复方茶多酚膜剂的制备和质量控制

Prepartion and quality of the compound tea polyphenols film

目的:制备复方茶多酚膜剂。方法:以茶多酚和木糖醇为主药制备复方茶多酚膜剂,采用高效液相色谱法测定主药的含量,对制备的膜剂进行质量控制。结果:该膜剂性质稳定,符合制剂要求,用HPLC法测定含量,茶多酚和木糖醇分别在0.024～0.144 mg.mL-1和0.012～0.072 mg.mL-1范围内线性关系良好,平均回收率分别为98.30%和99.75%,RSD分别为1.01%和0.76%。结论:该膜剂制备工艺简单,质量可靠,可供临床使用。

OBJECTIVE To investigate the preparation of compound tea polyphenols film.METHODS The main drug was tea polyphenols and xylitol.A HPLC method was established for the determination of mian drug and the quality control of the preparation.RESULTS The film was stabile.The prepared film met the pharmaceutical requirements.The linear range of tea polyphenols was 0.024-0.144 mg·mL-1 with average recovery of 98.30%（RSD=1.01%）（n=9）,The linear range of xylitol was 0.012-0.072 mg·mL-1with average recovery of 99.75%（RSD=0.76%）（n=9）.CONCLUSION Perparation and prescription design process is feasible.It can be used in clinic.