草酸盐的危害及测定方法研究进展

Advances in the Study on the Hazards and Determination Methods of Oxalate

草酸在体内与钙等元素形成草酸钙导致结石,高钙尿症、高草酸尿症、低枸橼酸尿症和低尿量均是矿物质过饱和度增加和草酸钙形成导致的主要疾病。本文结合草酸盐的存在及危害,介绍了草酸盐的测定方法研究情况。文中以几种草酸盐检测方法为例,从方法原理、样品制备、试验操作、限度控制和注意事项等方面,对目视比色法、分光光度法、离子色谱法、高效液相色谱法等方法进行了比较,列明了各种方法的优缺点,为草酸盐分析检测提供参考。结合葡萄糖酸钙国家药品标准草案公示稿中的检测方法,以及《中国药典》2020年版各部收载品种的质量标准中草酸盐的检测方法及控制情况,阐述了草酸盐在药品质量控制的必要性,明确了基于产品质量控制提升检测方法的精密度和准确度以符合现行技术指南要求的趋势。

Oxalic acid forms calcium oxalate in the body,which leads to stones,Hypercalcemia,hyperoxaluria,hypocitruria,and low urine output are the main diseases caused by increased mineral supersaturation and calcium oxalate formation.In this paper,the existence and hazards of oxalate are introduced,and the research on the determination method of oxalate is introduced.Taking several oxalate detection methods as examples,this article compares visual colorimetry,spectrophotometry,ion chromatography,and high-performance liquid chromatography methods from the aspects of method principles,sample preparation,experimental operations,limit control,and precautions.The advantages and disadvantages of each method are listed,providing reference for oxalate analysis and detection.Combining the testing methods in the draft national drug standard for calcium gluconate and the quality standards and control of oxalate in various parts of the 2020 edition of the Chinese Pharmacopoeia,the necessity of oxalate in drug quality control is elaborated,and the trend of improving the precision and accuracy of testing methods based on product quality control to meet the requirements of current technical guidelines is clarified.