中国药事
中國藥事
중국약사
CHINESE PHARMACEUTICAL AFFAIRS
2014年
12期
1309-1312
,共4页
张娟%范治云%祝清芬%曲见松
張娟%範治雲%祝清芬%麯見鬆
장연%범치운%축청분%곡견송
人参多糖注射液%人参多糖%细菌内毒素检查%干扰试验
人參多糖註射液%人參多糖%細菌內毒素檢查%榦擾試驗
인삼다당주사액%인삼다당%세균내독소검사%간우시험
ginseng polysacchride inj ection%ginseng polysaccharide%bacterial endotoxin test%inter-ference test
目的：建立人参多糖注射液及原料药细菌内毒素检查的方法。方法按《中国药典》2010年版一部附录ⅩⅢ D,确定本品细菌内毒素限值,并研究人参多糖注射液及原料药对细菌内毒素检查试验的干扰情况。结果人参多糖注射液在稀释36倍及以下时,对试验无干扰作用,人参多糖在0.08 mg·mL-1稀释浓度及以下时对试验无干扰作用,其细菌内毒素限值为每1 mg半乳糖醛酸中含内毒素应小于6 EU。结论鲎试剂法可用于本品的细菌内毒素检查。
目的：建立人參多糖註射液及原料藥細菌內毒素檢查的方法。方法按《中國藥典》2010年版一部附錄ⅩⅢ D,確定本品細菌內毒素限值,併研究人參多糖註射液及原料藥對細菌內毒素檢查試驗的榦擾情況。結果人參多糖註射液在稀釋36倍及以下時,對試驗無榦擾作用,人參多糖在0.08 mg·mL-1稀釋濃度及以下時對試驗無榦擾作用,其細菌內毒素限值為每1 mg半乳糖醛痠中含內毒素應小于6 EU。結論鱟試劑法可用于本品的細菌內毒素檢查。
목적：건립인삼다당주사액급원료약세균내독소검사적방법。방법안《중국약전》2010년판일부부록ⅩⅢ D,학정본품세균내독소한치,병연구인삼다당주사액급원료약대세균내독소검사시험적간우정황。결과인삼다당주사액재희석36배급이하시,대시험무간우작용,인삼다당재0.08 mg·mL-1희석농도급이하시대시험무간우작용,기세균내독소한치위매1 mg반유당철산중함내독소응소우6 EU。결론후시제법가용우본품적세균내독소검사。
Objective To establish the bacterial endotoxin test method for Ginseng polysacchride injec-tion and bulk drug.Methods The limit of the amount of bacterial endotoxin in this product was determined according to the appendix ⅩⅢ D of Chinese Pharmacopoeia (2010 edition),and the interference of the product with bacterial endotoxin test was studied.Results The solution of Ginseng polysacchride inj ection diluted by 36 times or below and bulk drug diluted to 0.08 mg·mL-1 or below had no interference with the test.The limit of bacterial endotoxin was 6EU in every 1 mg of galacturonic acid.Conclusion The method of tachypleus amebocyte lysate is suitable for bacterial endotoxin test for Ginseng polysacchride in-j ection and bulk drug.
