右旋布洛芬乳膏剂的制备及质量标准

Study on preparation and quality control of dexibuprofen cream

目的 研制以右旋布洛芬为主药的乳膏剂。方法 拟定处方组成与制备工艺 ,用高效液相色谱法测定含量 ,并进行稳定性试验。结果 处方设计合理 ,制备工艺可行 ,右旋布洛芬测定的标准曲线为c=- 37.6 6 +2 .81× 10 -4A ,r =0 .9986 ,平均回收率 10 0 .39% ,RSD =3.0 1%。结论 该乳膏剂处方合理 ,质量控制方法可靠。

OBJECTIVE To prepare dexibuprofen cream and establish its standard of quality control.METHODS The composition of recipe and manufacturing technique were designed.The content of dexibuprofen in preparation was determined by HPLC and its stability tests were carried out.RESULTS The designation of the recipe was reasonable,and manufacturing technique was feasible.The recovery of the assay was 100.39%.The stability tests of preparation showed not remarked change.CONCLUSION The preparation is rational in formula and the method of quality control was suitable.