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Study On Quality Standard And Preclinical Pharmacokinetics Of The Main Effective Ingredient From Jiang Xiang Dripping Pill

Posted on:2010-05-07Degree:MasterType:Thesis
Country:ChinaCandidate:Q XuFull Text:PDF
GTID:2144360275975560Subject:Drug Analysis
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Jiang-Xiang dripping pill is a new designed formula based on the Ping An Dan formula which was used in royalty of Qing Dynasty. On the basis of the traditional Chinese medicine theory, as well as pre-experimental with animal model of Motion Sickness, we selected the new preparation made of ginger, cablin patchouli herb and costustroot. Pre-clinical experiments shows that the drug is safe and effective, stable performance, take action quickly and long-lasting and effective dose small; mainly used in modern warfare to combat the occurrence of motion sickness.The ginger in the formula is warming middle energizer to arrest vomiting and used in nervous vomiting,sea-sickness and vomiting. It is the main integrative. Agastache rugosa;agastachis also prevent vomiting, headache.This research is to establish the methods of detecting the main effective ingredient in Jiang-Xiang dripping pill and its pharmacokinetics in rats.1. Study on quality standard of Jiang-Xiang dripping pillThe content analysis methods based on HPLC for detecting 6-gingerol, costunolide and dehydrocostuslactone was seted up. The pre-treatment of sample was as follows: The sample was extracted by petroleum benzin, then petroleum benzin was evaporated to dryness and the remnant was dissolved in methanol for detecting 6-gingerol, dissolved in ethanol for detecting costunolide and dehydrocostuslactone. chromatographic column: Agilent ZORBAX Eclipse DB C18(4.6mm×250mm, 5μm), column temperature: 35℃. The detecting parameters of 6-gingerol were like this: mobile phase: methanol - water (60:40); flow rate: 1.0ml?min-1; detection wavelength: 280nm; injection volume: 20μl, Standard curve: A =8.3757C-30.609(r=1), linear range:13.6-272μg/ml. The detecting parameters of costunolide and dehydrocostuslactone were like this: mobile phase: methanol - water–natrium aceticum(64:28:8); flow rate: 1.0ml?min-1; detection wavelength: 225nm; injection volume: 20μl. The standard curve of costunolide: A = 21.654C-27.283 (r = 1), linear range: 3.8-76μg/ml, the standard curve of dehydrocostuslactone: A = 18.663C-22.876 (r = 1), linear range: 4.8-96μg/ml. At the same time, these three detected compounds in Jiang-Xiang drop pill were identified by TlC, and a series of foreign materials were checked for limiting their content. The quality standard of Jiang-Xiang dripping pill was seted up.2. The main effective ingredient of Jiang Xiang dripping pill and the Pharmacokinetics of 6-gingerol in rats.The reports have shown that 6-gingerol,the main ingredient of ginger, has the property of anti-tumor and preventing vomiting caused by chemical therapy. Therefore, 6-gingerol is a worthy ingredient for the evaluation of new formula, and the pre-clinical pharmacokinetics of it will provide data and reference for the clinical pharmacokinetics. In our research we estimate the method of analysis of 6-gingerol in rat plasma, the plasma was firstly precipitated with acetoacetate and N-hexane (1:1),then 6-gingerol in the sample was detected using HPLC-MS-MS (Thermo Finnigan TSQ Quantum) with meloxicam as the internal standard. The HPLC included column(AQ C18 5μm 250mm×4.6mmm, Japan),flow phase (methanol:water=80:20, (0.1% formic acid added),flow rate (0.5 ml/min). The recovery rate of this method was high and the precision, accuracy and linearity all satisfied the demand of the drug analysis in plasma.The result of 6 Wistar rats (180g-250g), male and female are half part showed that the administration of Jiang Xiang formula (2.1mg/Kg, oral) could make six concentration-time curves of 6-gingerol in plasma. And the parameters of pharmacokinetics was calculated using the DAS2.0 software based on the room model, the Tmax, Cmax and AUC were respectively. It showed that the absorption and elimination were both soon in Wistar rats.
Keywords/Search Tags:Jiang Xiang dripping pill, 6-gingerol, costunolide, dehydrocostuslactone, HPLC-MS-MS, pharmacokinetics, plasma
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