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目的对虾壳来源的医用几丁糖病原体灭活/去除工艺进行验证。方法根据生产所用原料虾壳确定其可能携带的病原体种类,选择蜡状芽孢杆菌芽孢、细小病毒(porcine parvovirus,PPV)和伪狂犬病病毒(pseudorabies virus,PRV)作为相关的指示病原体;依据《消毒技术规范》方法制备病原体溶液。对医用几丁糖的加工工艺进行分析,确定几丁质碱化反应和几丁糖除菌过滤工艺作为可能灭活/去除病原体的工艺,并进行病原体灭活/去除效果的验证。结果蜡状芽孢杆菌芽孢液经碱化反应处理的去除数值为8 184 cfu/mL,除菌过滤处理的去除数值为30 818 cfu/mL。PPV和PRV经碱化反应处理的平均灭活对数值分别为≥4.76 logTCID50/0.1 mL和≥6.67 logTCID50/0.1 mL,过滤处理的平均灭活对数值分别为2.25 logTCID50/0.1 mL和3.04 logTCID50/0.1 mL。几丁质碱化工艺可有效灭活/去除病原体,几丁糖除菌过滤能有效去除细菌,但不能完全有效灭活病毒。结论几丁质碱化工艺可作为医用几丁糖制备过程中灭活/去除病原体工艺,能有效保证产品的安全性。
Objective To verify the inactivation / removal of medical chitin pathogen from shrimp shell. Methods According to the shrimp shell used in the production, the species of pathogens that it might carry were identified. The selected pathogens Bacillus cereus, porcine parvovirus (PPV) and pseudorabies virus (PRV) Standard "method for the preparation of pathogen solution. The process of medical chitosan processing was analyzed to determine the chitin alkalization reaction and the chitosan sterilization filtration process as the possible inactivation / removal process of pathogens, and the verification of the inactivation / removal of pathogens. Results Bacillus cereus sp. By alkalization reaction removal value of 8 184 cfu / mL, sterilization filter removal value of 30 818 cfu / mL. The average inactivation logarithm values of PPV and PRV treated by alkalization were ≥4.76 log TCID50 / 0.1 mL and ≥6.67 log TCID50 / 0.1 mL respectively. The average inactivation logarithm of filtration treatment were 2.25 log TCID50 / 0.1 mL and 3.04 log TCID50 / 0.1 mL. Chitin alkalization process can effectively inactivate / remove pathogens, chitosan sterilization filter can effectively remove bacteria, but can not completely inactivate the virus. Conclusion The chitin alkalization process can be used as inactivation / removal of pathogens during the preparation of medical chitosan, which can effectively ensure the safety of the product.