| Pudilan Xiaoyan Oral Liquid is composed of 4 traditional Chinese medicines:Dandelion,Kuditin,Isatis indigotica and Radix Scutellariae.It has the effects of clearing away heat,detoxifying,reducing swelling and pharyngitis,and antibacterial.It is clinically effective in the treatment of hand,foot and mouth disease,bronchitis,pharyngitis,mumps,and tonsillitis.Pudilan Xiaoyan Oral Liquid have significant curative effects on Inflammation and other diseases,and are prescription preparations included in the 2020 edition of the Chinese Pharmacopoeia.Because the single medicinal materials that make up the preparation are produced in many places,there are large differences in quality and unevenness of good and bad.The quality of the original medicinal materials has a great influence on the efficacy of the preparation,and many researchers have commented on the pharmacological effects of Pudilan Xiaoyan Oral Liquid.And there are many researches on the content determination of certain chemical components in preparations,but there are relatively few studies on the quality of a single medicinal material comprehensively evaluating the quality of a variety of indicators,and the research on the evaluation of Chinese medicine resources is even rarer.Therefore,the resource assessment of the raw material of the preparation was carried out to formulate a stable,feasible and comprehensive quality standard system,to screen out raw materials with high quality and stable supply for the composition of Pudilan Xiaoyan Oral Liquid,and to establish quality standards for the original materials,The formulation of "Enterprise Internal Control Standards" for various medicinal materials is very important.This article takes four Chinese medicinal materials,the raw materials of Pudilan Xiaoyan Oral Liquid,dandelion,Kuditin,Isatis indigotica,and scutellaria,as the research object.Based on the current pharmacopoeia,a variety of quality control indicators are added to analyze and evaluate the quality of each medicinal material,and establish an evaluation system for high-quality medicinal materials The evaluation system conducts a comprehensive evaluation of each medicinal material to ensure the uniformity,quality and stability of the quality of medicinal materials.In addition,in view of the mixing of the original plants of Kudibutyl and the different harvesting standards,this study established the DNA molecular identification of the kuditin and its congeners and its genus based on the ITS2 sequence,and the chemical composition differences of the genus and its genus based on the HPLC fingerprint.Sexual research methods were used for the identification of kuditin,and the differences of alkaloids in different parts of kuditin in different harvest periods were studied.The subject research content is mainly divided into the following aspects:Chapter 1:Evaluation of the raw material resources of Pudilan Xiaoyan Oral LiquidThrough systematic research on the four herbs of dandelion,kudiding,Isatis indigotica and scutellaria,and combined with modern research,we have conducted visits and investigations to genuine producting area and the planting bases of cooperative enterprises,including the estimated consumption,the estimated availability,potential risks,quality analysis and evaluation,sustainable use and quality stabilization measures of raw materials.The quality analysis and evaluation part is mainly based on the 2020 version of the Chinese Pharmacopoeia to evaluate the quality of different batches of medicinal materials collected from different origins and establish quality control standards for high-quality medicinal materials based on measured data.Considering the relationship between the quality and output of various medicinal materials,the evaluation conclusions are as follows:1.Dandelion:Three dandelion planting bases in Weinan City,Shaanxi Province are used as high-quality bases to provide enterprises with dandelion raw materials.Taking into account uncontrollable factors,the dandelion planting base in Qingyuan County,Baoding City,Hebei Province is used as a reserve base for emergency need.2.Kuditin:The Kuditin planting base in Anguo City,Hebei Province is used as a high-quality base to provide enterprises with Kuditin raw materials,and the Kuditin planting base in Xinbei Disrict,Jiangsu Province is used as a reserve base.3.Isatis indigotica:Thelsatis indigotica planting base in Minle County,Zhangye,Gansu Province will be used as a high-quality base to providelsatis indigotica raw materials for enterprises,and thelsatis indigotica planting base in Datong District,Daqing City,Heilongjiang Province will be used as a reserve base.4.Radix Scutellariae:The Scutellaria baicalensis plantation base in Niujiayingzi Town,Chifeng City,Inner Mongolia is used as a high-quality base to provide enterprises with raw materials for Scutellaria baicalensis.The Scutellaria baicalensis plantation base in Weichang Manchu and Mongolian Autonomous County of Chengde City,Hebei Province is used as a reserve base.The sustainable use of four medicinal materials can effectively prevent potential risks,the estimated consumption and the estimated availability.Xiaoyan Oral Liquid poses a low risk to the sustainable use of traditional Chinese medicine resources.Chapter 2:Quality evaluation and analysis of the raw materials of Pudilan Xiaoyan Oral LiquidThrough the quality analysis and evaluation of the samples collected from each producing area,the planting bases with high quality and stability are selected,and the quality control standards for medicines are established.Dandelion:In the thin-layer identification study,caffeic acid index was added on the basis of the 2020 edition of the Chinese Pharmacopoeia,and the thin layer identification method that the corresponding position of the reference substance caffeic acid,cichoric acid and the reference medicinal material showed the same color in the sample for test of chromatogram was established.The test items for total ash,acid-insoluble ash,water-soluble extract and alcohol-soluble extract have been added,and quality control standards for pharmaceutical materials have been established on the basis of the data obtained.The fingerprint of dandelion established by high performance liquid chromatography(HPLC)take cichoric acid as the reference peak,14 common peaks were determined,the simultaneous determination of chlorogenic acid,caffeic acid,cichoric acid isochlorogenic acid A and total flavonoid conten was established and the quality control standard of the medicine was established.Kuditin:On the basis of the 2020 edition of the Chinese Pharmacopoeia,the total ash and acid-insoluble ash testing items have been added and the quality control standards for high-quality drugs have been formulated,and the content standards for the pharmacopoeia extracts have been increased by 20%.The fingerprint of Kuditin established by high performance liquid chromatography(HPLC),15 common peaks were determined with coryllin as the reference peak,and the simultaneous determination of coryllin,acetyl coryllin and blood root was established.The method for determining the content of alkali and establishing quality control standards for drug materials.Isatis indigotica:On the basis of the 2020 Chinese Pharmacopoeia,the fingerprint of Radix isatidis was established by high performance liquid chromatography(HPLC).With(R,S)-Gaoyichun as the reference peak,10 common peaks were determined and established Simultaneous determination of uridine,guanosine,(R,S)geirulin and adenosine content determination methods and establishment of high-quality drug material control standards.Radix Scutellariae:On the basis of the 2020 edition of the Chinese Pharmacopoeia,a fingerprint profile of scutellaria baicalensis was established by high performance liquidchromatography(HPLC).With baicalin as the reference peak,14 common peaks were determined,and the simultaneous determination of baicalin and scutellaria was established.Determination methods for the content of Liaozhisu A glycosides,wogonin,baicalein and wogonin,and establish quality control standards for drug materials.Chapter 3:Study on the Identification of the Original Plant of KuditinDNA molecular identification based on the ITS2 sequence of D.edulis and its genus:Through the identification and analysis of the ITS2 sequence of the original plant of bitter butyl grass and the same genus,the total DNA extraction,PCR amplification,and sequencing success rate was 100%,indicating that ITS2 has a good completion rate and a strong applicability for the identification of the same genus.Based on the analysis of the sequence length,GC content,K2P genetic distance and inter-species variation of the ITS2 sequence of Geodin and its genus,we can effectively identify Geodin and its genus.Study on the difference of chemical constituents of D.chinensis and its plants based on HPLC fingerprint:Through the establishment of a characteristic map of Geodin and its genus,the similarities between Tianmawu,Corydalis,Corydalis and Badong Corydalis are higher,with more common peaks,and similar chemical components.The content of Corydalis and Acetyl Corydalis in Jingyuan Corydalis is much higher than that of Corydalis.Chapter 4:Study on the Differences of Alkaloids in Different Parts of Kuditin at Different Harvest PeriodsIn the study of the differences of alkaloids in different parts of Kuditin at different harvesting periods,it can be concluded that the content of corydalis in the above-ground parts of any place of production is significantly higher than that in the underground parts.The difference of acetyl corydalis in the above ground and underground parts of Kuditin is not as great as corydalis,but the content in the above ground is generally higher than that in the underground part;The content of dihydrosanguinarine in Kuditin is lower than that of Corydalis and Acetylcorylline.The content of dihydrosanguinarine in Pizhou production area is The content of underground parts is the highest,even higher than the content of Corydalis.The three alkaloids in Kuditin reach their peaks in mid-to-late May,regardless of the above-ground or underground parts.Considering the relationship between the dose-effect ratio,the best harvesting period for Kuditin is mid-May.Late. |
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