荧光光度法测定重组人生长激素注射液中聚山梨醇酯20的含量.pdf

药物分析杂志Chin J Pharm Anal 2007，27(12) 荧光光度法测定重组人生长激素注射液中聚山梨醇酯20的含量 辛中帅，梁成罡，李克坚，杨化新 (中国药品生物制品检定所，北京100050) 摘要 目的：建立荧光光度法测定重组人生长激素注射液中聚山梨醇酯2O的含量。方法：利用Ⅳ～苯基一1一萘胺(NPN)能 摄取溶液中的聚山梨醇酯2O并产生荧光，以其荧光强度与浓度正相关的特性来测定聚山梨醇酯2O的含量。同时考察该方法 的影响因素，确定了最佳实验条件。结果：根据影响因素与荧光强度的关系确定了35 oC、0．o5％NPN浓度反应5 min的试验 条件，该法的平均仪器精密度、方法精密度和板间精密度分别为2．O％，4．O％，5．O％，平均加样回收率为102．6％。本法测定 的2批生长激素注射液结果，与企业采用的方法结果一致。结论：本法快速、简便、准确，可用于测定重组人生长激素注射液中 聚山梨醇酯2O的含量。 关键词：荧光光度法；聚山梨醇酯20；重组人生长激素；Ⅳ一苯基一1一萘胺(NPN) 中图分类号：R917 文献标识码：A 文章编号：0254—1793(2007)12—1887～OL4 Fluorescence photometry determination of polysorbate 20 in recombinant human growth hormone injection XIN Zhong—shuai，LIANG Cheng—gang，LI Ke—jian，YANG Hua—xin (National Institute for the Control of Pharmaceutical and Biological Products，Beijing 100050，China) Abstract Objective：A new fluorescence photometry was developed to determine the assay of polysorbate 20 in re— combinant human growth hormone injection．Method：N—phenyl一1一naphthylamine(NPN)could absorb polysor— bate 20 in solution and generate fluorescence．The fluorescence strength was directly correlated with the concentra— tion of polysorbate 20，which could be adopted for assay of polysorbate 20．Meanwhile the influencing factor was re— searched，to get the optimum test conditions．Result：35 oC，0．05％NPN concentration and reacting 5 min were es— tablished as test conditions．The average instrument precision，intra—and inter—plate precision were 2．O％ ，4．O％ and 5．O％ respectively．The average spike recovery was 102．6％．The test results of two lots of productions con— formed to the results given by its producing enterprise．Conclusion：This method is quick，simple，accurate and call be used to determine the assay of polysorbate 20 in drugs． Key words：fluorescence photometry；polysorbate 20；recombinant human growth hormone；N—phenyl一1一naph— thylami