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目的:优选乌鳖颗粒中间体的醇沉工艺,降低该制剂的日服用量。方法:通过考察卵巢摘除大鼠雌二醇(E2),卵泡刺激素(FSH),黄体生成素(LH)的活性和幼鼠子宫、卵巢发育情况,评价乌鳖颗粒中间体醇沉工艺的合理性。以二苯乙烯苷、川续断皂苷Ⅵ和固含物转移率为指标,通过单因素试验确定最佳醇沉工艺。采用HPLC测定二苯乙烯苷、川续断皂苷Ⅵ含量。结果:乌鳖颗粒中间体醇沉前后对药效试验无显著性差异。最佳醇沉工艺为何首乌组提取液浓缩至相对密度1.10(60℃),加乙醇使含醇量达60%,静置时间>12 h,上清液减压浓缩至相对密度1.20~1.23(60℃)。结论:药效评价结合单因素试验确定的何首乌组醇沉工艺更加合理、可靠,降低乌鳖颗粒日服用量的同时,还保证了该制剂的有效性。
OBJECTIVE: To optimize the alcohol precipitation process of Ulton turtle granule intermediates and to reduce the daily dosage of this preparation. Methods: The ovariectomy rats estradiol (E2), follicle stimulating hormone (FSH), luteinizing hormone (LH) activity and development of uterus and ovary in pups Sex. With stilbene glucoside, Dictyostelium anas saponin Ⅵ and solid transfer rate as an indicator, through the single factor test to determine the best alcohol precipitation process. Stilbene glycosides were determined by HPLC. Results: There was no significant difference in the efficacy test between Wu Tuo granules intermediates before and after alcohol precipitation. The best alcohol precipitation process Shouwu extract was concentrated to a relative density of 1.10 (60 ℃), add ethanol to make the alcohol content of 60%, standing time> 12 h, the supernatant was concentrated under reduced pressure to a relative density of 1.20 ~ 1.23 60 ° C). Conclusion: The pharmacodynamics evaluation combined with the single factor experiment determined that the alcohol precipitation process of Polygonum multiflorum was more reasonable and reliable, reducing the daily dosage of Uv turtle granules and also ensuring the effectiveness of the preparation.