近红外和拉曼光谱法对溴己新注射剂处方工艺的一致性研究

doi:10.19803/j.1672-8629.20230435

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (3): 300-306.
DOI: 10.19803/j.1672-8629.20230435

• 药品质量控制及评价专栏 • 上一篇下一篇

近红外和拉曼光谱法对溴己新注射剂处方工艺的一致性研究

耿颖¹, 刘毅^1,Δ, 王雪蕾¹, 朱容蝶², 金滢³, 陈华^1,*, 郑丽娥^4,#

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厦门大学附属第一医院,厦门市心血管病研究所,厦门大学医学院,福建厦门 361005;
⁴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:2024-03-15 发布日期:2024-03-18
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。^Δ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）

Comformity study of formulation and manufacture process for bromohexine hydrochloride parenteral preparations using Near-infrared and Raman spectroscopy

GENG Ying¹, LIU Yi^1,Δ, WANG Xuelei¹, ZHU Rongdie², JIN Ying³, CHEN Hua^1,*, ZHENG Li'e^4,#

¹Institute for Chemical Drug Control, National Institutes for Food and Drug Control, Beijing 102629, China;
²Beijing Union Pharmaceutical Factory LTD, Beijing 102629, China;
³Xiamen Institute of Cardiovascular Diseases, The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen Fujian 361003, China;
⁴Information Center, National Institutes for Food and Drug Control, Beijing 102629, China

Received:2023-07-12 Online:2024-03-15 Published:2024-03-18

摘要/Abstract

摘要： 目的建立溴己新注射剂的近红外光谱法一致性检验定性模型和定量模型,考察制剂处方和工艺的差别并对溴己新含量进行测定;分别采用拉曼光谱法和近红外光谱法对盐酸溴己新注射液（包括输液和水针2种剂型）进行制剂处方工艺一致性研究。方法对评价性抽验选取的盐酸溴己新注射剂（冻干粉针、输液剂和水针剂）进行近红外和拉曼光谱研究：建立2个厂家的注射用盐酸溴己新冻干粉针近红外一致性定性模型;建立盐酸溴己新注射用粉针的近红外光谱定量模型;采用拉曼光谱主成分分析法对2种盐酸溴己新注射液（输液和水针）进行研究,对制剂处方工艺的相似程度进行评价。结果建立了2个厂家注射用盐酸溴己新冻干粉针的近红外一致性模型,可100%鉴别本厂家和其他厂家的冻干粉针制剂;盐酸溴己新粉针定量模型稳健且准确,能够用于盐酸溴己新含量测定。采用主成分分析法研究冻干粉针、水针及输液制剂处方工艺的相似程度,结果与一致性模型相对应,较好地反映了处方工艺的相似程度。结论近红外光谱法与拉曼光谱法相结合,可对质量工艺稳定的药物制剂进行鉴别,对药品安全性、有效性和合理用药进行监控和警戒;近红外光谱定量模型可对未知冻干粉针样品的溴己新含量进行预测、快速检测筛查、过程控制和放行;拉曼光谱主成分分析法能够反映出盐酸溴己新注射液（输液及水针）处方工艺的差异。

关键词: 溴己新, 注射剂, 一致性模型, 定量模型, 近红外光谱法, 拉曼光谱法, 主成分分析法

Abstract: Objective To establish qualitative models of Near-infrared spectroscopy for the conformity investigation of bromohexine hydrochloride powder for injection in terms of formulation and manufacture process, develop quantitatvie models of Near-infrared spectroscopy for the determination of bromohexine of bromohexine hydrochloride powder for injection. To develop Raman spectroscopy qualitative models to investigate the conformity of formulation and manufacture process for bromohexine hydrochloride injections and infusions. Methods The Near-infrared and Raman spectra of bromohexine hydrochloride parenteral preparations (powder for injection, injections and infusions) selected for evaluative sampling were investigated: Near-infrared spectroscopic qualitative and quantitative models were established for bromohexine hydrochloride powder for injection. Raman spectroscopy-principal component analysis was used to study bromohexazine hydrochloride injections and infusion. Results Near-infrared and Raman conformity models for bromohexine hydrochloride powder for injection of two manufacturers was established, and the prediction success rate was 100%. The principal component analysis method was used to study the conformity of powder for injection, injections and infusions. The results corresponded to the conformity models reflected the similarity of the formulation and manufacture process. The Near-infrared quantitative models showed to be robust and accurate for the determination of the content of bromohexine hydrochloride. Conclusion Near-infrared spectroscopy and Raman spectroscopy can be used to identify Bromohexine Hydrochloride Parenteral preparations (powder for injection, injections and infusions) with stable quality process. Near-infrared spectroscopy quantitative model can be used to predict the content of bromohexine for bromohexine hydrochloride powder for injection and enables rapid detection, screening as well as process control and release.

Key words: bromohexine, injection, comformity model, quantitative models, Near-infrared spectroscopy, Raman spectroscopy, principal component analysis

中图分类号:

R927.1

耿颖, 刘毅, 王雪蕾, 朱容蝶, 金滢, 陈华, 郑丽娥. 近红外和拉曼光谱法对溴己新注射剂处方工艺的一致性研究[J]. 中国药物警戒, 2024, 21(3): 300-306.

GENG Ying, LIU Yi, WANG Xuelei, ZHU Rongdie, JIN Ying, CHEN Hua, ZHENG Li'e. Comformity study of formulation and manufacture process for bromohexine hydrochloride parenteral preparations using Near-infrared and Raman spectroscopy[J]. Chinese Journal of Pharmacovigilance, 2024, 21(3): 300-306.

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近红外和拉曼光谱法对溴己新注射剂处方工艺的一致性研究

Comformity study of formulation and manufacture process for bromohexine hydrochloride parenteral preparations using Near-infrared and Raman spectroscopy

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