CN112156162B - Medicine for protecting gastric mucosa and preparation method thereof - Google Patents

Medicine for protecting gastric mucosa and preparation method thereof Download PDF

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CN112156162B
CN112156162B CN202011185679.8A CN202011185679A CN112156162B CN 112156162 B CN112156162 B CN 112156162B CN 202011185679 A CN202011185679 A CN 202011185679A CN 112156162 B CN112156162 B CN 112156162B
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gastric mucosa
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骆春秀
李先荣
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Shanxi Jianshuo Food And Drug Research Institute Co ltd
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Abstract

The invention belongs to the technical field of medicines, and particularly relates to a medicine for protecting gastric mucosa and a preparation method thereof. The technical scheme is that the medicine is prepared from the following medicines in parts by weight: 6-25 parts of astragalus membranaceus, 3-12 parts of Chinese yam, 3-12 parts of orange peel, 2-8 parts of fructus amomi, 5-18 parts of rhizoma bletillae, 5-18 parts of radix paeoniae alba and 3-9 parts of caulis bambusae in taeniam. The preparation method comprises the following steps: adding 8-12 times of water into the seven medicines, decocting for 1-3 times, 1-2 hours each time, filtering, concentrating the filtrate under reduced pressure to obtain thick paste with the relative density of 1.10-1.50 at 50-70 ℃, drying, adding a proper amount of auxiliary materials into the dry paste powder, mixing uniformly, and preparing the oral preparation by a conventional process. The invention gives play to the compatibility of traditional Chinese medicines, takes the basic principles of strengthening spleen, regulating qi, harmonizing stomach and lowering adverse qi, focuses on regulating qi, blood and yin and yang to improve the immunity of the organism, and completes the digestion of food and the distribution of essence and marrow together; the rat gastric mucosa injury experiment and clinical test fully prove that the formula has good repairing effect on the gastric mucosa injury.

Description

Medicine for protecting gastric mucosa and preparation method thereof
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a medicine for protecting gastric mucosa and a preparation method thereof.
Background
The gastric mucosa is the mucosal tissue of the inner aspect of the gastric cavity, the innermost layer of the gastric wall, which plays a major role in the digestive function of the stomach, and is an important barrier of the stomach, preventing the erosion of digestive juices and digestive enzymes, and protecting it from some food damage. Once the gastric mucosa is damaged, the health of the human body is greatly influenced.
Environmental factors, diet, medicines, smoking, alcoholism, bacterial infection and the like in modern society can cause damage to gastric mucosa, and the main symptoms of gastric mucosa damage are rhythmic and periodic epigastric pain which is often accompanied by symptoms of stomach qi disharmony such as inappetence, nausea and vomiting, acid regurgitation and gastric upset. Gastric mucosal injury is the major pathophysiological link leading to gastric ulcer and acute and chronic gastritis. The traditional Chinese medicine is quite common clinically, accounts for 80-90% of patients who receive gastroscopy, more men than women have, and the incidence rate gradually increases with age. The medicine has important significance for treating acute and chronic gastritis and gastric ulcer patients with damaged gastric mucosa and protecting the gastric mucosa; people who like drinking, like eating spicy food, like heavy taste, and who take antipyretic analgesics such as aspirin, etc., and are easy to cause gastric mucosa injury, should pay attention to the protection of the gastric mucosa and prevent diseases in advance.
The most varieties of western medicines for treating gastric mucosa injury are available in the market, and the western medicines mainly inhibit gastric acid secretion, protect gastric mucosa and adjust gastrointestinal motility functions. Drugs for inhibiting gastric acid secretion such as omeprazole, lansoprazole, etc., and drugs for protecting gastric mucosa such as bismuth potassium citrate, misoprostol, etc.; the medicines for regulating gastrointestinal motility function include WEIFUNING, MALINLIN, and cisapride; the medicines all relieve symptoms from different angles, but the symptoms are easy to relapse after stopping the medicines, and the medicines have toxic and side effects on liver and kidney after being taken for a long time.
Based on the basic pathogenesis of spleen qi deficiency, stomach qi blockage and stomach qi adverse rise, the full formula compatibility takes the basic principles of strengthening spleen, regulating qi, harmonizing stomach and descending adverse rise as the basic principles, not only focuses on regulating qi, blood, yin and yang to improve the immunity of the organism, but also aims at the qi blockage and adverse rise of the spleen and stomach, and adopts the functions of regulating qi, harmonizing stomach and descending adverse rise to protect the stomach and protect the stomach for suitable people with gastric mucosa injury.
The invention content is as follows:
the invention aims to exert the compatibility of traditional Chinese medicines, take the functions of strengthening the spleen, regulating the flow of qi, harmonizing the stomach and lowering the adverse flow of qi as basic principles, pay attention to harmonizing qi, blood and yin and yang to improve the immunity of the organism, and finish the digestion of food and the distribution of essence together; the rat gastric mucosa injury experiment and clinical test fully prove that the formula has good repairing effect on the gastric mucosa injury.
The invention provides a medicament for protecting gastric mucosa.
Another object of the present invention is to provide a process for the preparation of the medicament.
The technical scheme adopted by the invention is that the medicine for protecting gastric mucosa is prepared from the following medicines in parts by weight:
6-25 parts of astragalus membranaceus, 3-12 parts of Chinese yam, 3-12 parts of orange peel, 2-8 parts of fructus amomi, 5-18 parts of rhizoma bletillae, 5-18 parts of radix paeoniae alba and 3-9 parts of bamboo shavings.
A preparation method of a medicament for protecting gastric mucosa from injury comprises the following steps: calculated according to parts by weight
Adding 8-12 times of water into the seven medicines, decocting for 1-3 times, 1-2 hours each time, filtering, concentrating the filtrate under reduced pressure to obtain thick paste with the relative density of 1.10-1.50 at 50-70 ℃, drying, adding a proper amount of auxiliary materials into the dry paste powder, mixing uniformly, and preparing the oral preparation by a conventional process.
The auxiliary materials are as follows: microcrystalline cellulose, starch, sucrose, lactose, dextrin, calcium carbonate, magnesium stearate, gelatin, hydroxymethyl cellulose, silica gel micropowder, xylitol, silicon dioxide, hydroxypropyl cellulose, sodium carboxymethyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose or sodium carboxymethyl starch.
The above medicine can also be made into any other oral preparation in pharmaceutics, such as tablet, granule, capsule, powder, pill, oral liquid, etc.;
the pharmacological action analysis of the medicine property and the combination of the components of the invention is as follows:
the formula of the medicine consists of astragalus, Chinese yam, orange peel, bamboo shavings, bletilla, white paeony root and villous amomum fruit, and has the effects of strengthening spleen, regulating qi, harmonizing stomach and lowering adverse qi; in the recipe, Huang Qi is sweet in flavor and slightly warm in nature. Enter spleen and lung meridians. Sweet and warm in nature, tonifying qi and raising yang, and tonifying spleen yang; the yam is sweet in taste and neutral in nature, enters spleen, stomach, lung and kidney channels, tonifies spleen and lung, nourishes yin and promotes production of body fluid, tonifies kidney and controls nocturnal emission, while emphasizes on tonifying spleen yin; the two are used together to achieve yin and yang. The yin and yang are combined, mutually promoted and mutually transformed, and the effects of strengthening the spleen and stomach, promoting transportation and transformation and astringing spleen essence are achieved; orange peel, pungent and bitter in flavor and warm in nature. Entering spleen and lung meridians, they are the herbs of spleen and lung qi system. It can promote qi circulation, invigorate spleen, regulate middle warmer, and quickly relieve abdominal distention, pain, anorexia, etc. caused by qi stagnation of spleen and stomach; it also has effects in invigorating spleen, eliminating dampness, regulating stomach function, lowering adverse qi, and relieving vomit, and can be used for treating singultus and emesis due to phlegm-dampness stagnation and failure of stomach qi to descend; zhuru is sweet in flavor and slightly cold in nature, enters lung, stomach and gallbladder meridians, clears heat and stops vomiting, and clears qi and dissolves phlegm. When used with orange peel, it has the actions of warming and cooling, harmonizing the stomach and lowering adverse qi, and removing the cold and heat in the stomach. Rhizoma Bletillae, bitter, sweet, astringent in taste, slightly cold in nature, enters liver, lung and stomach channels, is sticky and astringent in texture, has special effects of astringing to stop bleeding, eliminating swelling and promoting granulation, and is used for treating hematemesis and gastroduodenal perforation caused by stomach and collaterals injury; white peony root, bitter and sour in taste, slightly cold in nature, enters liver and spleen channels, nourishes blood, astringes yin, soothes liver and blood, relieves spasm and pain, suppresses liver yang, and clears deficiency heat; sha ren, pungent in flavor and warm in nature. Enter spleen and stomach meridians. Pungent and warm in nature, and has effects in regulating qi, activating spleen, promoting digestion, stimulating appetite, relieving vomit, promoting qi circulation, and relieving pain; the compatibility of the whole formula accords with the theory of traditional Chinese medicine, and the effects of strengthening spleen, regulating qi, harmonizing stomach and lowering adverse qi are achieved, so that the immunity of the organism is improved by regulating qi, blood and yin and yang, and the effects of protecting and nourishing stomach are achieved for the adaptation population with gastric mucosa injury by regulating qi, harmonizing stomach and lowering adverse qi aiming at the condition that the spleen and stomach are easy to block qi movement and are adverse to the upper part, and the gastric mucosa can be effectively protected.
Modern pharmacological studies have demonstrated that:
astragalus membranaceus has the effects of tonifying qi, invigorating yang, promoting production of body fluid, nourishing blood, healing sore and promoting granulation, and contains various active ingredients such as flavonoids, saponins and polysaccharides. The radix astragali extract can improve structure and function of epithelial cells, protect stomach wall barrier, and inhibit occurrence and development of gastric mucosa atrophy. The astragalosides can reduce the expression of mRNA of H +, K + -ATP enzyme, reduce the secretion of gastric acid, reduce the stimulation of gastric acid to gastric mucosa and protect the gastric mucosa by inhibiting the activities of the H +, K + -ATP enzyme and pepsin. Researches on the sun saussurea involucrata and the like find that astragalus saponin and astragaloside have protection effects of different degrees on gastric mucosal barriers of rats with chronic gastric mucosal injury caused by rheum officinale, and the like take mouse gastric ulcer models caused by absolute ethyl alcohol as research objects, and compare the gastric ulcer resistance effects of astragalus extracts in different producing areas, so that the total astragalus extract has obvious drug effect, and the effect is consistent with the sore healing and granulation promoting effects of the total astragalus extract. The astragalus root and the extract thereof have the function of resisting mucosal damage.
The Chinese yam has the effects of tonifying middle-jiao and Qi, regulating spleen and stomach and helping digestion, amylase and polyphenol oxidase exist in the Chinese yam, the substances can effectively stimulate gastrointestinal peristalsis and help to decompose protein and starch, and the Chinese yam has a positive effect on emptying intestinal contents and is beneficial to digestion and absorption by the spleen and the stomach. Research of Luodingtian and the like finds that the dioscorea opposita has a protective effect on the gastric mucosa of rats with acute alcoholic gastric mucosa injury, and the mechanism of the dioscorea opposita is probably related to the expression of COX-2 in gastric mucosa cells of rats with acute alcoholic gastric mucosa injury. Studies of Shenifen and the like show that the fresh yam extract can reduce the level of serum gastrin in a dose-dependent manner to play a role in resisting gastric ulcer. Studies on the basis of Wenyuzhen show that allantoin contained in Chinese yam can repair epithelial tissues, promote the healing of skin ulcer surfaces and wounds, has the effect of promoting tissue regeneration, and can be used for treating gastric and duodenal ulcers.
The orange peel has the functions of regulating qi, strengthening spleen, lowering adverse qi, stopping vomit, regulating middle warmer and stimulating appetite, and contains volatile oil, flavonoids, organic amines, trace elements and other components. Qin de' an and the like discuss the removing effect of the effective component hesperidin in the dried orange peel on hydroxyl radical and the inhibiting effect on lipid peroxidation, and the result shows that the hesperidin has obvious removing effect on the hydroxyl radical and is in a dose dependent relation; in addition, hesperidin also has an obvious inhibiting effect on lipid peroxidation of erythrocyte membranes caused by hydroxyl radicals. Modern pharmacology indicates that the dried orange peel volatile oil can promote gastric secretion and is beneficial to digestion; the tangerine peel water extract has obvious promotion effect on the activity of in-vitro salivary amylase, and the effect of regulating qi and tonifying spleen of the tangerine peel has experimental basis.
The study results of the caulis bambusae in taeniam on the caulis bambusae in taeniam show that the caulis bambusae in taeniam can clear heat and reduce phlegm, relieve restlessness and stop vomiting, and Hongxiyuyu and the like: the caulis Bambusae in Taenia flavone has effects of reducing MDA generation and increasing SOD activity in 0.005g/L dosage, increasing MDA content in 0.5g/L dosage, and reducing SOD activity, while antioxidant effect in 0.0005 and 0.5g/L dosages is not obvious. This indicates that the bamboo shavings flavone has good effect of resisting oxidative damage under partial dosage. The experimental study of orange peel bamboo shavings decoction and reduction treatment mechanism of bile reflux gastritis is carried out by YaoChun and other people in Guangxi traditional Chinese medicine university, and the results show that the orange peel bamboo shavings decoction has a remarkable protection effect on the gastric mucosa of a model rat, and the action mechanism of the orange peel bamboo shavings decoction is related to serum GAS increase and gastric mucosa PGE 2.
Bai Ji can astringe to stop bleeding, resolve swelling and promote granulation. The white and ultra-fine powder researches of Liuying and the like show that: the common bletilla pseudobulb powder can obviously reduce the ulcer area of a rat, and improve the punctate bleeding and the injury degree of the gastric mucosa. Studies of Bai and polysaccharides with Huang 40849, et al, showed that: the bletilla polysaccharide can reduce gastric mucosal injury of a stress gastric ulcer mouse model; the bletilla polysaccharide can reduce the gastric ulcer index of an ethanol-induced gastric ulcer mouse model and can reduce the gastric mucosal injury of a pylorus ligation type mouse model. The research on white and polysaccharide by the royal heavy ocean and the like shows that: the bletilla polysaccharide can obviously prevent the formation of mouse gastric ulcer caused by absolute ethyl alcohol; the area of gastric ulcer of rats caused by acetic acid can be reduced; can also reduce the MDA content in the blood serum of the ulcer rat, can improve the SOD content, and indicates that the mechanism of resisting gastric ulcer of the bletilla polysaccharide is probably related to the promotion of gastric mucosa repair by inhibiting lipid peroxidation.
White peony root, radix Paeoniae alba, radix Angelicae sinensis, radix Paeoniae alba, radix Aconiti lateralis Preparata, radix Paeoniae alba, blood nourishing, menstruation regulating, yin astringing, and antiperspirant. The main chemical components include paeoniflorin, albiflorin, hydroxy paeoniflorin, benzoyl paeoniflorin, etc. Wuzhenhua et al found through clinical observation: the traditional Chinese medicine mainly comprising white paeony root has obvious curative effect on treating atrophic gastritis, and the blood SOD level of a patient is increased after treatment, which indicates that the traditional Chinese medicine mainly comprising white paeony root can effectively eliminate free radicals, reduce lipid peroxides, not only protect gastric mucosa from being damaged, but also have the effects of cancer prevention and aging resistance, and the curative effect of the traditional Chinese medicine is more obvious than that of a natural powerful free radical scavenger vitamin E with positive effect.
Fructus amomi, resolving dampness and promoting appetite, warming spleen and stopping diarrhea, chemical components comprise volatile components, non-volatile components, polysaccharide, flavonoid glycoside and the like, and the study of magnolia liliflora and the like on fructus amomi volatile oil shows that: the amomum fruit volatile oil can reduce the ulcer area of a rat, and the gastric ulcer shrinkage rates are respectively 25.5 percent and 50.4 percent. Research on resolution suggests that the mechanism of amomum fruit in protecting gastric mucosa may be related to the scavenging of free radicals. The study of fructus Amomi by Huang Guozhong et al shows that: fructus amomi can influence the content of hexosamine and phospholipid in gastric mucosa by improving the expression of Spasmolytic Polypeptide (SP), improving the level of breast cancer related peptide (PS2) in the bone mucosa and reducing the expression of Platelet Activating Factor (PAF), thereby influencing the hydrophobicity of the gastric mucosa and strengthening the stability of a mucus gel layer, thereby preventing the generation and the recurrence of ulcer.
To show the effect of the present invention on protecting gastric mucosa, the pharmacodynamic experimental report providing the drug of the present invention is as follows:
1 materials and methods
1.1 the sample uses dry paste powder without auxiliary materials provided by manufacturing enterprises as a test substance. 3.0 g/bag. The recommended amount for human body is 2 times daily, 1 bag each time.
1.2 test animal SD rat male 50, weight 180-220 g, provided by Beijing Wittingle laboratory animal technology Limited, quality certificate number: 11400700042761, SPF class. License number for experimental animals: SYXK (Yu) 2012-.
1.3 complete nutrition mouse feed, clean grade, provided by the experimental animal center of Henan province, and the certification number: 41000100000708.
1.4 instrumental vernier calipers.
1.5 animal experiments
1.5.1 dose grouping rats were randomly divided into three dose groups, a blank control group and a model control group.
1.5.2 dosage design is provided with three dosage groups of low, medium and high, which are respectively 5 times, 10 times and 30 times of the recommended amount of human body, namely 0.25g/kg, 0.50g/kg and 1.50g/kg, the tested object is administered by a gastric lavage method, and 2.5g, 5.0g and 15.0g of samples are respectively weighed and added with distilled water to 100ml to be used as gastric lavage liquid of the low dosage group, the medium dosage group and the high dosage group. The blank control group and the model control group were administered with distilled water only, and the test substance was administered continuously for 30 days with a gavage amount of 10 ml/kg.
1.5.3 Experimental methods and observational indices after 30 days of continuous administration of the test substance to rats in the acute gastric mucosal injury alcohol model, all animals were fasted strictly for 24 hours (without water deprivation) during which time the administration of the test substance was prohibited. Except for the blank control group, all experimental animals were given 1.0 ml/animal of absolute ethanol, and the animals were sacrificed after 1 hour, the intact stomach was exposed, the pylorus was ligated, a proper amount of 10% formaldehyde solution was perfused, fixed for 20 minutes, and then cut along the greater curvature of the stomach, the stomach contents were washed off, the gastric mucosa was developed, and the length and width of the bleeding spot or band were measured with a vernier caliper under the flesh eye. The severity of the lesion represented by the width is doubled since it is much greater than the length. The scoring criteria are shown in table 1.
TABLE 1 macroscopic evaluation of acute alcohol Damage
Figure BDA0002751370680000051
Figure BDA0002751370680000061
Observation indexes are as follows: the degree of gastric mucosal damage in each experimental group was expressed as the incidence of damage (%), the damage integral index and the damage inhibition rate. Incidence (%) of injury ═ number of rats with bleeding in a certain group/number of rats in the group × 100%; lesion score index is the sum of group lesion scores/number of animals in the group; the damage inhibition ratio (%) (a-B)/ax100% (A, B is the damage integral of the model group and the test group, respectively).
Histopathological observation and scoring: after the gross examination, the most severely damaged parts of the gastric mucosa of each animal were excised, fixed in 10% formaldehyde solution, and subjected to routine flaking, HE staining, and microscopic observation. Note that the normal transverse section of the gastric mucosa, including the observation of the entire layer of mucosa, was selected. The scoring method comprises the following steps: the degree of involvement of congestion, hemorrhage and degenerative necrosis of mucosal cells in the entire mucosal epithelial layer was classified into 5 grades. The hyperemia weight is 1, the hemorrhage weight is 2, the epithelial degeneration and necrosis weight is 3, and the scoring standard and the total integral formula of the pathological changes are shown in table 2.
TABLE 2 evaluation criteria under acute gastric mucosal injury scope
Figure BDA0002751370680000062
1.6 statistical methods the experimental data were analyzed for variance using SPSS software.
2 results
2.1 Effect on rat body weight
TABLE 1 Effect on rat body weight
Figure BDA0002751370680000063
Figure BDA0002751370680000071
As can be seen from Table 1, the differences between the body weight groups at the early, middle and end stages of the experiment were not significant (P > 0.05). Indicating that there was no significant effect on animal body weight under the conditions of this test.
2.2 macroscopic examination of gastric mucosal Damage in rats
TABLE 2 macroscopic integration of gastric mucosal lesions in rats
Figure BDA0002751370680000072
Note: comparison of P <0.01 with model control group
As can be seen from Table 2, the visual observation of the gastric mucosal lesion integrated values in the blank control group has a very significant difference (P <0.01) compared with the model control group, which indicates that the model is established. The macroscopic observation integral of the gastric mucosa injury of the rats in the three dose groups is lower than that of the model control group, the difference has extremely significant significance (P <0.01), and the experimental result is positive.
2.3 pathological histology observation of gastric mucosal injury in rats
TABLE 3 Observation integration under the mirror for gastric mucosal injury in rats
Figure BDA0002751370680000073
Note: comparison of P <0.01 with model control group
As can be seen from Table 3, the difference between the observation integral under the gastric mucosa lesion microscope of the blank control group and the observation integral under the gastric mucosa lesion microscope of the model control group has very significant significance (P <0.01), which indicates that the model is established. The observation integral of rats in the 1.0g/kg dose group and the 3.0g/kg dose group under a gastric mucosa lesion microscope is lower than that of the model control group, the difference has significant significance (P <0.05 and P <0.01), and the experimental result is positive.
3 conclusion
1) The result of the macroscopic observation index of the injury of the gastric mucosa of the rat is positive.
2) The pathological histological observation result of the rat gastric mucosa injury is positive.
The experimental sample has a protection function on the damage of gastric mucosa.
Human body feeding trial test report with protective effect on gastric mucosa injury
1. Materials and methods
1.1 sample protection gastric mucosa drug was manufactured by Beijing Haidenhu pharmaceutical Co. The positive control is stomach-recovering granule produced by Heilongjiang sunflower pharmaceutical industry, approved article No.: national drug standard Z20090010, batch number: 20140707.
1.2 subject selection
1.2.1 inclusion criteria
1.2.1.1 age 18-65 years old, both male and female.
1.2.1.2 obtaining informed consent, meeting the diagnosis standard of chronic superficial gastritis and being confirmed to be a volunteer subject of superficial gastritis by gastroscope screening. Diagnosis standard of chronic superficial gastritis: prolonged course of disease, with different degrees of clinical symptoms such as dyspepsia, epigastric pain, heartburn, belching, acid regurgitation, abdominal distension, etc., and mild tenderness of the upper abdomen. The diagnostic standard of the chronic superficial gastritis fiberoptic gastroscope and the biopsy diagnostic standard are met, and gastric ulcer patients are excluded.
1.2.2 exclusion criteria
1.2.2.1 age under 18 or over 65, pregnant or lactating women, allergic constitution and those allergic to this sample.
1.2.2.2 Secondary Chronic gastritis.
1.2.2.3 patients with serious systemic diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic system.
1.2.2.4 Severe symptoms and signs were classified.
1.2.2.5 frequent medication, alcohol addiction, and large number of smokers.
1.2.2.6 patients with digestive system ulcers.
1.2.2.7 are taking other medications or receiving other treatments.
1.2.2.8 taking the article related to the tested function in a short period of time affects the judgment of the result.
1.2.2.9 the efficacy or safety is not judged by taking the sample according to the regulations, or the data is not complete.
1.3 Subjects grouping
Two control designs, self and group, were used. 120 cases of chronic superficial gastritis patients meeting the above standard after gastroscopy are selected, and divided into a trial group and a positive control group randomly according to the grading integral level of symptoms of the subjects, and main factors influencing the result, such as age, sex, course of disease and the like are considered to carry out balance test to ensure comparability among the groups. The final effective cases are 53 positive control cases and 51 test-feeding cases.
1.4 method of tasting
During the test eating period, other articles for treating chronic gastropathy are not used, and the original eating habit is not changed. The trial group takes the medicine for protecting gastric mucosa 2 times a day, 1 bag each time. The positive control group takes the stomach-recovering granule produced in Heilongjiang sunflower pharmacy 2 times a day, 1 bag each time, 4g each bag. The observation time of both groups was 30 days, and the original diet habit was not changed during the test period, and the diet was normal.
1.5 Observation index
Each index is detected once before the beginning and once after the end of the test feeding.
1.5.1 safety observations
1.5.1.1 general condition signs include mental, sleep, diet, stool and urine, blood pressure, etc
1.5.1.2 routine examination of blood, urine and feces
1.5.1.3 examination of liver and kidney function
1.5.1.4 chest X-ray, electrocardiogram, abdomen B-ultrasonic examination (only one examination before test)
1.5.2 Observation of efficacy
1.5.2.1 Observation of symptoms
Stomachache, belching, acid regurgitation, abdominal distension, inappetence, anorexia and other clinical symptoms. The score was counted according to the severity of the symptoms (3 points of severe, 2 points of moderate, 1 point of mild).
Grading table for severity of symptoms
Figure BDA0002751370680000091
Figure BDA0002751370680000101
1.5.2.2 gastroscope review and sign observation
The test group and the positive control group were examined with a gastroscope for 15 subjects, and changes before and after the test were compared.
The examination of the pain degree of the subxiphoid process is divided into mild (1 point), moderate (2 points) and heavy (3 points) according to the pain degree.
Mild: pain only occurs when force is applied, and tenderness is slight for 1 point.
Medium: pain occurs immediately after exertion, but the pain is still tolerable and the tenderness is obviously 2 points.
Severe disease: pain occurs with slight effort, pain cannot be tolerated, and tenderness is severe for 3 points.
1.6 SPSS statistical software is used for data processing, pairing t test is used for self comparison before and after test eating, and grouping t test is used for comparison of two groups of averages.
2. As a result, the
2.1 Subjects enrollment and completion
The two groups are combined into a test group, wherein the test group comprises 120 patients with shedding, 16 patients with shedding and 13.33% of shedding, the test group comprises 7 patients with shedding and 11.67% of shedding, and the positive control group comprises 9 patients with shedding and 15.00% of shedding.
TABLE 1 Subjects enrollment and completion
Figure BDA0002751370680000102
2.2 analysis of balance between groups before group entry
2.2.1 general data comparison
The general data (sex, age, height, weight, body temperature, respiration, heart rate, blood pressure, course of disease) of two groups of candidates are compared, and the difference has no statistical significance (P >0.05), which indicates that the general data of the two groups of candidates are comparable.
TABLE 2-1 comparison of two general data sets
Figure BDA0002751370680000103
Figure BDA0002751370680000104
Figure BDA0002751370680000111
2.2.2 analysis of score results of individual symptoms of test feeders before group entry
The symptom scores of the first two groups of test feeders are compared, the difference has no statistical significance (P is more than 0.05), and the symptom scores have certain comparability when the test feeders are used in the group.
TABLE 2-2 comparison of the results of the scores of the symptoms of the two groups before the test
Figure BDA0002751370680000112
Figure BDA0002751370680000113
2.3 Observation
2.3.1 Effect on clinical symptom score
The comparison of the integral of each symptom between the two groups before the test feeding has no significant difference (P is more than 0.05), which indicates that the clinical symptoms between the two groups before the test feeding are similar and comparable; after the test meal, the symptom scores in each group have significant differences (P < 0.01) in comparison before and after the group, which shows that the clinical symptom scores of two groups of test-eaten patients can be obviously improved after the test meal; after the test eating, the symptom scores between the two groups have no significant difference (P is more than 0.05), which indicates that the degrees of improving the single symptoms of stomachache, belching, acid regurgitation, abdominal distension and inappetence of the two groups are similar to those of the positive control group, and the results are shown in Table 3.
3-1 stomach ache
Figure BDA0002751370680000114
Figure BDA0002751370680000115
Figure BDA0002751370680000121
3-2 belching
Figure BDA0002751370680000122
Figure BDA0002751370680000123
3-3 counter acid
Figure BDA0002751370680000124
Figure BDA0002751370680000125
3-4 abdominal distention
Figure BDA0002751370680000126
Figure BDA0002751370680000127
3-5 Xiao Shi
Figure BDA0002751370680000128
Figure BDA0002751370680000129
3-6 Total integration of symptoms
Figure BDA00027513706800001210
Figure BDA00027513706800001211
Figure BDA0002751370680000131
2.3.2 analysis of symptom and sign improvement rates
The improvement rate of each clinical symptom between the two groups has no obvious difference (P is more than 0.05), and the improvement rates of stomachache, belching, acid regurgitation, abdominal distension, poor appetite and abdominal distension between the two groups are similar as seen from the eating trial result.
TABLE 4 comparison of the rate of improvement of clinical symptoms in two groups of test feeders
Figure BDA0002751370680000132
2.3.3 Effect on the integration of the tenderness under the xiphoid Process
Compared with the scores of the Jiantu tenderness before and after the test diet of the two groups of test diets, the score has significant difference (P < 0.01), compared with the score itself in the two groups of test diets (P < 0.01), which indicates that the score of the Jiantu tenderness of the gastric mucosa injury crowd can be significantly reduced by the test diet group and the control group.
TABLE 5 Callicarpa tenderness score statistics before and after trial
Figure BDA0002751370680000133
Figure BDA0002751370680000134
2.3.4 effects on gastroscopy and pathology
The gastroscopy of 16 test food groups and 18 positive control groups is randomly selected, the condition under the mirror and the pathology are improved after the test food, and the recheck result is not aggravated.
TABLE 6 Change of gastroscopy before and after test
Figure BDA0002751370680000135
Figure BDA0002751370680000141
2.4 safety index Observation before and after eating trial
2.4.1 the general conditions (including mental, sleep, diet, urine, blood pressure, heart rate) of the test taker before and after the test meal did not change significantly.
2.4.2 before eating the trial, the chest X-ray, the electrocardiogram and the B-super junction fruit in the abdomen are all basically normal.
2.4.3 after the test taker eats the test food, the adverse reaction and anaphylactic reaction symptoms of the test subject are not seen, and the table 7 shows.
TABLE 7 adverse reactions and allergic reactions after eating test
Figure BDA0002751370680000142
2.4.4 before and after eating the test food, no obvious abnormality is found in the routine examination of urine (pH, specific gravity, nitrous acid, protein, bilirubin, urobilinogen, ketone body and microscopic examination) and routine indexes of excrement (color, shape, ova, red blood cells, white blood cells, parasites and the like), and the table 8 shows.
2.4.5 the results of the blood routine test and the serum biochemical test before and after the test are within the normal range. In addition, the blood pressure and heart rate are within normal ranges. Shows that no harm is caused to the health of the test eaters after the test eating of the medicament for preventing and treating the gastric mucosa injury, and is shown in a table 8.
TABLE 8 Pre-and post-test safety check
Figure BDA0002751370680000143
Figure BDA0002751370680000144
Figure BDA0002751370680000151
3. Small knot
Selecting volunteers which accord with the diagnosis standard of chronic superficial gastritis and are confirmed to be superficial gastritis by gastroscope screening, roughly and evenly dividing the volunteers into two groups by adopting a random method according to the grading and grading of the severity of gastroscope result symptoms, namely a test food group and a positive control group, and considering the balance of sex, age and the like of the test subjects, wherein 53 test food groups and 51 positive control groups are finally effective cases; the test group is administered with the medicine for protecting gastric mucosa 2 times a day, 1 bag each time, and 3g each bag. The positive control group takes the stomach-recovering granule produced in Heilongjiang sunflower pharmacy 2 times a day, 1 bag each time, 4g each bag. The observation time is 30 days, and all subjects stop using other medicines for treating chronic gastropathy during the test period, and the original dietary habits and normal diet are not changed. The results show that: after the medicine for protecting gastric mucosa is taken, the grading integral of clinical symptoms and the grading integral of the degree of the pain under the xiphoid process are both obviously reduced before and after the test eating of the test eating group, the comparative difference per se has extremely significant (P is less than 0.01), the grading integral of clinical symptoms and the grading integral of the degree of the pain under the xiphoid process are also obviously reduced before and after the test eating of the positive control group, and the comparative difference per se also has extremely significant (P is less than 0.01); after eating the trial group and the positive control group, the clinical symptoms such as stomachache, eructation, acid regurgitation, abdominal distension, inappetence, poor appetite and the like are obviously improved; the clinical symptom grading score and the comparison difference of the sword process lower pressure pain degree score of the test group and the positive control group before and after the test are not significant (P is more than 0.05); the patients in the test group 16 and the positive control group 18 have improved under-gastroscopy and pathology without aggravation. Safety indexes of blood routine, liver and kidney function, urine and stool routine and the like of two groups have no obvious change before and after the test, and B ultrasonic, chest X-ray and electrocardiogram are basically in normal ranges before the test.
Experiments prove that the product can be used for repairing the damage of gastric mucosa and effectively protecting the gastric mucosa.
Detailed Description
Example 1
The medicine for protecting gastric mucosa is prepared from the following medicines in parts by weight:
6 parts of astragalus, 3 parts of Chinese yam, 3 parts of orange peel, 2 parts of fructus amomi, 5 parts of rhizoma bletillae, 5 parts of radix paeoniae alba and 3 parts of caulis bambusae in taeniam.
A preparation method of a medicament for protecting gastric mucosa comprises the following steps: calculated according to parts by weight
Decocting the above seven materials with 8 times of water for 1 time, each time for 1 hr, filtering, concentrating the filtrate under reduced pressure to relative density of 1.10 soft extract at 50 deg.C, drying, mixing the dry extract powder with appropriate amount of adjuvant, and making into oral dosage form by conventional method.
Example 2
The medicine for protecting gastric mucosa is prepared from the following medicines in parts by weight:
25 parts of astragalus membranaceus, 12 parts of Chinese yam, 12 parts of orange peel, 8 parts of fructus amomi, 18 parts of rhizoma bletillae, 18 parts of radix paeoniae alba and 9 parts of caulis bambusae in taeniam.
A preparation method of a medicament for protecting gastric mucosa comprises the following steps: calculated according to parts by weight
Decocting the above seven materials with 12 times of water for 3 times, each for 2 hr, filtering, concentrating the filtrate under reduced pressure to relative density of 1.50 soft extract at 70 deg.C, drying, mixing the dry extract powder with appropriate amount of adjuvant, and making into oral dosage form by conventional method.
Example 3
The medicine for protecting gastric mucosa is prepared from the following medicines in parts by weight:
15 parts of astragalus membranaceus, 8 parts of Chinese yam, 8 parts of orange peel, 6 parts of fructus amomi, 9 parts of rhizoma bletillae, 1 part of radix paeoniae alba and 6 parts of caulis bambusae in taeniam.
A preparation method of a medicament for protecting gastric mucosa comprises the following steps: calculated according to parts by weight
Decocting the above seven materials with 10 times of water for 2 times, each for 2 hr, filtering, concentrating the filtrate under reduced pressure to relative density of 1.30 soft extract at 60 deg.C, drying, mixing the dry extract powder with appropriate amount of adjuvant, and making into oral dosage form by conventional method.
The auxiliary materials used in all the above embodiments can be one or a mixture of any more of microcrystalline cellulose, starch, sucrose, lactose, dextrin, calcium carbonate, magnesium stearate, gelatin, hydroxymethyl cellulose, aerosil, xylitol, silicon dioxide, hydroxypropyl cellulose, sodium carboxymethyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose or sodium carboxymethyl starch.
The invention can be prepared into other dosage forms by the conventional process besides preparing oral dosage forms.

Claims (3)

1. The medicine for protecting gastric mucosa is characterized by being prepared from the following medicines in parts by weight:
6-25 parts of astragalus membranaceus, 3-12 parts of Chinese yam, 3-12 parts of orange peel, 2-8 parts of fructus amomi, 5-18 parts of rhizoma bletillae, 5-18 parts of radix paeoniae alba and 3-9 parts of caulis bambusae in taeniam.
2. A process for preparing a medicament according to claim 1 for protecting the gastric mucosa, characterized by: the method comprises the following steps: calculated according to parts by weight
Adding 8-12 times of water into the seven medicines, decocting for 1-3 times, 1-2 hours each time, filtering, concentrating the filtrate under reduced pressure to obtain thick paste with the relative density of 1.10-1.50 at 50-70 ℃, drying, adding a proper amount of auxiliary materials into the dry paste powder, mixing uniformly, and preparing the oral preparation by a conventional process.
3. The method for preparing a medicament for protecting gastric mucosa according to claim 2, wherein: the auxiliary materials are as follows: microcrystalline cellulose, starch, sucrose, lactose, dextrin, calcium carbonate, magnesium stearate, gelatin, hydroxymethyl cellulose, silica gel micropowder, xylitol, silicon dioxide, hydroxypropyl cellulose, sodium carboxymethyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose or sodium carboxymethyl starch.
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