CN105796654B - Traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome, navel patch and application - Google Patents
Traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome, navel patch and application Download PDFInfo
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- A—HUMAN NECESSITIES
- 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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/285—Aucklandia
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- A—HUMAN NECESSITIES
- 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)
- A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
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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
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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
- 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
Abstract
The invention discloses a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome, a navel patch and application, wherein the composition comprises, by mass, 1-10 parts of elecampane extract and 1-10 parts of clove volatile oil. The composition, in particular to the navel patch containing the composition, enables the medicine to play a role in vivo, simultaneously has the aromatherapy effect of volatile components to play the roles of in-vitro regulation of mood soothing and spirit relaxing, and enables the inhibition of the in-vitro rat smooth muscle movement and the mouse muscle movement to generate a synergistic effect; the anti-diarrhea effect is better than that of single use; has obvious effect of improving diarrhea and obvious effect, and achieves the purpose of treating irritable bowel syndrome.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a preparation method and application of a traditional Chinese medicine composition extract and an umbilical paste for treating diarrhea-predominant irritable bowel syndrome.
Background
According to the survey results of 2013 by the world health organization, the diarrhea is the second leading cause of death of children under five years old, about 76 million children under five years old die from diarrhea diseases every year, and about 17 hundred million diarrhea patients are worldwide each year. Diarrhea, abdominal pain, abdominal distention, food stagnation, milk stagnation, enteritis and bacillary dysentery are common diseases of the gastrointestinal tract, and are mostly caused by improper diet and invasion of exogenous pathogenic factors to damage the spleen and stomach. The common symptoms of diarrhea (diarrhea) are frequent defecation with frequency significantly exceeding that of ordinary daily habit, thin stool, increased moisture, or containing undigested food or purulent blood, mucus. Patients with diarrhea often have abdominal pain, abdominal distention, food stagnation, and mammary mass; it may be accompanied by symptoms such as fever and vomiting. Irritable Bowel Syndrome (IBS) is a common chronic functional gastrointestinal disease, which is a method for modern medicine, and the IBS is not a concept in the theory of traditional Chinese medicine, and is classified into the categories of abdominal pain, diarrhea or constipation, however, there are many factors causing digestive system diseases such as abdominal pain and diarrhea, and the mechanism is also complicated. The western medicine considers that the occurrence of IBS is related to gastrointestinal motility abnormality, visceral sensibility abnormality, infection and intestinal flora imbalance, brain-intestinal axis action abnormality and mental factors, and the traditional Chinese medicine considers that the IBS is caused by emotional damage to the liver, liver qi stagnation to cause spleen failure or internal weakness of the spleen and the stomach or improper diet to cause damage to spleen soil.
In terms of treatment, most of therapeutic drugs for diarrhea-type IBS are symptomatic therapy, such as 5-HT receptor blockers, calcium ion antagonists, somatostatin drugs, anticholinergic drugs, and the like, which can effectively improve symptoms such as abdominal pain, diarrhea, constipation, and the like, but have many toxic and side effects, and are not suitable for long-term application. The traditional Chinese medicine mainly treats 'whole regulation', has small side effect and lasting effect, can take both symptoms and root causes into consideration, and regulates the gastrointestinal tract while stopping diarrhea.
The umbilical administration is easier to absorb the medicine than other administration modes, has high bioavailability, the recess of the umbilical part forms a recess, the medicine is pasted to form a natural closed state, the medicine can be stored for a long time and is absorbed more durably, and the medicine enters the blood circulation and lymphatic system to play the role of systemic treatment. Is one of the best modes for human administration, especially for administration to children. Studies in y.w.chien in the united states show that the bioavailability of the drug administered umbilically is 1-6 times that of the drug administered forearm.
The costustoot and clove which are used as a compatible medicine pair for warming stomach and promoting qi circulation are often used in a prescription for regulating gastrointestinal functions, and the oral medicine is as follows: the clove powder recorded in the Taiping Huimin mixture local prescription, the Liushen pill recorded in the Sanyin Jiyi disease and syndrome prescription, and the costustoot qi-dispersing pill and external preparations such as an infantile warm diarrhea paste, a compound clove appetite-stimulating paste and the like are also provided.
The flos Caryophylli is dried bud of Eugenia caryophyllata (Eugenia caryophyllata Thumb) of Myrtaceae. It is a Chinese herbal medicine used as both medicine and food, and it is recorded in the treatise on herb properties, pungent in flavor and warm in nature, enters spleen, stomach, lung and kidney meridians, has the effects of warming middle-jiao to check adverse rise of qi, dispelling cold and relieving pain. Can be clinically used for treating symptoms such as spleen and stomach cold deficiency, hiccup vomiting and diarrhea, heart and abdomen psychroalgia, kidney deficiency and impotence, and is also a common traditional Chinese medicine for treating epigastric pain in ancient times. The modern pharmacological action research of clove mainly focuses on the action on the digestive system, the blood system and the nervous system.
Radix Aucklandiae Aucklandiae Radix is dried root of Aucklandia lappa Decne of Compositae, has effects of activating qi-flowing, relieving pain, warming spleen and stomach, and can be used for treating chest and abdomen distending pain, emesis, diarrhea, dysentery, tenesmus, dyspepsia, etc. It is mainly used for treating dyspepsia, diarrhea, abdominal pain, and damp-heat stagnation of liver and gallbladder caused by qi stagnation of spleen and stomach. Modern pharmacological research shows that costus root has a plurality of pharmacological actions such as anti-inflammatory, anti-tumor, anti-cardiovascular disease, anti-inflammatory, anti-cancer, anti-ulcer, anti-pathogenic microorganism and the like.
However, at present, no composition consisting of costus root extract and clove volatile oil is reported to treat diarrhea-predominant irritable bowel syndrome.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome with definite curative effect.
The second purpose of the invention is to provide the application of the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome in preparing the medicine for treating diarrhea-predominant irritable bowel syndrome.
The third purpose of the invention is to provide a traditional Chinese medicine composition navel paste for treating diarrhea-predominant irritable bowel syndrome.
The technical scheme of the invention is summarized as follows:
a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome comprises, by mass, 1-10 parts of an elecampane extract and 1-10 parts of clove volatile oil.
It is preferable that: the mass ratio of the costustoot extract to the clove volatile oil is 1:1 or 2.5: 1.
The costus root extract is prepared by the following method: drying and crushing a radix aucklandiae medicinal material, adding absolute methanol which is 8-10 times of the mass of the radix aucklandiae medicinal material, heating, refluxing and extracting for 0.5-2 hours for 2-3 times, combining extracting solutions, concentrating the extracting solutions, and drying at 40-60 ℃ to obtain the radix aucklandiae extract.
The clove volatile oil is prepared by the following method: drying and crushing the clove medicinal material by adopting a steam distillation extraction method, adding distilled water which is 5-8 times of the mass of the clove medicinal material, heating and refluxing, condensing the volatile oil in a constant-pressure dropping funnel together with steam, extracting for 4-6 hours, placing the liquid in the constant-pressure dropping funnel in a separating funnel, separating and separating an oil layer, and dehydrating and drying by using anhydrous sodium sulfate to obtain the clove volatile oil.
The composition can be used for preparing medicine for treating diarrhea-predominant irritable bowel syndrome.
The preparation of the medicine is oral preparation or external preparation.
The dosage form of the oral preparation is tablets, capsules, dripping pills, sustained release preparations or controlled release preparations.
The dosage form of the external preparation is cataplasm or gel.
The navel patch containing the composition comprises the following components in parts by mass: 4-10 parts of sodium alginate, 4-10 parts of beeswax, 305-10 parts of polyvinylpyrrolidone K, 30-70 parts of glycerol, 1-10 parts of menthol, 10-30 parts of a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome and 10-30 parts of distilled water.
The preparation method of the umbilical patch containing the composition comprises the following steps:
(1) weighing 5-10 parts by weight of polyvinylpyrrolidone K30 and 30-70 parts by weight of glycerol, adding 10-30 parts by weight of distilled water, continuously stirring on a water bath at 60-80 ℃ until polyvinylpyrrolidone K30 is completely dissolved, and cooling to 40-60 ℃;
(2) adding 4-10 parts of sodium alginate, stirring uniformly to form a colloid, and placing in a water bath at 40-60 ℃ for heat preservation;
(3) melting 4-10 parts of beeswax, adding 10-30 parts of a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome, adding 1-10 parts of menthol, uniformly mixing, adding the mixture into the jelly obtained in the step (2), uniformly stirring, coating the mixture in a self-made mold, and curing at 40-60 ℃ for 4-6 hours to obtain the umbilical patch.
The invention has the advantages that:
the composition, in particular to the navel patch containing the composition, adopts a navel patch administration mode to ensure that the medicine plays a role in vivo, and simultaneously the aromatherapy effect of volatile components of the medicine plays an in vitro regulation role in soothing mood and relaxing spirit, so that the inhibition of the smooth muscle movement of an isolated rat and the muscle movement of a mouse generates a synergistic effect; the anti-diarrhea effect is better than that of single use; has obvious effect of improving diarrhea and obvious effect, and achieves the purpose of treating irritable bowel syndrome.
Detailed Description
The present invention is further described with reference to the following specific examples, which are provided to enable those skilled in the art to better understand the present invention, but are not intended to limit the present invention in any way.
Example 1
The preparation method of the costustoot extract comprises the following steps: drying radix aucklandiae, pulverizing, adding anhydrous methanol 9 times the weight of radix aucklandiae, reflux-extracting under heating for 1 hr for 3 times, mixing extractive solutions, concentrating, and drying at 50 deg.C to obtain radix aucklandiae extract.
Example 2
The preparation method of the costustoot extract comprises the following steps: drying radix aucklandiae, pulverizing, adding anhydrous methanol 8 times the weight of radix aucklandiae, reflux-extracting for 2 hr for 2 times, mixing extractive solutions, concentrating, and drying at 40 deg.C to obtain radix aucklandiae extract.
Example 3
The preparation method of the costustoot extract comprises the following steps: drying radix aucklandiae, pulverizing, adding anhydrous methanol 10 times the weight of radix aucklandiae, reflux-extracting under heating for 0.5 hr for 3 times, mixing extractive solutions, concentrating, and drying at 60 deg.C to obtain radix aucklandiae extract.
Example 4
The preparation method of the clove volatile oil comprises the following steps: drying flos Caryophylli by steam distillation, pulverizing, adding distilled water 7 times of flos Caryophylli, heating and refluxing, condensing volatile oil together with steam in constant pressure dropping funnel, extracting for 5 hr, placing the liquid in constant pressure dropping funnel in separating funnel, separating and collecting oil layer, and dehydrating and drying with anhydrous sodium sulfate to obtain flos Caryophylli volatile oil.
Example 5
The preparation method of the clove volatile oil comprises the following steps: drying flos Caryophylli by steam distillation, pulverizing, adding 5 times of distilled water, heating and refluxing, condensing volatile oil together with steam in constant pressure dropping funnel, extracting for 6 hr, placing the liquid in constant pressure dropping funnel in separating funnel, separating and collecting oil layer, and dehydrating and drying with anhydrous sodium sulfate to obtain flos Caryophylli volatile oil.
Example 6
The preparation method of the clove volatile oil comprises the following steps: drying flos Caryophylli by steam distillation, pulverizing, adding distilled water 8 times of flos Caryophylli, heating and refluxing, condensing volatile oil together with steam in constant pressure dropping funnel, extracting for 4 hr, placing the liquid in constant pressure dropping funnel in separating funnel, separating and collecting oil layer, and dehydrating and drying with anhydrous sodium sulfate to obtain flos Caryophylli volatile oil.
Example 7
A traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome comprises, by mass, 1 part of costustoot extract prepared in example 1 and 10 parts of clove volatile oil prepared in example 4.
Example 8
A traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome comprises, by mass, 10 parts of costustoot extract prepared in example 2 and 1 part of clove volatile oil prepared in example 5.
Example 9
A traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome comprises, by mass, 1 part of costustoot extract prepared in example 3 and 1 part of clove volatile oil prepared in example 6.
Example 10
A traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome comprises, by mass, 2.5 parts of costustoot extract prepared in example 1 and 1 part of clove volatile oil prepared in example 5.
Example 11 (umbilical patch containing Aucklandia lappa extract)
Prescription: 4 parts of sodium alginate, 10 parts of beeswax, 305 parts of polyvinylpyrrolidone K, 30 parts of glycerol, 1 part of menthol, 10 parts of the elecampane extract prepared in example 1 and 30 parts of distilled water;
the preparation method comprises the following steps:
(1) adding distilled water into polyvinylpyrrolidone K30 and glycerol, stirring continuously on a water bath at 80 ℃ until polyvinylpyrrolidone K30 is completely dissolved, and cooling to 60 ℃;
(2) adding sodium alginate, stirring to form gel, and placing in water bath at 60 deg.C for heat preservation;
(3) melting Cera flava, adding radix aucklandiae extract prepared in example 1, adding Mentholum, mixing, adding the jelly obtained in step (2), stirring, coating on a mold, and curing at 40 deg.C for 4 hr to obtain umbilical patch.
Example 12 (umbilical patch containing clove volatile oil)
Prescription: 4 parts of sodium alginate, 10 parts of beeswax, 305 parts of polyvinylpyrrolidone K, 30 parts of glycerol, 1 part of menthol, 10 parts of clove volatile oil prepared in example 4 and 30 parts of distilled water;
the preparation method comprises the following steps:
(1) adding distilled water into polyvinylpyrrolidone K30 and glycerol, stirring continuously on a water bath at 80 ℃ until polyvinylpyrrolidone K30 is completely dissolved, and cooling to 60 ℃;
(2) adding sodium alginate, stirring to form gel, and placing in water bath at 60 deg.C for heat preservation;
(3) melting beeswax, adding 10 parts of clove volatile oil prepared in example 4, adding menthol, mixing uniformly, adding the jelly obtained in step (2), stirring uniformly, coating the mixture in a mold, and curing at 40 ℃ for 4 hours to obtain the umbilical patch.
Example 13 preparation of a navel patch containing a Chinese medicinal composition for the treatment of diarrhea-predominant irritable bowel syndrome
Prescription: 6 parts of sodium alginate, 6 parts of beeswax, 308 parts of polyvinylpyrrolidone K, 50 parts of glycerol, 5 parts of menthol, 20 parts of the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome in example 7 and 10 parts of distilled water;
the preparation method comprises the following steps:
(1) weighing polyvinylpyrrolidone K30 and glycerol by weight, adding distilled water, continuously stirring on a 70 ℃ water bath until polyvinylpyrrolidone K30 is completely dissolved, and cooling to 50 ℃;
(2) adding sodium alginate, stirring to form gel, and placing in 50 deg.C water bath for heat preservation;
(3) melting beeswax, adding the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome in example 7, adding menthol, mixing uniformly, adding the jelly obtained in step (2), stirring uniformly, coating the mixture in a mold, and curing at 50 ℃ for 5 hours to obtain the umbilical patch.
Example 14 preparation of a navel patch containing a Chinese medicinal composition for the treatment of diarrhea-predominant irritable bowel syndrome
Prescription: 4 parts of sodium alginate, 10 parts of beeswax, 305 parts of polyvinylpyrrolidone K, 30 parts of glycerol, 1 part of menthol, 10 parts of the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome in example 8 and 30 parts of distilled water;
the preparation method comprises the following steps:
(1) weighing polyvinylpyrrolidone K30 and glycerol, adding distilled water, stirring continuously on a water bath at 60 ℃ until polyvinylpyrrolidone K30 is completely dissolved, and cooling to 60 ℃;
(2) adding sodium alginate, stirring to form gel, and placing in 40 deg.C water bath for heat preservation;
(3) melting beeswax, adding the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome in example 8, adding menthol, mixing uniformly, adding the mixture into the jelly obtained in step (2), stirring uniformly, coating the mixture in a mold, and curing at 40 ℃ for 4 hours to obtain the umbilical patch.
Example 15 preparation of umbilical Patch containing a Chinese medicinal composition for the treatment of diarrhea-predominant irritable bowel syndrome
Prescription: 10 parts of sodium alginate, 4 parts of beeswax, 0 part of polyvinylpyrrolidone K3010 part, 70 parts of glycerol, 10 parts of menthol, 30 parts of the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome in example 9 and 10 parts of distilled water;
the preparation method comprises the following steps:
(1) weighing polyvinylpyrrolidone K30 and glycerol, adding distilled water, stirring continuously on a water bath at 80 ℃ until polyvinylpyrrolidone K30 is completely dissolved, and cooling to 40 ℃;
(2) adding sodium alginate, stirring to form gel, and placing in water bath at 60 deg.C for heat preservation;
(3) melting beeswax, adding the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome in example 9, adding menthol, mixing uniformly, adding the mixture into the jelly obtained in step (2), stirring uniformly, coating the mixture in a self-made mold, and curing at 60 ℃ for 6 hours to obtain the umbilical patch.
Example 16 preparation of a navel patch containing a Chinese medicinal composition for the treatment of diarrhea-predominant irritable bowel syndrome
Prescription: 7 parts of sodium alginate, 7 parts of beeswax, 307 parts of polyvinylpyrrolidone K, 40 parts of glycerol, 8 parts of menthol, 25 parts of the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome in example 10 and 30 parts of distilled water;
the preparation method comprises the following steps:
(1) weighing polyvinylpyrrolidone K30 and glycerol, adding distilled water, stirring continuously on a water bath at 65 ℃ until polyvinylpyrrolidone K30 is completely dissolved, and cooling to 50 ℃;
(2) adding sodium alginate, stirring to form gel, and placing in 50 deg.C water bath for heat preservation;
(3) melting beeswax, adding the traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome in example 10, adding menthol, mixing uniformly, adding the mixture into the jelly obtained in step (2), stirring uniformly, coating the mixture in a self-made mold, and curing at 45 ℃ for 4 hours to obtain the umbilical patch.
Experimental part
1. Acute skin irritation test
24 healthy New Zealand white rabbits with the weight of 1.5-2.5kg and half of male and female are selected, the hair removal treatment is carried out on the administration area 24 hours before the white rabbit test, the white rabbits are divided into two groups, namely 12 normal control groups and 12 skin damage groups, in the hair removal range of 3cm × 3 cm., the white rabbits are cut into a Chinese character 'jing' at the application part of the skin damage test, and the blood exudation degree is used.
Skin irritation experiments were performed on the umbilical cord patches prepared in examples 11-16 in the normal group and the skin damaged group, respectively. Dividing the normal skin control white rabbits into 6 groups of 2 rabbits each; the skin-damaged white rabbits were divided into 6 groups of 2 rabbits each, and the experiment was performed by a homeostatic left-right self-contrast method.
The left depilated area was attached to the umbilical patch of the invention of examples 11-16 and the right side was coated with medical glycerin control. The application time is 24h, 1 time per day and 7 days continuously; after each application, the test article is removed and the application site is cleaned with warm water or a non-irritating solvent. Before each medicine application, carefully observing whether the skin has erythema and edema, after stopping medicine application, continuously observing for 3d, performing skin irritation evaluation according to the requirements of new medicine toxicological technical specifications, and simultaneously taking the skin for histopathological examination.
Evaluation of skin irritation
(1) Grading standard: erythema: no erythema for 0 point; mild erythema (barely visible) 1 point; medium red shift (clearly visible) 2 points; 3 points of severe erythema; purple red erythema to mild charred skin was formed for 4 points. Edema: no edema 0 point; mild edema (barely visible) score 1; moderate edema (marked swelling) 2 points; severe edema (1 mm skin bulge, clear outline) 3 points; severe edema (skin bulge >1mm with enlargement) was divided by 4. The highest total score was 8.
(2) Evaluation criteria for skin irritation intensity: 0-0.49 points of nonirritating; mild irritation of 0.50-2.99 points; 3.00-5.99 points of moderate irritation; strong irritation at 6.00-8.00 points.
As a result: during the test period, two groups of rabbits have good spirit and physical signs and normal appetite activity; no death and no adverse reaction; skin irritation response scores were all 0 parts; no abnormality is found in hematology examination and biochemical examination; the autopsy of the system and the pathological histology of each organ are not abnormal; no delayed toxic reaction was observed with restorative observations. It is shown that the rabbits did not produce toxic reaction when they were used the umbilicus patches of examples 11-16 of the present invention for a long period of time.
2. In vitro intestinal smooth muscle exercise test
According to examples 11-16, the added Chinese medicinal extracts were subjected to in vitro experiments to examine the effect of the radix aucklandiae extract, the clove volatile oil and the composition prepared by mixing the above materials in different proportions on the autonomous contraction of isolated jejunal smooth muscle of normal rat. The rats are fed adaptively for 1 week, fasted for 24 hours before the experiment without water prohibition, killed by cervical dislocation, and the jejunum is taken out quickly. Placing in Tyrode's nutrient solution, washing the content of the intestine to be clean, placing in a culture dish containing the nutrient solution, tying the two ends of the intestine tube with a fine wire to the ventilation hook and the tension transducer respectivelyThe above. Placing the specimen in a constant-temperature wheat water bath Tyrode's nutrient solution at 37 ℃, and slowly introducing mixed gas (95% O)2、5％CO2) And controlling the air flow to be 2-3 bubbles/second. The adjustment load is 1.5g, the balance is carried out for 20min by a BL-410 biological signal acquisition system, and after the autonomous contraction motion of the intestinal smooth muscle is in a balanced state, the contraction curve of the smooth muscle of the jejunal segment of the normal group is recorded. Adding medicine after balancing for 90min, and replacing the nutrient solution in the bath once every 20min during balancing.
(1) The influence of liquid medicines with different concentrations on the contraction and movement of the normal isolated intestine of the rat: adding liquid medicine with a certain concentration into the intestine section with the normal contraction function of the rat, respectively recording the contraction curve of the smooth muscle, and investigating the influence of the liquid medicine with different concentrations on the contraction motion of the isolated intestinal smooth muscle through parameters such as contraction amplitude, peak value difference and the like. The results are shown in tables 1 and 4.
(2) The influence of liquid medicine with different concentrations on isolated intestinal contractile hyperkinesia caused by rat acetylcholine (Ach): ach (10) was added first-5M) adding extracts with certain concentration into the perfusion muscle grooves respectively, recording the contraction curves of the smooth muscles respectively, and investigating the influence of liquid medicines with different concentrations on the contraction movement of the isolated intestinal smooth muscles through parameters such as contraction amplitude, peak difference and the like. The results are shown in tables 2 and 5.
(3) The influence of liquid medicines with different concentrations on isolated intestinal contraction and hyperkinesia caused by potassium chloride (KCl) of rats: adding KCl (60mM) firstly, then respectively adding extracts with certain concentration into perfusion muscle grooves, respectively recording the contraction curve of smooth muscle, and carrying out the influence of liquid medicines with different concentrations on the contraction movement of isolated intestinal smooth muscle through parameters such as contraction amplitude, peak value difference and the like. The results are shown in tables 3 and 6.
(4) The costustoot extract and the clove volatile oil are prepared into the composition according to different proportions, and the effect of the composition on the intestinal canal is calculated by probability sum method (Q value method) according to the inhibition rate.
The obtained data is calculated according to the following formula to obtain a Q value, wherein Q is more than 1.15 to show that the two have synergistic effect after being compatible, Q is less than 0.85 to show that the two have antagonism, and the effect is added after the two are compatible.
Wherein EAAnd EBRespectively represent the effects of the drugs alone, EA+EBRepresenting the actual effect of the two combined, EA+EB-EA×EBRepresenting the effect that should be theoretically obtained by combining the two. According to the compatibility of the compositions with different concentrations, the following components are prepared: q<0.85 exhibited antagonism; q>1.15 shows a synergistic effect; 0.85<Q<1.15 shows an additive effect. The compatibility of the costustoot extract and the clove volatile oil has the synergistic effect, and the compatibility and the use effects are better than those of the single component.
Table 1 examples 11-16 inhibition of isolated jejunal smooth muscle voluntary contraction in normal rats.
Comparison with example 11 group: p<0.05；**p<0.01; comparison with example 12 group:#p<0.05；##p<0.01.
table 2 examples 11-16 inhibition of Ach induced abnormal contraction of isolated jejunal smooth muscle in rats.
Comparison with example 11 group: p<0.05；**p<0.01; comparison with example 12 group:#p<0.05；##p<0.01；
table 3 examples 11-16 inhibit KCl-induced abnormal contraction of isolated jejunal smooth muscle in rats.
Comparison with example 11 group: p<0.05；**p<0.01; comparison with example 12 group:#p<0.05；##p<0.01；
table 4Q values of inhibition rates of isolated jejunal smooth muscle voluntary contraction in normal rats of examples 13 to 16.
Table 5 examples 13-16Q values for inhibition of abnormal rat isolated jejunal smooth muscle contraction induced by Ach.
Table 6 examples 13-16Q values for inhibition of KCl-induced abnormal contraction of rat isolated jejunal smooth muscle.
3. In vivo small intestine propulsion test
Effect on Normal mouse intestinal motility
The influence of transdermal administration on gastrointestinal motility of normal mice was studied by phenol red method in examples 11 to 16, 80 normal mice, each half of male and female, were taken, animals were fasted for 24 hours before the experiment, and were randomly divided into 8 groups of 10, each group was blank group, positive control group (bungui navel patch), examples 11 to 16 groups, blank group was blank matrix (blank matrix in example 11), administration was carried out for 3 days, 0.05% phenol red reagent was administered to each group for 1 hour after the last application, cervical dislocation was sacrificed after 20min, Intestinal mesentery was removed, Intestinal canals from pylorus was cut to ileocecal region were placed on a tray, small intestine was gently pulled straight, distance of phenol red advancement was measured, and small intestine advancement rate (Intestinal) percent was calculated as × 100% of phenol red advancement distance/total length of small intestine, as shown in table 7 and table 9.
Influence on mice intestinal hypermotility caused by neostigmine
The influence of transdermal administration on gastrointestinal motility of neostigmine mice in different examples 11-16 was studied by phenol red method, 90 mice were taken, female and male halves, animals before experiment were fasted for 24h and randomly divided into 9 groups of 10, each group was blank group, model group, positive control group (Ting Gui navel patch), example 11-16 group, administration was carried out for 3 days, after the last administration for 1h, each group was intraperitoneally injected with neostigmine 0.1mg/kg except blank group, after 15min, each group was intragastrically administered with 0.05% phenol red solution 0.3 ml/mouse, after 20min, cervical spondylolysis was sacrificed, Intestinal mesentery was taken out, pylorus to ileocecum was cut out, and placed on a tray, the small intestine was gently pulled straight, the distance of phenol red was measured, and the rate of propulsion of small intestine (Intestinal transit) was calculated as × 100% distance of phenol red per full length of intestine, as shown in table of 100%.
Table 7 effect of examples 11-16 on intestinal transit rate in normal mice.
Comparison with blank group:△p<0.05；△△p<0.01; comparison with example 11 group:*p<0.05；**p<0.01; comparison with example 12 group:#p<0.05；##p<0.01.
table 8 effects of examples 11-16 on gut propulsion in neostigmine diarrheal mice.
Comparison with model groups:△p<0.05；△△p<0.01; comparison with example 11 group:*p<0.05；**p<0.01; comparison with example 12 group:#p<0.05；##p<0.01.
table 9Q values for intestinal propulsion of examples 13-16 in normal mice.
Table 10Q values for the intestinal propulsion of neostigmine-induced diarrhea mice of examples 13-16.
The compositions prepared in example 7, example 8, example 9 and example 10 are added with pharmaceutically acceptable auxiliary materials to prepare tablets according to a conventional method.
The compositions prepared in example 7, example 8, example 9 and example 10 are added with pharmaceutically acceptable auxiliary materials according to a conventional method to prepare capsules.
The compositions prepared in the embodiments 7, 8, 9 and 10 are added with pharmaceutically acceptable auxiliary materials according to a conventional method to prepare the dripping pills.
The compositions prepared in example 7, example 8, example 9 and example 10 are added with pharmaceutically acceptable auxiliary materials according to a conventional method to prepare sustained-release tablets or sustained-release capsules.
The compositions prepared in example 7, example 8, example 9 and example 10 are added with pharmaceutically acceptable auxiliary materials to prepare controlled release tablets according to a conventional method.
The compositions prepared in example 7, example 8, example 9 and example 10 are added with pharmaceutically acceptable auxiliary materials to prepare cataplasm according to a conventional method.
The gel is prepared by adding pharmaceutically acceptable auxiliary materials into the compositions prepared in example 7, example 8, example 9 and example 10 according to a conventional method.
Claims (10)
1. The traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome is characterized by comprising 1-10 parts of elecampane extract and 1-10 parts of clove volatile oil by mass.
2. The traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome according to claim 1, wherein the mass ratio of the costus root extract to the clove volatile oil is 1:1 or 2.5: 1.
3. The traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome according to claim 1 or 2, wherein the radix aucklandiae extract is prepared by the following method: drying and crushing a radix aucklandiae medicinal material, adding absolute methanol which is 8-10 times of the mass of the radix aucklandiae medicinal material, heating, refluxing and extracting for 0.5-2 hours for 2-3 times, combining extracting solutions, concentrating the extracting solutions, and drying at 40-60 ℃ to obtain the radix aucklandiae extract.
4. The traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome according to claim 1 or 2, wherein the clove volatile oil is prepared by the following method: drying and crushing the clove medicinal material by adopting a steam distillation extraction method, adding distilled water which is 5-8 times of the mass of the clove medicinal material, heating and refluxing, condensing the volatile oil in a constant-pressure dropping funnel together with steam, extracting for 4-6 hours, placing the liquid in the constant-pressure dropping funnel in a separating funnel, separating and separating an oil layer, and dehydrating and drying by using anhydrous sodium sulfate to obtain the clove volatile oil.
5. Use of a composition according to any one of claims 1 to 4 for the manufacture of a medicament for the treatment of diarrhea-predominant irritable bowel syndrome.
6. The use according to claim 5, wherein the pharmaceutical formulation is an oral formulation or an external formulation.
7. The use of claim 6, wherein the oral dosage form is tablet, capsule, drop pill, sustained release formulation or controlled release formulation.
8. The use according to claim 6, wherein the external preparation is in the form of a cataplasm or a gel.
9. An umbilical patch comprising the composition of any of claims 1 to 4 characterized by comprising in parts by mass: 4-10 parts of sodium alginate, 4-10 parts of beeswax, 305-10 parts of polyvinylpyrrolidone K, 30-70 parts of glycerol, 1-10 parts of menthol, 10-30 parts of a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome and 10-30 parts of distilled water.
10. A method for preparing the umbilical patch of claim 9 characterized by the steps of:
(1) weighing 5-10 parts by weight of polyvinylpyrrolidone K30 and 30-70 parts by weight of glycerol, adding 10-30 parts by weight of distilled water, continuously stirring on a water bath at 60-80 ℃ until polyvinylpyrrolidone K30 is completely dissolved, and cooling to 40-60 ℃;
(2) adding 4-10 parts of sodium alginate, stirring uniformly to form a colloid, and placing in a water bath at 40-60 ℃ for heat preservation;
(3) melting 4-10 parts of beeswax, adding 10-30 parts of a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome, adding 1-10 parts of menthol, uniformly mixing, adding the mixture into the jelly obtained in the step (2), uniformly stirring, coating the mixture in a self-made mold, and curing at 40-60 ℃ for 4-6 hours to obtain the umbilical patch.
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| 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 |
| 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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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102861124A (en) * | 2012-10-29 | 2013-01-09 | 重庆师范大学 | Costus root combination medicine and application thereof |
| CN103961391A (en) * | 2014-04-17 | 2014-08-06 | 陈新灵 | Medicine composition for treating gastrointestinal psychoneurosis |
| 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 |
| CN105287812A (en) * | 2014-07-16 | 2016-02-03 | 成都三恒和创生物技术有限公司 | Medicine composition for treating irritable bowel syndromes and application of medicine composition |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102861124A (en) * | 2012-10-29 | 2013-01-09 | 重庆师范大学 | Costus root combination medicine and application thereof |
| CN103961391A (en) * | 2014-04-17 | 2014-08-06 | 陈新灵 | Medicine composition for treating gastrointestinal psychoneurosis |
| CN105287812A (en) * | 2014-07-16 | 2016-02-03 | 成都三恒和创生物技术有限公司 | Medicine composition for treating irritable bowel syndromes and application of medicine composition |
| 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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