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Sodium paeonolsilate ophthalmic preparation

A technology of sodium paeonol sulfonate and ophthalmic preparations, applied in the field of sodium paeonol sulfonate ophthalmic preparations, can solve problems such as application and reports of unseen eye preparations, and achieves improved ocular bioavailability and improved ocular bioavailability. Stability, the effect of reducing toxic and side effects

Inactive Publication Date: 2017-05-31
JIANGXI UNIVERSITY OF TRADITIONAL CHINESE MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the commercially available dosage form is Paeonol Sodium Sulfonate Injection, and there is no application and report of using Paeonol Sodium Sulfonate to prepare ocular preparations

Method used

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  • Sodium paeonolsilate ophthalmic preparation
  • Sodium paeonolsilate ophthalmic preparation
  • Sodium paeonolsilate ophthalmic preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment 1: Sodium Paeonol Sulfonate Eye Drops

[0044] Take 50mL of water for injection, add NaCl 0.7g, boric acid 1.9g, sodium bisulfite 0.2g, EDTA-2Na 0.03g, benzalkonium chloride 0.03g, sodium hyaluronate 0.1g, stir to dissolve, then add paeonol Sodium sulfonate 3.5g, after dissolving completely, add water for injection to 100mL, adjust pH to 6.0 with citric acid, filter with 0.22μm microporous membrane, aseptically dispense into brown plastic eye drop bottles, and pack to get ready.

Embodiment 2

[0045] Embodiment 2: Paeonol Sulfonate Sodium Liposome Eye Drops

[0046] Using the film dispersion method, take 1g of soybean lecithin and 0.75g of cholesterol dissolved in chloroform as the oil phase, use a rotary evaporator to evaporate to dryness at 55°C to form a film, remove the chloroform, stop the rotation and keep vacuuming for 2 hours, then stop, add sodium sulfite 0.15g, 0.03g of EDTA-2Na, 0.02g of benzalkonium bromide and 0.2g of paeonol sodium sulfonate in 50mL of phosphate buffer (pH6.0), shake vigorously for 40min, wash the membrane at 4℃ Homogenize with a high-pressure homogenizer (homogenization pressure 80Mpa, cycle times 5 times) to obtain paeonol sulfonate liposome eye drops. Slowly drop the prepared paeonol sulfonate liposome eye drops into 50ml of phosphate buffer (1%, w / v) of chitosan oligosaccharide (50kDa), stir and mix at 10°C for 60min to obtain Chitooligosaccharide-coated paeonol sulfonate liposome suspension was adjusted to isotonicity with NaCl, ...

Embodiment 3

[0047] Embodiment 3: Paeonol Sulfonate Sodium Inclusion Complex Eye Drops

[0048]Take 1g of HP-β-cyclodextrin, add 75mL of water for injection, heat to dissolve, add 0.1g of sodium paeonol sulfonate, stir to dissolve, put it on an ultrasonic oscillator for 10min, then add 0.6g of sodium chloride, boric acid 0.4g, 1.3g of borax, 0.1g of methylparaben, 0.02g of propylparaben, 0.04g of EDTA-2K, 0.1g of sodium bisulfite, stir to dissolve, and adjust the pH to 6.5 with HCl. 0.22μm micropore Membrane filtration, aseptically dispensed into brown plastic eye droppers, ready to pack.

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Abstract

The invention discloses a sodium paeonolsilate ophthalmic preparation, which is prepared by adding ophthalmic preparation pharmaceutic adjuvants into sodium paeonolsilate, wherein the weight percentage of the contained sodium paeonolsilate is 0.01 to 30 percent; the balance is auxiliary materials for the ophthalmic preparation; the sodium paeonolsilate ophthalmic preparation contains eye drops, ophthalmic lipidosome, inclusion compound eye drops, eye ointment, ophthalmic gel, in-situ gel, ophthalmic liposome gel, ophthalmic injection, ophthalmic lipidosome injection and the like. The sodium paeonolsilate is used as the active effective ingredients; the ophthalmic preparation pharmaceutic adjuvants are added for preparation according to a conventional preparation method. The sodium paeonolsilate is prepared into ophthalmic medicine; the effective absorption of the medicine is enhanced; the medicine stability is improved; the retention time in the eyes can be prolonged; the toxic and side effects of the medicine are reduced; the eye bioavailability of the medicine is improved. The preparation method provided by the invention has the advantages that the process is feasible; the quality is controllable; wide industrialization prospects are very wide.

Description

technical field [0001] The invention relates to medicines for eye diseases, in particular to a paeonol sodium sulfonate ophthalmic preparation. Background technique [0002] Paeonol sulfonate is widely used in the treatment of postoperative pain, rheumatism, rheumatoid and fruit preservation, etc., and has a wide range of clinical applications. Currently, the commercially available dosage form is Paeonol Sodium Sulfonate Injection, and there is no application or report of using Paeonol Sodium Sulfonate to prepare ocular preparations. [0003] Chinese patent CN102166205B discloses the medical use of paeonol and its derivatives, showing that paeonol sodium sulfonate has the effect of treating or preventing immune conjunctivitis, dry eye, uveitis and scleritis. US2008 / 0194700A1 discloses that paeonol or a pharmaceutically acceptable salt can be used to prevent, improve or treat diseases related to angiogenesis, such as neovascular glaucoma, diabetic retinopathy, corneal diseas...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/12A61K9/00A61P27/02A61P27/12
CPCA61K31/12A61K9/0048
Inventor 张婧谢学军
Owner JIANGXI UNIVERSITY OF TRADITIONAL CHINESE MEDICINE
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