A medical bio-gel preparation for adjuvant treatment of hemorrhoids and its preparation method

Abstract

The present invention provides a medical biological gel preparation for assisting in the treatment of hemorrhoids and a preparation method thereof, comprising 45% - 55% of carbomer gel, 15% - 25% of biological polysaccharide composition, 15% - 20% of mussel mucin, 10% - 15% of acetyl hexapeptide, and 2% - 5% of chitin. The biological polysaccharide composition includes carboxymethyl chitosan, polysulfated mucopolysaccharide, and glycosaminoglycan. The carbomer gel components are carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate, and water. The present invention uses carbomer as the main raw material and polysaccharide composition and protein as auxiliary materials. Through the synergistic effect of polysaccharide and protein in the gel, the prepared gel forms a protective film on the anorectal mucosa, physically isolating it from external bacteria, thereby preventing the colonization of pathogenic microorganisms, and thus achieving excellent anti-inflammatory, antibacterial, hemostatic, and promoting tissue cell proliferation effects, and having a good auxiliary effect on the treatment of internal hemorrhoids, external hemorrhoids, mixed hemorrhoids, and after hemorrhoid surgery.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and particularly relates to a medical biological gel preparation for assisting in the treatment of hemorrhoids and a preparation method thereof. Background Art

[0002] Hemorrhoids are a chronic disease in which varicose veins form in the bottom of the anorectal area and the anal mucosa, resulting in one or more soft venous masses. Hemorrhoid nuclei located inside the anus mucosa are called internal hemorrhoids, those located near the inner side of the anus are called external hemorrhoids, and those with both are called mixed hemorrhoids. This disease not only poses a threat to the physical health of patients, but also affects the daily life and work of patients.

[0003] Currently, the treatment methods for hemorrhoids usually include the following: 1. Physical therapy: Generally refers to warm water sitz bath, which can achieve the effect of locally improving hemorrhoid symptoms; 2. Drug therapy: Early-stage patients with stage I and stage II hemorrhoids can undergo drug therapy, including oral medications such as Puji Hemorrhoid Suppository, Daflon, and Diosmin Tablets, which can locally improve and promote the absorption of swelling; 3. Surgical treatment: For patients with stage III and stage V annular prolapsed hemorrhoids, minimally invasive surgeries such as PPH and TST are generally used for treatment. The PPH surgery, that is, circumcision of the hemorrhoidal mucosa, can perform circumcision of the rectal mucosa and upward displacement of the anal cushions from an anatomical perspective, reducing the recurrence rate of mixed hemorrhoids. The technology is mature, the curative effect is good, and the trauma is small.

[0004] For physical therapy and oral drug therapy, the current treatment effects are not significant, and the affected area is prone to virus and bacteria infections in daily life, leading to the aggravation of the condition. In addition, oral medications sometimes cause physical discomfort to the takers; for surgical treatment, the cost is too high and postoperative problems such as pain, bleeding, slow wound healing, and easy infection of the wound leading to recurrence are likely to occur; for existing external hemorrhoid gel preparations, the treatment effect is too single and the preparation cost is too high. Summary of the Invention

[0005] Based on the limitations and deficiencies in the background art, the present invention proposes a medical biological gel preparation for assisting in the treatment of hemorrhoids and a preparation method thereof to solve the above problems.

[0006] The technical solution of the present invention is realized as follows: A medical biological gel preparation for assisting in the treatment of hemorrhoids, with carbomer as the main raw material, and the gel comprises the following components in mass percentage: 45% - 55% of carbomer gel, 15% - 25% of biological polysaccharide composition, 15% - 20% of mussel adhesive protein, 10% - 15% of acetyl hexapeptide, and 2% - 5% of chitin. The biological polysaccharide composition comprises carboxymethyl chitosan, polysulfated mucopolysaccharide, and glycosaminoglycan;

[0007] Further explanation: A medical biological gel preparation for adjuvant treatment of hemorrhoids, its composition and weight ratio are as follows based on 100%: carbomer gel 50%, biological polysaccharide composition 21%, mussel mucin 15%, acetyl hexapeptide 10%, chitin 4%.

[0008] Further explanation: The carbomer gel is prepared from carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate and water.

[0009] Further explanation: The glycosaminoglycan is one or a mixture of more of hyaluronic acid, dermatan sulfate, heparin, heparan sulfate.

[0010] Further explanation: The components of the biological polysaccharide composition are in a mass ratio of 2 - 4:1 - 4:1 - 3.

[0011] Further explanation: The preparation method of the medical biological gel for adjuvant treatment of hemorrhoids includes the following steps:

[0012] S1. Preparation of the biological polysaccharide composition: Prepare raw materials according to the said weight ratio, add carboxymethyl chitosan, polysulfated mucopolysaccharide and glycosaminoglycan to water, stir ultrasonically until completely dissolved, then filter, and perform vacuum degassing on the filtrate to obtain the biological polysaccharide composition, where the weight ratio of the three biological polysaccharide compositions to water is 1:1.5 - 1.8;

[0013] S2. Preparation of the carbomer gel: Add carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate and water with a mass ratio of 4 - 8:1 - 2:0.2 - 1:0.5 - 1.5:6 to the reaction kettle and stir, let it stand at room temperature or heat in a water bath to fully swell, and use 1mol / L sodium hydroxide solution to adjust the pH value to neutral to obtain the carbomer gel;

[0014] S3. Pour the carbomer gel, biological polysaccharide composition, mussel mucin, acetyl hexapeptide and chitin into the same container according to the ratio and stir for 20 - 30 min. After waiting for full swelling, obtain a medical biological gel preparation for adjuvant treatment of hemorrhoids.

[0015] Further explanation: In the step S1, the ultrasonic time is 10 - 20 min and the ultrasonic frequency is 30 - 40 kHz.

[0016] Further explanation: In the step S2, when standing at room temperature for 1 - 3 h or heating in a water bath for 30 - 60 min, the pH value of the carbomer gel is between 6.0 - 7.0.

[0017] Compared with the prior art, the beneficial effects of the present invention are:

[0018] The medical biological gel preparation for auxiliary treatment of hemorrhoids prepared by the present invention is added with non-toxic and readily available biopolysaccharide composition and protein, and has the effects of promoting cell metabolism, promoting rapid growth of tissue cells, stopping bleeding and inhibiting bacteria. The gel preparation prepared by the present invention forms a protective film in the anorectal mucosa, which is physically isolated from external bacteria, thereby preventing pathogenic microorganisms from colonizing, thereby achieving the effects of antibacterial, antiviral, isolation, anti-inflammatory, analgesic, heat-clearing and detoxifying, and has obvious improvement effects on hemorrhoid bleeding, anal swelling, hemorrhoid prolapse, and hemorrhoid mucosal congestion and edema caused by different stages of hemorrhoids and mixed hemorrhoids. In addition, the gel can act on the diseased part through a disposable introducer to achieve a fast and safe effect.

[0019] The medical biological gel preparation for auxiliary treatment of hemorrhoids of the present invention adopts carbomer gel, which is mainly used to relieve the symptoms of congestion and bloody stool caused by hemorrhoids; adopts the biological polysaccharide composition, which mainly plays the role of removing blood stasis and stopping bleeding, and reducing inflammation and relieving pain; adopts protein, which mainly plays the role of antibacterial, sterilizing, anti-infection and promoting wound repair. DETAILED DESCRIPTION

[0020] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0021] Example 1

[0022] A medical biological gel preparation for assisting the treatment of hemorrhoids, the gel preparation comprising the following components in percentage by mass: 45% carbomer gel, 20% biopolysaccharide composition, 20% mussel mucin, 10% acetyl hexapeptide, and 5% chitin; the biopolysaccharide composition comprises carboxymethyl chitosan, polysulfonated mucopolysaccharide, and glycosaminoglycans; the carbomer gel comprises carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetic acid, and water; the glycosaminoglycans are a mixture of hyaluronic acid and dermatan sulfate in a weight ratio of 2:1; the components of the biopolysaccharide composition are in a weight ratio of 2:1:1. The preparation method of the medical biological gel preparation for assisting the treatment of hemorrhoids comprises the following steps:

[0023] S1. Preparation of a biopolysaccharide composition: preparing raw materials according to the weight ratio, adding carboxymethyl chitosan, polysulfonated mucopolysaccharide and glycosaminoglycan to water, stirring with ultrasound until completely dissolved, filtering, and vacuum degassing the filtrate to obtain a biopolysaccharide composition, wherein the weight ratio of the three biopolysaccharides to water is 1:1.5, the ultrasound time is 10 min, and the ultrasound frequency is 30 kHz;

[0024] S2. Preparation of Carbomer Gel: Add carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate, and water with a mass ratio of 4:1:0.2:0.5:6 into a reaction kettle and stir. Let it stand at room temperature or heat in a water bath to fully swell, and adjust the pH value to neutral to obtain the carbomer gel. The standing time is 1 h, and the pH value of the carbogel is 6.0;

[0025] S3. Pour the carbomer gel, biological polysaccharide composition, mussel adhesive protein, acetyl hexapeptide, and chitin into the same container in proportion and stir for 20 min. Wait for full swelling to obtain a medical biological gel preparation for auxiliary treatment of hemorrhoids.

[0026] Example 2

[0027] A medical biological gel preparation for auxiliary treatment of hemorrhoids, characterized in that the gel preparation comprises the following components in mass percentage: 45% of carbomer gel, 25% of biological polysaccharide composition, 15% of mussel adhesive protein, 12% of acetyl hexapeptide, and 3% of chitin; the biological polysaccharide composition comprises carboxymethyl chitosan, polysulfated mucopolysaccharide, and glycosaminoglycan. The components of the carbomer gel are carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate, and water. The glycosaminoglycan is a mixture of dermatan sulfate and heparan sulfate with a weight ratio of 1:2. The components of the biological polysaccharide composition are in a mass ratio of 2:2:1.5. The preparation method of the medical biological gel preparation for auxiliary treatment of hemorrhoids comprises the following steps:

[0028] S1. Preparation of biological polysaccharide composition: Prepare raw materials according to the said weight ratio. Add carboxymethyl chitosan, polysulfated mucopolysaccharide, and glycosaminoglycan into water, stir ultrasonically until completely dissolved, then filter, and degas the filtrate under vacuum to obtain the biological polysaccharide composition. The weight ratio of the three biological polysaccharides to water is 1:1.7. The ultrasonic time is 12 min, and the ultrasonic frequency is 35 kHz;

[0029] S2. Preparation of carbomer gel: Add carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate, and water with a mass ratio of 5:1:0.4:0.8:8 into a reaction kettle and stir. Let it stand at room temperature or heat in a water bath to fully swell, and adjust the pH value to neutral to obtain the carbomer gel. The standing time is 1.5 h, and the pH value of the carbogel is 6.3;

[0030] S3. Pour the carbomer gel, biological polysaccharide composition, mussel adhesive protein, acetyl hexapeptide, and chitin into the same container in proportion and stir for 25 min. Wait for full swelling to obtain a medical biological gel preparation for auxiliary treatment of hemorrhoids.

[0031] Example 3

[0032] A medical bio - gel preparation for adjuvant treatment of hemorrhoids. The gel preparation comprises the following components in mass percentage: carbomer gel 48%, biological polysaccharide composition 15%, mussel mucin 18%, acetyl hexapeptide 15%, chitin 4%; the biological polysaccharide composition includes carboxymethyl chitosan, polysulfated mucopolysaccharide and glycosaminoglycan. The components of the carbomer gel are carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate and water. The glycosaminoglycan is a mixture of heparin and heparan sulfate with a weight ratio of 2:1. The components of the biological polysaccharide composition are in a mass ratio of 2.5:3:2.5. The medical bio - gel preparation for adjuvant treatment of hemorrhoids has a preparation method including the following steps:

[0033] S1. Preparation of the biological polysaccharide composition: Prepare raw materials according to the said weight ratio. Add carboxymethyl chitosan, polysulfated mucopolysaccharide and glycosaminoglycan into water, stir ultrasonically until completely dissolved, then filter, and perform vacuum degassing on the filtrate to obtain the biological polysaccharide composition. The weight ratio of the three biological polysaccharides to water is 1:1.7. The ultrasonic time is 15 min and the ultrasonic frequency is 35 kHz;

[0034] S2. Preparation of the carbomer gel: Add carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate and water with a mass ratio of 6:1:0.6:1:8 into a reaction kettle and stir. Let it stand at room temperature or heat in a water bath to fully swell, adjust the pH value to neutral to obtain the carbomer gel. The standing time is 1 h, and the pH value of the carbogel is 6.5;

[0035] S3. Pour the carbomer gel, biological polysaccharide composition, mussel mucin, acetyl hexapeptide and chitin into the same container according to the ratio and stir for 25 min. Wait for full swelling, and then obtain a medical bio - gel preparation for adjuvant treatment of hemorrhoids.

[0036] Example 4

[0037] A medical bio - gel preparation for adjuvant treatment of hemorrhoids. The gel preparation comprises the following components in mass percentage: carbomer gel 50%, biological polysaccharide composition 21%, mussel mucin 15%, acetyl hexapeptide 10%, chitin 4%; the biological polysaccharide composition includes carboxymethyl chitosan, polysulfated mucopolysaccharide and glycosaminoglycan. The components of the carbomer gel are carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate and water. The glycosaminoglycan is hyaluronic acid. The components of the biological polysaccharide composition are in a mass ratio of 2:1:1. The medical bio - gel preparation for adjuvant treatment of hemorrhoids has a preparation method including the following steps:

[0038] S1. Preparation of the biological polysaccharide composition: Prepare the raw materials according to the stated weight ratio. Add carboxymethyl chitosan, polysulfated glycosaminoglycan, and glycosaminoglycan to water, and stir ultrasonically until completely dissolved. Then, filter the solution and degas the filtrate under vacuum to obtain the biological polysaccharide composition. The weight ratio of the three biological polysaccharides to water is 1:1.8. The ultrasonic time is 20 min, and the ultrasonic frequency is 40 kHz.

[0039] S2. Preparation of the carbomer gel: Add carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate, and water with a mass ratio of 6:1:0.6:1:8 to the reaction kettle and stir. Let it stand at room temperature or heat in a water bath to allow it to swell sufficiently. Adjust the pH value to neutral to obtain the carbomer gel. The standing time is 2 h, and the pH value of the carbogel is 7.0.

[0040] S3. Pour the carbomer gel, biological polysaccharide composition, mussel adhesive protein, acetyl hexapeptide, and chitin into the same container in proportion and stir for 20 min. Wait for sufficient swelling, and then obtain a medical biological gel preparation for the adjuvant treatment of hemorrhoids.

[0041] Example 5

[0042] A medical biological gel preparation for the adjuvant treatment of hemorrhoids, the gel preparation comprising the following components in mass percentage: 55% of carbomer gel, 17% of biological polysaccharide composition, 16% of mussel adhesive protein, 10% of acetyl hexapeptide, and 2% of chitin; the biological polysaccharide composition includes carboxymethyl chitosan, polysulfated glycosaminoglycan, and glycosaminoglycan, the components of the carbomer gel are carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate, and water, the glycosaminoglycan is heparin sulfate, and the components of the biological polysaccharide composition are in a mass ratio of 2:1:1. The preparation method of the medical biological gel preparation for the adjuvant treatment of hemorrhoids includes the following steps:

[0043] S1. Preparation of the biological polysaccharide composition: Prepare the raw materials according to the stated weight ratio. Add carboxymethyl chitosan, polysulfated glycosaminoglycan, and glycosaminoglycan to water, and stir ultrasonically until completely dissolved. Then, filter the solution and degas the filtrate under vacuum to obtain the biological polysaccharide composition. The weight ratio of the three biological polysaccharides to water is 1:1.8. The ultrasonic time is 10 min, and the ultrasonic frequency is 40 kHz.

[0044] S2. Preparation of the carbomer gel: Add carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate, and water with a mass ratio of 8:2:0.8:1.5:10 to the reaction kettle and stir. Let it stand at room temperature or heat in a water bath to allow it to swell sufficiently. Adjust the pH value to neutral to obtain the carbomer gel. The standing time is 3 h, and the pH value of the carbogel is 6.5.

[0045] S3. Pour carbomer gel, biological polysaccharide composition, mussel adhesive protein, acetyl hexapeptide and chitin into the same container in proportion and stir for 30 min. After waiting for sufficient swelling, a medical biological gel preparation for adjuvant treatment of hemorrhoids is obtained.

[0046] Comparative Example 1

[0047] The difference between this comparative example and Example 4 is that chitin is not added. Specifically, it is a medical biological gel preparation for adjuvant treatment of hemorrhoids. The gel preparation includes the following components in mass percentage: carbomer gel 50%, biological polysaccharide composition 21%, mussel adhesive protein 15%, acetyl hexapeptide 14%; the biological polysaccharide composition includes carboxymethyl chitosan, polysulfated mucopolysaccharide and glycosaminoglycan. The components of the carbomer gel are carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate and water. The glycosaminoglycan is hyaluronic acid. The components of the biological polysaccharide composition are in a mass ratio of 2:1:1. The preparation method of the medical biological gel preparation for adjuvant treatment of hemorrhoids includes the following steps:

[0048] S1. Preparation of biological polysaccharide composition: Prepare raw materials according to the above weight ratio. Add carboxymethyl chitosan, polysulfated mucopolysaccharide and glycosaminoglycan to water, stir ultrasonically until completely dissolved, then filter, and perform vacuum degassing on the filtrate to obtain the biological polysaccharide composition. The weight ratio of the three biological polysaccharides to water is 1:1.8. The ultrasonic time is 20 min and the ultrasonic frequency is 40 kHz.

[0049] S2. Preparation of carbomer gel: Add carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate and water with a mass ratio of 6:1:0.6:1:8 to the reaction kettle and stir. Let it stand at room temperature or heat in a water bath to make it swell sufficiently, and adjust the pH value to neutral to obtain carbomer gel. The standing time is 2 h, and the pH value of the carbomer gel is 7.0.

[0050] S3. Pour carbomer gel, biological polysaccharide composition, mussel adhesive protein, and acetyl hexapeptide into the same container in proportion and stir for 20 min. After waiting for sufficient swelling, a medical biological gel preparation for adjuvant treatment of hemorrhoids is obtained.

[0051] Comparative Example 2

[0052] The difference between this comparative example and Example 4 is that acetyl hexapeptide is replaced by fibrin. Specifically, it is a medical bio-gel preparation for adjuvant treatment of hemorrhoids. The gel preparation comprises the following components in mass percentage: carbomer gel 50%, biological polysaccharide composition 21%, mussel adhesive protein 15%, fibrin 10%, chitin 4%; the biological polysaccharide composition comprises carboxymethyl chitosan, polysulfated mucopolysaccharide and glycosaminoglycan, the component of the carbomer gel is carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate and water, the glycosaminoglycan is hyaluronic acid, and the components of the biological polysaccharide composition are in a mass ratio of 2:1:1. The medical bio-gel preparation for adjuvant treatment of hemorrhoids comprises the following steps:

[0053] S1. Preparation of biological polysaccharide composition: Carboxymethyl chitosan, polysulfated mucopolysaccharide and glycosaminoglycan are added to water, and stirred ultrasonically until completely dissolved, then filtered, and the filtrate is vacuum degassed to obtain the biological polysaccharide composition, wherein the weight ratio of the three biological polysaccharides to water is 1:1.8, the ultrasonic time is 20 min, and the ultrasonic frequency is 40 kHz;

[0054] S2. Preparation of carbomer gel: Carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate and water are added to a reaction kettle in a mass ratio of 6:1:0.6:1:8 and stirred, and left standing at room temperature or heated in a water bath to allow it to swell sufficiently, and the pH value is adjusted to neutral to obtain the carbomer gel. The standing time is 2 h, and the pH value of the carbogel is 7.0;

[0055] S3. Pour the carbomer gel, biological polysaccharide composition, mussel adhesive protein, fibrin and chitin into the same container according to the proportion and stir for 20 min. After standing for sufficient swelling, a medical bio-gel preparation for adjuvant treatment of hemorrhoids is obtained.

[0056] Comparative Example 3

[0057] The difference between this comparative example and Example 4 is that the biological polysaccharide composition is replaced by a traditional Chinese medicine polysaccharide composition. Specifically, it is a medical bio-gel preparation for adjuvant treatment of hemorrhoids. The gel preparation comprises the following components in mass percentage: carbomer gel 50%, traditional Chinese medicine polysaccharide composition 21%, mussel adhesive protein 15%, acetyl hexapeptide 10%, chitin 4%; the traditional Chinese medicine polysaccharide composition comprises phellodendron amurense polysaccharide, gallnut leaf polysaccharide and angelica dahurica polysaccharide, the component of the carbomer gel is carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate and water, the glycosaminoglycan is hyaluronic acid, and the components of the traditional Chinese medicine polysaccharide composition are in a mass ratio of 2:1:1. The medical bio-gel preparation for adjuvant treatment of hemorrhoids comprises the following steps:

[0058] S1. Preparation of traditional Chinese medicine polysaccharide composition: Prepare raw materials according to the stated weight ratio. Add phellodendron amurense polysaccharide, gallnut leaf polysaccharide, and angelica dahurica polysaccharide into water, and stir ultrasonically until completely dissolved. Then filter, and degas the filtrate under vacuum to obtain the traditional Chinese medicine polysaccharide composition, where the weight ratio of the three traditional Chinese medicine polysaccharides to water is 1:1.8. The ultrasonic time is 20 min, and the ultrasonic frequency is 40 kHz;

[0059] S2. Preparation of carbomer gel: Add carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate, and water with a mass ratio of 6:1:0.6:1:8 into a reaction kettle and stir. Let it stand at room temperature or heat in a water bath to make it fully swell, and adjust the pH value to neutral to obtain the carbomer gel. The standing time is 2 h, and the pH value of the carbomer gel is 7.0;

[0060] S3. Pour the carbomer gel, traditional Chinese medicine polysaccharide composition, mussel adhesive protein, acetyl hexapeptide, and chitin into the same container according to the ratio and stir for 20 min. Wait for full swelling, and obtain a medical bio-gel preparation for adjuvant treatment of hemorrhoids.

[0061] Experimental Example 1

[0062] Detect the medical bio-gel preparations for adjuvant treatment of hemorrhoids prepared in Examples 1 - 5 and Comparative Examples 1 - 3. The detection indicators are as follows: The bacteriostatic rate is detected according to the WS / T650 - 2019 standard, and the test strain is Escherichia coli; the hemostasis time is detected according to the YY / T 1477.5 - 2020 standard. The performance test results are shown in the following table.

[0063]

[0064] It can be seen from the test results that the medical bio-gel preparations for adjuvant treatment of hemorrhoids prepared in Examples 1 - 5 have high bacteriostatic efficiency and fast hemostasis speed. In Comparative Examples 1, 2, and 3, the bacteriostatic rate is significantly reduced. In Comparative Example 3, the bacteriostatic rate is the lowest, which is 75.1%; in addition, among Comparative Examples 1 - 3, the hemostasis time of Comparative Example 2 is the longest, much longer than that of the best example. It can be seen that the added biological polysaccharide composition of the present invention has obvious antibacterial and bacteriostatic effects; the added protein has the effects of removing stasis and stopping bleeding, and anti-inflammatory.

[0065] Experimental Example 2

[0066] The animals used in this experiment were selected from male Wistar rats, with 5 animals in each group. The backs of the rats were depilated with 8% sodium sulfide solution. After 24 hours, sodium pentobarbital was injected intraperitoneally. After successful anesthesia, a circular full-thickness skin incision with a diameter of about 1.0 cm was made with surgical scissors, disinfected with 70% alcohol solution. The medical bio-gel preparations for adjuvant treatment of hemorrhoids prepared in Examples 1-5 and Comparative Examples 1-3 were respectively applied to the wound, covered with paraffin degreased gauze, and then bandaged. After the injury, normal saline was given intraperitoneally. The wound healing rate was observed at 1, 3, 6, 10, and 25 days after the injury, and the wound healing rate was calculated.

[0067] The method for calculating the wound healing rate is as follows: First, mark the wound on semi-transparent paper, then use this as a template to cut a uniformly textured cardboard into the same size, and then weigh it with a balance. The weight of the cardboard is used to indirectly represent the wound size. The wound healing rate is calculated according to the following formula:

[0068] Wound healing rate (%) = (original wound area - unhealed wound area) / original wound area.

[0069] Pathological examination was carried out to understand the quality of wound healing, and the healing time was determined according to the wound healing situation. The experimental results are shown in the following table;

[0070] Sampling days 1d 3d 6d 10d 25d Example 1 12.4±0.9 25.1±1.0 35.4±0.6 64.2±0.5 96.2±0.3 Example 2 14.7±0.4 24.8±1.1 36.7±0.4 66.3±0.8 97.4±0.7 Example 3 13.5±0.8 24.1±0.7 34.2±0.8 65.1±0.7 97.8±0.7 Example 4 16.2±0.4 26.1±0.5 38.1±1.2 69.2±0.4 98.9±0.6 Example 5 14.4±0.7 26.4±0.8 35.1±0.1 64.3±0.7 98.1±0.5 Comparative Example 1 8.1±0.3 14.5±0.6 20.4±0.5 50.4±0.7 76.4±0.6 Comparative Example 2 11.5±0.6 20.1±0.2 28.1±0.1 52.3±0.5 80.4±0.9 Comparative Example 3 12.3±0.3 18.1±0.5 21.4±0.6 55.4±0.7 83.3±1.2

[0071] As can be seen from the table, after the medical bio-gel preparations for adjuvant treatment of hemorrhoids prepared in Examples 1-5 were used, the wound healing rates at each sampling point were higher than those prepared in the comparative examples, and the wound healing rate at the 25th day was above 96%, more than 20% higher than that of the comparative examples, indicating that the medical bio-gel preparation for adjuvant treatment of hemorrhoids of the present invention has a very good effect on promoting wound healing. In addition, it highlights that the added chitin has the effect of promoting the growth of tissue cells and repairing wounds.

[0072] Experimental Example 3

[0073] Detect the therapeutic effects of the medical bio-gel preparations for adjuvant treatment of hemorrhoids prepared in Examples 1-5 and Comparative Examples 1-3 on acetic acid-induced anal ulcers in rats. Establish an acetic acid-induced anal ulcer model in rats: Select 8 groups of healthy male SD rats, with 5 rats in each group. Filter paper pieces of equal size were prepared with a punching tool with an inner diameter of 6 mm. The filter paper pieces were fully soaked in 99.0% acetic acid solution, and then placed around the anus of the rats to make the perianal skin and mucosa fully contact with the filter paper pieces. The filter paper pieces were changed every 40 s, and the paper pieces were removed every 80 s. After modeling, the degree of ulceration was observed, and the maximum diameter of the rat anus was measured with a micrometer caliper. Finally, the ulcer area was calculated [ulcer area (mm 2 ) = π (maximum diameter / 2) 2Apply the medical bio-gel preparations prepared in Examples 1-5 and Comparative Examples 1-3 to the anal ulcers of 8 groups of rats, once in the morning and once in the evening every day, and observe the changes in the ulcer area of each group of rats after 1, 3, 5, 7, 9, and 11 days. The experimental results are shown in the following table:

[0074]

[0075]

[0076] From the data results, it can be seen that the gel preparations prepared in Examples 1-5 have a good therapeutic effect on acetic acid-induced anal ulcers in rats. The gel preparation prepared in Comparative Example 1 has the worst therapeutic effect, with little change in the anal ulcer area of rats. The therapeutic effects of the remaining Comparative Examples 2 and 3 are also not significant. Therefore, it can be known that the medical bio-gel preparation for assisting in the treatment of hemorrhoids of the present invention has an obvious effect on the treatment of hemorrhoids.

[0077] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A medical bio-gel preparation for adjuvant treatment of hemorrhoids, characterized in that, the gel preparation comprises the following components in mass percentage: carbomer gel 45% - 55%, biological polysaccharide composition 15% - 25%, mussel adhesive protein 15% - 20%, acetyl hexapeptide 10% - 15%, chitin 2% - 5%; the biological polysaccharide composition is composed of carboxymethyl chitosan, polysulfated mucopolysaccharide and glycosaminoglycan with a mass ratio of 2 - 4:1 - 4:1 - 3; the glycosaminoglycan is one or a mixture of more of hyaluronic acid, dermatan sulfate, heparin, heparan sulfate.

2. A medical bio-gel preparation for adjuvant treatment of hemorrhoids according to claim 1, characterized in that, its composition and weight ratio are calculated as 100%, carbomer gel 50%, biological polysaccharide composition 21%, mussel adhesive protein 15%, acetyl hexapeptide 10%, chitin 4%.

3. A medical bio-gel preparation for adjuvant treatment of hemorrhoids according to claim 1, characterized in that, the components of the carbomer gel are carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate, water.

4. A medical bio-gel preparation for adjuvant treatment of hemorrhoids according to any one of claims 1 - 3, characterized in that, the preparation method comprises the following steps: S1. Preparation of the biological polysaccharide composition: Add carboxymethyl chitosan, polysulfated mucopolysaccharide and glycosaminoglycan to water, stir ultrasonically until completely dissolved, then filter, and perform vacuum degassing on the filtrate to obtain the biological polysaccharide composition, wherein the weight ratio of the three biological polysaccharides to water is 1:1.5 - 1.8; S2. Preparation of the carbomer gel: Add carbomer, glycerol, triethanolamine, disodium ethylenediaminetetraacetate, water with a mass ratio of 4 - 8:1 - 2:0.2 - 1:0.5 - 1.5:6 - 10 to a reaction kettle and stir, let it stand at room temperature for 1 - 3 h or heat it in a water bath to make it fully swell, and adjust the pH value to between 6.0 - 7.0 to obtain the carbomer gel; S3. Pour the carbomer gel, biological polysaccharide composition, mussel adhesive protein, acetyl hexapeptide and chitin into the same container according to the ratio and stir for 20 - 30 min, wait for full swelling, and obtain a medical bio-gel preparation for adjuvant treatment of hemorrhoids.

5. A medical bio-gel preparation for adjuvant treatment of hemorrhoids according to claim 4, characterized in that: in step S1 of the preparation method, the ultrasonic time is 10 - 20 min, and the ultrasonic frequency is 30 - 40 kHz.

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