基于药效筛选和正交试验优化健脾益肾丸的制备工艺

Optimization of preparation process of Jianpi Yishen Pill based on pharmacodynamic screening and orthogonal test

目的通过药效研究筛选健脾益肾丸的制备工艺,并以正交试验进行优化,确定健脾益肾丸的最佳提取工艺。方法采用5/6肾切除方法制备大鼠慢性肾衰竭模型,以大鼠肌酐(Cr)、尿素氮(BUN)含量降低值为指标,对拟定的健脾益肾丸A(打粉入药+水提)、B(打粉入药+提油+水提)和C(提油+水提)3种工艺路线进行筛选;继以黄芪甲苷含量和固形物质量为指标,采用正交试验优化加水量、煎煮时间和煎煮次数的提取工艺。结果药效实验表明,工艺A对慢性肾衰竭大鼠模型具有明显的改善作用,可作为该方丸剂成型工艺。该工艺中白术等5味药材单独粉碎成细粉,黄芪等其余药材的最佳提取工艺为药材每次加8倍量水,煎煮2次,每次煎煮1 h。结论健脾益肾丸能明显改善5/6肾切除大鼠模型的Cr、BUN含量,优选的制备工艺稳定、可行,为健脾益肾丸的后续开发提供依据。

Objective To screen the preparation technology of Jianpi Yishen Pill(JYP) by pharmacodynamics screening, and optimize it by orthogonal test to determine the best extraction technology. Methods The chronic renal failure model in rats was established by 5/6 nephrectomy. Three technological routes of JYP were selected, including A(powder of medicinal materials and decocting with water), B(powder of medicinal materials, extraction of volatile oil, and decocting with water), and C(extraction of volatile oil and decocting with water), with the content of Cr and BUN in rats as index. The orthogonal test was optimized by using the content of astragaloside and the quality of solid as indexes, with water volum, decoction time, decoction freguency as factors. Results The pharmacological efficacy test showed that technology A could obviously improve the rat model of chronic renal failure, and it could be used as the molding technology of this prescription pill. In this technology, five herbs such as Atractylodis Macrocephalae Rhizoma were crushed into fine powder alone, and the optimal extraction condition of other medical materials such as Astragalus Radix was as follows: 8-fold water per time, decocting 1 h, for two times. Conclusion JYP can obviously improve the content of Cr and BUN in rats model of 5/6 nephrectomy. The optimized preparation technology is stable and feasible, which can provide the basis for the follow-up development of JYP.