Study On Quality Evaluation And Standard Of Yimujiang Of Yao Medicine

Objective:To establish the quality control method for Yimujiang,the pharmacognosy,inspection items and content determination of Yimujiang from11 regions of Guangxi were comprehensively and systematically evaluated by this method,and the corresponding quality standards(draft)were formulated according to the quality evaluation results,which provided scientific basis for the formulation of the quality standards of Yimujiang.Methods:1.Using the literature research method to carry out the herbal textual research on Yimujiang.2.The pharmacognosy of Yimujiang was studied from the aspects of primordia,properties,microscope,TLC according to the relevant methods of Chinese Pharmacopoeia in 2015 edition.3.According to the general principles of Chinese Pharmacopoeia in 2015,the water content,ash content,swelling degree,heavy metals,pesticide residues and aflatoxin of Yimujiang were examined and evaluated respectively,and the limit of relevant items was drawn up.4.Referring to the general rules of Chinese Pharmacopoeia in 2015,a method for the determination of extract of Yimujiang was established,and the detection and evaluation of Yimujiang from 11 producing areas were carried out.5.Through the single factor test and the multi-factor orthogonal test method,the preparation method of the sample solution of Yimujiang was explored;a method for the determination of diosgenin in Yimujiang was established under suitable chromatographic conditions.The method was used to determine and evaluate the content of diosgenin in Yimujiang from 11 places of origin.6.The fingerprints of Yimujiang from different habitats were studied by high performance liquid chromatography(HPLC),and the fingerprints of 11 batches of characteristic parts of Leonurus officinalis were analyzed by similarity analysis.7.The acute toxicity test of Yimujiang was carried out by intragastric administration in mice,and the safety of Yimujiang was evaluated according to the test results.8.The antimicrobial effects of fresh juice,water extract and alcohol extract of Yimujiang on Staphylococcus aureus,Staphylococcus aureus resistant bacteria,Escherichia coli and Pseudomonas aeruginosa were investigated by double dilution method.9.According to the relevant format of Chinese Pharmacopoeia in 2015 edition,and the quality evaluation results of Yimujiang from 11 origins,the quality standard of Yimujiang from Yao medicine(draft)was formulated.Results:1.Completed the origin of Yimujiang,the function of sexual taste,alias and processing of the origin of textual research.2.The identification characteristics of Yimujiang were determined,including its base,properties,microscopy and TLC.The origin of Yimujiang was identified as the root of Costaceae,Costus speciosus(Koen.)Smith.The characters of Yimujiang were as follows: dry rhizomes are mostly irregular,dry and twisted strips,light brown to dark brown,with longitudinal wrinkles on the surface,sparse links and residual stem marks,fibrous roots and brown leaf residues.Most of the pieces were irregular with residual roots,occasionally brown leaf residues.The section is grayish-white or light brown-yellow,with obvious endothelial rings,brittle texture,scattered punctate fibers and starchy.Smell slightly,taste bitter,slightly bitter.3.The moisture,ash,expansion,heavy metals,agricultural residues and aflatoxin of Yimujiang from 11 producing areas were examined.Water content ranged from 6.29% to 8.76%;ash content was 5.74% ～14.56%,acid insoluble ash content was 1.655% ～2.89%,expansion degree was 7.50 ～12.13 g/ml.The heavy metals are: lead content 1.30～4.60 mg/kg,cadmium content 0.02～2.00mg/kg,arsenic content 0.30～1.60 mg/kg,mercury content 0.08～1.19 mg/kg,copper content 2.10～10.00 mg/kg;aflatoxin B1 content is 0～0.008 μg/kg,total amount of aflatoxin G1,G2,B1,B2 is 0～0.0023μg/kg;no pesticide residues were detected in 11 batches of samples.4.The test method of extract content of Yimujiang was determined.The extract content of 11 batches of samples was 8.73～14.22%.5.A method for the determination of diosgenin in Yimujiang by HPLC was established.The content of diosgenin in 11 regions of Yimujiang was1.86～15.31 mg/g with an average of 4.68 mg/g.According to the dried product,the content of diosgenin in Yimujiang should not be less than 0.30%.6.The HPLC fingerprint of dichloromethane fraction of Yimujaing was established.Diosgenin was used as reference substance.10 common peaks were identified and the 5th peak was calibrated as Diosgenin peak.According to the similarity results,the similarity between the fingerprint of the provisional sample and the control fingerprint should not be less than 0.80.7.The MTD and the MLD of water extract of Yimujiang in mice were91.25 g/kg and 114.40 g/kg,and the lethal dose of the water extract and alcohol precipitation of Yimujiang in mice was 87.90 g/kg.8.The MIC of alcohol extract and water extract of Yimujiang were 0.063g/ml and 0.125 g/ml for Staphylococcus aureus,0.063 g/ml and 0.125 g/ml for Staphylococcus aureus,0.25 g/ml for Escherichia coli,0.5 g/ml for Pseudomonas aeruginosa and almost no bacteriostatic effect for fresh juice.9.The quality standard(draft)of Yimujiang for Yao medicine and its drafting instructions were completed.10.The quality standard(draft)of Yimujiang and its drafting instructions were completed.Conclusion: In this paper,the origin,properties,microscopy,TLC identification,inspection items,extracts,content determination,fingerprint and acute toxicity of Yimujiang were studied and evaluated comprehensively and systematically.The quality standard(draft)and description of Yimujiang were drafted,which provided a scientific and feasible quality standard for the quality control of Yimujiang and provided safety and safety for clinical medication.