CN109820954A - A kind of Chinese medicine composition, preparation method and its purposes on chronic non-atrophic gastritis drug is treated in preparation - Google Patents
A kind of Chinese medicine composition, preparation method and its purposes on chronic non-atrophic gastritis drug is treated in preparation Download PDFInfo
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Abstract
The invention belongs to a kind of technical field of traditional Chinese medicines, it is specifically related to a kind of Chinese medicine composition, preparation method and its purposes on the chronic non-atrophic gastritis drug of preparation treatment, following parts by weight of component, 3 parts of hedgehog fungus mycelium, 3 parts of the coptis, 1 part of evodia rutaecarpa processed, 3 parts and 1 part of bletilla of vinegar rhizoma corydalis, present invention reduces the contents of bletilla, with hedgehog fungus mycelium, the coptis and vinegar rhizoma corydalis are as main formula, using evodia rutaecarpa processed and bletilla as auxiliary formula, limit its specific ratio, and limit the coptis, evodia rutaecarpa processed, the extracting method of vinegar rhizoma corydalis and bletilla four traditional Chinese medicine material, it was found that it has good effect in terms for the treatment of chronic non-atrophic gastritis, compared to original formula, its effect goes up not down, its possible reason is that the proportion of 5 kinds of specific components has played the effect of drug matching, and the extracting method of glacial acetic acid increases The content for having added its effective component has reached extraordinary effect.
Description
Technical field
The invention belongs to a kind of technical field of traditional Chinese medicines, be specifically related to a kind of Chinese medicine composition, preparation method and its
The purposes on chronic non-atrophic gastritis drug is treated in preparation.
Background technique
Chronic non-atrophic gastritis (Chronic non-atrophic, CNAG) refers to be changed without atrophy of gastric mucosa
The chronic gastritis of the chronic inflammatory cell infiltration based on lymphocyte and thick liquid cell is shown in change, gastric mucosa layer.It is distributed according to lesion,
It can be further divided into antral gastritis, body of stomach inflammation, full gastritis, belong to one kind of chronic gastritis.As a kind of common clinical of digestive system,
Its clinical manifestation lacks specificity, based on the above gastrointestinal tract indigestion symptom of most of patients, as post-prandial fullness, upper abdomen secret anguish,
Epigastric discomfort exacerbation of symptoms etc. after gastral cavilty portion burning heat sensation, belch, appetite or appetite are reduced, had meal has some patientss can be with
The symptoms such as body is tired, weakness of limbs, the change of stool and urine and the mitigation of weight.Due to the disease clinical symptoms be not it is very serious,
Most of patients attention degree is not high, is not treated in time, and causes the disease course of disease long, with the passing of time protracted course of disease, very influences the life of patient
Bioplasm amount.It is shown according to gastroscope findings of the survey, the disease incidence of China's chronic gastritis is up to 50% or more, rather than atrophic gastritis accounts for
The 90% of chronic gastritis, non-atrophic gastritis disease incidence account for the 80%-90% for receiving gastrocopy crowd, and disease incidence be in by
The trend that year rises, shows in stomach trouble investigation result, and chronic non-atrophic gastritis disease incidence occupy the first.And, it was reported that
80% or more adult has different degrees of chronic superficial gastritis.If do not carried out therapeutic intervention actively, the state of an illness can be further
Development.Currently, " the normal gastric mucosa-superficial gastritis-one dysplasia of atrophic gastritis-intestinal metaplasia-that Correa is proposed
The development law of gastric cancer " has been that domestic and international most experts approve.Chinese medicine thinks: feelings will is unsuccessful, intemperance of taking food, damp and hot interior life, stomach
Internal organs mechanism of qi becomes estranged and falls ill.With people's living habit, the change of dietary structure, disease incidence is increasingly increased；Helicobacter pylori
(H.pylori, Hp) since nineteen eighty-three finds, researchers largely grind to the relationship of itself and disease of digestive system
Study carefully.Hp is the main reason for causing gastritis, peptic ulcer, gastric cancer and gastric mucosa tissue sample lymthoma[7].Research shows that 80%-
There are Hp infection in 95% chronic active gastritis patient's stomach lining, Hp infection is the Etiological of chronic active gastritis,
After Long-term Infection, Mucosal atrophy and intestines can occur for some patientss.All parts of the world area Hp infection difference is very big, developing country
Infection rate is higher than developed country.It is in close relations with operating condition, educational level, economic situation, diet and hygienic habit etc..It is economical
More backward, schooling is lower, and diet and hygienic habit are poorer, and Hp infection rate is higher[12].The people that the whole world has more than 50% has
Hp infection, Western Countries Hp infection rate are 25%-50%, and developing country is up to 90%.Epidemiological survey shows me
Infection rate reaches 40%-60%, average out to 55% in state Hp adult.
The applicant applied for a kind of helicobacter pylori-resisting pharmaceutical composition for stomach illness in 2013, application No. is:
201310013628.0, including Hericium erinaceus culture 4~10, the coptis 4~8, evodia rutaecarpa 1~3, rhizoma corydalis 6~10, bletilla 6~
10, preparation method is that its above-mentioned a few taste medicine are carried out with water to mention or alcohol extracting.This formula is only adapted to treatment helicobacter pylori and draws
The disease of stomach risen, and its curative effect has further improved space.
Summary of the invention
It is treated the technical problem to be solved in the present invention is to provide a kind of Chinese medicine composition, preparation method and its in preparation chronic
Purposes on non-atrophic gastritis drug can effectively eradicate chronic non-atrophic gastritis, shorten treatment cycle.
The contents of the present invention include being no less than 0.12mg/g containing ergosterol, and hydrochloric jamaicin is no less than 18mg/g, contains
Tetrahydropalmatine is no less than 0.3mg/g, and is no less than 0.5mg/g containing rutaecarpin.
Its raw material includes following parts by weight of component, 3 parts of hedgehog fungus mycelium, 3 parts of the coptis, 1 part of evodia rutaecarpa processed, vinegar rhizoma corydalis 3
Part and 1 part of bletilla.
The preparation method of Chinese medicine composition of the invention is to extract hedgehog fungus mycelium with ethyl alcohol, and concentration obtains Hericium erinaceus
Filament medicinal extract；The coptis, evodia rutaecarpa processed, vinegar rhizoma corydalis and bletilla are added in the mixed liquor of glacial acetic acid and water, the pH of mixed liquor
Value is 2.5-3.5, is decocted, and concentration obtains medicinal material concentrate, it is mixed with hedgehog fungus mycelium medicinal extract, obtains Chinese medicine composition.
Preferably, hedgehog fungus mycelium is the second for being 60% by hedgehog fungus mycelium and volumetric concentration with the method that ethyl alcohol extracts
Alcohol mixing, extracts in three times.
Preferably, the pH value of the mixed liquor is 3.
Preferably, the density of the medicinal material concentrate is 1.10~1.15.
It preferably, further include that following preparation method, Chinese medicine composition is dry, then addition granulated into particles is added
The magnesium stearate of the silica of particle total weight 2%, particle total weight 0.7%, is made capsule.
The invention also includes the Chinese medicine compositions to treat the purposes on chronic non-atrophic gastritis drug in preparation.
The invention also includes purposes of the Chinese medicine composition on preparation treatment side of body rib pain drug.
Each Chinese medicine of recipe quantity of the invention is preferably made the capsule of every 1.22g containing crude drug, and 0.32g/.Of the invention
Drug be it is oral, three times per day, three every time.
The present invention cures mainly as chronic non-atrophic gastritis and side of body rib pain, has certain benefiting stomach and stopping pain, and easypro liver expels the heat-evil function,
For the hot and suffocating gastral cavity pain to injure one's stomach, swollen ruffian, indigestion and loss of appetite, dry mouth with bitter taste, noisy pantothenic acid etc..
We cure mainly the hot and suffocating card that injures one's stomach.We's card is by depressed liver and heat transmission, and perverse and unreasonable manner violates stomach, liver-stomach disharmony, caused by stomach internal organs is impaired.
Liver property happiness item reaches, and dislikes depression, be store blood this, body yin and use it is positive, if feelings will is unsmooth, edema with the liver involved cannot item reach, liver dysfunction, it is strongly fragrant and
Change fire；The passages through which vital energy circulates of liver is distributed in side of body rib, the certainly sick then distending pain in hypochondrium of Liver Channel；Liver body loses in soft, and taste element is weak in addition, edema with the liver involved be disease easily
In passing taste, liver-qi attacking stomach is then stomach Qi rising, therefore noisy acid regurgitation, vomiting bitter taste；Red tongue with yellowish fur, stringy,thready and rapid pulse are stagnated heat of liver channel
Time." Plain Questions to very to discuss greatly " is said: " all inverse rush to, come under fire ", " all vomitings are sour, and emergent diarrhea and tenesmus comes under heat ".It can
See on all that rush acid regurgitation etc. related with " fire ", " heat ".Intimately when clear, the circulation of vital energy in the wrong direction when drop, stomach internal organs preferably and.Therefore control and preferably let out stagnated fire clearly,
Protecting the stomach and relieve the pain, and it is inverse to drop.
We add taste to form by " danxi's experiential therapy " Zuojin Wan.Hedgehog fungus mycelium is sweet natured in side, enters taste warp, has greatly strong
Spleen benefit stomach, sharp void helps the weak, the function of promoting the circulation of qi helps digestion, can help transporting and spirit of shaking, strong decomposed and promote digestion, is longer than and controls gastral cavity pain,
Therefore be monarch with it, reason person, " seeing the disease of liver, knowing the liver disease will be transmitted into the spleen, in the ban real spleen ".Hot and suffocating because of liver injures one's stomach, and stomach internal organs has been hurt, stomach soil
It is thin and weak, it more difficult to which that imperial edema with the liver involved gram is cut down；Therefore it is intended to clear stagnated fire, when helping stomach native；Stomach soil one is prosperous, then stagnated fire difficulty is violated.Coptis bitter cold, enter the heart, liver,
Stomach meridian can rush down stagnated fire in stomach, also kind " antiemetic benefit acid regurgitation " (Compendium of Material Medica)；If the wooden fire multiplies soil, the coptis can purge the sthenic heart-fire and calming the liver
Wood, there is the wonderful of " rush down actually its son ", and the coptis can detoxify more ulcer, therefore using it is minister.It is with evodia rutaecarpa processed, bletilla, vinegar rhizoma corydalis
Assistant.Wherein evodia rutaecarpa acrid flavour processed is warm-natured, enters the warp of liver stomach two, uses it on a small quantity, can pungent scattered stagnated fire and easypro edema with the liver involved, i.e. " fire stagnation requiring dissipation " it
Meaning；It is even cold that manufacture-yellow can be helped, then the coptis is without the cool disadvantage held back and upset one's stomach；" it is stagnant that strongly fragrantization can be opened, control acid regurgitation " (Compendium of Material Medica), smooth mechanism of qi
With the swollen ruffian for the gastral cavilty that disappears；" stomach function regulating drops in coptis instinct hardship, and evodia rutaecarpa also dissipates stomach Qi pent-up, and the toil of similar Xiexin Tang shares " is (" modest
Vegetarian medicine lecture notes ").Bletilla bitter sweet and cool, myogenic sore, are longer than hemostasis, can not only prevent and treat the bleeding of stagnated fire damage stomach network, but also can make
Erosion restrains healing at the stomach internal organs of ulcer, is conducive to play its overall effect experiments have shown that improving its content.Again with the vinegar for entering liver stomach
Rhizoma corydalis, adjust edema with the liver involved, blood-activating and qi-promoting and relieve pain；" medicine origin " claims it, and " controlling that taste are depressed not to be dissipated ..., pain in the chest and abdomen, lower gas disappear
Food ", can helping for monarch drug in a prescription.Vinegar rhizoma corydalis and bletilla match, and bletilla obtains the disadvantage that rhizoma corydalis myogenic holds back ulcer and coagulates the stasis of blood without sepsis, prolong recklessly
Rope obtains bletilla, and then stagnation resolvation promoting the circulation of qi does not have the anxiety that dynamic blood injures one's stomach, and one, which walks one, keeps, and opposes each other and yet also complement each other.Furthermore modern experimental research shows that:
Hericium erinaceus can protect gastrointestinal mucosa, inhibit helicobacter pylori, promote ulcer healing, and the coptis and evodia rutaecarpa processed then have anti-gastric mucosa
Damaging action, bletilla, vinegar rhizoma corydalis have the benefits of antiulcer.
All medicines are harmonious, and spleen deficiency must mend, and stomach is empty to be good for, and stagnated fire obtains clearly, and liver stomach reconciles, and lifting is multiple normal, then gastral cavity pain can fully recover from an illness.
Therefore taste-blindness rate is controlled with we, especially chronic non-atrophic gastritis can be rated as good dose.
The invention has the advantages that the present invention is modified on the basis of original formula, original formula is hedgehog hydnum
Bacterium culture 4~10, the coptis 4~8, evodia rutaecarpa 1~3, rhizoma corydalis 6~10 and bletilla 6~10, bletilla therein are orchid family many years
The dry tuber of the raw herbaceous plant bletilla striata, major function include: 1, hemostasis, have good local hemostasis to act on, and are seen according to preliminary
It examines, principle is to make hemagglutination, forms artificial thrombus.The haemostatic effect at bletilla striata end is certain rapidly, is better than Japanses beauty-berry grass, size
Ji etc..2, antibacterial, in vitro test significantly inhibit effect to large-scale tubercle bacillus, can also inhibit gram-positive bacteria.3, resist true
Bacterium, flooding agent in vitro have inhibiting effect to Microsporon audouini.Just because of its antibiotic and sterilizing function, so in original
Have in formula, the amount of bletilla be it is most, with this come achieve the purpose that control helicobacter pylori.
Chronic non-atrophic gastritis and side of body rib pain belong to inflammation caused by bacterium etc., these diseases are treated using Chinese medicine
When, in order to reach its therapeutic effect, general way is that component or increasing of the addition with antiinflammation have antiinflammation
Constituent content, for example application No. is a kind of 201310013628.0 helicobacter pylori-resisting pharmaceutical composition for stomach illness.This
Application on this basis, reduces the content of bletilla, using hedgehog fungus mycelium, the coptis and vinegar rhizoma corydalis as main formula, with Wu processed
The fruit of medicinal cornel and bletilla limit its specific ratio as auxiliary formula, and limit the coptis, evodia rutaecarpa processed, vinegar rhizoma corydalis and bletilla four
It is fine to find that it has in terms for the treatment of chronic non-atrophic gastritis and side of body rib pain for the extracting method (glacial acetic acid extraction) of taste medicinal material
Effect, compare original formula, effect goes up not down, and possible reason is during the proportion of 5 kinds of specific components has played
The effect of medicine compatibility and the extracting method of glacial acetic acid increase the content of its effective component, have reached extraordinary effect.
Detailed description of the invention
Fig. 1 is preparation method flow chart of the invention.
Specific embodiment
Embodiment 1
The contents of the present invention include following parts by weight of component, and 3 parts of hedgehog fungus mycelium, 3 parts of the coptis, 1 part of evodia rutaecarpa processed, vinegar prolong
3 parts and 1 part of bletilla of Hu rope.
Hedgehog fungus mycelium is taken, adding volumetric concentration is that 60% ethyl alcohol extracts three times, and for the first time plus 6 times of 60% ethyl alcohol are measured, and is impregnated
It 0.5 hour, extracts 2 hours, second plus 4 times of 60% ethyl alcohol amounts are extracted 1.5 hours, and third time plus 4 times of 60% ethyl alcohol amounts mention
It takes 1.5 hours, filters, combined extract, recycle ethyl alcohol, be concentrated under reduced pressure into relative density 1.10~1.15 (60 DEG C), obtain hedgehog hydnum
Mycelium liquid extract, it is spare.Remaining coptis, evodia rutaecarpa processed, vinegar rhizoma corydalis, bletilla four traditional Chinese medicine material, acid adding water (glacial acetic acid tune
PH3.0 it) decocts three times, 6 times of amounts of first time acid adding water are impregnated 0.5 hour, are decocted 2 hours, 5 times of acid adding water respectively of second and third time
Amount decocts 1.5 hours respectively, and combined extract, being concentrated under reduced pressure into relative density is about 1.10~1.15 (60 DEG C), with Hericium erinaceus
Filament liquid extract mixes, and spray drying obtains dry extract.Above-mentioned dry extract is taken, appropriate amount of starch is added, 75% alcohol granulation dries
The magnesium stearate of dry (60 DEG C), whole grain, the silica, total weight 0.7% that add up weight 2% mixes, and is packed into capsule, is made
1000 to get.Detailed process is as shown in Figure 1.
Product characters: it visually the appearance of the three batches of samples and smells, taste, in conjunction with the actual conditions of mass production, by this moral character
Shape is set to: this product content is powder of the brown color to sepia, gas fragrance, bitter.
Identify: this product is made of hedgehog fungus mycelium, the coptis, evodia rutaecarpa processed, vinegar rhizoma corydalis, bletilla gomi herbs, with medicine-feeding
Material is that " Chinese Pharmacopoeia " 2015 editions includes kind.Therefore, medicinal material discrimination method reference " Chinese Pharmacopoeia " 2015 editions.
The contents of the present invention include following parts by weight of component, and 3 parts of hedgehog fungus mycelium, 3 parts of the coptis, 1 part of evodia rutaecarpa processed, vinegar prolong
3 parts and 1 part of bletilla of Hu rope.
Embodiment 2
Hedgehog fungus mycelium is taken, adding volumetric concentration is that 50% ethyl alcohol extracts three times, and for the first time plus 6 times of 50% ethyl alcohol are measured, and is impregnated
It 0.5 hour, extracts 2 hours, second plus 4 times of 50% ethyl alcohol amounts are extracted 1.5 hours, and third time plus 4 times of 50% ethyl alcohol amounts mention
It takes 1.5 hours, filters, combined extract, recycle ethyl alcohol, be concentrated under reduced pressure into relative density 1.10~1.15 (60 DEG C), obtain hedgehog hydnum
Mycelium liquid extract, it is spare.Remaining coptis, evodia rutaecarpa processed, vinegar rhizoma corydalis, bletilla four traditional Chinese medicine material, acid adding water (glacial acetic acid tune
PH4.0 it) decocts three times, 7 times of amounts of first time acid adding water are impregnated 0.5 hour, are decocted 2 hours, 5 times of acid adding water respectively of second and third time
Amount decocts 1.5 hours respectively, and combined extract, being concentrated under reduced pressure into relative density is about 1.10~1.15 (60 DEG C), with Hericium erinaceus
Filament liquid extract mixes, and spray drying obtains dry extract.Above-mentioned dry extract is taken, appropriate amount of starch is added, 75% alcohol granulation dries
The magnesium stearate of dry (60 DEG C), whole grain, the silica, total weight 0.7% that add up weight 2% mixes, and is packed into capsule, is made
1000 to get.Detailed process is as shown in Figure 1.
Embodiment 3
Study on the efficiency interpretation of result and evaluation
Control group: application No. is a kind of (the stomach trouble medication combinations of helicobacter pylori resistant of 201310013628.0 patent
Object).
(1) the application helicobacter pylori resistant (Hp) is tested: being divided into extracorporeal bacteria inhibitor test and is infected cause rat to Hp in vivo
Two parts are tested in the influence of chronic non-atrophic gastritis model:
1. extracorporeal bacteria inhibitor test: conventional preparation Hp bacterium solution (type strain ATCC43504) is lived after cultivating 7 days in 37 DEG C
Bacterium culture counts, and adjustment bacterial concentration is 1 × 108CFU/mL is standby as female bacteria suspension, and 4 DEG C save backup.Female bacterium is taken when test
It is 2 × 10 that liquid, which adjusts bacterial concentration,7CFU/mL is as work bacteria suspension.The appropriate the application dry extract of precise is steamed with sterilizing
Distilled water dissolution is formulated as 200.0mg/mL mother liquor, then uses two-fold dilution's method, and compound concentration is 0.3906~200.0 total respectively
10 concentration working solutions.Control group 4 (350mg/) are taken, content is taken to be formulated as 200.0mg/mL with sterile purified water dissolution
Then mother liquor uses two-fold dilution's method, compound concentration is 0.3906~200.0mg/mL totally 10 concentration working solutions respectively.Take Ah
Amdinocillin 1.0g is formulated as 8.00mg/mL mother liquor with sterile purified water dissolution and then uses two-fold dilution's method, respectively compound concentration
For 0.01563~8.00mg/mL totally 10 concentration working solutions.Hp bacteria suspension is inoculated in this Shen of various concentration by volume 1:1
It please be in drug, control group or Amoxicillin medical fluid.37 DEG C are cultivated and are observed fungistatic effect, with clarification (being visible by naked eyes bacterium growth)
The minimum concentration of developmental tube is minimal inhibitory concentration (MIC) of the sample to the bacterium.
2. infecting Hp the influence for causing the non-atrophic gastritis model of rat chronic: SD rat 80, half male and half female, weight
180~220g takes male and female each 5 to be only used as other than Normal group, remaining animal gives Hp bacterium solution (concentration by 1.5mL/ stomach-filling
It is 1 × 108CFU/mL), 1 times/week, continuous 5 weeks, duplication Hp caused chronic non-atrophic gastritis model.7 after last time infection
It, takes tail vein to carry out the anti-Hp antibody of Serological testing with slide agglutination, and antibody positive person is considered as modeling success.Selection is anti-
Body animals showing positive 50, half male and half female is randomly divided into 5 groups by gender weight, i.e., model control group, control group (0.25g/kg),
The application (dry extract) low, middle and high dose groups (0.99,1.98,3.96g crude drug/kg).Each group rat is given by 10mL/kg stomach-filling
Give corresponding dosage medical fluid, 1 times/day, continuous 28 days.Isometric distilled water is given in Normal group and model control group stomach-filling.
Next day after the last administration, each group rat CO2Anesthesia euthanasia, dissection take stomach, cut off gastral cavity along greater curvature, rushed with physiological saline
Gastric lavage chamber, from pylorus end, fixed position takes 1 piece of gastric tissue, carries out histopathology after rapid urease test detection Hp infection conditions
It learns and checks.
(2) influence of the application to the multiple factors method cause non-atrophic gastritis model of rat chronic: SD rat 60, weight
180~220g, half male and half female take male and female each 5 to be only used as other than Normal group, remaining animal uses multiple factors method (ethyl alcohol
Joint deoxysodium cholate and ammonium hydroxide) the chronic non-atrophic gastritis model of duplication, the specific method is as follows: rat model presses 10ml/kg
60% ethyl alcohol (2 times/week) and 20mmol/L deoxysodium cholate (1 times/day) are given in stomach-filling, and continuous 12 weeks；And in the 1st~6 week with
0.05% ammonium hydroxide is freely drunk as the daily drinking water of animal, the 7th~12 week using 0.1% ammonium hydroxide as the daily drinking water of rat from
By drinking.Selection hair color is withered and yellow after modeling, apathetic, take action reduced rat model 50, half male and half female, by gender
Weight be randomly divided into model control group, control group (0.25g/kg), the application (dry extract) low, middle and high dose groups (0.99,
1.98,3.96g crude drug/kg), every group 10.Each group rat gives corresponding medical fluid by 10mL/kg stomach-filling, and 1 times/day, continuous 28
It.Isometric distilled water is given in Normal group and model control group stomach-filling.It is deprived of food but not water before last dose for 24 hours, last is given
Next day after medicine, each group rat CO2Anesthesia euthanasia, dissection take stomach, ligature and cut pylorus and cardia, simultaneously with distilled water flushing
Content is collected, takes supernatant to be settled to 5mL after centrifugation, using determination of acid-basetitration stomach free acid, total acid content, and detects
Pepsin activity.Gastric tissue is taken to carry out pathological examination simultaneously.
(3) influence of the application to indocin cause rat gastric ulcer model: SD rat 70, half male and half female, weight 180~
220g.7 groups, i.e. Normal group are randomly divided by gender weight, and model control group, control group (0.25g/kg), the application is (dry
Medicinal extract) 1,2,3,4 group of dosage (0.99,1.98,3.96,7.92g crude drug/kg), every group 10.Each group rat is filled by 10mL/kg
Stomach gives corresponding dosage medical fluid, and 1 times/day, continuous 7 days, same volume was given in stomach-filling to Normal group respectively with model control group
Distilled water.It is deprived of food but not water before last dose for 24 hours, after the last administration after 30min, in addition to Normal group, the equal abdomen of remaining each group
The indocin 20mg/kg of chamber injection 2mg/mL.Cardia, pylorus are ligatured after 7h, and 10% formalin solution 5mL is injected into stomach,
Then stomach wall is cut off along greater curvature, after normal saline flushing, on a glass, reference standard carries out ulcer score for tiling, calculates
Ulcer index and 50% effective dose (ED50)。
(4) influence of the application to swollen hyperplasia of rat granuloma: SD rat 50, male, 140~180g of weight, abdominal cavity note
2% yellow Jackets 40mg/kg anesthesia, the groin at left and right sides of rat are penetrated, the operation of row aseptic operation is respectively cut 1cm long and cut
Mouthful, about 20mg disinfecting silk or cotton ball warp opening is implanted into subcutaneous, skin suture with ophthalmic tweezers.Animal is divided at random by weight after operation
5 groups, it may be assumed that blank control group, aspirin group (0.027g/kg), the application (dry extract) low, middle and high dose groups (0.99,
1.98,3.96g crude drug/kg).Each group rat gives corresponding dosage medical fluid by 10mL/kg stomach-filling, and 1 times/day, continuous 7 days.Blank
Isometric distilled water is given in the daily stomach-filling of control group.1h after the last administration, 2% yellow Jackets of each group rats by intraperitoneal injection
40mg/kg anesthesia euthanasia, dissection take out cotton balls together with granulation tissue, reject adipose tissue, weigh after 70 DEG C of baking 1h, calculate meat
Bud swells weight=cotton balls weight-cotton balls original weight amount.
(5) influence that the application Dichlorodiphenyl Acetate causes mouse writhing to react: ICR mouse 50, half male and half female, 18~22g of weight,
5 groups are randomly divided by gender weight, it may be assumed that blank control group, aspirin group (0.017g/kg), the application (dry extract) be low,
Middle and high dosage group (1.43,2.86,5.72g crude drug/kg), every group 10.Each group mouse gives corresponding agent by 20mL/kg stomach-filling
Medicine amount liquid, 1 times/day, continuous 7 days.Isometric distilled water is given in the daily stomach-filling of blank control group.30min after the last administration, each group
Mouse is only injected intraperitoneally 0.6% glacial acetic acid by 0.2mL/, each group mouse writhing incubation period and writhing in 15min after record injection
Reaction times.
Experimental result
(1) the anti-Hp test of the application: 1. extracorporeal bacteria inhibitor test, the application are 3.125mg/ to the MIC of helicobacter pylori
ML, control group are 3.125mg/mL to the MIC of helicobacter pylori；Amoxicillin is to the MIC of helicobacter pylori
0.0625mg/mL.2. infecting Hp the influence for causing the non-atrophic gastritis model of rat chronic: rat is caused chronic non-using Hp infection
Atrophic gastritis model, model rat stomach tissue fast urease detects positive reaction rate up to 100% after modeling, histopathology
It checks that display stomach lining has a large amount of inflammatory cell infiltrations, and with stomach lining necrosis and falls off, have no body of gland atrophy and enteric epithelium
Metaplasia, gastric tissue histological scores are up to 3.00 ± 0.47.The application low, middle and high dose groups fast urease detects positive reaction
Rate is respectively 70%, 50%, 30%, and high dose group Hp bacterium eradication rate dramatically increases；The detection of control group fast urease is positive
Reacting number of animals is 40%.The application low, middle and high dose groups and control group histological scores are respectively 1.90 ± 0.57,1.90
± 0.74,1.60 ± 0.84,1.50 ± 0.53, it is substantially reduced compared with model control group.
(2) the application to multiple factors method cause non-atrophic gastritis mould inflammation of rat chronic influence: rat use it is compound because
Plain method (ethyl alcohol combines deoxysodium cholate and ammonium hydroxide) the chronic non-atrophic gastritis model of duplication, rat stomach acid content is significant after modeling
Increase, pepsin activity significantly reduces, and histopathological examination shows that stomach lining there are a large amount of inflammatory cell infiltrations, and with stomach
It mucous membrane necrosis and falls off, has no body of gland atrophy and intestinal metaplasia, gastric tissue histological scores are up to 2.7 ± 0.7.The application is low,
Middle and high dosage group and control group can reduce pepsin activity, gastric acid secretion inhibiting.The application low, middle and high dose groups and right
It is respectively 2.4 ± 0.7,1.9 ± 0.9,0.7 ± 0.7,1.8 ± 1.0 according to a group histological scores, the wherein middle and high dosage group of the application
It is substantially reduced with control group histological scores.
(3) the application causes the influence of rat gastric ulcer model to indocin: rats in normal control group stomach lining is smooth, without gruel
Rotten or blutpunkte, ulcer index 0；There is red and swollen erosion in various degree, has significantly in model control group gastric mucosa
Blutpunkte, red or black threadiness ulcer, ulcer index is up to 15.40 ± 3.44；The application and control can be substantially reduced big
Mouse ulcer index, 0.99~7.92g of the application crude drug/kg can be substantially reduced ulcer index caused by indocin, resist and burst
Ulcer ED50For 1.96g crude drug/kg, 95% confidence interval is 1.29-2.76g crude drug/kg, and control group can reduce big caused by indocin
Mouse ulcer index, antiulcer ED50For 2.54g crude drug/kg.
(4) influence of the application to swollen hyperplasia of rat granuloma: rat forms obvious meat 7 days after groin is implanted into cotton balls
Bud is swollen, and wherein blank control group granuloma weight is up to 0.119 ± 0.021g, and middle and high dose of aspirin group, control group, the application
Amount group granuloma weight is respectively 0.085 ± 0.019g, 0.113 ± 0.023g, 0.095 ± 0.023g, 0.086 ± 0.016g,
Wherein aspirin group and the application group granuloma weight are substantially reduced compared with blank control group.
(5) the application Dichlorodiphenyl Acetate causes the influence of mouse writhing reaction: mouse is anti-using intraperitoneal injection glacial acetic acid induction writhing
It answers, after injection in 15min, blank control group writhing number is up to 11 ± 4 times, and writhing incubation period is 254 ± 51 seconds, with blank control
Group is compared, and aspirin group animal writhing incubation period significantly extends, the application each dosage group animal writhing incubation period in dosage according to
Property is relied to extend trend.The application low, middle and high dose groups and aspirin group and control group mice writhing number are respectively 2 ± 1
Secondary, 4 ± 1 times, 3 ± 1 times, 2 ± 1 times, 6 ± 1 times, substantially reduce compared with blank control group.Aspirin group writhing response inhibits
Rate is 71.96%, the application low, middle and high dose groups writhing response inhibiting rate in dose dependent increase be respectively 38.32%,
59.81%, 81.31%.
Experiment conclusion
In conclusion the effective dose tested of the Pharmacodynamics of the application be its clinical quasi- equivalent dose (mouse:
1.43g crude drug/kg, rat: 0.99g crude drug/kg), and equivalent dose 1 again between 8 times effectively.Pharmacodynamics test result with
Major function is almost the same, prompts the application to have and significantly treats chronic non-atrophic gastritis and side of body rib pain effect.
Nature,taste and action of the development person according to each flavour of a drug of the application composition, physicochemical property, take into account medication history and habit
Used to have formulated relatively reasonable extraction and purification process, the yield of extract, anti-H.P activity reaches design requirement；The 3 of scale up test
It criticizes medicament appearance, content uniformity, Qualitive test and main active content, microorganism and meets pharmacopoeial requirements；Scale up test
The long-time stability of 3 batches of drugs, Acceleration study show that said preparation is stablized in 24 months.It is chronic non-with significantly treating
Atrophic gastritis and side of body rib pain act on, and have biggish safety within the scope of therapeutic dose.
Comparative example 1
The contents of the present invention include following parts by weight of component, and 3 parts of hedgehog fungus mycelium, 3 parts of the coptis, 1 part of evodia rutaecarpa processed, vinegar prolong
3 parts and 1 part of bletilla of Hu rope.
Hedgehog fungus mycelium is taken, three times, every time plus 6 times are measured extracting in water (i.e. the weight ratio of water and medicinal material is 6:1), are mentioned every time
It takes 1 hour, filters, combined extract, be concentrated and dried, obtain hedgehog fungus mycelium liquid extract, it is spare.Remaining coptis, evodia rutaecarpa processed, vinegar
Rhizoma corydalis, bletilla four traditional Chinese medicine material, add water to cook three times, and for the first time plus 6 times of amounts of water are impregnated 0.5 hour, decoct 2 hours, second and third
It is secondary to add 5 times of water amounts respectively, it decocts 1.5 hours respectively, combined extract, being concentrated under reduced pressure into relative density is about 1.10~1.15
(60 DEG C) are mixed with hedgehog fungus mycelium liquid extract, and spray drying obtains dry extract.Above-mentioned dry extract is taken, appropriate amount of starch is added,
75% alcohol granulation is dried (60 DEG C), whole grain, and the magnesium stearate of the silica, total weight 0.7% that add up weight 2% mixes,
Be packed into capsule to get.
The content of the effective component of comparative analysis embodiment 1 and comparative example 1, obtains data shown in table 1.
The content balance of the effective component of 1 embodiment 1 of table and comparative example 1
| Technical solution | Ergosterol | Berberine hydrochloride | Tetrahydropalmatine | Rutaecarpin |
| Embodiment 1 | 0.21mg/g | 19.8mg/g | 0.42mg/g | 0.59mg/g |
| Comparative example 1 | 0.06mg/g | 14.2mg/g | 0.21mg/g | 0.36mg/g |
Chinese medicine composition of the invention is all significantly better than existing Chinese medicine preparation in terms of effective component and curative effect.
Claims (8)
1. a kind of Chinese medicine composition, characterized in that be no less than 0.12mg/g containing ergosterol, hydrochloric jamaicin is no less than
18mg/g is no less than 0.3mg/g containing tetrahydropalmatine, and is no less than 0.5mg/g containing rutaecarpin.
2. a kind of Chinese medicine composition as described in claim 1 contains following parts by weight of component, 3 parts of hedgehog fungus mycelium, the coptis 3
Part, 1 part of evodia rutaecarpa processed, 3 parts of vinegar rhizoma corydalis and 1 part of bletilla.
3. a kind of preparation method of Chinese medicine composition as claimed in claim 1 or 2, characterized in that include the following steps, by monkey
Head mycelium is extracted with ethyl alcohol, is concentrated, is obtained hedgehog fungus mycelium medicinal extract；The coptis, evodia rutaecarpa processed, vinegar rhizoma corydalis and bletilla are added
To in the mixed liquor of glacial acetic acid and water, the pH value of mixed liquor is 2.5-3.5, is decocted, and concentration obtains medicinal material concentrate, by itself and
The mixing of hedgehog fungus mycelium medicinal extract, obtains Chinese medicine composition.
4. preparation method as claimed in claim 3, characterized in that hedgehog fungus mycelium is with the method that ethyl alcohol extracts, by hedgehog hydnum
The ethyl alcohol that mycelium and volumetric concentration are 60% mixes, and extracts in three times.
5. preparation method as claimed in claim 3, characterized in that the pH value of the mixed liquor is 3.
6. preparation method as claimed in claim 3, characterized in that the density of the medicinal material concentrate is 1.10~1.15.
7. preparation method as claimed in claim 3, characterized in that it further include that following preparation method, Chinese medicine composition is dried,
Granulated into particles is added, the silica of particle total weight 2%, the magnesium stearate of particle total weight 0.7%, system is then added
At capsule.
8. a kind of Chinese medicine composition that the preparation method such as any one of claim 1,2 or claim 3-7 obtains is controlled in preparation
Treat the purposes on chronic non-atrophic gastritis drug.
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| CN112569308A (en) * | 2020-12-24 | 2021-03-30 | 湖南新汇制药股份有限公司 | Stomach-invigorating and adverse-rising energy-lowering capsule and preparation method and application thereof |
| CN113694140A (en) * | 2021-09-30 | 2021-11-26 | 安徽九洲方圆制药有限公司 | Traditional Chinese medicine composition for treating digestive system diseases and application thereof |
| WO2024078507A1 (en) * | 2022-10-10 | 2024-04-18 | 深圳市中医院 | Use of ergosterol in preparation of drug for preventing and treating gastric ulcers |
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