注射用甲泼尼龙琥珀酸钠的制备及质量研究-中国药事.PDFVIP

808 中国药事 2016 年 8 月 第 30 卷 第 8 期 注射用甲泼尼龙琥珀酸钠的制备及质量研究 贾元超，彭怡星 （江苏奥赛康药业股份有限公司，南京 211112） 摘要 目的：制备注射用甲泼尼龙琥珀酸钠，对其进行质量研究，并考察其稳定性。方法：通过溶液稳 定性考察、辅料筛选及不同 pH 值的考察，确定注射用甲泼尼龙琥珀酸钠的处方组成和制备工艺；采用 高效液相色谱法测定其含量及有关物质，并对制剂进行了加速和长期条件稳定性考察。结果：制备条件 以 15℃为宜，处方中选用乳糖为赋形剂，其与主药用量比为 25 ∶ 40，中间体溶液的 pH 以 7 ～ 8 为宜； -1 甲泼尼龙琥珀酸钠进样量线性范围为 0.01002 ～ 5.00800 mg·mL （r ＝ 0.9999，n ＝ 7）；低、中、高 浓度平均回收率为 99.26％、99.24％、99.15％，RSD 分别为 0.30％、0.20％、0.34％。稳定性考察期内 各指标未见明显变化。结论：该制剂处方工艺可行，质量可控，稳定性较好。 关键词： 注射用甲泼尼龙琥珀酸钠；制备；质量研究；稳定性；高效液相色谱法 中图分类号：R943 文献标识码：A 文章编号： 1002-7777(2016)08-0808-07 doi:10.16153/j.1002-7777.2016.08.012 The preparation and Quality Study of Methylprednisolone Sodium Succinate for Injection Jia Yuanchao, PengYixing (Jiangsu Aosaikang Pharmaceutical Co.Ltd., Nanjing 211112, China) Abstract Objective: To prepare methylprednisolone sodium succinate for injection, study the quality and investigate its stability. Methods: The preparation technology and formulation of methylprednisolone sodium succinate for injection were confirmed by solution stability study, excipients and pH value selection. The contents and related substance of methylprednisolone sodium succinate were determined by HPLC. Meanwhile, the stability of accelerated test and long-term sample observation test were investigated. Results: The preparation temperature was maintained within 15℃, and lactose was used as excipient, ratio of which to main component was 25 : 40. pH value of intermediate solution was 7~8. The linear range of methylprednisolone sodium succinate was 0.01002~5.008μg (r=0.9999 n=7). The average recovery rates of low medium high concentration were ， ， ， 99.26％, 99.24％ and 99.15 ％, RSD were 0.30％, 0.20％ and 0.34 ％, respectively. No obvious changes were observed in each ind