CN114632126B - Traditional Chinese medicine combination medicine for treating functional constipation and preparation method and application thereof - Google Patents

Abstract

The invention discloses a traditional Chinese medicine combination drug 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 semen cassiae, 10-40 parts of cordate houttuynia, 10-40 parts of dandelion, 10-40 parts of cogongrass rhizome, 5-30 parts of medlar, 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 Chinese medicinal materials, and extracting with ethanol solution to obtain 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, has no adverse reaction, and has industrial popularization value.

Description

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

Technical Field

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

Background

With the acceleration of the work and life pace of people, the change of refined diet structure, the abuse of drugs and other reasons, the incidence of constipation has been rapidly increasing in recent years. According to the research data, the incidence rate of constipation of middle-aged and young people is 1% -5%, the incidence rate of constipation of old people is 5% -30%, even the incidence rate of constipation of old people lying in bed for a long time is 80%, and about 9000 tens of thousands of people suffer from constipation in the whole country. Among them, chronic functional constipation is a common and frequently occurring disease in clinic, and clinically manifested by long defecation interval, less times of defecation (less than 3 times per week), dry stool, difficult defecation or difficult and unsmooth stool, and the like, and meanwhile, the lack of organic etiology capable of explaining the clinical manifestations of patients.

Often constipation can affect the digestive and non-digestive systems. Often causes a great deal of stool in the intestinal cavity, including harmful substances and harmful gases gather in the intestinal tract for a long time, is easy to stimulate the intestinal tract to produce colon polyps, can even generate canceration on the basis of the polyps for a long time, and is high in risk of suffering from the intestinal polyps, benign adenoma of the intestinal tract and colon cancer for patients with frequent constipation. The elderly mostly combine hypertension and diabetes, if constipation occurs, abdominal pressure is enhanced, defecation is laborious, and blood pressure and cardiovascular and cerebrovascular accidents can be induced.

Aiming at different constipation types and different disease degrees, the adopted treatment means and medicines are different. Currently, the therapeutic drugs for constipation are mainly laxatives (local irritant laxatives, intestinal mucosa irritant laxatives, softening laxatives, solvent type laxatives), colonic motility agents, microecologics, enemas, and the like. The cathartic (anthraquinone and its derivatives such as radix et rhizoma Rhei and folium sennae) with strong irritation can cause colon blackening disease in addition to dependence. The colon motility agent (cisapride, moxapride, etc.) can increase acetylcholine release and stimulate intestinal peristalsis after long-term administration; the side effect can increase the absorption of the central inhibitory drug, and the combined application of the side effect and the central inhibitory drug should be careful; and the heart should be cautious to heart patients and patients with liver and kidney hypofunction by prolonging the electrocardio S-T section. In summary, modern medicine mainly aims at symptoms, generally only takes medicines for focus, has direct effect and is quick in effect, but the medicine resistance/side effect is easy to generate after long-term taking, the disease condition is easy to relapse, and the symptoms are cured without curing the root cause.

The traditional Chinese medicine uses a unique theoretical system, starts from analyzing etiology and pathology on a human macroscopic system, and achieves the effects of eliminating the medical effect and treating both principal and secondary aspect of disease by adjusting and recovering organs with various malfunctions as acting points. Along with the increasing trend of human return to nature, the traditional Chinese medicine has a long application history, and a large amount of clinical use histories have proved 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 medicine (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 semen cassiae, 10-40 parts of cordate houttuynia, 10-40 parts of dandelion, 10-40 parts of cogongrass rhizome, 5-30 parts of medlar, 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 semen cassiae, 20-25 parts of cordate houttuynia, 20-30 parts of dandelion, 20-30 parts of cogongrass rhizome, 20-30 parts of medlar, 30 parts of chrysanthemum, 20-30 parts of honeysuckle, 20-25 parts of purslane and 20-30 parts of allium macrostemon.

Exemplary, the raw materials are as follows: 20 parts of semen cassiae, 20 parts of cordate houttuynia, 30 parts of dandelion, 20 parts of cogongrass rhizome, 30 parts of medlar, 30 parts of chrysanthemum, 20 parts of honeysuckle, 20 parts of purslane and 30 parts of allium macrostemon.

Exemplary, the raw materials are as follows: 25 parts of semen cassiae, 25 parts of cordate houttuynia, 20 parts of dandelion, 30 parts of cogongrass rhizome, 20 parts of medlar, 30 parts of chrysanthemum, 25 parts of honeysuckle, 20 parts of purslane and 25 parts of allium macrostemon.

Exemplary, the raw materials are as follows: 25 parts of semen cassiae, 25 parts of cordate houttuynia, 30 parts of dandelion, 20 parts of cogongrass 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 semen cassiae, 10-40 parts of cordate houttuynia, 10-40 parts of dandelion, 10-40 parts of cogongrass rhizome, 5-30 parts of medlar, 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 semen cassiae, 20-25 parts of cordate houttuynia, 20-30 parts of dandelion, 20-30 parts of cogongrass rhizome, 20-30 parts of medlar, 30 parts of chrysanthemum, 20-30 parts of honeysuckle, 20-25 parts of purslane and 20-30 parts of allium macrostemon.

The medicine is prepared from the following traditional Chinese medicine raw materials in parts by mass: 20 parts of semen cassiae, 20 parts of cordate houttuynia, 30 parts of dandelion, 20 parts of cogongrass rhizome, 30 parts of medlar, 30 parts of chrysanthemum, 20 parts of honeysuckle, 20 parts of purslane and 30 parts of allium macrostemon.

The medicine is prepared from the following traditional Chinese medicine raw materials in parts by mass: 25 parts of semen cassiae, 25 parts of cordate houttuynia, 20 parts of dandelion, 30 parts of cogongrass rhizome, 20 parts of medlar, 30 parts of chrysanthemum, 25 parts of honeysuckle, 20 parts of purslane and 25 parts of allium macrostemon.

The medicine is prepared from the following traditional Chinese medicine raw materials in parts by mass: 25 parts of semen cassiae, 25 parts of cordate houttuynia, 30 parts of dandelion, 20 parts of cogongrass 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 the nine traditional Chinese medicine raw materials, and extracting by adopting ethanol solution to obtain an extract; the nine traditional Chinese medicine raw materials and the proportion thereof are as follows: 10-40 parts of semen cassiae, 10-40 parts of cordate houttuynia, 10-40 parts of dandelion, 10-40 parts of cogongrass rhizome, 5-30 parts of medlar, 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 proportions thereof are as follows: 20-25 parts of semen cassiae, 20-25 parts of cordate houttuynia, 20-30 parts of dandelion, 20-30 parts of cogongrass rhizome, 20-30 parts of medlar, 30 parts of chrysanthemum, 20-30 parts of honeysuckle, 20-25 parts of purslane and 20-30 parts of allium macrostemon.

The nine traditional Chinese medicine raw materials and the proportions thereof are as follows: 20 parts of semen cassiae, 20 parts of cordate houttuynia, 30 parts of dandelion, 20 parts of cogongrass rhizome, 30 parts of medlar, 30 parts of chrysanthemum, 20 parts of honeysuckle, 20 parts of purslane and 30 parts of allium macrostemon.

The nine traditional Chinese medicine raw materials and the proportions thereof are as follows: 25 parts of semen cassiae, 25 parts of cordate houttuynia, 20 parts of dandelion, 30 parts of cogongrass rhizome, 20 parts of medlar, 30 parts of chrysanthemum, 25 parts of honeysuckle, 20 parts of purslane and 25 parts of allium macrostemon.

The nine traditional Chinese medicine raw materials and the proportions thereof are as follows: 25 parts of semen cassiae, 25 parts of cordate houttuynia, 30 parts of dandelion, 20 parts of cogongrass 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 the extraction is completed, filtering and collecting filtrate, and concentrating under reduced pressure until the relative density is 1.0-1.3 (specifically 1.0-1.1, more specifically 1.05), namely an extract-like product, namely an 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 in the step (1), stirring, filtering, and collecting filtrate;

(3) And (3) combining the filtrate obtained in the step (1) with the filtrate obtained in the step (2), and concentrating under reduced pressure to obtain an extractum-like product.

The rotational speed of the stirring may be 100-500rpm.

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

The rotational speed of the stirring may be 200rpm.

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

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

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

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

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

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

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

The filtering specifically adopts a 300-800 mesh filter screen.

The filtering specifically adopts a 400-600 mesh filter screen.

The filtering specifically adopts a 500-mesh filter screen.

The ethanol solution may specifically be an aqueous ethanol solution.

The aqueous ethanol solution may specifically be a 20% (V/V) or more ethanol solution.

The aqueous ethanol solution may specifically be a 50% (V/V) or more ethanol solution.

The aqueous ethanol solution may specifically be a 50-90% (V/V) ethanol solution.

The aqueous ethanol solution may specifically be 60-80% (V/V) ethanol solution.

The aqueous ethanol solution may specifically be a 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: 1kg:2-15L:2-15L.

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: 1kg:3-12L:2-11L.

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: 1kg: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: 1kg:7L:6L.

In the step (3), the relative density is reduced to 1.0-1.3.

In the step (3), the relative density is reduced to 1.0-1.1.

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

The relative density may specifically be that at 60 ℃.

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

The decompression concentration parameters can be specifically as follows: vacuum degree 0.1Mpa and temperature 70 ℃.

Specifically, the Chinese medicinal materials are crushed before use to obtain granule with diameter below 0.9 mm.

The extract has the function of 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: and (3) drying and granulating the extract to obtain a granular preparation with the water content of less than 5%.

And adding auxiliary materials during drying and granulating.

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

The auxiliary material specifically comprises 1 part by mass of beta-cyclodextrin and 3 parts by mass of maltodextrin.

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

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

The preparation method specifically comprises the following steps: weighing auxiliary materials, placing the auxiliary materials in a boiling granulating dryer, 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 a boiling bed by using a peristaltic pump; and after spraying is finished, continuing to dry for about 20 minutes to obtain the granular preparation with the moisture content less than or equal to 5%.

The granule 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 provides application of the extract or the granular preparation in preparing a medicine 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 further comprise a carrier material. Carrier materials include, but are not limited to, water soluble carrier materials (e.g., polyethylene glycol, polyvinylpyrrolidone, organic acids, etc.), poorly soluble carrier materials (e.g., ethylcellulose, cholesterol stearate, etc.), enteric carrier materials (e.g., cellulose acetate phthalate, carboxymethyl ethyl cellulose, 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 injection and the like. Can be common preparation, slow release preparation, controlled release preparation and various microparticle administration systems. For the purpose of shaping the unit dosage form into a tablet, various carriers known in the art can be widely used. Examples of carriers 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, etc.; humectants and binders such as water, glycerin, polyethylene glycol, ethanol, propanol, starch slurry, dextrin, syrup, honey, dextrose solution, acacia slurry, gelatin slurry, sodium carboxymethyl cellulose, shellac, methyl cellulose, potassium phosphate, polyvinylpyrrolidone, and the like; disintegrants such as dry starch, alginate, agar powder, brown algae starch, sodium bicarbonate and citric acid, calcium carbonate, polyoxyethylene, sorbitol fatty acid ester, sodium dodecyl sulfonate, methylcellulose, ethylcellulose, etc.; disintegration inhibitors such as sucrose, glyceryl tristearate, cocoa butter, hydrogenated oils and the like; absorption promoters such as quaternary ammonium salts, sodium lauryl sulfate, and the like; lubricants such as 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 bilayer and multilayer tablets. For the purpose of formulating the unit dosage form into a pill, various carriers well known in the art can be widely used. Examples of carriers are, for example, diluents and absorbents such as glucose, lactose, starch, cocoa butter, hydrogenated vegetable oils, polyvinylpyrrolidone, kaolin, talc, etc.; binders such as acacia, tragacanth, gelatin, ethanol, honey, liquid sugar, rice paste or batter, and the like; disintegrants such as agar powder, dry starch, alginate, sodium dodecyl sulfate, methylcellulose, ethylcellulose, etc. For preparing unit dosage forms into injectable preparations 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, polyoxyisostearyl alcohol, polyoxyethylene sorbitol fatty acid esters, etc. may be used. In addition, in order to prepare an isotonic injection, an appropriate amount of sodium chloride, glucose or glycerin may be added to the preparation for injection, and further, a conventional cosolvent, a buffer, a pH adjuster, and the like may be added. In addition, colorants, preservatives, flavors, flavoring agents, sweeteners, or other materials may also be added to the pharmaceutical formulation, if desired.

The invention also protects the application of the nine traditional Chinese medicine raw materials in preparing medicines for treating constipation; the nine traditional Chinese medicine raw materials and the proportion thereof are as follows: 10-40 parts of semen cassiae, 10-40 parts of cordate houttuynia, 10-40 parts of dandelion, 10-40 parts of cogongrass rhizome, 5-30 parts of medlar, 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 proportions thereof are as follows: 20-25 parts of semen cassiae, 20-25 parts of cordate houttuynia, 20-30 parts of dandelion, 20-30 parts of cogongrass rhizome, 20-30 parts of medlar, 30 parts of chrysanthemum, 20-30 parts of honeysuckle, 20-25 parts of purslane and 20-30 parts of allium macrostemon.

The nine traditional Chinese medicine raw materials and the proportions thereof are as follows: 20 parts of semen cassiae, 20 parts of cordate houttuynia, 30 parts of dandelion, 20 parts of cogongrass rhizome, 30 parts of medlar, 30 parts of chrysanthemum, 20 parts of honeysuckle, 20 parts of purslane and 30 parts of allium macrostemon.

The nine traditional Chinese medicine raw materials and the proportions thereof are as follows: 25 parts of semen cassiae, 25 parts of cordate houttuynia, 20 parts of dandelion, 30 parts of cogongrass rhizome, 20 parts of medlar, 30 parts of chrysanthemum, 25 parts of honeysuckle, 20 parts of purslane and 25 parts of allium macrostemon.

The nine traditional Chinese medicine raw materials and the proportions thereof are as follows: 25 parts of semen cassiae, 25 parts of cordate houttuynia, 30 parts of dandelion, 20 parts of cogongrass rhizome, 25 parts of medlar, 30 parts of chrysanthemum, 30 parts of honeysuckle, 25 parts of purslane and 20 parts of allium macrostemon.

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 disease or intestinal disease.

The traditional Chinese medicine formula provided by the invention comprises the following components: the cordate houttuynia, the chrysanthemum and the honeysuckle are used for clearing lung heat, dispersing lung qi, eliminating excessive heat of the large intestine and enhancing the large intestine conduction; the functions of regulating and nourishing spleen and stomach are realized through dandelion and cogongrass rhizome; the functions of liver and kidney are regulated and maintained by medlar, cogongrass rhizome and purslane; simultaneously, the allium macrostemon is used for activating yang, resolving masses, promoting qi and removing stagnation. Through the reasonable formulas, the above components act cooperatively, so that the symptoms of unbalanced functions of various viscera, qi deficiency and the like caused by constipation are solved, and the clinical effect of treating constipation is good.

The medicine provided by the invention has a good effect on constipation, has no adverse reaction, and has industrial popularization value.

Detailed Description

The following detailed description of the invention is provided in connection with the accompanying drawings that are presented to illustrate the invention and not to limit the scope thereof. The examples provided below are intended as guidelines for further modifications by one of ordinary skill in the art and are not to be construed as limiting the invention in any way.

The experimental methods in the following examples, unless otherwise specified, are conventional methods, and are carried out according to techniques or conditions described in the literature in the field or according to the product specifications. Materials, reagents and the like used in the examples described below are commercially available unless otherwise specified. Beta-cyclodextrin is a product of Huaxing biochemical industry Limited liability company in Monzhou, lot number 20210809. Maltodextrin was available from Shandong West Wang Tangye 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 medicinal materials (dry products) and all accord with the relevant regulations under each medicinal material item of a body part of Chinese pharmacopoeia (2020 edition). Before feeding, the identification shows that the physical objects of the medicinal materials conform to the names and the quality conforms to the standard.

The Chinese medicinal material semen Cassiae is dry mature seed of Leguminosae plant Concha Haliotidis Cassia obtusifolia L or semen Cassiae (Cassia obtusifolia) Cassia tora L. The herba Houttuyniae is fresh whole herb or dry aerial part of herba Houttuyniae Houttuynia cordata Thunb. The Chinese medicinal material herba Taraxaci is Taraxacum mongolicum hand-Mazz, taraxacum borealisinense Kitam, or dried whole herb of plants of the same genus. The Chinese medicinal material lalang grass rhizome is dried rhizome of grass Imperata cylindrica Beauv.var.major (Nees) C.E.Hubb. The Chinese medicinal material fructus Lycii is dried mature fruit of Lycium barbarum L. Of Solanaceae. The flos Chrysanthemi is dried head-like inflorescence of chrysanthemum Chrysanthemum morifolium Ramat. The Chinese medicinal material flos Lonicerae is dried flower bud or flower with primary opening of Lonicera japonica Lonicera japonica thunder. The herba Portulacae is dry aerial part of herba Portulacae Portulaca oleracea L. The Chinese medicinal material Bulbus Allii Macrostemi is dried bulb of Bulbus Allii Allium macrostemon Bge or Bulbus Allii Macrostemi Allium chinensis G.don of Liliaceae.

Example 1 obtaining of Chinese herbal formulation

In the theory of traditional Chinese medicine, constipation is related to dysfunction of the lung, spleen (stomach), liver and kidney, although the disease location is in the large intestine. The lung is exterior-interior-related with the large intestine, and the lung failing to disperse and descend leads to weak conduction of large intestine or lung heat to large intestine, resulting in excessive heat accumulation in large intestine; abnormal spleen deficiency and abnormal transportation and transformation can lead to internal arrest of dregs; excessive stomach heat consuming body fluids failing to moisten the intestines; liver qi stagnation, or long-term qi stagnation consuming fire and fluid, failing to smooth the viscera; kidneys govern water and drive urine, kidney yin is deficient, and intestinal tracts are not soft; constipation can be caused by deficiency of kidney yang failing to warm and unblock.

The inventor of the invention finally obtains the traditional Chinese medicine formula which can be widely applied to constipation people and has the best effect through a great amount of formula optimization (clinical effect verification).

The traditional Chinese medicine formula of the invention is as follows: 10-40 parts of semen cassiae, 10-40 parts of cordate houttuynia, 10-40 parts of dandelion, 10-40 parts of cogongrass rhizome, 5-30 parts of medlar, 10-40 parts of chrysanthemum, 10-40 parts of honeysuckle, 10-30 parts of purslane and 10-40 parts of allium macrostemon.

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 first traditional Chinese medicine formula: 20 parts of semen cassiae, 20 parts of cordate houttuynia, 30 parts of dandelion, 20 parts of cogongrass rhizome, 30 parts of medlar, 30 parts of chrysanthemum, 20 parts of honeysuckle, 20 parts of purslane and 30 parts of allium macrostemon.

And a traditional Chinese medicine formula II: 25 parts of semen cassiae, 25 parts of cordate houttuynia, 20 parts of dandelion, 30 parts of cogongrass rhizome, 20 parts of medlar, 30 parts of chrysanthemum, 25 parts of honeysuckle, 20 parts of purslane and 25 parts of allium macrostemon.

And the traditional Chinese medicine formula III: 25 parts of semen cassiae, 25 parts of cordate houttuynia, 30 parts of dandelion, 20 parts of cogongrass rhizome, 25 parts of medlar, 30 parts of chrysanthemum, 30 parts of honeysuckle, 25 parts of purslane and 20 parts of allium macrostemon.

Honeysuckle flower has cold nature and sweet taste, enters lung, heart and stomach channels, and has the effects of clearing heat and detoxicating, resisting inflammation, tonifying deficiency and treating wind; is a monarch drug. Herba Houttuyniae has effects of dispelling cold and lowering, clearing lung heat, eliminating dampness and treating stranguria; dandelion has the effects of resolving carbuncles and eliminating stagnation; both are ministerial drugs. Purslane is combined with cogongrass rhizome to moisten intestines and relieve constipation, dispel edema and damp-heat; is an adjuvant drug. Fructus Lycii has effects of nourishing liver and kidney. Xie Bai Zhen has the actions of activating blood because of its action of tonifying heart-yang and relieving qi stagnation in the chest and large intestine. Flos Chrysanthemi can dispel wind-heat and clear head and eyes. The medicines are used together, so that the medicine has the effects of cooling but not cold, relieving diarrhea, dispelling internal heat and tonifying.

Example 2 preparation of Chinese medicinal preparation

1. Preparation of extractum

1. The preparation method comprises the following steps of weighing the powder of each medicinal material according to a first traditional Chinese medicine formula: weighing 3kg of semen cassiae, 3kg of cordate houttuynia, 4.5kg of dandelion, 3kg of cogongrass rhizome, 4.5kg of medlar, 4.5kg of chrysanthemum, 3kg of honeysuckle, 3kg of purslane and 4.5kg of allium macrostemon, and mixing the materials together to obtain 33 kg. Each medicine was pulverized to obtain powder with particle diameter of 0.9mm or less before weighing.

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

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

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 and the temperature is 70 ℃) until the relative density is 1.05 (the relative density at 60 ℃), thus obtaining an extractum-like product, wherein the total amount of the extractum-like product is 38.6kg.

2. Preparation of granular formulations

6.6kg of auxiliary materials (the auxiliary materials consist of 1 part by mass of beta-cyclodextrin and 3 parts by mass of maltodextrin) are weighed and placed in a boiling granulating dryer, the temperature of an air inlet is regulated to 70-100 ℃, and the temperature of the auxiliary materials in a boiling bed is preheated to 45-60 ℃. And adding the prepared 38.6kg of extractum-shaped product into a feed liquid tank, uniformly stirring, adjusting the atomization pressure to have good atomization effect, and gradually spraying the extractum in the feed liquid tank onto the auxiliary materials boiling in the boiling bed by using a peristaltic pump. After spraying, the product obtained is granular preparation (moisture content is less than or equal to 5%) after drying is continued for about 20 minutes.

A total of 14.1kg of a granular formulation was obtained.

The granular formulation was packaged to a 4 g/bag gauge.

Example 3 evaluation of clinical Effect

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

The international roman IV diagnostic criteria for functional constipation are as follows:

(1) more than 25% of the defecation feel laborious;

(2) the defecation of more than 25% is dry feces ball or hard feces;

(3) more than 25% of the bowel movements have anorectal obstruction/blockage sensation;

(4) more than 25% of the bowel movements need assistance by manipulation (e.g. assisting the bowel movements with fingers and supporting the bottom of the basin);

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

Diagnostic criteria for functional constipation in the present invention: the subject has developed more than one symptom of roman IV diagnostic criteria for at least 6 months and has developed more than two symptoms of roman IV diagnostic criteria for approximately 3 months, i.e., is diagnosed as functional constipation.

Subject inclusion criteria (inclusion after all criteria were met at the same time): (1) age 18-65 years, and is not limited for men and women; (2) diagnosing functional constipation according to the above standard; (3) subjects informed consent and signed informed consent.

Subject exclusion criteria (meeting more than one, i.e., exclusion): (1) constipation caused by intestinal organic diseases such as intestinal stenosis caused by rectum and colon organic lesions (such as inflammatory bowel disease, tumor, colon polyp, intestinal tuberculosis, etc.); patients with constipation caused by anal lesions and constipation caused by other systemic organic lesions or drug factors; (2) secondary constipation of definite etiology; (3) irritable bowel syndrome or fecal occult blood positive; (4) pregnant or women preparing for gestation, women in the breast period; (5) a person who uses the medicine for treating functional constipation in a near week; (6) the subjects participated in other clinical trials within 1 month; (7) researchers consider other situations not likely to participate in this trial.

The criteria for grading and quantifying the main symptoms of constipation are shown in Table 1.

TABLE 1 Constipation main symptom grading quantification criteria

A total of 30 subjects. The time for the drug effect test was 12 weeks (12 weeks for continuous administration), 1 dose per day, and 1 bag of the granule preparation prepared in example 2 (taken after dissolution with 200ml of hot water) was used per subject.

The data were analyzed using the statistical software package minitab 15.0. The measurement data is firstly subjected to a normalization test, and the measurement data conforming to the normalization distribution is measured by means of average number plus or minus standard deviation

The comparison of the curative effects before and after treatment is carried out by adopting paired t test. P <0.05 is statistically significant for the differences.

After the completion of the drug efficacy test, the drug efficacy was evaluated. The drug effect evaluation is divided into three types of cure, effective and ineffective. And (3) curing: the constipation symptoms of patients basically disappear, the body constitution of the patients is removed, and the patients are moist, not dry and not astringent; zhou Pai the number of times of defecation is obviously increased, the feeling of defecation of patients is enhanced, the degree of defecation difficulty is reduced, the feeling of abdominal pain is reduced, appetite is increased, and physique is improved. The method is effective: the chronic constipation symptom of the patient is improved, the stool quality is improved, and the patient is not dry and astringent; the number of times of Zhou Pai feces is increased, the feces feeling of patients is enhanced compared with that of patients before administration, the difficulty degree of defecation is reduced, the abdominal pain feeling is reduced, and the appetite is increased. Invalidation: the constipation symptoms of the patient are not improved. Effective rate = cure rate + 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 efficacy

n	Healing	Effective and effective	Invalidation of	Total effective rate
					30	11	17	2	93.3％

The individual bowel movement indexes of the subjects were classified according to the constipation main symptom classification quantization standard before the initiation of the pharmacodynamic test (before the treatment) and after the completion of the pharmacodynamic test (after the treatment), and the results are shown in table 3. After 12 weeks of treatment, the constipation symptom observation indexes (defecation frequency, defecation time, fecal property and defecation effort) of the subjects are obviously improved compared with those before treatment, and the constipation symptom observation indexes have statistical significance (P < 0.05).

TABLE 3 changes in the observed indicators of constipation major symptoms in subjects before and after treatment

In the whole drug effect test process, 30 subjects have no obvious side effects such as anaphylactic reaction, diarrhea edema, blood pressure change and the like.

The present invention is described in detail above. It will be apparent to those skilled in the art that the present 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 respect to specific embodiments, it will be appreciated that the invention may 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 application of some of the basic features may be done in accordance with the scope of the claims that follow.

Claims (3)

1. A traditional Chinese medicine composition for treating constipation is characterized in that: the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by mass: 20-25 parts of semen cassiae, 20-25 parts of cordate houttuynia, 20-30 parts of dandelion, 20-30 parts of cogongrass rhizome, 20-30 parts of medlar, 30 parts of chrysanthemum, 20-30 parts of honeysuckle, 20-25 parts of purslane and 20-30 parts of allium macrostemon.

2. The use of the Chinese medicinal composition for treating constipation of claim 1 in the preparation of a medicament for treating constipation, which is characterized in that:

the preparation method of the extract comprises the following steps: mixing the nine traditional Chinese medicine raw materials, and extracting by adopting 70% ethanol solution to obtain an extract;

or preparing the traditional Chinese medicine composition into a granular preparation, wherein the preparation method comprises the following steps: drying and granulating the extract to obtain granule with water content below 5%.

3. A medicament for treating constipation, the active ingredient of which is an extract or a granular preparation prepared from the Chinese medicinal composition for treating constipation of claim 1;

the preparation method of the extract comprises the following steps: mixing the nine traditional Chinese medicine raw materials, and extracting by adopting 70% ethanol solution to obtain an extract;

the preparation method of the granular preparation comprises the following steps: drying and granulating the extract to obtain granule with water content below 5%.