静脉滴注用抗生素粉针剂中不溶性微粒考察

Determination of particulate matter after reconstituting antibioties in NS by Coulter counter

目的 :考察复配抗生素粉针后静脉注射液中的不溶性微粒变化。方法 :将 2 8个厂家产效期内青霉素、氨苄西林、哌拉西林、阿洛西林、头孢拉定、头孢唑啉、头孢呋辛、头孢噻肟、头孢曲松、头孢他啶、头孢哌酮和含 β 内酰胺酶抑制剂类等 62种粉针剂溶配于 10 0ml氯化钠注射液中 ,利用库尔特计数仪计数直径大于 2 .0 ,5 .0 ,10 .0 ,2 5 .0 μm的粒数 ,得每 1ml复配液所含抗生素粉针的不溶性微粒数。结果 :复配后有 4 6个批号的制剂不含 2 5 .0 μm以上的粒子 ,占样品总数的 74 .19% ,6批制剂不含10 .0 μm以上的微粒 ,1批制剂不含 5 .0 μm以上的粒子 ,分别占 9.68%和 1.61% ,含 2 .0 μm以上粒子数 <10 0 0个 /ml的有 5批 ,占 8.0 6%。结论 :各样品基本符合美国药典注射用抗生素粉针剂不溶性微粒的限度要求 ,但不同厂家、来源和批号的产品差距很大。

OBJECTIVE :Toevaluatethequalityofseveralsterileantibioticsintermsoftheparticulatematterafterreconstituted inNS .METHODS :62batchesofantibiotics ,whichincludedpenicillins,cephalosporinsandβ lactamaseinhibitorsmanufacturedby 2 8 factories,werereconstitutedinNS .Theparticulatematterwithdiameterslargerthan 2 .0 ,5 .0 ,10 .0and 2 5 .0 μmwererecordedby Coultercounter.RESULTS :Itwasfoundthatthebatchesofparticulatematterwiththediameterlessthan 2 5 .0 ,10 .0and 5 .0 μma mongthe 62batchesofdifferentreconstitutingantibioticswere 4 6( 74 .19% ) ,6( 9.68% )and 1( 1.61% ) ,respectively .Thecontam natedparticulatewithdiameterlargerthan 2 .0 μmwerefoundlessthan 10 0 0permilliliteronlyin 5 products .CONCLUSION :It showedthattheparticulatematterofthesterileantibioticsevaluatedherecompliedwiththelimitationofUSPXXⅢ ,thoughthere weredifferecesinthoseproductsfromdifferentbatchesand/ormanufacturers.