| The rate of Diabetes mellitus patients is rising up with the society rhythm speeding up year by year. The traditional Chinese medicine has been more and more getting the recognition and favored by the world for its ?medicine food homology? in diabetes treatment.In this paper, with the new-made hypoglycemic chinese medicine made of ?the black bean and the Gynura procumbensrecu extract? being taken as the research object, the extraction process of the gynura procumbens was optimized and the analysis methods of the medicine were established, including the UV spectrophotometry, High Performance Liquid Chromatography(HPLC); A correlation research of the biological active ingredients between UV and HPLC was carried out. Then, based on this, a quality control system of the medicine was established.The main content is as follows:The establishmenot of the analysis methods.Some related studies show, "the oligopeptides, the chlorogenic acids" are the active ingredient in this medicine. Using the characters of the absorption at ?220,275 nm; 280,325 nm? of the active substances, the methods of ?the UV spectrophotometry?, ?GPC, C18 HPLC with the DAD detector? were established to control the quality of the medicine.Besides,the C18 fingerprint spectra was methodology validated, and the results showed that the method had high precision, stability and repeatability.The optimization of the extraction process.Based on the positive correlation between the UV absorbance and the extraction rate of chlorogenic acid in the Gynura procumbensrecu, the method of the UV spectrophotometry was taken to monitor the content of the chlorogenic acid under different extraction conditions. Considering that the broken degree of the stalk and leaf sample of the Gynura procumbensrecu has great effect to the extraction rate of chlorogenic acid, the sample on 0.5 mm sieve was choosen as the test sample, taking the factors of ?extracting time, crushing energy and the later filter? into consider;Then, in order to improve the extraction rate of the active substances, the conditions of the extraction process were optimized, including the "alcohol content, liquid-solid ratio and soaking time, extracting time and times". The results showed, the optimized conditions were: the alcohol content being 40%, liquid-solid ratio being 25 m L/g, soaking time being 0 min, extraction time being 30 min, extraction times being 1 times.The quality control of the medicine.Based on the correlation of the active substance's UV absorbance and the HPLC results, the UV- HPLC fast test method was established. Its linear correlation equations were as follows: for soybean peptide in the black bean extract: y = 5673.25 x- 307.77, R2 = 0.9811; for chlorogenic acids in stalk of the Gynura procumbensrecu extract: y = 1378.17 x- 72.66, R2 = 0.9636; for chlorogenic acids in leaf of the Gynura procumbensrecu extract: y = 1204.32 x- 130.85, R2 = 0.9739. The peptide molecular distribution was analyzed by GPC. The results showed, the commercial black bean from different regions had a different peptide molecular distribution;the different batches of black bean extracts offered by part A had a similar peptide molecular distribution, with high percent of peptide with the molecular < 1000, including the percent of smaller than 2 peptide being about 22%, 2-6 peptide being about 50%.The extension of the fermentation could lead to a smaller molecular of the peptide;The C18 fingerprint chromatogram, combined ?the traditional Chinese medicine(TCM) fingerprint computer aided similarity evaluation software ", was used for quality evaluation of the actual samples. The results showed that each batch of the black bean extract had a high similarity, as the the Gynura procumbensrecu had a poor one. |
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