必需磷脂产品的互换性

N. Bunyatyan, B. Sysuev, L. Nikolaeva
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引用次数: 1

摘要

肝保护药物市场的重要份额由含有必需磷脂的创新产品和仿制产品代表。药物治疗中的一个主要问题是确认参考产品和仿制产品之间的相似性,这有助于评估它们的互换性。因此,似乎有必要进行比较研究,检查产品的配方(活性药物成分和赋形剂的含量)、剂型和给药途径,以确定可能影响必需磷脂产品互换性的特征。该研究的目的是分析含有必需磷脂的通用和参考肝保护剂的互换性。必需磷脂(口服(胶囊)、静脉注射(静脉输注溶液和冻干液静脉输注溶液)和外用(皮肤使用凝胶)剂型的命名法根据国家药品注册、信息存储和检索系统以及图书馆数据库(图书馆、PubMed、CyberLeninka、ResearchGate)给出。不同厂家生产的磷脂物质中磷脂酰胆碱含量差异显著(29 - 93%);溶液中辅料的定量组成存在微小差异,胶囊中辅料的组成和数量存在显著差异,这很可能是由于不同的生产方法造成的。获得的数据可用于优化药物开发和评估必需磷脂产品的互换性。
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Interchangeability of Essential Phospholipid Products
A significant share of the hepatoprotectors pharmaceutical market is represented by innovator and generic products containing essential phospholipids. One of the main issues in pharmacotherapy is confirmation of similarity between reference and generic products, which helps to assess their interchangeability. Therefore, it seems relevant to conduct comparative studies examining the products’ formulations (content of active pharmaceutical ingredients and excipients), dosage forms and routes of administration to identify characteristics that can affect interchangeability of essential phospholipid products. The objective of the study was to analyse interchangeability of generic and reference hepatoprotectors containing essential phospholipids. The nomenclature of essential phospholipids (oral (capsules), parenteral (solution for intravenous infusion and lyophilisate for solution for intravenous infusion), and topical (gel for cutaneous use) dosage forms) is given in accordance with the State Register of Medicinal Products, information storage and retrieval systems, and library databases (eLibrary, PubMed, CyberLeninka, ResearchGate).There was a significant difference in the content of phosphatidylcholine (29—93 %) in phospholipid substances produced by different manufacturers; minor differences were found in the quantitative composition of excipients in solutions, and significant differences were observed in the composition and quantities of excipients in capsules, which is most likely attributed to different production methods. The obtained data may be used to optimise pharmaceutical development and assess interchangeability of essential phospholipid products.
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