奥沙利铂静脉输液处方工艺优化及其稳定性考察-中国药房.PDFVIP

奥沙利铂静脉输液处方工艺优化及其稳定性考察 1＊ 2# 2 2 苏晨霞 ，李健和 ，易利丹 ，彭六保 （1.湖南新化县孟公镇中心卫生院，湖南娄底 417605；2. 中南大学湘雅二 医院药学部，长沙 410011） 中图分类号 R943；R979.1 文献标志码 A 文章编号 1001-0408（2013）13-1201-04 DOI 10.6039/j.issn.1001-0408.2013.13.17 摘 要 目的：制备奥沙利铂静脉输液，并考察其稳定性。方法：分别以葡萄糖和甘露醇为等渗调节剂，优化处方中奥沙利铂和甘 露醇的用量、pH 值调节剂类型及药液的pH 值；确定制备工艺并进行质量考察；采用高效液相色谱法测定奥沙利铂和有关物质含 量，氧化还原滴定法测定甘露醇含量；影响因素试验、加速试验和长期试验考察其稳定性。结果：以甘露醇调节等渗的奥沙利铂静 脉输液稳定性良好，最佳处方为：奥沙利铂1.0g ，甘露醇51g ，5％草酸溶液适量调节药液pH 值至3.0～4.5，灭菌条件为116℃热压 灭菌40min ；质量考察pH 值、渗透压、热原、无菌等均符合规定，奥沙利铂、甘露醇含量分别为99.85％、100.48％，有关物质含量为 0.23％；恒温加速试验6个月和长期留样试验12个月，除在光照、高温60 ℃条件下pH 值略有升高、有关物质有所增加（但仍在＜ 1.0％的合格范围内），以及高温60 ℃条件下颜色略有加深外，其他指标均无明显变化。结论：该制剂处方合理，制备工艺简便可 行，质量可控，稳定性良好。 关键词 奥沙利铂静脉输液；处方；工艺；优化；有关物质；含量测定；稳定性 Optimization of Formulation and Technology of Oxaliplatin Intravenous Infusion and Its Stability Study 1 2 2 2 SU Chen-xia ，LI Jian-he ，YI Li-dan ，PENG Liu-bao （1.Menggong Township Center Hospital of Xinhua Coun- ty of Hunan Province ，Hunan Loudi 417605，China ；2.Dept. of Pharmacy ，The Second Xiangya Hospital of Cen- tral South University ，Changsha 410011，China ） ABSTRACT OBJECTIVE ：To prepare Oxaliplatin intravenous infusion ，and to investigate its stability. METHODS ：Using glu- cose and mannitol as isoosmotic adjusting agents ，the amount of oxaliplatin and mannitol ，types of pH adjusting agent and pH val- ue of infusion were optimized. Preparation technology was determined and the quality of preparation was investigated. The contents of oxaliplatin and related substances were determined by HPLC ，and the content of mannitol was determined by oxidation-reduction titration. The stability of preparations was investigated by using influence factors test ，accelerated test and long-term test. RE- SULTS ：Adjusted with mannitol ，isoosmotic Oxaliplatin intravenous infusion was stable. Optimal formulation was as follows