Preparation method and application of traditional Chinese medicine composition for haemorrhoids anal fissure

Abstract

The invention provides a preparation method and application of a traditional Chinese medicine composition for haemorrhoids and anal fissure, the preparation method comprises the following steps: preparing raw materials: 300g of acacia catechu, 100g of borneol, 100g of cibotium barometz, 100g of angelica dahurica, 100g of safflower, 50g of dragon's blood and 300g of Zhang dan, respectively grinding the raw materials into powder during preparation, uniformly mixing, taking 1000g of vaseline and 800g of wool fat, and uniformly mixing the powder with the vaseline and the wool fat to prepare the traditional Chinese medicine composition for haemorrhoids and anal fissure. And heating, filtering, cooling to 55 DEG C, adding the powder of the raw materials, and stirring until the powder is semi-solidified. The formula disclosed by the invention is simple to prepare, few in adverse reaction after being used, good in treatment effect on red and swollen, pain, swelling, bleeding, prolapse, anal fissure, haemorrhoids, internal hemorrhoids, external hemorrhoids and mixed hemorrhoids, and capable of promoting recovery of local wounds of the anus, relieving inflammation, promoting blood circulation, accelerating the blood coagulation process, reducing bleeding, reducing local hyperemia and vein blood vessel pressure; and moreover, by inhibiting the release of an inflammatory mediator, local scorching hot stabbing pain and falling swelling feeling can be relieved.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine technology, and more particularly to a method for preparing and using a traditional Chinese medicine composition for treating hemorrhoids and anal fissures. Through the synergistic action of a specific proportion of traditional Chinese medicine ingredients, the composition acts directly on the affected area in the form of an external ointment, exhibiting anti-inflammatory and analgesic effects, hemostasis and tissue regeneration, and wound healing. The composition is suitable for relieving symptoms and treating a variety of anorectal diseases, including internal hemorrhoids, external hemorrhoids, mixed hemorrhoids, and anal fissures. Background Art

[0002] Hemorrhoids and anal fissures are common anorectal diseases, mainly manifested in symptoms such as anal pain, bleeding, swelling, and prolapse. Current treatment methods include surgery and drug therapy, but surgical trauma is large and recovery is slow, and Western medicine topical preparations (such as hormones and antibiotics) easily induce drug resistance or allergic reactions. Traditional Chinese medicine external preparations are gradually gaining attention because of their small side effects and definite efficacy, but existing formulas often have problems such as complex preparation, unstable ingredients, or insufficient specificity. Therefore, developing a simple, safe, and effective Chinese medicine composition has important clinical significance. Summary of the Invention

[0003] In view of this, the present invention proposes a preparation method and application of a traditional Chinese medicine composition for treating hemorrhoids and anal fissures. The specific technical solution is as follows:

[0004] A preparation method of a traditional Chinese medicine composition for hemorrhoids and anal fissures comprises raw material preparation and formulation. The raw material preparation requires the following raw materials: 300g of Haiercha, 100g of borneol, 100g of Cibotium barometz, 100g of Angelica dahurica, 100g of Carthamus tinctorius, 50g of Sanguisorba officinalis, and 300g of Zhangdan. During the formulation, the raw materials are respectively ground into powder and then mixed evenly. 1000g of vaseline and 800g of lanolin are taken, heated, filtered, and cooled to 55 degrees Celsius. The powders of the raw materials are added and stirred until semi-solidified.

[0005] Furthermore, in the raw material preparation, the herb Herba Epimedii, Borneolum Syntheticum, Cibotium Chinense, Angelica Dahurica, Carthamus Tinctorius, Sanguisorba Officinalis, and Radix Angelicae Dahuricae are respectively ground through a 500-mesh sieve and mixed evenly to obtain a medicinal powder;

[0006] Furthermore, in the preparation, vaseline and lanolin are mixed, heated to 80°C to melt, filtered to remove impurities, cooled to 55°C to form a matrix, and the powder is slowly added to the matrix while stirring until it is semi-solidified, and then packaged to obtain the ointment.

[0007] The traditional Chinese medicine preparation prepared by the preparation method is used in medicines for treating hemorrhoids and anal fissures.

[0008] Furthermore, the symptoms of hemorrhoids and anal fissures include at least one of redness, pain, swelling, bleeding, prolapse, anal fissures, hemorrhoid plugs, hemorrhoids, internal hemorrhoids, external hemorrhoids, and mixed hemorrhoids.

[0009] The above technical solution has the following beneficial effects:

[0010] The formula of the present invention is simple to prepare and has few adverse reactions after use. It has good therapeutic effects on redness, pain, swelling, bleeding, prolapse, anal fissures, hemorrhoids, internal hemorrhoids, external hemorrhoids, and mixed hemorrhoids. At the same time, it can also promote the recovery of local anal wounds, alleviate inflammation, promote blood circulation, accelerate the coagulation process, reduce bleeding, reduce local congestion and venous blood vessel pressure, accelerate the relief of hemorrhoidal swelling, and alleviate local burning, stinging, and heaviness by inhibiting the release of inflammatory mediators. It is particularly suitable for acute attacks and thrombosed external hemorrhoids, can reduce friction bleeding in damaged areas, promote the contraction of damaged blood vessels, and can be used for patients with friction bleeding caused by prolapse, ulcers, erosions, etc. It has a particularly good effect on sore surfaces that have not healed for a long time after hemorrhoid surgery. DETAILED DESCRIPTION

[0011] The following is a clear and complete description of the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of the present invention.

[0012] Example 1, a method for preparing a traditional Chinese medicine composition for hemorrhoids and anal fissures, including raw material preparation and formulation, wherein the following raw materials need to be prepared in the raw material preparation: 300g of Haiercha, 100g of borneol, 100g of Cibotium barometz, 100g of Angelica dahurica, 100g of Carthamus tinctorius, 50g of Sanguisorba officinalis, and 300g of Zhang Dan. During the formulation, the above raw materials are respectively ground into powder and mixed evenly. 1000g of vaseline and 800g of lanolin are taken, heated, filtered, and cooled to 55 degrees Celsius. The powder of the raw materials is added and stirred until semi-solidified.

[0013] In the raw material preparation, the tea leaves, borneol, Cibotium barometz, Angelica dahurica, safflower, dragon's blood, and dandelion are respectively crushed through a 500-mesh sieve and mixed evenly to obtain a medicinal powder;

[0014] In the preparation, vaseline and lanolin are mixed, heated to 80°C to melt, filtered to remove impurities, and cooled to 55°C to form a matrix. The powder is slowly added to the matrix while stirring until it is semi-solidified, and then packaged to obtain the ointment.

[0015] The traditional Chinese medicine preparation prepared by the preparation method is used in medicines for treating hemorrhoids and anal fissures.

[0016] The symptoms of hemorrhoids and anal fissures include at least one of redness, pain, swelling, bleeding, prolapse, anal fissures, hemorrhoid plugs, hemorrhoids, internal hemorrhoids, external hemorrhoids, and mixed hemorrhoids.

[0017] The borneol and angelica dahurica in the present invention inhibit inflammatory mediators (such as PGE2 and TNF-α), relieve burning sensation and heaviness; Sanguisorba officinalis and Herba Epimedii promote platelet aggregation, shrink damaged blood vessels, and accelerate wound repair; Safflower improves local microcirculation and subsides hemorrhoidal swelling; Zhang Dan and Cibotium barometz reduce exudation and prevent infection.

[0018] This invention scientifically combines seven medicinal herbs—herb tea, borneol, Cibotium barometz, Angelica dahurica, safflower, Sanguisorba officinalis, and Radix Angelicae Dahuricae—to achieve a synergistic effect through specific proportions. A vaseline-lanolin composite matrix is ​​then used to achieve sustained drug release and transdermal absorption. During preparation, the herbs are first crushed and passed through a 500-mesh sieve to ensure uniformity. They are then mixed with a molten matrix until they reach a semi-solid state, ultimately forming an ointment. In this composition, borneol and Angelica dahurica inhibit the release of inflammatory mediators such as prostaglandin E2, rapidly relieving burning pain. Tannins in Sanguisorba officinalis and herb tea constrict blood vessels and promote platelet aggregation. Safflower promotes blood circulation and blood stasis, improving local microcirculation and resolving hemorrhoids. Danguisorba officinalis and Cibotium barometz provide astringency and antibacterial properties, reducing wound exudation. By optimizing the ratios of these ingredients, the triple effects of anti-inflammatory, hemostatic, and repair are achieved without increasing the number of raw materials.

[0019] Example 2, this example adopts the basic formula ratio, 300g of Haiercha, 100g of Borneolum Syntheticum, 100g of Cibotium Officinale, 100g of Angelica Dahurica, 100g of Carthamus Tinctorius, 50g of Sanguisorba Officinalis, and 300g of Zhang Dan. The powder particle size is adjusted to 600 mesh sieve, which can improve the dissolution rate of the ingredients by 15% compared with the original 500 mesh sieve; the matrix melting temperature is controlled at 75°C to avoid the loss of volatile components such as Borneolum Syntheticum. After comparative tests, the in vitro transdermal absorption rate of the improved ointment increased by 22%, and the stability test showed that the effective ingredient retention rate was ≥95% under 40°C / 75% humidity for 3 months. Clinical observations show that the analgesic onset time of this solution for acute thrombosed external hemorrhoids is shortened to 30 minutes, which is better than the 45 minutes of the traditional formula, but the astringent hemostatic effect is comparable to the original solution.

[0020] Example 3. In this example, the matrix ratio is adjusted to 150g of vaseline and 750g of lanolin. The proportion of vaseline is increased to enhance the consistency of the paste and prevent softening at high temperatures. The ointment remains stable in shape at 35°C. Pharmacological experiments show that the adjusted matrix reduces the release rate of fat-soluble components such as Sanguisorba officinalis and Zhang Dan by 18%, and extends the duration of action to 6-8 hours, making it more suitable for nighttime use. However, the reduction in lanolin may slightly reduce the transdermal efficiency of ingredients such as safflower, which needs to be compensated by increasing the amount of powder by 10%, that is, the amount of each medicinal material is fed at 1.1 times the rate. This solution is particularly suitable for patients in tropical areas. In a clinical trial conducted in Malaysia, the average healing time of postoperative hemorrhoidal wounds was shortened by 2.3 days.

[0021] Example 4. This example is aimed at the indication of bleeding hemorrhoids. In this example, the ratio of medicinal materials is adjusted to 400g of Haiercha, 80g of Sanguisorba officinalis, and the ratio of Zhang Dan is reduced to 250g to enhance the hemostatic effect. In vitro coagulation experiments show that this formula shortens the plasma clotting time to 28 seconds and increases the capillary contraction rate by 40%. However, the proportion of the anti-inflammatory ingredient borneol is relatively reduced, and the rate of relief of swelling is 20% slower than the basic formula, so it is recommended to be used in combination with oral anti-inflammatory drugs. The gradient mixing method is adopted during preparation: first, the Sanguisorba officinalis and Haiercha powder are premixed with 1 / 3 of the matrix to form a high-concentration hemostatic layer, and then mixed with other medicinal materials so that the hemostatic components are preferentially released when the ointment contacts the wound. In the application of this solution for patients at high risk of gastrointestinal bleeding, the hemostatic efficiency can reach 96.7%, but it should be noted that continuous use should not exceed 7 days to avoid excessive convergence.

[0022] The three kinds of implementation methods in embodiment 2-embodiment 4 are optimized from the three dimensions of process accuracy, environmental adaptability, symptom targeting respectively.Thus illustrating that the present invention's formula preparation is simple, with few adverse reactions after use, good therapeutic effect to redness, pain, swelling, bleeding, prolapse, anal fissure, hemorrhoids, internal hemorrhoids, external hemorrhoids, mixed hemorrhoids, it is also possible to promote the recovery of anal local wounds, reduce inflammation, promote blood circulation, accelerate blood coagulation process, reduce bleeding, reduce local congestion and venous blood vessel pressure, accelerate the relief of hemorrhoidal swelling, it is also possible to reduce local burning stinging and falling sensation by suppressing the release of inflammatory mediators, it is particularly suitable for acute attack and thrombotic external hemorrhoids, it is also possible to reduce damaged part friction bleeding, promote damaged blood vessel contraction, it is also possible to cause friction bleeding for prolapse, ulcer, erosion and other patients, especially better for the effect of hemorrhoidal postoperative sore surface not healing for a long time.

[0023] The above describes the basic principles and main features of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The above embodiments and descriptions only illustrate the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, which fall within the scope of the invention to be protected. The scope of protection of the invention is defined by the attached claims and their equivalents.

Claims

1. A method for preparing a Chinese medicine composition for hemorrhoids and anal fissures, characterized in that: The method includes raw material preparation and formulation. The following raw materials need to be prepared in the raw material preparation: 300g of Haiercha, 100g of borneol, 100g of Cibotium barometz, 100g of Angelica dahurica, 100g of Safflower, 50g of Sanguisorba officinalis, and 300g of Zhangdan. During the formulation, the above raw materials are respectively ground into powder and mixed evenly. 1000g of Vaseline and 800g of lanolin are taken, heated, filtered, and cooled to 55 degrees Celsius. The powder of the raw materials is added and stirred until semi-solidified.

2. A method for preparing a Chinese medicine composition for hemorrhoids and anal fissures according to claim 1, characterized in that: In the raw material preparation, Haiercha, borneol, Cibotium barometz, Angelica dahurica, safflower, Sanguisorba officinalis, and Zhangdan are respectively crushed through a 500-mesh sieve and uniformly mixed to obtain medicinal powder.

3. A method for preparing a Chinese medicine composition for hemorrhoids and anal fissures according to claim 1, characterized in that: In the preparation, vaseline and lanolin are mixed, heated to 80°C to melt, filtered to remove impurities, and cooled to 55°C to form a matrix. The powder is slowly added to the matrix while stirring until it is semi-solidified, and then packaged to obtain the ointment.

4. The Chinese medicine preparation prepared by the preparation method is used in medicines for treating hemorrhoids and anal fissures.

5. A method for preparing a Chinese medicine composition for treating hemorrhoids and anal fissures according to claim 4, characterized in that: The symptoms of hemorrhoids and anal fissures include at least one of redness, pain, swelling, bleeding, prolapse, anal fissures, hemorrhoid plugs, hemorrhoids, internal hemorrhoids, external hemorrhoids, and mixed hemorrhoids.