中国药典2020年版脂肪与脂肪油测定法增订内容解析及反式脂肪酸检测实例

Introduction of the Updated Content of Tests of Fats and Fatty Oils in the Chinese Pharmacopoeia 2020 Edition and Determination Examples of Trans Fatty Acids

关键词:  中国药典2020年版  脂肪与脂肪油测定法  增订  反式脂肪酸

Key words:  Chinese Pharmacopoeia 2020 Edition  tests of fats and fatty oils  supplement  trans fatty acids

摘要:

目的 解析中国药典2020年版通则0713“脂肪与脂肪油测定法”增订内容。方法 将增订项目与国外药典比较，介绍增订项目的概念、测定原理及应用，并应用反式脂肪酸检测方法对大豆油（供注射用）进行测定。结果 增订的不皂化物、碱性杂质、脂肪酸组成、甲氧基苯胺值、甾醇组成和反式脂肪酸体现了近年来中国脂肪与脂肪油测定领域的新理念、新方法和新技术。对反式脂肪酸检测方法进行方法学考察，系列典型反式脂肪酸甲酯在20~450 μg·mL^-1线性关系良好（R²均 ≥ 0.998 0），重复性的相对标准偏差为0.7%~10.2%，检出限为5~10 μg·mL^-1，定量限为15~34 μg·mL^-1。20批大豆油（供注射用）归一化法测定结果与内标法基本一致，国内企业产品中的反式脂肪酸含量高于国外企业。结论 本版通则紧跟国际先进药典的发展趋势，同时实现了自我革新和突破，其实施有益于更好地提高酯类物质检验的技术能力和管理水平。反式脂肪酸检测方法可用于大豆油（供注射用）中反式脂肪酸含量的测定。

Abstract:

OBJECTIVE To introduce updated content in the general principle 0713 "tests of fats and fatty oils" in Chinese Pharmacopoeia 2020 Edition. METHODS Compared the updated items with foreign pharmacopoeias, introduced the concepts, measurement principles and applications of the updated items, and determined the trans fatty acids in soybean oil(for injection) using the trans fatty acid determination method. RESULTS The updated content unsaponifiable matter, alkaline impurities, fatty acid composition, anisidine value, sterol composition and trans fatty acids reflected the new concepts, new methods and new technologies in the field of test of fat and fatty oil in China in recent years. Verification of trans fatty acid determination method showed that typical trans fatty acid methyl esters had good linear relationship within the ranges of 20-450 μg·mL^-1(all R² ≥ 0.998 0), and the RSD of repeatability test was of 0.7%^-10.2%, the limit of detection was of 5^-10 μg·mL^-1 and the limit of quantitation was of 15-34 μg·mL^-1. The results of 20 batches of soybean oil(for injection) based on the normalization method were basically consistent with the internal standard method. The content of trans fatty acids in the products of domestic enterprises was higher than that of foreign enterprises. CONCLUSION This edition of the general principle closely follows the development trend of the international advanced pharmacopoeias, and at the same time has achieved self-innovation and breakthroughs. Its implementation is beneficial to better improve the technical ability and management level of ester substance inspection. The trans fatty acid determination method can be used to determine the content of trans fatty acids in soybean oil(for injection).