CAJ | 학술논문

目的：通过评价现行各国药典中聚山梨酯80的质量标准及相关文献，为进一步提高聚山梨酯80标准提供参考。方法：对美国药典、欧洲药典、英国药典、日本药典和《中国药典》中聚山梨酯80的质量标准进行了分析讨论，并对几项主要指标，如过氧化值、脂肪酸组成、环氧乙烷与二氧六环等的测定方法和限度进行了分析比较。过氧化值，日本药局方没有要求，其余四国药典要求一样，不得过10.0；脂肪酸组成，《中国药典》和日本药局方没有要求，美国药典、欧洲药典和英国药典的检测方法和限度完全相同；环氧乙烷与二氧六环，《中国药典》的检测要求达到欧美标准。结果与结论：提出了提高聚山梨酯80质量的方法和建议，为生产高质量的聚山梨酯80以及制定注射用聚山梨酯80的质量标准提供参考。
목적：통과평개현행각국약전중취산리지80적질량표준급상관문헌，위진일보제고취산리지80표준제공삼고。방법：대미국약전、구주약전、영국약전、일본약전화《중국약전》중취산리지80적질량표준진행료분석토론，병대궤항주요지표，여과양화치、지방산조성、배양을완여이양륙배등적측정방법화한도진행료분석비교。과양화치，일본약국방몰유요구，기여사국약전요구일양，불득과10.0；지방산조성，《중국약전》화일본약국방몰유요구，미국약전、구주약전화영국약전적검측방법화한도완전상동；배양을완여이양륙배，《중국약전》적검측요구체도구미표준。결과여결론：제출료제고취산리지80질량적방법화건의，위생산고질량적취산리지80이급제정주사용취산리지80적질량표준제공삼고。
Objective:To provide the reference for promoting the polysorbate 80 standards by evaluating the current quality specifications in national pharmacopeias and relevant literatures. Methods: The polysorbate 80 standards in different pharmacopeias, i.e., the United States pharmacopeia,the European pharmacopeia, the British pharmacopeia, the Japanese pharmacopeia and the Chinese pharmacopeia, were analyzed and discussed in this paper. The test methods and limits of several main indicators in different pharmacopeias were compared,such as peroxide value,compositions of fatty acids,ethylene oxide and dioxane,etc. As for peroxide value,there were no requirements in the Japanese pharmacopeia,but the same requirements,with the limit of NMT10.0,appeared in four other pharmacopeias. As for compositions of fatty acids,there were no requirements both in the Chinese and the Japanese pharmacopeias,while test methods and limits were identical in three other pharmacopeias. With respect to ethylene oxide and dioxane,acceptance criteria of the Chinese pharmacopeia lived up to the U.S. and the European standards. Results and Conclusion:This paper proposed methods and suggestions for improving polysorbate 80 quality and provided reference for the establishment of quality speciifcation for polysorbate 80 for injection.