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本文介绍高效液相色谱法分析结晶胰岛素作为制备注射剂的质量评价。 Waters色谱仪,附有紫外检测器(λ=220nm)。200×4毫米柱,填充5μm的Nucleosil C_(18)吸附剂。流动相为含有0.01M的1-丁基磺酸钠和0.1M的硫酸钠溶液的乙腈和pH3.0、0.005M的酒石酸盐缓冲液(29:71)的混合液。流速每分钟1cm~3。对照物用单组分胰岛素。分析时间为20分钟。图示由大型有角家畜和猪胃下腺制得的结晶胰岛素分离色谱(略)。两者结构上有所区别。比如由大型有角家畜胃腺得到的胰岛素,在肽链
This article describes the high performance liquid chromatography analysis of crystalline insulin as a preparation of injection quality evaluation. Waters chromatograph with UV detector (λ = 220 nm). 200 × 4 mm column packed with 5 μm Nucleosil C 18 adsorbent. The mobile phase consisted of a mixture of acetonitrile and 0.01 M sodium tartarate buffer (29:71) containing 0.01 M sodium 1-butanesulfonate and 0.1 M sodium sulfate solution. Flow rate 1cm ~ 3 per minute. Control with one-component insulin. Analysis time is 20 minutes. Crystalline insulin isolated chromatograms from large-horned livestock and porcine subgaps (omitted). The difference between the two structures. For example, the insulin produced by the glandular glands of large horned livestock is in the peptide chain