Study On The Improvement Of Quality Standard And Material Basis Of Xue Niao Capsules

Objective:In order to establish the quality control standard of Palm kernel,establish the quality control indexes such as content determination and fingerprint,and improve the quality standard of Xue Niao capsules comprehensively.On the basis of this,we carried out spectrum – effect relationship research,defined its pharmacological basis initially,providing the reference for the quality and clinical application of Xue Niao capsules.Methods : Based on the existing pharmacopoeia and ministerial standards,the qualitative identification was carried out by thin layer chromatography,and the determination of the contents of the index components was established by high performance liquid chromatography to further consummate the quality standard of the Palm kernel and Xue Niao capsules.Considering the specificity of the components contained in the Xue Niao capsules and the preparation process,the fingerprints were established by HPLC and GC-MS,and the data of the two detection methods were normalized to fuse the fingerprints of Xue Niao capsules.By comparing to the reference substances and search the NIST2008 database to identify the typical components.Together with the main efficacy datas,the spectrum – effect relationship analysis was conducted by the bivariate correlation statistic methods which compare the Xue Niao capsules,the deficiency compound and the four parts fingerprints.Results:The quality of the finished product was controlled from the source of the medicinal materials,and the quality standard of the finished product was established.The thin layer identification methods of Palm kernel,smilax china,semen coicis were built and the main contents were determined by HPLC-UV and HPLC-ELSD.HPLC fingerprints and GC-MS fingerprints were established.HPLC chromatographic peaks belonged to the palm and smilax china,mainly concentrated in the n-butanol part,GC-MS fingerprints were part of the coix seed,mainly concentrated in the petroleum ether part;through the National Pharmacopoeia Commission "Chinese medicine chromatography fingerprint similarity evaluation System version 2.0 " for the integration of fingerprints,the establishment of the Xue Niao capsules fusion fingerprints.Compare the Zhendong Pharmaceutical and other manufacturers of Xue Niao capsules,apart from individual manufacturers,the similarity of remaining enterprises is 0.8 or even more,and detected 34 common peaks.Protocatechuic acid,catechins,chlorogenic acid,caffeic acid,polydatin,astilbin,engeletin,resveratrol and quercetin were identified by reference compounds.Some of the methyl esters such as Hexadecanoic acid,methyl ester;Hexadecanoic acid,ethyl ester;9,12-Octadecadienoic acid,methyl ester;9-Octadecenoic acid,methyl ester,(E)-;Octadecanoic acid,methyl ester;Linoleic acid ethyl ester;Ethyl Oleate;7,10-Octadecadienoic acid,methyl ester;Octadecanoic acid,ethyl ester;11-Eicosenoic acid,methyl ester;Eicosanoic acid,methyl ester;Docosanoic acid,methyl ester were identified by NIST2008 database search.s IgA,CD4 / CD8,IL-10,urinary creatinine and metabolites(choline,succinic acid,acetic acid)were correlated with GC-MS and HPLC fingerprints of Xue Niao capsules.The results showed that four parts of hematuria capsule had different emphasis on different indexes,and the four parts complement each other and play clinical effect.Conclusion: The thin-layer identification method is specific and easy to operate,the content determination methods of protocatechuic acid and resveratrol can control the quality of Palm kernel and smilax china effectively,glycerol trioleate content can be used to control Coix seed quality,the establishment of fusion-fingerprints reflect the overall characteristics of Xue Niao capsules comprehensively.The enhanced Xue Niao capsules quality standards can control the quality of finished products generally and guarantee the clinical efficacy.The association study showed that the Xue Niao capsules was incisive and the extraction process was reasonable and scientific.