Justification of the choice of excipients during the development of the composition of “Pastinocard” tablets

N. А. Symonenko, O. Shpychak, O. Kukhtenko, Ye. A. Bezrukavyi, H. B. Yurieva
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Abstract

The aim of the work is to justify the choice of excipients as components for the cardioprotective medicine “Pastinocard” tablets based on the domestic raw material of cultivated parsnip herb thick extract (CPHTE). Materials and methods. Experimental test samples of mixtures of the plant substance of domestic origin CPHTE with groups of excipients, approved for medical use, were used as the object of research. Results. We conducted experimental research by a mathematical planning method called the Greek–Latin square. In this study, we investigated how 16 different auxiliary substances affected the pharmacotechnological properties of tableting masses and tablets made from PPTEG with cardioprotective properties. Our goal was to determine the optimal composition and manufacturing process for a medication, specifically “Pastinocard” tablets. We also developed project plans for manufacturing regulations and quality control methods, which we successfully tested in the industrial production setting at Pharmaceutical Company “Zdorovye”, LTD in Kharkiv. Conclusions. The formulation for cardioprotective tablets, designated as “Pastinocard”, has been both theoretically justified and experimentally developed by domestic CPHTE raw materials. These research findings have been instrumental in crafting the regulatory documentation for quality control and the production processes of the resulting tablet medication.
在开发 "Pastinocard "片剂成分时选择辅料的理由
这项工作的目的是证明选择辅料作为 "Pastinocard "片剂成分的合理性,该药片是以国产原料栽培香芹草本植物浓提取物(CPHTE)为基础的心脏保护药物。材料和方法研究对象是国产香芹厚朴萃取物与经批准用于医疗用途的各类辅料的混合物试验样品。结果。我们采用一种名为 "希腊-拉丁方阵 "的数学规划方法进行了实验研究。在这项研究中,我们调查了 16 种不同的辅助物质如何影响由具有心脏保护特性的 PPTEG 制成的片剂和药片的药理特性。我们的目标是确定药物(特别是 "Pastinocard "片剂)的最佳成分和生产工艺。我们还制定了生产规范和质量控制方法的项目计划,并在哈尔科夫 "Zdorovye "制药公司的工业生产环境中进行了成功测试。结论名为 "Pastinocard "的心脏保护片剂配方已通过国产 CPHTE 原料的理论论证和实验开发出来。这些研究成果有助于制定质量控制监管文件和由此产生的片剂药物的生产工艺。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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