龟鹿二仙口服液质量标准研究

Quality Standards Research on Guiluerxian Oral Liquid

目的:通过对龟鹿二仙口服液的质量标准进行再研究,建立更简便易操作的定性、定量方法,提高产品的质量标准。方法:采用薄层色谱法(TLC)对龟鹿二仙口服液中龟甲、鹿角、党参、枸杞子进行定性鉴别;采用高效液相色谱法(HPLC)对甜菜碱进行含量测定,以丙基酰胺键合硅胶为填充剂,以乙腈-水(80∶20)为流动相,用蒸发光散射检测器检测,理论板数按甜菜碱峰计算应不低于4000。结果:薄层鉴别均斑点清晰,阴性对照无干扰。结论:建立的方法操作简便、专属性强、重复性好、结果准确,可作为龟鹿二仙口服液的质量控制标准。

Objective: To establish simple and convenient methods for qualitative and quantitative analysis of Guiluerxian oral liquid,and improve the quality standard of the product. Methods: The qualitative identification of Testudinis Carapax et Plastrum,Saigae Tataricae Cornu,Salviae Miltiorrhizae Radix et Rhizoma,Lycii Fructus were carried out by TLC.The content of betaine was determined by HPLC. Results: The TLC spots were clear with no interference. Conclusion: The established methods are simple and convenient,and be used for the quality control of Guiluerxian oral liquid.