Preparation method and application of a traditional Chinese medicine composition for treating hemorrhoids

Abstract

The present invention provides a Chinese medicine composition of Antai stock solution and its preparation method and application, which belongs to the technical field of drug preparation. The preparation method is to take 5-15 weight parts of Phellodendron chinense, 3-12 weight parts of Sophora flavescens, 3-10 weight parts of Sophora japonica seeds, 3-10 weight parts of Lonicera japonica, 1-5 weight parts of Sanguisorba officinalis, 3-10 weight parts of Imperata cylindrica, 3-10 weight parts of Citrus aurantium, 1-5 weight parts of Panax notoginseng and 1-5 weight parts of Corydalis yanhusuo, soak, enzymolysis and ultrasonic extraction to prepare the Antai stock solution; the Antai stock solution is used to prepare products of different dosage forms such as sanitary wet wipes, wet toilet paper, antibacterial spray, antibacterial lotion or antibacterial gel. The Antai stock solution prepared by the present invention has a definite therapeutic effect. Its components are prepared from authentic Chinese medicinal materials through reasonable proportioning and modern biological extraction technology, and have good antibacterial, antipruritic, anti-swelling and analgesic effects on patients with hemorrhoids.

Description

Technical Field

[0001] The present invention relates to the preparation of traditional Chinese medicine, in particular to an Antai stock solution traditional Chinese medicine composition and a preparation method and application thereof. Background Art

[0002] Hemorrhoids are a common condition located in the anus. They can occur at any age, but their incidence increases with age, with a higher incidence in people aged 20 to 60. Hemorrhoids are categorized by location as internal, external, and mixed. Clinical manifestations of hemorrhoids include anal itching, swelling, pain, bleeding, and even ulceration. According to relevant survey data, the incidence of anorectal diseases is 59.1%, with hemorrhoids accounting for 87.25% of all anorectal diseases. Of these, internal hemorrhoids account for 59.86%, external hemorrhoids for 16.1%, and mixed hemorrhoids for 24.13%. The overall incidence of hemorrhoids is approximately 50%, leading to the saying that "nine out of ten people suffer from hemorrhoids." Hemorrhoids can cause unbearable pain, and in severe cases, patients can become restless, disrupting their normal work and daily life. Therefore, timely treatment of hemorrhoids is crucial.

[0003] Western medicine treatments for hemorrhoids primarily include surgical therapy, ultra-low and ultra-high temperature therapy, sleeve and ligation therapy, and injection therapy. These therapies are expensive, have a long recovery period, and are prone to complications. Traditional Chinese Medicine (TCM) treatments for hemorrhoids emphasize the principle of syndrome differentiation and treatment. Treatments for hemorrhoids can be divided into external and internal therapies. In ancient times, internal treatments for hemorrhoids often advocated clearing heat and detoxifying, cooling blood and removing blood stasis, and treating according to different syndrome types. External TCM treatments for hemorrhoids primarily include fumigation therapy, compress therapy, and suppository therapy. TCM treatments for hemorrhoids offer significant efficacy, address both the symptoms and the root cause, and have minimal side effects, leading to their rapid application and promotion in the field of hemorrhoidal diseases.

[0004] However, 90% of Chinese medicines are herbal medicines with complex chemical compositions. Traditional Chinese medicines are generally extracted using decoction, water distillation, and solvent extraction methods. However, the extraction efficiency of their active ingredients is low and the specificity of the ingredients is not strong. The main reason is that the active ingredients of most plants are encapsulated in the cell walls, making it difficult to extract them completely using water as a solvent. In addition, the existing Chinese medicine formulas are not rational, resulting in insignificant therapeutic effects and low cure rates for hemorrhoidal diseases. Therefore, the research of a new Chinese medicine for the treatment of hemorrhoids and a new Chinese medicine extraction method is an urgent need for Chinese medicine refinement and is of great importance to the development of Chinese medicine for the treatment of hemorrhoids.

[0005] Currently, there are also related technologies about traditional Chinese medicine for hemorrhoids, such as:

[0006] Chinese invention patent application publication number CN 116832122 A discloses a traditional Chinese medicine composition, preparation, preparation method, and application thereof. Specifically, the hemorrhoids treatment composition includes: rhubarb, gentian, white flower vine, ternate bitter leaf, honeysuckle, diffusa root bark, calendula, borneol, mint, ice silkworm, coptis root, pure bezoar, chlorhexidine acetate, red ochre, and gastrodia elata seed. However, the traditional Chinese medicine composition employed in this invention contains numerous ingredients and an inappropriate combination. Long-term use of rhubarb, gentian, and diffusa root can be absorbed through the skin and cause liver damage. Chlorhexidine acetate is a chemical antibacterial ingredient, indicating that the formulation is inappropriate.

[0007] The Chinese invention patent application with publication number CN 116920037 A discloses a Chinese medicine composition for treating hemorrhoids, and specifically discloses that the Chinese medicine composition for treating hemorrhoids includes: 15% to 30% of Tripterygium wilfordii, 5% to 13% of Cimicifuga heracleifolia, 3% to 15% of Fig leaves, 3% to 10% of Portulaca oleracea, 3% to 10% of Sophora japonica, 3% to 10% of Sanguisorba officinalis, 1% to 5% of Honeysuckle, 2% to 8% of Artemisia capillaris, 1% to 6% of Smilax glabra, 1% to 8% of Verbena officinalis, 1% to 7% of Sophora japonica seeds, 1% to 9% of Polygonum cuspidatum, and 1% to 9% of Indigo naturalis, and is prepared by alcohol extraction. Although alcohol extraction can increase the dissolution of active ingredients, there is a problem of poor control of the extraction time. If the extraction time is too short, the extraction will be incomplete, and if the extraction time is too long, the effective ingredients will be reduced. In addition, the overall formula is complex and the compatibility is unreasonable.

[0008] Chinese invention patent application publication number CN 117482141 A discloses a traditional Chinese medicine composition for treating hemorrhoids and its preparation method. Specifically, the composition is prepared using a traditional decoction process using six herbs: Sanguisorba officinalis, Sophora japonica fruit, Cassia seed, Calcined Oyster shell, Ginseng, and Scutellaria baicalensis. While the composition is streamlined and highly targeted, the traditional preparation process employed makes it difficult to fully extract the active ingredients, significantly reducing its effectiveness. Furthermore, its overall efficacy remains to be improved.

[0009] To address the above problems, the present invention utilizes traditional Chinese medicine theory combined with modern biotechnology - enzymatic hydrolysis technology and ultrasonic technology to develop a fast, environmentally friendly, efficient and economical extraction technology, laying the foundation for the development of Chinese medicine refining technology. Summary of the Invention

[0010] In response to the above problems, the present invention provides a Chinese medicine composition of Antai stock solution and its preparation method and application.

[0011] To achieve the above object, the technical solution adopted by the present invention is:

[0012] A traditional Chinese medicine composition of Antai stock solution, wherein the prescription of the traditional Chinese medicine composition of Antai stock solution is as follows, in parts by weight: 5-15 parts of Phellodendron chinense, 3-12 parts of Sophora flavescens, 3-10 parts of Sophora japonica seeds, 3-10 parts of Honeysuckle, 1-5 parts of Sanguisorba officinalis, 3-10 parts of Imperata cylindrica, 3-10 parts of Citrus aurantium, 1-5 parts of Panax notoginseng, and 1-5 parts of Corydalis yanhusuo;

[0013] Preferably, 10 parts of Phellodendron chinense, 8 parts of Sophora flavescens, 6 parts of Sophora japonica seeds, 6 parts of Honeysuckle, 3 parts of Sanguisorba officinalis, 6 parts of Imperata cylindrica roots, 6 parts of Citrus aurantium, 3 parts of Panax notoginseng and 3 parts of Corydalis yanhusuo.

[0014] A method for preparing an Antai stock solution, comprising taking the above-mentioned Antai stock solution Chinese medicine composition, soaking, enzymolysis, and ultrasonic extraction to prepare the Antai stock solution;

[0015] Alternatively, the preparation method is to take the above-mentioned An Tai stock solution Chinese medicine composition and use water extraction method to prepare the An Tai stock solution.

[0016] Furthermore, the preparation method comprises the following steps:

[0017] S1. Phellodendron amurense, Sophora flavescens, Sophora japonica seeds, Lonicera japonica, Sanguisorba officinalis, Imperata cylindrica, Fructus aurantii, Panax notoginseng, and Corydalis yanhusuo were crushed, sieved, and soaked in water to obtain a soaked medicinal material system;

[0018] Take cellulase, pectinase and hemicellulase to prepare a complex enzyme solution;

[0019] S2, adding the complex enzyme solution to the soaked medicinal material system, performing enzymatic hydrolysis, inactivating the enzyme, and filtering to obtain a filtrate;

[0020] S3, the filtrate is subjected to ultrasonic extraction, and the precipitation is separated by centrifugation to obtain a centrifuge;

[0021] S4. The centrifuged liquid is sterilized to obtain the Antai stock solution.

[0022] Furthermore, the weight ratio of cellulase, pectinase and hemicellulase is 2-4:2-4:1-2, preferably 2:2:1;

[0023] The enzyme concentration in the complex enzyme solution is 0.1-1.0%, preferably 0.3-0.8%;

[0024] The pH value of the complex enzyme solution is 3.0 to 6.0, preferably 4.5 to 6.0;

[0025] In the process of preparing the complex enzyme solution, the solvent used is sodium citrate-citric acid buffer, phosphate buffer, acetate buffer or disodium hydrogen phosphate-citric acid buffer.

[0026] Furthermore, the enzymatic hydrolysis temperature is 30-66° C. and the time is 1-4 h.

[0027] Furthermore, the ultrasonic extraction temperature is 40-50° C., the frequency is 35-45 kHz, and the time is 30-90 min, preferably the temperature is 45° C., the frequency is 40 kHz, and the time is 60-75 min.

[0028] Furthermore, the soaking is performed by adding 8 to 13 times by weight of the prescribed amount of water for 2 to 3 hours, preferably adding 8 to 10 times by weight of the prescribed amount of water.

[0029] Furthermore, the Antai stock solution is 5 to 10 times by weight of the prescribed amount.

[0030] Furthermore, the sieve aperture is 12 to 24 meshes.

[0031] An application of An Tai stock solution, which is made from the above-mentioned An Tai stock solution Chinese medicine composition, and the An Tai stock solution is used to prepare products of different dosage forms such as sanitary wet wipes, wet toilet paper, antibacterial spray, antibacterial lotion or antibacterial gel.

[0032] The beneficial effects of the Antai stock solution Chinese medicine composition of the present invention and its preparation method and application are as follows:

[0033] The prescription of the present invention is reasonable. The prescription adopted is based on the traditional theory of traditional Chinese medicine and the principle of dialectical treatment of traditional Chinese medicine, and targets the causes of wind, heat, dampness, dryness and the like of the disease, and utilizes the ratio of monarch, minister, assistant and guiding drugs. Phellodendron chinense is used as the monarch drug, and exerts the effects of clearing heat and drying dampness, purging fire and detoxifying, and stopping bleeding; Sophora flavescens, Sophora japonica seed, honeysuckle, sanguisorba officinalis, and Imperata cylindrica are used as the guiding drugs, among which Sophora flavescens clears heat and dries dampness to stop itching, Sophora japonica seed cools blood to stop bleeding, honeysuckle clears heat and detoxifies, sanguisorba officinalis astringes and stops bleeding, and Imperata cylindrica is used as the guiding drug, thereby strengthening the effects of the monarch drug in clearing heat and drying dampness to stop itching; Fructus aurantii and Panax notoginseng are used as the guiding drugs, and have the effects of promoting blood circulation and regulating qi; Corydalis yanhusuo is used as the guiding drug, and promotes blood circulation and stops pain; the combination of the drugs achieves the therapeutic effect of treating both the symptoms and the root causes of the itching, swelling and bleeding of hemorrhoids, and the prescription is simple and has no toxic or side effects;

[0034] The present invention adopts an advanced extraction process, which greatly increases the dissolution of effective ingredients of traditional Chinese medicine by combining modern biotechnology-enzymatic hydrolysis technology and ultrasonic extraction technology. The preparation method has a mild reaction, does not destroy the original three-dimensional structure and biological activity of the active ingredients, has a short extraction time, a high extraction rate, a high reaction specification, and is simple to operate. It is a fast, environmentally friendly, efficient and economical extraction technology, laying a foundation for the development of traditional Chinese medicine refining technology.

[0035] The Antai stock solution prepared by the present invention has definite therapeutic effect. Its ingredients are made from authentic Chinese medicinal materials through reasonable proportioning and modern biological extraction technology. It has good antibacterial, antipruritic, anti-swelling and analgesic effects on patients with hemorrhoids. It can be used to treat internal hemorrhoids, external hemorrhoids and mixed hemorrhoids. It has good efficacy, quick effect, safety and no side effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 This is a spectrum of the active ingredient content contained in the Antai stock solution DG1 prepared in Example 1 of the present invention;

[0037] Figure 2 This is a spectrum of the active ingredient content contained in the Antai stock solution G1 prepared in Example 1 of the present invention;

[0038] Figure 3 This is a diagram showing the antibacterial effect in the antibacterial test of Example 4 of the present invention;

[0039] Figure 4 This is a rendering of the effect of the anorectal model repair experiment in Experimental Group 2 in the swelling and pain relief test of Example 4 of the present invention. DETAILED DESCRIPTION

[0040] The technical solutions in the embodiments of the present invention are described clearly and completely below. Many specific details are set forth in the following description to facilitate a full understanding of the present invention. However, the present invention may also be implemented in other ways different from those described herein, and those skilled in the art may make similar generalizations without violating the scope of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0041] Example 1 A method for preparing Antai stock solution

[0042] 1. Preparation of Antai stock solution

[0043] This embodiment is a preparation method of Antai stock solution, which adopts modern biotechnology-enzyme hydrolysis technology and ultrasonic technology, and specifically comprises the following steps:

[0044] S1. Take nine herbs, including 10g of Phellodendron amurense, 8g of Sophora flavescens, 6g of Sophora japonica seeds, 6g of Lonicera japonica, 3g of Sanguisorba officinalis, 6g of Imperata cylindrica, 6g of Citrus aurantium, 3g of Panax notoginseng, and 3g of Corydalis yanhusuo, grind them in proportion, pass through a 24-mesh sieve, add 8 times the weight of the prescribed amount of water, and soak them for 2 hours to obtain a soaked herbal medicine system;

[0045] Cellulase, pectinase and hemicellulase were taken in a weight ratio of 2:2:1, added to an acetic acid-sodium acetate buffer solution with a pH value of 4.5 and mixed to prepare a complex enzyme solution with an enzyme concentration of 0.5% and a pH value of 4.5.

[0046] S2. Add the complex enzyme solution to the soaked medicinal material system, fully enzymatically hydrolyze in a constant temperature water bath at 45°C for 2 hours, then heat to 100°C, boil for 10 minutes to inactivate the enzyme, take out, cool, and filter to obtain the filtrate.

[0047] S3. The filtrate was transferred to an ultrasonic instrument and ultrasonically extracted for 60 min at a temperature of 45°C and a frequency of 40 kHz. After the reaction was completed, the precipitate was separated by centrifugation to obtain a centrifuge.

[0048] S4. Take the centrifuged liquid and sterilize it at high temperature for a short time at 130℃ for 30s to obtain a 1:5 extract, which is the Antai stock solution and is marked as G1.

[0049] Among them, the 1:5 in the 1:5 times extract represents the weight ratio between the total weight of the nine medicinal materials (that is, the prescription amount) and the extract, that is, the An Tai original solution is 5 times the weight of the prescription amount.

[0050] 2. Preparation method of control Antai stock solution

[0051] Furthermore, the extract prepared by the traditional preparation process water extraction method was used as a control Antai stock solution, and the specific steps were as follows:

[0052] Take nine medicinal materials, including 10g of Phellodendron amurense, 8g of Sophora flavescens, 6g of Sophora japonica seeds, 6g of Lonicera japonica, 3g of Sanguisorba officinalis, 6g of Imperata cylindrica, 6g of Citrus aurantium, 3g of Panax notoginseng and 3g of Corydalis yanhusuo (the total weight of the nine medicinal materials is also the prescription amount), grind them according to the proportion, pass through a 24-mesh sieve, add 8 times the prescription amount of water, soak them for 2 hours, and then decoct and extract twice, each time for 1 hour, combine the decoctions, filter, and concentrate the filtrate to 5 times the weight of the prescription amount to obtain a 1:5 control extract, which is the control An Tai stock solution, marked as DG1.

[0053] 3. Analysis

[0054] The content and extraction rate of the active ingredients in Antai stock solution G1 and the control Antai stock solution DG1 were compared. The results are shown in Table 1 and Figures 1 and 2 As shown:

[0055] Table 1 Comparison of the content and extraction rate of each component under different process conditions

[0056]

[0057] As can be seen from Table 1, the content of effective ingredients contained in the An Tai stock solution G1 extracted by modern biotechnology - enzymatic hydrolysis technology and ultrasonic technology is significantly higher than that of the An Tai stock solution DG1 prepared by water extraction method, and the extraction rate is significantly increased, which is beneficial to improving efficacy and reducing costs.

[0058] Example 2 A method for preparing Antai stock solution

[0059] This embodiment is a preparation method of Antai stock solution, which specifically comprises the following steps:

[0060] S1. Take nine herbs, including 10g of Phellodendron amurense, 8g of Sophora flavescens, 6g of Sophora japonica seeds, 6g of Lonicera japonica, 3g of Sanguisorba officinalis, 6g of Imperata cylindrica, 6g of Citrus aurantium, 3g of Panax notoginseng, and 3g of Corydalis yanhusuo, grind them in proportion, pass through a 12-mesh sieve, add 10 times the weight of the prescribed amount of water, and soak them for 3 hours to obtain a soaked herbal medicine system;

[0061] Cellulase, pectinase and hemicellulase were taken in a weight ratio of 3:3:1, added to an acetic acid-sodium acetate buffer solution with a pH value of 5.0 and mixed evenly to prepare a complex enzyme solution with an enzyme concentration of 0.5% and a pH value of 5.0.

[0062] S2. Add the complex enzyme solution to the soaked medicinal material system, fully enzymolyze in a constant temperature water bath at 50°C for 3 hours, then heat to 100°C, boil for 10 minutes to inactivate the enzyme, take out, cool, and filter to obtain the filtrate.

[0063] S3. The filtrate was transferred to an ultrasonic instrument and ultrasonically extracted for 75 min at a temperature of 45°C and a frequency of 40 kHz. After the reaction was completed, the precipitate was separated by centrifugation to obtain the centrifuge liquid.

[0064] S4. Take the centrifuged liquid and sterilize it at high temperature for a short time at 130℃ for 30s to obtain a 1:7.2 extract, which is the Antai stock solution and is marked as G2.

[0065] Among them, the 1:7.2 in the 1:7.2 times extract represents the weight ratio between the total weight of the nine medicinal materials and the extract, that is, the An Tai original solution is 7.2 times the weight of the prescription amount.

[0066] S5. Comparison of the effective ingredient content and extraction rate of Antai stock solution G2 and the control Antai stock solution DG1 prepared in Example 1 is shown in Table 2.

[0067] Table 2 Comparison of the content and extraction rate of each component under different process conditions

[0068]

[0069] As can be seen from Table 2, the content of active ingredients contained in the An Tai stock solution G2 extracted by modern biotechnology - enzymatic hydrolysis technology and ultrasonic technology is significantly higher than that in the An Tai stock solution DG1 prepared by water extraction method, and the extraction rate is significantly increased, which is beneficial to improving efficacy and reducing costs.

[0070] Example 3 A method for preparing Antai stock solution

[0071] This embodiment is a preparation method of Antai stock solution, which specifically comprises the following steps:

[0072] S1. Take nine herbs, including 10g of Phellodendron amurense, 8g of Sophora flavescens, 6g of Sophora japonica seeds, 6g of Lonicera japonica, 3g of Sanguisorba officinalis, 6g of Imperata cylindrica, 6g of Citrus aurantium, 3g of Panax notoginseng, and 3g of Corydalis yanhusuo, grind them in proportion, pass through a 24-mesh sieve, add 13 times the weight of the prescribed amount of water, and soak them for 2 hours to obtain a soaked herbal system;

[0073] Cellulase, pectinase and hemicellulase were taken in a weight ratio of 2:2:1, added to an acetic acid-sodium acetate buffer solution with a pH value of 5.5 and mixed to prepare a complex enzyme solution with an enzyme concentration of 1.0% and a pH value of 5.5.

[0074] S2. Add the complex enzyme solution to the soaked medicinal material system, fully enzymatically hydrolyze in a constant temperature water bath at 55°C for 2 hours, then heat to 100°C, boil for 10 minutes to inactivate the enzyme, take out, cool, and filter to obtain the filtrate.

[0075] S3. The filtrate was transferred to an ultrasonic instrument and ultrasonically extracted for 90 min at a temperature of 45°C and a frequency of 40 kHz. After the reaction was completed, the precipitate was separated by centrifugation to obtain a centrifuge.

[0076] S4. Take the centrifuged liquid and sterilize it at high temperature for a short time at 130℃ for 30s to obtain a 1:9.5 extract, which is the Antai stock solution and is marked as G3.

[0077] Among them, the 1:9.5 in the 1:9.5 times extract represents the weight ratio between the total weight of the nine medicinal materials and the extract, that is, the An Tai original solution is 9.5 times the weight of the prescription amount.

[0078] S5. Comparison of the effective ingredient content and extraction rate of Antai stock solution G3 and the control Antai stock solution DG1 prepared in Example 1 is shown in Table 3.

[0079] Table 3 Comparison of the content and extraction rate of each component under different process conditions

[0080]

[0081]

[0082] As can be seen from Table 3, the content of active ingredients contained in the An Tai stock solution G3 extracted by modern biotechnology - enzymatic hydrolysis technology and ultrasonic technology is significantly higher than that of the An Tai stock solution DG1 prepared by water extraction method, and the extraction rate is significantly increased, which is beneficial to improving efficacy and reducing costs.

[0083] Example 4 Application of Antai Stock Solution

[0084] The Antai stock solution G1 and the control Antai stock solution DG1 prepared in Example 1 were used to prepare hemorrhoid gel and hemorrhoid spray, respectively, as follows:

[0085] 1) Preparation of hemorrhoid gel

[0086] According to weight percentage, 1.8% of medium-viscosity hydroxyethyl cellulose (viscosity is generally 3000-10000cps), 50% of the corresponding An Tai stock solution (i.e. An Tai stock solution G1 or control An Tai stock solution DG1), 5% of glycerin, 2% of propylene glycol, and 41.2% of purified water are taken to prepare the corresponding hemorrhoid gel (i.e. An Tai stock solution G1 is configured into hemorrhoid gel GJ1, and An Tai stock solution DG1 is configured into hemorrhoid gel DGJ1), and its antibacterial, antipruritic and repair effects are tested.

[0087] 2) Preparation of hemorrhoid spray

[0088] According to weight percentage, 0.5% of low-viscosity hydroxyethyl cellulose (viscosity is generally 10-500cps), 50% of the corresponding An Tai stock solution (i.e. An Tai stock solution G1 or control An Tai stock solution DG1), 5% of glycerin, 2% of propylene glycol, and 42.5% of purified water are taken to prepare a hemorrhoid spray (i.e. An Tai stock solution G1 is configured into hemorrhoid spray GW1, and An Tai stock solution DG1 is configured into hemorrhoid spray DGW1), and its antibacterial, antipruritic and repair effects are tested.

[0089] 3) Antibacterial test

[0090] 31) Experimental methods

[0091] Test basis: "Disinfection Technical Specifications" (2002 edition);

[0092] Test conditions: The test environment temperature is 20.1-22.5°C and the relative humidity is 49-53%RH.

[0093] 32) Experimental results

[0094] The two hemorrhoid sprays were subjected to antibacterial experiments. Hemorrhoid spray DGW1 was used as experimental group 1, hemorrhoid spray GW1 was used as experimental group 2, and sodium chloride buffer was used as the positive control. Microbial inhibition experiments were performed on Staphylococcus aureus, Escherichia coli, and Candida albicans. The results are shown in Tables 4 and Figure 3 .

[0095] Table 4 Antibacterial test results

[0096]

[0097] Note: The evaluation standard is based on the 2002 edition of the Technical Specifications for Disinfection; if the inhibition rate is >50-90%, the product has an antibacterial effect; if the inhibition rate is >90%, it has a strong antibacterial effect.

[0098] From Table 4 and Figure 3 It can be seen that the hemorrhoid spray GW1 and hemorrhoid spray DGW1 prepared by the present invention both have good antibacterial effects, among which the antibacterial effect of hemorrhoid spray GW1 is significantly better than that of hemorrhoid spray DGW1.

[0099] 4) Itch relief test

[0100] 41) Experimental Materials

[0101] Experimental animals: SPF grade male rats.

[0102] Reagents: acetone, ether, distilled water, chloral hydrate, depilatory cream, etc.

[0103] Instruments: HD camera, etc.

[0104] 42) Animal Modeling and Experimental Methods

[0105] Eighteen SPF mice weighing 20-25 g were randomly divided into three groups, each consisting of six mice: experimental group 1, experimental group 2, and control group. All mice were anesthetized with 10% chloral hydrate. The hair on the dorsal area of ​​the neck (approximately 2 cm × 2 cm, extending from the line between the ears to the second thoracic vertebrae) was shaved until the skin was completely exposed. A cotton dressing soaked in a 1:1 mixture of equal volumes of acetone and ether was applied to the exposed skin on the dorsal area of ​​the mice for 15 seconds. Immediately, a cotton dressing with distilled water was applied for 30 seconds twice daily for 7 days. The corresponding hemorrhoid gel was evenly applied (i.e., hemorrhoid gel DGJ1 in experimental group 1 and hemorrhoid gel GJ1 in experimental group 2). The control group underwent the same procedure, but only a 45-second application of distilled water was applied. Spontaneous pruritus activity was recorded on the 3rd, 5th, and 7th days before application of the drug, and statistical analysis was performed. The results are shown in Table 5.

[0106] Table 5 Comparison of the number of scratching in the two groups ( Second-rate)

[0107] Group Number Day 1 Day 3 Day 5 Day 7 control group 6 <![CDATA[323.0±5.6 a ]]> <![CDATA[291.0±6.8 a ]]> <![CDATA[236.0±5.3 a ]]> <![CDATA[201.0±4.7 a ]]> Experimental Group 1 6 <![CDATA[302.0±6.4 a ]]> <![CDATA[277.0±4.3 a ]]> <![CDATA[168.0±6.9 a ]]> 93.0±3.2 Experimental Group 2 6 <![CDATA[314.0±6.6 a ]]> <![CDATA[225.0±5.1 a ]]> <![CDATA[129.0±7.7 a ]]> 17.0±1.7

[0108] As shown in Table 5, compared with the control group, the number of scratching episodes in Experimental Groups 1 and 2 was significantly lower, indicating that both Hemorrhoid Gel GJ1 and Hemorrhoid Gel DGJ1 have antipruritic effects. In particular, the number of scratching episodes in Experimental Group 2 was significantly lower than in Experimental Group 1, indicating that Hemorrhoid Gel GJ1 has a more significant antipruritic effect.

[0109] 5) Swelling and pain relief test

[0110] 51) Experimental Materials

[0111] Experimental animals: SPF grade male rats.

[0112] Reagent: Chloral hydrate.

[0113] Instrument: High-frequency electrocautery therapy device.

[0114] 52) Animal modeling and experimental methods

[0115] An anorectal model repair experiment was used to test swelling and pain relief. Specifically, 15 SPF rats weighing 80-100g were randomly divided into three groups, with 5 rats in each group, namely experimental group 1, experimental group 2 and control group. After each group of rats was anesthetized with 10% chloral hydrate, an anorectal burn model was established using a high-frequency electrocautery therapy device. One day after modeling, the rats had redness and swelling around the anus and ulcers in the rectal mucosa. Experimental group 1 used a sterile cotton swab to dip hemorrhoid gel DGJ1 and evenly applied it to the perianal injury site. Experimental group 2 used a sterile cotton swab to dip hemorrhoid gel GJ1 and evenly applied it to the perianal injury site, twice a day, for 7 consecutive days. The control group used the same operation, but only applied it with distilled water. Before applying the medicine on the 3rd, 5th and 7th days, photos were taken to observe the recovery of the rats' anorectal. The results are shown in Tables 6 and Figure 4 .

[0116] Table 6 Recovery of anorectal burns

[0117]

[0118] As shown in Table 6, both experimental groups 1 and 2 recovered within 6–7 days, while the control group took 10–12 days to recover. This indicates that experimental groups 1 and 2 recovered faster than the control group, and the ulcers formed were smaller, demonstrating that both Hemorrhoid Gel GJ1 and Hemorrhoid Gel DGJ1 are effective in reducing swelling and alleviating pain. Experimental group 2 recovered faster than experimental group 1, indicating that Hemorrhoid Gel GJ1 is more effective in reducing swelling and alleviating pain.

[0119] In summary, it can be seen that the An Tai stock solution prepared using the formula of the present invention has good antibacterial, antipruritic, anti-swelling and analgesic effects, among which the An Tai stock solution prepared using modern biotechnology-enzymatic hydrolysis technology and ultrasonic technology has better effects. And the An Tai stock solution prepared using modern biotechnology-enzymatic hydrolysis technology and ultrasonic technology has a higher content of active ingredients and extraction rate than the traditional water extraction method.

[0120] The Antai stock solution prepared by the present invention can be used to prepare products of different dosage forms such as sanitary wet wipes, wet toilet paper, antibacterial sprays, antibacterial lotions or antibacterial gels.

[0121] Example 5-8 Preparation Method of Antai Stock Solution

[0122] Examples 5 to 8 are respectively methods for preparing an Antai stock solution. Their steps are substantially the same as those for preparing Antai stock solution G in Example 1, with the only difference being the amounts of some raw materials and process parameters. See Table 7 for details:

[0123] Table 7 List of process parameters in Examples 5 to 8

[0124]

[0125]

[0126] The other contents of Examples 5 to 8 are the same as those of Example 1.

[0127] Obviously, the embodiments described are only some 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 making creative efforts are within the scope of protection of the present invention.

Claims

1. A method for preparing a Chinese medicine composition for treating hemorrhoids, characterized in that: The prescription of the traditional Chinese medicine composition for treating hemorrhoids is as follows, in parts by weight: 5-15 parts of Phellodendron chinense, 3-12 parts of Sophora flavescens, 3-10 parts of Sophora japonica seeds, 3-10 parts of Honeysuckle, 1-5 parts of Sanguisorba officinalis, 3-10 parts of Imperata cylindrica, 3-10 parts of Citrus aurantium, 1-5 parts of Panax notoginseng and 1-5 parts of Corydalis yanhusuo; The preparation method comprises the following steps: S1. Phellodendron amurense, Sophora flavescens, Sophora japonica seeds, Lonicera japonica, Sanguisorba officinalis, Imperata cylindrica, Fructus aurantii, Panax notoginseng, and Corydalis yanhusuo were crushed, sieved, and soaked in water to obtain a soaked medicinal material system; Take cellulase, pectinase and hemicellulase in a weight ratio of 2-4:2-4:1-2 to prepare a complex enzyme solution; S2. Add a complex enzyme solution with an enzyme concentration of 0.1-1.0% and a pH of 3.0-6.0 to the soaked medicinal material system, perform enzymatic hydrolysis at 30-66°C for 1-4 hours, inactivate the enzyme, and filter to obtain a filtrate; S3, the filtrate is subjected to ultrasonic extraction, and the precipitation is separated by centrifugation to obtain a centrifuge; S4. The centrifuged liquid is sterilized to obtain the Chinese medicinal composition for treating hemorrhoids.

2. The method for preparing the Chinese medicine composition for treating hemorrhoids according to claim 1, wherein In the process of preparing the complex enzyme solution, the solvent used is sodium citrate-citric acid buffer, phosphate buffer, acetate buffer or disodium hydrogen phosphate-citric acid buffer.

3. The preparation method of the Chinese medicine composition for treating hemorrhoids according to claim 1 or 2, wherein The temperature of ultrasonic extraction is 40~50℃, the frequency is 35~45kHz, and the time is 30~90min.

4. The method for preparing the Chinese medicine composition for treating hemorrhoids according to claim 1 or 2, wherein: Soaking is done by adding 8 to 13 times the weight of the prescribed amount of water and soaking for 2 to 3 hours.

5. The method for preparing the Chinese medicine composition for treating hemorrhoids according to claim 1 or 2, wherein: The traditional Chinese medicine composition for treating hemorrhoids is 5 to 10 times by weight of the prescribed amount.

6. The method for preparing the Chinese medicine composition for treating hemorrhoids according to claim 1 or 2, wherein: The sieve aperture is 12~24 mesh.

7. An application of a Chinese medicine composition for treating hemorrhoids, characterized in that: The application is: the traditional Chinese medicine composition for treating hemorrhoids prepared by the preparation method according to any one of claims 1 to 6 is used to prepare sanitary wet wipes, wet toilet paper, antibacterial spray, antibacterial lotion or antibacterial gel.

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