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机构地区:[1]北京市药品监督管理局西城分局,北京100032 [2]北京儿童医院,北京100045 [3]北京市药品监督管理局,北京100053
出 处:《中国中医药信息杂志》2007年第7期49-50,共2页Chinese Journal of Information on Traditional Chinese Medicine
摘 要:目的测定白细咳喘膏中芥子碱硫氰酸盐的含量,为制定该制剂的质量标准奠定基础。方法采用HPLC法,色谱柱:DIKMA inertsil(pH=3,5μm,250mm×4.6mm);以乙腈为流动相A,以3%醋酸溶液为流动相B,按比例进行梯度洗脱;检测波长:326nm;流速:1.0mL/min;柱温:室温。结果线性范围为0.8~4.0μg(r=0.9996,n=5),平均回收率100.83%,RSD=1.95%(n=5)。结论该法快速、简便,重现性和稳定性良好,可用于该制剂的质量控制。Objective To determine the content of Sinapine thiocyanate in the Baixi Kechuan Cream by HPLC and to lay foundation for establishing the quality control standard of the preparation. Methods The HPLC system consisted of the column of DIKMA inertsil (pH=3, 5 pm, 250 mm×4.6 mm). The acetonitrile and 3% acetic acid were used as the mobile phase A and B, respectively, and gradient elution was used. The detective wavelength was 326 nm and the flow rate was 1.0 mL/min. The column temperature was room temperature. Results The method was linear within the range of 0.8~4.0μg (r=0.9996, n=5). The average recovery was 100.83%, and RSD=l.95% (n=5). Conclusion The method is quick, simple, highly reproductive and steady, and it can be used for quality control of the preparation.
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