胃乐宁片的质量标准  

Quality standards for Weilening Tables

作　　者：毕春洋 李国源[1] 李俊松[1,2] 陈坤 狄留庆[1,2] 郭青 

机构地区：[1]南京中医药大学药学院,江苏南京210023 [2]江苏省中药高效给药系统工程技术研究中心,江苏南京210023 [3]南京老山药业有限公司,江苏南京211811 [4]江苏省食品药品监督检验研究院,江苏南京210000

出　　处：《中国医院药学杂志》2017年第2期142-145,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:建立胃乐宁片的质量标准。方法:采用TLC法对胃乐宁片中腺苷、氨基酸类成分(亮氨酸、缬氨酸、苏氨酸、甘氨酸、组氨酸)进行定性鉴别;HPLC法测定腺苷含量,色谱柱为Kromasil 100-5 C18柱(4.6×250 mm,5μm),流动相为乙腈-水(5∶95),流速为1.0mL·min-1;检测波长为260 nm;柱温为30℃;进样量为20μL。结果:薄层色谱斑点清晰,样品与对照药材和对照品在相应的位置上,分别显示相同颜色的荧光斑点;腺苷在1.27~20.32μg·mL-1范围内呈良好的线性关系,R2=1.0000,平均加样回收率(n=6)为101.77%,RSD为1.61%。结论:建立的分析方法简便、准确,重复性好,可用于胃乐宁片的质量控制。OBJECTVIVE To establish the quality standards for Weilening Tables. METHODS Adenosine and amino acids （including leucine, valine, threonine, glycine, histidine） were identified by thin-layer chromatography（TLC）, and the content of adenosine was determined by high performance liquid chromatography （HPLC） on the column of Kromasil 100-5 C18 （4.6×250 mm,5μm） with the mobile phase of acetonitrile-water （5：95） at the flow rate of 1.0 mL.min-1, the detection wavelength at 260 nm, the temperature at 30 ℃ and the volume of 20μL. RESULTS The TLC spots developed were clear, samples were in the corresponding positions with the reference herb and the reference substance, respectively. Adenosine showed good linear- ity in the range of 1.27-20. 32 μg.mL-1 （R2 = 1. 000 0）. The average recovery of adenosine was 101.77% and the RSD was 1.61% （n = 6）. CONCLUSION The established methods are simple, accurate and reproducible, and can be used to control the quality of Weilening Tablets.

关 键 词：胃乐宁片 质量标准 腺苷 氨基酸 TLC HPLC 

分 类 号：R927.2[医药卫生—药学]