| Objective:To establish quality control methods for Zhuang medicinal herb Bauhinia aurea.10 batches of Bauhinia aurea from 7 different producing areas in Guangxi were comprehensively and systematically evaluated through the study of pharmacognostical identification,test items,content determination,etc.,and the quality standards(draft)of Bauhinia aurea were formulated according to the quality evaluation results,which provided scientific basis for the development of its quality standards.Methods:1.The herbal textual research of Bauhinia aurea was carried out by the method of literature research.2.According to the general chapters of the current edition of Chinese Pharmacopoeia,the methods of primary identification,morphological identification,microscopic identification,TLC identification and HPLC were used in the pharmacognostical study of Bauhinia aurea.3.Referring to the relevant methods of the general chapters of the current edition of Chinese Pharmacopoeia,the water content and ash content of Bauhinia aurea were tested respectively,and the limits of the 2 items were drawn up.4.The determination method of extract content was established,and the contents of Bauhinia aurea from 7 regions of Guangxi were tested,according to the general chapters of the current edition of Chinese Pharmacopoeia.5.A HPLC method was developed for content determination of astilbin and quercitin in Bauhinia aurea under suitable chromatographic conditions,and it was used to determine the content of the 2 components and evaluate the quality of Bauhinia aurea from 7 places.6.The method of HPLC was used to establish fingerprints of Bauhinia aurea from different producers,and the characteristic parts of fingerprints of10 batches were analyzed by similarity evaluation,cluster analysis and principal component analysis.7.The acute toxicity test of Bauhinia aurea was carried out by maximum tolerance method,and the safety of Bauhinia aurea was evaluated according to the test results.8.According to the format of the current edition of Chinese Pharmacopoeia and the quality evaluation results of Bauhinia aurea from 7places of origin,the quality standard(draft)and the draft descriptions of this Zhuang medicinal herb were formulated.Results:1.The origin,alias,producing area,processing,tropism of taste and function of Bauhinia aurea was completed by literature research.2.The characteristics of primary identification,morphological identification,microscopic identification of Bauhinia aurea were determined,and the method of TLC was developed.The origin of Bauhinia aurea was identified as the stem with leaves of Bauhinia aurea.The characters of Bauhinia aurea were as follows: It is a perennial stout woody vine with reddish brown hairs on the surface of stems,leaves,flowers and fruits.A large number of stone cell groups and crystal fibers can be seen in the cortex of the transverse section of stems.The xylem is wide,and the calcium oxalate cluster crystals and square crystals are scattered in the parenchyma of pith.The cross section of the leaves showed that the leaves are bifacial leaves.Calcium oxalate cluster crystals and square crystals are commonly found in the cortical parenchyma cells.Secretory cavities are arranged intermittently into a ring in the phloem.Around the lateral phloem,there are fiber bundles,and crystal fibers are often seen here.Calcium oxalate cluster crystals,crystal fibers,stone cells,bordered pit vessels,non-glandular hairs and stomatas can be found in the powder.The fluorescence spots of samples were displayed in the same color and in the same position as the reference substances hyperin,quercitin and astilbin in the TLC figure.Smell slightly,taste bitter,slightly bitter.3.The moisture content ranged from 4.81%~10.43%,the total ash content was 4.01%~7.13%,and the acid-insoluble ash content was0.09%~0.51%.4.The test method of extract content of Bauhinia aurea was determined,and the content of 50% ethanol-soluble extract of 10 batches of samples was7.47%~10.83%.5.A HPLC method for the determination of astilbin and quercitin in Bauhinia aurea was established.The linear ranges of astilbin and quercitin were 0.005888~2.355 μg(R=0.9996)and 0.03955~1.582 μg(R=0.9998).The average recoveries(n=6)were 96.42%(RSD=2.55%)and 104.2%(RSD=1.79%).The content of astilbin and quercitin in Bauhinia aurea from 7regions was 0.01794~2.9121 mg/g and 1.364~2.431 mg/g.10 batches of Bauhinia aurea all contained astilbin and quercitin.The contents of quercitin from 7 places were uniform,but the contents of astilbin were different.The contents of astilbin and quercitin were both high in HST-7、HST-10 while low in HST-2.According to the dry medicinal herb,the content of astilbin and quercitin in Bauhinia aurea should not be less than 0.02% and 0.10%.6.The HPLC fingerprints of Bauhinia aurea of 10 batches were established.The quercitin peak was used as reference peak.11 common peaks were found in the fingerprints,and 3 of them were identified as components epicatechin,hyperoside and quercitin.The similarities of 10 samples were all greater than 0.9.Different batches of Bauhinia aurea were divided into 4categories by cluster analysis and principal component analysis.7.The MTD of water extract of Bauhinia aurea for mice≥408g crude drug/kg.8.The quality standard(draft)and the draft descriptions of Bauhinia aurea were compiled.Conclusion: In this paper,the studies of pharmacognostical identification,test items,extracts,content determination,fingerprints and acute toxicity of Bauhinia aurea were carried out,and 10 batches of sample were evaluated comprehensively and systematically.The quality standard(draft)and description of Bauhinia aurea were drafted according to the current edition of Chinese Pharmacopoeia,which were scientific and feasible,and provided basises for the quality control and clinical medication of Bauhinia aurea. |