Traditional Chinese medicine composition for treating anal fissure and perianal ulcer and preparation method thereof

Abstract

The invention relates to a traditional Chinese medicine composition for treating anal fissure and perianal ulcer and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine preparations. The traditional Chinese medicine composition is prepared from 3-5 parts of radix notoginseng extract, 3-5 parts of radix sophorae flavescentis extract, 1-2 parts of lucid ganoderma extract, 1-2 parts of cowherb seed extract and 1-2 parts of radix puerariae extract. The core pathological problem of anal fissure and perianal ulcer is specifically solved through a multi-link synergistic mechanism of anti-inflammation and bacteriostasis, blood circulation promoting and collateral dredging, repairing and regeneration and microenvironment regulation. Wherein the pseudo-ginseng and the radix sophorae flavescentis are the core of eliminating evil, the lucid ganoderma and the radix puerariae are the key of strengthening the body resistance, and the cowherb seed acts as the link of dredging and guiding to jointly form a pharmacodynamic system of purgation and tonification and simultaneous treatment of both symptoms and root causes, so that a scientific traditional Chinese medicine scheme is provided for non-surgical treatment of the anal fissure, and compared with the prior art, the traditional Chinese medicine composition has remarkable progress.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine composition for treating anal fissures and perianal ulcers and a preparation method thereof. Background Art

[0002] Anal fissures are common anorectal diseases. Currently, clinical treatment primarily relies on surgery, with a lack of effective drug therapies. Existing treatments often rely on skin disinfectants, antibiotic plasters, and other methods to prevent wound infection, relying on wound self-healing. This can lead to long treatment cycles and limited healing effects. Therefore, developing a safe and effective traditional Chinese medicine preparation for the treatment of anal fissures and perianal ulcers is of great significance. Summary of the Invention

[0003] The purpose of the present invention is to provide a Chinese medicine composition for treating anal fissures and perianal ulcers and a preparation method thereof, so as to improve the deficiencies of the prior art.

[0004] In order to achieve the above object, the present invention provides the following technical solutions: A traditional Chinese medicine composition for treating anal fissure and perianal ulcer, comprising the following components in parts by weight: 3-5 parts of Panax notoginseng extract, 3-5 parts of Sophora flavescens extract, 1-2 parts of Ganoderma lucidum extract, 1-2 parts of Vaccaria segetalis extract, 1-2 parts of Pueraria root extract, 0.5-0.7 parts of Carbomer, 0.5-0.7 parts of Xanthan gum, 10-16 parts of Glycerin, 1-2 parts of Vitamin E, and 3-6 parts of Purified Water.

[0005] A method for preparing the above-mentioned Chinese medicine composition for treating anal fissure and perianal ulcer comprises the following steps: S1: Preparation of Panax notoginseng and Ganoderma lucidum extracts: Soak Panax notoginseng and Ganoderma lucidum in 8 times the weight of 70% ethanol for 12 hours, then reflux and extract the soaked solution for 2 hours, and then filter the obtained extract through 120 mesh; Then, the Panax notoginseng and Ganoderma lucidum were soaked in 6 times the weight of 70% ethanol for 12 hours, and then the soaked solution was refluxed for extraction for 2 hours, and then the obtained extract was filtered through 120 mesh; The filtrates obtained twice were concentrated to 1.05-1.1, and the concentrated solutions were spray-dried to obtain Panax notoginseng extract and Ganoderma lucidum extract, respectively; S2: Preparation of extracts of Sophora flavescens, Vaccaria segetalis and Pueraria root: Soak Sophora flavescens, Vaccaria segetalis and Pueraria root in 10 times the weight of water for 2 hours, then boil and extract for 2 hours, and then filter the obtained extract through 120 mesh; Then, the above-mentioned Sophora flavescens, Vaccaria segetalis and Pueraria root were soaked in 8 times the weight of water for 2 hours, and then boiled and extracted for 2 hours, and then the obtained extract was filtered through 120 mesh; The filtrate obtained twice was concentrated to 1.05-1.1, and the obtained concentrate was spray-dried to obtain Sophora flavescens extract, Vaccaria segetalis extract and Pueraria root extract respectively; S3: Preparation of pharmaceutical preparation: 3-5 parts of Panax notoginseng extract, 3-5 parts of Sophora flavescens extract, 1-2 parts of Ganoderma lucidum extract, and 1-2 parts of Vaccaria segetalis extract are dissolved in ten parts by weight of water, the resulting solution is filtered through 120 mesh, and the filtrate is collected. Then, 0.5-0.7 parts of carbomer, 0.5-0.7 parts of xanthan gum, 10-16 parts of glycerin, 1-2 parts of vitamin E, and 3-6 parts of purified water are added to the filtrate to obtain the traditional Chinese medicine composition of the present invention.

[0006] The following is an explanation and analysis of each drug component in the present invention: 1. Multi-target anti-inflammatory and antibacterial The combination of Sophora flavescens and Panax notoginseng can cover bacterial infections (such as Escherichia coli) and sterile inflammation (such as chemical damage induced by acetic acid), reducing the risk of exudation and ulcer worsening.

[0007] Ganoderma lucidum inhibits excessive inflammatory response by regulating the activity of immune cells (such as macrophages and T lymphocytes), thus avoiding the vicious cycle of "inflammation-damage".

[0008] 2. Promote wound repair Panax notoginseng + Vaccaria segetalis + Pueraria root: accelerate granulation tissue formation and epithelialization process by improving microcirculation (increasing capillary density) and promoting the expression of vascular endothelial growth factor (VEGF).

[0009] Ganoderma lucidum polysaccharides directly stimulate fibroblasts to synthesize collagen, improve wound healing quality and reduce scar formation.

[0010] 3. Improve the local microenvironment The heat-clearing and dampness-drying effects of Sophora flavescens are combined with the body-boosting and moisturizing effects of Pueraria lobata to regulate the humidity and pH value around the anus, avoid the breeding of bacteria in a humid environment, and prevent the mucosa from drying out and cracking.

[0011] The blood-activating and menstrual-promoting effects of fenugreek can relieve the "blood stasis and qi stagnation" type of pain common in patients with anal fissure (such as severe stinging pain during defecation).

[0012] The beneficial effects of the present invention are: This traditional Chinese medicine composition specifically addresses the core pathological issues of anal fissures and perianal ulcers (inflammation, bleeding, and slow healing) through a multi-step synergistic mechanism: anti-inflammatory and antibacterial, blood circulation and meridian dredging, repair and regeneration, and microenvironmental regulation. Panax notoginseng and Sophora flavescens are the core "eliminating pathogens" (anti-inflammation and hemostasis), Ganoderma lucidum and Pueraria root are key "strengthening" (enhancing immunity and promoting repair), and Scutellaria baicalensis provides the "conduction" (promoting blood circulation and improving circulation). Together, these ingredients combine to achieve a "combined attack and supplement, addressing both the symptoms and the root cause," providing a scientific, traditional Chinese medicine solution for the non-surgical treatment of anal fissures and a significant advancement over existing technologies.

[0013] The above description is only an overview of the technical solution of the present invention. In order to more clearly understand the technical means of the present invention and implement it according to the contents of the specification, the following is a detailed description of the preferred embodiments of the present invention. DETAILED DESCRIPTION

[0014] The technical solution of the present invention will be described clearly and completely below. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0015] In addition, the technical features involved in different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other. Example 1

[0016] A traditional Chinese medicine composition for treating anal fissures and perianal ulcers according to a preferred embodiment of the present application comprises the following traditional Chinese medicines in parts by weight: 5 parts of Panax notoginseng extract, 5 parts of Sophora flavescens extract, 2 parts of Ganoderma lucidum extract, 2 parts of Vaccaria segetalis extract, 2 parts of Pueraria root extract, 0.7 parts of carbomer, 0.7 parts of xanthan gum, 16 parts of glycerin, 2 parts of vitamin E, and 6 parts of purified water. Example 2

[0017] A traditional Chinese medicine composition for treating anal fissures and perianal ulcers according to a preferred embodiment of the present application comprises the following traditional Chinese medicines in parts by weight: 3 parts of Panax notoginseng extract, 3 parts of Sophora flavescens extract, 1 part of Ganoderma lucidum extract, 1 part of Vaccaria segetalis extract, 1 part of Pueraria root extract, 0.5 parts of carbomer, 0.5 parts of xanthan gum, 10 parts of glycerin, 1 part of vitamin E, and 3 parts of purified water.

[0018] Specifically, the preparation method of the above-mentioned Chinese medicine composition comprises the following steps: Ingredient extraction: 1. The Panax notoginseng and Ganoderma lucidum were soaked, extracted and filtered twice respectively, wherein: The first step is to soak the mixture in 70% ethanol (8 times the weight) for 12 hours, then reflux the soaking solution for 2 hours, and then filter the obtained extract through 120 mesh. The second time, 6 times the weight of 70% ethanol was used for soaking for 12 hours, and then the soaking liquid was refluxed for extraction for 2 hours. The obtained extract was filtered through 120 mesh, and then the filtrate obtained twice was concentrated to 1.05-1.1. The obtained concentrated solution was spray-dried to obtain extract powders of Panax notoginseng and Ganoderma lucidum respectively.

[0019] 2. Sophora flavescens, Vaccaria segetalis, and Pueraria root were soaked, extracted, and filtered twice respectively, wherein: The first step is to soak the mixture with 10 times the weight of water for 2 hours, then boil and extract for 2 hours, and then filter the obtained extract through 120 mesh; The second time, 8 times the weight of water was used for soaking for 2 hours, and then boiling extraction was carried out for 2 hours. The obtained extract was then filtered through 120 mesh, and then the filtrate obtained twice was concentrated to 1.05-1.1. The obtained concentrate was spray-dried to obtain extract powders of Sophora flavescens, Vaccaria segetalis and Pueraria root respectively.

[0020] Preparation of medicine: The obtained extracts were dissolved in 10 parts by weight of water, the obtained solution was filtered through 120 mesh, carbomer, xanthan gum, glycerin, vitamin E and purified water were added to the filtrate, and the mixture was mixed and stirred to obtain an ointment, which is the traditional Chinese medicine composition of the present invention. Example 3

[0021] Thirty rats, half male and half female, weighing 150-200 grams, were collected. Filter paper was punched out of equal size using a 6mm inner diameter hole punch. These were then thoroughly soaked in 99.0% acetic acid solution. The soaked filter paper was then placed around the rat's anus, ensuring close contact with the perianal skin and mucosa. One filter paper piece was used at a time for 1 minute per rat, with the filter paper changed every 0.5 minutes. After 24 hours, white ulcers appeared on the rat's anus.

[0022] On the second day, the rats were randomly divided into 3 groups and medicated for 7 days. The dosage was as follows: the control group was smeared with glycerol on the ulcer three times a day, the drug group 1 was smeared with the ointment obtained in Example 2 on the ulcer once a day, and the drug group 2 was smeared with the ointment obtained in Example 2 on the ulcer three times a day.

[0023] Scoring criteria: The ulcer healing of rats was observed on days 3, 5, 7, and 9 of drug administration to assess the degree of ulceration. 1 point was given for ulcer exudate; 2 points were given for slight ulcer exudate; 3 points were given for scab formation and basic healing; and 4 points were given for complete healing. The results are shown in the table below: Group 3d 5d 7d 9d control group 1.00±0.00 1.10±0.35 1.30±0.66 2.20±0.58 Drug Group 1 1.20±0.52 1.80±0.71 2.90±0.47 3.40±0.65 Drug Group 2 1.60±0.77* 2.85±0.56** 3.50±0.42** 3.90±0.57** Table 1 Results of treatment of perianal ulcers in rats (x±s, n=10) Note: Compared with the control group, *P<0.05, **P<0.01 In summary, it can be seen that drug group 2 has a significant therapeutic effect on perianal ulcers in rats caused by acetic acid (P<0.01). On the ninth day, the anal ulcers in the rats were basically completely healed, which was significantly better than the control group.

[0024] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0025] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A Chinese medicine composition for treating anal fissure and perianal ulcer, characterized in that: The composition comprises the following components in parts by weight: 3-5 parts of Panax notoginseng extract, 3-5 parts of Sophora flavescens extract, 1-2 parts of Ganoderma lucidum extract, 1-2 parts of Vaccaria segetalis extract, 1-2 parts of Pueraria root extract, 0.5-0.7 parts of Carbomer, 0.5-0.7 parts of Xanthan gum, 10-16 parts of Glycerin, 1-2 parts of Vitamin E, and 3-6 parts of Purified Water.

2. A method for preparing a Chinese medicine composition for treating anal fissure and perianal ulcer according to claim 1, characterized in that: The following steps are involved: S1: Preparation of Panax notoginseng and Ganoderma lucidum extracts: Soak Panax notoginseng and Ganoderma lucidum in 8 times the weight of 70% ethanol for 12 hours, then reflux and extract the soaked solution for 2 hours, and then filter the obtained extract through 120 mesh; Then, the Panax notoginseng and Ganoderma lucidum were soaked in 6 times the weight of 70% ethanol for 12 hours, and then the soaked solution was refluxed for extraction for 2 hours, and then the obtained extract was filtered through 120 mesh; The filtrates obtained twice were concentrated to 1.05-1.1, and the concentrated solutions were spray-dried to obtain Panax notoginseng extract and Ganoderma lucidum extract, respectively; S2: Preparation of extracts of Sophora flavescens, Vaccaria segetalis and Pueraria root: Soak Sophora flavescens, Vaccaria segetalis and Pueraria root in 10 times the weight of water for 2 hours, then boil and extract for 2 hours, and then filter the obtained extract through 120 mesh; Then, the above-mentioned Sophora flavescens, Vaccaria segetalis and Pueraria root were soaked in 8 times the weight of water for 2 hours, and then boiled and extracted for 2 hours, and then the obtained extract was filtered through 120 mesh; The filtrate obtained twice was concentrated to 1.05-1.1, and the obtained concentrate was spray-dried to obtain Sophora flavescens extract, Vaccaria segetalis extract and Pueraria root extract respectively; S3: Preparation of pharmaceutical preparation: 3-5 parts of Panax notoginseng extract, 3-5 parts of Sophora flavescens extract, 1-2 parts of Ganoderma lucidum extract, and 1-2 parts of Vaccaria segetalis extract are dissolved in ten parts by weight of water, the resulting solution is filtered through 120 mesh, and the filtrate is collected. Then, 0.5-0.7 parts of carbomer, 0.5-0.7 parts of xanthan gum, 10-16 parts of glycerin, 1-2 parts of vitamin E, and 3-6 parts of purified water are added to the filtrate to obtain the traditional Chinese medicine composition of the present invention.