CN114632126A

CN114632126A - Traditional Chinese medicine composition for treating functional constipation and preparation method and application thereof

Info

Publication number: CN114632126A
Application number: CN202210359382.1A
Authority: CN
Inventors: 李�浩; 刘野; 马长雨; 许静; 娄民安; 郭加静; 冯海洋; 马春丽; 赵静静
Original assignee: Beijing Dekerui Medical Technology Co ltd
Current assignee: Beijing Dekerui Medical Technology Co ltd
Priority date: 2022-04-07
Filing date: 2022-04-07
Publication date: 2022-06-17
Anticipated expiration: 2042-04-07
Also published as: CN114632126B

Abstract

The invention discloses a traditional Chinese medicine composition for treating functional constipation and a preparation method and application thereof. The invention provides a medicine for treating constipation, which comprises the following raw materials in parts by weight: 10-40 parts of cassia seed, 10-40 parts of houttuynia cordata, 10-40 parts of dandelion, 10-40 parts of cogongrass rhizome, 5-30 parts of wolfberry fruit, 10-40 parts of chrysanthemum, 10-40 parts of honeysuckle, 10-30 parts of purslane and 10-40 parts of allium macrostemon. The invention also provides a preparation method of the extract, which comprises the following steps: mixing the nine traditional Chinese medicine raw materials, and extracting by adopting an ethanol solution to obtain the extract. The invention also provides a medicine for treating constipation, and the active ingredient of the medicine is the extract. The medicine provided by the invention has a good effect on constipation, does not have adverse reaction, and has industrial popularization value.

Description

Traditional Chinese medicine composition for treating functional constipation and preparation method and application thereof

Technical Field

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a medicine (traditional Chinese medicine composition) for treating functional constipation and a preparation method and application thereof.

Background

Along with the acceleration of the pace of work and life of people, the change of refined dietary structure, drug abuse and other reasons, the incidence rate of constipation is on a rapid increase trend in recent years. According to relevant research data, the incidence rate of constipation of the young and the middle-aged people is 1% -5%, the incidence rate of constipation of the old is 5% -30%, the incidence rate of constipation of the old in long-term bed is even as high as 80%, and more than 9000 million people in the whole country suffer from constipation. Among them, chronic functional constipation is a common and frequently-occurring disease in clinic, and is clinically manifested by long defecation intervals, few defecation times (less than 3 times per week), dry stools, difficult defecation or hard and difficult defecation, and the like, and lack of organic disease causes capable of explaining clinical manifestation of patients.

Frequent constipation can affect both the digestive and non-digestive systems. A large amount of excrement including harmful substances and harmful gases in intestinal cavities is accumulated in the intestinal tracts for a long time, the intestinal tracts are easily stimulated to generate colon polyps, even the colon polyps can be cancerated on the basis of the polyps for a long time, and the risk of patients with frequent constipation suffering from the intestinal polyps, the benign adenomas of the intestinal tracts and the colon cancer is increased. The elderly often have hypertension and diabetes, and if constipation occurs, the abdominal pressure is increased, defecation is hard, and blood pressure and cardiovascular and cerebrovascular accidents may be induced.

The treatment methods and medicines adopted by the traditional Chinese medicine preparation are different according to different constipation types and different disease degrees. At present, the treatment medicines for constipation mainly comprise laxatives (local irritant laxatives, intestinal mucosa irritant laxatives, softening laxatives and solvent laxatives), colon motives, microecologics, enemas and the like. If the laxative (containing anthraquinone and its derivatives such as radix et rhizoma Rhei and folium sennae) with strong irritation is taken for a long time, it can cause melanosis of colon in addition to dependence. If the colon motility agent (such as cisapride and mosapride) is taken for a long time, the release of acetylcholine can be increased, and the intestinal peristalsis is stimulated; side effects can increase the absorption of central inhibitory drugs, and the combined application of the drugs should be careful; and the electrocardio S-T section is prolonged, so patients with heart diseases should use with cautions, and patients with liver and kidney function decline should use with cautions. In conclusion, modern medicine is mainly used for symptoms, generally only used for focus, has direct and quick effect, but is easy to generate drug resistance/side effect after long-term administration, is easy to relapse, and treats both symptoms and root causes.

The traditional Chinese medicine starts from analyzing etiology and pathology on a human body macroscopic system by a unique theoretical system, and achieves the effects of eliminating diseases and treating both principal and secondary aspects of diseases after medicine is taken as an impetus by adjusting and recovering various dysfunctional organs. Along with the increasing of the voice of the human returning to nature and the long application history of the traditional Chinese medicine, a large amount of clinical application history proves that the traditional Chinese medicine has the characteristics of definite curative effect and small side effect.

Disclosure of Invention

The invention aims to provide a medicament (traditional Chinese medicine composition) for treating functional constipation and a preparation method and application thereof.

The invention provides a medicine for treating constipation, which comprises the following raw materials in parts by weight: 10-40 parts of cassia seed, 10-40 parts of houttuynia cordata, 10-40 parts of dandelion, 10-40 parts of cogongrass rhizome, 5-30 parts of wolfberry fruit, 10-40 parts of chrysanthemum, 10-40 parts of honeysuckle, 10-30 parts of purslane and 10-40 parts of allium macrostemon.

Specifically, the raw materials are as follows: 20-25 parts of cassia seed, 20-25 parts of houttuynia cordata, 20-30 parts of dandelion, 20-30 parts of cogongrass rhizome, 20-30 parts of wolfberry fruit, 30 parts of chrysanthemum, 20-30 parts of honeysuckle, 20-25 parts of purslane and 20-30 parts of allium macrostemon.

Illustratively, the raw material ratio is as follows: 20 parts of cassia seed, 20 parts of heartleaf houttuynia herb, 30 parts of dandelion, 20 parts of lalang grass rhizome, 30 parts of medlar, 30 parts of chrysanthemum, 20 parts of honeysuckle, 20 parts of purslane and 30 parts of allium macrostemon.

Illustratively, the raw material ratio is as follows: 25 parts of cassia seed, 25 parts of heartleaf houttuynia herb, 20 parts of dandelion, 30 parts of lalang grass rhizome, 20 parts of barbary wolfberry fruit, 30 parts of chrysanthemum, 25 parts of honeysuckle, 20 parts of purslane and 25 parts of longstamen onion bulb.

Illustratively, the raw material ratio is as follows: 25 parts of cassia seed, 25 parts of heartleaf houttuynia herb, 30 parts of dandelion, 20 parts of lalang grass rhizome, 25 parts of medlar, 30 parts of chrysanthemum, 30 parts of honeysuckle, 25 parts of purslane and 20 parts of allium macrostemon.

The medicine is prepared from the following traditional Chinese medicine raw materials in parts by mass: 10-40 parts of cassia seed, 10-40 parts of houttuynia cordata, 10-40 parts of dandelion, 10-40 parts of cogongrass rhizome, 5-30 parts of wolfberry fruit, 10-40 parts of chrysanthemum, 10-40 parts of honeysuckle, 10-30 parts of purslane and 10-40 parts of allium macrostemon.

Specifically, the medicine is prepared from the following traditional Chinese medicine raw materials in parts by mass: 20-25 parts of cassia seed, 20-25 parts of houttuynia cordata, 20-30 parts of dandelion, 20-30 parts of cogongrass rhizome, 20-30 parts of wolfberry fruit, 30 parts of chrysanthemum, 20-30 parts of honeysuckle, 20-25 parts of purslane and 20-30 parts of allium macrostemon.

Illustratively, the medicine is prepared from the following traditional Chinese medicine raw materials in parts by mass: 20 parts of cassia seed, 20 parts of heartleaf houttuynia herb, 30 parts of dandelion, 20 parts of lalang grass rhizome, 30 parts of barbary wolfberry fruit, 30 parts of chrysanthemum, 20 parts of honeysuckle, 20 parts of purslane and 30 parts of longstamen onion bulb.

Illustratively, the medicine is prepared from the following traditional Chinese medicine raw materials in parts by mass: 25 parts of cassia seed, 25 parts of heartleaf houttuynia herb, 20 parts of dandelion, 30 parts of lalang grass rhizome, 20 parts of medlar, 30 parts of chrysanthemum, 25 parts of honeysuckle, 20 parts of purslane and 25 parts of allium macrostemon.

Illustratively, the medicine is prepared from the following traditional Chinese medicine raw materials in parts by mass: 25 parts of cassia seed, 25 parts of heartleaf houttuynia herb, 30 parts of dandelion, 20 parts of lalang grass rhizome, 25 parts of medlar, 30 parts of chrysanthemum, 30 parts of honeysuckle, 25 parts of purslane and 20 parts of allium macrostemon.

The invention also provides a preparation method of the extract, which comprises the following steps: mixing nine traditional Chinese medicine raw materials, and extracting by adopting an ethanol solution to obtain an extract; the nine traditional Chinese medicine raw materials and the mixture ratio thereof are as follows: 10-40 parts of cassia seed, 10-40 parts of houttuynia cordata, 10-40 parts of dandelion, 10-40 parts of cogongrass rhizome, 5-30 parts of wolfberry fruit, 10-40 parts of chrysanthemum, 10-40 parts of honeysuckle, 10-30 parts of purslane and 10-40 parts of allium macrostemon.

Specifically, the nine traditional Chinese medicine raw materials and the mixture ratio thereof are as follows: 20-25 parts of cassia seed, 20-25 parts of houttuynia cordata, 20-30 parts of dandelion, 20-30 parts of cogongrass rhizome, 20-30 parts of wolfberry fruit, 30 parts of chrysanthemum, 20-30 parts of honeysuckle, 20-25 parts of purslane and 20-30 parts of allium macrostemon.

Illustratively, the nine traditional Chinese medicine raw materials and the mixture ratio thereof are as follows: 20 parts of cassia seed, 20 parts of heartleaf houttuynia herb, 30 parts of dandelion, 20 parts of lalang grass rhizome, 30 parts of medlar, 30 parts of chrysanthemum, 20 parts of honeysuckle, 20 parts of purslane and 30 parts of allium macrostemon.

Illustratively, the nine traditional Chinese medicine raw materials and the mixture ratio thereof are as follows: 25 parts of cassia seed, 25 parts of heartleaf houttuynia herb, 20 parts of dandelion, 30 parts of lalang grass rhizome, 20 parts of medlar, 30 parts of chrysanthemum, 25 parts of honeysuckle, 20 parts of purslane and 25 parts of allium macrostemon.

Illustratively, the nine traditional Chinese medicine raw materials and the mixture ratio thereof are as follows: 25 parts of cassia seed, 25 parts of heartleaf houttuynia herb, 30 parts of dandelion, 20 parts of lalang grass rhizome, 25 parts of medlar, 30 parts of chrysanthemum, 30 parts of honeysuckle, 25 parts of purslane and 20 parts of allium macrostemon.

The method further comprises the steps of: after extraction is finished, filtering and collecting filtrate, and concentrating under reduced pressure until the relative density is 1.0-1.3 (specifically 1.0-1.1, and more specifically 1.05), so as to obtain an extractum-like product, which is the extract.

Illustratively, the method specifically includes the steps of:

(1) mixing the nine traditional Chinese medicine raw materials, adding an ethanol solution, stirring, filtering, and collecting filtrate;

(2) adding an ethanol solution into the residue obtained in the step (1), stirring, filtering, and collecting filtrate;

(3) and (3) combining the filtrate obtained in the step (1) and the filtrate obtained in the step (2), and concentrating under reduced pressure to obtain an extract-shaped product.

The rotation speed of the stirring can be 100-500 rpm.

The rotational speed of the stirring may be 100-300 rpm.

The rotational speed of the stirring may be 200 rpm.

In the step (1), the stirring time may be specifically 40 to 120 minutes.

In the step (1), the stirring time may be 40 to 100 minutes.

In the step (1), the stirring time may be 40 to 80 minutes.

In the step (1), the stirring time may be 60 minutes.

In the step (2), the stirring time may be 20 to 90 minutes.

In the step (2), the stirring time may be 20 to 60 minutes.

In the step (2), the stirring time may be 40 minutes.

The filtering is carried out by adopting a 300-mesh and 800-mesh filter screen.

The filter is a 400-mesh and 600-mesh filter screen.

The filtration is specifically performed by using a 500-mesh filter screen.

The ethanol solution can be specifically an ethanol water solution.

The ethanol water solution can be more than 20% (V/V) ethanol solution.

The ethanol water solution can be more than 50% (V/V) ethanol solution.

The ethanol water solution can be 50-90% (V/V) ethanol solution.

The ethanol water solution can be 60-80% (V/V) ethanol solution.

The ethanol water solution can be 70% (V/V) ethanol solution.

In the method, the ratio of the total mass of the traditional Chinese medicine raw materials, the volume of the ethanol solution in the step (1) and the volume of the ethanol solution in the step (2) can be as follows: 1 kg: 2-15L: 2 to 15L.

In the method, the ratio of the total mass of the traditional Chinese medicine raw materials, the volume of the ethanol solution in the step (1) and the volume of the ethanol solution in the step (2) can be as follows: 1 kg: 3-12L: 2 to 11L.

In the method, the ratio of the total mass of the traditional Chinese medicine raw materials, the volume of the ethanol solution in the step (1) and the volume of the ethanol solution in the step (2) can be as follows: 1 kg: 5-9L: 4-8L.

In the method, the ratio of the total mass of the traditional Chinese medicine raw materials, the volume of the ethanol solution in the step (1) and the volume of the ethanol solution in the step (2) can be as follows: 1 kg: 7L: 6L.

In the step (3), the concentration under reduced pressure to a relative density is carried out under reduced pressure to a relative density of 1.0 to 1.3.

In the step (3), the concentration under reduced pressure to a relative density is carried out under reduced pressure to a relative density of 1.0-1.1.

In the step (3), the mixture is concentrated under reduced pressure until the relative density is 1.05.

The relative density may specifically be a relative density at 60 ℃.

The parameters of the reduced pressure concentration can be specifically as follows: the temperature is 60-80 ℃.

The parameters of the reduced pressure concentration can be specifically as follows: vacuum degree of 0.1Mpa, temperature of 70 ℃.

Specifically, the Chinese medicinal materials are pulverized before use to obtain particle size of below 0.9 mm.

The extract is useful for treating constipation.

The extract prepared by the method also belongs to the protection scope of the invention.

The invention also provides a preparation method of the granular preparation, which comprises the following steps: drying and granulating the extract to obtain a granular preparation with the water content of less than 5%.

Adding adjuvants during drying and granulating.

The auxiliary material can be beta-cyclodextrin and/or maltodextrin.

The auxiliary material can be composed of 1 part by mass of beta-cyclodextrin and 3 parts by mass of maltodextrin.

The proportion of the extract and the auxiliary materials can be specifically as follows: 38.6kg of extract: 4-9kg of auxiliary materials.

The proportion of the extract and the auxiliary materials can be specifically as follows: 38.6kg of extract: 6.6kg of auxiliary materials.

For example, the preparation method may specifically be: weighing auxiliary materials, placing the auxiliary materials in a boiling type granulating drier, adjusting the temperature of an air inlet to 70-100 ℃, and preheating the auxiliary materials in a boiling bed to 45-60 ℃; adding the extract into a feed liquid tank, uniformly stirring, adjusting the atomization pressure until the atomization effect is good, and gradually spraying the extract in the feed liquid tank onto the auxiliary materials boiling in the boiling bed by using a peristaltic pump; and after the spraying is finished, continuously drying for about 20 minutes to obtain the granular preparation with the moisture content of less than or equal to 5 percent.

The granular preparation has the function of treating constipation.

The granular preparation prepared by the method also belongs to the protection scope of the invention.

The invention also protects the application of the extract or the granular preparation in preparing a medicament for treating constipation.

The invention also provides a medicine for treating constipation, and the active ingredient of the medicine is the extract or the granular preparation.

The medicament may also include a carrier material. Carrier materials include, but are not limited to, water-soluble carrier materials (e.g., polyethylene glycol, polyvinylpyrrolidone, organic acids, etc.), sparingly soluble carrier materials (e.g., ethyl cellulose, cholesterol stearate, etc.), enteric carrier materials (e.g., cellulose acetate phthalate, and carboxymethylcellulose, etc.). The materials can be prepared into various dosage forms, including but not limited to tablets, capsules, dripping pills, aerosols, pills, powders, solutions, suspensions, emulsions, granules, liposomes, transdermal agents, buccal tablets, freeze-dried powder injections and the like. Can be common preparation, sustained release preparation, controlled release preparation and various microparticle drug delivery systems. In order to prepare the unit dosage form into tablets, various carriers well known in the art can be widely used. Examples of the carrier are, for example, diluents and absorbents such as starch, dextrin, calcium sulfate, lactose, mannitol, sucrose, sodium chloride, glucose, urea, calcium carbonate, kaolin, microcrystalline cellulose, aluminum silicate and the like; wetting agents and binders such as water, glycerin, polyethylene glycol, ethanol, propanol, starch slurry, dextrin, syrup, honey, glucose solution, acacia slurry, gelatin slurry, sodium carboxymethylcellulose, shellac, methyl cellulose, potassium phosphate, polyvinylpyrrolidone and the like; disintegrating agents such as dried starch, alginate, agar powder, brown algae starch, sodium bicarbonate and citric acid, calcium carbonate, polyoxyethylene, sorbitol fatty acid ester, sodium dodecylsulfate, methyl cellulose, ethyl cellulose, etc.; disintegration inhibitors such as sucrose, glyceryl tristearate, cacao butter, hydrogenated oil and the like; absorption accelerators such as quaternary ammonium salts, sodium lauryl sulfate and the like; lubricants, for example, talc, silica, corn starch, stearate, boric acid, liquid paraffin, polyethylene glycol, and the like. The tablets may be further formulated into coated tablets, such as sugar-coated tablets, film-coated tablets, enteric-coated tablets, or double-layer and multi-layer tablets. In order to prepare the dosage form for unit administration into a pill, various carriers well known in the art can be widely used. Examples of the carrier are, for example, diluents and absorbents such as glucose, lactose, starch, cacao butter, hydrogenated vegetable oil, polyvinylpyrrolidone, kaolin, talc and the like; binders such as acacia, tragacanth, gelatin, ethanol, honey, liquid sugar, rice paste or batter, etc.; disintegrating agents, such as agar powder, dried starch, alginate, sodium dodecylsulfate, methylcellulose, ethylcellulose, etc. In order to prepare the unit dosage form into preparations for injection, such as solutions, emulsions, lyophilized powders and suspensions, all diluents commonly used in the art, for example, water, ethanol, polyethylene glycol, 1, 3-propanediol, ethoxylated isostearyl alcohol, polyoxylated isostearyl alcohol, polyoxyethylene sorbitol fatty acid esters, etc., can be used. In addition, for the preparation of isotonic injection, sodium chloride, glucose or glycerol may be added in an appropriate amount to the preparation for injection, and conventional cosolvents, buffers, pH adjusters and the like may also be added. In addition, colorants, preservatives, flavors, flavorings, sweeteners or other materials may also be added to the pharmaceutical preparation, if desired.

The invention also protects the application of the nine traditional Chinese medicine raw materials in preparing the medicine for treating constipation; the nine traditional Chinese medicine raw materials and the mixture ratio thereof are as follows: 10-40 parts of cassia seed, 10-40 parts of houttuynia cordata, 10-40 parts of dandelion, 10-40 parts of cogongrass rhizome, 5-30 parts of wolfberry fruit, 10-40 parts of chrysanthemum, 10-40 parts of honeysuckle, 10-30 parts of purslane and 10-40 parts of allium macrostemon.

Illustratively, the nine traditional Chinese medicine raw materials and the mixture ratio thereof are as follows: 25 parts of cassia seed, 25 parts of heartleaf houttuynia herb, 30 parts of dandelion, 20 parts of lalang grass rhizome, 25 parts of barbary wolfberry fruit, 30 parts of chrysanthemum, 30 parts of honeysuckle, 25 parts of purslane and 20 parts of longstamen onion bulb.

The constipation is chronic constipation.

The constipation is functional constipation.

The constipation is primary constipation.

The constipation is primary persistent constipation caused by non-systemic diseases or intestinal diseases.

The traditional Chinese medicine provided by the invention has the following formula: the heartleaf houttuynia herb, the chrysanthemum and the honeysuckle realize the effects of clearing lung heat, dispersing and descending lung qi, eliminating excess heat of large intestine and enhancing the large intestine conductivity; the functions of nourishing the spleen and the stomach are realized through the dandelion and the lalang grass rhizome; the functions of nourishing liver and kidney are realized through the medlar, the cogongrass rhizome and the purslane; meanwhile, Bulbus Allii Macrostemi is used as adjuvant drug for activating yang, resolving hard mass, promoting qi circulation and removing food stagnation. Through the reasonable formula and the synergistic effect, the symptoms of various viscera function imbalance, qi deficiency and the like caused by constipation are solved, and a good clinical effect of treating constipation is achieved.

The medicine provided by the invention has a good effect on constipation, does not have adverse reaction, and has industrial popularization value.

Detailed Description

The present invention is described in further detail below with reference to specific embodiments, which are given for the purpose of illustration only and are not intended to limit the scope of the invention. The examples provided below serve as a guide for further modifications by a person skilled in the art and do not constitute a limitation of the invention in any way.

The experimental procedures in the following examples, unless otherwise specified, were carried out in a conventional manner according to the techniques or conditions described in the literature in this field or according to the product instructions. Materials, reagents and the like used in the following examples are commercially available unless otherwise specified. Beta-cyclodextrin is a product of Huaxing Biochemical industry, Limited liability, Inc. of Mengzhou, lot number 20210809. Maltodextrin is a product of Shandong West King sugar industry Co., Ltd, lot number 20210622.

The cassia seed, the cordate houttuynia, the dandelion, the cogongrass rhizome, the medlar, the chrysanthemum, the honeysuckle, the purslane and the allium macrostemon which are used as raw materials in the embodiment are all traditional Chinese medicine materials (dried products) and all meet the relevant regulations under each medicinal material item in the text of the Chinese pharmacopoeia (2020 edition). Before feeding, the material objects are identified to be consistent with the names of the medicinal materials, and the quality is in accordance with the standard.

Semen Cassiae is dry mature seed of Cassia obtusifolia L. or Cassia tora L. of Leguminosae. A Chinese medicinal material herba Houttuyniae is fresh whole plant or dried aerial part of Houttuynia cordata Thunb of Saururaceae. The Chinese medicinal material herba Taraxaci is Taraxacum mongolicum hand-Mazz of Compositae, Taraxacum borealisinsens Kitam of Taraxacum alopecuroides or dried whole plant of plants of the same genus. The Chinese medicinal material lalang grass rhizome is dried rhizome of Imperata cylindrica Cylindrica Beauv.var.major (Nees) C.E.Hubb. Fructus Lycii is dried mature fruit of Lycium barbarum L. of Solanaceae. A Chinese medicinal material flos Chrysanthemi is dried head-shaped inflorescence of Chrysanthemum morifolium Ramat of Compositae. The Chinese medicinal material honeysuckle is a dried flower bud or a flower with initial bloom of Lonicera japonica Thunb. Herba Portulacae is dry aerial part of Portulaca oleracea L. Bulbus Allii Macrostemi is dried bulb of Allium macrostemon Bge or Allium macrostemon G.Don.

Example 1 preparation of Chinese medicinal composition

From the theory of traditional Chinese medicine, the disease location of constipation is in the large intestine, but is related to the dysfunction of the lung, spleen (stomach), liver and kidney. The lung is exterior-interior to the large intestine, and the lung fails to disperse and descend, so that the large intestine fails to conduct energy or the lung heat is conducted to the large intestine, resulting in the accumulation of excessive heat in the large intestine; the dregs are stopped when the spleen is deficient and the transportation and transformation are abnormal; when stomach heat is excessive and consumes body fluids, the intestines are not moistened; stagnation of liver qi, stagnation of qi, or transformation of qi into fire and impairment of body fluids after long-term stagnation of qi may cause obstruction of fu-organs; kidneys governing water and governing urination and defecation, kidney yin deficiency and lack of moistening of the intestinal tract; constipation can be caused by kidney yang deficiency and failure of warming and unblocking.

The inventor finally obtains the traditional Chinese medicine formula which is suitable for constipation people and has the best effect through a large amount of formula optimization (clinical effect verification).

The traditional Chinese medicine formula of the invention is as follows: 10-40 parts of cassia seed, 10-40 parts of houttuynia cordata, 10-40 parts of dandelion, 10-40 parts of cogongrass rhizome, 5-30 parts of wolfberry fruit, 10-40 parts of chrysanthemum, 10-40 parts of honeysuckle, 10-30 parts of purslane and 10-40 parts of allium macrostemon.

For example, the specific traditional Chinese medicine formula can be a traditional Chinese medicine formula I, a traditional Chinese medicine formula II or a traditional Chinese medicine formula III.

The traditional Chinese medicine formula I is as follows: 20 parts of cassia seed, 20 parts of heartleaf houttuynia herb, 30 parts of dandelion, 20 parts of lalang grass rhizome, 30 parts of medlar, 30 parts of chrysanthemum, 20 parts of honeysuckle, 20 parts of purslane and 30 parts of allium macrostemon.

The second traditional Chinese medicine formula is as follows: 25 parts of cassia seed, 25 parts of heartleaf houttuynia herb, 20 parts of dandelion, 30 parts of lalang grass rhizome, 20 parts of barbary wolfberry fruit, 30 parts of chrysanthemum, 25 parts of honeysuckle, 20 parts of purslane and 25 parts of longstamen onion bulb.

The third traditional Chinese medicine formula is as follows: 25 parts of cassia seed, 25 parts of heartleaf houttuynia herb, 30 parts of dandelion, 20 parts of lalang grass rhizome, 25 parts of medlar, 30 parts of chrysanthemum, 30 parts of honeysuckle, 25 parts of purslane and 20 parts of allium macrostemon.

The honeysuckle flower is cold in nature and sweet in taste, enters lung, heart and stomach meridians, and has the effects of clearing away heat and toxic materials, resisting inflammation, tonifying deficiency and treating wind; is a monarch drug. The cordate houttuynia is cold in nature and can be used for clearing and reducing the lung heat, and clearing damp and treating stranguria; herba Taraxaci is effective in removing carbuncle and resolving hard mass; the two drugs are used as ministerial drugs. The purslane is matched with the lalang grass rhizome, so that the bowel relaxing, edema eliminating and damp-heat removing effects can be realized; is used as adjuvant drug. Fructus Lycii has effects of nourishing liver and kidney. Xie Bai can tonify heart yang, disperse qi stagnation of the chest and large intestine, and activate blood. Chrysanthemum flower, flos Chrysanthemi, for dispelling wind-heat, refreshing the head and eyes. The combination of herbs can cool but not cold, dredge but not discharge, clear internal heat, and perform both purgation and tonification.

Example 2 preparation of Chinese medicinal preparation

First, preparation of extract

1. Weighing the medicinal powder according to a first traditional Chinese medicine formula, wherein the specific amount is as follows: weighing 3kg of cassia seed, 3kg of heartleaf houttuynia herb, 4.5kg of dandelion, 3kg of lalang grass rhizome, 4.5kg of medlar, 4.5kg of chrysanthemum, 3kg of honeysuckle, 3kg of purslane and 4.5kg of allium macrostemon, and mixing the weighed materials, wherein the total weight is 33 kg. The medicines are firstly crushed before being weighed to obtain powder with the particle size of less than 0.9 mm.

2. The mixture of step 1 was taken, 231L of 70% (V/V) ethanol aqueous solution was added, stirred at 200rpm for 60 minutes, and then filtered through a 500 mesh sieve, and the filtrate was collected (196L total).

3. To the residue of step 2 was added 198L of 70% (V/V) aqueous ethanol and stirred at 200rpm for 40 minutes. Then filtered through a 500 mesh screen and the filtrate was collected (total 189L).

4. And (3) combining the filtrate obtained in the step (2) and the filtrate obtained in the step (3), and concentrating under reduced pressure (the vacuum degree is 0.1Mpa, the temperature is 70 ℃) until the relative density is 1.05 (the relative density at 60 ℃), so that an extractum-like product is obtained, wherein the total amount of the extractum-like product is 38.6 kg.

Preparation of granular preparation

Weighing 6.6kg of auxiliary materials (the auxiliary materials comprise 1 part by mass of beta-cyclodextrin and 3 parts by mass of maltodextrin), placing the auxiliary materials in a boiling type granulating drier, adjusting the temperature of an air inlet to 70-100 ℃, and preheating the temperature of the auxiliary materials in a boiling bed to 45-60 ℃. Adding the prepared extract-shaped product of 38.6kg into a material liquid tank, uniformly stirring, adjusting the atomizing pressure until the atomizing effect is good, and gradually spraying the extract in the material liquid tank onto the auxiliary material boiling in the boiling bed by using a peristaltic pump. And after the spraying is finished, continuing to dry for about 20 minutes to obtain the product, namely the granular preparation (the moisture content is less than or equal to 5 percent).

A total of 14.1kg of the granulated preparation was obtained.

Packaging the granular preparation, wherein the packaging specification is 4 g/bag.

Example 3 evaluation of clinical Effect

Functional constipation: primary persistent constipation caused by non-systemic diseases or intestinal diseases.

International roman IV diagnostic criteria common to functional constipation are as follows:

more than 25% of defecation feels labor;

over 25% of the excrement is dry excrement balls or hard excrement;

③ more than 25 percent of defecation has obstruction/blockage of anus and rectum;

over 25% of defecation needs manipulation assistance (such as assisting defecation by fingers and supporting the basin bottom);

less than 3 times per week for spontaneous defecation (SBM).

The diagnosis standard of the functional constipation in the invention is as follows: the subject had developed more than one symptom of the roman IV diagnostic criteria for at least 6 months and the symptoms of the subject met more than two of the roman IV diagnostic criteria in the last 3 months, i.e., was diagnosed with functional constipation.

Subject inclusion criteria (inclusion after meeting all criteria at the same time): the age is 18-65 years, and the male and the female are not limited; diagnosing functional constipation according to the above criteria; ③ the subject agrees with the informed consent and signs the informed consent.

Subject exclusion criteria (meeting one or more criteria for exclusion): constipation caused by intestinal organic diseases such as intestinal stenosis due to rectal and colonic organic lesions (such as inflammatory bowel disease, tumor, colonic polyp, and intestinal tuberculosis); those with defecation disorder due to anal lesion and constipation caused by other systemic organic lesions or drug factors; secondly, the secondary constipation of the cause of disease is determined; ③ irritable bowel syndrome or positive occult blood in stool; fourthly, pregnant women or women ready for pregnancy, women in breast period; use the medicine for treating functional constipation within a week; sixthly, the subject participates in other clinical tests within 1 month; and the researchers do not consider the other cases which are not easy to participate in the test.

The grading and quantification standard of the main symptoms of constipation is shown in table 1.

TABLE 1 grading and quantification standard of constipation main symptoms

A total of 30 subjects were tested. The duration of the drug effect test was 12 weeks (continuous administration for 12 weeks), and 1 dose per day was 1 bag of the granular formulation prepared in example 2 (administered after dissolving in 200ml of hot water).

The data were analyzed using the statistical software package minitab15.0. The measured data is first tested for normality and the measured data in normal distribution is averaged to +/-standard deviation

The results of the treatment were compared by the paired t test. P <0.05 isThe difference is statistically significant.

After the pharmacodynamic test was completed, the efficacy was evaluated. The evaluation of the drug effect is divided into three types of cure, effective and ineffective. And (3) curing: the constipation symptom of the patient basically disappears, and the defecation constitution is moist, not dry and not astringent; the frequency of defecation is obviously increased, the defecation feeling of a patient is enhanced, the defecation difficulty degree is reduced, the abdominal pain feeling is reduced, the appetite is increased, and the physique is improved. The method has the following advantages: the symptoms of chronic constipation of patients are improved, and the stool quality is improved, and the patients are not dry and astringent; the frequency of defecation is increased, the defecation feeling of a patient is enhanced compared with that before the medicine is taken, the defecation difficulty degree is reduced, the abdominal pain feeling is reduced, and the appetite is increased. And (4) invalidation: the patient's constipation symptoms were not improved. Effective rate is the cure rate plus effective rate. The results are shown in Table 2. The results showed a total effective rate of 93.3%.

TABLE 2 results of evaluation of drug efficacy

n	Cure of disease	Is effective	Nullification	Total effective rate
					30	11	17	2	93.3％

Before the beginning of the pharmacodynamic test (before treatment) and after the pharmacodynamic test (after treatment), the defecation indexes of the testee are graded according to the grading quantitative standard of the main symptoms of constipation, and the results are shown in table 3. After 12 weeks of treatment, the observation indexes (defecation frequency, defecation time, stool property and defecation labor) of the constipation symptoms of the subjects are remarkably improved compared with those before treatment, and the statistical significance is achieved (P is less than 0.05).

TABLE 3 Constipation chief symptom observation index change table for subjects before and after treatment

No obvious side reactions such as anaphylactic reaction, diarrhea and edema, blood pressure change and the like are found in the whole drug effect test process of 30 subjects.

The present invention has been described in detail above. It will be apparent to those skilled in the art that the invention can be practiced in a wide range of equivalent parameters, concentrations, and conditions without departing from the spirit and scope of the invention and without undue experimentation. While the invention has been described with reference to specific embodiments, it will be appreciated that the invention can be further modified. In general, this application is intended to cover any variations, uses, or adaptations of the invention following, in general, the principles of the invention and including such departures from the present disclosure as come within known or customary practice within the art to which the invention pertains. The use of some of the essential features is possible within the scope of the claims attached below.

Claims

1. A medicine for treating constipation comprises the following raw materials in parts by weight: 10-40 parts of cassia seed, 10-40 parts of houttuynia cordata, 10-40 parts of dandelion, 10-40 parts of cogongrass rhizome, 5-30 parts of wolfberry fruit, 10-40 parts of chrysanthemum, 10-40 parts of honeysuckle, 10-30 parts of purslane and 10-40 parts of allium macrostemon.

2. The medicament of claim 1, wherein: the medicine is prepared from the following traditional Chinese medicine raw materials in parts by mass: 10-40 parts of cassia seed, 10-40 parts of houttuynia cordata, 10-40 parts of dandelion, 10-40 parts of cogongrass rhizome, 5-30 parts of wolfberry fruit, 10-40 parts of chrysanthemum, 10-40 parts of honeysuckle, 10-30 parts of purslane and 10-40 parts of allium macrostemon.

3. A method for preparing an extract comprises the following steps: mixing nine traditional Chinese medicine raw materials, and extracting with ethanol solution to obtain extract; the nine traditional Chinese medicine raw materials and the mixture ratio thereof are as follows: 10-40 parts of cassia seed, 10-40 parts of houttuynia cordata, 10-40 parts of dandelion, 10-40 parts of cogongrass rhizome, 5-30 parts of wolfberry fruit, 10-40 parts of chrysanthemum, 10-40 parts of honeysuckle, 10-30 parts of purslane and 10-40 parts of allium macrostemon.

4. The extract prepared by the method of claim 3.

5. A method for preparing a granular formulation comprising the steps of: drying and granulating the extract of claim 4 to obtain a granular preparation with a water content of 5% or less.

6. A granular formulation prepared by the process of claim 5.

7. Use of the extract of claim 4 or the granular formulation of claim 6 for the manufacture of a medicament for the treatment of constipation.

8. A medicament for treating constipation, which comprises the extract according to claim 4 or the granular preparation according to claim 6 as an active ingredient.

9. The application of nine Chinese medicinal materials in preparing medicine for treating constipation; the nine traditional Chinese medicine raw materials and the mixture ratio thereof are as follows: 10-40 parts of cassia seed, 10-40 parts of heartleaf houttuynia herb, 10-40 parts of dandelion, 10-40 parts of lalang grass rhizome, 5-30 parts of barbary wolfberry fruit, 10-40 parts of chrysanthemum, 10-40 parts of honeysuckle, 10-30 parts of purslane and 10-40 parts of allium macrostemon.