EMA对药用辅料右旋糖酐新的安全性评价
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摘要
欧洲药品局(EMA)于2018年11月发布了"人用药品辅料右旋糖酐的包装说明书资料",该文件引用大量文献全面评价了右旋糖酐的安全性,特别指出含有右旋糖酐辅料的注射和吸入制剂的疫苗与药品,应在说明书中描述有关其过敏反应信息的新要求。介绍该文件的主要内容,期望对我国这类药品说明书的撰写和监管有所帮助。
EMA issued Information for the package leaflet regarding dextrans used as excipients in medicinal products for human use(Draft) in November 2018. Citing a large number of references, the document comprehensively evaluated the safety of dextran,and pointed out in particular that vaccines and drugs containing dextran excipients for injection and inhalation should be described in the package leaflets for new requirements for information on their allergic reactions. This document is described in detail in the article and is expected to be helpful for the writing and supervision of such drug labeling in our country.
EMA issued Information for the package leaflet regarding dextrans used as excipients in medicinal products for human use(Draft) in November 2018. Citing a large number of references, the document comprehensively evaluated the safety of dextran,and pointed out in particular that vaccines and drugs containing dextran excipients for injection and inhalation should be described in the package leaflets for new requirements for information on their allergic reactions. This document is described in detail in the article and is expected to be helpful for the writing and supervision of such drug labeling in our country.
引文
[1] EMA. Guideline on Excipients in the label and package leaflet of medicinal products for human use[EB/OL].(2018-03-01)[2018-12-27]. https://ec. europa. eu/health/sites/health/files/files/eudralex/vol-2/c/guidelines_excipients_march2018_en.pdf.
[2] EMA. Annex of Guideline on Excipients in the labelling and package leaflet of medicinal products for human use(EMA/CHMP/302620)[EB/OL].(2017-10-09)[2018-12-27]. https://www. ema. europa. eu/documents/scientificguideline/annex-european-commission-guidelineexcipients-labelling-package-leaflet-medicinal-productshuman_en.pdf.
[3] EMA. Information for the package leaflet regarding dextrans used as excipients in medicinal products for human use(Draft)[EB/OL].(2018-11-19)[2018-12-27].https://www. ema. europa. eu/documents/scientificguideline/draft-information-package-leaflet-regardingdextrans-used-excipients-medicinal-products-humanuse_en.pdf.
[4] Hint H C, Richter A W. Chronic toxicity of dextran sulphate in rabbits[J]. Brit J Pharmacol, 1958, 13(2):109-112.
[5] M?hler M, Bristol I J, Leiter E H, et al. Differential susceptibility of inbred mouse strains to dextran sulfate sodium-induced colitis[J]. Am J Physiol, 1998, 274(3 Pt1):544-551.
[6] Stevceva L, Pavli P, Buffinton G, et al. Dextran sodium sulphateinduced colitis activity varies with mouse strain but develops in lipopolysaccharideunresponsive mice[J].J Gastroenterol Hepatol, 1999, 14(1):54-60.
[7] Trivedi P P, Jena G B. Dextran sulfate sodium-induced ulcerative colitis leads to increased hematopoiesis and induces both local as well as systemic genotoxicity in mice[J]. Mutat Res, 2012, 744(2):172-183.
[8] Tardieu D, Jaeg J P, Cadet J, et al. Dextran sulfate enhances the level of an oxidative DNA damage biomarker, 8-oxo-7, 8-dihydro-20-deoxyguanosine, in rat colonic mucosa[J]. Cancer Lett, 1998, 134:1-5.
[9] Westbroo A M, Wei B, Braun J, et al. Intestinal mucosal inflammation leads to systemic genotoxicity in mice[J].Cancer Res, 2009, 69(11):4827-4834.
[10] Westbrook A M, Wei B, Braun J, et al. More damaging than we think:systemic effects of intestinal inflammation[J]. Cell Cycle, 2009, 8:2482-2483.
[11] Lubin J H, Boice J D Jr, Edling C, et al. Lung cancer in radon-exposed miners and estimation of risk from indoor exposure[J]. J Nat Cancer Inst, 1995, 87(11):817-827.
[12] Seifried H E, Seifried R M, Clarke J J, et al. A compilation of two decades of mutagenicity test results with the Ames Salmonella typhimurium and L5178Y mouse lymphoma cell mutation assays[J]. Chem Res Toxico, 2006, 19(5):627-644.
[13] Hirono I, Kuhara K, Hosaka S, et al. Induction of intestinal tumors in rats by dextran sulfate sodium[J]. J Natl Cancer Inst, 1981, 66(3):579-583.
[14] Hirono I, Kuhara K, Yamaji T, et al. Induction of colorectal squamous cell carcinomas in rats by dextran sulfate sodium[J]. Carcinogenesis, 1982, 3(3):353-355.
[15] Hirono I, Kuhara K, Yamaji T, et al. Carcinogenicity of dextran sulfate sodium in relation to its molecular weight[J]. Cancer Lett, 1983, 18(1):29-34.
[16] Hahn H, Biertherm M. Morphological changes induced by dextran sulfate 500 in mononuclear phagocytes of listeria-infected mice[J]. Infect Immun, 1974, 10(5):1110-1119.
[17] Siebeck M, Cheronis J C, Fink E, et al. Dextran sulfate activates contact system and mediates arterial hypotension via B2 kinin receptors[J]. J Appl Physiol,1985, 77(6):2675-2680.
[18] Hedin H, Ljungstrom K G. Prevention of dextran anaphylaxiss[J]. Int Arch Allergy Immunol, 1997, 113:358-359.
[19] Mehvar R, Shepard T L. Molecular-weight-dependent pharmacokinetics of fluoresceinlabeleddextrans in rats[J]. J Pharm Sci, 1992, 81(9):908-912.
[20] Koyama Y, Miyagawa T, Kawaide A, at al. Receptormediated absorption of high molecular weight dextrans from intestinal tract[J]. J Contr Rel, 1996, 41:171-176.
[21] Lake J R, Licko V, van Dyke R W. Biliary secretion of fluid-phase markers by the isolated perfused rat liver.Role of transcellular vesicular transport[J]. J Clin Invest,1985, 76(2):676-684.
[22] Mehvar R, Robinson M A, Reynolds J M. Molecular weight dependent tissue accumulation of dextrans:in vivo studies in rats[J]. J Pharm Sci, 1994, 83(10):1495-1499.
[23] Mehvar R, Robinson M A, Reynolds J M. Dose dependency of the kinetics of dextrans in rats:effects of molecular weight[J]. J Pharm Sci, 1995, 84(7):815-818.
[24] Takakura Y, Fujita T, Hashida M, et al. Disposition characteristics of macromolecules in tumor-bearing mice[J]. Pharm Res, 1990, 7(4):339-346.
[25] Babier P. Fetal risks with dextran during delivery[J].Drug saf, 1992, 7(1):71-73.
[26] Hedin H, Richter W, Kraft D. Pathomechanism of dextran-induced anaphylactoid reactions in man[J]. Int Archs Allergy appl Immun, 1981, 66:75-77.
[27] Scientific Committee on Food. Opinion of the Scientific committee on food on a dextran preparation, produced using Leuconostoc mesenteroides, Saccharomyces cerevisiae and Lactobacillus spp as a novel food ingredient in bakery products CS/NF/DOS/7/ADD 3FINAL[EB/OL].(2000-10-18)[2018-12-27]. http://citeseerx. ist. psu. edu/viewdoc/download; jsessionid=943B66B9CC1C83A36B526406E9B0698D? doi=10.1.1.583.5590&rep=rep1&type=pdf.
[28]长春卫尔赛生物药业有限公司.冻干人用狂犬病疫苗(Vero细胞)说明书[EB/OL].(2016-11-23)[2018-12-27].file:///C:/Users/xiao/Downloads/%E5%86%BB%E5%B9%B2%E4%BA%BA%E7%94%A8%E7%8B%82%E7%8A%AC%E7%97%85%E7%96%AB%E8%8B%97(Vero%E7%BB%86%E8%83%9E)%EF%BC%88CXSS1300015%EF%BC%89%E8%AF%B4%E6%98%8E%E4%B9%A6.pdf.
[29]北京四环科宝制药有限公司.注射用肌氨肽苷说明书[EB/OL].(2014-06-13)[2018-12-27]. http://www.docin.com/p-774327942.html.
[30]北京四环科宝制药有限公司.注射用棓丙酯说明书[EB/OL].(2014-06-13)[2018-12-27]. http://drugs.medlive.cn/drugref/html/14509.shtml.
[31]国家药监局药品审评中心.常用药用辅料数据库[EB/OL].(2012-03-06)[2018-12-27]. http://www.cde.org.cn/drugInfo.do?method=init&frameStr=1.
[2] EMA. Annex of Guideline on Excipients in the labelling and package leaflet of medicinal products for human use(EMA/CHMP/302620)[EB/OL].(2017-10-09)[2018-12-27]. https://www. ema. europa. eu/documents/scientificguideline/annex-european-commission-guidelineexcipients-labelling-package-leaflet-medicinal-productshuman_en.pdf.
[3] EMA. Information for the package leaflet regarding dextrans used as excipients in medicinal products for human use(Draft)[EB/OL].(2018-11-19)[2018-12-27].https://www. ema. europa. eu/documents/scientificguideline/draft-information-package-leaflet-regardingdextrans-used-excipients-medicinal-products-humanuse_en.pdf.
[4] Hint H C, Richter A W. Chronic toxicity of dextran sulphate in rabbits[J]. Brit J Pharmacol, 1958, 13(2):109-112.
[5] M?hler M, Bristol I J, Leiter E H, et al. Differential susceptibility of inbred mouse strains to dextran sulfate sodium-induced colitis[J]. Am J Physiol, 1998, 274(3 Pt1):544-551.
[6] Stevceva L, Pavli P, Buffinton G, et al. Dextran sodium sulphateinduced colitis activity varies with mouse strain but develops in lipopolysaccharideunresponsive mice[J].J Gastroenterol Hepatol, 1999, 14(1):54-60.
[7] Trivedi P P, Jena G B. Dextran sulfate sodium-induced ulcerative colitis leads to increased hematopoiesis and induces both local as well as systemic genotoxicity in mice[J]. Mutat Res, 2012, 744(2):172-183.
[8] Tardieu D, Jaeg J P, Cadet J, et al. Dextran sulfate enhances the level of an oxidative DNA damage biomarker, 8-oxo-7, 8-dihydro-20-deoxyguanosine, in rat colonic mucosa[J]. Cancer Lett, 1998, 134:1-5.
[9] Westbroo A M, Wei B, Braun J, et al. Intestinal mucosal inflammation leads to systemic genotoxicity in mice[J].Cancer Res, 2009, 69(11):4827-4834.
[10] Westbrook A M, Wei B, Braun J, et al. More damaging than we think:systemic effects of intestinal inflammation[J]. Cell Cycle, 2009, 8:2482-2483.
[11] Lubin J H, Boice J D Jr, Edling C, et al. Lung cancer in radon-exposed miners and estimation of risk from indoor exposure[J]. J Nat Cancer Inst, 1995, 87(11):817-827.
[12] Seifried H E, Seifried R M, Clarke J J, et al. A compilation of two decades of mutagenicity test results with the Ames Salmonella typhimurium and L5178Y mouse lymphoma cell mutation assays[J]. Chem Res Toxico, 2006, 19(5):627-644.
[13] Hirono I, Kuhara K, Hosaka S, et al. Induction of intestinal tumors in rats by dextran sulfate sodium[J]. J Natl Cancer Inst, 1981, 66(3):579-583.
[14] Hirono I, Kuhara K, Yamaji T, et al. Induction of colorectal squamous cell carcinomas in rats by dextran sulfate sodium[J]. Carcinogenesis, 1982, 3(3):353-355.
[15] Hirono I, Kuhara K, Yamaji T, et al. Carcinogenicity of dextran sulfate sodium in relation to its molecular weight[J]. Cancer Lett, 1983, 18(1):29-34.
[16] Hahn H, Biertherm M. Morphological changes induced by dextran sulfate 500 in mononuclear phagocytes of listeria-infected mice[J]. Infect Immun, 1974, 10(5):1110-1119.
[17] Siebeck M, Cheronis J C, Fink E, et al. Dextran sulfate activates contact system and mediates arterial hypotension via B2 kinin receptors[J]. J Appl Physiol,1985, 77(6):2675-2680.
[18] Hedin H, Ljungstrom K G. Prevention of dextran anaphylaxiss[J]. Int Arch Allergy Immunol, 1997, 113:358-359.
[19] Mehvar R, Shepard T L. Molecular-weight-dependent pharmacokinetics of fluoresceinlabeleddextrans in rats[J]. J Pharm Sci, 1992, 81(9):908-912.
[20] Koyama Y, Miyagawa T, Kawaide A, at al. Receptormediated absorption of high molecular weight dextrans from intestinal tract[J]. J Contr Rel, 1996, 41:171-176.
[21] Lake J R, Licko V, van Dyke R W. Biliary secretion of fluid-phase markers by the isolated perfused rat liver.Role of transcellular vesicular transport[J]. J Clin Invest,1985, 76(2):676-684.
[22] Mehvar R, Robinson M A, Reynolds J M. Molecular weight dependent tissue accumulation of dextrans:in vivo studies in rats[J]. J Pharm Sci, 1994, 83(10):1495-1499.
[23] Mehvar R, Robinson M A, Reynolds J M. Dose dependency of the kinetics of dextrans in rats:effects of molecular weight[J]. J Pharm Sci, 1995, 84(7):815-818.
[24] Takakura Y, Fujita T, Hashida M, et al. Disposition characteristics of macromolecules in tumor-bearing mice[J]. Pharm Res, 1990, 7(4):339-346.
[25] Babier P. Fetal risks with dextran during delivery[J].Drug saf, 1992, 7(1):71-73.
[26] Hedin H, Richter W, Kraft D. Pathomechanism of dextran-induced anaphylactoid reactions in man[J]. Int Archs Allergy appl Immun, 1981, 66:75-77.
[27] Scientific Committee on Food. Opinion of the Scientific committee on food on a dextran preparation, produced using Leuconostoc mesenteroides, Saccharomyces cerevisiae and Lactobacillus spp as a novel food ingredient in bakery products CS/NF/DOS/7/ADD 3FINAL[EB/OL].(2000-10-18)[2018-12-27]. http://citeseerx. ist. psu. edu/viewdoc/download; jsessionid=943B66B9CC1C83A36B526406E9B0698D? doi=10.1.1.583.5590&rep=rep1&type=pdf.
[28]长春卫尔赛生物药业有限公司.冻干人用狂犬病疫苗(Vero细胞)说明书[EB/OL].(2016-11-23)[2018-12-27].file:///C:/Users/xiao/Downloads/%E5%86%BB%E5%B9%B2%E4%BA%BA%E7%94%A8%E7%8B%82%E7%8A%AC%E7%97%85%E7%96%AB%E8%8B%97(Vero%E7%BB%86%E8%83%9E)%EF%BC%88CXSS1300015%EF%BC%89%E8%AF%B4%E6%98%8E%E4%B9%A6.pdf.
[29]北京四环科宝制药有限公司.注射用肌氨肽苷说明书[EB/OL].(2014-06-13)[2018-12-27]. http://www.docin.com/p-774327942.html.
[30]北京四环科宝制药有限公司.注射用棓丙酯说明书[EB/OL].(2014-06-13)[2018-12-27]. http://drugs.medlive.cn/drugref/html/14509.shtml.
[31]国家药监局药品审评中心.常用药用辅料数据库[EB/OL].(2012-03-06)[2018-12-27]. http://www.cde.org.cn/drugInfo.do?method=init&frameStr=1.