化妆品防腐体系效能测试方法的比较与选择

doi:10.3969/j.issn.1001-1803.2021.03.012

Abstract

Abstract:

The research progress of effectiveness test methods of cosmetic antiseptic system were introduced, and the related standards of cosmetic were analyzed and compared, including Toiletry and Fragrance Association （CTFA） , American Society for Testing and Materials （ASTM）, International Organization for Standardization （ISO） , United States Pharmacopeia （USP）, European Pharmacopeia （EP） and Pharmacopoeia of the People’s Republic of China （ChP）, and it provided a reference for cosmetics enterprises to select the method of preservation test scientifically.

Key words: cosmetic, preservation test, microbial challenge test

CLC Number:

TQ658

LUO Jun,WANG Xiao-wei,LIU Yi,ZHOU Hai-mu,YING Guo-hong. Comparison and selection of effectiveness test methods of cosmetic antiseptic system[J].China Surfactant Detergent & Cosmetics, 2021, 51(3): 243-249.

Figures/Tables 4

Tab. 1

Comparison of experimental microorganisms in national standards involving microbial challenge testing"

菌种类别	CTFA*	ASTM	ISO	USP	EP	ChP
革兰氏阳性球菌	金黄色葡萄球菌Staphylococcus aureus （ATCC 6538）表皮葡萄球菌Staphylococcus epidermidis （ATCC 12228）	金黄色葡萄球菌Staphylococcus aureus （ATCC 6538）	金黄色葡萄球菌Staphylococcus aureus ATCC 6538 CIP 4.83 CIMB 9518 NBRC 13276 KCTC 3881 NCTC 10788	金黄色葡萄球菌 Staphylococcus aureus （ATCC 6538）	金黄色葡萄球菌Staphylococcus aureus ATCC 6538 CIP 4.83 CIMB 9518 NCTC 10788	金黄色葡萄球菌 Staphylococcus aureus CMCC（B）26003
发酵型革兰氏阴性杆菌	肺炎克雷伯氏菌Klebsiella pneumoniae （ATCC 10031）阴沟肠杆菌 Enterobacter cloacae （ATCC 13047）大肠埃希菌 Escherichia coli （ATCC 8739）日沟维肠杆菌Enterobacter gergoviae （ATCC 33028）变形杆菌属 Proteus species	大肠埃希菌Escherichia coli （ATCC 8739）日沟维肠杆菌Enterobacter gergoviae （ATCC 33028）	大肠埃希菌Escherichia coli ATCC 8739 CIP 53.126 CIMB 8545 NBRC 3972 KCTC 2571 NCTC 12923	大肠埃希菌Escherichia coli （ATCC 8739）	大肠埃希菌 Escherichia coli ATCC 8739 CIP 53.126 CIMB 8545 （用于口服制剂）	大肠埃希菌 Escherichia coli CMCC（B）44102
非发酵型革兰氏阴性杆菌	铜绿假单胞菌Pseudomonas aeruginosa （ATCC 9027）洋葱伯克霍尔德菌Burkholderia cepacia （ATCC 25416）荧光假单胞菌Pseudomonas fluorescens （ATCC 13525）恶臭假单胞菌Pseudomonas putida （ATCC 31483）黄杆菌属Flavobacterium species 不动杆菌属Acinetobacter species	铜绿假单胞菌Pseudomonas aeruginosa （ATCC 9027）洋葱伯克霍尔德菌Burkholderia cepacia （ATCC 25416）	铜绿假单胞菌Pseudomonas aeruginosa ATCC 9027 CIP 82.118 NCIMB 8626 NBRC 13275 KCTC 2513	铜绿假单胞菌Pseudomonas aeruginosa （ATCC 9027）	铜绿假单胞菌Pseudomonas aeruginosa ATCC 9027 CIP 82.118 NCIMB 8626	铜绿假单胞菌Pseudomonas aeruginosa CMCC（B）10104
酵母	白色念珠菌 Candida albicans （ATCC 10231）假丝酵母 Candida parapsilosis （ATCC 22019）	白色念珠菌 Candida albicans （ATCC 10231）	白色念珠菌 Candida albicans ATCC 10231 IP 48.72 NCPF 3179 NBRC 1594 KCTC 7965	白色念珠菌 Candida albicans （ATCC 10231）	白色念珠菌 Candida albicans ATCC 10231 IP 48.72 NCPF 3179 鲁氏酵母 Zygosaccharomyces rouxii NCYC 381 IP2021.92 （鲁氏酵母用于含糖量较高的口服制剂）	白色念珠菌 Candida albicans CMCC（F）98001
霉菌	黑曲霉 Aspergillus niger （ATCC 16404）^[18] 青霉菌 Penicillium species 球毛壳霉 Chaetomium globosum （ATCC 6205）里氏木霉 Trichoderma reesei （ATCC 13631）尖孢枝孢菌Cladosporium oxysporum （ATCC 76499）	黑曲霉 Aspergillus niger （ATCC 16404） ^[18] 雷氏真青霉Eupenicillium levitum （ATCC 10464）	巴西曲霉Aspergillus brasiliensis ATCC 16404 IP 1431 IMI 149007 NBRC 9455 KCTC 6196	巴西曲霉Aspergillus brasiliensis （ATCC 16404）	巴西曲霉Aspergillus brasiliensis ATCC 16404 IP 1431.83 IMI 149007	黑曲霉 Aspergillus niger CMCC（F）98003
芽孢杆菌	枯草芽孢杆菌 Bacillus subtilis （ATCC 6051）可选做	—	—	—	—	—
In-house 菌株	选做或至少一种	可选做	—	可选做	可选做	可选做

Tab. 1

Tab. 2

The difference of methodology in national standards involving microbial challenge testing"

	CTFA	ASTM	ISO	USP	EP	ChP
接种量	细菌：10⁶CFU/g （mL）真菌：10⁵CFU/g （mL）非典型产品（比如无水产品）：10³~10⁴CFU/g （mL）	细菌：10⁵~10⁶CFU/g （mL）真菌：10⁴~10⁵CFU/g （mL）	细菌：10⁵~10⁶CFU/g （mL）真菌：10⁴~10⁵CFU/g （mL）	10⁵~10⁶CFU/g （mL）另外液体抗酸药： 10³~10⁴CFU/g （mL）	10⁵~10⁶CFU/g （mL）	10⁵~10⁶CFU/g （mL）
样品贮存条件	按样品外包装贮存环境存放	20~25 ℃	（22. 5±2.5）℃	（22.5±2.5）℃	20~25 ℃避光	20~25 ℃避光
计数用培养基	细菌：Eugon琼脂 Letheen琼脂微生物含量测试琼脂改良Latheen琼脂 PCA TSA 含吐温的微生物含量测试琼脂真菌：Malt琼脂 Malt提取物琼脂 Mycophil琼脂 PDA SDA （以上细菌和真菌琼脂各选一种）	细菌：Eugon琼脂 Letheen琼脂微生物含量测试琼脂改良Letheen琼脂 PCA TSA 真菌：Malt琼脂 Malt提取物琼脂 Mycophil琼脂 PDA （以上细菌和真菌琼脂各选一种）	细菌：TSA; 酵母：SDA; 霉菌：PDA	细菌：TSA 真菌：SDA	细菌：TSA 真菌：SDA	细菌：TSA 真菌：SDA
计数培养温度	细菌：30~37 ℃ 酵母：25~35 ℃ 霉菌：20~30 ℃	细菌：（35±2） ℃ 真菌：（25±2） ℃	细菌和酵母：（32.5±2.5） ℃ 霉菌：（22.5±2.5） ℃	细菌：30~35 ℃ 真菌：20~25 ℃	细菌：30~35 ℃ 真菌：20~25 ℃	细菌：30~35 ℃ 真菌：20~25 ℃
计数培养时间	细菌：24~72 h 酵母：48~72 h 霉菌：3~7 d	细菌：48~72 h 真菌：3~5 d	细菌和酵母：48~72 h 霉菌：3~5 d	细菌：3~5 d 真菌：5~7 d	细菌：3~5 d 真菌：5~7 d	细菌：3~5 d 真菌：5~7 d
计数方法	平皿倾注法涂布法	平皿倾注法	平皿倾注法涂布法薄膜过滤法	平皿倾注法涂布法薄膜过滤法 MPN法	平皿倾注法涂布法薄膜过滤法 MPN法	平皿倾注法涂布法薄膜过滤法 MPN法

Tab. 2

Tab. 3

Tab. 4

References 31

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产品类别	USP	EP和ChP
1	注射剂、其他非肠胃药剂,包括乳剂、无菌耳用剂、鼻用剂和眼用水溶液制剂	注射剂、眼用制剂、用于子宫和乳腺的制剂
2	水溶性制剂,非无菌鼻用制剂、用于黏膜的乳膏剂	耳用制剂、鼻用制剂、皮肤给药制剂、吸入制剂
3	除水溶性抗酸药外的口服制剂	口服制剂、口腔黏膜制剂、直肠给药制剂
4	水溶性抗酸药	—

减少的lg值要求（R_X=lg N₀-lg N_X） ^a
测试时间	细菌			白色念珠菌			巴西曲霉
测试时间	T7	T14	T28	T7	T14	T28	T14	T28
标准A	≥3	≥3并且NI^b	≥3并且NI	≥1	≥1并且NI	≥1并且NI	≥0	≥1并且NI
标准B	不作要求	≥3	≥3并且NI	不作要求	≥1	≥1并且NI	≥0	≥1并且NI

Comparison and selection of effectiveness test methods of cosmetic antiseptic system

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