脂康口崩片的制剂处方筛选及大黄素、大黄酚的含量测定

Formula Optimization of Zhikang Orally Disintegrating Tablets and Assay of Emodin and Chrysophanol in the Tablets

目的:筛选脂康口崩片的制剂处方和成型工艺,建立制剂中大黄素及大黄酚含量测定的HPLC法。方法:以成型性、崩解时限和口感为指标,采用平行设计法筛选最佳处方。采用HPLC测定制剂中大黄素和大黄酚的含量,流动相甲醇-0.2%甲酸(82∶18);检测波长254 nm;柱温35℃;流速1.0 mL·min-1。结果:经最佳制备工艺制得的脂康口崩片外观及口感良好,在1 min内能崩解完全。HPLC测定大黄素及大黄酚分别在0.100 5～0.201 0μg,0.040 2～1.608 0μg线性关系良好,平均回收率分别为99.44%和98.18%。结论:脂康口崩片组方合理,制备工艺可行,建立的含量测定方法简便、准确,专属性好。

Objective： To optimize the formulation and preparation process of Zhi-kang orally disintegrating tablets,and establish an HPLC method for determination of emodin and chrysophanol in the tablets.Method：The prescription of Zhi-kang orally disintegrating tablets were optimized by parallel design technique,with disintegrating time,appearance and taste as the assessment index.The analytical column was packed with Kromasil C18（200 mm × 4.6 mm,5 μm） and performed at 35 ℃.The mobile phase was consisted of methanol-0.2% formic acid（82∶ 18）.The flow rate was 1.0 mL.min-1.Result：The tablets prepared were fine in appearance and taste,disintegrated within 1 min.Emodin and chrysophanol were linear in the range of 0.100 5-0.201 0 μg and 0.040 2-1.608 0 μg respectively.The average recovery was 99.44%（emodin） and 98.18%（chrysophanol）.Conclusion： The disintegrating tablets were designed rationally and feasible to operate.HPLC assay was simple,accurate and specific.