CN108096346B - Qianluoye cherry pit composition, preparation method thereof and application thereof in preparation of gastrointestinal motility promoting medicine - Google Patents
Qianluoye cherry pit composition, preparation method thereof and application thereof in preparation of gastrointestinal motility promoting medicine 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)
- A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
- A61K36/638—Ligustrum, e.g. Chinese privet
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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)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
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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
- A61K2236/33—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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- 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 relates to a natural medicine composition, a preparation method thereof and application thereof in preparing a medicine for promoting gastrointestinal peristalsis. The natural medicine composition consists of a Qianluo leaf cherry pit water decoction concentrated extract, a Qianluo leaf ethanol extract and a cherry pit supercritical extract according to the proportion of 4-6:2-3:1-2, has an obvious function of promoting movement for animal intestines and stomachs with normal and inhibited gastrointestinal movement, can be used for preparing a medicine for promoting gastrointestinal motility, treats gastrointestinal motility disorder, has exact curative effect and no obvious toxic or side effect, and has good application prospect.
Description
Technical Field
The invention relates to a natural pharmaceutical composition, in particular to a natural pharmaceutical composition consisting of a condensed extract of the stone of the cherry with water decoction, an ethanol extract of the stone of the cherry and a supercritical extract of the stone of the cherry, a preparation method of the natural pharmaceutical composition and application of the natural pharmaceutical composition in the preparation of medicines for promoting gastrointestinal motility.
Background
Gastrointestinal motility disorder refers to gastrointestinal diseases with various digestive tract symptoms caused by gastrointestinal motility disorder, and is the most common disease of the digestive system. Gastrointestinal motility disorders include gastrointestinal motility disorders (GIMD) and functional gastrointestinal disorders (FGID), and almost all of the gastrointestinal tract is affected. The incidence rate of Asian countries is about 5% -10%, which not only affects the quality of life and work efficiency of patients, but also consumes a large amount of public health resources, and increasingly draws attention.
The mechanisms by which gastrointestinal motility functions are regulated are complex, including the action of the central nervous system, the enteric wall nervous system, and the regulation of numerous neurotransmitters. Among them, gastrointestinal tract Cajal interstitial cells (ICC), gastrointestinal hormone and 5-hydroxytryptamine (5-HT) are important regulatory factors for gastrointestinal motility, functional and structural abnormalities are one of the factors causing gastrointestinal motility disorders, and in addition, gastrointestinal motility disorders can be caused by microangiopathy, microcirculation disturbance, metabolic disorders, helicobacter pylori infection, uremia, abnormal gastric acid secretion and the like. Except changing diet, western medicine treatment is mainly used clinically at present, and the medicines for treating gastrointestinal motility disorders comprise gastrointestinal motility promoting medicines, acid-inhibiting medicines, antacids, gastric mucosa protecting medicines, Helicobacter Pylori (HP) infection resisting medicines, antidepressants, gastrointestinal motility regulators and the like. However, clinical studies find that the adverse reactions of western medicine for treating gastrointestinal motility disorders are obvious, such as the anticholinergic metoclopramide which has the effect of inhibiting vomiting and simultaneously can block dopamine receptors, so that cholinergic receptors are relatively hyperfunction, and extrapyramidal reactions are caused. Especially, when children take the medicine, extrapyramidal reactions such as muscle tremor, head and neck backward bending, difficult pronunciation, dyskinesia and the like are more likely to occur.
The traditional Chinese medicine has rich experience in treating gastrointestinal motility disorder diseases, and is concerned by people due to definite curative effect, little side effect and difficult relapse. The Chinese medicine application includes that the qi-regulating and depression-relieving medicine includes immature bitter orange, costustoot, combined spicebush root, areca seed and the like, the spleen-strengthening and stomach-harmonizing medicine includes wrinkled gianthyssop herb, officinal magnolia bark, fortune eupatorium herb, round cardamom, tsaoko amomum fruit and the like, the dampness-drying, heat-clearing and warming medicine includes coptis root, amur corktree bark, lightyellow sophora root, swordlike atractylodes rhizome, baical skullcap root, ash bark and the like, and the blood-activating and stasis-removing medicine includes peach seed.
Qianluo is a plant of Ligustrum genus of Oleaceae family, and is mainly distributed along the coast of Shandong peninsula. Qian Luo Xiguang is cold-resistant and mostly grows at the high cliff stone slit with the elevation of 600 + 1000 m along the sea. Qian Luo Zhi, Ye, Guo and Gen all can be used as medicine, and its leaves are nutritious and can be drunk as tea. The Qianluo leaves contain a plurality of amino acids, and contain 10 kinds of inorganic elements such as rich Ca, K, Mg, Na and the like, and also contain rich medicinal components such as triterpene acid, chlorogenic acid, flavonoid compounds and the like, and have pharmacological effects of clearing away heat and toxic materials, inhibiting bacteria and diminishing inflammation, reducing blood pressure and losing weight, inhibiting cancers and preventing cancers, regulating mechanisms, resisting radiation, resisting aging, reducing blood fat and blood sugar, reducing cholesterol and triglyceride, improving blood viscosity, expanding capillaries, improving microcirculation, calming nerves, benefiting sleep and the like, and nutritional health-care effects. The cherry stone is dry mature seed of cherry (Cerasus pseudocerasus) belonging to Rosaceae deciduous shrub. According to the traditional Chinese medicine, cherry stone has the functions of releasing exterior and promoting eruption, eliminating tumor and removing scar, and promoting qi circulation and relieving pain, and belongs to the pungent-warm exterior-releasing medicines classified under exterior-releasing medicines. Research shows that the main component of cherry pit is flavonoid, which has the functions of antibiosis, antiphlogosis, mutation resistance, blood pressure reduction, heat clearing and detoxifying, sedation, diuresis, etc. and can be used as additive to be applied to food. The present inventors have completed the present invention by extensive studies and experiments on the ratio of each formulation to finally obtain the composition of the present invention having the optimum pharmaceutical ratio and confirmed that it promotes gastrointestinal motility.
Disclosure of Invention
The invention aims to provide a natural medicine composition which has the advantages of cheap and easily obtained raw materials, definite curative effect, safety, reliability, convenient application and popularization and good function of promoting gastrointestinal peristalsis.
The second purpose of the invention is to provide a preparation method of the natural medicine composition.
The third purpose of the invention is to provide the application of the natural medicine composition in preparing the medicine for promoting gastrointestinal peristalsis.
The invention provides a natural medicine composition, which consists of a condensed extract of the cherry stone decocted by water, an ethanol extract of the Qianluo leaf and a supercritical extract of the cherry stone in a ratio of 4-6:2-3: 1-2.
The natural medicinal composition comprises the water-decocted extract of the cherry stone, the ethanol extract of the cherry stone and the dosage ratio of the supercritical extract of the cherry stone of 6:3: 2.
The extract is prepared by extracting the condensed extract of the cherry stone by water decoction, the ethanol extract of the cherry stone and the supercritical extract of the cherry stone by conventional methods known by the technicians in the field, and the same curative effect can be obtained. The methods listed below are only the methods that the inventors consider to be more preferable, and are not intended to make particular restrictions on the extraction method of each component in the natural pharmaceutical composition.
Preferably, the preparation method of the condensed extract of the cherry stone decocted by water in the natural medicine composition comprises the following steps:
the compatibility proportion is 1: 1 or 1 to 5: 1 soaking folium Qian Luo and cherry pit in 10-12 times of distilled water at room temperature for 12 hr, heating and decocting in electric furnace for 2 hr, filtering with silk cloth to obtain filtrate, adding 10 times of distilled water into the residue, decocting for 1.5 hr, filtering, mixing filtrates, heating and concentrating to small volume, and vacuum drying at 50 deg.C for 48 hr to obtain brown yellow powder, which is concentrated extract of folium Qian Luo cherry pit.
The preparation method of the ethanol extract of the Qian Luo Ye in the natural medicine composition comprises the following steps:
taking dried folium Qianluo, sieving, placing in a round bottom flask, adding 10-12 times of 70% ethanol, heating and extracting in an electric heating jacket for 3 times, each time for 2h, 1.5h and 1.5h respectively, filtering, mixing filtrates, recovering ethanol with a rotary evaporator, concentrating, drying under reduced pressure to obtain dry extract, pulverizing, and sieving with 80 mesh sieve to obtain folium Qianluo ethanol extract.
The preparation method of the supercritical extract of cherry stone in the natural medicine composition comprises the following steps:
removing impurities on the surface of cherry pit, drying, pulverizing, sieving with 80 mesh sieve, extracting in supercritical device at 55 deg.C under 15MPa for 2 hr, drying the obtained extract under reduced pressure to obtain dry extract, pulverizing, sieving with 80 mesh sieve to obtain cherry pit supercritical extract;
the invention also provides a preferable preparation method of the natural medicine composition, which comprises the following steps:
(1) preparation of concentrated water decoction of Qianluoye cherry stone
The compatibility proportion is 1: 1 or 1 to 5: 1 soaking folium Qian Luo and cherry pit in 10-12 times of distilled water at room temperature for 12 hr, heating and decocting in electric furnace for 2 hr, filtering with silk cloth to obtain filtrate, adding 10 times of distilled water into the residue, decocting for 1.5 hr, filtering, mixing filtrates, heating and concentrating to small volume, and vacuum drying at 50 deg.C for 48 hr to obtain brown yellow powder, which is concentrated extract of folium Qian Luo cherry pit.
(2) Preparation of ethanol extract of folium Qian Luo
Taking dried folium Qianluo, sieving, placing in a round bottom flask, adding 10-12 times of 70% ethanol, heating and extracting in an electric heating jacket for 3 times, each time for 2h, 1.5h and 1.5h respectively, filtering, mixing filtrates, recovering ethanol with a rotary evaporator, concentrating, drying under reduced pressure to obtain dry extract, pulverizing, and sieving with 80 mesh sieve to obtain folium Qianluo ethanol extract.
(3) Preparation of supercritical extract of cherry pit
Removing impurities on the surface of cherry pit, drying, pulverizing, sieving with 80 mesh sieve, extracting in supercritical device at 55 deg.C under 15MPa for 2 hr, drying the obtained extract under reduced pressure to obtain dry extract, pulverizing, sieving with 80 mesh sieve to obtain cherry pit supercritical extract;
(4) selecting folium Rosae Laevigatae and fructus Pruni Pseudocerasi kernel at a certain proportion, decocting in water, concentrating extract, extracting folium Rosae Laevigatae with ethanol, and mixing with fructus Pruni Pseudocerasi kernel supercritical extract.
The natural medicine composition for preparing the medicine for promoting gastrointestinal motility is prepared into a preparation containing the natural medicine composition with the specification of 100mg or 500mg by adopting the conventional preparation technology, the selection of the dosage form is not particularly limited, and the natural medicine composition can be prepared into tablets, capsules, granules and the like.
The invention also comprises the application of the natural medicine composition in preparing the medicine for promoting gastrointestinal peristalsis.
The natural medicine composition has the following beneficial effects on the aspect of promoting gastrointestinal peristalsis:
1. the natural medicine composition has good function of promoting gastrointestinal peristalsis, and the composition has the advantages of cheap and easily-obtained raw materials, exact curative effect, safety, reliability and convenient application and popularization.
2. The inventor originally combines the Qianluo leaf cherry pit water decoction concentrated extract, Qianluo leaf ethanol extract and cherry pit supercritical extract, and determines the dosage ratio among the components through a large number of experiments, so that the composition plays a good synergistic effect, has obvious synergistic effect and obtains an unexpected effect of promoting gastrointestinal motility.
Detailed Description
The preparation of the natural pharmaceutical compositions of the present invention, and their beneficial effects in promoting gastrointestinal motility, are further illustrated by the following examples and test examples.
Example 1: the invention relates to a Qian Luo leaf cherry stone composition and preparation of preparation thereof
The first step is as follows: preparation of various extracts
(1) Preparation of concentrated water decoction of Qianluoye cherry stone
The compatibility proportion is 1: 1 or 1 to 5: 1 soaking folium Qian Luo and cherry pit in 10-12 times of distilled water at room temperature for 12 hr, heating and decocting in electric furnace for 2 hr, filtering with silk cloth to obtain filtrate, adding 10 times of distilled water into the residue, decocting for 1.5 hr, filtering, mixing filtrates, heating and concentrating to small volume, and vacuum drying at 50 deg.C for 48 hr to obtain brown yellow powder, which is concentrated extract of folium Qian Luo cherry pit.
(2) Preparation of ethanol extract of folium Qian Luo
Taking dried folium Qianluo, sieving, placing in a round bottom flask, adding 10-12 times of 70% ethanol, heating and extracting in an electric heating jacket for 3 times, each time for 2h, 1.5h and 1.5h respectively, filtering, mixing filtrates, recovering ethanol with a rotary evaporator, concentrating, drying under reduced pressure to obtain dry extract, pulverizing, and sieving with 80 mesh sieve to obtain folium Qianluo ethanol extract.
(3) Preparation of supercritical extract of cherry pit
Removing impurities on the surface of cherry pit, drying, pulverizing, sieving with 80 mesh sieve, extracting in supercritical device at 55 deg.C under 15MPa for 2 hr, drying the obtained extract under reduced pressure to obtain dry extract, pulverizing, sieving with 80 mesh sieve to obtain cherry pit supercritical extract;
the second step is that: preparation of the formulations
(1) Preparation of the natural medicine composition capsule of the invention
Respectively weighing 120mg of the prepared Qian Luo leaf cherry pit water decoction concentrated extract, 60mg of Qian Luo leaf ethanol extract and 40mg of cherry pit supercritical extract, simultaneously weighing 195mg of starch and 85mg of dextrin, mixing uniformly, filling into capsules, and preparing into capsules with each pure weight of 500 mg.
(2) Preparation of the Natural pharmaceutical composition tablet of the invention
Respectively weighing 120mg of the prepared Qianluo leaf cherry pit water decoction concentrated extract, 60mg of Qianluo leaf ethanol extract and 40mg of cherry pit supercritical extract, simultaneously weighing 190mg of starch and 85mg of dextrin, uniformly mixing, spraying 80% ethanol for wet granulation, drying, adding 5mg of magnesium stearate after granulation, uniformly mixing, and tabletting to obtain tablets with the pure weight of 500 mg.
(3) Preparation of the natural pharmaceutical composition granule of the invention
Respectively weighing 120mg of the prepared Qianluo leaf cherry pit water decoction concentrated extract, 60mg of Qianluo leaf ethanol extract and 40mg of cherry pit supercritical extract, simultaneously weighing 180mg of starch, 85mg of dextrin and 15mg of powdered sugar, uniformly mixing, spraying 65% ethanol for wet granulation, drying, and granulating to obtain granules with the pure weight of 500mg per bag.
Test example 1: effect of Qianluo cherry pit composition on gastric emptying and intestinal propulsion in normal mice
1. Test materials
Folium Qian Luo, collected from Laoshan mountain of Qingdao, cleaned, air dried, identified as the leaf of Qian Luo of Oleaceae;
cherry pit purchased from the Qingdao drugstore and identified as dry seed of Rosaceae plant;
preparing the composition of the water-decocted concentrated extract of the cherry stone and the ethanol extract of the cherry stone, the supercritical extract of the cherry stone, the water-decocted concentrated extract of the cherry stone and the supercritical extract of the cherry stone, and the composition of the cherry stone;
metoclopramide tablets, beijing, taiyang pharmaceutical ltd;
clean-grade Kunming mice, with the body mass of l 8-22 g, half male and half female, provided by the animal center of drug testing institute in Qingdao city, were used for experiments after being adaptively fed for one week.
2. Test method
The 60 mice are randomly divided into 6 groups, each group contains 10 mice, and the groups respectively include blank control group, Qianluo leaf cherry pit water decoction concentrated extract and Qianluo leaf ethanol extract group (composition 1), Qianluo leaf ethanol extract and cherry pit supercritical extract group (composition 2), Qianluo leaf cherry pit water decoction concentrated extract and cherry pit supercritical extract groupCritical extract group (composition 3), Qianluoye cherry stone composition group (composition 4) (20mg/10g) and Weifu' an group (0.5mg/10 g). The composition of Qian Luo Ye cherry stone is administered with corresponding medicine respectively, and the blank control group is administered with equal amount of distilled water 1 time per day for 7 days. Fasting was carried out for 14h before the last administration, and each mouse was gavaged with 0.04% phenol red solution (containing 10% gelatin) 0.11mL/100g 30min after administration. The animals were sacrificed after 20min, the stomach and small intestine were immediately removed, the small intestine was laid on white paper, the stomach was placed in 30ml of 0.5mol/L NaOH solution, the stomach was cut open along the greater curvature of the stomach, the stomach contents were washed down sufficiently, 5ml was centrifuged (3000rpm) for 10min, and the absorbance of the supernatant was measured at 560nm wavelength using T6 new century uv-vis spectrophotometer. And calculating the residual rate of the gastrol, and evaluating the gastric emptying speed by taking the residual rate of the gastrol red as an index. The intestinal tube length was measured as "total small intestine length". The distance from the pylorus to the leading edge of phenol red is taken as "the distance that phenol red advances in the intestine". By the formula
The percent of small bowel advancement was calculated.
Another 10 mice were fasted for 14h and each mouse was gavaged with 0.04% phenol red solution (containing 10% gelatin) 0.1mL/10g and sacrificed immediately. Processing according to the above method, measuring absorbance, taking the average value as standard value (gastric phenol red emptying is zero), and according to formula stomach emptying rate (%) (1-test group OD)560Standard OD560) X 100% gastric phenol red evacuation rate (%) was calculated.
3. Test results
The results are shown in Table 1. The composition of the cherry seeds can promote gastric emptying and small intestine propulsion of normal mice to different degrees, wherein the gastric emptying and small intestine propulsion promotion effect of the composition 4 is obviously better than that of other compositions (P is less than 0.05 or P is less than 0.01 compared with the compositions 1, 2 and 3 respectively), and the effect is similar to that of metoclopramide. The Qian Luo cherry stone composition has the function of promoting the gastrointestinal motility of normal mice.
TABLE 1 Effect of Qianluo cherry pit composition on gastric emptying and intestinal motility in Normal mice
Note: comparison with blank control:△P<0.05，△△P<0.01; comparison with composition 1:#P<0.05; comparison with composition 2:*P<0.05; comparison with composition 3:
test example 2: influence of Qianluo cherry pit composition on inhibition of gastric emptying and small intestine propulsion of mice caused by atropine
1. Test materials
Folium Qian Luo, collected from Laoshan mountain of Qingdao, cleaned, air dried, identified as the leaf of Qian Luo of Oleaceae;
cherry pit purchased from the Qingdao drugstore and identified as dry seed of Rosaceae plant;
preparing the composition of the water-decocted concentrated extract of the cherry stone and the ethanol extract of the cherry stone, the supercritical extract of the cherry stone, the water-decocted concentrated extract of the cherry stone and the supercritical extract of the cherry stone, and the composition of the cherry stone;
metoclopramide tablets, beijing, taiyang pharmaceutical ltd;
atropine sulfate injection, Shandong Tianfu pharmaceutical factory;
clean-grade Kunming mice, with the body mass of l 8-22 g, half male and half female, provided by the animal center of drug testing institute in Qingdao city, were used for experiments after being adaptively fed for one week.
2. Test method
70 mice were randomly divided into 7 groups of 10 mice, each group was composed of blank control group, atropine model group (1.8 μ g/10g), Qianluo cherry stone water-decocted concentrated extract and Qianluo leaf ethanol extract group (composition 1), Qianluo leaf ethanol extract and cherry stone supercritical extract group (composition 2), Qianluo cherry stone water-decocted concentrated extract and cherry stone supercritical extract group (composition 3), Qianluo cherry stone composition group (composition 4) (20mg/10g) and Weifuan group (0.5mg/10 g). The composition of Qian Luo Ye cherry stone is administered with corresponding medicine respectively, and the blank control group is administered with equal amount of distilled water 1 time per day for 7 days. Fasting is carried out for 14h before the last administration, mice in each group except a blank control group are injected with atropine 1.8 mu g/10g subcutaneously 30min after administration, and are perfused with a gastric phenol red solution 15min later, and animals are sacrificed 20min later, and the gastric phenol red evacuation rate and the small intestine propulsion rate are respectively measured according to the above methods.
3. Test results
The results are shown in Table 2. Compared with the blank control group, the mice in the atropine model group have delayed gastric emptying (P <0.01) and slow intestinal propulsion (P < 0.01). The composition of the Qianluo cherry pit can improve the slow gastrointestinal motility caused by atropine to different degrees, and the effect is most obvious by the amount of the composition 4 (compared with an atropine model group, P is less than 0.01; compared with the composition 1, the composition 2 and the composition 3, P is less than 0.05 or P is less than 0.01). The Qian Luo cherry stone composition has effect in promoting inhibition of gastric emptying and small intestine propulsion of mice caused by atropine.
Influence of composition of S.pulveratum and cherry pit on inhibition of gastric emptying and intestinal transit of atropine in mice
Note: comparison with blank control:△P<0.05; comparison with atropine model group:^P<0.01; comparison with composition 1:#P<0.05; comparison with composition 2:*P<0.05，**P<0.01; comparison with composition 3:
test example 3: influence of Qianluo cherry stone composition on inhibition of gastric emptying and small intestine propulsion of mice caused by cisplatin
1. Test materials
Folium Qian Luo, collected from Laoshan mountain of Qingdao, cleaned, air dried, identified as the leaf of Qian Luo of Oleaceae;
cherry pit purchased from the Qingdao drugstore and identified as dry seed of Rosaceae plant;
preparing the composition of the water-decocted concentrated extract of the cherry stone and the ethanol extract of the cherry stone, the supercritical extract of the cherry stone, the water-decocted concentrated extract of the cherry stone and the supercritical extract of the cherry stone, and the composition of the cherry stone;
metoclopramide tablets, beijing, taiyang pharmaceutical ltd;
cisplatin injection, Jiangsu Haofen pharmaceutical Co., Ltd;
clean-grade Kunming mice, with the body mass of l 8-22 g, half male and half female, provided by the animal center of drug testing institute in Qingdao city, were used for experiments after being adaptively fed for one week.
2. Test method
70 mice were randomly divided into 7 groups of 10 mice, each group was composed of blank control group, cisplatin group (0.1mg/10g), Qianluo cherry stone water-decocted concentrated extract and Qianluo leaf ethanol extract group (composition 1), Qianluo leaf ethanol extract and cherry stone supercritical extract group (composition 2), Qianluo cherry stone water-decocted concentrated extract and cherry stone supercritical extract group (composition 3), Qianluo cherry stone composition group (composition 4) (20mg/10g) and Weifuan group (0.5mg/10 g). Each group of mice (except blank group) was given an intraperitoneal injection of cisplatin (0.2 mL/mouse) on days 1, 3, 5, and 7, respectively. The composition of Qian Luo Ye cherry stone is administered with corresponding medicine respectively, and the blank control group is administered with equal amount of distilled water 1 time per day for 7 days. Fasting for 14h before the last administration, perfusing a phenol red solution for stomach 30min after the administration, killing the animals 20min later, taking out the stomach and the small intestine immediately, spreading the small intestine on white paper, placing the stomach in 30ml of 0.5mol/L NaOH solution, cutting the stomach along the greater curvature of the stomach, fully washing the stomach content, taking 5ml for centrifugation (3000rpm) for 10min, and measuring the absorbance of the supernatant by using a T6 new century ultraviolet visible spectrophotometer at the wavelength of 560 nm. And calculating the residual rate of the gastrol, and evaluating the gastric emptying speed by taking the residual rate of the gastrol red as an index. The intestinal tube length was measured as "total small intestine length". The distance from the pylorus to the leading edge of phenol red is taken as "the distance that phenol red advances in the intestine". By the formula
The percent of small bowel advancement was calculated.
Another 10 mice were fasted for 14h and each mouse was gavaged with 0.04% phenol red solution (containing 10% gelatin) 0.1mL/10g and sacrificed immediately. Processing according to the above method, measuring absorbance, taking the average value as standard value (gastric phenol red emptying is zero), and according to formula stomach emptying rate (%) (1-test group OD)560Standard OD560) X 100% gastric phenol red evacuation rate (%) was calculated.
3. Test results
The results are shown in Table 3. Compared with the blank control group, the mice of the cisplatin model group have delayed gastric emptying (P <0.01) and slow intestinal propulsion (P < 0.01). The composition of Qianluo cherry stone can improve the gastrointestinal motility caused by cisplatin to different degrees, wherein the composition 4 has the best effect of improving the gastrointestinal motility (compared with a cisplatin model group, P is less than 0.01; compared with the composition 1, the composition 2 and the composition 3, P is less than 0.05 or P is less than 0.01). The Qian Luo cherry stone composition has the effect of promoting the inhibition of gastric emptying and small intestine propulsion of mice caused by cisplatin.
TABLE 3 influence of composition of Qian Luo Ye cherry stone on inhibition of gastric emptying and small intestine propulsion of rats caused by cisplatin
Note: comparison with blank control:△P<0.05，△△P<0.01; comparison with cisplatin model group:^P<0.01; comparison with composition 1:#P<0.05，##P<0.01; comparison with composition 2:*P<0.05，**P<0.01; comparison with composition 3:
test example 4: acute toxicity study of Qian Luo Ye cherry pit composition of the invention
1. Test animals:
kunming mice, weighing 20 + -2 g, were purchased from the center of drug laboratory animals in Qingdao city.
2. Test drugs:
the invention relates to a Qian Luo cherry pit composition.
3. The test method comprises the following steps:
the Qianluo cherry pit composition of the present invention was subjected to acute toxicity test according to "acute toxicity test" issued by Ministry of public health of the people's republic of China and the national Committee of standardization management in China on 5.1.2004. The maximum tolerated dose method was used because LD50 could not be determined due to drug concentration and volume limitations. 20 Kunming mice, half female and half male, were taken and administered with 50mg/10g weight of Qian Luo cherry pit composition by intragastric administration. After administration, mice were observed for activity, diet, feces, respiration, body weight and death for 14 days.
4. Test results
After the gastric lavage administration, the mice of each group have good growth, weight gain and normal behavior, and have no death and abnormal reaction. After the animals were sacrificed, the main organs were not abnormally changed by visual and pathological observation.
The results show that the Qian Luo Ye cherry pit composition of the invention is orally applied in maximum dosage, has no obvious damage to animals, does not generate toxic reaction to organisms, and is a safe and reliable novel medicine composition for promoting gastrointestinal motility.
Claims (2)
1. A natural medicine composition for preparing a medicine for promoting gastrointestinal motility is characterized in that: the dosage ratio of the Qianluo leaf cherry stone water decoction concentrated extract, Qianluo leaf ethanol extract and cherry stone supercritical extract is 4-6:2-3: 1-2;
the preparation method of the Qian Luo Ye cherry stone water decoction concentrated extract comprises the following steps:
the compatibility proportion is 1: 1 or 1 to 5: soaking folium Qian Luo and cherry pit in 10-12 times of distilled water at room temperature for 12 hr, decocting in electric furnace for 2 times (2 hr and 1.5 hr for each time), filtering with silk cloth, mixing filtrates, heating and concentrating to small volume, vacuum drying at 50 deg.C for 48 hr to obtain brown yellow powder, which is concentrated extract of folium Qian Luo cherry pit;
the preparation method of the Qian Luo Ye ethanol extract comprises the following steps:
taking dry folium Qianluo, pulverizing, sieving, placing in a round-bottom flask, adding 10-12 times of 70% ethanol, heating and reflux extracting in an electric heating jacket for 3 times, each time for 2 hr, 1.5 hr, and 1.5 hr, filtering, mixing filtrates, recovering ethanol with rotary evaporator, concentrating, drying under reduced pressure to obtain dry extract, pulverizing, and sieving with 80 mesh sieve to obtain folium Qianluo ethanol extract;
the preparation method of the cherry pit supercritical extract comprises the following steps:
taking cherry pit, removing surface impurities, drying, crushing, sieving with a 80-mesh sieve, extracting in a supercritical device, extracting for 2h under the conditions that the extraction pressure is 15MPa, the extraction temperature is 55 ℃ and the solid-to-liquid ratio is 1.0mL/mg, drying the obtained extract under reduced pressure to obtain a dry extract, crushing, and sieving with the 80-mesh sieve to obtain the cherry pit supercritical extract;
selecting Qian Luo leaf cherry stone water decoction concentrated extract, Qian Luo leaf ethanol extract and cherry stone supercritical extract according to a proportion, and mixing uniformly to obtain natural pharmaceutical composition for promoting gastrointestinal motility;
the natural medicine composition for preparing the medicine for promoting gastrointestinal peristalsis is prepared into the natural medicine composition by adopting the conventional preparation technology
100mg or 200mg size formulations.
2. A natural pharmaceutical composition for the preparation of a medicament for promoting gastrointestinal motility according to claim 1, wherein: the dosage ratio of the Qianluo leaf cherry stone water decoction concentrated extract, Qianluo leaf ethanol extract and cherry stone supercritical extract is 6:3: 2.
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| 芊罗（甘枣叶）;个人图书馆;《http://www.360doc.com/content/16/1117/20/21137025_607359858.shtml》;20161117;第1-4页，尤其是第2页倒数第4段、第2段 * |
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