消炎止痒洗剂的质量标准提高研究

Study on a quality specification standard of Diminishing Inflammation and Relieving Itching Lotion

目的对消炎止痒洗剂的质量标准进行再提高研究。方法采用薄层色谱法增加对本品处方中的功效成分薄荷进行了鉴别,以正己烷-乙酸乙酯(8.5∶1.5)为展开剂展开。应用高效液相色谱法增加对本品处方中的功效成分黄连中的四种主要成分的含量测定,以乙腈-0.05 mol/L磷酸二氢钾溶液为流动相,在345 nm下检测。结果采用薄层色谱法进行鉴别,其结果特异性强,重现性良好;采用高效液相色谱方法进行含量测定,其精密度,重现性,稳定性实验RSD不大于3%,表明方法学良好,并符合《中国药典》(2010年版附录ⅥD)中高效液相色谱法的要求。结论本项研究可作为日后消炎止痒洗剂的质量标准再提高的依据。

Objective To improve study quality standards of Diminishing Inflammation and Relieving Itching Lotion.Methods Efficacy of prescription composition mint was identified by TLC.The n-hexane,ethyl acetate （8.5∶1.5） as spread solvent was selected.The four kinds of active principle of Coptis chinensis was assayed by HPLC.In this method,345 nm was selected as the detection wavelength,the mobile phase was acetonitrile-0.05 mol/L monopotassium phosphate.Results The result of TLC method had the advantages of high specificity,reproducibility and stability.The RSD of precision and reproducibility didn＇t reach 3%.The assaying by HPLC accord with Appendix Ⅵ D of Chinese Pharmacopeia （2010 edition）.Conclusion The research will be pursuant of quality standard of Diminishing Inflammation and Relieving Itching Lotion.