本文選題：疏血通注射液 + 芪膠升白膠囊�。� 參考：《浙江大學》2017年博士論文

【摘要】：在2015年屠呦呦榮獲諾貝爾獎和國家提出"一帶一路"戰(zhàn)略布局的背景下,中藥國際化時代已經到來。雖然中藥行業(yè)發(fā)展迅速并已經形成了一定規(guī)模的產業(yè)體系,但是由于中藥的復雜性和生產過程的不穩(wěn)定,我國中藥的質量檢測方法及控制手段相對落后,導致我國中藥制劑質量難以保證,從一定程度上制約了中藥國際化的進程。中藥國際化要求應用現(xiàn)代科學理論和高新技術手段對中藥進行現(xiàn)代化研究,建立中藥及其生產過程的質量控制體系尤為重要。中藥制劑質量的影響因素除了藥材本身,還有其各個生產加工環(huán)節(jié)。因此,中藥材的基礎研究和質量控制手段仍需加強,同時還要重視建立中藥生產過程的質量控制體系。近年來,得益于化學計量學的快速發(fā)展,光譜分析技術作為快速分析技術在中藥領域的應用越加成熟,特別是近紅外光譜(Near-infrared Spectroscopy,NIRS)分析技術用于中藥及生產過程中的快速質量控制研究。本研究以中藥特色大品種疏血通注射液和芪膠升白膠囊為對象,開展了基于光譜分析技術構建原藥材和關鍵生產工藝環(huán)節(jié)的快速質量控制體系研究,具體包含以下兩個方面:(1)以中藥特色大品種疏血通注射液為研究對象,將NIRS分析技術結合化學計量學用于其生產過程的快速質控體系構建。首先開展動物藥水蛭和地龍的質量控制體系,與植物藥相比其研究相對落后。本文運用NIRS結合化學計量學,建立水分、可溶性固形物、次黃嘌呤、多糖和多肽的定量分析模型,同時考察了異常點診斷方法對模型的影響程度。結果表明,馬氏距離(MD)、學生化殘差-杠桿值(LD)和主成分得分診斷(PCSD)三者聯(lián)合更能全面診斷異常點,所建立的方法能夠對質控指標進行快速準確的定量分析,所建模型穩(wěn)定可靠。同理,采用PLS法分別建立可溶性固形物、次黃嘌呤、多糖和多肽為的定量校正模型,從而構建浸漬過程、凍融過程和膜過濾過程的快速質控體系。(2)以中藥特色大品種苗藥芪膠升白膠囊為研究對象,構建其生產過程的快速質控體系。以淫羊藿苷、黃芪甲苷、總黃酮和總皂苷等為質量控制指標,分別建立了原藥材、提取過程和濃縮過程的快速質量控制方法。原藥材以淫羊藿和黃芪為研究對象,基于NIRS和中紅外光譜(MIRS)分析技術,建立了淫羊藿苷、總黃酮、黃芪甲苷和總皂苷的快速定量分析模型,結果表明,近紅外和中紅外(NIR+MIR)光譜數據整合后所建立的模型性能更優(yōu),相關系數都達到0.99以上。提取液以水為溶劑不適合采用MIRS分析技術,所以提取過程的快速質控體系構建采用NIRS快速檢測淫羊藿苷、總黃酮和總皂苷的含量變化。濃縮過程的快速質控體系構建采用NIRS和MIRS快速檢測密度值、淫羊藿苷、總黃酮和總皂苷的含量變化,結果表明,NIR+MIR光譜數據整合后所建立的模型性能均比基于單一的NIRS和MIRS要好,相關系數都在0.99以上。
[Abstract]:In 2015, Tu Youyou won the Nobel Prize and proposed Belt and Road's strategic layout. Although the traditional Chinese medicine industry has developed rapidly and has formed a certain scale industrial system, due to the complexity of traditional Chinese medicine and the instability of the production process, the quality detection methods and control means of Chinese traditional medicine are relatively backward. The quality of Chinese traditional medicine preparations is difficult to guarantee, which restricts the internationalization of traditional Chinese medicine to some extent. The internationalization of traditional Chinese medicine requires the application of modern scientific theory and high-tech means to study the modernization of traditional Chinese medicine. It is particularly important to establish the quality control system of Chinese medicine and its production process. In addition to the quality of traditional Chinese medicine preparation itself, there are various production and processing links. Therefore, the basic research and quality control methods of traditional Chinese medicine should be strengthened, and the quality control system of traditional Chinese medicine should be established. In recent years, thanks to the rapid development of chemometrics, spectral analysis technology as a rapid analysis technology in the field of traditional Chinese medicine has become more and more mature. In particular, Near-infrared Spectroscopy (NIR) analysis technology is used to study the rapid quality control of traditional Chinese medicine and its production. Taking Shuxuetong injection and Qijiaoshengbai capsule as the objects, the rapid quality control system of the original medicinal materials and the key production process was studied based on the spectral analysis technology. Taking Shuxuetong injection as the research object, the NIRS analysis technology combined with chemometrics was used to construct the rapid quality control system in the production process of Shuxuetong injection. First, the quality control system of the animal medicine leech and Geosaurus was developed, and the research was relatively backward compared with the plant medicine. In this paper, a quantitative analysis model of water, soluble solids, Hypoxanthine, polysaccharides and polypeptides was established by means of NIRS combined with chemometrics. The results show that the combination of Markov distance (MD), student-based residual-lever value (LDV) and principal component score (PCSD) can diagnose outliers more comprehensively. The established method can be used for rapid and accurate quantitative analysis of quality control indexes, and the established model is stable and reliable. Similarly, the PLS method was used to establish the quantitative calibration models of soluble solids, Hypoxanthine, polysaccharides and polypeptides respectively, so as to construct the impregnation process. The rapid quality control system of freeze-thaw process and membrane filtration process. Taking icariin, astragaloside A, total flavonoids and total saponins as quality control indexes, a rapid quality control method for raw medicinal materials, extraction process and concentration process was established. A rapid quantitative analysis model of icariin, total flavone, astragaloside A and total saponins was established based on NIRS and mid-infrared spectroscopy (Mir) analysis of Herba Epimedii and Astragalus membranaceus. The results showed that the quantitative analysis of Icariin, total flavone, astragaloside A and total saponins was rapid. The performance of NIR and Mir NIR MIR-based models is better than that of NIR data, and the correlation coefficient is above 0.99. Water as solvent was not suitable for MIRS analysis, so the rapid quality control system of extraction process was constructed to detect the changes of Icariin, flavonoids and saponins by NIRS. The rapid quality control system of concentration process was constructed by using NIRS and MIRS to detect the density of icariin, total flavonoids and total saponins, and the changes of Icariin, total flavonoids and total saponins were analyzed. The results show that the performance of the model is better than that based on single NIRS and MIRS, and the correlation coefficient is above 0.99.
【學位授予單位】：浙江大學
【學位級別】：博士
【學位授予年份】：2017
【分類號】：R286.0

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