中国药品标准
中國藥品標準
중국약품표준
Drug Standards of China
2015年
5期
359-361
,共3页
王似锦%张光华%刘文杰%高春%佟立今
王似錦%張光華%劉文傑%高春%佟立今
왕사금%장광화%류문걸%고춘%동립금
注射用醋酸卡泊芬净%右旋糖酐%无菌检查
註射用醋痠卡泊芬淨%右鏇糖酐%無菌檢查
주사용작산잡박분정%우선당항%무균검사
Caspofungin Acetate for Injection%dextran%sterility test
目的:通过无菌方法学验证试验,建立注射用醋酸卡泊芬净的无菌检查法。方法:样品分别用0.9%无菌氯化钠溶液溶解,采用薄膜过滤法处理,每膜分别用0.9%无菌氯化钠溶液和右旋糖酐40葡萄糖注射液冲洗若干次,并在培养基中加入右旋糖酐1 g,以白色念珠菌为阳性对照菌。结果:各验证菌株均能够正常生长,方法可行。结论:通过添加外源的右旋糖酐,使真菌通过利用外源的肽聚糖用于自身细胞壁的合成,从而消除了醋酸卡泊芬净的抑菌作用,建立了抗真菌药物注射用醋酸卡泊芬净的无菌检查法。
目的:通過無菌方法學驗證試驗,建立註射用醋痠卡泊芬淨的無菌檢查法。方法:樣品分彆用0.9%無菌氯化鈉溶液溶解,採用薄膜過濾法處理,每膜分彆用0.9%無菌氯化鈉溶液和右鏇糖酐40葡萄糖註射液遲洗若榦次,併在培養基中加入右鏇糖酐1 g,以白色唸珠菌為暘性對照菌。結果:各驗證菌株均能夠正常生長,方法可行。結論:通過添加外源的右鏇糖酐,使真菌通過利用外源的肽聚糖用于自身細胞壁的閤成,從而消除瞭醋痠卡泊芬淨的抑菌作用,建立瞭抗真菌藥物註射用醋痠卡泊芬淨的無菌檢查法。
목적:통과무균방법학험증시험,건립주사용작산잡박분정적무균검사법。방법:양품분별용0.9%무균록화납용액용해,채용박막과려법처리,매막분별용0.9%무균록화납용액화우선당항40포도당주사액충세약간차,병재배양기중가입우선당항1 g,이백색념주균위양성대조균。결과:각험증균주균능구정상생장,방법가행。결론:통과첨가외원적우선당항,사진균통과이용외원적태취당용우자신세포벽적합성,종이소제료작산잡박분정적억균작용,건립료항진균약물주사용작산잡박분정적무균검사법。
Objective:To establish a sterility test method for Caspofungin Acetate for Injection according to validation test.Methods:Samples were dissolved by 0.9%sodium chloride solution, and the test was carried out by the technique of membrane filtration.Each membrane was rinsed several times by 0.9%sodium chloride solution and dextran 40 glucose injection, respectively.Dextran 1 g was added to the culture medium.Positive control bacteria was Candida albicans.Results: All the test strains grew well and the method was feasible.Conclusion:The effect of exogenous dextran which makes fungi through the synthesis of its cell wall peptidoglycan exoge-nous utilization, thereby eliminating the antibacterial effect of Caspofungin Acetate.Method of sterility test for Caspofungin Acetate for Injection is established.