| 引用本文: | 仲婕,李保山,朱德领,张金钟,施明珠,殷爱军.寡核苷酸抗流感药物流感泰得钠含量测定[J].中国现代应用药学,2012,29(8):730-734. |
| ZHONG Jie,LI Baoshan,ZHU Deling,ZHANG Jinzhong,SHI Mingzhu,YIN Aijun.Study on the Content of Sodium in Oligonucleotide Bulk Pharmaceuticals-Flutide[J].Chin J Mod Appl Pharm(中国现代应用药学),2012,29(8):730-734. |
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| 寡核苷酸抗流感药物流感泰得钠含量测定 |
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仲婕1,2, 李保山1,2, 朱德领1,2, 张金钟1,2, 施明珠1,2, 殷爱军1,2
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1.杭州天龙药业有限公司，杭州 310021;2.军科天龙药物研究院，杭州 310021
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| 摘要: |
| 目的 用离子色谱法(IC)、原子吸收光谱法(AAS)评价抗流感药物钠含量，探讨两种测量方法定量结果的一致性。方法 在戴安ICS900离子色谱仪上，用阳离子分析柱Ionpac CS12(4 mm×250 mm)，流动相：甲烷磺酸；抑制型电导检测；流速1 mL·min-1；测量结果与国标方法(火焰原子收光谱法)进行方法学评价比较；应用配对t检验和Bland -Altman法对两种测量方法进行一致性评价。结果 两种方法的精密度分别为2.0%和0.7%，重现性分别为2.0%和7.96%，回收率分别为99.6%和89.8%，测量结果无显著性差异，配对t检验P>0.05；Bland-Altman法一致性评价的95%一致性界限为：(-1.514，1.487)，绝大多数差值都位于该区间内。结论 IC的重复性和回收率均优于AAS；Bland-Altman法综合判断两组数据具有高度的一致性。 |
| 关键词: 离子色谱法 原子吸收光谱法 钠含量 t检验 Bland-Altman法 一致性 |
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| 基金项目:“十二五”国家重大新药创制科技重大专项(2011ZX09102-009-09) |
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| Study on the Content of Sodium in Oligonucleotide Bulk Pharmaceuticals-Flutide |
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ZHONG Jie1,2, LI Baoshan1,2, ZHU Deling1,2, ZHANG Jinzhong1,2, SHI Mingzhu1,2, YIN Aijun1,2
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1.Hangzhou Tianlong Pharmaceutinal Co., Ltd., Hangzhou 310021, China;2.Institute of Junke Tianlong Materia Medical, Hangzhou 310021, China
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| Abstract: |
| OBJECTIVE To determine sodium content in oligonucleotide bulk pharmaceuticals by ion-chromatography and atomic absorption spectrophotometry. To evaluate the degree of agreement between measurements. METHODS Ion chromatography (IC) was carried out by using an Ion-pac CS12 column (4 mm×250 mm) with methanesulfonic acid as the mobile phase, suppressed conductivity detector, on Dionex ICS 900. The results was compared with atomic absorption spectrophotometry (AAS) method provided by national standard. By using paired t test and Bland-Sltman method to estimate consistency of two methods. RESULTS The two method results showed that the precision were 2.0% and 0.7%, the repeatability were 2.0% and 7.96%, the analytical recovery were 99.6% and 89.8% for ion-chromatography and atomic absorption spectrophotometry, respectively. The mean difference was -0.0136% with 95% confidence. CONCLUSION There is no significant difference compared with the national standard method-AAS. Moreover, the ion-chromatography method had demonstrated its superiority in repeatability and analytical recovery. |
| Key words: IC AAS sodium content paired t test bland-altman method the degree of agreement |
