中国药物警戒 ›› 2023, Vol. 20 ›› Issue (11): 1221-1227.
DOI: 10.19803/j.1672-8629.20230432

• 国家药品标准物质研究专栏 • 上一篇    下一篇

近红外光谱法和统计学过程控制方法对亚叶酸钙药品对照品水分进行质量控制的研究

耿颖1, 刘毅1△, 王雪蕾1, 谭德讲1, 朱容蝶2, 郭贤辉1, 陈华1,*, 郑丽娥3#   

  1. 1中国食品药品检定研究院化学药品检定所,北京 102629;
    2北京协和药厂有限公司,北京 102629;
    3中国食品药品检定研究院信息中心,北京 102629
  • 收稿日期:2023-07-12 出版日期:2023-11-15 发布日期:2023-11-13
  • 通讯作者: *陈华,男,硕士,主任药师,药物分析与药品质量监管。E-mail: chenhua@nifdc.org.cn,#为共同通信作者。
  • 作者简介:耿颖,女,博士,副研究员,药物光谱分析与统计学监管科学。△为并列第一作者。
  • 基金资助:
    国家自然科学基金资助项目（81803621）; 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）

Near-infrared spectroscopic and statistical process control methods for the quantitative control of the moisture content of calcium folinate drug reference substance

GENG Ying1, LIU Yi1△, WANG Xuelei1, TAN Dejiang1, ZHU Rongdie2, GUO Xianhui1, CHEN Hua1,*, ZHENG Li’e3#   

  1. 1Institute for Chemical Drug Control, National Institutes for Food and Drug Control, Beijing, 102629, China;
    2Beijing Union Pharmaceutical Factory LTD, Beijing 102629, China;
    3Information Center, National Institutes for Food and Drug Control, Beijing 102629, China
  • Received:2023-07-12 Online:2023-11-15 Published:2023-11-13

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摘要： 目的 应用近红外光谱技术对化学药品对照品水分质量控制和警戒方法开展研究,结合统计学方法和多元校正方法建立质量控制图,开发对化学药品对照品水分测定和质量监控的方法。方法 以亚叶酸钙对照品为研究对象,应用近红外光谱技术对分装后的对照品水分进行测定;以卡氏水分测定结果为参考,建立近红外光谱法水分测定定量模型;结合统计学控制图确定亚叶酸钙化学药品对照品水分测定值的上下限,进而实现近红外光谱对水分的无损检测和质量控制。结果 本研究建立的近红外光谱水分测定定量模型稳健准确,可实现亚叶酸钙对照品水分的无损测定,同时可实现化学对照品在分装过程中水分均匀性和稳定性的质量控制。结论 将近红外光谱法与统计学质量控制原理相结合,可作为化学药品对照品水分质量控制的新方法,实现在线、无损测定和质量监控。

关键词: 近红外光谱法, 亚叶酸钙, 统计学过程控制, 无损检测, 多元校正, 水分

Abstract: Objective To study quantitative model and quality control method for the determination of moisture content for chemical drug reference substances using near-infrared spectroscopy. To establish quality control chart combining statistical inference and multivariate calibration for the quality monitoring of moisture content for chemical drug reference substances. Methods Near-infrared spectroscopy quantitative model for the determination of moisture content of the reference substance was determined using calcium folinate reference substance after sub-packaging as the research object. Karl Fischer titration data was used as reference data. Statistical control chart was established, and the upper and lower limits of moisture determination values of calcium folinate chemical reference were determined. Non-destructive determination and quality control of moisture content by near-infrared spectroscopy were realized. Results The quantitative model of near-infrared moisture content determination established in this paper was robust and accurate, which can achieve the non-destructive determination of moisture content of calcium folinate reference substance, and the quality control of uniformity and stability of chemical reference substance during sub-packaging. Conclusion Near-infrared spectroscopic method combined with statistical quality control technic can be used as a new method for moisture content determination and to achieve online and non-destructive quality control of moisture content for chemical drug reference substances.

Key words: near-infrared spectroscopy, calcium folinate, statistical process control, non-destructive testing, multivariate calibration, moisture content

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