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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 " promptly discloses adopting 160 ℃ of dry heat or 2-2.5 Mrad radiation or A method for sterilizing dexamethasone by irradiation with ultraviolet light of a wavelength, but the above-mentioned sterilization method has the defect that the sterilization is not thorough enough or has special requirements for the sterilization equipment

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

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Effect test

Embodiment 1

[0031] prescription:

[0032]

[0033] Preparation Process:

[0034] 1) Weigh the prescribed amount of tobramycin, sodium chloride, and edetate disodium, dissolve them in an appropriate amount of water for injection, measure benzalkonium bromide solution, and add Tween 80 solution to the above solution, stir evenly, 0.22 μm Sterilize by filtering through a pore filter; weigh the prescribed amount of hypromellose (E50), dissolve it in an appropriate amount of water for injection, filter and sterilize with a 0.22 μm microporous membrane, mix with the above solution, and set aside.

[0035] 2) Weigh the prescribed amount of dexamethasone, suspend it in an appropriate amount of water for injection, add dilute hydrochloric acid to adjust the pH value to 3.0-4.0, and shear it with a high-shear dispersing emulsifier for 15 minutes (1000r / min) to prepare the mixed dexamethasone Suspension (particle size range: 50-200nm), sterilized by filtration through a 0.22 μm microporous membr...

Embodiment 2

[0038] prescription:

[0039]

[0040] Preparation Process:

[0041] 1) Weigh the prescribed amount of tobramycin, sodium chloride, and edetate disodium, dissolve them in an appropriate amount of water for injection, measure benzalkonium bromide solution, and add Tween 80 solution to the above solution, stir evenly, 0.22 μm Sterilize by filtering through a pore filter; weigh the prescribed amount of hypromellose (15000 cps), dissolve it in an appropriate amount of water for injection, filter and sterilize with a 0.22 μm microporous filter, mix with the above solution, and set aside.

[0042] 2) Weigh the prescribed amount of dexamethasone, suspend it in an appropriate amount of water for injection, add dilute hydrochloric acid to adjust the pH value to 3.0-4.0, and shear it with a high-shear dispersing emulsifier for 15 minutes (1000r / min) to prepare the mixed dexamethasone Suspension (particle size range: 50-200nm), sterilized by filtration through a 0.22 μm microporous m...

Embodiment 3

[0045] prescription:

[0046]

[0047]

[0048] Preparation Process:

[0049] 1) Weigh the prescribed amount of tobramycin, sodium chloride, and edetate disodium, dissolve them in an appropriate amount of water for injection, measure benzalkonium bromide solution, and add Tween 80 solution to the above solution, stir evenly, 0.22 μm Sterilize by filtering through a pore filter; weigh the prescribed amount of hypromellose (K100M), dissolve it in an appropriate amount of water for injection, filter through a 0.22 μm microporous membrane, mix with the above solution, and set aside.

[0050] 2) Weigh the prescribed amount of dexamethasone, suspend it in an appropriate amount of water for injection, add dilute hydrochloric acid to adjust the pH value to 3.0-4.0, and shear it with a high-shear dispersing emulsifier for 15 minutes (1000r / min) to prepare the mixed dexamethasone Suspension (particle size range: 50-200nm), sterilized by filtration through a 0.22 μm microporous me...

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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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