CAJ | 학술논문

目的：建立生物制品用内包材（中性硼硅玻璃管制注射剂瓶、药用卤化丁基橡胶塞和抗生素瓶用铝塑组合盖）微生物限度检查方法，并进行验证。方法采用薄膜过滤法检查上述3种内包材的微生物限度，并按照验证试验方法，在供试品中加入5种标准菌，测定其回收率。结果金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌和黑曲霉5种标准菌在上述3种内包材供试品溶液中的平均回收率均为70%～110%，符合公示的2015年版药典中要求的50%～200%的标准。结论薄膜过滤法适用于上述3种内包材的微生物限度检验。
목적：건립생물제품용내포재（중성붕규파리관제주사제병、약용서화정기상효새화항생소병용려소조합개）미생물한도검사방법，병진행험증。방법채용박막과려법검사상술3충내포재적미생물한도，병안조험증시험방법，재공시품중가입5충표준균，측정기회수솔。결과금황색포도구균、동록가단포균、고초아포간균、백색념주균화흑곡매5충표준균재상술3충내포재공시품용액중적평균회수솔균위70%～110%，부합공시적2015년판약전중요구적50%～200%적표준。결론박막과려법괄용우상술3충내포재적미생물한도검험。
ObjectiveTo develop and verify a method for microbial limit test on inner packing material of biologics.MethodsThe microbial limits of 3 kinds of inner packing material of biologics, i.e. vial, rubber closures and aluminum-plastic combination cover, were tested by membrane filtration method, and the developed method was verified by adding standard microorganisms with known counts into the test samples and determining their recovery rates.Results All the recovery rates of standard Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans and Aspergillus niger in the test samples of 3 kinds of inner packing material were 70%~110%, which met the requirements(50%~200%) in Chinese Pharmacopoeia(Draft of the 2015 edition).ConclusionThe developed membrane filtration method was suitable for above-mentioned 3 kinds of inner packing material.