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Skinniness hormone packing matter water solution and application thereof

A technology of corticosteroids and inclusion compounds, which is applied in the direction of non-active ingredients of polymer compounds, drug combinations, and drug delivery, and can solve the problem of instability of dexamethasone sodium phosphate eye drops to light and poor stability of corticosteroid sodium salts , ethanol solvent residues and other problems, to achieve the effect of low solvent moisture requirements, overcome uneven inclusion, and the preparation process is simple and easy to operate

Inactive Publication Date: 2008-06-18
TIANJIN PHARMA GROUP CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The clathrate preparation process is finally concentrated to leave a certain volume. Since hydroxypropyl β-cyclodextrin is easily soluble in ethanol, the yield of this process is low.
Then the slurry clathrate obtained after processing is very sticky, and it is very troublesome to handle.
At the same time, since the preparation process of the clathrate uses pure solvent absolute ethanol, the ethanol itself will be clathrated into hydroxypropyl β-cyclodextrin (chem.pharm, Bull, 720-750, 1988), so in order to increase the clathrate rate , the application of this invention needs a large amount of hydroxypropyl β-cyclodextrin when it is used in clathrate, and the resulting clathrate ethanol solvent residue is relatively high
[0009] Prepare liquid antibiotic / corticosteroid preparations, wherein corticosteroid salts can also be used, such as dexamethasone sodium phosphate, methylprednisolone sodium succinate, etc., but corticosteroid sodium salts are generally not stable, and Sun Qiang et al. Dexamethasone Sodium Phosphate Ophthalmic Solution is unstable to light in "West China Journal of Pharmaceutical Sciences" 2000 Issue 03

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Dissolve 2g of 3-hydroxypropyl β-cyclodextrin in 15ml of 95% ethanol at room temperature, add 0.2g of dexamethasone acetate, stir to dissolve, stir for another 30 minutes, filter through a microporous membrane (220nm), add 8ml of injection Water was stirred for 5 minutes, concentrated under reduced pressure, and the ethanol was evaporated to obtain an aqueous solution of dexamethasone acetate / 3-hydroxypropyl β-cyclodextrin inclusion complex, which was set aside.

Embodiment 2

[0043] Dissolve 2g of 2-hydroxypropyl β-cyclodextrin in 20ml of acetone at 40±2°C, add 0.5g of dexamethasone, stir to dissolve, stir for another 30 minutes, filter through a microporous membrane (220nm), add 3mL of injection Stir with water for 5 minutes, concentrate under reduced pressure, and add 4ml of water for injection twice during the concentration process to remove all acetone to obtain a dexamethasone / 2-hydroxypropyl β-cyclodextrin inclusion complex aqueous solution for future use.

Embodiment 3

[0045] Dissolve 7g of hydroxyethyl β-cyclodextrin in 20ml of absolute ethanol at room temperature, add 0.5g of fluorometholone, stir to dissolve, stir for another 30 minutes, filter with a microporous membrane (220nm), stir for 5 minutes, and concentrate under reduced pressure , adding 3.5ml of water for injection three times during the concentration process, distilled off ethanol to obtain fluorometholone / hydroxyethyl β-cyclodextrin inclusion aqueous solution, set aside.

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PUM

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Abstract

The invention relates to a preparation of antibiotic and cortical hormone, in particular to an eye-used or ear-used preparation combining cortical-hormone inclusion compound and antibiotic. Cyclodextrin derivative is used to prepare insoluble cortical hormone into water-soluble inclusion compound, and then the inclusion compound solution, along with antibiotic is used to prepare pellucid medicinal dropping liquid or transparent gelatine solution preparation, for local eye or ear treatment. The preparation, which is based on cortical-hormone inclusion compound, has the advantage of stable liquid, high inclusion efficiency, simple preparation process, high yield and good adaptability. The invention can obtain the dropping liquid and gelatine solution prepared jointly by cortical-hormone inclusion compound and antibiotic.

Description

technical field [0001] The present invention relates to the preparation of antibiotics and corticosteroids, in particular to a kind of ophthalmic and ear-used corticosteroid clathrate aqueous solution combined with antibiotics. Background technique [0002] The combination of antibiotics and corticosteroids has been reported for a long time to treat diseases. It is mentioned in the world patent WO90 / 01933: the combined use of antibiotics and corticosteroids has been very much in the field of pharmacy. Combination corticosteroids are used in the eyes with excellent results. In addition, Chinese patent ZL94113676.0 discloses an ear drop preparation in combination with ciprofloxacin and glucocorticoid. [0003] Spanish patent ES2065846A1 discloses a topically administrable ophthalmic and otic antibiotic / corticosteroid combination product. The Examples therein disclose ophthalmic suspension formulations containing certain drugs in combination with excipients including nonionic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/40A61K47/38A61K47/34A61K9/08A61K9/00A61K45/06A61K31/573A61K31/58A61P27/02A61P27/16A61K31/496A61K31/5383A61K47/10A61K47/26
Inventor 冯祎飞陈立营陈德翠张其婉
Owner TIANJIN PHARMA GROUP CORP
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