Puzovic Marko, Hardy Gil
Croatian Institute of Transfusion Medicine, Pharmaceutical Department, Petrova 3, HR-10000 Zagreb, Croatia.
Curr Opin Clin Nutr Metab Care. 2007 May;10(3):311-7. doi: 10.1097/MCO.0b013e3280ebb427.
To examine the stability and compatibility of histamine H2-receptor antagonists in parenteral nutrition admixtures in order to provide well tolerated and effective therapy.
Many stability investigations were carried out before 2005, but no critical appraisal of published data has been undertaken. H2-receptor antagonists are stable in most parenteral nutrition admixtures for 2-48 h, with long-term stability up to 4 weeks claimed for a few combinations. Some earlier data are questionable in the light of more recent analytical technology and pharmaceutical knowledge regarding stability assessment. As stability is dependent upon the source of constituents, we have listed all products tested and their respective manufacturers. A general recommendation is made not to store H2-receptor antagonists in parenteral nutrition for more than 24 h at refrigerated temperature before use.
Administration of H2-receptor antagonists in parenteral nutrition admixtures has several clinical and economical advantages, but, in order for these benefits to be well tolerated and efficacious, the stability and compatibility of the drugs, as well as the parenteral nutrition components after mixing, have to be ascertained. Factors that influence stability are assessed, the need for more controlled study protocols is evaluated and recommendations are made for safe storage and administration.
研究组胺H2受体拮抗剂在肠外营养混合液中的稳定性和相容性,以提供耐受性良好且有效的治疗。
2005年之前进行了许多稳定性研究,但尚未对已发表的数据进行批判性评估。H2受体拮抗剂在大多数肠外营养混合液中可稳定存在2至48小时,少数组合声称长期稳定性可达4周。鉴于有关稳定性评估的最新分析技术和药学知识,一些早期数据存在疑问。由于稳定性取决于成分来源,我们列出了所有测试产品及其各自的制造商。一般建议在使用前,肠外营养中组胺H2受体拮抗剂在冷藏温度下储存时间不要超过24小时。
在肠外营养混合液中使用组胺H2受体拮抗剂具有若干临床和经济优势,但是,为了使这些益处具有良好的耐受性和有效性,必须确定药物以及混合后肠外营养成分的稳定性和相容性。评估影响稳定性的因素,评估对更严格研究方案的需求,并就安全储存和给药提出建议。