2019 年第 9 期 第 14 卷

注射剂药品说明书中辅料标注情况与安全性分析

Analysis of labeling and safety of excipients in injections

作者：曹译丹刘雅娟宋燕青王相峰

英文作者：

单位：130021长春，吉林大学第一医院药学部

英文单位：

关键词：药品说明书；注射剂；辅料；安全性

英文关键词：

• 摘要：

• 【摘要】目的    调查注射剂药品说明书中辅料信息的标注情况，为临床安全用药提供参考。方法    根据《中华人民共和国药典：2015年版》《药品说明书和标签管理规定》和《化学药品和治疗用生物制品说明书规范细则》，对吉林大学第一医院截至2018年12月31日有使用记录的823份注射剂药品说明书辅料、注意事项、主要成分、禁忌证、性状、不良反应、相互作用等标注项中辅料的标注信息进行统计，并对辅料标注的规范性及安全性进行分析。结果    823份注射剂药品说明书中进口药品说明书115份（14.0%），国产药品说明书668份（81.2%），合资药品说明书40份（4.9%），明确标注辅料的说明书640份，涉及辅料134种，未标注辅料的药品说明书177份，标注“无辅料”的药品说明书6份。640份辅料信息被标注在辅料、注意事项、主要成分、禁忌证、性状、相互作用等单个或多个标注项内，排在前3位的依次为辅料616份（74.8%）、注意事项64份（7.8%）、主要成分44份（5.3%），其余为禁忌证30份（3.6%）、性状12份（1.5%）、不良反应11份（1.3%）、相互作用1份（0.1%），存在辅料信息同时标注在多个标注项的情况，如同时标注在注意事项、辅料54份（6.6%），同时标注在禁忌证、辅料29份（3.5%），同时标注在主要成分、辅料20份（2.4%），同时标注在不良反应、辅料8份（1.0%），同时标注在性状、辅料7份（0.8%），同时标注在相互作用、辅料1份（0.1%），同时标注在注意事项、性状1份（0.1%）。134种辅料中药典收录57种，收录占比为42.5%，主要分为pH调节剂和缓冲剂（25种）、增溶剂和乳化剂（24种）、溶剂（15种）、渗透压调节剂（9种）、抗氧剂和抗氧增效剂（9种）、增稠剂和稳定剂（8种）、矫味剂（8种）、助溶剂（3种）、抑菌剂和防腐剂（3种）、吸附剂（1种）、其他（29种）。标注供注射用等级辅料8种。结论    注射剂药品说明书中辅料信息的标注尚不规范，辅料信息标注缺失、标注项不统一、标注信息不完善，临床用药存在风险，建议药品生产企业及时修订药品说明书辅料信息，相关部门应加强对辅料安全的监管，从国家层面上敦促企业药品说明书的补充修订。

• 【Abstract】Objective    To investigate the labeling information of excipients in injections and provide reference for clinical safe medication. Methods    According to Pharmacopoeia of People′s Republic of China 2015 version, Drug Instructions and Label Management Regulations and Specifications for the Instructions of Chemical Medicine and Biological Products, 823 instructions for injectable drugs used in the First Hospital of Jilin University up to December 31st, 2018 were collected. Labeling information of "excipients" "precautions" "main ingredients" "contraindications", "properties" "adverse reactions" and "interactions" were counted; the standardization and safety of excipients were analyzed. Results    Among the 823 injections, there were 115 imported products（14.0%）, 668 domestic products(81.2%) and 40 joint venture products(4.9%). A total of 134 excipients were listed in 640 drug instructions. One hundred and seventy-seven drug instructions were lack of excipient information, and 6 drug instructions labeled "no excipient". Excipient information was described in single or multiple labeling items such as "excipients" "precautions" "main ingredients" "contraindications" "traits" "interactions", etc. The top three items were "excipients" ［616 (74.8%)］, "precautions" ［64(7.8%)］, "main ingredients" ［44(5.3%)］, following with "contraindications" ［30(3.6%)］, "traits" ［12(1.5%)］, "adverse reactions" ［11(1.3%)］ and "interactions" ［1(0.1%)］. Meanwhile, 54 items (6.6%) were marked in "precautions" and "excipients"; 29 items (3.5%) were marked in "contraindications" and "excipients"; 20 items (2.4%) were marked in "main ingredients" and "excipients"; 8 (1.0%) items were marked in "adverse reactions" and "excipients"; 7 items (0.8%) were marked in "traits" and "excipients"; 1 (0.1%) item was marked in "interactions" and "excipients"; 1 (0.1%) item was marked in "precautions" and "traits". Among the 134 excipients, 57 were included in the Pharmacopoeia, accounting for 42.5%, including pH regulators and buffers (25), solvents and emulsifiers (24), solvents (15), osmotic pressure regulators (9), antioxidants and antioxidant synergists (9), thickeners and stabilizers (8), odorants (8), cosolvents (3), bacteriostasis and preservatives (3), adsorbents (1) and others (29). Eight excipients were labeled for injection. Conclusions    Labeling of excipients in introductions for injections is not standard. Many drugs are lake of excipient information. It is important for drug manufacturers to revise the introductions appropriately and add accurate excipient information. Governments should strengthen supervision over the safety of drug excipients.