CN112569286A

CN112569286A - A pharmaceutical composition for treating anorectal diseases, and its preparation method

Info

Publication number: CN112569286A
Application number: CN202011638536.8A
Authority: CN
Inventors: 杨杰
Original assignee: Chengdu Zhengzhong Medical Investment Management Co ltd
Current assignee: Chengdu Zhengzhong Medical Investment Management Co ltd
Priority date: 2020-12-31
Filing date: 2020-12-31
Publication date: 2021-03-30

Abstract

The invention discloses a pharmaceutical composition for treating anorectal diseases, which is prepared from the following raw material medicines in parts by weight: 7-13 parts of radix bupleuri, 7-13 parts of radix scutellariae, 8-13 parts of angelica tail, 2-4 parts of raw rhubarb, 8-18 parts of garden burnet root, 21-39 parts of hairyvein agrimonia herb and bud, 7-13 parts of golden cypress, 8-18 parts of sophora flower, 7-13 parts of raw liquorice and 2-4 parts of cimicifugae foetidae. The composition has the effects of clearing heat, relaxing bowels, eliminating stagnation, relieving pain and stopping bleeding, and has obvious effect on treating anorectal diseases such as haemorrhoids, bleeding, dry stool, constipation, haemorrhoids pain and the like.

Description

A pharmaceutical composition for treating anorectal diseases, and its preparation method

Technical Field

The invention relates to a pharmaceutical composition for treating anorectal diseases and a preparation method thereof.

Background

Anorectal diseases are common diseases and frequently encountered diseases which are specific to human beings. From a broad aspect: various diseases occurring in anus and large intestine are called anorectal diseases, and more than 100 common diseases are caused. In a narrow sense: various diseases occur in anus and rectum, and more than 30 diseases are common, such as: hemorrhoids, perianal abscess, and constipation, wherein the incidence rate of anorectal diseases such as hemorrhoids is 59.1%, hemorrhoids account for 87.2% of all anorectal diseases, and can be cured at any age and gradually worsen with the increase of the age.

Patent CN111544526A discloses a Chinese medicinal composition for treating hemorrhoids, which can be used for treating external hemorrhoids, internal hemorrhoids, mixed hemorrhoids; patent CN 110339249a discloses a Chinese medicinal composition for treating hemorrhoids and anal fissure, which can be used for treating hemorrhoids and anal fissure in perianal diseases; patent CN 107126495A discloses a traditional Chinese medicine composition for treating rectal polyp, which has a remarkable effect in treating rectal polyp; the published reports show that the existing Chinese patent medicines for treating the perianal diseases are more, mainly for treating the hemorrhoids, and have obvious effect on treating the hemorrhoids, but no medicine which can treat the hemorrhoids and has obvious treatment effect on the hemorrhoids with other anorectal diseases is available.

Disclosure of Invention

In order to solve the problems, the invention provides a pharmaceutical composition for treating anorectal diseases, which is prepared from the following raw material medicines in parts by weight:

7-13 parts of radix bupleuri, 7-13 parts of radix scutellariae, 8-13 parts of angelica tail, 2-4 parts of raw rhubarb, 8-18 parts of garden burnet root, 21-39 parts of hairyvein agrimonia herb and bud, 7-13 parts of golden cypress, 8-18 parts of sophora flower, 7-13 parts of raw liquorice and 2-4 parts of cimicifugae foetidae.

Further, the feed additive is prepared from the following raw materials in parts by weight:

10 parts of radix bupleuri, 10 parts of scutellaria baicalensis, 12 parts of angelica tail, 3 parts of raw rhubarb, 15 parts of garden burnet root, 30 parts of hairyvein agrimony, 10 parts of golden cypress, 15 parts of sophora flower, 10 parts of raw liquorice and 3 parts of cimicifuga foetida.

Furthermore, the traditional Chinese medicine composition is a preparation prepared by taking medicinal powder of raw material medicines, or water or organic solvent extracts of the raw material medicines as active ingredients and adding pharmaceutically acceptable auxiliary materials.

Further, the oral preparation is granules, powder, pills or solution.

Further, the oral preparation is a granule.

Furthermore, every 1g of the granule is equivalent to 2g of crude drug.

The invention provides a preparation method of the pharmaceutical composition, which comprises the following steps:

(1) weighing the raw materials according to the proportion;

(2) grinding the raw materials into powder, or extracting with water or organic solvent, and adding pharmaceutically-acceptable adjuvants or auxiliary components.

The invention also provides application of the pharmaceutical composition in preparing a medicament for treating anorectal diseases.

The invention finally provides the application of the pharmaceutical composition in preparing the medicine with the effects of clearing heat, relaxing bowels, resolving masses, relieving pain and stopping bleeding.

Further, the medicament is a medicament for treating hemorrhoids, rectal polyps, dry stools, constipation and/or hemorrhoidal pain.

In the pharmaceutical composition, the radix bupleuri and the rhizoma cimicifugae are used as monarch drugs, the radix scutellariae, the rheum officinale and the golden cypress are used as ministers, the angelica tail, the sophora flower and the garden burnet are used as assistants, and the honey-fried licorice root is used as a guide. Rhubarb, scutellaria and phellodendron bark clear heat of fu organs, sanguisorba, sophora flower and agrimony clear heat and stop bleeding, radix bupleuri leads all the medicines to enter the qi system and clear stagnated heat of the qi system, angelica is led to enter the blood system and clear stagnated heat of the blood system, the qi and blood clearing method is parallel and not contradictory, cimicifuga foetida is fewer to lift yang qi, so that the bitter cold and the descending and discharging medicines can not damage yang qi, and liquorice regulates all the medicines and can clear heat and remove toxicity. The composition has the effects of clearing heat, relaxing bowels, eliminating stagnation, relieving pain and stopping bleeding, has obvious effects on treating anorectal diseases such as hemorrhoids, anorectal bleeding, dry stool, constipation, hemorrhoid pain and the like, particularly has obvious effects on treating hemorrhoids, rectal polyp and anal fissure, and has clinical popularization and application values.

Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.

The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.

Detailed Description

Example 1 preparation of the medicament of the invention

The formula is as follows: 10g of radix bupleuri, 10g of scutellaria baicalensis, 12g of angelica tail, 3g of raw rhubarb, 15g of sanguisorba, 30g of hairyvein agrimonia herb and bud, 10g of golden cypress, 15g of sophora flower, 10g of raw liquorice and 3g of cimicifuga foetida.

The preparation method comprises the following steps: decocting the above raw materials in 10 times of water for 2 times, each time for 1 hr, mixing water decoctions, standing, collecting supernatant, concentrating, drying, pulverizing into powder, adding appropriate amount of dextrin and 1% steviosin, mixing, granulating, drying, and making into granule 1g equivalent to 2g crude drug.

Example 2 preparation of the inventive Agents

The formula is as follows: 7g of radix bupleuri, 7g of scutellaria baicalensis, 8g of angelica tail, 2g of raw rhubarb, 8g of sanguisorba, 21g of hairyvein agrimonia herb and bud, 7g of golden cypress, 8g of sophora flower, 7g of raw liquorice and 2g of cimicifuga foetida.

Example 3 preparation of the inventive Agents

The formula is as follows: 13g of radix bupleuri, 4g of scutellaria baicalensis, 18g of angelica tail, 39g of raw rhubarb, 18g of garden burnet root, 39g of hairyvein agrimonia herb and bud, 13g of golden cypress, 18g of sophora flower, 13g of raw liquorice and 3g of cimicifuga foetida.

The advantageous effects of the present invention are described below by way of test examples.

Test example 1 therapeutic Effect of the pharmaceutical composition of the present invention on hemorrhoid

First, it is used to treat external hemorrhoid and internal hemorrhoid

Diagnostic criteria:

1. internal hemorrhoids:

bloody stool, bright red, or no symptoms. And (3) anoscopy: the mucous membrane is raised above the tooth line, and the surface is pale red, which is often seen in the first stage of internal hemorrhoids.

Bloody stool with bright red color accompanied by the protrusion of the lump out of the anus, which can be automatically restored after defecation. And (3) anoscopy: the mucous membrane is raised above the tooth line, and the surface is dark red, which is often seen in internal hemorrhoids in stage II.

When defecation or abdominal pressure is increased, the lump in the jar is separated out and can not be reset by self, and needs to be reset after rest or by a manipulation, and the anoscope is checked: the mucosa is raised above the tooth line, and the surface is mostly fibrous, which is often seen in three-stage internal hemorrhoids.

The hemorrhoids are complicated by prolapse and failure of manipulation to recover in time, and can even be embedded with severe pain, little or no fecal blood due to congestion, edema and thrombosis, which is often seen in the four-stage internal hemorrhoids.

2. External hemorrhoids:

the anal skin is damaged or infected, and becomes red and swollen or ulcerated to pus with obvious pain. It is commonly seen in inflammatory external hemorrhoids.

A bluish purple lump and local skin edema appear under the anal margin, the lump is soft in the initial stage, severe in pain, gradually hardened, movable and obvious in touch pain. It is commonly seen in thrombotic external hemorrhoids.

When defecation occurs or squatting for a long time, the subcutaneous part of the anal margin suddenly becomes a bluish purple mass and swells (varicose veins), which can be accompanied by a feeling of tenesmus, and the mass can disappear after being pressed. It is commonly seen in varicose external hemorrhoids.

The skin of the folds at the anus edge is hyperplastic and hypertrophic, and there is no venous plexus in the hemorrhoids, including anus foreign body sensation such as sentinel hemorrhoids, skin-excrescence hemorrhoids and the like. It is commonly seen in connective tissue external hemorrhoids.

3. The treatment method comprises the following steps: cases meeting the diagnosis criteria of sections 1 and 2 were included. 60 patients were randomly selected and randomized into 3 groups of 20 patients, example 1, example 2, and example 3.

The granules prepared in examples 1 to 3 were administered to each group 3 times a day, 20g each time.

4. The curative effect standard is as follows:

internal hemorrhoids:

(1) and (3) healing: the symptoms disappear, the hemorrhoids disappear or all atrophy.

(2) The method has the following advantages: symptoms are improved, and haemorrhoids shrink or atrophy is incomplete.

(3) And (4) invalidation: there was no change in symptoms or signs.

External hemorrhoids:

(1) and (3) healing: the symptoms disappear, and the hemorrhoids disappear.

(2) The method has the following advantages: symptoms are improved and hemorrhoids are reduced.

(3) And (4) invalidation: there was no change in symptoms or signs.

5. Therapeutic results

TABLE 1 hemorrhoid treatment Effect

Group of	Recovery (case)	Effective (example)	Invalid (example)	Effective rate (%)
					EXAMPLE 1 group	9	11	0	100％
EXAMPLE 2 group	4	13	4	85％
					EXAMPLE 3 group	3	13	5	80％

As can be seen from the results in Table 1, the composition for treating external hemorrhoid and internal hemorrhoid provided in example 1 of the present invention can effectively treat the symptoms of external hemorrhoid and internal hemorrhoid by combining the specific components and the specific ratio.

Secondly, treating rectal polyp

Diagnostic criteria:

1. hematochezia is red and fresh, accompanied by mucus or anal tenesmus.

2. After defecation, the lump may be pulled out of the anus, and can be returned or replaced by manipulation.

3. Anus digital diagnosis: can touch the local polyp or the high-position pedicel polyp, and the tumor is soft or tough, smooth and movable.

4. Proctoscopy: the neoplasm has pedicles or guanodes, and the surface is mucosa-like tissue, single or multiple.

Inclusion criteria were:

cases meeting the diagnosis criteria in sections 1, 2, 3 and 4 were included.

5. The treatment method comprises the following steps:

60 patients were randomly selected and randomized into 3 groups of 20 patients, example 1, example 2, and example 3.

6. The curative effect standard is as follows:

and (3) curing: symptoms disappear, and lumps disappear.

Improvement: the symptoms are relieved, and the lumps are reduced.

The disease is not cured: there was no change in symptoms or physical diagnosis.

7. The treatment results are as follows:

TABLE 2 treatment Effect of rectal polyps

Group of	Recovery (case)	Effective (example)	Invalid (example)	Effective rate (%)
					EXAMPLE 1 group	9	10	1	95％
EXAMPLE 2 group	4	11	5	75％
					EXAMPLE 3 group	4	13	3	85％

As can be seen from the results in table 2, the composition for treating rectal polyp provided in example 1 of the present invention can effectively treat the symptoms of rectal polyp by the specific combination of the components and the specific ratio.

Third, treat anal fissure

Diagnostic criteria:

1. the pain is obvious when defecating, the pain is aggravated after defecating, and constipation and a small amount of hematochezia frequently occur. It is well developed in the anterior, posterior and medial aspect of the anus.

2. The superficial longitudinal fissure of the anal canal skin has regular wound margin, fresh base, red color, obvious tenderness and elastic wound surface. It is mostly seen in the first stage of anal fissure.

Inclusion criteria were:

cases meeting the diagnosis criteria in sections 1, 2, 3 and 4 were included.

5. The treatment method comprises the following steps:

6. The curative effect standard is as follows:

and (3) curing: symptoms disappear, and lumps disappear.

Improvement: the symptoms are relieved, and the lumps are reduced.

8. The treatment results are as follows:

TABLE 3 anal fissure treatment Effect

Group of	Recovery (case)	Effective (example)	Invalid (example)	Effective rate (%)
					EXAMPLE 1 group	11	8	1	95％
EXAMPLE 2 group	5	11	4	80％
					EXAMPLE 3 group	3	11	6	70％

As can be seen from the results in Table 3, the composition for treating anal fissure provided in the embodiment 1 of the present invention can effectively treat the symptoms of anal fissure through the specific combination of the components and the specific ratio.

From the results in tables 1 to 3, the average effective rate of the group of example 1 in the aspect of treating anorectal diseases is 96.7%, the average effective rate of the group of example 2 is 80%, and the average effective rate of the group of example 3 is 78.3%. The effective rate in the group of example 1 was higher than that of the other group of examples. The composition provided by the embodiment 1 of the invention can effectively treat the symptoms of external hemorrhoid, internal hemorrhoid, rectal polyp and anal fissure by combining the specific components and the specific proportion.

To sum up: the composition has the effects of clearing heat, relaxing bowels, eliminating stagnation, relieving pain and stopping bleeding, has obvious effect on treating hemorrhoids, rectal polyp and anal fissure and has clinical popularization and application values.

Claims

1. A pharmaceutical composition for treating anorectal diseases, which is characterized in that: the traditional Chinese medicine is prepared from the following raw materials in parts by weight:

2. The pharmaceutical composition of claim 1, wherein: the traditional Chinese medicine is prepared from the following raw materials in parts by weight:

3. The pharmaceutical composition according to claim 1 or 2, characterized in that: the preparation is prepared by taking medicinal powder of raw material medicines, or water or organic solvent extracts of the raw material medicines as active ingredients and adding pharmaceutically acceptable auxiliary materials.

4. The pharmaceutical composition according to any one of claims 1 to 3, wherein: the preparation is an oral preparation.

5. The pharmaceutical composition of claim 4, wherein: the oral preparation is granule, powder, pill or solution, preferably granule.

6. The pharmaceutical composition of claim 5, wherein: every 1g of the granule is equivalent to 2g of crude drugs.

7. A process for preparing a pharmaceutical composition according to any one of claims 1 to 6, characterized in that: it comprises the following steps:

(1) weighing the raw material medicines according to the proportion of claim 1;

8. Use of a pharmaceutical composition according to any one of claims 1 to 6 in the manufacture of a medicament for the treatment of anorectal diseases.

9. Use of the pharmaceutical composition of any one of claims 1 to 6 in the preparation of a medicament having effects of clearing heat, relaxing bowels, resolving masses, relieving pain and arresting bleeding.

10. The pharmaceutical composition according to claim 8 or 9, characterized in that: the medicine is used for treating hemorrhoids, rectal polyp, dry stool, constipation and/or hemorrhoid pain.