20％抗坏血酸注射液处方改进及稳定性预测

Improvement of 20% ascorbic acid injection and prediction of its stability

用正交试验法筛选了20%抗坏血酸注射液的较优处方。在该处方中,以甲醛合次硫酸氢钠作抗氧剂,乙二胺四乙酸二钠为螯合剂,用碳酸氢钠调节pH值在6.4～66之间。用单点测定法对该注射液的贮存期进行了预测,结果贮存期约为5年。

The better recipe of 20% ascorbic acid injectionwas selected with orthogonal test. We used rongaliteas an antioxgen agent, and EDTA-Na_2 as a chelator.The pH value was adjusted to 6.4～6.6 with bicar-bonate sodium (NaHCO_3). To determine the stabilityof the injection, we predicted the shelflife by single-point determination. The shelflife of the injectionwas found to be more than five years.