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Article(id=1200147769445941432, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1200147768326062257, articleNumber=1001-2494(2024)09-0840-05, orderNo=null, doi=10.11669/cpj.2024.09.010, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1689696000000, receivedDateStr=2023-07-19, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1764067125902, onlineDateStr=2025-11-25, pubDate=1715097600000, pubDateStr=2024-05-08, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1764067125902, onlineIssueDateStr=2025-11-25, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1764067125902, creator=13701087609, updateTime=1764067125902, updator=13701087609, issue=Issue{id=1200147768326062257, tenantId=1146029695717560320, journalId=1190317699101192196, year='2024', volume='59', issue='9', pageStart='757', pageEnd='856', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1764067125636, creator=13701087609, updateTime=1764067301065, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1200148504178950495, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1200147768326062257, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1200148504178950496, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1200147768326062257, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=840, endPage=844, ext={EN=ArticleExt(id=1200147769756319931, articleId=1200147769445941432, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Methods for Examining Viable Bacterial Count and Contaminating Bacteria of Bacillus cereus Tablets, columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

OBJECTIVE To discuss the rationality of the current methods for examining viable bacterial count and contaminating bacteria in the standard of Bacillus cereus tablets, and optimize the two methods. METHODS The factors that affect the method for viable bacterial count were compared and analyzed, such as medium, diluent, dilution ratio, and pre-treatment, then the optimal experimental conditions were selected. The microbial limit test in the current standard was replaced with the contaminating bacteria test under the general chapter for probiotic in Chinese Pharmacopoeia part III, and its suitability was studied. RESULTS The optimized method for determination of viable bacterial count could more effectively recover Bacillus cereus in the sample, and the results were significantly higher than the current standard method. The use of a new method for detecting non-pathogenic bacteria can discover potential risks in the sample, and its suitability investigation results basically met the requirements of the Chinese Pharmacopoeia. CONCLUSION The new methods are suitable for the determination of viable bacterial count and detection of contaminating bacteria in Bacillus cereus tablets. The current standards for the determination of viable bacterial count and microbial limit testing cannot effectively monitor product quality risks. It is recommended to revise the methods. This can not only more effectively regulate products, but also better assist manufacturers in improving product quality.

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目的 对蜡样芽孢杆菌片现行标准中活菌数测定方法以及杂菌检查法的合理性进行探讨,并对这两法进行优化。方法 对影响活菌数测定的因素,如培养基、稀释剂、稀释倍数、前处理方法,进行比较分析,选择较优的实验条件。使用微生态活菌制品总论下的杂菌检查法替代标准中的微生物限度检查法,并对其适用性进行研究。结果 优化后的活菌数测定方法可以更加有效地复苏样品中的蜡样芽孢杆菌,结果明显高于现行标准方法。采用新的杂菌检查法能检出非致病性杂菌,发现样品可能存在风险,其适用性结果基本符合《中国药典》的要求。结论 新方法适用于蜡样芽孢杆菌片活菌数测定和杂菌检查。现行标准中的活菌数测定法以及微生物限度检查不能很好地监测产品的质量风险,建议对方法进行修订,这样既可以更有效地监管产品,又可以更好地帮助生产企业提高产品质量。

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陈伟盛,男,硕士,副主任药师 研究方向:分子生物学、药品分析、微生物检验 Tel:(020)81245120

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陈伟盛,男,硕士,副主任药师 研究方向:分子生物学、药品分析、微生物检验 Tel:(020)81245120

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陈伟盛,男,硕士,副主任药师 研究方向:分子生物学、药品分析、微生物检验 Tel:(020)81245120

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Gansu Anim Husb Vet(甘肃畜牧兽医), 2022, 52(3):34-36, 40., articleTitle=Stress resistance studies of Bacillus cereus, refAbstract=null), Reference(id=1200147776257491465, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147769445941432, doi=null, pmid=null, pmcid=null, year=2022, volume=57, issue=3, pageStart=231, pageEnd=236, url=null, language=null, rfNumber=[8], rfOrder=7, authorNames=WANG Y H, ZHENG X L, RUAN H, journalName=Chin Pharm J(中国药学杂志), refType=null, unstructuredReference=WANG Y H, ZHENG X L, RUAN H, et al. Detection of staphylococcus aureus in Bacillus licheniformis live products by PMA-qPCR[J]. 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A-rose bengal agar; B-rose red sodium agar.

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A-孟加拉红培养基;B-玫瑰红钠琼脂培养基。

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Comparison of viable bacterial count in Bacillus cereus tablets under different pre-treatment conditions

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Batch
No.		 Different pre-treatment viable bacterial count/cfu·g-1
Saline
group		 0.3% Lecithin-saline
group		 Heat treatment saline
group
190825 7.6×108 1.7×109 1.5×109
190829 8.4×108 1.3×109 1.6×109
190831 7.2×108 2.1×109 1.9×109
), ArticleFig(id=1200147774000955803, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147769445941432, language=CN, label=表1, caption=

蜡样芽孢杆菌片不同处理条件下活菌数测定比较

, figureFileSmall=null, figureFileBig=null, tableContent=
Batch
No.		 Different pre-treatment viable bacterial count/cfu·g-1
Saline
group		 0.3% Lecithin-saline
group		 Heat treatment saline
group
190825 7.6×108 1.7×109 1.5×109
190829 8.4×108 1.3×109 1.6×109
190831 7.2×108 2.1×109 1.9×109
), ArticleFig(id=1200147774130979236, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147769445941432, language=EN, label=Tab.2, caption=

Comparison of viable count of Bacillus cereus under different dilutions

, figureFileSmall=null, figureFileBig=null, tableContent=
Batch
No.		 Plate colony count at different dilutions/cfu
1∶106 1∶107 5∶107 5∶108
190825 213 19 87 12
190829 156 16 64 13
190831 223 20 104 9
), ArticleFig(id=1200147774202282410, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147769445941432, language=CN, label=表2, caption=

不同稀释方法下蜡样芽孢杆菌的活菌数测定比较

, figureFileSmall=null, figureFileBig=null, tableContent=
Batch
No.		 Plate colony count at different dilutions/cfu
1∶106 1∶107 5∶107 5∶108
190825 213 19 87 12
190829 156 16 64 13
190831 223 20 104 9
), ArticleFig(id=1200147774286168494, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147769445941432, language=EN, label=Tab.3, caption=

Result of specified microorganisms of Bacillus cereus tablets

, figureFileSmall=null, figureFileBig=null, tableContent=
Specified microorganisms Escherichia coli Shigella Fuchii Salmonella Pseudomonas aeruginosa Staphylococcus aureus
Enrichment medium Turbidity Turbidity Turbidity Turbidity Turbidity
Selective agar medium -,-,- -,-,- -,-,- -,-,- Bacillus cereus1)
Positive control +,+,+ +,+,+ +,+,+ +,+,+ +,-1),-1)
), ArticleFig(id=1200147774378443187, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147769445941432, language=CN, label=表3, caption=

蜡样芽孢杆菌片控制菌检查结果

, figureFileSmall=null, figureFileBig=null, tableContent=
Specified microorganisms Escherichia coli Shigella Fuchii Salmonella Pseudomonas aeruginosa Staphylococcus aureus
Enrichment medium Turbidity Turbidity Turbidity Turbidity Turbidity
Selective agar medium -,-,- -,-,- -,-,- -,-,- Bacillus cereus1)
Positive control +,+,+ +,+,+ +,+,+ +,+,+ +,-1),-1)
), ArticleFig(id=1200147774542021051, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147769445941432, language=EN, label=Tab.4, caption=

Medium suitability results in fungal count

, figureFileSmall=null, figureFileBig=null, tableContent=
Medium Recovery ratio
Staphylococcus
aureus		 Bacillus
subtilis		 Escherichia
coli
Mannitol salt agar 0.9 0.9 0
0.9 g·L-1 Deoxycholic acid nutrient agar 0 0 0.7
), ArticleFig(id=1200147774630101440, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147769445941432, language=CN, label=表4, caption=

真菌计数培养基适用性结果

, figureFileSmall=null, figureFileBig=null, tableContent=
Medium Recovery ratio
Staphylococcus
aureus		 Bacillus
subtilis		 Escherichia
coli
Mannitol salt agar 0.9 0.9 0
0.9 g·L-1 Deoxycholic acid nutrient agar 0 0 0.7
), ArticleFig(id=1200147774730764741, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147769445941432, language=EN, label=Tab.5, caption=

Test results of non-pathogenic contaminating bacteria of Bacillus cereus tablets

, figureFileSmall=null, figureFileBig=null, tableContent=
Medium Result/cfu·g-1 Positive rate
190825 190829 190831 1∶10 Test solution 0.1 mL coating 1 000 cfu Bacillus cereus coating
Mannitol salt agar 5.9×104 4.4×104 4.8×104 0 1) 0.9
0.9 g·L-1 Deoxycholic acid nutrient agar 0 0 0 1.2 0.7
), ArticleFig(id=1200147774860788173, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147769445941432, language=CN, label=表5, caption=

蜡样芽孢杆菌片非致病性杂菌检查结果

, figureFileSmall=null, figureFileBig=null, tableContent=
Medium Result/cfu·g-1 Positive rate
190825 190829 190831 1∶10 Test solution 0.1 mL coating 1 000 cfu Bacillus cereus coating
Mannitol salt agar 5.9×104 4.4×104 4.8×104 0 1) 0.9
0.9 g·L-1 Deoxycholic acid nutrient agar 0 0 0 1.2 0.7
), ArticleFig(id=1200147775074697685, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147769445941432, language=EN, label=Tab.6, caption=

Fungal count results of Bacillus cereus tablets

, figureFileSmall=null, figureFileBig=null, tableContent=
Medium Suitability rate Positive rate
Rose red sodium agar 1.1 1.1
Rose bengal agar 1.1 1.2
), ArticleFig(id=1200147775179555292, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1200147769445941432, language=CN, label=表6, caption=

蜡样芽孢杆菌片真菌计数结果

, figureFileSmall=null, figureFileBig=null, tableContent=
Medium Suitability rate Positive rate
Rose red sodium agar 1.1 1.1
Rose bengal agar 1.1 1.2
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关于蜡样芽孢杆菌片活菌数测定和杂菌检查方法的研究
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陈伟盛 1 , 简敏骞 1 , 刘瑜 1 , 郑小玲 2
中国药学杂志 | 论著 2024,59(9): 840-844
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中国药学杂志 | 论著 2024, 59(9): 840-844
关于蜡样芽孢杆菌片活菌数测定和杂菌检查方法的研究
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陈伟盛1, 简敏骞1, 刘瑜1, 郑小玲2
作者信息
  • 1 广州市药品检验所, 广州 510160
  • 2 浙江省食品药品检验研究院, 杭州 310004

    • 陈伟盛,男,硕士,副主任药师 研究方向:分子生物学、药品分析、微生物检验 Tel:(020)81245120

Methods for Examining Viable Bacterial Count and Contaminating Bacteria of Bacillus cereus Tablets
Weisheng CHEN1, Minqian JIAN1, Yu LIU1, Xiaoling ZHENG2
Affiliations
  • 1 Guangzhou Institute for Drug Control, Guangzhou 510160, China
  • 2 Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China
出版时间: 2024-05-08 doi: 10.11669/cpj.2024.09.010
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摘要
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目的 对蜡样芽孢杆菌片现行标准中活菌数测定方法以及杂菌检查法的合理性进行探讨,并对这两法进行优化。方法 对影响活菌数测定的因素,如培养基、稀释剂、稀释倍数、前处理方法,进行比较分析,选择较优的实验条件。使用微生态活菌制品总论下的杂菌检查法替代标准中的微生物限度检查法,并对其适用性进行研究。结果 优化后的活菌数测定方法可以更加有效地复苏样品中的蜡样芽孢杆菌,结果明显高于现行标准方法。采用新的杂菌检查法能检出非致病性杂菌,发现样品可能存在风险,其适用性结果基本符合《中国药典》的要求。结论 新方法适用于蜡样芽孢杆菌片活菌数测定和杂菌检查。现行标准中的活菌数测定法以及微生物限度检查不能很好地监测产品的质量风险,建议对方法进行修订,这样既可以更有效地监管产品,又可以更好地帮助生产企业提高产品质量。

微生态活菌制剂  /  杂菌检查  /  活菌数测定  /  辐射

OBJECTIVE To discuss the rationality of the current methods for examining viable bacterial count and contaminating bacteria in the standard of Bacillus cereus tablets, and optimize the two methods. METHODS The factors that affect the method for viable bacterial count were compared and analyzed, such as medium, diluent, dilution ratio, and pre-treatment, then the optimal experimental conditions were selected. The microbial limit test in the current standard was replaced with the contaminating bacteria test under the general chapter for probiotic in Chinese Pharmacopoeia part III, and its suitability was studied. RESULTS The optimized method for determination of viable bacterial count could more effectively recover Bacillus cereus in the sample, and the results were significantly higher than the current standard method. The use of a new method for detecting non-pathogenic bacteria can discover potential risks in the sample, and its suitability investigation results basically met the requirements of the Chinese Pharmacopoeia. CONCLUSION The new methods are suitable for the determination of viable bacterial count and detection of contaminating bacteria in Bacillus cereus tablets. The current standards for the determination of viable bacterial count and microbial limit testing cannot effectively monitor product quality risks. It is recommended to revise the methods. This can not only more effectively regulate products, but also better assist manufacturers in improving product quality.

probiotic  /  contaminating bacteria  /  viable bacterial count  /  radiation
陈伟盛, 简敏骞, 刘瑜, 郑小玲. 关于蜡样芽孢杆菌片活菌数测定和杂菌检查方法的研究. 中国药学杂志, 2024 , 59 (9) : 840 -844 . DOI: 10.11669/cpj.2024.09.010
Weisheng CHEN, Minqian JIAN, Yu LIU, Xiaoling ZHENG. Methods for Examining Viable Bacterial Count and Contaminating Bacteria of Bacillus cereus Tablets[J]. Chinese Pharmaceutical Journal, 2024 , 59 (9) : 840 -844 . DOI: 10.11669/cpj.2024.09.010
正文
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微生态活菌制品,也称微生态制剂,是一类生物制品。根据资料显示,在临床上有很多微生态活菌制品与常规药物联合应用的案例,对儿童、老年人疾病的治疗有显著效果,提高了治疗质量[1]。蜡样芽孢杆菌片,又称蜡样芽孢杆菌活菌片,该产品的有效成分为蜡样芽孢杆菌,该菌的作用主要包括抑菌功能、抗炎作用以及促生长作用,属于微生态活菌制品,常用于婴幼儿腹泻、慢性腹泻、肠功能紊乱及肠炎的治疗。蜡样芽孢杆菌片为我国批准上市的微生态制剂之一,目前使用的标准为WS-10001-(HD-0901)-2002,起草时间为2002年。而《中国药典》已经更新至2020年版,其标准面临修订与更新以适应新版药典体系,提高药品用药安全。
评价微生态活菌制品质量的两个重要指标分别活菌数和杂菌。活菌数测定结果可以表示其效力[2],杂菌检查是微生态活菌制品安全指标之一。2020年版《中国药典》三部微生态活菌制品总论项下附录2和3分别列出了微生态活菌制品活菌数测定法和杂菌检查法的基本规定,但是没有针对具体品种提出具体的检测方法[3]。本研究对现行标准中的活菌数测定法和杂菌检查方法进行优化,并就发现的问题进行探讨。
1 仪器与试药
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1.1 仪器
IGS180 培养箱、1378型生物安全柜(美国Thermo 公司);MIR-254 低温培养箱(日本Panasonic 公司);HTY-761匀浆仪(杭州泰林有限公司);PM200电子天平(梅特勒-托利多国际有限公司)。
1.2 菌种
金黄色葡萄球菌[CMCC(B)26003]、大肠埃希菌[CMCC(B)44102]、铜绿假单胞菌[CMCC(B)10104]、乙型副伤寒沙门菌[CMCC(B)50094]、福氏志贺菌[CMCC(B)51571]、白色念珠菌[CMCC(F)98001]、黑曲霉[CMCC(F)98003],以上菌株均来自中国食品药品检定研究院。
1.3 试剂及培养基
脱氧胆酸钠(麦克林,D6128-10g)、胰酪大豆胨液体培养基(2001092)、NAC液体培养基(2003022)、胆盐乳糖培养基(1806072)、7.5%氯化钠肉汤培养基(190215)、NAC琼脂培养基(180719)、曙红亚甲基蓝琼脂培养基(190103)、沙门,志贺菌属琼脂培养基(190625)、甘露醇氯化钠琼脂培养基(200901)、玫瑰红纳琼脂培养基(180607)(北京三药科技开发公司);血琼脂平板(201221)、孟加拉红琼脂培养基(190926)(北京陆桥技术股份有限公司)。
1.4 样品情况
标准提高项目,样品来源于函调样品,由生产企业A提供,共计3批样品,其批次为:190825;190829;190831。
2 方法
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2.1 活菌数测定
现行标准WS-100010(HD-0901)-2002活菌计数测定采用常规的10倍稀释法,稀释剂为生理盐水,采用0.1 mL涂布法,测定培养基是血琼脂培养基。2020年版《中国药典》三部微生态活菌制品总论采用的活菌数测定培养基为营养琼脂,首先比对不同培养基的测定结果差异。由于蜡样芽孢杆菌一般以芽孢休眠体存在于样品中,因此还要考察稀释液、热处理(热激活)对计数结果的影响。
2.2 杂菌检查法
按照2020年版《中国药典》三部微生态活菌制品总论的杂菌检查方法对样品进行杂菌检查,考察不同培养基对杂菌检查结果的影响,同时按照2020年版《中国药典》三部微生态活菌制品总论的要求进行培养基适用性以及阳性对照的实验。
3 结果
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3.1 活菌数测定结果
首先考察血琼脂培养基和营养琼脂培养基对活菌数测定结果的影响,3批样品结果为:①血琼脂培养基:6.3×108、7.8×108、1.0×109 cfu·g-1;②营养琼脂培养基:8.1×108、1.0×109、1.1×109 cfu·g-1。从测定结果可以看出,两种培养基的活菌数测定结果基本一致,但是根据培养基上的形态结果,血琼脂培养基上的蜡样芽孢杆菌有明显的溶血圈,菌落容易识别,因此认为现行标准的血琼脂培养基更加适合活菌数测定。
接着考察不同稀释液以及是否热激活对活菌数测定结果的影响,热激活处理条件参照2020年版《中国药典》四部通则9208,选择80 ℃×10 min。结果见表1。含0.3%卵磷脂的生理盐水和经过热激活处理的活菌数测定结果基本一致,而且明显高于生理盐水的活菌数测定结果。说明活菌数测定适宜采用含有0.3%卵磷脂的生理盐水作为稀释剂或对1∶10供试液进行激活处理。
在活菌数测定实验中发现蜡样芽孢杆菌生长具有蔓延性,平皿菌落数量最好控制在100左右,超过100个时由于蔓延生长会导致计数困难。因此对常规10倍稀释进行了调整,在制备1∶10供试液后,取5 mL供试液至100 mL,制成5∶100供试液,然后再进行10倍稀释。不同稀释方法比较结果见表2。
3.2 杂菌检查结果
现行标准WS-100010(HD-0901)-2002参照微生物限度进行,不进行细菌总数检查,仅规定霉菌数每克不得过100个,不得检出大肠埃希菌。但是按照2020年版《中国药典》三部生态活菌制品总论附录1,该样品属于微生态活菌制剂,应该进行杂菌检查,而不是微生物限度检查,因此参考2020年版《中国药典》三部微生态活菌制品总论进行杂菌检查。
3.2.1 控制菌
根据微生态活菌制品总论的限度要求,口服制剂的控制菌需要检查大肠埃希菌、志贺菌、沙门菌、铜绿假单胞菌及金黄色葡萄球菌。检查控制菌的培养基均进行了培养基适用性检查,结果均符合《中国药典》要求。在进行样品检验时,按照《中国药典》要求,需要加入阳性对照,样品检查结果及阳性对照结果见表3。根据检查结果,3批样品均未检出规定的控制菌,但是在金黄色葡萄球菌的检查中,阳性对照并没有全部检出相应的阳性菌,只有1个批次的样品检出金黄色葡萄球菌,同时在3批次的金黄色葡萄球菌的选择性培养基上均能观察到蜡样芽孢杆菌。说明蜡样芽孢菌一定程度抑制了金黄色葡萄球菌的生长,从而导致了只有1批次的阳性对照检出金黄色葡萄球菌。在其余的控制菌选择性培养基上均未观察到蜡样芽孢杆菌的生长,说明其他选择性培养基能很好地抑制蜡样芽孢杆菌生长。
3.2.2 非致病性杂菌
非致病性杂菌的检查,《中国药典》一般选用营养琼脂。但是检查过程中发现营养琼脂上的蜡样芽孢杆菌蔓延生长,其观察结果为无杂菌生长,无对照菌(金黄色葡萄球菌)生长。从结果可以得知,蜡样芽孢杆菌抑制金黄色葡萄球菌的生长。根据《中国药典》要求,大量活菌干扰杂菌检查时,也可以使用其他经验证的培养基。
参考控制菌检查结果,对控制菌选择性培养基配方进行分析,发现质量分数7.5%的氯化钠以及0.9 g·L-1脱氧胆酸对蜡样芽孢杆菌有一定的抑制作用,因此考察甘露醇氯化钠琼脂培养基以及0.9 g·L-1脱氧胆酸营养琼脂培养基的培养基适用性,结果见表4。根据结果,两种培养基均无法全部满足中国药典培养基适用性的要求,但是两种培养基合并使用,可以满足《中国药典》培养基适用性的要求。于是采用同时使用两种培养基合并计数的方法对样品的非致病性杂菌进行检查,甘露醇氯化钠琼脂培养基以金黄色葡萄球菌为阳性对照菌,0.9 g·L-1脱氧胆酸营养琼脂培养基以大肠埃希菌为阳性对照菌,结果见表5。根据非致病性杂菌检查结果,样品在甘露醇氯化钠琼脂培养基上观察到杂菌生长,且可以进行计数。在0.9 g·L-1脱氧胆酸营养琼脂培养基无杂菌生长。阳性对照菌在0.9 g·L-1脱氧胆酸营养琼脂培养基上回收率符合《中国药典》要求,甘露醇氯化钠琼脂培养基只有在1 000 cfu的蜡样芽孢杆菌平皿上的回收率符合《中国药典》要求,1∶10供试液涂布的平皿上回收率为0,但是能观察到零星的金黄色葡萄球菌。
3.2.3 真菌计数
根据非致病性杂菌的结果,以及文献[3]的记载,蜡样芽孢杆菌属于非苛养型细菌[4],在一般的生长条件下均能生长,因此在真菌计数时除了采用《中国药典》的玫瑰红钠琼脂培养基外,还使用了含有抗生素的孟加拉红琼脂培养基进行对比,结果见表6。结果显示,蜡样芽孢杆菌在玫瑰红钠琼脂培养基上有生长,虽然不影响阳性菌的计数,但是由于蜡样芽孢杆菌的生长对真菌计数会存在一定的干扰,见图1。孟加拉红琼脂培养基上可以完全抑制蜡样芽孢杆菌的生长,对计数结果干扰比较少。3批样品在孟加拉红琼脂培养基均未检出真菌。
3.3 杂菌鉴定结果
48 h后在蜡样芽孢杆菌表面长出了3种形态的小菌落,分别是米白色大颗粒、米白色小颗粒、黄色小颗粒。72 h后小菌落在平板上的生长更明显,结果见图2。经革兰染色镜检均为革兰阳性杆菌,结果见图3。使用Vitek 2 Compact 全自动生化分析仪进行鉴定,结果显示低鉴别率,无鉴定结果。使用16S rDNA测序方法对其进行鉴定,鉴定结果分别为Corynebacterium ammoniagenes, Corynebacterium humireducens, Corynebacterium pollutisoli,均为棒状杆菌属(Corynebacterium)。通过鉴定结果可知,甘露醇氯化钠琼脂培养基上生长的确实不是蜡样蜡样杆菌。
4 讨论与结论
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4.1 活菌测定的讨论
蜡样芽孢杆菌一般以休眠体形式存在于制剂中,活菌数测定就是要最大程度地复苏样品中处于休眠状态的蜡样芽孢杆菌。蜡样芽孢菌复苏效率越高,活菌测定结果越准确。芽孢的复苏一般可以通过提供良好的培养条件和热激活处理两种方式进行。因此,本研究比较了培养条件以及热激活的处理方法,发现两者结果基本一致。考虑到热激活操作复杂,该品种活菌数测定最终采用0.3%卵磷脂的生理盐水作为稀释剂,血琼脂培养基作为测定培养基的试验方法。新方法复苏效率高于现行标准方法,因此认为新方法优于现行标准方法。
4.2 杂菌检查结果的讨论
蜡样芽孢杆菌片应属于2020年版《中国药典》三部微生态活菌制品总论附录1中已批准上市的微生态活菌制品。其杂菌检查应该按照微生态活菌制品总论附录3进行。微生态活菌制品总论的杂菌检查有3个部分,分别为控制菌、非致病性杂菌和真菌,控制菌检查包括大肠埃希菌、志贺菌、沙门菌、铜绿假单胞菌及金黄色葡萄球菌。但是现行标准中的微生物限度仅进行霉菌计数、大肠埃希菌检查,杂菌检查项少于微生态活菌制品总论规定。实验中,在甘露醇氯化钠琼脂培养基上观察到样品存在的杂菌,经鉴定后确认为棒状杆菌属(Corynebacterium),其杂菌量超过了《中国药典》的规定限度(不得过1 000 cfu·g-1),说明该品种确实存在细菌污染的风险,现行标准只进行霉菌计数显然不合理。
在金黄色葡萄球菌检查中发现蜡样芽孢杆菌对金黄色葡萄球菌具有一定的抑制作用,导致阳性对照菌的生长不稳定。在非致病性杂菌检查中也发现类似情况,当采用营养琼脂进行检查时,无法观察到阳性对照菌——金黄色葡萄球菌的生长,这是由于蜡样芽孢杆菌的生长产生了抑菌物质[6-8]。采用甘露醇氯化钠琼脂培养基以及0.9 g·L-1脱氧胆酸营养琼脂培养基进行非致病性杂菌检查,在甘露醇氯化钠琼脂培养基上虽然回收率为0,但是可以在培养基上观察到零星的金黄色葡萄球菌生长。当平皿中的蜡样芽孢杆菌数调整至约1 000 cfu时,就可以获得理想的回收率,说明甘露醇氯化钠琼脂培养基能在一定程度上抑制蜡样芽孢杆菌的生长。通过观察平皿上的菌落形态,发现蜡样芽孢杆菌在甘露醇氯化钠琼脂培养基上的形态明显变小,生长变慢,没有出现营养琼脂上的蔓延生长,加上培养基对金黄色葡萄球菌有指示作用,所以更加容易观察到阳性对照菌的生长。
由于样品菌为蜡样芽孢杆菌,其抗逆性较强[9],经实验发现该产品经过3 kGy辐射处理后其活菌数量没有明显变化。说明一般的处理手段比较难以靶向性完全抑制其生长,只能减慢其生长速度,提高其他杂菌的检出率。
对于真菌计数,虽然《中国药典》没有特殊的要求,但是根据上述的实验结果,玫瑰红钠培养基虽然可以回收阳性对照菌,但是蜡样芽孢杆菌的生长在一定程度还是会影响计数,因此建议对于蜡样芽孢杆菌片直接采用含有抗生素的孟加拉红培养基进行真菌计数。
4.3 结论及建议
经优化后的方法可以检出样品中的杂菌,发现样品风险,同时阳性对照基本符合《中国药典》的要求,表明经优化的方法适用于该产品的活菌数测定与杂菌检查。同时通过上述实验结果发现,现行标准中的活菌数测定法以及微生物限度检查不能很好地监测产品的质量风险,建议对方法进行修订。这样即可以更有效地监管产品,也可以更好地帮助生产企业提高产品质量。
基金
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  • 广州市科技计划项目资助(202201011615)
  • 浙江省药品监督管理局科技计划项目资助(2023011)
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参考文献 引证文献
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2024年第59卷第9期
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doi: 10.11669/cpj.2024.09.010
  • 接收时间：2023-07-19
  • 首发时间：2025-11-25
  • 出版时间：2024-05-08
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  • 收稿日期：2023-07-19
基金
广州市科技计划项目资助(202201011615)
浙江省药品监督管理局科技计划项目资助(2023011)
作者信息
    1 广州市药品检验所, 广州 510160
    2 浙江省食品药品检验研究院, 杭州 310004
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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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