| Objective: To elucidate the quality transfer,dynamic change and compatibility of the main components of Radix Astragali-decoction pieces-whole prescription in the classic prescription Shengxian decoction,and to establish the chemical characterization atlas of Shengxian decoction,to provide the basis for the determination of the quality marker of Shengxian decoction and its application in quality control and preparation development.Methods:(1)To evaluate and control the quality of 15 batches of Radix Astragali by the methods described in the Chinese Pharmacopoeia 2015 edition of Radix Astragali;(2)cluster analysis was used to analyze the similarity of different parts of Radix Astragali in order to determine the parts of Radix Astragali,Box-Behnken response surface test was used to optimize the processing technology of Radix Astragali in order to determine the processing technology of Radix Astragali;(3)to evaluate and control the quality of 15 batches of Radix Astragali decoction pieces by using the methods described in the 2015 edition of Chinese pharmacopoeia under a Radix Astragali decoction;(4)according to Shengxian decoction,it is mostly used in the treatment of qi-deficiency diseases,the anti-hypoxia effect of Shengxian decoction was studied by the experiment of normal pressure Hypoxia in mice,and the compatible dosage of Radix Astragali was analyzed;(5)the content of Astragaloside IV in Shengxian decoction was determined by HPLC-ELSD,the method of HPLC-DAD was used to determine the content of Calycosin-7-glucoside in Shengxian decoction;(6)the method was used to determine the contents of Astragaloside IV and Calycosin-7-glucoside in 15 batches of Shengxian decoction,the dynamic change law of principal components of Radix Astragali-decoction pieces-whole prescription was analyzed with the index of component transfer rate and extraction rate;(7)to analyze the compatibility of the prescription based on the content of Mangiferin in Rhizoma anemarrhenae,3-Hydroxy-4-methoxycinnamic acid in Cimicifuga and Platycodin D in Radix Platycodonis;(8)by HPLC-ELSD and HPLC-DAD,the chemical characteristic chromatogram of Shengxian decoction was established,the common peaks were identifiedand assigned,and the similarity of 15 batches of Shengxian decoction was evaluated and analyzed by the similarity evaluation system of chromatographic fingerprints of traditional Chinese medicine.Results:(1)The test items of 15 batches of Radix astragali conformed to the items of Radix Astragali in Chinese Pharmacopoeia 2015 edition;(2)the main root and lateral root of Radix Astragali were determined,and the processing technology of Radix Astragali decoction pieces was determined as follows: root head,fiber root and its impurity were removed,washed clean,moistened with water,cut into thick slices(3.5 mm),and placed in the air-blast drying box,set the temperature to 42 °C and dry for 5.5 hours;(3)the contents of 15 batches of Radix Astragali decoction pieces were all in accordance with the provisions of Chinese Pharmacopoeia 2015 edition;(4)the anti-hypoxia time of Shengxian decoction group was significantly higher than that of the blank control group(p<0.05),there was no significant difference between Shengxian decoction double group and Shengxian decoction group(p>0.05);(5)the method for determination of Astragaloside IV in Shengxian decoction by HPLC-ELSD was studied.The results showed that the method was stable and feasible,the method of HPLC-DAD was used to determine the content of Calycosin-7-glucoside in Shengxian decoction.The results showed that the method was stable and feasible;(6)the transfer rate of Astragaloside IV from Radix Astragali to Radix Astragali decoction pieces was 57.47%~87.00%,the total extraction rate was36.52%~47.23%,the transfer rate of Calycosin-7-glucoside from Radix Astragali to Radix Astragali decoction pieces was 76.69%~122.53%,the total extraction rate was39.92%~59.21%;(7)compared with the whole prescription of Shengxian decoction,the Mangiferin and 3-Hydroxy-4-methoxycinnamic acid in Shengxia decoction increased obviously after the drug was removed,the dissolution rate of Mangiferin was34.95%~39.53%,the dissolution rate of 3-Hydroxy-4-methoxycinnamic acid was54.93%~63.54%,and the dissolution rate of Platycoside D in Platycodon grandiflorum was obviously decreased,the content of Platycoside D in Platycodon grandiflorum decreased by32.69%~38.87%;(8)there are 8 common peaks in the chemical characterization ofShengxian decoction by HPLC-ELSD,among which 2 peaks are Timosaponin BII,4 peaks are Platycodin D,8 peaks are Astragaloside IV,and 15 batches of Shengxian decoction are compared with the control,the similarity was between 0.977 and 0.999,and the chemical characterization of Shengxintang by HPLC-ELSD had 10 common peaks,among which the1 peaks was Mangiferin,the 3 peaks was 3-Hydroxy-4-methoxycinnamic,and the 4 peaks was Calycosin-7-glucoside,compared with the control map,the similarity of 15 batches of sheng-xia-tang is between 0.929 and 0.989,and the similarity of the two whole-part chemical characterization maps of Shengxian decoction is more than 0.9,the results showed that the quality of 15 batches of Shengxian decoction was stable and controllable.Conclusion:(1)The processing technology of Radix Astragali decoction pieces for Shengxian decoction was determined through multi-index evaluation,according to the processing technology,15 batches of Radix Astragali with traceable quality were prepared,at the same time,it provides the basis and detailed operational parameters for the establishment of internal control standard of Shengxian decoction Radix Astragali and decoction pieces;(2)through the traditional anti-hypoxia experiment in mice,it shows that Shengxian decoction has the effect of prolonging the anti-hypoxia time at normal pressure in mice,it is proved that Shengxian decoction has the effect of invigorating Qi,and it is concluded that the dosage of Radix Astragali,the original prescription of Shengxian decoction,can achieve a good effect of invigorating Qi;(3)a method for the determination of Astragaloside IV and Calycosin-7-glucoside in Shengxian decoction was established,the changes of principal components in Radix Astragali-decoction pieces-whole prescription of Shengxian decoction were determined and analyzed,and the correlation between the dynamic changing trend of principal components in Radix Astragali-decoction pieces and the difference of components distribution in different parts was found,as well as the correlation between the dynamic changes of the main components of Radix Astragali and the time of extraction,the dynamic changes of the main components of Radix Astragali in Shengxian decoction were explained,at the same time,it provides guidance for the treatment of decoction pieces in the further preparation production;(4)the law ofcompatibility of Shengxian decoction was studied and analyzed based on the method of sovereign drug knock-out,according to the pharmacological action of the related components,it is found that the dissolution of the components of Radix Astragali follows the compatibility relationship of different kinds of herbs,or restricts or promotes each other,and further reveals the scientific connotation of compatibility law of Radix Astragali from the angle of chemical components,at the same time,from the point of view of Shengxian decoction,some reasonable suggestions on the use of traditional Chinese Medicine Formula Granules were put forward;(5)the chemical characterization atlas of Shengxian decoction was established,the Astragaloside IV and the Calycosin-7-glucoside in Radix Astragali,3-Hydroxy-4-methoxycinnamic acid in Cimicifuga,the Mangiferin and Timosaponin BII in Anemarrhena asphodeloides bunge and Platycodin D in Platycodon grandiflorum were identified and their common peaks were assigned,the overall chemical composition of Shengxian decoction was characterized,and the consistency of 15 batches of Shengxian decoction was evaluated,and a standard decoction of Shengxian decoction with stable and traceable quality was formed,which provided the basis for the quality evaluation of Shengxian decoction,it also provides the research methods and ideas for the research of Shengxian decoction material standard and the research and development of the preparation. |
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