CN1274351C - Medicine combination for treating child fastidium - Google Patents
Medicine combination for treating child fastidium Download PDFInfo
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- CN1274351C CN1274351C CNB031194753A CN03119475A CN1274351C CN 1274351 C CN1274351 C CN 1274351C CN B031194753 A CNB031194753 A CN B031194753A CN 03119475 A CN03119475 A CN 03119475A CN 1274351 C CN1274351 C CN 1274351C
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Abstract
The present invention relates to a medicine composition for curing child anorexia, particularly to a medicine composition contains Chinese yam, chicken gizzard-membrane or extracts of the chicken gizzard-membrane, optional coix seed, lotus seed, tuckahoe, fructus, hawthorn, medicated leaven, malt, radish seed or extracts of the radish seed.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition that is used for the treatment of infantile anorexia.The pharmaceutical composition that particularly contains Rhizoma Dioscoreae and Endothelium Corneum Gigeriae Galli or its extract.
Background technology
Along with the improving constantly and child rearing is not very done in the proper way of people's living standard, the incidence rate of infantile anorexia is ascendant trend year by year, has now become one of department of pediatrics common disease.Primary disease mostly occurred in 1-12 year.The cardinal symptom of this disease is inappetence, see that food do not covet, sees that food detests, even the refusal feed.This disease often makes child's neurolysis, loses weight, resistance against diseases weakens, and very easily causes other diseases.
For a long time, need a kind of determined curative effect, get the medicine that effect is treated infantile anorexia efficiently.
Summary of the invention
The invention provides a kind of pharmaceutical composition that is used for the treatment of infantile anorexia, it contains Rhizoma Dioscoreae and Endothelium Corneum Gigeriae Galli or their extract.
In a preferred version of the present invention, pharmaceutical composition of the present invention also contains one or more or its extract that is selected from down group: Semen Coicis, Semen Nelumbinis, Poria, Fructus Jujubae, Fructus Crataegi, Massa Medicata Fermentata, Fructus Hordei Germinatus and Semen Raphani.
For example, contain in the pharmaceutical composition of the present invention except that Rhizoma Dioscoreae and Endothelium Corneum Gigeriae Galli or its extract, also contain Semen Coicis and Semen Nelumbinis or its extract.
Preferably, in the pharmaceutical composition of the present invention, except that Rhizoma Dioscoreae and Endothelium Corneum Gigeriae Galli or its extract, also contain Semen Coicis, Semen Nelumbinis and Poria or its extract.
More preferably, in the pharmaceutical composition of the present invention, except that Rhizoma Dioscoreae and Endothelium Corneum Gigeriae Galli or its extract, also contain Semen Coicis, Semen Nelumbinis, Poria and Fructus Jujubae or its extract.
More preferably, in the pharmaceutical composition of the present invention, except that Rhizoma Dioscoreae and Endothelium Corneum Gigeriae Galli or its extract, also contain Semen Coicis, Semen Nelumbinis, Poria, Fructus Jujubae and Fructus Crataegi or its extract.
More preferably, in the pharmaceutical composition of the present invention, except that Rhizoma Dioscoreae and Endothelium Corneum Gigeriae Galli or its extract, also contain Semen Coicis, Semen Nelumbinis, Poria, Fructus Jujubae, Fructus Crataegi and Massa Medicata Fermentata or its extract.
More preferably, in the pharmaceutical composition of the present invention, except that Rhizoma Dioscoreae and Endothelium Corneum Gigeriae Galli or its extract, also contain Semen Coicis, Semen Nelumbinis, Poria, Fructus Jujubae, Fructus Crataegi and Massa Medicata Fermentata or its extract.
More preferably, in the pharmaceutical composition of the present invention, except that Rhizoma Dioscoreae and Endothelium Corneum Gigeriae Galli or its extract, also contain Semen Coicis, Semen Nelumbinis, Poria, Fructus Jujubae, Fructus Crataegi, Massa Medicata Fermentata and Fructus Hordei Germinatus or its extract.
More preferably, in the pharmaceutical composition of the present invention, except that Rhizoma Dioscoreae and Endothelium Corneum Gigeriae Galli or its extract, also contain Semen Coicis, Semen Nelumbinis, Poria, Fructus Jujubae, Fructus Crataegi, Massa Medicata Fermentata, Fructus Hordei Germinatus and Semen Raphani or its extract.
The weight ratio of respectively distinguishing the flavor of between the medicine that contains in the preferred pharmaceutical composition of the present invention is between 1: 5 to 5: 1, and the existing of promptly every flavor medicine is 1-5 part (weight) to consumption.
More preferably, in the pharmaceutical composition of the present invention, the weight ratio between Rhizoma Dioscoreae and Endothelium Corneum Gigeriae Galli or their extract is 3: 1 to 1: 3.
In an especially preferred embodiment, in the pharmaceutical composition of the present invention, by weight, contain 250 portions of Rhizoma Dioscoreaes, 250 parts of Endothelium Corneum Gigeriae Galli, 165 parts of Semen Coiciss, 165 parts of Semen Nelumbinis, 165 parts of Poria, 250 portions of Fructus Jujubaes, 250 portions of Fructus Crataegis, 250 parts of Massa Medicata Fermentatas, 165 parts of Fructus Hordei Germinatus and 165 parts of Semen Raphanis.
Preferably, in the pharmaceutical composition of the present invention, Endothelium Corneum Gigeriae Galli and the Fructus Hordei Germinatus that may contain, the former medicine form of Massa Medicata Fermentata for pulverizing.
Preferably, in the pharmaceutical composition of the present invention, the Fructus Crataegi extract that may contain comprises water, C
1-C
3Lower alcohol and/or water-C
1-C
3The extract of lower alcohol mixture.
Preferably, in the pharmaceutical composition of the present invention, Rhizoma Dioscoreae and the corresponding extract of Semen Coicis, Semen Nelumbinis, Poria, Fructus Jujubae and Semen Raphani that may contain are water extract.
More preferably described water extract is the hot water extract.
Pharmaceutical composition of the present invention is preferably powder, oral liquid, electuary or granule.
More preferably, pharmaceutical composition of the present invention is a granule.
In addition, the present invention also provides a kind of method for preparing the pharmaceutical composition for the treatment of infantile anorexia, comprising the step of the water extract that mixes former medicine that Endothelium Corneum Gigeriae Galli, optional Fructus Hordei Germinatus and Massa Medicata Fermentata pulverize, optional Fructus Crataegi ethanol extraction and Rhizoma Dioscoreae and optional Semen Coicis, Semen Nelumbinis, Poria, Fructus Jujubae and Semen Raphani.
Evidence, pharmaceutical composition of the present invention can promote the gastric emptying of mice and the propulsion functions of small intestinal, and can suppress the hyperfunction gastrointestinal motility of " insufficiency of the spleen " mice.This illustrates that pharmaceutical composition of the present invention has dual regulation to the gastrointestinal motility function.In addition, pharmaceutical composition of the present invention can significantly increase gastric secretion, total acid, the pepsin output of rat or improve peptic activity of stomach.Therefore, pharmaceutical composition of the present invention has the effect that strengthens mechanicalness and chemical digestion.In addition, animal experiment shows, the food ration of pharmaceutical composition energy appetite stimulator of the present invention, increase rat.
Detailed Description Of The Invention
The raw material of Chinese medicine that uses in the pharmaceutical composition of the present invention is not had special requirement, but preferably these raw material of Chinese medicine meet the pertinent regulations under the corresponding entry in the Pharmacopoeia of the People's Republic of China nineteen ninety-five version.
Rhizoma Dioscoreae is the dry rhizome of Dioscoreaceae plant Rhizoma Dioscoreae Dioscorea opposita Thunb.According to bibliographical information, contain diosgenin, Saponin, lymphatic temperament, choline, starch, glycoprotein, free amino acid in the Rhizoma Dioscoreae, end wooden fork element, vitamin C, 3, compositions such as 4-dihydroxy benzenes ethamine.
Endothelium Corneum Gigeriae Galli is the dry inner wall of sandbag of the chicken Gallus gallus domesticus Brisson of Phasianidae animal man.According to the literature, Endothelium Corneum Gigeriae Galli contains gastric hormone and keratin etc.
Semen Coicis is the dry mature kernal of gramineae plant Semen Coicis Coix lacryma-joli L.var.ma-yuen (Roman) Stapf.According to the literature, Semen Coicis contains starch, protein, fatty oil, Palmic acid, stearic acid, oleic acid, linoleic acid, myristic acid, glyceryl linolenate, glycolipid phospholipid, vitamin B1, aminoacid, adenosine and mineral.Semen Coicis also contains Coixenolide, Coixol, Resina Ferulae acyl stigmasterol, Resina Ferulae acyl brassicasterol, Semen Coicis polysaccharide etc. in addition.
Semen Nelumbinis are the dry mature seed of nymphaeaceae plant lotus Nelumo nucifera Gaertn.Main chemical compositions in the Semen Nelumbinis is an aporphine alkaloid, and other also have trace element, polysaccharide and protein.Main alkaloid has nuciferine, N-demethyl nuciferine, pronuciferine (+)-Pronuciferine, (-)-Neferine, liensinine, isoliensinine, oxoushinsunine, miltanthin, N-methyl asimilobine, anonaine, nuciferine, armepavine, N-demethyl armepavine etc.
Poria is the dry sclerotia of Polyporaceae fungus Poria Poria cocos (Schw) Wolf.Chemical constituent in the Poria comprises polysaccharide, as pachymose, cellulose, β-pachyman, pachymaran etc.; Triterpenes is herded acid, eburicoic acid, loose Siberian cocklebur acid, loose Siberian cocklebur eo-acid etc. as pachymic acid, soil; Fatty acid is as sad, undecanoic acid, lauric acid, dodecoic acid and Palmic acid; Other are as ergosterol, natural gum, albumen, fat, mineral etc.
Fructus Jujubae is the dry mature fruit of Rhamnaceae plant Fructus Jujubae Ziziphus jujuba Mill.Fructus Jujubae contains organic acid, as belulinic acid Betulinic acid, oleanolic acid, Crataegolic acid, malic acid, tartaric acid, catechuic acid, oleic acid etc.; Triterpenes such as Crataegolic acid-3-O-be trans-and right-coumaric acyl ester alphitolic acid-3-O-is trans-right-coumaric acyl ester, Fructus Jujubae Saponin etc.; Alkaloids is Te Faling, N-nornuciferine etc. like that; Flavonoid is as 6,8-glucosulfone-2 (S)-Naringenin etc.; And saccharide, vitamin etc.
Fructus Crataegi is the dry mature fruit of rosaceous plant Fructus Crataegi Crataegus pinnatifida Bge, forms through the process of preparing Chinese medicine.Contain flavonoid such as hyperin, Quercetin, vitexin, rutin etc. in the Fructus Crataegi; Organic acid is as citric acid and methyl ester thereof, chlorogenic acid, ursolic acid, oxalic acid, malic acid, oleanolic acid, Palmic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, succinic acid etc.; Also have liposoluble constituent, saccharide, albumen, trace element etc.
Fructus Hordei Germinatus is that the mature fruit of grass Fructus Hordei Vulgaris Hordem Vulgare L. gets through the drying of germinateing.After wheat grain is soaked in water, keep preference temperature, humidity, drying when treating that plumelet grows to about 0.5 centimetre.Mainly contain amylase in the Fructus Hordei Germinatus, transform carbohydrase, vitamin, fat, phospholipid, dextrin, maltose, glucose, lipase, proteinase, oxidase, catalyzing enzyme, cellobiase, gentiobiase, agricultural clothing dextranase, emulsin, peroxidating isomerase, hordenine, hordenine, adenine, choline, betanin, lecithin etc.
Semen Raphani is the dry mature seed of crucifer Radix Raphani Raphanus sativus L..Semen Raphani contains fatty oil, volatilization wet goods.Contain erucic acid, linoleic acid, linolenic acid, glycerol sinapate, raphanin etc. in the fatty oil.
Massa Medicata Fermentata is that medicines such as Herba polygoni hydropiperis, Herba Artemisiae Annuae, Semen Armeniacae Amarum add flour or wheat bran mixes after the herbal leaven that fermentation is made.See the 22nd page of appendix of Pharmacopoeia of the People's Republic of China nineteen ninety-five version.Massa Medicata Fermentata contains volatile oil, glycoside, fatty oil and vitamin B etc.
The Chinese medicine of respectively distinguishing the flavor of that uses in the pharmaceutical composition of the present invention can be former medicine form, also can be form of extract.
In the pharmaceutical composition of the present invention, Endothelium Corneum Gigeriae Galli and Fructus Hordei Germinatus, the Massa Medicata Fermentata that may contain are preferably the former medicine form of pulverizing.
In the pharmaceutical composition of the present invention, Fructus Crataegi is preferably the form of Fructus Crataegi extract.Fructus Crataegi extract can be water body thing, C
1-C
3The extract of lower alcohol, water-C
1-C
3The extract of lower alcohol mixture or their mixture.C
1-C
3Lower alcohol is preferably ethanol.Water-alcohol mixture is preferably ethanol/water mixture, for example 50% to 95% ethanol water.
In the pharmaceutical composition of the present invention, Rhizoma Dioscoreae and Semen Coicis, Semen Nelumbinis, Poria, Fructus Jujubae and the Semen Raphani that may contain are preferably used corresponding water extract.
More preferably described water extract is the hot water extract.
Pharmaceutical composition of the present invention can be made various preparations according to the conventional method of this area, comprises water decoction, powder, oral liquid, electuary or granule.
Pharmaceutical composition of the present invention is preferably granule, more preferably the suspension ability granule.
The present invention also provides a kind of method for preparing treatment infantile anorexia disease drug, comprise one or more or its extract in Rhizoma Dioscoreae, Endothelium Corneum Gigeriae Galli or its extract and optional Semen Coicis, Semen Nelumbinis, Poria, Fructus Jujubae, Fructus Crataegi, Massa Medicata Fermentata, Fructus Hordei Germinatus and the Semen Raphani is mixed, and make final preparation in case of necessity according to a conventional method.
In a preferred version of preparation of pharmaceutical compositions method of the present invention, comprise that the water extract of former medicine that Endothelium Corneum Gigeriae Galli, optional Fructus Hordei Germinatus and Massa Medicata Fermentata are pulverized, optional Fructus Crataegi ethanol extraction and Rhizoma Dioscoreae and optional Semen Coicis, Semen Nelumbinis, Poria, Fructus Jujubae and Semen Raphani carries out blended step.
Show that through animal experiment pharmaceutical composition of the present invention has dual regulation to the gastrointestinal motility function.And can strengthen the effect of mechanicalness digestion and chemical digestion.This shows as the raising of animal appetite, food ration increase etc.
Preliminary clinical trial shows, total obvious effective rate of pharmaceutical composition of the present invention is about 83%, and cure rate is about 53%.
In addition, medicine of the present invention is the Chinese medicine preparation of safety, does not have polarity toxicity and significant long term toxicity.643 times of filling stomaches with clinical dosage do not cause acute toxic reaction to mice.With 8 weeks of dosage continuous irrigation stomach of clinical dosage 30 and 90 times, drug withdrawal observed for 2 weeks.General state, blood cell, content of hemoglobin and hepatic and renal function to rat all do not have influence, and pathological anatomy checks that each main organs sees that toxic pathology changes.Illustrate that pharmaceutical composition of the present invention does not have obvious long term toxicity, the long-time continuous medication is safe.
Further specify the present invention by following examples.
The specific embodiment
Preparation embodiment 1
Get Endothelium Corneum Gigeriae Galli 250 grams, Fructus Hordei Germinatus 165 grams and Massa Medicata Fermentata 250 grams and mix, be ground into fine powder, standby.
Get Fructus Crataegi 250 grams, add twice of 90% alcohol reflux: add the ethanol of 6 times of amounts for the first time, refluxed 2 hours; Add for the second time the ethanol of 4 times of amounts, refluxed 1.5 hours.Filter merging filtrate.The filtrate evaporated under reduced pressure that is combined is concentrated into relative density and is the clear paste of 1.26-1.30 (70 ℃), and is standby.
Get Rhizoma Dioscoreae 250 gram, Semen Coicis 165 grams, Semen Nelumbinis 165 grams, Poria 165 grams, Fructus Jujubae 250 grams, Semen Raphani 165 grams and mix with the ethanol extraction medicinal residues of Fructus Crataegi, decoct with water three times: add the water of 6 times of amounts the first time, decocted 2 hours; Add for the second time the water of 6 times of amounts, decocted 1 hour; The water that adds 4 times of amounts for the third time decocted 1 hour.Filter, merging filtrate leaves standstill.Get supernatant, be concentrated into the clear paste of relative density 1.26-1.30 (70 ℃).
With above-mentioned medicated powder and two kinds of clear paste mix homogeneously, and at 50-55 ℃ of following drying under reduced pressure.Dry thing is ground into fine powder, adds an amount of Icing Sugar, mixing.Add 40% an amount of ethanol again, granulate and drying.Make about 1000 gram granules altogether.
Preparation embodiment 2
According to the method operation for preparing embodiment 1, just wherein save Semen Coicis.
Preparation embodiment 3
According to the method operation for preparing embodiment 1, just wherein save Semen Coicis and Semen Nelumbinis.
Preparation embodiment 4
According to the method operation for preparing embodiment 1, just wherein save Semen Coicis, Semen Nelumbinis and Poria.
Preparation embodiment 5
According to the method operation for preparing embodiment 1, just wherein save Semen Coicis, Semen Nelumbinis, Poria and Fructus Jujubae.
Preparation embodiment 6
According to the method operation for preparing embodiment 1, just wherein save Semen Coicis, Semen Nelumbinis, Poria, Fructus Jujubae and Massa Medicata Fermentata.
Preparation embodiment 7
According to the method operation for preparing embodiment 1, just wherein save Semen Coicis, Semen Nelumbinis, Poria, Fructus Jujubae, Massa Medicata Fermentata and Fructus Hordei Germinatus.
Preparation embodiment 8
According to the method operation for preparing embodiment 1, just wherein save Semen Coicis, Semen Nelumbinis, Poria, Fructus Jujubae, Massa Medicata Fermentata, Fructus Hordei Germinatus and Semen Raphani.
Animal experiment
Test material
Main test material used in the following animal experiment is as follows:
1, medicine
Preparation of the present invention: prepare the preparation that embodiment obtains by the present invention, every bag of granule contains 2.0g medicated powder, and amounting to the crude drug amount is 4.15g.Just intending clinical dosage is 0.045g/kg. ≈ 0.135g/kg.d of 0.5g/11kg. ≈ of 1-3 one full year of life child.
Children's's compound recipe Endothelium Corneum Gigeriae Galli looses (being called for short Endothelium Corneum Gigeriae Galli looses): Hebei province Zunhua Municiple Pharmaceutical Factory, and the accurate word (1995) of medicine is defended No. 020084 in the Ji, and lot number is 960606.Clinical dosage is 1-3 one full year of life child 0.5g/ time, 3 times/day.Be calculated as 0.045g/kg. ≈ 0.135g/kg.d of 0.5g/11kg. ≈ by 2 one full year of life.
The reserpine injection: red flag pharmaceutical factory of Shanghai Medical Univ, lot number is 951102.
2, key instrument
Spectrophotometer: Shanghai the 3rd analytical tool factory, 721 types
3, animal
Kunming mouse, Wistar rat: provide by laboratory animal portion of Chinese Medical Sciences University.The quality certification number: distant essence is closed word No. 3, and distant essence is closed word No. 1.With the muroid feed block feed that this one produces, freely drink water.
The influence of 1 pair of mice gastric emptying of experimental example
Get test 21-23g body weight Kunming mouse, male and female half and half.By body weight, sex animal is divided into 4 groups at random, is respectively: contrast, low dosage of the present invention (1.35g/kg), high dose of the present invention (4.05g/kg) and contrast medicine Endothelium Corneum Gigeriae Galli diffusing (4.05g/kg is clinical consumptions such as high dose of the present invention) group, 20 every group.Every day, gastric infusion was 1 time.Matched group is irritated stomach and is waited capacity (0.2ml/10g) distilled water.After continuous 4 days, fasting 12 hours is freely drunk water.The next day of administration 1 time again, administration is after 40 minutes, and every group of 10 mices are only irritated stomach by 0.2ml/ and give 0.1% methyl orange solution.After the last administration 60 minutes, break cervical vertebra and put to death animal, cut open the belly, behind ligation pylorus, the cardia, get stomach and place the beaker of containing the 10ml distilled water.Cut off stomach along greater gastric curvature, gastric content is fully washed in distilled water, with NaHCO
3Solution is transferred PH to 6.0, centrifugal 10 minutes of 2000rpm.Under 420nm,, be residual methyl orange of gastric and Chinese medicine optical density with 721 type spectrophotometer photometry density.Every group of 10 mices were in addition put to death (not giving methyl orange solution) in 60 minutes behind the gastric infusion, got gastric content, and its optical density of the same survey is the residual Chinese medicine optical density of gastric with its meansigma methods.0.1% methyl orange solution 0.2ml is added in the 10ml distilled water, shake up the back and measure its optical density, be total methyl orange optical density.Be calculated as follows gastric emptying rate.Calculate each class mean and standard deviation, the significance (following examples all herewith) of difference between t value method check group.
Experimental result sees Table 1.
Table 1 preparation of the present invention is to the influence of mice gastric emptying
| Group | Dosage (g/kg.d) | Number of animals (only) | Gastric emptying rate (%, X ± SD) | |
| Contrast | Deng capacity * 5d | 10 | 35.7±5.0 | |
| The present invention | Low dosage | 1.35×5d | 10 | 38.8±6.5 |
| High dose | 4.05×5d | 10 | 44.6±5.8 ** | |
| Endothelium Corneum Gigeriae Galli looses | 4.05×5d | 10 | 41.7±6.3 * | |
Annotate: compare with matched group,
*P＜0.05,
*P＜0.01.Dosage is medicated powder amount (following each table all with).
The result shows: low dosage preparation of the present invention can improve the mice gastric emptying rate, and high dose can make the mice gastric emptying rate significantly improve (P＜0.01).Under this experimental condition, Endothelium Corneum Gigeriae Galli looses and also can obviously improve mice gastric emptying rate (P＜0.05), but it is strong the effect of clinical consumption preparation of the present invention such as to be not so good as.
The influence of 2 pairs of mice intestinal of experimental example propulsion functions
Below test is substantially according to " (herbal pharmacology experimental technique " of Qi Chen chief editor, People's Health Publisher, 1994; Method described in the 59-61 is carried out.
(1) charcoal end efflux time is measured
Get test 23-25g body weight Kunming mouse, male and female half and half.With animal fasting 24h, freely drink water.Grouping, administration is all described with experimental example 1, but contains 10% charcoal end in the last medicinal liquid.The record administration after to the time that begins to arrange melena, feces character and anus pollution condition.Press significant difference between harmonic mean method check group.Result such as table 2.
Table 2 preparation of the present invention is to the mice influence of row's melena time
| Group | Dosage (g/kg.d) | Number of animals (only) | Gastric emptying rate (divide, X ± SD) | |
| Contrast | Deng capacity * 5d | 10 | 181.8±31.3 | |
| The present invention | Low dosage | 1.35×5d | 10 | 157.0±41.4 |
| High dose | 4.05×5d | 10 | 130.7±35.2 ** | |
| Endothelium Corneum Gigeriae Galli looses | 4.05×5d | 10 | 143.6±34.4 * | |
Annotate: compare with matched group,
*P＜0.05,
*P＜0.01.
By table 2 result as seen: low dose of preparation of the present invention can shorten the time that mice begins to arrange melena.Its effect strengthens with dosage, compares with matched group during high dose, and the time that begins to arrange melena significantly shortens (P＜0.01).And etc. the effect of loosing of clinical consumption Endothelium Corneum Gigeriae Galli is strong.Each is organized stool in mice and all is shaped, and anus is uncontaminated.
(2) the intestinal propulsion rate is measured
1, coloclysis dose regimen
Animal, grouping, administration are all described with experimental example 1.Broke cervical vertebra execution animal in 30 minutes after the administration, cut open the belly, separate mesentery, the clip pylorus is to the small intestinal of ileocecus.Measure small intestinal total length and charcoal end advance distance in enteric cavity.Be calculated as follows the intestinal propulsion rate.
Result of the test such as table 3.
Table 3 preparation gastric infusion of the present invention is to the propulsive influence of mouse small intestine
| Group | Dosage (g/kg.d) | Number of animals (only) | The intestinal propulsion rate (%, X ± SD) | |
| Contrast | Deng capacity * 5d | 10 | 54.7±6.5 | |
| The present invention | Low dosage | 1.35×5d | 10 | 62.1±7.6 * |
| High dose | 4.05×5d | 10 | 66.5±9.7 ** | |
| Endothelium Corneum Gigeriae Galli looses | 4.05×5d | 10 | 64.8±10.9 * | |
Annotate: compare with matched group,
*P＜0.05,
*P＜0.01.
Table 3 is the result show: can improve mouse small intestine propelling rate significantly during preparation low dosage of the present invention, its effect strengthens with dosage.It is slightly strong the effect that clinical consumption Endothelium Corneum Gigeriae Galli looses such as to compare.
2, duodenal administration method
Animal, grouping, dosage, intestinal propulsion rate are measured and calculate all the same, but by duodenum 25 minutes execution animals after jejunal lumen slowly injects medicine.Result such as table 4.
Table 4 preparation duodenal administration of the present invention is to the propulsive influence of mouse small intestine
| Group | Dosage (g/kg.d) | Number of animals (only) | Gastric emptying rate (%, X ± SD) | |
| Contrast | Deng capacity * 5d | 10 | 32.1±8.0 | |
| The present invention | Low dosage | 1.35×5d | 10 | 39.3±5.1 * |
| High dose | 4.05×5d | 10 | 46.7±5.2 *** | |
| Endothelium Corneum Gigeriae Galli looses | 4.05×5d | 10 | 40.8±6.8 *△ | |
Annotate: compare with matched group,
*P＜0.05,
* *P＜0.01;
Compare △ P＜0.05 with high dose group.
By table 4 result as seen: can obviously improve intestinal propulsion rate (P＜0.05) during preparation low dosage of the present invention, the effect of high dose is than the remarkable enhancing of low dosage, and clinical consumption Endothelium Corneum Gigeriae Galli loose strong (P＜0.05) such as compares.The result who measures with gastric infusion intestinal propulsion rate and charcoal end efflux time is consistent, but lower than the propelling rate of gastric infusion, and it is relevant wriggling function to be weakened with the operation stimulation.Though intestinal propulsion rate and efflux time that Gastric lavage is measured mainly reflect the intestinal propulsion function, are subjected to the interference of gastric emptying.This result of the test further shows: preparation of the present invention can promote the intestinal propulsion function.
3 pairs of reserpines of experimental example cause the influence of " insufficiency of the spleen " mice intestinal propulsion functions
Get test 22-24g body weight Kunming mouse, male and female half and half.Animal is divided into 5 groups at random by sex, body weight, is respectively: normal control, model contrast, low dosage of the present invention, high dose of the present invention and Endothelium Corneum Gigeriae Galli loose and organize.Except that capacity normal saline such as normal control group subcutaneous injection, press 0.25mg/kg dosage subcutaneous injection of reserpine injection, every day 1 time, continuous 10 days.Since the 6th day, by the described dosage gastric infusion of previous embodiment (two matched groups wait the capacity distilled water), every day 1 time, totally 5 times, the 5th then contained the medicinal liquid at 10% charcoal end.30 fens the same mensuration intestinal propulsion rates after the last administration.The results are shown in Table 5.
Table 5 preparation of the present invention causes the propulsive influence of " insufficiency of the spleen " mouse small intestine to reserpine
| Group | Dosage (g/kg.d) | Number of animals (only) | The intestinal propulsion rate (%, X ± SD) | |
| Normal control | Deng capacity * 5d | 10 | 54.2±7.2 | |
| The model contrast | Deng capacity * 5d | 10 | 61.3±6.7△ | |
| The present invention | Low dosage | 1.35×5d | 10 | 59.3±7.2 |
| High dose | 4.05×5d | 10 | 55.6±3.9 * | |
| Endothelium Corneum Gigeriae Galli looses | 4.05×5d | 10 | 56.2±3.7 * | |
Annotate: compare with model control group,
*P＜0.05;
Compare △ P＜0.05 with the normal control group.
The result shows: the model control group animal action is slow, bradykinesia, Curled contracts, the quilt hair is withered, arranges yellow half congealed soft stool, and the intestinal propulsion rate significantly improves (P＜0.05) than normal control group.Above-mentioned " insufficiency of the spleen " symptom of administration treated animal alleviates than model control group is obvious.The existing effect trend that reduces of preparation low dose group animal intestinal propulsion rate of the present invention can significantly reduce (P＜0.05) during high dose, and it is strong the effect of loosing of clinical consumption Endothelium Corneum Gigeriae Galli such as to compare.This shows that preparation of the present invention can suppress hyperfunction gastrointestinal motility.
The influence of 4 pairs of rat gastric juice of experimental example secretory function
Get test 140-160g body weight Wistar rat, male and female half and half.Be divided into 4 groups at random by sex, body weight, be respectively: contrast, preparation low dosage of the present invention (0.81g/kg), preparation high dose of the present invention (2.43g/kg), Endothelium Corneum Gigeriae Galli diffusing (2.43g/kg) group.Every day gastric infusion once, successive administration 4 days, single cage is raised after the last administration, fasting 24h freely drinks water.Under etherization, cut open the belly, behind the ligation pylorus,, sew up incision of abdominal wall again by duodenal administration 1 time.Fasting, taboo water were broken cervical vertebra and are put to death animal after 5 hour, took out stomach behind the ligation cardia, collected gastric juice.Collected gastric juice centrifugal 15 minutes with 3000rpm is drawn supernatant.After measuring the gastric juice amount, titrimetry is surveyed total acidity, calculates total acid output; Measure peptic activity of stomach with wheat Te Shi capillary glass-tube method, calculate the pepsin output.Result such as table 6.
Table 6 preparation of the present invention is to the excretory influence of rat gastric juice (X ± SD)
| Group | Dosage (g/kg.d) | Number of animals (only) | Gastric juice amount (ml/ only) | Total acidity (mEq/h) | Total acid output (μ Eq/h) | Peptic activity of stomach (unit of activity/ml) | The pepsin output (unit of activity/h) | |
| Contrast | Deng capacity * 5d | 10 | 5.07± 0.73 | 88.85± 6.85 | 89.81± 12.55 | 407.45± 53.60 | 417.06± 94.58 | |
| The present invention | Low dosage | 0.81×5d | 10 | 6.01± 0.79 * | 88.60± 20.08 | 108.85± 38.19 | 488.90± 66.12 ** | 586.04± 99.05 ** |
| High dose | 2.43×5d | 10 | 6.34± 1.12 ** | 90.49± 21.56 | 112.76± 24.44 * | 508.90± 69.07 ** | 645.56± 138.18 *** | |
| Endothelium Corneum Gigeriae Galli looses | 2.43×5d | 10 | 6.27± 0.81 ** | 88.94± 18.11 | 110.86± 20.93 * | 490.18± 64.90 ** | 614.13± 108.43 *** | |
Annotate: compare with matched group
*P＜0.05,
*P＜0.01,
* *P＜0.001.
Table 6 is the result show: preparation of the present invention can increase gastric secretion significantly, though can not obviously improve total acidity, can significantly increase total acid output; And can improve peptic activity of stomach, increase the pepsin output.Its effect clinical consumption Endothelium Corneum Gigeriae Galli such as is compared and is loose strong slightly.
The influence of 5 pairs of rat food rations of experimental example
Get the Wistar rat of test, male and female half and half with the 105-120g body weight.Grouping is with above-mentioned embodiment, each 5 of every group of male and female.Female tom sub-cage rearing is fed the pellet with the capacity oven dry, freely drinks water, but does not feed vegetable.Claim feedstuff heavy in 8 o'clock mornings of every day, the decrement method is asked feed consumption every day.Calculate average food ration of every of male and female rat, every day respectively.By dosage gastric infusion every day in the experimental example 41 time, successive administration 7 days (being n=14).The results are shown in Table 7.
Table 7 preparation of the present invention is to the influence of rat food ration
| Group | Dosage (g/kg.d) | Number of animals (only) | The intestinal propulsion rate (g/ is only. day, X ± SD) | |
| Contrast | Deng capacity * 7d | 10 | 6.9±2.5 | |
| The present invention | Low dosage | 0.81×7d | 10 | 8.6±4.9 |
| High dose | 2.43×7d | 10 | 9.6±4.2 * | |
| Endothelium Corneum Gigeriae Galli looses | 2.43×7d | 10 | 9.0±4.2 * | |
Annotate: compare with matched group,
*P＜0.05;
By table 7 result as seen: preparation of the present invention can make the food ration of rat increase when low dosage, and its effect strengthens with increase of dosage, compares significantly with matched group during high dose and increases (P＜0.05).It is strong slightly the effect that clinical consumption Endothelium Corneum Gigeriae Galli looses such as to compare.
The influence that 6 pairs of rat body weights of experimental example increase
Get the Wistar rat of test, male and female half and half with the 90-105g body weight.Grouping, administration are with above-mentioned embodiment.Feed with capacity essence, greenfeed, freely drink water.Weigh morning next day after the last administration, with body weight difference before the administration be the index of body weight gain.Be calculated as follows the body weight gain rate.
Result such as table 8.
The influence that table 8 preparation of the present invention increases rat body weight
| Group | Dosage (g/kg.d) | Number of animals (only) | The intestinal propulsion rate (%, X ± SD) | |
| Contrast | Deng capacity * 7d | 10 | 21.15±3.21 | |
| The present invention | Low dosage | 0.81×7d | 10 | 22.19±2.82 |
| High dose | 2.43×7d | 10 | 23.50±2.67 | |
| Endothelium Corneum Gigeriae Galli looses | 2.43×7d | 10 | 23.27±2.74 | |
Table 8 is the result show: preparation of the present invention and Endothelium Corneum Gigeriae Galli loose the rat body weight rate of increase is increased, but with matched group difference with insignificance (P＞0.05), may be because administration time be short (so long term toxicity test is because dosage is big, administration time is long, and the body weight gain rate is significantly increased).
Above animal experiment shows that preparation of the present invention can promote the gastric emptying of mice, the intestinal propulsion function, and can suppress the hyperfunction gastrointestinal motility of " insufficiency of the spleen " mice, illustrating has dual regulation to the gastrointestinal motility function.Still can significantly increase the gastric secretion of rat, total acid and pepsin output, improve peptic activity of stomach.Illustrate that preparation of the present invention has the effect that strengthens mechanicalness and chemical digestion, this has also obtained further confirmation in the test of preparation energy appetite stimulator of the present invention, increase rat food ration.Irritating body weight gain that stomach gives the precious rat of my child in continuous 7 days has the effect trend of increase, illustrates that also preparation of the present invention has the effect that strengthens digestive function.
Clinical trial
The present inventor utilizes the preparation for treating infantile anorexia of preparation embodiment 1, has carried out clinical observation, and the result is summarized as follows.
Object and method
One, physical data
30 routine patients are all from Hospital Attached to Liaoning Inst. of Traditional Chinese Medicine Pediatric Clinic patient, male's 18 examples, women's 12 examples, the oldest 12 years old, minimum 2 years old, average 5.5 years old.Simple weakness of the spleen and stomach person 24 examples, weakness of the spleen and stomach dyspepsia inner stopper 6 examples of holding concurrently.The course of disease is the shortest two months, and is the longest 48 months, average course of disease 26 months.
Two, diagnostic criteria
Tcm diagnosis, medicine typing standard with reference to due to weakness of spleen and stomach in " Pediatrics of Chinese Medicine " five editions relevant infantile anorexia of teaching material.
1. infantile anorexia diagnostic criteria
(1) long-term inappetence, and do not have other disease patient, the course of disease is more than 2 months.
(2) lustreless complexion, body are thin partially, but spirit is fair, no abdominal distention.
(3) the improper feeding history is arranged, do not have at regular time and quantity, feed raw food, sweet savoury or monophagia etc. as feed.
2. qi-deficiency of spleen and stomach infantile anorexia diagnostic criteria
Cardinal symptom: 1. anorexia or refusing to eat; 2. shallow complexion
Minor symptom: 1. refreshing tired weak; 2. emaciated physique; 3. big loose stool is thin; 4. pale tongue with white fur; 5. moderate pulse is unable.
Diagnosis: possess any two of cardinal symptom and minor symptom, can establish diagnosis.
Therapy: give the pharmaceutical preparation that obtains by preparation embodiment 1, every day 3 times, 2-3 year infant obey 0.5g at every turn, the 4-8 infant is obeyed 1.0g at every turn, each clothes 2.0g of 9-12 year.
Three, curative effect determinate standard: formulate with reference to the relevant apositia content of " disease of tcm criterion of therapeutical effect " department of pediatrics part.
1. clinical recovery: appetite and appetite all recover normal; Weight recovery is to standard body weight; Other clinical symptoms disappears substantially.
2. produce effects: appetite and appetite all obviously increase; Body weight obviously increases, and body weight is near the mark; Other clinical symptoms is obviously improved.
3. effective: appetite and appetite all increase to some extent; Body weight increases to some extent; Other clinical symptoms makes moderate progress.
4. invalid: the basic no change of appetite, appetite and body weight, or increase the weight of; Other clinical symptoms does not also have improvement.
Result and analysis
In whole 30 examples, clinical cure 16 examples (53.3%), produce effects 9 examples (30%), effective 4 examples (13.3%), invalid 1 example (3.3%).Total obvious effective rate 83.3%.Wherein weakness of the spleen and stomach is held concurrently and is stopped to cure in 6 examples 3 examples (50%) in the dyspepsia, produce effects 2 examples (33.3%), effective 1 example (16.6%), due to illness routine less, with simple weakness of the spleen and stomach person relatively, see the following form.
| Pattern of syndrome | The example number | Cure | Produce effects | Effectively | Total effective rate |
| The weakness of the spleen and stomach weakness of the spleen and stomach is held concurrently and is stopped in the dyspepsia to add up to | 24 6 30 | 13(54.2％) 3(50％) 16(53.3％) | 7(29.2％) 2(33.3％) 9(30％) | 3(9％) 2(33.3％) 4(13.3％) | (95.8％) (100％) (96.7％) |
Prove that through above-mentioned preliminary clinical trial pharmaceutical composition of the present invention has definite curative effect to the treatment infantile anorexia.
Claims (18)
1. pharmaceutical composition that is used for the treatment of infantile anorexia is characterized in that being made by following raw medicaments in portion by weight:
Endothelium Corneum Gigeriae Galli 250, Rhizoma Dioscoreae 250, Fructus Crataegi 250, Fructus Jujubae 250, Massa Medicata Fermentata 250, Fructus Hordei Germinatus 165, Semen Raphani 165.
2. pharmaceutical composition according to claim 1, wherein Rhizoma Dioscoreae and Fructus Jujubae, Semen Raphani are the water extract that it is made with water extraction.
3. pharmaceutical composition according to claim 2, wherein said water extract are the hot water extract.
4. pharmaceutical composition according to claim 1 is characterized in that also having Poria 165 weight portions in the crude drug.
5. pharmaceutical composition according to claim 4, wherein Poria is the water extract that it is made with water extraction.
6. pharmaceutical composition according to claim 5, wherein said water extract are the hot water extract.
7. pharmaceutical composition according to claim 4 is characterized in that also having Semen Nelumbinis 165 weight portions in the crude drug.
8. pharmaceutical composition according to claim 7, wherein Semen Nelumbinis are water extract that it is made with water extraction.
9. pharmaceutical composition according to claim 8, wherein said water extract are the hot water extract.
10. pharmaceutical composition according to claim 7 is characterized in that also having Semen Coicis 165 weight portions in the crude drug.
11. pharmaceutical composition according to claim 10, wherein Semen Coicis is the water extract that it is made with water extraction.
12. pharmaceutical composition according to claim 11, wherein said water extract are the hot water extract.
13. according to each described pharmaceutical composition of claim 1～12, wherein Endothelium Corneum Gigeriae Galli and Fructus Hordei Germinatus, Massa Medicata Fermentata are the former medicine form of pulverizing.
14. according to each described pharmaceutical composition of claim 1～12, wherein Fructus Crataegi is the extract that its extraction is made.
15. pharmaceutical composition according to claim 14, wherein Fructus Crataegi extract is meant water, C
1-C
3Lower alcohol and/or water-C
1-C
3The extract of lower alcohol mixture.
16. according to each described pharmaceutical composition of claim 1～12, it is powder, oral liquid, electuary or granule.
17. pharmaceutical composition according to claim 16, it is a granule.
18. a method for preparing the described pharmaceutical composition of claim 10 is comprising the step of the water extract that mixes former medicine, Fructus Crataegi ethanol extraction and Rhizoma Dioscoreae, Semen Coicis, Semen Nelumbinis, Poria, Fructus Jujubae and Semen Raphani that Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus and Massa Medicata Fermentata pulverize.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101327015B (en) * | 2008-07-21 | 2012-03-28 | 范十足 | Bone-tonifying growth-encouraging rice flour |
| CN101455385B (en) * | 2008-11-27 | 2012-03-21 | 成都润馨堂药业有限公司 | Nutrient food capable of stimulating the appetite and invigorating the spleen |
| CN101856090B (en) * | 2010-04-21 | 2012-04-25 | 江西钰鑫健康实业有限公司 | Method for preparing nutritious food particles with infant digesting and appetizing factors |
| CN102948746B (en) * | 2011-08-31 | 2015-01-07 | 江西江中制药(集团)有限责任公司 | Milk companion for clearing fire and aiding digestion and preparation method of milk companion |
| CN102396708A (en) * | 2011-11-04 | 2012-04-04 | 黎秋萍 | Food for treating child anorexia |
| CN104366464A (en) * | 2014-01-08 | 2015-02-25 | 张生辉 | Children digestion absorption promotion health-care food and preparation method thereof |
| CN104083574A (en) * | 2014-05-31 | 2014-10-08 | 山东欣希安药业股份有限公司 | Medicine for improving children anorexia and monophagia and improving children immunity |
| CN104127756A (en) * | 2014-06-27 | 2014-11-05 | 郑尧基 | Spleen invigorating anti-diarrheal paste |
| CN104585282A (en) * | 2014-12-31 | 2015-05-06 | 无限极（中国）有限公司 | Biscuit and preparation method thereof |
| CN104826038A (en) * | 2015-04-16 | 2015-08-12 | 李殿国 | Pediatric digestion promoting syrup and preparation method thereof |
| CN104857484A (en) * | 2015-06-01 | 2015-08-26 | 湖南中医药大学 | Traditional Chinese medicine with effect of improving digestion and preparation method of traditional Chinese medicine |
| CN105194515A (en) * | 2015-10-28 | 2015-12-30 | 广州善康生物科技有限公司 | Spleen invigorating and appetite stimulating crocodile extract product composition and preparation method thereof |
| CN106417802A (en) * | 2016-07-07 | 2017-02-22 | 安徽绿月茶业有限公司 | Granulated Chinese yam tea beverage capable of assisting digestion and preparation method thereof |
| CN108245668A (en) * | 2018-01-09 | 2018-07-06 | 成都通德药业有限公司 | A kind of preparation method of compound Pepsin |
| CN108936601A (en) * | 2018-06-05 | 2018-12-07 | 河北晟和生物科技有限公司 | A kind of health food and preparation method thereof preventing children anorexia, partial eclipse |
| CN108653528A (en) * | 2018-07-30 | 2018-10-16 | 顾倪瑄 | A kind of Chinese medicine for treating children anorexia |
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