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Chitosan gel for women as well as preparation method and medical application thereof

A chitosan and gel technology, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, antibacterial drugs, etc. joint reaction problems

Inactive Publication Date: 2013-04-17
FUZHOU QIANZHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The first point is that because chitosan has good cross-linking viscosity reaction and gelation characteristics in acidic environment, the addition of these poor biocompatibility polymer chemicals hinders the cross-linking reaction of chitosan linear molecules , also reduces the effective content of chitosan, so that the content of chitosan is all small, generally less than 3%, or even smaller, making the gel properties of the product worse;
[0007] The second point is that although the addition of these polymer substances has the effect of thickening agent, the adhesion performance of chitosan becomes worse. Under the action of vaginal secretions, the adhesion ability of chitosan and vaginal wall becomes smaller, It is easy to flow out from the vagina, which greatly reduces the action time and greatly reduces the therapeutic effect;
[0008] The third point is that for patients with vaginal and cervical erosion, the addition of these substances with poor biocompatibility will often cause irritation to the wound, sticky touch injury and heterogeneous reaction, which will adversely affect the care of erosive wounds

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Embodiment 1, chitosan gel for women and preparation method thereof

[0059] Recipe: Chitosan 10g (viscosity average molecular weight 60,000, degree of deacetylation ≥ 90%)

[0060] Glycerin 8g

[0061] 37% mixture of hydrochloric acid and glacial acetic acid (V:V=5:1) appropriate amount

[0062] Purified water was added to 100g.

[0063] Preparation method: in an environment with a cleanliness of 100,000, take 80ml of purified water, add chitosan with a molecular weight of 60,000 in the prescribed amount, stir and add an appropriate amount of hydrochloric acid-acetic acid mixed solution to make the reactant form a gel. And make the pH value of the gel at 4.2-4.5, add glycerin and stir evenly, degas, fill in high-density polyethylene vaginal administration tube and seal, and further sterilize with cobalt-60 radiation at a dose of 10-11KGy, Promptly get the sterile chitosan gel for women of the present invention, the viscosity is 152 Pa.s, and...

Embodiment 2

[0064] Embodiment 2, chitosan gel for women and preparation method thereof

[0065] Recipe: Chitosan 9g (viscosity average molecular weight 50,000, deacetylation degree ≥ 95%)

[0066] Glycerin 8g

[0067] 37% mixture of hydrochloric acid and glacial acetic acid (V:V=5:1) appropriate amount

[0068] Purified water was added to 100g.

[0069] Preparation method: in an environment with a cleanliness of 100,000, take 80ml of purified water, add chitosan with a molecular weight of 50,000 in the prescribed amount, stir and add an appropriate amount of hydrochloric acid-acetic acid mixed solution to make the reactant form a gel. And make the pH value of the gel at 4.2-4.5, add glycerin and stir evenly, degas, fill in high-density polyethylene vaginal administration tube and seal, and further sterilize with cobalt-60 radiation at a dose of 10-11KGy, Promptly get the sterile chitosan gel for women of the present invention, the viscosity is 91 Pa.s, and the g...

Embodiment 3

[0070] Embodiment 3, chitosan gel for women and preparation method thereof

[0071] Recipe: chitosan 7g (viscosity average molecular weight 90,000, degree of deacetylation ≥ 85%)

[0072] Glycerin 8g

[0073] Lactic acid amount

[0074] Purified water was added to 100g.

[0075] Preparation method: In an environment with a cleanliness of 100,000, take 80ml of purified water, add chitosan with a molecular weight of 90,000, stir and add an appropriate amount of lactic acid to make the reactant form a gel, and make the gel When the pH value is between 4.0 and 4.5, add glycerin and stir evenly, degas, fill in a high-density polyethylene vaginal administration tube and seal it, and further sterilize it with cobalt-60 radiation at a dose of 8 to 9.5KGy to obtain this product. Invent chitosan sterile gel for women with a viscosity of 79 Pa.s; or fill it in a vial after degassing, seal it, and further sterilize it at 121°C for 15 minutes to obtain chitosan sterile g...

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Abstract

The invention relates to chitosan gel for women. The chitosan gel for women is obtained by mixing chitosan with specific molecular weight and degree of deacetylation, glycerol, acidifier and purified water in a gelatinization manner and then sterilizing. The chitosan gel for women, provided by the invention, has good adhesive power, uniform colour and lustre and stability, and has the advantages of good curative effect, safety, natural property, good biocompatibility and the like when used for treating monilial vaginitis, bacterial vaginitis, mixed vaginitis, cervicitis, cervical erosion and the like of women. The invention also relates to a preparation method and medical application of the chitosan gel for women.

Description

Technical field [0001] The present invention involves the field of pharmaceutical products. Specifically, the invention involves a shell gel for women, which is used for women with pearl vaginitis, bacterial vaginitis, mixed vaginitis, cervicitis, and cervical erosionWait, it has the advantages of good efficacy, safety, natural, and biocompatibility. The present invention also involves its preparation methods and medical applications. Background technique [0002] The ideal gynecological external pharmaceutical products should have good antibacterial, anti -inflammatory, safety, biocompatibility, convenience of use, and easy to store and use. [0003] Chitosan (Chitosan), chemical name is poly (1, 4) -2-amino-2-deoxy-β-D-glucose.It is the only polymer alkaline polysaccharide in nature, also known as soluble crustacin, shell glycosamine, a few butanose, chitamine, has good biocompatibility, non -toxic side effects, easy to be absorbed, rich in source, rich in sourceThe characteris...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/722A61P15/02A61P15/00A61P31/02A61P31/04A61P31/10A61P33/02
Inventor 张耿元赵海静白东跃
Owner FUZHOU QIANZHENG PHARMA
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