丹参注射剂中丹参酮Ⅱ_A的含量测定及贮存期的预测

The Determination of the Contents of Tanshinone Ⅱ_A and Prediction of the Shelf-life of Danshen Injection

本文通过建立丹参注射剂中丹参酮ⅡA含量测定的高效液相色谱方法,并考察丹参注射液和丹参粉针剂两种剂型的贮存期.采用以丹参酮ⅡA为指标成分,经典恒温法,预测和比较了丹参注射液和丹参粉针剂的贮存期.结果表明,丹参酮ⅡA的含量随温度升高和时间延长逐渐下降.经典恒温法测定得丹参注射液中丹参酮ⅡA贮存期0.43年,其在粉针剂中贮存期可达2年以上.故制备中药冻干粉针的方法可以提高中药注射剂有效成分稳定性,延长有效期.

Objective：To establish a HPLC method for determination of the content of tanshinone ⅡA in Danshen injection and estimate the shelf-lifes of Danshen injection and Danshen injectable powder.Methods： Taking tanshinone ⅡA as target,the shelf-lifes of Danshen injection and its injectable powder were compared by classical isotermal method.Results：The content of tanshinone ⅡA was gradually decreased while temperature rising and time prolonging.The result showed the shelf-life of Danshen injection was only 0.43 years,while the period of validity of its powder for injection could be above two years.Conclusion： Preparing lyophilized powder could increase the compounds stability and extend its shelf-life.The result suggests the potential use of the lyophilized powder for improving the stability of tanshinone ⅡA.