External ointment for treating haemorrhoids

Abstract

The invention discloses an external ointment for treating haemorrhoids, which belongs to the technical field of traditional Chinese medicines and is obtained by mixing sophora flowers, sophora flower buds, szechwan chinaberry fruits, angelica sinensis, angelica dahurica, phaseolus calcaratus, scutellaria baicalensis, gallnut and liquorice, adding a pig, frying until the mixture is golden and cooling. Natural Chinese herbal medicines are selected as active ingredients to prepare the external ointment, the medicine directly acts on an affected part, local absorption is mainly performed, the amount of the medicine entering whole body circulation is reduced, the medicine effect is mild, and the safety is high.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to an external medicinal ointment for treating hemorrhoids. Background Art

[0002] Hemorrhoids are a common anorectal disease clinically, which are soft venous masses formed by the dilation and flexion of the venous plexus under the submucosa of the distal rectum and under the anal skin. Its incidence rate is relatively high, and it can occur at any age, but the incidence rate gradually increases with age. As the saying goes, "nine out of ten people have hemorrhoids", which shows its universality. The main clinical manifestations of hemorrhoids are blood in the stool, prolapse of hemorrhoid nuclei, anal pain, itching, and a sense of swelling and falling, which seriously affect the quality of life, physical and mental health of patients. According to the different occurrence sites, hemorrhoids can be divided into internal hemorrhoids, external hemorrhoids, and mixed hemorrhoids.

[0003] At present, there are various treatment methods for hemorrhoids, mainly including conservative treatment and surgical treatment. Conservative treatment is usually applicable to patients with mild symptoms, and the methods include adjusting the diet structure, improving the defecation habit, sitz bath with warm water, and using drug treatment, etc. Drug treatment includes oral drugs and local external drugs, aiming to relieve pain, stop bleeding, reduce swelling, and anti-inflammatory. However, the existing drug treatment often has problems such as slow onset, limited efficacy, easy recurrence, or possible side effects. Especially for patients with moderate to severe hemorrhoids, the effect is often not ideal.

[0004] Surgical treatment is the main means for treating moderate to severe hemorrhoids, and the methods include traditional hemorrhoidectomy, stapled hemorrhoidopexy (PPH), hemorrhoidal artery ligation (HAL), etc. Although the surgical treatment effect is relatively definite, it is often accompanied by risks such as severe postoperative pain, long recovery time, possible anal stenosis, anal incontinence and other complications, and the medical cost is relatively high, bringing a greater physical and economic burden to patients.

[0005] Therefore, developing an external drug with definite curative effect, high safety, convenient use, few side effects and not easy to relapse has important clinical significance and application value for improving the treatment status of hemorrhoid patients. Summary of the Invention

[0006] The present invention provides an external medicinal ointment for treating hemorrhoids, which is prepared by using natural herbs, has good efficacy, mild drug effect, and few side effects.

[0007] The present invention provides a preparation method of an external medicinal ointment for treating hemorrhoids, which is obtained by mixing sophora flower, sophora flower bud, toosendan fruit, angelica, dahurian angelica root, adzuki bean, scutellaria baicalensis, Chinese gall and liquorice, adding lard and frying until golden yellow, and then cooling.

[0008] Preferably, it includes the following steps:

[0009] Step 1: Mix sophora flower, sophora flower bud, toosendan fruit, angelica, dahurian angelica root, adzuki bean, skullcap root, Chinese gallnut and liquorice to obtain a precursor mixed medicinal material;

[0010] Step 2: Fry the precursor medicinal material in lard until golden, filter, and let it cool to obtain an external medicinal ointment for treating hemorrhoids.

[0011] Preferably, the weight ratio of sophora flower, sophora flower bud, toosendan fruit, angelica, dahurian angelica root, adzuki bean, skullcap root, Chinese gallnut, liquorice and lard is 10 - 30:10 - 30:10 - 30:10 - 30:8 - 22:8 - 22:8 - 22:8 - 22:8 - 22:250 - 750.

[0012] Preferably, the weight ratio of sophora flower, sophora flower bud, toosendan fruit, angelica, dahurian angelica root, adzuki bean, skullcap root, Chinese gallnut, liquorice and lard is 15 - 25, 15 - 25, 15 - 25, 15 - 25, 12 - 18, 12 - 18, 12 - 18, 12 - 18, 12 - 18, 375 - 625.

[0013] Preferably, the weight ratio of sophora flower, sophora flower bud, toosendan fruit, angelica, dahurian angelica root, adzuki bean, skullcap root, Chinese gallnut, liquorice and lard is 20:20:20:20:15:15:15:15:15:500.

[0014] Preferably, it specifically includes the following steps:

[0015] Step 1: Mix 20 g of sophora flower, 20 g of sophora flower bud, 20 g of toosendan fruit, 20 g of angelica, 15 g of dahurian angelica root, 15 g of adzuki bean, 15 g of skullcap root, 15 g of Chinese gallnut and 15 g of liquorice to obtain a precursor mixed medicinal material;

[0016] Step 2: Mix the medicinal liquid with 500 ml of cooked lard, fry until golden, filter, and let it cool to obtain an external medicinal ointment for treating hemorrhoids.

[0017] The present invention also discloses an external medicinal ointment prepared by the above - mentioned preparation method.

[0018] Analysis of the efficacy of traditional Chinese medicines in the traditional Chinese medicine formula of the present invention:

[0019] Sophora flower and sophora flower bud: Both are from the leguminous plant Sophora japonica. Their main efficacy is to cool blood for hemostasis and purge liver - fire. They are commonly used to treat bleeding syndromes such as hematochezia, hemorrhoid bleeding, bloody dysentery, etc., and red eyes, headache, etc. caused by exuberant liver - fire. In this formula, their efficacy of cooling blood for hemostasis is mainly utilized for hemorrhoid bleeding.

[0020] Toosendan fruit: It is the dried ripe fruit of the meliaceous plant Melia toosendan. It has the efficacy of dispersing the stagnated liver - qi and clearing heat, promoting qi - movement to stop pain, and killing parasites. It is used for stagnation of liver - qi transforming into fire, chest and hypochondrium, abdominal distension and pain, hernia pain, etc. In this formula, it may be used for promoting qi - movement to stop pain, drying dampness or having a certain anti - inflammatory effect.

[0021] Angelica sinensis (Oliv.) Diels: The dried root of Angelica sinensis (Oliv.) Diels, a plant of the Umbelliferae family. Its main effects are enriching blood and promoting blood circulation, regulating menstruation and alleviating pain, and moistening the intestines and promoting defecation. It is used for sallow complexion due to blood deficiency, irregular menstruation, amenorrhea and dysmenorrhea, mass in the abdomen, metrorrhagia and metrostaxis, abdominal pain due to deficiency-cold, rheumatic arthralgia, injury from falls and fractures, carbuncles and sores, as well as constipation due to intestinal dryness. In this formula, its effects of promoting blood circulation to relieve pain and promoting tissue repair may be utilized to promote blood circulation in the affected area and tissue repair.

[0022] Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav. or Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. var. formosana (Boiss.) Shan et Yuan: The dried root of Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav. or Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. var. formosana (Boiss.) Shan et Yuan, plants of the Umbelliferae family. It has the effects of dispersing wind and removing dampness, promoting nasal orifices and relieving pain, and detumescence and discharging pus. It is commonly used for common cold due to wind-cold, headache, nasal sinusitis, toothache, leukorrhea, and swelling and pain of sores and ulcers. In this formula, its main effects of detumescence and discharging pus and relieving pain are taken.

[0023] Vigna umbellata (Thunb.) Ohwi et Ohashi or Vigna angularis (Willd.) Ohwi et Ohashi: The dried mature seeds of Vigna umbellata (Thunb.) Ohwi et Ohashi or Vigna angularis (Willd.) Ohwi et Ohashi, plants of the Leguminosae family. It has the effects of promoting diuresis and alleviating edema, and detoxifying and discharging pus. It is used for edema and fullness, beriberi edema, jaundice with reddish urine, rheumatic heat arthralgia, carbuncles and sores, and abdominal pain due to intestinal abscess. In this formula, its effects of clearing heat and detoxifying, and promoting diuresis and alleviating edema may be utilized.

[0024] Scutellaria baicalensis Georgi: The dried root of Scutellaria baicalensis Georgi, a plant of the Labiatae family. It has the effects of clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and preventing miscarriage. It is used for damp-warm syndrome, summer-heat and dampness syndrome with chest distress and nausea, damp-heat obstruction, diarrhea, dysentery, jaundice, cough due to lung heat, high fever and restlessness, hematemesis and epistaxis due to blood heat, carbuncles and sores, and threatened abortion. In this formula, its effects of clearing heat and drying dampness, purging fire and detoxifying, and stopping bleeding are mainly utilized for hemorrhoids with damp-heat accumulation, swelling and pain, and bleeding.

[0025] Galla chinensis: The gallnut on the leaves of Rhus chinensis Mill., Rhus potaninii Maxim. or Rhus punjabensis Stew. var. sinica (Diels) Rehd. et Wils., plants of the Anacardiaceae family. Its main effects are astringing the lung and reducing fire, astringing the intestine and stopping diarrhea, astringing sweating, stopping bleeding, and astringing dampness and promoting granulation. It is used for chronic cough due to lung deficiency, cough with excessive phlegm due to lung heat, chronic diarrhea and dysentery, spontaneous sweating and night sweating, diabetes, hematochezia and hemorrhoids, bleeding from trauma, carbuncles and sores, and moist erosion of the skin. In this formula, its effects of astringing and consolidating, stopping bleeding, and astringing dampness and promoting granulation are mainly utilized to help shrink hemorrhoids, stop bleeding, and promote wound healing.

[0026] Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L.: The dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L., plants of the Leguminosae family. It has the effects of invigorating the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, alleviating spasm and pain, and coordinating the actions of various drugs. In this formula, in addition to clearing heat and detoxifying, and alleviating spasm and pain, it mainly plays the role of coordinating the properties of the drugs, making the whole formula act more mildly and coordinately.

[0027] The present invention has at least the following beneficial effects:

[0028] (1) The present invention selects natural Chinese herbal medicines as active ingredients and prepares them into an external ointment. The drug acts directly on the affected area and is mainly absorbed locally, reducing the amount of the drug entering the systemic circulation. The drug effect is mild and the safety is high.

[0029] (2) The present invention adopts an external medicinal ointment dosage form, which is directly applied to the affected area. The usage method is simple and convenient, and the patient compliance is good. Using lard as the matrix not only facilitates the application of the drug and its retention at the affected area, but also may play a certain role in lubrication and protection.

[0030] (3) After the ointment of the present invention is used, it can effectively stop bleeding, reduce swelling, relieve pain, relieve itching, and improve the symptoms of prolapsed hemorrhoids, with a high overall effective rate; it adopts natural Chinese herbal medicines and is administered externally, and no obvious local or systemic toxic and side effects are found, and the drug effect is mild; the ointment dosage form is easy to apply, and the patient compliance is good; it provides an effective non-surgical treatment method for patients with mild to moderate hemorrhoids, and is expected to relieve the pain and economic burden of patients. Detailed implementation manners

[0031] The technical solutions of the present invention will be clearly and completely described below in conjunction with the embodiments. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0032] Example 1. In this example, an external medicinal ointment for treating hemorrhoids was prepared.

[0033] Step 1: Mix 20 g of sophora flower, 20 g of sophora flower bud, 20 g of toosendan fruit, 20 g of angelica, 15 g of dahurian angelica root, 15 g of adzuki bean, 15 g of scutellaria baicalensis, 15 g of gallnut, and 15 g of liquorice to obtain a precursor mixed medicinal material;

[0034] Step 2: Mix the medicinal liquid with 500 ml of cooked lard, fry until golden, filter, and let it cool to obtain an external medicinal ointment for treating hemorrhoids.

[0035] Clinical application effect verification

[0036] 1. Case selection

[0037] Select the medical treatment data of this hospital from January 2021 to December 2023, and 350 cases of hemorrhoid patients with clear diagnosis. Exclusion criteria: pregnant or lactating women, those with severe cardiovascular and cerebrovascular diseases, impaired liver and kidney functions, those allergic to the components of this product, and those who have received other hemorrhoid surgeries or sclerosing agent injection treatments.

[0038] Disease classification: Internal hemorrhoids (stage I): 120 cases; Internal hemorrhoids (stage II): 95 cases; Mixed hemorrhoids (mainly internal hemorrhoids or varicose veins): 110 cases; Thrombotic external hemorrhoids (acute stage): 25 cases.

[0039] Clinical symptoms: 230 cases with blood in the stool; 100 cases with prolapsed hemorrhoids; 150 cases with anal pain; 280 cases with anal swelling and discomfort; 180 cases with anal itching.

[0040] 2. Treatment method

[0041] Instruct the patient to clean the anus and its surrounding area with warm water after defecation every morning and evening or before going to bed, and then dry it. Take an appropriate amount (about the size of a soybean) of the external medicated ointment of the present invention, and evenly apply it to the internal and external hemorrhoids and the uncomfortable areas of the anus, and gently massage for a moment. Use it 2 times a day. Take 7 days as a course of treatment, and it can be continuously used for 1 - 2 courses according to the condition.

[0042] Observation indicators: Record and evaluate the improvement of the main symptoms such as blood in the stool, prolapse of hemorrhoids, pain, swelling, itching, etc. in the patient after medication. At the same time, closely observe whether there are adverse reactions such as redness, stabbing pain, and allergy at the medication site.

[0043] 3. Treatment results (statistics based on patients who have completed at least one course of treatment)

[0044] Improvement of blood in the stool: After 1 course of treatment, 205 cases (accounting for 89.13% of the original patients with blood in the stool) had complete cessation of blood in the stool; 20 cases (accounting for 8.70%) had a significant reduction in the frequency or amount of blood in the stool; 5 cases (accounting for 2.17%) were ineffective. The total effective rate was 97.83%.

[0045] Improvement of prolapse of hemorrhoids: After 1 - 2 courses of treatment, 85 cases (accounting for 85.00% of the original patients with prolapsed hemorrhoids) had no more prolapse of hemorrhoids; 10 cases (accounting for 10.00%) had a reduced degree of prolapse or a shortened retraction time; 5 cases (accounting for 5.00%) were ineffective. The total effective rate was 95.00%.

[0046] Relief of pain: After 1 course of treatment, 130 cases (accounting for 86.67% of the original patients with pain) had complete disappearance of pain; 15 cases (accounting for 10.00%) had a significant reduction in pain; 5 cases (accounting for 3.33%) were ineffective. The total effective rate was 96.67%.

[0047] Improvement of swelling: After 1 course of treatment, 210 cases (accounting for 75.00% of the original patients with swelling) had complete disappearance of the swelling sensation in the anus; 60 cases (accounting for 21.43%) had a significant reduction in swelling; 10 cases (accounting for 3.57%) were ineffective. The total effective rate was 96.43%.

[0048] Relief of itching: After 1 course of treatment, 155 cases (accounting for 86.11% of the original patients with itching) had complete disappearance of itching; 20 cases (accounting for 11.11%) had a significant reduction in itching; 5 cases (accounting for 2.78%) were ineffective. The total effective rate was 97.22%.

[0049] Adverse reactions: Among 350 patients, only 3 patients reported having mild local cool or warm sensations at the initial stage of medication, without discomfort, and these sensations disappeared on their own after continued medication. No obvious local adverse reactions such as skin redness, stinging, or allergies were observed, nor were any systemic adverse reactions related to the drug found. There were no obvious abnormal changes in blood and urine routine and liver and kidney function tests before and after treatment.

[0050] 4. Conclusions

[0051] The external medicinal ointment for treating hemorrhoids provided by the present invention is applicable to patients mainly presenting with symptoms such as blood in the stool, swelling, pain, prolapse, and itching caused by internal hemorrhoids (stages I and II), mixed hemorrhoids, and some external hemorrhoids. Clinical application observations show that the medicinal ointment of the present invention has the following advantages:

[0052] (1) It can effectively stop bleeding, reduce swelling, relieve pain, relieve itching, and improve the symptoms of prolapsed hemorrhoids, with a high overall effective rate.

[0053] (2) It uses natural Chinese herbal medicines and is administered externally, with no obvious local or systemic toxic and side effects found, and the drug effect is mild.

[0054] (3) The ointment dosage form is easy to apply, and the patient compliance is good.

[0055] (4) It provides an effective non-surgical treatment method for patients with mild to moderate hemorrhoids, and is expected to relieve the pain and economic burden of patients.

[0056] In summary, the external medicinal ointment of the present invention has good clinical application value and promotion prospects.

[0057] Although the embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and spirit of the present invention. All equivalent changes and improvements made in accordance with the scope of the present invention application shall still fall within the scope covered by the patent of the present invention.

Claims

1. A method for preparing an external ointment for treating hemorrhoids, characterized in that: It is made by mixing Sophora japonica flowers, Sophora japonica seeds, Toosendan fruits, Chinese angelica, Angelica dahurica, Adzuki beans, Scutellaria baicalensis, Gallnut and licorice, then adding lard and frying until golden brown and letting it cool.

2. The preparation method according to claim 1, characterized in that: The following steps are involved: Step 1: Mixing Sophora japonica flower, Sophora japonica seed, Toosendan fruit, Chinese angelica root, Angelica dahurica, Adzuki bean, Scutellaria baicalensis, Gallnut and Licorice to obtain a precursor mixed medicinal material; Step 2: Fry the precursor medicinal material in lard until golden brown, filter it, and let it cool to obtain an external ointment for treating hemorrhoids.

3. The preparation method according to claim 2, characterized in that: The weight ratio of the flower of Sophora japonica, the seed of Sophora japonica, the fruit of Chuanlian, the Chinese angelica, the angelica root, the red bean, the scutellaria root, the Chinese gallnut, the liquorice and the lard is 10-30:10-30:10-30:10-30:8-22:8-22:8-22:8-22:8-22:250-750.

4. The preparation method according to claim 2, characterized in that: The weight ratios of the sophora japonica flower, sophora japonica seed, toosendan fruit, angelica sinensis, angelica dahurica, adzuki bean, scutellaria baicalensis, gallnut, licorice and lard are 15-25, 15-25, 15-25, 15-25, 12-18, 12-18, 12-18, 12-18, 12-18, 375-625.

5. The preparation method according to claim 2, characterized in that: The weight ratio of the sophora japonica flower, sophora japonica seed, toosendan fruit, angelica sinensis, angelica dahurica, adzuki bean, scutellaria baicalensis, gallnut, liquorice and lard is 20:20:20:20:15:15:15:15:15:

500.

6. The preparation method according to claim 2, characterized in that: The specific steps include: Step 1: Mix 20g of Sophora japonica flower, 20g of Sophora japonica seed, 20g of Toosendan fruit, 20g of Angelica sinensis, 15g of Angelica dahurica, 15g of Adzuki bean, 15g of Scutellaria baicalensis, 15g of Galla chinensis and 15g of Licorice to obtain a precursor mixed medicinal material; Step 2: Mix the medicinal liquid with 500 ml of cooked lard, fry until golden brown, filter, and cool to obtain an external ointment for treating hemorrhoids.

7. An external ointment prepared by the preparation method according to any one of claims 1 to 6.