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Article(id=1193674741081928702, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1193674740352119804, articleNumber=1001-2494(2025)06-0658-05, orderNo=null, doi=10.11669/cpj.2025.06.013, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1726070400000, receivedDateStr=2024-09-12, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1762523835677, onlineDateStr=2025-11-07, pubDate=1742572800000, pubDateStr=2025-03-22, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1762523835677, onlineIssueDateStr=2025-11-07, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1762523835677, creator=13701087609, updateTime=1762523835677, updator=13701087609, issue=Issue{id=1193674740352119804, tenantId=1146029695717560320, journalId=1190317699101192196, year='2025', volume='60', issue='6', pageStart='553', pageEnd='662', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1762523835503, creator=13701087609, updateTime=1762524041683, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1193675605205025683, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1193674740352119804, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1193675605205025684, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1193674740352119804, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=658, endPage=662, ext={EN=ArticleExt(id=1193674742147281921, articleId=1193674741081928702, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Analysis and Comparison of Microbial Control Criteria Among Chinese Pharmacopeia, United States Pharmacopeia and European Pharmacopeia, columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

OBJECTIVE To investigate the key factors and directions for construction of a standard system for microbial control of pharmaceutical excipients. METHODS The contents related to pharmaceutical excipient microbial control including general requirements and monographs of standards in Chinese Pharmacopeia, United States Pharmacopeia and European Pharmacopeia were extracted and analyzed in combination with the current industrial status. RESULTS The included pharmacopoeias exhibit considerable differences in the coverage of pharmaceutical excipients and requirement for microbial control and there is still a lack of scientific and systematic guiding standards. The industrial requirements are yet to be met in terms of testing methodology, standardization, and instruction. CONCLUSION Attention should be paid to the methodological research and risk management of microbial control of pharmaceutical excipients. Instructive standards for microbial control of pharmaceutical excipients should be developed based on comprehensive consideration of excipient features and intended use with formulation as a core, to improve the quality standard system of pharmaceutical excipients and ensure drug safety.

, correspAuthors=Meicheng YANG, 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=Jing WANG, Yiling FAN, Meicheng YANG), CN=ArticleExt(id=1193674742935810056, articleId=1193674741081928702, tenantId=1146029695717560320, journalId=1190317699101192196, language=CN, title=《中国药典》《美国药典》及《欧洲药典》中药用辅料微生物控制标准的比较分析, columnId=1190352405612040510, journalTitle=中国药学杂志, columnName=论著, runingTitle=null, highlight=null, articleAbstract=

目的 探讨药用辅料微生物控制关键要素及药用辅料微生物控制标准体系建设方向。方法 通过比较《中国药典》《美国药典》及《欧洲药典》中药用辅料通则、各论标准,结合行业现状与发展,分析现行标准体系,展开未来标准体系建设方向的讨论。结果 《中国药典》《美国药典》及《欧洲药典》在药用辅料品种、微生物控制要求等方面具有较多差异;针对药用辅料微生物控制均缺乏科学系统且具有指导性的标准,在检测方法、标准规范性与指导性等方面无法满足行业需求。结论 应重视药用辅料的方法学研究及微生物控制风险管理研究,以制剂为核心综合药用辅料自身因素及预期用途形成药用辅料微生物控制指导标准,完善药用辅料质量标准体系,确保药品安全。

, correspAuthors=杨美成, authorNote=null, correspAuthorsNote=
*杨美成,女,博士,主任药师 研究方向:药物分析 Tel:(021)50121712
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王静,女,硕士,工程师 研究方向:药品包装及药用辅料检验检测

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王静,女,硕士,工程师 研究方向:药品包装及药用辅料检验检测

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王静,女,硕士,工程师 研究方向:药品包装及药用辅料检验检测

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articleId=1193674741081928702, language=CN, orderNo=5, keyword=关联审评审批), Keyword(id=1193712695200416516, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, language=CN, orderNo=6, keyword=风险管理)], refs=[Reference(id=1193712700107752214, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, doi=null, pmid=null, pmcid=null, year=2021, volume=35, issue=9, pageStart=972, pageEnd=977, url=null, language=null, rfNumber=[1], rfOrder=0, authorNames=CHEN L, ZHANG Y Y, ZHENG A P, journalName=Chin Pharm Aff(中国药事), refType=null, unstructuredReference=CHEN L, ZHANG Y Y, ZHENG A P, et al. 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China Food Drug Admin Mag(中国食品药品监管), 2018(9):52-58., articleTitle=The quality of pharmaceutical excipients of animal origin should be based on whole-process quality control, refAbstract=null), Reference(id=1193712700925641503, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, doi=null, pmid=null, pmcid=null, year=2022, volume=53, issue=3, pageStart=376, pageEnd=382, url=null, language=null, rfNumber=[10], rfOrder=9, authorNames=SUN C M, CHEN L, LI Y N, journalName=J China Pharm Univ(中国药科大学学报), refType=null, unstructuredReference=SUN C M, CHEN L, LI Y N, et al. Interpretation of theguideline for pharmaceutical excipients of animal origin[J]. 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Pharm Eng Des(医药工程设计), 2006(4):24-26., articleTitle=The microbiological requirements for pharmaceutical excipients in US, refAbstract=null), Reference(id=1193712701093413665, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, doi=null, pmid=null, pmcid=null, year=2020, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[12], rfOrder=11, authorNames=null, journalName=Ch.P(2020) Vol Ⅳ(中国药典2020年版.四部), refType=null, unstructuredReference=Ch.P(2020) Vol Ⅳ(中国药典2020年版.四部)[S]. 2020., articleTitle=null, refAbstract=null), Reference(id=1193712701680616226, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, doi=null, pmid=null, pmcid=null, year=2020, volume=55, issue=14, pageStart=1177, pageEnd=1183, url=null, language=null, rfNumber=[13], rfOrder=12, authorNames=CHEN L, SONG Z H, HU S J, journalName=Chin Pharm J(中国药学杂志), refType=null, unstructuredReference=CHEN L, SONG Z H, HU S J, et al. An introduction to the standards system and main characteristics of pharmaceutical excipients in the 2020 Edition of Chinese Pharmacopoeia[J]. Chin Pharm J(中国药学杂志), 2020, 55(14):1177-1183., articleTitle=An introduction to the standards system and main characteristics of pharmaceutical excipients in the 2020 Edition of Chinese Pharmacopoeia, refAbstract=null), Reference(id=1193712701772890915, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, doi=null, pmid=null, pmcid=null, year=2018, volume=null, issue=9, pageStart=31, pageEnd=35, url=null, language=null, rfNumber=[14], rfOrder=13, authorNames=TU J S, journalName=China Food Drug Admin Mag(中国食品药品监管), refType=null, unstructuredReference=TU J S. The formulation and significance of standards for pharmaceutical excipients[J]. 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药典名称 通则
《中国药典》 <0251>药用辅料
<9601>药用辅料功能性相关指标指导原则
<9602>动物奶源药用辅料指导原则
<9603>预混与共处理药用辅料质量控制指导原则
<9202>非无菌产品微生物限度检查指导原则
<1101>无菌检查法
<1105>非无菌产品微生物限度检查:微生物计数法
<1106>非无菌产品微生物限度检查:控制菌检查法
<1107>非无菌药品微生物限度标准
《美国药典》 <61>非无菌产品的微生物检查:微生物计数检查
<62>非无菌产品的微生物检查:控制菌检查
<71>无菌检查
<1111>非无菌产品的微生物检查:药用制剂和药用物质可接受标准
<1059>药用辅料性能
<1115>非无菌原料药及其制品的生物负荷控制
《欧洲药典》 <2.6.12>非无菌产品的微生物检查:微生物计数检查
<2.6.13>非无菌产品的微生物检查:控制菌检查
<2.6.1>无菌检查
<5.1.4>非无菌药物制剂和药用物质的微生物控制
<2034>药用物质通则
), ArticleFig(id=1193712695460463366, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, language=CN, label=表1, caption=

《中国药典》《美国药典》及《欧洲药典》中药用辅料相关通则

, figureFileSmall=null, figureFileBig=null, tableContent=
药典名称 通则
《中国药典》 <0251>药用辅料
<9601>药用辅料功能性相关指标指导原则
<9602>动物奶源药用辅料指导原则
<9603>预混与共处理药用辅料质量控制指导原则
<9202>非无菌产品微生物限度检查指导原则
<1101>无菌检查法
<1105>非无菌产品微生物限度检查:微生物计数法
<1106>非无菌产品微生物限度检查:控制菌检查法
<1107>非无菌药品微生物限度标准
《美国药典》 <61>非无菌产品的微生物检查:微生物计数检查
<62>非无菌产品的微生物检查:控制菌检查
<71>无菌检查
<1111>非无菌产品的微生物检查:药用制剂和药用物质可接受标准
<1059>药用辅料性能
<1115>非无菌原料药及其制品的生物负荷控制
《欧洲药典》 <2.6.12>非无菌产品的微生物检查:微生物计数检查
<2.6.13>非无菌产品的微生物检查:控制菌检查
<2.6.1>无菌检查
<5.1.4>非无菌药物制剂和药用物质的微生物控制
<2034>药用物质通则
), ArticleFig(id=1193712695556932359, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
所收载药典 药用辅料各论数量
《中国药典》收载 335
《美国药典》收载 509
《欧洲药典》收载 347
《美国药典》及《欧洲药典》均收载 122
《美国药典》及《中国药典》均收载 58
《欧洲药典》及《中国药典》均收载 12
《中国药典》《美国药典》及《欧洲药典》均收载 164
仅《中国药典》收载 101
仅《美国药典》收载 165
仅《欧洲药典》收载 49
), ArticleFig(id=1193712695624041224, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, language=CN, label=表2, caption=

《中国药典》《美国药典》及《欧洲药典》中药用辅料各论收载情况

, figureFileSmall=null, figureFileBig=null, tableContent=
所收载药典 药用辅料各论数量
《中国药典》收载 335
《美国药典》收载 509
《欧洲药典》收载 347
《美国药典》及《欧洲药典》均收载 122
《美国药典》及《中国药典》均收载 58
《欧洲药典》及《中国药典》均收载 12
《中国药典》《美国药典》及《欧洲药典》均收载 164
仅《中国药典》收载 101
仅《美国药典》收载 165
仅《欧洲药典》收载 49
), ArticleFig(id=1193712695712121609, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
品种数量 品种名录
164 阿拉伯胶,冰乙酸,己二酸,琼脂,乙醇,阿尔法环糊精,海藻酸,浓氨溶液,阿司帕坦,苯扎氯铵,苯甲酸,苯甲醇,倍他环糊精,硼酸,丁基羟基苯甲醚,二丁基羟基甲苯,氯化钙,无水磷酸氢钙,磷酸氢钙二水合物,磷酸钙,硬脂酸钙,硫酸钙,辛酸,卡波姆共聚物,二氧化碳,羧甲纤维素钙,羧甲纤维素钠,氢化蓖麻油,纤维醋法酯,醋酸纤维素,微晶纤维素,粉状纤维素,十六十八醇,西曲溴铵,十六醇,三氯叔丁醇,氯甲酚,胆固醇,枸橼酸,无水枸橼酸,可可脂,椰子油,共聚维酮,交联羧甲纤维素钠,交联聚维酮,糊精,二甲基硅油,二甲基亚砜,依地酸二钠,乙酸乙酯,丙烯酸乙酯-甲基丙烯酸甲酯共聚物水分散体,油酸乙酯,乙基纤维素,单硬脂酸乙二醇酯,果糖,伽马环糊精,明胶,甘油,山嵛酸甘油酯,单亚油酸甘油酯,单油酸甘油酯,甘氨酸,瓜尔胶,混合脂肪酸甘油酯,盐酸,稀盐酸,羟乙纤维素,羟丙基倍他环糊精,羟丙纤维素,低取代羟丙纤维素,羟丙甲纤维素,羟丙甲纤维素邻苯二甲酸酯,异丙醇,肉豆蔻酸异丙酯,棕榈酸异丙酯,白陶土,无水乳糖,乳糖,羊毛脂,亮氨酸,硅酸镁铝,氧化镁,硬脂酸镁,三硅酸镁,马来酸,DL-苹果酸,麦芽糖醇,麦芽糊精,中链甘油三酸酯,薄荷脑,甲基纤维素,橄榄油,棕榈酸,苯氧乙醇,磷酸,稀磷酸,聚氧乙烯,聚氧乙烯(35)蓖麻油,聚氧乙烯(40)氢化蓖麻油,硬脂酸聚烃氧(40)酯,聚氧乙(50)硬脂酸酯,聚山梨酯20,聚山梨酯40,聚山梨酯60,聚山梨酯80,聚乙烯醇,碳酸氢钾,氯化钾,氢氧化钾,山梨酸钾,没食子酸丙酯,丙二醇,普鲁兰,胶态二氧化硅,醋酸钠,海藻酸钠,苯甲酸钠,无水碳酸钠,枸橼酸钠,氢氧化钠,焦亚硫酸钠,羧甲淀粉钠,硬脂富马酸钠,无水亚硫酸钠,山梨酸,月桂山梨坦,油酸山梨坦,棕榈山梨坦,硬脂山梨坦,三油酸山梨坦,山梨醇,山梨醇溶液,大豆油,氢化大豆油,玉米淀粉,豌豆淀粉,马铃薯淀粉,预胶化淀粉,预胶化羟丙基玉米淀粉,小麦淀粉,硬脂酸,十八醇,三氯蔗糖,蔗糖,蔗糖硬脂酸酯,蔗糖丸芯,硫酸,滑石粉,酒石酸,麝香草酚,二氧化钛,西黄蓍胶,海藻糖,甘油三乙酯,枸橼酸三乙酯,三乙醇胺,香草醛,注射用水,注射用水,纯化水,黄原胶,木糖醇,氧化锌,硬脂酸锌
), ArticleFig(id=1193712695787619082, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, language=CN, label=表3, caption=

《中国药典》《美国药典》及《欧洲药典》中均收载的药用辅料品种

, figureFileSmall=null, figureFileBig=null, tableContent=
品种数量 品种名录
164 阿拉伯胶,冰乙酸,己二酸,琼脂,乙醇,阿尔法环糊精,海藻酸,浓氨溶液,阿司帕坦,苯扎氯铵,苯甲酸,苯甲醇,倍他环糊精,硼酸,丁基羟基苯甲醚,二丁基羟基甲苯,氯化钙,无水磷酸氢钙,磷酸氢钙二水合物,磷酸钙,硬脂酸钙,硫酸钙,辛酸,卡波姆共聚物,二氧化碳,羧甲纤维素钙,羧甲纤维素钠,氢化蓖麻油,纤维醋法酯,醋酸纤维素,微晶纤维素,粉状纤维素,十六十八醇,西曲溴铵,十六醇,三氯叔丁醇,氯甲酚,胆固醇,枸橼酸,无水枸橼酸,可可脂,椰子油,共聚维酮,交联羧甲纤维素钠,交联聚维酮,糊精,二甲基硅油,二甲基亚砜,依地酸二钠,乙酸乙酯,丙烯酸乙酯-甲基丙烯酸甲酯共聚物水分散体,油酸乙酯,乙基纤维素,单硬脂酸乙二醇酯,果糖,伽马环糊精,明胶,甘油,山嵛酸甘油酯,单亚油酸甘油酯,单油酸甘油酯,甘氨酸,瓜尔胶,混合脂肪酸甘油酯,盐酸,稀盐酸,羟乙纤维素,羟丙基倍他环糊精,羟丙纤维素,低取代羟丙纤维素,羟丙甲纤维素,羟丙甲纤维素邻苯二甲酸酯,异丙醇,肉豆蔻酸异丙酯,棕榈酸异丙酯,白陶土,无水乳糖,乳糖,羊毛脂,亮氨酸,硅酸镁铝,氧化镁,硬脂酸镁,三硅酸镁,马来酸,DL-苹果酸,麦芽糖醇,麦芽糊精,中链甘油三酸酯,薄荷脑,甲基纤维素,橄榄油,棕榈酸,苯氧乙醇,磷酸,稀磷酸,聚氧乙烯,聚氧乙烯(35)蓖麻油,聚氧乙烯(40)氢化蓖麻油,硬脂酸聚烃氧(40)酯,聚氧乙(50)硬脂酸酯,聚山梨酯20,聚山梨酯40,聚山梨酯60,聚山梨酯80,聚乙烯醇,碳酸氢钾,氯化钾,氢氧化钾,山梨酸钾,没食子酸丙酯,丙二醇,普鲁兰,胶态二氧化硅,醋酸钠,海藻酸钠,苯甲酸钠,无水碳酸钠,枸橼酸钠,氢氧化钠,焦亚硫酸钠,羧甲淀粉钠,硬脂富马酸钠,无水亚硫酸钠,山梨酸,月桂山梨坦,油酸山梨坦,棕榈山梨坦,硬脂山梨坦,三油酸山梨坦,山梨醇,山梨醇溶液,大豆油,氢化大豆油,玉米淀粉,豌豆淀粉,马铃薯淀粉,预胶化淀粉,预胶化羟丙基玉米淀粉,小麦淀粉,硬脂酸,十八醇,三氯蔗糖,蔗糖,蔗糖硬脂酸酯,蔗糖丸芯,硫酸,滑石粉,酒石酸,麝香草酚,二氧化钛,西黄蓍胶,海藻糖,甘油三乙酯,枸橼酸三乙酯,三乙醇胺,香草醛,注射用水,注射用水,纯化水,黄原胶,木糖醇,氧化锌,硬脂酸锌
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药典
名称		 药用辅料
收载数量		 要求微生物控制的
药用辅料数量		 占比
/%
《中国药典》 335 64 19
《美国药典》 509 88 17
《欧洲药典》 347 66 19
), ArticleFig(id=1193712695942808332, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, language=CN, label=表4, caption=

《美国药典》《欧洲药典》和《中国药典》中要求微生物控制的药用辅料

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药典
名称		 药用辅料
收载数量		 要求微生物控制的
药用辅料数量		 占比
/%
《中国药典》 335 64 19
《美国药典》 509 88 17
《欧洲药典》 347 66 19
), ArticleFig(id=1193712696030888717, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
药典名称 需氧菌总数(TAMC)
/CFU·g-1或CFU·mL-1		 霉菌和酵母菌总数(TYMC)
/CFU·g-1或CFU·mL-1		 控制菌
《中国药典》 1 000 100 -
《美国药典》 1 000 100 -
《欧洲药典》 1 000 100 -
), ArticleFig(id=1193712696102191886, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, language=CN, label=表5, caption=

《中国药典》《美国药典》及《欧洲药典》通则中微生物限度标准情况

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药典名称 需氧菌总数(TAMC)
/CFU·g-1或CFU·mL-1		 霉菌和酵母菌总数(TYMC)
/CFU·g-1或CFU·mL-1		 控制菌
《中国药典》 1 000 100 -
《美国药典》 1 000 100 -
《欧洲药典》 1 000 100 -
), ArticleFig(id=1193712696186077967, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
药典名称 要求微生物计数检查的
辅料数量		 采用通则标准的
辅料数量(占比)		 相较于通则收紧的
辅料数量(占比)		 相较于通则放宽的
辅料数量(占比)
《中国药典》 62 47(76%) 14(22%) 0(0%)
《美国药典》 69 48(68%) 16(23%) 2(3%)
《欧洲药典》 61 35(57%) 18(30%) 3(5%)
), ArticleFig(id=1193712696391598864, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, language=CN, label=表6, caption=

《中国药典》《美国药典》及《欧洲药典》药用辅料各论中微生物计数检查限度要求统计

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药典名称 要求微生物计数检查的
辅料数量		 采用通则标准的
辅料数量(占比)		 相较于通则收紧的
辅料数量(占比)		 相较于通则放宽的
辅料数量(占比)
《中国药典》 62 47(76%) 14(22%) 0(0%)
《美国药典》 69 48(68%) 16(23%) 2(3%)
《欧洲药典》 61 35(57%) 18(30%) 3(5%)
), ArticleFig(id=1193712696542593809, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
药典名称 要求控制菌检查的
辅料数量		 要求大肠埃希菌检查的
辅料数量(占比)		 要求沙门菌检查的
辅料数量(占比)		 要求其他控制菌检查的
辅料数量(占比)
《中国药典》 61 61(100%) 22(36%) 0
《美国药典》 60 57(95%) 34(57%) 8(13%)
《欧洲药典》 51 47(92%) 39(76%) 4(8%)
), ArticleFig(id=1193712697645695762, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, language=CN, label=表7, caption=

《中国药典》《美国药典》及《欧洲药典》药用辅料各论中控制菌检查情况统计

, figureFileSmall=null, figureFileBig=null, tableContent=
药典名称 要求控制菌检查的
辅料数量		 要求大肠埃希菌检查的
辅料数量(占比)		 要求沙门菌检查的
辅料数量(占比)		 要求其他控制菌检查的
辅料数量(占比)
《中国药典》 61 61(100%) 22(36%) 0
《美国药典》 60 57(95%) 34(57%) 8(13%)
《欧洲药典》 51 47(92%) 39(76%) 4(8%)
), ArticleFig(id=1193712697750553363, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
检测项目 《中国药典》 《美国药典》 《欧洲药典》
TAMC 不得过1 000 CFU·g-1 用于局部用药 不得过100 CFU·g-1 用于皮肤给药 不得过100 CFU·g-1
用于口服 不得过1 000 CFU·g-1 用于口服 不得过1 000 CFU·g-1
TYMC 不得过100 CFU·g-1 用于局部用药 不得过50 CFU·g-1 用于皮肤给药 -
用于口服 不得过100 CFU·g-1 用于口服 不得过100 CFU·g-1
大肠埃希菌 不得检出 - -
沙门菌 不得检出 - -
), ArticleFig(id=1193712697847022356, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193674741081928702, language=CN, label=表8, caption=

滑石粉在《中国药典》《美国药典》及《欧洲药典》中的微生物控制要求

, figureFileSmall=null, figureFileBig=null, tableContent=
检测项目 《中国药典》 《美国药典》 《欧洲药典》
TAMC 不得过1 000 CFU·g-1 用于局部用药 不得过100 CFU·g-1 用于皮肤给药 不得过100 CFU·g-1
用于口服 不得过1 000 CFU·g-1 用于口服 不得过1 000 CFU·g-1
TYMC 不得过100 CFU·g-1 用于局部用药 不得过50 CFU·g-1 用于皮肤给药 -
用于口服 不得过100 CFU·g-1 用于口服 不得过100 CFU·g-1
大肠埃希菌 不得检出 - -
沙门菌 不得检出 - -
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《中国药典》《美国药典》及《欧洲药典》中药用辅料微生物控制标准的比较分析
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王静 1 , 范一灵 2 , 杨美成 3, *
中国药学杂志 | 论著 2025,60(6): 658-662
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中国药学杂志 | 论著 2025, 60(6): 658-662
《中国药典》《美国药典》及《欧洲药典》中药用辅料微生物控制标准的比较分析
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王静1, 范一灵2, 杨美成3, *
作者信息
  • 1 上海市食品药品包装材料测试所, 上海 201203
  • 2 上海市食品药品检验研究院, 上海 201203
  • 3 上海药品审评核查中心, 上海 201203

    • 王静,女,硕士,工程师 研究方向:药品包装及药用辅料检验检测

通讯作者:

*杨美成,女,博士,主任药师 研究方向:药物分析 Tel:(021)50121712
Analysis and Comparison of Microbial Control Criteria Among Chinese Pharmacopeia, United States Pharmacopeia and European Pharmacopeia
Jing WANG1, Yiling FAN2, Meicheng YANG3, *
Affiliations
  • 1 Shanghai Food and Drug Packaging Material Control Center, Shanghai 201203, China
  • 2 Shanghai Institute for Food and Drug Control, Shanghai 201203, China
  • 3 Shanghai Center for Drug Evaluation and Inspection, Shanghai 201203, China
出版时间: 2025-03-22 doi: 10.11669/cpj.2025.06.013
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摘要
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目的 探讨药用辅料微生物控制关键要素及药用辅料微生物控制标准体系建设方向。方法 通过比较《中国药典》《美国药典》及《欧洲药典》中药用辅料通则、各论标准,结合行业现状与发展,分析现行标准体系,展开未来标准体系建设方向的讨论。结果 《中国药典》《美国药典》及《欧洲药典》在药用辅料品种、微生物控制要求等方面具有较多差异;针对药用辅料微生物控制均缺乏科学系统且具有指导性的标准,在检测方法、标准规范性与指导性等方面无法满足行业需求。结论 应重视药用辅料的方法学研究及微生物控制风险管理研究,以制剂为核心综合药用辅料自身因素及预期用途形成药用辅料微生物控制指导标准,完善药用辅料质量标准体系,确保药品安全。

药用辅料  /  微生物控制  /  药典标准  /  药品安全  /  关联审评审批  /  风险管理

OBJECTIVE To investigate the key factors and directions for construction of a standard system for microbial control of pharmaceutical excipients. METHODS The contents related to pharmaceutical excipient microbial control including general requirements and monographs of standards in Chinese Pharmacopeia, United States Pharmacopeia and European Pharmacopeia were extracted and analyzed in combination with the current industrial status. RESULTS The included pharmacopoeias exhibit considerable differences in the coverage of pharmaceutical excipients and requirement for microbial control and there is still a lack of scientific and systematic guiding standards. The industrial requirements are yet to be met in terms of testing methodology, standardization, and instruction. CONCLUSION Attention should be paid to the methodological research and risk management of microbial control of pharmaceutical excipients. Instructive standards for microbial control of pharmaceutical excipients should be developed based on comprehensive consideration of excipient features and intended use with formulation as a core, to improve the quality standard system of pharmaceutical excipients and ensure drug safety.

pharmaceutical excipient  /  microbial control  /  pharmacopeia standard  /  drug safety  /  associated evaluation and approval  /  risk management
王静, 范一灵, 杨美成. 《中国药典》《美国药典》及《欧洲药典》中药用辅料微生物控制标准的比较分析. 中国药学杂志, 2025 , 60 (6) : 658 -662 . DOI: 10.11669/cpj.2025.06.013
Jing WANG, Yiling FAN, Meicheng YANG. Analysis and Comparison of Microbial Control Criteria Among Chinese Pharmacopeia, United States Pharmacopeia and European Pharmacopeia[J]. Chinese Pharmaceutical Journal, 2025 , 60 (6) : 658 -662 . DOI: 10.11669/cpj.2025.06.013
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药用辅料在药物制剂中发挥着赋形、载体、稳定剂等作用,是制剂的重要组成部分,关系药物安全性、有效性等[1-3]。相较于原料药与制剂的快速发展,我国药用辅料发展较为滞后[3-5]。随着仿制药一致性评价工作的推进及关联审评审批制度实施,药用辅料、药包材孤立分散的管理方式调整为以制剂为核心的统一管理模式,对药用辅料标准建设提出了更高、更新的要求[6-8]。
药用辅料来源复杂,生产工艺各不相同,且功能众多,可应用于不同制剂或给药途径,在微生物污染方面存在较高风险且控制标准较低[4,9-11]。《中国药典》自1953年版开始收载药用辅料概论,体现了药用辅料标准对于药品质量的重要性[12-14],目前行业对药用辅料的微生物控制标准较低,当前药典标准在一定情况下已不能完全满足行业需求[2-3],另外,新型辅料不断涌现对标准体系同样带来挑战。
本文对《中国药典》2020年版[12]、《美国药典》2022年版[15]及《欧洲药典》10.8版[16]中药用辅料微生物控制标准进行梳理与比较,结合行业需求分析3国药典中药用辅料微生物控制差异性及关键要素,为药用辅料标准体系的完善提供研究基础,从而更好保证药品安全。
1 《中国药典》《美国药典》及《欧洲药典》中药用辅料通则现状
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药典通则反映药典对该领域的整体指导思想,《中国药典》《美国药典》及《欧洲药典》中药用辅料及微生物控制相关通则见表1。
《中国药典》《美国药典》及《欧洲药典》在药用辅料的通用性内容、微生物检测方法及限度要求等方面均具有相关通则标准。其中,《欧洲药典》10.8<2034>及《美国药典》2022<1115>均提出根据品种特性及预期用途确定检测限值[15-16],《中国药典》<0251><9602>亦指出药用辅料的微生物控制需结合来源、生产工艺、应用制剂等因素综合评估[12],《中国药典》《美国药典》及《欧洲药典》间具有一致性。
另外,《中国药典》《美国药典》及《欧洲药典》中均具有相关通则,例如《中国药典》<1105><1106><1107>,《美国药典》2022<61><62><71>以及《欧洲药典》10.8<2.6.12><2.6.13><2.6.1>,对微生物检测方法及限度要求等进行了通用的指导与要求,而对于如何确定药用辅料在不同制剂应用及给药途径下的微生物控制要求,《中国药典》《美国药典》及《欧洲药典》均没有具体且具有针对性的相关标准。
2 《中国药典》《美国药典》及《欧洲药典》中药用辅料各论现状
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《中国药典》《美国药典》及《欧洲药典》均收载多个药用辅料各论,《美国药典》和《欧洲药典》中分别收载509和347个,《中国药典》收载的各论从2005年版的73个增加至2020年版的335个[1,5],不同药典收载的药用辅料品种存在一定差异,见表2。
其中,有164个药用辅料品种各论同时收载于《中国药典》《美国药典》及《欧洲药典》中,具体品种见表3。
2.1 《中国药典》《美国药典》及《欧洲药典》药用辅料各论中微生物控制要求现状
《美国药典》《欧洲药典》和《中国药典》中要求微生物控制的药用辅料分别为88、66和64个,占比均在20%左右,见表4。
《中国药典》与《美国药典》中均要求微生物控制的药用辅料有39个,其中仅8个其微生物控制要求在两国药典中一致,即明胶、白陶土、豌豆淀粉、马铃薯淀粉、预胶化羟丙基玉米淀粉、木薯淀粉、小麦淀粉、注射用水。
《中国药典》与《欧洲药典》中仅有6个药用辅料其微生物控制要求一致,即明胶、瓜尔胶、硅酸镁铝、海藻酸钠、注射用水、纯化水。
由此可见,药典中要求微生物控制的药用辅料品种以及控制要求均存在较大差异,控制要求的差异性一方面是微生物计数检查限度要求,另一方面则是控制菌检查种类。
2.1.1 微生物计数检查限度要求差异性
《中国药典》《美国药典》及《欧洲药典》中相关通则均给出药用辅料微生物限度标准[12,15-16],见表5,并指出除另有规定外其微生物限度以通则要求为准。药典中各药用辅料微生物计数检查限度要求部分依照通则,部分相较于通则放宽或收紧,统计情况见表6。《中国药典》采用通则要求的药用辅料比例较欧美药典更高,欧美药典中更多药用辅料在微生物计数检查方面有个性化要求,个性化要求背后是药用辅料微生物污染程度的评估。
2.1.2 控制菌检查要求差异性
控制菌检查是微生物控制的重要项目,《中国药典》《美国药典》及《欧洲药典》中相关通则对药用辅料控制菌检查没有明确要求(表5)[12,15-16],药用辅料各论中控制菌检查要求情况见表7。
控制菌检查要求与药用辅料来源、预期用途等密切相关,欧美药典中要求沙门菌检查的药用辅料占比远高于《中国药典》。另外,欧美药典中部分药用辅料还对金黄色葡萄球菌、铜绿假单胞菌、耐胆盐革兰阴性菌做出控制要求,而《中国药典》仅涉及大肠埃希菌和沙门菌。
2.2 《中国药典》《美国药典》及《欧洲药典》中药用辅料微生物限度检查方法现状
《中国药典》《美国药典》及《欧洲药典》中相关通则针对非无菌产品微生物限度检查提供了通用检测方法,而许多药用辅料具有难溶于水、抑菌性等特质,通用方法并不适用。
《中国药典》《美国药典》及《欧洲药典》中仅有极少数药用辅料各论对检查方法进行了通则以外的详细规范,《中国药典》《美国药典》和《欧洲药典》中分别各有3、2和4个,难以满足行业需求。
2.3 《中国药典》《美国药典》及《欧洲药典》中药用辅料微生物控制要求与预期用途关联现状
药用辅料功能众多,同一种辅料可用于不同剂型,其风险水平及微生物控制要求均具有差异。欧美药典中各有7个药用辅料根据制剂类型或给药途径对微生物控制做出差异化要求,而《中国药典》中则没有此类情况。
例如,滑石粉在各国药典中均要求微生物控制(表8),欧美药典中不同给药途径下滑石粉的微生物计数检查限度要求具有差异,而《中国药典》没有进行差异化要求。另外,欧美药典对滑石粉的控制菌检查均未作出要求,《中国药典》则要求大肠埃希菌与沙门菌均不得检出。
3 讨论与分析
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伴随医药产业飞速发展及仿制药一致性评价等工作的快速推进,药用辅料的质量控制及标准体系亟须进一步完善。国内外关于药用辅料微生物控制的主要标准依据为各国药典中的相关通则及各论要求,本文对《中国药典》《美国药典》及《欧洲药典》中药用辅料微生物控制相关标准现状比较分析,结合行业发展需求,对药用辅料微生物控制标准体系建设提出以下思考。
3.1 开展药用辅料微生物控制风险评估研究
通过《中国药典》《美国药典》及《欧洲药典》中药用辅料微生物控制相关标准的比较分析发现,不同药典对药用辅料的微生物控制要求处于较为“简化”的水平,虽有相关通则指出药用辅料的微生物控制需结合来源、生产工艺、应用制剂等因素综合评估,但均未详细明确药用辅料其全生命周期各个环节的微生物风险因子及风险水平,均缺少科学且适用的评估方法及标准指导。
分析发现目前国内外药典通则中针对药用辅料的微生物限度标准是一致的,均为“单一、刚性化”的通用标准,且仅对需氧菌总数以及霉菌和酵母菌总数进行了限度要求,对控制菌检查未作出具体要求。在各论方面,《中国药典》《美国药典》及《欧洲药典》中药用辅料各论项下的微生物计数检查限度要求部分依照通则,部分相较于通则放宽或收紧,《中国药典》采用通则要求的药用辅料比例较欧美药典更高,欧美药典中更多药用辅料在微生物计数检查方面有个性化要求。控制菌检查要求与药用辅料来源、预期用途等密切相关,欧美药典中要求沙门菌检查的药用辅料占比远高于《中国药典》,欧美药典中部分药用辅料还对金黄色葡萄球菌、铜绿假单胞菌、耐胆盐革兰阴性菌做出控制要求,而《中国药典》仅涉及大肠埃希菌和沙门菌。另外,欧美药典中各有7个药用辅料根据制剂类型或给药途径对微生物控制做出差异化要求,而《中国药典》辅料各论中辅料的微生物控制要求缺乏与预期用途的紧密关联。“个性化”“差异化”要求的背后是对具体药用辅料其微生物风险水平的评估。
虽然部分药用辅料各论项下针对该药用辅料品种的微生物风险水平进行了“个性化”“差异化”的要求,但仅适用于该药用辅料品种的质量控制。而药用辅料品种极为庞杂,各国正在使用的药用辅料品种远超目前国内外药典中收载的药用辅料品种,且不断有新型品种涌现,因此应建立以“风险评估”为基础的药用辅料微生物控制策略及指导标准,确定药用辅料微生物风险评估思路与方法,从而指导不同药用辅料微生物控制要求的制定,对药用辅料采取“适当”“差异化”的有效质量管理。在过度微生物控制与微生物控制不足之间通过科学、有效的风险评估策略以保障监管的有效以及促进产业的健康发展。
风险管理的一项基本原则便是以保护患者为最终目的,基于科学知识进行质量风险的评价,因此在药用辅料全生命周期引入风险管理理念,可有效保障用药安全[1,3-4]。对药用辅料在原料管理、生产过程、质量控制、贮存运输、应用使用等各个环节中发生微生物污染的潜在风险来源以及风险危害程度进行综合评估,确定其微生物可能的种类、含量和生长特性,以制定适宜药用辅料微生物控制的风险评估策略。
应关注药用辅料上游来源和生产工艺,根据可能携带的污染菌和污染量来确定具有针对性的微生物检测项目。例如动植物来源的药用辅料,其成分复杂且微生物风险水平较高,应重点关注沙门菌的控制[9,11]。
药用辅料功能众多,可应用于多种制剂类型[4],在原辅包关联审评审批背景之下,药用辅料更多强调以制剂需求为核心,药用辅料的生产者、使用者、监管者都需高度重视这一关联性[6-7],根据制剂的微生物控制需求,有必要对特定药用辅料中的风险微生物进行评估、控制和检测。
3.2 开展药用辅料微生物检查方法学研究
药用辅料领域品种庞杂、特性各异,需使用适用于该类产品、能充分采集其中微生物、能真实有效地反映药用辅料微生物污染情况的微生物检测方法,这对控制产品微生物污染具有积极意义。因此,药用辅料微生物检查的方法学研究是行业关注度极高的难点问题,特别是对于理化性质或生物特性较为特殊的药用辅料,在供试品制备、方法选择等方面存在较多问题。通过《中国药典》《美国药典》及《欧洲药典》中相关标准比较分析发现,目前国内外药典在通则及各论方面均缺少针对药用辅料领域不同特性产品的微生物检测方法,行业时常面临“无法可循”或各种检查方法“百花齐放”的问题,给产业发展与科学监管造成很多困难与风险。
因此,亟须开展药用辅料微生物控制方法学研究,可对特性辅料梳理与分类,以不同特性为研究单元开展检查方法的比较研究与验证,必要时将经验证的具体方法收录于药典各论以提高药用辅料微生物检查标准的科学性、严谨性和规范性[3],同时为企业标准制定提供参考。
3.3 根据历史数据合理制订内控质量标准
药用辅料生产企业也可结合工艺特点、质量控制水平、微生物负载和检测历史数据等,合理设置个性化且具有针对性的药用辅料微生物内控标准,实现按需控制、按需检测、规范验证,从而达到兼顾质量与效率的目标。
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  • 国家药典委《中国药典》药用辅料微生物控制相关标准研究项目资助(2024Y27-1)
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2025年第60卷第6期
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doi: 10.11669/cpj.2025.06.013
  • 接收时间：2024-09-12
  • 首发时间：2025-11-07
  • 出版时间：2025-03-22
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  • 收稿日期：2024-09-12
基金
国家药典委《中国药典》药用辅料微生物控制相关标准研究项目资助(2024Y27-1)
作者信息
    1 上海市食品药品包装材料测试所, 上海 201203
    2 上海市食品药品检验研究院, 上海 201203
    3 上海药品审评核查中心, 上海 201203

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*杨美成,女,博士,主任药师 研究方向:药物分析 Tel:(021)50121712
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2种不同金属材料的力学参数
科
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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