罗红霉素电子药膜的研制及其稳定性考察

目的 :制备罗红霉素电子药膜 ,建立测定罗红霉素电子药膜含量的方法 ,考察其膜剂稳定性。方法 :采用电热成膜法制备膜剂 ;含量测定采用高效液相色谱法 ,色谱柱为YWG -C18柱 ,流动相为乙腈 -甲醇 -0 .5 %乙酸铵 ( 10 0 80 60 ) ,检测波长为 2 35nm ;稳定性实验 ,采用 4 0℃、60℃、80℃为考察温度 ,以相对湿度 75 % (NaCl)和 92 .5 % (KNO3 )为考察湿度 ,于第 0、1、3、5、10d时取样测定罗红霉素含量。结果 :每片膜剂含罗红霉素 75mg ,重量差异限度小于 10 % ;高效液相色谱法加样回收率高 ,在 0 .3～ 1.7mg·ml- 1范围内 ,峰面积与浓度 (mg·ml- 1)呈良好的线性关系 ,r =0 .9998,平均回收率为 99.2 3% ,RSD为 0 .84 % ,日内、日间相对标准偏差均小于 2 % ,精密度较好 ,符合分析测试的要求 ;罗红霉素膜剂热稳定性良好 ,在高湿条件下罗红霉素含量几乎无变化。结论 :罗红霉素膜剂稳定性良好 ,含量测定方法简便 ,专属、重现性好

Preparation and stability observation of electron medicinal membrane of roxithromycin

OBJECTIVE To prepare electron medicinal membrane of roxithromycin. To develop a method for assay about electron medicinal membrane of roxithromycin and observe its stabilities.METHODS The electron medicinal membrane of roxithromycin was prepared with the electrothermic equipment.The content of roxithromycin was determined by HPLC.The analytical column was YWG-C₁₈ column.The mobile phase was a mixture of acetonitrile methanol 0.5% ammonium acetate(100:80:60), with the detection wavelength at 235 nm. The stabilities of electron medicinal membrane of roxithromycin was studied by determining the changes of roxithromycin contents by HPLC after subjected to high temperature and humidity test.RESULTS The dosage of membrane of roxithromycin is 75mg. Its difference degree of weight is below 10%.Precision and stability were fine. The linear correlation was observed from the concentrations of 0.3 to 1.7mg·ml^-1(r=0.9998). The average recovery was 99.23%. Resolution between roxithromycin and other peaks met the requirements. Thermal stabilities of electron medicinal membrane of roxithromycin is good. So is its moist stabilitie. CONCLUSIONS: Stabilities of electron medicinal membrane of roxithromycin is good.The method was convenient, selective and reproducible for assay about electron medicinal membrane of roxithromycin.