GLP管理体系下实验动物设施消毒剂、饲料和垫料有效期管理实践

doi:10.12300/j.issn.1674-5817.2025.162

摘要/Abstract

摘要：

目的为符合药物非临床研究质量管理规范（good laboratory practice for non-clinical pharmaceutical research， GLP）管理要求，本中心针对实验动物设施消毒剂、饲料、垫料使用过程中有效期规定缺乏数据支撑的问题，开展专项验证研究，同时总结物料管理实操经验，为实验动物设施物料规范化管理提供科学依据和参考。方法在本中心实验动物设施日常运行环境下，对配制和开封后第0d、7d、1、2和 3个月的常用4种消毒剂采用悬液定量杀灭试验以确认其消毒效力，对开封后储存7d的实验动物饲料进行营养成分、化学污染和微生物指标检测，对开封的SPF 级实验动物专用玉米芯垫料和经高温高压灭菌的普通级玉米芯垫料储存7d后进行微生物指标检测。结果在本中心GLP管理体系实验动物设施环境中，1% 84消毒液、0.1%百毒杀、0.2%新洁尔灭配制后第0d和第7d消毒剂效力杀灭对数值均≥5，75%酒精开封后第0d、第7d、第1个月、第2个月和第3个月消毒剂效力杀灭对数值均≥5，上述消毒剂均判定为合格有效；与出厂质检数据相比，开封后7d的SPF大小鼠维持饲料、SPF豚鼠生长繁殖饲料、普通级豚鼠生长繁殖饲料、兔维持饲料、犬维持饲料的营养成分、化学污染和微生物指标，虽整体呈轻微下降趋势，但无明显波动，各项指标仍均满足GB/T 14924.2—2001《实验动物配合饲料卫生标准》及GB 14924.3—2010《实验动物配合饲料营养成分》的相关要求；与出厂质检数据相比，开封后储存7d的SPF 级实验动物专用玉米芯垫料和普通级玉米芯垫料经高温高压灭菌后储存7d，微生物指标无明显波动，亦符合上述卫生标准规定。结论结合本中心GLP实验动物设施管理实践与实操经验，经核心质量指标检测验证，明确设定的消毒剂、饲料及垫料有效期满足质量要求，为实验动物设施的规范化管理提供参考。

关键词: 药物非临床研究质量管理规范（GLP）, 消毒剂, 饲料, 垫料, 有效期, 物料管理

Abstract:

Objective To meet the management requirements of Good Laboratory Practice for Non-clinical Pharmaceutical Research (GLP), our center focuses on addressing the problem that the specifications for the validity periods of disinfectants, feed and bedding in the laboratory animal facility lack data support during their application process. We have conducted special verification research and summarized the practical experience of material management, providing a scientific basis and reference for the standardized management of materials in the laboratory animal facility. Methods Under the daily operating environment of the GLP laboratory animal facility in our center,the disinfection efficacy of four commonly used disinfectants was confirmed via the quantitative suspension kill test, with the disinfectants tested on day 0 and day 7 after preparation, as well as on day 0, day 7, and at 1month, 2month, and 3 months after opening. For laboratory animal feed, nutritional components, chemical contamination, and microbial indicators were detected 7 days after opening. Microbiological indicators were also tested on both SPF-grade laboratory animal-specific corncob bedding stored for 7 days after opening and conventional-grade corncob bedding stored for 7 days after autoclaving. Results Within the laboratory animal facility under the GLP management system of our center, the log reduction values of disinfection efficacy for 1% 84 disinfectant, 0.1% Baidusha, and 0.2% benzalkonium bromide were all ≥ 5 on day 0 and day 7 after preparation. For 75% alcohol, the log reduction values remained ≥5 on day 0, day 7, and at 1, 2, and 3 months after opening, all the above disinfectants were determined to be qualified and effective. Compared with the factory inspection data, the nutritional components, chemical contamination, and microbial indicators of the maintenance diets for SPF rats and mice, growth and reproduction diets for SPF guinea pigs, growth and reproduction diets for conventional guinea pigs, maintenance diets for rabbits, and maintenance diets for dogs showed a slight overall downward trend but no significant fluctuations at 7 days of opening, and all indicators still met the relevant requirements of GB/T 14924.2-2001 Hygienic Standard for Formula Feeds for Laboratory Animals and GB 14924.3-2010 Nutritional Components of Formula Feeds for Laboratory Animals. Similarly, Compared with factory quality inspection data, the microbial indicators of specialized corncob bedding for SPF-grade laboratory animals stored for 7 days after opening and conventional-grade corncob bedding stored for 7 days after autoclaving showed no significant fluctuations, and also conform to the above-mentioned hygienic standards. Conclusion Combined with the management practice and practical experience of the GLP laboratory animal facility in our center, the set validity periods of disinfectants, feed and bedding have been verified to meet the quality requirements through the detection and validation of core quality indicators, which can provide a practical reference for the standardized management of laboratory animal facilities.

Key words: Good laboratory practice for non-clinical pharmaceutical research(GLP), Disinfectant, Feed, Bedding, Expiry date, Material management

中图分类号:

Q95-33

马文静,刘燕萍,李一帆,等.GLP管理体系下实验动物设施消毒剂、饲料和垫料有效期管理实践[J]. 实验动物与比较医学.. DOI: 10.12300/j.issn.1674-5817.2025.162.

MA Wenjing,LIU Yanping,LI yifan,et al. Practice on Validity Period Management of Disinfectants, Feed and Bedding in Laboratory Animal Facilities under Good Laboratory Practice for Non-Clinical Pharmaceutical Research Management System[J]. Laboratory Animal and Comparative Medicine. DOI: 10.12300/j.issn.1674-5817.2025.162.

图/表 6

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名称 Name	存放周期 Storage period	活菌计数结果（cfu/mL） Viable bacterial count results	实测杀灭对数值（KL） Actual measured killing logarithm value（KL）	可接受标准 Acceptable standards	是否合格 qualified
1% 84消毒液 1% 84 Disinfectant	消毒剂存放第0d	2.5×10³	5	杀灭对数值均≥5	合格
0.1％百毒杀溶液 0.1% Baidusha		1×10³	5		合格
0.2%新洁尔灭溶液 0.2% Benzalkonium bromide		4×10³	5		合格
阳性对照 Positive control		5×10⁸	/		/
1% 84消毒液 1% 84 Disinfectant	消毒剂存放第7d	5.5×10³	5	杀灭对数值均≥5	合格
0.1％百毒杀溶液 0.1% Baidusha		6×10³	5		合格
0.2%新洁尔灭溶液 0.2% Benzalkonium bromide		8×10³	5		合格
阳性对照 Positive control		4.7×10⁸	/		/

名称 Name	存放周期 Storage period	活菌计数结果（cfu/mL） Viable bacterial count results	实测杀灭对数值（KL） Actual measured killing logarithm value（KL）	可接受标准 Acceptable standards	是否合格 qualified
1% 84消毒液 1% 84 Disinfectant	消毒剂存放第0d	2.5×10³	5	杀灭对数值均≥5	合格
0.1％百毒杀溶液 0.1% Baidusha		1×10³	5		合格
0.2%新洁尔灭溶液 0.2% Benzalkonium bromide		4×10³	5		合格
阳性对照 Positive control		5×10⁸	/		/
1% 84消毒液 1% 84 Disinfectant	消毒剂存放第7d	5.5×10³	5	杀灭对数值均≥5	合格
0.1％百毒杀溶液 0.1% Baidusha		6×10³	5		合格
0.2%新洁尔灭溶液 0.2% Benzalkonium bromide		8×10³	5		合格
阳性对照 Positive control		4.7×10⁸	/		/

名称 Name	存放周期 Storage period	活菌计数结果（cfu/mL） Viable bacterial count results	实测杀灭对数值（KL） Actual measured killing logarithm value（KL）	可接受标准 Acceptable standards	是否合格 qualified
75%酒精 75% Alcohol 阳性对照 Positive control	第0d	8.5×10³ 5×10⁸	5 /	杀灭对数值均≥5	合格 /
75%酒精（1号喷壶） 75% Alcohol (Spray Bottle No.1)	第7d	8.5×10³	5		合格
75%酒精（2号喷壶） 75% Alcohol (Spray Bottle No.2)		5×10³	5		合格
75%酒精（3号喷雾器） 75% Alcohol (Sprayer No.3)		6×10³	5		合格
阳性对照 Positive control		4.7×10⁸	/		/
75%酒精（1号喷壶） 75% Alcohol (Spray Bottle No.1)	第1个月	4.5×10³	5		合格
75%酒精（2号喷壶） 75% Alcohol (Spray Bottle No.2)		6×10³	5		合格
75%酒精（3号喷雾器） 75% Alcohol (Sprayer No.3)		8×10³	5		合格
阳性对照 Positive control		2.3×10⁸	/		/
75%酒精（1号喷壶） 75% Alcohol (Spray Bottle No.1)	第2个月	0	8		合格
75%酒精（2号喷壶） 75% Alcohol (Spray Bottle No.2)		4.5×10³	5		合格
75%酒精（3号喷雾器） 75% Alcohol (Sprayer No.3)		7×10³	5		合格
阳性对照 Positive control		1.92×10⁸	/		/
75%酒精（1号喷壶） 75% Alcohol (Spray Bottle No.1)	第3个月	5.5×10³	5		合格
75%酒精（2号喷壶） 75% Alcohol (Spray Bottle No.2)		0	8		合格
75%酒精（3号喷雾器） 75% Alcohol (Sprayer No.3)		5×10³	5		合格
阳性对照 Positive control		1.28×10⁸	/		/

名称 Name	存放周期 Storage period	活菌计数结果（cfu/mL） Viable bacterial count results	实测杀灭对数值（KL） Actual measured killing logarithm value（KL）	可接受标准 Acceptable standards	是否合格 qualified
75%酒精 75% Alcohol 阳性对照 Positive control	第0d	8.5×10³ 5×10⁸	5 /	杀灭对数值均≥5	合格 /
75%酒精（1号喷壶） 75% Alcohol (Spray Bottle No.1)	第7d	8.5×10³	5		合格
75%酒精（2号喷壶） 75% Alcohol (Spray Bottle No.2)		5×10³	5		合格
75%酒精（3号喷雾器） 75% Alcohol (Sprayer No.3)		6×10³	5		合格
阳性对照 Positive control		4.7×10⁸	/		/
75%酒精（1号喷壶） 75% Alcohol (Spray Bottle No.1)	第1个月	4.5×10³	5		合格
75%酒精（2号喷壶） 75% Alcohol (Spray Bottle No.2)		6×10³	5		合格
75%酒精（3号喷雾器） 75% Alcohol (Sprayer No.3)		8×10³	5		合格
阳性对照 Positive control		2.3×10⁸	/		/
75%酒精（1号喷壶） 75% Alcohol (Spray Bottle No.1)	第2个月	0	8		合格
75%酒精（2号喷壶） 75% Alcohol (Spray Bottle No.2)		4.5×10³	5		合格
75%酒精（3号喷雾器） 75% Alcohol (Sprayer No.3)		7×10³	5		合格
阳性对照 Positive control		1.92×10⁸	/		/
75%酒精（1号喷壶） 75% Alcohol (Spray Bottle No.1)	第3个月	5.5×10³	5		合格
75%酒精（2号喷壶） 75% Alcohol (Spray Bottle No.2)		0	8		合格
75%酒精（3号喷雾器） 75% Alcohol (Sprayer No.3)		5×10³	5		合格
阳性对照 Positive control		1.28×10⁸	/		/

营养成分 Nutritional ingredient	普通级豚鼠生长繁殖饲料/(g•kg^-1) Ordinary grade guinea pig growth and reproduction feed/(g•kg^-1)				兔维持饲料/(g•kg^-1) Rabbit maintains feed/(g•kg^-1)				犬维持饲料/(g•kg^-1) Dog maintains feed/(g•kg^-1)				SPF大、小鼠维持饲料/(g•kg^-1) SPF mice maintain feed/(g•kg^-1)				SPF豚鼠生长繁殖饲料/(g•kg^-1) SPF guinea pig growth and reproduction feed/(g•kg^-1)
营养成分 Nutritional ingredient	规定值	出厂值	检测值	是否符合	规定值	出厂值	检测值	是否符合	规定值	出厂值	检测值	是否符合	规定值	出厂值	检测值	是否符合	规定值	出厂值	检测值	是否符合
水分(≤) Moisture(≤)	110	56	104	是	110	105	75	是	100	88	69	是	100	14	82	是	110	93	104	是
粗蛋白(≥) Crude Protein(≥)	170	224.2	192.3	是	140	141	149.5	是	200	206.8	209.1	是	180	221.1	184.9	是	170	201	201.7	是
粗脂肪(≥) Crude Fat(≥)	30	42	33	是	30	41	34	是	45	94	88	是	40	62	43	是	30	41	39	是
粗纤维 Crude Fiber	100～150	137	101	是	100～150	148	137	是	≤40	28	18	是	≤50	42	33	是	100～150	107	101	是
粗灰分(≤) Crude Ash(≤)	90	80	83	是	90	85	85	是	90	46	48	是	80	66	68	是	90	86	82	是
钙 Ca	10～15	13.6	14.9	是	10～15	12.9	12.5	是	7～10	7.56	9.89	是	10～18	12.6	14.9	是	10～15	14.8	14.8	是
磷 P	5～8	7.8	7.6	是	5～8	7.7	6.4	是	5～8	6.2	7.1	是	6～12	7.6	8.9	是	5～8	8.0	7.6	是