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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 screen formulation prescription and molding process of Zhikang orally disintegrating tablets, and establish HPLC method for determination of emodin and chrysophanol in preparations. Methods: Taking the formability, disintegration time and mouthfeel as indicators, the parallel design method was used to screen the best prescription. The content of emodin and chrysophanol in the preparation was determined by HPLC. The mobile phase was methanol-0.2% formic acid (82:18). The detection wavelength was 254 nm; the column temperature was 35° C. and the flow rate was 1.0 mL·min-1. RESULTS: The taste and taste of Zhikang orally disintegrating tablets obtained by the best preparation process were good, and they could disintegrate completely within 1 min. HPLC showed that the emodin and chrysophanol were linear from 0.100 5 to 0.201 0 μg, and 0.040 2 to 1.608 0 μg. The average recoveries were 99.44% and 98.18%, respectively. Conclusion: The composition of Zhikangkou disintegration tablet is reasonable and the preparation process is feasible. The established method of content determination is simple, accurate and specific.