CN107137672B

CN107137672B - Traditional Chinese medicine composition for treating liver-stomach disharmony type chronic superficial gastritis and application thereof

Info

Publication number: CN107137672B
Application number: CN201710582753.1A
Authority: CN
Inventors: 薛宁; 季晓霞
Original assignee: Shanghai Jing'an Traditional Chinese Medicine Hospital
Current assignee: Shanghai Jing'an Traditional Chinese Medicine Hospital
Priority date: 2017-07-17
Filing date: 2017-07-17
Publication date: 2020-09-04
Anticipated expiration: 2037-07-17
Also published as: CN107137672A

Abstract

The invention relates to a traditional Chinese medicine composition for treating liver-stomach disharmony type chronic superficial gastritis, which is prepared from the following raw material medicines: bupleuri radix, Scutellariae radix, radix Curcumae, cortex Magnolia officinalis, fructus Lipuidambaris, Os Sepiae, and rhizoma corydalis. The invention also provides application of the traditional Chinese medicine composition. Its advantages are: the traditional Chinese medicine composition can obviously improve the symptoms of epigastric pain, epigastric fullness, pantothenic acid, warm air, chest and hypochondrium pain and the like of a patient, has an obvious effect of up-regulating serum PGR of the patient, has a function of reducing serum CRP of the patient, has a good clinical curative effect on liver-stomach disharmony type chronic superficial gastritis, can play the curative effects of soothing liver and relieving depression and regulating qi to relieve pain on the whole for the patient, and does not generate obvious adverse effects and toxic and side effects on the patient.

Description

Traditional Chinese medicine composition for treating liver-stomach disharmony type chronic superficial gastritis and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating liver-stomach disharmony type chronic superficial gastritis and application thereof.

Background

The ancient books of traditional Chinese medicine do not have records of the names of chronic superficial gastritis, but belong to the categories of epigastric pain, epigastric upset, fullness and the like in traditional Chinese medicine according to clinical symptoms. The record of the disease name of epigastric pain is from the "Nei Jing" (internal classic), for example, Ling Shu & Jing Mai "(Ling Shu & Jing Mai): for gastric distention, abdominal fullness and epigastric pain. The traditional Chinese medicine considers that the stomach governs reception and the spleen governs transportation and transformation, the two coordinate with each other to digest diet and ingest food essence to nourish human body, and the normal operation of the stomach qi depends on the normal dispersion of the liver qi. As in the book "blood syndrome and zang-fu organ pathogenesis: the wood property is mainly to dredge qi, food qi enters stomach, and it depends on qi of liver wood to dredge qi, and water and food are transformed into food. If liver qi is impaired by anxiety, anger, depression of qi and liver qi failing to dredge, it may affect stomach-qi and cause incoordination between liver and stomach. Clinically, patients often suffer from emotional disorder, stagnation of liver qi, failure of smoothing flow, transverse flow affecting the stomach, stagnation of qi and blood, and pain caused by obstruction of qi and blood, and can also cause the formation of blood stasis and blood stasis in collaterals for a long time due to qi and blood dependence; the long-term stagnation of heart-liver qi into fire, the fire of five zang organs is the violence of liver fire, the fire-type inflammation scorches the yin of liver and stomach, aggravates pain.

The chronic gastritis is chronic inflammation of gastric mucosa caused by various reasons, the incidence rate is at the head of digestive system diseases, the chronic gastritis can be clinically divided into superficial gastritis, atrophic gastritis and special gastritis, the most common chronic superficial gastritis is one type of chronic superficial gastritis, the etiology of the chronic superficial gastritis is related to various factors such as helicobacter pylori infection, bile and other alkaline intestinal reflux and other exogenous factors, the symptoms are various, the disease condition is easy to repeat, and therefore, the modern medicine is lack of a complete treatment means. Pepsinogen is a precursor of pepsin and is an endoprotease with digestion function, PG1 is mainly secreted by a major cell of a fundus stomach gland, and PG2 is secreted by a pyloric gland and a Brunner gland of duodenum. The level of which may reflect pepsin secretion as well as gastric mucosal status. Studies have shown that PG1 and PG2 are significantly higher in patients with superficial gastritis than in patients with physical examination, and increase with increasing intensity of inflammation and activity of inflammation. CRP reactive protein is used as an extremely sensitive index of acute phase reaction, CRP concentration in plasma is rapidly and obviously increased in acute myocardial infarction, trauma, infection, inflammation, surgical operation and tumor infiltration, and research shows that hs-CRP level of chronic superficial gastritis patients is obviously increased compared with healthy patients, and the CRP reactive protein can be used as one of indexes of disease prognosis and development of chronic gastritis patients.

According to the modern Chinese medicine pharmacological analysis, the saikosaponin has the inhibition effect on various inflammatory processes including inflammatory exudation, capillary permeability increase, inflammatory mediator release, leukocyte migration, connective tissue hyperplasia and the like. Experiments prove that the acidic polysaccharide BR-2 separated and refined from the bupleurum chinense hot water extract has obvious inhibition effect on alcoholic ulcer, water immersion stress ulcer and pylorus ligation ulcer of a rat. The baicalin has obvious protective effect on cell injury, and the action mechanism of the baicalin is probably that the baicalin plays a role in resisting oxidation and then playing a role in resisting apoptosis by up-regulating Trx expression.

Chinese patent document CN102764406A discloses a traditional Chinese medicine for treating chronic superficial gastritis, which is prepared from coptis chinensis, fried bighead atractylodes rhizome, long-noded pit viper, herba hedyotis, barbed skullcap herb, dandelion, eupatorium, caulis perillae, rhizoma corydalis, paniculate swallowwort root, radix curcumae, fried cattail pollen, galangal and other bulk drugs. Chinese patent document CN103520650A discloses a traditional Chinese medicine for treating chronic superficial gastritis, which is composed of thirteen medicines of ginseng, astragalus root, lightyellow sophora root, cimicifuga foetida, bupleurum root, coix seed, nardostachyos root and rhizome, zedoary, peach kernel, poria, fructus gardeniae, white mustard seed and fennel. The preparation method comprises the following steps: weighing the raw materials in parts by weight, adding cold water to the powder, soaking for 1-1.5 hours, boiling with strong fire, decocting with slow fire for 25-35 minutes, filtering to remove residues to obtain liquid medicine, decocting twice, mixing the liquid medicines, then boiling, decocting with slow fire for 4-5 minutes to obtain 400ml, and evenly dividing into two parts. However, the traditional Chinese medicine composition for treating liver-stomach disharmony type chronic superficial gastritis and the application thereof are not reported at present.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for treating liver-stomach disharmony type chronic superficial gastritis, aiming at the defects in the prior art.

The invention further aims to provide application of the traditional Chinese medicine composition for treating liver-stomach disharmony type chronic superficial gastritis.

In order to achieve the purpose, the invention adopts the technical scheme that: the traditional Chinese medicine composition for treating liver-stomach disharmony type chronic superficial gastritis is prepared from the following raw material medicines in parts by weight: 7-11 parts of radix bupleuri, 7-11 parts of radix scutellariae, 12-18 parts of radix curcumae, 12-18 parts of magnolia officinalis, 12-18 parts of fructus liquidambaris, 25-35 parts of cuttlebone and 15-21 parts of rhizoma corydalis.

The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 8-10 parts of radix bupleuri, 8-10 parts of radix scutellariae, 13-17 parts of radix curcumae, 13-17 parts of magnolia officinalis, 13-17 parts of fructus liquidambaris, 24-34 parts of cuttlebone and 16-20 parts of rhizoma corydalis.

The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 8-10 parts of radix bupleuri, 8-10 parts of radix scutellariae, 14-16 parts of radix curcumae, 14-16 parts of mangnolia officinalis, 14-16 parts of fructus liquidambaris, 28-32 parts of cuttlebone and 17-19 parts of rhizoma corydalis.

The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 9 parts of radix bupleuri, 9 parts of scutellaria baicalensis, 15 parts of radix curcumae, 15 parts of mangnolia officinalis, 15 parts of fructus liquidambaris, 30 parts of cuttlebone and 18 parts of rhizoma corydalis.

In order to achieve the second object, the invention adopts the technical scheme that: the traditional Chinese medicine composition is applied to preparation of a medicine for treating liver-stomach disharmony type chronic superficial gastritis.

The dosage form of the medicine is granules, capsules, tablets, pills or oral liquid.

The invention has the advantages that:

1. the traditional Chinese medicine composition has a good clinical curative effect on liver-stomach disharmony type chronic superficial gastritis, can obviously improve the symptoms of epigastric pain, epigastric fullness, pantothenic acid, warm air, chest and hypochondrium pain and the like of a patient, and does not generate obvious adverse effect and toxic or side effect.

2. The traditional Chinese medicine composition disclosed by the invention has an obvious effect of up-regulating the serum PGR of a patient with liver-stomach disharmony type chronic superficial gastritis and has a function of reducing the serum CRP of the patient.

3. The traditional Chinese medicine composition provided by the invention has the advantages that the raw materials supplement each other and have comprehensive effects, and the effect of treating liver-stomach disharmony type chronic superficial gastritis is achieved. The radix bupleuri and the radix scutellariae have the effects of smoothing liver and gallbladder qi, clearing away damp-heat in the interior, promoting blood circulation to relieve pain, promoting qi circulation to relieve depression, magnolia officinalis is pungent in taste and warm in nature, promoting qi circulation to remove dampness, warming the middle warmer to relieve pain, and relieving distension and fullness, so that qi can be discharged, liquidambar formosana hance is enabled to activate collaterals to relieve pain, cuttlebone is used for astringing and stopping bleeding, relieving hyperacidity and pain, and corydalis tuber is used for regulating pain of the upper part and the lower part of the body, and has the peculiar effects of dissipating blood stasis, regulating qi and relieving pain, so that the.

Detailed Description

The following examples are provided to illustrate specific embodiments of the present invention.

The invention provides a traditional Chinese medicine composition for treating liver-stomach disharmony type chronic superficial gastritis, which comprises the following raw material medicines in parts by weight:

7-11 parts of radix bupleuri, 7-11 parts of radix scutellariae, 12-18 parts of radix curcumae, 12-18 parts of magnolia officinalis, 12-18 parts of fructus liquidambaris, 25-35 parts of cuttlebone and 15-21 parts of rhizoma corydalis.

EXAMPLE 1 Chinese medicinal composition

7 parts of radix bupleuri, 11 parts of scutellaria baicalensis, 12 parts of radix curcumae, 12 parts of mangnolia officinalis, 12 parts of fructus liquidambaris, 25 parts of cuttlebone and 15 parts of rhizoma corydalis.

EXAMPLE 2 Chinese medicinal composition

8 parts of radix bupleuri, 10 parts of radix scutellariae, 13 parts of radix curcumae, 13 parts of mangnolia officinalis, 13 parts of fructus liquidambaris, 26 parts of cuttlebone and 16 parts of rhizoma corydalis.

Example 3 Chinese medicinal composition

9 parts of radix bupleuri, 9 parts of scutellaria baicalensis, 14 parts of radix curcumae, 14 parts of mangnolia officinalis, 14 parts of fructus liquidambaris, 27 parts of cuttlebone and 17 parts of rhizoma corydalis.

EXAMPLE 4 Chinese medicinal composition

10 parts of radix bupleuri, 8 parts of radix scutellariae, 15 parts of radix curcumae, 15 parts of mangnolia officinalis, 15 parts of fructus liquidambaris, 28 parts of cuttlebone and 18 parts of rhizoma corydalis.

EXAMPLE 5 Chinese medicinal composition

11 parts of radix bupleuri, 7 parts of radix scutellariae, 16 parts of radix curcumae, 16 parts of mangnolia officinalis, 16 parts of fructus liquidambaris, 29 parts of cuttlebone and 19 parts of rhizoma corydalis.

EXAMPLE 6 Chinese medicinal composition

11 parts of radix bupleuri, 11 parts of scutellaria baicalensis, 17 parts of radix curcumae, 17 parts of mangnolia officinalis, 17 parts of fructus liquidambaris, 30 parts of cuttlebone and 21 parts of rhizoma corydalis.

Example 7 Chinese medicinal composition

11 parts of radix bupleuri, 11 parts of scutellaria baicalensis, 18 parts of radix curcumae, 18 parts of mangnolia officinalis, 18 parts of fructus liquidambaris, 31 parts of cuttlebone and 20 parts of rhizoma corydalis.

Example 8 Chinese medicinal composition

11 parts of radix bupleuri, 11 parts of scutellaria baicalensis, 18 parts of radix curcumae, 18 parts of mangnolia officinalis, 18 parts of fructus liquidambaris, 32 parts of cuttlebone and 21 parts of rhizoma corydalis.

Example 9 Chinese medicinal composition

9 parts of radix bupleuri, 9 parts of scutellaria baicalensis, 15 parts of radix curcumae, 15 parts of mangnolia officinalis, 15 parts of fructus liquidambaris, 30 parts of cuttlebone and 18 parts of rhizoma corydalis.

EXAMPLE 10 preparation of the Chinese medicinal composition

The conventional preparation method of the sealed package liquid medicine is adopted, namely, the traditional Chinese medicine composition in any one of the embodiments 1 to 9 is put into a decocting machine to prepare 200ml of sealed package liquid medicine.

EXAMPLE 11 preparation of the Chinese medicinal composition

Any of the Chinese medicinal compositions of examples 1 to 9 may be prepared into any dosage form, such as granules, capsules, tablets, pills, oral liquids, etc., by conventional preparation means.

Comparative example 1 traditional Chinese medicine composition

9 parts of radix bupleuri, 9 parts of radix scutellariae, 9 parts of radix curcumae, 9 parts of mangnolia officinalis, 9 parts of fructus liquidambaris, 9 parts of cuttlebone and 9 parts of rhizoma corydalis.

Comparative example 2 traditional Chinese medicine composition

9 parts of radix bupleuri, 9 parts of scutellaria baicalensis, 15 parts of radix curcumae, 15 parts of mangnolia officinalis, 15 parts of fructus liquidambaris, 30 parts of cuttlebone, 18 parts of rhizoma corydalis, 15 parts of pinellia ternate and 10 parts of codonopsis pilosula.

Comparative example 3 traditional Chinese medicine composition

9 parts of radix bupleuri, 9 parts of scutellaria baicalensis, 15 parts of radix curcumae, 15 parts of mangnolia officinalis, 15 parts of fructus liquidambaris and 30 parts of cuttlebone.

Comparative example 4 traditional Chinese medicine composition

10 parts of radix bupleuri, 15 parts of scutellaria baicalensis, 15 parts of radix curcumae, 15 parts of mangnolia officinalis, 15 parts of fructus liquidambaris, 30 parts of cuttlebone and 18 parts of rhizoma corydalis.

Comparative example 5 traditional Chinese medicine composition

12 parts of radix bupleuri, 10 parts of red peony root, 15 parts of white peony root, 9 parts of ligusticum wallichii, 12 parts of rhizoma cyperi, 12 parts of pericarpium citri reticulatae, 10 parts of fructus aurantii, 10 parts of inula flower, 10 parts of szechwan chinaberry fruit, 12 parts of rhizoma corydalis, 12 parts of medicinal fermented mass, 12 parts of malt, 12 parts of hawthorn and 6 parts of liquorice.

Example 12 animal experiments

1.1 materials

1.11 animal ICR mice.

1.12 Chinese medicinal compositions for treating liver-stomach disharmony type chronic superficial gastritis comprising the Chinese medicinal compositions of examples 2, 6, 8, 9 and comparative examples 1-5.

1.13 Instrument Du-640 model ultraviolet spectrophotometer; model IX71 inverted fluorescence phase contrast microscope; SN-695B type radioimmunity Y counter.

1.2 methods

1.21 modeling, grouping and administration 100 mice were selected, weighed 18-22g, and divided into groups of 10 animals each, each consisting of a male and female half, and randomly divided into groups of example 2, example 6, example 8, example 9, comparative example 1, comparative example 2, comparative example 3, comparative example 4, comparative example 5 and a control group. Except for the control group, the animal is administered with 0.45 g.L^-1The methimazole water solution is drunk in water for 4 weeks. Then, the administration is started, and the medicine is prepared into suspension with the administration volume of 20mL kg^-1The control group was replaced with physiological saline 1 time a day for 3 weeks, and animals in each group except the control group were continued to be administered with the methimazole aqueous solution as a water substitute drink during the administration period.

1.22 after the sample is collected and processed for the last administration, each group of mice is fasted for 24 hours, killed at broken ends to take blood, kept stand for 2-3 hours, separated from serum, and placed in an EP tube to be stored in a refrigerator at-20 ℃ to be tested; the abdominal cavity of the mouse is cut open, the cardia and the pylorus end are respectively ligated, the stomach is taken out, the stomach is cut open along the greater curvature of the stomach, the materials are taken by using the longest diameter of the ulcer scar parallel to the long axis direction of the stomach as the center, and the materials are quickly placed in 10% formaldehyde for fixation for 24 hours.

1.23 pathological examination method mucous membrane tissue of 2mm size is taken from the gastric antrum, fixed and tabletted conventionally, and then is subjected to HE staining and light microscope observation.

The lesion judging standard and scoring method includes infiltrating inflammatory cells, which are scattered on the surface layer or bottom of gastric mucosa and counted as 1 point; the mucosal layers were 4 points free of inflammatory cells. Hyperplasia, the glandular duct structure is regular and arranged regularly for 1 point; the ducts are regular in structure, regular in size and shape, and not branched into 2 points. ③ no degeneration, interstitial congestion and edema, no dispersion in pathological changes is 1 point; no lesion to score 2; the sum of the no lesion scores for each animal was the treatment score for that animal.

1.24 serum Gastrin assay the serum Gastrin content of mice was determined by radioimmunoassay.

1.25 gastric mucosal PGE₂Measuring contents of phospholipid and hexosamine by scraping gastric mucosa with slide glass, accurately weighing, adding physiological saline at a ratio of 1:10, shaking, centrifuging to collect supernatant, measuring and calculating PGE₂Phospholipid, hexosamine content.

1.26 statistical treatment groups of data are expressed as means ± standard deviation, and multiple groups of means are compared using ANOVA analysis. The differences were statistically significant when P <0.05 was treated with SPSS10.0 statistical software.

1.3 results

1.31 the histological observation result of the traditional Chinese medicine composition on the histomorphology of the mice shows obvious pathological changes, and no obvious pathological changes are shown in a normal group; the control group can see gastric mucosa cell infiltration, mucosal epithelial degeneration and hyperplasia, inflammatory cell infiltration and interstitial hyperemia and edema, but no obvious gastric mucosa atrophy and intestinal epithelial metaplasia; the pathological changes of the administration group were obviously reduced (see table 1).

TABLE 1 histomorphometric Effect of the Chinese medicinal compositions on mice

Group of	Dosage form	Scoring
			Control group	18	10
Example 2	18	7.0
			Example 6	18	9.1
Example 8	18	8.2
			Example 9	18	9.8
Comparative example 1	18	3.2
			Comparative example 2	18	3.1
Comparative example 3	18	4.0
			Comparative example 4	18	5.3
Comparative example 5	18	6.0

The experimental results show that the mucosa layer of the control group is complete, the glands are arranged regularly, and the serosa layer is complete. The comparative example group basically shows mucosal coloboma, occasional and muscular layers, serious gland destruction, inflammatory cell infiltration, blood seepage in the submucosa and obvious thickening of the mucosal layer; the serosal layer has fibrin exudation and is infiltrated by more inflammatory cells. In the comparative example 5, partial mucosal defects, occasional and muscular layers, mild atypical hyperplasia of the fundus stomach, regular arrangement of glandular cells and rare infiltration of inflammatory cells in the submucosa were observed. In example 6, the cells were covered with newly formed gastric epithelial cells and glandular cells, and inflammatory infiltration was observed in the mucosal layer, but the inflammatory infiltration was observed occasionally in the submucosa, which was less than that of the control group, and swelling and hyperplasia of the endothelium of small artery blood vessels were observed in the submucosa. The group of example 8 is slightly different from the group of comparative example 6, the healing condition of the mucosa is relatively good, no obvious pathological change is seen in the blood vessel under the mucosa, and a small amount of inflammatory cells infiltrate. The mucosa of the group 9 was substantially intact, the morphology and distribution of gastric epithelial cells and glandular cells were good, no significant pathological changes were observed in the submucosal microcirculation, and the serosal layer was intact.

1.32 Effect of Chinese medicinal composition on serum Gastrin content of model mouse

The results showed that the gastrin content was significantly increased (P <0.05) in the example 9 group compared to the control group (see table 2).

TABLE 2 Effect of Chinese medicinal compositions on serum Gastrin content of model mice

Group of	Dosage form	n	Serum gastrin
				Control group	0.5	10	33.62±9.70
Example 2	0.5	10	39.48±6.11
				Example 6	0.5	10	41.40±7.33
Example 8	0.5	10	39.27±8.29
				Example 9	0.5	10	41.90±8.92
Comparative example 1	0.5	10	32.98±6.98
				Comparative example 2	0.5	10	32.24±6.38
Comparative example 3	0.5	10	32.37±6.39
				Comparative example 4	0.5	10	32.25±7.29
Comparative example 5	0.5	10	36.35±6.31

1.33 PGE in homogenate of gastric mucosa of model mouse by using the Chinese medicinal composition₂Influence of phospholipid and hexosamine content

The experimental results show that the PGE groups of example 9, example 8 and example 6 are compared with the control group₂The content is obviously increased (P)<0.01); example 9, example 8 group (P)<0.05) the phospholipid content was significantly increased; example 6 group amino hexose content was significantly increased (P)<0.01), the content of aminohexose in the groups of example 9 and example 8 is remarkably increased (P)<0.01) (see table 3).

TABLE 3 influence of the Chinese medicinal composition on the content of each component in the gastric mucosa homogenate of the model mouse

1.34 Effect of the Chinese medicinal composition on the body weight of model mice

Before modeling, the body weight of each group of mice has no significant difference. After molding, the weight of each group given methimazole started to decrease at the time of molding 29d, compared to the control group; compared to the comparative example 5 group, the body weight of the example 9 group significantly increased after 10d administration (P <0.05), and very significantly increased after 21d administration (P <0.01) (see table 4).

TABLE 4 Effect of Chinese medicinal composition on weight of model mice

1.4 conclusion example 9 is the best, examples 2, 6, 8 is the second best, comparative examples 1, 2, 3 is the worst, and comparative example 5 is the second best.

EXAMPLE 13 clinical trial

1 data and method

1.1 case selection

1.1.1 the diagnosis standard of the traditional Chinese medicine syndrome belongs to the liver-stomach disharmony syndrome, which is incorporated into the standard reference 2003 'the scheme of combined diagnosis and treatment of traditional Chinese and western medicine for chronic gastritis'; according to the consensus on Chinese chronic gastritis in 2006, the patient is diagnosed with chronic superficial gastritis according to endoscopy and pathological examination; the age is 18-70 years (inclusive), and male and female are not limited.

1.1.2 exclusion criteria ages below 18 years or above 70 years; acute upper gastrointestinal hemorrhage, pyloric obstruction, combined digestive tract ulcer or pathological diagnosis with cachexia; patients with liver, gallbladder and pancreas diseases; alcoholism or the combined use of other drugs that may affect the observation of efficacy (e.g., glucocorticoids, non-steroidal anti-inflammatory drugs); patients with serious primary diseases and mental diseases such as heart, brain, liver, kidney and hematopoietic system; allergic constitution and people allergic to various drugs.

1.1.3 rejection, shedding, termination test Standard

1.1.3.1 cases which do not meet the inclusion standard after the elimination and the inclusion of the shedding standard, or cases which are not administrated according to the test scheme need to be eliminated; if a patient is involved in a disease and has serious adverse events and complications, the patient should not be subjected to the test continuously, and the patient who breaks blind in the blind test is either left alone or does not complete the whole treatment course to affect the curative effect or safety judgment, and the patient should be considered to fall off.

1.1.3.2 discontinuation of test Standard clinical trials in which severe adverse events occurred; the test should be discontinued when severe complications or rapid deterioration of the disease occurs.

1.1.4 random grouping method the random grouping is performed using SPSS21.0 in accordance with a full randomization method. The selected patients are numbered according to the treatment order, random numbers are obtained through SPSS21.0, all the random numbers are sorted from small to large, 1 is a treatment group, and 2 is a control group.

1.1.5 the patients with chronic superficial gastritis and liver-stomach disharmony syndrome, which are treated by department of gastroenterology and department of academia of the same institute in 2016 to 2017 in 5 months, were selected. Patients who are included in the study are randomly divided into treatment groups and control groups, and the factors of the gender and the age of the patients in each group after the grouping are analyzed. Wherein, the treatment group comprises 40 cases, wherein 20 cases of males and 20 cases of females have the age of 26-69 years, and the average (52.45 +/-2.05) years; coronary heart disease is combined in 16 cases, hypertension is combined in 14 cases, and coronary heart disease and hypertension are combined in 7 cases. 40 control groups, wherein 20 male and 20 female are aged between 28 and 68 years, and the average (52.43 +/-1.79) years; coronary heart disease is combined with 11 cases, hypertension is combined with 17 cases, and coronary heart disease and hypertension are combined with 10 cases. The treatment group and the control group are statistically treated for sex, age, complications and the like, have no statistical significance (P is 1.000, P is 0.993, and P is 0.208), and have comparability.

1.2 methods of treatment control group: rabeprazole sodium enteric-coated capsules are taken as a control group, 10mg is taken once a day, and the oral administration is started in the morning. Treatment groups: the Chinese medicinal composition of example 9 was orally administered twice a day as a 200ml liquid medicine in a sealed package prepared by an automatic decoction machine in our hospital. Both groups were treated for 8 weeks.

1.3 Observation index

1.3.1 Observation of therapeutic Effect

1.3.1.1 the observation of traditional Chinese medicine clinical symptoms refers to the 2010 Standard of the Chinese medicine symptom grading Table of gastrointestinal diseases, including epigastric pain, epigastric fullness, acid regurgitation, belch, and distending pain in chest and hypochondrium. Meanwhile, the clinical symptoms of no, mild, moderate and heavy are respectively counted as 0, 2, 4 and 6.

1.3.1.2 gastroscope observation and observation of the affected degree of congestion and erosion of mucous membrane under the gastroscope of a patient, and referring to the gastroscope grading standard of the special discussion of chronic gastritis in China in the year 2003: level 0: the mucous membrane has no obvious congestion and no mucous membrane damage; stage I: the local mucous membrane is reddish compared with the surrounding mucous membrane and is in a dispersed or discontinuous line shape, and single-shot mucous membrane erosion can be seen; II stage: congestion of mucous membrane is dense spots or continuous lines, and the number of local erosion is more than or equal to 5; grade III: the congestion of mucous membrane is widely fused, and the number of extensive erosion is larger than or equal to 6.

1.3.1.3 histological diagnosis refers to the Combined Chinese and Western diagnosis and treatment plan for chronic gastritis 2003.

1.3.1.3.1 were classified by inflammatory activity into non-, mild-, moderate-, and severe 4-grade (or 0, +, ++).

1.3.1.3.2 the classification method is as follows:

1.3.1.3.3 active inflammation: there is neutrophil infiltration on the chronic inflammatory background.

Mild: the mucous membrane lamina propria is infiltrated by a few neutrophils;

medium: neutrophils are more present in the mucosal layer and can be found between surface epithelial cells, foveal epithelial cells or glandular duct epithelium;

and (3) severe degree: neutrophils are more dense, or in addition to the mild findings, foveal abscesses are also visible.

1.3.1.3.4 chronic inflammation: the density and infiltration depth of chronic inflammatory cells are graded, and the former is the main factor.

And (3) normal: the number of the mononuclear cells in each high-power visual field is not more than 5, for example, the number of the mononuclear cells slightly exceeds the normal state, no obvious abnormality exists under an endoscope, and the pathology can be diagnosed as no obvious abnormality;

mild: the chronic inflammatory cells are fewer and limited to the superficial mucosa and do not exceed 1/3 of the mucosa layer;

medium: the chronic inflammatory cells are dense, occupy 1/3 in the whole mucous membrane layer, and reach 2/3;

and (3) severe degree: chronic inflammatory cells are dense and occupy the whole mucous membrane.

1.3.1.4 HP assay A quick urease assay for H.pylori was performed on patients who had received a biopsy of the mucosa under a gastroscope.

1.3.1.5 serum PG I, PG II, PGR assay this assay was performed with the assistance of our hospital clinical laboratory and the test was performed on patients admitted to the clinic before treatment and at 8 weeks early morning on an empty stomach for elbow venous blood sampling. PGR values were calculated after determination of serum PG1 and PG2 values.

1.3.1.6 serum CRP assay this assay was performed with the assistance of the clinical laboratory in my hospital and was performed on patients admitted to the clinic prior to treatment and at 8 weeks of treatment, on an empty stomach early in the morning.

1.3.2 safety Observation indicators

1.3.2.1 record the routine of blood, urine and stool before and after treatment.

1.3.2.2 recording the liver and kidney function for examination.

1.3.2.3 adverse events during dosing were recorded.

1.4 therapeutic efficacy assessment criteria

1.4.1 the curative effect of the traditional Chinese medicine clinical syndrome refers to the standard of the traditional Chinese medicine symptom scoring table of gastrointestinal diseases in 2010. The clinical cure is as follows: the syndrome basically disappears, and the integral reduction is equal to or larger than 95 percent; the effect is shown: the effective rate of the syndrome is reduced by more than 75 percent compared with that before treatment; the method has the following advantages: the integral of the effective rate of the syndrome is reduced by more than or equal to 50 percent compared with that before treatment; and (4) invalidation: the effective rate of the syndrome is reduced by less than 50% compared with that before the treatment.

1.4.2 evaluation criteria for gastroscope efficacy reference is made to the gastroscope grading criteria discussed in the monograph of chronic gastritis in 2003. The recent clinical cure is as follows: the mucosa erosion disappears after the gastroscope review; the effect is shown: the gastroscope reexamines that the acute inflammation of the mucous membrane lesion basically disappears, and the congestion and erosion of mucous membranes under the gastroscope are relieved by more than 2 levels (including 2 levels); the method has the following advantages: the scope of acute inflammation lesion of mucous membrane is reduced by more than 1/2 in gastroscopy, or congestion and erosion of mucous membrane under endoscope are reduced by 1 degree; and (4) invalidation: those who do not reach the effective standard and do not worsen.

1.4.3 histological efficacy evaluation criteria: refer to the Chinese and Western medicine integrated diagnosis and treatment plan for chronic gastritis in 2003. The recent clinical cure is as follows: biopsy tissue pathology confirmed that mucosal active inflammation disappeared, and chronic inflammation improved to mild (+); the effect is shown: the biopsy tissue pathology proves that the acute inflammation of the mucous membrane basically disappears, the inflammation activity is recovered or reduced by more than 2 grades (including 2 grades), and the chronic inflammation is improved to be mild (+); the method has the following advantages: the biopsy tissue pathology proves that the acute and chronic inflammation of the mucous membrane is reduced by 1 grade; and (4) invalidation: those who do not reach the effective standard and do not worsen.

1.5 statistical methods statistical analysis the SPSS21.0 statistical analysis system was used. The observed value, if it is normally distributed, is expressed as

Giving a repeated measurement check; if the distribution is in a non-normal distribution, expressing the distribution in a median form, and carrying out non-parametric rank sum test; the rating data is checked with non-parametric rank sum. In statistical analysis, with P<0.05 is statistically different.

2 results

2.1 the evaluation and comparison of the curative effects of two groups of clinical syndromes

2.1.1 the syndrome integrals of the two groups of Chinese traditional medicine before treatment are compared before the two groups of treatment, and the two groups have no obvious difference and are comparable (Table 5).

TABLE 5 comparison of Chinese medicine symptom integrals before treatment

2.1.2 evaluation and comparison of the integral curative effect of two groups of Chinese medicine syndromes for 8 weeks, the curative effect of the two groups of Chinese medicine syndromes for 8 weeks is compared in the curative effect of 2 groups of Chinese medicine syndromes for 8 weeks, the statistic z is-4.333 through test, and P is less than 0.0001, thus the prompt difference has statistical significance, and the result shows that the curative effect of the two groups of Chinese medicine syndromes is different, and the curative group is superior to the control group (Table 6).

TABLE 6 evaluation and comparison of the Chinese medicine syndrome integral curative effect after two groups of treatment (8 weeks)

2.2 integral comparison of symptoms of two groups of Chinese medicine

Before treatment, symptoms of the two groups of patients are integrated, such as epigastric pain, epigastric fullness, pantothenic acid, belching and chest and hypochondrium pain, and the epigastric pain, epigastric fullness, pantothenic acid, eructation and chest and hypochondrium pain are all greater than 0.05 through a test P, which shows that the difference has no obvious statistical significance and has clinical comparability. In the comparison of traditional Chinese medicine symptoms such as epigastric pain, epigastric fullness, pantothenic acid, belching, chest and hypochondriac pain and the like after 8 weeks of treatment of the two groups, the comparison in each symptom accumulation group and between the treatment group and the control group is verified (P is less than 0.0001), so that the comparison difference in each symptom accumulation group and between the treatment group and the control group has statistical significance, and the treatment group is superior to the control group (tables 7, 8, 9, 10 and 11).

TABLE 7 integration of two groups of TCM symptoms

Comparison

TABLE 8 two groups of Chinese medicine symptom integrals

Comparison

TABLE 9 two groups of Chinese medicine symptom integrals

Comparison

TABLE 10 two groups of Chinese medicine symptom integrals

Comparison

TABLE 11 two groups of Chinese medicine symptom integrals

Comparison

2.3 gastroscopic fractional comparison

2.3.1 two Pre-treatment gastroscope grading

The pretreatment gastroscopic grading of the two groups of patients was tested at P >0.05, indicating that the gastroscopic grading was not statistically significant and comparable before treatment (Table 12).

TABLE 12 two pre-treatment gastroscope grading comparisons

2.3.2 two groups of 8 weeks of gastroscopy grading comparison

The research results show that the total effective rate of the treatment group is 92.5 percent, the total effective rate of the control group is 70 percent, the gastroscope curative effects of the two groups after 8 weeks of treatment are compared, and the test (P <0.0001) indicates that the difference between the two groups has statistical significance, which indicates that the gastroscope curative effect of the group has statistical difference, and the treatment group is superior to the control group (Table 13).

TABLE 13 two groups for 8 weeks gastroscopy efficacy comparison

2.4 comparison of histological therapeutic Effect

2.4.1 grading comparison of histologically active inflammation before treatment in two groups

The histologically active inflammation score of both groups of patients before treatment was tested P >0.05, indicating that the histologically active inflammation score was not statistically significant and comparable before treatment (table 14).

TABLE 14 two pre-treatment histological active inflammation grading comparisons

2.4.2 two Pre-treatment histological Chronic inflammation grading comparisons

The histological chronic inflammation grading of both groups of patients before treatment was tested with P >0.05, indicating that the histological chronic inflammation grading was not statistically significant and comparable before treatment (table 15).

TABLE 15 two-panel pre-treatment histological grading comparison of chronic inflammation

2.4.3 comparison of histological efficacy of the two groups for 8 weeks of treatment

The results show that the total effective rate of the treatment group is 87.5%, the total effective rate of the control group is 57.5%, the comparison of the histological curative effects of the two groups after 8 weeks of treatment is verified (P <0.0001), which indicates that the difference between the two histological curative effects is statistically significant, and the results show that the histological curative effects of the treatment group and the control group are different, and the treatment group is superior to the control group (Table 16).

TABLE 16 comparison of histological efficacy of the two groups at 8 weeks of treatment

2.5 HP assay

2.5.1 two Pre-treatment gastroscope HP assay comparisons

The patient's gastroscopic HP assay before treatment tested P >0.05, indicating that the gastroscopic HP assay was not statistically significant and comparable before treatment (table 17).

TABLE 17 comparison of two groups of Pre-treatment HP assays

2.5.2 two groups of gastroscope HP assays for 8 weeks of treatment

The results show that the two groups of gastroscope HP determination comparison after 8 weeks of treatment, through the test (P is both >0.05), the two differences are not statistically significant, and the results show that the gastroscope HP determination after 8 weeks of treatment of the treatment group and the control group has no obvious statistical difference. The results of this study demonstrate that the Chinese medicinal composition and rabeprazole sodium enteric-coated capsule of example 9 have no significant therapeutic effect on helicobacter pylori infection of gastric mucosa (table 18).

TABLE 18 two treatment groups 8 weeks HP assay comparison

2.6 comparison of two groups of serum PG, I PG, II PGR, CRP

Both groups of patients had pre-treatment PG I, PG II, PGR, CRP values of > 0.05. The difference between values of PG I, PGII, PGR and CRP in the two groups before treatment has no statistical significance and is comparable. After 8 weeks of treatment, the two groups of PG I, PG II, PGR and CRP are compared, wherein no statistical difference exists in the PG I and PG II groups in the treatment group and the control group and between the two groups through tests (P is more than 0.05), which indicates that the traditional Chinese medicine composition and the rabeprazole sodium enteric-coated capsule in the example 9 have no obvious statistical significance on the difference of the influence of the patient serum PG I and PG II. Meanwhile, the treated group, the control group PGR and CRP have statistical difference in each group and the group through the test (P is less than 0.0001), and the treated group is superior to the control group. The results show that the traditional Chinese medicine composition and the rabeprazole sodium enteric-coated capsule in the example 9 have no obvious statistical significance on the difference between the serum PG I and the serum PG II of the patient, but have obvious effect of up-regulating the serum PGR, and the effect of the traditional Chinese medicine composition in the example 9 is better than that of the rabeprazole sodium enteric-coated capsule. Meanwhile, the traditional Chinese medicine composition and the rabeprazole sodium enteric-coated capsule in the embodiment 9 have a reduction effect on serum CRP of a patient, and the traditional Chinese medicine composition in the embodiment 9 has a stronger effect than that of the rabeprazole sodium enteric-coated capsule (tables 19, 20, 21 and 22).

TABLE 19 two groups for 8 weeks of treatment (PG1)

TABLE 20 two groups for 8 weeks of treatment (PG2)

TABLE 21 two groups for 8 weeks of treatment (PGR)

TABLE 22 two groups of treatment 8 weeks (CRP)

2.7 adverse reactions in the course of this experiment, there were no cases of complaints due to the taking of the Chinese medicinal composition of example 9, and no abnormal changes occurred before and after observation of each safety observation index, indicating that the treatment with the Chinese medicinal composition of example 9 did not produce significant adverse effects and toxic side effects on the subjects.

The ancient books of traditional Chinese medicine do not have records of the names of chronic superficial gastritis, but belong to the categories of epigastric pain, epigastric upset, fullness and the like in traditional Chinese medicine according to clinical symptoms. The record of the disease name of epigastric pain is from the "Nei Jing" (internal classic), for example, Ling Shu & Jing Mai "(Ling Shu & Jing Mai): for gastric distention, abdominal fullness and epigastric pain. The traditional Chinese medicine considers that the stomach governs reception and the spleen governs transportation and transformation, the two coordinate with each other to digest diet and ingest food essence to nourish human body, and the normal operation of the stomach qi depends on the normal dispersion of the liver qi. As in the book "blood syndrome and zang-fu organ pathogenesis treatise": the wood property is mainly to dredge qi, food qi enters stomach, and it depends on qi of liver wood to dredge qi, and water and food are transformed into food. If liver qi is impaired by anxiety, anger, depression of qi and liver qi failing to dredge, it may affect stomach-qi and cause incoordination between liver and stomach. Clinically, patients often suffer from emotional disorder, stagnation of liver qi, failure of smoothing flow, transverse flow affecting the stomach, stagnation of qi and blood, and pain caused by obstruction of qi and blood, and can also cause the formation of blood stasis and blood stasis in collaterals for a long time due to qi and blood dependence; the long-term stagnation of heart-liver qi into fire, the fire of five zang organs is the violence of liver fire, the fire-type inflammation scorches the yin of liver and stomach, aggravates pain. That is, the liver is the origin of diseases and the stomach is the origin of diseases, so the traditional Chinese medicine composition is used for treating liver-stomach disharmony type superficial gastritis. In the recipe, chaihu and Huang Qin can smooth qi of liver and gallbladder and clear damp-heat in the interior; the radix curcumae has the effects of activating blood and relieving pain, promoting qi circulation and relieving depression, the magnolia officinalis is pungent in taste, warm in nature, promoting qi circulation and eliminating dampness, warming the middle warmer and relieving pain, and the distension and fullness are strong, so that qi can flow out; fructus Lipuidambaris has effects of dredging meridian passage and relieving pain; the cuttlebone can astringe to stop bleeding, relieve hyperacidity and stop pain; yan Hu Suo manages all pains in the upper and lower parts of the body, and has the specific effects of dissipating blood stasis, regulating qi and relieving pain. The whole formula has the effects of dispersing stagnated liver qi, relieving depression, regulating qi-flowing and relieving pain.

Chronic gastritis is chronic inflammation of gastric mucosa caused by various reasons, the incidence rate of the chronic gastritis is the first disease of a digestive system, and the chronic gastritis can be clinically divided into superficial gastritis, atrophic gastritis and special gastritis, wherein the chronic superficial gastritis is the most common type, and the etiology of the chronic superficial gastritis is related to various factors such as helicobacter pylori infection, bile and other alkaline intestinal reflux and other exogenous factors. Pepsinogen is a precursor of pepsin and is an endoprotease with digestion function, PG1 is mainly secreted by a major cell of a fundus stomach gland, and PG2 is secreted by a pyloric gland and a Brunner gland of duodenum. The level of which may reflect pepsin secretion as well as gastric mucosal status. It has been shown that PG I and PG II are significantly higher in patients with superficial gastritis than in patients with physical examination, and increase with increasing intensity of inflammation and activity of inflammation. CRP reactive protein is used as an extremely sensitive index of acute phase reaction, CRP concentration in plasma is rapidly and obviously increased in acute myocardial infarction, trauma, infection, inflammation, surgical operation and tumor infiltration, and research shows that hs-CRP level of chronic superficial gastritis patients is obviously increased compared with healthy patients, and the CRP reactive protein can be used as one of indexes of disease prognosis and development of chronic gastritis patients.

According to the modern Chinese medicine pharmacological analysis, the saikosaponin has the effect of inhibiting various inflammatory processes including inflammatory exudation, capillary permeability increase, inflammatory mediator release, leukocyte migration, connective tissue hyperplasia and the like. Experiments prove that the acidic polysaccharide BR-2 separated and refined from the bupleurum chinense hot water extract has obvious inhibition effect on alcoholic ulcer, water immersion stress ulcer and pylorus ligation ulcer of a rat. The baicalin has obvious protective effect on cell injury, and the action mechanism of the baicalin is that the baicalin plays an anti-oxidation role and then plays an anti-apoptosis role by up-regulating Trx-CRP expression.

The traditional Chinese medicine composition can obviously improve the traditional Chinese medicine syndrome scores and symptom scores of patients such as epigastric pain, epigastric fullness, pantothenic acid, eructation, chest and hypochondrium pain and the like, and the traditional Chinese medicine syndrome curative effect is superior to that of rabeprazole sodium enteric-coated capsules; the total effective rate of the gastroscope curative effect is 92.5 percent, the total effective rate of the histological curative effect is 87.5 percent, the difference of the gastroscope curative effect and the histological curative effect of patients can be obviously improved, and the curative effect of the gastroscope curative effect and the histological curative effect difference of the patients are better than that of the rabeprazole sodium enteric-coated capsule. Although the traditional Chinese medicine composition in example 9 has no obvious statistical significance for the difference between the serum PG I and the serum PG II of the patient, the traditional Chinese medicine composition has an obvious effect of up-regulating the serum PGR value, and the effect of the traditional Chinese medicine composition in example 9 is superior to that of rabeprazole sodium enteric-coated capsules. Meanwhile, the traditional Chinese medicine composition and the rabeprazole sodium enteric-coated capsule in the embodiment 9 have the effect of reducing serum CRP of a patient, and the traditional Chinese medicine composition in the embodiment 9 has stronger effect than the rabeprazole sodium enteric-coated capsule.

In conclusion, the traditional Chinese medicine composition has a better clinical curative effect on liver-stomach disharmony type chronic superficial gastritis, is considered to be related to the treatment effects of the traditional Chinese medicine composition on anti-inflammatory reaction, reduction of gastric mucosa injury and the like, and is worthy of clinical further popularization.

The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and additions can be made without departing from the method of the present invention, and these modifications and additions should also be regarded as the protection scope of the present invention.

Claims

1. The traditional Chinese medicine composition for treating liver-stomach disharmony type chronic superficial gastritis is characterized by being prepared from the following raw material medicines in parts by weight: 9 parts of radix bupleuri, 9 parts of scutellaria baicalensis, 15 parts of radix curcumae, 15 parts of mangnolia officinalis, 15 parts of fructus liquidambaris, 30 parts of cuttlebone and 18 parts of rhizoma corydalis.

2. The use of the Chinese medicinal composition according to claim 1 in the preparation of a medicament for treating liver-stomach disharmony type chronic superficial gastritis.

3. The use of claim 2, wherein the pharmaceutical dosage form is a granule, a capsule, a tablet, a pill, or an oral liquid.