| 重组干扰素α1b壳聚糖涂膜剂的制备及质量控制 |
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| 引用本文： | 陈勇,陈妍.重组干扰素α1b壳聚糖涂膜剂的制备及质量控制[J].中国药房,2006,17(1):27-28. |
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| 作者姓名： | 陈勇 陈妍 |
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| 作者单位： | 1. 辽宁抚顺市第二医院药剂科,抚顺市,113001
2. 吉林大学生命科学学院,长春市,130012 |
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| 摘 要： | 目的研制重组干扰素α1b壳聚糖涂膜剂并建立其质量控制方法。方法采用壳聚糖为主要辅料制备涂膜剂,用二喹啉甲酸试剂盒测定制剂中重组干扰素α1b的含量,考察制剂的稳定性,并进行皮肤刺激性试验。结果所制涂膜剂中重组干扰素α1b检测浓度线性范围为1~11mg/L(r=0.9999),方法回收率为101.04%,RSD=1.05%(n=5)。结论该制剂制备工艺简单,含量测定方法准确,质量稳定,对皮肤未见刺激性。
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| 关 键 词： | 重组干扰素α1b 壳聚糖 涂膜剂 制备 质量控制 |
| 文章编号： | 1001-0408(2006)01-0027-02 |
| 收稿时间： | 08 10 2005 12:00AM |
| 修稿时间： | 11 10 2005 12:00AM |
Preparation and Quality Control of Recombinant Interferon α1b Chitosan Plastics |
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| CHEN Yong,CHEN Yan.Preparation and Quality Control of Recombinant Interferon α1b Chitosan Plastics[J].China Pharmacy,2006,17(1):27-28. |
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| Authors: | CHEN Yong CHEN Yan |
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| Institution: | 1,Dept. of Pharmacy,Fushun No. 2 Hospital in Liaoning Province, Fushun 113001,China;2,College of Life Science, Jilin University, Changchun 130012, China |
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| Abstract: | OBJECTIVE:To prepare recombinant interferon(INF)α1b chitosan plastics and to establish a way for its quality control.METHODS:The plastics was prepared with chitosan as the main excipients,the content of INFα1b was de-termined by di-quinoline methanoic acid kit,the stability of the plastics was determined and its skin irritation test was con-ducted.RESULTS:The linear range for recombinant INFα1b in the prepared paint was1～11mg/L(r=0.9999)with methodological recovery rate at101.04%,RSD=1.05%(n=5).CONCLUSION:The recombinant INFα1b chitosan plastics is simple in preparation,accurate in assaying,stable in quality yet the skin irritation induced by which was failed to be noted. |
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| Keywords: | Recombinant interferon α1b Chitosan Plastics Preparation Quality control |
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