In vitro compatibility and stability of admixtures containing etoposide, epirubicin hydrochloride and vindesine sulphate in a single infusion bag
In vitro compatibility and stability of admixtures containing etoposide, epirubicin hydrochloride and vindesine sulphate in a single infusion bag
复制标题
单输液袋中含有依托泊苷、盐酸表柔比星和硫酸长春地辛的混合物的体外相容性和稳定性
DOI：
10.1111/jcpt.13007
复制
发表时间：
2019-09-17
影响因子：
2
通讯作者：
Sun, Yan
中科院分区：
文献类型：
--
作者：
Li, Jiafei;Yao, Chong;Sun, Yan
依托泊苷、盐酸多柔比星、硫酸长春新碱、环磷酰胺和泼尼松（EPOCH）化疗方案治疗复发或难治性非霍奇金淋巴瘤有效。然而，长春新碱和盐酸多柔比星毒性相对较大，分别导致神经毒性和心脏毒性。在这项研究中，我们取代这些药物与长春地辛和盐酸表阿霉素，以减少心脏毒性，并评估了混合物含有这些药物沿着依托泊苷在一个单一的输液袋在体外。方法采用外观、pH值、微粒数等指标对混合物进行评价。采用高效液相色谱法测定各混合物中依托泊苷、盐酸表吡鲁胺和硫酸长春地辛的浓度和降解速率。结果和讨论在0.9%NaCl注射液中混合临床相关浓度的依托泊苷、盐酸表柔比星和硫酸长春地辛时，未发生沉淀。此外，在制备后24小时内，溶液中混合物的Δ pH值为≤ 10和≥ 25 μ m，符合USP标准。在实验过程中，依托泊苷、盐酸依匹林和硫酸长春地辛在25 ° C下在混合物中保持其初始浓度的>96%。当在0.9% NaCl注射液中混合时，依托泊苷、盐酸表吡格雷和硫酸长春地辛相容，并且当储存在输液袋中时，混合物可稳定至少24小时。什么是新的和结论这种体外分析表明，我们的新的混合物含有毒性较低的药物等效物在一个单一的输液袋用于临床应用的适用性。
What is known and objectives The etoposide, doxorubicin hydrochloride, vincristine sulphate, cyclophosphamide and prednisone (EPOCH) chemotherapy regimen is effective in patients with relapsed or refractory non-Hodgkin's lymphoma. However, vincristine and doxorubicin hydrochloride are relatively toxic, leading to neurovirulence and cardiotoxicity, respectively. In this study, we replaced these drugs with vindesine and epirubicin hydrochloride to reduce the cardiotoxicity and evaluated admixtures containing these drugs along with etoposide in a single infusion bag in vitro. Methods The appearance and pH of the admixtures were evaluated, and the number of particles was detected. High-performance liquid chromatography was used to measure the concentration and degradation rates of etoposide, epirubicin hydrochloride and vindesine sulphate in each admixture. Results and discussion No precipitation occurred when mixing clinically relevant concentrations of etoposide, epirubicin hydrochloride and vindesine sulphate in a 0.9% NaCl injection solution. Furthermore, the delta pH of the admixtures was = 10 and >= 25 mu m) in the solutions over the 24 hours post-preparation period met USP standards. Etoposide, epirubicin hydrochloride and vindesine sulphate were retained at >96% of their initial concentrations in the admixtures at 25 degrees C over the course of the experiment. Etoposide, epirubicin hydrochloride and vindesine sulphate are compatible when mixed in a 0.9% NaCl injection solution, and the admixtures are stable for at least 24 hours when stored in infusion bags. What is new and conclusion This in vitro analysis indicates the suitability of our novel admixtures containing less toxic drug equivalents in a single infusion bag for clinical application.