复方海螵蛸泡腾片的鉴别含量溶出度测定实验研究  

Experimental Study of Identification Content and dissolution of Compound Endoconcha Sepiae Effervescent Tablets

作　　者：栾中山[1] 迟强[1] 车凯[1] 邵全胜[1] 周虎[1] 李俗军[1] 

机构地区：[1]中国人民解放军第215医院药械科,辽宁大连116041

出　　处：《解放军药学学报》2003年第1期29-31,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的　建立复方海螵蛸泡腾片的化学鉴别、含量测定、溶出度测定方法 ,以控制该药的制剂质量。方法　应用化学鉴别法、薄层层析法对所含中药成分进行鉴别。采用HPLC法对所含阿莫西林、甲硝唑进行鉴别试验及含量测定 ,流动相为磷酸盐缓冲液 (pH5 .0 ) -乙腈 (96∶4 ) ;流速为 1ml/min ;检测波长为 2 5 4nm。用药典方法对药物的溶出度进行测定。结果　化学鉴别碳酸钙和延胡索中的生物碱反应为 (+) ,甘草与对照品甘草次酸钠薄层层析结果相符。含量测定 :阿莫西林的标准曲线方程为 :A1=1.6 34× 10 5C - 6 .2 4 2× 10 3 ,r =0 .9997(n =5 ) ;甲硝唑的标准曲线方程为 :A2 =1.2 19× 10 5C +1.5 6 1× 10 3 ,r =0 .994 6 (n =5 ) ;两者在 2 .5～ 30 μg·ml-1范围内线性关系良好。甲硝唑的平均回收率为 98.7% ,RSD 1.4 7% ,阿莫西林的平均回收率为 98.3% ,RSD0 .6 9%。结论　本文建立的三项检查方法 ,快速、简便 。Aim To establish some methods for identification,determination and dissolution of Compound Endoconcha sepiae Effervescent Tablets to control the quality of the product.Methods Chemical reactions and TLC were used to identify the traditional medicine constituents.Amoxicillin and Metronidazole in the tablets were identified and determined by HPLC,Phosphate buffer solution (pH5.0)-acetonitrile (96∶4) was used as mobile phase.The flow rate was 1ml/min.The detective wavelength was 254nm,and the dissolution was determined according to Chinese Pharmacopoeia.Results Chemical reactions to calcium carbonate and alkaloids in Corydalis bulbosa were positive.Radix Glycyrrhizae has the same spot as Glycyrrhetinic acid in the TLC.The calibration curve for Amoxicillin was A1=1.634×10 5C-6.242×10 3,r=0.999 7(n=5);The calibration curve for Metronidazole was A2=1.219×10 5C+1.561×103,r=0.994 6 (n=5).The peak areas were linear to their concentrations in the range of 2.5～30μg·ml -1 .The average recovery of Metronidazole was98.7%,RSD=1.47%.The average recovery of Amoxicillin was 98.3%,RSD=0.69%.Conclusion The above three methods were rapid and simple,which could be used in the quality control of this product.

关 键 词：实验研究 复方海螵蛸泡腾片 阿莫西林 甲硝唑 HPLC 中药 

分 类 号：R286.0[医药卫生—中药学]