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

作　　者：张传香[1] 喻娅婷[1] 于倩[1] Zhang Chuanxiang;Yu Yating;Yu Qian(Hunan Children’s Hospital,Changsha 410007,China)

机构地区：[1]湖南省儿童医院,长沙410007

出　　处：《儿科药学杂志》2024年第3期20-22,共3页Journal of Pediatric Pharmacy

基　　金：湖南省自然科学基金,编号2022JJ80061。

摘　　要：目的:制备对乙酰氨基酚泡腾栓并拟定质量控制标准。方法:采用正交试验法筛选泡腾栓处方,并制备对乙酰氨基酚泡腾栓。按《中国药典》通则栓剂项下的规定检查其性状外观、质量差异和融变时限等指标,采用高效液相色谱(HPLC)法测定泡腾栓对乙酰氨基酚含量。结果:对乙酰氨基酚泡腾栓为乳白色子弹型栓剂,质量差异、融变时限符合《中国药典》规定,最大发泡量>10 mL,对乙酰氨基酚含量为49.69 mg/g,相对标准偏差(RSD)为0.6%(n=9)。结论:该泡腾栓制备工艺简单易行,质量控制方法稳定可靠。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 

分 类 号：R917[医药卫生—药物分析学]