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Chin J Mod Appl Pharm，201??，38(5)：513, articleTitle=Current situation and prospect of microbial control system for drugs, refAbstract=null), Reference(id=1239231289811850012, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239231271126225100, doi=null, pmid=null, pmcid=null, year=2023, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[16], rfOrder=26, authorNames=null, journalName=null, refType=null, unstructuredReference=USP-NF [S/OL]. 2023[2023-11-01]. https://doi.org/10.31003/USPNF_M11076_02_01, articleTitle=null, refAbstract=null), Reference(id=1239231289887347487, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239231271126225100, doi=null, pmid=null, pmcid=null, year=2019, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[17], rfOrder=27, authorNames=null, journalName=null, refType=null, unstructuredReference=EP 10.0[S]. 2019, articleTitle=null, 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language=EN, label=Fig.6, caption=Suitability of the total combined yeasts（molds） counting method in the presence of Bacillus coagulans tablets，live, figureFileSmall=UVfWxU3FzyRDt6FGM85g/g==, figureFileBig=UWdG1TN+nZlnq+xHNkox5A==, tableContent=null), ArticleFig(id=1239231283637834402, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239231271126225100, language=CN, label=图6　, caption=凝结芽孢杆菌片霉菌和酵母菌总数（真菌）计数方法适用性试验, figureFileSmall=UVfWxU3FzyRDt6FGM85g/g==, figureFileBig=UWdG1TN+nZlnq+xHNkox5A==, tableContent=null), ArticleFig(id=1239231283755274920, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239231271126225100, language=EN, label=Fig.7, caption=Suitability of the total aerobic microbial counting method in the presence of Bacillus licheniformis capsules，live, figureFileSmall=o/8BRW00SRSqKoPiCiiHeA==, figureFileBig=Oj8RN6tkudpHjBs3hKnrng==, tableContent=null), ArticleFig(id=1239231283864326830, tenantId=1146029695717560320, 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tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239231271126225100, language=CN, label=图10　, caption=蜡样芽孢杆菌活菌片霉菌和酵母菌总数（真菌）计数方法适用性试验, figureFileSmall=JOXTxNZOYb+bR67EDVE+0Q==, figureFileBig=iU+XiYIOkhHVoz6TpJanBw==, tableContent=null), ArticleFig(id=1239231284787073730, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239231271126225100, language=EN, label=Fig.11, caption=Suitability of the total aerobic microbial counting method in the presence of Combined Bacillus subtilis and Enterococcus faecium granules with multivitamines，live, figureFileSmall=mN0gjhNdSIdxk7qVLQIG+Q==, figureFileBig=nG9eWiEWmqR87BW1NzKFBA==, tableContent=null), ArticleFig(id=1239231284896125638, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239231271126225100, language=CN, label=图11　, caption=枯草杆菌二联活菌颗粒需氧菌总数计数方法适用性试验, figureFileSmall=mN0gjhNdSIdxk7qVLQIG+Q==, figureFileBig=nG9eWiEWmqR87BW1NzKFBA==, tableContent=null), 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Bifidobacterium，Lactobacillus and Enterococcus powder，oral, figureFileSmall=dJAc7xoz9qgkh3j3Bmq80Q==, figureFileBig=Ib6h9jhYFapbKgfsl9Fsdw==, tableContent=null), ArticleFig(id=1239231285340721874, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239231271126225100, language=CN, label=图13　, caption=双歧杆菌三联活菌散需氧菌总数计数方法适用性试验, figureFileSmall=dJAc7xoz9qgkh3j3Bmq80Q==, figureFileBig=Ib6h9jhYFapbKgfsl9Fsdw==, tableContent=null), ArticleFig(id=1239231285449773782, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239231271126225100, language=EN, label=Fig.14, caption=Suitability of the total combined yeasts（molds） counting method in the presence of live combined Bifidobacterium，Lactobacillus and Enterococcus powder，oral, figureFileSmall=vxe3nNYowIRBpm7zHlLwCw==, figureFileBig=SZuhvXTNNrS0EUXZqi5fnA==, tableContent=null), ArticleFig(id=1239231285533659864, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239231271126225100, language=CN, label=图14　, caption=双歧杆菌三联活菌散霉菌和酵母菌总数（真菌）计数方法适用性试验, figureFileSmall=vxe3nNYowIRBpm7zHlLwCw==, figureFileBig=SZuhvXTNNrS0EUXZqi5fnA==, tableContent=null), ArticleFig(id=1239231285642711771, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239231271126225100, language=EN, label=Fig.15, caption=Study on total aerobic microbial counting method of Bacillus licheniformis capsules，live, figureFileSmall=stB5Lt5nWOkY4ngpoNgJDQ==, figureFileBig=XwSd27rYEb2+MlrsrWHqBA==, tableContent=null), ArticleFig(id=1239231285726597853, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239231271126225100, language=CN, label=图15　, caption=地衣芽孢杆菌活菌胶囊非致病性杂菌方法探索, figureFileSmall=stB5Lt5nWOkY4ngpoNgJDQ==, figureFileBig=XwSd27rYEb2+MlrsrWHqBA==, tableContent=null), ArticleFig(id=1239231285806289630, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239231271126225100, language=EN, label=Fig.16, caption=Decision tree for the microbial contamination enumeration methods of live microecological products, figureFileSmall=zxt/c82Vj+zPEq9MPIIWMA==, figureFileBig=JCPaR0Y7MXX+nXJJczafrQ==, tableContent=null), ArticleFig(id=1239231285885981408, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239231271126225100, language=CN, label=图16　, caption=微生态活菌制品杂菌检查决策树, figureFileSmall=zxt/c82Vj+zPEq9MPIIWMA==, figureFileBig=JCPaR0Y7MXX+nXJJczafrQ==, tableContent=null), ArticleFig(id=1239231285999227619, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239231271126225100, language=EN, label=Tab.1, caption=

Approved live microecological products for marketing and samples collected or not

, figureFileSmall=null, figureFileBig=null, tableContent=

序号 (No.)	制品名称 (name of product)	细菌种类 (type of strain)	国药准字 （National Medicine Permit No.）	上市许可持有人 (marketing authorization holder)	是否征集到样品 (samples collected or not)
1	双歧杆菌活菌胶囊(live Bifidobacterium Capsules)	青春型双歧杆菌(Bifidobacterium adolescentis)	S10960040	丽珠集团丽珠制药厂(Livzon Group Livzon Pharmaceutical Factory)	是(yes)
2	双歧杆菌活菌散(live Bifidobacteria Powder)	青春型双歧杆菌(Bifidobacterium adolescentis)	S20040081	丽珠集团丽珠制药厂(Livzon Group Livzon Pharmaceutical Factory)	否(no)
3	双歧杆菌三联活菌胶囊(live combined Bifidobacterium，Lactobacillus and Enterococcus capsules，oral)	长型双歧杆菌(Bifidobacterium longum) 嗜酸乳杆菌(Lactobacillus acidophilus) 粪肠球菌(Enterococcus faecalis)	S10950032	上海上药信谊药厂有限公司(SPH Sine Pharmaceutical Laboratories Co.，Ltd.)	是(yes)
4	双歧杆菌三联活菌肠溶胶囊(Bifid triple viable capsules dissolving at intestines)	长型双歧杆菌(Bifidobacterium longum) 嗜酸乳杆菌(Lactobacillus acidophilus) 粪肠球菌(Enterococcus faecalis)	S19993065	晋城海斯制药有限公司(Jincheng Health Pharmaceutical Co.，Ltd.)	是(yes)
5	双歧杆菌三联活菌散(live combined Bifidobacterium，Lactobacillus and Enterococcus oowder，oral)	长型双歧杆菌(Bifidobacterium longum) 嗜酸乳杆菌(Enterococcus faecalis) 粪肠球菌(Lactobacillus acidophilus)	S10970104	上海上药信谊药厂有限公司(SPH Sine Pharmaceutical Laboratories Co.，Ltd.)	是(yes)
6	双歧杆菌乳杆菌三联活菌片(live combined Bifidobacterium and Lactobacillus tablets)	长型双歧杆菌(Bifidobacterium longum) 保加利亚乳杆菌(Lactobacillus bulgaricus) 嗜热链球菌(Streptococcus thermophilus)	S19980004	内蒙古双奇药业股份有限公司(Inner Mongolia Shuangqi Pharmaceutical Co.，Ltd.)	否(no)
7	地衣芽孢杆菌活菌胶囊(Bacillus licheniformis capsules，live)	地衣芽孢杆菌(Bacillus licheniformis)	S20083112	浙江京新药业股份有限公司(Zhejiang Jingxin Pharmaceutical Co.，Ltd.)	是(yes)
			S20153010		是(yes)
			S10950019	东北制药集团沈阳第一制药有限公司(Northeast Pharmaceutical Group Shenyang No.1 Pharmaceutical Co.，Ltd.)	是(yes)
8	地衣芽孢杆菌活菌颗粒(Bacillus licheniformis granules，live)	地衣芽孢杆菌(Bacillus licheniformis)	S20073008	东北制药集团沈阳第一制药有限公司(Northeast Pharmaceutical Group Shenyang No.1 Pharmaceutical Co.，Ltd.)	是(yes)
			S20143001		是(yes)
9	地衣芽孢杆菌活菌片(Bacillus licheniformis tablets，live)①	地衣芽孢杆菌(Bacillus licheniformis)	/	/	/
10	蜡样芽孢杆菌活菌胶囊(live Bacillus cereus capsules)	蜡样芽孢杆菌(Bacillus cereus)	S10980014	安阳市源首生物药业有限责任公司(Anyang Yuanshou Biological Pharmaceutical Industry Co.，Ltd.)	是(yes)
11	蜡样芽孢杆菌活菌片(live Bacillus cereus tablets)	蜡样芽孢杆菌(Bacillus cereus)	S10970030		是(yes)
12	双歧杆菌四联活菌片(combined Bifidobacterium，Lactobacillus，Enterococcus and Bacillus cereus tablets，live)	婴儿型双歧杆菌(Bifidobacterium longum subsp. infantis) 嗜酸乳杆菌(Bifidobacterium longum subsp. infantis) 粪肠球菌(Enterococcus faecalis) 蜡样芽孢杆菌(Bacillus cereus)	S20060010	杭州远大生物制药有限公司(Hanazhou Grand Biologic Pharmaceutical INC.)	是(yes)
13	酪酸梭菌活菌胶囊(Clostridium butyricum capsules，live)	酪酸梭状芽孢杆菌(Clostridium butyricum)	S20040054	远大生命科学（重庆）有限公司(Grand Life Sciences (Chongqing) INC.)	是(yes)
			S20040084	青岛东海药业有限公司(Qingdao Eastsea Pharmaceutical Co.，Ltd.)	是(yes)
14	酪酸梭菌活菌散(Clostridium butyricum powder，live)	酪酸梭状芽孢杆菌(Clostridium butyricum)	S20040088	青岛东海药业有限公司(Qingdao Eastsea Pharmaceutical Co.，Ltd.)	是(yes)
15	酪酸梭菌活菌片(Clostridium butyricum tablets，live)	酪酸梭状芽孢杆菌(Clostridium butyricum)	S20040083	青岛东海药业有限公司(Qingdao Eastsea Pharmaceutical Co.，Ltd.)	是(yes)
16	凝结芽孢杆菌活菌片(Bacillus coagulans tablets，live)	凝结芽孢杆菌(Bacillus coagulans)	S20040032	青岛东海药业有限公司(Qingdao Eastsea Pharmaceutical Co.，Ltd.)	是(yes)
17	酪酸梭菌二联活菌胶囊(combined Clostridium butyricum and Bifidobacterium capsules，live)	酪酸梭状芽孢杆菌(Clostridium butyricum) 婴儿型双歧杆菌(Bifidobacterium longum subsp. infantis)	S20020015	科兴生物制药股份有限公司(Shandong Kexing Biological Products Co.，Ltd.)	是(yes)
18	酪酸梭菌二联活菌散(combined Clostridium butyricum and Bifidobacterium powders，live)	酪酸梭状芽孢杆菌(Clostridium butyricum) 婴儿型双歧杆菌(Bifidobacterium longum subsp. infantis)	S20020014		是(yes)
19	枯草杆菌活菌胶囊(Bacillus subtilis capsules，live)	枯草芽孢杆菌(Bacillus subtilis)	S20030018	华润紫竹药业有限公司(China Resources Zizhu Pharmaceutical Co.，Ltd.)	否(no)
20	枯草杆菌二联活菌颗粒(combined Bacillus subtilis and Enterococcus faecium granules with multivitamines，live)②	枯草芽孢杆菌(Bacillus subtilis) 屎肠球菌(Enterococcus faecium)	S20020037	北京韩美药品有限公司(Inner Mongolia Shuangqi Pharmaceutical Co.，Ltd.)	是(yes)
21	枯草杆菌肠球菌二联活菌肠溶胶囊(live combined Bacillus subtilis and Enterococcus faecium enteric-coated capsules)③	枯草芽孢杆菌(Bacillus subtilis) 屎肠球菌(Enterococcus faecium)	S20030087		是(yes)
22	阴道用乳杆菌活菌胶囊(live Lactobacillus capsules for vaginal use)	德氏乳杆菌(Lactobacillus delbrueckii)	S20030005	内蒙古双奇药业股份有限公司(Inner Mongolia Shuangqi Pharmaceutical Co.，Ltd.)	否(no)

), ArticleFig(id=1239231286108279526, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239231271126225100, language=CN, label=表1, caption=

已批准上市的微生态活菌制品及样品征集情况

, figureFileSmall=null, figureFileBig=null, tableContent=

序号 (No.)	制品名称 (name of product)	细菌种类 (type of strain)	国药准字 （National Medicine Permit No.）	上市许可持有人 (marketing authorization holder)	是否征集到样品 (samples collected or not)
1	双歧杆菌活菌胶囊(live Bifidobacterium Capsules)	青春型双歧杆菌(Bifidobacterium adolescentis)	S10960040	丽珠集团丽珠制药厂(Livzon Group Livzon Pharmaceutical Factory)	是(yes)
2	双歧杆菌活菌散(live Bifidobacteria Powder)	青春型双歧杆菌(Bifidobacterium adolescentis)	S20040081	丽珠集团丽珠制药厂(Livzon Group Livzon Pharmaceutical Factory)	否(no)
3	双歧杆菌三联活菌胶囊(live combined Bifidobacterium，Lactobacillus and Enterococcus capsules，oral)	长型双歧杆菌(Bifidobacterium longum) 嗜酸乳杆菌(Lactobacillus acidophilus) 粪肠球菌(Enterococcus faecalis)	S10950032	上海上药信谊药厂有限公司(SPH Sine Pharmaceutical Laboratories Co.，Ltd.)	是(yes)
4	双歧杆菌三联活菌肠溶胶囊(Bifid triple viable capsules dissolving at intestines)	长型双歧杆菌(Bifidobacterium longum) 嗜酸乳杆菌(Lactobacillus acidophilus) 粪肠球菌(Enterococcus faecalis)	S19993065	晋城海斯制药有限公司(Jincheng Health Pharmaceutical Co.，Ltd.)	是(yes)
5	双歧杆菌三联活菌散(live combined Bifidobacterium，Lactobacillus and Enterococcus oowder，oral)	长型双歧杆菌(Bifidobacterium longum) 嗜酸乳杆菌(Enterococcus faecalis) 粪肠球菌(Lactobacillus acidophilus)	S10970104	上海上药信谊药厂有限公司(SPH Sine Pharmaceutical Laboratories Co.，Ltd.)	是(yes)
6	双歧杆菌乳杆菌三联活菌片(live combined Bifidobacterium and Lactobacillus tablets)	长型双歧杆菌(Bifidobacterium longum) 保加利亚乳杆菌(Lactobacillus bulgaricus) 嗜热链球菌(Streptococcus thermophilus)	S19980004	内蒙古双奇药业股份有限公司(Inner Mongolia Shuangqi Pharmaceutical Co.，Ltd.)	否(no)
7	地衣芽孢杆菌活菌胶囊(Bacillus licheniformis capsules，live)	地衣芽孢杆菌(Bacillus licheniformis)	S20083112	浙江京新药业股份有限公司(Zhejiang Jingxin Pharmaceutical Co.，Ltd.)	是(yes)
			S20153010		是(yes)
			S10950019	东北制药集团沈阳第一制药有限公司(Northeast Pharmaceutical Group Shenyang No.1 Pharmaceutical Co.，Ltd.)	是(yes)
8	地衣芽孢杆菌活菌颗粒(Bacillus licheniformis granules，live)	地衣芽孢杆菌(Bacillus licheniformis)	S20073008	东北制药集团沈阳第一制药有限公司(Northeast Pharmaceutical Group Shenyang No.1 Pharmaceutical Co.，Ltd.)	是(yes)
			S20143001		是(yes)
9	地衣芽孢杆菌活菌片(Bacillus licheniformis tablets，live)①	地衣芽孢杆菌(Bacillus licheniformis)	/	/	/
10	蜡样芽孢杆菌活菌胶囊(live Bacillus cereus capsules)	蜡样芽孢杆菌(Bacillus cereus)	S10980014	安阳市源首生物药业有限责任公司(Anyang Yuanshou Biological Pharmaceutical Industry Co.，Ltd.)	是(yes)
11	蜡样芽孢杆菌活菌片(live Bacillus cereus tablets)	蜡样芽孢杆菌(Bacillus cereus)	S10970030		是(yes)
12	双歧杆菌四联活菌片(combined Bifidobacterium，Lactobacillus，Enterococcus and Bacillus cereus tablets，live)	婴儿型双歧杆菌(Bifidobacterium longum subsp. infantis) 嗜酸乳杆菌(Bifidobacterium longum subsp. infantis) 粪肠球菌(Enterococcus faecalis) 蜡样芽孢杆菌(Bacillus cereus)	S20060010	杭州远大生物制药有限公司(Hanazhou Grand Biologic Pharmaceutical INC.)	是(yes)
13	酪酸梭菌活菌胶囊(Clostridium butyricum capsules，live)	酪酸梭状芽孢杆菌(Clostridium butyricum)	S20040054	远大生命科学（重庆）有限公司(Grand Life Sciences (Chongqing) INC.)	是(yes)
			S20040084	青岛东海药业有限公司(Qingdao Eastsea Pharmaceutical Co.，Ltd.)	是(yes)
14	酪酸梭菌活菌散(Clostridium butyricum powder，live)	酪酸梭状芽孢杆菌(Clostridium butyricum)	S20040088	青岛东海药业有限公司(Qingdao Eastsea Pharmaceutical Co.，Ltd.)	是(yes)
15	酪酸梭菌活菌片(Clostridium butyricum tablets，live)	酪酸梭状芽孢杆菌(Clostridium butyricum)	S20040083	青岛东海药业有限公司(Qingdao Eastsea Pharmaceutical Co.，Ltd.)	是(yes)
16	凝结芽孢杆菌活菌片(Bacillus coagulans tablets，live)	凝结芽孢杆菌(Bacillus coagulans)	S20040032	青岛东海药业有限公司(Qingdao Eastsea Pharmaceutical Co.，Ltd.)	是(yes)
17	酪酸梭菌二联活菌胶囊(combined Clostridium butyricum and Bifidobacterium capsules，live)	酪酸梭状芽孢杆菌(Clostridium butyricum) 婴儿型双歧杆菌(Bifidobacterium longum subsp. infantis)	S20020015	科兴生物制药股份有限公司(Shandong Kexing Biological Products Co.，Ltd.)	是(yes)
18	酪酸梭菌二联活菌散(combined Clostridium butyricum and Bifidobacterium powders，live)	酪酸梭状芽孢杆菌(Clostridium butyricum) 婴儿型双歧杆菌(Bifidobacterium longum subsp. infantis)	S20020014		是(yes)
19	枯草杆菌活菌胶囊(Bacillus subtilis capsules，live)	枯草芽孢杆菌(Bacillus subtilis)	S20030018	华润紫竹药业有限公司(China Resources Zizhu Pharmaceutical Co.，Ltd.)	否(no)
20	枯草杆菌二联活菌颗粒(combined Bacillus subtilis and Enterococcus faecium granules with multivitamines，live)②	枯草芽孢杆菌(Bacillus subtilis) 屎肠球菌(Enterococcus faecium)	S20020037	北京韩美药品有限公司(Inner Mongolia Shuangqi Pharmaceutical Co.，Ltd.)	是(yes)
21	枯草杆菌肠球菌二联活菌肠溶胶囊(live combined Bacillus subtilis and Enterococcus faecium enteric-coated capsules)③	枯草芽孢杆菌(Bacillus subtilis) 屎肠球菌(Enterococcus faecium)	S20030087		是(yes)
22	阴道用乳杆菌活菌胶囊(live Lactobacillus capsules for vaginal use)	德氏乳杆菌(Lactobacillus delbrueckii)	S20030005	内蒙古双奇药业股份有限公司(Inner Mongolia Shuangqi Pharmaceutical Co.，Ltd.)	否(no)

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