中药注射剂色差与安全性研究进展
|
摘要
中药注射剂作为我国独创的新剂型,具有生物利用度高、起效快等特点,在对急重症的治疗上起到重要作用。但是,随着中药注射剂在临床上的广泛应用及品种的日益增多,不良反应的报道逐渐增加。临床应用过程中常发现同一品种的注射剂存在明显的色泽差异现象,这是否与安全性有关联,已引起研究者的关注。中药注射剂的安全性问题越来越突出,这极大限制了中药注射剂的应用和发展。因此,对影响中药注射剂色差和安全性的因素进行综述,并分析了二者之间的关系,以期为寻找影响中药注射剂安全性的因素提供思路,且通过工艺改进提高中药注射剂的质量,为临床安全合理应用中药注射剂提供一定的指导。
As a unique innovative dosage form of China, traditional Chinese medicine injection(TCMI) has the characteristics of high bioavailability and rapid onset, therefore it plays an important role in the treatment of acute and severe diseases. However, more adverse reactions of TCMI have been reported along with its wide application in clinic and the increasing varieties. In the clinical application process, there are obvious color differences between the same kind of injection, which has attracted the attention of researchers whether this phenomenon is related to safety. The safety issue of TCMI has become more and more prominent, which greatly limits the application and development of TCMI. In this article, we summarized the reasons that influenced the chromatic aberration and safety of the TCMI, and analyzed the relationships between them. It is expected to provide some new ideas for exploring the reasons that affect the safety of TCMI and improving TCMI quality by technical improvement. This article provided a reference for rational application of TCMI in clinical practice.
As a unique innovative dosage form of China, traditional Chinese medicine injection(TCMI) has the characteristics of high bioavailability and rapid onset, therefore it plays an important role in the treatment of acute and severe diseases. However, more adverse reactions of TCMI have been reported along with its wide application in clinic and the increasing varieties. In the clinical application process, there are obvious color differences between the same kind of injection, which has attracted the attention of researchers whether this phenomenon is related to safety. The safety issue of TCMI has become more and more prominent, which greatly limits the application and development of TCMI. In this article, we summarized the reasons that influenced the chromatic aberration and safety of the TCMI, and analyzed the relationships between them. It is expected to provide some new ideas for exploring the reasons that affect the safety of TCMI and improving TCMI quality by technical improvement. This article provided a reference for rational application of TCMI in clinical practice.
引文
[1]中国药典[S].一部.2015.
[2]Zou J B,Zhang X F,Wang J,et al.The therapeutic efficacy of Danhong Injection combined with percutaneous coronary intervention in acute coronary syndrome:A systematic review and meta-analysis[J].Front Pharmacol,2018,9:550.
[3]Zheng X,Wang C,Sun Y,et al.Can Aidi injection restore cellular immunity and improve clinical efficacy in non-small-cell lung cancer patients treated with platinum-based chemotherapy?A meta-analysis of 17randomized controlled trials following the PRISMAguidelines[J].Medicine,2016,95(44):e5210.
[4]张洪峰,肖卫国.疏血通注射液治疗活动期类风湿关节炎的临床观察[J].中国中西医结合杂志,2008,28(3):255-257.
[5]Luo F,Gu J,Zhang X,et al.Multiscale modeling of drug-induced effects of Reduning Injection on human disease:From drug molecules to clinical symptoms of disease[J].Sci Rep,2015,doi:10.1038/srep10064.
[6]刘炜,潘卫松,张嘉莹,等.色差计法在注射剂溶液颜色检查法中的应用[J].药物分析杂志,2015,35(12):2131-2137.
[7]孙春艳,定天明,陈宁林,等.维生素C注射液质量评价及现行标准分析[J].中国现代应用药学,2014,31(7):853-857.
[8]王瑞芹,冯锐,王欣.中药注射剂在临床的合理应用[J].临床合理用药杂志,2011,4(18):176-177.
[9]康玉斌.常用中药注射液配伍后不溶性微粒影响因素的探讨[D].温州:温州医学院,2011.
[10]曲婷丽,魏玉海,李爱平,等.黄芪注射液1H-NMR指纹图谱研究[J].药学学报,2016,51(5):780-785.
[11]陈幼华.中成药肿节风注射液色泽影响因素的分析[J].海峡药学,2007,19(6):73-74.
[12]仝俊太.银杏达莫注射液配伍时颜色变化的探讨[J].现代中药研究与实践,2009,23(2):72.
[13]林南星,王景红,梅娜,等.银杏达莫注射液致不良反应192例分析[J].中国药房,2015,26(12):1607-1609.
[14]张敏红.38例银杏达莫注射液不良反应报告分析[J].中国医药导报,2013,10(2):109-110.
[15]罗清,彭伟文,曾聪彦.肿节风注射液致不良反应19例文献分析[J].临床合理用药杂志,2010,3(3):85-86.
[16]陈富超,方宝霞,李鹏,等.肿节风注射液致不良反应25例文献分析[J].中国药房,2009,20(12):945-947.
[17]刘光敏,贾晓斌,陈彦,等.HPLC法比较不同产地夏枯草属药材中成分组成的差异性[J].中草药,2010,41(8):1384-1386.
[18]赵红宁,黄柳芳,刘喜乐,等.不同产地阳春砂仁药材的质量差异研究[J].广东药学院学报,2016,32(2):176-180.
[19]欧阳慧,封亮,徐友华,等.不同产地夏枯草中抗非小细胞肺癌成分科罗索酸的差异比较[J].中华中医药杂志,2012,27(6):1571-1574.
[20]吴健民,唐洁锋.葛根素注射液抗氧剂的方法学探讨[J].中医药导报,2006,12(11):59-61.
[21]杨振伟,刘会东,屈战果.超滤法和水醇法制备黄芪注射液的实验研究[J].时珍国医国药,2004,15(12):32-33.
[22]刘继鑫,王克霞,李朝品.水蒸气蒸馏法提取中药挥发油存在的问题及解决方法[J].时珍国医国药,2008,19(1):97-98.
[23]赖正熬.放置时间及温度对康艾注射液稳定性研究[J].四川中医,2015,33(11):86-88.
[24]杨丽敏,高梅英,申迎.维生素C注射液颜色、pH值及含量的稳定性考察[J].黑龙江医药,2002,15(6):451-452.
[25]葛明东,乔昌明,李明,等.铁离子致环丙沙星注射液变色机理探讨[J].中国药师,2001,4(6):475-476.
[26]陈晋红,刘大伟,汤毅珊,等.中药材重金属和农药残留的研究进展[J].中药新药与临床药理,2009,20(2):187-190.
[27]张传兰,徐全华,马伟平,等.活性炭对注射用丁二磺酸腺苷蛋氨酸含量及澄清度与颜色的影响[J].安徽医药,2016,20(7):1265-1267.
[28]Ji K M,Li M,Chen J J,et al.Anaphylactic shock and lethal anaphylaxis caused by Houttuynia cordata injection,a herbal treatment in China[J].Allergy,2009,64(5):816-817.
[29]国家食品药品监督管理总局.国家药品不良反应监测年度报告:2015年[EB/OL].(2016-07-13)[2018-12-20].http://eng.sfda.gov.cn/WS01/CL0844/20158940.html.
[30]宋雪英.木通的品种、剂量与不良反应关系[J].浙江临床医学,2001,3(8):623.
[31]王东琴.基于代谢组学的不同基源柴胡功效比较研究[D].太原:山西大学,2013.
[32]周超凡,徐植灵,林育华.从制备方法看中药注射剂[J].中国中药杂志,2006,31(17):1477.
[33]张玉生.双黄连注射剂药物不良反应的探讨和研究[D].济南:山东大学,2009.
[34]张海燕,齐云,廖永红,等.注射剂常用增溶性药用辅料的安全与增溶研究[J].中国实验方剂学杂志,2011,17(11):1-4.
[35]周超凡,徐植灵,林育华.从药物组成看中药注射剂[J].中国中药杂志,2006,31(11):86-88.
[36]Yan D,Li J,Xiong Y,et al.Promotion of quality standard of herbal medicine by constituent removing and adding[J].Sci Rep,2014,doi:10.1038/srep03668.
[37]林子超,刘韬,黄伟强,等.109例肿瘤患者中药注射剂不良反应调研分析[J].中药材,2010,33(10):1671-1674.
[2]Zou J B,Zhang X F,Wang J,et al.The therapeutic efficacy of Danhong Injection combined with percutaneous coronary intervention in acute coronary syndrome:A systematic review and meta-analysis[J].Front Pharmacol,2018,9:550.
[3]Zheng X,Wang C,Sun Y,et al.Can Aidi injection restore cellular immunity and improve clinical efficacy in non-small-cell lung cancer patients treated with platinum-based chemotherapy?A meta-analysis of 17randomized controlled trials following the PRISMAguidelines[J].Medicine,2016,95(44):e5210.
[4]张洪峰,肖卫国.疏血通注射液治疗活动期类风湿关节炎的临床观察[J].中国中西医结合杂志,2008,28(3):255-257.
[5]Luo F,Gu J,Zhang X,et al.Multiscale modeling of drug-induced effects of Reduning Injection on human disease:From drug molecules to clinical symptoms of disease[J].Sci Rep,2015,doi:10.1038/srep10064.
[6]刘炜,潘卫松,张嘉莹,等.色差计法在注射剂溶液颜色检查法中的应用[J].药物分析杂志,2015,35(12):2131-2137.
[7]孙春艳,定天明,陈宁林,等.维生素C注射液质量评价及现行标准分析[J].中国现代应用药学,2014,31(7):853-857.
[8]王瑞芹,冯锐,王欣.中药注射剂在临床的合理应用[J].临床合理用药杂志,2011,4(18):176-177.
[9]康玉斌.常用中药注射液配伍后不溶性微粒影响因素的探讨[D].温州:温州医学院,2011.
[10]曲婷丽,魏玉海,李爱平,等.黄芪注射液1H-NMR指纹图谱研究[J].药学学报,2016,51(5):780-785.
[11]陈幼华.中成药肿节风注射液色泽影响因素的分析[J].海峡药学,2007,19(6):73-74.
[12]仝俊太.银杏达莫注射液配伍时颜色变化的探讨[J].现代中药研究与实践,2009,23(2):72.
[13]林南星,王景红,梅娜,等.银杏达莫注射液致不良反应192例分析[J].中国药房,2015,26(12):1607-1609.
[14]张敏红.38例银杏达莫注射液不良反应报告分析[J].中国医药导报,2013,10(2):109-110.
[15]罗清,彭伟文,曾聪彦.肿节风注射液致不良反应19例文献分析[J].临床合理用药杂志,2010,3(3):85-86.
[16]陈富超,方宝霞,李鹏,等.肿节风注射液致不良反应25例文献分析[J].中国药房,2009,20(12):945-947.
[17]刘光敏,贾晓斌,陈彦,等.HPLC法比较不同产地夏枯草属药材中成分组成的差异性[J].中草药,2010,41(8):1384-1386.
[18]赵红宁,黄柳芳,刘喜乐,等.不同产地阳春砂仁药材的质量差异研究[J].广东药学院学报,2016,32(2):176-180.
[19]欧阳慧,封亮,徐友华,等.不同产地夏枯草中抗非小细胞肺癌成分科罗索酸的差异比较[J].中华中医药杂志,2012,27(6):1571-1574.
[20]吴健民,唐洁锋.葛根素注射液抗氧剂的方法学探讨[J].中医药导报,2006,12(11):59-61.
[21]杨振伟,刘会东,屈战果.超滤法和水醇法制备黄芪注射液的实验研究[J].时珍国医国药,2004,15(12):32-33.
[22]刘继鑫,王克霞,李朝品.水蒸气蒸馏法提取中药挥发油存在的问题及解决方法[J].时珍国医国药,2008,19(1):97-98.
[23]赖正熬.放置时间及温度对康艾注射液稳定性研究[J].四川中医,2015,33(11):86-88.
[24]杨丽敏,高梅英,申迎.维生素C注射液颜色、pH值及含量的稳定性考察[J].黑龙江医药,2002,15(6):451-452.
[25]葛明东,乔昌明,李明,等.铁离子致环丙沙星注射液变色机理探讨[J].中国药师,2001,4(6):475-476.
[26]陈晋红,刘大伟,汤毅珊,等.中药材重金属和农药残留的研究进展[J].中药新药与临床药理,2009,20(2):187-190.
[27]张传兰,徐全华,马伟平,等.活性炭对注射用丁二磺酸腺苷蛋氨酸含量及澄清度与颜色的影响[J].安徽医药,2016,20(7):1265-1267.
[28]Ji K M,Li M,Chen J J,et al.Anaphylactic shock and lethal anaphylaxis caused by Houttuynia cordata injection,a herbal treatment in China[J].Allergy,2009,64(5):816-817.
[29]国家食品药品监督管理总局.国家药品不良反应监测年度报告:2015年[EB/OL].(2016-07-13)[2018-12-20].http://eng.sfda.gov.cn/WS01/CL0844/20158940.html.
[30]宋雪英.木通的品种、剂量与不良反应关系[J].浙江临床医学,2001,3(8):623.
[31]王东琴.基于代谢组学的不同基源柴胡功效比较研究[D].太原:山西大学,2013.
[32]周超凡,徐植灵,林育华.从制备方法看中药注射剂[J].中国中药杂志,2006,31(17):1477.
[33]张玉生.双黄连注射剂药物不良反应的探讨和研究[D].济南:山东大学,2009.
[34]张海燕,齐云,廖永红,等.注射剂常用增溶性药用辅料的安全与增溶研究[J].中国实验方剂学杂志,2011,17(11):1-4.
[35]周超凡,徐植灵,林育华.从药物组成看中药注射剂[J].中国中药杂志,2006,31(11):86-88.
[36]Yan D,Li J,Xiong Y,et al.Promotion of quality standard of herbal medicine by constituent removing and adding[J].Sci Rep,2014,doi:10.1038/srep03668.
[37]林子超,刘韬,黄伟强,等.109例肿瘤患者中药注射剂不良反应调研分析[J].中药材,2010,33(10):1671-1674.