目的: 验证运用有机溶剂/去污剂（S/D）处理法和干热法对C1酯酶抑制剂（C1-INH）中病毒灭活效果。方法: 采用S/D处理法灭活含S/D样品中添加的辛德毕斯病毒,噬斑滴定法检测灭活前后的病毒滴度,干热法灭活脑心肌炎病毒（EMCV）和猪细小病毒（PPV）,细胞病变法检测灭活前后的病毒滴度。结果: 经S/D处理法灭活后,3批含S/D样品中辛德毕斯病毒降低量分别为>4.35 lgPFU · mL-1、>4.51 lgPFU · mL-1、>4.64 lgPFU · mL-1。经干热法灭活后,3批不含S/D样品中EMCV降低量分别为≥5.38 lgTCID50/0.1 mL、≥5.12 lgTCID50/0.1 mL、≥5.25 lgTCID50/0.1 mL,PPV降低量分别为4.57 lgTCID50/0.1 mL、4.18 lgTCID50/0.1 mL、4.68 lgTCID50/0.1 mL。结论: 通过对指示病毒的验证效果评估,证明S/D法和干热法对C1-INH中的辛德毕斯病毒、EMCV和PPV均有较好的灭活效果。
Abstract
Objective: To confirm the validity of solvent/detergent (S/D) treatment and dry heating for inactivation of virus in C1 esterase inhibitor (C1-INH). Methods: The Sindbis virus in samples with S/D was inactivated by the S/D method, and the virus titer before and after inactivation was detected using the plaque assay. Dry heating method was used to inactivate encephalomyocarditis virus (EMCV) and porcine parvovirus (PPV), and cytopathic assay was used to detect the virus titer before and after inactivation. Results: After inactivation by the S/D method, the reductions of Sindbis virus in three batches of smaples with S/D were > 4.35 lgPFU · mL-1, > 4.51 lgPFU · mL-1, > 4.64 lgPFU · mL-1, respectively. After dry heating, the reductions of EMCV in three batches of samples without S/D were ≥5.38 lgTCID50/0.1 mL、≥5.12 lgTCID50/0.1 mL、≥5.25 lgTCID50/0.1 mL, respectively, and the reductions of PPV in three batches of samples without S/D were 4.57 lgTCID50/0.1 mL、4.18 lgTCID50/0.1 mL、4.68 lgTCID50/0.1 mL, respectively. Conclusion: With evaluation on the inactivation capability of the indicator viruses, it is proved that the S/D treatment and dry heating has good inactivation and removal effect on the virus in C1-INH.
关键词
有机溶剂/去污剂处理法 /
干热法 /
C1酯酶抑制剂 /
病毒灭活 /
辛德毕斯病毒 /
脑心肌炎病毒 /
猪细小病毒
{{custom_keyword}} /
Key words
S/D treatment /
dry heating /
C1 esterase inhibitor /
virus inactivation /
Sindbis virus /
encephalomyocarditis virus /
porcine parvovirus
{{custom_keyword}} /
中图分类号：
R917
{{custom_clc.code}}
({{custom_clc.text}})
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
[1] BOWEN T, CICARDI M, FARKAS H, et al.2010 international consensus algorithm for the diagnosis, therapy and management of hereditary angioedema[J]. Allergy Asthma Clin Immunol, 2010, 6(1): 24
[2] CRAIG T, AYGÖREN-PÜRSÜN E, BORK K, et al. WAO guideline for the management of hereditary angioedema[J]. World Allergy Organ J, 2012, 5(12): 182
[3] AZZAM R, BOUTROS J, IRANI C.Hereditary angioedema: a literature review and national management guidelines[J]. J Med Liban, 2015, 63(2): 97
[4] CABALLERO T, FARKAS H, BOUILLET L, et al.International consensus and practical guidelines on the gynecologic and obstetric management of female patients with hereditary angioedema caused by C1 inhibitor deficiency[J]. J Allergy Clin Immunol, 2012, 129(2): 308
[5] GRANT JA, WHITE MV, LI HH, et al.Preprocedural administration of nanofiltered C1 esterase inhibitor to prevent hereditary angioedema attacks[J]. Allergy Asthma Proc, 2012, 33(4): 348
[6] RIEDL MA, HUREWITZ DS, LEVY R, et al.Nanofiltered C1 esterase inhibitor (human) for the treatment of acute attacks of hereditary angioedema: an open-label trial[J]. Ann Allergy Asthma Immunol, 2012, 108(1): 49
[7] SINGER M, JONES AM Bench-to-bedside review: the role of C1-esterase inhibitor in sepsis and other critical illnesses[J]. Crit Care, 2011, 15(1): 203
[8] 国家药品监督管理局药品审评中心. 血液制品去除灭活病毒技术方法及验证指导原则[S/OL]. (2008-09-04)[2024-11-19]. https://www.cde.org.cn/zdyz/domesticinfopage?zdyzIdCODE=1df43aa707869a9c8bc11afe1ed48ff1
CENTER FOR DRUG EVALUATION. Guidelines for Methods and Validation of Virus Removal/inactivation from Blood Product[S/OL]. (2008-09-04)[2024-11-19]. https://www.cde.org.cn/zdyz/domesticinfopage?zdyzIdCODE=1df43aa707869a9c8bc11afe1ed48ff1
[9] WHO. Guidelines on Viral Inactivation and Removal Procedures Intended to Assure the Viral Safety of Human Blood Plasma Products[S/OL]. (2009-07-06)[2024-11-19]. https://www.who.int/bloodproducts/publications/WHO TRS 924 A4.pdf
[10] NISHIZAWA T, OKAMOTO H, KONISHI K, et al.A novel DNA virus (TTV) associated with elevated transaminase levels in posttransfusion hepatitis of unknown etiology[J]. Biochem Biophys Res Commun, 1997, 241(1): 92
[11] 卜凤荣,于军,宿艳笋. 血浆制品中人细小病毒B19的灭活/去除研究进展[J]. 国际生物制品学杂志,2009(6): 320
BU FY, YU J, SU YS.The progress in research of the inactivation/removal of human parvovirus B19 in plasma-derived products[J]. Int J Biol, 2009(6): 320
[12] 张延莹,李宏昊,姜燕. 血液制品灭活及去除病毒工艺[J]. 中国生化药物杂志,2002,23(4): 207
ZHANG YY, LI HH, JIANG Y.Review of processing about inactivation and removal of virus from blood products[J]. Chin J Biochem Pharm, 2002, 23(4): 207
[13] KIM IS, CHOI YW, KANG Y, et al.Dry-heat treatment process for enhancing viral safety of an antihemophilic factor Ⅷ concentrate prepared from human plasma[J]. J Microbiol Biotechnol, 2008, 18(5): 997
[14] 杨立宏,岳广智,徐宏山,等. 终端干热法灭活凝血因子类制品中细小病毒的工艺验证[J]. 中国生物制品学杂志,2010,23(9): 4
YANG LH, YUE GZ, XU HS.Validation of procedure for inactivation of parvovirus in coagulation factor products by terminal dry heating[J]. Chin J Biol, 2010, 23(9): 4
[15] PRIKHOD’KO GG. Dry-heat sensitivity of human B19 and porcine parvoviruses[J]. Transfusion, 2005, 45(10): 1692
[16] ROBERTS PL, EL HANA C, SALDANA J.Inactivation of parvovirus B19 and model viruses in factor Ⅷ by dry heat treatment at 80 degrees C[J]. Transfusion, 2006, 46(9): 1648
{{custom_fnGroup.title_cn}}
脚注
{{custom_fn.content}}
PDF(1574 KB)
