丙泊酚注射液异常毒性检查方法的建立
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摘要
目的建立丙泊酚注射液异常毒性检查限值及检查方法。方法采用两种不同来源的小鼠进行丙泊酚注射液半数致死量(LD50)的研究,以确定异常毒性检查限值。检查方法均依据《中国药典》(2015年版)。结果有两种不同来源小鼠求得的丙泊酚注射液的LD50分别为45. 670 mg/kg和48. 110 mg/kg,确定30 mg/kg作为限值进行异常毒性检查,结果符合中国药典规定。结论本研究测定了丙泊酚注射液异常毒性的限值并建立了相关检查方法。
Objective To establish detection limit and methods for abnormal toxicity of propofol injection. Methods Rats from two different sources were used to study the median lethal dose( LD50) of propofol injection to determine the abnormal toxicity detection limit. The detection methods were based on the Chinese Pharmacopoeia( 2015 Edition). Results The LD50 of Propofol injection obtained from two different sources of rats were 45. 670 mg/kg and 48. 110 mg/kg,respectively. The abnormal toxicity test was performed with 30 mg/kg as the limit. The results were in accordance with the Chinese Pharmacopoeia. Conclusion This study determined the limit of abnormal toxicity of propofol injection and established related detection methods.
Objective To establish detection limit and methods for abnormal toxicity of propofol injection. Methods Rats from two different sources were used to study the median lethal dose( LD50) of propofol injection to determine the abnormal toxicity detection limit. The detection methods were based on the Chinese Pharmacopoeia( 2015 Edition). Results The LD50 of Propofol injection obtained from two different sources of rats were 45. 670 mg/kg and 48. 110 mg/kg,respectively. The abnormal toxicity test was performed with 30 mg/kg as the limit. The results were in accordance with the Chinese Pharmacopoeia. Conclusion This study determined the limit of abnormal toxicity of propofol injection and established related detection methods.
引文
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[2]邓庆华,王韵,顾群,等.丙泊酚用于无痛胃镜检查的不良反应文献分析[J].中国药业,2015,24(21):136-138.
[3]邓莎,张德波,罗洁,等.细辛脑注射制剂异常毒性检查标准研究[J].中国比较医学杂志,2016,26(3):35-39.
[4]肖佳音,李庆忠,王宗尉.门冬氨酸鸟氨酸注射液异常毒性及降压物质方法学研究[J].药学研究,2013,32(5):261-263.
[5]梁玉景,华伟,孙青虎,等.丹参注射液安全性检查方法的建立[J].齐鲁药事,2010,29(5):306-307.
[6]国家药典委员会.中华人民共和国药典(四部)[M].北京:中国医药科技出版社,2015.
[7]中国药品生物制品检定所.中国药品检验标准操作规范(2010年版)[M].北京:中国医药科技出版社,2010:310-325.
[8]翁鹭娜,宋婧,洪颖,等.葡萄糖依诺沙星注射液的异常毒性检查与体外溶血反应研究[J].中国药房,2016,27(31):4398-4400.
[9]莫语,麦叶娇.注射用rhCNB小鼠异常毒性检查方法的建立[J].世界最新医学信息文摘,2017,17(50):100,255.
[10]王欣,周继春,张军霞,等.注射用丹参酮Ⅱ_A磺酸钠安全性检查法的研究[J].中国现代应用药学,2017,34(5):723-725.
[11]丁苏苏,姚晶晶,凌真,等.丹酚酸B的安全性研究[J].华西药学杂志,2017,32(1):49-51.
[12]刘娜,魏霞,郑凤家,等.注射用还原型谷胱甘肽生物安全性检查方法[J].中国药师,2016,19(6):1208-1211.
[13]吴超权,周智,张赞,等.注射用甲磺酸加贝酯异常毒性及降压物质方法学研究[J].食品与药品,2015,17(4):247-251.
[14]刘春,赵毓梅,郑霞,等.比伐卢定的升降压物质检查和毒性实验[J].中国药房,2014,25(9):805-807.