CN111514274A

CN111514274A - Traditional Chinese medicine composition for treating reflux esophagitis and preparation method and application thereof

Info

Publication number: CN111514274A
Application number: CN202010469612.0A
Authority: CN
Inventors: 张松; 龙坤兰; 钱琳; 周秀娟; 丁鹏
Original assignee: Teaching Hospital of Chengdu University of TCM
Current assignee: Teaching Hospital of Chengdu University of TCM
Priority date: 2020-05-28
Filing date: 2020-05-28
Publication date: 2020-08-11

Abstract

The invention provides a medicine composition for treating reflux esophagitis, which is prepared from the following raw materials in parts by weight: 10-20g of scutellaria baicalensis, 5-15g of coptis chinensis, 10-20g of rhizoma pinellinae praeparata, 10-20g of dried ginger, 20-40g of cuttle bone, 10-20g of rhizoma bletillae, 5-15g of radix bupleuri and 5-15g of honey-fried licorice root. The invention provides a preparation method and application of the medicine. The composition has remarkable curative effect of treating the reflux esophagitis and has excellent clinical application prospect.

Description

Traditional Chinese medicine composition for treating reflux esophagitis and preparation method and application thereof

Technical Field

The invention relates to the field of medicines, and in particular relates to a traditional Chinese medicine composition for treating reflux esophagitis and a preparation method and application thereof.

Background

Reflux Esophagitis (RE) refers to inflammatory lesions of the esophageal mucosa caused by Reflux of gastric and duodenal contents into the esophagus, and complications such as esophageal stenosis, bleeding, perforation and Barrett's esophagus are clinically common and frequently encountered diseases.

The incidence of RE is high all over the world, about 7-15% of people have gastroesophageal reflux symptoms, and the incidence of RE in western countries even exceeds 20%. The incidence rate increases with age, with an increasing prevalence above 40 years of age, more men than women with reflux esophagitis (2:1 to 3: 1). The incidence of RE in China is about 6% on average, and the prevalence of the RE in large cities such as Beijing, Shanghai, Xian and the like can be as high as 17%.

Modern medicine mainly relieves clinical symptoms of patients through western medicines and surgical treatment, and the western medicines mainly adopt combined application of H2 receptor blockers (such as cimetidine, ranitidine, famotidine and nizatidine), acid-inhibiting medicines (such as omeprazole), gastric motility promoting medicines (such as domperidone) and sucralfate and other gastric mucosa protection medicines.

The medicine is widely applied in RE treatment, achieves a certain treatment effect, but can cause certain adverse reactions due to long administration time in the treatment process, particularly H2 receptor blockers and proton pump medicines all take inhibition of gastric acid secretion as the action mechanism, and long-term application can cause insufficient gastric acid secretion, possibly lead to vitamin B12 malabsorption and even cause pernicious anemia. Elevated intragastric pH can lead to the potential for overgrowth of potential intragastric bacteria, which can reduce ingested nitrate to carcinogens such as nitrite and nitrosamine.

Patent CN 110279807a discloses a traditional Chinese medicine composition for treating reflux esophagitis, which has an effective rate of 91.7%, but has a low cure rate of only 72.3%, and is long in medication time, which is likely to cause poor compliance of patients.

Disclosure of Invention

In order to solve the problems, the invention provides a pharmaceutical composition for treating reflux esophagitis, which is prepared from the following raw materials in parts by weight:

10-20g of scutellaria baicalensis, 5-15g of coptis chinensis, 10-20g of rhizoma pinellinae praeparata, 10-20g of dried ginger, 20-40g of cuttle bone, 10-20g of rhizoma bletillae, 5-15g of radix bupleuri and 5-15g of honey-fried licorice root.

Further, the feed additive is prepared from the following raw materials in parts by weight:

15g of scutellaria baicalensis, 10g of coptis chinensis, 15g of rhizoma pinellinae praeparata, 15g of dried ginger, 30g of cuttle bone, 15g of rhizoma bletillae, 10g of radix bupleuri and 10g of honey-fried licorice root.

Furthermore, the preparation is prepared into a common preparation by taking the raw powder of the raw materials, or water or organic solvent extract as an active ingredient and adding acceptable auxiliary materials or auxiliary ingredients.

Further, the formulation is an oral formulation.

Further, the oral preparation is powder, syrup, tincture, solution, suspension, emulsion, granule, tablet, capsule, pill, soft extract, mixture, decoction, fluid extract, or extract.

Further, a method of preparing said composition comprising the steps of:

a) weighing raw materials in each weight ratio;

b) oven drying, grinding into powder, and mixing.

The invention provides application of the composition in preparing a medicine for treating reflux esophagitis.

Further, the medicine is a medicine for clearing heat and promoting diuresis and/or harmonizing stomach and lowering adverse qi.

Further, the medicine is a medicine for relieving hyperacidity and pain and/or harmonizing liver and spleen.

The traditional Chinese medicine composition for treating reflux esophagitis provided by the invention accords with the compatibility principle of traditional Chinese medicine prescriptions, and the scutellaria baicalensis is bitter in taste and cold in nature, enters heart and lung channels, has the functions of purging excess fire and removing damp heat, can be used for treating chest distress and nausea, damp heat and fullness, diarrhea, jaundice and the like, has a good antibacterial effect, and does not generate drug resistance; the coptis chinensis is bitter in taste and cold in nature, enters heart, liver and stomach channels, has the functions of clearing heat, eliminating dampness, purging fire and detoxifying, can treat damp-heat fullness, vomiting, acid regurgitation, dysentery, jaundice and the like, contains berberine and coptisine at rhizome, and has the effects of inhibiting bacteria, inhibiting acid, protecting gastric mucosa and the like; rhizoma Pinelliae Preparata is pungent and warm in flavor, warm in nature, and has effects of invigorating spleen, stomach and lung channels, eliminating dampness and phlegm, lowering adverse qi and relieving vomit, relieving stuffiness and resolving hard mass, can be used for treating excessive phlegm cough and asthma, emesis and regurgitation, chest and gastric stuffiness and stuffiness, etc., and has effects of relieving vomit, resisting ulcer, etc.; zingiberis rhizoma is pungent and hot in flavor, and has the effects of warming spleen, stomach, kidney, heart and lung channels, warming spleen and stomach, dispelling cold, and can be used for treating abdominal psychroalgia, emesis, diarrhea, etc.; the cuttlefish bone is salty and astringent in taste and warm in nature, has effects of regulating spleen and kidney meridians, relieving hyperacidity and pain, eliminating dampness and healing sore, can be used for treating ulcer, hyperchlorhydria, gastralgia and acid regurgitation, etc., and has effects of regulating hyperacidity, relieving pain, resisting ulcer, etc.; rhizoma Bletillae is bitter, sweet, astringent, and slightly cold in nature, and has effects of entering lung, liver, and stomach channels, astringing to stop bleeding, and protecting gastric mucosa; bupleuri radix is bitter and slightly cold in property, enters liver and gallbladder channels, has the functions of harmonizing exterior and interior, soothing liver and invigorating yang, and is used for treating diseases related to liver depression and qi stagnation; the prepared licorice root is sweet in taste and warm in nature, has the functions of tonifying the spleen, benefiting qi and harmonizing the other drugs, is used for treating diseases such as weakness of the spleen and the stomach and can relieve toxicity and intensity of the drugs, and the prepared licorice root enters heart, lung, spleen and stomach channels. The medicines are combined to play the effects of clearing heat and promoting diuresis, harmonizing stomach and lowering adverse qi, relieving hyperacidity and pain and harmonizing liver and spleen.

The traditional Chinese medicine composition for treating reflux esophagitis has scientific formula, belongs to a method for treating both principal and secondary aspects of a disease, can directly make the efficacy of a medicine directly reach an affected part, has obvious curative effect, can effectively prevent disease recurrence, has no toxic or side effect, is convenient to carry, store and use, is economical and practical, and has popularization and application values.

Unless otherwise specified, the herbs used in the Chinese medicinal composition of the present invention are as described in the Chinese pharmacopoeia.

Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.

The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.

Detailed Description

EXAMPLE 1 preparation of a composition according to the invention

15g of scutellaria baicalensis, 10g of coptis chinensis, 15g of rhizoma pinellinae praeparata, 15g of dried ginger, 30g of cuttle bone, 15g of rhizoma bletillae, 10g of radix bupleuri and 10g of honey-fried licorice root, drying, grinding into powder and mixing uniformly.

Example 2 preparation of a composition according to the invention

10g of scutellaria baicalensis, 5g of coptis chinensis, 10g of rhizoma pinellinae praeparata, 10g of dried ginger, 20g of cuttle bone, 10g of rhizoma bletillae, 5g of radix bupleuri and 5g of honey-fried licorice root, drying, grinding into powder and mixing uniformly.

EXAMPLE 3 preparation of the composition of the invention

20g of scutellaria baicalensis, 15g of coptis chinensis, 20g of rhizoma pinellinae praeparata, 20g of dried ginger, 40g of cuttle bone, 20g of rhizoma bletillae, 15g of radix bupleuri and 15g of honey-fried licorice root, drying, grinding into powder and mixing uniformly.

The advantageous effects of the present invention are further illustrated by the following test examples

Test example 1 clinical test of the composition of the present invention

1 clinical data

1.1 general data

146 patients with the reflux oesophagitis who are seen at the subsidiary hospital of the Chengdu traditional Chinese medicine university from 2017 to 2019 and 10 are selected and randomly divided into a treatment group and a control group according to a random digital table method, wherein the treatment group comprises 74 and the control group comprises 72. The treatment groups were 44 men and 30 women; the age is 20-56 years, and the average (36.98 +/-9.60) years; the course of the disease is 1-10 years, and the median time is 4.95(2.55, 7.85) years. 46 men and 26 women in the control group; the age is 20-54 years, and the average (38.21 +/-8.88) years; the course of the disease is 1-9 years, and the median time is 5.09(3.47 Shi 7.83) years. Compared with the two groups of patients in terms of sex, age, disease course and the like, the difference is not statistically significant (P >0.05) and is comparable.

1.2 the diagnosis standard refers to the consensus opinion of traditional Chinese medicine diagnosis and treatment experts of gastroesophageal reflux disease (2017) made by the spleen and stomach disease division of the Chinese traditional medicine society.

1.2.1 clinical symptoms

The clinical manifestations are various, heartburn and acid regurgitation are the most common typical symptoms, and chest pain is also a common symptom; other atypical symptoms comprise dyspepsia symptoms such as epigastric pain, gastrectasia, belch, nausea, etc., or simultaneously discomfort of throat, dysphagia, and sleep disorder; the symptoms outside the esophagus include chronic cough, bronchial asthma, chronic laryngitis, dental erosion and the like, and complications comprise upper gastrointestinal hemorrhage, esophageal stenosis and the like.

1.2.2 endoscopy

Endoscopy revealed the presence or absence of Reflux Esophagitis (RE) and Barrett's Esophagus (BE). RE was ranked according to LA classification by the world gastroenteropathy university of los Angeles, 1994.

A level: one or more mucosal lesions of the esophagus mucosa are smaller than 5mm in diameter;

b stage: one or more mucous membrane lesions with diameter larger than 5mm but no fusion phenomenon among lesions;

c level: (ii) mucosal fusogenic lesions over 2 folds, but less than 75% of the esophageal circumference;

d stage: the range of mucosal lesions fused to each other accumulates at least 75% of the esophageal circumference.

BE is diagnosed mainly according to endoscopy and esophageal mucosa biopsy, and can BE diagnosed as BE when the endoscopy finds that the far end of the esophagus has obvious columnar epithelialization and obtains pathological examination and verification. Clinically, patients have typical symptoms of heartburn and acid regurgitation, and can be preliminarily diagnosed as GERD; the upper gastrointestinal endoscopy has RE and BE expressions, and the diagnosis of the disease can BE established; for patients suspected of GERD or patients suspected of having extra-esophageal symptoms associated with reflux, PPI trial therapy can be used, and if significant results are available, a diagnosis of the condition will generally be established. For the atypical patients, diagnosis is often performed by combining endoscopy, esophageal pH impedance monitoring and PPI experimental therapy comprehensive analysis.

1.3 inclusion criteria

(1) Meets the above diagnostic criteria;

(2) the age is 20-60 years old, and the nature is not limited;

(3) PPI and H are not used₂Receptor antagonists and the like;

(4) those who agree to receive relevant examination and treatment such as blood drawing; (5) consent signed an informed consent and the followed was able to be completed.

1.4 exclusion criteria

(1) Pregnant or lactating women;

(2) patients with other immune system diseases are combined;

(3) patients with serious diseases such as liver, kidney, cardiovascular disease, and hematopoietic system;

(4) those allergic to the drug components in this study.

2 method

2.1 methods of treatment

The control group was administered omeprazole enteric capsule (Aslicon pharmaceutical Co., Ltd.) with a dosage of 40mg bid for 1 month.

The medicine composition prepared in the embodiment 1 of the invention is taken by 20g bid taken with warm boiled water 50ml, and the treatment course is 1 month.

2.2 observation indexes of traditional Chinese medicine syndrome score and RE endoscope diagnosis score.

2.2.1 Chinese medicine symptom integration

The pain feeling, pantothenic acid and the integral of heartburn at the back of the sternum before and after the treatment of the patient are respectively calculated. Asymptomatic score was 0, mild clinical presentation was 1 score, moderate clinical presentation was 2 score, and severe clinical presentation was 3 score.

The efficacy index was calculated as (pre-treatment integral-post-treatment integral)/pre-treatment integral 100%. The evaluation standard of the traditional Chinese medicine syndrome curative effect is as follows: and (3) healing: the curative effect index is more than or equal to 80 percent; the effect is shown: the curative effect index is 50% -80%; the method has the following advantages: the curative effect index is 10% -50%; and (4) invalidation: the curative effect index is less than 0 percent; deterioration: the curative effect index is less than 0%. Effective rate of each group is (cure + significant effect + number of effective cases)/(number of groups).

2.2.2RE integration of the extent of reduction of gastroscopic esophageal inflammation before and after treatment

0-grade of esophagus under gastroscope; the improvement is obvious, and the degree is reduced by more than 3 grades and 1 point; improvement, the degree is reduced to exceed 2 grades and 2 grades; the improvement is realized, the degree is reduced by more than 1 grade, and the product is 3 points; no obvious improvement product is 4 points; the product was weighted by 5 points. The efficacy index was calculated as (pre-treatment integral-post-treatment integral)/pre-treatment integral 100%.

Endoscope diagnosis evaluation standard: the effect is shown: the curative effect index is more than or equal to 66 percent; the method has the following advantages: the curative effect index is more than or equal to 33 percent; and (4) invalidation: the curative effect index is less than 33 percent; deterioration: the curative effect index is less than 0%. Effective rate of each group is (effective + effective case number)/(group case number).

3 results

3.1 analysis of the integrated differences between two groups of patients

The differences of the traditional Chinese medicine syndrome integral differences and the RE endoscopic diagnosis score differences of two groups of patients are compared, the differences of the treatment groups are respectively 1.19 and 3.71, the differences of the control groups are respectively 0.60 and 2.16, the comparison differences of the two groups of patients have statistical significance (Z is respectively 2.781 and 3.466, and P is less than 0.05), and the details are shown in Table 1.

TABLE 1 comparison of before and after clinical treatment integration and efficacy of the compositions of the invention

3.2 analysis of the evaluation of the TCM syndrome in two groups of patients

The evaluation and comparison of the traditional Chinese medicine syndromes of two groups of patients are carried out, and the difference has statistical significance (Z is 2.904, P is 0.004<0.05); the effective rate of the treatment group is 89.19%, the effective rate of the control group is 72.22%, and the difference of the effective rates of the two groups of patients is statistically significant (X)²＝6.778,P＝0.009<0.05) as detailed in table 2.

TABLE 2 evaluation and comparison of the efficacy of the compositions of the present invention in traditional Chinese medicine

3.3 analysis of endoscopic diagnostic evaluation of two groups of patients

The difference was statistically significant (Z: 2.509, P: 0.012) in comparison of endoscopic diagnostic evaluations of two groups of patients<0.05); the effective rate of the treatment group is 81.08 percent, the effective rate of the control group is 65.28 percent, and the difference of the effective rates of the two groups of patients in traditional Chinese medicine is of statistical significance (X)²＝4.655,P＝0.031<0.05) as detailed in table 3.

TABLE 3 comparison of endoscopic diagnostic evaluation of the compositions of the invention

4 conclusion

The combined medicine can improve the clinical symptoms of reflux esophagitis, effectively reduce the traditional Chinese medicine syndrome integral and RE endoscope diagnosis score of a patient, and improve the effective rate of traditional Chinese medicine treatment and RE endoscope diagnosis.

In conclusion, the traditional Chinese medicine composition for treating reflux esophagitis belongs to a method for treating both principal and secondary aspects of a disease, has an obvious curative effect, can effectively prevent disease recurrence, has no toxic or side effect, is convenient to carry, store and use, is economical and practical, and has popularization and application values.

Claims

1. A pharmaceutical composition for treating reflux esophagitis, which is characterized in that: the traditional Chinese medicine is prepared from the following raw materials in parts by weight:

2. The composition of claim 1, wherein: the traditional Chinese medicine is prepared from the following raw materials in parts by weight:

3. The composition according to claim 1 or 2, characterized in that: the preparation is prepared by taking the raw powder of the raw materials, or water or organic solvent extract as an active ingredient, and adding acceptable auxiliary materials or auxiliary ingredients into the active ingredient to prepare a common preparation.

4. The composition according to any one of claims 1 to 3, characterized in that: the preparation is an oral preparation.

5. The oral formulation of claim 4, wherein: the oral preparation is in the form of powder, syrup, tincture, solution, suspension, emulsion, granule, tablet, capsule, pill, soft extract, mixture, decoction, fluid extract, or extract.

6. A method of preparing the composition of any one of claims 1 to 5, wherein: it comprises the following steps:

a) weighing raw materials in each weight ratio;

b) oven drying, grinding into powder, and mixing.

7. Use of a composition according to any one of claims 1 to 5 in the manufacture of a medicament for the treatment of reflux esophagitis.

8. Use according to claim 7, characterized in that: the medicine is a medicine for clearing heat and promoting diuresis and/or harmonizing stomach and lowering adverse qi.

9. Use according to claim 7, characterized in that: the medicine is used for relieving hyperacidity and pain and/or harmonizing liver and spleen.