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Studies on the Quality Control of Ozagrel Hydrochloride and Its Pharmacokinetics

Author: YanLinZuo
Tutor: GuoXingJie
School: Shenyang Pharmaceutical University
Course: Pharmaceutical Analysis
Keywords: Hydrochloric acid ozagrel The hydrochloric acid ozagrel sheet Of hydrochloric acid ozagrel capsule Pharmacokinetics
CLC: R96
Type: Master's thesis
Year: 2006
Downloads: 65
Quote: 0
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Abstract

The hydrochloric acid ozagrel belong to lipid inflammatory mediators inhibitor class of anti-asthma drug. The drug has been on sale in Japan for many years, in our country is still in the pre-clinical research stage. In this paper, the quality control method of hydrochloric ozagrel its preparation; designed and optimized prescription tablets and capsules, studied the preparation process of the preparation; and efficient solution of the test animal after administration of the drug concentration in the plasma phase chromatography, used to study the hydrochloric acid ozagrel in rats in vivo pharmacokinetics. 1. The hydrochloric acid ozagrel indicators of bulk drugs, bulk drugs and formulations quality control methods in accordance with the technical requirements of the guiding principles of the Pharmacopoeia and chemical substances were investigated. Its non-aqueous titration Determination Method; using high performance liquid chromatography (HPLC) and conducted in-depth research on of hydrochloric acid ozagrel intermediates and decomposition products, synthetic hydrochloric ozagrel identified four possible intermediates exist impurities by reverse phase ion pair chromatography achieve ozagrel hydrochloride and the separation of the four different polarities intermediates, and by using the same chromatographic conditions, the separation of the decomposition product of the compound pH destruction. Establish a quality control method of hydrochloric acid ozagrel tablet, using ultraviolet spectrophotometry dissolution of hydrochloric acid ozagrel tablets; using high performance liquid chromatography Determination of hydrochloric ozagrel sheet content; using reversed-phase ion chromatography The method checks ozagrel piece decomposition products. Reference of hydrochloric acid ozagrel tablet quality control methods, and quality control methods established of hydrochloric acid ozagrel capsules. 2. The hydrochloride ozagrel preparations research based on hydrochloric ozagrel physical and chemical properties, reference to similar foreign drugs designed tablet prescription. Combined with commonly used excipients and tablet, examine the compatibility of the of hydrochloric acid ozagrel and accessories. Compatibility, choose accessories design does not work with the drug prescription, and then optimize the prescription. The optimized prescription tablets prepared appearance, suitable hardness, dissolution and high impact factor test; prepared the hydrochloric acid ozagrel chip, the results show that the tablets are stable under high temperature, high humidity, and bright light conditions. The prescription for optimization, the reference to the development of the tablet design capsules prescription and its preparation has been load difference meet the requirements, the dissolution rate, nature and stability of capsules; the influencing factors on the capsules obtained The test results show that its contents are stable under high temperature, high humidity, and bright light conditions. 3. Of hydrochloric acid ozagrel pharmacokinetic studies in rats in this article establish a simple, sensitive high performance liquid chromatography determination the rat plasma hydrochloric ozagrel and its pharmacokinetic process. Acetaminophen as an internal standard, the samples using protein precipitation with methanol, C ₁₈ reversed-phase column filter membrane separation, detection wavelength of 300 nm. Of hydrochloric ozagrel linear range 0.1μg · mL ^{-1 ~ 50μg · mL ^{-1 , quantitative limit was 0.1μg · mL ^{-1 . Intraday precision (RSD) of 2.2% to 5.0%, inter-day precision (RSD) was 3.3% to 7.0%, from 0.2% to 8.6% accuracy (RE) of the Act applies to rats in vivo pharmacokinetic research. Rats were given a single dose the hydrochloric acid ozagrel 20 mg · kg ^{-1 measured plasma concentration of hydrochloric ozagrel in, pharmacokinetic parameters show that the absorption of the drug in rats rapidly, with an average peak time 0.72h, average peak concentration of 6.0μg · mL ^{-1 , AUC _{0 ~ t} to 473.8 ± 88.5μg · min · mL ^{-1 , the rats were orally administered drug process in line with the single-compartment model.}}}}}}

Studies on the Quality Control of Ozagrel Hydrochloride and Its Pharmacokinetics

Abstract

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