An in situ injectable temperature-sensitive response water-soluble chitosan composite hydrogel for lacrimal embolism, its preparation method and application

A technology of water-soluble chitosan and composite hydrogel, which can be applied to medical preparations without active ingredients, medical preparations containing active ingredients, and drug combinations, etc. Reduce the patient's compliance with treatment, increase the patient's economic burden, etc., to achieve the effect of low operation cost, low toxicity and side effects, and low cost

Active Publication Date: 2021-01-26
陕西靓双瞳医疗科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Nevertheless, the main problems in the clinical application of artificial tears are: the inability to stably maintain the physiological amount of tears required for the ocular surface, the antibacterial agents and preservatives contained in the preparation will aggravate ocular surface damage, frequent use can reduce the patient's treatment compliance, etc.
At present, the lacrimal duct embolism products used in the clinical treatment of dry eye disease in my country all rely on imports, which are expensive and greatly increase the economic burden of patients
In addition, the imported lacrimal plug products designed based on European and American populations cannot fully adapt to the anatomical characteristics of the eyes of Asian populations. In clinical applications, there are often problems of embolus displacement or falling off, resulting in surgical failure.

Method used

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  • An in situ injectable temperature-sensitive response water-soluble chitosan composite hydrogel for lacrimal embolism, its preparation method and application
  • An in situ injectable temperature-sensitive response water-soluble chitosan composite hydrogel for lacrimal embolism, its preparation method and application
  • An in situ injectable temperature-sensitive response water-soluble chitosan composite hydrogel for lacrimal embolism, its preparation method and application

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Experimental program
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Effect test

Embodiment 1

[0044]Seefigure 1 , Is the experimental process of the present invention, the specific method is as follows: accurately weigh 6wt% of HTCC powder and dissolve it in deionized water to prepare an HTCC) aqueous solution, similarly prepare 14wt% of β-glycerophosphate sodium (GP) aqueous solution, and adjust the volume The HTCC aqueous solution and the GP aqueous solution with a ratio of 1:0.7 are mixed and stirred uniformly, and then 2% Na-Alg powder is added to the above-mentioned HTCC-GP mixed aqueous solution, and fully stirred and dissolved. Add 3% CaCl to the HTCC-GP-Na-Alg mixed aqueous solution of Example 12The aqueous solution is stirred evenly and moved into the mold, and the mold is placed in a constant temperature water bath at 37°C to make it gelatinize and transform into a hydrogel.

[0045]The mechanism in the gelation process is asfigure 2 ,image 3 andFigure 4 ,figure 2 It is a diagram of the gelation mechanism of HTCC-GP. At room temperature, water molecules bind to the lo...

Embodiment 2

[0048]The HTCC-GP-Na-Alg-Ca of Example 12+The mixed aqueous solution was transferred into the vial, the result was fromFigure 5 It can be seen that it is a fluid mixed solution at room temperature. After gelation at 37°C, an in-situ injectable temperature-sensitive chitosan quaternary ammonium salt complex water for lacrimal embolism is obtained that loses fluidity. gel(Figure 6 ).

Embodiment 3

[0050]Dissolve 1wt%, 3wt%, 5wt%, 7wt% and 9wt% of HTCC powder in deionized water to prepare an HTCC aqueous solution. Similarly, prepare a 15% GP aqueous solution with a volume ratio of 1:0.8 to prepare HTCC-GP Mix the aqueous solution, move it into the mold, and undergo gelation at 37°C to obtain an in-situ injectable temperature-sensitive chitosan quaternary ammonium salt gel for lacrimal embolization, and pass the test tube inversion method in Example 1 The system loses fluidity to observe its gelation time. The specific implementation method is: place the parallel vial with the same formula at a constant temperature of 37℃, and use a stopwatch to tilt the vial every 10s to observe the system If the system loses fluidity or the liquid level does not change after tilting, this time is recorded as the phase inversion time of the gel. Observe the influence of HTCC concentration changes on the gelation time (Figure 7 ),FromFigure 7 It can be seen that the gelation time first shortens...

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Abstract

The invention discloses an in-situ injectable temperature-sensitive response water-soluble chitosan composite hydrogel for lacrimal duct embolism, a preparation method and application thereof, and belongs to the technical field of medical products. The composite hydrogel of the present invention is a liquid sol with fluidity at room temperature, and the sol is placed into the lacrimal duct of a human body through punctum injection. Utilizing the gel phase transition characteristic of the sol that is sensitive to body temperature, the in-situ gel embolization of the sol in the lacrimal duct is realized, and a small amount of tear fluid secreted by the affected eye is retained in the orbit, so as to achieve the purpose of keeping the ocular surface moist for a long time. Using the body temperature responsiveness of water-soluble chitosan and sodium glycerophosphate complex, and adding alginate and calcium chloride to adjust its mechanical properties, sol-gel phase transition time, mechanical strength, etc., the operation is simple and the reaction The condition is mild, the cost is low, the biocompatibility is good, the trauma is small, and the lacrimal duct of any shape and size can be filled, and it has a good relief effect on patients with dry eye.

Description

Technical field[0001]The invention belongs to the technical field of medical products, and relates to an in-situ injectable temperature-sensitive and responsive water-soluble chitosan composite hydrogel for lacrimal duct embolization, and a preparation method and application thereof.Background technique[0002]Dry eye disease (dry eye disease) is an eye disease caused by congenital lacrimal gland hypoplasia, trachoma, corneal sclerosis and other causes, such as decreased tear film stability and abnormal tear quality or quantity. The essence of the disease is the decrease in the number and density of goblet cells in the tear film, which causes changes in the quality or quantity of tear secretion. The main clinical symptoms are dry eyes, itching, etc. The long-term accumulation of symptoms will cause deep-seated lesions in the patient's cornea and conjunctiva, which may cause vision loss in severe cases. Epidemiological survey results show that the prevalence of dry eye disease is relat...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/722A61K31/661A61K47/02A61K47/36A61K9/06A61P27/02
CPCA61K9/0048A61K9/06A61K31/661A61K31/722A61K47/02A61K47/36A61P27/02A61K2300/00
Inventor 薛伟明魏荣李可欣许宁侠温惠云黄赛朋杨华潘士印
Owner 陕西靓双瞳医疗科技发展有限公司
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