CN110051785A - A kind of composition and its preparation and preparation method for protecting gastric mucosa - Google Patents

A kind of composition and its preparation and preparation method for protecting gastric mucosa Download PDF

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Publication number
CN110051785A
CN110051785A CN201910319408.8A CN201910319408A CN110051785A CN 110051785 A CN110051785 A CN 110051785A CN 201910319408 A CN201910319408 A CN 201910319408A CN 110051785 A CN110051785 A CN 110051785A
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parts
preparation
bletilla
extract
rhizoma atractylodis
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袁俊玲
高俊鹏
兰祥
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Yuan Junling
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Zhongtai Health Science And Technology (beijing) Co Ltd
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    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105Plant extracts, their artificial duplicates or their derivatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06Fungi, e.g. yeasts
    • A61K36/07Basidiomycota, e.g. Cryptococcus
    • A61K36/076Poria
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/284Atractylodes
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/34Campanulaceae (Bellflower family)
    • A61K36/344Codonopsis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/898Orchidaceae (Orchid family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23VINDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00Food compositions, function of food ingredients or processes for food or foodstuffs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

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Abstract

The invention belongs to field of medicaments, provide the composition that a kind of pair of gastric mucosa has assistant protection function, including following component in parts by mass: 1~12 part of Radix Codonopsis, 1~12 part of Poria cocos, 1~12 part of Rhizoma Atractylodis Macrocephalae, 0.5~4 part of Radix Glycyrrhizae and 0.5~4 part of bletilla.In composition of the invention, the rich content of glycyrrhizic acid, general flavone and Thick many candies is beneficial to the maintenance of gastric mucosa.

Description

A kind of composition and its preparation and preparation method for protecting gastric mucosa
Technical field
The invention belongs to medical and health fields, are related to the composition that a kind of pair of gastric mucosa has assistant protection function.
Background technique
Gastric mucosa is the mucous membrane of gastral cavity innermost layer, is made of epithelium, lamina propria and 3 layers of muscular layer of mucosa, includes whole gastric glands, Play secrete gastric juice, the vital the digestion function of stomach effect such as gastric mucosal barrier;It is opposite in this, stomach lining inflammation, damage Wound is also main, the most common stomach illness.
Gastric mucosa damage is more common in chronic superficial gastritis patient, is a kind of common clinical, and clinic is often shown as Abdominal pain, heartburn, sour regurgitation, appetite stimulator, gasteremphraxis, belch, nausea, the symptoms such as difference of receiving.Belong to the stomachache of traditional Chinese medicine, feeling of fullness, spit The scopes such as acid, hiccup, noisy.For the ease of preferably instructing clinical and scientific research, the spleen-stomach diseases branch, China Association of Traditional Chinese Medicine will be slow Property superficial gastritis is divided into following two categories: using post-prandial fullness discomfort as primary symptom person, belonging to the scope of Chinese medicine feeling of fullness, can be named as stomach Ruffian;With epigastric pain for main disease person, it should belong to Chinese medicine stomachache scope, stomachache can be named as.Eating and drinking without temperance, spirits, pungent product etc. Impairing the spleen and stomach, transformation failure of spleen, endogenous damp formation block mechanism of qi or Yu Jiuhua thermal burn stomach, stomach Qi rising cause feeling of fullness, stomachache, vomiting etc. Disease;Or taste insufficiency of natural endowment or chronic dietary do not save or Nian Gaoti declines, weakness of the spleen and the stomach, transporting mistake department, is difficult to operate mechanism of qi, water It is wet, the stagnation of the circulation of vital energy, dampness, blood stasis are caused, it is stomach Qi rising, pretend feeling of fullness, pain.Disease disease position is dirty in close relations with liver, spleen two in stomach. Chinese medicine thinks that gastric ulcer has many-sided reason, essentially consists in stagnation of spleen-QI, dysfunction of the spleen in transportation and transformation, deficiency of stomach-Yin etc..
With the continuous improvement of social development and living standard, there are the chronic diseases marked by deficiency of vital energy (to show as that colourless lip is light, the tired body of mind is tired, palpitaition The symptoms such as the tender no tongue fur of shortness of breath, spontaneous sweating, diarrhea, frequent urination, tongue, thready and weak pulse without strength) syndrome crowd gradually decreases, In with the deficiency of Yin, yang-deficiency constitution tendency crowd reduce it is the most obvious, however because undesirable living habit still become induce taste lose The deficiency of vital energy crowd of tune goes up not down, according to State Administration of Traditional Chinese Medicine " preventive treatment of disease " health engineering announcement data show, the deficiency of vital energy Matter crowd accounting is only second to the 32.75% of gentle matter up to 12.71%, and it is the first to be in biased constitution.And for syndrome angle, Chinese medicine thinks whether which kind of cause of disease, and what is eventually led to is the chronic diseases marked by deficiency of vital energy that taste are become estranged, and with " The spleen has the function to transport and transform nutrients ", therefore chronic Superficial gastritis is often based on the tcm clinical practice syndrome of deficiency of spleen-QI and stomach-QI.
Summary of the invention
The present invention provides the composition that a kind of pair of gastric mucosa damage has auxiliary protection function based on traditional Chinese medicine and pharmacy, can It is used as health care product, is primarily adapted for use in the crowd of gastric mucosa damage.
First aspect, the present invention provide it is a kind of for protecting the composition of gastric mucosa, it is following including in parts by mass Ingredient: 1~12 part of Radix Codonopsis, 1~12 part of Poria cocos, 1~12 part of Rhizoma Atractylodis Macrocephalae, 0.5~4 part of Radix Glycyrrhizae and 0.5~4 part of bletilla.
Preferably, the composition includes following component in parts by mass: 2~6 parts of Radix Codonopsis, 2~6 parts of Poria cocos, Rhizoma Atractylodis Macrocephalae 2 ~6 parts, 1~2 part of Radix Glycyrrhizae and 1~2 part of bletilla.
It is further preferred that the composition includes following component in parts by mass: 3 parts of Radix Codonopsis, 3 parts of Poria cocos, Rhizoma Atractylodis Macrocephalae 3 Part, 1 part of Radix Glycyrrhizae, 1 part of bletilla.
On the other hand, in composition of the invention, Radix Codonopsis, Poria cocos, Rhizoma Atractylodis Macrocephalae and Radix Glycyrrhizae are by each mass parts material The extract of extraction;It preferably, is water logging extract, such as dry cream.
In the composition, Radix Codonopsis, Poria cocos, Rhizoma Atractylodis Macrocephalae and Radix Glycyrrhizae are containing by the extract of each mass parts material extraction Justice is: composition contain by the above-mentioned Radix Codonopsis for limiting mass parts, Poria cocos, Rhizoma Atractylodis Macrocephalae and each part material extraction of Radix Glycyrrhizae extract.Such as, Composition includes 1~12 part of Radix Codonopsis, 1~12 part of Poria cocos, 1~12 part of Rhizoma Atractylodis Macrocephalae, 0.5~4 part of Radix Glycyrrhizae, substantially includes by these Extract after mass parts material is extracted.
The method that extract is obtained from the drug material is well known in the art.Water logging is extracted and preparation dry cream is The extracting method of this field routine.The paste-forming rate that water logging is extracted is about 42%.
Preferably, the composition includes following component in parts by mass: 0.42~5.04 part of Radix Codonopsis extract, Poria cocos 0.42~5.04 part of extract, 0.42~5.04 part of Rhizoma Atractylodis Macrocephalae extract, 0.21~1.68 part of licorice, bletilla 0.5~4 Part.
It is further preferred that the composition includes following component in parts by mass: Radix Codonopsis extract 0.84~2.52 Part, 0.84~2.52 part of tuckahoe extracts, 0.84~2.52 part of Rhizoma Atractylodis Macrocephalae extract, 0.42~0.84 part of licorice, bletilla 1 ~2 parts.
Still further preferably, the composition includes following component in parts by mass: 1.26 parts of Radix Codonopsis extract, Fu 1.26 parts of Siberian cocklebur extract, 1.26 parts of Rhizoma Atractylodis Macrocephalae extract, 0.42 part of licorice and 1 part of bletilla.
The second aspect, provide it is a kind of for protecting the preparation of gastric mucosa, including effective component and auxiliary material, it is described effectively at It is divided into composition of the invention.
Preferably, the dosage form of the preparation be pulvis, granule, pill, tablet, capsule, paste, aqua, preferably Granule.
Preferably, the preparation is drug, health care product, food.
Those skilled in the art can the unambiguously preparation according to prior art preparation.
Preferably, in the preparation, the mass content of effective component is 60~90%, more preferably 70%~85%.
Preferably, the auxiliary material further includes sweetener, bitterness screening agent, mouthfeel modifying agent, fragrance modifying agent, solvent, battalion Support one of dose, filler or a variety of.
These auxiliary materials are all this field conventional materials, and those skilled in the art can be added according to actual needs.Example Such as, sweetener can be Sucralose, Aspartame, steviol glycoside, lactose, sorbierite etc.;Fragrance modifying agent can be ethyl Maltol, maltol, vanillic aldehyde, Red jujube flavor etc.;The filler can be maltodextrin, hydroxymethyl cellulose, rye essence, Magnesium stearate, microcrystalline cellulose, silica, xanthan gum, carragheen, guar gum etc..
In terms of third, the method for preparing invention formulation is provided, comprising: extract mentioning for Radix Codonopsis, Poria cocos, Rhizoma Atractylodis Macrocephalae and Radix Glycyrrhizae Object is taken, dry powder is made, is mixed with bletilla and auxiliary material, preparation is prepared into.
Preferably, which comprises
1) Radix Codonopsis, Poria cocos, Rhizoma Atractylodis Macrocephalae and Radix Glycyrrhizae are soaked in water, decocts and extract 2 times, obtains extracting solution;
2) it by extracting solution concentration, drying, gets dry extract;Preferably, to be concentrated under reduced pressure, vacuum degree is -0.06MPa for the concentration ~-0.08MPa, temperature are 60~65 DEG C;The drying is to be dried under reduced pressure, and vacuum degree is -0.06MPa~-0.08MPa, temperature It is 60~65 DEG C;
3) dry cream is crushed, is sieved, get dry extract powder;Bletilla and auxiliary material are crushed respectively, are sieved, bletilla powder and auxiliary material are obtained Powder;
4) dried cream powder, bletilla powder and ingredient powder are mixed, mixed powder is obtained, is prepared into preparation.
4th aspect provides composition of the invention and is preparing the application in the preparation for protecting gastric mucosa.
In the present invention, the sweet temperature of Radix Codonopsis, invigorating middle warmer and replenishing QI is monarch;Rhizoma Atractylodis Macrocephalae invigorating the spleen to dry, Poria cocos excreting dampness invigorating the spleen close Radix Codonopsis with QI invigorating Invigorating the spleen is minister;Bletilla astringing to arrest bleeding, detumescence and promoting granulation can make gastric ulcer faster heal.With for adjutant.In addition being in the sweet mitigation of Radix Glycyrrhizae Make.Four tastes are all gentle product, warm but not dry, are mended without high, strengthening spleen and nourishing stomach.Five play strengthening the spleen and replenishing qi jointly, stomach function regulating dehumidifies, The effect of expelling pus and promoting granulation, and without any incompatibility, reach the health-care effect for having assistant protection function to gastric mucosa jointly.
In composition of the invention, the rich content of glycyrrhizic acid, general flavone and Thick many candies is beneficial to the maintenance of gastric mucosa. The present invention belongs to the crowd of deficiency-weakness of spleen-QI, turbi damp obstructing in middle-JIAO for gastric mucosa damage person, using strengthening the spleen and replenishing qi, stomach function regulating dehumidifying, convergence The method of myogenic is improved, and achievees the effect that protect gastric mucosa, can meet the needs of health food market.
Detailed description of the invention
Fig. 1 is the preparation flow figure of the granular preparation of the present invention in embodiment 1.
Specific embodiment
Illustrate the present invention below in conjunction with specific embodiment, but the contents of the present invention are without being limited thereto.In following embodiment Used medicinal material, reagent, instrument can be obtained by commercially available mode;Used method etc. is also this field routine side Method, those skilled in the art's content according to specification can unambiguously implement the process and obtain accordingly result.
The present invention is, by applicant's many experiments, five kinds of ingredients to be carried out reasonable compatibility based on health protection with Chinese medicine, Obtain composition and preparation of the invention, wherein
Radix Codonopsis sweet and neutral.Returns spleen, lung channel." materia medica " record: " Radix Codonopsis power energy tonifying spleen nourishing the stomach, moistening lung and producing body fluid, tendon fortune in Gas, this is not very mutually remote with ginseng." " new compilation of materia medica " cloud: " tonifying middle-Jiao and Qi and taste, relieving thirst and restlessness.The middle micro- void of gas is mended to adjust, It is very smooth and proper." all deficiency of qi in middle-jiao physically weak burnout, the diseases such as anorexia and loose stool usually select, there is the function of good invigorating middle warmer and replenishing QI.Effect Power is gentle, is used as monarch drug in a prescription.
Poria cocos is sweet, light, puts down.Return heart, lung, spleen, kidney channel.Clearing damp and promoting diuresis, invigorating the spleen and stomach." haigoushen ": " appetizing, preventing or arresting vomiting is inverse, Kind tranquilizing mind." Rhizoma Atractylodis Macrocephalae hardship, sweet, warm.Returns spleen, stomach meridian.Strengthening the spleen and replenishing qi, eliminate dampness and have diuretic effect." Japan hanako materia medica " calls it: " only gastric disorder causing nausea is vomitted Inverse and muscles and bones is weak soft, Xuan addiction air parcel, the cold abdominal mass of married woman, Wen Ji, mountainous evil air, the long flesh of relieving restlessness." " medicine origin " cloud its: " remove Wet and middle QI invigorating, middle benefit gas, go it is wet in taste, remove stomach energy, strong taste, into diet, stomach function regulating, born fluid." always it is known as " spleen The first key medicine of air making-up and spleen enlivening ".With Poria cocos phase 5, strengthening the spleen and replenishing qi is dispelled wet turbid.As ministerial drug.
Bletilla is bitter, sweet, puckery, slightly cold.Return lung, liver, stomach meridian.Shennong's Herbal carries it: " main Carbuncle swells dislikes sore loses subcutaneous ulcer, impairment of yin Dead flesh, perverse trend in stomach." there is astringing to arrest bleeding, the function of detumescence and promoting granulation has obvious protective function to gastric mucosa damage.As adjutant.
Radix Glycyrrhizae is sweet, flat.Return heart, lung, spleen, stomach meridian." collected statements on the herbal foundation " carry its for " in and, QI invigorating, qi-restoratives, removing toxic substances medicine "." book on Chinese herbal medicine just " calls it: " taste to property that is sweet, must neutralizing, there is the function for adjusting benefit, therefore it is malicious for the solution that obtains of poison, the sum of rigid medicine obtains its Property ... help ginseng stilbene at the function of the deficiency of vital energy ".Radix Codonopsis, Rhizoma Atractylodis Macrocephalae, Poria cocos can be assisted to enhance the function invigorated the spleen and benefited qi;Again can be clearing heat and detoxicating, Relieving spasm to stop pain;Can also coordinating the drug actions of a prescription, be used as adjuvant.
Radix Codonopsis is monarch, tonifying middle-Jiao and Qi, stomach function regulating of promoting the production of body fluid in side;Minister, with the hardship temperature invigorating the spleen to dry of Rhizoma Atractylodis Macrocephalae, uses Fu with the matching of Siberian cocklebur art The sweet light invigorating the spleen excreting dampness of Siberian cocklebur, QI invigorating clearing damp is to help the function of transporting;Skilfully using bletilla is assistant, and regulating the function of the liver and stomach presses down the perverse trend (" legendary god of farming in stomach Book on Chinese herbal medicine warp "), it also can detumescence and promoting granulation, astringing to arrest bleeding.Make with Radix Glycyrrhizae, QI invigorating is in, coordinating the drug actions of a prescription.All medicine compatibilities, assist into spleen, stomach, Liver three passes through, and plays middle burnt tonifying middle-Jiao and Qi altogether, clearing damp invigorating the spleen, stomach function regulating are promoted the production of body fluid, the function of hemostasia and promoting granulation, i.e., the tune chronic diseases marked by deficiency of vital energy this, control gastral cavilty it Mark, stabilizes liver gastric injury, so that gastric mucosa damage be caused to reach simultaneous treatment of principal and subordinate symptoms to weakness of the spleen and the stomach, the body disease people having the same aspiration and interest prevents and treats combination Effect.
Embodiment 1: the preparation of granular preparation
Process as shown in Figure 1 takes Radix Codonopsis 3kg, Poria cocos 3kg, Rhizoma Atractylodis Macrocephalae 3kg, Radix Glycyrrhizae 1kg, adds the water of 10 times of quality of medicinal material (that is, 100kg) impregnates 1 hour, decocts 1.5 hours, take extracting solution;Again plus 80kg water, decoction 1.5 hours take extracting solution.It closes And extracting solution twice.It is concentrated at a temperature of -0.06MPa~-0.08MPa vacuum degree, 60~65 DEG C, obtains thick paste;Continue- It is 0.06MPa~-0.08MPa vacuum degree, dry at a temperature of 60~65 DEG C, it gets dry extract, crushes, cross 80 meshes, get dry extract powder.Out Cream rate is 42%, that is, includes Radix Codonopsis dried cream powder 1.26kg, Poria cocos dried cream powder 1.26kg, Rhizoma Atractylodis Macrocephalae dried cream powder 1.26kg, Radix Glycyrrhizae dry cream Powder 0.42kg.Bletilla 1kg, auxiliary material Sucralose 15g, xanthan gum 96g, maltodextrin 2.689kg separately are taken, is crushed, 80 meshes are crossed, Bletilla powder and ingredient powder are obtained, is mixed with dried cream powder, obtains mixed powder.By mixed powder granulation, dry and whole grain, granule is obtained.Again Through packed and inspection, final finished is obtained.
Embodiment 2: the preparation of chewable tablets
Radix Codonopsis 3kg, Poria cocos 3kg, Rhizoma Atractylodis Macrocephalae 3kg, Radix Glycyrrhizae 1kg are taken, the water (that is, 100kg) of 10 times of quality of medicinal material is added, impregnates 1 Hour, it decocts 1.5 hours, takes extracting solution;Again plus 80kg water, decoction 1.5 hours take extracting solution.Merge extracting solution twice.- 0.06MPa~-0.08MPa vacuum degree is concentrated at a temperature of 60~65 DEG C, obtains thick paste;Continue in -0.06MPa~-0.08MPa Vacuum degree, dry at a temperature of 60~65 DEG C, get dry extract, paste-forming rate 42% crushes, and crosses 80 meshes, and get dry extract powder 4.2kg, That is, including Radix Codonopsis dried cream powder 1.26kg, Poria cocos dried cream powder 1.26kg, Rhizoma Atractylodis Macrocephalae dried cream powder 1.26kg, Radix Glycyrrhizae dried cream powder 0.42kg.
It takes bletilla 1kg to crush, crosses 80 meshes, obtain bletilla powder;Lactose 1.24kg, sorbierite 1.5kg, Sucralose 5g are taken, 80 meshes are crossed, is uniformly mixed with above-mentioned dried cream powder and bletilla powder, obtains mixed powder.
It takes above-mentioned mixed powder to add 95% ethyl alcohol softwood, crosses the granulation of 20 meshes, it is dry, through 20 mesh sieves, obtain particle.
Magnesium stearate 55g is taken, 80 meshes is crossed, is uniformly mixed with above-mentioned particle, obtains total mix particle;By total mix granulation 1g/ piece, obtains plain piece.It takes film coating pre-mix dose to be dissolved with water, plain piece is coated, coating weight gain 2.5% obtains coating tablet.It takes Tablet is stated, is bottled, through outer packing after the assay was approved, as finished product.
Test case 1: mouse ethanol-induced gastric mucosal lesion restores test
Take 2 monthly age healthy male mices (purchased from Beijing Vital River Experimental Animals Technology Co., Ltd.) 45, random point At Normal group, model control group and test group, every group 15, this experiment is carried out.
The granular preparation 2g of Example 1, is configured to 10ml solution, to test group intragastric administration on mice, Normal group and mould Type control group stomach-filling 10ml physiological saline.After 30min, test group and model control group mouse are again with the 30% of 8ml/kg mouse weight Ethanol solution stomach-filling, Normal group is with the weight physiological saline stomach-filling of 8ml/kg mouse.It is administered once a day by above-mentioned medication each Group, successive administration 10 days.After administration in 10th day, it is deprived of food but not water, puts to death mouse afterwards for 24 hours, cut open the belly and take stomach.
1, Mouse Gastric Mucous Membrane damaged area is tested
Stomach is fixed in the formalin of 10v/v%, flushing is cut off after 20min, is placed in and double is seen under stereomicroscope It examines, counts damaged area (mm by micrometer2), it the results are shown in Table 1.
Table 1: Mouse Gastric Mucous Membrane damaged area statistics
Seen from table 1, for model control group relative to Normal group, gastric mucosa has conspicuousness damage, illustrates that ethyl alcohol models Success.Test group is substantially reduced relative to model control group, gastric mucosa damage area, and damage inhibiting rate reaches 48.9%, explanation Preparation of the invention can effective protection gastric mucosa, repair the gastric mucosa of damage.
2, mouse gastric tissue MDA and NO assay
Oxygen radical may participate in a plurality of types of gastric mucosa damage processes, and the abnormal stomach that may also lead to of the generation and release of NO glues Membrane damage, but have under physiological concentration to the gastrointestinal tract mucous blood flow of adjusting, the integrality for maintaining mucous membrane and barrier function important Meaning.
Mouse gastric tissue MDA and NO content assaying method: mouse takes rapidly stomach after putting to death, cuts off, and is rinsed with 4 DEG C of NS, filter Paper blots weighing preparation homogenate.0.3ml is taken to be homogenized, by MDA content in thio barbital method measurement sample.0.5ml is taken, is pressed Green method measures NO content.It the results are shown in Table 2.
Table 2: mouse gastric tissue MDA and NO content
The abnormal of gastric tissue MDA content increases during preparation of the invention can significantly lower ethanol-induced gastric mucosal lesion Height makes the horizontal rebound significantly of the NO lowered in gastric tissue, illustrates that preparation of the invention can significantly improve gastric mucosa damage, to stomach Mucous membrane has protective effect.
2 different formulations of test case compare rat pipe film injury protective effect
1, sample preparation
Sample 1: according to granule made from embodiment 1, quantitatively it is mixed into rat feed for nursing;
Sample 2: taking Radix Codonopsis 3g, Poria cocos 3g, Rhizoma Atractylodis Macrocephalae 3g, Radix Glycyrrhizae 1g, and granule is made according to the preparation process of embodiment 1, Quantitatively it is mixed into rat feed for nursing;
Sample 3: taking ginseng 3g, Poria cocos 3g, Rhizoma Atractylodis Macrocephalae 3g, Radix Glycyrrhizae 1g, and granule is made according to the preparation process of embodiment 1, Quantitatively it is mixed into rat feed for nursing;
Sample 4: taking bletilla 1g, and granule is made according to the preparation process of embodiment 1, is quantitatively mixed into rat feed for nursing;
Sample 5: taking bletilla 2g, and granule is made according to the preparation process of embodiment 1, is quantitatively mixed into rat feed for nursing.
2, test method
Healthy SD rat 56 are taken, every group 8, is randomly divided into 7 groups, respectively control group, model group and 5 samples Group.In addition to control group, gastric mucosa damage model is made using the multifactor comprehensive method, including eating and drinking without temperance, overturn round the clock, it is moist and Tilt padding, folder anal spine swashs, frequent Restraint Stress etc., continue to off-test;After modeling 4 weeks, control group and model group continue Chow diet is fed, and 5 sample sets are fed by 1~sample of sample 5 respectively, according to the dosage of each 8g, feeds 3 daily It is secondary, then persistently feed 4 weeks.
After final study is fed, it is deprived of food but not water 24 hours, then each group rat gavages battalion by 1ml/100g stomach-filling volume (black for being configured to respective concentration containing 4% milk powder, 3% sucrose, 2% cornstarch, 1% active carbon is suspended semisolid of nourishing one's nature paste Liquid), after 50 minutes, anesthetized rat is complete respectively to take out rat stomach, intestines, measures gastric emptying rate, Intestinal propulsive rate respectively.
Then, egg is connected to each group rat stomach endothelial cell tight using reverse transcription polymerase chain reaction method (RT-PCR) The expression of white (OCLN) and adhesion molecule (ICAM-1) related gene is detected.
Finally, detecting body of stomach tissue apoptosis-related protein Caspase-3 using protein immunoblot (Western-blot) With the expression of Caspase-8.
3, test result (table 3)
(1) compared with model group, P < 0.05 * prompts rat stomach injury model modeling success
(2) compared with model group,P < 0.05,P < 0.05,P < 0.05,P>0.05
(3) compared with 2 groups of sample,P>0.05
(4) compare with 2 groups of sample, 3 groups of sample, 4 groups of sample, sample 5,P<0.05
4, conclusion (of pressure testing)
(1) 3 groups of 1 group of sample, 2 groups of sample, sample protective effects shown to rat pipe film injury, 4 groups of sample, 5 groups of sample do not play protective effect, prompt the effect for being unable to reach protection gastric mucosa using the bletilla of 2 groups of dosage merely;
(2) compared with 2 groups of sample, 3 groups of the sample effects for not showing more significantly to protect gastric mucosa of rat are prompted Ginseng, Radix Codonopsis are replaced mutually smaller on composition protection gastric mucosa influential effect or without influence in composition, but Radix Codonopsis it is opposite and Say that price is lower, economy is stronger;
(3) 1 group of sample is in terms of the effect of protection gastric mucosa of rat, hence it is evident that better than 2 groups of sample, 3 groups of sample, 4 groups of sample, It 5 groups of sample, although prompt bletilla exclusive use can not play protection gastric mucosa effect, plays in the compositions of the present invention bright The effect of aobvious enhancing protection gastric mucosa effect, is indispensable.
3 auxiliary protection gastric mucosa effect human trial of test case
The patients w ith peptic ulcer disease for meeting the following conditions for 35~65 years old: 1, stomach is collected in Beijing, Hebei Province clinical base outpatient service Ulcer active stage;2, without smoking, alcohol drinking patterns;3, antibiotic, bismuth agent and acid inhibitor were not taken in January before treating.Collection altogether 126 people of subject is randomly divided into 3 groups, every group of 42 people.
Above-mentioned 3 groups are applied Primary Care, including (1) through C14Breath test detects helicobacter pylori (HP) positive, gives Give the treatment in 1 week of oral amoxicillin 1.0g (2 times a day), clarithromycin 0.5g (2 times a day);(2) Omeprazole glue is taken Capsule 20mg (2 times a day), Bismuth Potassium Citrate capsule 100mg (3 times a day), the course for the treatment of are 4 weeks.
3 groups of subjects, control group only carry out Primary Care;Test 1 group take embodiment 1 preparation granule, 8g/ bags, 1 Bag/time, 3 times/day;Test 2 groups take embodiment 2 preparation chewable tablets, 1 piece/times, 3 times/day;The course for the treatment of is 4 weeks.
Curative effect judgement: (1) about gastral cavity pain in subjective symptom judgement reference " new Chinese medicine guideline of clinical investigations " Clinical symptoms scalar quantization standard and the standard of curative effect evaluation, including 1. clinic control: symptom disappears after the course for the treatment of;2. showing Effect: after the course for the treatment of, Syndrome Scale reduces 2 grades;3. effectively: after the course for the treatment of, Syndrome Scale reduces 1 grade;4. invalid: not up to Above-mentioned standard.(2) gastroscopy effect criterion, including 1. clinical recovery: ulcer and surrounding are verified and are all disappeared;2. effective: bursting Ulcer disappears, and still has inflammation 3. effective: ulcer surface reduces 50% or more;4. invalid: ulcer surface, which reduces, is lower than 50%.
Test result
Table 4: gastral cavity pain subjective symptom judging result (case load)
Group Clinic control It is effective Effectively In vain Total effective rate
Control group 12 12 9 11 73.8%
Example 1 group 18 13 7 4 90.5%
2 groups of embodiment 19 14 6 3 92.9%
Table 5: gastral cavity pain gastroscopy effect judging result (case load)
Group Clinical recovery It is effective Effectively In vain Total effective rate
Control group 5 15 10 12 71.4%
Example 1 group 11 18 7 6 85.7%
2 groups of embodiment 9 16 12 5 88.1%
Conclusion (of pressure testing): as seen from the experiment, compared to control group, example 1 group, 2 groups of embodiment become in whole curative effect More outstanding performance is shown in terms of gesture, and is better than in terms of 3 clinic control, clinical recovery and total effective rate important indicators Control group (uses x2It examines, P < 0.05, there are significant differences).

Claims (10)

1. it is a kind of for protecting the composition of gastric mucosa, including following component in parts by mass: 1~12 part of Radix Codonopsis, Poria cocos 1~ 12 parts, 1~12 part of Rhizoma Atractylodis Macrocephalae, 0.5~4 part of Radix Glycyrrhizae and 0.5~4 part of bletilla.
2. composition according to claim 1, wherein the composition includes following component in parts by mass: Radix Codonopsis 2 ~6 parts, 2~6 parts of Poria cocos, 2~6 parts of Rhizoma Atractylodis Macrocephalae, 1~2 part of Radix Glycyrrhizae and 1~2 part of bletilla.
3. composition according to claim 1, wherein the composition includes following component in parts by mass: Radix Codonopsis 3 Part, 3 parts of Poria cocos, 3 parts of Rhizoma Atractylodis Macrocephalae, 1 part of Radix Glycyrrhizae, 1 part of bletilla.
4. described in any item compositions according to claim 1~3, including following component in parts by mass: Radix Codonopsis extract 0.42~5.04 part, 0.42~5.04 part of tuckahoe extracts, 0.42~5.04 part of Rhizoma Atractylodis Macrocephalae extract, licorice 0.21~ 1.68 parts, 0.5~4 part of bletilla;Preferably, the extract is dry cream.
5. composition according to claim 4, the composition includes following component in parts by mass: Radix Codonopsis extract 0.84~2.52 part, 0.84~2.52 part of tuckahoe extracts, 0.84~2.52 part of Rhizoma Atractylodis Macrocephalae extract, licorice 0.42~ 0.84 part, 1~2 part of bletilla;Preferably, including 1.26 parts of Radix Codonopsis extract, 1.26 parts of tuckahoe extracts, Rhizoma Atractylodis Macrocephalae extract 1.26 Part, 0.42 part of licorice and 1 part of bletilla.
6. a kind of for protecting the preparation of gastric mucosa, including effective component and auxiliary material, the effective component is Claims 1 to 5 Described in any item compositions;Preferably, the auxiliary material includes sweetener, bitterness screening agent, mouthfeel modifying agent, fragrance improvement One of agent, solvent, nutrition dose, filler are a variety of.
7. preparation according to claim 6, wherein the dosage form of the preparation is pulvis, granule, pill, tablet, capsule Agent, paste or aqua;Preferably, the preparation is drug, health care product or food.
8. preparation according to claim 6 or 7, wherein the mass content of effective component is 60~90%, preferably 70% ~85%.
9. the method for preparing any one of claim 6~8 preparation, comprising: extract mentioning for Radix Codonopsis, Poria cocos, Rhizoma Atractylodis Macrocephalae and Radix Glycyrrhizae Object is taken, dry powder is made, is mixed with bletilla and auxiliary material, preparation is prepared into;
Preferably, which comprises
1) Radix Codonopsis, Poria cocos, Rhizoma Atractylodis Macrocephalae and Radix Glycyrrhizae are soaked in water, decocts and extract 2 times, obtains extracting solution;
2) it by extracting solution concentration, drying, gets dry extract;Preferably, it is described concentration for be concentrated under reduced pressure, vacuum degree be -0.06MPa~- 0.08MPa, temperature are 60~65 DEG C;The drying is to be dried under reduced pressure, and vacuum degree is -0.06MPa~-0.08MPa, temperature 60 ~65 DEG C;
3) dry cream is crushed, is sieved, get dry extract powder;Bletilla and auxiliary material are crushed respectively, are sieved, bletilla powder and ingredient powder are obtained;
4) dried cream powder, bletilla powder and ingredient powder are mixed, mixed powder is obtained, is prepared into preparation.
10. any one of Claims 1 to 5 composition is preparing the application in the preparation for protecting gastric mucosa.
CN201910319408.8A 2019-04-19 2019-04-19 A kind of composition and its preparation and preparation method for protecting gastric mucosa Pending CN110051785A (en)

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