Studies On The Improvement Of Quality Standard Of Ultrafine Granular Powder Of Astragali Radix

Objective In 2011,the standards for 62 kinds of Ultrafine Granular Powder(UGP)were established,and subsequently approved as the standards for UGP in Guangdong province,which mainly includes thin-layer identification,content determination and microscopic identification.Howewer,with the more systematic and in-depth research on UGP.it is recognized that the quality standards established before need to be further improved.This research with Astragali Radix UGP as object.through quality evaluation research to enhance and improve the original quality standards.establish a new Astragali Radix UGP quality standards,to be more scientific and systematic characterization of Astragali Radix UGP of authenticity,to improve its effectiveness,safety,stability and controllability of level,It provides reterence for the research and improvement of quality standard of other UGP.Method1.Multiple batches of Astragali Radix UGP were tested,review quality evaluation index of Astragalus in the "Chinese pharmacopoeia" is applied to Astragali Radix UGP,to verify Astragali Radix UGP quality whether meet the "Chinese pharmacopoeia" in Astrogali Radix requirements,to verify the applicability of the limits set by the Guangdong provincial standards for the original Astragali Radix UGP with the same indicators,and to retain or adjust the quality control indexes of Astragali Radix.UGP in the quality standards for UGP in Guangdong province according to the analysis results;2.Screening the key indicators that can characterize the powder properties,and investigating the analysis methods of each powder index,and establish analytical methods and parameters as the evaluation criteria for powder properties,and bring it into the quality standard system of Astragali Radix UGP.3.Adding exogenous safety indicators to evaluate the exogenous safety of Astragali Radix UGP: Refer to the four editions of 2015 edition of the Chinese Pharmacopoeia,based on the microbiological limit inspection of non-sterile products(controlled bacteria inspection method(1106),Pb,Cd,As,Hg,Cu determination method(2321)inductively coupled plasma mass spectrometry,Determination of Pesticide Residues(2341),Aflatoxin Determination(2351),and Sulfur Dioxide Determination(2331)for microbial limits,heavy metal residues,pesticide residues,and Aspergillus flavus in 10 batches of Astragali Radix UGP Toxin,sulfur dioxide amount.4.Establish HPLC fingerprint standard of Astragali Radix UGP to evaluate the stability and consistency of chemical composition between batches:High-performance liquid chromatography,using DAD detector full-wavelength scanning to optimize the optimal wavelength,compare the extraction efficiency of different extraction solutions and different extraction methods to investigate different columns,different mobile phase composition and ratio,different column temperature,flow rate,elution and effect of the gradient.the corresponding methodological investigation was carried out after establishing the method,and the similarity evaluation was carried out on 15 batches of Astragali Radix UGP to establish a fingerprint standard.5.Establish a DNA barcode analysis method for Astragali Radix UGP to evaluate the authenticity of the product.Method validation of existing DNA extraction and amplification methods,including sampling,water bath time,water bath temperature,denaturation time,annealing temperature and time,extension time factors,and corresponding methodological investigation,15 batches of Astragali Radix UGP was taken for DNA barcode and compared with the DNA barcode of the database to confirm its source.6.Establish a Near-infrared analysis method for Astragali Radix Ultrafine Powder(UP)/UGP to evaluate the uniformity of the product.The effects of different resolutions,scanning times,loading and unloading methods on the Near-infrared spectrum of Astragali Radix UP/UGP were investigated.Near-infrared(NIR)technique was used to analyze UP/UGP samples before and after mixing,and the method of Principal Component Analysis(PCA)and Moving Block Standard Deviation(MBSD)was used to evaluate its uniformity.Results This paper established a covers four modules of Astragali Radix UGP quality standard system:?the original evaluation index of traditional Chinese medicine legal standard(character,microscopic identification,TLC identification,astragalus glycosides content,four kinds of flavonoids content determination,extract,total ash,moisture);?powder evaluation index(particle size,particle size distribution,tap density,specific surface area,chromaticity,Angle of repose);?Oral traditional Chinese medicine exogenous security index(limit of heavy metals and pesticide residues,aflatoxin,sulfur dioxide,microbial limit inspection);?new technology index(HPLC fingerprints,DNA barcode,Near-infrared technology).And draft the new quality standard of Astragali Radix UGP.The new quality standard of Astragali Radix UGP added more comprehensive evaluation index of powder on the basis of the original one,which enhanced the quality controllability.Improve the exogenous safety index to ensure the drug safety;HPLC fingerprint technology,DNA barcode technology and Near-infrared technology were introduced to evaluate the consistency,authenticity and in-batch uniformity among batches,so as to improve the quality evaluation of Astragali Radix UGP.Conclusions:The newly established quality standard of Astragali Radix UGP greatly improves the effectiveness,safety,stability and controllability of the evaluation of Astragali Radix UGP.which can more scientifically reflect the quality of Astragali UGP and greatly enhance the quality evaluation level of Astragali Radix UGP.