Study On The Improvement Of Quality Standard Of Mongolian Medicine Naren Mandula

Objective:According to the theory of Mongolian medicine and the characteristics of clinical medicine,the QAMS and HPLC fingerprint mapping method were adopted to improve the quality standard of the common clinical compound Mongolian medicine,and the quality evaluation system of"multi-flavor drug-multiple component"as the index in line with the characteristics of Mongolian medicine was established.Methods:（1）Microscopic identification and thin layer chromatography were used to qualitatively identify Mongolian medicine Naren Mandula;（2）Using the high-performance liquid chromatography（HPLC）method,Using piperine as an internal reference,Establish the relative correction factor for gallic acid,ellagic acid,tarractin,and piperine(f_s/i),The content of five components was determined by multiple evaluation method QAMS and ESM,two methods are used as comparisons in the results,Using two different HPLC instruments and three different columns,Study the robustness of the established relative correction factors.（3）Check the appearance,character,moisture,disintegration degree,weight difference and loading difference according to Pharmacopoeia of China thewater-bindered pill inspection method（2020 Edition four General Rules0108）.（4）HPLC fingerprint method was used to analyze 12 batches of common peaks produced by different manufacturers.Results:（1）Through microscopic identification,it was found that the powder was yellow brown,and the characteristic microstructural contained in pomegranate,safflower,cassia bark,and teristus were identified.（2）TLC method is used to identify,Bibo,Yizhi,Honghua and Shiliu;In the chromatogram of the test product,the spots of the same color were displayed in the same position as the control medicinal materials,the negative control had no interference,the spots were clearly colored,the separation was good,and Rf was within the specified range.（3）Piperine as the internal standard to establish a test more evaluation method,determination of kernel in gallic acid,hydroxyl safflower yellow A,ellagic acid,cinnamon aldehyde and other four components of relative correction factor(f_s/i),RSD is less than 2%,using two different HPLC instruments and three different column,different column temperature,different flow rate to establish relatively positive factor durability,have good durability.The relative error（RE）of the QAMS and ESM methods is less than3%with less difference.（4）The general inspection items comply with the provisions of the water pill inspection method under the Chinese Pharmacopoeia（the fourth general Rules 0108 of the 2020 edition）.（5）19 common peaks were identified by HPl C fingerprint method,and 5 common peaks were identified.Conclusion:The microscopic identification method established in this experiment identifies the microscopic features of Mongolian medicine Na Ren Mandula and has the simple and reliable characteristics;The TLC method established in this experiment is exclusive and can be used for the qualitative identification of this preparation.In the first quantitative analysis and validation of the method,the stable,accurate,reliable and feasible method can be used for quantitative analysis of this preparation.The general inspection items for the preparation are in accordance with the Pharmacopoeia of China.