Study on Effective Phase Resolution of Xiaoyao Powder and its Anti-Mammary Hyperplasia Effect

IF 2.7 4区 医学 Q2 PHARMACOLOGY & PHARMACY Journal of Pharmaceutical Innovation Pub Date : 2025-03-07 DOI:10.1007/s12247-025-09937-y
Dai Xiaofang, Zhu Meiwei, Yan Lili, Yang Fangfang, Yang Han, Wang Rui, Guan Qingxia
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Abstract

Purpose

Xiaoyao San (XYS) is an ancient clinical dosage form in China. Our previous research discovered that the compound decoction of traditional Chinese medicine presents a mixed-phase system, encompassing nanophase, precipitated phase, suspension phase, and true solution phase. Hence, this study is intended to screen out the effective phases among the four phases of XYS and explore its anti-hyperplasia effect on mammary glands.

Methods

Four phases of XYS were prepared by centrifugation-dialysis. The preparation process, characterization, determination of chemical composition, and anti-breast hyperplasia effects were investigated.

Results

The four phases of XYS were successfully separated. The characterization results indicated that the nanophase of XYS had the smallest particle size, polydispersity index (PDI) value, and the largest potential value, with an average particle size of approximately 100 nm. In the content determination, the component content ratios of the four phases were consistent, and the content of the nanophase was much higher than that of the other phases. The pharmacodynamic results demonstrated that all indicators of rats in the XYS whole liquid and nanophase groups were significantly improved compared with those in the model group (p < 0.05). At the same time, there were no significant differences in the indicators of rats in the other phase groups. The grey correlation degree analysis revealed that the common peaks of both XYS whole liquid and nanophase were correlated with the pharmacological effect, and the correlation degrees were all greater than 0.7.

Conclusion

This research successfully proved from physicochemical characterization and pharmacodynamics perspectives that the nanophase is the effective phase and that multiple components jointly exert the anti-hyperplasia effect of mammary glands.

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小药粉的有效相溶及其抗乳腺增生作用研究
目的逍遥散(XYS)是中国古老的临床剂型。我们前期的研究发现,中药复方汤剂呈现出纳米相、沉淀相、悬浮相、真溶液相的混相体系。因此,本研究拟在四期中筛选出XYS的有效期,探讨其对乳腺的抗增生作用。方法采用离心透析法制备4相XYS。对其制备工艺、表征、化学成分测定及抗乳腺增生作用进行了研究。结果XYS的四相分离成功。表征结果表明,XYS纳米相的粒径最小,PDI值最大,平均粒径约为100 nm。在含量测定中,四相的组分含量比一致,纳米相的含量远高于其他相。药效学结果显示,与模型组相比,XYS全液组和纳米相组大鼠各项指标均有显著改善(p < 0.05)。同时,其他阶段各组大鼠各项指标均无显著差异。灰色关联度分析显示,XYS全液和纳米相的共有峰均与药理作用相关,关联度均大于0.7。结论本研究从理化表征和药效学角度成功证明纳米相为有效相,多种成分共同发挥乳腺抗增生作用。
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来源期刊
Journal of Pharmaceutical Innovation
Journal of Pharmaceutical Innovation PHARMACOLOGY & PHARMACY-
CiteScore
3.70
自引率
3.80%
发文量
90
审稿时长
>12 weeks
期刊介绍: The Journal of Pharmaceutical Innovation (JPI), is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI''s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation, from R&D to market. Topics will fall under the following categories: Materials science, Product design, Process design, optimization, automation and control, Facilities; Information management, Regulatory policy and strategy, Supply chain developments , Education and professional development, Journal of Pharmaceutical Innovation publishes four issues a year.
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