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Ophthalmic pharmaceutical composition

A composition and drug technology, applied in the directions of drug combination, drug delivery, active ingredients of heterocyclic compounds, etc., can solve the problems of bacteria growth, expensive eye drops, allergy or irritation to the eyes of preservatives, etc.

Inactive Publication Date: 2020-10-27
RXVISION PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Many existing technologies use preservatives to inhibit the growth of bacteria in atropine sulfate eye drops, but preservatives often cause eye allergy or irritation, and long-term use of patients may also damage corneal epithelial cells
The atropine sulfate eye drops in a single-dose package must be discarded if it is not used up on the same day, otherwise there will still be bacteria growth problems; Eye drop bottles with sterile air filtration function, but eye drops using the above two containers are usually more expensive, which is not conducive to popularization

Method used

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Embodiment 1-7

[0058] Embodiments 1-12 of the present invention provide an ophthalmic pharmaceutical composition, the formulation of which comprises: atropine sulfate, citric acid as a pH value regulator, sodium chloride as an osmotic pressure regulator, and water; and the ophthalmic The pharmaceutical composition contains no preservatives. The content of each component of the ophthalmic pharmaceutical composition and its pH value and osmotic pressure parameters are shown in Table 1 below.

[0059] Table 1

[0060]

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Abstract

The present invention discloses an ophthalmic pharmaceutical composition. The ophthalmic pharmaceutical composition comprises 0.01-1wt% of atropine sulfate; the pH value of the ophthalmic pharmaceutical composition is 3.5-4.0; and the osmotic pressure is 180 to 300 mOsm / kg. The pharmaceutical composition can obviously improve the related substance problems which are not easy to solve in the priorart; and the composition is simple in component and not prone to forming agglomerates with the micron level or above, so that the corneal penetrability of atropine sulfate molecules can be improved.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical compositions, in particular to an ophthalmic pharmaceutical composition, in particular to an ophthalmic pharmaceutical composition for enhancing atropine sulfate corneal penetration and reducing the content of related substances. Background technique [0002] Atropine sulfate (atropine sulfate) belongs to ester drugs, and it is easy to decompose in aqueous solution to generate belladonna phenol (Tropine), tropic acid (TropicAcid), scopolamine (Scopolamine) and other related substances. Easy hydrolysis failure. When there is no element that can stabilize hydroxide ions in the aqueous solution, atropine sulfate is easily affected by the hydroxide ions, thus breaking bonds and degrading to form related substances such as belladonnaol and tropic acid ( figure 1 / path 1); Or, hydroxide ion is easy to produce bond with the chair structure of atropine sulfate, forms related substances such as 6-...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/46A61K47/02A61K47/12A61P27/02A61P27/10
CPCA61K9/08A61K9/0048A61K31/46A61K47/02A61K47/12A61P27/02A61P27/10
Inventor 周延张丽荣周杰周欣王朋
Owner RXVISION PHARMA CO LTD
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