吴茱萸碱分散片及吴茱萸碱不同处理方法的溶出度测定

Determination of Dissolution of Evodiamine Dispersible Tablets and Evodiamine Been Processed by Different Methods

摘要:

目的: 测定吴茱萸碱分散片及吴茱萸碱经不同方法处理后的溶出度。 方法: 依据《中华人民共和国药典》2010年版溶出度测定法第二法(浆法),以1%SDS 900 mL为溶出介质,转速100 r·min^-1;制备吴茱萸碱-泊洛沙姆188固体分散体、吴茱萸碱超微粉及吴茱萸碱超微粉-泊洛沙姆188固体分散体,HPLC测定溶出度。 结果: 吴茱萸碱分散片45 min溶出度>60%;吴茱萸碱超微粉-泊洛沙姆188固体分散体体外溶出度较好。 结论: 建立的吴茱萸碱分散片溶出度测定方法简便、快速,可作为吴茱萸碱分散片的溶出度检测方法;吴茱萸碱几乎不溶于水,超微粉碎联合固体分散体技术能显著提高吴茱萸碱的溶出度。

Abstract:

Objective:To determine dissolution of evodiamine dispersible tablets and evodiamine which were processed by different methods. Method: According to the second dissolution method(slurry method) in 2010 edition 'Chinese Pharmacopoeia',1%SDS solution of 900 mL was used as dissolution medium,rotation speed was 100 r·min^-1,HPLC was as quantitative method to determine dissolution,evodiamine-poloxamer 188 solid dispersions,evodiamine ultrafine powder and evodiamine ultrafine powder-poloxamer 188 solid dispersions were prepared. Result: Ddissolution of evodiamine dispersible tablets was more than 60% at 45 min;Dissolution of evodiamine ultrafine-poloxamer 188 solid dispersions was higher than others. Conclusion: This established dissolution determination method of evodiamine dispersible tablets was simple and rapid,which could be as dissolution detection method of evodiamine dispersible tablets;Evodiamine was almost insoluble in water,but ultrafine grinding combined with solid dispersion technology could significantly improve dissolution of it.