HJCET  >> Vol. 7 No. 1 (January 2017)

    The Principle of Lyophilization and Its Application in Biological Products

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黄章泷,雷 霆,常 宇:北京工业大学生命科学与生物工程学院,北京

冷冻干燥生物制品蛋白质Lyophilization Biological Products Proteins



The rapid development of medical industry raises new requirement for the reservation of biological products, which also means new developing opportunities to the lyophilization technique. In this paper, we introduce the principle of lyophilization and the key points in recipe designing. We also discuss the prospect of lyophilization in biological industry.

黄章泷, 雷霆, 常宇. 冷冻干燥技术的原理及其在生物制品中的应用[J]. 化学工程与技术, 2017, 7(1): 8-12. http://dx.doi.org/10.12677/HJCET.2017.71002


[1] Kasper, J.C., Winter, G. and Friess, W. (2013) Recent Advances and Further Challenges in Lyophilization. European Journal of Pharmaceutics and Biopharmaceutics, 85, 162-169. https://doi.org/10.1016/j.ejpb.2013.05.019
[2] Gibson, M. (1999) Pharmaceutical Preformulation & Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form, 2, Drugs & the Pharmaceutical Sciences, 333.
[3] Wang, W. (2000) Lyophilization and Development of Solid Protein Pharmaceuticals. International Journal of Pharmaceutics, 203, 1-60. https://doi.org/10.1016/S0378-5173(00)00423-3
[4] Baheti, A., Kumar, L. and Bansalb, A.K. (2010) Excipients Used in Lyophilization of Small Molecules. Journal of Excipients and Food Chemicals, 1, 41-54.
[5] Tang, X. and Pikal, M.J. (2004) Design of Freeze-Drying Processes for Pharmaceuticals: Practical Advice. Pharmaceutical Research, 21, 191-200. https://doi.org/10.1023/B:PHAM.0000016234.73023.75
[6] Costantino, H.R., Carrasquillo, K.G., Cordero, R.A., et al. (1998) Effect of Excipients on the Stability and Structure of Lyophilized Recombinant Human Growth Hormone. Journal of Pharmaceutical Sciences, 87, 1412-1420. https://doi.org/10.1021/js980069t
[7] Souillac, P.O., Middaugh, C.R. and Rytting, J.H. (2002) Investigation of Pro-tein/Carbohydrate Interactions in the Dried State. 2. Diffuse Reflectance FTIR Studies. International Journal of Pharmaceutics, 235, 207-218. https://doi.org/10.1016/S0378-5173(01)00987-5
[8] Mattern, M., Winter, G., Kohnert, U., et al. (1999) Formulation of Proteins in Cacuum-Dried Glasses. II. Process and Storage Stability in Sugar-Free Amino Acid Systems. Pharmaceutical Development and Technology, 4, 199-208. https://doi.org/10.1081/PDT-100101354
[9] Izutsu, K., Yoshioka, S. and Kojima, S. (1995) Increased Stabilizing Effects of Amphiphilic Excipients on Freeze- Drying of Lactate Dehydrogenase (LDH) by Dispersion into Sugar Matrices. Pharmaceutical Research, 12, 838-843. https://doi.org/10.1023/A:1016252802413
[10] Tarelli, E., Mire-Sluis, A., TIvnann, H.A., et al. (1998) Recombinant Human Albumin as a Stabilizer for Biological Materials and for the Preparation of International Reference Reagents. Biologicals, 26, 331-346. https://doi.org/10.1006/biol.1998.0163
[11] Kreilgaard, L., Frokjaer, S., Flink, J.M., et al. (1999) Effects of Additives on the Stability of Humicola Lanuginose Lipase during Freeze-Drying and Storage in the Dried Solid. Journal of Pharmaceutical Sciences, 88, 281-290. https://doi.org/10.1021/js980399d
[12] 武华丽, 胡一桥. 冷冻干燥制剂的稳定性研究进展[J]. 中国药学杂志, 2001, 36(7): 436-438.