摘要
目的对牛跟腱来源胶原蛋白海绵的病毒灭活/去除工艺进行验证。方法根据生产所用原料牛跟腱确定其可能病原体种类,选择水疱性口炎病毒(vesicular stomatitis virus,VSV)、小鼠脑脊髓炎病毒(theiler’s mouseencephalomyelitis virus,TEMV)、伪狂犬病毒(pseudorabies virus,PRV)和猴空泡病毒40(simian vacuolating virus 40,SV40)作为指示病毒体;依据《消毒技术规范》中的方法制备病毒悬液。对胶原蛋白海绵的加工工艺进行分析,确定胶原蛋白海绵以25 kGy60Co辐照处理作为可灭活/去除病毒的工艺,并测定半数细胞感染剂量(median tissue cultureinfective dose,TCID50),以病毒降低系数(处理前后样本平均检测值对数之差)对病毒灭活/去除效果进行验证。结果经辐照灭菌处理后,VSV、TEMV、PRV和SV40病毒降低系数分别为5.646、4.792、5.042、5.292 logTCID50/0.1 mL(logs)。各指示病毒的降低系数均>4 logs,表明25 kGy60Co辐照灭菌工艺能有效灭活/去除病毒。结论 25 kGy60Co辐照处理工艺可作为牛跟腱来源的胶原蛋白海绵制备过程中病毒灭活/去除工艺,能有效保证产品的安全性。
Objective To verify the technics of inactivating/removing virus in collagen sponge derived from bovine Achilles tendon. Methods Possible pathogen species were determined according to the raw material of bovine Achilles tendon used in production, then vesicular stomatitis virus （VSV）, theiler’s mouse encephalomyelitis virus （TEMV）, pseudorabies virus （PRV）, and simian vacuolating virus 40 （SV40） were selected as indicator virus. Virus suspension was prepared in accordance with Technical Standard for Disinfection. 60Co radiation 25 kGy of collagen sponge was determined as inactivating/removing virus process according to the analysis of the manufacture process, the virus inactivation/removal effect was verified by the measurement of median tissue culture infective dose （TCID50） and showed by virus reduction factor （sample average values of numerical difference before and after processing）. Results Reduction factors of VSV, TEMV, PRV, and SV40 after 60Co radiation 25 kGy were 5.646, 4.792, 5.042, and 5.292 logTCID50/0.1 mL （logs）, respectively. Reduction factor of each indicator virus was greater than 4 logs, showing that 60Co irradiation 25 kGy can effectively inactivate and remove viruses. Conclusion 60Co radiation 25 kGy of collagen sponge derived from bovine Achilles tendon can be used as the technics of inactivating/removing virus during the preparation process of collagen sponge to guarantee the safety of the product.
出处
《中国修复重建外科杂志》
CAS
CSCD
北大核心
2013年第7期885-888,共4页
Chinese Journal of Reparative and Reconstructive Surgery
关键词
胶原蛋白海绵
60Co
辐照灭菌
病毒灭活/去除工艺
牛跟腱
Collagen sponge ^60Co Radiation sterilization Virus inactivating/removing Bovine Achilles tendon
