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A kind of tobramycin dexamethasone nano-suspension eye drops and preparation method thereof

A technology of dexamethasone and nano-suspension, which is applied in the fields of pharmaceutical formulation, liquid transportation, emulsion transportation, etc., can solve the problems of insufficient sterilization and special requirements for sterilization equipment, and achieve stable and reliable product quality, sterilization The method is simple and effective, and the eye area is comfortable and safe to use

Active Publication Date: 2019-02-19
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: the Chinese invention patent "Ophthalmic Compound Correct" with patent number ZL 97105772.9 The preparation method of bumycin suspension "discloses the use of 160 ℃ 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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  • A kind of tobramycin dexamethasone nano-suspension eye drops and preparation method thereof
  • A kind of tobramycin dexamethasone nano-suspension eye drops and preparation method thereof
  • A kind of tobramycin dexamethasone nano-suspension eye drops and preparation method thereof

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Experimental program
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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 and dexamethasone nanosuspension eye drop, which is prepared from the following active pharmaceutical ingredients and auxiliary ingredients in percentage by weight: 0.1 percent w / v of dexamethasone, 0.3 percent w / v of tobramycin, 0.2 to 0.5 percent w / v of water-solubility macromeclecule polymers, 0.025 to 0.1 percent v / v of wetting agents, 0.3 to 0.6 percent w / v of osmotic pressure regulators, 1.0 to 1.5 percent v / v of pH regulators, 0.0025 to 0.01 percent w / v of metal ion complexing agents and 0.1 to 0.3 percent v / v of preservatives. The invention also provides a preparation method of the eye drop. The preparation method of the tobramycin and dexamethasone nanosuspension eye drop has the advantages that the process is simple and convenient; the repeatability is high; a degerming method is simple and effective; the auxiliary ingredients can be easily obtained; and the method is suitable for industrial 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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Patent Type & Authority Patents(China)
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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