国产羟乙基淀粉130/0.4注射液质量评价及质量研究

doi:10.19803/j.1672-8629.20220224

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (10): 1067-1072.
DOI: 10.19803/j.1672-8629.20220224

国产羟乙基淀粉130/0.4注射液质量评价及质量研究

王悦, 宋玉娟, 刘倩, 赵湘美, 邓利娟, 范慧红^*

中国食品药品检定研究院,国家药品监督管理局化学药品质量研究与评价重点实验室,北京 102629

收稿日期:2022-05-07 出版日期:2022-10-15 发布日期:2022-10-17
通讯作者: ^*范慧红,女,博士,研究员,生化药品质量控制。E-mail: shenghuayaoshi@126.com
作者简介:王悦,女,硕士,副研究员,生化药品质量控制。
基金资助:
国家重点研发计划（2020YFE02011700）; 国家药典委员会“光散射技术在大分子质量控制中的应用”专项课题; 中国食品药品检定研究院学科带头人培养基金（2021X6）

Quality evaluation and quality research of domestic hydroxyethyl starch 130/0.4 injection

WANG Yue, SONG Yujuan, LIU Qian, ZHAO Xiangmei, DENG Lijuan, FAN Huihong^*

National Institute for Food and Drug Control, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing 102629, China

Received:2022-05-07 Online:2022-10-15 Published:2022-10-17

摘要/Abstract

摘要： 目的评价国产羟乙基淀粉130/0.4注射液质量现状和存在的问题,为该药品国家标准制修定提供依据。方法对国家抽检的样品进行全项检验,对检验结果进行统计分析,并开展了摩尔取代度、C2/C6比值、相对分子质量与相对分子质量分布、残留溶剂考察等项目的探索性研究工作。结果 15个生产厂家的146批样品按照标准检验有6批样品不合格,总体不合格率为4.1%,不合格项目为装量和可见异物。探索性研究发现相对分子质量及其分布方法,部分企业标准中的摩尔取代度、氯化钠测定方法准确度存在问题。结论目前国产羟乙基淀粉130/0.4注射液产品质量状况一般,现行标准多且参差不齐,建议尽快统一和完善质量标准。

关键词: 羟乙基淀粉, 质量评价, 质量标准, 相对分子质量, 相对分子质量分布, 含量测定, 摩尔取代度, C2/C6

Abstract: Objective To evaluate the quality status and existing problems of domestic hydroxyethyl starch 130/0.4 injection, and provide a basis for the establishment and revision of national drug standards. Methods All of the samples by national sampling evaluation were tested, and the results were statistically analyzed. Exploratory research works were carried out on items such as molar degree of substitution, C2/C6 ratio, molecular weight and molecular weight distribution, and residual solvents. Results 146 batches of samples from 15 manufacturers were tested, and 6 batches were unqualified, the overall unqualified rate was 4.1%, and the unqualified items were the loading and visible particles. The exploratory study found that the relative molecular weight and its distribution, the molar substitution degree and the accuracy of the sodium chloride determination method in some registration standards should be revised. Conclusion At present, the quality of domestic hydroxyethyl starch 130/0.4 injection is just passable. Quality standards are numerous and varied. It is recommended to unify and improve the quality standards as soon as possible.

Key words: hydroxyethyl starch, quality analysis, quality standards, relative molecular weight, relative molecular weight distribution, assay, molar substitution, C2/C6

中图分类号:

R927.11

王悦, 宋玉娟, 刘倩, 赵湘美, 邓利娟, 范慧红. 国产羟乙基淀粉130/0.4注射液质量评价及质量研究[J]. 中国药物警戒, 2022, 19(10): 1067-1072.

WANG Yue, SONG Yujuan, LIU Qian, ZHAO Xiangmei, DENG Lijuan, FAN Huihong. Quality evaluation and quality research of domestic hydroxyethyl starch 130/0.4 injection[J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1067-1072.

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国产羟乙基淀粉130/0.4注射液质量评价及质量研究

Quality evaluation and quality research of domestic hydroxyethyl starch 130/0.4 injection

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