目的：研究活性炭对注射用丁二磺酸腺苷蛋氨酸含量及澄清度与颜色的影响，为该制剂工艺研究中活性炭用量的选择提供科学依据。方法采用高效液相色谱法测定丁二磺酸腺苷蛋氨酸含量和紫外－可见分光光度法测定澄清度与颜色。结果随着活性炭用量的增加，药物的含量降低；当活性炭用量为0．05％时，溶液的澄清度与颜色有轻微的改善，但随着活性炭用量的增加，溶液的澄清度逐渐降低，颜色加深。结论注射用丁二磺酸腺苷蛋氨酸的活性炭适宜用量为0．05％，过量的活性炭加入可直接影响药品的质量。%Objective Tostudythe effect of activated carbon on the content,clarity and color of Ademetionine 1,4-Butanedisulfonate-forInjectionin order toprovidescientific basis for the selection of concentration of activated carbon.Methods HPLC was adopted to measure the content of Ademetionine 1,4-Butanedisulfonate.Ultraviolet-visible spectrophotometry was used for the examination of its clarity and color.Results The content of active ingredientwas reduced with the increase inconcentration of activated carbon.The clarity and color of the solution was slightly improved when the concentration of activated carbon was 0.05%,but the clarity became turbidand the color was deepenedwith the increase inconcentration of activated carbon.Conclusions The suitable concentration of activated car-bon for Ademetionine 1,4-Butanedisulfonate for Injection was 0.05%,and excessive use of activated carbon may affect the pharmaceu-tical preparation’s quality directly.
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