摘要
目的:对硫酸特布他林口服溶液进行逆向工程研究,确定其处方、工艺。方法:采用HPLC法测定参比制剂中硫酸特布他林、苯甲酸钠、枸橼酸和山梨醇的含量。结果:测得参比制剂中每1 mL硫酸特布他林口服溶液中含硫酸特布他林0.5 mg,苯甲酸钠1 mg,山梨醇205 mg,枸橼酸3.8 mg。结论:逆向工程研究能有效解析硫酸特布他林口服溶液的处方、工艺,结果准确可靠。
[Objective]To conduct reverse engineering research on the oral solution of terbutaline sulfate to determine its prescription and process.[Method]HPLC was used to determine the contents of terbutaline sulfate,sodium benzoate,citric acid,and sorbitol in the reference preparation.[Results]The RLD was found to contain 0.5mg of terbutaline sulfate,1mg of sodium benzoate,205mg of sorbitol,and 3.8mg of citric acid per 1mL of terbutaline sulfate oral solution.[Conclusion]Reverse engineering research can effectively analyze the prescription and process of terbutaline sulfate oral solution,and the results are accurate and reliable.
作者
袁哲友
张发成
杨芳
蒋雪琴
张文钦
YUAN Zheyou;ZHANG Facheng;YANG Fang;JIANG Xueqin;ZHANG Wenqin(Polifarma(Nanjing)Co.,Ltd.,Nanjing,210038,China;Jurong Country Garden School,Zhenjiang 212400,China)
出处
《云南化工》
2026年第1期63-68,共6页
Yunnan Chemical Technology
关键词
硫酸特布他林口服溶液
逆向工程
处方
制备工艺
Tebutaline Sulfate Oral Solution
Reverse Engineering
Prescription
Preparation Process
