中国现代药物应用
中國現代藥物應用
중국현대약물응용
CHINESE JOURNAL OF MODERN DRUG APPLICATION
2014年
5期
1-2,3
,共3页
盐酸莫西沙星氯化钠注射液%中和剂%无菌检查
鹽痠莫西沙星氯化鈉註射液%中和劑%無菌檢查
염산막서사성록화납주사액%중화제%무균검사
Moxifloxacin hydrochloride and sodium chloride injection%Neutralization%Sterility test
目的：建立盐酸莫西沙星氯化钠注射液无菌检查方法。方法参照《中国药典》2010年版方法进行试验。结果采用薄膜过滤法(冲洗量：400 ml/膜)并结合中和法(每100 ml培养基加入：0.1 mol/L的硫酸锰溶液5 ml)即可消除样品对各菌株的抗菌活性。结论建立的方法可行，可用于盐酸莫西沙星氯化钠注射液无菌检查。
目的：建立鹽痠莫西沙星氯化鈉註射液無菌檢查方法。方法參照《中國藥典》2010年版方法進行試驗。結果採用薄膜過濾法(遲洗量：400 ml/膜)併結閤中和法(每100 ml培養基加入：0.1 mol/L的硫痠錳溶液5 ml)即可消除樣品對各菌株的抗菌活性。結論建立的方法可行，可用于鹽痠莫西沙星氯化鈉註射液無菌檢查。
목적：건립염산막서사성록화납주사액무균검사방법。방법삼조《중국약전》2010년판방법진행시험。결과채용박막과려법(충세량：400 ml/막)병결합중화법(매100 ml배양기가입：0.1 mol/L적류산맹용액5 ml)즉가소제양품대각균주적항균활성。결론건립적방법가행，가용우염산막서사성록화납주사액무균검사。
Objective To establish a sterility test method for moxifloxacin hydrochloride and sodium chloride injection. Methods A test method was set up and improved on the basis of the officia line of Chinese Pharmacopoeia(edited in 2010). Results Antibacterial activity of moxifloxacin hydrochloride could be eliminated by membrane filtration method in which a water solution of 0.1% peptone was used as rinse solution. The volume of the rinse solution was 400 ml, 0.1 mol/L of manganese sulfate solution was used for neutralization. Conclusion The method established in the paper is valid in sterility test for moxifloxacin hydrochloride and sodium chloride injection.
