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基于多元统计分析的药用辅料聚乙二醇6000质量控制方法研究*

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  • 1.天士力医药集团股份有限公司,中药先进制造技术国家地方联合工程实验室,天津 300410;
    2.中国药科大学,南京 211198
第一作者 Tel:(022)26735903;E-mail: xionghaoshu@tasly.com
** 闫凯境 Tel:(022)86343362;E-mail: yk@tasly.com
张凯旋 Tel:(022)26736785;E-mail: tsl-zhangkaixuan@tasly.com

收稿日期: 2020-02-25

  网络出版日期: 2024-05-31

基金资助

* 天津市 2019 年智能制造专项“基于大数据的中药产品质量管理应用示范”

Research on quality control method of pharmaceutical excipient PEG 6000 based on the multivariate statistical analysis*

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  • 1. National & Local United Engineering Laboratory for TCM Advanced Manufacturing Technology, Tasly Pharmaceutical Co., Ltd., Tianjing 300410, China;
    2. China Pharmaceutical University, Nanjing 211198, China

Received date: 2020-02-25

  Online published: 2024-05-31

摘要

目的:研究建立符合滴丸剂生产工艺性能和滴丸质量控制要求的 PEG 6 000 质量控制方法。方法:本研究选取常用辅料聚乙二醇 6 000(polyethylene glycol 6 000,PEG 6 000),以复方丹参滴丸为例,首先开发了适用于滴丸剂生产工况条件下的黏度检测方法,并与《中华人民共和国药典》规定的分子量、黏度、凝 点、酸度4 类质量属性指标结合,采用多元统计分析方法,以生产出合格滴丸、符合生产要求的 15 个批次样本作为训练集,建立多元统计控制模型。结果:选取不同供应商的符合、不符合工艺要求的 12 个批次样本作为验证集,模型准确性达到 100%,能够准确区分出 PEG 6 000 是否符合滴丸生产要求。结论:本研究建立的方法能够为药品制造企业提高辅料质量控制以及供应商提升质量管理提供参考。

本文引用格式

熊皓舒, 张凯旋, 李瑶瑶, 赵万顺, 章顺楠, 朱永宏, 闫凯境 . 基于多元统计分析的药用辅料聚乙二醇6000质量控制方法研究*[J]. 药物分析杂志, 2021 , 41(2) : 329 -337 . DOI: 10.16155/j.0254-1793.2021.02.17

Abstract

Objective:Taking the compound Danshen dropping pills as an example,the PEG 6 000 quality control method. Methods:In this study,PEG6 000 was selected as the common used excipient.Firstly,the viscosity measurement method of PEG 6 000 suitable for the production conditions of dropping pills was established by rotary rheometer.Then,multivariable statistical analysis was carried out on the key attribute indexes such as average molecular weight,viscosity,condensation point and acidity.Fifteen batches of samples that met the requirements of compound Danshen dropping pills were used as the training set to establish the multi-variable statistical control chart. Results:12 batches of samples from different suppliers were selected as the validation set,and the accuracy of the model reached 100%,which could accurately distinguish whether PEG 6 000 met the production requirements of dropping pills. Conclusion:The method established in this study provides reference for pharmaceutical manufacturing enterprises to improve the abilities of excipients quality control and suppliers quality management.

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