儿科药学杂志2024，Vol.30Issue(3)：20-22,3.DOI:10.13407/j.cnki.jpp.1672-108X.2024.03.005
水溶性基质对乙酰氨基酚泡腾栓的制备及质量控制
Preparation and Quality Control of Acetaminophen Effervescent Suppository with Water-Soluble Matrix
摘要
Abstract
Objective:To prepare the acetaminophen effervescent suppository and establish its quality control standards.Methods:The formula of effervescent suppository was optimized by an orthogonal experiment and the acetaminophen effervescent suppository was fabricated.In accordance with the standard of suppository in the Chinese Pharmacopoeia,the appearance,weight difference and melting time limit were checked,and the content of acetaminophen in effervescent suppository was determined by high performance liquid chromatography.Results:The acetaminophen effervescent suppository showed milk white and bullet shape,the weight difference and melting time limit were in line with the standard of the Chinese Pharmacopoeia.The maximum foaming volume of suppository was determined to be more than 10 mL,and the content of acetaminophen was obtained to be 49.69 mg/g with relative standard deviation(RSD)of 0.6％(n=9).Conclusion:The preparation method explored for the effervescent suppository is considered to be simple,and the method for quality control is stable and reliable.关键词
正交试验/对乙酰氨基酚/泡腾栓/直肠给药/高效液相色谱Key words
orthogonal experiment/acetaminophen/effervescent suppository/rectal administration/high performance liquid chromatography分类
医药卫生引用本文复制引用
张传香,喻娅婷,于倩..水溶性基质对乙酰氨基酚泡腾栓的制备及质量控制[J].儿科药学杂志,2024,30(3):20-22,3.基金项目
湖南省自然科学基金,编号2022JJ80061. （）
