布洛芬颗粒的溶出度限量检查 |
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引用本文: | 刘宇,于广华,杜晓丹,单红竹. 布洛芬颗粒的溶出度限量检查[J]. 黑龙江医药, 2012, 25(4): 564-565 |
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作者姓名: | 刘宇 于广华 杜晓丹 单红竹 |
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作者单位: | 哈尔滨华瑞生化药业有限责任公司 150025 |
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摘 要: | 目的:对布洛芬颗粒的溶出度进行限量检查;方法:采用溶出度测定法(《中国药典》二部附录XC第一法),以磷酸盐缓冲液(pH7.2)900ml为溶出介质,转速为每分钟100转,用高效液相色谱法进行限量检查。结果:该方法在19.47~584.1μg/ml范围内,线性关系良好(R2=0.9994),溶液稳定性试验RSD=0.48%。结论:该方法准确、可靠,重现性好,可用于该药品的质量控制。
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关 键 词: | 布洛芬颗粒 溶出度测定 高效液相色谱法 |
Ibuprofen Dissolution of Limited Particle Inspection |
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Affiliation: | Liu Yu,et al Harbin Huarui Biochemical Pharmaceutical Co.,Ltd(150025) |
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Abstract: | Objective:Dissolution of the ibuprofen particles to a limited check;Methods:The dissolution test method("Chinese Pharmacopoeia" Appendix 2 XC first method),with phosphate buffer(pH7.2)900ml of dissolution medium,rotation speed 100 revolutions per minute,high-performance liquid chromatography with limited check.Results:The method in 19.47-584.1μg/ml range,a good linear relationship(R2 = 0.9994),the solution stability test RSD = 0.48%.Conclusion:The method is accurate,reliable,reproducible,and can be used for quality control of the drug. |
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Keywords: | Ibuprofen particles dissolution test high-performance liquid chromatography |
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