CAJ | 학술논문

目的：建立盐酸左氧氟沙星凝胶的微生物限度检查方法。方法加入钙离子(Ca2＋)中和喹诺酮类抗菌药物的抗菌活性，并与凝胶中的卡波姆形成不溶性沉淀，从而破坏凝胶的大分子溶液稳定性，结合薄膜过滤、平皿法等方法对盐酸左氧氟沙星凝胶的微生物限度检查方法进行验证实验。结果盐酸左氧氟沙星凝胶的真菌及酵母菌数测定采用平皿法，其回收率>70％；细菌数测定需采用中和、离心及薄膜过滤法，其回收率<70％，而控制菌检查采用中和、离心及薄膜过滤法。结论盐酸左氧氟沙星凝胶的真菌及酵母菌计数和控制菌检查采用上述不同方法准确可行。细菌计数采用该方法存在一定风险，需进一步进行风险评估。
목적：건립염산좌양불사성응효적미생물한도검사방법。방법가입개리자(Ca2＋)중화규낙동류항균약물적항균활성，병여응효중적잡파모형성불용성침정，종이파배응효적대분자용액은정성，결합박막과려、평명법등방법대염산좌양불사성응효적미생물한도검사방법진행험증실험。결과염산좌양불사성응효적진균급효모균수측정채용평명법，기회수솔>70％；세균수측정수채용중화、리심급박막과려법，기회수솔<70％，이공제균검사채용중화、리심급박막과려법。결론염산좌양불사성응효적진균급효모균계수화공제균검사채용상술불동방법준학가행。세균계수채용해방법존재일정풍험，수진일보진행풍험평고。
Objective To establish a microbial limit test for levofloxacin hydrochloride gel. Methods Ca2+ was added to neutralize the antibacterial activity of quinolone,and to form the insoluble precipitate by binding with carbomer, therefore destroying the stability of macromolecules in the gel. The microbial limit test for levofloxacin hydrochloride gel was confirmed combining with membrane filtration and plate methods. Results The normal plate counting was used in detecting the mold and yeast colony in the gel, the recovery was more than 70%.Simultaneously neutralization centrifugation and membrane filtration were used in bacterial count,with recovery less than 70%,and controlling bacteria test. Conclusion The method is accurate and practical for microbial limit test of levofloxacin hydrochloride gel, but is risky for bacterial counting and needs further risk assessment.