参梅养胃颗粒质量标准的研究  

Quality standard for Shenmei Yangwei Granules

作　　者：陈镭[1] 郭青 

机构地区：[1]南京中医药大学,江苏南京210000 [2]江苏省食品药品监督检验研究院,江苏南京210000

出　　处：《中成药》2016年第6期1279-1284,共6页Chinese Traditional Patent Medicine

摘　　要：目的建立参梅养胃颗粒（蒲公英、甘草、土木香等）的质量标准。方法 TLC法鉴定蒲公英和甘草,HPLC法定性分析土木香内酯和异土木香内酯,并定量测定丹参素钠和芍药苷的含有量。结果 TLC鉴定专属性强,阴性无干扰。4批样品未检出蒲公英,6批未检出甘草,3批未检出土木香内酯。丹参素钠和芍药苷分别在40.5～506.25μg（r=1.000）和50.19～627.38μg（r=0.999 5）范围内线性关系良好,平均回收率分别为97.16%和99.83%,RSD分别为1.51%和0.62%（n=6）。两者平均含有量分别为4.560 mg/袋和12.191 mg/袋,每袋含丹参和白芍不得少于3.5 mg和9.4 mg。结论该方法简便准确,专属性强,可为参梅养胃颗粒质量标准的建立提供参考。而且,统一工艺制备的12批样品均符合相关要求。AIM To establish the quality standard for Shenmei Yangwei Granules（Taraxaci Herba,Glycyrrhizae Radix et Rhizoma,Inulae Radix,etc.）.METHODS TLC was applied to identifying T.Herba and G.Radix.HPLC was used for the qualitative analyses of alantolactone and isoalantolactone,and quantitative determination of salvianic acid A sodium and paeoniflorin.RESULTS Free from interference from the negative reference,the TLC identification displayed its good specificity.T.Herba was not detected in four batches of samples,G.Radix was not found in six batches,and there existed no alantolactone in three batches.Salvianic acid A sodium and paeoniflorin showed good linear relationships within the ranges of 40.5-506.25 μg（r = 1.000） and 50.19-627.38 μg（r = 0.999 5）.The average recoveries were 97.16% and 99.83% with the RSDs of 1.51% and0.62%（n = 6）,respectively.The average contents of these two constituents were 4.560 mg/bag and12.191 mg/bag,while the content limits of Salviae miltiorrhizae Radix et Rhizoma and Paeoniae Radix Alba were suggested no less than 3.5 mg/bag and 9.4 mg/bag,respectively.CONCLUSION This simple,accurate and highly specific method can contribute to the establishment of quality standard for Shenmei Yangwei Granules.In addition,twelve batches of samples prepared by unified technology meet the related requirements.

关 键 词：参梅养胃颗粒 蒲公英 甘草 土木香内酯 异土木香内酯 丹参素钠 芍药苷 

分 类 号：R927.2[医药卫生—药学]