诺氟沙星胶囊近红外在线质量控制初探

Production Process Control of Norfloxacin Capsules by Near-Infrared Spectroscopy Technology

目的探讨近红外分析法在线控制诺氟沙星胶囊的原料、辅料、混匀过程中间体及终产品质量的效果。方法采用近红外光谱(NIR)法,采集原料、辅料、中间体及诺氟沙星胶囊的NIR,测定诺氟沙星胶囊的含量,最终建立一致性检验定性模型及定量模型实时控制诺氟沙星胶囊生产过程产品质量。结果所建立的一致性检验模型可对不同企业生产的诺氟沙星原料、辅料进行鉴别验收,实时控制混匀过程;定量模型可实现对终端产品的定性、定量检测,其中NIR预测值与真实值的平均RSD为0.27%,且建模的预测结果与《中国药典(二部)》中方法比较无显著差异(P=0.036>0.05)。结论近红外分析技术可初步实现在线控制诺氟沙星胶囊生产过程中原料、辅料及中间体质量,继而控制终产品质量,且该技术分析速度快,不会破坏样品,绿色环保。

Objective To investigate the effect of production process control on the quality of active pharmaceutical ingredients(API),excipients,intermediates in the mixing process and final products of Norfloxacin Capsules by the near-infrared(NIR)spectroscopy technology.Methods NIR spectrogram of API,excipients,intermediates and Norfloxacin Capsules were collected to determine the content of norfloxacin in Norfloxacin Capsules.Finally,the consistency test qualitative model and quantitative model were established to control the product quality of Norfloxacin Capsules in the production process in real-time.Results The consistency test model could be used to identify and accept API and excipients of norfloxacin from different manufacturers,and to control the mixing process in real-time.The quantitative model could realize the qualitative and quantitative detection of final products.The average RSD of the predicted value and the real value of NIR was 0.27%,and there is no significant difference between the predicted value detected by the model and the value detected by the methods in the Chinese Pharmacopoeia(VolumeⅡ)(P=0.036>0.05).Conclusion The NIR spectroscopy technology can preliminarily realize the production process control of the quality of API,excipients and intermediates in the production process of Norfloxacin Capsules,and then control the quality of the final products.This technology has the advantages of fast speed,no damage to samples and green environmental protection.