小儿遗尿分散片的制剂处方筛选与α-细辛醚、β-细辛醚含量测定

Formula Optimization of Xiaoer Yiniao Dispersible Tablets and Content Determination of α-Asarone and β-Asarone in the Tablets

目的筛选小儿遗尿分散片的制剂处方和成型工艺,建立制剂中α-细辛醚、β-细辛醚含量测定的高效液相色谱法。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;采用高效液相色谱法测定制剂中α-细辛醚、β-细辛醚的含量,流动相为甲醇-水(60∶40),检测波长为257 nm,柱温30℃,流速1.0 mL/min。结果经最佳制备工艺制得的小儿遗尿分散片外观及口感良好,崩解时间小于60 s;经高效液相色谱法测定,α-细辛醚和β-细辛醚质量浓度分别在0.054～1.286 g/L,0.187～4.672 g/L范围内与峰面积积分值线性关系良好,平均回收率分别为101.48%和99.65%,RSD分别为1.07%和1.31%(n=6)。结论小儿遗尿分散片组方合理,制备工艺可行,所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 Xiaoer Yiniao Dispersible Tablets,and to establish an HPLC method for determination of α-asarone and β-asarone in the tablets.Methods The prescription of Xiaoer Yiniao Dispersible Tablets were optimized by parallel design technique,with disintegrating time,appearance and taste as the assessment index.The analytical column was packed with Hypersil ODS（250 mm×4.6 mm,5 μm） and performed at 30 ℃.The mobile phase was consisted of methanol-water（60 ∶40）.The flow rate was 1.0 mL/min.Results The dispersible tablets prepared fine in appearance and taste,disintegrated within 60 s.α-asarone and β-asarone were linear in the range of 0.054-1.286 g/L and 0.187-4.672 g/L respectively.The average recovery was 101.48%and 99.65%with RSD of 1.07%and 1.31%（n=6）,respectively.Conclusion The dispersible tablets were designed rationally and feasible to operate.HPLC method was simple,accurate and specific.