复方樟柳碱注射液的稳定性研究

Study on the stability of compound anisodine injection

目的 :考察复方樟柳碱注射液的稳定性。方法 :依据质量标准考察外观、色泽 ,pH值 ,分解产物 ,无菌检查 ,澄明度和含量。结果 :本品在 6 0℃ 3d ,80℃ 1d和 40℃ 3个月分解产物不合格 ;室温考察 2年 ,各项结果均符合规定。结论 :本品对高温不稳定 ,需在 30℃以下贮存 ,贮存期为 2年。

Aim To study the stability of compound anisodine injection including causative factors test, accelerate test and room temperature deposited test.Methods All the tests were conducted according to the quality control standard.The content changes of compound anisodine injection were measured by high performance liquid chromatography(HPLC).The discompose products were checked by thin layer chromatography(TLC).The changes of pH,appearance and color,clarity and sterile of compound anisodine injection were measured.Results Discompose products of the injection failed to pass the quality control test after exposing it to the temperature of 40℃ for 3months;60℃for 5 days and 80℃for 1 day, while other tested items were within the quality control standard.Conclusion Compound anisodine injection is unstable under high temperature.The injection should be kept under 30℃.