疏络片的质量标准研究  

Quality Standard of Shuluo Tablets

作　　者：林建昌[1] 邬伟魁 朱庄松[1] 刘丹静[1] 

机构地区：[1]广东省梅州市人民医院,广东梅州514031 [2]广东省梅州市食品药品监督检验所,广东梅州514071

出　　处：《今日药学》2014年第7期496-498,501,共4页Pharmacy Today

摘　　要：目的建立疏络片的质量标准。方法采用薄层色谱（TLC）法对浙贝母、延胡索进行定性鉴别。采用高效液相色谱（HPLC）法测定延胡索乙素的含量。色谱柱为SHIMADZU VP-ODS,流动相为乙腈-0.1%磷酸溶液（用三乙胺调节pH值至6.0）（40∶60）,流速为1.0 mL/min,柱温为30℃,检测波长为280 nm,进样量为10μL。结果 TLC斑点清晰、分离度好,各阴性对照无干扰。延胡索乙素在0.025~0.75μg范围内与峰面积呈良好的线性关系（r=0.999 9）;精密度、稳定性、重复性良好;平均加样回收率为96.27%,RSD=1.2%（n=6）。结论该方法操作简便、结果准确、专属性强,可用于疏络片的质量控制。Objective To study and revise the quality standard of Shuluo tablets. Methods Frititlaria thunbergii Miq and Tetrahydropalmatine in Shuluo tablets were identified by TLC method. The content of Tetrahydropalmatine was determined by HPLC. The separation was performed on a SHIMADZU VP-ODS column. The mobile phase was composed of acetonitriie- 0.1% phosphoric acid solution （adjusted the pH to 6.0 with triethylamine） （40：60）, the detection wavelength was 280 nm, the column temperature was 30 ℃, and the flow rate was 1.0 mL/min and sample loop volume being 10 μL.Results TLC identification method for Frititlaria thunbergii Miq and Tetrahydropalmatine was simple and feasible with strong specificity. The linear relation of tetrahydropalmatine was excellent within the range of 0.025-0.75 p,g （r = 0.999 9）, and the mean recovery was 96.27%, RSD = 1.2% （ n = 6）. Conclusion The method is simple and accurate. It can be used for the quality control of Shuluo tablets.

关 键 词：疏络片 延胡索乙素 高效液相色谱法 含量测定 

分 类 号：R285[医药卫生—中药学]