Study On Quality Standard Of Wild-simulated Astragali Radix Based On Chemical Composition

Rationales: As one of the commonly used Chinese herbal medicines,Astragali Radix has a huge market demand.Currently,the market mainly have wild-simulated Astragali Radix in Shanxi and cultivated Astragali Radix in Gansu.Wild-simulated Astragali Radix is well-known "authentic Chinese herb",and enjoys a high reputation and prices.Wild-simulated Astragali Radix as a high quality specification,adopted on Chinese Medicine Association group standards(standard encdoing: T/CACM 1021.4-2018).However,There are only trait standards in this standard and there is a lack of chemical composition standards.There is no clear distinction of two types of Astragali Radix in2015 Chinese Pharmacopoeia.The main reason is:(1)There is no difference in the content limits of isoflavonoid glycosides(≥0.02%)and Astragaloside IV(≥0.04%).(2)There are no fingerprint or feature map distinguish two types Astragali Radix.Therefore,This article combined specification grades with chemical evaluations.Find the differential components of the two types of Astragali Radix from the chemical composition.At the same time,Astragali Radix flavonoids characteristic spectrum were established to distinguish two types Astragali Radix.Establish quality standards for Astragali Radix and promote high quality and good prices in the market.Objective: To establish the high much 2015 Chinese Pharmacopoeia quality standard of Wild-simulated Astragali Radix by measuring the chemical constituents and characteristic spectrum of different specification grades of Astragali Radix.Method:(1)Isoflavones glucoside contents of wild-simulated and cultivated Astragali Radix were determined by using the method of 2015 Chinese Pharmacopoeia.Data was statistically analyzed and the ROC curve was used to determine the critical value of the wild-simulated Astragali Radix and cultivated Astragali Radix.(2)Improve the pretreatment method of astragaloside IV in 2015 Chinese Pharmacopoeia.And the method was applied to determine the contents of astragaloside IV of the wild-simulated Astragali Radix and cultivated Astragali Radix.Comparing the contents of astragaloside IV in two types of Astragali Radix.(3)HPLC-UV with similarity evaluation software,cluster analysis and multivariate statistical analysis were used to establish the flavonoids characteristic spectrum of Astragali Radix.(4)The n-hexanal contents determinationmethod of Astragali Radix was established by using the purge-trap coupled with gas chromatography-mass,comparing the n-hexanal contents in two types of Astragali Radix.Results:(1)225 samples of 45 batches wild-simulated Astragali Radix and 210 samples of 42 batches cultivated Astragali Radix of isoflavones glucoside contents were determined.The average contents of isoflavones glucoside in wild-simulated Astragali Radix and cultivated Astragali Radix were 0.107% and 0.039%,the contents of wild-simulated Astragali Radix were three times as much as cultivated Astragali Radix.The contents of isoflavone glucoside were a high-quality ingredient in wild-simulated Astragali Radix.the ROC curve had a critical value of 0.069%,the accuracy of the ROC curve was 90% by measuring the content of the isoflavone glucoside of the Astragali Radix pieces.This result indicated that the judgment result was more accurate.This result provided the basis for the development of high quality medicinal standards.The results of grade analysis showed that the contents of isoflavone glucoside in the wild-simulated Astragali Radix were first-class,top,second-class,third-class,fourth-class.The first-class was not highest contents.The reason was that the longer growth period wild-simulated Astragali Radix had a higher degree of decay.There was no correlation between the contents of isoflavones glucosides and grades in cultivated Astragali Radix.(2)The optimized method avoided the problem that the consumable quality unstable and the recovery rate was not high.The contents of optimized method were higher than the pharmacopoeia method,and saved time and improved recovery rate.The ROC curve analysis showed that there was no significant difference of contents of astragaloside IV between the wild-simulated Astragali Radix top、first and cultivated Astragali Radix.The contents of astragaloside IV in second、third、fourth in wild-simulated Astragali Radix were significantly higher than cultivated Astragali Radix(wild-simulated Astragali Radix content limit can be increased to 0.082%).Since the contents of astragaloside IV were increased to 0.082%,the contents of the top and first grades astragaloside IV in wild-simulated Astragali Radix were unqualified.Therefore,this paper did not distinguish the limit of the contents of wild-simulated Astragali Radix and cultivated Astragali Radix.There was a significant negative correlation between the contents of astragaloside IV and grade in wild-simulated Astragali Radix.There was no correlation between the contents of astragaloside IV and grade in cultivated Astragali Radix.(3)The results of characteristic spectrum showed that HPLC-UV characteristic spectrum based on five flavonoids was established.Wild-simulated Astragali Radix was taken wild as a control,the similarity of wild-simulated Astragali Radix was 0.892 ~ 0.994 and cultivated Astragali Radix was 0.274 ~ 0.531.Astragali Radix were classified as two clusters including wild-simulated Astragali Radix and cultivated Astragali Radix by clustering analysis(CA)and principle component analysis(PCA).Different grades of wild-simulated Astragali Radix were clear distinction,different grades of cultivated Astragali Radix were not clear distinction.(4)Determination results of n-hexanal contents: The method for determining the contents of n-hexanal by using purge-trap coupled with gas chromatography-masstechnique was stable and efficient.The n-hexanal contents in Shanxi was significantly higher than that in Gansu.There is no obvious rules for the n-hexanal contents of different grades of Astragali Radix.Conclusion:This study determined a large number of samples of wild-simulated Astragali Radix and cultivated Astragali Radix.The limit of the contents of isoflavone glucoside in wild-simulated Astragali Radix was increased to 0.069% based in 2015 Chinese Pharmacopoeia.It can clearly distinguish two types of Astragali Radix.The improved pretreatment method of astragaloside IV is simple and efficient.Astragaloside IV contents significantly was increased.Astragali Radix were classified as two clusters including wild-simulated Astragali Radix and cultivated Astragali Radix by using characteristic spectrum.Because the n-hexanal component is unstable,it can not be accept the standard.When the storage period is determined,n-hexanal can be used as a reference index to evaluate two types of Astragali Radix.The quality standards established results promoted the law of "high quality and good price" in the market.