复方槲皮素乳膏的制备和质量控制∗

摘要

目的：研究复方槲皮素乳膏的制备,并建立其质量控制方法。方法拟定处方组成与制备工艺,用高效液相色谱法测定浓度,并进行稳定性实验。结果该制剂呈黄色细腻乳膏。槲皮素在0.053~1.696μg 范围内线性关系良好(r =0.9999),8-甲氧补骨脂素(8-MOP)在0.053~1.696μg 范围内线性关系良好(r=0.9998),倍他米松在0.100~1.000μg 范围内线性关系良好(r=0.9999),处方量槲皮素、8-MOP 和倍他米松的平均回收率依次为99.83%、99.52%和99.74%(n=9)。3批制剂样品经过12个月的长期稳定性考察,各项指标均符合要求。结论该制剂处方组成合理,制备工艺可行,制剂质量稳定可控。%Objective To study the preparation of quercetin compound cream and establish its standard of quality control. Methods The composition of recipe and manufacturing technique were designed.The content of components were determined by HPLC,and its stability tests were carried out.Results The product was a kind of yellow smooth cream.The linear ranges were 0.053-1.696 μg for quercetin(r=0.999 9),0.053-1.696 μg for 8-methoxypsoralen(r=0.999 8)and 0.100-1.000 μg for beta-methasone(r=0.999 9).The average recovery rate were 99.83%,99.52%,and 99.74% of quercetin,8-methoxypsoralen,and beta-methasone(n=9).After 12 months′long term stability test,all the 3 batches of sample preparations were in line with relevant regu-lations.Conclusion The designed recipe was reasonable,and the manufacturing technique was feasible,with stable and controllable quality.