Study On Quality Standard Of Gardenia Fructus From Gardenia Jasminoides Ellis. Var. Grandiflora Nakai And Preparation And Quality Control Of Gardenia Yellow Pigment

Objective: Belonging to Gardenia genus in Rubiaceae family,Gardenia jasminoides Ellis var.grandiflora Nakai is a variant of Gardenia jasminoides,and it can be used for preparation of gardenia yellow pigment(GYP),which is widely applied in food and dyestuff industry.However,the origin of crude drug Shuizhizi(fructs mainly from Gardenia jasminoides Ellis var.grandiflora Nakai)is complex,widely distributed,and it lacks effective quality control method and systematic research.Therefore,it is necessary to establish the quality standard of Shuizhizi by this research.At the same time,it was found that the GYP extracted from the fruits of Gardenia jasminoides Ellis var.grandiflora Nakai could be used to produce crocetin which is an effective component of saffron.As an alternative plant resource of saffron,the fruits could be used as the starting material for mass production of crocetin.In this thesis,it is urgent to study the preparation process and the internal control standard of GYP to provide the intermediate material with continuous resources,huge output,feasible process,low cost and stable quality for the research and development of new drugs of crocetin and its derivatives.Methods: Based on the collection and systematic study on the fruits of Gardenia jasminoides Ellis var.grandiflora Nakai from different areas and harvest times,the pharmacognosic identification method of Gardenia jasminoides Ellis var.grandiflora Nakai and its fruits was established,and the UV detection and the color value evaluation method of the effective total components of Crocetins were established.At the same time,methods was established for the determination of Crocins I & II,and geniposide by HPLC and fingerprint of Shuizhizi by UPLC-MS.On the basis of the above research,the quality comparison of 48 batches of Shuizhizi from different areas and 11 batches of Gardenia Fructus(the fruits of Gardenia jasminoides Ellis var.grandiflora Nakai)with different harvest time were carried out,and the best area and the best harvest time of Gardenia jasminoides Ellis var.grandiflora Nakai were determined.Concurrently,the quality of Shuizhizi were systematically analyzed and compared with that of Gardenia Fructus.The method of extracting and purifying GYP from Shuizhizi were determined by the single factor investigation and orthogonal experiment.Three batches of polit-plant enlargement tests were completed to verify the homogeneity and stability of the preparation method.Meanwhile,the internal enterprise standards of GYP were established by TLC identification,determination of total crocetins content(by ultraviolet spectrophotometer),color value and OD,and the stability of GYP was investigated.Result:The quality standard of Shuizhizi has been established in this thesis,which provides a systematic evaluation method for the quality control of the crude drug.Based on the quality comparison of Shuizhizi from different areas,Shuizhizi from Anhui was determined to be the best one in quality.The quality of Shuizhizi in different harvest time was compared.The optimum harvest time was determined to be from mid-October to late November of every year.By comparing the quality of Shuizhizi with that of Gardenia Fructus,it is determined to choose Shuizhizi as the starting material.At the same time,the preparation method and internal enterprise standards of GYP were established,the process was stable,and the quality was controlled.To sum up,the research results of this subject: The fruits of Gardenia jasminoides Ellis var.grandiflora Nakai can become a alternative resources of saffron which is a valuable and rare traditional Chinese medicine for crocetins.It can be used to develop new drugs of crocetin and its derivatives for the treatment of cardiovascular and cerebrovascular diseases.