[1] |
FDA. Guidance for industry PAT—A framework for innovative pharmaceutical development, manufacturing and quality assurance. 2004. https://www.fda.gov/media/71012/download. |
[2] |
褚小立. 近红外光谱分析技术实用手册[M]. 北京: 机械工业出版社. 2016: 127-129. |
[3] |
FINDLAY W P, PECK G R, MORRIS K R. Determination of fluidized bed granulation end point using near-infrared spectroscopy and phenomenological analysis[J]. J Pharm Sci,2005,94(3):604-612. doi: 10.1002/jps.20276 |
[4] |
MOLTGEN C V, PUCHERT T, MENEZES J C, et al. A novel in-line NIR spectroscopy application for the monitoring of tablet film coating in an industrial scale process[J]. Talanta,2012,92:26-37. doi: 10.1016/j.talanta.2011.12.034 |
[5] |
KARANDE A D, HENG P W, LIEW C V. In-line quantification of micronized drug and excipients in tablets by near infrared (NIR) spectroscopy: Real time monitoring of tabletting process[J]. Int J Pharm,2010,396(1-2):63-74. doi: 10.1016/j.ijpharm.2010.06.011 |
[6] |
年秀玲. 类风湿性关节炎应用硫酸羟氯喹治疗的安全性和疗效探析[J]. 北方药学, 2016, 13(12):145. |
[7] |
王文灵. 硫酸羟氯喹治疗风湿病的临床效果研究[J]. 中国现代药物应用, 2016, 10(12):138-139. |
[8] |
魏薇, 何金昌, 余素君. 羟氯喹治疗系统性红斑狼疮的效果评析[J]. 当代医药论丛, 2017, 15(16):138-139. |
[9] |
YAMAMOTO Y, SUZUKI T, MATSUMOTO M, et al. Evaluation of the degree of mixing of combinations of dry syrup, powder, and fine granule products in consideration of particle size distribution using near infrared spectrometry[J]. Chem Pharm Bull,2012,60(5):624-631. doi: 10.1248/cpb.60.624 |
[10] |
李沙沙, 陈辉, 赵云丽, 等. 硫酸羟氯喹颗粒水分含量测定近红外定量模型的建立[J]. 沈阳药科大学学报, 2019, 36(7):593-599. |
[11] |
王维皓, 张永欣, 冯伟红, 等. 基于近红外光谱及组合间隔偏最小二乘法的天南星中水分及总黄酮含量测定研究[J]. 中国中医药信息杂志, 2017, 24(7):72-75. |
[12] |
王遥琼, 王维皓. 近红外光谱用于甘草中甘草苷、甘草酸及水分测定[J]. 中国实验方剂学杂志, 2016, 22(19):59-62. |
[13] |
张翠, 柴欣生. 近红外光谱法快速测定甘蔗渣水分和糖分含量[J]. 中华纸业, 2011, 32(22):55-58. |
[14] |
CHEN Y, XIE M Y, ZHANG H, et al. Quantification of total polysaccharides and triterpenoids in Ganoderma lucidum and Ganoderma atrum by near infrared spectroscopy and chemometrics[J]. Food Chem,2012,135(1):268-275. doi: 10.1016/j.foodchem.2012.04.089 |
[15] |
杜敏. 中药近红外光谱检测影响因素的研究[D]. 北京中医药大学, 2013. |
[16] |
FERNANDEZ PIERNA J A, WAHL F, de NOORD O E, et al. Methods for outlier detection in prediction[J]. Chem Intell Lab Sys,2002,63(1):27-39. doi: 10.1016/S0169-7439(02)00034-5 |
[17] |
闵顺耕, 李宁, 张明祥. 近红外光谱分析中异常值的判别与定量模型优化[J]. 光谱学与光谱分析, 2004, 24(10):1205-1209. |
[18] |
刘蓉, 陈文亮, 徐可欣, 等. 奇异点快速检测在牛奶成分近红外光谱测量中的应用[J]. 光谱学与光谱分析, 2005, 25(2):207-210. |
[19] |
GALVAO R K, ARAUJO M C, JOSE G E, et al. A method for calibration and validation subset partitioning[J]. Talanta,2005,67(4):736-740. doi: 10.1016/j.talanta.2005.03.025 |
[20] |
孔霁虹. 青霉素类产品专属在线混合均匀度监测体系设计[D]. 山东大学, 2014. |
[21] |
张学博, 冯艳春, 胡昌勤. 近红外多元校正模型传递的进展[J]. 药物分析杂志, 2009, 29(8):1390-1399. |