目的 建立外用人粒细胞巨噬细胞刺激因子凝胶的生物学活性检测方法,并对方法进行验证。方法 按照《中国药典》2020年版三部规定的方法对工作细胞进行检测,对活性测定方法进行优化,并验证方法的准确度、线性范围、中间精密度、耐用性。结果 不同细胞代次、不同细胞密度、不同饥饿处理时间下相对效价测定值的几何变异系数为6.51%。结论 建立了外用人粒细胞巨噬细胞刺激因子凝胶的生物学活性测定方法,该方法准确度高、精密度好、耐用性强、检测结果可靠,可用于产品的生物学活性评价和质量控制。
Abstract
OBJECTIVE To develop and verify a method for determination of biological activity of human granulocyte/macrophage colony-stimulating factor gel for external use. METHODS The cells from the cell banks were tested according to the Chinese pharmacopoeia (Volume Ⅲ, 2020 edition). The method was optimized and verified for accuracy, linear range, intermediate precision, and durability. RESULTS The geometric coefficient of variation of the measured relative potencies with cells of different passages, densities and starvation time was 6.51%. CONCLUSION A method for determination of the biological activity of human granulocyte/macrophage colony-stimulating factor gel for external use is successfully developed, which shows high accuracy, precision and durability, and may be used for the biological activity evaluation and quality control of the product.
关键词
人粒细胞巨噬细胞刺激因子 /
生物学活性 /
细胞饥饿
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Key words
human granulocyte/macrophage colony-stimulating factor /
biological activity /
cell starvation
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中图分类号：
R917
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参考文献
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脚注
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基金
广东省药品监督管理局科技创新项目资助(2021ZDZ02,2022ZDZ02,2023YDZ02,2023YDZ04,2023ZDZ02);广东省医学科学技术研究基金项目资助(B2022285,B2022321)
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