Study On The Normalization Of Quality Standard Of Silybum Marianum As Medicinal Materials

Milk Thistle is the desiccative ripe fruit of Silybum mariamum(L.)Gaertrn,which belongs to the Composite family.Due to its effects of heat-clearing,detoxifying,liver-relieving and gallbladder,it is often applied to treat liver and gallbladder damp heat,rib pain,and jaundice.Milk Thistle contains a large number of flavonoids,which is called silymarin including silybin,isosilybin,silidianin and silychristin.Silymarin is one of the mainly used natural medicine for clinical to treat NAFLD.In this wok,a total of 13 batches of Milk Thistle from 6 different areas was used.The quality requirements of Pharmacopoeia around world and the research concepts of QbD is combined.The traditional quality,chemical quality,and safety quality were together applied to construct the standardized design of comprehensive quality evaluation system for Silymarin.We hope that it could effectively compensate for the limitations of single content measurement control,and that the quality of silymarin is evaluated as a whole.The main results were as following:1)The traditional quality evaluation standards of silymarin in Chinese and American Pharmacopoeia are basically consistent.The principle of detection method is the same.Their differences in the parameters and standards of some test methods do not affect the quality evaluation of silymarin.In this work,Silymarin in terms of their properties,microscopic identification,dry weight loss and ash content from different places of origin can meet the requirements of Chinese and American Pharmacopoeia.There was no significant difference.Cpmpared with the 4 batches of medicinal materials from Hailaer and Baiquan,More non medicinal impurities such as straw,sand and gravel are mainly related to the initial processing of silymarin after harvest.Therefore,exogenous impurities can be used as one of basis standards for grading the silymarin medicinal materials in the market.2)The results with Thin layer chromatography and high performance liquid phase analysis show that the chemical compositions of Milk Thistle from different areas were higher consistency,while their contents showed significantly different.In view of the levels of silybin and silymarin,the contents of silymarin in the 3 batches of Milk Thistle from Haichheng were relatively high,while their silymarin contents from the Baiquan and Panjin were relatively low.There were also significant differences in the relative peak area of silithin or silybin in the medicinal materials from different place of origin.These differences are likely related to the growth earth,climatic condition,geographical environment,processing technology,and so on.3)Although aflatoxin was not detected in MilkThistle from different areas,it was found that the Cu content in all batches of MilkThistle maintained the higher levels.This may be related to the accumulation of Cu elements in the soil during the growth of silymarin.So it is necessary to detect the level of heavy metals during the process of planting silymarin,so as to prevent the accumulation of heavy metal elements in growth process of MilkThistle to make sure the safety of Milk Thistle.Taken together,a standardized quality evaluation and standard system for silymarin is established preliminarily combined Optimization detection method through applicability evaluation with TLC identification,fingerprint and content measurement.These results provide reference and experimental basis for improving the quality control of Milk Thistle.