CN101406599B - Pharmaceutical composition for treating chronic atrophic gastritis - Google Patents
Pharmaceutical composition for treating chronic atrophic gastritis Download PDFInfo
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- CN101406599B CN101406599B CN2008101824060A CN200810182406A CN101406599B CN 101406599 B CN101406599 B CN 101406599B CN 2008101824060 A CN2008101824060 A CN 2008101824060A CN 200810182406 A CN200810182406 A CN 200810182406A CN 101406599 B CN101406599 B CN 101406599B
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Abstract
The invention provides a medicine composition for treating chronic atrophic gastritis, which has the advantages of obvious curative effect and convenient carrying. The medicine composition can not only improve various clinical symptoms of the chronic atrophic gastritis, but also improve intestinal metaplasia and heterotypic hyperplasia accompanying the chronic atrophic gastritis, thereby realizing stomach cancer prevention by the medicine. The medicine composition is prepared by the extracts of roasted milkvetch root, radix codonopsis pilosulae, dried orange peel, nutagrass flatsedge rhizome, white peony root, Chinese yam, black plum and liquorice; the preparation process is simple and is suitable for mass production; the clinical tests show that the preparation 'stomach nourishing granules' prepared by the technical proposal can fully improve various symptoms of the chronic atrophic gastritis, achieve the aim of clinical curing, and has more stable efficacies in particular to the chronic atrophic gastritis caused by weakness of the spleen and the stomach or weakness of the spleen and the stomach and qi stasis.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, particularly a kind of pharmaceutical composition that is used for the treatment of chronic atrophic gastritis.
Background technology
Chronic atrophic gastritis (chronic atrophic gastritis, CAG) be with gastric epithelial and body of gland atrophy, mucosa attenuation, muscular layer of mucosa thickens and many be the chronic disease of feature with intestinal gland metaplasia, atypical hyperplasia.Show as gastral cavilty feeling of fullness, pain, loss of appetite, belch, pantothenic acid etc. clinical more, belong to motherland's medical science " stomach painful abdominal mass ", " gastric abscess " category.CAG is listed in the preceding disease of cancer or the precancerous condition of gastric cancer, and intestinal epithelial metaplasia that occurs together on its basis and dysplasia then are called the precancerous lesion of gastric cancer.Effectively prevent and treat, alleviate chronic atrophic gastritis and associated disease thereof, can prevent the generation of gastric cancer.
Chronic atrophic gastritis is divided into weakness of the spleen and stomach, syndrome of incoordination between liver and stomach, deficiency of stomach-Yin card, syndrome of dampness-heat of spleen and stomach, stomach network blood stasis symptom 5 types according to 2002 " the clinical research guideline of new Chinese medicine treatment chronic atrophic gastritis ".Wherein weakness of the spleen and stomach show as that vague epigastralgia, distention and fullness in the abdomen, poor appetite, weak, the lazy speech of losing heart, shallow complexion, loose stool, the tender matter of tongue are light, white and thin fur or little thick, thready and weak pulse.The common gastric mucosa canescence of gastroscope and pathologic finding is simple hyperemia and edema, body of gland atrophy, gastric secretion is few than the normal person.Control at present with invigorating the spleen and regulating the stomach, warming middle-JIAO QI invigorating method, Xiangsha Liujunzi decoction (Radix Ginseng commonly used, the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae, Pericarpium Citri Reticulatae, the Rhizoma Pinelliae, Fructus Amomi, the Radix Aucklandiae), Huangqi Jianzhong Tang (maltose, Ramulus Cinnamomi, Radix Paeoniae, Rhizoma Zingiberis Recens, Fructus Jujubae, the Radix Astragali, Radix Glycyrrhizae Preparata), Sini San, Chinese medicine decoction such as Fructus Citri trifoliate orange art soup, add the flavor Zuojin Wan, Chinese patent medicine preparations such as XIANGSHA YANGWEI WAN, this type of mostly is spleen invigorating, help digestion, eliminate indigestion, intestinal stasis relieving, curative effect is not remarkable, the medicine of specially controlling chronic atrophic gastritis is less, the decoction dose is big, patient's compliance is low, clinical demanding urgently taken, dosage form easy to carry can make a new height is brought up in clinical research and the treatment of CAG.
Summary of the invention
The present invention follows the traditional Chinese medical science and cures the disease and must ask it, set upright with the eliminating evil indiscrete principle of rule of treatment method of treatment, provide a kind of evident in efficacy, take the pharmaceutical composition of treatment chronic atrophic gastritis easy to carry, said composition can not only be improved the various clinical symptoms of chronic atrophic gastritis, can also improve the intestinal epithelial metaplasia and the dysplasia that occur together on its basis, realize chemoprophylaxis gastric cancer.
Said composition is made up of Radix Astragali Preparata, Radix Codonopsis, Pericarpium Citri Reticulatae, Rhizoma Cyperi, the Radix Paeoniae Alba, Rhizoma Dioscoreae, Fructus Mume, Radix Glycyrrhizae, Rhizoma Dioscoreae is good with Rhizoma dioscoreae, it has effects such as protection gastric mucosa, hormone-like effect, and the Radix Astragali, Radix Codonopsis, Rhizoma Dioscoreae focus on replenishing QI to invigorate the spleen to set upright in the compositions, to strengthen or the adjusting body function; The Radix Paeoniae Alba, Radix Glycyrrhizae have and in emergency, end the effect of stomachache, the peoniflorin in the Radix Paeoniae Alba has antiinflammatory action, Radix Glycyrrhizae contains enoxolone the effect of protection gastric mucosal barrier; Pericarpium Citri Reticulatae, Rhizoma Cyperi, Fructus Mume have the regulating qi-flowing for harmonizing stomach pain relieving, and the effect that convergence is promoted the production of body fluid helps to eliminate diseases such as upper abdomen distending pain, discomfort.The Fructus Mume appetizing of promoting the production of body fluid, help digestion and appetite stimulator, above-mentioned closing and use it, but nourishing stomach and spleen, regulate the flow of vital energy and in, be used for the stomachache due to the insufficiency of the spleen stagnation of QI, in the treatment chronic atrophic gastritis gastral cavilty distending pain, belch do not relax, diseases such as indigestion and loss of appetite lack of appetite, spiritlessness and weakness, obviously improve the body of gland atrophy, even reverse the atrophy of gastric mucosa body of gland.
Show that through clinical trial this pharmaceutical composition can improve the various symptoms of chronic atrophic gastritis comprehensively, reaches clinical recovery, especially the chronic atrophic gastritis that weakness of the spleen and stomach or weak weakness of the spleen and stomach are held concurrently due to the stagnation of QI has more definite curative effect.
We according to " Chinese pharmacopoeia standard, clinical application experience and pharmacological effect result of study determine, this pharmaceutical composition is made up of active component or active component and acceptable accessories, and wherein active component is made by the raw material of following weight portion:
Radix Astragali Preparata 6～12 Radix Codonopsis 5～9 Pericarpium Citri Reticulataes 3～5
Rhizoma Cyperi 6～9 Radix Paeoniae Albas 6～15 Rhizoma Dioscoreaes 6～30
Fructus Mume 2～9 Radix Glycyrrhizaes 4～6
Preferably, wherein active component is made by the raw material of following weight portion:
Radix Astragali Preparata 6～8 Radix Codonopsis 5～6 Pericarpium Citri Reticulataes 3～5
Rhizoma Cyperi 6～8 Radix Paeoniae Albas 6～9 Rhizoma Dioscoreaes 6～12
Fructus Mume 2～5 Radix Glycyrrhizaes 4～5
The preparation method of said composition is as follows:
Above-mentioned raw materials is carried through hydro-thermal, behind the acquisition extracting solution (or the concentrated extractum that obtains), adds acceptable accessories, according to this area conventional production process, make various oral formulations dosage forms, for example oral liquid or granule, the preferred particulates agent, its extraction ratio is greater than 22%.
Describedly put forward technology through hydro-thermal, can carry out according to techniques well known, after preferred Pericarpium Citri Reticulatae extracted volatile oil, all the other seven flavors decocted with water second extraction twice, added the Pericarpium Citri Reticulatae residue that extracts behind the volatile oil when decocting for the second time.
Described acceptable accessories comprises correctives, thickening agent, excipient etc., and those skilled in the art can choose the concrete kind and the consumption of adjuvant according to the dosage form of required preparation according to techniques well known.
Preferably prepare granule (called after " stomach nourishing granule ") according to following technology:
1, gets Radix Astragali Preparata, Radix Codonopsis, Pericarpium Citri Reticulatae, Rhizoma Cyperi, the Radix Paeoniae Alba, Rhizoma Dioscoreae, Fructus Mume, Radix Glycyrrhizae, above eight flavors are cleaned, Pericarpium Citri Reticulatae is wherein extracted volatile oil, all the other seven flavors decoct with water secondary, 3 hours for the first time, 2 hours for the second time (the Pericarpium Citri Reticulatae residue when decocting for the second time behind the adding extraction volatile oil) merges decoction liquor, filters.Filtrate staticly settles, and gets the concentrated solution of supernatant concentration to relative density 1.05～1.10 (85 ℃ of heat are surveyed), and concentrated solution left standstill more than 8 hours, got supernatant and filtered, and filtrate is concentrated into the clear paste of relative density 1.14～1.16 (measuring after diluting 2 times).1 part of qinghuo reagent adds 1.75 parts of cane sugar powders, and dextrin is made granule for 1.75 parts, and drying sprays into Pericarpium Citri Reticulatae volatile oil again, and mixing promptly gets granule.
2, get Radix Astragali Preparata, Radix Codonopsis, Pericarpium Citri Reticulatae, Rhizoma Cyperi, the Radix Paeoniae Alba, Rhizoma Dioscoreae, Fructus Mume, Radix Glycyrrhizae, above eight flavor medical materials are cleaned, Pericarpium Citri Reticulatae is wherein extracted volatile oil, all the other seven flavors decoct with water secondary, 3 hours for the first time, 2 hours for the second time (the Pericarpium Citri Reticulatae residue when decocting for the second time behind the adding extraction volatile oil) merges decoction liquor, filters.Filtrate staticly settles, and getting supernatant concentration to relative density is 1.08～1.12 (85 ℃ of heat are surveyed), adds dextrin and obtains the concentrated solution that relative density is 1.14～1.18 (85 ℃ of heat are surveyed).The concentrated solution spray drying is made granule, sprays into Pericarpium Citri Reticulatae volatile oil again, and mixing promptly gets granule.
Preferably prepare oral liquid (called after " oral liquid for nourishing stomach ") according to following technology:
Get Radix Astragali Preparata, Radix Codonopsis, Pericarpium Citri Reticulatae, Rhizoma Cyperi, the Radix Paeoniae Alba, Rhizoma Dioscoreae, Fructus Mume, the Radix Glycyrrhizae of recipe quantity, above eight flavor medical materials are cleaned, Pericarpium Citri Reticulatae is wherein extracted volatile oil, all the other seven flavors decoct with water secondary, 2 hours for the first time, 2 hours for the second time (the Pericarpium Citri Reticulatae residue when decocting for the second time behind the adding extraction volatile oil) merges decoction liquor, filters.Filtrate staticly settles, and gets the concentrated solution of supernatant concentration to relative density 1.00～1.10 (85 ℃ of heat are surveyed), adds Pericarpium Citri Reticulatae volatile oil, adds essence, antiseptic again, and sucrose is an amount of, mixing, and adding distil water filters, fill, sterilization, promptly.
Specific embodiments
Below in conjunction with specific embodiment, further set forth the present invention.Should be appreciated that these embodiment only to be used to the present invention is described and be not used in restriction the scope of protection of present invention, in the following example if unreceipted concrete experiment condition and method implement according to normal condition usually:
Embodiment 1: get Radix Astragali Preparata 6kg, Radix Codonopsis 9kg, Pericarpium Citri Reticulatae 3kg, Rhizoma Cyperi 9kg, Radix Paeoniae Alba 6kg, Rhizoma Dioscoreae 6kg, Fructus Mume 2kg, Radix Glycyrrhizae 4kg, above eight flavors are cleaned, Pericarpium Citri Reticulatae is wherein extracted volatile oil, all the other seven flavors decoct with water secondary, 3 hours for the first time, 2 hours for the second time (the Pericarpium Citri Reticulatae residue when decocting for the second time behind the adding extraction volatile oil) merges decoction liquor, filters.Filtrate staticly settles, and gets the concentrated solution of supernatant concentration to relative density 1.05～1.10 (85 ℃ of heat are surveyed), and concentrated solution left standstill more than 8 hours, got supernatant and filtered, and filtrate is concentrated into the clear paste of relative density 1.14～1.16 (measuring after diluting 2 times).1 part of qinghuo reagent adds 1.75 parts of cane sugar powders, and dextrin is made granule for 1.75 parts and sprayed into Pericarpium Citri Reticulatae volatile oil again, mixing, promptly.
Embodiment 2: get Radix Astragali Preparata 8kg, Radix Codonopsis 6kg., Pericarpium Citri Reticulatae 4kg, Rhizoma Cyperi 6kg, Radix Paeoniae Alba 12kg, Rhizoma Dioscoreae 12kg, Fructus Mume 5kg, Radix Glycyrrhizae 6kg, above eight flavor medical materials are cleaned, Pericarpium Citri Reticulatae is wherein extracted volatile oil, all the other seven flavors decoct with water secondary, 3 hours for the first time, 2 hours for the second time (the Pericarpium Citri Reticulatae residue when decocting for the second time behind the adding extraction volatile oil) merges decoction liquor, filters.Filtrate staticly settles, and getting supernatant concentration to relative density is 1.08～1.12 (85 ℃ of heat are surveyed), adds the concentrated solution that dextrin obtains relative density 1.14～1.18 (85 ℃ of heat are surveyed).The concentrated solution spray drying is made granule, sprays into Pericarpium Citri Reticulatae volatile oil again, and mixing promptly gets granule.
Embodiment 3: get Radix Astragali Preparata 6kg, Radix Codonopsis 5kg., Pericarpium Citri Reticulatae 5kg, Rhizoma Cyperi 6kg, Radix Paeoniae Alba 6kg, Rhizoma Dioscoreae 6kg, Fructus Mume 2kg, Radix Glycyrrhizae 4kg, above eight flavor medical materials are cleaned, Pericarpium Citri Reticulatae is wherein extracted volatile oil, all the other seven flavors decoct with water secondary, 2 hours for the first time, 2 hours for the second time (the Pericarpium Citri Reticulatae residue when decocting for the second time behind the adding extraction volatile oil) merges decoction liquor, filters.Filtrate staticly settles, and gets the concentrated solution of supernatant concentration to relative density 1.00～1.10 (85 ℃ of heat are surveyed), adds Pericarpium Citri Reticulatae volatile oil, adds essence 10ml, and antiseptic is an amount of, sucrose 8.5kg, and mixing, adding distil water make full dose become 30L, filter, fill, sterilization, promptly.
Embodiment 4: get Radix Astragali Preparata 12kg, Radix Codonopsis 5kg., Pericarpium Citri Reticulatae 4kg, Rhizoma Cyperi 6kg, Radix Paeoniae Alba 9kg, Rhizoma Dioscoreae 30kg, Fructus Mume 9kg, Radix Glycyrrhizae 4.2kg, make granule or oral liquid with reference to the preparation method of embodiment 1, embodiment 2 and embodiment 3.
Embodiment 5: get Radix Astragali Preparata 7.5kg, Radix Codonopsis 5kg., Pericarpium Citri Reticulatae 3.8kg, Rhizoma Cyperi 7.5kg, Radix Paeoniae Alba 7.5kg, Rhizoma Dioscoreae 7.5kg, Fructus Mume 2.5kg, Radix Glycyrrhizae 4.2kg, make granule or oral liquid with reference to the preparation method of embodiment 1, embodiment 2 and embodiment 3.
Embodiment 6: to pharmacological toxicology and the clinical research that the extractum of the foregoing description extraction is correlated with, specific as follows:
One, pharmacological effect research:
Trial drug: tried thing: pharmaceutical composition extractum, content are 4.24g/ml (extractum crude drug amount).
Positive control drug: XIANGSHA YANGWEI WAN (manufacturer: the Henan Province Wanxi Pharmacy Stock Co., Ltd)
Test objective: the assessment pharmaceutical composition is to the therapeutical effect of rat bile reflux gastritis and autoimmune chronic gastritis, to the influence of the influence of the model mice gastric emptying of suffering from a deficiency of the kidney, intestinal propulsion functions and the small intestinal contractile response that small intestine of guinea pig self-disciplining contractile response, Carbacol are caused, pipe smooth muscle directly acts on and Carbacol causes pipe smooth muscle contractile response.
Result of the test: through laboratory observation, pharmaceutical composition 1 of the present invention, 5, the continuous gastric infusion of 10g/kg (extractum crude drug amount) 3 months, can obviously suppress and alleviate the chronic bile reflux stomach lining inflammation of rat operation modeling cellular infiltration, fundic gland hypertrophy, gastric metaplasia and gastric pits expansion reaction, and can improve the body constitution of chronic reflux gastritis rat; This pharmaceutical composition 1,5,10g/kg (extractum crude drug amount) gastric infusion continuously can suppress the inflammation performance of autoimmune gastritis after 2 months, and the coat of the stomach organizational structure is recovered, and also can improve the body constitution of chronic immunity gastritis rat; This pharmaceutical composition 7.5,15g/kg (extractum crude drug amount) is gastric infusion continuously, and model of spleen deficiency mice gastric emptying speed is obviously slowed down, and mice with spleen deficiency weight loss amplitude is significantly reduced; This pharmaceutical composition 7.5,15g/kg (extractum crude drug amount) be the gastric infusion mice with spleen deficiency gastric emptying speed that slows down continuously, and the methyl orange residual rate is increased; This pharmaceutical composition 7.5,15g/kg (extractum crude drug amount) be can obviously the slow down intestinal propulsion function of mice with spleen deficiency of gastric infusion continuously; This pharmaceutical composition can obviously improve mice with spleen deficiency body constitution and descend.
Content of the test:
Experiment 1: to the therapeutical effect of experimental reflux gastritis
Carry out the making of rat stomach intestinal anastomosis model earlier, because this model meets the characteristics that chronic reflux gastritis pathologic structure changes.Above-mentioned rat is divided at random: operation modeling group (normal saline 10ml/kg, i.g), positive drug control group (3g/kg, i.g), be subjected to reagent I, II, III group (to use this pharmaceutical composition 1,5 respectively, 10g/kg, i.g), non-operation group (is got with the normal rat normal saline 10ml/kg that buys goods wholesale into, i.g).From performing the operation back the 3rd day by waiting the continuous i.g administration of capacity variable concentrations 3 months, be observation index with the inspection of rat body weight stomach function regulating tectology, experimental result is shown in following table 1-2:
Table 1. pharmaceutical composition is to the influence of reflux gastritis rat body weight (X ± SD)
Table 2. pharmaceutical composition is to the morphological observation of reflux gastritis gastric mucosal lesion protective effect (X ± SD)
Table is annotated: non-operation group and surgery models group all give normal saline; Statistical method: (◇): t-test, ★: X
2Compare with the surgery models group
*P＜0.05,
*P＜0.01, following table is identical.
Experiment 2: to the therapeutical effect of autoimmune gastritis
Carry out the making of SD rat immunity gastritis model earlier, above-mentioned rat is divided at random: operation modeling group (normal saline 10ml/kg, i.g), positive drug control group (XIANGSHA YANGWEI WAN 3g/kg, i.g), be subjected to reagent I, II, III group (to use this pharmaceutical composition 1,5 respectively, 10g/kg, i.g), non-operation group (get with buying goods wholesale into normal rat normal saline 10ml/kg, i.g), from the 2nd day grade of immunity capacity isoconcentration successive administration 2 months not.Tectology inspection with the rat body weight stomach function regulating is an observation index, and experimental result is shown in following table 3-4:
Table 3 pharmaceutical composition is to the influence of autoimmune gastritis rat body weight (X ± SD)
Table 4. pharmaceutical composition is to the morphological observation of autoimmune gastritis gastric mucosal lesion protective effect (X ± SD)
Experiment 3: to the influence of mice with spleen deficiency gastric emptying
Get 60 of ICR mices, male and female half and half, random packet: matched group, model of spleen deficiency group, positive controls, pharmaceutical composition I, II, III group.Make the model of spleen deficiency group, modeling began administration on the 5th day simultaneously, and dosage sees the following form, successive administration 14 days, fasting 12h before the experiment, experiment intraperitoneal injection on the same day, 40min irritates the methyl orange solution 0.2ml/10g body weight of stomach 0.1% after the administration, put to death mice behind the 20min, the full stomach of the clip of cutting open the belly, distilled water thorough washing stomach, transferring PH with sodium bicarbonate is 6, get supernatant, in 420nm wavelength place colorimetric, the distilled water zeroing.Other gets 0.1% methyl orange solution 0.2ml adding distil water and surveys numeral for the standard pipe optical density to 10ml, by formula calculates and respectively organizes the methyl orange residual rate, with the speed of the high low reaction gastric emptying of residual rate.The results are shown in following table 5:
Table 5. pharmaceutical composition is to the influence of mice with spleen deficiency gastric emptying (X ± SD)
Compare with the model of spleen deficiency group
*P＜0.05,
*P＜0.01
The pharmaceutical composition mice with spleen deficiency gastric emptying speed that can slow down increases the methyl orange residual rate.
Experiment 4: to the influence of mice with spleen deficiency small intestinal carbon powder progradation
Undertaken by experiment 3 grouping medications, water 16h is can't help in fasting before the experiment, 1h irritates stomach 5% carbon powder suspension 0.1ml/10g body weight after the experiment last administration on the same day, put to death mice behind the 20min, dissect rapidly, stomach to ileocecus small intestinal is tiled on the glass plate, measures small intestinal total length and carbon powder, calculate the percentage rate that carbon powder advances length and accounts for the small intestinal total length at enteral advance distance.Experimental result is shown in following table 6-7:
Table 6. pharmaceutical composition is to the influence of mice with spleen deficiency intestinal propulsion (X ± SD)
Compare with model group
*P＜0.05,
*P＜0.01
Table 7. pharmaceutical composition is to the influence of mice with spleen deficiency body weight gain (X ± SD)
Compare with model group
*P＜0.05,
*P＜0.01,
* *P＜0.01
Two, toxicological study
In the anxious poison test, NIH is mice non-toxic reaction under 80 times of human dosage; Rat 1g/kg, 2g/kg irritated stomach 3 months childhood in the subacute toxicity test, did not influence growth promoter, and biochemical indicator does not have obvious influence, internal organs system no abnormality seen.
Test shows: this pharmaceutical composition has higher safety.
Three, clinical trial
The not clinical trial of typing of chronic atrophic gastritis that preparation according to technical solution of the present invention preparation has been carried out: test medication 3 times/day, each one bag, clinical observation shows, said preparation is to through fibergastroscopy, and through gastric mucosa or tissue examination, conclusive evidence is 88.23% for the total effective rate of 30 routine cases of chronic atrophic gastritis, and wherein obvious effective rate is 41.18%, and effective percentage accounts for 47.05%.Finish the course of treatment all and check, carried out 3 months follow up a case by regular visits to after the clinical end, subjective symptoms does not recur, and it is more satisfied that preparation is improved symptom, and the body of gland atrophy is clearly better, wherein the body of gland atresia accounts for 41.18%, body of gland atrophy position is clearly better before the treatment, and atrophy degree also alleviates, prompting, through the said preparation treatment, the atrophy of gastric mucosa body of gland can reverse.
Embodiment 7: the stomach nourishing granule of obtaining according to the technical scheme of embodiment 5 carries out open clinical trial:
Test objective: observe granule treatment chronic atrophic gastritis weakness of the spleen and stomach or weakness of the spleen and stomach the hold concurrently clinical efficacy and the safety of stagnation of QI disease.
Test method: select to meet hold concurrently experimenter's 307 examples of the stagnation of QI of chronic atrophic gastritis weakness of the spleen and stomach or weakness of the spleen and stomach, adopt the stomach nourishing granule treatment, 1 time 1 bag, 3 times on the 1st (day crude drug amount 45.5g), boiled water is taken after mixing it with water.
Case is included standard in:
One, Western medicine diagnose standard:
1, atrophic gastritis gastroscope diagnostic criteria: gastric mucosa is canescence, sallow, ash or celadon, little blood vessel in the visible mucosa, or visible mucosa is following to dendroid, bolarious trunk, or mucous layer thickening, rough surface injustice.
2, atrophic gastritis pathology diagnostic criteria: intrinsic body of gland atrophy, minimizing 1/3 serve as slight with interior person, and minimizing 1/3-2/3 person is a moderate, and reducing by 2/3 above person is severe;
Mucosa basic unit thickens;
Intestinal epithelial metaplasia or false pylorus glandular metaplasia can be arranged;
The lamina propria inflammation;
Can there be lymph follicle to form.
3, gastric mucosa chronic inflammatory disease grade scale:
Slightly: inflammatory cell infiltration is positioned at more than the gastric pits bottom;
Moderate: inflammatory cell infiltration reaches the body of gland lamina propria deeply;
Severe: inflammatory cell infiltration reaches muscular layer of mucosa deeply.
Two, Chinese medical discrimination standard:
Weakness of the spleen and stomach: vague epigastralgia, stomachache pain relieved by pressing happiness is warm, food back feeling of distension and oppression, feeling of fullness, appetite stimulator, loose stool or diarrhoea, weak, extremity are aching and limp, pale tongue or tooth seal, white and thin fur, deep-thready pulse are arranged.
The weakness of the spleen and stomach syndrome of stagnation of QI of holding concurrently: vague epigastralgia, the happiness of stomachache pain relieved by pressing is warm, food back feeling of distension and oppression, feeling of fullness, appetite stimulator, loose stool or diarrhoea, weak, extremity are aching and limp, pale tongue or the tooth seal is arranged, white and thin fur, deep-thready pulse, belch is done frequently, and noisy pantothenic acid is easily sent out because of feelings will.
Have the gastric abscess symptom, continue to meet Western medicine diagnose standard and Chinese medical discrimination standard patient informed consent more than 3 months, the volunteer can include the test case in.
Result of the test:
1, the clinical symptoms integrated value compares before and after the treatment: after 292 routine experimenters adopt the granule treatment, each symptom integral value and total mark value significantly descend (P＜0.01) before the treatment, show: this medicine is held concurrently to chronic atrophic gastritis weakness of the spleen and stomach or weakness of the spleen and stomach, and various clinical symptoms all have significant improvement effect due to the stagnation of QI.The results are shown in Table 8,9:
Table 8, mild symptoms weight classification standard
| Symptom | Slightly (1 minute) | Moderate (2 minutes) | Severe (3 minutes) |
| Gastralgia | Often have | Take place frequently, influence work | All day endlessly, influence work and rest |
| Food back feeling of distension and oppression | Abdominal distention after meal | Every day is more than 6 hours | All day |
| Indigestion and loss of appetite, few food | Appetite is poor, and appetite reduces below 1/2 | Poor appetite, appetite reduces 1/2-2/3 | No appetite, appetite reduces more than 2/3 |
| The stool character | Soft stool or mashed slightly, in heaps shapeless, 2-3 time/day | Mashed just, loose stool, 4-5 time/day, or 1-2 time/day of loose stool | Loose stool is more than 3 times/day |
| Spiritlessness and weakness | Lassitude, tired slightly, can adhere to light physical labor | Spirit is tired, supports daily routines reluctantly | Myasthenia of limbs can not be adhered to daily routines |
| Belch | Every day at least 5 times | Every day 5-9 time | Every day is more than 10 times |
| Noisy, pantothenic acid | Be less than 3 hours noisy every day, and it is heartburn to suddenly feel | At 3-6 hour noisy every day, heartburn sense is arranged | Noisy all day, and have sour water to glow |
Each symptom integral value comparison before and after table 9, the treatment (X ± S)
| Symptom | The example number | Score value before the treatment | Treatment back score value | d±S | The t value | The P value |
| Gastralgia | 285 | 1.93±0.57 | 0.59±0.61 | -1.35±0.77 | 29.7 | <0.01 |
| Food back feeling of distension and oppression | 281 | 1.93±0.63 | 0.74±0.63 | -1.19±0.76 | 26.1 | <0.01 |
| Indigestion and loss of appetite, few food | 258 | 1.58±0.61 | 0.55±0.60 | -1.03±0.68 | 224.3 | <0.01 |
| The stool character | 227 | 1.45±0.61 | 0.48±0.57 | -0.97±0.65 | 22.5 | <0.01 |
| Spiritlessness and weakness | 267 | 1.59±0.56 | 0.69±0.60 | -0.90±0.67 | 21.8 | <0.01 |
| Belch | 218 | 1.85±0.71 | 0.68±0.66 | -1.16±0.80 | 21.4 | <0.01 |
| Noisy, pantothenic acid | 192 | 1.52±0.63 | 0.54±0.64 | -0.98±0.71 | 19.1 | <0.01 |
| The total mark value | 292 | 10.08±2.93 | 3.63±2.69 | -6.44±3.01 | 36.5 | <0.01 |
2, the relation of TCM Syndrome Type and curative effect:
Add up the effective situation of its clinical symptoms respectively by TCM Syndrome Type weakness of the spleen and stomach and the weakness of the spleen and stomach syndrome of stagnation of QI of holding concurrently, the results are shown in Table 10.Show that this granule all has obvious curative effects to two pattern of syndrome, the curative effect there was no significant difference of different pattern of syndrome, (P〉0.05).
The relation of table 10 TCM Syndrome Type and curative effect
| Pattern of syndrome | The example number | Clinical recovery | Produce effects | Effectively | Invalid | Obvious effective rate (%) * | Total effective rate (%) * |
| Weakness of the spleen and stomach | 120 | 18 | 51 | 37 | 14 | 57.5 | 88.3 |
| The weakness of the spleen and stomach stagnation of QI of holding concurrently | 172 | 17 | 64 | 71 | 20 | 47.1 | 88.4 |
*：P>0.05
3, gastric tissue pathologic finding relative analysis before and after the treatment:
All carry out the gastric tissue case control before and after 132 routine experimenter's medication treatments are arranged in this clinical trial, the body of gland atrophy of treatment back has significant difference (X before treatment is compared in minimizing
2=56.2, P＜0.01), prompting granule treatment atrophic gastritis has obvious curative effects; Compare before and after the intestinal epithelial metaplasia treatment significant difference (X is also arranged
2=10.8, P＜0.05), the results are shown in Table 11.
The relative analysis of gastric tissue pathologic finding before and after table 11, the treatment
Improve situation according to above-mentioned pathological examination results, totally be assessed as produce effects 28 examples (21.2%), effective 38 examples (28.8%), invalid 66 examples (50.0%), effective percentage (improvement rate) 50.0%.
4, the relative analysis that helicobacter pylori is checked before and after the treatment
All carry out the helicobacter pylori inspection before and after 132 routine experimenters treat, treatment back positive rate is than (the X that obviously descends before treating
2=12.2, P＜0.01), the results are shown in Table 12.
The relative analysis that helicobacter pylori is checked before and after table 12 treatment
5, total effects analysis
292 routine experimenters adopt granule treatment of the present invention, wherein gastroscope check person 132 examples.All experimenter's clinical symptoms are improved situation, and overall assessment is clinical recovery 35 examples (12.0%), produce effects 115 examples (38.4%), and effective 108 examples (37.0%), invalid 34 examples (11.6%), doing well,improving obvious effective rate 51.4%, total effective rate are 88.4%; 132 routine gastroscopes check cases are improved situation according to pathological examination results before and after the treatment, and the pathology therapeutic evaluation is a produce effects 21.2%, and are effective 28.8%, invalid 50.0%, effective percentage (improvement rate) 50.0%.
6, safety results
Treatment back safety (blood, urine, stool routine examination, liver, renal function, electrocardiogram) inspection, each index no abnormality seen change (P〉0.05).
7, analysis of adverse reactions
Do not see relevant with investigational agent or may be with investigational agent relevant adverse events.
Claims (9)
1. pharmaceutical composition that is used for the treatment of chronic atrophic gastritis is characterized in that being made up of active component or active component and acceptable accessories, and wherein active component is made by the raw material of following weight portion:
Radix Astragali Preparata 6～12 Radix Codonopsis 5～9 Pericarpium Citri Reticulataes 3～5
Rhizoma Cyperi 6～9 Radix Paeoniae Albas 6～15 Rhizoma Dioscoreaes 6～30
Fructus Mume 2～9 Radix Glycyrrhizaes 4～6.
2. the chronic atrophic gastritis pharmaceutical composition that is used for the treatment of as claimed in claim 1 is characterized in that described active component made by the raw material of following weight portion:
Radix Astragali Preparata 6～8 Radix Codonopsis 5～6 Pericarpium Citri Reticulataes 3～5
Rhizoma Cyperi 6～8 Radix Paeoniae Albas 6～9 Rhizoma Dioscoreaes 6～12
Fructus Mume 2～5 Radix Glycyrrhizaes 4～5.
3. the chronic atrophic gastritis pharmaceutical composition that is used for the treatment of as claimed in claim 1 or 2 is characterized in that described chronic atrophic gastritis is the due to weakness of spleen and stomach chronic atrophic gastritis.
4. the chronic atrophic gastritis pharmaceutical composition that is used for the treatment of as claimed in claim 1 or 2 is characterized in that described chronic atrophic gastritis is the weakness of the spleen and stomach Qi-stagnation type chronic atrophic gastritis of holding concurrently.
5. the chronic atrophic gastritis pharmaceutical composition that is used for the treatment of as claimed in claim 1 or 2 is characterized in that described pharmaceutical composition is a peroral dosage form.
6. the chronic atrophic gastritis pharmaceutical composition that is used for the treatment of as claimed in claim 1 or 2 is characterized in that described pharmaceutical composition is oral liquid or granule.
7. the chronic atrophic gastritis pharmaceutical composition that is used for the treatment of as claimed in claim 1 or 2 is characterized in that described pharmaceutical composition is a granule.
8. as the preparation method of granule as described in the claim 7, it is characterized in that comprising following steps: get Radix Astragali Preparata, Radix Codonopsis, Pericarpium Citri Reticulatae, Rhizoma Cyperi, the Radix Paeoniae Alba, Rhizoma Dioscoreae, Fructus Mume, Radix Glycyrrhizae, above eight flavors are cleaned, Pericarpium Citri Reticulatae is wherein extracted volatile oil, and all the other seven flavors decoct with water secondary, 3 hours for the first time, 2 hours for the second time, Pericarpium Citri Reticulatae residue when decocting for the second time behind the adding extraction volatile oil merges decoction liquor, filters; Filtrate staticly settles, get the concentrated solution that supernatant concentration to 85 ℃ heat is surveyed relative density 1.05～1.10, concentrated solution left standstill more than 8 hours, got supernatant and filtered, filtrate is concentrated into the clear paste of relative density 1.14～1.16, and need are measured after clear paste is diluted 2 times when measuring this relative density; 1 part of qinghuo reagent, with 1.75 parts of sucrose, dextrin is made granule for 1.75 parts, and drying sprays into Pericarpium Citri Reticulatae volatile oil again, and mixing promptly gets granule.
9. as the preparation method of granule as described in the claim 7, it is characterized in that comprising following steps: get Radix Astragali Preparata, Radix Codonopsis, Pericarpium Citri Reticulatae, Rhizoma Cyperi, the Radix Paeoniae Alba, Rhizoma Dioscoreae, Fructus Mume, Radix Glycyrrhizae, above eight flavor medical materials are cleaned, Pericarpium Citri Reticulatae is wherein extracted volatile oil, and all the other seven flavors decoct with water secondary, 3 hours for the first time, 2 hours for the second time, Pericarpium Citri Reticulatae residue when decocting for the second time behind the adding extraction volatile oil merges decoction liquor, filters; Filtrate staticly settles, and getting supernatant concentration to 85 a ℃ heat survey relative density is 1.08～1.12, adds dextrin and obtains the concentrated solutions that 85 ℃ of heat are surveyed relative densities 1.14～1.18.The concentrated solution spray drying is made granule, sprays into Pericarpium Citri Reticulatae volatile oil again, and mixing promptly gets granule.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102406905A (en) * | 2011-11-07 | 2012-04-11 | 许从玉 | Medicinal composition for preventing or treating chronic atrophic gastritis and use thereof |
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| CN103316188B (en) * | 2013-06-24 | 2014-09-17 | 蒋卫忠 | Traditional Chinese medicine for treating chronic atrophic gastritis |
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| CN105362646A (en) * | 2015-12-10 | 2016-03-02 | 杨献美 | Pharmaceutical preparation for treating spleen-stomach deficiency type chronic gastritis |
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| CN109091640A (en) * | 2018-10-10 | 2018-12-28 | 天津普庆医疗科技开发有限公司 | It is a kind of for treating the Chinese medicine composition of tumor in digestive tract |
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