alcohol precipitation group. Conclusion: The comparison of the pharmacokinetics of geniposide in different products suggests that the preparation process of traditional Chinese medicine compound may adopt different preparation techniques according to the dosage form of the drug and the time interval of drug delivery. All-round preparation technology provides a new idea.