Establishment Of Quality Grade Standard Based On Appearance Characteristics And Internal Indexes Of Astragali Radix

Rationales:In recent years,with the rapid increase in the use of Astragali Radix,wild resources have been unable to meet the market demand.In order to alleviate the shortage of wild Astragali Radix resources,the large-scale cultivated Radix Astragali has become an important way to solve the supply and demand gap of Astragali Radix.However,the cultivated Astragali Radix is far from the traditional wild Astragali Radix in terms of appearance traits and internal qualities.At the same time,due to the inconsistency of various specifications and grade standards,the situation of "homogeneity and different prices" in the commodity trading process of Astragali Radix is common.In order to regulate the medicinal material market,in 2018,the research and development group standard of the Chinese Society of Traditional Chinese Medicine unified the specifications and grades of Astragali Radix and confirmed the high quality of simulated wild Astragali Radix from the appearance traits.However,the content of chemical components associated with drug efficacy also greatly affected the quality of Astragali Radix.Therefore,in order to improve the quality level and competitiveness of Chinese medicine products in China,experts and scholars are committed to the quality evaluation of Chinese medicine from "specification level" to "quality level".On this basis,the correlation between appearance traits and inner quality of different grades of simulated wild Astragali Radix and cultivated Astragali Radix were studied in this paper,and the flavonoid characteristic chromatogram were established to distinguish Astragali Radix of different specifications,so as to reflect the high quality of simulated wild Astragali Radix and lay the foundation for the establishment of quality grade standards of Astragali Radix.Objective : According to the method of "China Pharmacopoeia",the content of internal quality index components of Astragali Radix were determined and classified according to the appearance traits,and the characteristic chromatograms of flavonoid components of Astragali Radix were established,which laid the foundation for the establishment of quality grade standards of Astragali Radix.Method:1.The diameter of 3.5cm below the head incision of simulated wild Astragali Radix and cultivated Astragali Radix were measured.The sample data of each batch were counted and the difference traits between wild and cultivated Astragali Radix were analyzed;2.The moisture,total ash,acid-insoluble ash,and water-soluble extracts of simulated wild and cultivated Astragali Radix were determined by the method in the 2020 edition of China Pharmacopoeia,and the content differences between the two specifications of Astragali Radix and the correlation with appearance traits were compared;3.Establishment of Characteristic Chromatograms of Flavonoids in Astragali Radix by HPLC-UV with Similarity Evaluation Software;4.The content of astragaloside IV and calycosin glucoside was determined by the method in the 2020 edition of China Pharmacopoeia,to explore the correlation between two chemical components of Astragali Radix of different specifications and grades and appearance traits,so as to divide the quality grade of Astragali Radix based on the content of astragaloside IV and calycosin glucoside;5.The contents of total flavonoids and total saponins of simulated wild Astragali Radix and cultivated Astragali Radix were measured and compared with the content differences among different grades,and the quality grades of Astragali Radix of different specifications were divided by correlation analysis with appearance traits.Results:1.The appearance traits of 60 batches of simulated wild Astragali Radix and 46 batches of cultivated Astragali Radix samples were observed and counted,and the results showed that simulated wild Astragali Radix and cultivated Astragali Radix had significant differences in shape,texture,color,odor,etc.The sample diameter of 3.5cm below the head incision of each batch were measured,and 60 batches of simulated wild Astragali Radix from different origins were divided according to the diameter ≥1.5 cm,1.4 cm,1.3cm,1.2 cm,1.1 cm and 1.0cm at 3.5 cm below the head incision.The 46 batches of cultivated Astragali Radix from different origins were also divided according to the diameter ≥1.5cm,1.2cm,1.1cm and 1.0 cm at 3.5 cm below the head incision.2.The moisture,total ash,acid-insoluble ash and water-soluble extract contents of Astragali Radix were determined in accordance with the China Pharmacopoeia(2020edition).The result showed that the content of moisture,total ash,acid-insoluble ash and water-soluble extract of simulated wild Astragali Radix were 2.51%～4.86%,2.80%～3.68%,0.19%～0.57%,22.77%～35.97%,respectively.The percentages of cultivated Astragali Radix were 2.34% ～ 5.25%,2.72%～3.80%,0.12%～ 0.92% and 26.13% ～41.00%,respectively.All sample strengths are in accordance with the China Pharmacopoeia 2020.With the increase of the diameter at the place 3.5 cm below the head incision,the moisture content of simulated wild Astragali Radix showed a downward trend,but there was no significant rule for the moisture content of simulated wild and cultivated Astragali Radix with different diameters.The maximum water content measured in the experiment was divided as follows: moisture content of simulated wild Astragali Radix ≤ 4.86%;the moisture content of that cultivated Astragali Radix is less than or equal to 5.25%.There was no correlation between the diameter of 3.5cm below the head cut and the total ash content of simulated wild Astragali Radix.However,with the increase of the diameter,the total ash content of cultivated Astragali Radix was gradually reduced.The maximum values of the total ash content measured in the experiment were divided as follows: The total ash content of simulated wild Astragali Radix ≤ 3.68%;the total ash content of that cultivate astragalus is less than or equal to 3.80%.The acidinsoluble ash content of simulated wild Astragali Radix was lower than that of cultivated Astragali Radix,and there was no significant rule between different diameter sizes and the acid-insoluble ash content of Astragali Radix.The maximum values of acid-insoluble ash content measured in experiments were divided as follows: acid-insoluble ash content of simulated wild Astragali Radix ≤ 0.57%;the acid-insoluble ash content of that cultivate astragalus was less than or equal to 0.92%.Although the content of water-soluble extract of simulated wild Astragali Radix was lower than that of cultivated Astragali Radix,its content was relatively stable,and the increase in diameter at 3.5cm below the scalp incision had no significant correlation with the accumulation of water-soluble extract content of Astragali Radix of different specifications.The lowest values of the contents of the water-soluble extracts measured in the experiment were divided as follows: the content of the water-soluble extracts of simulated wild Astragali Radix ≥ 22.77%;the watersoluble extract content of that cultivated Astragali Radix is not less than 26.13%.3.Characteristic chromatogram of Astragali Radix Results: The HPLC-UV characteristic chromatograms of six flavonoid components including calycosin glucoside and ononin were established,and the similarity analysis was performed using the simulated wild Astragali Radix characteristic chromatograms as the reference.The results showed that the similarity of the simulated wild Astragali Radix samples was ≥0.994,and that of the cultivated Astragali Radix samples was ≥0.809,indicating that the qualities of Astragali Radix samples planted in different ways varied significantly,the similarity of the simulated wild Astragali Radix samples was high,and the chemical compositions showed high similarity.Besides,compared with the simulated wild Astragali Radix,the quality of cultivated Astragali Radix was significantly different,with weak regularity.4.In this experiment,the contents of astragaloside IV of 66 batches of simulated wild Astragali Radix and cultivated Astragali Radix were determined.The content of astragaloside IV in the simulated wild Astragali Radix is 0.12%～0.42%,and the content of cultivated Astragali Radix is 0.08%～0.18%,both of which meet the requirements of China Pharmacopoeia(2020 edition),that is,not less than 0.08%.There were significant differences in the content of astragaloside IV between the simulated wild Astragali Radix and the cultivated Astragali Radix,and the content of astragaloside IV of the simulated wild Astragali Radix was higher than that of the cultivated Astragali Radix.With the increase of the diameter of the part 3.5 cm below the head incision,the content of astragaloside IV decreased gradually,and there was a significant negative correlation between the diameter and content.The lowest astragalosides IV content is divided as follows: astragalosides IV content of imitated wild astragalus ≥0.12%,and astragalosides IV content of cultivated astragalus ≥0.08%.In this experiment,the contents of astragalosides IV in 106 batches of simulated wild Astragali Radix and cultivated Astragali Radix were determined.The content of the simulated wild astragalosides IV is0.058%～0.126%,and that of the cultivated astragalosides IV is 0.027%～0.066%,which are in accordance with the regulations of China Pharmacopoeia(2020 edition),that is,not less than 0.02%.The results showed that the content of astragalosides IV in simulated wild Astragali Radix was significantly higher than that in cultivated Astragali Radix,and the content of astragalosides IV in simulated wild Astragali Radix of different batches was increased with the increase of the diameter.The traditional grading index(diameter)had a significant positive correlation with the modern grading index(intrinsic glycosides content),so the glycosides content could be used as the basis for grading of Astragali Radix.The special grade d ≥1.5 cm of the simulated wild Astragali Radix,and the content of glycosides should not be less than 0.09%;the first-class d ≥1.3 cm,the content of glycosides should not be less than 0.08%;the second-class d ≥1.0 cm,the content of glycosides should not be less than 0.06%.Cultivated Astragali Radix d≥1.0 cm,the content of glycosides should not be less than 0.03%.5.In this experiment,the total flavonoids and saponins contents of simulated wild Astragali Radix and cultivated Astragali Radix were determined in 106 batches.The results showed that the content of total flavonoids in simulated wild Astragali Radix ranged from 4.788 mg/g to 7.393 mg/g,and that in cultivated Astragali Radix ranged from3.565 mg/g to 5.556 mg/g.The diameter of the part 3.5 cm below the beheading of the head affected the accumulation of total flavonoids in Astragali Radix.The classification of total flavonoids in simulated wild Astragali Radix was as follows: d ≥1.5 cm,the content of total flavonoids ≥5.70 mg/g as principal level,d ≥1.3cm,the content of total flavonoids≥5.33 mg/g as first level,d ≥1.0 cm,and the content of total flavonoids ≥4.79 mg as second level.Cultivated Astragali Radix was classified as optional if d≥1.1 cm,and the content of total flavonoids ≥3.75 mg/g,and unified if d ≥1.0 cm,and the content of total flavonoids ≥3.57 mg/g.The content of total saponins of simulated wild Astragali Radix ranged from 9.960 mg/g to 18.883 mg/g,and that of cultivated Astragali Radix ranged from 7.604 mg/g to 16.884 mg/g.The content of total saponin of the simulated wild astragalus was higher than that of the cultivated astragalus.There was no significant difference in the accumulation of total saponins in Astragali Radix of different specifications with a diameter of 3.5 cm below the head incision.The lowest content of total saponins was divided as follows: the content of total saponins of simulated wild Astragali Radix ≥9.96 mg/g;Total saponins content of cultivated Astragali Radix ≥7.60mg/g.Conclusion:In this study,calycosin glucoside and total flavonoids could be used as the basis for the establishment of quality grade standards of Astragali Radix.However,moisture,total ash,acid-insoluble ash,water-soluble extract,astragalosides IV and total saponins could only be used to divide the specifications of Astragali Radix.In addition,a characteristic chromatogram of flavonoids was established,which could obviously distinguish simulated wild Astragali Radix and cultivated Astragali Radix.It reflects the "high quality and high price" of Chinese medicinal materials market and lays a foundation for the protection and development of high quality authentic Chinese medicinal resources.