CN116077523A

CN116077523A - Composition for preventing and treating hemorrhoids and preparation method and application thereof

Info

Publication number: CN116077523A
Application number: CN202310175180.6A
Authority: CN
Inventors: 杨鹏; 刘锐; 谭健兵; 张伟; 肖雅丽; 俞利林
Original assignee: Hunan Tiangenle Weijun Technology Co ltd
Current assignee: Hunan Tiangenle Weijun Technology Co ltd
Priority date: 2023-02-27
Filing date: 2023-02-27
Publication date: 2023-05-09

Abstract

The invention discloses a composition for preventing and treating hemorrhoids, a preparation method and application thereof. The invention combines beta-glucan, manna, sodium hyaluronate and carbomer to form a mixture, plays a role in functional combination, and the beta-glucan and the carbomer can form a layer of protective film on anorectal mucosa, and can be physically isolated from external bacteria, thereby preventing the colonization of pathogenic microorganisms, being used for covering and nursing hemorrhoids wound surfaces and wound surfaces after hemorrhoids operation, and simultaneously adding the manna and the sodium hyaluronate for combination can also improve internal hemorrhoids, anal pendant and pain caused by mixed hemorrhoids, hemorrhoids prolapse, mucous membrane congestion, hematochezia, constipation symptoms and hemorrhoid shrinkage, and can be effectively used for preventing and treating hemorrhoids.

Description

Composition for preventing and treating hemorrhoids and preparation method and application thereof

Technical Field

The invention belongs to the technical fields of pharmaceutical chemicals and medical appliances, and particularly relates to a composition for preventing and treating hemorrhoids and a preparation method and application thereof.

Background

Anal fistula is commonly known as hemorrhoid, and is a common disease and frequently occurring disease. The soft vein group is mainly formed by expansion and bending of vein clusters under the mucous membrane of the tail end of the rectum, the anal canal and the anus margin; or inflamed skin, hypertrophy and connective tissue hyperplasia of the anal verge folds; or rupture of anal veins and blood stasis to form thrombus.

Ancient doctors in the western week period, "Shanhaijing" had originally developed the name of hemorrhoids. The earliest medical book in China, "fifty-two disease prescription", describes the classification and syndromes of hemorrhoids, which are classified into 4 types of hemorrhoids, namely, a mu Zhi, a Yu Zhi, a Mai Zhi and a blood Zhi. Except for the treatment of pulse hemorrhoids and blood hemorrhoids, with no symptoms, both the symptoms of both the mu hemorrhoids and the Yu hemorrhoids are recorded in the treatment method. Hemorrhoids, which are referred to in modern medicine, include internal hemorrhoids, external hemorrhoids, and mixed hemorrhoids, which are chronic diseases. The traditional Chinese medicine considers that the hemorrhoids are caused by imbalance of yin and yang, deficiency of qi and blood of viscera, re-humidification, heat, wind, dryness and other pathogenic factors, and influence of internal injury of emotion, improper diet and the like, so that qi and blood imbalance, blockage of collaterals, stagnation of blood stasis and turbid airflow into anus and accumulation of masses into hemorrhoids are caused. Regarding the etiology and pathology of hemorrhoids, intensive researches are currently carried out at home and abroad, and various theories are proposed, mainly including varicose theory, vascular hyperplasia theory, mucous membrane sliding theory, sphincter dysfunction theory, hemorrhoid venous pump dysfunction theory and the like. Some doctors consider that sedentary, standing, tiredness and the like cause the human body to be in a fixed position for a long time, or that hypokinesia, slow intestinal peristalsis, slow fecal descending or habitual constipation can all cause hemorrhoids to form.

According to the general investigation data, the incidence rate of anorectal diseases is 59.1%, hemorrhoids account for 87.25% of all rectal diseases and 52.19% of all anorectal diseases. Both men and women can develop the disease, the incidence rate of women is 67%, the incidence rate of men is 53.9%, and the incidence rate of women is high; onset occurs at any age, with people between 20 and 40 being more common and progressively aggravated with age. The disease is most common with three symptoms of bleeding, pain and constipation.

At present, the traditional Chinese medicine for treating hemorrhoids mainly comprises oral administration, injection, fumigation and washing, external application, acupuncture, operation and the like in clinic, and the methods can be singly used or can be combined for use, but the methods are complex, all require a long period and are difficult to completely cure.

Disclosure of Invention

The present invention aims to solve at least one of the technical problems in the prior art described above. For this purpose, the invention proposes a composition for the prevention and treatment of hemorrhoids.

The invention also provides a preparation method of the composition.

The invention also provides application of the composition.

The invention also provides a product.

According to one aspect of the present invention, a composition for controlling hemorrhoids is presented, the composition comprising beta-glucan, mannan, sodium hyaluronate, carbomer, and a humectant.

In some embodiments of the invention, the composition comprises the following components in weight percent: 0.2 to 1.0 percent of beta-glucan, 0.1 to 0.4 percent of mannan, 0.05 to 0.5 percent of sodium hyaluronate, 0.4 to 3 percent of carbomer and 1 to 5 percent of humectant.

In some embodiments of the invention, the composition comprises the following components in weight percent: 0.3 to 0.8 percent of beta-glucan, 0.1 to 0.4 percent of mannan, 0.1 to 0.4 percent of sodium hyaluronate, 1 to 3 percent of carbomer and 1 to 4 percent of humectant.

In some embodiments of the invention, the humectant comprises at least one of glycerin, propylene glycol, butylene glycol, and panthenol.

In some embodiments of the invention, the carbomer is selected from at least one of the following: carbomer 940, carbomer 941, carbomer 934.

In some embodiments of the invention, the beta-glucan is yeast beta-glucan or lentinus edodes beta-glucan.

In some embodiments of the invention, the composition further comprises a perfume, a preservative, and a pH balancing agent. In some embodiments of the invention, the preservative comprises at least one of sodium methylparaben, benzoic acid, sodium benzoate, phenoxyethanol, sorbic acid, and sodium sorbate.

In some embodiments of the invention, the flavour comprises peppermint flavour.

In some embodiments of the invention, the pH balancing agent comprises at least one of triethanolamine, sodium bicarbonate, potassium bicarbonate.

In some embodiments of the invention, the composition further comprises the following components in weight percent: 0.05 to 0.2 percent of essence, 0.1 to 0.5 percent of preservative and 0.01 to 0.1 percent of pH balancing agent.

In a second aspect of the present invention, a method for preparing the above product is provided, comprising the steps of: mixing the above compositions.

In a third aspect of the invention, the use of the above composition for the preparation of a medicament for the prevention and treatment of hemorrhoids is presented.

In some embodiments of the invention, the hemorrhoids include internal hemorrhoids, external hemorrhoids, and mixed hemorrhoids.

In a third aspect of the invention, a product is provided, comprising the above composition.

In some embodiments of the invention, the product is a pharmaceutical product or a medical device.

In some embodiments of the invention, the pharmaceutical product further comprises a pharmaceutically acceptable carrier and/or a pharmaceutically acceptable adjuvant.

In some embodiments of the invention, the pharmaceutically acceptable carrier comprises at least one of diluents, excipients, fillers, binders, disintegrants, absorption enhancers, surfactants, adsorption carriers, lubricants, sweeteners, and flavoring agents.

In some embodiments of the invention, the excipient comprises water.

In some embodiments of the invention, the filler comprises at least one of starch and sucrose.

In some embodiments of the invention, the binder comprises at least one of cellulose derivatives, alginate, gelatin, and polyvinylpyrrolidone.

In some embodiments of the invention, the humectant comprises glycerin.

In some embodiments of the invention, the disintegrant comprises at least one of agar, calcium carbonate, and sodium bicarbonate.

In some embodiments of the invention, the absorption enhancer comprises a quaternary ammonium compound.

In some embodiments of the invention, the surfactant comprises cetyl alcohol.

In some embodiments of the invention, the adsorption carrier comprises at least one of kaolin clay and soap clay.

In some embodiments of the invention, the lubricant comprises at least one of talc, calcium stearate, magnesium stearate, and polyethylene glycol.

In some embodiments of the invention, the product is in the form of one of a powder, a paste, and a gel.

According to some embodiments of the invention, there is at least the following beneficial effects: the invention combines beta-glucan, manna, sodium hyaluronate and carbomer to form a mixture, plays a role in functional combination, and the beta-glucan and the carbomer can form a layer of protective film on anorectal mucosa, and can be physically isolated from external bacteria, thereby preventing the colonization of pathogenic microorganisms, being used for covering and nursing hemorrhoids wound surfaces and wound surfaces after hemorrhoids operation, and simultaneously adding the manna and the sodium hyaluronate for combination can also improve internal hemorrhoids, anal pendant and pain caused by mixed hemorrhoids, hemorrhoids prolapse, mucous membrane congestion, hematochezia, constipation symptoms and hemorrhoid shrinkage, and can be effectively used for preventing and treating hemorrhoids.

Detailed Description

The conception and the technical effects produced by the present invention will be clearly and completely described in conjunction with the embodiments below to fully understand the objects, features and effects of the present invention. It is apparent that the described embodiments are only some embodiments of the present invention, but not all embodiments, and that other embodiments obtained by those skilled in the art without inventive effort are within the scope of the present invention based on the embodiments of the present invention.

The test methods used in the examples are conventional methods unless otherwise specified; the materials, reagents and the like used, unless otherwise specified, are those commercially available.

Example 1

An example of a composition of the invention, this example contains the following components in weight percent: yeast beta-glucan 0.5%, manna 0.2%, sodium hyaluronate 0.2%, carbomer 941%, glycerin 3%, peppermint essence 0.08%, sodium methylparaben 0.2% and the balance being water.

The preparation method of the composition in this example is as follows:

(1) Adding a proper amount of purified water into a stirring tank, adding 2% carbomer 941, stirring at 80 ℃ to dissolve, preserving heat at 80 ℃ for 30 minutes, starting cooling water, and cooling;

(2) Adding yeast beta-glucan 0.5%, manna 0.2%, sodium hyaluronate 2%, carbomer 9412%, glycerin 3%, peppermint essence 0.08% and sodium methylparaben 0.2% into a stirring tank according to the weight ratio, and adding the rest water into the stirring tank to dissolve the components;

(3) And (3) mixing and stirring the mixture obtained in the step (1) and the mixture obtained in the step (2) for 20 minutes, and then adding a pH balancing agent triethanolamine to adjust the pH to 7.0 (6.8-7.2).

Example 2

An example of a composition of the invention, this example contains the following components in weight percent: yeast beta-glucan 0.4%, manna 0.2%, sodium hyaluronate 0.3%, carbomer 941%, glycerin 3%, peppermint essence 0.08%, sodium methylparaben 0.2% and the balance being water.

The method for producing the composition in this example was the same as in example 1.

Example 3

An example of a composition of the invention, this example contains the following components in weight percent: yeast beta-glucan 0.7%, manna 0.2%, sodium hyaluronate 0.1%, carbomer 941%, glycerin 2%, peppermint essence 0.08%, sodium methylparaben 0.2% and the balance being water.

Example 4

An example of a composition of the invention, this example contains the following components in weight percent: yeast beta-glucan 0.5%, manna 0.4%, sodium hyaluronate 0.1%, carbomer 941%, glycerin 2%, peppermint essence 0.08%, sodium methylparaben 0.2% and the balance being water.

Comparative example 1

A comparative example of the composition of the invention, which differs from example 1 only in the preparation of the default yeast beta-glucan in the starting material. The sources of the remaining components and the method of making the composition were the same as in example 1.

Comparative example 2

A comparative example of the composition of the present invention, which differs from example 1 only in the preparation of the default mannans in the starting material. The sources of the remaining components and the method of making the composition were the same as in example 1.

Comparative example 3

A comparative example of the composition of the present invention, which differs from example 1 only in the default sodium hyaluronate in the preparation of the starting material. The sources of the remaining components and the method of making the composition were the same as in example 1.

Comparative example 4

A comparative example of the composition of the present invention, which differs from example 1 only in that yeast beta glucan was replaced with lentinan beta glucan as the preparation material. The sources of the remaining components and the method of making the composition were the same as in example 1.

Test case

1. Security detection

The composition prepared in example 1 was subjected to safety test in accordance with cosmetic safety Specification (2015 edition) using an experimental rabbit. 6 healthy and adult rabbits are selected, the male and female rabbits are divided into 3 groups, and the fur on two sides of the back spine of the animal is reduced before the experiment, and the fur removing range is about 3cm multiplied by 3cm. The control was not treated. The experimental group adopts a self-comparison method of the left side and the right side of the same body, 0.5g of the test object is smeared on the dehaired skin on the right side of the back of the rabbit, the smearing area is 2.5cm multiplied by 2.5cm, and the application is carried out once a day for 14 days continuously; shearing hair before each application; the left depilatory area was not treated as a self-control. From the next day, the residual test sample was removed with warm water, and after 1 hour, the results were observed and scored according to the skin irritation response scoring criteria of cosmetic hygiene Specification (2015 edition). Through 14 days of observation experiments, the test animal has no systemic poisoning, and the local skin coated by the test object has no erythema, edema and other manifestations, so that the composition provided by the embodiment 1 of the invention has no irritation on multiple skin irritation.

2. Clinical trial

(1) Subject inclusion criteria:

70 patients with obvious anal redness, pain, hematochezia, prolapse, distention, edema, pruritus and burning phenomena are selected from the patients with the confirmed hemorrhoids. The invention is approved by the ethical committee of hospitals, all patients agree informed, and good life work and rest time and eating habits can be maintained during the trial period.

(2) Therapeutic method

Grouping: 70 patients were divided into 9 groups, wherein 8 patients of examples 1-4 and comparative examples 1-4 each, and 6 patients selected from the control group were not subjected to any treatment.

The using mode is as follows: the compositions prepared in examples 1-4 and comparative examples 1-4, respectively, were used for the experimental group, once daily for external use; the anus is cleaned after the defecation in the morning, the compositions prepared in examples 1-4 and comparative examples 1-4 are applied to the affected parts in equal amounts, and people should pay attention to avoiding hard defecation or sitting for a long time in daily life; the use was continued for 2 weeks. After the treatment is finished, the call is returned, and the experiences of the patient after trial are collected and summarized.

(3) Efficacy evaluation criteria

And (3) healing: the red swelling, pain, hematochezia, falling, distension, edema, burning and itching of the anus all disappear;

the method is effective: the symptoms are controlled and obviously improved;

invalidation: the symptom improvement condition is not obvious, and even the aggravation trend occurs.

TABLE 1

The results are shown in Table 1, and it can be seen from the table that the composition for preventing and treating hemorrhoids prepared according to the scheme of the present invention has good therapeutic effects on anal inflammation and hemorrhoids. After 2 weeks of use, the patients with red and swollen anus, pain, hematochezia, prolapse, distention, edema, burning and itching all disappeared reach 87.5%. Meanwhile, according to feedback of patients, adverse reactions do not occur after the composition of the scheme is used.

While the embodiments of the present invention have been described in detail, the present invention is not limited to the above embodiments, and various changes can be made without departing from the spirit of the present invention within the knowledge of those skilled in the art. Furthermore, embodiments of the invention and features of the embodiments may be combined with each other without conflict.

Claims

1. A composition for the prevention and treatment of hemorrhoids, characterized in that it comprises beta-glucan, mannan, sodium hyaluronate, carbomer and a humectant.

2. The composition according to claim 1, characterized in that it comprises the following components in weight percentage: 0.2 to 1.0 percent of beta-glucan, 0.1 to 0.4 percent of mannan, 0.05 to 0.5 percent of sodium hyaluronate, 0.4 to 3 percent of carbomer and 1 to 5 percent of humectant.

3. The composition of claim 1, wherein the humectant comprises at least one of glycerin, propylene glycol, butylene glycol, and panthenol.

4. The composition of claim 1, wherein the carbomer is selected from at least one of the following: carbomer 940, carbomer 941, carbomer 934.

5. The composition of claim 1, wherein the composition further comprises a fragrance, a preservative, and a pH balancing agent; preferably, the flavour comprises peppermint flavour; preferably, the preservative comprises at least one of sodium methylparaben, benzoic acid, sodium benzoate, phenoxyethanol, sorbic acid, and sodium sorbate; preferably, the pH balancing agent comprises at least one of triethanolamine, sodium bicarbonate, and potassium bicarbonate.

6. A method of preparing the composition of claim 1, comprising the steps of: the composition of claim 1 is obtained by mixing the components.

7. Use of a composition according to any one of claims 1 to 5 for the preparation of a medicament for the prevention and treatment of hemorrhoids.

8. A product comprising the composition of any one of claims 1-5.

9. The product of claim 8, wherein the product is a pharmaceutical product or a medical device.

10. The product of claim 8, wherein the product is in a dosage form selected from the group consisting of a powder, a paste, and a gel.