中国药典2015年版大环内酯类抗生素的拟增修订重点
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摘要
中国药典2020年版的增修订工作已经启动。本文针对大环内酯类抗生素的特点,在进一步解读中国药典2015年版变化的基础上,提出对其进一步进行修订的重点。鉴于大环内酯类抗生素具有组分/杂质谱复杂之特点,增修订中应关注对大环内酯类抗生素中组分/有关物质,特别是与工艺相关的特定杂质的控制;而开发具有高专属性的HPLC方法,保证分析方法具有理想的重复性和粗放性,方便地实现对样本中各组分/杂质的快速定位,仍是方法学研究的重点。
The supplement and revision of Chinese Pharmacopoeia 2020 Edition has been started.In this paper,the future keypoints of revising macrolide antibiotics are introduced,on the basis of summarizing the characteristics of macrolides and further interpretation of changes in Chinese Pharmacopoeia 2015 Edition.In view of the complex components/impurity profile of macrolides,the supplement and revision work should be focused on the control of components/related substances,especially those which are process-related.Therefore,the development of HPLC methods with high specificity,desired repeatability robustness,and the capacity of identifying various components/impurities rapidly is still the key point of future methodology research.
The supplement and revision of Chinese Pharmacopoeia 2020 Edition has been started.In this paper,the future keypoints of revising macrolide antibiotics are introduced,on the basis of summarizing the characteristics of macrolides and further interpretation of changes in Chinese Pharmacopoeia 2015 Edition.In view of the complex components/impurity profile of macrolides,the supplement and revision work should be focused on the control of components/related substances,especially those which are process-related.Therefore,the development of HPLC methods with high specificity,desired repeatability robustness,and the capacity of identifying various components/impurities rapidly is still the key point of future methodology research.
引文
[1]Omura S.Macrolide antibiotics:Chemistry,biology,and practice[M].Academic Press,2002.
[2]胡昌勤.中国药典2015年版的增修订与抗生素质量控制方向[J].中国药学杂志,2015,50(20):1764-1769.
[3]孙忠实,朱珠.新型抗生素泰利霉素[J].中国新药杂志,2002,11(7):528-530.
[4]林菲菲,陈笑艳,戴晓健,等.液相色谱-串联质谱法测定人血浆中环酯红霉素[J].中国药学杂志,2010,45(13):1020-1023.
[5]The China Pharmacopoeia Committee.Pharmacopoeia of the People's Republic of China(in Chinese)[S].2015ed.Beijing:China Medical Science Press,2015.
[6]The European Pharmacopoeia Commission.The European Pharmacopoeia 8th Ed[S].Strasbourg:Council of Europe,2013.
[7]The United States Pharmacopoeial Convention.The United States Pharmacopoeia-National Formulary(USP38-NF)[S].The United States Pharmacopoeial Convention,2015.
[8]Bossche L,Lodi A,Schaar J,et al.An interlaboratory study on the suitability of a gradient LC-UV method as a compendial method for the determination of erythromycin and its related substances[J].J Pharm Biomed Anal,2010,53(1):109-112.
[9]Morimoto S,Takahashi Y,Watanabe Y,et al.Chemical modification of erythromycins.I.Synthesis and antibacterial activity of 6-O-methylerythromycins A[J].J Antibiot,1984,37(2):187-189.
[10]Moellering R C Jr.Introduction:Revolutionary changes in the macrolide and azalideantibiotics[J].Am J Med,1991,91(3A):1S-4S.
[11]马敏,姚国伟,史颖,等.阿奇霉素合成工艺的改进[J].精细化工,2006,23(8):781-783.
[12]Chang Y,Wang L X,Li Y P,et al.Factors influencing the HPLC determination for related substances of azithromycin[J].J Chromatogra Sci,2016,54(2):187-194.
[13]Chepkwony H K,Dehouck P,Roets E,et al.Isocratic separation of erythromycin,related substances and degradation products by liquid chromatography on XTerra RP18[J].Chromatographia,2000,53(3-4):159-165.
[14]Zhang X,Hu C Q.Selecting optimal columns for clarithromycin impurity analysis according to the quantitative relationship of hydrophobic subtraction model[J].J Pharma Biomed Anal,2017,136(3):162-169.
[15]Hu M,Hu C Q.Identification of the components of16-membered macrolide antibiotics by LC/MS[J].Analyt Chim Acta,2005,535(1-2):89-99.
[16]Vézina C,Bolduc C,Kudelsk A,et al.Biosynthesis of kitasamycin(leucomycin)by leucine analog-resistant mutants of Streptomyces kitasatoensis[J].Antimicrob Agents Chemother,1979,15(5):738-746.
[17]Kirst H A.Semi-synthetic derivatives of 16-membered macrolide antibiotics[M].Progress in Medicinal Chemistry,1994,31:265-296.
[18]胡敏,胡昌勤.LC-MS分析乙酰吉他霉素组分及水解产物[J].药学学报,2006,41(5):476-480.
[19]Wang M J,Pendela M,Hu C Q,et al.Impurity profiling of acetylspiramycin by liquid chromatography-ion trap mass spectrometry[J].J Chromatogra A,2010,1217(42):6531-6544.
[20]Omura S,Hironaka Y,Hata T.Chemistry of leucomycin.IX identification of leucomycin A3 with josamycin[J].J Antibiot,1970,23(10):511-513.
[21]Pharmacopoeia of Japan 16th Ed.日本厚生省出版社,2010.
[22]Omura S.Macrolide antibiotics:Chemistry,biology and practice[M].Academic Press,2002.
[2]胡昌勤.中国药典2015年版的增修订与抗生素质量控制方向[J].中国药学杂志,2015,50(20):1764-1769.
[3]孙忠实,朱珠.新型抗生素泰利霉素[J].中国新药杂志,2002,11(7):528-530.
[4]林菲菲,陈笑艳,戴晓健,等.液相色谱-串联质谱法测定人血浆中环酯红霉素[J].中国药学杂志,2010,45(13):1020-1023.
[5]The China Pharmacopoeia Committee.Pharmacopoeia of the People's Republic of China(in Chinese)[S].2015ed.Beijing:China Medical Science Press,2015.
[6]The European Pharmacopoeia Commission.The European Pharmacopoeia 8th Ed[S].Strasbourg:Council of Europe,2013.
[7]The United States Pharmacopoeial Convention.The United States Pharmacopoeia-National Formulary(USP38-NF)[S].The United States Pharmacopoeial Convention,2015.
[8]Bossche L,Lodi A,Schaar J,et al.An interlaboratory study on the suitability of a gradient LC-UV method as a compendial method for the determination of erythromycin and its related substances[J].J Pharm Biomed Anal,2010,53(1):109-112.
[9]Morimoto S,Takahashi Y,Watanabe Y,et al.Chemical modification of erythromycins.I.Synthesis and antibacterial activity of 6-O-methylerythromycins A[J].J Antibiot,1984,37(2):187-189.
[10]Moellering R C Jr.Introduction:Revolutionary changes in the macrolide and azalideantibiotics[J].Am J Med,1991,91(3A):1S-4S.
[11]马敏,姚国伟,史颖,等.阿奇霉素合成工艺的改进[J].精细化工,2006,23(8):781-783.
[12]Chang Y,Wang L X,Li Y P,et al.Factors influencing the HPLC determination for related substances of azithromycin[J].J Chromatogra Sci,2016,54(2):187-194.
[13]Chepkwony H K,Dehouck P,Roets E,et al.Isocratic separation of erythromycin,related substances and degradation products by liquid chromatography on XTerra RP18[J].Chromatographia,2000,53(3-4):159-165.
[14]Zhang X,Hu C Q.Selecting optimal columns for clarithromycin impurity analysis according to the quantitative relationship of hydrophobic subtraction model[J].J Pharma Biomed Anal,2017,136(3):162-169.
[15]Hu M,Hu C Q.Identification of the components of16-membered macrolide antibiotics by LC/MS[J].Analyt Chim Acta,2005,535(1-2):89-99.
[16]Vézina C,Bolduc C,Kudelsk A,et al.Biosynthesis of kitasamycin(leucomycin)by leucine analog-resistant mutants of Streptomyces kitasatoensis[J].Antimicrob Agents Chemother,1979,15(5):738-746.
[17]Kirst H A.Semi-synthetic derivatives of 16-membered macrolide antibiotics[M].Progress in Medicinal Chemistry,1994,31:265-296.
[18]胡敏,胡昌勤.LC-MS分析乙酰吉他霉素组分及水解产物[J].药学学报,2006,41(5):476-480.
[19]Wang M J,Pendela M,Hu C Q,et al.Impurity profiling of acetylspiramycin by liquid chromatography-ion trap mass spectrometry[J].J Chromatogra A,2010,1217(42):6531-6544.
[20]Omura S,Hironaka Y,Hata T.Chemistry of leucomycin.IX identification of leucomycin A3 with josamycin[J].J Antibiot,1970,23(10):511-513.
[21]Pharmacopoeia of Japan 16th Ed.日本厚生省出版社,2010.
[22]Omura S.Macrolide antibiotics:Chemistry,biology and practice[M].Academic Press,2002.