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化工学报  2015 

奥拉西坦的逐步冻凝结晶

DOI: 10.11949/j.issn.0438-1157.20150903, PP. 3563-3569

Keywords: 冻干,相互作用能,玻璃态,热台显微镜,结晶

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Abstract:

奥拉西坦简单冻干往往导致所需时间长、产品质量差等问题,本文应用MS软件计算了山梨醇和奥拉西坦晶体各个晶面的相互作用能,结果表明山梨醇和奥拉西坦之间的相互作用能较小,实验也证明冻干过程中奥拉西坦晶型、晶习不受山梨醇影响。通过DSC和热台显微镜分析,奥拉西坦简单冻干问题的关键因素在于原预冻过程处方逐步冻凝产生的是玻璃态,不利于水分子升华干燥,因此本文提出奥拉西坦冻干过程的逐步冻凝结晶工艺,改变山梨醇的结晶状态,使各组分分别冻凝分离成微晶态,实验放大结果表明冻干所需时间大幅度缩短,产品质量得到很大提高。

References

[1]  Spignoli G, Pepeu G. Oxiracetam prevents electroshock- induced decrease in brain acetylcholine and amnesia [J]. European Journal of Pharmacology, 1986, 126 (3): 253- 257.
[2]  Saletu B, Linzmayer L, Grünberger J, Pietschmann H. Double-blind, placebo-controlled, clinical, psychometric and neurophysiological investigations with oxiracetam in the organic brain syndrome of late life [J]. Neuropsychobiology, 1985, 13 (1/2): 44-52.
[3]  Ye Lei. (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide racemate crystal form ii and preparation method therefor [P]: US, 14/237894. 2012-4-24.
[4]  Iriuchijima S, Kobayashi H, Aoki K, et al. Process for producing oxiracetam [P]: U.S, 4686296. 1987-8-11.
[5]  Wang Z Z, Chen J M, Lu T B. Enhancing the hygroscopic stability of S-oxiracetam via pharmaceutical cocrystals [J]. Crystal Growth & Design, 2012, 12(9): 4562-4566.
[6]  Mellor J D. Fundamentals of Freeze-Drying [M]. London: Academic Press Inc. Ltd., 1978.
[7]  Pikal M J. Freeze-drying of proteins. Process, formulation, and stability [J]. ChemInform, 1995, 26(4). DOI: 10.1002/chin.199504315.
[8]  Liapis A I, Pim M L, Bruttini R. Research and development needs and opportunities in freeze drying [J]. Drying Technology, 1996, 14 (6): 1265-1300.
[9]  Yu Jianping, Liu J H, Pu L Q, Cui Xiangdong, Wang Changzheng, Ouyang S L, Gao Dayong. Freeze-drying of human red blood cells: influence of carbohydrates and their concentrations [J]. Cell Preservation Technology, 2004, 2 (4): 270-275.
[10]  Zhou Xinli (周新丽), Liu Jianfeng (刘建峰), Zhang Shaozhi (张绍志), Chen Guangming (陈光明). Thermal analysis on lyoprotectants for biomaterials [J] Journal of Refrigeration (制冷学报), 2008, 29 (5): 54-57.
[11]  Wang Jingkang (王静康). Crystallization (结晶)//Shi Jun (时钧), Wang Jiading (汪家鼎), Yu Kuo Tsung (余国琮), Chen Minheng (陈敏恒). Handbook of Chemical Engineering (化学工程手册) [M]. Beijing: Chemical Industry Press. 1996.
[12]  Dubochet J, Chang J J, Freeman R, Lepault J, McDowall A W. Frozen aqueous suspensions [J]. Ultramicroscopy, 1982, 10 (1): 55-61.
[13]  Liu H, Lelièvre J. Transitions in frozen gelatinized-starch systems studied by differential scanning calorimetry [J]. Carbohydrate Polymers, 1992, 19 (3): 179-183.
[14]  Varshney D B, Kumar S, Shalaev E Y, Kang S W, Gatlin L A, Suryanarayanan R. Solute crystallization in frozen systems-use of synchrotron radiation to improve sensitivity [J]. Pharmaceutical Research, 2006, 23 (10): 2368-2374.
[15]  Zhu Liang(朱亮). Effects of pre-freeze in the freeze drying process [J]. Drying Technology & Equipment (干燥技术与设备), 2014, 12 (1): 32-34.
[16]  López-Urue?a E, Alvarez M, Gomes-Alves S, et al. Tolerance of brown bear spermatozoa to conditions of pre-freezing cooling rate and equilibration time [J]. Theriogenology, 2014, 81 (9): 1229-1238.
[17]  Gao Zhifeng(高志峰). A freeze-dried powder and preparation method of oxiracetam [P]: CN, 102274195 A. 2011-07-18.
[18]  Yani Y, Chow P S, Tan R B H. Molecular simulation study of the effect of various additives on salbutamol sulfate crystal habi [J]. Molecular pharmaceutics, 2011, 8 (5): 1910-1918.
[19]  Schmidt C, Ulrich J. Morphology prediction of crystals grown in the presence of impurities and solvents-an evaluation of the state of the art [J]. Journal of Crystal Growth, 2012, 353 (1): 168-173.
[20]  Gupta P, Thilagavathi R, Chakraborti A K, Bansal A K. Role of molecular interaction in stability of celecoxib-PVP amorphous systems [J]. Molecular Pharmaceutics, 2005, 2 (5): 384-391.
[21]  Belfiore P, Ponzio F, Biagetti R, Berettera C, Magnani M, Pozzi O. Oxiracetam prevents the hippocampal cholinergic hypofunction induced by the NMDA receptor blocker AP7 [J]. Neuroscience Letters, 1992, 143 (1): 127-130.

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