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p H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p H以7～8为宜;甲泼尼龙琥珀酸钠进样量线性范围为0.01002～5.00800 mg·m L-1（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。
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 p H 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. p H 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 index of stability test. Conclusion： The preparation is feasible in technology, controllable and stable in quality.
出处
《中国药事》
CAS
2016年第8期808-814,共7页
Chinese Pharmaceutical Affairs
