Infusion Requirements on Labels of 39 Chinese Traditional Medicine Injections

doi:10.19803/j.1672-8629.2020.07.11

Abstract

Abstract: Objective To investigate the instructions on infusion on some labels of Traditional Chinese Medicine (TCM) injections in order to provide reference for clinical treatment and standardized management. Methods The instructions of some TCM injections were collected, and the requirements specified in the instructions were analyzed, involving the administration route, preparation methods, solvents, concentration, storage conditions, and infusion speed before the integrity of and problems with the labels were examined. Results All the thirty-nine instructions of TCM injections had the routes of administration specified. Twenty-seven of them (87.10%) were marked with preparation methods, twenty-four (77.42%) concentrations of preparation solutions, ten (32.26%) storage conditions, twenty-four (61.54%) the infusion speed, eighteen (48.65%) flushing tubes, and two (5.13%) with material requirements of infusion sets. Conclusion Among these TCM injection instructions, requirements are not quite specific as to the storage of solvents, flushing of tubes and the materials of infusion sets. It is suggested that manufacturers supplement the details in the instructions to provide reference for clinical treatment and standardized management.

Key words: Traditional Chinese Medicine(TCM) injection, labeling, drug instructions

CLC Number:

R978.7

WENG Lihong, GAO Huan, HU Xue, ZHANG Wenrui. Infusion Requirements on Labels of 39 Chinese Traditional Medicine Injections[J]. Chinese Journal of Pharmacovigilance, 2020, 17(7): 437-440.

References

[1] 夏东胜, 我国药品说明书孕妇及哺乳期妇女用药标示问题分析及风险控制建议[J]. 中国药物警戒, 2015, 12(4):211-218.
[2] 金立军. 329份处方药品说明书的调查分析[J]. 中国药事, 2012,26(3):255-257.
[3] 张彦昭, 文占权, 刘传绪, 等. 2013~2016年国家药品不良反应监测年度报告统计分析[J]. 药物流行病学杂志, 2017, 26(11):763-765.
[4] 国家药品监督管理局. 国家药品不良反应监测年度报告:2017年[J]. 中国药物评价, 2018, 35(2):154-160.
[5] 王艳丽. 我院40组注射剂药品说明书调查分析[J].中国药物警戒, 2018, 15(3):147-151.
[6] 朱熠, 王双梅. 中药注射液高不良反应发生率问题探讨[J]. 北方药学,2018, 15(8):160-161.
[7] 张凌云. 中药注射剂说明书内容调查[J]. 中国药师, 2013, 16(2):309-311.
[8] 刘辰翔,谭乐俊,王萌,等. 中药注射剂配伍稳定性的研究进展[J]. 中成药, 2015, 37(4):844-849.
[9] 韦曦, 吕超智, 杨荔, 等. 中药注射剂与输液配伍的不溶性微粒变化[J]. 中国中药杂志, 2007, 32(14):1477-1480.
[10] 胡雪,刘雅娟,刘鑫,等.静脉输注药品调配后的贮存信息标注情况调查与建议[J]. 中国医院药学杂志, 2018, 38(22):2377-2379.
[11] 阎爱荣,彭芳辰.10种中药注射液的不良反应及相关因素分析[J]. 中国医院药学杂志, 2008, 28(9):765-766.
[12] 朱熠, 王双梅. 中药注射液高不良反应发生率问题探讨[J]. 北方药学, 2018, 15(8):160-161.
[13] 谭朝丹, 时扣荣, 刘娟, 等. 中药注射剂超说明书使用情况调查分析[[J]. 中成药, 2015, 37(9):2095-2097.
[14] 孙燕伟, 韩博. 三种不同材质输液容器对三种中药注射剂有效成分吸附性研究[J]. 中小企业管理与科技, 2011,11(19):322-323.
[15] 余强, 李佳宁, 郭亮, 等. 输液器材质对输注药物吸附作用的研究进展[J]. 中国护理管理, 2016, 16(6): 862-864.
[16] 夏东胜. 近8年我国药品监督管理部门发文修订药品说明书情况及趋势[J]. 中国药房, 2014, 25(41): 3853-3856.