| ObjectiveBasing on clinical application,we select the efficacy index to optimized the Qige Yangwei granules in the prescription prescription proportion,and optimized its best extraction and formation techniques.Finally,under the optimization results,the prescription of Qige Granules was carried out to prepare granules.At the same time,in order to control the quality of Qige Granules,we has established the qualitative identification and quantitative analysis of index components to control the quality of Qige Granules,as well as its fingerprint was established.It is good to more comprehensive quality assessment and provide scientific basis for clinical drug safety.It would provide a theoretical basis for the further development of the preparation.Methods1.In this study,we select the damage of alcohol-induced gastric mucosa as model,which is commonly efficacy in anti-gastric mucosal injury.In order to obtain the best prescription of Qige granules gastric mucosal lesion scores,content of AstragalosideⅣ and puerarin were used to comprehensive study Qige Granules,which its pharmaceutical composition in different proportions and pharmacodynamics of anti-gastric mucosal lesions.Finally,obtaining the best optimum formula of Qige Granules.2.According to the composition of drug Qige granules in the physical and chemical characteristics as well as the drug contained the main effective components.By orthogonal test,with the content of Astragaloside IV and Puerarin were comprehensive evaluation as the index to optimize the extraction process.The particle forming rate,melting rate,moisture absorption,moisture content as the index,the ratio of material selection and dosage of particles,the best process parameters were used to obtain Qige granules.At the same time.it would provide the basis for the further development of the preparation.3.We selected the particle forming rate,melting rate,moisture absorption,moisture content as the index,the ratio of material selection and dosage of particles,the optimum parameters of molding process for Qige granules,provide the basis for the further development of the preparation.4.In accordance with the requirements of the stability of preparation of the Pharmacopoeia of the People’s Republic of China which was Edited in 2010.We investigated the stability of Qige granules,including the influencing factors test,accelerated test and long-term test5.The traditional Chinese medicine fingerprint technology was used to establish the fingerprint of Qige granules.In order to determine the correlation peaks,the common peaks were calibrated using the control of the goods and the peak components identified with single herbs of comparison.6.A method of "spectrum efficiency"was establish,whiah is related to the multivariate statistical analysis mathematical methods:correlation analysis,gray correlation degree analysis,to investigate the correlation between the different formula of Qige liquor and gastric mucosal injury score and preliminary study of Qige granules on gastric mucosal injury of active substance.7.Using the technology of UPLC/Q-TOF-MSE to analysis the the chemical composition in Qige granules.According to retention time,accurate molecular weight,molecular fragment peak and control product information and related literature,the chemical structure for inference and identification,the Qige granules of chemical compositions clarified.These results lay a foundation for the Qige granules in the studies of pharmacodynamic material basis and quality control.Results1.Macroscopic observation showed that the surface of the gastric mucosa damage by orthogonal test in rats is lighter than the model group;the statistical results showed that:compared with the gastric mucosal injuried score group group 1～9 orthogonal experimental gastric mucosal injuried with the model group,respectively.There was significant difference by comparing with gastric mucosal injuried score of between each othergroups of 1,2,3,4,6,7 and fifth group(P<0.05).There was significant difference(P<0.05)by comparison of gastric mucosal injuried score of between each othergroups in the 1,2,4 groups and the ninth groups were compare with model group,there were significant differences(P<0.05).2.Through the statistical analysis of the experimental results of the orthogonal test group,to optimize the extraction process of Qige Yangwei granules and the statistical analysis of paste and other auxiliary material type,proportion of the investigation results,we could infer the optimal molding process of Qige Yangwei granules.3.We has establish the method of TLC to identify Qige Yangwei granules which in prescription of Astragalus and Radix Puerariae.At the same time,we has established a method for determination the content of Astragaloside Ⅳ,Puerarin with Qige Yangwei granules,their linear equation is lgy=1.303x+3.383,r = 0.9993,0.48μg～4.8μg,the average recovery was 102.01%,RSD was 2.79%(n=6),puerarin linear equation isy = 2.20 × 106x +8.88 × 105,r =0.9998,0.416μg～2.08μg,the average recovery was 99.33%,RSD%was 2.30%(n=6).4.the experimental results show that the stability of Qige Yangwei granules under high humidity,high temperature,strong light irradiation stability,accelerated test and long-term stability test the Qige Yangwei granules were stable under the experimental conditions in the study within the stipulated time.5.We has established Qige Yangwei granules fingerprint analysis method,and identified 12 characteristic peaks from the 10 batches of samples with 20 common peaks,what’s more,we has the belonged peaks by compared with standard substance.10 batches of samples in 0.9～1.0 between similarity,which showedthat the fingerprint established in this experiment the method has good specificity,stability and reproducibility.6.The result of correlation analysis showed common peaks 5,7,10,13,15,16,17,19,20,21,22 and gastric mucosal injury score a negative correlation,besides,grey correlation statistical results showed that the total peak correlation degree was greater than 0.8.It is indicated that the common peaks in the certain degree has protective effect on gastric mucosa.7.With the rapid separation of UPLC and the accurate relative molecular mass spectrometry data and literature data analysis,41 compounds including flavonoids,saponins and saponins were identified in the Q-TOF-MS.Conclusion1.This experiment successfully prepared Qige raise gastric particles,as well as the extraction process,molding process is reasonable,simply and stable physicochemical property.It is suitable for mass production of Qige granules.2.The establishment of TLC method for the Astragaloside and Puerarin Radix and the content of AstragalosideⅣ and Puerarin determination method were showed good specificity,strong applicability.We can infer that it is suitable for the quality control of Qige Yangwei granules.3.This research showed that the established of Qige granules fingerprint has good specificity,reproducibility,precision,stability what’s more,the common peaks have good separation and fully reflect the overall characteristics of Qige Yangwei granules information.It is indicated that the Qige granules fingerprint could be used to evaluate the quality of Qige Yangwei granules.The effect of spectral analysis results show that the common peaks has protective effect on damage of 5,7,10,13,15,16,17,19,20,21,22 on the gastric mucosa,which infer the total peak is probably Qige granules in protecting gastric mucosa of pharmacodynamic substance.Therefore the establishment of Qige granules fingerprint can be used to control the quality of Qige granules.4.This method is rapid,accurate,sensitive,and short detection time,which provides a rapid and accurate,practical and reliable technical method for the identification and quality control of Qi Ge granule. |
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