CN112675276A - Medicine for treating gastroesophageal reflux disease and preparation method thereof - Google Patents
Medicine for treating gastroesophageal reflux disease and preparation method thereof Download PDFInfo
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- CN112675276A CN112675276A CN202110018889.6A CN202110018889A CN112675276A CN 112675276 A CN112675276 A CN 112675276A CN 202110018889 A CN202110018889 A CN 202110018889A CN 112675276 A CN112675276 A CN 112675276A
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Abstract
The invention discloses a medicine for treating gastroesophageal reflux disease and a preparation method thereof, wherein the medicine comprises the following steps: 250g of scutellaria baicalensis-. The invention overcomes the defect of poor curative effect of treating reflux esophagitis in the prior art. The invention has the advantages of refined formula, reasonable compatibility, reliable curative effect after years of clinical use and no toxic or side effect and adverse reaction.
Description
Technical Field
The invention belongs to the field of traditional Chinese medicines, and particularly relates to a medicine for treating gastroesophageal reflux disease. The invention also relates to a preparation method of the medicine.
Background
Reflux Esophagitis (RE) is an inflammatory disorder of the esophagus caused by reflux of the contents of the stomach and duodenum into the esophagus, and shows damage to the esophageal mucosa under an endoscope, namely esophageal erosion and/or esophageal ulcer. The pathogenesis of reflux esophagitis is not clear, and multiple factors are involved, and the main pathophysiological mechanism of reflux esophagitis is the result of decline of an anti-reflux defense mechanism (transient lower esophageal sphincter relaxations, weakening of diaphragmatic angle anti-reflux effect and hiatal hernia) and enhancement of attack effect of a reflux substance on esophageal mucosa. Refluxes include acid reflux and non-acid reflux, which are generally considered to be the major cause of esophageal mucosal damage, but with 24h esophageal pH and bile monitoring by schwann et al in patients, bile reflux was found to be as high as 72.4% in RE patients, with mixed reflux accounting for 62.1%. The damage degree of the esophageal mucosa depends on the removal capacity and the barrier function of the esophagus to the regurgitation, the removal capacity depends on the contraction and the relaxation of esophageal smooth muscle, the removal capacity of the esophagus is reduced due to the movement dysfunction of the esophageal body, and the dioxin is determined by the esophageal pressure before and after the patient is cured, so that the movement dysfunction of the esophageal body and the acid regurgitation are found to be important pathogenesis of RE, especially severe RE; the esophageal mucosa barrier function maintains a neutral environment by esophageal epithelial cells and intercellular spaces, Lileap and the like are discovered by a transmission electron microscope imaging method that the mucosal thickness is increased, the intercellular spaces are widened, desmosomes are obviously reduced along with the development of RE, and foreign researches also discover that 90% of RE patients have esophageal mucosa intercellular spaces widened. At home and abroad, the literature finds that various cytokines and signal paths participate in the generation mechanism of RE, and the related cytokines and signal paths provide guiding significance for the target discovery and new drug screening of new drugs.
The proton pump inhibitor PPI is preferred for reflux esophagitis drug therapy, the treatment course is at least 8 weeks, the PPI has obvious curative effect and quick response, the main action mechanism is H + -K + -ATP enzyme which is the last link of inhibiting the wall cells from secreting H +, and the effect of efficiently and quickly inhibiting gastric acid is achieved. But extension of Lower Esophageal Sphincter (LES) dysfunction or transient LES relaxation is the major mechanism of reflux, with gastric acid and other refluxes (pepsin, bile) involved in mucosal damage and complications. PPI does not improve LES dysfunction and PPI treatment presents potential windAt risk, long-term use of PPI will increase the probability of occurrence of Clostridium difficile infection[9]. The PPI is most concerned about the recurrence of symptoms after withdrawal of the drug, and researches show that 2/3 patients are easy to recur and aggravate after withdrawal of the drug, the original erosion can recur, and the acid-inhibiting withdrawal causes the recurrence of the disease state to form Refractory Reflux Esophagitis (RRE). Why is reflux esophagitis "refractory"? The cause of the RRE is still unclear at present, and probably the high sensitivity of the esophagus and psychologic factors play an important role in the pathogenesis of the RRE.
According to 2013 ACG guidelines, combined with the clinical practice in China, the RRE is defined as Reflux Esophagitis (RE) with the symptoms not improved obviously after 8 weeks of standard dose PPI treatment. Drug therapy is mainly effective in controlling gastric acid, and the most important treatment is to optimize PPI therapy. In addition to the combination of a prokinetic drug, a muscle relaxant, a mucosal protective agent to treat non-acid reflux, and a visceral pain modifier for patients with functional heartburn that cannot be addressed after high dose PPI and antireflux surgery. Although modern medicine develops various treatment medicines and operation methods at present, the clinical curative effect is not satisfactory due to the complex mechanism, high recurrence rate and difficult treatment, and the traditional Chinese medicine can play the role of the traditional Chinese medicine, so that the advantages of inducing and maintaining the remission of the disease, preventing the recurrence of the disease, improving the life quality of patients and reducing the complications are highlighted.
According to the main clinical manifestations of the reflux esophagitis, the reflux esophagitis is acid regurgitation, heartburn, poststernal burning pain, nausea, belching, vomiting and the like, and the angelica sinensis belongs to the categories of diseases such as acid regurgitation, stomach distension, stomach regurgitation, dysphagia, vomiting, globus hystericus, esophageal pyretic fever and the like in the traditional Chinese medicine. The common types include liver-stomach stagnated heat syndrome, gallbladder heat invading stomach syndrome, qi stagnation and phlegm obstruction syndrome, blood stasis obstruction syndrome, middle-jiao deficiency and adverse qi, spleen deficiency and damp-heat syndrome. At present, the syndrome differentiation and classification of the disease still have divergence among various clinical families, and the syndrome of disharmony between the liver and stomach and the syndrome of stagnated heat in the liver and stomach are generally accepted by various experts and are consistent with the clinical research and verification. However, long-term clinical observation shows that patients with mild symptoms and patients with short course of disease can still obtain satisfactory curative effect if treatment is performed based on the above common symptoms, but if the course of disease is long, the condition of the disease is stubborn, reflux esophagitis is refractory, and the treatment is performed based on the conventional thinking, the curative effect is poor.
Disclosure of Invention
In order to overcome the defect of poor curative effect of treating reflux esophagitis in the prior art, the invention provides the medicine for treating the gastroesophageal reflux disease and the preparation method thereof, wherein the medicine has reliable curative effect and does not have any toxic or side effect or adverse reaction.
A traditional Chinese medicine for treating gastroesophageal reflux disease is composed of the following raw material medicines in parts by weight:
preferably, the raw material medicines comprise the following components in parts by weight:
further, the medicament of the medicine is any one of the dosage forms in pharmaceutics.
Preferably, the dosage form is a granule.
A preparation method of a medicine for treating gastroesophageal reflux disease comprises the following steps: the preparation method comprises the following steps of uniformly mixing the medicines according to the parts by weight, adding 10 times of water by weight of the medicines, soaking for 24 hours, decocting for three times, 2 hours each time, combining decoctions, filtering, concentrating the filtrate under reduced pressure to obtain clear paste with the relative density of 1.08-1.13, drying under reduced pressure, crushing into fine powder, adding the fine powder and a proper amount of starch, uniformly mixing, and preparing into granules.
Preferably, the reduced pressure condition between the decoction and the filtrate concentration is vacuum degree: -0.03 to-0.05 MPa, temperature: 70-80 ℃; the condition of decompressing and drying the clear paste is that the vacuum degree is as follows: -0.07 to-0.08 MPa, temperature: 70-80 ℃, and concentrating the filtrate to the temperature of 80 ℃ of clear paste with the relative density of 1.08-1.13.
Preferably, the particle size is 10 to 40 mesh.
In the formula of the invention, the monarch drug is rhizoma pinelliae preparata, and the ministerial drugs are coptis chinensis and scutellaria baicalensis. The pinellia tuber, rhizoma Pinelliae is pungent in flavor and warm in property and can dry dampness, subside in property and descend the adverse qi, the magnolia bark, cortex magnoliae officinalis and the cortex magnoliae officinalis are used together to promote the circulation of qi and to dredge the qi, and the two medicines can dry dampness and dispel the cold, and can harmonize the stomach and descend the adverse qi, so that the ascending and descending functions of the. Huang Lian and Huang Qin clear heat and dry dampness to remove cold and damp pathogen stagnated heat. Agastache rugosus is fragrant and capable of eliminating turbid qi in stomach and restoring healthy qi, and ban Xia is combined with clearing dampness and eliminating dampness to treat damp-turbidity encumbering spleen. Long pepper, fructus Piperis Longi, while warming the middle energizer to dispel cold, sending qi downward to alleviate pain, is combined with ren Shen and gan Jiang to warm the middle energizer. Licorice root, radix Glycyrrhizae is sweet and warm in nature, and has the effects of tonifying qi, strengthening the middle-jiao and harmonizing the property of the herbs. The medicines are matched, the spleen yang transports and removes cold dampness, the dampness and heat transforms into qi regulation, and finally the spleen and stomach have normal ascending and descending functions, the spleen ascends and descends, the stomach qi descends smoothly, and the reflux does not occur any more. Li Yan quan professor considers that the disease of reflux esophagitis is located in the esophagus and closely related to the stomach, and considers that deficiency-cold of the spleen and stomach is the origin of the disease, stomach qi is the key of pathogenesis, and cold-dampness-heat is mixed with middle energizer and is difficult to treat. Spleen deficiency, yang deficiency leading to internal cold, water liquid not returning to normal, accumulating to form dampness, cold-dampness accumulating for a long time, diet being stagnated in the stomach, heat transforming for a long time, and damp-heat brewing, so cold-dampness-heat is mixed in the middle energizer, while the spleen mainly ascends, the stomach mainly descends, the spleen and stomach are weak, ascending and descending disharmony occurs, the middle energizer is unfavorable, the regulation of the liver is affected, the liver fails to dredge and defecate, the liver wood takes the spleen, the stomach is invaded by transverse reversal, the stomach qi is reversed, and the reflux of gastric contents causes the esophagus to cause the disease, so the root cause of the disease is the disease of gastrointestinal dysfunction, and the acid is only a direct factor for generating the disease, is a sufficient condition, and is an unnecessary condition. In the formula, the ginseng and the dried ginger warm and tonify spleen yang and help the spleen to transport and transform, because the deficiency-cold of spleen and stomach is the origin of the disease. Therefore, the treatment of this disease is mainly based on the recovery of the spleen's function of ascending and descending the stomach. The traditional Chinese medicine preparation for treating reflux has no similar preparation to be marketed, and can serve more reflux esophagitis patients by popularizing and applying the traditional Chinese medicine preparation.
In the clinical observation research, 72 patients meeting the medium and western medical diagnosis standards of reflux esophagitis are selected and randomly divided into 36 treatment groups and 36 control groups, the treatment groups are orally administered with the medicament of the invention, the control groups are orally administered with esomeprazole magnesium enteric-coated tablets, the two groups are treated for 8 weeks, the inflammation conditions of the esophageal mucosa under the gastroscope of the two groups of patients are respectively observed before and after the treatment, the scores of a tolerance rating scale (RDQ) of the two groups of patients and a grading scale of the medium and medical syndrome are compared, and follow-up is carried out after 4 weeks of the treatment is finished, and the recurrence rates of the two groups are compared.
The results show that: (1) changes in esophageal mucosa inflammation under gastroscopy: the inflammation of esophageal mucosa under gastroscope of two groups of patients is improved, the total effective rate of a treatment group is 68.75 percent, the total effective rate of a control group is 92.86 percent, and the difference of the two groups of total effective rates has no statistical significance (P is more than 0.05); (2) tolerance table (RDQ) integral comparison: after the treatment of the two groups, the tolerance table score of the patients can be improved, the total effective rate of the treatment group is 91.67 percent, the total effective rate of the control group is 72.22 percent, and the difference of the two groups has statistical significance (P is less than 0.05); (3) the traditional Chinese medicine syndrome curative effect comparison: the total integral of the traditional Chinese medicine symptoms of two groups of patients is reduced after treatment, the total effective rate of a treatment group is 86.11%, the total effective rate of a control group is 47.22%, the two groups of patients have statistical significance (P <0.05), compared between the two groups of patients after treatment, the effects of the treatment group on the aspects of improving heartburn, satiety, belching, dry mouth, bitter taste in mouth, sticky stool and fatigue are superior to those of the control group, the difference has statistical significance (P <0.05), and the difference has no statistical significance (P >0.05) on the aspects of improving acid regurgitation, epigastric pain, poststernal pain and poor appetite; (4) after 4 weeks of treatment, the two groups were followed up, and the recurrence rate was low in the treatment group, 5.6% in the treatment group, and 27.8% in the control group, with statistical differences (P < 0.05).
The research shows that the traditional Chinese medicine composition can obviously improve symptoms and traditional Chinese medicine symptoms of patients with reflux esophagitis, improve esophageal mucosa inflammation and reduce recurrence rate, has better effect than a control group in the aspects of improving heartburn and belch, and is supposed to play a role in the aspects of promoting gastrointestinal emptying, relieving stimulation of reflux and promoting injured mucosa repair. The invention has been used clinically for many years, has achieved satisfactory curative effect, it is convenient to carry and use.
Detailed Description
Example 1
The preparation method of the medicine for treating gastroesophageal reflux disease comprises the following steps: 250g of scutellaria baicalensis, 150g of coptis chinensis, 150g of dried ginger, 150g of ginseng, 250g of rhizoma pinelliae preparata, 150g of long pepper, 150g of patchouli, 800g of mangnolia officinalis and 150g of liquorice are uniformly mixed, 10 times of water by weight of the medicines is added, the mixture is soaked for 24 hours, decocted for three times and 2 hours each time, decoction solutions are combined, filtered, decompressed filtrate is concentrated to clear paste with the relative density of 1.08, decompressed and dried, crushed into fine powder, the fine powder and a proper amount of starch are added, and the mixture is uniformly mixed and prepared into particles.
Preferably, the reduced pressure condition between the decoction and the filtrate concentration is vacuum degree: -0.03MPa, temperature: 70 ℃; the condition of decompressing and drying the clear paste is that the vacuum degree is as follows: -0.07MPa, temperature: concentrating the filtrate to fluid extract with relative density of 1.08 at 70 deg.C, and heating to 80 deg.C.
Preferably, the particle size is 10 mesh.
Example 2
The preparation method of the medicine for treating gastroesophageal reflux disease comprises the following steps: 300g of scutellaria baicalensis, 180g of coptis chinensis, 180g of dried ginger, 180g of ginseng, 300g of rhizoma pinelliae preparata, 180g of long pepper, 180g of pogostemon cablin, 900g of mangnolia officinalis and 180g of liquorice are uniformly mixed, 10 times of water by weight of the medicines is added, the mixture is soaked for 24 hours, the mixture is decocted for three times, 2 hours each time, the decoction liquid is combined, the decoction liquid is filtered, the reduced pressure filtrate is concentrated to clear paste with the relative density of 1.11, the reduced pressure drying is carried out, the fine powder is crushed into fine powder, the fine powder and a proper.
Preferably, the reduced pressure condition between the decoction and the filtrate concentration is vacuum degree: -0.04MPa, temperature: 75 ℃; the condition of decompressing and drying the clear paste is that the vacuum degree is as follows: -0.08MPa, temperature: the filtrate was concentrated to a relative density of 1.11 paste temperature of 80 ℃ at 75 ℃.
Preferably, the particle size is 35 mesh.
Example 3
The preparation method of the medicine for treating gastroesophageal reflux disease comprises the following steps: mixing Scutellariae radix 350g, Coptidis rhizoma 200g, Zingiberis rhizoma 200g, Ginseng radix 200g, rhizoma Pinelliae Preparata 350g, fructus Piperis Longi 200g, herba Agastaches 200g, cortex Magnolia officinalis 1000g, and Glycyrrhrizae radix 200g uniformly, adding 10 times of water by weight of the medicines, soaking for 24 hr, decocting for three times, each time for 2 hr, mixing decoctions, filtering, concentrating the filtrate under reduced pressure to obtain fluid extract with relative density of 1.13, drying under reduced pressure, pulverizing into fine powder, adding above fine powder and appropriate amount of starch, mixing well, and granulating.
Claims (7)
1. The medicine for treating gastroesophageal reflux disease is characterized by comprising the following raw material medicines in parts by weight:
2. the medicine for treating gastroesophageal reflux disease according to claim 1, wherein the raw material medicines are, by weight:
3. the medicament for treating gastroesophageal reflux disease according to any one of claims 1 to 2, wherein the medicament is any one of the dosage forms in pharmaceutics.
4. A medicament for the treatment of gastroesophageal reflux disease according to claim 3, wherein the dosage form is a granule.
5. A process for the preparation of a medicament according to any one of claims 1 to 2 for the treatment of gastroesophageal reflux disease, comprising the steps of: the preparation method comprises the following steps of uniformly mixing the medicines according to the parts by weight, adding 10 times of water by weight of the medicines, soaking for 24 hours, decocting for three times, 2 hours each time, combining decoctions, filtering, concentrating the filtrate under reduced pressure to obtain clear paste with the relative density of 1.08-1.13, drying under reduced pressure, crushing into fine powder, adding the fine powder and a proper amount of starch, uniformly mixing, and preparing into granules.
6. The method for preparing a medicine for treating gastroesophageal reflux disease according to claim 5, wherein the decompression condition between the decoction and the filtrate concentration is vacuum degree: -0.03 to-0.05 MPa, temperature: 70-80 ℃; the condition of decompressing and drying the clear paste is that the vacuum degree is as follows: -0.07 to-0.08 MPa, temperature: 70-80 ℃, and concentrating the filtrate to the temperature of 80 ℃ of clear paste with the relative density of 1.08-1.13.
7. The method for preparing a medicament for treating gastroesophageal reflux disease according to claim 5, wherein the particle size is 10-40 mesh.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102764422A (en) * | 2012-08-17 | 2012-11-07 | 河南中医学院 | Xialian Yiyou capsule for curing chronic gastritis |
| CN105056173A (en) * | 2015-07-31 | 2015-11-18 | 济南邦文医药科技有限公司 | Chinese herbal medicament for treating gastroesophageal reflux disease with intermingled cold and heat symptom |
| CN111514274A (en) * | 2020-05-28 | 2020-08-11 | 成都中医药大学附属医院 | Traditional Chinese medicine composition for treating reflux esophagitis and preparation method and application thereof |
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- 2021-01-07 CN CN202110018889.6A patent/CN112675276A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102764422A (en) * | 2012-08-17 | 2012-11-07 | 河南中医学院 | Xialian Yiyou capsule for curing chronic gastritis |
| CN105056173A (en) * | 2015-07-31 | 2015-11-18 | 济南邦文医药科技有限公司 | Chinese herbal medicament for treating gastroesophageal reflux disease with intermingled cold and heat symptom |
| CN111514274A (en) * | 2020-05-28 | 2020-08-11 | 成都中医药大学附属医院 | Traditional Chinese medicine composition for treating reflux esophagitis and preparation method and application thereof |
Non-Patent Citations (2)
| Title |
|---|
| 樊凯丽: "顺胃降逆方治疗难治性胃食管反流病的临床观察", 《中国优秀硕士学位论文全文数据库（硕士） 医药卫生科技辑》 * |
| 马敏宁: "泻心汤加味治疗胆汁反流性胃炎78例", 《河北中医》 * |
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