凝血酶冻干制剂冻干工艺选择研究

在对凝血酶精制、制剂配制、稳定剂选择和冻干工艺试验、冻干制剂稳定性等进行了一系列的试验之后,建立了凝血酶冻干制剂的活性单位检测方法,得到了凝血酶冻干制剂(速效局部止血药200 IU/m l和500 IU/m l)的试制结果。在选定的制造工艺条件下,连续生产三批,经甘肃省药品检验所检定结果,无菌试验合格,单位含量合格并相当于标示量的100%~140%,比活高于10 IU/mg,残余水份含量低于3%,制剂质量均达到2005版药典标准的要求。凝血酶冻干制剂的稳定性良好,37℃保存三个月后标示量下降在10%以内。

Studies on technological process of lyophilization for thrombin

This paper reported the studies on production process of lyophilized thrombin,including purification,formulation,stabilizer selection,lyophilization,and the stability of final preparation.Under the optimal manufacturing process,the tested results of continuous three batches of final preparations were in accordance with standard of thrombin in "Requirements for Pharmacopoeia of PRC" year 2005 edition.The thrombin content in the unit was 100%-140% of that originally indicated,the specific activity was more then 10IU/mg.Residual water was less then 3%.The quality of lyophilized preparation was stable,for which the indicated unit was decreased less than 10% after stored at 37℃ for three months.