CN111789924A

CN111789924A - Chinese medicinal compound preparation for treating gastrointestinal diseases and preparation method thereof

Info

Publication number: CN111789924A
Application number: CN201910214518.8A
Authority: CN
Inventors: 金兆祥; 王琳; 张宇; 王玉晶; 范迪; 郭琳
Original assignee: Letrentang Pharmaceutical Factory Of Tianjin Zhongxin Pharmaceutical Group Co ltd
Current assignee: Letrentang Pharmaceutical Factory Of Tianjin Zhongxin Pharmaceutical Group Co ltd; Lerentang Pharmaceutical Factory of Tianjin Zhongxin Pharmaceutical Group Co Ltd
Priority date: 2019-03-20
Filing date: 2019-03-20
Publication date: 2020-10-20

Abstract

The invention provides a traditional Chinese medicine compound preparation for treating gastrointestinal diseases and a preparation method thereof, and relates to the technical field of traditional Chinese medicine preparations. The traditional Chinese medicine compound preparation mainly comprises 5-15 parts of costustoot, 5-15 parts of agilawood, 1-5 parts of sandalwood, 10-20 parts of fructus amomi, 5-20 parts of fructus aurantii, 5-20 parts of mangnolia officinalis, 1-10 parts of ligusticum wallichii, 1-5 parts of rheum officinale, 1-5 parts of defatted croton seed powder, 10-20 parts of coptis chinensis, 30-50 parts of Chinese date and 0.1-1 part of musk; and any pharmaceutically acceptable auxiliary materials, and has the advantages of quick response, wide indication and no toxic or side effect.

Description

Chinese medicinal compound preparation for treating gastrointestinal diseases and preparation method thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine compound preparation for treating gastrointestinal diseases and a preparation method thereof.

Background

Diarrhea is a common symptom of many diseases. Normal adults defecate 1 time a day, become brownish yellow in color, and have a small amount of mucus attached. The diarrhea is clinically manifested by increased defecation and decreased stool dilution, and more than 3 times per day or more than 200-300 g/d defecation amount.

The major hazards of diarrhea are: diarrhea can cause water electrolyte imbalance and acid-base balance disorder, and can cause dehydration, acidosis and other hazards in severe cases; ② diarrhea can lead to malnutrition; third, the long-term diarrhea can cause the energy supply deficiency, so as to cause symptoms of mental fatigue, palpitation, short breath, dizziness and the like; fourthly, the diarrhea can cause anemia, vitamin deficiency and resistance reduction due to the indigestion and malabsorption.

The conventional medicines for treating diarrhea are mainly western medicines which contain antibiotics, but the diarrhea is not all infectious diarrhea caused by pathogenic microorganisms, the non-infectious diarrhea is not suitable for the antibiotic medicines, only 30% of diarrhea patients in China need the antibiotics for treatment, and the western medicines are strong in pertinence and have no universality compared with the traditional Chinese medicines. According to traditional Chinese medicine, diarrhea is mainly caused by the viscera in the spleen, stomach, large intestine and small intestine. The pathogenic factors are mainly caused by external wind pathogen, improper diet, emotional impairment, and weak zang-fu organs. Due to various causes of diarrhea, the effect of using western medicines to treat diarrhea is quite different. Therefore, a widely-used traditional Chinese medicine compound preparation for treating diarrhea is needed in the market at present.

In view of the above, the present invention is particularly proposed.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine compound preparation for treating gastrointestinal diseases, and solves the technical problem that a traditional Chinese medicine compound preparation capable of effectively relieving gastrointestinal diseases is lacked in the prior art.

The second purpose of the invention is to provide a preparation method of the traditional Chinese medicine compound preparation for treating gastrointestinal diseases.

In order to solve the technical problems, the invention adopts the following technical scheme:

a traditional Chinese medicine compound preparation for treating gastrointestinal diseases is mainly prepared from the following raw materials in parts by weight:

5-15 parts of costustoot, 5-15 parts of agilawood, 1-5 parts of sandalwood, 10-20 parts of fructus amomi, 5-20 parts of fructus aurantii, 5-20 parts of mangnolia officinalis, 1-10 parts of ligusticum wallichii, 1-5 parts of rheum officinale, 1-5 parts of defatted croton seed powder, 10-20 parts of coptis chinensis, 30-50 parts of Chinese date and 0.1-1 part of musk; and any pharmaceutically acceptable auxiliary material.

Preferably, the traditional Chinese medicine compound preparation is mainly prepared from the following raw materials in parts by weight: 8-10 parts of costustoot, 8-10 parts of agilawood, 2-4 parts of sandalwood, 15-18 parts of fructus amomi, 10-15 parts of fructus aurantii, 12-15 parts of mangnolia officinalis, 2-8 parts of ligusticum wallichii, 2-4 parts of rheum officinale, 2-4 parts of defatted croton seed powder, 15-18 parts of coptis chinensis, 40-45 parts of Chinese date and 0.35-0.55 part of musk; and any pharmaceutically acceptable auxiliary material.

More preferably, the traditional Chinese medicine compound preparation is mainly prepared from the following raw materials in parts by weight: 9.5 parts of costustoot, 8.5 parts of agilawood, 3 parts of sandalwood, 15.5 parts of fructus amomi, 12 parts of fructus aurantii, 14.5 parts of mangnolia officinalis, 5 parts of ligusticum wallichii, 3 parts of rheum officinale, 2.5 parts of defatted croton seed powder, 16 parts of coptis chinensis, 40 parts of Chinese date and 0.5 part of musk; and any pharmaceutically acceptable auxiliary material.

Preferably, the fructus aurantii is bran-fried fructus aurantii; and/or the magnolia officinalis is ginger-fried magnolia officinalis; and/or the Chinese dates are pitted Chinese dates.

Preferably, the pharmaceutically acceptable excipients include one or more of binders, excipients, disintegrants, coating agents, stabilizers, lubricants, buffers, sustained release agents, controlled release agents, diluents, glidants, co-solvents, surfactants, absorption enhancers, sweeteners, flavoring agents, colorants and pharmaceutical carriers.

Preferably, the traditional Chinese medicine compound preparation is an oral preparation.

Preferably, the oral formulation is selected from the following dosage forms: dripping pill, tablet, honeyed pill, solution, soft extract, syrup, granule or capsule.

The invention also provides a preparation method of the traditional Chinese medicine compound preparation, which comprises the following steps: mixing radix aucklandiae, lignum Aquilariae Resinatum, lignum Santali albi, fructus Amomi, fructus Aurantii, cortex Magnolia officinalis, rhizoma Ligustici Chuanxiong, radix et rhizoma Rhei, semen crotonis Pulveratum, Coptidis rhizoma, fructus Jujubae and Moschus according to formula ratio to obtain the compound preparation.

Preferably, the traditional Chinese medicine compound preparation is a dropping pill, and the dropping pill is prepared by the following method: preparing the components of the first group into powder respectively; preparing the components of the second group into powder respectively; grinding the powder of the component in the second group and the powder of the component in the first group, mixing the ground powder and the molten matrix uniformly, dropping the mixture into a coolant when the temperature is reduced to 75-85 ℃, and cooling to obtain the dripping pill;

the first group comprises semen crotonis Pulveratum and Moschus; the second group comprises radix aucklandiae, lignum Aquilariae Resinatum, lignum Santali albi, fructus Amomi, fructus Aurantii, cortex Magnolia officinalis, rhizoma Ligustici Chuanxiong, radix et rhizoma Rhei, Coptidis rhizoma and fructus Jujubae.

Preferably, the matrix comprises polyethylene glycol 4000, polyethylene glycol 6000, polyethylene glycol 8000, poloxamer, sodium carboxymethylcellulose, stearic acid or sodium stearate; and/or the coolant comprises liquid paraffin, silicone oil or vegetable oil.

Compared with the prior art, the invention has the following beneficial effects:

the invention provides a traditional Chinese medicine compound preparation for treating gastrointestinal diseases, which mainly comprises the following functional components of costustoot, agilawood, sandalwood, fructus amomi, fructus aurantii, mangnolia officinalis, ligusticum wallichii, rheum officinale, defatted croton seed powder, coptis chinensis, Chinese date and musk. The Chinese medicinal compound preparation can be used for treating irritable bowel syndrome, acute diarrhea, bacillary dysentery, enteronitis and lientery. The Chinese medicinal compound preparation has quick action and wide adaptation diseases when used for treating gastrointestinal diseases, and can be used for treating infectious diarrhea and non-infectious diarrhea; the diarrhea symptom can be relieved, and the symptoms such as abdominal distension, bellyache and weakness accompanied by diarrhea can be relieved; the traditional Chinese medicine compound preparation has low side effect, and the preparation raw materials do not contain mercury-containing components such as cinnabar and the like, so that constipation can not be caused while diarrhea is relieved. The preparation method of the traditional Chinese medicine compound preparation for treating gastrointestinal diseases provided by the invention is simple to operate and is suitable for wide application.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the following embodiments, and it should be understood that the described embodiments are some, but not all, embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.

It should be noted that:

in the present invention, all the embodiments and preferred methods mentioned herein can be combined with each other to form a new technical solution, if not specifically stated.

In the present invention, all the technical features mentioned herein and preferred features may be combined with each other to form a new technical solution, if not specifically stated.

In the present invention, the percentage (%) or parts means the weight percentage or parts by weight with respect to the composition, if not otherwise specified.

In the present invention, the components referred to or the preferred components thereof may be combined with each other to form a novel embodiment, if not specifically stated.

In the present invention, unless otherwise stated, the numerical range "a-b" represents a shorthand representation of any combination of real numbers between a and b, where a and b are both real numbers. For example, a numerical range of "6 to 22" means that all real numbers between "6 to 22" have been listed herein, and "6 to 22" is simply a shorthand representation of the combination of these values.

The "ranges" disclosed herein may have one or more lower limits and one or more upper limits, respectively, in the form of lower limits and upper limits.

In the present invention, unless otherwise specified, the individual reactions or operation steps may be performed sequentially or may be performed in sequence. Preferably, the reaction processes herein are carried out sequentially.

Unless otherwise defined, technical and scientific terms used herein have the same meaning as is familiar to those skilled in the art. In addition, any methods or materials similar or equivalent to those described herein can also be used in the present invention.

The invention provides a Chinese medicinal compound preparation for treating gastrointestinal diseases, which mainly comprises costustoot, agilawood, sandalwood, fructus amomi, fructus aurantii, mangnolia officinalis, ligusticum wallichii, rheum officinale, defatted croton seed powder, coptis chinensis, Chinese date and musk; and any pharmaceutically acceptable auxiliary materials.

The dosages of costustoot, agilawood, sandalwood, fructus amomi, fructus aurantii, mangnolia officinalis, ligusticum wallichii, rheum officinale, defatted croton seed powder, coptis chinensis, Chinese date and musk are as follows:

5-15 parts of costustoot, typically but not limited to 5 parts, 6 parts, 6.5 parts, 7 parts, 8.5 parts, 9 parts, 9.5 parts, 10 parts, 11 parts, 12.5 parts, 13 parts, 14 parts, 14.5 parts or 15 parts. Radix aucklandiae is pungent and bitter in flavor and warm in nature, and has the effects of promoting qi circulation, relieving pain, invigorating spleen and promoting digestion.

5-15 parts of agilawood, typically but not limited to 5 parts, 6 parts, 6.5 parts, 7 parts, 8.5 parts, 9 parts, 9.5 parts, 10 parts, 11 parts, 12.5 parts, 13 parts, 14 parts, 14.5 parts or 15 parts. Chenxiang is pungent, bitter and slightly warm in flavor, and has the effects of promoting qi circulation, relieving pain, warming middle energizer, relieving vomiting, absorbing qi and relieving asthma.

1-5 parts of sandalwood, typically but not limited to 1 part, 2 parts, 3 parts, 4 parts or 5 parts. Sandalwood is pungent and warm in flavor. Has effects in promoting qi circulation, warming middle warmer, stimulating appetite, and relieving pain.

10-20 parts of fructus amomi, typically but not limited to 10 parts, 11 parts, 12.5 parts, 13 parts, 14 parts, 14.5 parts, 15 parts, 15.5 parts, 16 parts, 17 parts, 18 parts, 18.5 parts, 19 parts or 20 parts. Fructus Amomi is pungent and warm in flavor, and has effects of eliminating dampness, stimulating appetite, warming spleen, relieving diarrhea, regulating qi-flowing, and preventing miscarriage.

5-20 parts of fructus aurantii, typically but not limited to 5 parts, 6 parts, 6.5 parts, 7 parts, 8.5 parts, 9 parts, 9.5 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 14.5 parts, 15 parts, 15.5 parts, 16 parts, 17 parts, 18 parts, 18.5 parts, 19 parts or 20 parts. The bitter orange is bitter, pungent and sour in taste and slightly cold in nature, and has the functions of regulating qi, relieving epigastric distention, activating stagnancy and relieving distension. Preferably, fructus Aurantii is parched with bran, and the fructus Aurantii is prepared by parching with bran to dark color by bran parching method (general rule 0213).

5-20 parts of magnolia officinalis, typically but not limited to 5 parts, 6 parts, 6.5 parts, 7 parts, 8.5 parts, 9 parts, 9.5 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 14.5 parts, 15 parts, 15.5 parts, 16 parts, 17 parts, 18 parts, 18.5 parts, 19 parts or 20 parts. Magnolia officinalis is bitter, pungent and warm in taste, and has the effects of eliminating dampness and phlegm, descending qi and relieving fullness. Preferably, cortex Magnolia officinalis processed with ginger is prepared by parching shredded cortex Magnolia officinalis with ginger juice (Tong rule 0213) to dry.

1-10 parts of ligusticum wallichii, typically but not limited to 1 part, 2 parts, 3 parts, 4 parts, 6 parts, 6.5 parts, 7 parts, 8.5 parts, 9 parts, 9.5 parts or 10 parts. Chuan Xiong is pungent and warm in flavor, and has the functions of promoting blood circulation, activating qi-flowing, dispelling wind and relieving pain.

1-5 parts of rhubarb, typically but not limited to 1 part, 2 parts, 3 parts, 4 parts or 5 parts. The rhubarb is bitter in taste and cold in nature, and has the functions of purging and eliminating accumulation, clearing heat and purging fire, cooling blood and removing toxicity, removing blood stasis and stimulating the menstrual flow, and promoting diuresis and removing jaundice.

1-5 parts of croton cream, typically but not limited to 1 part, 2 parts, 2.5 parts, 3 parts, 4 parts or 5 parts. Croton cream is pungent and hot, and has the functions of drastically purging cold accumulation, eliminating edema, eliminating phlegm and relieving sore throat.

10-20 parts of coptis chinensis, typically but not limited to 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 14.5 parts, 15 parts, 15.5 parts, 16 parts, 17 parts, 18 parts, 18.5 parts, 19 parts or 20 parts. Coptis root, rhizoma Coptidis is bitter and cold in taste, and has the effects of clearing heat, eliminating dampness, purging pathogenic fire and removing toxic substance.

30-50 parts of Chinese dates, typically but not limited to 30 parts, 31 parts, 33 parts, 35 parts, 36 parts, 38 parts, 40 parts, 42.5 parts, 45 parts, 48 parts or 50 parts. The Chinese dates are sweet in taste and warm in nature, and have the effects of tonifying middle-jiao and Qi, nourishing blood and soothing nerves. The fructus Jujubae is preferably pitted fructus Jujubae.

Musk 0.1-1 part, typically but not limited to 0.1 part, 0.2 part, 0.3 part, 0.35 part, 0.4 part, 0.5 part, 0.55 part, 0.6 part, 0.7 part, 0.8 part, 0.9 part or 1 part. Musk is pungent and warm in flavor, and has effects of inducing resuscitation, refreshing mind, promoting blood circulation, dredging channels, and relieving swelling and pain.

The pharmaceutically acceptable auxiliary material is approved by medicine management departments of various countries in the world and can be used for medicine production and manufacturing. Pharmaceutical adjuvants do not themselves produce biologically or otherwise undesirable substances, nor do they produce biologically or otherwise undesirable substances and biological effects with the active ingredient of the medicament when the pharmaceutical adjuvant is mixed with or co-administered to a patient as an active substance having a therapeutic effect.

The term "optionally" refers to that the compound preparation may or may not contain pharmaceutically acceptable auxiliary materials, and may also contain one or more pharmaceutically acceptable auxiliary materials.

Wherein the pharmaceutical excipients typically, but not by way of limitation, may include one or more of binders, excipients, disintegrants, coatings, stabilizers, lubricants, buffers, sustained release agents, controlled release agents, diluents, fluidizing agents, cosolvents, surfactants, absorption enhancers, sweeteners, flavoring agents, colorants, and pharmaceutical carriers.

Examples of the disintegrant include, but are not limited to, hydroxypropylcellulose, sodium carboxymethyl starch, calcium carboxymethyl starch, croscarmellose sodium, or low substituted hydroxypropylcellulose, etc.; examples of such binders include, but are not limited to, hydroxypropylcellulose, hydroxypropylmethylcellulose, pregelatinized starch, polyvinylpyrrolidone, syrup or starch syrup, and the like; examples of such excipients include, but are not limited to, mannitol, sucrose, lactose, dextrin, xylitol, microcrystalline cellulose, sorbitol, corn starch, or anhydrous calcium phosphate, and the like; examples of such fillers include, but are not limited to, powdered sugar, starch, lactose, calcium carbonate or sulfate, and the like; examples of such lubricants include, but are not limited to, magnesium stearate, calcium stearate, zinc stearate, sodium benzoate, talc, magnesium lauryl sulfate, sodium stearyl fumarate, aerosil, aluminum silicate, magnesium oxide or magnesium carbonate, and the like; examples of the coating agent include, but are not limited to, polyvinyl alcohol, hydroxypropylmethylcellulose, polyethylene glycol, polysorbate, talc, or the like; examples of the surfactant include, but are not limited to, polysorbate, sodium lauryl sulfate, polyoxyethylene hydrogenated castor oil, and the like; examples of such sweeteners include, but are not limited to, aspartame, saccharin sodium, starch syrup, fructose, or the like.

The traditional Chinese medicine compound preparation for treating gastrointestinal diseases provided by the invention can eliminate turbid pathogen with aromatics, regulate qi to alleviate pain, remove food retention and remove food stagnation, invigorate spleen to arrest diarrhea, arrest diarrhea and dysentery, and stop bloody dysentery, and can be used for treating irritable bowel syndrome, acute diarrhea, bacillary dysentery, enteritis and lienteric diarrhea. The Chinese medicinal compound preparation has quick action and wide adaptation diseases when used for treating gastrointestinal diseases, and can be used for treating infectious diarrhea and non-infectious diarrhea; the diarrhea symptom can be relieved, and the symptoms such as abdominal distension, bellyache and weakness accompanied by diarrhea can be relieved; the traditional Chinese medicine compound preparation has low side effect, and the preparation raw materials do not contain mercury-containing components such as cinnabar and the like, so that constipation can not be caused while diarrhea is relieved.

The treatment effect of the traditional Chinese medicine composition can be further improved by adjusting the dosage of costustoot, agilawood, sandalwood, fructus amomi, fructus aurantii, mangnolia officinalis, ligusticum wallichii, rheum officinale, defatted croton seed powder, coptis chinensis, Chinese date and musk in the compound preparation, and in some preferred embodiments, the traditional Chinese medicine compound preparation is mainly prepared from the following raw materials in parts by weight: 8-10 parts of costustoot, 8-10 parts of agilawood, 2-4 parts of sandalwood, 15-18 parts of fructus amomi, 10-15 parts of fructus aurantii, 12-15 parts of mangnolia officinalis, 2-8 parts of ligusticum wallichii, 2-4 parts of rheum officinale, 2-4 parts of defatted croton seed powder, 15-18 parts of coptis chinensis, 40-45 parts of Chinese date and 0.35-0.55 part of musk. In some more preferable embodiments, the compound traditional Chinese medicine preparation is mainly prepared from the following raw materials in parts by weight: 9.5 parts of costustoot, 8.5 parts of agilawood, 3 parts of sandalwood, 15.5 parts of fructus amomi, 12 parts of fructus aurantii, 14.5 parts of mangnolia officinalis, 5 parts of ligusticum wallichii, 3 parts of rheum officinale, 2.5 parts of defatted croton seed powder, 16 parts of coptis chinensis, 40 parts of Chinese date and 0.5 part of musk

The traditional Chinese medicine compound preparation provided by the invention is preferably an oral dosage form, wherein the oral dosage form comprises the following dosage forms: dripping pill, tablet, honeyed pill, solution, soft extract, syrup, granule or capsule. The oral preparation has the advantages of quick action, and convenient storage, carrying and administration.

The invention also provides a preparation method of the traditional Chinese medicine compound preparation, and the preparation method comprises the step of mixing elecampane, agilawood, sandalwood, fructus amomi, fructus aurantii, mangnolia officinalis, ligusticum wallichii, rheum officinale, defatted croton seed powder, coptis chinensis, Chinese date and musk according to the formula amount to obtain the traditional Chinese medicine compound preparation. According to the preparation method provided by the invention, the components can be directly mixed according to the formula amount to obtain a compound preparation; or processing the raw materials into active ingredients, and adding pharmaceutically acceptable adjuvants to make into compound preparation. Optionally, the active ingredients are prepared respectively and independently from the components, and then are mixed according to the formula amount; alternatively, all or part of the components can be mixed according to the formula amount and then the active ingredients are prepared together, and then the Chinese herbal compound preparation is prepared by further adding. The Chinese medicinal compound preparation has multiple effects of inhibiting intestinal peristalsis, sterilizing, diminishing inflammation, regulating qi, relieving diarrhea and the like, can treat diarrhea from outside to inside, and has the advantages of quick response, safety, no side effect and convenient administration.

In a specific embodiment, the traditional Chinese medicine compound preparation is prepared into a dripping pill, and can be prepared according to the following method: respectively grinding clove, sandalwood, bitter orange, rhizoma atractylodis, scutellaria baicalensis, rheum officinale, defatted croton seed powder, musk, Chinese date and ligusticum wallichii into fine powder, mixing the fine powder and the ground powder, uniformly mixing the mixture with a molten substrate, dropping the mixture into a coolant when the temperature is reduced to 75-85 ℃, and cooling to obtain the dropping pill. Wherein, optionally, the matrix comprises polyethylene glycol 4000, polyethylene glycol 6000, polyethylene glycol 8000, poloxamer, sodium carboxymethylcellulose, stearic acid or sodium stearate; optionally, the coolant comprises liquid paraffin, silicone oil or vegetable oil.

In a specific embodiment, the Chinese herbal compound preparation is prepared into tablets, and can be prepared according to the following method:

the technical solution and the advantages of the present invention will be further explained with reference to the preferred embodiments.

Example 1

The embodiment provides a water pill for treating gastrointestinal diseases, which mainly comprises the following raw materials:

50g of costustoot, 150g of agilawood, 10g of sandalwood, 200g of fructus amomi, 50g of fructus aurantii stir-fried with bran, 200g of ginger-fried mangnolia officinalis, 10g of ligusticum wallichii, 50g of rheum officinale, 10g of defatted croton seed powder, 200g of coptis chinensis, 300g of pitted Chinese date and 10g of musk; respectively pulverizing the above materials into fine powder, mixing semen crotonis Pulveratum and Moschus, adding into the mixed powder of semen crotonis Pulveratum and Moschus, sieving, making into pill with water, drying at low temperature, polishing, and drying in the shade.

Example 2

150g of costustoot, 50g of agilawood, 50g of sandalwood, 100g of fructus amomi, 200g of fructus aurantii stir-fried with bran, 50g of ginger-fried mangnolia officinalis, 100g of ligusticum wallichii, 10g of rheum officinale, 50g of defatted croton seed powder, 100g of coptis chinensis, 500g of pitted Chinese date and 1g of musk; the preparation method is the same as example 1.

Example 3

80g of costustoot, 100g of agilawood, 20g of sandalwood, 180g of fructus amomi, 100g of fructus aurantii stir-fried with bran, 150g of ginger-fried mangnolia officinalis, 20g of ligusticum wallichii, 40g of rheum officinale, 20g of defatted croton seed powder, 180g of coptis chinensis, 400g of pitted Chinese date and 5.5g of musk; the preparation method is the same as example 1.

Example 4

100g of costustoot, 80g of agilawood, 40g of sandalwood, 150g of fructus amomi, 150g of bran-fried fructus aurantii, 120g of ginger-fried mangnolia officinalis, 80g of ligusticum wallichii, 20g of rheum officinale, 40g of defatted croton seed powder, 150g of coptis chinensis, 450g of pitted Chinese date and 3.5g of musk; the preparation method is the same as example 1.

Example 5

95g of costustoot, 85g of agilawood, 30g of sandalwood, 150g of fructus amomi, 120g of fructus aurantii stir-fried with bran, 145g of ginger-fried mangnolia officinalis, 50g of ligusticum wallichii, 30g of rheum officinale, 25g of defatted croton seed powder, 160g of coptis chinensis, 400g of pitted Chinese date and 5g of musk; the preparation method is the same as example 1.

Comparative example 1

The comparative example provides a water-bindered pill for treating gastrointestinal diseases, which comprises the following main raw materials:

25g of costustoot, 200g of agilawood, 10g of sandalwood, 250g of fructus amomi, 25g of fructus aurantii stir-fried with bran, 250g of ginger-fried mangnolia officinalis, 10g of ligusticum wallichii, 100g of rheum officinale, 5g of defatted croton seed powder, 250g of coptis chinensis, 150g of pitted Chinese date and 15g of musk; the preparation method is the same as example 1.

Comparative example 2

200g of costustoot, 25g of agilawood, 75g of sandalwood, 50g of fructus amomi, 250g of fructus aurantii stir-fried with bran, 25g of ginger-fried mangnolia officinalis, 120g of ligusticum wallichii, 5g of rheum officinale, 75g of defatted croton seed powder, 50g of coptis chinensis, 600g of pitted Chinese date and 1g of musk; the preparation method is the same as example 1.

Comparative example 3

This comparative example provides a water-bindered pill for treating gastrointestinal diseases, which is different from example 1 in that aucklandia root is not contained.

Comparative example 4

This comparative example provides a water-bindered pill for treating gastrointestinal diseases, which is different from example 1 in that it does not contain agilawood.

Comparative example 5

This comparative example provides a water-bindered pill for treating gastrointestinal diseases, which is different from example 1 in that sandalwood is not contained.

Comparative example 6

This comparative example provides a water-bindered pill for treating gastrointestinal diseases, which is different from example 1 in that fructus amomi is not contained.

Comparative example 7

This comparative example provides a watered pill for the treatment of gastrointestinal disorders which differs from example 1 in that bran-fried bitter orange is not present.

Comparative example 8

This comparative example provides a water-bindered pill for treating gastrointestinal diseases, which is different from example 1 in that it does not contain magnolia officinalis roasted with ginger.

Comparative example 9

This comparative example provides a water-bindered pill for treating gastrointestinal diseases, which is different from example 1 in that it does not contain chuanxiong rhizome.

Comparative example 10

This comparative example provides a water-bindered pill for treating gastrointestinal diseases, which is different from example 1 in that rhubarb is not contained.

Comparative example 11

This comparative example provides a water-bindered pill for treating gastrointestinal diseases, which is different from example 1 in that croton cream is not contained; the preparation method comprises the following steps: pulverizing the above materials into fine powder, respectively, mixing radix et rhizoma Rhei and Moschus, adding into the mixed powder of radix et rhizoma Rhei and Moschus gradually by grinding, sieving, making into pill with water, drying at low temperature, polishing, and drying in the shade.

Comparative example 12

This comparative example provides a water-bindered pill for treating gastrointestinal diseases, which is different from example 1 in that it does not contain coptis chinensis.

Comparative example 13

This comparative example provides a water-bindered pill for treating gastrointestinal diseases, which is different from example 1 in that jujube having no pit removed is not contained.

Comparative example 14

This comparative example provides a water-bindered pill for treating gastrointestinal diseases, which is different from example 1 in that musk is not contained. The preparation method comprises the following steps: pulverizing the above materials into fine powder, respectively, mixing the powders, sieving, making into pill with water, drying at low temperature, polishing, and drying in the shade.

Effect example 1

Experimental animals: SPF grade ICR mice, weight 18 ~ 22g, are all male. The test group comprises a normal animal control group, a model control group, a positive control group and an experimental group.

Experimental reagent:

the neostigmine injection is prepared into a solution with the concentration of 0.03mg/mL by using physiological saline, the injection dose is 0.1mL/20g, and the injection is performed subcutaneously.

5% ink solution: 100g of Arabic gum and 800mL of water are mixed uniformly, boiled to be transparent, 50g of activated carbon powder is boiled for 3 times, cooled to room temperature, and added with water to reach the constant volume of 1000 mL.

Suspension of trimebutine maleate tablets: commercially available trimebutine maleate tablets with 0.1 g/tablet of active ingredients are crushed to prepare 40mg/mL suspension, the administration dose is 100mg/kg, and the intragastric administration is 0.5 mL.

Suspension of water pill: the water pills provided by examples 1-5 and comparative examples 1-14 are respectively crushed into powder, and are prepared into 100mg/mL suspension by using distilled water, the administration dosage is 2.5g/kg, and the intragastric administration is 0.5 mL.

The administration scheme is as follows: normal animal control group was given physiological saline of equal volume only; the model control group is only given the same volume of physiological saline except for the injection of neostigmine injection; the positive control group is given with 1 time of trimebutine maleate suspension; the test groups were given the suspensions prepared in each example and comparative example twice with a time interval of 2 h. After 1h of the last administration, the subcutaneous injection of neostigmine was removed from the normal animal control group.

And (3) after the mice are injected with Xinsidmin for 15min, the mice are subjected to intragastric administration with 5% ink solution, the animals are killed after 20min, and the animals are subjected to depallegation, the length of the small intestine from the pylorus to the ileocecal part and the distance from the carbon powder to the pylorus from the front end of the intestinal tract are measured. Carbon-end propulsion rate ═ carbon-end propulsion distance/small intestine length (%), the results are shown in table 1:

TABLE 1 mouse carbon dust propelling test results

Effect example 2

The water pellets of examples 1 to 5 and comparative examples 1 to 15 were pulverized into powder, and prepared into a suspension with a concentration of 0.16g/mL using distilled water. 1mg/mL of compound dinonol ester physiological saline solution was used as a positive control.

Selecting Kunming mice and SPF-level experimental animals, weighing 20 +/-2 g, randomly grouping, feeding 6 mice in each group, feeding physiological saline to a control group, feeding compound dinonol ester with the dosage of 25mg/kg to a positive control group, and feeding 0.5mL of compound dinonol ester physiological saline solution to a stomach; the experimental group was dosed at 2.5g/kg and the gavage administered 0.5mL of a suspension of the watered pills of each of the above groups of examples and comparative examples. One hour after the administration, each group of mice was re-gavaged with 50mL/kg of castor oil, and then the mice were placed in a box to observe the total number of wet feces discharged from the mice for 4 hours to investigate the antidiarrheal effect. The results are shown in table 2:

TABLE 2 Effect of examples and comparative examples on Castor oil induced diarrhea in mice

According to the experimental data, the compound preparation provided by the application can effectively relieve diarrhea, improve the intestinal propulsion function and relieve the irritable bowel syndrome of mice induced by neostigmine. As can be seen from the comparison between the example 5 and the comparative examples 3 to 14, the compound preparation provided by the application has reasonable selection of the raw material medicines, the lack of one of the raw material medicines can affect the treatment effect of the compound preparation on gastrointestinal diseases, and as can be seen from the comparison between the examples 1 to 5, the formula amount of the raw material medicines is adjusted to optimize the matching relationship among the components, so that the treatment effect of the compound preparation can be further optimized; as can be seen from comparison between examples 1-5 and comparative examples 1-2, the dosage of each raw material provided by the invention is more reasonable, and the treatment effect is more excellent; and from the treatment effects among the above examples, it can be found that the dosage effect of each raw material provided in example 5 is optimal.

Example 7

The embodiment provides a compound preparation for treating gastrointestinal diseases, which comprises the following main raw materials: 95g of costustoot, 85g of agilawood, 30g of sandalwood, 150g of fructus amomi, 120g of fructus aurantii stir-fried with bran, 145g of ginger-fried mangnolia officinalis, 50g of ligusticum wallichii, 30g of rheum officinale, 25g of defatted croton seed powder, 160g of coptis chinensis, 400g of pitted Chinese date and 5g of musk; respectively crushing the components into fine powder, uniformly mixing the croton cream and the musk, then gradually adding the croton cream and the musk into the mixed powder of the croton cream and the musk by a proportioning and grinding method, sieving, uniformly mixing 100g of the mixed powder with 3400g of starch, granulating by using starch slurry, sieving, drying, adding 6 per mill of magnesium stearate, uniformly mixing, pressing into tablets, and coating with a film coating to obtain the tablets.

Example 8

The embodiment provides a compound preparation for treating gastrointestinal diseases, which comprises the following main raw materials: 90g of costustoot, 80g of agilawood, 30g of sandalwood, 150g of fructus amomi, 130g of fructus aurantii stir-fried with bran, 145g of ginger-fried mangnolia officinalis, 50g of ligusticum wallichii, 35g of rheum officinale, 20g of defatted croton seed powder, 160g of coptis chinensis, 400g of pitted Chinese date and 5g of musk; the preparation method comprises the steps of respectively crushing the components into fine powder, uniformly mixing the croton cream and the musk, then gradually adding the croton cream and the musk into the mixed powder of the croton cream and the musk by a proportioning and grinding method, sieving, uniformly mixing 100g of the mixed powder with 3000g of starch, granulating with starch slurry, sieving, drying and encapsulating to obtain the capsule.

Example 9

The embodiment provides a compound preparation for treating gastrointestinal diseases, which comprises the following main raw materials: 100g of costustoot, 80g of agilawood, 30g of sandalwood, 150g of fructus amomi, 120g of bran-fried fructus aurantii, 150g of ginger-fried mangnolia officinalis, 50g of ligusticum wallichii, 25g of rheum officinale, 25g of defatted croton seed powder, 160g of coptis chinensis, 400g of pitted Chinese date and 5g of musk; respectively pulverizing the above components into fine powder, mixing semen crotonis Pulveratum and Moschus uniformly, adding the above components and components into the mixed powder of semen crotonis Pulveratum and Moschus gradually by grinding, sieving, mixing with 4150g of polyethylene glycol-6000 at about 100 deg.C, adding the powder into molten polyethylene glycol-6000 slowly, stirring, dropping into liquid paraffin by a multi-head dropping pill machine with a weight of 40mg when the temperature is reduced to about 80 deg.C, collecting the dropping pill in coolant, wiping, air drying, selecting and bottling.

Example 10

The embodiment provides a compound preparation for treating gastrointestinal diseases, which comprises the following main raw materials: 95g of costustoot, 85g of agilawood, 40g of sandalwood, 145g of fructus amomi, 120g of bran-fried fructus aurantii, 145g of ginger-fried mangnolia officinalis, 50g of ligusticum wallichii, 30g of rheum officinale, 25g of defatted croton seed powder, 155g of coptis chinensis, 400g of pitted Chinese date and 5g of musk; respectively pulverizing semen crotonis Pulveratum and Moschus into powder, decocting the rest materials in water for 2 times, each for two hours, mixing decoctions, filtering, concentrating into soft extract, adding semen crotonis Pulveratum and Moschus powder into the soft extract, mixing to obtain mixture, mixing the mixture with molten polyethylene glycol-6000, dripping into liquid paraffin with a multi-head dripping pill machine with pill weight of 40mg, collecting dripping pills in coolant, wiping, air drying, selecting and bottling.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine compound preparation for treating gastrointestinal diseases is characterized by being mainly prepared from the following raw materials in parts by weight:

2. The compound traditional Chinese medicine preparation as claimed in claim 1, which is prepared from the following raw materials in parts by weight:

8-10 parts of costustoot, 8-10 parts of agilawood, 2-4 parts of sandalwood, 15-18 parts of fructus amomi, 10-15 parts of fructus aurantii, 12-15 parts of mangnolia officinalis, 2-8 parts of ligusticum wallichii, 2-4 parts of rheum officinale, 2-4 parts of defatted croton seed powder, 15-18 parts of coptis chinensis, 40-45 parts of Chinese date and 0.35-0.55 part of musk; and any pharmaceutically acceptable auxiliary material.

3. The compound traditional Chinese medicine preparation as claimed in claim 2, which is prepared from the following raw materials in parts by weight:

9.5 parts of costustoot, 8.5 parts of agilawood, 3 parts of sandalwood, 15.5 parts of fructus amomi, 12 parts of fructus aurantii, 14.5 parts of mangnolia officinalis, 5 parts of ligusticum wallichii, 3 parts of rheum officinale, 2.5 parts of defatted croton seed powder, 16 parts of coptis chinensis, 40 parts of Chinese date and 0.5 part of musk; and any pharmaceutically acceptable auxiliary material.

4. The compound Chinese medicinal preparation according to any one of claims 1 to 3, wherein the fructus Aurantii is bran-parched fructus Aurantii; and/or the magnolia officinalis is ginger-fried magnolia officinalis; and/or the Chinese dates are pitted Chinese dates.

5. The compound Chinese medicinal preparation according to any one of claims 1 to 3, wherein the pharmaceutically acceptable excipients comprise one or more of a binder, an excipient, a disintegrant, a coating agent, a stabilizer, a lubricant, a buffering agent, a sustained-release agent, a controlled-release agent, a diluent, a glidant, a cosolvent, a surfactant, an absorption enhancer, a sweetener, a flavoring agent, a coloring agent and a pharmaceutical carrier.

6. The compound Chinese medicinal preparation according to any one of claims 1 to 3, wherein the compound Chinese medicinal preparation is an oral preparation.

7. The compound traditional Chinese medicine preparation as claimed in claim 6, wherein the oral preparation is selected from the following dosage forms: dripping pill, tablet, honeyed pill, solution, soft extract, syrup, granule or capsule.

8. The method for preparing a compound Chinese medicinal preparation according to any one of claims 1 to 7, wherein the compound Chinese medicinal preparation is prepared by mixing radix aucklandiae, lignum Aquilariae Resinatum, lignum Santali albi, fructus Amomi, fructus Aurantii, cortex Magnolia officinalis, rhizoma Ligustici Chuanxiong, radix et rhizoma Rhei, semen crotonis Pulveratum, Coptidis rhizoma, fructus Jujubae and Moschus according to the formula.

9. The preparation method of claim 8, wherein the compound Chinese medicinal preparation is a drop pill, and the drop pill is prepared by the following steps: preparing the components of the first group into powder respectively; preparing the components of the second group into powder respectively; grinding the powder of the component in the second group and the powder of the component in the first group, mixing the ground powder and the molten matrix uniformly, dropping the mixture into a coolant when the temperature is reduced to 75-85 ℃, and cooling to obtain the dripping pill;

10. The method of claim 8, wherein the matrix comprises polyethylene glycol 4000, polyethylene glycol 6000, polyethylene glycol 8000, poloxamer, sodium carboxymethyl cellulose, stearic acid or sodium stearate; and/or the coolant comprises liquid paraffin, silicone oil or vegetable oil.