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Itraconazole temperature-sensitive type gel preparation as well as preparation method and application thereof

A temperature-sensitive, gel preparation technology, applied in the field of medicine, can solve the problems of difficult dispersion and uniform local administration, low drug solubility, unstable absorption, etc. sexual effect

Inactive Publication Date: 2014-09-10
JINAN UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] In order to overcome the deficiencies of unstable absorption and large toxic and side effects of itraconazole systemic drug preparations in the clinical application of local treatment, the primary purpose of the present invention is to provide a temperature-sensitive gel preparation of itraconazole for local use , the gel formulation solves the problem of low drug solubility and is difficult to disperse uniformly in topical formulations, so that itraconazole can be better applied to the treatment of local fungal infections

Method used

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  • Itraconazole temperature-sensitive type gel preparation as well as preparation method and application thereof
  • Itraconazole temperature-sensitive type gel preparation as well as preparation method and application thereof
  • Itraconazole temperature-sensitive type gel preparation as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] blank gel prescription

[0049]

[0050] Preparation process: Add various ingredients in the prescription to an appropriate amount of distilled water to disperse evenly, place at 0-4°C, and stir evenly after the solid components are completely swollen and dissolved, and it becomes a blank temperature-sensitive gel. The gelation temperature of the prepared blank temperature-sensitive gel is 18~37 ℃, according to blank temperature-sensitive gel: simulated vaginal fluid=6.7:1 (w / v), blank temperature-sensitive gel: simulated The gelation temperature of the blank temperature-sensitive gel is 25-48° C. after mixing and diluting the ratio of tear fluid = 40:7 (v / v).

Embodiment 2

[0052] blank gel prescription

[0053]

[0054] Preparation process: Prepare a blank temperature-sensitive gel according to the preparation process in Example 1. The gelation temperature of the prepared blank temperature-sensitive gel is 28° C., according to blank temperature-sensitive gel: simulated vaginal fluid=6.7:1 (w / v), blank temperature-sensitive gel: simulated tear fluid= After mixing and diluting at a ratio of 40:7 (v / v), the gelation temperatures of the blank temperature-sensitive gels were 36°C and 35°C, respectively.

Embodiment 3

[0056] gel prescription

[0057]

[0058] Preparation process: (1) Itraconazole is dissolved in diethylene glycol monoethyl ether HP to obtain a drug solution. (2) Add an appropriate amount of distilled water to other components in the prescription to disperse evenly, place it at 0-4°C, wait for the solid components to swell and dissolve completely, add the drug solution prepared in (1), and stir evenly, that is Itraconazole temperature-sensitive gel preparation; or (2) add other components in the prescription to an appropriate amount of distilled water to disperse evenly, add the drug solution prepared in (1), mix well and place it at 0-4°C, After the solid component is completely swollen and dissolved, it is stirred evenly, and the itraconazole temperature-sensitive gel preparation is obtained. The gelation temperature of the prepared itraconazole temperature-sensitive gel preparation is 28° C., respectively according to itraconazole temperature-sensitive gel preparation...

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Abstract

The invention belongs to the technical field of medicines and discloses an itraconazole temperature-sensitive type gel preparation as well as a preparation method and application thereof. The itraconazole temperature-sensitive type gel preparation is composed of the following components in percentage by weight: 0.02-3% of medicines, 0.05-15% of solubilizing agent, 5-50% of gel matrix, 0-15% of biological adhesive, 0.001-2% of preservative, 0-10% of other additives and the balance of solvent. The itraconazole temperature-sensitive type gel preparation can regulate gelatinization temperature by adjusting composition and control drug release rate and degree, can effectively inhibit growth of candida in vitro and can be used for drug administration on skins, eyes, nasal cavity, oral cavity, straight intestine or vaginal mucosa. The itraconazole temperature-sensitive type gel preparation has obvious slow release and biological adhesion property and can prolong action time of medicines on an infection part, realize long-acting treatment, reduce dosage and toxic and side effects and improve patient compliance.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a temperature-sensitive gel preparation and a preparation method thereof, more specifically, to a temperature-sensitive gel preparation with bioadhesion and a preparation method thereof, in particular to a Itraconazole temperature-sensitive gel preparation and its preparation method and application. Background technique [0002] Itraconazole (Itraconazole, ITZ), chemical name: (±)-1-sec-butyl-4-[4-[4-[4-[[(2R * , 4S * )2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazolyl-1-methyl)-1,3-dioxol-4-yl]methanol Oxy]phenyl]-1-piperazinyl]phenyl]-△ 2 -1,2,4-Triazol-5-one, the molecular formula is C 35 h 38 Cl 2 N 8 o 4 , the structural formula is as follows: [0003] [0004] Itraconazole (ITZ) is a fat-soluble triazole broad-spectrum antifungal drug, insoluble in water, with 3 chiral centers in its molecular structure, which is composed of 4 isomers according to the ratio of 1:1:1:1 ...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K31/496A61P31/10
Inventor 李沙罗芮叶小翠蒋杰欧金来冯翠娟洪宝贤
Owner JINAN UNIVERSITY
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