[提取过程优化和基于质量设计理念的Reyanning混合物的链接评估]
Ying Zhang1, Jin-Qing Qiu1, Xuan Wei1
1Shaanxi University of Chinese Medicine Xianyang 712046, China.
概括
使用设计质量 (QbD) 优化Reyanning混合物提取过程可确保一致的质量. 近红外光谱 (NIRS) 提供了对关键化合物的快速质量控制.
科学领域:
- 制药科学 制药科学
- 传统中国医药 传统中国医药
- 分析化学 分析化学
背景情况:
- 瑞南混合是一种重要的中国专利药物.
- 确保传统药物的质量一致对于疗效和安全至关重要.
- 设计质量 (QbD) 原则为流程优化提供了一种系统的方法.
研究的目的:
- 为了优化使用QbD的Reyanning混合物的提取过程.
- 为关键质量属性 (CQA) 建立一个可靠的定量模型.
- 验证近红外光谱学 (NIRS) 的可行性,以快速进行质量控制.
主要方法:
- 利用Plackett-Burman和恒星设计效应表面方法来优化工艺.
- 确定了材料-液体比,提取温度和时间作为关键过程参数 (CPP).
- 开发了一种使用NIRS与高性能液态染色学 (HPLC) 结合的部分最小平方 (PLS) 定量模型.
主要成果:
- 确定了最佳的提取条件:物质-液体比为11.84g·mL-1,81°C,并进行了两次提取.
- 在NIRS-HPLC对四个CQA的定量模型中实现了高相关系数 (R_c,R_p > 0.9).
- 对于校正和验证集,证明了低根平均平方误差 (RMSE),表明模型的准确性.
结论:
- 针对Reyanning混合物的优化提取过程是坚固的,可重复的,可靠的.
- NIRS定量模型适合在提取过程中快速确定CQAs.
- 这项研究为工艺研究和Reyanning混合物的质量控制提供了基础.
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