Gel preparation for treating gynecological diseases and preparation method thereof

Abstract

The invention relates to a gel preparation for treating gynecological diseases. The gel preparation consists of chitosan with specific molecular weight and degree of deacetylation, chlorhexidine, glycerin, an acidifying agent and purified water. The preparation method comprises the following steps of: mixing the chitosan with the purified water to form suspension liquid in an environment with cleanliness at one-hundred-thousand level; adding the acidifying agent to regulate pH to 3.8-5.8 to obtain chitosan gel; dissolving chlorhexidine in the glycerin, adding into the chitosan gel, uniformly stirring, degassing, filling, sealing, and sterilizing to obtain the gel preparation, wherein the acidifying agent is lactic acid, acetic acid or a hydrochloric acid-acetic acid mixture; and the sterilizing mode is cobalt-60 irradiation treatment or high-temperature damp-hot sterilization. The gel has good adhesion force, uniform color and good stability, is used for treating women monilial vaginitis, bacterial vaginitis, mixed vaginitis, cervicitis, cervical erosion and the like, and has the advantages of being good in curative effect, safe, natural, good in biocompatibility and the like. The invention further relates to a preparation method and medical application of the gel preparation.

Description

technical field [0001] The present invention relates to the field of pharmaceutical products. Specifically, the present invention relates to a gel preparation for treating gynecological diseases, which is used for the treatment of women's candida vaginitis, bacterial vaginitis, mixed vaginitis, cervicitis, and cervical erosion etc., have the advantages of good curative effect, safety, naturalness, good biocompatibility, etc., and the present invention also relates to its preparation method and medical application. Background technique [0002] Ideal gynecological topical pharmaceutical products should have good antibacterial and anti-inflammatory properties, safety, biocompatibility, and ease of use. They should also be stable, easy to store, and easy to use. [0003] Chitosan (Chitosan), chemically named poly(1,4)-2-amino-2-deoxy-β-D-glucose, is a natural biopolymer obtained after partial or complete deacetylation of chitin. It is the only macromolecular alkaline polysacch...

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, although the addition of these polymer substances has the effect of a thickener, it will make the adhesion of chitosan gel worse. Under the action of vaginal secretions, the adhesion of chitosan to the vaginal wall The capacity becomes smaller, and 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

[0009] In addition, as an external antibacterial agent and wound care agent used in the vagina, although chitosan has a good effect on wound repair (such as wound repair and care of cervical erosion), but in terms of antibacterial properties, especially in killing pathogenic There are obvious deficiencies in germs, and chitosan alone has insufficient antibacterial effects in the treatment of severe and intractable gynecological diseases

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