| 两种不同剂型重组人生长激素在体生物活性比较 |
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| 引用本文： | 王亚敏,李湛军. 两种不同剂型重组人生长激素在体生物活性比较[J]. 中国生化药物杂志, 2008, 29(6) |
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| 作者姓名： | 王亚敏 李湛军 |
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| 作者单位： | [1]国家食品药品监督管理局药品审评中心,北京100038 [2]中国药品生物制品检定所北京100050,北京100038 |
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| 摘 要： | 目的比较两种不同剂型的重组人生长激素在体生物活性。方法以摘除脑垂体的雄性大鼠为动物模型,rhGH国家标准品为对照,应用量反应平行线原理,6 d总量的高剂量10.7 IU/kg、低剂量2.7 IU/kg,按体重增加法和胫骨骨骺板增宽法分别测定rhGH注射液(T1~T4)和注射用rhGH(T5~T11)的生物活性,并比较两种剂型的比活性。结果rhGH注射液比活性比注射用rhGH的比活性高(P<0.01)。结论rhGH注射液比注射用rhGH的比活性高。
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| 关 键 词： | 重组人生长激素注射液 注射用重组人生长激素 在体 生物活性 |
Comparing the bioactivities between two kinds of preparations of recombinant human growth Hormone |
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| WANG Ya-ming,LI Zhan-jun. Comparing the bioactivities between two kinds of preparations of recombinant human growth Hormone[J]. Chinese Journal of Biochemical Pharmaceutics, 2008, 29(6) |
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| Authors: | WANG Ya-ming LI Zhan-jun |
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| Affiliation: | WANG Ya-ming1,LI Zhan-jun2 |
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| Abstract: | Purpose To evaluate the in vivo bioactivities between recombinant human growth hormone(rhGH)injection in aqueous state and lyophilized rhGH for injection.Methods In vivo bioassay was developed in hypophysectomized(Hpx)male rat model in 2.7 and 10.7 IU/kg(6 days total dose).The bioactivities of 4 sample of rhGH in liquid formulation(T1-T4)and 7 sample of rhGH for reconstitution(T5-T11)were evaluated respectively by parallel line analysis against rhGH national standard in body-weight gain and tibial epiphyseal growth plate width.The bioactivity ratio between two kinds of preparations was compared.Results The bioactivities of the liquid formulation of rhGH were higher than those of the lyophilized formulation of rhGH(P<0.01).Conclusion The bioactivity ratio of rhGH injection in aqueous state was higher than that of lyophilized rhGH for injection. |
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| Keywords: | rhGH injection lyophilized rhGH for injection in vivo bioactivity |
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