CN100534498C - Pharmaceutical composition used for chronic atrophic gastritis and preparation method thereof - Google Patents
Pharmaceutical composition used for chronic atrophic gastritis and preparation method thereof Download PDFInfo
- Publication number
- CN100534498C CN100534498C CNB2006100684374A CN200610068437A CN100534498C CN 100534498 C CN100534498 C CN 100534498C CN B2006100684374 A CNB2006100684374 A CN B2006100684374A CN 200610068437 A CN200610068437 A CN 200610068437A CN 100534498 C CN100534498 C CN 100534498C
- Authority
- CN
- China
- Prior art keywords
- pharmaceutical composition
- parts
- rhizoma pinelliae
- radix glycyrrhizae
- radix paeoniae
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Abstract
The invention discloses a pharmaceutical composition for treating chronic atrophic gastritis and process for preparation, wherein the raw materials of the medicinal constituents mainly include pinellia tuber, Dendrobium nobile, root of herbaceous peony and honey-fried licorice root by a predetermined weight ratio. The composition can be made into any clinically and pharmaceutically acceptable dose forms, preferably oral preparations. The pharmaceutical composition has the functions of regulating the stomach energy and promoting the secretion of the body fluid.
Description
1, technical field
The invention belongs to medical technical field, be specifically related to a kind of pharmaceutical composition that is used for chronic atrophic gastritis and preparation method thereof.
2, background technology
Chronic atrophic gastritis be a kind of be the clinical common disease of characteristics of lesion with the intrinsic body of gland atrophy of gastric mucosa, be one of clinical intractable digestive tract disease, and be attended by preventing precancerous lesion of stomach cancer characteristics such as intestinal epithelial metaplasia, atypical hyperplasia.Seek effective, reliable medicine, be the problem that domestic and international medical circle is made great efforts discussion always.Be equivalent to the traditional Chinese medical science alleged " stomach painful abdominal mass ", " asthenia ", " gastric abscess " etc. from traditional Chinese medical science angle analysis chronic atrophic gastritis, the pathological changes of chronic atrophic gastritis is this with weakened body resistance, comprises the deficiency of vital energy, yang deficiency and three kinds of basic lesion of the deficiency of YIN.Three kinds of basic lesion often intermesh, and show as weakened body resistance types such as gas yang deficiency, the gas deficiency of YIN, deficiency of both YIN and YANG.On the other hand, also may there be pathogen factors such as turbid damp, dyspepsia, blood stasis, burning hot, diseases caused by retention of fluid, the stagnation of QI in primary disease, makes its pathological changes present comparatively complicated situation.At present, doctor trained in Western medicine mainly adopts protection gastric mucosa, anti-helicobacter pylori, enhancing gastric motility to the treatment of chronic atrophic gastritis, and symptomatic treatment such as pain relieving, still lacks effective blocking-up and reverses this sick medicine.And the Chinese traditional treatment chronic atrophic gastritis is mainly controlled the principle of organic conception from the differential diagnosis in tcm opinion, microcosmic is dialectical under disease and the gastroscope treats in conjunction with debating, can giving consideration to both the incidental and fundamental, and use the treatment by Chinese herbs chronic atrophic gastritis and have no side effect, safety does not stimulate stomach, is a new treatment thinking.The medicine commonly used of treatment chronic atrophic gastritis has SANJIU WEITAI, QIXING SIFANGWEI PIAN etc. at present, though treatment gastropathy is had certain curative effect, effect is unsatisfactory.So the Chinese medicine medicine of exploitation determined curative effect, safety low-poison treatment chronic atrophic gastritis necessitates.
The Rhizoma Pinelliae is the dry tuber of aroid Rhizoma Pinelliae Pinellia ternata (Thunb.) Breit..Acrid in the mouth, warm in nature.Return spleen, stomach, lung, warp.Drying dampness to eliminate phlegm is arranged, stopping nausea and vomiting by lowering the adverse flow of QI, the effect of dissolving lump and resolving mass.Be used for the abundant expectoration cough with asthma, the phlegm retention vertigo and palpitation, dizziness due to wind-phlegm, the syncope due to accumulation of phlegm headache, vomiting regurgitation, breast gastral cavity painful abdominal mass is vexed; Give birth to external treatment carbuncle sucutaneous nodule.Rhizoma Pinelliae is the processed product of the Rhizoma Pinelliae, and its concocting method is soaked with cold water and floated a few days for getting the clean Rhizoma Pinelliae, avoid Exposure to Sunlight, bubble is after 10 days, when playing foam, per 100 jin of Rhizoma Pinelliaes add 2 jin of Alumens, steep and change water again after 1 day, after extremely mouth is tasted spicy sense is arranged slightly, it is well-done altogether to add Alumen and water, take out, dry in the air to sixty percent and do, cut into slices behind the moistening, dry, get final product.
Herba Dendrobii is the fresh or dry stem of orchid Dendrobium nobile Dendrobium nobile Lindl., Herba Dendrobii Dendrobium candidum Wall.ex Lindl. or Herba Dendrobii oculati Dendrobium fimbriatum Hook.Var.oculatum Hook. and allied species thereof.Sweet in the mouth, cold nature is returned stomach, kidney channel.Reinforcing stomach reg fluid is arranged, the effect of nourishing YIN and clearing away heat.Be used for cloudy impairment of body fluid and lose, the xerostomia excessive thirst, lack of appetite is retched, deficiency-heat after being ill, poor vision.
The Radix Paeoniae Alba is the dry root of cohosh Radix Paeoniae Paeonia lactiflora Pall..Bitter in the mouth, acid, cold nature.Return liver, spleen channel.The suppressing the hyperactive liver pain relieving is arranged, nourishing blood for regulating menstruation, the effect of astringing YIN to stop sweating.It is dizzy to be used to have a headache, hypochondriac pain, stomachache, limb pain twin, blood deficiency and yellow complexion, menoxenia, spontaneous perspiration, night sweat.
Radix Glycyrrhizae is the dry root and rhizome of glycyrrhizic legume Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. Glycyrrhizaglabra L..Sweet in the mouth, property is flat.GUIXIN, lung, spleen, stomach warp.Invigorating the spleen and replenishing QI is arranged, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, the effect of coordinating the actions of various ingredients in a prescription.Be used for weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, gastral cavity abdomen, the anxious pain of extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.Radix Glycyrrhizae Preparata is the process of preparing Chinese medicine processed goods of Radix Glycyrrhizae, and method for making is for getting clean Radix Glycyrrhizae tabellae, and according to the processed with honey method, stir-fry, is taken out when tack-free to buff to yellow, and the cold of drying in the air gets final product.Sweet in the mouth, property is flat.GUIXIN, lung, spleen, stomach warp.The spleen reinforcing stomach function regulating is arranged, the effect of Yiqi and vein recovery.Be used for weakness of the spleen and stomach, fatigue and weakness.
At present, utilize Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba and Radix Glycyrrhizae Preparata to interact, composition of prescription is used to prepare the medicine for the treatment of chronic atrophic gastritis, does not appear in the newspapers as yet.
3, summary of the invention
The purpose of this invention is to provide that a kind of prescription science for the treatment of chronic atrophic gastritis, preparation are simple, the pharmaceutical composition of determined curative effect and preparation method thereof.
The spleen is the source of growth and development, and stomach is a reservoir of food and drink, and the two is with placed in the middle burnt, and main altogether digesting and assimilating is " the foundation of acquired constitution " by honor often.Temper should rise, and gastric qi should be fallen, rising-falling tone and then in burnt balance, so saying of " middle Jiao as weighing apparatus, non-flat uneasiness " arranged; Right taste physiological activity still depends on the hepatobiliary catharsis, and the chronic gastritis initial stage is often not normal because of suffocating of liver and gall, hot and suffocating criminal's stomach, thus there is gastric abscess to expand, diseases such as belch, bitter taste.The victory of few sun, heat visitor is in stomach, so with the passing of time bitter taste, yellow, greasy and thin fur must cause venation and damage, injures middle gas, and QI and blood is all tired out, and gradually causes deficiency of spleen-QI and stomach-QI and has stagnant heat concurrently.So the treatment chronic atrophic gastritis, when with regulating qi and activating blood, clearing heat to ease the stomach.
Pharmaceutical composition of the present invention is according to the theoretical composition of prescription of Chinese medicine and pharmacy: the Rhizoma Pinelliae drying dampness to eliminate phlegm; Herba Dendrobii is sweet, be slightly cold, and returns stomach, kidney channel, reinforcing stomach reg fluid, nourishing YIN and clearing away heat; Radix Paeoniae Alba hardship, acid are slightly cold, and return liver, spleen channel, nourishing blood to suppress the hyperactive liver, slow in pain relieving, remove arthralgia due to stagnation of blood; Radix Glycyrrhizae Preparata, coordinating the actions of various ingredients in a prescription is in harmonious proportion the property of medicine, is beneficial to nourishing the stomach.All medicines share, collaborative onset, treatment chronic atrophic gastritis.
To be the inventor through a large amount of experiments grope to sum up the consumption of making the crude drug of the contained composition and effectiveness of pharmaceutical composition of the present invention draws, and it consists of: 6～18 parts of Rhizoma Pinelliae, 10～20 parts of Herba Dendrobiis, 10～20 parts of the Radix Paeoniae Albas, 5～15 parts of Radix Glycyrrhizae Preparatas.
The composition of making the crude drug of the contained composition and effectiveness of pharmaceutical composition of the present invention is preferably:
10～15 parts of Rhizoma Pinelliae, 12～18 parts of Herba Dendrobiis, 12～18 parts of the Radix Paeoniae Albas, 8～12 parts of Radix Glycyrrhizae Preparatas.
Make the contained composition and effectiveness of pharmaceutical composition of the present invention crude drug composition more preferably:
12 parts of Rhizoma Pinelliae, 15 parts of Herba Dendrobiis, 15 parts of the Radix Paeoniae Albas, 10 parts of Radix Glycyrrhizae Preparatas.
The crude drug of making the contained composition and effectiveness of pharmaceutical composition of the present invention is by weight as proportioning, when producing, can or reduce according to the corresponding proportion increase, as large-scale production can kilogram be unit, or be unit with the ton, small-scale production also can restrain and be unit, and weight can increase or reduce.The weight proportion of pharmaceutical composition crude drug of the present invention obtains through science screening, and for especial patient, the ratio of can corresponding adjustment forming increases or reduce being no more than 100%.
Aforementioned pharmaceutical compositions can adopt the conventional method of Chinese medicine preparation to be prepared into any conventional formulation.For example, these crude drug pulverize mix homogeneously can be made powder takes after mixing it with water; Also these crude drug decocting together can be taken decocting liquid; In order to make the crude drug of making the contained composition and effectiveness of pharmaceutical composition of the present invention better bring into play drug effect, the invention provides following selection process, but these can not limit protection scope of the present invention.
The preparation method of aforementioned pharmaceutical compositions may further comprise the steps:
1) take by weighing Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba, the Radix Glycyrrhizae Preparata of described parts by weight, standby;
2) Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba, the Radix Glycyrrhizae Preparata that weighs up decocted with water, merge extractive liquid, filters, and filtrate is concentrated into finite concentration, adds ethanol, stir, precipitate with ethanol is left standstill in cold preservation, filters, and decompression filtrate recycling ethanol is to there not being the alcohol flavor, continue to be concentrated into thick paste, oven dry is pulverized, and gets medicated powder;
3) above-mentioned medicated powder is added adjuvant and make preparation.
The preparation method of aforementioned pharmaceutical compositions is preferably:
1) take by weighing Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba, the Radix Glycyrrhizae Preparata of described parts by weight, standby;
2) Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba, the Radix Glycyrrhizae Preparata that weighs up decocted with water secondary, add 8～10 times of amounts of water, decocted 2～2.5 hours, merge extractive liquid, filters, and it is 1.10～1.15 that filtrate is concentrated into relative density, adding ethanol is 65%～80% to containing the alcohol amount, stirs, and cold preservation was left standstill 12～24 hours, filter, decompression filtrate recycling ethanol continues to be concentrated into thick paste to there not being the alcohol flavor, oven dry, pulverize, get medicated powder;
3) above-mentioned medicated powder is added adjuvant and make preparation.
The preparation technology of aforementioned pharmaceutical compositions is more preferably:
1) take by weighing Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba, the Radix Glycyrrhizae Preparata of described parts by weight, standby;
2) Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba, the Radix Glycyrrhizae Preparata that weighs up decocted with water secondary, add 10 times of amounts of water for the first time, decocted 2.5 hours, for the second time add 8 times of amounts of water, decocted merge extractive liquid, 2 hours, filter, it is 1.13～1.15 that filtrate is concentrated into relative density, and adding ethanol is 75% to containing the alcohol amount, stir, cold preservation was left standstill 24 hours, filtered, decompression filtrate recycling ethanol continues to be concentrated into thick paste to there not being the alcohol flavor, oven dry, pulverize, get medicated powder;
3) above-mentioned medicated powder is added adjuvant and make preparation.
Pharmaceutical composition of the present invention has the effect of stomach function regulating nourishing the stomach to promote the production of body fluid, dissolving lump and resolving mass pain relieving, is used for chronic atrophic gastritis, and effect is remarkable.
Pharmaceutical composition of the present invention can be mixed and made into clinically any or pharmaceutically acceptable dosage form, preferred oral preparation with one or more pharmaceutically acceptable carriers.Be used for when oral, can be made into conventional solid preparation, as tablet, capsule, pill, granule etc.; Also can be made into oral liquid, as oral solution, oral suspensions, syrup etc.Tablet means disk shape or the special-shaped flaky solid preparation that medicine and the auxiliary materials and mixing compacting that suits form, based on oral ordinary tablet, other has buccal tablet, Sublingual tablet, mouth paster, chewable tablet, dispersible tablet, fuse, effervescent tablet, slow releasing tablet, controlled release tablet and enteric coatel tablets etc.Capsule means medicine or is added with the adjuvant filling in Capsules or be sealed in solid preparation in the soft capsule material, according to its dissolving and release characteristics, can be divided into hard capsule (being commonly referred to as capsule), soft capsule (soft gelatin capsule), slow releasing capsule, controlled release capsule and enteric coated capsule etc.Pill means medicine and suitable adjuvant uniform mixing, and the spherical or near-spherical solid preparation so that proper method is made comprises drop pill, sugar pill, piller etc.Granule means that medicine and suitable adjuvant make the dried particles shape preparation with certain particle size, can be divided into soluble particles (being commonly referred to as granule), mix suspension grain, effervescent granule, enteric coated particles, slow-releasing granules and controlled release granule etc.Oral solution means that medicine dissolution makes for oral supernatant liquid preparation in suitable solvent.Oral suspensions means the slightly solubility solid drugs, is dispersed in the liquid medium, makes for oral suspension body preparation, also comprises dry suspension or dense suspension.Syrup means the dense aqueous sucrose solution that contains medicine.
When pharmaceutical composition of the present invention is made oral formulations, can add suitable filler, binding agent, disintegrating agent, lubricant etc.Filler commonly used comprises starch, Icing Sugar, calcium phosphate, calcium sulfate two water things, dextrin, microcrystalline Cellulose, lactose, pregelatinized Starch, mannitol etc.; Typical binders comprises sodium carboxymethyl cellulose, PVP-K30, hydroxypropyl cellulose, starch slurry, methylcellulose, ethyl cellulose, hypromellose, gelling starch etc.; Disintegrating agent commonly used comprises dried starch, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose etc.; Conventional lubricants comprises magnesium stearate, Pulvis Talci, sodium lauryl sulphate, micropowder silica gel etc.
The advantage of pharmaceutical composition of the present invention is:
(1) provides a kind of being used to prepare the pharmaceutical composition for the treatment of chronic atrophic gastritis, increased the clinical application kind, satisfied clinical needs;
(2) pharmacological evaluation shows, pharmaceutical composition of the present invention can make the gastric acidity of the gastric juice of deficiency of spleen-QI type, blood stasis type rat significantly improve, pepsin activity significantly improves, pathological examination is the result well improve, promote the mice gastric emptying, curative effect that medicine of the present invention reaches is that those of ordinary skills are beyond thought;
(3) pharmaceutical preparation of the present invention is simple, and mass discrepancy is little between the different batches medicine, and drug quality is uniform and stable.
Below routine by experiment beneficial effect of further setting forth the pharmaceutical composition of making by Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba and Radix Glycyrrhizae Preparata.
Experimental example 1: pharmaceutical composition of the present invention is irritated the influence that stomach causes rat chronic atrophic gastritis model to salicylic acid
Animal subject: Wistar rat, male and female half and half, body weight 180～220g, 72.
Test sample and reagent: the basic, normal, high dosage group of medicament composition granule agent of the present invention, self-control;
Positive control drug: SANJIU WEITAI KELI, 20g/ bag;
Salicylic acid.
Animal grouping: 72 rats are divided into following 6 groups at random by sex, body weight equilibrium, 12 every group.Pharmaceutical composition low dose group of the present invention, middle and high three dosage groups, SANJIU WEITAI group, normal control group, model group.
Experimental technique:
Model preparation: 1. medicine configuration: the 2g sodium salicylate is put into the alcoholic solution of 100ml 30%, be configured to the mixed solution of the ethanol of 2% sodium salicylate and 30%, irritate stomach; 2. administration: the stimulation mode to stomach is to use the oral administration method.The oxter, the left and right sides that the thumb and the middle finger of a hands is put into rat, forefinger is put into cervical region, makes rat stretch out preceding two limbs, holds, the plastics that employing is installed on 5～10ml syringe are irritated stomach tube (with rifle head evenly baking on alcohol burner of micro sample adding appliance, take off after waiting to soften, curve upper gastrointestinal shape, and cut 1cm at rifle head point place, mouth is polished, it is about 6～7cm, diameter 0.5cm), insert in the oral cavity from the rat bicker earlier, press its head with intrusion pipe then, intrusion pipe is entered esophagus gently along its maxillary wall, feel opposing when entering gently slightly when the intrusion pipe continuation, this position is equivalent to the position of esophagus by diaphram, generally get final product in this injection, if animal peace and quiet this moment are breathed no abnormally, medicine can be injected, if resistance is arranged, should extract the filling stomach tube out, examination is inserted it again, pulls out the filling stomach tube gently behind the injection medicine.Every day 1 time, each every injection 2.5ml; 3. tired model of action: around the back, rat is movable in a rotating cage, and the rotating cage device is divided into 8 little lattice with dividing plate, put a rat in each little lattice when movable, put 8 altogether, shake the runner handle lentamente, rat just beats forward along with the rotation of cage therein, each every movable 10min, once a day, after activity finishes, rat is slow in action, out of puff, put in people's case, just gather in the case angle; 4. fasting: water is prohibited in each 1h fasting before and after 10 administrations in morning every day, administration, and medicine is fully contacted with gastric mucosa, strengthens the stimulation to gastric mucosa.Odd-numbered day fasting around the back is freely drunk water, and even-numbered days, the capacity feeding was freely drunk water.
Dosage: pharmaceutical composition high dose group of the present invention (dosage group in 4g crude drug/kg), the pharmaceutical composition of the present invention (2g crude drug/kg), pharmaceutical composition low dose group of the present invention (the 1g crude drug/kg), SANJIU WEITAI group (4g/kg), the normal control group, model group.Each is organized and irritates stomach respectively every day and give relative medicine, and the normal control group is irritated stomach drinking water 1ml/100g.Capacity diet during the treatment is treated and is carried out gastric analysis and pathologic finding after 2 months.
The normal control group: the normal raising, carry out gastric analysis and pathologic finding.
Gastric acid and determination of peptic activity
Gastric juice is collected: rat fasting 24 hours, and 1.5% pentobarbital intraperitoneal injection of anesthesia, 3mg/kg, last median abdominal incision exposes stomach, ligation pylorus.After 4～6 hours, the ligation cardia is cut off esophagus lower end and duodenum near-end respectively again, collects gastric juice in container, and the centrifuging and taking supernatant is done gastric acidity respectively and measured and determination of peptic activity.
Gastric acidity is measured: the gastric juice of getting after centrifugal is measured pH value with acidometer, and uses dimethyl azoaniline and phenolphthalein ethanol respectively to be free acid and total acid indicator, to use the NaOH titration, measure free acid and total acid content respectively.
Determination of peptic activity: the glass capillary of internal diameter 2mm even thickness is cut into the long section of 10cm.After getting an amount of Ovum Gallus domesticus album and stirring, the capillary glass is filled Ovum Gallus domesticus album from pipe, put immediately that water-bath is solidified it more than 85 ℃.The two ends 4 ℃ of cold preservations of sealing with wax are stand-by.To solidify the good glass tubing that is full of Ovum Gallus domesticus album and put into 1ml gastric juice, the length of capillary pipe end transparent part is accurately measured in 37 ℃ of digestion after 8 hours.Represent the height of pepsin activity with the length of transparent part.
The gastric tissue pathological examination: from each experimental group, randomly draw 2 examples, cut stomach respectively at the bottom of, body of stomach, gastric antrum portion tissue, formalin fixed, paraffin embedding, is taken pictures at HE dyeing.
Data statistical approach: each The data x ± s represents that the t check is adopted in contrast between two groups.
Experimental result:
Each was organized in medication after 2 months, and every group is extracted 2 examples, got gastric tissue and did pathological examination, and all the other Mus carry out gastric juice, pH value, stomach free acid, stomach total acid and determination of peptic activity, the results are shown in Table 1.
Table 1 pharmaceutical composition of the present invention causes the influence of chronic atrophic gastritis rat stomach liquid acidity and proteinase activity to salicylic acid
(X±SD)
Annotate:
##P＜0.01,
#Compare with the blank group p＜0.05;
*P＜0.01,
*Compare with model group p＜0.05;
$$P＜0.01,
$Compare with the SANJIU WEITAI group p＜0.05.
By table 1 as seen:
1) model group and normal control group compare, and gastric juice pH obviously raises (p＜0.05), and the stomach free acid significantly reduces (p＜0.01), pepsin activity obviously reduces (p＜0.05), meet the clinical manifestation of chronic atrophic gastritis, binding of pathological proves this modelling success.
2) pharmaceutical composition of the present invention and model group relatively, gastric acidity significantly improves (p＜0.05, p＜0.01), pepsin activity significantly raise (p＜0.05, p＜0.01).Illustrate that pharmaceutical composition of the present invention has gastric acid secretion, increase the effect of pepsin activity, salicylic acid is caused the chronic atrophic gastritis rat model significant curative effect.
3) statistical significance is little though low, the middle dosage group of pharmaceutical composition of the present invention is compared with the SANJIU WEITAI group, but SANJIU WEITAI group free acid and pepsin and model group are relatively not as pharmaceutical composition significant difference of the present invention, pharmaceutical composition high dose group of the present invention is compared with the SANJIU WEITAI group, gastric acidity obviously improves (p＜0.05), pepsin activity obviously raise (p＜0.05).Illustrate that pharmaceutical composition of the present invention is better than the SANJIU WEITAI group to the curative effect that salicylic acid causes the chronic atrophic gastritis rat model, and dose dependent is arranged, the high dose effect is best.
Pathology shows: salicylic acid causes chronic atrophic gastritis rat model gastric mucosa parietal cell to be reduced, and mucomembranous cell is the cavity sample and becomes, the body of gland atrophy, and the mucosa attenuation, mucous layer and tela submucosa have a large amount of cell infiltration.About 12% rat obvious intestinalization occurred and has given birth to.It is normal that medicine composite for curing group gastric mucosa form of the present invention is recovered, and a small amount of cavity sample of mucomembranous cell becomes, and the body of gland atrophy is clearly better than model group, do not find the living phenomenon of intestinalization.
Conclusion: this experimental selection salicylic acid filling stomach and hunger, the modeling of overstrain factor, the traditional Chinese medical science belongs to the deficiency of spleen-QI type.Salicylic acid is caused the gastric analysis of chronic atrophic gastritis rat to pharmaceutical composition of the present invention and the pathological examination result shows, the pharmaceutical composition of being made by Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba and Radix Glycyrrhizae Preparata of the present invention irritates to salicylic acid that chronic atrophic gastritis has the good curing effect due to the stomach.
Experimental example 2: pharmaceutical composition of the present invention adds the shadow that adjuvant causes rat chronic atrophic gastritis model to the allogeneic gastric mucosa
Ring
Animal subject: Wistar rat, male and female half and half, body weight 180～220g, 72.
Test sample and reagent: the basic, normal, high dosage group of medicament composition granule agent of the present invention, self-control;
Positive control drug: SANJIU WEITAI KELI, 20g/ bag;
The Freund Freund's complete adjuvant.
Animal grouping: 72 rats are divided into following 6 groups at random, 12 every group.Basic, normal, high three the dosage groups of pharmaceutical composition of the present invention, SANJIU WEITAI group, normal control group, model group.
Experimental technique:
Model preparation: 72 of Wistar rats, male and female half and half, every rat skin lower injection adjuvant antigen (using normal saline tissue homogenate and Freund adjuvant to be made into Emulsion at 1: 1) 0.3ml, 3 week back duplicate injections 1 time with the strain gastric mucosa of rat, the odd-numbered day fasting, even-numbered days ad lib.
Dosage: 72 rat 2 weeks after 2 sensitization recover normal diet and are divided into following 6 groups, 12 every group.Give experimental therapy respectively.Dosage group (2g/kg), pharmaceutical composition low dose group of the present invention (1g/kg) in pharmaceutical composition high dose group of the present invention (4g/kg), the pharmaceutical composition of the present invention, SANJIU WEITAI group (3g/kg), normal control group, model group.Below respectively organize and irritate stomach respectively every day and give 60%, 30%, 15% pharmaceutical composition of the present invention, 40% SANJIU WEITAI and drinking water 1ml/100g treat and carry out gastric analysis and pathologic finding after 2 months.
The normal control group: the normal raising, carry out gastric analysis and pathologic finding.
Gastric acid and determination of peptic activity: with the method in the experiment 1.
Experimental result:
Each was organized in medication after 2 months, and every group is extracted 2 examples, got gastric tissue and did pathological examination, and all the other Mus carry out gastric juice, pH value, stomach free acid, stomach total acid and determination of peptic activity, the results are shown in Table 2.
Table 2 medicine of the present invention causes the influence (X ± SD) of chronic atrophic gastritis rat stomach liquid acidity and proteinase activity to adjuvant antigen
Annotate:
##P＜0.01,
#Compare with the blank group p＜0.05;
*P＜0.01,
*Compare with model group p＜0.05.
By table 2 as seen:
1) model group and normal control group are relatively, gastric juice pH obviously raise (p＜0.05), the stomach free acid significantly reduces (p＜0.01), pepsin activity obviously lowers (p＜0.05), meet the clinical manifestation of chronic atrophic gastritis, binding of pathological. prove that adjuvant antigen causes the chronic atrophic gastritis rat model and sets up successfully.
2) each curative effect group of pharmaceutical composition of the present invention and model group relatively, gastric acidity obviously improves (p＜0.05, p＜0.01), pepsin activity significantly raise (p＜0.05, p＜0.01).Illustrate that pharmaceutical composition of the present invention has gastric acid secretion, increase the effect of pepsin activity.
3) though pharmaceutical composition group of the present invention is compared not statistically significant on the curative effect with the SANJIU WEITAI group, and the therapeutical effect that adjuvant antigen is caused the chronic atrophic gastritis rat model is more remarkable, the better effects if of especially middle and high dosage group.
Pathology shows: adjuvant antigen causes chronic atrophic gastritis rat model gastric mucosa parietal cell to be reduced, and mucomembranous cell is the cavity sample and becomes, the body of gland atrophy, and the mucosa attenuation, mucous layer and tela submucosa have a large amount of cell infiltration.About 12% rat obvious intestinalization occurred and has given birth to.It is normal that medicine composite for curing group gastric mucosa form of the present invention is recovered, and a small amount of cavity sample of mucomembranous cell becomes, and the body of gland atrophy is clearly better than model group, do not find the living phenomenon of intestinalization.
Conclusion: former bile on the rocks of this experimental selection adjuvant and hunger, the modeling of overstrain factor, the traditional Chinese medical science belongs to blood stasis, type of depression of QI.Medicine of the present invention shows that to gastric analysis and the pathological examination result that adjuvant antigen causes the chronic atrophic gastritis rat pharmaceutical composition of the present invention causes chronic atrophic gastritis to adjuvant antigen the good curing effect.
Experimental example 3 pharmaceutical compositions of the present invention are to the influence of mice gastric emptying
Animal subject: Kunming mouse, male and female half and half, body weight 18～25g, 40.
Test sample and reagent: the basic, normal, high dosage group of medicament composition granule agent of the present invention, self-control;
Negative control: dextrin.
Experimental technique: Kunming mouse is divided into 4 groups at random: the heavy dose of group of pharmaceutical composition of the present invention (4g crude drug/kg), middle dosage group (2g crude drug/kg) and small dose group (1g crude drug/kg) and blank dextrin (3.1g/kg) matched group.Every group of 10 mices, male and female half and half.
The experiment mice non-fasting is freely drunk water.Granule of the present invention is made into 2.6%, 5.2% and 10.4% barium meal with barium sulfate glue; Be made into negative control with dextrin and barium sulfate glue.Each group is all by 0.3ml/kg body weight gastric infusion.Put to death animal behind the administration 1h,, observe the gastric emptying situation with TOSHIBA KXO-30R type-ray machine film making (film making Index A EC is-2).The degree of gastric emptying can be from the X-mating plate size of stomach push away, promptly gastric surface is long-pending more little, gastric barium sulfate is residual few more, gastric emptying is complete more; Gastric surface is long-pending big more, and gastric barium sulfate is residual many more, and gastric emptying is incomplete more.
Statistical method:,, carried out the sxemiquantitative comparison with negative control so the result has been adopted double blinding range estimation method relatively because of the final result of experiment is graphic materials (a molybdenum target X-mating plate).
Experimental result:
Compare with negative control group, medicament composition granule agent low dose group of the present invention there is no tangible gastric emptying, and the gastric emptying of middle and high dosage group is (the long-pending difference in size of gastric surface is obvious) obviously.Show that medicament composition granule agent of the present invention can promote the mice gastric emptying, effect is remarkable.
4, the specific embodiment
The specific embodiment of form is described in further detail foregoing of the present invention by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following embodiment.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
Embodiment 1: the preparation of pharmaceutical composition tablet of the present invention
Rhizoma Pinelliae 12g Herba Dendrobii 15g Radix Paeoniae Alba 15g Radix Glycyrrhizae Preparata 10g
Take by weighing Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba and Radix Glycyrrhizae Preparata, decoct with water secondary, add 10 times of amounts of water for the first time, decocted 2.5 hours, add for the second time 8 times of amounts of water, decocted 2 hours, merge extractive liquid, filters, it is 1.13～1.15 that filtrate is concentrated into relative density, adding ethanol is 75% to containing the alcohol amount, stirs, and cold preservation was left standstill precipitate with ethanol 24 hours, filter, decompression filtrate recycling ethanol continues to be concentrated into thick paste to there not being the alcohol flavor, oven dry, pulverize, add binding agent, disintegrating agent and lubricant and make granule, drying, compacting is in flakes.
Embodiment 2: the preparation of medicament composition capsule agent of the present invention
Rhizoma Pinelliae 10g Herba Dendrobii 12g Radix Paeoniae Alba 12g Radix Glycyrrhizae Preparata 8g
Take by weighing Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba and Radix Glycyrrhizae Preparata, decoct with water secondary, add 10 times of amounts of water for the first time, decocted 2.5 hours, for the second time add 8 times of amounts of water, decocted merge extractive liquid, 2 hours, filter, it is 1.13～1.15 that filtrate is concentrated into relative density, and adding ethanol is 75% to containing the alcohol amount, stir, cold preservation was left standstill precipitate with ethanol 24 hours, filtered, decompression filtrate recycling ethanol continues to be concentrated into thick paste to there not being the alcohol flavor, oven dry, pulverize, add binding agent and make granule, the hard capsule of packing into.
Embodiment 3: the preparation of medicament composition granule agent of the present invention
Rhizoma Pinelliae 15g Herba Dendrobii 18g Radix Paeoniae Alba 18g Radix Glycyrrhizae Preparata 12g
Take by weighing Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba and Radix Glycyrrhizae Preparata, decoct with water secondary, add 10 times of amounts of water for the first time, decocted 2.5 hours, and added 8 times of amounts of water for the second time, decocted 2 hours, merge extractive liquid, filters, and it is 1.13～1.15 that filtrate is concentrated into relative density, adding ethanol is 75% to containing the alcohol amount, stirs, and cold preservation was left standstill precipitate with ethanol 24 hours, filter, decompression filtrate recycling ethanol continues to be concentrated into thick paste to there not being the alcohol flavor, oven dry is pulverized, and adding Icing Sugar, binding agent are made granule.
Embodiment 4: the preparation of medicinal composition soft capsule of the present invention
Rhizoma Pinelliae 15g Herba Dendrobii 16g Radix Paeoniae Alba 17g Radix Glycyrrhizae Preparata 8g
Take by weighing Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba and Radix Glycyrrhizae Preparata, decoct with water secondary, add 10 times of amounts of water for the first time, decocted 2.5 hours, and added 8 times of amounts of water for the second time, decocted 2 hours, merge extractive liquid, filters, and it is 1.13～1.15 that filtrate is concentrated into relative density, adding ethanol is 75% to containing the alcohol amount, stir, cold preservation was left standstill precipitate with ethanol 24 hours, filtered, decompression filtrate recycling ethanol is to there not being the alcohol flavor, continue to be concentrated into thick paste, oven dry is pulverized, get medicated powder, with soybean oil and soybean phospholipid, Cera Flava heating and melting, mixing is put cold, add medicated powder, be pressed into soft capsule.
Embodiment 5: the preparation of medicament composition dropping pills of the present invention
Rhizoma Pinelliae 11g Herba Dendrobii 13g Radix Paeoniae Alba 14g Radix Glycyrrhizae Preparata 9g
Take by weighing Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba and Radix Glycyrrhizae Preparata decoct with water secondary, add 10 times of amounts of water for the first time, decocted 2.5 hours, and added 8 times of amounts of water for the second time, decocted 2 hours, merge extractive liquid, filters, and it is 1.13～1.15 that filtrate is concentrated into relative density, adding ethanol is 75% to containing the alcohol amount, stir, cold preservation was left standstill precipitate with ethanol 24 hours, filtered, decompression filtrate recycling ethanol is to there not being the alcohol flavor, continue to be concentrated into thick paste, oven dry is pulverized, get medicated powder, with polyethylene glycol 6000 heating and melting in water-bath, treat to add medicated powder after whole fusions, stirring and dissolving, 60 mesh sieves filter, and keep 60 ℃ to splash in the liquid paraffin that is chilled to below 10 ℃ and make ball.
Claims (8)
1. a pharmaceutical composition that is used for chronic atrophic gastritis is characterized in that, the weight portion of making the crude drug of the contained active ingredient of this pharmaceutical composition consists of: 6～18 parts of Rhizoma Pinelliae, 10～20 parts of Herba Dendrobiis, 10～20 parts of the Radix Paeoniae Albas, 5～15 parts of Radix Glycyrrhizae Preparatas.
2. pharmaceutical composition according to claim 1 is characterized in that, the weight portion of making the crude drug of the contained active ingredient of this pharmaceutical composition consists of: 10～15 parts of Rhizoma Pinelliae, 12～18 parts of Herba Dendrobiis, 12～18 parts of the Radix Paeoniae Albas, 8～12 parts of Radix Glycyrrhizae Preparatas.
3. pharmaceutical composition according to claim 2 is characterized in that, the weight portion of making the crude drug of the contained active ingredient of this pharmaceutical composition consists of: 12 parts of Rhizoma Pinelliae, 15 parts of Herba Dendrobiis, 15 parts of the Radix Paeoniae Albas, 10 parts of Radix Glycyrrhizae Preparatas.
4. according to the described arbitrary preparation of drug combination method of claim 1～3, comprise the following steps:
1) take by weighing Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba, the Radix Glycyrrhizae Preparata of described parts by weight, standby;
2) Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba, the Radix Glycyrrhizae Preparata that weighs up decocted with water, merge extractive liquid, filters, and filtrate concentrates, and adds ethanol, stir, cold preservation is left standstill, and filters, and decompression filtrate recycling ethanol is to there not being the alcohol flavor, continue to be concentrated into thick paste, oven dry is pulverized, and gets medicated powder;
3) above-mentioned medicated powder is added adjuvant and make preparation.
5. arbitrary preparation of drug combination method according to claim 4 comprises the following steps:
1) take by weighing Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba, the Radix Glycyrrhizae Preparata of described parts by weight, standby;
2) Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba, the Radix Glycyrrhizae Preparata that weighs up decocted with water secondary, add 8～10 times of amounts of water, decocted 2～2.5 hours, merge extractive liquid, filters, and it is 1.10～1.15 that filtrate is concentrated into relative density, adding ethanol is 65%～80% to containing the alcohol amount, stirs, and cold preservation was left standstill 12～24 hours, filter, decompression filtrate recycling ethanol continues to be concentrated into thick paste to there not being the alcohol flavor, oven dry, pulverize, get medicated powder;
3) above-mentioned medicated powder is added adjuvant and make preparation.
6. arbitrary preparation of drug combination method according to claim 5 comprises the following steps:
1) take by weighing Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba, the Radix Glycyrrhizae Preparata of described parts by weight, standby;
2) Rhizoma Pinelliae, Herba Dendrobii, the Radix Paeoniae Alba, the Radix Glycyrrhizae Preparata that weighs up decocted with water secondary, add 10 times of amounts of water for the first time, decocted 2.5 hours, for the second time add 8 times of amounts of water, decocted merge extractive liquid, 2 hours, filter, it is 1.13～1.15 that filtrate is concentrated into relative density, and adding ethanol is 75% to containing the alcohol amount, stir, cold preservation was left standstill 24 hours, filtered, decompression filtrate recycling ethanol continues to be concentrated into thick paste to there not being the alcohol flavor, oven dry, pulverize, get medicated powder;
3) above-mentioned medicated powder is added adjuvant and make preparation.
7. according to the described arbitrary pharmaceutical composition of claim 1～3, it is characterized in that this pharmaceutical composition and mixing acceptable accessories are made arbitrary preparation.
8. pharmaceutical composition according to claim 7 is characterized in that this pharmaceutical composition and mixing acceptable accessories are made oral formulations.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100684374A CN100534498C (en) | 2006-08-25 | 2006-08-25 | Pharmaceutical composition used for chronic atrophic gastritis and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100684374A CN100534498C (en) | 2006-08-25 | 2006-08-25 | Pharmaceutical composition used for chronic atrophic gastritis and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101129796A CN101129796A (en) | 2008-02-27 |
| CN100534498C true CN100534498C (en) | 2009-09-02 |
Family
ID=39127308
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2006100684374A Expired - Fee Related CN100534498C (en) | 2006-08-25 | 2006-08-25 | Pharmaceutical composition used for chronic atrophic gastritis and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100534498C (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104524516A (en) * | 2014-12-29 | 2015-04-22 | 安徽中医药大学第一附属医院 | Traditional Chinese medicine composition for treating liver stagnation and spleen deficiency type chronic atrophic gastritis |
| CN106620632A (en) * | 2017-03-02 | 2017-05-10 | 刘志华 | Drug capsules for preventing and treating chronic atrophic gastritis |
-
2006
- 2006-08-25 CN CNB2006100684374A patent/CN100534498C/en not_active Expired - Fee Related
Non-Patent Citations (2)
| Title |
|---|
| 慢性萎缩性胃炎的中医治疗研究进展. 邵文彬，朱丽红.中医药学刊，第24卷第1期. 2006 |
| 慢性萎缩性胃炎的中医治疗研究进展. 邵文彬，朱丽红.中医药学刊，第24卷第1期. 2006 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101129796A (en) | 2008-02-27 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102342992B (en) | Chinese medicinal composition for treating insomnia and preparation method of preparation thereof | |
| CN104288644A (en) | Pharmaceutical composition for treating spleen deficiency and preparation method thereof | |
| CN100509034C (en) | Medicine for treating chronic atrophic gastritis | |
| CN100534498C (en) | Pharmaceutical composition used for chronic atrophic gastritis and preparation method thereof | |
| CN103656461A (en) | Traditional Chinese medicinal honeyed pill for treating gastric cancer and preparation method thereof | |
| CN103520405A (en) | Pure Chinese medicinal health preservation preparation with effects of clearing heat, nourishing yin, moistening dryness, reinforcing qi, nourishing blood and relaxing bowels | |
| CN1840087B (en) | King solomonseal- and fleece-flower root-containing Chinese medicinal formulation for treating chronic fatigue syndrome and its preparation method | |
| CN104258359A (en) | Traditional Chinese medicine combination for curing pregnancy reaction and preparation method of preparations thereof | |
| CN104645232A (en) | Traditional Chinese medicine combinatorial composition for treatment of double-flexure syndrome and preparation method and applications thereof | |
| CN101129659B (en) | Pharmaceutical composition used for gastroptosis and processes for producing same | |
| CN105749127A (en) | Pharmaceutic preparation for treating stomach cancer and application thereof | |
| CN100563706C (en) | A kind of pharmaceutical composition that is used for infantile diarrhea | |
| CN104623152A (en) | Traditional Chinese medicine composition for treating thyroid adenoma due to phlegm-damp stagnation and preparation method thereof | |
| CN104435962A (en) | Pharmaceutical composition for treating dyspeptic diarrhea of piglets and preparation method thereof | |
| CN104689151A (en) | Traditional Chinese medicine composition for treating diabetes and use of composition | |
| CN101108229B (en) | Medicament for treating tummy bug | |
| CN106620367A (en) | Traditional Chinese medicine sustained-release capsule for treating cystolith and preparation method thereof | |
| CN106563095A (en) | Compound preparation for dental ulcer, and preparation method of compound preparation | |
| CN106377624A (en) | Bismuth-containing solid dispersible tablet for treating peptic ulcer | |
| CN106389679A (en) | Bismuth-containing solid dispersion granules for treating peptic ulcer | |
| CN108721274B (en) | Application of arctigenin in preparation of medicine for treating chronic atrophic gastritis | |
| CN105878742A (en) | Traditional Chinese medicine composition for tonifying stomach | |
| CN114949031A (en) | Traditional Chinese medicine composition for improving spleen and stomach functions and enhancing immunity and application | |
| CN104958689A (en) | Application of traditional Chinese medicinal composition in preparation of medicine for treating chronic gastritis | |
| CN104815179A (en) | Traditional Chinese medicine composition for treating neurasthenia type sleep disorder and preparation method of traditional Chinese medicine composition |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| ASS | Succession or assignment of patent right |
Owner name: XUAN ZHU SHANDONG MEDICINE TECHNOLOGY CO. Free format text: FORMER OWNER: HUANG ZHENHUA Effective date: 20080516 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| TA01 | Transfer of patent application right |
Effective date of registration: 20080516 Address after: Post encoding No. 2518 block A, Tianchen Avenue Ji'nan High-tech Development Zone in Shandong Province: 250101 Applicant after: Shandong Xuanzhu Medical Technology Co., Ltd. Address before: Post encoding No. 2518 block A, Tianchen Avenue Ji'nan High-tech Development Zone in Shandong Province: 250101 Applicant before: Huang Zhenhua |
|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C17 | Cessation of patent right | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20090902 Termination date: 20120825 |