A Chinese medicine composition for treating gastroesophageal reflux disease and its preparation method and Chinese medicine preparation

Abstract

This invention relates to the field of traditional Chinese medicine (TCM) technology, and in particular to a TCM composition for treating gastroesophageal reflux disease (GERD), its preparation method, and a TCM preparation thereof. This application discloses a TCM composition for treating GERD, comprising the following raw materials in parts by weight: Bupleurum chinense 1-15 parts, Paeonia lactiflora 2-20 parts, Citrus aurantium 1-15 parts, Pinellia ternata 1-12 parts, Sepia esculenta 2-15 parts, Bletilla striata 2-20 parts, Pueraria lobata 2-19 parts, Panax notoginseng 1-12 parts, and Glycyrrhiza uralensis 1-15 parts. The TCM preparation provided by this application has good efficacy in treating GERD, and its preparation method is simple and easy to scale up.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating gastroesophageal reflux disease, a preparation method thereof and a traditional Chinese medicine preparation. Background Art

[0002] Gastroesophageal reflux disease is a common clinical disease, which refers to the discomfort symptoms and / or complications caused by the reflux of gastric and duodenal contents into the esophagus or above, and into the pharynx, oral cavity or lungs. The incidence of gastroesophageal reflux disease in my country is as high as 1.9% to 7.0%. Among the symptoms of gastroesophageal reflux disease, heartburn and reflux are typical symptoms, while some patients only show atypical symptoms or extraesophageal symptoms, such as abdominal pain, epigastric burning sensation, epigastric pain, epigastric distension, belching, etc., which may also be accompanied by cough, throat discomfort, asthma and tooth erosion.

[0003] At present, gastroesophageal reflux disease seriously affects the quality of life of patients. At present, the first choice of Western medicine treatment is acid suppression therapy with proton pump inhibitors (PPI) and potassium ion competitive acid blockers (P-CAB), as well as H2 receptor antagonists, gastrointestinal prokinetic drugs and other drugs. If the patient does not show significant improvement after the above-mentioned drug treatment, anti-reflux surgery can be considered as a last resort. Compared with Western medicine treatment, traditional Chinese medicine treatment has significant advantages in reducing the recurrence rate of the disease, reducing adverse reactions, improving clinical efficacy and improving the quality of life of patients.

[0004] Therefore, developing a Chinese medicine composition for treating gastroesophageal reflux disease and a preparation method and Chinese medicine preparation thereof will meet the current market demand. Summary of the invention

[0005] In order to overcome the deficiencies of the prior art, the present invention provides a Chinese medicine composition for treating gastroesophageal reflux disease, a preparation method thereof, and a Chinese medicine preparation; the Chinese medicine composition provided in the present application has a good effect in treating gastroesophageal reflux disease, and the preparation method is simple and easy to mass produce.

[0006] The technical solution adopted by the present invention to solve its technical problem is:

[0007] A traditional Chinese medicine composition for treating gastroesophageal reflux disease is composed of the following raw materials in parts by weight: 3-10 parts of bupleurum, 6-15 parts of white peony root, 3-10 parts of immature bitter orange, 3-9 parts of pinellia, 5-9 parts of cuttlebone, 3-9 parts of bletilla, 6-15 parts of kudzu root, 1-9 parts of panax notoginseng and 2-10 parts of liquorice.

[0008] A method for preparing a traditional Chinese medicine composition for treating gastroesophageal reflux disease comprises the following steps:

[0009] After weighing various raw materials according to the weight of the above-mentioned traditional Chinese medicine composition, add water and boil for 1 to 2 times, each time for 20 to 90 minutes, filter and take the medicine juice; and obtain the traditional Chinese medicine composition.

[0010] As a preferred solution, the amount of water added each time of decoction is 4 to 10 times the total weight of the raw materials.

[0011] A Chinese medicine preparation comprises the above-mentioned Chinese medicine composition.

[0012] The compatibility principle of each raw material of the Chinese medicine composition described in this application is as follows:

[0013] Bupleurum enters the liver and gallbladder meridians, promotes the development of Yang Qi, soothes the liver and relieves depression, and expels evil, making it the monarch medicine.

[0014] White peony root can nourish the liver and blood, relieve pain, and restrain yin and sweat; Citrus aurantium can regulate qi and relieve depression, relieve heat and break up knots; Cuttlebone can astringe and stop bleeding, and can be astringent and acid-reducing; Pinellia can dry dampness, resolve phlegm and disperse knots, and can lower adverse qi, harmonize the stomach and stop vomiting, and they are all ministerial drugs. White peony root, Citrus aurantium, Cuttlebone, Pinellia and Bupleurum can be used together to nourish liver blood and smooth liver qi, which can make Bupleurum ascend and disperse without the disadvantage of damaging yin and blood. One ascend and three descend, strengthen the function of soothing qi and lowering adverse qi, and play the effect of raising clear and lowering turbidity, regulating qi and blood, and harmonizing qi and blood; in addition, Cuttlebone can astringe and stop bleeding, and can be astringent and acid-reducing, so that symptoms such as heartburn, acid reflux, belching, hiccups, and noisy discomfort can be relieved. Pueraria root is used to protect the liver and detoxify, promote fluid and moisten the spleen, relieve muscles and relieve restlessness, and raise yang and stop diarrhea, so as to assist Bupleurum and play the function of ascending clear. Bletilla striata and Panax notoginseng are used as adjuvants for astringing and stopping bleeding, promoting menstruation and removing blood stasis, reducing swelling and relieving pain.

[0015] Use licorice as a messenger to harmonize the unbalanced qi, coordinate various medicines, benefit the spleen and harmonize the middle.

[0016] The beneficial effects of the present invention are:

[0017] The Chinese medicine composition described in the present application is a prescription composed of nine herbs, which has the effects of soothing the liver, regulating qi and relieving depression, supporting the spleen and harmonizing the stomach, and can be used to prepare a Chinese medicine composition for treating gastroesophageal reflux disease. DETAILED DESCRIPTION

[0018] In order to facilitate the understanding of those skilled in the art, the present invention is further described below in conjunction with embodiments, and the contents mentioned in the implementation modes are not intended to limit the present invention.

[0019] Example 1

[0020] A Chinese medicine composition for treating gastroesophageal reflux disease, comprising the following raw materials in parts by weight:

[0021] 1 part of Bupleurum, 2 parts of White Peony Root, 1 part of Citrus Aurantii, 1 part of Pinellia, 2 parts of Cuttlebone, 2 parts of Bletilla, 2 parts of Pueraria, 1 part of Panax Notoginseng, and 1 part of Licorice.

[0022] The preparation method of the above-mentioned Chinese medicine composition comprises the following steps:

[0023] After weighing each raw material according to the weight of the Chinese medicine composition, add water (the amount of water added each time is 10 times the total weight of the raw materials) and boil once for 20 minutes, filter, and take the juice to obtain a Chinese medicine composition decoction.

[0024] Example 2

[0025] A Chinese medicine composition for treating gastroesophageal reflux disease, comprising the following raw materials in parts by weight:

[0026] 15 parts of bupleurum, 20 parts of white peony root, 15 parts of immature bitter orange, 12 parts of pinellia, 15 parts of cuttlebone, 20 parts of bletilla, 19 parts of kudzu root, 12 parts of panax notoginseng, and 15 parts of liquorice.

[0027] The preparation method of the above-mentioned Chinese medicine composition comprises the following steps:

[0028] After weighing each raw material according to the weight of the Chinese medicine composition, add water (the amount of water added each time is 4 times the total weight of the raw materials) and boil twice, each time for 20 minutes, filter, and take the juice to obtain a Chinese medicine composition decoction.

[0029] Example 3

[0030] A Chinese medicine composition for treating gastroesophageal reflux disease, comprising the following raw materials in parts by weight:

[0031] 10 parts of Bupleurum, 3 parts of White Peony Root, 2 parts of Immature Citrus Aurantium, 3 parts of Pinellia, 4 parts of Cuttlebone, 4 parts of Bletilla, 3 parts of Pueraria, 2 parts of Panax Notoginseng, and 3 parts of Licorice.

[0032] The preparation method of the above-mentioned Chinese medicine composition comprises the following steps:

[0033] After weighing each raw material according to the weight of the Chinese medicine composition, add water (the amount of water added for each decoction is 5 times the total weight of the raw materials), decoct twice, each decoction for 50 minutes, filter, and take the juice to obtain a Chinese medicine composition decoction.

[0034] Example 4

[0035] A Chinese medicine composition for treating gastroesophageal reflux disease, comprising the following raw materials in parts by weight:

[0036] 3 parts of Bupleurum, 6 parts of White Peony Root, 3 parts of Citrus Aurantii, 3 parts of Pinellia, 1 part of Cuttlebone, 3 parts of Bletilla, 6 parts of Pueraria, 1 part of Panax Notoginseng, and 2 parts of Licorice.

[0037] The preparation method of the above-mentioned Chinese medicine composition comprises the following steps:

[0038] After weighing each raw material according to the weight of the Chinese medicine composition, add water (the amount of water added each time is 6 times the total weight of the raw materials) and boil once for 80 minutes, filter, and take the juice to obtain a Chinese medicine composition decoction.

[0039] Example 5

[0040] A Chinese medicine composition for treating gastroesophageal reflux disease, comprising the following raw materials in parts by weight:

[0041] 10 parts of bupleurum, 15 parts of white peony root, 10 parts of immature bitter orange, 9 parts of pinellia, 9 parts of cuttlebone, 9 parts of bletilla, 15 parts of kudzu root, 9 parts of notoginseng, and 10 parts of liquorice.

[0042] The preparation method of the above-mentioned Chinese medicine composition comprises the following steps:

[0043] After weighing each raw material according to the weight of the Chinese medicine composition, add water (the amount of water added each time is 7 times the total weight of the raw materials) and boil twice, each time for 35 minutes, filter, and take the juice to obtain a Chinese medicine composition decoction.

[0044] 1. Clinical case data

[0045] All cases in this embodiment are patients who visited the Department of Gastroenterology, Dongzhimen Hospital, Beijing University of Chinese Medicine in 2022, a total of 16 cases.

[0046] 2. Diagnostic criteria:

[0047] 1. The Western medicine diagnostic standards refer to the "2020 Chinese Gastroesophageal Reflux Disease Expert Consensus" formulated by the Gastroenterology Branch of the Chinese Medical Association.

[0048] Gastroesophageal reflux disease (GERD) refers to a disease in which gastric contents reflux into the esophagus, causing discomfort and / or complications. Heartburn and reflux are the most common symptoms of GERD. Heartburn refers to a burning sensation behind the sternum; reflux refers to the feeling of gastric contents flowing toward the pharynx or mouth. The Gastroesophageal Reflux Disease Questionnaire (Gerd Q) is a tool to assist in the diagnosis of GERD. A GerdQ score of ≥8 points can be used to diagnose GERD. The content of the questionnaire is shown in Table 1 below:

[0049] Table 1 Gastroesophageal reflux disease questionnaire

[0050]

[0051]

[0052] 2. The TCM diagnostic criteria refer to the "Expert Consensus on TCM Diagnosis and Treatment of Gastroesophageal Reflux Disease (2017)". The main symptoms of TCM are acid reflux and heartburn; secondary symptoms are burning pain behind the sternum, pain or distension in the abdomen, bitter mouth and dry throat, belching, nausea, irritability, restlessness and insomnia, tooth erosion, etc.; red or light red tongue, white or thin yellow fur, stringy or stringy pulse, etc. If the above two main symptoms and 1 to 2 secondary symptoms are met, the diagnosis can be confirmed. The tongue and pulse are for reference only.

[0053] 3. Case Selection Criteria

[0054] (I) Inclusion criteria

[0055] 1. Meet the Western medical diagnostic criteria for gastroesophageal reflux disease;

[0056] 2. Reflux and heartburn are the main symptoms;

[0057] 3. Age 18-65 (inclusive);

[0058] 4. The patient is informed and agrees to receive appropriate treatment.

[0059] (II) Exclusion criteria

[0060] 1. Organic lesions of the digestive tract are found during examination;

[0061] 2. Patients with heartburn, acid reflux, and chest pain caused by other diseases, such as gastrinoma, duodenal ulcer with pyloric obstruction, etc.;

[0062] 3. Patients who are found to have abnormal digestive tract structure or other diseases that may cause reflux-related symptoms (such as achalasia, hiatal hernia, eosinophilic esophagitis, diabetic gastroparesis, etc.);

[0063] 4. Patients with other major systemic diseases such as respiratory system, nervous system, immune system, blood system, malignant tumor patients, patients with severe trauma, infection, etc.; patients with severe liver and kidney damage, alanine aminotransferase and serum creatinine> 1.5 times the upper limit of normal value. And patients with severe mental illness that is not effectively controlled;

[0064] 5. Those who have been taking acid-suppressing drugs for a long time and cannot stop taking them;

[0065] 6. Women of childbearing age who are pregnant, breastfeeding, intending to become pregnant, or have a positive pregnancy test (urine or blood HCG test);

[0066] 7. Those who are allergic to the ingredients of this drug;

[0067] 8. Patients who participated in other drug clinical trials within 4 weeks;

[0068] 9. Suspected or confirmed history of alcohol or drug abuse, or other diseases that, according to the investigator's judgment, reduce the possibility of enrollment or complicate enrollment, such as frequent changes in work environment, which may easily lead to loss to follow-up.

[0069] (III) Data elimination criteria

[0070] 1. After the start of the trial, it is found that the subject does not meet the case inclusion criteria or meets the exclusion criteria;

[0071] 2. No data were recorded after enrollment;

[0072] 3. Those who cannot complete the test as required;

[0073] 4. Those who fail to use the trial drugs according to the research regulations and whose efficacy cannot be determined;

[0074] 5. Cases where prohibited drugs have been used and their effectiveness and safety cannot be determined.

[0075] IV. Treatment Methods

[0076] The Chinese medicine decoction prepared in Example 1 of the present invention is taken one dose per day (liquid volume 150-600 ml), and one course of treatment is two weeks.

[0077] V. Observation of therapeutic effects

[0078] 1. Observation indicators

[0079] The GERD Q self-rating scale and the gastroesophageal reflux disease-health-related quality of life scale were used to evaluate:

[0080] Table 2 GERD Q self-rating scale

[0081]

[0082]

[0083] If the score of either A or C of the follow-up patient is ≤1, it indicates that the treatment is effective; if the score of either A or C is ≥2, it indicates that the treatment plan needs to be adjusted.

[0084] Positive score = A + C score, which reflects the score of positive symptoms and their impact on the patient's quality of life.

[0085] The quality of life impact score = item C, which refers to the score of the impact of reflux symptoms on the patient's quality of life.

[0086] Note: Item A = positive symptoms, Item B = negative symptoms, Item C = positive impact (quality of life); for newly diagnosed patients, A+B+C ≥ 8 points indicates a diagnosis of GERD, and Item C ≥ 3 points indicates that GERD affects the quality of life.

[0087] Table 3 Gastroesophageal reflux disease-health-related quality of life table

[0088] Rating: 0: No symptoms; 1: Significant symptoms, but not bothering; 2: Significant and bothering symptoms, but not every day; 3: Bothering symptoms every day; 4: Symptoms affect daily life; 5: Symptoms prevent daily life

[0089]

[0090]

[0091]

[0092] 2. Data Analysis

[0093] SPSS software was used for statistical analysis. Before and after treatment, paired sample t test was used if the data obeyed normal distribution; rank sum test was used if the data did not obey normal distribution. When P < 0.05, the difference was considered statistically significant.

[0094] type Mean ± SD P Difference in total GERD scores between the first visit and the follow-up visit 2.56±2.73 0.002 Difference in total heartburn score between the first visit and the follow-up visit 5.38±4.94 0.001 Difference in total reflux score between the first visit and the follow-up visit 4.31±3.36 0.000

[0095] The results in the above table show that after one course of treatment, the GERD score, heartburn score and reflux score of the patients were all reduced after treatment (P<0.01), proving the effectiveness of the Chinese herbal decoction of the present invention in treating gastroesophageal reflux disease.

[0096] Classic case:

[0097] Case 1

[0098] Liu, female, 38 years old. Main complaint: acid reflux, epigastric burning, bitter taste in the mouth, irritability and anger. Medical history: The patient developed the above symptoms after a family member died four months ago. She was diagnosed with non-erosive gastroesophageal reflux disease three months ago. She took rabeprazole enteric-coated tablets for 8 weeks. During the medication period, she had symptoms such as irritability, anxiety, and dry mouth. The symptoms recurred after stopping the medication.

[0099] Tongue and pulse: red tongue with yellow coating, deep and stringy pulse.

[0100] TCM diagnosis: vomiting acid (heat in the liver and stomach)

[0101] Second diagnosis: acid reflux is relieved, bitter mouth symptoms are significantly relieved, upper abdominal burning symptoms are significantly relieved, and emotions are improved. Third diagnosis: acid reflux and bitter mouth symptoms are basically gone, upper abdominal burning symptoms are gone, and emotions are comfortable. Tongue and pulse are normal.

[0102] Follow-up: Follow-up two months later showed no recurrence of acid reflux, bitter taste in the mouth, and upper abdominal burning.

[0103] Case 2

[0104] Chen, male, 42 years old. Main complaint: bitter mouth and dry throat, heartburn, acid reflux, occasional belching, flank pain, noisy discomfort, denies stomachache and other discomfort.

[0105] Medical history: Endoscopy was performed in April, which showed gastroesophageal reflux disease. Omeprazole enteric-coated capsules and mosapride were taken orally for more than 3 weeks. Heartburn and acid reflux symptoms were relieved during medication, but dry mouth worsened, so the patient stopped taking the medication on his own. Half a month after stopping the medication, dry mouth did not significantly improve, and other symptoms recurred.

[0106] Tongue and pulse: red tongue, yellow and greasy coating, stringy and rapid pulse.

[0107] TCM diagnosis: vomiting acid (bile heat attacking the stomach)

[0108] Second visit: The patient reported that acid reflux and heartburn were relieved, with occasional belching, and the bitter mouth and dry throat were significantly relieved, and no flank pain was felt. Third visit: The patient reported that acid reflux, heartburn, belching, and noisy were basically gone, and the appetite was good.

[0109] Follow-up: Follow-up two months later showed no recurrence of bitter mouth, dry throat, heartburn, and acid reflux.

[0110] The above embodiments are preferred implementation schemes of the present invention. In addition, the present invention may also be implemented in other ways. Any obvious replacement without departing from the concept of the present invention is within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating gastroesophageal reflux disease, characterized in that: The invention is prepared from the following raw materials in parts by weight: 3-10 parts of bupleurum, 6-15 parts of white peony root, 3-10 parts of immature bitter orange, 3-9 parts of pinellia, 5-9 parts of cuttlebone, 3-9 parts of bletilla, 6-15 parts of kudzu root, 1-9 parts of panax notoginseng and 2-10 parts of liquorice.

2. A method for preparing the Chinese medicine composition for treating gastroesophageal reflux disease according to claim 1, characterized in that: The following steps are involved: After weighing each raw material according to the weight portion of the Chinese medicine composition of claim 1, add water and boil for 1 to 2 times, each time for 20 to 90 minutes, filter and take the medicine juice; and obtain the Chinese medicine composition.

3. The method for preparing the Chinese medicine composition for treating gastroesophageal reflux disease according to claim 2, characterized in that: The amount of water added each time of decoction is 4-10 times the total weight of the raw materials.

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