多索茶碱胶囊的制备及含量测定

目的制备多索茶碱胶囊并建立含量测定方法。方法以多索茶碱为主要成份制备胶囊剂，并用高效液相色谱法测定含量。结果采用全粉末填充工艺成功制备出多索茶碱胶囊，含量测定方法学验证结果表明主药进样浓度在10．2～81．6μg／mL范围内，峰面积与浓度呈良好的线性关系，线性方程为A=30151C＋59420（R=0．9999），平均回收率100．6％，RSD=1．1％。测定的精密度良好，样品溶液在24h内稳定（RSD=0．5％），色谱条件和处理方法耐用性良好。结论该胶囊的制备方法可行，含量测定方法操作简单，准确快速，可用于多索茶碱胶囊的含量测定。

Preparation of Doxofylline Capsule and Determination of the Content

Objective To prepare doxofylline capsules and establish the method of content determination. Methods Doxofylline was the mainly component for capsules preparation. The content was determined by HPLC. Results Doxofylline capsules were prepared by powder filling process successfully. A good linear relationship was found when the sample concentration was 10.2-81.6（μg/mL）. The linear equation was A= 30151 C＋ 59420（R= 0.9999）. The average recovery of the low, middle and high concentration was 100.6% and RSD was 1.1%. The method has good precision and the liquid of sample was stable in 24 hours （RSD=0.5%）. The durability of condition and processing method of HPLC were good. Conclusions The capsule preparation method was feasible. The content determination method was simple, rapid and accurate for doxofylline capsules.