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| 喷雾干燥对干扰素α-2b稳定性的影响 | |
| 引用本文： | 江荣高,张磊,王春龙,刘衡,潘卫三.喷雾干燥对干扰素α-2b稳定性的影响[J].中国药学杂志,2005,40(9):681-683. |
| 作者姓名： | 江荣高 张磊 王春龙 刘衡 潘卫三 |
| 作者单位： | 1. 沈阳药科大学药学院,辽宁,沈阳,110016;天津药物研究院,天津,300193 2. 天津华立达生物工程有限公司,天津 300457 3. 天津药物研究院,天津,300193 4. 沈阳药科大学药学院,辽宁,沈阳,110016 |
| 摘 要： | 目的研究不同方法来提高蛋白质在喷雾干燥过程中的稳定性。方法以干扰素α-2b为模型药,分别考察喷雾干燥条件、pH值及缓冲体系、赋形剂及添加剂对干扰素α-2b活性的影响。结果在雾化气体流速约575 L·h-1、进口温度110℃的喷雾干燥条件下,利用大豆卵磷脂、十二烷基硫酸钠、羟丙基甲基纤维素、羟丙基β-环糊精、L-赖氨酸为添加剂,干扰素α-2b的活性损失较小。结论干扰素α-2b在喷雾干燥过程中的稳定性可以通过工艺及处方因素得到提高。 |
| 关 键 词： | 干扰素α-2b 喷雾干燥 |
| 文章编号： | 1001-2494(2005)09-0681-04 |
| 收稿时间： | 2004-08-24; |
Effect of spray drying on stability of recombinant human interferon α-2b |
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| JIANG Rong-gao,ZHANG Lei,WANG Chun-long,LIU Heng,PAN Wei-san.Effect of spray drying on stability of recombinant human interferon α-2b[J].Chinese Pharmaceutical Journal,2005,40(9):681-683. | |
| Authors: | JIANG Rong-gao ZHANG Lei WANG Chun-long LIU Heng PAN Wei-san |
| Institution: | 1.School of Pharmacy， Shenyang Pharmaceutical University， Shenyang 110016， China； 2. Tianjin Hualida Biotechnology Co.，LTD，Tianjin 300457， China；3. Tianjin Institute of Pharmaceutical Research，Tianjin 300193， China |
| Abstract: | OBJECTIVE To investigate the effects of the spray drying conditions and formulations on the stability of protein.METHODS Recombinant human interferon alpha-2b (rHuIFN α-2b) was used as a model protein. The effects of spray drying conditions, pH, buffer systems, excipients and additives were evaluated. RESULTS The stability of rHuIFN α-2b was improved by the addition of lecithin, sodium dodecyl sulfate (SDS), Tween 20, lysine , hydroxypropyl-β-cyclodextrin(HPCD) and hydroxypropyl methyl cellulose (HPMC) when lactose was chosen as excipient. CONCLUSION Formulation variables and processes can be optimized to improve the stability of rHuIFN α-2b. |
| Keywords: | interferon α-2b spray drying stability |
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