紫锥菊栓剂的组成及稳定性研究

I. Herasymova, H. B. Yurieva, T. Yarnykh, D. Voronenko
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引用次数: 0

摘要

本研究的目的是通过实验证实紫锥菊外用栓剂的组成和稳定性,以期用于泌尿生殖系统疾病的综合治疗和预防。材料和方法。本研究以紫锥菊液体提取物为有效药物成分,采用灌制方法制备栓剂样品。用可可脂、Witepsol H15和Witepsol W35作为栓剂基质。本研究采用现代理化、药理学和微生物学方法进行。结果。在进行了理化和药理学研究的基础上,发现在用液体紫锥菊提取物制作栓剂时,可可脂或威普索尔均可作为栓剂的基质。考察了栓样质量的主要指标:感官特性、平均重量、熔点、完全变形时间、微生物纯度,符合国家药典的要求。结论。在进行了物理化学、药物技术和微生物学研究后,选定了栓剂基地,用于生产治疗和预防泌尿生殖系统疾病的外用栓剂,确定了符合乌克兰国家药法典要求的主要质量指标,栓剂的保质期为10天。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Research on the composition development of suppositories with echinacea and study of their stability
The purpose of the work was to experimentally substantiate the composition and study the stability of extemporal suppositories with Echinacea, intended for use in complex therapy and prevention of genitourinary diseases. Materials and methods. The object of the study was samples of suppositories made by pouring using liquid Echinacea extract as an active pharmaceutical ingredient. Cocoa butter, Witepsol H15 and Witepsol W35 were used as suppository bases. The study was carried out using modern physicochemical, pharmaco-technological and microbiological methods. Results. On the basis of the carried out physicochemical and pharmaco-technological studies, it was found that in the manufacture of suppositories using liquid Echinacea extract, Cocoa butter or Witepsol can be used as a suppository bases. The main indicators of the quality of suppository samples were also studied: organoleptic characteristics, average weight, melting point, time of complete deformation, microbiological purity, meeting the requirements of the State Pharmacopoeia. Conclusions. As a result of the carried out physicochemical, pharmaco-technological and microbiological studies, a suppository base was selected for the creation of extemporal suppositories for the treatment and prevention of genitourinary diseases, the main quality indicators were established that meet the requirements of the State Pharmacopoeia of Ukraine, and the shelf life of the suppositories is 10 days.
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