CN105796654A - Traditional Chinese medicine composition for treating diarrhea irritable bowel syndrome, navel paste and application - Google Patents

Traditional Chinese medicine composition for treating diarrhea irritable bowel syndrome, navel paste and application Download PDF

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CN105796654A
CN105796654A CN201610209222.3A CN201610209222A CN105796654A CN 105796654 A CN105796654 A CN 105796654A CN 201610209222 A CN201610209222 A CN 201610209222A CN 105796654 A CN105796654 A CN 105796654A
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bowel syndrome
irritable bowel
chinese medicine
medicine composition
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CN105796654B (en
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张静泽
陈钰玲
郑虹
陈虹
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LOGISTICS COLLEGE OF CHINESE ARMED POLICE FORCE
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/285Aucklandia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/61Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

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Abstract

The invention discloses traditional Chinese medicine composition for treating a diarrhea irritable bowel syndrome, navel paste and an application. The composition is prepared from 1-10 parts by mass of a common aucklandia root extract and 1-10 parts by mass of clove volatile oil. The composition, particularly the navel paste containing the composition, enables medicines to take effect in vivo, and the volatile component of the navel paste plays a role in aromatherapy and has in-vitro regulating effects including emotion calming and mental relaxing, so that inhibition of smooth-muscle movement of an isolated rat and inhibition of muscle movement of a mouse both produce a synergistic interaction function; the anti-diarrhea effect is better than that produced during the independent use of thecommon aucklandia root extract or the clove volatile oil, an obvious improvement effect on diarrhea is achieved, the effect is remarkable, and the purpose of treating the irritable bowel syndrome is achieved.

Description

Treatment diarrhea type irritable bowel syndrome Chinese medicine composition and umbilicus paste and application
Technical field
The invention belongs to technical field of Chinese medicines, more particularly to a kind of preparation method treating diarrhea type irritable bowel syndrome Chinese medicine composition extract and umbilicus patch and application.
Background technology
Showing according to World Health Organization's survey result in 2013, diarrhoea is to cause the second largest reason of less than five years old death of child, there are about less than 760,000 five years old child every year and dies from diarrhoeal diseases, and the whole world there are about 1,700,000,000 example diarrhea patients every year.Diarrhoea, stomachache, distension and fullness in the abdomen, food stagnation, infantile dyspepsia, enteritis, bacillary dysentery are gastrointestinal tract common disease, and how due to eating and drinking without temperance, exopathogen is attacked, caused by impairing the spleen and stomach.The common sympton of diarrhoea (diarrhea), refers to that defecation frequency is significantly more than the frequency being on ordinary days accustomed to, and excrement matter is thin, and moisture increases, or containing not digesting food or pus and blood, mucus.Occur the patient of diarrhoea often simultaneously with stomachache, distension and fullness in the abdomen, food stagnation, infantile dyspepsia;Sometimes being also possible to can with symptoms such as heating, vomitings.Irritable bowel syndrome (Irritablebowelsyndrome, IBS) it is a kind of common chronic functional gastrointestinal disease, lifting manipulation for modern medicine, theory of Chinese medical science there is no this concept, it is classified as stomachache, diarrhoea or the category of constipation, however cause stomachache, the many factors of this kind of digestive system disease of suffering from diarrhoea, mechanism is also intricate.Doctor trained in Western medicine thinks that the generation of IBS is abnormal with digestive tract power, visceral sensitivity is abnormal, infect and alteration of intestinal flora, brain-gut axis effect exception and Nervous and Mental Factors are relevant, and the traditional Chinese medical science thinks that this disease is feelings will impairing the liver, the irritability stasis of blood is stagnant and causes that dysfunction of the spleen in transportation or inherent weakness of the spleen and stomach or eating and drinking without temperance cause injuring caused by spleen soil.
For treatment, for the medicine of diarrhea-type IBS mostly based on symptomatic treatment, such as 5-HT receptor blocking agent, calcium ion antagonist, somatostatin class medicine, cholinolytic class medicine etc., these medicines can effectively improve the symptoms such as stomachache, diarrhoea, constipation, but there is more toxic and side effects, unsuitable prolonged application.The treatment of Chinese medicine is little, persistent with " integrally-regulated " for primary and secondary effect, can accomplish giving consideration to both the incidental and fundamental, while antidiarrheal, regulates gastrointestinal tract.
Umbilical region administration is easier to drug absorption than other application method, and bioavailability is high, and umbilical part depression forms crypts, medicine paste conformal becomes natural closure state, and medicine is able to the long period and deposits, and it is more lasting to absorb, enter blood circulation and lymphsystem, play medicine whole body therapeutic effect.It it is one of the best mode of human administration especially child administration.The research of U.S. Y.W.chien shows, medicine through the bioavailability of umbilical region administration is forearm administration 1-6 times.
The Radix Aucklandiae, Flos Caryophylli are as stomach warming circulation of qi promoting compatibility drug pair, the prescription that gastrointestinal function of being everlasting regulates uses, oral medicine as: the Flos Caryophylli recorded in " peaceful Huimin mixture office side " dissipates, the LIUSHEN WAN recorded in " Sanyin Ji Yi Bingzheng Fang Lun ", in addition still there is Muxiang Fenqi Pill, and external preparation such as children's warms up and rushes down cream, compound clove stomach health plaster etc..
Chinese medicine Flos Caryophylli is the dry flower of plant clove of myrtaceae (EugeniacaryophyllataThumb.).Begin to remember in " property of medicine opinion ", acrid in the mouth, warm in nature, return spleen, stomach, lung, kidney channel, there is warming middle-JIAO to send down the adverse QI, dispersing cold for relieving pain effect, be the Chinese herbal medicine of a kind of medicine-food two-purpose.Can be clinically used for the symptoms such as the cold void for the treatment of taste, singultus vomiting and diarrhoea, trusted subordinate's cold type of pain and impotence due to deficiency of the kidney, also for treating the conventional Chinese medicine of gastric abscess ancient times.The modern pharmacology Effect study of Flos Caryophylli is concentrated mainly on digestive system, blood system, neural effect.
Chinese medicine Radix Aucklandiae AucklandiaeRadix is the dry root of feverfew Radix Aucklandiae AucklandialappaDecne., has effect of promoting the circulation of QI to relieve pain, warming middle-JIAO for easing the stomach, the disease such as does not disappear for chest and abdomen swelling and pain, vomiting, diarrhoea, dysentery, tenesmus, food stagnation.It is mainly used in the cards such as the dyspepsia caused by stagnation of QI in spleen and stomach, diarrhoea, dysentery stomachache and the dampness-heat in the liver and gallbladder stagnation of QI clinically.Modern pharmacological research shows, the Radix Aucklandiae has the multiple pharmacological effect such as antiinflammatory, antitumor, anti-cardiovascular disease, antiinflammatory, anticancer, antiulcer, resisting pathogenic microbes.
But at present, not yet by the report of the compositions treatment diarrhea type irritable bowel syndrome being made up of Radix Aucklandiae extract and Flos Caryophylli volatile oil.
Summary of the invention
It is an object of the invention to provide the treatment diarrhea type irritable bowel syndrome Chinese medicine composition of a kind of determined curative effect.
Second purpose of the present invention is to provide the application at preparation treatment diarrhea type irritable bowel syndrome medicine of the treatment diarrhea type irritable bowel syndrome Chinese medicine composition.
3rd purpose of the present invention is to provide a kind of containing treatment diarrhea type irritable bowel syndrome Chinese medicine composition umbilicus patch.
Technical scheme is summarized as follows:
One treats diarrhea type irritable bowel syndrome Chinese medicine composition, is made up of Radix Aucklandiae extract 1 part~10 parts, Flos Caryophylli volatile oil 1 part~10 parts according to mass parts meter.
Preferably: the mass ratio of Radix Aucklandiae extract and Flos Caryophylli volatile oil is 1:1 or 2.5:1.
Radix Aucklandiae extract is made by following method: by Radix Aucklandiae medicinal material drying, pulverizes, the absolute methanol adding with being equivalent to Radix Aucklandiae quality of medicinal material 8~10 times, heating and refluxing extraction 0.5~2 hour, extracts 2~3 times, united extraction liquid, extracting solution concentrates, and 40~60 DEG C dry, obtain Radix Aucklandiae extract.
Flos Caryophylli volatile oil is made by following method: adopt vapor distillation extraction method, by Flos Caryophylli medicinal material drying, pulverize, add and be equivalent to 5~8 times of distilled water of Flos Caryophylli quality of medicinal material, be heated to reflux, volatile oil together condenses in constant pressure funnel in company with steam, 4~6 hours extraction times, by the liquid in constant pressure funnel, it is placed in separatory funnel, separate and take oil reservoir, dry with anhydrous sodium sulfate dehydration and obtain Flos Caryophylli volatile oil.
Above-mentioned composition is in the application of preparation treatment diarrhea type irritable bowel syndrome medicine.
The preparation of medicine is oral formulations or external preparation.
The dosage form of described oral formulations is tablet, capsule, drop pill, slow releasing preparation or controlled release agent.
The dosage form of described external preparation is cataplasma or gel.
Containing the navel patch of above-mentioned composition, include by mass parts: sodium alginate 4~10 parts, 4~10 parts of Cera Flava, PVP K30 5~10 parts, glycerol 30~70 parts, Mentholum 1~10 part, treatment diarrhea type irritable bowel syndrome Chinese medicine composition 10~30 parts, distilled water 10~30 parts.
The preparation method of the navel patch containing above-mentioned composition, comprises the steps:
(1) weigh 5~10 parts of PVP K30s and 30~70 parts of glycerol by weight, add distilled water 10~30 parts, in 60~80 DEG C of water-baths, be stirred continuously and all dissolve to PVP K30, be cooled to 40~60 DEG C;
(2) adding 4~10 parts of sodium alginates, the agglutination that stirs is placed in 40~60 DEG C of water bath heat preservations;
(3) by 4~10 parts of Cera Flavas, 10~30 parts for the treatment of diarrhea type irritable bowel syndrome Chinese medicine compositions are added after thawing, add Mentholum 1~10 part, add in the jelly that step (2) obtains after mix homogeneously and stir, coat in molding jig, solidify 4~6 hours in 40~60 DEG C, obtain navel patch.
Advantages of the present invention:
The compositions of the present invention, navel patch especially with the present composition, the external adjustment effect that while adopting the mode that umbilicus patch is administered to make medicine play a role in vivo, the champignon effect of its volatile ingredient is played mood placating, minded at rest, makes isolated rat smooth muscle movement and the myokinetic suppression of mice all produce synergistic function;Anti-CaM antibody is better than being used alone;Diarrhoea is improved significantly, and effect is notable, reaches treatment irritable bowel syndrome purpose.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is further illustrated, and embodiments of the invention are to enable those skilled in the art to be more fully understood that the present invention, but the present invention are not imposed any restrictions.
Embodiment 1
The preparation method of Radix Aucklandiae extract: by Radix Aucklandiae medicinal material drying, pulverizes, the absolute methanol adding with being equivalent to Radix Aucklandiae quality of medicinal material 9 times, heating and refluxing extraction 1 hour, extracts 3 times, united extraction liquid, and extracting solution concentrates, and 50 DEG C dry, obtain Radix Aucklandiae extract.
Embodiment 2
The preparation method of Radix Aucklandiae extract: by Radix Aucklandiae medicinal material drying, pulverizes, the absolute methanol adding with being equivalent to Radix Aucklandiae quality of medicinal material 8 times, heating and refluxing extraction 2 hours, extracts 2 times, united extraction liquid, and extracting solution concentrates, and 40 DEG C dry, obtain Radix Aucklandiae extract.
Embodiment 3
The preparation method of Radix Aucklandiae extract: by Radix Aucklandiae medicinal material drying, pulverizes, the absolute methanol adding with being equivalent to Radix Aucklandiae quality of medicinal material 10 times, heating and refluxing extraction 0.5 hour, extracts 3 times, united extraction liquid, and extracting solution concentrates, and 60 DEG C dry, obtain Radix Aucklandiae extract.
Embodiment 4
The preparation method of Flos Caryophylli volatile oil: adopt vapor distillation extraction method, by Flos Caryophylli medicinal material drying, pulverize, add and be equivalent to 7 times of distilled water of Flos Caryophylli quality of medicinal material, be heated to reflux, volatile oil together condenses in constant pressure funnel in company with steam, 5 hours extraction times, by the liquid in constant pressure funnel, it is placed in separatory funnel, separate and take oil reservoir, dry with anhydrous sodium sulfate dehydration and obtain Flos Caryophylli volatile oil.
Embodiment 5
The preparation method of Flos Caryophylli volatile oil: adopt vapor distillation extraction method, by Flos Caryophylli medicinal material drying, pulverize, add and be equivalent to 5 times of distilled water of Flos Caryophylli quality of medicinal material, be heated to reflux, volatile oil together condenses in constant pressure funnel in company with steam, 6 hours extraction times, by the liquid in constant pressure funnel, it is placed in separatory funnel, separate and take oil reservoir, dry with anhydrous sodium sulfate dehydration and obtain Flos Caryophylli volatile oil.
Embodiment 6
The preparation method of Flos Caryophylli volatile oil: adopt vapor distillation extraction method, by Flos Caryophylli medicinal material drying, pulverize, add and be equivalent to 8 times of distilled water of Flos Caryophylli quality of medicinal material, be heated to reflux, volatile oil together condenses in constant pressure funnel in company with steam, 4 hours extraction times, by the liquid in constant pressure funnel, it is placed in separatory funnel, separate and take oil reservoir, dry with anhydrous sodium sulfate dehydration and obtain Flos Caryophylli volatile oil.
Embodiment 7
One treats diarrhea type irritable bowel syndrome Chinese medicine composition, and Flos Caryophylli volatile oil 10 parts prepared by the Radix Aucklandiae extract 1 part prepared by embodiment 1 by mass parts, embodiment 4 forms.
Embodiment 8
One treats diarrhea type irritable bowel syndrome Chinese medicine composition, and Flos Caryophylli volatile oil 1 part prepared by the Radix Aucklandiae extract 10 parts prepared by embodiment 2 by mass parts, embodiment 5 forms.
Embodiment 9
One treats diarrhea type irritable bowel syndrome Chinese medicine composition, and Flos Caryophylli volatile oil 1 part prepared by the Radix Aucklandiae extract 1 part prepared by embodiment 3 by mass parts, embodiment 6 forms.
Embodiment 10
One treats diarrhea type irritable bowel syndrome Chinese medicine composition, and Flos Caryophylli volatile oil 1 part prepared by the Radix Aucklandiae extract 2.5 parts prepared by embodiment 1 by mass parts, embodiment 5 forms.
Embodiment 11 (navel patch containing Radix Aucklandiae extract)
Prescription: by weight, sodium alginate 4 parts, 10 parts of Cera Flava, PVP K30 5 parts, glycerol 30 parts, Mentholum 1 part, the Radix Aucklandiae extract 10 parts of embodiment 1 preparation, distilled water 30 parts;
Preparation process:
(1) take PVP K30 and glycerol, add distilled water, in 80 DEG C of water-baths, be stirred continuously and all dissolve to PVP K30, be cooled to 60 DEG C;
(2) adding sodium alginate, the agglutination that stirs is placed in 60 DEG C of water bath heat preservations;
(3) add Radix Aucklandiae extract prepared by embodiment 1 after being melted by Cera Flava, add Mentholum, add in the jelly that step (2) obtains after mix homogeneously and stir, coat in mould, solidify 4h in 40 DEG C, obtain navel patch.
Embodiment 12 (navel patch containing Flos Caryophylli volatile oil)
Prescription: by weight, sodium alginate 4 parts, 10 parts of Cera Flava, PVP K30 5 parts, glycerol 30 parts, Mentholum 1 part, the Flos Caryophylli volatile oil 10 parts of embodiment 4 preparation, distilled water 30 parts;
Preparation process:
(1) take PVP K30 and glycerol, add distilled water, in 80 DEG C of water-baths, be stirred continuously and all dissolve to PVP K30, be cooled to 60 DEG C;
(2) adding sodium alginate, the agglutination that stirs is placed in 60 DEG C of water bath heat preservations;
(3) add Flos Caryophylli volatile oil 10 parts prepared by embodiment 4 after being melted by Cera Flava, add Mentholum, add in the jelly that step (2) obtains after mix homogeneously and stir, coat in mould, solidify 4h in 40 DEG C, obtain navel patch.
The embodiment 13 preparation containing a kind of navel patch treating diarrhea type irritable bowel syndrome Chinese medicine composition
Prescription: sodium alginate 6 parts by weight, 6 parts of Cera Flava, PVP K30 8 parts, glycerol 50 parts, Mentholum 5 parts, embodiment 7 treats diarrhea type irritable bowel syndrome Chinese medicine composition 20 parts, distilled water 10 parts;
Preparation process:
(1) by weight, weigh PVP K30 and glycerol, add distilled water, in 70 DEG C of water-baths, be stirred continuously and all dissolve to PVP K30, be cooled to 50 DEG C;
(2) adding sodium alginate, the agglutination that stirs is placed in 50 DEG C of water bath heat preservations;
(3) by Cera Flava, add embodiment 7 after thawing and treat diarrhea type irritable bowel syndrome Chinese medicine composition, add Mentholum, add in the jelly that step (2) obtains after mix homogeneously and stir, coat in mould, solidify 5h in 50 DEG C, obtain navel patch.
The embodiment 14 preparation containing a kind of navel patch treating diarrhea type irritable bowel syndrome Chinese medicine composition
Prescription: by weight, sodium alginate 4 parts, 10 parts of Cera Flava, PVP K30 5 parts, glycerol 30 parts, Mentholum 1 part, embodiment 8 treats diarrhea type irritable bowel syndrome Chinese medicine composition 10 parts, distilled water 30 parts;
Preparation process:
(1) weigh PVP K30 and glycerol, add distilled water, in 60 DEG C of water-baths, be stirred continuously and all dissolve to PVP K30, be cooled to 60 DEG C;
(2) adding sodium alginate, the agglutination that stirs is placed in 40 DEG C of water bath heat preservations;
(3) by Cera Flava, add embodiment 8 after thawing and treat diarrhea type irritable bowel syndrome Chinese medicine composition, add Mentholum, add in the jelly that step (2) obtains after mix homogeneously and stir, coat in mould, solidify 4h in 40 DEG C, obtain navel patch.
The embodiment 15 preparation containing a kind of navel patch treating diarrhea type irritable bowel syndrome Chinese medicine composition
Prescription: sodium alginate 10 parts by weight, 4 parts of Cera Flava, PVP K30 10 parts, glycerol 70 parts, Mentholum 10 parts, embodiment 9 treats diarrhea type irritable bowel syndrome Chinese medicine composition 30 parts, distilled water 10 parts;
Preparation process:
(1) weigh PVP K30 and glycerol, add distilled water, in 80 DEG C of water-baths, be stirred continuously and all dissolve to PVP K30, be cooled to 40 DEG C;
(2) adding sodium alginate, the agglutination that stirs is placed in 60 DEG C of water bath heat preservations;
(3) by Cera Flava, add embodiment 9 after thawing and treat diarrhea type irritable bowel syndrome Chinese medicine composition, add Mentholum, add in the jelly that step (2) obtains after mix homogeneously and stir, coat in molding jig, solidify 6h in 60 DEG C, obtain navel patch.
The embodiment 16 preparation containing a kind of navel patch treating diarrhea type irritable bowel syndrome Chinese medicine composition
Prescription: sodium alginate 7 parts by weight, 7 parts of Cera Flava, PVP K30 7 parts, glycerol 40 parts, Mentholum 8 parts, embodiment 10 treats diarrhea type irritable bowel syndrome Chinese medicine composition 25 parts, distilled water 30 parts;
Preparation process:
(1) weigh PVP K30 and glycerol, add distilled water, in 65 DEG C of water-baths, be stirred continuously and all dissolve to PVP K30, be cooled to 50 DEG C;
(2) adding sodium alginate, the agglutination that stirs is placed in 50 DEG C of water bath heat preservations;
(3) by Cera Flava, add embodiment 10 after thawing and treat diarrhea type irritable bowel syndrome Chinese medicine composition, add Mentholum, add in the jelly that step (2) obtains after mix homogeneously and stir, coat in molding jig, solidify 4h in 45 DEG C, obtain navel patch.
Experimental section
1. acute skin irritation experiment
Select healthy new zealand white rabbit 24, body weight 1.5-2.5kg, male and female half and half, administration district is carried out depilation process by 24h before the test of described white rabbit, each one piece of left and right, unhairing scope 3cm × 3cm.24 white rabbits are divided into two groups, and namely Normal group 12 only reaches skin injury group 12, and at agents area, skin injury experiment contrast white rabbit is drawn " well " word, to ooze out blood for degree.
With normal group and skin injury group, navel patch prepared by embodiment 11-16 is carried out skin irritation test respectively.Normal skin is compareed white rabbit and is divided into 6 groups, often group 2;Skin injury white rabbit is divided into 6 groups, often group 2, adopts consubstantiality left and right sides self-contrast method to test.
Left side depilation place lose money in a business inventive embodiments 11-16 umbilicus patch, right side be coated with medical glycerol comparison.Application time 24h, every day 1 time, continuous 7d;After sticking end, remove test sample and with warm water or nonirritant solvent cleaned medicine-feeding part every time.Examine coating place skin before each coating with or without erythema, edema, continue after drug withdrawal to observe 3d, carry out skin irritation evaluation by the requirement of new drug toxicity technical specification, simultaneously bark fetching Fu Zuo tissue pathology checking.
Skin irritation is evaluated
(1) standards of grading: erythema: without erythema 0 point;Slight erythema (visible reluctantly) 1 point;2 points of the red class of moderate (clearly visible);Severe erythema 3 points;Aubergine erythema forms 4 points to slight burnt being crazy about.Edema: without edema 0 point;Mild edema (visible reluctantly) 1 point;Intermediate edema (substantially protuberance) 2 points;Severe edema (cutaneous protuberance 1mm, profile is clear) 3 points;Severe edema (cutaneous protuberance > 1mm have expansion) 4 points.Highest point total is worth 8 points.
(2) skin irritation intensity evaluation standard: 0-0.49 divides nonirritant;0.50-2.99 divides slight zest;3.00-5.99 divides moderate zest;6.00-8.00 divides strong and stimulating.
Result: two groups of rabbit spirit of test period, sign are good, and appetite activity is normal;Without dead, also have no any untoward reaction;Skin wound repair scoring is 0 part;Hematological examination, biochemical investigation are showed no exception;System becomes celestial and each internal organs histopathology no abnormality seen;Restorative observation has no retardance toxic reaction.Show that described white rabbit does not produce toxic reaction by embodiment of the present invention 11-16 umbilicus patch for a long time.
2. external in vitro intestinal smooth muscle exercise test
According to embodiment 11-16, added Chinese medicine extract is carried out experiment in vitro, investigate the impact on normal isolated rat Jejunal smooth muscle spontaneous contractions of the compositions after Radix Aucklandiae extract, Flos Caryophylli volatile oil and different proportion compatibility thereof.Adaptability feeds rat 1 week, tests front 24 h fast and can't help water, puts to death and adopt cervical dislocation, quickly remove jejunum.Be placed in Tyrode ' s nutritional solution, rinse intestinal contents to clean, after put in the culture dish containing nutritional solution, with fine rule, intestinal tube two ends are lain on ventilation hook and tonotransducer respectively.Specimen is placed in 37 DEG C of constant temperature Maxwell water-bath ware Tyrode ' s nutritional solutions, is slowly introducing mixing gas (95%O2, 5%CO2), control 2-3 bubbles per second of air-flow.Load adjustment is 1.5g, balances 20min with BL-410 Biological Signal Collecting System, after the motion of intestinal smooth muscle spontaneous contractions is in poised state, records normal group in vitro jejunum intestinal segment smooth muscle contraction curve.Starting dosing after balance 90min, during balance, in bath, the every 20min of nutritional solution changes once.
(1) the variable concentrations medicinal liquid impact on rat normally in vitro intestinal contractile motion: certain density medicinal liquid is added in the intestinal segment of rat normal contraction function, record smooth muscle contraction curve respectively, by parameter investigation variable concentrations medicinal liquid impacts in vitro intestinal smooth muscle contractile motion such as shrinkage amplitude, peak difference.Result is in Table 1 and table 4.
(2) impact that variable concentrations medicinal liquid is hyperfunction on the caused in vitro intestinal contractile motion of rat acetylcholine (Ach): be initially charged Ach (10-5M) it is separately added into certain density extract in backward perfusion flesh groove, respectively record smooth muscle contraction curve, by parameter investigation variable concentrations medicinal liquid impacts in vitro intestinal smooth muscle contractile motion such as shrinkage amplitude, peak difference.Result is in Table 2 and 5.
(3) impact that variable concentrations medicinal liquid is hyperfunction on the caused in vitro intestinal contractile motion of rat potassium chloride (KCl): be initially charged in KCl (60mM) backward perfusion flesh groove and be separately added into certain density extract, record smooth muscle contraction curve respectively, by shrinkage amplitude, the parameter such as peak difference carries out the impact in vitro intestinal smooth muscle contractile motion of the variable concentrations medicinal liquid.Result is in Table 3 and 6.
(4) Radix Aucklandiae extract, Flos Caryophylli volatile oil and prepare the compositions effect to jejunum intestinal tube by different proportion compatibility, carries out probability by its suppression ratio and method (Q-value method) calculates.
The data obtained is calculated with following formula, obtains Q-value, Q>1.15 represent the two compatibility after there is synergism, Q<0.85 represents the two antagonism, and the effect after then representing the two compatibility between the two that is in is added.
Q = E A + E B E A + E B - E A &times; E B
Wherein EAAnd EBRepresent respectively medicine alone time effect, EA+EBEffect actual after representing Papillary, EA+EB-EA×EBRepresent the effect that Papillary should obtain in theory.According to variable concentrations compatible composition: Q < 0.85 shows as antagonism;Q > 1.15 shows as synergism;0.85 < Q < 1.15 shows as summation action.Radix Aucklandiae extract and Flos Caryophylli volatile oil compatibility have the effect of Synergistic, and compatibility use drug effect all shows as and is better than independent component.
The table 1 embodiment 11-16 suppression ratio to normal isolated rat Jejunal smooth muscle spontaneous contractions.
Compare with embodiment 11 groups: * p < 0.05;**p<0.01;Compare with embodiment 12 groups:#p<0.05;##p<0.01.
The suppression ratio of the isolated rat Jejunal smooth muscle contraction abnormalities that Ach is caused by table 2 embodiment 11-16.
Compare with embodiment 11 groups: * p < 0.05;**p<0.01;Compare with embodiment 12 groups:#p<0.05;##p<0.01;
The suppression ratio of the isolated rat Jejunal smooth muscle contraction abnormalities that KCl is caused by table 3 embodiment 11-16.
Compare with embodiment 11 groups: * p < 0.05;**p<0.01;Compare with embodiment 12 groups:#p<0.05;##p<0.01;
The table 4 embodiment 13-16 Q-value to normal isolated rat Jejunal smooth muscle spontaneous contractions suppression ratio.
The Q-value of the isolated rat Jejunal smooth muscle contraction abnormalities suppression ratio that Ach is caused by table 5 embodiment 13-16.
The Q-value of the isolated rat Jejunal smooth muscle contraction abnormalities suppression ratio that KCl is caused by table 6 embodiment 13-16.
3. intestinal propulsion test in body
Impact on normal mouse bowel movement
Adopt the impact on gastrointestinal motility in normal mice after phenol red method research embodiment 11-16 percutaneous dosing.Taking normal mouse 80, male and female half and half, before experiment, water 24h is can't help in animal fasting, is randomly divided into 8 groups, often group 10, respectively blank group;Positive controls (fourth osmanthus umbilicus patch);Embodiment 11-16 group.Blank group is bare substrate (bare substrate of embodiment 11).It is administered 3 days, give phenol red reagent 0.3ml/ of 0.05% in each group of last drug of topical application 1h, after 20min, cervical dislocation is put to death respectively, takes out small intestinal separation mesentery, clip pylorus is to the intestinal tube in ileocecum portion, it is placed on pallet, gently small intestinal is pulled into straight line, measure the distance of phenol red advance, calculate Intestinal propulsive rate, total length × 100% of the distance/small intestinal of the phenol red advance of Intestinal propulsive rate (Intestinaltransit) %=, such as table 7, shown in table 9.
The impact that mice bowel movement that neostigmine is caused is hyperfunction
Adopt the impact on neostigmine gastrointestinal motility in mice after the different embodiment 11-16 percutaneous dosing of phenol red method research.Taking mice 90, male and female half and half, before experiment, water 24h is can't help in animal fasting, is randomly divided into 9 groups, often group 10, respectively blank group;Model group;Positive controls (fourth osmanthus umbilicus patch);Embodiment 11-16 group.It is administered 3 days, after last drug of topical application 1h, each group lumbar injection neostigmine 0.1mg/kg respectively except blank group, after 15min, each organize gastric infusion 0.05% phenol red solution 0.3ml/, after 20min, the de-cervical approach of cervical vertebra is put to death, and takes out small intestinal separation mesentery, clip pylorus is to the intestinal tube in ileocecum portion, it is placed on pallet, gently small intestinal is pulled into straight line, measure the distance of phenol red advance, calculate Intestinal propulsive rate, total length × 100% of the distance/small intestinal of the phenol red advance of Intestinal propulsive rate (Intestinaltransit) %=, as shown in table 8,10.
The table 7 embodiment 11-16 impact on normal mouse alvine pushing rate effect.
Compare with blank group:p<0.05;△△p<0.01;Compare with embodiment 11 groups:*p<0.05;**p<0.01;Compare with embodiment 12 groups:#p<0.05;##p<0.01.
The table 8 embodiment 11-16 impact on neostigmine diarrhea inducing mice Intestinal pushing effect.
Compare with model group:p<0.05;△△p<0.01;Compare with embodiment 11 groups:*p<0.05;**p<0.01;Compare with embodiment 12 groups:#p<0.05;##p<0.01.
The table 9 embodiment 13-16 Q-value to normal mouse Intestinal pushing effect.
The table 10 embodiment 13-16 Q-value to neostigmine diarrhea inducing mice Intestinal pushing effect.
Compositions embodiment 7, embodiment 8, embodiment 9, embodiment 10 prepared, according to a conventional method, adds that tablet prepared by pharmaceutically acceptable adjuvant.
Compositions embodiment 7, embodiment 8, embodiment 9, embodiment 10 prepared, according to a conventional method, adds that capsule prepared by pharmaceutically acceptable adjuvant.
Compositions embodiment 7, embodiment 8, embodiment 9, embodiment 10 prepared, according to a conventional method, adds that drop pill prepared by pharmaceutically acceptable adjuvant.
Compositions embodiment 7, embodiment 8, embodiment 9, embodiment 10 prepared, according to a conventional method, adds that pharmaceutically acceptable adjuvant prepares slow releasing tablet or slow releasing capsule.
Compositions embodiment 7, embodiment 8, embodiment 9, embodiment 10 prepared, according to a conventional method, adds that controlled release tablet prepared by pharmaceutically acceptable adjuvant.
Compositions embodiment 7, embodiment 8, embodiment 9, embodiment 10 prepared, according to a conventional method, adds that cataplasma prepared by pharmaceutically acceptable adjuvant.
Compositions embodiment 7, embodiment 8, embodiment 9, embodiment 10 prepared, according to a conventional method, adds that gel prepared by pharmaceutically acceptable adjuvant.

Claims (10)

1. a treatment diarrhea type irritable bowel syndrome Chinese medicine composition, is characterized in that being made up of Radix Aucklandiae extract 1 part~10 parts, Flos Caryophylli volatile oil 1 part~10 parts according to mass parts meter.
2. one according to claim 1 treats diarrhea type irritable bowel syndrome Chinese medicine composition, it is characterized in that the mass ratio of Radix Aucklandiae extract and Flos Caryophylli volatile oil is 1:1 or 2.5:1.
3. one according to claim 1 and 2 treats diarrhea type irritable bowel syndrome Chinese medicine composition, it is characterized in that described Radix Aucklandiae extract is made by following method: by Radix Aucklandiae medicinal material drying, pulverize, the absolute methanol added and be equivalent to Radix Aucklandiae quality of medicinal material 8~10 times, heating and refluxing extraction 0.5~2 hour, extract 2~3 times, united extraction liquid, extracting solution concentrates, and 40~60 DEG C dry, obtain Radix Aucklandiae extract.
4. one according to claim 1 and 2 treats diarrhea type irritable bowel syndrome Chinese medicine composition, it is characterized in that described Flos Caryophylli volatile oil is made by following method: adopt vapor distillation extraction method, by Flos Caryophylli medicinal material drying, pulverize, add and be equivalent to 5~8 times of distilled water of Flos Caryophylli quality of medicinal material, it is heated to reflux, volatile oil together condenses in constant pressure funnel in company with steam, 4~6 hours extraction times, by the liquid in constant pressure funnel, it is placed in separatory funnel, separates and take oil reservoir, dry with anhydrous sodium sulfate dehydration and obtain Flos Caryophylli volatile oil.
5. the compositions of one of claim 1-4 is in the application of preparation treatment diarrhea type irritable bowel syndrome medicine.
6. the application described in claim 5, is characterized in that the preparation of described medicine is oral formulations or external preparation.
7. application according to claim 6, it is characterised in that the dosage form of described oral formulations is tablet, capsule, drop pill, slow releasing preparation or controlled release agent.
8. application according to claim 6, it is characterised in that the dosage form of described external preparation is cataplasma or gel.
9. contain the navel patch of the compositions of one of claim 1-4, it is characterized in that including by mass parts: sodium alginate 4~10 parts, 4~10 parts of Cera Flava, PVP K30 5~10 parts, glycerol 30~70 parts, Mentholum 1~10 part, treats diarrhea type irritable bowel syndrome Chinese medicine composition 10~30 parts, distilled water 10~30 parts.
10. the preparation method of the navel patch of claim 9, is characterized in that comprising the steps:
(1) weigh 5~10 parts of PVP K30s and 30~70 parts of glycerol by weight, add distilled water 10~30 parts, in 60~80 DEG C of water-baths, be stirred continuously and all dissolve to PVP K30, be cooled to 40~60 DEG C;
(2) adding 4~10 parts of sodium alginates, the agglutination that stirs is placed in 40~60 DEG C of water bath heat preservations;
(3) by 4~10 parts of Cera Flavas, 10~30 parts for the treatment of diarrhea type irritable bowel syndrome Chinese medicine compositions are added after thawing, add Mentholum 1~10 part, add in the jelly that step (2) obtains after mix homogeneously and stir, coat in molding jig, solidify 4~6 hours in 40~60 DEG C, obtain navel patch.
CN201610209222.3A 2016-04-05 2016-04-05 Traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome, navel patch and application Expired - Fee Related CN105796654B (en)

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CN107744584A (en) * 2017-10-31 2018-03-02 孙国营 A kind of navel paster for treating virus diarrhea and preparation method thereof
CN110882308A (en) * 2019-12-16 2020-03-17 河南省中医院(河南中医药大学第二附属医院) Traditional Chinese medicine for treating irritable bowel syndrome and preparation method thereof
CN114652778A (en) * 2022-03-11 2022-06-24 北京惠民中医儿童医院有限公司 Traditional Chinese medicine composition and patch for promoting qi circulation, relieving pain, warming middle-jiao, invigorating spleen and stopping diarrhea and preparation method

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CN105168187A (en) * 2015-09-07 2015-12-23 北京东方凯恩医药科技有限公司 Cutaneous penetration system
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CN107744584A (en) * 2017-10-31 2018-03-02 孙国营 A kind of navel paster for treating virus diarrhea and preparation method thereof
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CN114652778A (en) * 2022-03-11 2022-06-24 北京惠民中医儿童医院有限公司 Traditional Chinese medicine composition and patch for promoting qi circulation, relieving pain, warming middle-jiao, invigorating spleen and stopping diarrhea and preparation method
CN114652778B (en) * 2022-03-11 2024-01-30 北京惠民中医儿童医院有限公司 Traditional Chinese medicine composition and patch for promoting qi circulation, relieving pain, warming spleen and stomach, strengthening spleen and relieving diarrhea and preparation method thereof

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