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Studies on Qulity Control and Pharmacokinetic of Fufangdanzhi Granule

Author: PanMeiMei
Tutor: YuZhiGuo
School: Shenyang Pharmaceutical University
Course: Pharmaceutical Analysis
Keywords: The compound Dan Gardenia particles Quality Control Pharmacokinetics
CLC: R285
Type: Master's thesis
Year: 2008
Downloads: 67
Quote: 0
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Abstract


Compound Danzhi particles is a compound Chinese medicine preparations, Salvia, gardenia, flavescens, Cork four flavor with silymarin efficacy has such as qingrejiedu dampness. Its quality control method, with the main index components of the original to protocatechuic aldehyde geniposide pharmacokinetic study. Matrine in Chinese herbal medicine Salvia of protocatechuic aldehyde and Sophora High Performance Liquid Chromatography. The linear range of 2.7 ~ 27μg · mL -1 (r = 0.9999) and 6.5 ~ 130μg · mL -1 (r = 0. 9999); recoveries were 96.5% (RSD = 1.2%) and 99.8% (RSD = 1.7%). Established HPLC assay meets the requirements of quantitative analysis for stabilize particles Compound Danzhi quality raw material security. The establishment of a compound Danzhi particles Zhongyuan catechu aldehyde, geniposide, matrine and berberine content HPLC assay, the linear range of 1.35 ~ 27.0μg · mL -1 (r = 0.9999), 11.6 ~ 232μg · mL -1 (r = 0.9998), 6.5 ~ 130μg · mL -1 ( r = 0.9999) and of 2.5 ~~ 50 μg · mL -1 (r = 0.9993); recoveries were 98.7% (RSD = 1.0%), 97. 2% (RSD = 0.9%), 97.5% (RSD = 1.9%) and 96.5% (RSD = 1.4%). Determination of three batches of samples, the results: protocatechuic aldehyde content of 2.01 ~ 2.16mg · Bag -1 , The content of Geniposide 21.9 ~ 23.2mg · bag -1 , the Matrine content 5.67 ~ 6.76mg · Bag -1 , the Berberine the content of 2.38 ~ 2.53mg · Bag -1 . The HPLC assay meets the requirements of quantitative analysis, stable quality the compound Danzhi particles, controlled methodologies protection. Of protocatechuic aldehyde in rat plasma, a geniposide the HPLC assay, p-hydroxybenzoic acid as an internal standard, the plasma by ethyl acetate extraction backward sample analysis. The use Diamonsil C 18 (200 mm x 4.6 mm, 5μm the Dima company) column, methanol -0.5% acetic acid solution (22:78, v / v) as the mobile phase ; flow rate of 1.0mL · min -1 , and the column temperature was 25 ° C; detection wavelength of 238nm for geniposide injection volume of 10 μL of. The linear range of protocatechuic aldehyde and geniposide were 0.0425 8.50μg · mL -1 (r gt; 0.995) and 0.07 ~ 14.0μg · mL -1 (r gt; 0.994); the extraction recoveries not less than 82.1% and 62.7% respectively; intraday and interday RSD not more than 8.9%. Established methods to comply with the requirements of the biological sample quantitative analysis. Gavage the given compound Danzhi particle solution of protocatechuic aldehyde in rat plasma concentration of 0.264 ± 0.034h Tmax, Cmax 1.858 ± 0.378μg · mL -1 , t 1/2 is 0.724 ± 0.103h the the AUC -t 1.724 ± 0.433μg · h · mL of -1 , the body process in line with the one-compartment model; the geniposide plasma concentration of 0.708 ± 0.188h Tmax, Cmax was 3.337 ± 0.738μg · mL -1 t 1/2 is 1.157 ± 0.582h the the AUC -t 5.445 ± 0.599μg · h · mL - body process in line with the two-compartment model.

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CLC: > Medicine, health > Chinese Medicine > Of Pharmacy > Pharmacology
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