Study On Improving The Quality Standard Of Shufeng Qingre Capsules

Objective:Improving the quality standard of Chinese traditional compound medicine Shufeng Qingre capsules was studied in this experiment.Microscopic identification of Bombyx batryticatus and TLC identification of Menthae haplocalycis herba and Scrophularia radix were revised in the original drug standard of Shufeng Qingre capsules.The characteristic map of the preparation was established,and the content of five anthraquinones was determined by method of QAMS,and the general formulation inspection of the preparation was carried out.That provides a reference for the establishment of a comprehensive,simple and controllable quality standard for Shufeng Qingre capsules.Methods:In the preparation,Bombyx batryticatus was used as raw powder for microscopic identification.Therefore,the microscopic characteristics with strong specificity and high microscopic examination rate were selected as inclusion criteria.According to the principles of traditional Chinese medicine composition,on the basis of the original standard,optimize the extraction method and inspection method of Scrophularia radix and Menthae haplocalycis herba,and record the chromatograms.The characteristic map of Shufeng Qingre capsules were established by high performance liquid chromatography with gradient elution.Using the map comparison method,the relative retention time was used as a parameter to identify the common peak components and trace the sources of the drugs.Using method of QAMS,Emodin was used as an internal standard to establish a relative correction factor with Aloe-emodin,Rhein,Chrysop hanol,and Physcion,and the durability of method was examined.When positioning the chromatographic peaks,the accuracy of the two methods of relative retention and control extract was investigated.The method was compared with the results of the external standard method.Two methods were compared to verify the rationality and feasibility of QAMS.According to the four items in the Pharmacopoeia,the capsules under the capsules were examined for the Shufeng Qingre capsules,and the microbial detection method used was verified.Since the antibacterial component may inhibit the growth of microorganisms,in order to make the microbiological examination accurately reflect the microbial contamination of the preparation,it is necessary to verify the method to ensure the accuracy of the determination method.Results:The selected microscopic features of Bombyx batryticatus can be accurately distinguished under the microscope;in the thin layer chromatogram,the spots of the test sample were consistent with the reference substance,the separation effect is good,and the negative control has no interference.The established HPLC characteristic map method has a resolution greater than 1.5 between the peaks,and the RSD values of the relative retention time and relative peak area precision,repeatability and stability test results are less than 2.0%.Nine peaks with a peak area greater than 5000 and good repeatability were selected as characteristic peaks.By matching with the mixed reference and the negative control chromatogram,the peaks and components of each characteristic peak were confirmed.The peak retention time of the No.2 peak habagsin was deter mined,and it was determined that it was the reference peak to locate other components.The relative correction factors of aloe-emodin,rhein,chrysophanol and emodin were established with emodin as internal reference,and the durability was investigated.The results of different influencing factors were averaged to determine the emodin and each.The relative correction factors of the components were 0.67,1.05,0.67,and 0.69,respectively.The rhubarb reference material was used as a random control to locate the chromatographic peak,and the chromatographic peak was completely consistent with the control.Comparing the measured values of the four components in the 10 batches with the calculated values of the multi-assay method,the relative errors of the two methods were less than 5.0%.Ten batches of samples were tested with different water loading and disintegration time limit,and the water content ranged 4.45%～5.03%.The labeled loading amount of the sample is 0.35 g.According to the loading difference calculated by the measured loading,the maximum value is 2.4%,and the minimum value is-1.14%.The disintegration time limit ranges 18 minutes.The bacterial count method and the control bacteria test method in the microbiological examination confirmed that the ratio of 5 species of bacteria,such as staphylococcus aureus,ranged 0.83 ～ 0.91.Conclusion:Microscopic identification of hyphae and undigested mulberry leaf tissue is unique to Bombyx batryticatus,with strong specificity.TLC method is simple and feasible method feature maps is reasonable,The chromatographic peaks in the characteristic spectrum were derived from three medicinal materials of Rhubarb,Curcuma longae rhizoma and Scrophularia radix,which comprehensively reflected the overall characteristics of the preparation.The multi-evaluation method simultaneously measures the content of five components,which can effectively and accurately control the active components of the sample.The moisture content is less than 9%,the difference in loading is with in ±10%,and the sample disintegration time is within 30 minutes.These test items are conformed to requirement of pharmacopoeia.The microbial count exa mination method verified that the ratio of colony number of five test bacteria were all within the range of 0.5～2,so the method of plate was used to carry out microbial limit examination on Shufeng Qingre capsules.