Research On Quality Control And Optimization Of Pericarpium Arecae And Other Herbs In A3 Preparation

In order to adapt to the fast development of modern society,the new economic environment and higher technical requirements of national drug regulators in the production and quality control, safety evaluation of Chinese formulated products. To achieve the modernization of TCM, internationalization. To accord with the standard of Chinese green medicine and establish a demonstration standard of the enterprises.A3 preparations as the demonstration, studied the quality control method of medical material, cut crude drug, extract, and the quality control of TCM production process,and established the quality control indexes of demonstration species. set an example for the total quality control of traditional Chinese medicine and establish the technical trade measure.A3 preparations is a millennium traditional prescription, composed with magnoliae cortex,pericarpium arecae,perillartine,Glycyrrhiza uralensis, ad. It's functions are dispelling pathogenic factors from the exterior of the body and resolving dampness,regulating the flow of qi and warming middle-jiao. It's indications are Exterior syndrome due to invasion of exopathogens,pathogenic dampness accumulating in the middle-jiao,headache and dizziness,abdominal distension and pain,vomiting and diarrhea,influenza of gastrointestinal type ad. By pharmacodynamics screening, ingredients in A3 preparation decocted segregated, intermediate preparations made the A3 preparation, and products quality is stable, controllable. Through the standardized management GAP in traditional Chinese crude drug planting,production, use modern technology to establish a reliable and stable quality control method and the feasible quality standards on traditional Chinese herbs.Through bencaological study and modern commodity investigation, identified the history of pericarpium arecae, and its use in past dynasties, Ten batch of pericarpium arecae samples were collected from different areas. Summarized the distribution,main producing areas,commodity circulation areas of pericarpium arecae.For the first time, systematically studied chemical composition of petroleum ether extraction of pericarpium arecae.17 compounds were obtained from this part, and their structure were identified by IR, UR and MS,¹H-HMR,¹³C-HMR.And they were:hexadecanoic acid, beta sitosterol and so on Definited the chemical composition of petroleum ether extraction of pericarpium arecae.For the first time, studied on the chemical constituent from petroleum ether extraction of pericarpium areca by Gas Chromatography-Mass Spectrometry, and established GC-MS finger printing of petroleum ether extraction of ten samples of pericarpium areca and evaluation method by GC-MS. and established a scientific and feasible quality evaluation system of pericarpium arecae based on multiple index. Provid theoretical basis for quality evaluating system in medical material planting,purchasing, production of Chinese formulated products.Pericarpium arecae have copious provenance source genetic diversity, based on the RAPD genetic distances clustering through molecular markers, the study indicated that ten batch of pericarpium arecae samples can be divided into 3 or 2 branch, clustering results and geographical distribution have no obviously correlation, Mantel inspection results showed that the genetic distance signed by two kinds of molecular markers was significant correlative, and RAPD marker can be used in the study of pericarpium arecae genetic diversity.Based on the study of 46 kinds of purple common perilla samples in the whole country, found that effective constituents content difference from different origin is very great. Therefore, systemly screened the breed variety of purple common perilla, planting base, harvest time, processing method, abstraction technology, and established quality criteria and finger printing method. The fuel oil was blended into effective component with stable quality, volatile oils was inclued by hydroxypropyl-beta cyclodextrin.Study on the long-term stability and accelerate the stability testing showed that the oil hydroxypropyl-β-cyclodextrin inclusion compound can increase the stability of effective ingredients and reduce the degradation rate.Applicated the Box-Behnken design-effect surface method to optimize preparation process of perillartine hydroxypropyl-β-cyclodextrin inclusion compound first time,used molecular simulation technology to study with inclusion principle. Studied the inclusion compound structure by the infrared spectrophotometry, X-ray,¹H-NMR,DSC-TG test, the results showed that the experiment can be in accordance with the designed scheme.Based on the systemly study of pericarpium arecae, perillartine, established an research model of other ingredients in A3 prescription and internal enterprise standards. Improved the production process, quality control, quality and therapeutic effect, and made the product is safe and effective, quality controled, stable. Enhanced the core competence of the enterprise, and expanded the market share of the products, provied a standard research model for TCM modernization and internationalization.