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Article(id=1239250702447472862, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1239250701583446236, articleNumber=null, orderNo=null, doi=10.16155/j.0254-1793.2024.04.13, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1706630400000, receivedDateStr=2024-01-31, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1773389991627, onlineDateStr=2026-03-13, pubDate=1714406400000, pubDateStr=2024-04-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773389991627, onlineIssueDateStr=2026-03-13, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773389991627, creator=13701087609, updateTime=1773389991627, updator=13701087609, issue=Issue{id=1239250701583446236, tenantId=1146029695717560320, journalId=1205117023404326918, year='2024', volume='44', issue='4', pageStart='553', pageEnd='736', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773389991422, creator=13701087609, updateTime=1773390513217, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1239252890213209050, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1239250701583446236, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1239252890213209051, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1239250701583446236, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=663, endPage=670, ext={EN=ArticleExt(id=1239250702665576674, articleId=1239250702447472862, tenantId=1146029695717560320, journalId=1205117023404326918, language=EN, title=Preparation of the candidate first Chinese national standard for oncolytic activity assay of herpes simplex virus type 1*, columnId=1206272757852074373, journalTitle=Chinese Journal of Pharmaceutical Analysis, columnName=Safety Monitoring, runingTitle=null, highlight=null, articleAbstract=
Objective:

To establish the first national standard for oncolytic activity assay of herpes simplex virus type 1(HSV-1).

Methods:

According to the requirements in Chinese Pharmacopoeia(Volume Ⅲ, 2020 edition), the liquid and freeze-dried standard for oncolytic activity of HSV-1 were prepared and tested, of which the stability were evaluated by thermal acceleration test. The oncolytic activity of the standard was calibrated collaboratively by U-2 OS cells/CCK-8 method in 3 laboratories. The liquid standard was compared with the freeze-dried standard, and the more suitable one was selected as the national standard.

Results:

The prepared standard substance was all qualified, among which the moisture content of the freeze-dried standard was 1.09% and the dispensing accuracy was 0.15%. The results of stability test were calculated by Arrhenius formula. It was preliminarily predicted that it would take 7.7 years for the oncolytic activity of liquid standard to decrease by 10% at -70 ℃, and it would take 6.1×105 years for the oncolytic activity of lyophilized standard to decrease by 10% at -70 ℃. Compared with liquid standard, the stability of lyophilized standard was greatly improved. Twenty-one times of collaborative calibration tests by 3 laboratories showed that the oncolytic activity liquid standard was 7.08×104 U·mL-1 and the oncolytic activity liquid standard was 1.82×104 U·vial-1. After lyophilized, the oncolytic activity of the bulk of HSV-1 standard decreased from 7.08×104 U·mL-1 to 3.03×104 U·mL-1. However, the good S-shaped dose-response curve still appeared after 100 times of pre-dilution, which did not affect the requirements of its use as a standard. When the liquid standard was used as the sample and the freeze-dried standard was used as the standard for calibration, the geometric coefficient of variation (GCV) of the results of the 3 laboratories decreased from 64.4% to 29.2%, and the precision of the experiment was greatly improved.

Conclusion:

The batch of freeze-dried HSV-1 standards for oncolytic activity assay meets the relavant requirements, and is more suitable for use as a national standard than liquid standards. Its oncolytic activity is assigned a value of 1.82×104 U·vial-1.

, correspAuthors=Cheng-gang LIANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=Xi QIN, Jin-pan HU, Yong-hong LI, Xin-chang SHI, You-xue DING, Hua BI, Chun-mei HAN, Hong-mei ZHENG, Chun-ming RAO, Cheng-gang LIANG), CN=ArticleExt(id=1239250703307305199, articleId=1239250702447472862, tenantId=1146029695717560320, journalId=1205117023404326918, language=CN, title=首批1型单纯疱疹病毒溶瘤活性测定国家候选标准品的研制*, columnId=1206272758036623764, journalTitle=药物分析杂志, columnName=安全监测, runingTitle=null, highlight=null, articleAbstract=
目的：

研制首批1型单纯疱疹病毒(herpes simplex virus 1，HSV-1)溶瘤活性测定国家标准品。

方法：

按2020年版《中华人民共和国药典》三部相关要求，分别进行HSV-1溶瘤活性测定液体标准品和冻干标准品的制备和质量检测，并使用热加速试验进行稳定性考察，以U-2 OS细胞/CCK-8法分别在3家实验室对标准品的溶瘤活性进行协作标定。对比研究液体标准品和冻干标准品，选择其中更为适用的1种作为国家标准品。

结果：

制备的2种HSV-1溶瘤活性测定标准品的质量检测结果均符合要求，其中冻干标准品水分含量为1.09%，分装精度为0.15%。稳定性试验结果用阿伦尼乌斯公式计算，初步预测液体标准品溶瘤活性在-70 ℃下降低10%需7.7年；冻干标准品溶瘤活性在-70 ℃下降低10%需6.1×105年，其稳定性得到很大提高。3个实验室协作标定进行了共21次测定，液体标准品的溶瘤活性值几何均数为7.08×104 U·mL-1，冻干标准品的溶瘤活性值几何均数为1.82×104 U·支-1。HSV-1标准品原液在冻干后溶瘤活性由7.08×104 U·mL-1下降至3.03×104 U·mL-1，但因其溶瘤活性在预稀释100倍后仍然出现良好的S型量效关系曲线，并不影响它作为标准品使用的要求。将液体标准品作为样品，用冻干标准品作为标准品进行校准后，3家实验室结果的几何变异系数(GCV)由64.4%下降到29.2%，实验的精密度得到较大提高。

结论：

该批HSV-1溶瘤活性测定冻干标准品各项指标均符合相关要求，与液体标准品相比更适合作为国家标准品使用，其溶瘤活性赋值为1.82×104 U·支-1。

, correspAuthors=梁成罡, authorNote=null, correspAuthorsNote=
** Tel：(010)67095380；E-mail：
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秦玺　Tel：(010)67095684；E-mail：

胡金盼　Tel：(010)67095359；E-mail：

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秦玺　Tel：(010)67095684；E-mail：

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Hum Gene Ther，2010，21(10)：1273, articleTitle=Characterization of a recombinant adeno-associated virus type 2 reference standard material, refAbstract=null), Reference(id=1239250715294626592, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, doi=null, pmid=null, pmcid=null, year=2014, volume=25, issue=11, pageStart=977, pageEnd=null, url=null, language=null, rfNumber=[14], rfOrder=16, authorNames=AYUSO E, BLOUIN V, LOCK M, journalName=Hum Gene Ther, refType=null, unstructuredReference=AYUSO E，BLOUIN V，LOCK M，et al. Manufacturing and characterization of a recombinant adeno-associated virus type 8 reference standard material[J]. Hum Gene Ther，2014，25(11)：977, articleTitle=Manufacturing and characterization of a recombinant adeno-associated virus type 8 reference standard material, refAbstract=null), Reference(id=1239250715386901285, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, doi=null, pmid=null, pmcid=null, year=2015, volume=89, issue=9, pageStart=5002, pageEnd=null, url=null, language=null, rfNumber=[15], rfOrder=17, authorNames=KOGANTI S, CLARK C, ZHI J, journalName=J Virol, refType=null, unstructuredReference=KOGANTI S，CLARK C，ZHI J，et al. Cellular STAT3 functions via PCBP2 to restrain Epstein-Barr Virus lytic activation in B lymphocytes[J]. J Virol，2015，89(9)：5002, articleTitle=Cellular STAT3 functions via PCBP2 to restrain Epstein-Barr Virus lytic activation in B lymphocytes, refAbstract=null)], funds=[Fund(id=1239250712270533311, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, awardId=2018ZX09733002-005, language=CN, fundingSource=*国家科技重大专项课题资助项目(2018ZX09733002-005), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1239250703563157751, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, xref=1., ext=[AuthorCompanyExt(id=1239250703571546360, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, companyId=1239250703563157751, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.National Institutes for Food and Drug Control, Beijing 100050, China), AuthorCompanyExt(id=1239250703579934969, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, companyId=1239250703563157751, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.中国食品药品检定研究院，北京 100050)]), AuthorCompany(id=1239250705018581247, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, xref=2., ext=[AuthorCompanyExt(id=1239250705026969856, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, companyId=1239250705018581247, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.School of Public Health and School of Life Sciences, Xiamen University, Xiamen 361005, China), AuthorCompanyExt(id=1239250705031164161, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, companyId=1239250705018581247, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.厦门大学公共卫生和生命科学学院，厦门 361005)])], figs=[ArticleFig(id=1239250710559257168, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, language=EN, label=Fig.1, caption=Comparison of three-month thermal stability between freeze-dried standard and liquid standard of HSV-1, figureFileSmall=qWVTox0dN5V91b/ShUuEqg==, figureFileBig=SKSzJqOr2OlnMxMxYHhQSA==, tableContent=null), ArticleFig(id=1239250710630560341, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, language=CN, label=图1, caption=1型单纯疱疹病毒冻干标准品和液体标准品3个月热稳定性比较, figureFileSmall=qWVTox0dN5V91b/ShUuEqg==, figureFileBig=SKSzJqOr2OlnMxMxYHhQSA==, tableContent=null), ArticleFig(id=1239250710819304037, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, language=EN, label=Tab.1, caption=

Testing results of HSV-1 bulk

, figureFileSmall=null, figureFileBig=null, tableContent=
检验项目
(test item) 		检验方法
(test method)		标准规定
(standard code)		检验结果
(test result)
鉴别试验(identification)限制性酶切图谱法(restriction enzyme digestion atlas method)与对照品一致(corresponding to reference substance)符合规定(meet the requirement)
QPCRICP 0、ICP 34.5无扩增，APD1扩增(ICP 0、ICP 34.5 were not amplified，APD1 was amplified)符合规定(meet the requirement)
细胞中和法(cell neutralization)无细胞病变(acellular lesion)符合规定(meet the requirement)
无菌检查(sterility test)薄膜过滤法(membrane-filter procedure)14 d内无菌生长(sterile growth within 14 d)符合规定(meet the requirement)
感染滴度(infection titer)噬斑法(plaque methods)≥1.0×107 PFU·mL-11.88×107 PFU·mL-1
溶瘤活性(oncolytic activity)U-2 OS细胞/CCK-8法(U-2 OS cells/CCK-8 method)≥1.0×104 U·mL-15.86×104 U·mL-1
选择性增殖活性(selective proliferative activity)细胞培养法(cell culture method)≥1002.14×105
), ArticleFig(id=1239250710949327468, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, language=CN, label=表1, caption=

1型单纯疱疹病毒原液相关检测结果

, figureFileSmall=null, figureFileBig=null, tableContent=
检验项目
(test item) 		检验方法
(test method)		标准规定
(standard code)		检验结果
(test result)
鉴别试验(identification)限制性酶切图谱法(restriction enzyme digestion atlas method)与对照品一致(corresponding to reference substance)符合规定(meet the requirement)
QPCRICP 0、ICP 34.5无扩增，APD1扩增(ICP 0、ICP 34.5 were not amplified，APD1 was amplified)符合规定(meet the requirement)
细胞中和法(cell neutralization)无细胞病变(acellular lesion)符合规定(meet the requirement)
无菌检查(sterility test)薄膜过滤法(membrane-filter procedure)14 d内无菌生长(sterile growth within 14 d)符合规定(meet the requirement)
感染滴度(infection titer)噬斑法(plaque methods)≥1.0×107 PFU·mL-11.88×107 PFU·mL-1
溶瘤活性(oncolytic activity)U-2 OS细胞/CCK-8法(U-2 OS cells/CCK-8 method)≥1.0×104 U·mL-15.86×104 U·mL-1
选择性增殖活性(selective proliferative activity)细胞培养法(cell culture method)≥1002.14×105
), ArticleFig(id=1239250711049990766, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, language=EN, label=Tab.2, caption=

Testing results of HSV-1 freeze-dried standard

, figureFileSmall=null, figureFileBig=null, tableContent=
检验项目
(test item)		检验方法
(test method)		标准规定
(standard code)		检验结果
(test result)
溶瘤活性(oncolytic activity)U-2 OS细胞/CCK-8法(U-2 OS cells/CCK-8 method)≥1.0×104 U·支-1(≥1.0×104 U·vial-1)1.5×104 U·支-1(1.5×104 U·vial-1)
分装精度(dispensing accuracy)抽样称重法(sampling weighting method)≤1%0.15%
水分(moisture content)库伦滴定法(coulomb titration)≤1.5%1.09%
无菌检查(sterility test)薄膜过滤(membrane-filter method)14 d内无菌生长(sterile growth within 14 d)符合规定(meet the requirement)
感染滴度(infection titer)噬斑法(plaque methods)≥2.0×106 PFU·mL-11.55×107 PFU·mL-1
), ArticleFig(id=1239250711142265463, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, language=CN, label=表2, caption=

1型单纯疱疹病毒冻干标准品相关检测结果

, figureFileSmall=null, figureFileBig=null, tableContent=
检验项目
(test item)		检验方法
(test method)		标准规定
(standard code)		检验结果
(test result)
溶瘤活性(oncolytic activity)U-2 OS细胞/CCK-8法(U-2 OS cells/CCK-8 method)≥1.0×104 U·支-1(≥1.0×104 U·vial-1)1.5×104 U·支-1(1.5×104 U·vial-1)
分装精度(dispensing accuracy)抽样称重法(sampling weighting method)≤1%0.15%
水分(moisture content)库伦滴定法(coulomb titration)≤1.5%1.09%
无菌检查(sterility test)薄膜过滤(membrane-filter method)14 d内无菌生长(sterile growth within 14 d)符合规定(meet the requirement)
感染滴度(infection titer)噬斑法(plaque methods)≥2.0×106 PFU·mL-11.55×107 PFU·mL-1
), ArticleFig(id=1239250711255511675, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, language=EN, label=Tab.3, caption=

Stability testing results of lyophilized standard

, figureFileSmall=null, figureFileBig=null, tableContent=
温度
(temperature)/℃		与-80 ℃溶瘤活性比
(oncolytic activity ratio compared with -80 ℃)/%
1个月
(1 month)		3个月
(3 months)		9个月
(9 months)
-2092.7110.993.6
491.792.274.1
2546.418.914.5
376.51.81.3
), ArticleFig(id=1239250711351980673, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, language=CN, label=表3, caption=

1型单纯疱疹病毒冻干标准品稳定性检测结果

, figureFileSmall=null, figureFileBig=null, tableContent=
温度
(temperature)/℃		与-80 ℃溶瘤活性比
(oncolytic activity ratio compared with -80 ℃)/%
1个月
(1 month)		3个月
(3 months)		9个月
(9 months)
-2092.7110.993.6
491.792.274.1
2546.418.914.5
376.51.81.3
), ArticleFig(id=1239250711486198412, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, language=EN, label=Tab 4, caption=

Stability testing results of HSV-1 liquid standard

, figureFileSmall=null, figureFileBig=null, tableContent=
温度
(temperature)/℃		与-80 ℃溶瘤活性比
(oncolytic activity ratio compared with -80 ℃)/%
1个月
(1 month)		3个月
(3 months)		9个月
(9 months)
-4098.291.478.1
-2072.870.021.4
460.2344.9
255.900
), ArticleFig(id=1239250711570084497, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, language=CN, label=表4, caption=

1型单纯疱疹病毒液体标准品稳定性检测结果

, figureFileSmall=null, figureFileBig=null, tableContent=
温度
(temperature)/℃		与-80 ℃溶瘤活性比
(oncolytic activity ratio compared with -80 ℃)/%
1个月
(1 month)		3个月
(3 months)		9个月
(9 months)
-4098.291.478.1
-2072.870.021.4
460.2344.9
255.900
), ArticleFig(id=1239250711674942104, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, language=EN, label=Tab.5, caption=

Collaborative calibration results of HSV-1 liquid standard

, figureFileSmall=null, figureFileBig=null, tableContent=
试验次数
(number of test)		实验室1(lab 1)实验室2(lab 2)实验室3(lab 3)
实测值
(measured value)/(U·mL-1)		lg转换值
(lg conversion value)		实测值
(measured value)/(U·mL-1)		lg转换值
(lg conversion value)		实测值
(measured value)/(U·mL-1)		lg转换值
(lg conversion value)
193 9004.9751 0344.7149 3004.69
2164 0005.2150 5574.7070 1004.85
3176 0005.2545 2204.6654 4004.74
4152 0005.1864 1154.8156 0004.75
5130 0005.1151 3764.7137 3004.57
6137 0005.1456 0844.7555 4004.74
7114 0005.0646 2254.6644 3004.65
均值(mean value)138 1295.1352 0874.7152 4004.71
SD28 5820.096 4050.0510 3480.09
RSD/%20.71.812.31.119.81.8
), ArticleFig(id=1239250711754633887, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, language=CN, label=表5, caption=

1型单纯疱疹病毒液体标准品协作标定结果

, figureFileSmall=null, figureFileBig=null, tableContent=
试验次数
(number of test)		实验室1(lab 1)实验室2(lab 2)实验室3(lab 3)
实测值
(measured value)/(U·mL-1)		lg转换值
(lg conversion value)		实测值
(measured value)/(U·mL-1)		lg转换值
(lg conversion value)		实测值
(measured value)/(U·mL-1)		lg转换值
(lg conversion value)
193 9004.9751 0344.7149 3004.69
2164 0005.2150 5574.7070 1004.85
3176 0005.2545 2204.6654 4004.74
4152 0005.1864 1154.8156 0004.75
5130 0005.1151 3764.7137 3004.57
6137 0005.1456 0844.7555 4004.74
7114 0005.0646 2254.6644 3004.65
均值(mean value)138 1295.1352 0874.7152 4004.71
SD28 5820.096 4050.0510 3480.09
RSD/%20.71.812.31.119.81.8
), ArticleFig(id=1239250711867880099, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, language=EN, label=Tab.6, caption=

Collaborative calibration results of HSV-1 freeze-dried standard

, figureFileSmall=null, figureFileBig=null, tableContent=
试验次数
(number of test)		实验室1(lab 1)实验室2(lab 2)实验室3(lab 3)
实测值
(measured value)/(U·vial-1)		lg转换值
(lg conversion value)		实测值
(measured value)/(U·vial -1)		lg转换值
(lg conversion value)		实测值
(measured value)/(U·vial -1)		lg转换值
(lg conversion value)
128 7004.4616 7324.2213 8004.14
238 6004.5913 2054.1215 6004.19
319 9004.3014 7114.1712 0004.08
430 0004.4822 9244.3615 5004.19
539 8004.6016 5254.2212 4004.09
620 5004.3117 0984.238 8303.95
731 2004.4918 1794.2612 7004.10
均值(mean value)29 8144.4617 0534.2212 9764.14
SD7 8010.123 0660.092 3270.05
RSD/%26.22.718.02.117.91.3
), ArticleFig(id=1239250711951766187, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, language=CN, label=表6, caption=

1型单纯疱疹病毒冻干标准品协作标定结果

, figureFileSmall=null, figureFileBig=null, tableContent=
试验次数
(number of test)		实验室1(lab 1)实验室2(lab 2)实验室3(lab 3)
实测值
(measured value)/(U·vial-1)		lg转换值
(lg conversion value)		实测值
(measured value)/(U·vial -1)		lg转换值
(lg conversion value)		实测值
(measured value)/(U·vial -1)		lg转换值
(lg conversion value)
128 7004.4616 7324.2213 8004.14
238 6004.5913 2054.1215 6004.19
319 9004.3014 7114.1712 0004.08
430 0004.4822 9244.3615 5004.19
539 8004.6016 5254.2212 4004.09
620 5004.3117 0984.238 8303.95
731 2004.4918 1794.2612 7004.10
均值(mean value)29 8144.4617 0534.2212 9764.14
SD7 8010.123 0660.092 3270.05
RSD/%26.22.718.02.117.91.3
), ArticleFig(id=1239250712065012401, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, language=EN, label=Tab.7, caption=

Testing results of HSV-1 liquid standard

, figureFileSmall=null, figureFileBig=null, tableContent=
实验室
(lab)		试验次数
(number of test)		未校准(no calibration)校准后(after calibration)
实测值
(measured value)/(U·mL-1)		lg转化值
(lg conversion value)		实测值
(measured value)/(U·mL-1)		lg转化值
(lg conversion value)
1193 9004.9787 2104.94
2164 0005.2190 7674.96
3176 0005.25120 4805.08
4130 0005.1179 3634.90
5152 0005.1867 2774.83
6137 0005.14109 9005.04
7114 0005.0690 2264.96
2851 0344.7156 7884.75
950 5574.7083 9454.92
1045 2204.6672 1234.86
1164 1154.8166 3214.82
1251 3764.7155 0214.74
1356 0844.75111 8375.05
1446 2254.6650 0494.70
31549 3004.6969 3194.84
1670 1004.8583 9454.92
1754 4004.7472 1234.86
1856 0004.7566 3214.82
1937 3004.5755 0214.74
2055 4004.74111 8375.05
2144 3004.6564 0654.81
统计学分析均值(mean value)80 8724.8579 2354.89
(statistical analysis)SD44 84020 692
RSD/%55.4526.12
几何平均数(geometric mean)70 79577 625
GSD0.220.11
GCV/%64.4329.16
), ArticleFig(id=1239250712157287100, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239250702447472862, language=CN, label=表7, caption=

1型单纯疱疹病毒液体标准品的检测结果

, figureFileSmall=null, figureFileBig=null, tableContent=
实验室
(lab)		试验次数
(number of test)		未校准(no calibration)校准后(after calibration)
实测值
(measured value)/(U·mL-1)		lg转化值
(lg conversion value)		实测值
(measured value)/(U·mL-1)		lg转化值
(lg conversion value)
1193 9004.9787 2104.94
2164 0005.2190 7674.96
3176 0005.25120 4805.08
4130 0005.1179 3634.90
5152 0005.1867 2774.83
6137 0005.14109 9005.04
7114 0005.0690 2264.96
2851 0344.7156 7884.75
950 5574.7083 9454.92
1045 2204.6672 1234.86
1164 1154.8166 3214.82
1251 3764.7155 0214.74
1356 0844.75111 8375.05
1446 2254.6650 0494.70
31549 3004.6969 3194.84
1670 1004.8583 9454.92
1754 4004.7472 1234.86
1856 0004.7566 3214.82
1937 3004.5755 0214.74
2055 4004.74111 8375.05
2144 3004.6564 0654.81
统计学分析均值(mean value)80 8724.8579 2354.89
(statistical analysis)SD44 84020 692
RSD/%55.4526.12
几何平均数(geometric mean)70 79577 625
GSD0.220.11
GCV/%64.4329.16
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首批1型单纯疱疹病毒溶瘤活性测定国家候选标准品的研制*
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秦玺 1 , 胡金盼 2 , 李永红 1 , 史新昌 1 , 丁有学 1 , 毕华 1 , 韩春梅 1 , 郑红梅 1 , 饶春明 1 , 梁成罡 1, **
药物分析杂志 | 安全监测 2024,44(4): 663-670
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药物分析杂志 | 安全监测 2024, 44(4): 663-670
首批1型单纯疱疹病毒溶瘤活性测定国家候选标准品的研制*
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秦玺1 , 胡金盼2 , 李永红1, 史新昌1, 丁有学1, 毕华1, 韩春梅1, 郑红梅1, 饶春明1, 梁成罡1, **
作者信息
  • 1.中国食品药品检定研究院，北京 100050
  • 2.厦门大学公共卫生和生命科学学院，厦门 361005

    • 秦玺　Tel：(010)67095684；E-mail：

    胡金盼　Tel：(010)67095359；E-mail：

通讯作者:

** Tel：(010)67095380；E-mail：
Preparation of the candidate first Chinese national standard for oncolytic activity assay of herpes simplex virus type 1*
Xi QIN1 , Jin-pan HU2 , Yong-hong LI1, Xin-chang SHI1, You-xue DING1, Hua BI1, Chun-mei HAN1, Hong-mei ZHENG1, Chun-ming RAO1, Cheng-gang LIANG1, **
Affiliations
  • 1.National Institutes for Food and Drug Control, Beijing 100050, China
  • 2.School of Public Health and School of Life Sciences, Xiamen University, Xiamen 361005, China
出版时间: 2024-04-30 doi: 10.16155/j.0254-1793.2024.04.13
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摘要
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目的：

研制首批1型单纯疱疹病毒(herpes simplex virus 1，HSV-1)溶瘤活性测定国家标准品。

方法：

按2020年版《中华人民共和国药典》三部相关要求，分别进行HSV-1溶瘤活性测定液体标准品和冻干标准品的制备和质量检测，并使用热加速试验进行稳定性考察，以U-2 OS细胞/CCK-8法分别在3家实验室对标准品的溶瘤活性进行协作标定。对比研究液体标准品和冻干标准品，选择其中更为适用的1种作为国家标准品。

结果：

制备的2种HSV-1溶瘤活性测定标准品的质量检测结果均符合要求，其中冻干标准品水分含量为1.09%，分装精度为0.15%。稳定性试验结果用阿伦尼乌斯公式计算，初步预测液体标准品溶瘤活性在-70 ℃下降低10%需7.7年；冻干标准品溶瘤活性在-70 ℃下降低10%需6.1×105年，其稳定性得到很大提高。3个实验室协作标定进行了共21次测定，液体标准品的溶瘤活性值几何均数为7.08×104 U·mL-1，冻干标准品的溶瘤活性值几何均数为1.82×104 U·支-1。HSV-1标准品原液在冻干后溶瘤活性由7.08×104 U·mL-1下降至3.03×104 U·mL-1，但因其溶瘤活性在预稀释100倍后仍然出现良好的S型量效关系曲线，并不影响它作为标准品使用的要求。将液体标准品作为样品，用冻干标准品作为标准品进行校准后，3家实验室结果的几何变异系数(GCV)由64.4%下降到29.2%，实验的精密度得到较大提高。

结论：

该批HSV-1溶瘤活性测定冻干标准品各项指标均符合相关要求，与液体标准品相比更适合作为国家标准品使用，其溶瘤活性赋值为1.82×104 U·支-1。

1型单纯疱疹病毒(HSV-1)  /  U-2 OS细胞/CCK-8法  /  溶瘤活性  /  标准品  /  冻干  /  稳定性
Objective:

To establish the first national standard for oncolytic activity assay of herpes simplex virus type 1(HSV-1).

Methods:

According to the requirements in Chinese Pharmacopoeia(Volume Ⅲ, 2020 edition), the liquid and freeze-dried standard for oncolytic activity of HSV-1 were prepared and tested, of which the stability were evaluated by thermal acceleration test. The oncolytic activity of the standard was calibrated collaboratively by U-2 OS cells/CCK-8 method in 3 laboratories. The liquid standard was compared with the freeze-dried standard, and the more suitable one was selected as the national standard.

Results:

The prepared standard substance was all qualified, among which the moisture content of the freeze-dried standard was 1.09% and the dispensing accuracy was 0.15%. The results of stability test were calculated by Arrhenius formula. It was preliminarily predicted that it would take 7.7 years for the oncolytic activity of liquid standard to decrease by 10% at -70 ℃, and it would take 6.1×105 years for the oncolytic activity of lyophilized standard to decrease by 10% at -70 ℃. Compared with liquid standard, the stability of lyophilized standard was greatly improved. Twenty-one times of collaborative calibration tests by 3 laboratories showed that the oncolytic activity liquid standard was 7.08×104 U·mL-1 and the oncolytic activity liquid standard was 1.82×104 U·vial-1. After lyophilized, the oncolytic activity of the bulk of HSV-1 standard decreased from 7.08×104 U·mL-1 to 3.03×104 U·mL-1. However, the good S-shaped dose-response curve still appeared after 100 times of pre-dilution, which did not affect the requirements of its use as a standard. When the liquid standard was used as the sample and the freeze-dried standard was used as the standard for calibration, the geometric coefficient of variation (GCV) of the results of the 3 laboratories decreased from 64.4% to 29.2%, and the precision of the experiment was greatly improved.

Conclusion:

The batch of freeze-dried HSV-1 standards for oncolytic activity assay meets the relavant requirements, and is more suitable for use as a national standard than liquid standards. Its oncolytic activity is assigned a value of 1.82×104 U·vial-1.

herpes simplex virus type 1(HSV-1)  /  U-2 OS cells/CCK-8 method  /  oncolytic activity  /  standard substance  /  freeze-drying  /  stability
秦玺, 胡金盼, 李永红, 史新昌, 丁有学, 毕华, 韩春梅, 郑红梅, 饶春明, 梁成罡. 首批1型单纯疱疹病毒溶瘤活性测定国家候选标准品的研制*. 药物分析杂志, 2024 , 44 (4) : 663 -670 . DOI: 10.16155/j.0254-1793.2024.04.13
Xi QIN, Jin-pan HU, Yong-hong LI, Xin-chang SHI, You-xue DING, Hua BI, Chun-mei HAN, Hong-mei ZHENG, Chun-ming RAO, Cheng-gang LIANG. Preparation of the candidate first Chinese national standard for oncolytic activity assay of herpes simplex virus type 1*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (4) : 663 -670 . DOI: 10.16155/j.0254-1793.2024.04.13
正文
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1型单纯疱疹病毒(herps simplex virus 1，HSV-1)属于疱疹病毒科中的α疱疹病毒亚科的单纯疱疹病毒属1型血清型[1]。该病毒具有感染宿主范围广，病毒复制周期短，基因组容量大，较高的安全性等优势[2-4]。目前对HSV-1作为溶瘤病毒的研发较多，取得的进展较大[5-8]。2015年10月27日，FDA批准了首个溶瘤病毒类治疗药物talimogene laherparepvec(T-Vec，Imlygic，Amgen公司)。该产品以HSV-1为溶瘤病毒，同时作为载体携带人粒细胞巨噬细胞集落刺激因子(GM-CSF)基因，用于首次手术后复发的黑色素瘤患者不可切除的皮肤、皮下和淋巴结病灶的局部治疗[9]。目前，国内也有多家单位正在开展以HSV-1溶瘤病毒为载体的基因治疗产品研发，并已有3个产品获批进入临床试验。在HSV-1载体药物开发的过程中，为保证产品的质量，质量控制方法和质量标准的研究尤为重要，而溶瘤活性测定是其关键的质量属性之一和重要的质量控制指标[10]。
在前期研究中建立了U-2 OS细胞/CCK-8法对HSV-1的溶瘤活性进行检测[11]，同时初步证实了引入标准品进行校准可以有效提高分析方法的精密度。目前基因治疗领域还没有建立国际统一的活性测定用标准品或参考品，仅在美国典型菌种保藏中心(American Type Culture Collection，ATCC)有5型腺病毒参考品AdV5RSM[12](ATCC；VR1516)、2型腺相关病毒参考品AAV2RSM[13](ATCC；VR1616)和8型腺相关病毒参考品AAV8RSM[14](ATCC；VR1816)3种病毒标准物质可用于相应病毒的检测分析。这3种病毒参考品均为液体的状态，由于病毒本身易失活，采用液体状态保存极易造成稳定性不足，影响以此为标准品进行检测分析的可靠性。由于在前期研究中采用的临时活性测定标准品也是液体制剂，存在同样问题。为了进一步提高HSV-1溶瘤活性检测方法的可靠性，本研究开展了HSV-1溶瘤活性测定冻干标准品 (HSV-1溶瘤活性测定国家候选标准品)的研制，进行了溶瘤活性的协作标定和初步的稳定性研究，并与同时制备的HSV-1液体标准品进行了溶瘤活性及稳定性的对比研究。
1　仪器与试药
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1.1　实验耗材及仪器
BIOSTAR生物安全柜购自TELSTAR公司；二氧化碳培养箱购自Thermo Fisher公司；M5酶标仪购自Molecular Devices公司；TE300倒置显微镜购自NIKON公司；AP-0650030细胞计数板购自MARIENFELD公司等。
1.2　试剂及细胞
DMEM/F12培养基(货号11320082)、新生牛血清(NBCS，货号16010159)、L-谷氨酰胺(L-glutamine，100 mL，货号25030-081)、青链霉素双抗(100 mL，货号15140-122)、0.25%胰酶(100 mL，货号25200056)、DPBS(1 L，货号A1285601)均购自Thermo Fisher公司；CCK-8(货号CK04)购自北仁化学科技有限公司；人骨肉瘤细胞U-2 OS为中国食品药品检定研究院重组药物室留存。HSV-1标准品原液(批号201907001)，按照我国生物制品的GMP相关要求生产，由北京万泰生物药业股份有限公司提供，总量为1 527 mL。
2　方法与结果
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2.1　标准品制备
取HSV-1标准品原液309 mL，按每支0.3 mL分装，共分装1 030支。取HSV-1标准品原液1 218 mL，按每支0.6 mL分装，分装结束后迅速送入冻干机冻干，共2 030支，作为候选冻干国家标准品。
2.2　标准品质量分析
对HSV-1标准品原液的关键质量属性进行了分析，包括无菌检查[参照2020年版《中华人民共和国药典》(以下简称《中国药典》)三部进行]、鉴别试验(包括限制性酶切：提取HSV-1病毒基因组后，用SmaI进行酶切鉴定；QPCR法：设计特异引物对目标序列进行扩增；细胞中和法：用HSV-1中和抗体将HSV-1中和后，感染U-2 OS细胞，观察细胞是否病变)、感染滴度(将HSV-1病毒原液适当稀释后，感染Vero细胞，计数噬斑数在10~100左右的感染孔的噬斑数，并乘以稀释倍数)、溶瘤活性和选择性增殖活性[用特定感染滴度的病毒分别感染正常细胞MRC-5和肿瘤细胞U-2 OS，分别取样2种细胞感染48 h的样品，进行感染滴度检测，之后按公式计算增殖倍数比，选择性增殖活性=(U-2 OS细胞48 h组织感染液滴度/U-2 OS起始组织感染液滴度)/(MRC-5细胞48 h组织感染液滴度/MRC-5起始组织感染液滴度)]等项目的检测分析，结果如表1所示，均符合《中国药典》三部对国家标准品的制备要求。
对HSV-1溶瘤活性冻干标准品进行了溶瘤活性、分装精度(参照2020年版《中国药典》三部进行)、水分(参照2020年版《中国药典》三部进行)、无菌检查和感染滴度等关键质量属性检测，结果如表2所示，均符合《中国药典》三部对国家标准品的制备要求。
2.3　稳定性试验
将标准品在不同温度(冻干标准品：-80、-20、4、25、37 ℃，液体标准品：-80、-40、-20、4、25 ℃)下放置不同时间(1、3和9个月)后，进行溶瘤活性测定，以评估其稳定性。使用U-2 OS细胞/CCK-8法在同一块96孔板上检测在不同温度下的溶瘤活性。分别将不同温度下的标准品接种到96孔板第2~11列的A行，每个温度2个复孔，然后用完全培养基(DMEM/F12培养基+10%NBCS+1% L-Glutamine+1%青链霉素双抗)4倍系列稀释，共10个稀释度，细胞板的第1列、第12列加入相同体积的完全培养基，以减轻边孔效应对溶瘤活性测定的影响。
在5种温度下放置冻干标准品至9个月，溶瘤活性在各个时间点与-80 ℃溶瘤活性比的测定结果见表3。根据表中的数据及简化的阿伦尼乌斯公式：ln｛k(t)｝=A+B/T+ln(T)(A：截距；B：斜率；k：温度函数；T：绝对温度)，初步预测在-70 ℃下，冻干标准品溶瘤活性降低10%需6.1×105年。
对于液体标准品，与冻干标准品相比，稳定性研究时去掉37 ℃，增加-40 ℃。表4中数据为其热稳定性1、3、9个月与-80 ℃溶瘤活性比的结果，根据阿伦尼乌斯公式：ln｛k(t)｝=A+B/T+ln(T)，选用-80、-40和-20 ℃相对溶瘤活性值，初步预测在-70 ℃下，HSV-1液体标准品溶瘤活性在-70 ℃下降低10%需7.7年。
冻干标准品与液体标准品热稳定实验中有3个相同的温度条件-20、4和25 ℃，对其相对溶瘤活性进行对比，如图1，结果显示冻干后HSV-1标准品更稳定，因此，可优先选择冻干后的HSV-1标准品作为国家标准品申报。
2.4　标准品协作标定
2.4.1　HSV-1溶瘤活性标准品协作标定方法[11]
将细胞U-2 OS用完全培养基稀释成2.5×105个·mL-1，每孔100 μL接种至96孔板。于37 ℃、5%CO2的培养箱中，培养18~20 h。用完全培养基分别将液体标准品和冻干标准品预稀释100倍后，再4倍比系列稀释，共10个稀释度，每个稀释度3个复孔，每孔160 μL转至U-2 OS细胞培养板中，然后将96孔板放置于湿饭盒中，在37 ℃、5%CO2培养箱中连续培养72 h后，每孔加入CCK-8溶液10 μL，轻轻振摇培养板。继续37 ℃培养4~4.5 h，取出后，在酶标仪上终点法读取吸收值A450。
2.4.2　协作标定及统计分析
协作标定由厦门大学、北京万泰生物药业股份有限公司和中国食品药品检定研究院3个相互独立的实验室按上述方法分别进行，通过EC50给标准品赋值，每个实验室须取得7次独立有效的实验结果(每次实验仅需做1块96板)。结果用几何均数法进行统计分析，得出每支标准品的效价单位。
HSV-1溶瘤活性测定液体标准品的协作标定结果如表5所示，共测21次，经计算，各次测定结果的lg值呈正态分布，使用几何均数进行计算。实验次数n=21，自由度f=n-1=20，t(20)0.05=2.086，各次测定结果lg值的均数为4.85，标准差为0.22，故溶瘤活性的几何均数为104.85=70 795 U·mL-1，为了方便计算，将标准品溶瘤活性值定为7.08×104 U·mL-1。平均溶瘤活性的95%可信区间为56 234~89 125 U·mL-1，单次测定的95%参考值范围为25 118~199 526 U·mL-1。
HSV-1溶瘤活性测定冻干标准品具体测定结果如表6所示。每个实验进行7次独立的测定，共测21次，经计算，各次测定结果的lg值呈正态分布，所以认为使用几何均数进行计算较为合理。实验次数n=21，自由度f=n-1=20，t(20)0.05=2.086，各次测定结果lg值的均数为4.26，标准差为0.18，故溶瘤活性的几何均数为104.26=18 197 U·支-1，为了方便计算，将标准品溶瘤活性值定为1.82×104 U·支-1。平均溶瘤活性的95%可信区间为15 135~21 877 U·支-1，单次测定的95%参考值范围为7 762~42 658 U·支-1。
冻干标准品是由0.6 mL液体标准品冻干而成，所以协作标定的结果为1.82×104 U·支-1可换算为3.03×104 U·mL-1，与冻干前的液体标准品溶瘤活性(7.08×104 U·mL-1)的比值为42.8%，说明在冻干后HSV-1的溶瘤活性下降了57.2%。，但在溶瘤活性测定中，预稀释100倍后仍然出现良好的S型量效关系曲线，并不影响其可作为标准品使用的要求。
另外，由于在冻干标准品和液体标准品的协作标定的过程中，实验是在同一块96孔板上同步进行。将冻干标准品作为校准用标准品，赋值为上述3家实验室的协作标定结果1.82×104 U·支-1，液体标准品作为样品进行测定，将3家实验室共计21次的实验结果进行统计学分析(表7)，其测定结果与未使用标准品校准的结果进行比较。发现在使用标准品校准后，3家实验室结果的GCV由64.4%下降到29.2%，实验的精密度大幅提升，这也说明在HSV-1溶瘤活性检测中引入标准品校准很有必要。
3　讨论
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按照2020年版《中国药典》中《人用基因治疗制品总论》的要求，对于效价、感染性滴度等活性检测方法，应建立具有长期稳定性的活性标准品。溶瘤活性是重组人HSV-1基因治疗制品一项重要的质控项目，其与药物的肿瘤杀伤效果直接相关[15]，若能准确定量，对于指导临床用药具有重要的指导意义。由于目前HSV-1溶瘤活性测定中未采用统一的活性测定标准品，造成该项目常出现检测结果不稳定，实验室间检测结果不一致等情况。
为了建立稳定的HSV-1溶瘤活性测定国家标准品，本实验采用冻干和液体2种剂型进行对比研究，首先选取了1批HSV-1标准品原液经检验合格后，一部分作为液体标准品，一部分进行冻干制备成冻干标准品。本实验按照2020年版《中国药典》三部国家标准品的制备要求，进行HSV-1国家标准品原液和成品的全面检定，结果表明，各项指标达到了标准品的相关要求。
标准品配方中含有人血白蛋白、二糖、氨基酸等，能够保证标准品具有较好的稳定性。通过热加速试验，可以评价标准品的稳定性。从现有的稳定性结果来看，冻干剂型稳定性更好，预期保存效期远长于液体剂型。另一方面，HSV-1标准品原液在冻干后溶瘤活性虽然下降了57.2%，但其溶瘤活性在预稀释100倍后仍然出现良好的S型量效关系曲线，并不影响它作为标准品使用的要求。因此，综合考虑标准品的稳定性和活性，以及保存、运输的影响，拟选用冻干标准品进行国家标准品的申报，同时也提示其他企业在病毒类基因治疗产品的内部标准品研制过程中应更多考虑采用冻干的方式。经3家不同实验室的协作标定，通过四参数曲线：
A：上渐近线；D：下渐近线；C：半效浓度；B：曲线斜率的EC50(半效浓度)给标准品赋值。经计算，冻干标准品的几何平均溶瘤活性为1.82×104 U·支-1，平均溶瘤活性的95%可信区间为15 135~21 877 U·支-1。
在液体标准品溶瘤活性测定中，经过统计学分析发现，不同实验室间采用标准品校准后的数值和未采用标准品校准的数值差异较大。将3家实验室共计21次的实验结果进行分析，发现在使用标准品校准后，3家实验室结果的GCV由64.4%下降到29.2%，实验的精密度大幅提升，这也说明在HSV-1活性检测中引入标准品校准很有必要。
总之，该批HSV-1溶瘤活性测定冻干标准品各项指标均符合要求，与液体标准品相比更适合作为国家标准品使用，其溶瘤活性赋值为1.82×104 U·支-1。本候选标准品的研制为HSV-1溶瘤活性测定的标准化，获得更稳定、可靠的检测结果奠定了良好的基础。
基金
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  • *国家科技重大专项课题资助项目(2018ZX09733002-005)
文献
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doi: 10.16155/j.0254-1793.2024.04.13
  • 接收时间：2024-01-31
  • 首发时间：2026-03-13
  • 出版时间：2024-04-30
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  • 收稿日期：2024-01-31
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*国家科技重大专项课题资助项目(2018ZX09733002-005)
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    1.中国食品药品检定研究院，北京 100050
    2.厦门大学公共卫生和生命科学学院，厦门 361005

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2种不同金属材料的力学参数
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Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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