Study On The Quality Control Of Yupingfeng Keli

Objective:Under the guidance of the traditional Chinese medicine theory and taking the traditional Chinese medicine compound preparation Yupingfeng Keli as the research object,based on the original quality standard,according to the new medicine quality control research technical requirements,the modern analytical techniques and methods are adopted synthetically.The quality control of raw materials was studied,and the comprehensive quality control methods of intermediate and finished product of Yupingfeng Keli were established.Through the establishment of the related fingerprint of raw materials,intermediates and finished products,In order to control the quality of the product and ensure the safety and stability of the clinical efficacy of the preparation,the fingerprint technology can be used to monitor the whole process of drug production.Methods:1.Study on the quality standard of crude medicinal materials(1)Collection-three raw materials of Astragalus membranaceus,Atractylodes macrocephala and Saposhnikovia divaricata were collected from different producing areas and different batches of Yupingfeng Keli.(2)Identification and examination of raw materials.According to the requirements of the Chinese Pharmacopoeia in 2015,the collected three raw materials were identified and examined,and the qualified samples were selected for fingerprint analysis.(3)study on finger pattern of raw material.The(HPLC)method of high efficient liquid phase color spectrum was used to study the development of raw materials in different production areas and different batches of raw materials.The method of preparation of different chromatographic strips and samples is selected separately,and the study of the method is completed.The HPLC finger pattern of raw material was established,and the evaluation of line similarity of the pattern spectrum was pointed out by the members of the National Pharmacopoeia Committee(4)Identification of ASTRAGALI RADLX source-The primordial identification of Astragalus membranaceus was carried out by using DNA barcode molecular biological identification technique.(5)GC-MS method was used to establish the fingerprint of volatile oil of Astragalus chinensis,and the relative components were identified by database comparison.2.Quality standard study on semi-finished products of Yupingfeng Keli.(1)Establishment of fingerprint.UPLC-PDA method and UPLC-ELSD method were used to establish the fingerprint of the intermediate of Yupingfeng Keli,and the methodology of the method was investigated.The system of evaluating the price of soft parts with similarity degree for transportation is used to separate and analyze the spectrum of finger patterns,and has passed through the comparison with various kinds of medicinal materials,and the ratio of the photographic materials to the products.The identified peaks of the cochromatic spectrum are identified as compartmentalized.(2)Content determination-According to the preparation process of Yupingfeng Keli,was selected indicators to establish ways of identifying UPLC dose.3.Quality standard study on end products of Yupingfeng Keli(1)Establishment of fingerprint.UPLC-PDA method and UPLC-ELSD method were used to establish the fingerprint of the intermediate of Yupingfeng Keli,and the methodology of the method was investigated.The system of evaluating the price of soft parts with similarity degree for transportation is used to separate and analyze the spectrum of finger patterns,and has passed through the comparison with various kinds of medicinal materials,and the ratio of the photographic materials to the products.The identified peaks of the cochromatic spectrum are identified as compartmentalized.(2)Content determination-According to the preparation process of Yupingfeng Keli,was selected indicators to establish ways of identifying UPLC dose.Results:1.Study on the quality standards of crude medicinal materials(1)The experiment was collected 48 batches of Astragalus membranaceus,45 batches of Atractylodes macrocephala,40batches of Saposhnikovia divaricata,as samples,and the results showed that the 3 crude medicinal materials were in conformity with the provisions of the Pharmacopoeia of 45,41 and 40 batches,and the qualified rates were 93.75%,88.89%and 100%.(2)The HPLC fingerprint for crude medicinal materials(including Astragalus membranaceus,Atractylodes macrocephala and Saposhnikovia divaricata)of Yupingfeng Keli was established,where all characteristic peaks overall have good resolution and strong specificity,and the HPLC fingerprint for Saposhnikoviae Radix can be used to quickly and accurately identified Saposhnikoviae Radix,and its adulterant,Radix Libonotidis.(3)The experiment selected psbA-trnH sequence as DNA bar code of Astragalus membranaceus,and compared the different sources of Astragalus membranaceus with DNA barcode identification system of traditional Chinese medicine.(4)The GC-MS fingerprint of volatile oil was established,the related components were identified,and the quality control of volatile oil was carried out.2.Quality standard study on semi-finished products of Yupingfeng Keli(1)The UPLC-PDA fingerprint of Yupingfeng Keli' s semi-finished products was established,and among the 15 commonly marked characteristic peaks,Nine of them were identified,which accordingly were 2#Prim-0-glucosylcimifugin,3#calycosin-7-glucoside,4#cimifugin,5#4'-0-be ta-Glucopyranosyl-5-0-Methylvisamminol,6#ononin,9#calycosin,10#sec-0-Glu cosylhamaudol,12#formononetin,15#atractylenolide III.The UPLC fingerprint of the 10 batches of Yupingfeng Keli ' s semi-finished products bears the similarity of 0.9 average with the compared standard fingerprint.(2)The UPLC-ELSD fingerprint of Yupingfeng Keli' s semi-finished products was established,and among the 18 commonly marked characteristic peaks,Nine of them were identified,which accordingly were 1#Prim-o-glucosylcimifugin,2#calycosin-7-glucoside,3#cimifugin,4#4'-0-be ta-Glucopyranosyl-5-0-Methylvisamminol,9#calycosin,10#Astragaloside?,13#Astragaloside ?,14#Isostragaloside ?,16#Astragaloside ?,17#Isostragaloside I.The UPLC-ELSD fingerprint of the 10 batches of Yupingfeng Keli ' s semi-finished products bears the similarity of 0.9 average with the compared standard fingerprint.(3)The method for the determination of 14 components in the prescription was established.The UPLC method were established for the determination of Prim-0-glucosylcimifugin,cimifugin,4'-0-beta-Glucopyranosyl-5-0-Methylvi samminol,ononin,calycosin,sec-0-Glucosylhamaudol,formononetin,atractyle nolide ?,Astragaloside I,Astragaloside ?,Isostragaloside?,Isostragaloside ?,Astragaloside?.3.Quality standard study on end products of Yupingfeng Keli(1)The TLC characteristic fingerprint of the finished product was established.In thin layer chromatography,Prim-0-glucosylcimifugin,calycosin-7-glucoside,cimifugin,4'-0-beta-Gluco pyranosyl-5-0-Methylvisamminol,ononin,calycosin,sec-0-Glucosylhamaudol,f ormononetin,Astragaloside ?,Astragaloside ?,Isostragaloside ?,Isostragaloside I,Astragaloside? were identified.This method can be used to identify the components of Yupingfeng Keli directly and quickly.(2)The UPLC-PDA fingerprint of Yupingfeng Keli' s end products was established,and among the 16 commonly marked characteristic peaks.Nine of them were identified,which accordingly were 2#Prim-0-glucosylcimifugin,3#calycosin-7-glucoside,4#cimifugin,5#4'-0-beta-Glucopyranosyl-5-0-Methy lvisamminol,6#ononin,9#calycosin,10#sec-O-Glucosylhamaudol,13#formononet in,16#atractylenolide III.The UPLC fingerprint of the 10 batches of Yupingfeng Keli ' s semi-finished products bears the similarity of 0.9 average with the compared standard fingerprint(3)The UPLC-ELSD fingerprint of Yupingfeng Keli' s end products was established,and among the 25 commonly marked characteristic peaks,Nine of them were identified,which accordingly were 1#Prim-o-glucosylcimifugin,2#calycosin-7-glucoside,3#cimifugin,4#4'-0-be ta-Glucopyranosyl-5-0-Methylvisamminol,9#calycosin,17#Astragaloside?,20#Astragaloside II,21#Isostragaloside II,23#Astragaloside I,24#Isostragaloside I.The UPLC-ELSD fingerprint of the 10 batches of Yupingfeng Keli ' s semi-finished products bears the similarity of 0.9 average with the compared standard fingerprint.(4)The method for the determination of 14 components in the prescription was established.The UPLC method were established for the determination of Prim-0-glucosylcimifugin,calycosin-7-glucoside,cimifugin,4'-0-beta-Gluco pyranosyl-5-0-Methylvisamminol,ononin,calycosin,sec-0-Glucosylhamaudol,f ormononetin,atractylenolide III,Astragaloside I,Astragaloside II,Isostragaloside II,Isostragaloside I,Astragaloside?Conclusions:This paper deals with the relation of "medicinal material to semi-finished product and end product of Yupingfeng Keli,a Chinese medicine compound preparation so as to ensure its secure and effective clinical medication via establishing its quality standard.Associative finger pattern,The quality of the drug can be controlled better,and the fingerprint technology can be used to monitor the whole process of drug production.