论文部分内容阅读
目的:利用近红外光谱(near-infrared spectroscopy,NIR)技术分析正天丸的混合过程,建立一种快速判断混合终点的方法,以提高混合过程的均匀度和混合效率。方法:采用在线取样采集正天丸混合过程中粉末的NIR,计算不同时间点混合均匀度,利用主成分分析(principal component analysis,PCA)结合马氏距离判断粉末混合终点。采用HPLC测定不同混合时间点芍药苷含量以验证定性判断结果,检测波长235 nm,流动相0.05%磷酸-乙腈梯度洗脱。结果:随着混合时间的延长,粉末混合均匀度增大,20 min后达97%以上;PCA-马氏距离判断结果显示20 min后,到校正光谱的马氏距离基本保持不变(<1.0),提示混合达到均匀状态,定量验证结果显示20 min后芍药苷含量的RSD趋于稳定。结论:近红外光谱技术可用于判定正天丸的混合过程终点,为其他大品种制剂的研究提供了参考。
OBJECTIVE: To analyze the mixing process of Zheng Tian Pills by near-infrared spectroscopy (NIR) and to establish a method for quickly judging the mixing end points to improve the uniformity and mixing efficiency of the mixing process. Methods: The online sampling was used to collect the NIR of powder during the mixing process of Zheng Tian Wan. The mixing uniformity was calculated at different time points. The end point of powder mixing was determined by principal component analysis (PCA) and Mahalanobis distance. The content of paeoniflorin at different mixing time points was determined by HPLC to verify the qualitative judgment. The detection wavelength was 235 nm and the mobile phase was eluted with 0.05% phosphoric acid-acetonitrile gradient. Results: As the mixing time prolonged, the uniformity of powder mixing increased more than 97% after 20 min. The results of PCA-Mahalanobis judgment showed that the Mahalanobis distance to the calibration spectrum remained unchanged (<1.0 ), Suggesting that the mixture reached a homogeneous state. The quantitative verification results showed that the RSD of paeoniflorin tended to be stable after 20 min. Conclusion: Near infrared spectroscopy can be used to determine the end of the mixing process of Zhengtian Pills, which provides a reference for the research of other large variety preparations.