1,3-丁二醇在医药领域应用及其质量标准研究

1,3-Butanediol: Pharmaceutical Applications and Quality Standards

摘要: 1,3-丁二醇是一种重要的二元醇化合物，因其良好的吸湿性、低毒性和广泛的相容性，在医药、化妆品及食品工业中应用广泛。在医药领域，作为功能性药用辅料发挥保湿、增塑、助溶等作用；近年来，亦发现其作为外源性酮体前体的潜在治疗价值。目前，我国尚未制订1,3-丁二醇药用级质量标准，国内药用级产品缺乏统一的法定标准，依赖国外药典及化工原料要求。本文系统梳理了1,3-丁二醇的理化性质、生物安全性及医药应用，重点分析其国内外质量标准现状及现有标准的共性缺陷，并在此基础上提出补足安全性检查项目、建立差异化杂质控制策略等建议，为我国药用级1,3-丁二醇质量标准的建立提供参考。

Abstract: 1,3-Butylene glycol is an important diol compound widely utilized in the pharmaceutical, cosmetic, and food industries due to its excellent hygroscopicity, low toxicity, and broad compatibility. In the pharmaceutical field, it serves as a functional excipient with moisturizing, plasticizing, and solubilizing effects. In recent years, its potential therapeutic value as an exogenous ketone body precursor has also been recognized. Currently, China has not established a pharmacopoeial grade standard for 1,3-butylene glycol, and domestic pharmaceutical-grade products lack a unified statutory specification, relying instead on foreign pharmacopoeias and chemical industry requirements. This article systematically reviews the physicochemical properties, biosafety, and pharmaceutical applications of 1,3-butylene glycol, with a focus on analyzing the current status of quality standards both domestically and internationally, as well as the common deficiencies in existing standards. On this basis, suggestions are proposed to supplement safety testing items and establish differentiated impurity control strategies, aiming to provide a reference for the development of quality standards for pharmaceutical-grade 1,3-butylene glycol in China.