注射用骨瓜提取物与不同注射液的配伍研究

摘要

目的 考察注射用骨瓜提取物与0.9％氯化钠注射液,5％葡萄糖注射液,10％葡萄糖注射液和葡萄糖氯化钠注射液配伍后的稳定性,为临床选择合适的溶媒提供依据.方法 按照临床常用剂量,将注射用骨瓜提取物加入到灭菌注射用水中作为对照组.将注射用骨瓜提取物分别与0.9％氯化钠注射液,5％葡萄糖注射液,10％葡萄糖注射液和葡萄糖氯化钠注射液配伍,作为实验组.分别在0、0.5、1、2、4、8h时测定溶液的pH值,检测溶液的澄明度,依据《中国药典》2015版四部不溶性微粒检查法测定不溶性微粒.结果 注射用骨瓜提取物在0.9％氯化钠注射液中,澄明度和pH值符合规定,不溶性微粒数符合要求,可以选用0.9％氯化钠注射作为注射用骨瓜提取物的溶媒.在5％葡萄糖注射液,10％葡萄糖注射液和葡萄糖氯化钠注射液中,≥10 μm的不溶性微粒数均超过《中国药典》2015版规定,澄明度和pH值符合规定.结论 注射用骨瓜提取物选用0.9％氯化钠注射液作为药物溶媒,在临床应用过程中,应慢速滴入,观察患者情况.%Objective To research the compatibility of Cervus and Cucumis polypeptide for injection combined with different injections and to provide favorable experimental basis for the clinical application of the Cervus and Cucumis polypeptide for injection.Methods According to the current dosage of clinical medicine,the Cervus and Cucumis polypeptide for injection was added to the sterilized water for injection as control group.Cervus and Cucumis polypeptide for injection was added to 0.9％ sodium chloride injection,5％ and 10％ glucose injection and glucose-sodium chloride injection as experimental group.The combination solution change of color,pH value,and the number of particles were reseached at 0 h,0.5 h,1 h,2 h,4 h,8 h which were detected by the method specified in China Pharmacopeia (2015 edition,No 4).Results The Cervus and Cucumis polypeptide for injection combined with the 0.9％ sodium chloride injection solution at different time was light yellow liquid,The pH value remained stable and the number of particles was conforms to the 2015 edition of China Pharmacopoeia standards.The numbers of≥10μm particles exceeded the limitation of China Pharmacopoeia after combinee with 5％ and 10％ glucose injection and glucose-sodium chloride injection.There were no significant changes in clarity and pH value.Conclusion The most suitable solvent compatibility for Cervus and Cucumis polypeptide for injection was 0.9％ sodium chloride injection.In the clinical application,the transfusion must be slowly infusied and close observation should be given to the patients.