Study On Quality Control Methods Of Jingfukang Tablet

Objective: Establish the methods of thin layer chromatography for Chinese medicine herbs identification,chinese medicine herbs HPLC deter-mineation and the HPLC fingerprint of Jingfukang tablet,so as to controlthe quality of the product.Methods:1 The chemical control substance and the traditional Chinese medic inecontrol medicine were used to identifiy the various medicinal material-s in the preparation by thin layer chromatography.The stable,controlled and the feasible methods were selected into the quality standard.2 The contents of puerarin,paeoniflorin were detected by HPLC.The final chromatographic conditions of puerarin were described below:Kromasil C18(4.6×250mm,5?m)column,acetonitrile-water-glacial acetic acid(11:89:1)as mobile phase,the speed of 1.0ml/min,detection wavelength of 250 nm,Colu-mn temperature of 35?,injection volume of 10?l;The fin-al chromatographic conditions of paeoniflorin were described below:Kromasil C18(4.6×250 mm,5?m)column,acetonitrile-water(14:86)as the mobile phase,the speed of 1.0ml/min,detection wavelength of 230 nm,Columnc temperature of 35?,injection volume of 10?l.3 The fingerprint of Jingfukang tablet was established by HPLC.The final chromatographic conditions for the fingerprint analysis were as follows: Kromasil C18(4.6×250mm,5.0?m)column,methanol-water as mobile phase,by gradient elution way,the speed of 1.0ml /min,detection wavelength of 270 nm,column temperature of 25?,injection volume 20?l;The fingerprints of 12 batches of Jingfukang tablets were analyzed by ? the Chinese Pharmacopoeia Fingerprint Similarity Evaluation System(2004A)? which was used in traditional Chinese medicine injection,and the HPLC control fingerprint was established.Results:1 Multi-flavor Chinese herbal medicines were identified by the thin layer chromatography and the methods were established,including Notopterygium,Pueraria,Gentiana,Salvia,Radix,Paeoniae Alba,Radix Astragali,Codonopsis,cork 8 chinese herbal medicines.Methodological results show that the identification methods were stable,with strong specificity,the tested sample spots were obvious,clearly visible,the separation between the spots was good,Negative samples were not interfered with the detection of other chinese herbal medicines.2 HPLC methods were established for the determination of puerarin and paeoniflorin in Jingfukang tablet.The linear intervals of puerarin and paeoniflorin were 1.202~ 24.04?g/m L,7.63~152.6?g/ml,The average recovery rate of puerarin was 99.5%,RSD was 0.86%(n=9)and The average recovery rate of paeoniflorin was 97.3%,RSD was 0.93%(n=9).3 A total of 22 common chromatographic peaks were identified in the cocalibration mode,and puerarin,3-hydroxy puerarin,3-methoxy puerari n,genistin,daidzin,paeoniflorin,Flavonoid glycoside and gentiopicroside wer e identified.The similarity of the fingerprints of 12 batches of Jingfukan g tablet Fingerprints were similar to that of the control fingerprints.The similarities of 12 batches of Jingfukang tablets were more than 0.99.Conclusion: The methods of thin layer chromatography identificatio-n,HPLC quantitative determination and HPLC fingerprint analysis were simple,stable,reproducible and strongly specific,which can provide scientif-ic basis for effectively and comprehensively evaluating and controlling quality of Jingfukang tablet.