USP-51抗菌效力测试.docVIP

USP-51抗菌效力测试

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anonsterileproductorcontrolthepresterilizationbioburdenofmultidoseformulationsduringmanufacturing.AntimicrobialpreservativesincompendialdosageformsmeettherequirementsforAddedSubstancesunderIngredientsandProcessesintheGeneralNotices.

抗菌防腐剂不应被作为在良好生产操作中的替代方式使用，或仅是用来减少一个有菌产品的微生物群数量，或是在生产时控制多剂量的微生物量。在剂量表里抗菌防腐剂与添加的要求必需符合规定。

Allusefulantimicrobialagentsaretoxicsubstances.Formaximumprotectionofpatients,theconcentrationofthepreservativeshowntobeeffectiveinthefinalpackagedproductshouldbebelowalevelthatmaybetoxictohumanbeings.Theconcentrationofanaddedantimicrobialpreservativecanbekeptataminimumiftheactiveingredientsoftheformulationpossessanintrinsicantimicrobialactivity.Antimicrobialeffectiveness,whetherinherentintheproductorwhetherproducedbecauseoftheadditionofanantimicrobialpreservative,mustbedemonstratedforallinjectionspackagedinmultiple-dosecontainersorforotherproductscontainingantimicrobialpreservatives.Antimicrobialeffectivenessmustbedemonstratedformultiple-dosetopicalandoraldosageformsandforotherdosageformssuchasophthalmic,otic,nasal,irrigation,anddialysisfluids(seePharmaceuticalDosageForms(1151).

所有有用的抗菌药剂都是有毒物质。为了最大的保护使用者，防腐剂的含量应被有效地显示在产品的最终包装上，并应会处在一个可能对人体有毒的水平线下。添加的抗菌防腐剂含量能够被保持在一个最小的浓度，如果配方的活性成分具有一个固定的抗菌力。抗菌的效力，不管是产品里固有的或者是生产中添加的抗菌防腐剂，都必须在所有注入包装的多剂量容器里或其它包含抗菌防腐剂的产品上显示。抗菌防腐剂必须被显示在多剂量和口头剂量型和给其它剂量型，如眼药，耳药，鼻药，冲洗的和透析液。(看PharmaceuticalDosageForms(a1151).

Thischapterprovidesteststodemonstratetheeffectivenessofantimicrobialprotection.Addedantimicrobialpreservativesmustbedeclaredonthelabel.Thetestsandcriteriaforeffectivenessapplytoaproductintheoriginal,unopenedcontainerinwhichitwasdistributedbythemanufacturer.

本章提供的测试用来显示抗菌保护的效力。添加的抗菌防腐