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The Quality Standards Of Spreading Hedyotis Herb Oral Liquid And Active Ingredients Pharmacokinetic Study

Posted on:2010-01-21Degree:MasterType:Thesis
Country:ChinaCandidate:H F ZhangFull Text:PDF
GTID:2244360305485832Subject:Drug Analysis
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Baihuasheshecao which belong to rubiaceous family is the whole dried herb of Hedyotis diffusa Wild,which is cultivated widely in many provinces of China, such as Guangdong Province, Fujian Province, Jiangsu Province, Jiangxi Province, Anhui Province. The fresh Baihuasheshecao fulfills the functions of promoting blood circulation and removing blood stasis、detoxification and damp elimination, in present, which has been commonly used for the treatment of various tumors.In this paper,the preparation technology of Baihuasheshecao oral solution was studied;the quality standard of Baihuasheshecao oral solution were established; 3,4-dihydroxy methyl benzoate that was an important component in the oral solution was determined in rat plasma using HPLC method, which was applied to the pharmacokinetics study in rat plasma after intragastric administration of 3,4-dihydroxy methyl benzoate.1. The study on preparation technology of Baihuasheshecao oral solutionThe extract technologies of Baihuasheshecao were based on the the properties of the components in oral solution. Baihuasheshecao oral solution was made by water extraction combined with alcohol extraction. The processes of water extraction were investigated by orthogonal test with the contents of total Flavonoids and total Polysaccharides as the index. The best water extraction technology was extracted twice with 12 times water,2 hr/time. The residue of Baihuasheshecao were extracted with 12 times 70% alcohol solvent,liquor of alcohol extraction were concentrated,and then precipitated using water, filter liquor combined with liquor of water extraction were clarified using Chitosan.The best clarification technology was chose by single factor invtestigation.2. The study on quality control methods of Baihuasheshecao oral solution.A HPLC method was established to determine the contents of 3,4-dihydroxy benzoate、P-coumatic acid、ferulaic acid and E-6-O-P-coumaroyl scandoside methyl ester in Baihuasheshecao oral solution. The separation was performed on a DiamonsilTM C18 column with gradient elution. A:acetonitrile, B:methonal-water-glacial acetic acid (5:95:0.25, v/v/v), A:0-20 min,1%-16%; 20-42 min,16%; 42-46 min,16%-20%; 46-65 min,20%. The UV detection was set at 265 nm; flow rate 1.0 mL-min-1. A HPLC method was developed to determine the contents of 9 components in Baihuasheshecao oral solution with more study on Baihuasheshecao. in addition of the four components which were mentioned above, the other components were scopoletin、kaempferol、2,7-dihyodroxy-3-methyl anthraquinone、2-hydroxy-3-methyl anthraquinone and 2-hydroxy-l-methoxy-3-methyl anthaquinone. UV-Vis spectrophotometric methods were established to determine the total Polysaccharides and total Flavonoids of the oral solution.3. The pharmacokinetics of 3,4-dihydroxy methyl benzoate in rat plasma after intragastric administrationA rapid and simple HPLC method has been established to determine 3,4-dihydroxy methyl benzoate in rat plasma after intragastric administration. The plasma samples were processed with the method of acid-hydrolysis-organic solvent extraction. The analytes were separated on a DiamonsilTM C18 column with water-methanol-acetonitrile-acetic acid(100:6: 3:0.25,v/v/v/v) as mobile phase and detected at 254 nm at room temperature. The calibration curves were linear over the concentration range 0.1313~25.25μg·mL-1. The lower limit of quantification of 3,4-dihydroxy methyl benzoate in rat plasma was 0.1313μg·mL-1. The pharmacokinetics parameters of 3,4-dihydroxy methyl benzoate were as follows:t1/2 is 39.17±5.66min,AUC(0-t) is 0.85±0.13 mg·min·mL-1,Tmax is 30min, Cmax is 12μg·mL-1.
Keywords/Search Tags:Baihuasheshecao oral solution, Preparation technology, Quality standard, 3,4-dihydroxy methyl benzoate, Pharmacokinetics
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