CN106166196A - A kind of Chinese medicine composition treating chronic enteritis and preparation method thereof - Google Patents
A kind of Chinese medicine composition treating chronic enteritis and preparation method thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/11—Pteridophyta or Filicophyta (ferns)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/27—Asclepiadaceae (Milkweed family), e.g. hoya
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/42—Cucurbitaceae (Cucumber family)
- A61K36/428—Trichosanthes
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/66—Papaveraceae (Poppy family), e.g. bloodroot
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/85—Verbenaceae (Verbena family)
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A61K9/08—Solutions
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
The invention discloses a kind of Chinese medicine composition treating chronic enteritis, comprising: Radix Osbeckiae Crinitae, determine grass roots, Rhizoma Corydalis, Herba Verbenae, Folium Raphani, Herba Portulacae, Marsdenia, mountain tofu pudding, Herba Mimosae Pudicae, Flos jasmini, Radix Trichosanthis Cucumeroidis, the invention also discloses the preparation method of above-mentioned Chinese medicine composition.This kind of Chinese medicine composition is used to have the advantages such as good effect, low cost, cure rate is high, have no adverse reaction in terms for the treatment of chronic enteritis.The Chinese medicine of the present invention can play clearing away heat-damp and promoting diuresis, invigorating the spleen and regulating the stomach, warming YANG and invigorating QI, the effect of bowel relieving removing dampness, and determined curative effect, instant effect, has no side effect, and cure rate is higher according to clinical verification.
Description
Technical field
The present invention relates to a kind of medicinal preparation, particularly relate to a kind of Chinese medicine composition for treating chronic enteritis and
Preparation method.
Background technology
Chronic enteritis is the one in enteritis, and including chronic ulcerative enteronitis, clone disease etc., countries in the world have, and are
A kind of commonly encountered diseases and frequently-occurring disease, its unknown etiology as yet.Though there being multiple theory: such as infective agent, Nervous and Mental Factors, the factor of enzyme,
Inherited genetic factors, immune factor, the theory such as Protective substances shortage factor, but current development of medical sciences does not the most make affirmative
Conclusion.Epidemiological study result shows: the sickness rate of developed country is significantly larger than developing country, and city sickness rate is higher than agriculture
Village, the sickness rate of developed regions is higher than the area relatively fallen behind.Along with the development sickness rate of society is on the rise, chronic enteritis
Onset is mostly slow, starts diarrhoea, stomachache, and gradually increases the weight of, hemafecia and bloody purulent stool occurs, simultaneously with heating, weak, become thin
Deng, also have Acute onset, severe patient to have high heat, hyperhidrosis, progressive emaciation, sudden and violent originator can direct life-threatening, patient has body weight
Alleviate, pale complexion, the crissum inflammation that also can occur together or back of the body vertebra are scorching etc., mucous hyperemia seen from fiber colonoscopy, edema, ulcer and
Pseudopolyp is formed.Patient's protracted course of disease, course of disease elder, up to several 10 years, separately has about 3% generation canceration.At present, domestic external treatment
The method treating chronic enteritis is more, and such as western medicine method, common medicine has oxytetracycline, atropine, berberine, furazolidone etc.;As
Treatment by Chinese herbs method, common medicine has HUOXIANG ZHENGQI SHUI, GEGEN QINLIAN TANG etc..But, at cure rate, treatment means, medical expense etc.
Aspect is difficult to reach satisfied effect.
Therefore, need badly a kind of clearing away heat-damp and promoting diuresis of offer, invigorating the spleen and regulating the stomach, warming YANG and invigorating QI, bowel relieving removing dampness, determined curative effect, instant effect,
The Chinese medicine composition of the treatment chronic enteritis having no side effect.
Summary of the invention
In order to solve the problems referred to above, the present invention provides a kind of clearing away heat-damp and promoting diuresis, invigorating the spleen and regulating the stomach, warming YANG and invigorating QI, bowel relieving removing dampness, treatment
Effect is definite, instant effect, the Chinese medicine composition for the treatment of chronic enteritis that has no side effect.
The technical solution used in the present invention is: a kind of Chinese medicine composition treating chronic enteritis, described Chinese medicine composition
Each component is Radix Osbeckiae Crinitae, determine grass roots, Rhizoma Corydalis, Herba Verbenae, Folium Raphani, Herba Portulacae, Marsdenia, mountain tofu pudding, Herba Mimosae Pudicae, Flos jasmini,
Radix Trichosanthis Cucumeroidis.
Preferably, the ratio of weight and number of various components be Radix Osbeckiae Crinitae 25-35 part, determine grass roots 15-25 part, Rhizoma Corydalis 15-25 part,
Herba Verbenae 10-20 part, Folium Raphani 10-20 part, Herba Portulacae 5-15 part, Marsdenia 5-15 part, mountain tofu pudding 5-15 part, Herba Mimosae Pudicae 5-15
Part, Flos jasmini 5-15 part, Radix Trichosanthis Cucumeroidis 5-15 part.
It is furthermore preferred that the ratio of weight and number of various components is Radix Osbeckiae Crinitae 30-35 part, determines grass roots 20-25 part, Rhizoma Corydalis 20-25
Part, Herba Verbenae 10-15 part, Folium Raphani 10-15 part, Herba Portulacae 5-10 part, Marsdenia 5-10 part, mountain tofu pudding 5-10 part, Herba Mimosae Pudicae
5-10 part, Flos jasmini 5-10 part, Radix Trichosanthis Cucumeroidis 5-10 part.
Wherein, the dosage form of described Chinese medicine composition is: film coated tablet, sublimed preparation, plaster, syrup, oral liquid, suck
Agent, granule, powder, injection, sugar coated tablet, capsule.
Present invention also offers the preparation method of above-mentioned Chinese medicine composition, when the dosage form of described Chinese medicine is capsule, bag
Include:
The first step, determines grass roots, Rhizoma Corydalis is mixed in proportion, and is 70-80% with the determining alcohol being equivalent to mixture quality 2-3 times
Normal propyl alcohol reflux, extract, 2-4 time, merging filtrate, concentrating under reduced pressure, be dried and be ground into powder, subsequently with ethyl alcohol purification 1-2 time,
United extraction liquid, decompression recycling ethanol to be concentrated into relative density at 60 DEG C be the mastic of 1.21-1.24, it is dried and is ground into powder
End;
Second step, by the n-propanol extraction 2-3 that Herba Verbenae, Folium Raphani, Herba Portulacae, Marsdenia determining alcohol are 80-90%
Secondary, united extraction liquid, concentrating under reduced pressure is also dried, is ground into powder, and the powder addition after pulverizing relative to its quality is
The water dissolution of 2-4 times amount, static 1-3 hour, filters, and filtrate reduced in volume is that at 60 DEG C, relative density is the cream of 1.21-1.24
Body also dry, pulverize into powder;
3rd step, is ground into powder by remainder component and is mixed in proportion, boiling 2 times, each 2-3 hour, filters respectively,
Merging filtrate, filtrate is condensed into mastic and dry, pulverize into powder, and the quality of the water added is the mixture quality of the 3rd step
2-4 times;
4th step, mixes above-mentioned powder and starch, carries out pelletization treatment subsequently and be dried, obtaining compound particles, then
Adding magnesium stearate in compound particles, described magnesium stearate and described compound particles mass ratio are 0.25-100:
0.5-100, it is thus achieved that capsule 's content, loads described capsule 's content in capsule housing and i.e. obtains capsule.
Present invention also offers the preparation method of above-mentioned Chinese medicine composition, when the dosage form of described Chinese medicine is injection, bag
Include:
The first step, determines grass roots, Rhizoma Corydalis is mixed in proportion, and is 70-80% with the determining alcohol being equivalent to mixture quality 2-3 times
Normal propyl alcohol reflux, extract, 2-4 time, merging filtrate, concentrating under reduced pressure, be dried and be ground into powder, subsequently with ethyl alcohol purification 1-2 time,
United extraction liquid, decompression recycling ethanol to be concentrated into relative density at 60 DEG C be the mastic of 1.21-1.24, it is dried and is ground into powder
End;
Second step, by the n-propanol extraction 2-3 that Herba Verbenae, Folium Raphani, Herba Portulacae, Marsdenia determining alcohol are 80-90%
Secondary, united extraction liquid, concentrating under reduced pressure is also dried, is ground into powder, and the powder addition after pulverizing relative to its quality is
The water dissolution of 2-4 times amount, static 1-3 hour, filters, and filtrate reduced in volume is that at 60 DEG C, relative density is the cream of 1.21-1.24
Body also dry, pulverize into powder;
3rd step, is ground into powder by remainder component and is mixed in proportion, boiling 2 times, each 2-3 hour, filters respectively,
Merging filtrate, filtrate is condensed into mastic and dry, pulverize into powder, and the quality of the water added is the mixture quality of the 3rd step
2-4 times;
4th step, mixes above-mentioned powder, is dissolved in the water that quality is 2-4 times of mixture subsequently, adds phase under stirring
For the sodium hydroxide hydrotropy of powder quality 5%-15%, filtering, adding the salt acid for adjusting pH value that concentration is 1mol/L is 5-6, mistake
Filter, precipitates standby, and filtrate passes through polyamide column, first washes decontamination with water, washes with the normal propyl alcohol that determining alcohol is 80-90% subsequently
De-, collect normal propyl alcohol eluent, precipitation determining alcohol is the n-propanol extraction 2 times of 80-90%, filters, filtrate and above-mentioned eluting
Liquid merges, and reclaims normal propyl alcohol, is evaporated to mastic and is spray dried to powder, adding the powder of acquisition relative to its quality 1-
The sodium chloride of 2 times and water for injection are appropriate, further inject water to the volume needed, filter, embedding, go out after dissolving
Bacterium, it is thus achieved that the injection of needs.
Radix Osbeckiae Crinitae, sour-puckery flavor, cold nature, nontoxic, clearing away heat-damp and promoting diuresis, cough-relieving, regulating menstruation.For acute gastroenteritis, bacillary dysentery
Disease, dyspepsia, chronic bronchitis, spit blood, menoxenia, leucorrhea.
Determining grass roots, acrid in the mouth, sweet, property is put down, removing damp-heat, blood circulation promoting and blood stasis dispelling, relieving cough and resolving phlegm, diuresis lactogenesis.For rheumatalgia,
Enteritis, dysentery, urinary tract infection, cough with copious phlegm, traumatic injury, spit blood, metrorrhagia, galactostasis;Fracture, traumatic hemorrhage are controlled in external.
Rhizoma Corydalis has another name called Rhizoma Corydalis, Rhizoma Corydalis, for Papaveraceae Corydalis herbaceos perennial, with the Rhizoma Atractylodis Macrocephalae, Radix Paeoniae, Bulbus Fritillariae Uninbracteatae etc. also
Claim " eight Zhe's ", for large conventional Chinese medicine.Rhizoma Corydalis history is loaded in " Kaibao Bencao ", warm in nature, and acrid in the mouth is bitter, enters the heart, spleen, liver, lung, is alive
Blood blood stasis dispelling, the quality goods of promoting the circulation of QI to relieve pain, be world-famous for effect of pain relieving especially.Li Shizhen (1518-1593 A.D.) concludes Rhizoma Corydalis in Compendium of Material Medica to be had
" invigorate blood circulation, regulate the flow of vital energy, pain relieving, diuresis " four large effects, and praise highly Rhizoma Corydalis " can the stagnation of QI in promoting the circulation of blood, stasis in gas, therefore specially control with
Under all pains ".
Herba Verbenae, bitter in the mouth, cold nature, heat-clearing and toxic substances removing, preventing the attack (or recurrence) of malaria parasite killing, inducing diuresis to remove edema, stimulate the menstrual flow dissipating blood stasis.Curing mainly: malaria, blood is inhaled
Parasitosis, filaricide, cat fever, acute gastroenteritis, bacillary dysentery, hepatitis, cirrhotic ascites, oedema due to nephritis, urinary tract infection,
Scrotum swells and ache, menoxenia, blood stasis amenorrhea, periodontitis, diphtheria, laryngopharynx swelling and pain;Traumatic injury, furuncle swelling toxin are controlled in external.
Herba Portulacae, sour in the mouth, cold in nature, clearing away heat-damp and promoting diuresis, removing pathogenic heat from blood and toxic substance from the body.For bacillary dysentery, acute gastroenteritis, acute vermiform appendix
Inflammation, mastitis, bleeding hemorrhoids, leucorrhea;Furuncle swelling toxin, eczema, herpes zoster are controlled in external.
Folium Raphani, helps digestion and quenches the thirst, thermal detoxification of dispelling.Curing mainly fullness in the chest vexed, two sides of body are made swollen, change stagnant, alcoholic intoxication.
Marsdenia, strengthening bone and muscle, stomach invigorating profit intestinal.
Mountain tofu pudding, sweet in the mouth, property is flat, spleen invigorating qi-restoratives.
Herba Mimosae Pudicae, sweet in the mouth, puckery, cool in nature, clearing away heat and promoting diuresis, preventing phlegm from forming and stopping coughing, ataralgesia.For catching a cold, infantile hyperpyrexia, acute
Conjunctivitis, bronchitis, gastritis, enteritis, urinary system calculus, malaria, neurasthenia;Treating swelling and pain by traumatic injury, sore swollen toxin are controlled in external.
Flos jasmini, bitter in the mouth, property is flat, circulation of qi promoting menstruction regulating and pain relieving, heat clearing away eliminating stagnation.For having a stomachache, hepatitis, menoxenia, dysmenorrhea, band
Under, stomatitis, skin itching, orchitis, mastitis, tuberculous lymphadenitis.
Radix Trichosanthis Cucumeroidis, bitter in the mouth, cold in nature, heat-clearing and toxic substances removing, inducing diuresis to remove edema, eliminating stasis to stop pain.For venom, acute tonsil
Inflammation, pharyngolaryngitis, ulcerative carbuncle toxic swelling, traumatic injury, dysuria, stomachache.
Beneficial effects of the present invention:
Relative to the medicine with treatment chronic enteritis effect of the prior art, use this kind of Chinese medicine composition in treatment
Chronic enteritis aspect has the advantages such as good effect, low cost, cure rate is high, have no adverse reaction.The Chinese medicine of the present invention can play
Clearing away heat-damp and promoting diuresis, invigorating the spleen and regulating the stomach, warming YANG and invigorating QI, the effect of bowel relieving removing dampness, and determined curative effect, instant effect, have no side effect, through clinic
Checking cure rate is higher.
Detailed description of the invention
Embodiment 1:
(1) a kind of Chinese medicine treating chronic enteritis, is formed by following raw material medicaments in part by weight proportioning:
Radix Osbeckiae Crinitae 30 parts, determine grass roots 25 parts, Rhizoma Corydalis 20 parts, Herba Verbenae 15 parts, Folium Raphani 15 parts, Herba Portulacae 10 parts, milk
Dish 10 parts, mountain tofu pudding 10 parts, Herba Mimosae Pudicae 10 parts, Flos jasmini 5 parts, Radix Trichosanthis Cucumeroidis 5 parts.
(2) preparation method:
The first step, determines grass roots, Rhizoma Corydalis is mixed in proportion, and is 70% just with the determining alcohol being equivalent to mixture quality 2 times
Propanol reflux, extract, 2 times, merging filtrate, concentrating under reduced pressure, it is dried and is ground into powder, subsequently with ethyl alcohol purification 1-2 time, merging carries
Take liquid, decompression recycling ethanol to be concentrated into relative density at 60 DEG C be the mastic of 1.21-1.24, it is dried and is ground into powder;
Second step, by the n-propanol extraction 2-3 that Herba Verbenae, Folium Raphani, Herba Portulacae, Marsdenia determining alcohol are 80-90%
Secondary, united extraction liquid, concentrating under reduced pressure is also dried, is ground into powder, and it is 2 that the powder after pulverizing adds relative to its quality
The water dissolution of times amount, static 1 hour, filters, and filtrate reduced in volume is that at 60 DEG C, relative density is the mastic of 1.21-1.24 and does
Dry, it is ground into powder;
3rd step, is ground into powder by remainder component and is mixed in proportion, boiling 2 times, each 2 hours, filters respectively, closes
And filtrate, filtrate is condensed into mastic and dry, pulverize into powder, and the quality of the water added is the mixture quality of the 3rd step
2 times;
4th step, mixes above-mentioned powder and starch, carries out pelletization treatment subsequently and be dried, obtaining compound particles, then
Adding magnesium stearate in compound particles, described magnesium stearate and described compound particles mass ratio are 0.25:0.5, obtain
Obtain capsule 's content, capsule 's content loading capsule housing that will be described i.e. obtains capsule.
Embodiment 2:
(1) a kind of Chinese medicine treating chronic enteritis, is formed by following raw material medicaments in part by weight proportioning: with embodiment 1.
(2) preparation method:
The first step, determines grass roots, Rhizoma Corydalis is mixed in proportion, and is 70% just with the determining alcohol being equivalent to mixture quality 2 times
Propanol reflux, extract, 2 times, merging filtrate, concentrating under reduced pressure, it is dried and is ground into powder, subsequently with ethyl alcohol purification 1 time, united extraction
Liquid, decompression recycling ethanol to be concentrated into relative density at 60 DEG C be the mastic of 1.21-1.24, it is dried and is ground into powder;
Second step, by n-propanol extraction that Herba Verbenae, Folium Raphani, Herba Portulacae, Marsdenia determining alcohol are 80% 2 times, closes
And extracting solution, concentrating under reduced pressure is also dried, is ground into powder, and it is 2 times amount that the powder after pulverizing adds relative to its quality
Water dissolution, static 1 hour, filter, filtrate reduced in volume is that at 60 DEG C, relative density is the mastic of 1.21-1.24 and is dried,
It is ground into powder;
3rd step, is ground into powder by remainder component and is mixed in proportion, boiling 2 times, each 2 hours, filters respectively, closes
And filtrate, filtrate is condensed into mastic and dry, pulverize into powder, and the quality of the water added is the mixture quality of the 3rd step
2 times;
4th step, mixes above-mentioned powder, is dissolved in the water that quality is 2 times of mixture subsequently, and stirring is lower to add relatively
In the sodium hydroxide hydrotropy of powder quality 5%, filtering, adding the salt acid for adjusting pH value that concentration is 1mol/L is 5-6, filters, precipitation
Standby, filtrate passes through polyamide column, first washes decontamination with water, subsequently with the normal propyl alcohol eluting that determining alcohol is 80, collects normal propyl alcohol
Eluent, precipitation determining alcohol is the n-propanol extraction 2 times of 80, filters, and filtrate merges with above-mentioned eluent, recovery normal propyl alcohol,
It is evaporated to mastic and is spray dried to powder, the powder of acquisition is added the sodium chloride relative to its quality 2 times and injection
Water is appropriate, further injects water to the volume needed, filter, embedding, sterilizing, it is thus achieved that the injection of needs after dissolving.
Embodiment 3:
1, long term toxicity test process:
Experimental agents is set as by application Wistar rat (Beijing Vital River Experimental Animals Technology Co., Ltd.'s offer)
High, medium and low three dosage, respectively capsule 8g/kg, 4g/kg, 2g/kg of embodiment 1 formula.Dosage 0.1g/ is used by people
Kg/ sky-backing calculates, and is 80 times of people's effective dose, 40 times and 20 times respectively;Separately set a matched group, continuous gastric infusion 90
My god, after 180 days and Some Animals drug withdrawal 10 days, observe physiology every on rat, the impact of biochemical indicator.Test result indicate that:
Increase all without affecting to rat continuous oral 180 days, food-intake and body weight on rat by various dose.To hepatic and renal function the most not
Find overt toxicity effect.Routine blood test, blood biochemistry, urine biochemistry and bone marrow sheet etc. are showed no and significantly affect, with right between each group
No significant difference is compared according to group.
2, acute toxicity test process:
Application ICR mice (Beijing Vital River Experimental Animals Technology Co., Ltd.'s offer) 40, body weight at 25-30 gram,
Carry out acute toxicity testing.Mice is randomly divided into two groups, i.e. matched group, administration group, fasting 12 hours before experiment, then give as
Chinese medicine capsules suspension (capsule the is dissolved in water acquisition suspension) gavage of the present invention that embodiment 1 prepares,
To the median lethal dose(LD 50) (LD being administered50) carry out test determination, but do not measure LD50, therefore carried out mtd test.
Result: with Cmax (60%), maximum dosage-feeding (120ml/kg, in a day, part gives for four times) 100g/kg gavage, be equivalent to
Crude drug amount 60g/kg, is equivalent to clinical 300 times (by the 75kg) intending daily dosage that are grown up, and in seven days, none death of mice, puts to death
The each internal organs of mice anatomic observation do not find toxic reaction, and administration group and control group mice are without any difference.
Embodiment 4:
The clinical treatment observation of the present invention is as follows:
(1) patient 240 example, 120 examples are women, and 120 examples are male.
(2) diagnostic criteria:
Diagnostic criteria: carry out clinical diagnosis with reference to the diagnosis basis in " internal medicine ":
1) during outbreak, occurring that diarrhoea, stomachache etc., disease then present chronic malnutrition for a long time, physical examination can have abdominal tenderness;
2) leukocyte seen from stool routine examination, erythrocyte and a small amount of pus cell, stool cultivation can find pathogenic bacterium;3) agent of x-ray barium check and
Colonoscopy can get rid of other specificity enteritiies.
(3) Therapeutic Method: 1 group: use the capsule 100g prepared such as embodiment 1 preparation method, be divided into 10 parts, every day
Morning, (medicine) being taken before meal was a, within 30 days, is a course for the treatment of, takes two courses for the treatment of continuously;2 groups: use such as embodiment 2 preparation method system
The injection 100g obtained, is divided into 10 parts, and every morning, injection portion on an empty stomach, 30 days was a course for the treatment of, injected two courses for the treatment of continuously;
Separately set a matched group.
(4) efficacy assessment standard:
Criterion of therapeutical effect:
Overall efficacy evaluation is with reference to " new Chinese medicine guideline of clinical investigations " relevant criterion:
Cure: Clinical symptom and sign disappears, recover normal;
Effective: Clinical symptom and sign substantially or mostly disappears;
Invalid: Clinical symptom and sign is without improving.
(5) therapeutic outcome is shown in Table 1:
Table 1 therapeutic outcome
Group | Recovery from illness | Effectively | Invalid |
Matched group | 0 | 5 | 75 |
1 group | 77 | 2 | 1 |
2 groups | 79 | 1 | 0 |
Above-described embodiment simply to illustrate that the technology design of the present invention and feature, its objective is to be to allow in this area
Those of ordinary skill will appreciate that present disclosure and implements according to this, can not limit the scope of the invention with this.All
It is the change according to the equivalence done by the essence of present invention or modification, all should contain in protection scope of the present invention.
Claims (6)
1. the Chinese medicine composition treating chronic enteritis, it is characterised in that: each component of described Chinese medicine composition be Radix Osbeckiae Crinitae,
Determine grass roots, Rhizoma Corydalis, Herba Verbenae, Folium Raphani, Herba Portulacae, Marsdenia, mountain tofu pudding, Herba Mimosae Pudicae, Flos jasmini, Radix Trichosanthis Cucumeroidis..
2. Chinese medicine composition as claimed in claim 1, it is characterised in that: the ratio of weight and number of various components is Radix Osbeckiae Crinitae 25-
35 parts, determine grass roots 15-25 part, Rhizoma Corydalis 15-25 part, Herba Verbenae 10-20 part, Folium Raphani 10-20 part, Herba Portulacae 5-15 part, milk
Dish 5-15 part, mountain tofu pudding 5-15 part, Herba Mimosae Pudicae 5-15 part, Flos jasmini 5-15 part, Radix Trichosanthis Cucumeroidis 5-15 part.
3. Chinese medicine composition as claimed in claim 1, it is characterised in that: the ratio of weight and number of various components is Radix Osbeckiae Crinitae 30-
35 parts, determine grass roots 20-25 part, Rhizoma Corydalis 20-25 part, Herba Verbenae 10-15 part, Folium Raphani 10-15 part, Herba Portulacae 5-10 part, milk
Dish 5-10 part, mountain tofu pudding 5-10 part, Herba Mimosae Pudicae 5-10 part, Flos jasmini 5-10 part, Radix Trichosanthis Cucumeroidis 5-10 part.
4. as according to any one of claim 1-3, treat the Chinese medicine composition of chronic enteritis, it is characterised in that described Chinese drug-treated group
The dosage form of compound is: film coated tablet, sublimed preparation, plaster, syrup, oral liquid, suck agent, granule, powder, injection,
Sugar coated tablet, capsule.
5. as according to any one of claim 1-3, treat a preparation method for the Chinese medicine composition of chronic enteritis, its feature
It is: when the dosage form of described Chinese medicine is capsule, including:
The first step, determines grass roots, Rhizoma Corydalis is mixed in proportion, with the determining alcohol being equivalent to mixture quality 2-3 times be 70-80% just
Propanol reflux, extract, 2-4 time, merging filtrate, concentrating under reduced pressure, it is dried and is ground into powder, subsequently with ethyl alcohol purification 1-2 time, merging
Extracting solution, decompression recycling ethanol to be concentrated into relative density at 60 DEG C be the mastic of 1.21-1.24, it is dried and is ground into powder;
Second step, by n-propanol extraction that Herba Verbenae, Folium Raphani, Herba Portulacae, Marsdenia determining alcohol are 80-90% 2-3 time, closes
And extracting solution, concentrating under reduced pressure is also dried, is ground into powder, and the powder addition after pulverizing is 2-4 times relative to its quality
The water dissolution of amount, static 1-3 hour, filters, and filtrate reduced in volume is that at 60 DEG C, relative density is the mastic of 1.21-1.24 and does
Dry, it is ground into powder;
3rd step, is ground into powder by remainder component and is mixed in proportion, boiling 2 times, each 2-3 hour, filters respectively, merges
Filtrate, filtrate is condensed into mastic and dry, pulverize into powder, and the quality of the water added is the 2-of the mixture quality of the 3rd step
4 times;
4th step, mixes above-mentioned powder and starch, carries out pelletization treatment subsequently and be dried, and obtains compound particles, then to mixed
Adding magnesium stearate in polymer beads, described magnesium stearate and described compound particles mass ratio are 0.25-100:0.5-
100, it is thus achieved that capsule 's content, described capsule 's content is loaded in capsule housing and i.e. obtains capsule.
6. as according to any one of claim 1-3, treat a preparation method for the Chinese medicine composition of chronic enteritis, its feature
It is: when the dosage form of described Chinese medicine is injection, including:
The first step, determines grass roots, Rhizoma Corydalis is mixed in proportion, with the determining alcohol being equivalent to mixture quality 2-3 times be 70-80% just
Propanol reflux, extract, 2-4 time, merging filtrate, concentrating under reduced pressure, it is dried and is ground into powder, subsequently with ethyl alcohol purification 1-2 time, merging
Extracting solution, decompression recycling ethanol to be concentrated into relative density at 60 DEG C be the mastic of 1.21-1.24, it is dried and is ground into powder;
Second step, by n-propanol extraction that Herba Verbenae, Folium Raphani, Herba Portulacae, Marsdenia determining alcohol are 80-90% 2-3 time, closes
And extracting solution, concentrating under reduced pressure is also dried, is ground into powder, and the powder addition after pulverizing is 2-4 times relative to its quality
The water dissolution of amount, static 1-3 hour, filters, and filtrate reduced in volume is that at 60 DEG C, relative density is the mastic of 1.21-1.24 and does
Dry, it is ground into powder;
3rd step, is ground into powder by remainder component and is mixed in proportion, boiling 2 times, each 2-3 hour, filters respectively, merges
Filtrate, filtrate is condensed into mastic and dry, pulverize into powder, and the quality of the water added is the 2-of the mixture quality of the 3rd step
4 times;
4th step, mixes above-mentioned powder, is dissolved in the water that quality is 2-4 times of mixture subsequently, stirring is lower add relative to
The sodium hydroxide hydrotropy of powder quality 5%-15%, filters, and adding the salt acid for adjusting pH value that concentration is 1mol/L is 5-6, filters, heavy
Forming sediment standby, filtrate passes through polyamide column, first washes decontamination with water, subsequently with the normal propyl alcohol eluting that determining alcohol is 80-90%, collects
Normal propyl alcohol eluent, precipitation determining alcohol is the n-propanol extraction 2 times of 80-90%, filters, and filtrate merges with above-mentioned eluent,
Reclaim normal propyl alcohol, be evaporated to mastic and be spray dried to powder, the powder of acquisition is added the chlorine relative to its quality 1-2 times
Change sodium and water for injection is appropriate, further inject water to the volume needed after dissolving, filter, embedding, sterilizing, it is thus achieved that need
The injection wanted.
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CN102764359A (en) * | 2012-07-18 | 2012-11-07 | 唐启裕 | Traditional Chinese medicine for treating enteritis and dysentery |
CN103394011A (en) * | 2013-08-10 | 2013-11-20 | 李万胜 | Chinese medicinal preparation for treating acute gastroenteritis |
CN103505629A (en) * | 2013-08-31 | 2014-01-15 | 宋景戈 | Traditional Chinese medicine composition for treating acute gastroenteritis |
CN105250808A (en) * | 2015-10-20 | 2016-01-20 | 黄培龙 | Traditional Chinese medicine composition for treating chronic enteritis |
CN105727144A (en) * | 2016-04-03 | 2016-07-06 | 张鸿 | Traditional Chinese medicine composition for treating bronchitis and preparation method thereof |
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2016
- 2016-10-09 CN CN201610879374.4A patent/CN106166196A/en not_active Withdrawn
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102764359A (en) * | 2012-07-18 | 2012-11-07 | 唐启裕 | Traditional Chinese medicine for treating enteritis and dysentery |
CN103394011A (en) * | 2013-08-10 | 2013-11-20 | 李万胜 | Chinese medicinal preparation for treating acute gastroenteritis |
CN103505629A (en) * | 2013-08-31 | 2014-01-15 | 宋景戈 | Traditional Chinese medicine composition for treating acute gastroenteritis |
CN105250808A (en) * | 2015-10-20 | 2016-01-20 | 黄培龙 | Traditional Chinese medicine composition for treating chronic enteritis |
CN105727144A (en) * | 2016-04-03 | 2016-07-06 | 张鸿 | Traditional Chinese medicine composition for treating bronchitis and preparation method thereof |
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