CN110897999A

CN110897999A - Light black type temperature-sensitive gel for vagina, preparation method and application thereof

Info

Publication number: CN110897999A
Application number: CN201911276909.9A
Authority: CN
Inventors: 刘志鹏; 徐俊
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-12-12
Filing date: 2019-12-12
Publication date: 2020-03-24

Abstract

The invention provides a light black type temperature-sensitive gel for vagina, a preparation method and application thereof. The temperature-sensitive gel comprises poloxamer, chitosan, chlorhexidine gluconate, cherry blossom extract and alpha arbutin in a specific ratio, and on the basis, effective components such as melanin lightening medicines, antibacterial medicines, antifungal medicines, mycoplasma resisting medicines and the like can be further added; the temperature-sensitive gel is a slow-release preparation, is in a liquid state at the temperature of below 28 ℃, can permeate into skin folds, forms gel after contacting with body temperature for 3-5 minutes, covers the smearing part, is not easy to overflow, and ensures the action time and the action concentration of the medicine and the medicine receiving part to the maximum extent. Moreover, the gel has the effects of desalting and preventing melanin precipitation, moisturizing, whitening and the like on the vagina, and enables the pudendum to be delicate and glossy, warm, moist, nourishing, moist, red, tender and elastic; also has anti-inflammatory and antibacterial effects.

Description

Light black type temperature-sensitive gel for vagina, preparation method and application thereof

Technical Field

The invention relates to the technical field of gynecological external medicines, in particular to a light black vaginal thermosensitive gel, and a preparation method and application thereof.

Background

To ameliorate the problem that female pudendal regions deposit melanin more readily than other body tissues, developments in the prior art have resulted in products specifically designed to lighten the female pudendal pigment. At present, in common gynecological pudendum light black products, liquid gel and gel are the two main formulations, wherein the liquid gel is used by smearing, the local action time is short, and the nursing and light black effects are poor; the gel is administrated in a solid gel form, has good local retention characteristics, but the gel strength of the existing gel is small, the biological adhesion is poor, the local acting time is insufficient, and the curative effect is greatly influenced.

In addition to the above drawbacks of dosage forms, most products need to be improved in terms of melanin lightening effect, and the problems of unobvious melanin lightening effect, uncertain moisturizing and caring effect and the like generally exist, so that improvement from the component level is necessary to ensure an exact and sufficient use effect.

In addition, the vagina of the female is naturally warm and wet, has more secretion and is easy to breed microorganisms, so that the nursing of the vagina is an important means for ensuring the health of the female. The light black product is closely contacted with the pudendum when in use, so if antibacterial components can be introduced into the light black product, the antibacterial care effect on the pudendum of a female can be expected to be realized at the same time; however, the conventional light black product does not have ideal antibacterial effect, and even if the product is a special antibacterial and anti-inflammatory drug gel, the curative effect on bacterial diseases such as vaginitis and the like is still to be improved.

Disclosure of Invention

The invention aims to provide a light black vaginal thermosensitive gel, a preparation method and application thereof aiming at overcoming the technical defects in the prior art, and aims to solve the technical problem that the melanin desalination effect of the pudendum of a conventional light black product needs to be improved in the prior art.

The invention also aims to solve the technical problem of how to simultaneously realize the antibacterial and anti-inflammatory effects in the pudendum light black product.

In order to achieve the technical purpose, the invention adopts the following technical scheme:

the light black vaginal thermosensitive gel comprises the following components in parts by weight: 10-30 parts of poloxamer, 0.05-1 part of chitosan, 0.1-1 part of chlorhexidine gluconate, 0.1-1 part of oriental cherry extract and 0.1-1 part of alpha arbutin.

Preferably, the light black vaginal thermosensitive gel comprises the following components in parts by weight: 15-25 parts of poloxamer, 0.5-1 part of chitosan, 0.1-0.5 part of chlorhexidine gluconate, 0.1-0.8 part of oriental cherry extract and 0.1-0.8 part of alpha arbutin; thereby obtaining the temperature-sensitive gel with higher adhesiveness.

Preferably, the poloxamer is selected from one or several of the following components: poloxamer 407, poloxamer 108, poloxamer 188, poloxamer 338.

Preferably, the temperature-sensitive gel further comprises one or more of the following components: melanin-lightening drugs, antibacterial drugs, antifungal drugs, and anti-mycoplasma drugs.

Preferably, the melanin-lightening medicine is selected from one or more of the following components: cherry blossom extract, peach blossom extract, alpha arbutin, tranexamic acid, tretinoin and azelaic acid.

Preferably, the antibacterial drug is selected from one of the following components: compound povidone iodine liniment, compound chlorhexidine gargle, compound neomycin, potassium permanganate, benzoyl peroxide, compound chlorhexidine, erythromycin, metronidazole chlorhexidine, a methyl violet solution, clindamycin metronidazole, lidocaine chlorhexidine, crotamiton, ftibamzone, metronidazole glucose, neomycin fluocinolone acetonide, ciprofloxacin hydrochloride, and lincomycin hydrochloride.

Preferably, the antifungal drug is selected from one of the following components: undecylenic acid, acetic acid, salicylic acid, lactic acid, griseofulvin, nystatin, candicidin, econazole, miconazole, bifonazole, clotrimazole, ketoconazole, amphotericin B, flucytosine, mepacrycin, globithromycin, fluconazole, itraconazole.

Preferably, the antimycotic drug is selected from one of the following components: nystatin, fluconazole, amphotericin B, miconazole, ketoconazole.

Preferably, the anti-mycoplasma drug is selected from one of the following ingredients: tetracycline, doxycycline, azithromycin, methacycline, minocycline, josamycin, zedoary turmeric oil.

Preferably, the pH value of the temperature-sensitive gel is 4.0-4.5; the temperature of the temperature-sensitive gel is 28 ℃.

On the basis of the technical scheme, the invention further provides a preparation method of the light black vaginal thermosensitive gel, which comprises the following steps:

1) adding water into poloxamer and chitosan according to the formula amount, uniformly stirring, standing for swelling, and then adjusting the pH value to 4.0-4.5 to obtain blank gel;

2) uniformly mixing the cherry blossom extract and the alpha arbutin with the formula amount with the blank gel obtained in the step 1), and adding other components with the formula amount to obtain the light black vaginal thermosensitive gel.

On the basis of the technical scheme, the invention further provides application of the light black vaginal thermosensitive gel in preparation of a pudendum melanin desalination medicine or an antibacterial and anti-inflammatory medicine.

Preferably, the chitosan is carboxymethyl chitosan.

The invention provides a light black type temperature-sensitive gel for vagina, a preparation method and application thereof. The technical scheme provides a temperature-sensitive blank gel which can carry out reversible sol-gel conversion along with temperature change as a matrix, and further functional components are added into the matrix. The temperature-sensitive gel comprises poloxamer, chitosan, chlorhexidine gluconate, cherry blossom extract and alpha arbutin in a specific ratio, and on the basis, effective components such as melanin lightening medicines, antibacterial medicines, antifungal medicines, mycoplasma resisting medicines and the like can be further added; the temperature-sensitive gel is a slow-release preparation, is in a liquid state at the temperature of below 28 ℃, can permeate into skin folds, forms gel after contacting with body temperature for 3-5 minutes, covers the smearing part, is not easy to overflow, and ensures the action time and the action concentration of the medicine and the medicine receiving part to the maximum extent. Moreover, the gel has the effects of desalting and preventing melanin precipitation, moisturizing, whitening and the like on the vagina, and enables the pudendum to be delicate and glossy, warm, moist, nourishing, moist, red, tender and elastic; also has anti-inflammatory and antibacterial effects.

The gel has a light black effect on female vagina, can prevent melanin precipitation, moisten and nourish the vagina and moisturize and whiten the vagina; the use is convenient, the effect is good, and the nursing of female private parts is provided; also has antibacterial and anti-inflammatory effects, and can be used for treating various vaginal diseases.

The invention can safely and effectively relieve the problem of melanin precipitation of the female vagina and has the effects of lightening the melanin of the vagina, moisturizing, whitening and the like. The temperature-sensitive characteristic of liquid at low temperature and gel at high temperature enables the medicine to be uniformly covered on the surface of the mucosa, and the characteristic successfully solves a plurality of defects of the conventional gel in the prior art. The vaginal melanin desalting solution is used as a solution for vaginal melanin desalting and vaginal antibiosis and antiphlogosis, and provides a choice with high compliance and better effect for patients.

Compared with the prior art, the technical effects of the invention are also reflected in the following aspects in a centralized way: when the temperature is lower than a certain gelling temperature, the preparation is in a liquid form, can permeate into any deep folds of the vagina, is converted into a solid state after contacting with the body temperature for 3-5 minutes, can form a film with certain strength on the surface of a mucosa, greatly enhances the coverage protection and lubricity of the vagina mucosa, and greatly improves the blackness and antibacterial capability. Successfully solves the problem of uneven dispersion of the common gel on the affected part, ensures the maintenance of the drug concentration in a certain time and has the function of mechanical protection on the mucous membrane. It has convenient and sanitary administration, and high patient compliance

Drawings

FIG. 1 is a graph showing the amount of residual gel in the vagina of an experimental animal with time, according to an embodiment of the present invention.

FIG. 2 is a graph showing the results of the degree of melanin depletion in different experimental groups in accordance with an embodiment of the present invention.

Detailed Description

Hereinafter, specific embodiments of the present invention will be described in detail. Well-known structures or functions may not be described in detail in the following embodiments in order to avoid unnecessarily obscuring the details. Approximating language, as used herein in the following examples, may be applied to identify quantitative representations that could permissibly vary in number without resulting in a change in the basic function. Unless defined otherwise, technical and scientific terms used in the following examples have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

Example 1

The light black vaginal thermosensitive gel comprises the following components in parts by weight: 10 parts of poloxamer, 0.05 part of chitosan, 0.1 part of chlorhexidine gluconate, 0.1 part of oriental cherry extract and 0.1 part of alpha arbutin.

Example 2

The light black vaginal thermosensitive gel comprises the following components in parts by weight: 30 parts of poloxamer, 1 part of chitosan, 1 part of chlorhexidine gluconate, 1 part of oriental cherry extract and 1 part of alpha arbutin.

Example 3

The light black vaginal thermosensitive gel comprises the following components in percentage by weight: 10 to 30 percent of poloxamer, 0.05 to 1 percent of chitosan, 0.1 to 1 percent of chlorhexidine gluconate, 0.1 to 1 percent of cherry blossom extract and 0.1 to 1 percent of alpha arbutin.

Example 4

The light black vaginal thermosensitive gel comprises the following components in percentage by weight: 20% of poloxamer, 0.07% of chitosan, 0.55% of chlorhexidine gluconate, 0.55% of cherry blossom extract and 0.55% of alpha arbutin. Meanwhile, the temperature-sensitive gel also comprises a melanin lightening drug, an antibacterial drug, an antifungal drug and an anti-mycoplasma drug.

Example 5 (testing the phase transition temperature of the inventive gel)

Pouring the temperature-sensitive gel into a penicillin bottle, and heating in a water bath. Pouring penicillin bottles, and taking gel non-flowing as a phase transition temperature.

The results show that the gel of the present invention changed in properties from liquid to gel at 28 ℃ and the gel was highly adhesive.

Example 6

Adding a fluorescent marker into the temperature-sensitive gel; taking a certain brand of solid gel, adding a fluorescent marker as a control group, respectively smearing the gel on the vagina of a rabbit for 1h, 3h, 6h, 12h, 16h, 20h and 24h, killing the rabbit, taking the vagina, and observing the residence time of the gel at the vagina of the rabbit. The results of the experiment are shown in FIG. 1.

The experimental result shows that after a certain brand of solid gel is administrated for 3 hours, the gel basically has no retention at the vagina, but the temperature-sensitive gel matrix of the invention can be observed for 24 hours, so that the retention time at the vagina is longer than 24 hours, and the treatment target of once-a-day administration can be realized.

Example 7

SPF grade female rabbits 45 were hormone pretreated and divided into 3 groups. One group was given a blank gel matrix, one group was given a certain brand of gel, one group was given the gel of the present invention once a day for 7 consecutive days, the vaginal state was observed after the last administration and compared using a standard color chart, with the vaginal melanin level of the blank gel group as the standard, and the other two groups were compared with the blank gel group. The results of the experiment are shown in FIG. 2.

The observation shows that the vagina of the rabbit using the gel experimental group is more ruddy, the melanin deposition condition is greatly improved, and the melanin deposition condition is reduced by 50 percent compared with that of the blank gel; the melanin deposition condition of a certain brand of gel vagina is slightly improved, and the melanin deposition condition is reduced by about 10 percent; the blank gel was unchanged. The temperature-sensitive gel has the characteristic of temperature sensitivity, can prolong the retention time of the medicine, improves the precipitation of melanin in the vagina, moisturizes and whitens the vagina.

The embodiments of the present invention have been described in detail, but the description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention. Any modification, equivalent replacement, and improvement made within the scope of the application of the present invention should be included in the protection scope of the present invention.

Claims

1. The light black vaginal thermosensitive gel is characterized by comprising the following components in parts by weight: 10-30 parts of poloxamer, 0.05-1 part of chitosan, 0.1-1 part of chlorhexidine gluconate, 0.1-1 part of oriental cherry extract and 0.1-1 part of alpha arbutin.

2. The pale black vaginal temperature-sensitive gel according to claim 1, wherein the poloxamer is selected from one or more of the following components: poloxamer 407, poloxamer 108, poloxamer 188, poloxamer 338.

3. The temperature-sensitive gel for vagina of light black type according to claim 1, characterized in that it further comprises one or several of the following components: melanin-lightening drugs, antibacterial drugs, antifungal drugs, and anti-mycoplasma drugs.

4. The mild black vaginal temperature-sensitive gel according to claim 3, wherein the melanin-lightening agent is selected from one or more of the following components: cherry blossom extract, peach blossom extract, alpha arbutin, tranexamic acid, tretinoin and azelaic acid.

5. The pale black vaginal temperature-sensitive gel according to claim 3, wherein the antibacterial drug is selected from one of the following components: compound povidone iodine liniment, compound chlorhexidine gargle, compound neomycin, potassium permanganate, benzoyl peroxide, compound chlorhexidine, erythromycin, metronidazole chlorhexidine, a methyl violet solution, clindamycin metronidazole, lidocaine chlorhexidine, crotamiton, ftibamzone, metronidazole glucose, neomycin fluocinolone acetonide, ciprofloxacin hydrochloride, and lincomycin hydrochloride.

6. The pale black vaginal temperature-sensitive gel according to claim 3, wherein the antifungal drug is selected from one of the following components: undecylenic acid, acetic acid, salicylic acid, lactic acid, griseofulvin, nystatin, candicidin, econazole, miconazole, bifonazole, clotrimazole, ketoconazole, amphotericin B, flucytosine, mepacrycin, globithromycin, fluconazole, itraconazole.

7. The pale black vaginal temperature-sensitive gel according to claim 3, wherein the antifungal drug is selected from one of the following components: nystatin, fluconazole, amphotericin B, miconazole, ketoconazole.

8. The pale black vaginal temperature-sensitive gel according to claim 3, wherein the anti-mycoplasma drug is selected from one of the following components: tetracycline, doxycycline, azithromycin, methacycline, minocycline, josamycin, zedoary turmeric oil.

9. The method for preparing the light black vaginal temperature-sensitive gel according to any one of claims 1 to 8, characterized by comprising the following steps:

10. The use of the light black vaginal temperature-sensitive gel of any one of claims 1-8 in the preparation of a pudendum melanin-lightening medicament or an antibacterial anti-inflammatory medicament.