宁肤露的质量标准研究

Study on the quality standards of Ningfulu

目的：建立宁肤露的质量控制新方法,以提高其质量标准。方法：采用TLC法,以环己烷-丙酮（9∶1）为展开剂对樟脑作定性鉴别。采用HPLC法,以甲醇-水（65∶35）为流动相,在240nm处测定醋酸地塞米松含量;以乙腈-0.01mol/L Na2HPO4水溶液（20∶80,用磷酸调pH为3.6）为流动相,在297nm处测定水杨酸含量。采用非水滴定法测定醋酸氯己定含量。结果：樟脑的TLC鉴别法专属性良好,显色清晰。醋酸地塞米松、水杨酸、醋酸氯己定分别在5.25～52.50μg/ml（r=0.999 8）、6.30～201.76μg/ml（r=0.999 9）、0.10～0.50g（r=0.999 6）范围内线性关系良好,平均回收率分别为（100.61±1.16）%、（98.66±1.02）%和（98.72±0.58）%（n=9）。结论：本研究建立的方法准确、灵敏,重现性好,可用于宁肤露的质量控制。

Objective： To establish a new method for the quality control of Ningfulu,in order to improve its quality stand ards. Methods：With cyclohexane-acetone （9 ： 1） as the eiuent,camphor was identified by thin layer chromatography（TLC） method. The content of dexamethasone acetate was determined by HPLC method at the wavelength of 240 nm with methanol- water （65 ： 35） as mobile phase. The content of salicylic acid was determined by HPLC method at the wavelength of 297 nm with acetonitrile-0.01 mol/L Na2 HPO4 solution（20 ： 80, the pH was adjusted to 3.6 with phosphoric acid） as mobile phase. The content of chlorhexidine acetate was determined by nonaqueous titration. Results.. The TLC method for the identification of camphor was accurate and spots color was clear. The levels of dexamethasone acetate, salicylic acid and chlorhexidine acetate were in good linear within the range of 5.25-52.5 μg/ml（r：0. 999 8）,6.30-201.76 μg/mt（r=0. 999 9）,0.10-0.50 g （r= 0.999 6）,respectively. The average recoveries were （100. 61±1.16）%,（98. 66±1.02）% and （98. 72±0.58）%（n=9）, respectively. Conclusion： The established method was accurate, sensitive, with reproducible detection results and could be used for the quality control of Ningfulu.