硝基咪唑类药物分析方法及其应用研究
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摘要
硝基咪唑类药物是一类具有硝基咪唑环结构的化合物,作为抗厌氧菌、滴虫和阿米巴虫等细菌在临床上有广泛的应用,也多与其他抗菌药物联合应用于临床各系统的厌氧菌与需氧菌混合感染。此类药物长期大剂量服用会出现不良反应,如神经系统损害、泌尿系统损害等。故针对不同硝基咪唑类产品需选择合理的分析方法:原料药的测定选择滴定法及紫外分光光度法;制剂的测定选择高效液相色谱法;体内药代动力学及硝基咪唑类痕量检测选择液相色谱-质谱联用技术。针对不同样品选择不同分析方法,可以达到提高效率、降低成本的目的,并可以为硝基咪唑类药物质量控制与合理应用提供理论与技术支持。
Nitroimidazoles are a kind of compound with nitroimidazole ring structures. It has wide applications in clinical as the germs of anti anaerobe, trichomonas and amoeba. It also has wide combined use with other antimicrobial medicines in clinical that anaerobia and aerobe have polyinfection in every system. But if these drugs have been taken for a long time they will have toxicity such as nervous system damage, urinary system damage and so on. Selecting reasonable analysis methods for different nitroimidazole drugs: using the titration method and UV method to test raw materials; using the HPLC method to test preparations; using the LC-MS method to test pharmacokinetics and the trace of nitroimidazole. Thus, we should select different analysis methods to aim at different samples. It can improve efficiency and reduce costs. In addition it provides the theory and techniques for quality control and reasonable application of nitromidazole drugs.
Nitroimidazoles are a kind of compound with nitroimidazole ring structures. It has wide applications in clinical as the germs of anti anaerobe, trichomonas and amoeba. It also has wide combined use with other antimicrobial medicines in clinical that anaerobia and aerobe have polyinfection in every system. But if these drugs have been taken for a long time they will have toxicity such as nervous system damage, urinary system damage and so on. Selecting reasonable analysis methods for different nitroimidazole drugs: using the titration method and UV method to test raw materials; using the HPLC method to test preparations; using the LC-MS method to test pharmacokinetics and the trace of nitroimidazole. Thus, we should select different analysis methods to aim at different samples. It can improve efficiency and reduce costs. In addition it provides the theory and techniques for quality control and reasonable application of nitromidazole drugs.
引文
[1]祖恩慧,张岚,于龙飞.3种硝基咪唑类药物治疗滴虫性阴道炎的有效性及不良反应研究[J].中国妇幼保健,2015,30(12):1936-1938.
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[4]The International Pharmacopoeia(7th)[S].The WHO Expert Committee on Specifications for Pharmaceutical Preparations(ECSPP),2017.
[5]施春阳,闵敏,王文清,等.双波长分光光度法测定氯硝唑酊中氯霉素与甲硝唑的含量[J].医药导报,2010,29(7):936-938.
[6]李为,雷凯,张程亮,等.HPLC法同时测定复方奥硝唑贴膜中奥硝唑和地塞米松磷酸钠的含量[J].中国药房,2016,27(21):2975-2977.
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[10]康现武,王毅.自制甲硝唑缓释微球结肠溶胶囊在家兔体内药代动力学研究[J].河北医药,2010,32(20):2814-2816.
[11]张黎媛.液质联用技术在中药质量控制中的应用[J].世界中医药,2018,13(2):513-516,521.
[12]STEPHANI L,STANCIL,LEON VAN HAANDELSTEPHANI L,et al.Development of a UPLC-MS/MSmethod for quantitation of metronidazole and 2-hydroxy metronidazole in human plasma and its application to a pharmacokinetic study[J].Journal of Chromatography B,2018,10(92):272-278.
[13]DAS S,LI J,ARMSTRONG J,et al.Randomized pharmacokinetic and drug-drug interaction studies of ceftazidime,avibactam,and metronidazole in healthy subjects[J].Pharmacology research&perspectives,2015,3(5):e00172.
[14]杨成对,宋莉晖.家禽肌肉组织中硝基咪唑类药物残留的液相色谱串联质谱测定[J].分析测试学报,2006,25(4):101-103.
[15]肖国军,蔡超海,王生,等.固相萃取高效液相色谱串联质谱法同时测定蜂蜜中甲硝唑、氯霉素、甲砜霉素和氟甲砜霉素残留[J].中国卫生检验杂志,2018,28(1):22-25.
[16]张鑫鑫,高媛惠,花锦,等.液相色谱-串联质谱法测定祛痘化妆品中5种硝基咪唑类化合物[J].日用化学工业,2016,46(11):661-664,670.
[17]傅哲,彭智,肖志勇.气相色谱法测定动物血中甲硝唑浓度及药动学研究[J].长沙医学院学报,2010(2):5-9,4.
[18]顾胜华,阿基业,査伟斌,等.代谢组学研究甲硝唑对高脂血症金黄地鼠机体代谢的影响[J].中国药科大学学报,2012,43(5):443-448.
[19]严拯宇,肖岸,吕华,等.ZnO掺杂碳量子点的流动注射化学发光法测定甲硝唑(英文)[J].新型炭材料,2014,29(3):216-224.
[20]王金中,刘波,周艳梅.流动注射荧光法测定甲硝唑[J].南阳师范学院学报,2006,5(3):38-41.
[21]马雄辉,韦柳鸽,吴婷,等.铜-金属有机框架物修饰电极的制备及甲硝唑测定[J].分析测试学报,2017,36(1):91-95.
[2]国家药典委员会.中华人民共和国药典(二部)[M].北京:中国医药科技出版社,2015:212.
[3]The Japanese Pharmacopoeia(17th)[S].The ministry of health,labour and welfare,2016:1246.
[4]The International Pharmacopoeia(7th)[S].The WHO Expert Committee on Specifications for Pharmaceutical Preparations(ECSPP),2017.
[5]施春阳,闵敏,王文清,等.双波长分光光度法测定氯硝唑酊中氯霉素与甲硝唑的含量[J].医药导报,2010,29(7):936-938.
[6]李为,雷凯,张程亮,等.HPLC法同时测定复方奥硝唑贴膜中奥硝唑和地塞米松磷酸钠的含量[J].中国药房,2016,27(21):2975-2977.
[7]COHENWOLKOWIEZ M,SAMPSON M,BLOOM B T,et al.Determining population and developmental pharmacokinetics of metronidazole using plasma and dried blood spot samples from premature infants[J].The Pediatric infectious disease journal,2013,32(9):956-961.
[8]辛显桐,刘克明,王虹,等.甲硝唑经口腔吸收在大鼠体内的代谢动力学[J].环境与健康杂志,2001,18(2):80-82.
[9]IIDA J,KUDO T,SHIMADA K,et al.Investigation of the safety of topical metronidazole from a pharmacokinetic perspective[J].Biological&pharmaceutical bulletin,2013,36(1):89-95.
[10]康现武,王毅.自制甲硝唑缓释微球结肠溶胶囊在家兔体内药代动力学研究[J].河北医药,2010,32(20):2814-2816.
[11]张黎媛.液质联用技术在中药质量控制中的应用[J].世界中医药,2018,13(2):513-516,521.
[12]STEPHANI L,STANCIL,LEON VAN HAANDELSTEPHANI L,et al.Development of a UPLC-MS/MSmethod for quantitation of metronidazole and 2-hydroxy metronidazole in human plasma and its application to a pharmacokinetic study[J].Journal of Chromatography B,2018,10(92):272-278.
[13]DAS S,LI J,ARMSTRONG J,et al.Randomized pharmacokinetic and drug-drug interaction studies of ceftazidime,avibactam,and metronidazole in healthy subjects[J].Pharmacology research&perspectives,2015,3(5):e00172.
[14]杨成对,宋莉晖.家禽肌肉组织中硝基咪唑类药物残留的液相色谱串联质谱测定[J].分析测试学报,2006,25(4):101-103.
[15]肖国军,蔡超海,王生,等.固相萃取高效液相色谱串联质谱法同时测定蜂蜜中甲硝唑、氯霉素、甲砜霉素和氟甲砜霉素残留[J].中国卫生检验杂志,2018,28(1):22-25.
[16]张鑫鑫,高媛惠,花锦,等.液相色谱-串联质谱法测定祛痘化妆品中5种硝基咪唑类化合物[J].日用化学工业,2016,46(11):661-664,670.
[17]傅哲,彭智,肖志勇.气相色谱法测定动物血中甲硝唑浓度及药动学研究[J].长沙医学院学报,2010(2):5-9,4.
[18]顾胜华,阿基业,査伟斌,等.代谢组学研究甲硝唑对高脂血症金黄地鼠机体代谢的影响[J].中国药科大学学报,2012,43(5):443-448.
[19]严拯宇,肖岸,吕华,等.ZnO掺杂碳量子点的流动注射化学发光法测定甲硝唑(英文)[J].新型炭材料,2014,29(3):216-224.
[20]王金中,刘波,周艳梅.流动注射荧光法测定甲硝唑[J].南阳师范学院学报,2006,5(3):38-41.
[21]马雄辉,韦柳鸽,吴婷,等.铜-金属有机框架物修饰电极的制备及甲硝唑测定[J].分析测试学报,2017,36(1):91-95.