Study On Technology Of Hedyotis Diffusa Willd. Injection And Its Quality Specification

Hedyotis diffusa Willd. was recorded in GuangxiChinese herbal medicine ambition,the whole grass of annual Hedyotis diffusa Willd.of Rubiaceae section,widely distributes in our country Yangtze valley and its south of.It mainly contains hentriacontane,stigmasterine,β-sitosterol,D-glucoside, oleanolic acid,ursolic acid,ferulic acid,polysaccharide and so on.It fulfills the functions of detoxification and damp elimination.It shows great effects on the treatments of urinary tract infection, sore throat, bacillary dysentery,snakebite, some cancers and so on.On the basis of examination,Hedyotis diffusa Willd. that is used to be anti-oncoma and immunoregulatory. Furthermore, injection has the fast pharmacodynamic action, The blood medicine density is high , The effective primary form absorption is complete high curative effect and so on.Thus, the quality of injection directly affect the result so that injection can play the good role in the course of treatment. In order to further enhances the existing quality specification of the injection for Hedyotis diffusa Willd. Myself have carried on the injection for Hedyotis diffusa Willd.craft and the quality specification research, what enables it to play the very good role in the anti- tumor domain.The main aim of this dissertation is to study the preparation procedure and quality control standards of Hedyotis diffusa Willd.Parenteral injection. The content of the dissertation are that the asperuloside extracts from Hedyotis diffusa Willd, study the preparation procedure and quality control standards,and that is the first time to set up the methord to assay the asperuloside in Hedyotis diffusa Willd. with HPLC. The results are as follows. 1. The preparation of asperuloside.It is reported that there are a few kinds of active substances presenting in Hedyotis diffusa Willd.Such as anthraquinones, iridoids, triterpeniods, coumari- ns. Asperuloside is one of iridoids exhibiting antitumor activity. Its isolation from Hedyotis diffusa Willd. An structure elucidation are determined in the paper.2. The preparation procedure2.1 Studying the alcohol extraction technics of Hedyotis diffusa Willd. by testing the content of asperuloside that is a effective component of Hedyotis diffusa Willd.The optimum alcohol concentration was studied firstly. Then selecting extraction time, extraction times, the alcohol amount as the investigating factors, the optimum preparation procedure was studied by orthogonal experiment. The reasonable and available process conditions were established.2.2 In order to ablate giant molecule maximum and active component loss smallest, by testing the content of asperuloside, we choose D-101 resin to depurate.The alcohol concentration, the cubic capacity of the water eluant, the cubic capacity of the alcohol eluant and the flow rate. The reasonable and available process conditions were established.2.3 In order to ablate the flocculent precipitate when the crude drug dissolved in the water or was refreezing we chose the methord of alcohol abstraction to depurate, and the asperuloside is the effective component of Hedyotis diffusa Willd. that has high dissolvability in alcohol.So the reasonable and available process conditions were established by testing the content of crude drug.3. Studying the methord that how to eliminate the tannin and definition the dissolubility of the crude drug in the aqua pro injectione.4. The quality criteria researchThe qualitative TLC and quantitative HPLC research were well studied in the dissertation.Hedyotis diffusa Willd. Parenteral injection were differentiated by TLC. The experimental results suggested that the spots on the chromatograms were clear, characteristic, reproducibility. The methods were applicable to controll the standards of crude drug-asperuloside and Hedyotis diffusa Willd.Parenteral injection asperuloside were quantitative determined by HPLC.The experimental results suggested that their linearity, precision, reproducibility, recovery were all satisfactory. Their content limit was regulated:the content of asperuloside(C18H22O11)in Hedyotis diffusa Willd. Parenteral injection is no less than 9.0mg per ramus(five ml).The results above-mentioned show that the preparation procedure of Hedyotis diffusa Willd. Parenteral injection is reasonable in technics, steady and controllable in quality. The Hedyotis diffusa Willd.Parenteral injection is a preparation of safety and effective antitumor drug.