固体分散技术制备葛根素亲水凝胶缓释片

Preparation of Puerarin Hydrophilic Sustained-release Tablets Using Solid Dispersion Technology

采用固体分散技术制备葛根素亲水凝胶缓释片。先采用单因素实验制备葛根素固体分散体,然后通过正交试验考察HPMC的K4M型和K15M型的质量比m(K4M):m(K15M)(A),HPMC的质量分数(B),淀粉与乳糖质量比m(淀粉):m(乳糖)(C),淀粉与乳糖合计的质量分数(D)4个因素对葛根素亲水凝胶缓释片的影响。得到葛根素固体分散体的最佳制备工艺:以PEG4000为载体,药物与载体的质量比为1:6;葛根素亲水凝胶缓释片的最佳制备工艺为:HPMC的K4M型和K15M型质量比m(K4M):m(K15M)=1:2,HPMC的质量分数为片重的30%,淀粉与乳糖的质量比m(淀粉):m(乳糖)=1:3,淀粉与乳糖合计的质量分数为片重的40%。该缓释片处方合理,工艺可行,达到缓释的预期目的。

Puerarin hydrophilic sustained-release tablets were prepared using a solid dispersion method.A single factor experiment was prepared for puerarin,and orthogonal design was carried out to investigate the effect of the ratio of HPMC m（K4M） ： m（K15M）（A）,the mass fraction of HPMC（B）,mass ratio of starch and lactose m（starch） ：m（lactose）（C）,and total starch and lactose content（D） on puerarin hydrophilic sustained-release tablets.The optimal preparation method of puerarin solid dispersion was regarded PEG4000 as the carrier,and the quality of drug and carrier ratio as 1：6.The best preparation of puerarin hydrophilic sustained-release tablets was the ratio of HPMC m（K4M）：m（K15M） as 1：2,mass fraction of HPMC as 30%,mass ratio of starch and lactose m（starch） ：m（lactose） as 1：3,and total starch and lactose content as 40%.The prescription and technology of the sustained release tablets was reasonable,and achieved the desired objective of sustained-release.