复方樟脑乳膏稳定性试验研究

Study on stability of Compound Camphor Cream

目的 考察复方樟脑乳膏的稳定性。方法 以岛津液相色谱柱(4.6 mm×150.0 mm,5μm),甲醇∶0.2%磷酸水溶液∶乙醚(60∶38∶2)为流动相,波长239 nm下用高效液相色谱法对复方樟脑乳膏中醋酸曲安奈德进行了定量测定。同色谱条件下按照《中华人民共和国药典》标准分别进行高温、强光、加速和长期试验。同时采用薄层色谱法对复方樟脑乳膏中的樟脑、薄荷脑进行定性鉴别。结果 醋酸曲安奈德在0.23~1.15μg呈良好的线性关系(r=0.999),精密度RSD为0.19%,稳定性RSD为0.12%,重复性RSD为0.09%,平均回收率为100.05%,RSD为0.95%(n=9)。乳膏中的樟脑、薄荷脑薄层色谱斑点清晰,Rf值适中,阴性无干扰。本品在高温(40±2)℃、强光(4 500±500)Lx下放置10 d,该制剂外观、性状、含量均符合规定,经加速试验、长期试验该制剂质量稳定。结论复方樟脑乳膏具有良好的稳定性。

Objective To study the stability of Compound Camphor Cream.Methods Triamcinolone acetate in Compound Camphor Cream was determined by high performance liquid chromatography with methanol∶0.2%aqueous phosphate∶ether(60∶38∶2)as mobile phase,shvmadzu chromatographic column(4.6 mm×150 mm,5μm)at a wavelength of 239 nm.High temperature,strong light,acceleration,and long-term tests were carried out under the same chromatographic conditions according to the Chinese pharmacopoeia standards.Thin layer chromatography was used to identify camphor and menthol in compound camphor cream.Results Triamcinolone acetate showed a good linear relationship(r=0.999)between 0.23-1.15μg,RSD of precision were 0.19%,RSD of stability were 0.12%,RSD of repeatability were 0.09%,average recovery was 100.05%,RSD of 0.95%(n=9).The thin layer chromatographic spots of camphor and menthol in the cream were clear,Rf value was moderate,negative without interference.The product was placed at high temperature(40±2)℃and strong light(4500±500)Lx for ten days.The appearance,character and content of the preparation all met the regulations.The quality of the preparation was stable after accelerated test and long-term test.Conclusion Compound Camphor Cream has good stability.