Erxieting Granules To Perfecting And Upgrading Of Quality Standards

1 Objective For better control of the product quality of Erxieting Granules,At the same time,strengthen the quality control of the medicinal herbs Rubiae Cordifoliae,We improve the quality standard of Erxieting Granules and Herba Rubiae Cordifoliae.2 Methods Herba Rubiae Cordifoliae was studied in the aspects of character,identification,extract and content.A High Performance Liquid Chromatography(HPLC)method was developed to establish the specific chromatogram of Herba Rubiae Cordifoliae.HPLC–QAMS was used to detect the content of glycyrrhizic acid and liquiritin.Identification of Herba Rubiae Cordifoliae and Fructus mume was revised by thin layer chromatography(TLC),and glycyrrhiza's identification was added.The study of the characteristics,identification,extractives,and content of Herbal Rubiae Cordifoliae.And the method of HPLC is constructed specific chromatograms.3 Results In Erxieting granulas,the contents of glycyrrhizic acid and liquiritin were detected by a HPLC method.The content ranges of liquiritin was 0.25 ~3.97 mg/g,and that of glycyrrhizic acid was 5.57~10.24 mg/g.Therefore,for each bag(1g/bag),the total contents of glycyrrhizic acid and liquiritin should be not less than 2.8mg.In the Herba Rubiae Cordifoliae,the contents of rutin were detected by HPLC,and the mean value was 0.0501%,which determined rutin content in Herba Rubiae Cordifoliae should be not less than 0.01%.Specific chromatogram,used rutin as the reference peak,contains six common peaks,and the relative retention times were 0.15,0.30,0.45,0.55,0.63 and 1.00,respectively.Moreover,according to the measured results of 19 batches of samples and technical requirements of Chinese pharmacopoeia,the error ranges of relative retention time were tentatively less than ±5%.4 Conclusion A HPLC was established to measure the contents of liquiritin and glycyrrhizinic acid in Erxieting granula,simultaneously.The method has a good specificity,precision,repeatability and accuracy that meet the requirements.Also,the revised and added TLC method exhibited good specificity with clear spots,which could effectively control the quality of product.The method for detecting rutin content in Herba Rubiae Cordifoliae is stable and reliable,and easily to be conducted,which issuitable for measuring rutin levels in Herba Rubiae Cordifoliae.The establishing specific chromatogram showed representative peaks with good precision,repeatability and stability.Furthermore,the specific peaks in constructed chromatogram of Herba Rubiae Cordifoliae were comprehensively displayed,accurately located,and its precision,stability as well as repeatability is good that can effectively evaluate and control the quality of Herba Rubiae Cordifoliae.