静脉注射用奥美拉唑钠质量一致性研究

doi:10.19803/j.1672-8629.2021.07.04

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (7): 614-619.
DOI: 10.19803/j.1672-8629.2021.07.04

• 化学药品一致性评价专栏 • 上一篇下一篇

静脉注射用奥美拉唑钠质量一致性研究

刘荷英¹, 刘绪平¹, 钟振华¹, 裴昆¹, 夏红英¹, 程奇珍^1,*, 王晨^2#

¹江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌 330029;
²中国食品药品检定研究院,北京 102629

收稿日期:2021-03-23 出版日期:2021-07-15 发布日期:2021-07-23
通讯作者: ^*程奇珍,女,本科,主任药师,药品质量和标准研究。E-mail: cqz1110@sina.com;^#为共同通信作者。
作者简介:刘荷英,女,硕士,副主任药师,药品质量和标准研究。
基金资助:
重大新药创制国家科技重大专项2017年度（2017zx09101001）; 江西省药品监督管理局科技计划（2019yp11）

Quality Consistency of Omeprazole Sodium for Intravenous Injection

LIU Heying¹, LIU Xuping¹, ZHONG Zhenhua¹, PEI Kun¹, XIA Hongying¹, CHENG Qizhen^1,*, WANG Chen^2#

¹Jiangxi Institute for Drug Control, NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine, Jiangxi Provincial Engineering Research Center of Drug and Medical Device Quality, Nanchang Jiangxi 330029, China;
²National Institutes for Food and Drug Control, Beijing 102629, China

Received:2021-03-23 Online:2021-07-15 Published:2021-07-23

摘要/Abstract

摘要： 目的通过比较晶型、杂质谱及其他法定检验项目的数据差异,研究静脉注射用奥美拉唑钠仿制制剂与参比制剂的质量一致性。方法采用X射线粉末衍射法测定原料药及制剂的晶型。按《中华人民共和国药典》2020年版二部标准,对7家企业生产的33批次40 mg规格的静脉注射用奥美拉唑钠进行检验,检验项目包括有关物质、碱度、溶液的澄清度与颜色、水分、装量差异、可见异物、不溶性微粒及含量测定,采用SPSS软件统计数据。结果各企业制剂均为无定形粉末,3家企业奥美拉唑钠原料药晶型与参比一致,但与奥美拉唑原料药晶型有差异。各企业杂质谱与参比无显著差异,碱度（1家）、溶液颜色（4家）、水分（2家）、平均装量（4家）、含量（1家）与参比有显著性差异。仅1家处方、晶型及各检验项目均与参比无显著性差异。结论仅有1家企业仿制制剂与参比制剂质量一致,提示企业需改进处方工艺,提高产品质量。

关键词: 奥美拉唑, 一致性, 晶型, 杂质谱, 质量

Abstract: Objective To study the quality consistency between generic drugs and reference drugs of omeprazole sodium for intravenous injection by comparing the data on the crystal form, impurity profiles and other standard tests. Methods Thirty-three batches of omeprazole sodium for intravenous injection (40 mg) produced by seven enterprises were tested. The crystal form was studied using the X-ray powder diffraction method. Related substances, alkalinity, clarity and color of solution, water content, weight uniformity, visible particles, insoluble particles and assay were determined according to the standards specified by Chinese Pharmacopoeia (2020 edition). Data was statistically processed using SPSS software. Results Generic drugs and reference drugs were both amorphous powders. The crystal form of omeprazole sodium from three enterprises was the same as that of reference drugs, but different from that of omeprazole. The generic drugs were not significantly different from reference drugs in impurity profiles, but significantly different from reference drugs in alkalinity (1 enterprise), color of solution (4 enterprises), water content (2 enterprises), average weight (4 enterprises) and content (1 enterprise). Only the generic drugs produced by one enterprise were not significantly different from reference drugs in the prescription, crystal form and test data. Conclusion Only the generic drugs produced by one enterprise are of the same quality as reference drugs, which suggests that enterprises should improve its product quality by improving its production process.

Key words: omeprazole, consistency, crystal form, impurity profile, quality

中图分类号:

R927.1

刘荷英, 刘绪平, 钟振华, 裴昆, 夏红英, 程奇珍, 王晨. 静脉注射用奥美拉唑钠质量一致性研究[J]. 中国药物警戒, 2021, 18(7): 614-619.

LIU Heying, LIU Xuping, ZHONG Zhenhua, PEI Kun, XIA Hongying, CHENG Qizhen, WANG Chen. Quality Consistency of Omeprazole Sodium for Intravenous Injection[J]. Chinese Journal of Pharmacovigilance, 2021, 18(7): 614-619.

参考文献

[1] National Medical Products Administration. Announcement on the release of the reference drugs list for generic drugs (batch 22) from national medical products administration(2019 No. 56)[EB/OL].(2019-08-27)[2021-01-05]. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20190827163001195.html.
[2] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People's Republic of China: VolumeⅡ2020 edition(中华人民共和国药典:二部,2020年版)[S]. Beijing: China Medical Science and Technology Publishing House, 2020: 1681-1682.
[3] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People's Republic of China: VolⅡ(中华人民共和国:药典二部,2015年版) [S]. Beijing: China Medical Science and Technology Publishing House, 2015: 1416-1417.
[4] General office of the State Council of The People's Republic of China. General Office of the State Council of the People's Republic of China published "Comments on the evaluation of quality and efficacy consistency of generic drugs" [EB/OL]. (2016-03-05)[2021-01-05]. http://www.gov.cn/xinwen/2016-03/05/content_5049517.html.
[5] Center for Drug Evaluation. Notice on public consultation about “Technical requirements for consistency evaluation of marketed chemical generic drugs (injections)” [EB/OL]. (2017-12-22) [2021-01-05]. http://www.cde.org.cn/news.do?method=largeInfo&id=60e47e4abf037f51.
[6] Hu CQ.Rethought on quality consistency evaluation for domestic drug injections[J]. Chinese Journal of Antibiotics(中国抗生素杂志), 2020, 45(3): 203-211.
[7] Gao JD, Song HM, Yao YQ, et al. The analysis on the critical points of consistency evaluation of amikacin sulfate injection[EB/OL].(2021-03-01)[2021-03-05]. https://kns.cnki.net/kcms/detail/51.1126.R.20210120.1654.008.html.
[8] Tian Y, Kong DZ, Liu ZQ, et al.Comparison of the quality of generic and original preparations of thioctic acid injection and study on its acute toxicity test in mice[J]. China Pharmacy(中国药房), 2019, 30(19): 2618-2623.
[9] Gai RY, Zhao TX, Yao JT, et al.Analysis of key evaluation points for consistency evaluation of generic drug dosage forms for injection[J]. Chinese Journal of Pharmaceuticals(中国医药工业杂志), 2019, 50(2): 226-228.
[10] Zhang LB, Wang F, Cai XT, et al.Study on the consistency evaluation of clindamycin phosphate injection[J]. Shandong Chemical Industry(山东化工), 2020, 49(22): 124-125.
[11] Song YJ.Quality consistency assessment in pharmaceutical research for generic drug-parecoxib sodium for injection[D]. Chengdu: Chengdu University of TCM, 2016.
[12] Yang CX.Evaluation of quality consistency of tirofiban hydrochloride injection[D]. Chengdu: Chengdu University of TCM, 2014.
[13] Zhang ZF.Several key factors in the risk control of drug impurity[J]. Drugs & Clinic(现代药物与临床), 2010, 25(5): 327-333.
[14] Government of Canada, Health Canada, Health Products and Food Branch, et al. Guidance for Industry: impurities in new drug products: ICH Topic Q3B(R)[EB/OL].(2003-09-25)[2021-01-05]. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/quality/industry-impurities-new-drug-products-topic.html.

[1]	贾茵茵, 张财树, 周颖, 刘丽, 耿颖, 魏宁漪, 钮思静, 陈华, 许卉. 吸入制剂微细粒子空气动力学粒径分布评价方法研究[J]. 中国药物警戒, 2024, 21(2): 141-146.
[2]	方志娥, 李承贤, 柏兆方, 赵旭, 王伽伯, 肖小河. 马兜铃酸致肝癌的客观性研究与思考[J]. 中国药物警戒, 2024, 21(1): 20-24.
[3]	夏旭东, 黎美霞, 孙阳, 杨胜亚. 药品上市许可持有人药物警戒远程检查流程探讨[J]. 中国药物警戒, 2023, 20(9): 967-970.
[4]	里筱竹, 王蔷, 逄瑜, 张轶菁. 个例药品不良反应报告管理浅析与思考[J]. 中国药物警戒, 2023, 20(9): 975-977.
[5]	逄瑜, 刘博, 吕少俐, 王涛, 邢颖, 秦星宇, 田月洁, 吴文宇. 基于国际药物警戒经验探讨收集患者报告的意义[J]. 中国药物警戒, 2023, 20(9): 978-981.
[6]	张雨琪, 徐昕怡, 朱兰, 朱彦. 药品剂型标准术语的比较研究[J]. 中国药物警戒, 2023, 20(8): 904-910.
[7]	王赵, 赵剑锋, 于新兰, 金红宇, 马双成. 柴胡舒肝丸光释光法辐射筛查研究[J]. 中国药物警戒, 2023, 20(5): 514-518.
[8]	黄茵茵, 张立雯, 刘静, 陈静, 周远华, 许明哲, 姚尚辰, 王晨, 张现化. 普卢利沙星3种晶型的制备、表征与稳定性研究[J]. 中国药物警戒, 2023, 20(4): 374-378.
[9]	李宁, 姜晓娅, 张泽昭, 高乐, 王鑫国, 刘晓明. 月季花饮片标准汤剂的制备与质量评价研究[J]. 中国药物警戒, 2023, 20(4): 397-402.
[10]	刘静, 刘燕, 郑笑为, 汪祺, 何风艳, 王菲菲, 王亚丹, 何轶, 聂黎行, 胡晓茹, 戴忠, 马双成. 基于国家药品抽检的骨刺片质量分析[J]. 中国药物警戒, 2023, 20(3): 292-295.
[11]	蔡于罗, 果佳慧, 王鑫国, 田义龙, 王梦, 牛丽颖, 李军山. 彝族药蜘蛛香的研究进展及质量标志物的预测分析[J]. 中国药物警戒, 2023, 20(3): 348-352.
[12]	王亚丹, 闫建功, 陈明慧, 逄瑜, 戴忠, 马双成. 不同厂家雷公藤多苷片的超高效液相色谱指纹图谱研究[J]. 中国药物警戒, 2023, 20(2): 146-151.
[13]	王国英, 周刚, 王勤, 纪紫薇, 宁霄, 崔黎. HPLC-QE-MS技术分析盐酸倍他司汀注射液杂质谱及质量控制[J]. 中国药物警戒, 2023, 20(12): 1332-1338.
[14]	郝钢, 韩峰, 周刚, 武星, 颜皓, 李旭扬, 候海玲, 宁霄, 崔黎. 注射用腺苷钴胺细菌内毒素检查方法学研究[J]. 中国药物警戒, 2023, 20(12): 1351-1356.
[15]	王赵, 刘越, 昝珂, 李海亮, 金红宇, 马双成. 心脑健制剂用茶叶提取物提取工艺初探[J]. 中国药物警戒, 2023, 20(12): 1362-1367.

静脉注射用奥美拉唑钠质量一致性研究

Quality Consistency of Omeprazole Sodium for Intravenous Injection

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