苁蓉通便口服液质量标准研究

Study on Quality Standard of Congrongtongbian Oral Liquid

目的制定苁蓉通便口服液质量标准。方法采用TLC法对制剂中何首乌、枳实、肉苁蓉进行定性鉴别。用HPLC法对制剂中2,3,5,4′-四羟基二苯乙烯-2-O-β-D-葡萄糖苷进行含量测定。结果 2,3,5,4′-四羟基二苯乙烯-2-O-β-D-葡萄糖苷在1.224～2.856μg范围内有良好线性关系,r=0.9999,平均回收率(n=6)为98.01%,RSD为1.08%。结论本定性、定量方法简便、可靠、准确、专属性强,可作为苁蓉通便口服液质量控制的方法。

Objective To establish the method for quality control of Congrongtongbian Oral Liquid.Methods The presence of Radix Polygoni Multiflori,Fructus Aurantii Immaturus,Herba Cistanches was identified by TLC.The content of 2,3,5,4＇-tetrahydroxydiphenystibene-2-O-β-D-glucoside was determined by HPLC.Results The linear range of 2,3,5,4＇-tetrahydroxydiphenystibene-2-O-β-D-glucoside was 1.224～2.856μg（r=0.9999）.The average recovery（n=6） was 98.01%（RSD=1.08%）.Conclusion This method is simple,accurate and reliable.It can be used as a determination method for the quality control of Congrongtongbian Oral Liquid.