Traditional Chinese medicine preparation for treating haemorrhoids and preparation method thereof

Abstract

The invention relates to the technical field of medical treatment, and particularly discloses a traditional Chinese medicine preparation for treating haemorrhoids and a preparation method, the traditional Chinese medicine preparation is prepared from the following raw material medicines in parts by mass: 3-30 parts of dandelion, 10-15 parts of sophora flower, 9-15 parts of chrysanthemum indicum, 15-30 parts of herba violae, 6-12 parts of moutan bark, 3-20 parts of angelica sinensis, 6-10 parts of sanguisorba officinalis, 9-15 parts of dried rehmannia root, 10-15 parts of radix scrophulariae, 10-15 parts of fructus forsythiae, 10-15 parts of hairyvein agrimony, 10-25 parts of rhizoma bolbostemmae, 6-9 parts of hedgehog hide, 6-12 parts of radix paeoniae rubra and 5-10 parts of radix angelicae. 8-15 parts of semen cassiae; the radix paeoniae rubra is added, so that the effects of dispersing blood stasis and dredging collaterals are enhanced, and hemorrhoid extravasated blood dissipation is promoted; angelica dahurica is supplemented to improve the swelling and pain relieving efficacy, and anus pendant expansion and pain in the acute attack period are relieved in a targeted mode. Meanwhile, semen cassiae is introduced to cooperate with angelica sinensis and dried rehmannia root to strengthen the bowel relaxing effect and improve the constipation inducement, and the properties and flavors of all the medicinal materials supplement each other.

Description

Technical Field

[0001] This invention belongs to the field of medical technology, specifically relating to a traditional Chinese medicine preparation for treating hemorrhoids and its preparation method. Background Technology

[0002] Currently, traditional Chinese medicine preparations for the clinical treatment of hemorrhoids mainly include oral and topical preparations. Among them, Sophora japonica fruit pills are based on Sophora japonica fruit and Sanguisorba officinalis, focusing on clearing heat, cooling blood and stopping bleeding; while Mayinglong suppositories rely on the local analgesic and swelling-reducing effects of musk and borneol.

[0003] While these medications have some efficacy, they are mostly based on a single treatment principle, focusing either on stopping bleeding or relieving pain. They fail to systematically integrate the concept of synergistic treatment in traditional Chinese medicine. Oral medications are insufficient in improving the causes of constipation, and topical preparations cannot regulate the endogenous pathogenesis of intestinal dryness and damp heat, resulting in a high recurrence rate. Summary of the Invention

[0004] The purpose of this invention is to provide a traditional Chinese medicine preparation for treating hemorrhoids and its preparation method, so as to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention provides the following technical solution:

[0006] A traditional Chinese medicine preparation for treating hemorrhoids is formulated from the following raw materials in the indicated weight ratios:

[0007] Dandelion 3-30 parts, Sophora japonica 10-15 parts, Chrysanthemum indicum 9-15 parts, Viola yedoensis 15-30 parts, Paeonia suffruticosa 6-12 parts, Angelica sinensis 3-20 parts, Sanguisorba officinalis 6-10 parts, Rehmannia glutinosa 9-15 parts, Scrophularia ningpoensis 10-15 parts, Forsythia suspensa 10-15 parts, Agrimonia pilosa 10-15 parts, Fritillaria cirrhosa 10-25 parts, hedgehog skin 6-9 parts, Paeonia lactiflora 6-12 parts, Angelica dahurica 5-10 parts, Cassia tora 8-15 parts.

[0008] Preferably, the mass ratio of each raw material is as follows: 10 parts dandelion, 10 parts sophora japonica, 15 parts wild chrysanthemum, 15 parts violet, 8 parts peony bark, 10 parts angelica sinensis, 9 parts burnet root, 10 parts dried rehmannia root, 12 parts scrophularia root, 10 parts forsythia, 15 parts agrimony, 18 parts fritillaria cirrhosa, 8 parts hedgehog skin, 9 parts red peony root, 6 parts angelica dahurica, and 10 parts cassia seed.

[0009] A method for preparing the above-mentioned traditional Chinese medicine preparation includes the following steps:

[0010] a. Prepare all raw materials according to the specified proportions;

[0011] b. Wash all raw materials except hedgehog skin and dry them in a cool, ventilated place;

[0012] c. Cut the dried raw materials into sections;

[0013] d. Grind the cut raw materials into a fine powder of 100-150 mesh for later use;

[0014] e. Take hedgehog skin, remove the tips, and prepare it with licorice in a mass ratio of 8:1. Boil the licorice in water, then simmer for 30 minutes. Filter out the dregs. After the licorice soup cools, add the hedgehog skin and soak for 6 hours. Take out the hedgehog skin, dry it in the shade, and grind it into 100-150 mesh for later use.

[0015] f. Mix the fine powder of each medicinal material obtained in step d with the hedgehog skin powder obtained in step e and granulate.

[0016] Preferably, in step e, the amount of licorice used is 1 / 8 of the weight of the hedgehog skin.

[0017] Preferably, the particle size of both step d and step e is 120 mesh.

[0018] Compared with the prior art, the beneficial effects of the present invention are:

[0019] (1) Based on the original formula’s core effects of clearing heat and cooling blood, promoting diuresis and stopping bleeding, this invention adds red peony to enhance the ability to disperse blood stasis and unblock collaterals, and promote the dissipation of hemorrhoid blood stasis; it also adds angelica to enhance the efficacy of reducing swelling and relieving pain, and specifically relieves anal distension and pain during acute attacks; at the same time, it introduces cassia seed to work with angelica and dried rehmannia to enhance the effect of moistening the intestines and promoting bowel movement, and improve the causes of constipation. The properties and meridians of each medicinal material complement each other.

[0020] (2) It regulates the pathogenesis of intestinal dryness and damp heat internally, and reduces the risk of recurrence by nourishing yin and moistening dryness; externally, it quickly controls acute symptoms such as bleeding and pain. Its multi-target mechanism of action significantly shortens the onset time, and long-term use has no liver and kidney toxicity or mucosal irritation. Its safety is better than external preparations containing irritating ingredients such as musk and borneol. Attached Figure Description

[0021] Figure 1 This is a process flow diagram of the present invention. Detailed Implementation

[0022] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0023] Example 1:

[0024] Please see Figure 1 As shown, a traditional Chinese medicine preparation for treating hemorrhoids includes:

[0025] Dandelion 10, Sophora japonica 10, Chrysanthemum indicum 15, Viola yedoensis 15, Paeonia suffruticosa 8, Angelica sinensis 10, Sanguisorba officinalis 9, Rehmannia glutinosa 10, Scrophularia ningpoensis 12, Forsythia suspensa 10, Agrimonia pilosa 15, Fritillaria cirrhosa 18, Hedgehog skin 8, Paeonia lactiflora 9, Angelica dahurica 6, Cassia tora 10.

[0026] A method for preparing a traditional Chinese medicine preparation includes the following steps:

[0027] a. Weigh all the medicinal materials according to the above proportions (hedgehog skin should be processed separately);

[0028] b. Wash all medicinal materials except hedgehog skin and dry them in a cool, ventilated place;

[0029] c. The cutting machine cuts the dried medicinal materials into 1–2 cm segments;

[0030] d. Grind the powder to 120 mesh using a pulverizer and set aside;

[0031] e. Take 8 parts hedgehog skin and remove the tips, 1 part licorice (1 / 8 of the weight of hedgehog skin), add 10 times the amount of water to the licorice and decoct for 30 minutes, filter the residue, cool the decoction, soak the hedgehog skin in the cold licorice soup for 6 hours, take it out and dry it in the shade, and grind it into 120 mesh.

[0032] f. Mix all the fine powdered medicinal materials with hedgehog skin powder evenly, and then granulate into pills.

[0033] Example 2:

[0034] Please see Figure 1 As shown, a traditional Chinese medicine preparation for treating hemorrhoids includes:

[0035] Dandelion 25, Sophora japonica 15, Chrysanthemum indicum 9, Viola yedoensis 30, Paeonia suffruticosa 12, Angelica sinensis 5, Sanguisorba officinalis 6, Rehmannia glutinosa 15, Scrophularia ningpoensis 10, Forsythia suspensa 15, Agrimonia pilosa 10, Fritillaria cirrhosa 10, Hedgehog skin 6, Paeonia lactiflora 12, Angelica dahurica 10, Cassia tora 15.

[0036] A method for preparing a traditional Chinese medicine preparation includes the following steps:

[0037] a. Weigh all the medicinal materials according to the above proportions (hedgehog skin should be processed separately);

[0038] b. Wash all medicinal materials except hedgehog skin and dry them in a cool, ventilated place;

[0039] c. The cutting machine cuts the dried medicinal materials into 1–2 cm segments;

[0040] d. Grind the powder to 150 mesh using a pulverizer and set aside;

[0041] e. Take 8 parts of hedgehog skin and remove the tips, 0.75 parts of licorice (1 / 8 of the weight of hedgehog skin), add 10 times the amount of water to the licorice and decoct for 30 minutes, filter the residue, cool the decoction, soak the hedgehog skin in the cold licorice decoction for 6 hours, take it out and dry it in the shade, and grind it into 120 mesh.

[0042] f. Mix all the fine powdered medicinal materials with hedgehog skin powder evenly, and then granulate into pills.

[0043] Example 3:

[0044] Please see Figure 1 As shown, a traditional Chinese medicine preparation for treating hemorrhoids includes:

[0045] Dandelion 5, Sophora japonica 14, wild chrysanthemum 9, Viola yedoensis 28, peony bark 6, Angelica sinensis 18, Sanguisorba officinalis 6, Rehmannia glutinosa 14, Scrophularia ningpoensis 10, Forsythia suspensa 15, Agrimonia pilosa 12, Fritillaria cirrhosa 24, hedgehog skin 6, Paeonia lactiflora 6, Angelica dahurica 5, Cassia tora 8.

[0046] A method for preparing a traditional Chinese medicine preparation includes the following steps:

[0047] a. Weigh all the medicinal materials according to the above proportions (hedgehog skin should be processed separately);

[0048] b. Wash all medicinal materials except hedgehog skin and dry them in a cool, ventilated place;

[0049] c. The cutting machine cuts the dried medicinal materials into 1–2 cm segments;

[0050] d. Grind the powder to 100 mesh using a pulverizer and set aside;

[0051] e. Take 8 parts of hedgehog skin and remove the tips, 0.75 parts of licorice (1 / 8 of the hedgehog skin's weight), add 10 times the amount of water to the licorice and decoct until the liquid is concentrated to 1 / 2 of its original volume, filter the residue, cool the liquid, soak the hedgehog skin in the cold licorice decoction for 6 hours, take it out and air dry it, and grind it to 120 mesh.

[0052] f. Mix all the fine powdered medicinal materials with hedgehog skin powder evenly, and then granulate into pills.

[0053] Example 4:

[0054] Please see Figure 1 As shown, a traditional Chinese medicine preparation for treating hemorrhoids includes:

[0055] Dandelion 28, Sophora japonica 10, Chrysanthemum indicum 15, Viola yedoensis 15, Paeonia suffruticosa 10, Angelica sinensis 3, Sanguisorba officinalis 10, Rehmannia glutinosa 9, Scrophularia ningpoensis 14, Forsythia suspensa 12, Agrimonia pilosa 15, Fritillaria cirrhosa 12, hedgehog skin 8, Paeonia lactiflora 8, Angelica dahurica 7, Cassia tora 12.

[0056] A method for preparing a traditional Chinese medicine preparation includes the following steps:

[0057] a. Weigh all the medicinal materials according to the above proportions (hedgehog skin should be processed separately);

[0058] b. Wash all medicinal materials except hedgehog skin and dry them in a cool, ventilated place;

[0059] c. The cutting machine cuts the dried medicinal materials into 1–2 cm segments;

[0060] d. Grind the powder to 150 mesh using a pulverizer and set aside;

[0061] e. Take 8 parts hedgehog skin and remove the tips, 1 part licorice (1 / 8 of the weight of hedgehog skin), add 10 times the amount of water and 50mL of rice wine to the licorice and decoct for 30 minutes. Filter the residue, cool the decoction, soak the hedgehog skin in the cold licorice soup for 6 hours, take it out and dry it in the shade, and grind it to 120 mesh.

[0062] f. Mix all the fine powdered medicinal materials with hedgehog skin powder evenly, and then granulate into pills.

[0063] Experimental example:

[0064] This study employed a multicenter, randomized, double-blind, positive-drug parallel-controlled trial design, enrolling a total of 600 patients with stage I-III internal hemorrhoids or mixed hemorrhoids, who were randomly assigned to 5 parallel groups (n=120 per group).

[0065] Among them, control group 1 received oral administration of Sophora japonica fruit pills (9g / time, twice a day), control group 2 received external application of Mayinglong musk hemorrhoid suppositories (1 suppository / time, once a day), while experimental groups 1 to 4 received oral administration of different formulations of the preparations of Examples 1-4 (9g / time, three times a day).

[0066] All participants received 14 days of treatment:

[0067] Efficacy was assessed using perianal microcirculation blood flow measurement (laser Doppler flowmeter, unit PU), which evaluated the improvement of congestion by measuring local blood flow in the hemorrhoids. Serum inflammatory factors (TNF-α, IL-6, unit pg / mL) were detected using ELISA, and fecal occult blood testing was performed using the colloidal gold method (positive results were recorded as uncontrolled bleeding). Safety monitoring included pre- and post-treatment liver and kidney function indicators (ALT, Cr), and skin allergic reactions were recorded separately for the external medication control group (Ma Yinglong Musk Hemorrhoid Suppository Group). Specific test data are shown in the table below:

[0068] Table 1: Comparison of symptom scores on day 14 of treatment (n=120)

[0069]

[0070]

[0071] Table 2: Improvement Rate of Objective Indicators (%)

[0072] Group Blood flow value increased by 30% TNF-α ↓50% Occult blood turns negative Constipation relief Control group 1 45.8％ 38.3％ 53.3％ 41.7％ Control group 2 62.5％* 55.0％* 85.0％* 43.3％ Experimental group 1 89.2％ 87.5％ 98.3％ 90.8％ Experimental group 2 92.5％ 90.8％ 99.2％ 95.0％ Experimental group 3 85.0％ 83.3％ 96.7％ 88.3％ Experimental group 4 90.8％ 88.3％ 97.5％ 93.3％

[0073] As can be seen from the above, the preparations in Examples 1-4 are significantly superior to Sophora japonica pills and Mayinglong suppositories in terms of core indicators such as hemostasis, analgesia, laxative effect, and anti-inflammation; Example 2 has the best overall efficacy; Example 3 still maintains an improvement rate of 85%+, confirming the robustness of the formula; the symptom scores of the experimental group on the 7th day of treatment have decreased by 50%+ compared with the control group.

[0074] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine preparation for treating hemorrhoids, characterized in that, It is formulated from the following raw materials in the indicated mass ratios: Dandelion 3-30 parts, Sophora japonica 10-15 parts, Chrysanthemum indicum 9-15 parts, Viola yedoensis 15-30 parts, Paeonia suffruticosa 6-12 parts, Angelica sinensis 3-20 parts, Sanguisorba officinalis 6-10 parts, Rehmannia glutinosa 9-15 parts, Scrophularia ningpoensis 10-15 parts, Forsythia suspensa 10-15 parts, Agrimonia pilosa 10-15 parts, Fritillaria cirrhosa 10-25 parts, hedgehog skin 6-9 parts, Paeonia lactiflora 6-12 parts, Angelica dahurica 5-10 parts, Cassia tora 8-15 parts.

2. The traditional Chinese medicine preparation for treating hemorrhoids according to claim 1, characterized in that, The mass fraction ratio of each active pharmaceutical ingredient is as follows: Dandelion 10 parts, Sophora japonica 10 parts, Chrysanthemum indicum 15 parts, Viola yedoensis 15 parts, Paeonia suffruticosa 8 parts, Angelica sinensis 10 parts, Sanguisorba officinalis 9 parts, Rehmannia glutinosa 10 parts, Scrophularia ningpoensis 12 parts, Forsythia suspensa 10 parts, Agrimonia pilosa 15 parts, Fritillaria cirrhosa 18 parts, hedgehog skin 8 parts, Paeonia lactiflora 9 parts, Angelica dahurica 6 parts, Cassia tora 10 parts.

3. A method for preparing the traditional Chinese medicine preparation as described in claim 1, characterized in that, Includes the following steps: a. Prepare all raw materials according to the specified proportions; b. Wash all raw materials except hedgehog skin and dry them in a cool, ventilated place; c. Cut the dried raw materials into sections; d. Grind the cut raw materials into a fine powder of 100-150 mesh for later use; e. Take hedgehog skin, remove the tips, and prepare it with licorice in a mass ratio of 8:

1. Boil the licorice in water, then simmer for 30 minutes. Filter out the dregs. After the licorice soup cools, add the hedgehog skin and soak for 6 hours. Take out the hedgehog skin, dry it in the shade, and grind it into 100-150 mesh for later use. f. Mix the fine powder of each medicinal material obtained in step d with the hedgehog skin powder obtained in step e and granulate.

4. The method for preparing a traditional Chinese medicine preparation for treating hemorrhoids according to claim 3, characterized in that: In step e, the amount of licorice used is 1 / 8 of the weight of the hedgehog skin.

5. The method for preparing a traditional Chinese medicine preparation for treating hemorrhoids according to claim 3, characterized in that: The particle size of the pulverization in steps d and e is 120 mesh.

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