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中国生物工程杂志

CHINA BIOTECHNOLOGY
中国生物工程杂志  2016, Vol. 36 Issue (11): 48-53    DOI: 10.13523/j.cb.20161107
技术与方法     
融合蛋白GGH粉针剂制备工艺研究
钱建瑛, 许正宏, 窦文芳
江南大学药学院 无锡 214122
Study on the Preparation Technology of Injectable Powder of Fusion Protein GGH
QIAN Jian ying, XU Zheng hong, DOU Wen fang
School of Pharmaceutical Science, Jiangnan University, Wuxi 214122, China
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摘要:

目的:建立高效液相色谱法测定融合蛋白GGH原料和注射用粉针剂含量的方法,筛选制备粉针剂的辅料和pH,进行6个月的长期稳定性试验。方法:高效液相色谱采用Waters DELTA PAK C18色谱柱,流动相为乙腈和水,梯度洗脱20min,检测波长280nm。根据粉针剂的外形、复溶性、稳定性和活性保留率筛选填充剂及pH。结果:GGH在0.2~1.6mg/ml范围内线性关系良好,可用此方法进行制剂的含量检测;选用4%的甘露醇作为填充剂并调节pH为5.5,可以制备性质较为稳定的GGH冻干粉针剂。结论:可采用含量和纯度检测结合外观性状观察法用于粉针剂的制备工艺筛选,为申报新药提供参考。

关键词: 粉针剂含量测定融合蛋白制备工艺    
Abstract:

Objective:To establish an HPLC method for the determination of content of GGH and its injectable powder. To screen the supplementary materials and pH and study on the stability for 6 months. Methods:The Waters DELTA PAK C18 column was used, and the mobile phase was acetonitrile and water with gradient elution for 20 minutes. The detection wavelength was 280nm. Screened the fillers and pH according to the powder shape, solubility, stability and activity. Results:The calibration curve was linear in the range of 0.2~1.6mg/ml,R2=0.999,which could be used to the content detection of the powder. Four percent mannitol and pH5.5 were selected to prepare the GGH injectable powder with stable quality. Conclusions:The determination of purity and activity, together with the appearance observation method, could be used for the study of preparation technology, which provided references for the application of new drugs.

Key words: Fusion protein    Determination of content    Preparation technology    Injectable powder
收稿日期: 2016-07-21 出版日期: 2016-11-25
ZTFLH:  Q819  
基金资助:

江苏省科技支撑(社会发展)计划资助项目(BE2009629)

通讯作者: 窦文芳,26199081@qq.com     E-mail: 26199081@qq.com
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引用本文:

钱建瑛, 许正宏, 窦文芳. 融合蛋白GGH粉针剂制备工艺研究[J]. 中国生物工程杂志, 2016, 36(11): 48-53.

QIAN Jian ying, XU Zheng hong, DOU Wen fang. Study on the Preparation Technology of Injectable Powder of Fusion Protein GGH. China Biotechnology, 2016, 36(11): 48-53.

链接本文:

https://manu60.magtech.com.cn/biotech/CN/10.13523/j.cb.20161107        https://manu60.magtech.com.cn/biotech/CN/Y2016/V36/I11/48

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