依维莫司分散片的制备及质量考察

摘要

OBJECTIVE To prepare everolimus dispersible tablets and establish a method for its quality control.Method:The everolimus dispersible tablets were prepared by the technique of solid dispersions and the fluid-ized-bed.The content, related substance and dissolution of the everolimus dispersible tablets were determined by HPLC,and its quality control method was established.RESULTS The everolimus dispersible tablets could com-pletely disintegrate within 1 minute,and the dispersible uniform was excellent,and its dissolution was more than 85%with 45 minutes.A good linear relationship was obtained in the range of 100~1200μg・ mL-1 with the average re-covery of 99.26%( RSD=0.52%) .The dissolution sample showed a good linear relationship at a range of 1.0~12.0μg・ mL-1 with the average recovery of 100.32% ( RSD=0.67%) .CONCLUSIONS The preparing tech-nique of the everolimus dispersible tablets is simple.The quality control method is accurate,and its quality meets the requirements of Pharmacopoeia.%目的：制备依维莫司分散片并建立其质量控制方法。方法用固体分散技术和流化床技术制备依维莫司分散片，采用高效液相色谱法测定其含量、有关物质和溶出度，建立依维莫司分散片质量控制方法。结果依维莫司分散片在1 min内全部崩解，分散性均匀，45 min溶出达85％以上。在高效液相色谱法含量测定中，依维莫司在100～1200μg・ mL －1范围线性良好，平均回收率为99．26％，RSD为0．52％；在溶出测定中，依维莫司在1．0～12．0μg・ mL －1范围线性良好，平均回收率为100．32％，RSD为0．67％。结论本品制备工艺简单，质量控制方法准确，质量符合药典要求。