Dissertation
Dissertation > Medicine, health > Pharmacy > Pharmacy

Coenzyme Q_ (10) Intravenous Emulsion

Author DuanPengJie
Tutor WangSiLing
School Shenyang Pharmaceutical University
Course Pharmacy
Keywords Coenzyme Q10 Intravenous emulsion Preparation Process Physical and Chemical Properties Pharmacokinetic visits
CLC R94
Type Master's thesis
Year 2008
Downloads 55
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The coenzyme Q 10 (the CoQ 10 ) widely present in the body in a variety of higher animals, mainly distributed in the body to the heart, liver. Kidney, muscle, thyroid and pancreas, adult total body content of about 0.5 ~ 1.5g. Epidemiological studies consistently show that the human body after the age of 20, the body of coenzyme Q 10 levels decreased gradually, the the coenzyme within patients and lesions organizations Q 10 level will reduce the variety of due Coenzyme Q 10 deficiency disease is serious harm to human health. As fat-soluble endogenous highly active anti-oxidant, hydrogen delivery body of the mitochondrial respiratory chain and cell metabolism activator coenzyme Q 10 is widely used in the treatment of diseases such as cardiovascular disease and adjuvant therapy. Currently, the coenzyme Q of domestic commercially 10 injections, tablets, capsules, oil balls forms, since the coenzyme Q 10 highly lipophilic, poorly water-soluble, in the choice of dosage form and appropriate route of administration, the need for deeper exploration. Therefore, this article examines the basic physical and chemical properties of coenzyme Q 10 measured solubility, apparent oil / water partition coefficient (P), in the light, high temperature oxidation and strong acid, alkali environment of stability , based on the data obtained to determine the feasibility of coenzyme Q 10 prepared as intravenous emulsions. HPLC detection coenzyme Q 40 content. Drugs, oil phase carrier, mixed emulsifier system is drawn on the basis of the investigation in the basic physical and chemical properties of coenzyme Q 10 pseudo ternary phase diagrams screened soy lecithin and PluronicF-68 as mixed emulsifiers, and to determine the the mixed emulsifier best ratio and the total amount of, by orthogonal design experiments to determine the the intravenous emulsion prescription concentration (2.0mg/ml). Through the single factor experiment ultimately determine a reasonable process. Coenzyme Q 10 intravenous emulsion stability study is divided into physical and chemical stability study two aspects: the physical stability of the effects of the osmotic pressure of the emulsion and saline and 5% dextrose injection two kinds dilutions of with emulsion mixed after the particle size distribution changes, should be used before use injection diluent diluted 1:4, to better ensure Coenzyme Q 10 intravenous emulsion clinical application security. Description of the intravenous emulsion long-term storage of the physical parameters of change by accelerated experimental results; chemical stability study including heat, light and acceleration experiments, described by high-performance liquid test results in the homemade coenzyme Q 10 intravenous emulsion drug content changes. In vivo experimental part, the HPLC assay of the method of the plasma samples coenzyme Q 10 content, good linear relationship, recovery compliance, accuracy, high precision. By the method of the diluted sample to eliminate the rat blank plasma endogenous coenzyme Q 10 drugs Determination and credibility so as to improve the detection results. Fit pharmacokinetic study data to BAPP2.0 common procedures, the results showed: Coenzyme Q 10 intravenous emulsion belong to the two-compartment model pharmacokinetics in rats, and the solution agent is a single-compartment model. Both compared the coenzyme Q ( 10 intravenous emulsions significantly prolong the average retention time in the body, the drug area under the curve increases. On coenzyme Q 10 intravenous emulsions stability and pharmacokinetic evaluation. coenzyme Q 10 intravenous emulsion prescription, process, physical and chemical properties, pharmacokinetics evaluation results show that: Coenzyme Q 10 intravenous emulsion prescription viable, mature technology, stable physical and chemical properties, body safe and effective, with good prospects for application development.

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