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Novel epinastine nasal drug delivery preparation and preparation method thereof

A nasal administration preparation, the technology of epilastine, which is applied in the field of medicine, can solve the problem of no nasal drops and the like, and achieve the effects of improving compliance and convenience, low production cost and high bioavailability

Inactive Publication Date: 2014-12-03
广州艾格生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, epinastine hydrochloride tablets and capsules are being sold domestically, and there are also eye drops and granules on the market abroad, but no nasal drops are yet on the market

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Prescription (100ml)

[0031] Element Dosage (g) Epinastine Hydrochloride 0.1 Sodium edetate 0.2 polyethylene glycol 10 Thimerosal 0.5 Sodium chloride 0.7 Sodium hydrogen phosphate 1 boric acid 1 Water for Injection Add to 100ml

[0032] The preparation process has the following steps:

[0033] Take an appropriate amount of sterilized water for injection at 60°C~70°C and add sodium edetate, polyethylene glycol, thimerosal, sodium chloride, and sodium hydrogen phosphate according to the above ratio, stir to dissolve, and finally add epinastine hydrochloride to dissolve. Use boric acid to adjust the pH value to 6~7.5, dilute to the full amount with sterile water for injection, mix well, filter with a 0.22μm filter membrane for sterilization, and pack aseptically.

[0034]

Embodiment 2

[0036] Prescription (100ml)

[0037] Element Dosage (g) Epinastine Hydrochloride 0.5 sodium bisulfite 10 polyvinylpyrrolidone 20 Chlorhexidine gluconate 1 calcium chloride 0.9 Sodium hydroxide / hydrochloric acid Appropriate amount Water for Injection Add to 100ml

[0038] The preparation process has the following steps:

[0039] Take an appropriate amount of sterilized water for injection at 60°C~70°C and add sodium bisulfite, polyvinylpyrrolidone, chlorhexidine gluconate, and calcium chloride according to the above ratio, stir to dissolve, and finally add epinastine hydrochloride to dissolve, and use hydrogen Sodium oxide / hydrochloric acid to adjust the pH value to 6~7.5, and dilute to the full amount with sterile water for injection, mix well, filter with 0.22μm filter membrane for sterilization, and pack aseptically.

[0040]

Embodiment 3

[0042] Prescription (100ml)

[0043] Element Dosage (g) Epinastine Hydrochloride 1 Sodium thiosulfate 50 Chondroitin Sulfate 10 Ethyl p-hydroxybenzoate 1 glycerin 0.9 Sodium Hydrogen Phosphate / Sodium Dihydrogen Phosphate Appropriate amount Water for Injection Add to 100ml

[0044] The preparation process has the following steps:

[0045] Take an appropriate amount of sterilized water for injection at 60°C~70°C and add sodium thiosulfate, chondroitin sulfate, ethyl p-hydroxybenzoate, and glycerin according to the above ratio, stir to dissolve, and finally add epinastine hydrochloride to dissolve. / Sodium dihydrogen phosphate to adjust the pH value to 6~7.5, dilute to the full amount with sterile water for injection, mix well, filter with a 0.22μm filter membrane to sterilize, and pack aseptically.

[0046]

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PUM

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Abstract

The invention provides a novel epinastine nasal drug delivery preparation and a preparation method thereof. According to the requirements of nose drops and biological characteristics of epinastine, an appropriate protective agent, a thickener and a corrosion remover are added to prepare aqueous solution nose drops. The novel epinastine nasal drug delivery preparation is free of bitter taste and thrill, and is suitable for nasal delivery, convenient to use, and especially suitable for medication on children and the old. The technological process provided by the invention has the advantages of being simple and reliable, and good in repeatability, can be applied to prevention and treatment of anaphylactic (including seasonal or non-seasonal) rhinitis, and has certain application value in clinical.

Description

technical field [0001] The invention relates to a novel epinastine hydrochloride nasal administration preparation and a preparation method thereof, which are used for nasal administration to treat allergic rhinitis and belong to the technical field of medicine. Background technique [0002] Preparations that are used in the nasal cavity and absorbed through the nasal mucosa to exert systemic therapeutic effects are called nasal administration preparations. Nasal administration can avoid hepatic first-pass effect, fast absorption and high bioavailability. Compared with injection administration, nasal administration is convenient to use, can be administered by oneself, and has less damage to the body. At the same time, it is also suitable for patients who cannot take oral administration due to various reasons. [0003] Nasal drops are the simplest form of nasal administration for nasal administration, that is, the solution (including suspension) of the drug is directly drippe...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/55A61K47/38A61K47/32A61K47/34A61K47/10
Inventor 何盛江
Owner 广州艾格生物科技有限公司
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