苦黄注射液成品输液稳定性研究

苦黄注射液成品输液稳定性研究
李宵;支旭然;吴茵;李倩;李颖;董占军
【期刊名称】《医药导报》
【年(卷),期】2017(036)011
【摘要】Objective To investigate the compatibility and room light' s influence on Kuhuang injection diluted by 5%glucose,10% glucose, and fructose for injection within 48 hours at room temperature. Methods Kuhuang injections( high or low dosage) were diluted by 3 solutions at room temperature and were divided into light-exposed group and light-screening group. Stability were then studied by changes of appearance, pH value, particulates, contents of matrine and sophocarpine in the solutions. Results The Kuhuang injection solution remained clear within 48 hours, showing no obvious turbidity, sedimentation or change of appearance ( deep yellow clear solution ) . The pH of the low concentration group with 10% glucose injection exposed to room light in creased significantly at 6 h,which was less stable than the light-screening group.The particulate content was acceptable according to regulation. The Kuhuang injection compatibility solution with fructose injection changed into weak acidic pH, and the particulate content did not meet regulation criteria in the high concentration group. The contents of matrine did not change, while the contents of sophocarpine decreased in each group.Sophocarpine seemed more stable in the light-screening group than in the light-exposed group.
Conclusion The fructose injection was not suitable as the solvent for Kuhuang injection.The solutions are more stable if protected from light, and should be used as early as possible to reduce the degradation of some effective components.%目的考察苦黄注射液最大剂量、最小剂量与5%葡萄糖注射液、10%葡萄糖注射液、果糖注射液配伍后的成品输液于室温下放置48 h的稳定性,以及室内光照对成品输液的影响.方法将苦黄注射液按最大剂量、最小剂量与3种溶媒配伍,分为室内光照组与遮光组,考察各成品输液于室温下放置48 h的外观、不溶性微粒、pH值、苦参碱与槐果碱含量.结果各成品输液在48 h均澄清,无明显浑浊、沉淀,颜色无明显变化,为深黄色澄清溶液;低浓度室内光照组10%葡萄糖注射液成品输液pH值在6 h显著升高,遮光组较室内光照组稳定,果糖注射液成品输液呈弱酸性;高浓度组果糖注射液成品输液24 h后微粒值不符合规定,其余组微粒值48 h内符合规定;各成品输液中苦参碱含量基本保持不变,槐果碱含量逐渐降低,遮光组较室内光照组稳定.结论果糖注射液不适合作为苦黄注射液的溶媒,成品输液由配制到输注遮光较稳定,且应尽早使用,以减少有效成分降解.
【总页数】6页(P1309-1314)
【作者】李宵;支旭然;吴茵;李倩;李颖;董占军
【作者单位】河北省人民医院药剂科,石家庄 050051;河北省人民医院药剂科,石家庄 050051;河北省人民医院药剂科,石家庄 050051;河北省人民医院药剂科,石家庄050051;河北省人民医院药剂科,石家庄 050051;河北省人民医院药剂科,石家庄050051
【正文语种】中文
【中图分类】R286;R969
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