目的 通过长期毒性与药效实验筛选五子衍宗加减方（WYR）的提取工艺，并以正交试验进行优化，确定WYR的最佳提取工艺。方法 对不同工艺WYR样品进行长期毒性实验，并以肾阳虚大鼠阴茎勃起潜伏期和性激素水平为药效指标，综合长期毒性与药效实验的结果，筛选出最佳工艺方案；以多个指标成分含量和出膏率为指标，采用正交试验筛选不同提取工艺的最优水平，并进行验证。结果 长期毒性实验结果显示所有小鼠均健康存活，未见明显毒性反应。药效实验结果表明，巴戟天、杜仲、桑寄生、续断、炙甘草以70%乙醇回流提取，其余药材用70%乙醇作为溶剂进行渗漉提取为WYR最佳提取方式；得到的最优提取工艺为巴戟天、杜仲、桑寄生、续断、炙甘草以10倍量70%乙醇回流提取3次，每次2.0 h；其余药材以10倍量70%乙醇1.5 mL/min渗漉提取，渗漉前药材先浸泡16 h。结论 WYR能明显改善肾阳虚大鼠阴茎勃起潜伏期和性激素水平，优选的工艺条件合理可行，为WYR的后续开发提供依据。

Objective To screen the extraction process of Wuzi Yanzong plus and minus Recipe (WYR) by pharmacodynamics and long-term toxicity test, and optimize it by orthogonal experiment to determine the best extraction process of WYR. Methods Long-term toxicity experiments were carried out on different processed WYR samples. The penile erection latency and sex hormone levels in rats with kidney-yang deficiency were used as pharmacodynamic indicators. The results of long-term toxicity and efficacy experiments were combined to screen out the optimal process plan. Using the content of ingredients and the rate of ointment as indicators, the orthogonal test was used to screen the optimal level of different extraction processes and verified. Results Long-term toxicity test results showed that all mice survived healthily and no obvious toxicity was observed. The results of pharmacodynamic experiments showed that the extracts of Morindae Officinalis Radix, Eucommiae Cortex, Taxilli Herba, Dipsaci Radix, and Glycyrrhizae Radix et Rhizoma Praeparata cum Melle were refluxed with 70% ethanol, and the remaining medicinal materials were extracted with 70% ethanol as the solvent to obtain the best extraction method of WYR. The suitable extraction process was as follows:Morindae Officinalis Radix, Eucommiae Cortex, Taxilli Herba, Dipsaci Radix, and Glycyrrhizae Radix et Rhizoma Praeparata cum Melle were extracted three times with 10 times 70% ethanol for 2.0 h each time; The remaining medicinal materials were percolated with 10 times 70% ethanol at 1.5 mL/min. The medicinal herbs were firstly soaked for 16 h before percolation. Conclusion WYR can significantly improve the penile erection latency and sex hormone levels in rats with kidney yang deficiency. The optimal process conditions are reasonable and feasible, which provides a basis for the follow-up development of WYR.

R284.2