| Objective:This study explores the combination of traditional experience and modern science and technology,and tries to construct a more operable and widely applied evaluation method basis based on the combination of "one main and two supplementary factors",i.e.,the comprehensive pharmacodynamic evaluation index-extract index,the biological effect evaluation index and the characteristic index as auxiliary indicators and the comprehensive analysis of the correlation among the characteristics,chemical composition and Clinical Pharmacodynamics of drugs.The evaluation method for the quality control of clinical dispensing of Chinese herbal pieces provides theoretical and experimental basis for further improving the level of clinical dispensing and ensuring the safety and effectiveness of clinical medication.Method:(1)Theoretical research:Through reviewing traditional medicine ancient books,ancient and modern Chinese and foreign pharmacopoeia,"CNKI" and "Wanfang" and other major databases,comprehensively combing the historical origins of Achyranthes bidentata,historical pharmacopoeia standards,foreign drug standards,and summarizing the tradition of Achyranthes bidentata’s Grade rating methods and modern research progress.(2)Physical and chemical research:49 batches of Achyranthes bidentata tablets and 28 batches of Achyranthes bidentata processed with wine tablets were collected and numbered according to the production area.Microscopic identification and cross-section identification method were used to determine the authenticity.The Pharmacopoeia method was used to determine the moisture,ash and leachate content of different specifications of Achyranthes bidentata.The different specifications of Achyranthes bidentata tablets were classified by the content of extract.(3)Relevance analysis of influencing factors of commodity specification grade:Quantitative indicators of various specifications of Achyranthes bidentata tablets were quantified by modern detection technology,and the chemical indicators of each batch of decoction pieces were correlated with data analysis techniques.The correlation between the content of the extract of Achyranthes bidentata sinensis,the length,diameter and chromaticity values was established to establish a method for evaluating the specification of Achyranthes bidentata tablets based on clinical quality control.(4)Biological effects:A rat model of pulmonary fibrosis induced by bleomycin,angiogenesis was used as a research entry point to verify the effects of various specifications of Achyranthes on angiogenesis in rats with pulmonary fibrosis.At the level of rat body,the pathological morphology of body weight,body temperature,respiratory rate and HE staining pathology were observed.At the tissue level,the expression of factor-related antigen and the thickness of pulmonary arterioles were used to verify the change of pulmonary tissue.At the cytokine level,the effects of vascular endothelial growth factor(VEGF),hypoxia inducible factor-la(HIF-la),recombinant human pigment epithelium-derived factor(PEDF)and endostatin(ES)in rat serum were studied.The effects of different specifications and grades of Achyranthes bidentata decoction pieces on biological effects were comprehensively judged.Results:(1)Theoretical research:The traditional identification quality experience of Achyranthes bidentata was found by consulting ancient books based on the two criteria of "differentiation of character" and "genuine medicinal materials".In the study of modern drug standards,it was found that too much attention was paid to the content of chemical monomer pharmacodynamic components,neglecting the overall pharmacodynamic evaluation results of traditional Chinese medicines;,and the main indicators to be extracted were proposed.Biological effect evaluation indicators and characteristics indicators were used as auxiliary indicat "Main and Two Supplementaries" as an evaluation index and a grading evaluation method for the specifications of Radix Achyranthes bidentata based on the quality control of clinical dispensing.(2)Physical and chemical research:It was confirmed by microscopic identification and cross-section identification experiments that the various grades of Achyranthes bidentata were dried roots of Achyranthes bidentata B1.,which were tested by pharmacopoeia.The water content of each grade of Achyranthes bidentata tablets was determined by pharmacopoeia method.It was found that the water content of each grade of Achyranthes bidentata tablets collected in the experiment did not exceed 15.0% of the water limit stipulated in Chinese Pharmacopoeia;the total ash content of Achyranthes bidentata tablets did not exceed 9.0%of the water limit stipulated in Chinese Pharmacopoeia;and the extract content of Achyranthes bidentata tablets exceeded the alcohol-soluble 5.0%of the extract,and 4.0%of the ethanol-soluble extract of Achyranthes bidentata in Chinese Pharmacopoeia.Choosing the comprehensive pharmacodynamic index-extract of Achyranthes bidentata as grading index,using cluster analysis technology,the decoction pieces of Achyranthes bidentata were scientifically and reasonably divided into three grades,and the Achyranthes bidentata tablets processed with wine were divided into two grades.(3)Relevance analysis of influencing factors of commodity specification grade:Analysis of origin factors showed that compared with the content of extracts from Henan,Hebei and Inner Mongolia,the content of extracts in Henan production area(%)>Inner Mongolia production area Leachate content(%)>Extract content(%)of Hebei production area.The analysis of traits showed that the content of extracts of Achyranthes bidentata was closely related to the chromaticity value,especially positively correlated with a*value.The content of Achyranthes bidentata extract was also closely related to the chroma value,especially negative correlation with L*value.(4)Biological effects study:A rat model of pulmonary fibrosis induced by bleomycin was established.According to the pathological morphology,it was found that different levels of Achyranthes bidentata can alleviate the pathological changes of pulmonary fibrosis rats.However,there was no significant difference in body weight and body temperature.Except Achyranthes bidentata,,the respiratory frequency of Achyranthes bidentata group was significantly different from that of model group(P<0.05),and that of First-class Achyranthes bidentata group was more significant(P<0.01).HE staining,Sirius red staining,comparison of collagen type I/collagen type III in rat lung tissue and HYP test results showed that different grades of Achyranthes bidentata administration group delayed the pathological changes of IPF rats.At the organizational level,the expression of factor-related antigen and pulmonary arterioles wall thickness were observed.The therapeutic effect of different grades of Achyranthes bidentata Decoction with the same specification decreases in varying degrees with the decline of commodity grade.Meanwhile,the therapeutic effect of Achyranthes bidentata processed with wine group is better than that of Achyranthes bidentata group in different specifications.At the cytokine level,the serum levels of VEGF,HIF-la,PEDF and ES were compared.It was found that the therapeutic effect of first-class Achyranthes bidentata in the treatment group was better than the other class of Achyranthes bidentata.Meanwhile,the excellent group has better curative effect among the Achyranthes bidentata processed with wine group.There was no significant difference in the expression of vascular endothelial growth factor,HIF-la,PEDF and ES in different specifications of Radix Achyranthes bidentata.Conclusions:Combining traditional experience with modern science and technology,the content of Achyranthes bidentata extract is used as the grading index,and the pulmonary fibrosis model is used to verify the difference of drug efficacy,correlating its appearance trait index and pharmacodynamic index,and establishing the specification of Achyranthes bidentata tablets based on clinical adjustment quality control.The grade evaluation method provides new ideas and new methods for the study of the specifications of Chinese medicine decoction pieces. |
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