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目的 :研究低分子量肝素在较高温度下pH降低及颜色变黄的原因。方法 :通过测定溶液电导率来确定低分子量肝素硫酸根与羧酸根比值 ,并与同类药物作比较。结果 :高温下低分子量肝素末端醛基转化为了羧基可能是其 pH降低的原因。结论 :低分子量肝素类制剂须在 30℃以下的室温 ,避光、避热保存 ,以保证其质量
OBJECTIVE: To investigate the reasons for the decrease of pH and color of low molecular weight heparin at higher temperature. Methods: The low molecular weight heparin sulphate to carboxylate ratio was determined by measuring the solution conductivity and compared with similar drugs. Results: The conversion of low molecular weight heparin terminal aldehyde groups to carboxyl groups at high temperature may be the reason for the decrease of pH. Conclusion: Low molecular weight heparin preparations must be below 30 ℃ room temperature, dark, heat preservation, to ensure its quality