复方血栓通胶囊丹参提取过程的近红外快速质量检测  

Rapid Quality Detection of Salvia miltiorrhiza in the Extraction Process of Compound Xueshuantong Capsule by Near Infrared Spectroscopy

作　　者：罗日康 徐媛 陈冠华 谌炎钦 王钧 李页瑞 

机构地区：[1]广东众生药业股份有限公司,广东 东莞 [2]苏州泽达兴邦医药科技有限公司,江苏 苏州

出　　处：《药物资讯》2021年第4期223-229,共7页Pharmacy Information

摘　　要：目的:利用近红外光谱分析技术(Near Infrared Spectroscopy)其操作简单、快速无损、准确可靠,以及在不破坏原检测物质的基础上结合化学计量学中的偏最小二乘法(PLSR)构建中药制剂生产过程工段丹参提取液中的丹酚酸B含量的快速检测方法,从而用于生产规模复杂中药体系中间过程的快速质量监控。方法:以高效液相色谱法(HPLC)作为参比分析方法测定丹参提取液丹酚酸B含量(C36H30O16),利用近红外光谱仪对取得的64批提取工段全过程的代表性样品进行扫描,对其光谱进行预处理和波段选择,并结合偏最小二乘法(PLSR)建立丹参含量快速无损检测方法。结果:所建立的模型的决定系数R2为0.9850;校正标准偏差RMSEC为0.1952;预测标准偏差RMSEP为0.8187。对验证集样品进行预测并统计分析,预测值与真实值之间无显著差异(P 】0.05)。结论:模型R2值接近于1、RMSEC为0.1952、RMSEP为0.8187,所建立的模型准确度高, 适用于丹参提取液中的丹酚酸B含量的快速检测。Objective: To establish a rapid method for the determination of salvianolic acid B in the extract of Salvia miltiorrhiza in the production process of traditional Chinese medicine preparation by using near infrared spectroscopy (Near Infrared Spectroscopy), which is simple, fast, nondestructive, accurate and reliable, and combined with partial least square method (PLSR) in stoichiometry without destroying the original detection substance. Therefore, it can be used for rapid quality control in the middle process of complex Chinese medicine system. Methods: HPLC was used as reference method to determine the content of salvianolic acid B (C36H30O16) in the extract of Salvia miltiorrhiza. The representative samples of the whole process of 64 batches of concentrated section were scanned by NIR spectrometer, and their spectra were pretreated and bands were selected. The method of rapid nondestructive determination of Salvia miltiorrhiza content was established by partial least square method (PLSR). Results: The determination coefficient R2 of the established model was 0.9850. Calibration standard deviation RMSEC is 0.1952;the prediction standard deviation RMSEP is 0.8187. The samples of the validation set were predicted and statistically analyzed, and there was no significant difference between the predicted and true values (P >0.05). Conclusions: The R2 value of the model is close to 1, RMSEC is 0.1952, and RMSEP is 0.8187. The established model has high accuracy and is suitable for the rapid detection of salvianolic acid B content in the extract of Salvia miltiorrhiza.

关 键 词：复方血栓通 丹参提取液 近红外光谱技术 偏最小二乘法 过程质量控制 

分 类 号：R28[医药卫生—中药学]