徐敏　张磊　岳洪水　庞洪伟　叶正良　丁黎

[摘要]将近红外光谱分析技术与多变量数据分析技术相结合，建立注射用益气复脉（冻干）组方药材五味子提取过程的在线监测方法。采用生产上5个正常批次建立了五味子提取过程的多变量统计过程控制（multivariate statistical process control， MSPC）模型，并利用PC scores，DModX和Hotelling T2 3种控制图对2个测试批次进行监测。结果显示，MSPC模型对提取过程具有良好的监测性能。将所建立的MSPC模型应用到实际生产中，能够有效地实现对五味子提取过程的在线监测，并实时反映生产过程中物料属性的变化。该文建立的监测方法为过程分析技术在中药注射剂生产过程质量控制领域的应用提供了参考。

[关键词]多变量统计过程控制； 近红外光谱分析技术； 五味子提取过程； 注射用益气复脉（冻干）

[Abstract]To establish an online monitoring method for extraction process of Schisandrae Chinensis Fructus， the formula medicinal material of Yiqi Fumai lyophilized injection by combining near infrared spectroscopy with multivariable data analysis technology The multivariate statistical process control （MSPC） model was established based on 5 normal batches in production and 2 test batches were monitored by PC scores， DModX and Hotelling T2 control charts The results showed that MSPC model had a good monitoring ability for the extraction process The application of the MSPC model to actual production process could effectively achieve online monitoring for extraction process of Schisandrae Chinensis Fructus， and can reflect the change of material properties in the production process in real time This established process monitoring method could provide reference for the application of process analysis technology in the process quality control of traditional Chinese medicine injections.

[Key words]multivariate statistical process control； near infrared spectroscopy （NIR）； extraction process of Schisandrae Chinensis Fructus； Yiqi Fumai lyophilized injection

注射用益氣复脉（冻干）是基于传统中药古方生脉散发展起来的一种新型冻干粉针制剂，由红参、麦冬、五味子3种药材组成，具有益气复脉，养阴生津的功效。其生产制造过程分为2个阶段，首先将3种药材单独加工成提取物（即原料药），再将提取物经过混合、配制、超滤、冷冻干燥等一系列工序制得最终产品。五味子作为其组方药材之一，具有收敛固湿、补肾宁心的功效[12]。五味子提取物的生产过程包括提取、浓缩、醇沉、过滤等多步工序，其中水煎煮回流提取是获得提取物的关键工艺单元，其工艺控制水平将直接影响提取液中有效成分的含量和质量一致性。五味子水提过程中涉及的参数众多，原料药材的质量、提取温度和提取时间的变化等都会对中间体以及产品质量产生影响。……