| 氧化槐定碱冻干粉针剂的制备及质量控制 |
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| 引用本文： | 张军帅,赵斌,龙伟,刘培勋. 氧化槐定碱冻干粉针剂的制备及质量控制[J]. 中国药师, 2011, 14(9): 1308-1310,1313 |
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| 作者姓名： | 张军帅 赵斌 龙伟 刘培勋 |
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| 作者单位： | 北京协和医学院中国医学科学院放射医学研究所 天津300192 |
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| 摘 要： | 目的:制备氧化槐定碱冻干粉针,建立质量控制方法并考察制剂质量稳定性。方法:采用正交设计试验方法,对处方及工艺进行优选;运用HPLC法,测定其含量。结果:优选的处方及工艺制成的冻干制品外观及溶解性良好。结论:处方设计合理,工艺可行,质量控制方法可靠。
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| 关 键 词： | 氧化槐定碱 冻干粉针 正交设计 质量控制 |
Preparation and Quality Control of Oxysophoridine Freeze-dried Powder Injection |
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| Zhang Junshuai,Zhao Bin,Long Wei,Liu Peixun. Preparation and Quality Control of Oxysophoridine Freeze-dried Powder Injection[J]. China Pharmacist, 2011, 14(9): 1308-1310,1313 |
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| Authors: | Zhang Junshuai Zhao Bin Long Wei Liu Peixun |
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| Affiliation: | Zhang Junshuai,Zhao Bin,Long Wei,Liu Peixun(Peking Union Medical College,Chinese Academy of Medical Sciences,Institute of Radiation Medicine,Tianjin 300192,China) |
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| Abstract: | Objective:To study the preparation process,quality control and stability of oxysophoridine freeze-dried powder injection. Method:The formulation and preparation process were optimized by orthogonal test.HPLC method was used for the determination of oxysophoridine in the injection.Result:With optimal formulation and preparation process,the freeze-dried products had promising solubility and appearance.Conclusion:The formulation is reasonable,the preparation phocess is feasible and the quality control method i... |
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| Keywords: | Oxysophoridine Freeze-dried powder Orthogonal design Quality control |
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