Chang Qian, Lan Lili, Gong Dandan, Guo Yong, Sun Guoxiang
College of Pharmacy, Shenyang Pharmaceutical University, Wenhua Road 103, Shenyang 110016, PR China.
College of Pharmacy, Shenyang Pharmaceutical University, Wenhua Road 103, Shenyang 110016, PR China.
J Pharm Biomed Anal. 2022 May 30;214:114733. doi: 10.1016/j.jpba.2022.114733. Epub 2022 Mar 19.
The present study was designed to establish a comprehensive and practical method for the quality evaluation and control of herbal preparation (HEP). The chemical information of belamcandae rhizoma antiviral injection (BRAI) was extracted using a dual-system control system comprised of HPLC chromatography and attenuated total reflection Fourier transform infrared (ATR-FT-IR) spectroscopy. To begin with, a quantitative analysis of six BRAI index components was accomplished. On this basis, HPLC five-wavelength fusion fingerprint was established to control the overall quality of BRAI. Secondly, the quality control system of ATR-FT-IR spectroscopy was constructed, that is, a quantitative analytic model to forecast the total amount of index components. Concurrently, the ATR-FT-IR quantized fingerprint was established for similarity analysis utilizing the Systematic quantified fingerprint method (SQFM). In addition, an integrated evaluation technique based on equal weights was presented to assure the comprehensiveness of chemical information. The 20 samples demonstrated good consistency in terms of quality, with a quality rating of grade 1-3. Notably, the rationality of the average method of Systematic quantified fingerprint method application in BRAI was further verified using PCA and low-level data fusion. Finally, this paper developed a model for intelligent analysis that is both quick and complete. We have redefined the quality standard of belamcandae rhizoma that can be put into production (70%< P<130%) in light of the influence of other HEM in the BRAI. This research demonstrated a quality analysis technique based on chromatography and spectrum, which was suited for HEP consistency control since it was easy, quick, accurate, and reliable.
本研究旨在建立一种全面且实用的中药制剂质量评价与控制方法。采用高效液相色谱(HPLC)和衰减全反射傅里叶变换红外光谱(ATR-FT-IR)双系统控制系统提取射干抗病毒注射液(BRAI)的化学信息。首先,完成了对BRAI六种指标成分的定量分析。在此基础上,建立HPLC五波长融合指纹图谱以控制BRAI的整体质量。其次,构建了ATR-FT-IR光谱质量控制系统,即预测指标成分总量的定量分析模型。同时,采用系统量化指纹法(SQFM)建立ATR-FT-IR量化指纹图谱进行相似度分析。此外,提出了基于等权重的综合评价技术以确保化学信息的全面性。20个样品在质量方面表现出良好的一致性,质量等级为1-3级。值得注意的是,利用主成分分析(PCA)和低水平数据融合进一步验证了系统量化指纹法在BRAI中应用平均法的合理性。最后,本文建立了一个快速且完整的智能分析模型。鉴于BRAI中其他中药提取物(HEM)的影响,重新定义了可投入生产的射干质量标准(70%<P<130%)。本研究展示了一种基于色谱和光谱法的质量分析技术,该技术简便、快速、准确且可靠,适用于中药制剂的一致性控制。