白英总碱质量标准研究

Studies on quality standard of total alkaloids from Solanum lyratum

目的建立白英总碱的质量标准。方法采用薄层色谱法进行定性鉴别;按照《中国药典》2015年版通则规定,对白英总碱水分、总灰分、有机溶剂残留、重金属及砷盐含量进行检查;采用紫外分光光度法及高效液相色谱法对白英总碱含量进行测定。结果薄层色谱斑点清晰、分离较好;白英总碱中水分≤9%,总灰分≤3%,重金属含量≤10 mg/kg,砷盐含量<0.004%,苯、甲苯、(邻、间二甲苯)、对二甲苯、正已烷依次不得过9.82×10-6、7.29×10-6、1.42×10-5、1.76×10-5、1.71×10-5;紫外分光光度法测定白英总碱含量不低于50%,高效液相色谱法测定白英总碱含量不低于35%。结论该方法准确可靠,重现性好,所建标准具有可行性,能有效控制白英总碱药品质量。

Objective To establish the quality standard of total alkaloids from Solanum lyratum(TAS).Methods The main component in the sample was identified by thin-layer chromatography(TLC).According to the methods described in the general principles of Chinese Pharmacopoeia(2015 edition),content of moisture,total ash,residue of organic solvent,heavy metal and arsenic salt content was analyzed.The content of TAS was measured by two methods,UV spectrophotometry and HPLC.Results TLC spots were well-separated.The limit of moisture,total ash and arsenic salt in TAS must be no more than 9%,3%,0.004%,respectively,and the limit of heavy metal must be no more than 10 mg/kg.The limit of benzene,toluene,(oxylene and meta-xylene),paraxylene,n-hexane in TAS must be less than 9.82×10-6,7.29×10-6,1.42×10-5,1.76×10-5,1.71×10-5,respectively.The content of TAS was no less than 50%when examined by UV spectrophotometry,and was no less than 35%when examined by HPLC.Conclusion The established quality control method is feasible and reliable,which could be used to assess the quality of TAS comprehensively.