溴己新注射剂临床配伍用药研究

doi:10.19803/j.1672-8629.20230305

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (8): 884-887.
DOI: 10.19803/j.1672-8629.20230305

溴己新注射剂临床配伍用药研究

刘毅¹, 刘晓强², 姚晓², 李选堂¹, 郭贤辉¹, 耿颖^1,*, 裴宇盛¹

¹中国食品药品检定研究院化学药品检定所,化学药品质量研究与评价重点实验室,北京 102629;
²江苏省常州市药品检验所,江苏常州 213002

收稿日期:2023-05-18 出版日期:2024-08-15 发布日期:2024-08-21
通讯作者: ^*耿颖,女,博士,副研究员,化学药品质量分析。E-mail: gengying@nifdc.org.cn
作者简介:刘毅,男,博士,主任药师,化学药品质量分析。
基金资助:
中国食品药品检定研究院化学药品检定所重点实验室学科建设项目（2023HYZX25）; 北京市自然科学基金资助项目（L222010）

Clinical compatibility of bromhexine injectable preparations

LIU Yi¹, LIU Xiaoqiang², YAO Xiao², LI Xuantang¹, GUO Xianhui¹, GENG Ying^1,*, PEI Yusheng¹

¹Institute for Chemical Drug Control, National Institutes for Food and Drug Control‚ NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing 102629‚ China;
²Changzhou Institute for Drug Control, Changzhou Jiangsu 213002‚ China

Received:2023-05-18 Online:2024-08-15 Published:2024-08-21

摘要/Abstract

摘要： 目的考察导致溴己新注射剂临床输液药液混浊原因,为保障该注射剂质量和临床安全使用提供参考。方法结合溴己新溶解度分析实验,开展代表性的临床配伍实验研究,关注非治疗性药物的配伍情况。结果药液pH环境高度影响溴己新的溶解度,结合复方氯化钠注射液和复方电解制注射液的验证性临床配伍实验,溴己新注射剂临床配伍用药的环境pH偏碱性时易出现药液变混浊的不良状况。结论溴己新注射液配伍后浑浊现象的关键影响因素为pH而非输液溶媒,提示非治疗性药物的临床配伍问题应予以重视。

关键词: 溴己新, 注射剂, 临床配伍, 溶解度, 酸碱度, 氯化钠注射液, 非治疗性药物, 电解质, 溶媒

Abstract: Objective To investigate the causes of turbidity that occurs during infusion of bromhexine injectable preparations. Methods Representative clinical compatibility tests for verification were carried out in combination with bromhexine solubility analysis, and the relevant compatibility of non therapeutic drugs was observed. Results The solubility of bromhexine was highly correlated with the pH environment. Combined with confirmatory clinical compatibility tests of compound sodium chloride injection and multiple electrolytes injection, it was confirmed that bromhexine injectable preparations were likely to become turbid when the environmental pH value of the clinical compatibility medication was slightly alkaline. Conclusion The turbidity of bromhexine injectable preparations is chiefly due to pH rather than the infusion solvent, suggesting the need to attach importance to clinical compatibility of non-therapeutic drugs.

Key words: bromhexine, injection, clinical compatibility, solubility, pH, sodium chloride injection, non therapeutic drugs, electrolytes, solvent

中图分类号:

R917

刘毅, 刘晓强, 姚晓, 李选堂, 郭贤辉, 耿颖, 裴宇盛. 溴己新注射剂临床配伍用药研究[J]. 中国药物警戒, 2024, 21(8): 884-887.

LIU Yi, LIU Xiaoqiang, YAO Xiao, LI Xuantang, GUO Xianhui, GENG Ying, PEI Yusheng. Clinical compatibility of bromhexine injectable preparations[J]. Chinese Journal of Pharmacovigilance, 2024, 21(8): 884-887.

导出引用管理器 EndNote|Ris|BibTeX

链接本文: https://zgywjj.magtechjournal.com/CN/10.19803/j.1672-8629.20230305

https://zgywjj.magtechjournal.com/CN/Y2024/V21/I8/884

参考文献

[1] WU J, FAN JY, YANG XQ.Effect of bromhexine hydrochloride combined with azithromycin in treatment of infant mycoplasmal pneumoniae pneumonia[J]. Chinese Community Doctors(中国社区医师), 2023, 39(6): 46-48.
[2] WEI GH, FENG NN.Clinical study of bromohexoxin hydrochloride combined with phentolamine in the treatment of children with pneumonia[J]. China Journal of Pharmaceutical Economics(中国药物经济学), 2022, 17(3): 80-83, 87.
[3] LIN JH, CHEN XJ, DING YL.Study on the bacterial endotoxin test in the raw material of bromhexine hydrochloride for injection[J]. Shanghai Medical & Pharmaceutical Journal(上海医药), 2020, 41(7): 75-77.
[4] LI XL, XIA YH, CHEN YF, et al.Clinical study on bromhexine combined with tiotropium bromide in treatment of chronic obstructive pulmonary disease in stable stage[J]. Drugs & Clinic(现代药物与临床), 2020, 35(1): 105-108.
[5] SUN J, LI Y, DUAN XX, et al.Bioequivalence evaluation of domestic bromhexine hydrochloride soluble powder in chickens[J]. Journal of Qingdao Agricultural University(Ziran Kexueban)(青岛农业大学学报自然科学版), 2022, 39(4): 252-258.
[6] XIAO GR, MAO YH, FANG SQ, et al.Observation on the efficacy of moxifloxacin combined with bromhexin hydrochloride in patients with MRSA severe ventilator-associated pneumonia[J]. Journal of Qiqihar University of Medicine(齐齐哈尔医学院学报), 2022, 43(17): 1634-1638.
[7] MA LJ, YANG L, GONG PS, et al.Efficacy of ceftazidime combined with bromhexine in the treatment of chronic obstructive pulmonary disease complicated with pulmonary infection and the effects of the combination on pulmonary function and inflammatory factors[J]. China Medicine and Pharmacy(中国医药科学), 2022, 12(2): 66-69.
[8] ZHANG W, ZHANG MX, TAN L, et al.Meta-analysis of adverse reactions of bromhexine[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2019, 16(3): 171-173, 178.
[9] WANG T, WU GZ, DONG Z.Analysis and consideration on risk of bromhexine hydrochloride injection[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2015, 12(1): 49-52.
[10] GUAN SX.Efficacy and adverse reactions of bromhexine hydrochloride combined with azithromycin in the treatment of children with mycoplasmal pneumonia[J]. Women’s Health Research(中外女性健康研究), 2019(24): 2-4.
[11] TENG HP.Efficacy and adverse reactions of bromhexine hydrochloride combined with azithromycin in the treatment of children with mycoplasmal pneumonia[J]. China Foreign Medical Treatment(中外医疗), 2019, 38(27): 124-126.
[12] JIANG Y, QI JJ, LI T, et al.Analysis of 208 cases of adverse drug reactions induced by bromhexine hydrochloride injection[J]. Chinese Journal of Pharmacoepidemiology(药物流行病学杂志), 2020, 29(8): 544-548.
[13] NJARIA PM, ABUGA KO, KAMAU FN, et al.A versatile HPLC method for the simultaneous determination of bromhexin, guaifenesin, ambroxol, salbutamol/terbutaline, pseudoephedrine, triprolidine, and chlorpheniramine maleate in cough-cold syrups[J]. Chromatographia, 2016, 79(21): 1507-1514.
[14] National Medical Products Administration. NMPA Public notice for revising the package insert of bromhexine hydrochloride injections(No.89, 2018)[EB/OL]. (2018-11-12) [2023-02-20]. https://www.nmpa.gov.cn/xxgk/ggtg/ypshmshxdgg/20181120170101624.html.
[15] XU MZ, LIU Y, HE L, et al.Study of key factors influencing the quality of bromhexin hydrochloride injectable preparations in clinical use[J]. Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2021, 41(2): 359-369.
[16] LIU Y, WU JM, LIU XQ, et al.Study on the quality standards of bromhexin hydrochloride injections[J]. Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2018, 38(11): 2008-2013.

溴己新注射剂临床配伍用药研究

Clinical compatibility of bromhexine injectable preparations

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 15

编辑推荐

Metrics

[1]	赵杰, 高明娥, 常虹, 范惠霞. 复方聚乙二醇电解质散致患儿过敏样反应2例分析[J]. 中国药物警戒, 2024, 21(7): 816-818.
[2]	耿颖, 刘毅, 王雪蕾, 朱容蝶, 金滢, 陈华, 郑丽娥. 近红外和拉曼光谱法对溴己新注射剂处方工艺的一致性研究[J]. 中国药物警戒, 2024, 21(3): 300-306.
[3]	张建, 方慧华. 某院活血化瘀类中药注射剂使用评价标准建立的探索[J]. 中国药物警戒, 2024, 21(2): 185-189.
[4]	李娜, 郭军, 郭文佳, 吕茵茵, 李彩宏, 牟向东. 奥马珠单抗注射剂治疗哮喘致迟发型皮肤过敏反应1 例分析[J]. 中国药物警戒, 2024, 21(2): 211-212.
[5]	邰隽, 于淼, 张琳, 雷毅, 刘军廷, 李涛, 黄贵民, 程毅菁, 聂晓璐, 王青. 基于自然语言处理技术的儿童病例注射用尖吻蝮蛇血凝酶不良反应主动监测方法构建与验证研究[J]. 中国药物警戒, 2023, 20(9): 1011-1016.
[6]	孟康康, 刘赛月. 辅酶Q10注射剂上市后安全性分析[J]. 中国药物警戒, 2023, 20(7): 795-798.
[7]	谢安劼, 王长德, 陈卉, 张士强. 复方聚乙二醇电解质散（Ⅱ）致低钠性脑病1例分析[J]. 中国药物警戒, 2023, 20(6): 709-711.
[8]	黄少兰, 杨戈, 李薇. 注射用头孢他啶阿维巴坦联用注射用硫酸多黏菌素B致肾移植患者肌无力1例分析[J]. 中国药物警戒, 2023, 20(5): 583-584.
[9]	杨茜, 惠艳春, 王晨, 张现化, 许明哲. 高效液相-纳克级激光计数检测器联用法测定注射用兰索拉唑中葡甲胺的含量[J]. 中国药物警戒, 2023, 20(4): 361-364.
[10]	杨乐, 夏东胜, 王涛. 维生素B₂注射剂安全性风险分析[J]. 中国药物警戒, 2023, 20(11): 1256-1258.
[11]	钟露苗, 杜娟, 邓华, 王亚锋, 仇萍, 曾令贵. 药品上市许可持有人开展中药注射剂安全性主动监测研究设计和质量管理的思考[J]. 中国药物警戒, 2022, 19(9): 994-998.
[12]	周鹏, 杨晶晶. 3种清热解毒类中药注射剂的药学监护[J]. 中国药物警戒, 2022, 19(4): 441-445.
[13]	易艳, 田婧卓, 李春英, 赵雍, 梁爱华. 中药注射剂上市后非临床安全性再评价类过敏反应相关研究[J]. 中国药物警戒, 2022, 19(2): 185-188.
[14]	刘春, 王巨才, 黄裕昌, 叶小青, 赵映淑, 詹媚媚, 王晨. 非临床安全性评价研究中注射用阿奇霉素豚鼠过敏试验研究[J]. 中国药物警戒, 2022, 19(11): 1161-1164.
[15]	王宗尉, 肖佳音, 王春雨, 高海舒, 姚尚辰, 许明哲. 注射用海参糖胺聚糖异常毒性和热原方法学研究[J]. 中国药物警戒, 2022, 19(11): 1165-1169.