| 光谱学与光谱分析 |
|
|
|
|
|
| Applications and Prospects of On-Line Near Infrared Spectroscopy Technology in Manufacturing of Chinese Materia Medica |
| LI Yang, WU Zhi-sheng*, PAN Xiao-ning, SHI Xin-yuan, GUO Ming-ye, XU Bing, QIAO Yan-jiang* |
| Beijing University of Chinese Medicine, Pharmaceutical Engineering and New Drug Development of TCM of Ministry of Education，Key Laboratory of TCM-information Engineering of State Administration of TCM, Beijing Key Laboratory for Basic and Development Research on Chinese Medicine, Beijing 100102, China |
|
|
|
|
Abstract The quality of Chinese materia medica (CMM) is affected by every process in CMM manufacturing. According to multi-unit complex features in the production of CMM, on-line near infrared spectroscopy (NIR) is used as an evaluating technology with its rapid, non-destructive and non-pollution etc. advantages. With the research in institutions, the on-line NIR applied in process analysis and control of CMM was described systematically, and the on-line NIR platform building was used as an example to clarify the feasibility of on-line NIR technology in CMM manufacturing process. Then, from the point of application by pharmaceutical companies, the current on-line NIR research on CMM and its production in pharmaceutical companies was relatively comprehensively summarized. Meanwhile, the types of CMM productions were classified in accordance with two formulations (liquid and solid dosage formulations). The different production processes (extraction, concentration and alcohol precipitation, etc.) were used as liquid formulation diacritical points; the different types (tablets, capsules and plasters, etc.) were used as solid dosage formulation diacritical points, and the reliability of on-line NIR used in the whole process in CMM production was proved in according to the summary of literatures in recent 10 years, which could support the modernization of CMM production.
|
|
Received: 2014-05-09
Accepted: 2014-07-22
|
|
|
|
Corresponding Authors:
WU Zhi-sheng, QIAO Yan-jiang
E-mail: yjqiao@263.net; wzs@bucm.edu.cn
|
|
[1] U.S. Food and Drug Administration. Guidance for Industry PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. New Hampshire Avenue: FDA, 2004.
[2] YUAN Hong-fu, LU Wan-zhen(袁洪福, 陆婉珍). Modern Scientific Instruments(现代科学仪器), 1998, 5(6): 6.
[3] FENG Xin-hu, SHI Yong-gang(冯新沪, 史永刚). Near Infrared Spectroscopy and Its Application in the Analysis of Petroleum Products(近红外光谱及其在石油产品分析中的应用). Beijing: China Petrochemical Press(北京: 中国石化出版社), 2002.
[4] CHU Xiao-li, YUAN Hong-fu, LU Wan-zhen(褚小立, 袁洪福, 陆婉珍). Modern Scientific Instruments(现代科学仪器), 2004, 2: 3.
[5] WU Z S, SUI C L, XU B, et al. Journal of Pharmaceutical and Biomedical Analysis, 2013, 77: 16.
[6] LI Wen-long, QU Hai-bin(李文龙, 瞿海斌). Chinese Traditional and Herbal Drugs(中草药), 2012, 43(8): 1531.
[7] JIN Ye, DING Hai-ying, WU Yong-jiang, et al(金 叶, 丁海樱, 吴永江, 等). Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2012, 32(7): 1214.
[8] CAI Shao-song, WU Wei-hong, WANG Ning, et al(蔡绍松, 武卫红, 王 宁, 等). Chinese Journal of Pharmaceuticals(中国医药工业杂志), 2008, 39(7): 527.
[9] LIU Yan, ZHANG Yan-ying, ZHANG Ai-jun, et al(刘 岩, 张延莹, 张爱军, 等). Chinese Traditional and Herbal Drugs(中草药), 2009, 40(3): 383.
[10] QU Hai-bin, LI Bin, LIU Xue-song, et al(瞿海斌, 李 斌, 刘雪松, 等). Chinese Pharmaceutical Journal(中国药学杂志), 2005, 40(24): 1897.
[11] SHEN Yong-xiang, YANG Hui-hua, QIN Feng, et al(申永祥, 杨辉华, 覃 锋, 等). Chinese Traditional Patent Medicine(中成药), 2010, 32(5): 831.
[12] SHI Chao-sheng, LIU Xue-song, CHEN Yong, et al(施朝晟, 刘雪松, 陈 勇, 等). Chinese Pharmaceutical Journal(中国药学杂志), 2006, 12(12): 69.
[13] CHEN Chen, LI Wen-long, QU Hai-bin, et al(陈 晨, 李文龙, 瞿海斌, 等). Chinese Traditional and Herbal Drugs(中草药), 2013, 44(1): 47.
[14] LI Yun-xia, GUO Yan-ling, LIU Xi(李云霞, 郭艳玲, 刘 玺). Drugs & Clinic(现代药物临床), 2012, 27(4): 374.
[15] YUAN Hong-fu(袁洪福). The Collection of the 3rd International Forum for China On-Line Analytical Instrument Application and Development Expo(第三届中国在线分析仪器应用及其发展国际论坛论文集), 2010.
[16] QIN Bing-da, LI Ling-qiao, LUO Guo-an, et al(覃炳达, 李灵巧, 罗国安, 等). Modern Computer(现代计算机), 2011, 4: 68.
[17] LI W L, Xing L H, Fang L M, et al. Pharmaceutical and Biomedical Analysis, 2010, 53: 350.
[18] LI W L, QU H B. Pharmaceutical and Biomedical Analysis, 2010, 52(4): 425.
[19] YANG Hui-hua, WANG Yong, WU Yun-ming, et al(杨辉华, 王 勇, 吴云鸣, 等). Chinese Traditional Patent Medicine(中成药), 2008, 30(3): 409.
[20] QIN Feng, YANG Hui-hua, Lü Lin-ang, et al(覃 锋, 杨辉华, 吕琳昂, 等). Chinese Traditional Patent Medicine(中成药), 2008, 30(10): 1465.
[21] SUI Cheng-lin, LIN Zhao-zhou, WU Zhi-sheng, et al(隋丞琳，林兆洲，吴志生，等). Chinese J. of Analytical Chemistry(分析化学)，2013，41(12)：1899.
[22] PENG Yan-fang, SHI Xin-yuan, PEI Yan-ling, et al(彭严芳, 史新元, 裴艳玲, 等). Conference Proceedings of The International Process Analytics and Control Congress(2013中国国际过程分析与控制会议论文集), 2013.
[23] Jin Y, Wu Z Z, Liu X S, et al. Journal of Pharmaceutical and Biomedical Analysis, 2013, 77: 32.
[24] DU Min, WU Zhi-sheng, LIN Zhao-zhou, et al(杜 敏, 吴志生, 林兆洲, 等). Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2012, 32(10): 1796.
[25] Nanjing Haichang Chinese Medicine Co., Ltd.(南京海昌中药集团有限公司). China Patent(中国专利), CN203389100U, 2014.
[26] Tianjin Tasky Modern TCM Resources Co., Ltd.(天津天士力现代中药资源有限公司). China Patent(中国专利), CN102058682B, 2014.
[27] Suzhou Zedaxingbang Pharmaceutical Co., Ltd.(苏州泽达兴邦医药科技有限公司). China Patent(中国专利), CN203203923U, 2013.
[28] Zhejiang University, Wenzhou Zhekang Pharmaceutical Equipment Co., Ltd.(温州浙康制药装备科技有限公司). China Patent(中国专利), CN101984343B, 2013.
[29] Chengde Jingfukang Pharmaceutical Co., Ltd.(承德颈复康药业集团有限公司). China Patent(中国专利), CN101832921A, 2010.
[30] Changshu Leiyunshang Pharmaceutical Co., Ltd.(常熟雷允上制药有限公司). China Patent(中国专利), CN101078685A, 2007.
[31] Jing brand Co., Ltd.(劲牌有限公司). China Patent(中国专利), CN101655453B, 2011.
[32] International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use(ICH). ICH Q8(R2): Pharmaceutical Development. Geneva: ICH, 2009.
[33] LIU Quan, QU Hai-bin, CHENG Yi-yu(刘 全, 瞿海斌, 程翼宇). Journal of Chemical Industry and Engineering(化工学报), 2003, 54: 1586.
[34] GENG Zhao, HU Hao-wu, LI Sheng-hua, et al(耿 炤,胡浩武, 李胜华, 等). Applied Chemical Industry(应用化工), 2011, 40(5): 900.
[35] NI Li-jun, SHI Xiao-hao, GAO Xiu-jiao, et al(倪力军, 史晓浩, 高秀蛟, 等). Chinese Pharmaceutical Journal(中国药学杂志), 2004, 39(8): 628.
[36] ZHANG Ai-jun, DAI Ning, ZHAO Guo-lei, et al(张爱军, 戴 宁, 赵国磊, 等). Chinese Traditional and Herbal Drugs(中草药), 2010, 41(2): 238.
[37] Sui C L, Wu Z S, Peng Y F, et al. International Journal of On-Line Engineering, 2003, 44.
[38] ZHANG Yan-ying, ZHANG Jin-wei, LIU Yan(张延莹, 张金巍, 刘 岩). Chinese Journal of Pharmaceuticals(中国医药工业杂志), 2010，41(9): 662.
[39] GUO Zheng-fei, DAI Lian-kui(郭正飞, 戴连奎). Chinese Journal of Spectroscopy Laboratory(光谱实验室), 2013, 30(5): 2418.
[40] JIA Jian-zhong, WU Chun-yan, LI Xiao-an(贾建忠, 吴春燕, 李小安). Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2013, 33(9): 1567.
[41] Wu Y J, Jin Y, Li Y R, et al. Vibrational Spectroscopy, 2012, 58: 109.
[42] Xiao X, Ma J F, Ge F H, et al. World Scientific, 2014, 7(4): 13500631.
[43] HUANG Hong-xia, LI Wen-long, QU Hai-bin, et al(黄红霞, 李文龙, 瞿海滨, 等). China Journal of Chinese Materia Medica(中国中药杂志), 2013, 38(11): 1663.
[44] LIU Shuang-yue, LI Wen-long, QU Hai-bin, et al(刘爽悦, 李文龙, 瞿海斌, 等). China Journal of Chinese Materia Medica(中国中药杂志), 2013, 38(11): 1657.
[45] ZOU Zhen-min, DONG Hai-ping, XU Xiang-feng, et al(邹振民,董海平, 许详峰, 等). The Collection of the 4th International Forum for China On-Line Analytical Instrument Application and Development Expo(第四届中国在线分析仪器应用及发展国际国际论坛论文集), 2011.
[46] JIANG Xue, ZHANG Jing-shuo, QIU Min, et al(蒋 雪, 张经硕, 邱 敏, 等). Chinese Journal of Analytical Chemistry(分析化学), 2006, 34(9): 171.
[47] LIU Hua, YE Xiao-lan, YANG Guang, et al(刘 桦, 叶晓岚, 杨 光, 等). Spectroscopy and Spectral Analysis(光谱学与光谱分析), 2013, 33(1): 98.
[48] YANG Hui-hua, WANG Yong, WU Yun-ming, et al(杨辉华, 王 勇, 吴云鸣, 等). Chinese Traditional Patent Medicine(中成药), 2008, 30(3): 409.
[49] WAN Wen-biao, JIANG Hong, SHEN Jia-te, et al(万文标, 姜 红, 沈佳特, 等). Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2013,33(1): 63.
[50] QU Zhan-guo, GENG Zhao, HU Hao-wu, et al(屈战果, 耿 炤,胡浩武, 等). Lishenzhen Medicine and Materia Medica Research(时珍国医国药), 2012, 23(10): 2555.
[51] GENG Zhao, HU Hao-wu, LI Sheng-hua, et al(耿 炤, 胡浩武, 李胜华, 等). China Pharmaceuticals(中国药业), 2012, 21(11): 14.
[52] JIANG Bo-hai, WANG Qing, WANG Shi-sheng, et al(蒋博海, 汪 晴, 王世盛, 等). Spectroscopy and Spectral Analysis(光谱学与光谱分析), 2013, 33(1): 74.
[53] HU Hao-wu, GENG Zhao, WANG Mu-lan, et al(胡浩武, 耿 炤, 王木兰, 等). Lishenzhen Medicine and Materia Medica Research(时珍国医国药), 2012, 23(2): 398.
[54] JIN Ye, YANG Kai, CHEN Mu-zhou, et al(金 叶, 杨 凯, 陈木洲, 等). China Journal of Chinese Materia Medica(中国中药杂志), 2011, 36(21): 2963.
[55] SHI Meng, GENG Chun-xian, YE Bin, et al(石 猛, 耿春贤, 叶 彬, 等). Chinese Journal of Experimental Traditional Medical Formulae(中国实验方剂学杂志), 2011, 17(11): 48.
[56] ZHANG Shun-nan, YANG Hai-lei, LIU Zhan-qiang, et al(章顺楠, 杨海雷, 刘占强, 等). Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2009, 29(2): 192.
[57] DING Hai-ying, JIN Ye, LIU Xue-song, et al(丁海樱, 金 叶, 刘雪松, 等). Chinese Pharmaceutical Journal(中国药学杂志), 2013, 48(14): 1151. |
| [1] |
XU Rong1, AO Dong-mei2*, LI Man-tian1, 2, LIU Sai1, GUO Kun1, HU Ying2, YANG Chun-mei2, XU Chang-qing1. Study on Traditional Chinese Medicine of Lonicera L. Based on Infrared Spectroscopy and Cluster Analysis[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2023, 43(11): 3518-3523. |
| [2] |
SUN Cheng-yu1, JIAO Long1*, YAN Na-ying1, YAN Chun-hua1, QU Le2, ZHANG Sheng-rui3, MA Ling1. Identification of Salvia Miltiorrhiza From Different Origins by Laser
Induced Breakdown Spectroscopy Combined with Artificial Neural
Network[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2023, 43(10): 3098-3104. |
| [3] |
ZHU Yu-qi1, 2, ZHANG Xin2, DU Pan-pan2, LIU Shu1, ZHANG Gui-xin1, 2, GUAN Song-lei2*, ZHENG Zhong1*. Infrared Spectroscopy and X-Ray Spectroscopy Combined With
Inductively Coupled Plasma Mass Spectrometry for Quality
Control of Mongolian Medicine Yu Grain Soil[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2023, 43(10): 3163-3169. |
| [4] |
MA Qian1, 2, YANG Wan-qi1, 2, LI Fu-sheng1, 2*, CHENG Hui-zhu1, 2, ZHAO Yan-chun1, 2. Research on Classification of Heavy Metal Pb in Honeysuckle Based on XRF and Transfer Learning[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2023, 43(09): 2729-2733. |
| [5] |
LI Wen-xia1, DU Yu-jun2, WANG Yue1, LIU Zheng-dong3*, ZHENG Jia-hui1, DU Wen-qian1, WANG Hua-ping4. Research on On-Line Efficient Near-Infrared Spectral Recognition and Automatic Sorting Technology of Waste Textiles Based on Convolutional Neural Network[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2023, 43(07): 2139-2145. |
| [6] |
JIN Cheng-liang1, WANG Yong-jun2*, HUANG He2, LIU Jun-min3. Application of High-Dimensional Infrared Spectral Data Preprocessing in the Origin Identification of Traditional Chinese Medicinal Materials[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2023, 43(07): 2238-2245. |
| [7] |
LI Meng1, 2, ZHANG Xiao-bo2, LIU Shao-bo3, CHEN Xing-feng4*, HUANG Lu-qi5*, SHI Ting-ting2, YANG Rui6, LIU Shu7, ZHENG Feng-jie8. Partly Interpretable Machine Learning Method of Ginseng Geographical Origins Recognition and Analysis by Hyperspectral Measurements[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2022, 42(04): 1217-1221. |
| [8] |
FAN Feng-jie1, XUAN Feng-lai1, BAI Yang1, JI Hui-fang2. Pattern Recognition of Traditional Chinese Medicine Property Based on Three-Dimensional Fluorescence Spectrum Characteristics[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2020, 40(06): 1763-1768. |
| [9] |
ZHANG En-hua1, QIU Xuan-bing1,2 *, WEI Yong-bo1, LI Ning1, LI Jie1, HE Xiao-hu1, GUO Gu-qing1, LI Chuan-liang1*, WEI Ji-lin1, ZANG Zhen-zhong2, YANG Ming2. Near-Infrared LED Moisture Content Sensor for Traditional Chinese Medicine Based on Square Wave Excitation[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2020, 40(05): 1656-1660. |
| [10] |
ZHENG Pei-chao1, ZHENG Shuang1, WANG Jin-mei1*, LIAO Xiang-yu1, LI Xiao-juan1, PENG Rui2. Study on Grade Identification of Dendrobium by LIBS[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2020, 40(03): 941-944. |
| [11] |
LI Jia-jia1*, LIU Jing-li1, JIN Ru-yi1, TANG Yu-ping1, YUE Shi-jun1，WANG Li-wen2, LONG Xu1, ZHANG Guang-hui1, MENG Qing-hua1, LI Rong-xi3. Quantitative Measurement of Artemisinin Content in Chinese Traditional Compound Medicine by Raman Spectroscopy[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2019, 39(08): 2403-2408. |
| [12] |
MAO Li, LI Rong-pei, LIU Xin, SU Hui-lan*. Quality Control to the Detection of Gross Alpha Activity in Drinking Water by Low-Background Gross Alpha/Beta Counter[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2019, 39(07): 2166-2170. |
| [13] |
LI Yun1,2,3, ZHANG Ji1,2, LIU Fei4, XU Fu-rong3, WANG Yuan-zhong1,2*, ZHANG Jin-yu1,2,3*. Prediction of Total Polysaccharides Content in P. notoginseng Using FTIR Combined with SVR[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2018, 38(06): 1696-1701. |
| [14] |
LIU Wei, DAI Lian-kui* . Online Analysis of Dynamic Trend Regression and Endpoint Determination for Chinese Traditional Medicine Extraction Process Based on Ultraviolet spectroscopy[J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2017, 37(02): 497-502. |
| [15] |
YANG Ni-na1, 2, YANG Chun-yong3, WANG Yuan-zhong4,5*, ZHAO Ying-hong1* . Application of FTIR and Active Ingredients Quantitative Analysis on Quality Control of Dai Medicine Alstonia scholaris (L.) R. Br. [J]. SPECTROSCOPY AND SPECTRAL ANALYSIS, 2017, 37(01): 58-64. |
|
|
|
|
