浅析水分活度测定在非无菌制剂微生物控制中的应用
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摘要
以美国药典(USP)收载的1112章节"水分活度测定在非无菌制剂中的应用"为参考,从水分活度的概念,测定原理与方法、与微生物的关系以及在药品质量控制中的应用、意义、问题和不足等角度,介绍和分析水分活度测定在非无菌制剂中的应用。USP率先将水分活度应用于制药领域微生物控制,代表了非无菌制剂的微生物控制由微生物限度测试逐渐向微生物风险评估下的参数放行转变的发展趋势,其理念更为科学合理,控制方法更为简便灵活。对水分活度的理解和认识有助于推动《中华人民共和国药典》2020年版相关内容的增订与推广。
The application of water activity determination of nonsterile pharmaceutical products which is relative to microbiological control in USP 40 was taken as reference. The application of water activity determination of nonsterile pharmaceutical products was introduced from the concepts of water activity,the principle and method of determination,the relationship with microorganisms,the application,significance,problems and shortcomings and development trends of drug quality control. USP pioneered the microbiological control standards with water activity applications in the pharmaceutical industry,which represents the developing trend of microbial control of non-sterile agents from a comprehensive microbiological limit test to the evolution of parameters under microbial risk assessment. The control method became simpler and more flexible. The idea became more scientific and reasonable. Exploring and understanding knowledge of water activity will help to promote the revision and development of relevant content of Pharmacopoeia of the People's Republic of China 2020 edition.
The application of water activity determination of nonsterile pharmaceutical products which is relative to microbiological control in USP 40 was taken as reference. The application of water activity determination of nonsterile pharmaceutical products was introduced from the concepts of water activity,the principle and method of determination,the relationship with microorganisms,the application,significance,problems and shortcomings and development trends of drug quality control. USP pioneered the microbiological control standards with water activity applications in the pharmaceutical industry,which represents the developing trend of microbial control of non-sterile agents from a comprehensive microbiological limit test to the evolution of parameters under microbial risk assessment. The control method became simpler and more flexible. The idea became more scientific and reasonable. Exploring and understanding knowledge of water activity will help to promote the revision and development of relevant content of Pharmacopoeia of the People's Republic of China 2020 edition.
引文
[1]杨晓莉,李辉,马英英,等.中国药典2015年版非无菌产品微生物限度检查:微生物计数法解读[J].药物分析杂志,2016,36(6):1101YANG XL,LI H,MA YY,et al.Interpretation of the microbiological examination of nonsterile products:microbial enumeration test of Chinese Pharmacopoeia 2015 edition[J].Chin J Pharm Anal,2016,36(6):1101
[2]杨晓莉,李辉,绳金房.中、美、英、欧药典制药用水微生物检查法对比研究[J].西北药学杂志,2013,28(5):515YANG XL,LI H,SHENG JF,et al.Comparative study of the microbiological test of pharmaceutial water by using ChP,USP,EPand BP methods[J].Northwest Pharm J,2013,28(5):515
[3]SCOTT VN,CLAVERO RS,TROLLER JA.Measurement of water activity(aw),acidity,and brix[M]//FRANCES PD,KEITH I.Compendium of Methods for The Microbiological Examination of Foods.4th Ed.Washington D.C:American Public Health Association,2001:649
[4]USP 40-NF 35.VolⅠ[S].2017:106,1445
[5]USP 29-NF 24 Second Supplement[S].2006:3802
[6]PORTER D.General information 1112 microbiological attributes of nonsterile pharmaceutical products-application of water activity determination[J].Pharmacopeial Forum,2002,28(6):2009
[7]AOAC978.18 Water Activity of Canned Vegetables in Official Methods of Analysis[S].1995
[8]ISO 21807-2004 Microbiology of Food and Animal Feeding stuffsDetermination of Water Activity[S].2004
[9]ISO29621-2010 Cosmetics Microbiology Guidelines for the Risk Assessment and Identification of Microbiologically Low-risk Products,Switzerland[S].2010
[10]中国商业部.GB 9695.12-1988肉与肉制品水分活度测定[S].1988China’s Ministry of Commerce.GB 9695.12-1988 Meat and Meat Products Method of Water Activity Determination[S].1988
[11]国家进出口商品检验局.SN0180-92中国进出口商品检验行业标准食品水活度测定方法[S].1992China National Import and Export Commodity Inspection Bureau.SN0180-92 Method of Determination of Water Activity of Food[S].1992
[12]GB/T 23490-2009食品水分活度的测定[S].2009GB/T 23490-2009 Determination of Water Activity in Foods[S].2009
[13]GB 5009.238-2016食品安全国家标准食品水分活度的测定[S].2016GB 5009.238-2016 National Food Safety Standards of Food and Water Activity Determination[S].2016
[14]中华人民共和国药典2015年版.四部[S].2015:103ChP 2015.VolⅣ[S].2015:103
[15]EP 9.0.VolⅠ[S].2017:369
[16]JP 17.VolⅠ[S].2016:108
[17]RAHMAN MS.Water activity and sorption properties of food[M]//Food Properties Handbook,Baca Raton:CRC Press,1995:1
[18]RAHMAN MS,SABLANI SS.Measurement of water activity by electronic sensors[M]//RONALD W,TERRY EA,HAEHUNG A,et al.Current Protocols in Food Analytical Chemistry.New York:John Wiley&Sons,Inc.,2001:A2.5.1
[19]REID D.Factors to consider when estimating water vapor pressure[M]//RONALD W,TERRY EA,HAEHUNG A,et al.Current Protocols in Food Analytical Chemistry.New York:John Wiley&Sons,Inc.,2001:A2.5.1
[20]SCOTT WJ.Water relations of staphylococcus aureus at 30℃[J].Aust J Biol Sci,1953,6(4):549
[21]CHRISTIAN JHB,SCOTT WJ.Water relations of salmonellae at30℃[J].Australian J Biol Sci,1953,6(4):565
[22]SCOTT WJ.Water relations of food spoilage microorganisms[J].Adv Food Res,1957,7:83
[23]MURRELL WG,SCOTT WJ.Heat resistance of bacterial spores at various water activities[J].Nature,1957,179(4557):481
[24]FRIESEL RR,CUNDELL T.The application of water activity measurement to the microbiological attributes testing of nonsterile over-the-counter drug products[J].Pharmacopeial Forum,1998,24(2):6087
[25]FRIESEL RR.The application of water activity(aw)measurement to the microbiological attributes testing of raw materials used in the manufacture of non-sterile pharmaceutical products[J].Pharmacopeial Forum,1999,25(6):8974
[26]CUNDELL T.The role of water activity in the microbial stability of non-sterile drug products[J].Eur Pharm Rev,2015,20(1):58(本文于2017年11月14日收到)
[2]杨晓莉,李辉,绳金房.中、美、英、欧药典制药用水微生物检查法对比研究[J].西北药学杂志,2013,28(5):515YANG XL,LI H,SHENG JF,et al.Comparative study of the microbiological test of pharmaceutial water by using ChP,USP,EPand BP methods[J].Northwest Pharm J,2013,28(5):515
[3]SCOTT VN,CLAVERO RS,TROLLER JA.Measurement of water activity(aw),acidity,and brix[M]//FRANCES PD,KEITH I.Compendium of Methods for The Microbiological Examination of Foods.4th Ed.Washington D.C:American Public Health Association,2001:649
[4]USP 40-NF 35.VolⅠ[S].2017:106,1445
[5]USP 29-NF 24 Second Supplement[S].2006:3802
[6]PORTER D.General information 1112 microbiological attributes of nonsterile pharmaceutical products-application of water activity determination[J].Pharmacopeial Forum,2002,28(6):2009
[7]AOAC978.18 Water Activity of Canned Vegetables in Official Methods of Analysis[S].1995
[8]ISO 21807-2004 Microbiology of Food and Animal Feeding stuffsDetermination of Water Activity[S].2004
[9]ISO29621-2010 Cosmetics Microbiology Guidelines for the Risk Assessment and Identification of Microbiologically Low-risk Products,Switzerland[S].2010
[10]中国商业部.GB 9695.12-1988肉与肉制品水分活度测定[S].1988China’s Ministry of Commerce.GB 9695.12-1988 Meat and Meat Products Method of Water Activity Determination[S].1988
[11]国家进出口商品检验局.SN0180-92中国进出口商品检验行业标准食品水活度测定方法[S].1992China National Import and Export Commodity Inspection Bureau.SN0180-92 Method of Determination of Water Activity of Food[S].1992
[12]GB/T 23490-2009食品水分活度的测定[S].2009GB/T 23490-2009 Determination of Water Activity in Foods[S].2009
[13]GB 5009.238-2016食品安全国家标准食品水分活度的测定[S].2016GB 5009.238-2016 National Food Safety Standards of Food and Water Activity Determination[S].2016
[14]中华人民共和国药典2015年版.四部[S].2015:103ChP 2015.VolⅣ[S].2015:103
[15]EP 9.0.VolⅠ[S].2017:369
[16]JP 17.VolⅠ[S].2016:108
[17]RAHMAN MS.Water activity and sorption properties of food[M]//Food Properties Handbook,Baca Raton:CRC Press,1995:1
[18]RAHMAN MS,SABLANI SS.Measurement of water activity by electronic sensors[M]//RONALD W,TERRY EA,HAEHUNG A,et al.Current Protocols in Food Analytical Chemistry.New York:John Wiley&Sons,Inc.,2001:A2.5.1
[19]REID D.Factors to consider when estimating water vapor pressure[M]//RONALD W,TERRY EA,HAEHUNG A,et al.Current Protocols in Food Analytical Chemistry.New York:John Wiley&Sons,Inc.,2001:A2.5.1
[20]SCOTT WJ.Water relations of staphylococcus aureus at 30℃[J].Aust J Biol Sci,1953,6(4):549
[21]CHRISTIAN JHB,SCOTT WJ.Water relations of salmonellae at30℃[J].Australian J Biol Sci,1953,6(4):565
[22]SCOTT WJ.Water relations of food spoilage microorganisms[J].Adv Food Res,1957,7:83
[23]MURRELL WG,SCOTT WJ.Heat resistance of bacterial spores at various water activities[J].Nature,1957,179(4557):481
[24]FRIESEL RR,CUNDELL T.The application of water activity measurement to the microbiological attributes testing of nonsterile over-the-counter drug products[J].Pharmacopeial Forum,1998,24(2):6087
[25]FRIESEL RR.The application of water activity(aw)measurement to the microbiological attributes testing of raw materials used in the manufacture of non-sterile pharmaceutical products[J].Pharmacopeial Forum,1999,25(6):8974
[26]CUNDELL T.The role of water activity in the microbial stability of non-sterile drug products[J].Eur Pharm Rev,2015,20(1):58(本文于2017年11月14日收到)