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Compound ophthalmic preparation and preparation method as well as application thereof

A technology of ophthalmic preparations and stabilizers, which is applied in the field of compound ophthalmic preparations and its preparation, can solve the problems of large eye irritation, affecting patient compliance and tolerance, achieve good stability, and improve compliance and tolerance. receptive effect

Active Publication Date: 2012-07-04
SHENYANG XINGQI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, its disadvantage is that it is more irritating to the eyes, which affects the patient's compliance and tolerance.

Method used

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  • Compound ophthalmic preparation and preparation method as well as application thereof
  • Compound ophthalmic preparation and preparation method as well as application thereof
  • Compound ophthalmic preparation and preparation method as well as application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1 Gentamicin Diclofenac Sodium Eye Drops 1 and its preparation

[0037] 1) Prescription:

[0038] Gentamicin Sulfate 1,000,000 Gentamicin Units

[0039] Diclofenac Sodium 0.5g

[0040]Sodium Hyaluronate 0.5g

[0041] Polyvinyl alcohol 1.4g

[0042] Glycerin 2.2g

[0043] Calcium chloride 0.5g

[0044] Acetic acid 3.7g

[0045] Sodium acetate 12.8g

[0046]

[0047] Add water to 1000ml

[0048] 2) Preparation method:

[0049] (1) sodium hyaluronate and polyvinyl alcohol are soaked in water respectively, and set aside;

[0050] (2) adding diclofenac sodium to dissolve in water;

[0051] (3) Add acetic acid, sodium acetate, glycerin, calcium chloride successively again, until all dissolve;

[0052] (4) Add sodium hyaluronate and polyvinyl alcohol respectively;

[0053] (5) Add gentamicin sulfate to dissolving again;

[0054] (6) Add water to the full amount, and filter with a 0.22μm filter element.

Embodiment 2

[0055] Example 2 Gentamicin Diclofenac Sodium Eye Drops 2 and its preparation

[0056] 1) Prescription:

[0057] Gentamicin Sulfate 1,500,000 Gentamicin Units

[0058] Diclofenac Sodium 0.1g

[0059] Hypromellose 4.0g

[0060] Propylene glycol 2.6g

[0061] Magnesium chloride 0.7g

[0062] Boric acid 3.1g

[0063] Borax 14.2g

[0064]

[0065] Add water to 1000ml

[0066] 2) Preparation method:

[0067] (1) Soak the hypromellose in water to swell, and set aside;

[0068] (2) adding diclofenac sodium to dissolve in water;

[0069] (3) add borax, boric acid, propylene glycol, magnesium chloride successively again, until all dissolve;

[0070] (4) adding hypromellose again;

[0071] (5) Add gentamicin sulfate to dissolving again;

[0072] (6) Add water to the full amount, and filter with a 0.22μm filter element.

Embodiment 3

[0073] Example 3 Gentamicin Diclofenac Sodium Eye Drops 3 and its preparation

[0074] 1) Prescription:

[0075] Gentamicin Sulfate 2 million Gentamicin Units

[0076] Diclofenac Sodium 1.5g

[0077] Sodium Carboxymethyl Cellulose 3.0g

[0078] Sodium chloride 0.6g

[0079] Edetate Disodium 0.1g

[0080] Sodium dihydrogen phosphate 5.4g

[0081] Disodium hydrogen phosphate 13.5g

[0082]

[0083] Add water to 1000ml

[0084] 2) Preparation method:

[0085] (1) Soak the hypromellose in water to swell, and set aside;

[0086] (2) adding diclofenac sodium to dissolve in water;

[0087] (3) Add sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride, and disodium edetate in sequence until all of them are dissolved;

[0088] (4) adding hypromellose again;

[0089] (5) Add gentamicin sulfate to dissolving again;

[0090] (6) Add water to the full amount, and filter with a 0.22μm filter element.

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Abstract

The invention relates to a compound ophthalmic preparation, in particular to a compound ophthalmic preparation containing aminoglycoside antibiotics and nonsteroidal anti-inflammatory drugs, such as gentamicin and diclofenac sodium eye drops. The pH value of the ophthalmic preparation is 7.0-10.0, preferably 7.5-9.5, more preferably 8.0-9.0, and further preferably 8.6-8.8. The invention also relates to a preparation method as well as application of the compound ophthalmic preparation. By regulating the pH value, the ophthalmic preparation provided by the invention has the advantages of small irritation and good stability.

Description

technical field [0001] The invention relates to a compound ophthalmic preparation, in particular to a compound ophthalmic preparation comprising aminoglycoside antibiotics and non-steroidal anti-inflammatory drugs and its preparation method and application. The ophthalmic preparation has little irritation and stable it is good. Background technique [0002] Currently commonly used eye antibacterial drugs include cephalosporins, macrolides, aminoglycosides, fluoroquinolones, rifampicin, chloramphenicol, lincomycin, and clindamycin. Aminoglycosides are antibiotics with bactericidal effect. Their mechanism of action is to inhibit the protein synthesis of sensitive bacteria. They have a good inhibitory effect on most bacteria that cause anterior segment infection. They are used in the prevention and treatment of external eye infection and postoperative infection. occupies an important position. [0003] Among them, gentamicin sulfate is one of the more commonly used aminoglyco...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/06A61K31/7036A61P27/02A61P31/04A61K31/196
Inventor 刘继东杨宇春艾立诚宫晓光
Owner SHENYANG XINGQI PHARM CO LTD
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