祛痘/抗粉刺类化妆品微生物检查方法学研究
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摘要
目的克服化妆品微生物检验中现行样品前处理方法局限性,提高祛痘/抗粉刺类化妆品潜在微生物检验灵敏度。方法选择典型祛痘/抗粉刺类化妆品,分别采用常规法、稀释法、中和剂法、薄膜过滤法处理后进行菌落总数和控制菌检查;依据《中国药典》(2015年版四部)要求,以试验菌回收率50%～200%作为灵敏度判定依据。结果不同的样品处理对5种典型化妆品春天祛痘植物精华素(A)、控油祛痘育养水(B)、益肤霜(C)、益肤宝祛痘霜(D)、益肤洁面膏+粉刺全效(E)中微生物检出结果不同。常规法仅能满足D类产品所有试验菌(回收率为72%～108%)和C类产品霉菌及酵母菌数检查(回收率为80%～92%),同时对B类产品控制菌检查有效;B类样品采用中和剂法检测菌落总数回收率为83%,以薄膜过滤法(300 ml/膜)进行霉菌及酵母菌数检查回收率达104%;A类和E类样品只有采用薄膜过滤法(300 ml/膜)才能使试验菌回收率超过50%限值。结论针对不同化妆品基质,优化微生物计数和控制菌检查样品处理方法,可以提高样品中潜在微生物的检查灵敏度和阳性检出率。
Objective To overcome the limitations of the current sample pretreatment methods in cosmetics microbiological assay and improve the sensitivity of detecting potential microorganisms in anti-acne cosmetics. Methods Typical anti-acne cosmetics were selected and treated by routine method, dilution method, add neutralizer method and membrane filtration method respectively, the total number of colonies and the control bacteria were examined, and the recovery rate of test bacteria was 50%-200% as the sensitivity criterion according to the Chinese Pharmacopoeia 2015. Results The results of microbial detection in five typical cosmetics including spring acne-removing plant essence(A), oil-controlling acne-removing and nourishing water(B), skin-tonifying cream(C), skin-tonifying cream(D), skin-tonifying cream and acne-removing cream(E) were different. The routine method can satisfy all the test bacteria(recovery rate 72%-108%) of Class D products, the mold and yeast counts of Class C products(recovery rate 80%-92%), and the control bacteria of Class B products. The recovery rate of total colony counts of Class B samples by neutralizer method is 83%, and the membrane filtration method(300 ml/membrane) for mold and yeast counts was 104%. The recovery rates for testing sample A and E could exceed 50% limit only by membrane filtration(300 ml/membrane) method. Conclusion According to different cosmetics substrate, optimizing sample preparation method can improve the detection sensitivity and positive test rate of potential microorganisms.
Objective To overcome the limitations of the current sample pretreatment methods in cosmetics microbiological assay and improve the sensitivity of detecting potential microorganisms in anti-acne cosmetics. Methods Typical anti-acne cosmetics were selected and treated by routine method, dilution method, add neutralizer method and membrane filtration method respectively, the total number of colonies and the control bacteria were examined, and the recovery rate of test bacteria was 50%-200% as the sensitivity criterion according to the Chinese Pharmacopoeia 2015. Results The results of microbial detection in five typical cosmetics including spring acne-removing plant essence(A), oil-controlling acne-removing and nourishing water(B), skin-tonifying cream(C), skin-tonifying cream(D), skin-tonifying cream and acne-removing cream(E) were different. The routine method can satisfy all the test bacteria(recovery rate 72%-108%) of Class D products, the mold and yeast counts of Class C products(recovery rate 80%-92%), and the control bacteria of Class B products. The recovery rate of total colony counts of Class B samples by neutralizer method is 83%, and the membrane filtration method(300 ml/membrane) for mold and yeast counts was 104%. The recovery rates for testing sample A and E could exceed 50% limit only by membrane filtration(300 ml/membrane) method. Conclusion According to different cosmetics substrate, optimizing sample preparation method can improve the detection sensitivity and positive test rate of potential microorganisms.
引文
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[11] 马仕洪,刘鹏,杨利红,等.药品微生物限度检查方法适用性试验中加菌方式的实验研究[J].药物分析杂志,2018,38(5):877-882.
[12] 陈磊,闵红,卢军.美容修饰类化妆品微生物限度检查方法学研究[J].中国卫生检验杂志,2015,25(18):3087-3090.
[13] 宫继鹏,姚湧,谈超,等.硝酸咪康唑拴微生物检查方法的验证[J].安徽医药,2011,15(3):313-315.
[14] 郑荣,王珂.除螨祛痘类化妆品中林可霉素和克林霉素的测定[J].中国卫生检验杂志,2014,24(5):677-681.
[15] 胡文红,刘广桢,徐晓洁,等.分析我国现行化妆品微生物检验方法存在的问题和改进建议[J].食品与药品,2013,15(3):183-185.
[2] 王慧,朱炯.祛痘类化妆品市场质量状况分析及监管研究[J].中国药事,2013,27(10):1021-1024.
[3] 国家食品药品监督管理总局.化妆品安全技术规范[S].北京:中国标准出版社,2016.
[4] 李武超,乔佳,邓娟,等.对浙江省化妆品不良反应监测体系的探讨[J].香料香精化妆品,2017,6(3):37-44.
[5] 胡芳华,郁琼花,袁海,等.浅析化妆品安全性风险因素[J].香料香精化妆品,2017,6(3):64-68.
[6] The United States Pharmacopeia Convention.United States Pharmacopeia[M].34th Edition.NF29.Maryland:USP press,2011:125-385.
[7] 国家药典委员会.《中华人民共和国药典》(2015年版)四部[S].北京:中国医药科技出版社,2015.
[8] 闵红,周志云,杨晓莉,等.洗发、护发化妆品微生物检查方法学研究[J].微生物学杂志,2016,36(5):103-107.
[9] 庞燕军,赵晓冬,郭春梅,等.薄膜过滤法在膏霜类化妆品微生物检验中的应用研究[J].香料香精化妆品,2011,2011(1):14-16.
[10] 周宏玉.薄膜过滤法在药品检验中的应用分析[J].医药卫生:文摘版,2016,22(4):244-244.
[11] 马仕洪,刘鹏,杨利红,等.药品微生物限度检查方法适用性试验中加菌方式的实验研究[J].药物分析杂志,2018,38(5):877-882.
[12] 陈磊,闵红,卢军.美容修饰类化妆品微生物限度检查方法学研究[J].中国卫生检验杂志,2015,25(18):3087-3090.
[13] 宫继鹏,姚湧,谈超,等.硝酸咪康唑拴微生物检查方法的验证[J].安徽医药,2011,15(3):313-315.
[14] 郑荣,王珂.除螨祛痘类化妆品中林可霉素和克林霉素的测定[J].中国卫生检验杂志,2014,24(5):677-681.
[15] 胡文红,刘广桢,徐晓洁,等.分析我国现行化妆品微生物检验方法存在的问题和改进建议[J].食品与药品,2013,15(3):183-185.
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