| RP-HPLC法测定重组人生长激素注射液中间甲酚含量 |
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| 引用本文： | 王永利,张自萍,李晶,梁成罡,杨化新.RP-HPLC法测定重组人生长激素注射液中间甲酚含量[J].生物磁学,2009(20):3935-3937. |
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| 作者姓名： | 王永利 张自萍 李晶 梁成罡 杨化新 |
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| 作者单位： | [1]宁夏大学生命科学学院,宁夏银川750021 [2]中国药品生物制品检定所 ,宁夏银川750021 [3]中国药品生物制品标准化研究中心,北京100050 |
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| 基金项目： | 基金项目：国家863“十一五”课题,”核酸和多肽药物质量标准和评价技术研究”.（2007AA021601） |
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| 摘 要： | 目的：建立测定重组人生长激素注射液中间甲酚含量的方法。方法：采用RP-HPLC法,色谱柱为ShiseidoC4（250mmx4.6mm,5um）,流动相为0.05MTris-HCL（pH7.5）-正丙醇（71：29）,流速0.5ml/min,检测波长为317nm,柱温为40℃。结果：间甲酚在0.2mg-0.8mg/ml（r=0.9996,n=5）浓度范围内与峰面积呈良好线性关系,最低检出线为0.1ng,平均回收率为100.5%（n=9）。结论：本方法准确,重现性好,可为重组人生长激素注射液质量评价提供较为可靠的分析方法。
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| 关 键 词： | 重组人生长激素注射液 间甲酚 反相高效液相色谱法 |
RP-HPLC determination of metacresol in Human growth hormone recombination injection |
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| WANG Yong-li,ZHANG Zi-ping,LI Jin,LIANG Cheng-gang,YANG Hua-xin.RP-HPLC determination of metacresol in Human growth hormone recombination injection[J].Biomagnetism,2009(20):3935-3937. |
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| Authors: | WANG Yong-li ZHANG Zi-ping LI Jin LIANG Cheng-gang YANG Hua-xin |
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| Institution: | 1 The College of Life Sciences, Ning Xia University, 750021, Yin Chuan, China; 2 National Institute for The Control of Pharmaceutical and Biological Product, 100050, Beijing Chin; 3 National standard research center for Pharmaceutical and Biological Product, 100050, Beijing China) |
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| Abstract: | Objective： To establish an HPLC method for the determination of metacresol in Human growth hormone recombination injection. Methods： ShiseidoC4 column （250 mm×4.6 mm, 5 um）was used and the mobile phase was 0.05 M Tris-HCL （pH 7.5 ）-n-propyl alcoho （71：29 ）at flow rate of 0.5 ml/min. The UV detection wavelength was 270 nm ,and the column temperature was 40~C. Result： the calibration curve of metacresol was linear in the range of 0.2 mgl-0.8 mg/ml （r=0.9996,n=5） with the minimum limit of detection was 1.0ng. The mean recovery （n=9）was 100.5 %. Conclusion： This is an accurate an credible quality control method for Human growth hormone recombination injection. |
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| Keywords: | Human growth hormone recombination injection metacresol RP-HPLC |
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