Tobramycin and dexamethasone nanosuspension eye drop and preparation method thereof

A technology of dexamethasone and tobramycin, which is applied in the directions of liquid delivery, pharmaceutical formula, emulsion delivery, etc., can solve the problems of insufficient sterilization and special requirements for sterilization equipment, and achieve stable and reliable product quality. The bacterial method is simple and effective with good reproducibility

Active Publication Date: 2016-06-29
CHENGDU QINGSHAN LIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, at present, the sterilization of dexamethasone, the main component of tobramycin dexamethasone eye drops, mainly adopts dry sterilization and irradiation sterilization, such as: Chinese invention patent "Ophthalmic Compound" with patent number ZL97105772.9 The preparation method of tobramycin suspension " prompt

Method used

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  • Tobramycin and dexamethasone nanosuspension eye drop and preparation method thereof
  • Tobramycin and dexamethasone nanosuspension eye drop and preparation method thereof
  • Tobramycin and dexamethasone nanosuspension eye drop and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0030] Example one:

[0031] prescription:

[0032]

[0033] Preparation Process:

[0034] 1) Weigh the prescribed amount of Tobramycin, Sodium Chloride, and Edetate Disodium, and dissolve them in an appropriate amount of water for injection. Add the benzalkonium bromide solution and Tween 80 solution to the above solution, stir evenly, 0.22μm micron Sterilization by filtration through a porous membrane; Weigh the prescribed amount of hypromellose (E50), dissolve it in an appropriate amount of water for injection, filter and sterilize with a 0.22μm microporous membrane, mix with the above solution, and set aside.

[0035] 2) Weigh the prescription amount of dexamethasone, suspend it in an appropriate amount of water for injection, add dilute hydrochloric acid to adjust the pH to 3.0-4.0, and cut 15min (1000r / min) with a high-shear dispersing emulsifier to prepare a dexamethasone mixture Suspension (particle size range: 50-200nm), 0.22μm microporous membrane filter sterilization, stan...

Example Embodiment

[0037] Embodiment two:

[0038] prescription:

[0039]

[0040] Preparation Process:

[0041] 1) Weigh the prescribed amount of Tobramycin, Sodium Chloride, and Edetate Disodium, and dissolve them in an appropriate amount of water for injection. Add the benzalkonium bromide solution and Tween 80 solution to the above solution, stir evenly, 0.22μm micron Sterilization by filtration through a pore membrane; Weigh the prescribed amount of hypromellose (15000cps), dissolve it in an appropriate amount of water for injection, filter and sterilize it with a 0.22μm microporous membrane, mix with the above solution for use.

[0042] 2) Weigh the prescription amount of dexamethasone, suspend it in an appropriate amount of water for injection, add dilute hydrochloric acid to adjust the pH to 3.0-4.0, and cut 15min (1000r / min) with a high-shear dispersing emulsifier to prepare a dexamethasone mixture Suspension (particle size range: 50-200nm), 0.22μm microporous membrane filter sterilization, st...

Example Embodiment

[0044] Example three:

[0045] prescription:

[0046]

[0047]

[0048] Preparation Process:

[0049] 1) Weigh the prescribed amount of Tobramycin, Sodium Chloride, and Edetate Disodium, and dissolve them in an appropriate amount of water for injection. Add the benzalkonium bromide solution and Tween 80 solution to the above solution, stir evenly, 0.22μm micron Sterilization by filtration through a porous membrane; Weigh the prescribed amount of hypromellose (K100M), dissolve it in an appropriate amount of water for injection, filter and sterilize with a 0.22μm microporous membrane, mix with the above solution, and set aside.

[0050] 2) Weigh the prescription amount of dexamethasone, suspend it in an appropriate amount of water for injection, add dilute hydrochloric acid to adjust the pH to 3.0-4.0, and cut 15min (1000r / min) with a high-shear dispersing emulsifier to prepare a dexamethasone mixture Suspension (particle size range: 50-200nm), 0.22μm microporous membrane filter steril...

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Abstract

The invention provides a tobramycin-dexamethasone nano-suspension eye drop, which is prepared from the following raw materials and auxiliary materials: 0.1% w/v dexamethasone, tobramycin Mycin 0.3% w/v, water-soluble polymer 0.2-0.5% w/v, humectant 0.025-0.1% v/v, osmotic pressure regulator 0.3-0.6% w/v, pH regulator 1.0-1.5 %v/v, metal ion complexing agent 0.0025~0.01%w/v, preservative 0.1~0.3%v/v. The invention also provides a preparation method of the eye drop. The preparation method of the tobramycin-dexamethasone nano-suspension eye drop of the present invention has simple production process, good reproducibility, simple and effective sterilization method, easily available auxiliary materials, and is suitable for industrialized production.

Description

technical field [0001] The invention relates to a tobramycin-dexamethasone nano-suspension eye drop. Background technique [0002] Tobramycin and dexamethasone eye drops are compound preparations of glucocorticoids and antibiotics, commonly used in the treatment of ophthalmic inflammatory lesions sensitive to adrenal cortex hormones, bacterial infections of the ocular surface and potential infectious diseases, and can reduce edema and inflammation. It is also suitable for chronic anterior uveitis, chemical, radiation, burn and foreign body penetrating corneal injury; it also has a certain effect on some common eye bacteria and pathogenic bacteria infections. [0003] The trade name of the original research drug of the preparation is "TOBRADEX", which is produced by ALCON of the United States and entered the Chinese market in 1995. Since the particle size of the suspension eye drops is closely related to the comfort of the patient, the curative effect of the drug, and the ac...

Claims

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Application Information

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IPC IPC(8): A61K31/702A61K9/10A61P27/02A61K31/573A61K31/198A61K31/14
Inventor 徐世兰朱勇范琴欧苏刘小英
Owner CHENGDU QINGSHAN LIKANG PHARMA CO LTD
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