摘要
优选对乙酰氨基酚注射液的制备工艺,并考察其稳定性。通过单因素考察确定制剂的辅料用量,最适pH,灭菌工艺等,筛选出最优工艺条件,并根据确定的条件进行稳定性考察。对乙酰氨基酚注射液制备工艺最优条件为磷酸氢二钠用量为175mg,控制产品p H在6.0,并在115℃下高压蒸汽灭菌30min,可以成功制得对乙酰氨基酚注射液,产品规格为10mg/mL。此产品在常温下密封放置30d稳定性良好。合理的制备工艺和条件,可更好的保证对乙酰氨基酚注射液的质量。
OBJECTIVE To optimise the preparation process of acetaminophen injection,and the stability of which was investigated.METHORD Single factor experiment was carried out to determine the dosage of adjuvants,pH of solution and sterilization process.And according to the determined conditions for the stability of the investigation.RESULTS The optimal conditions were determined as follows:The amount of disodium hydrogen phosphate was 175mg,Control product pH at 6.0.The solution was sterilized at 115℃ for 30min.The product is stable when it is sealed at room temperature for 30d.CONCLUSION Reasonable preparation process and conditions can better ensure the quality of acetaminophen injection.
作者
叶静
张晓宇
方群
张全
李长兵
Ye Jing;Zhang Xiao-yu;Fang Qun;Zhang Quan;Li Chang-bing(School of pharmacy,Chengdu Medical College,Chengdu 610500;School of pharmacy,Tianjin Medical College,Tianjin 300072)
出处
《云南化工》
CAS
2019年第1期59-61,共3页
Yunnan Chemical Technology
基金
省级大学生创新创业项目(201813705094)
关键词
对乙酰氨基酚
注射液
制备工艺
稳定性
Acetaminophen
intravenous injection
preparation process
stability
