溴吡斯的明注射液的制备及其含量测定

Preparation and assay of pyridostigmine bromide injection

目的:研究溴吡斯的明注射液的处方及制备工艺,并建立高效液相色谱法检测溴吡斯的明注射液的含量。方法:以稳定性为指标,筛选处方。采用十八烷基硅烷键合硅胶色谱法检测溴吡斯的明注射液的含量。结果:本品最适pH值为4.5～5.5。溴吡斯的明在150～350μg.mL-1范围内具有较好的线性关系,相关系数r=0.999 9,平均回收率为(99.79±0.69)%,精密度及稳定性均较好。制备的3批样品的含量分别为100.12%,99.98%和99.99%。结论:本品处方设计合理,工艺可行,质量稳定。所建立的高效液相色谱法可用于溴吡斯的明注射液含量的测定,且方法简便、准确。

Objective：To develop an injection formulation and to establish the assay method of pyridostigmine bromide injection. Methods ： The stability of the injection was used as an indicator for development of the formulation. Pyridostigmine bromide in injection was assayed using HPLC method. Results ： The optimum pH for the injection formulation was 4.5 - 5.5 according to the stability. Linear range for measurement of pyridostigmine bromide was from 150μg·mL^-1 to 350μg·mL^-1（ r = 0. 999 9） , and the average recovery was （99.79 ± 0.69） % （ n = 6 ）. The contents of three batches of pyridostigmine bromide were 100.12% ,99. 98% and 99.99% respectively. Conclusion：The developed injection formulation was stable and suitable for industrial production. The assay method is rapid, simple, and accurate.