A composition for treating reflux esophagitis and use thereof

Abstract

The application relates to a composition for treating reflux esophagitis and application thereof. The composition comprises the following components in parts by weight: 2-8 parts of scutellaria baicalensis, 3-7 parts of licorice, 5-10 parts of beeswax and 80-120 parts of vegetable oil. The composition for treating reflux esophagitis contains scutellaria baicalensis, licorice, beeswax and vegetable oil, and through mutual cooperation among the components, the drug prepared from the composition can significantly increase the plasma motilin level of a patient, further increase the pressure of the lower esophageal sphincter, promote gastric emptying and prevent acid reflux, promote the recovery of reflux esophagitis, the esophagus of the patient is obviously improved, and no adverse reaction is found; meanwhile, the content of lipid peroxide can be obviously reduced, the activities of superoxide dismutase and glutathione peroxidase are increased, the esophageal mucosa is protected and treated, the pathological changes of the esophagus are obviously improved, and the treatment effect is excellent.

Description

Technical Field

[0001] This application relates to the field of pharmaceutical technology, and in particular to a composition for treating reflux esophagitis and its application. Background Technology

[0002] The reflux of stomach contents (including duodenal fluid) into the esophagus, causing symptoms or complications, is called gastroesophageal reflux disease (GERD). Acid (or alkali) reflux leading to esophageal mucosal damage is called reflux esophagitis (RE). Digestive endoscopy is the primary diagnostic method for RE.

[0003] The esophageal antireflux barrier refers to an anatomical region at the junction of the esophagus and stomach, including the lower esophageal sphincter (LES), the crus of the diaphragm, the phrenic esophageal ligament, and the acute angle between the esophagus and the gastric fundus (His angle). Functional and structural defects in any part of this region can lead to the reflux of gastric contents. Factors such as gastric acid, pepsin, and pancreatic enzymes in the refluxed material continuously attack the esophageal mucosal barrier, thereby causing esophageal damage.

[0004] In 2003, the Chinese Society of Digestive Endoscopy issued the "Guidelines for the Diagnosis and Treatment of Reflux Esophagitis." Treatment for reflux esophagitis includes general treatment, drug therapy, endoscopic treatment, and surgical treatment. Drug therapy utilizes proton pump inhibitors, H2 receptor antagonists, or prokinetic agents. While these drugs can temporarily relieve symptoms, their therapeutic effects are limited, and long-term use can cause various side effects. Therefore, there is a need to research new combinations that can effectively treat reflux esophagitis. Summary of the Invention

[0005] To address the shortcomings of existing technologies, this application provides a composition for treating reflux esophagitis. The composition or a drug comprising the composition can effectively treat reflux esophagitis, and no adverse reactions have been observed during the treatment process. It can be well applied in the treatment of reflux esophagitis.

[0006] Therefore, the first aspect of this application provides a composition for treating reflux esophagitis, which, by weight, comprises the following components: 2-8 parts of Scutellaria baicalensis, 3-7 parts of Glycyrrhiza uralensis, 5-10 parts of beeswax, and 80-120 parts of vegetable oil.

[0007] The composition described in this application contains Scutellaria baicalensis, which is bitter and cold, and can clear heat from the Shaoyang meridian; Glycyrrhiza uralensis, which is sweet and warm, tonifies the spleen, benefits qi and stomach, relieves spasms and pain, strengthens the body and harmonizes the middle jiao, and harmonizes the other herbs, thus preventing Scutellaria baicalensis and Curcuma longa from damaging yang due to their bitter and cold nature; plant oil, which lubricates the intestines and promotes bowel movement, and is moderately warm; and beeswax, which is neutral in taste, can alleviate various sores and toxins. Through the synergistic effect of its components, the composition described in this application enables the drug prepared using this composition to significantly increase the patient's plasma motilin level, thereby increasing the pressure of the lower esophageal sphincter, promoting gastric emptying, preventing acid reflux, and promoting the recovery of reflux esophagitis. The patient's esophagus shows significant improvement, and no adverse reactions have been observed. Simultaneously, the drug prepared using this composition can significantly reduce the content of lipid peroxides (MDA) in reflux esophagitis model animals, increase the activity of superoxide dismutase (SOD) and glutathione peroxidase (GSH-PX), and play a protective and therapeutic role in the esophageal mucosa, significantly improving the lesions of the esophagus in the test animals, with excellent therapeutic effects.

[0008] In some embodiments, the vegetable oil is sesame oil.

[0009] In this application, when the composition is used to prepare a drug for treating reflux esophagitis, the Chinese medicinal materials in the composition are extracted with sesame oil at high temperature to neutralize and remove the bitter and cold properties of Scutellaria baicalensis, while retaining the benefits of relieving heat and pain, and promoting qi circulation and unblocking the meridians.

[0010] In some embodiments, the vegetable oil is a mixture of sesame oil and safflower seed oil, and the mass ratio of sesame oil to safflower seed oil is (10-20):1.

[0011] In this application, safflower seed oil has the effects of increasing the levels of SOD and GSH-Px in serum and liver, reducing MDA content, and protecting against oxidative damage. Introducing safflower seed oil into the composition can enhance the therapeutic effect of the drug prepared using the composition on reflux esophagitis.

[0012] In some specific embodiments, the mass ratio of sesame oil to safflower seed oil in the vegetable oil can be 10:1, 11:1, 12:1, 13:1, 14:1, 15:1, 16:1, 17:1, 18:1, 19:1, or 20:1, etc. In some preferred embodiments, the mass ratio of sesame oil to safflower seed oil in the vegetable oil is 19:1.

[0013] This application optimizes the quality relationship between sesame oil and safflower seed oil in vegetable oils, which helps to further improve the efficacy of drugs prepared using this composition for treating reflux esophagitis.

[0014] In some embodiments, the composition further includes 1 to 5 parts of Citrus aurantium.

[0015] In this application, Fructus Aurantii Immaturus has the effects of breaking up qi stagnation, eliminating phlegm and removing abdominal distension. It can increase plasma motilin levels, treat chronic superficial gastritis, atrophic gastritis, erosive gastritis, bile reflux gastritis, and relieve symptoms of insufficient gastric motility such as stomach pain, bloating, abdominal distension, belching, acid reflux, nausea, and poor appetite.

[0016] In some embodiments, the mass ratio of Scutellaria baicalensis to Citrus aurantium is (2-3):1.

[0017] In some preferred embodiments, the mass ratio of Scutellaria baicalensis to Citrus aurantium is 2.5:1.

[0018] This application optimizes the mass relationship between Scutellaria baicalensis and Citrus aurantium in the composition, which helps to further improve the efficacy of drugs prepared using this composition for treating reflux esophagitis.

[0019] In some embodiments, the composition further includes 1 to 3 parts of Atractylodes macrocephala and 1 to 3 parts of Poria cocos.

[0020] In this application, Atractylodes macrocephala is bitter, sweet, and warm in nature, and enters the spleen and stomach meridians. It has multiple medicinal functions, including tonifying the spleen and stomach, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. Poria cocos has the effects of promoting diuresis and reducing swelling, eliminating dampness, strengthening the spleen, and calming the mind. It is mainly used to treat edema, phlegm retention, spleen deficiency diarrhea, palpitations, and insomnia. It can reduce gastric juice secretion and free acid content, and has an inhibitory effect on gastric ulcers. Atractylodes macrocephala, Poria cocos, and Glycyrrhiza uralensis have a synergistic promoting effect on increasing plasma motilin levels. By further adding Atractylodes macrocephala and Poria cocos to the composition, the drug prepared using this composition can have a better therapeutic effect on reflux esophagitis.

[0021] In some embodiments, the total mass ratio of Atractylodes macrocephala and Poria cocos to the mass ratio of Glycyrrhiza uralensis is 1:(1-1.5).

[0022] In some preferred embodiments, the total mass ratio of Atractylodes macrocephala and Poria cocos to the mass ratio of Glycyrrhiza uralensis is 1:1.

[0023] This application optimizes the quality relationship between Atractylodes macrocephala, Poria cocos, and Glycyrrhiza uralensis, which helps to further improve the efficacy of drugs prepared using this composition for treating reflux esophagitis.

[0024] In some preferred embodiments, the composition comprises the following components in parts by weight:

[0025] The ingredients are: 5 parts Scutellaria baicalensis, 5 parts Glycyrrhiza uralensis, 7 parts beeswax, 2 parts Citrus aurantium, 2.5 parts Atractylodes macrocephala, 2.5 parts Poria cocos, and 100 parts vegetable oil. Among the vegetable oil, 90 parts are sesame oil and 10 parts are safflower seed oil, with a mass ratio of 9:1. The mass ratio of Scutellaria baicalensis to Citrus aurantium is 2.5:1. The total mass ratio of Atractylodes macrocephala and Poria cocos to Glycyrrhiza uralensis is 1:1.

[0026] In this application, when the composition with the above-mentioned composition and proportions is used, the effect of the same combination and coordination among the components in the composition is the best, thereby enabling the drug prepared using the composition to have the best therapeutic effect on reflux esophagitis.

[0027] The second aspect of this application provides a medicament for treating reflux esophagitis, the medicament comprising the composition described in the first aspect of this application.

[0028] The drug provided in this application contains the aforementioned composition. The components of the composition work together synergistically to significantly increase the patient's plasma motilin level, thereby increasing the pressure of the lower esophageal sphincter, promoting gastric emptying, preventing acid reflux, and promoting the recovery of reflux esophagitis. The patient's esophagus shows significant improvement, and no adverse reactions have been observed. At the same time, it can also significantly reduce the content of lipid peroxides (MDA) and increase the activity of superoxide dismutase (SOD) and glutathione peroxidase (GSH-PX), playing a protective and therapeutic role in the esophageal mucosa, significantly improving esophageal lesions, and achieving excellent therapeutic effects.

[0029] In some embodiments, the dosage form of the drug is a capsule.

[0030] The capsules in this application are soft capsules. The soft capsule shell can be a transparent soft capsule skin made of gelatin, water and glycerin; it can also be a colored soft capsule skin made by adding appropriate amounts of titanium dioxide, caramel coloring, Allura Red, Sunset Yellow, etc.; or it can be a plant-based soft capsule skin made of hydroxypropyl methylcellulose, modified starch, etc.

[0031] A third aspect of this application provides the use of the composition as described in the first aspect of this application in the preparation of a medicament for treating reflux esophagitis.

[0032] The composition provided in this application is used to prepare a drug for reflux esophagitis. The prepared drug can effectively treat reflux esophagitis, and no adverse reactions were observed during the treatment process, showing good application prospects.

[0033] The beneficial technical effects of this application are as follows: The composition for treating reflux esophagitis provided in this application contains Scutellaria baicalensis, licorice, beeswax, and vegetable oil (sesame oil or a mixture of sesame oil and safflower seed oil). Through the synergistic effect of the components, the drug prepared using this composition can significantly increase the patient's plasma motilin level, thereby increasing the pressure of the lower esophageal sphincter, promoting gastric emptying, preventing acid reflux, and promoting the recovery of reflux esophagitis. The patient's esophagus shows significant improvement, and no adverse reactions have been observed. At the same time, it can also significantly reduce the content of lipid peroxides (MDA) and increase the activity of superoxide dismutase (SOD) and glutathione peroxidase (GSH-PX), playing a protective and therapeutic role on the esophageal mucosa, significantly improving esophageal lesions, and showing excellent therapeutic effects. Furthermore, by further adding Citrus aurantium, Atractylodes macrocephala, and Poria cocos, the therapeutic effect of the drug prepared using this composition on reflux esophagitis can be further enhanced. Detailed Implementation

[0034] To make this application easier to understand, the following detailed description will be provided with reference to embodiments. These embodiments are for illustrative purposes only and are not intended to limit the scope of application of this application. Unless otherwise specified, the raw materials or components used in this application can be obtained commercially or by conventional methods.

[0035] Example 1: Preparation of a capsule drug for treating reflux esophagitis

[0036] Composition of raw material composition: 100 kg sesame oil, 5 kg Scutellaria baicalensis, 5 kg licorice, 7 kg beeswax.

[0037] Preparation process:

[0038] Purchase Scutellaria baicalensis and Glycyrrhiza uralensis slices, grind them into coarse granules, and set aside. Purchase sesame oil, filter it, and pour it into an oil storage tank for later use. Purchase beeswax, refine it using the water boiling method, and set aside.

[0039] Take 100 kg of sesame oil, 5 kg of Scutellaria baicalensis, and 5 kg of licorice root, put them into a reaction vessel, heat the reaction vessel, and when the temperature reaches 120℃, stop heating and keep it warm for 50 minutes. At the same time, stir thoroughly, filter thoroughly, remove the dregs, and keep the extract to make medicinal oil I.

[0040] All of the medicinal oil I was pressed into another reaction vessel and heated. When the temperature reached 85°C, 7 kg of beeswax was added and stirred thoroughly. When the temperature reached 120°C, the heating was stopped, and the mixture was stirred continuously for 20 minutes to produce medicinal oil II.

[0041] Oil II was ground using a colloid press with a tooth pitch of 0.7 μm and an output speed of 1 kg / min. The homogenized material was stirred at 100 rpm, evacuated to below 0.09 MPa, and cooled to 40°C, then held at that temperature for 50 minutes. When the temperature dropped to 20°C and the vacuum reached 0.7 MPa, this was maintained for 20 minutes, completing the capsule contents. Then, following standard operating procedures, the capsule contents were compressed into soft capsules to produce a capsule formulation for treating reflux esophagitis. The capsule shell of this formulation is a transparent soft capsule skin made of gelatin, water, and glycerin.

[0042] Example 2: Preparation of a capsule drug for treating reflux esophagitis

[0043] The composition of the raw material composition is as follows: 95 kg of sesame oil, 5 kg of safflower seed oil, 5 kg of scutellaria baicalensis, 5 kg of licorice, and 7 kg of beeswax; wherein the mass ratio of sesame oil to safflower seed oil is 19:1.

[0044] Preparation process:

[0045] Purchase Scutellaria baicalensis and Glycyrrhiza uralensis slices, grind them into coarse granules, and set aside. Purchase sesame oil and safflower seed oil, filter them separately, and pour them into different storage tanks, and set aside. Purchase beeswax, refine it using the water boiling method, and set aside.

[0046] Take 95 kg of sesame oil, 5 kg of safflower seed oil, 5 kg of scutellaria baicalensis, and 5 kg of licorice root, put them into a reaction vessel, heat the reaction vessel, and when the temperature reaches 120℃, stop heating and keep it warm for 50 minutes. At the same time, stir thoroughly, filter thoroughly, remove the dregs, and keep the extract to make medicinal oil I.

[0047] The remaining preparation steps are the same as in Example 1.

[0048] Example 3: Preparation of a capsule drug for treating reflux esophagitis

[0049] The composition of the raw material composition is as follows: 90 kg of sesame oil, 10 kg of safflower seed oil, 5 kg of scutellaria baicalensis, 5 kg of licorice, and 7 kg of beeswax; wherein the mass ratio of sesame oil to safflower seed oil is 9:1.

[0050] Preparation process:

[0051] Purchase Scutellaria baicalensis and Glycyrrhiza uralensis slices, grind them into coarse granules, and set aside. Purchase sesame oil and safflower seed oil, filter them separately, and pour them into different storage tanks, and set aside. Purchase beeswax, refine it using the water boiling method, and set aside.

[0052] Take 90 kg of sesame oil, 10 kg of safflower seed oil, 5 kg of scutellaria baicalensis, and 5 kg of licorice root, put them into a reaction vessel, heat the reaction vessel, and when the temperature reaches 120℃, stop heating and keep it warm for 50 minutes. At the same time, stir thoroughly, filter thoroughly, remove the dregs, and keep the extract to make medicinal oil I.

[0053] The remaining preparation steps are the same as in Example 1.

[0054] Example 4: Preparation of a capsule drug for treating reflux esophagitis

[0055] The composition of the raw material composition is as follows: 95 kg of sesame oil, 5 kg of safflower seed oil, 5 kg of Scutellaria baicalensis, 2 kg of Citrus aurantium, 5 kg of licorice, and 7 kg of beeswax; wherein the mass ratio of sesame oil to safflower seed oil is 19:1, and the mass ratio of Scutellaria baicalensis to Citrus aurantium is 2.5:1.

[0056] Preparation process:

[0057] Purchase Scutellaria baicalensis slices, Glycyrrhiza uralensis slices, and Citrus aurantium slices, and grind them into coarse granules for later use. Purchase sesame oil and safflower seed oil, filter them separately, and pour them into different storage tanks for later use. Purchase beeswax, refine it using the water boiling method, and set it aside for later use.

[0058] Take 95 kg of sesame oil, 5 kg of safflower seed oil, 5 kg of Scutellaria baicalensis, 2 kg of Citrus aurantium, and 5 kg of Glycyrrhiza uralensis, put them into a reaction vessel, heat the reaction vessel, and when the temperature reaches 120℃, stop heating and keep it warm for 50 minutes. At the same time, stir thoroughly, filter thoroughly, remove the dregs, and keep the extract to make medicinal oil I.

[0059] The remaining preparation steps are the same as in Example 1.

[0060] Example 5: Preparation of a capsule drug for treating reflux esophagitis

[0061] The composition of the raw material composition is as follows: 95 kg of sesame oil, 5 kg of safflower seed oil, 3.5 kg of Scutellaria baicalensis, 3.5 kg of Citrus aurantium, 5 kg of licorice, and 7 kg of beeswax; wherein the mass ratio of sesame oil to safflower seed oil is 19:1, and the mass ratio of Scutellaria baicalensis to Citrus aurantium is 1:1.

[0062] Preparation process:

[0063] Purchase Scutellaria baicalensis slices, Glycyrrhiza uralensis slices, and Citrus aurantium slices, and grind them into coarse granules for later use. Purchase sesame oil and safflower seed oil, filter them separately, and pour them into different storage tanks for later use. Purchase beeswax, refine it using the water boiling method, and set it aside for later use.

[0064] Take 95 kg of sesame oil, 5 kg of safflower seed oil, 3.5 kg of Scutellaria baicalensis, 3.5 kg of Citrus aurantium, and 5 kg of Glycyrrhiza uralensis, put them into a reaction vessel, heat the reaction vessel, and when the temperature reaches 120℃, stop heating and keep it warm for 50 minutes. At the same time, stir thoroughly, filter thoroughly, remove the dregs, and keep the extract to make medicinal oil I.

[0065] The remaining preparation steps are the same as in Example 1.

[0066] Example 6: Preparation of a capsule drug for treating reflux esophagitis

[0067] The composition of the raw material composition is as follows: 95 kg sesame oil, 5 kg safflower seed oil, 5 kg Scutellaria baicalensis, 2 kg Citrus aurantium, 5 kg licorice, 2.5 kg Atractylodes macrocephala, 2.5 kg Poria cocos, and 7 kg beeswax; wherein the mass ratio of sesame oil to safflower seed oil is 19:1, the mass ratio of Scutellaria baicalensis to Citrus aurantium is 2.5:1, and the mass ratio of the sum of Atractylodes macrocephala and Poria cocos to the mass of licorice is 1:1.

[0068] Preparation process:

[0069] Purchase Scutellaria baicalensis slices, Glycyrrhiza uralensis slices, Atractylodes macrocephala slices, and Poria cocos slices, and grind them into coarse granules for later use. Purchase sesame oil and safflower seed oil, filter them separately, and pour them into different storage tanks for later use. Purchase beeswax, refine it using the water boiling method, and for later use.

[0070] Take 95 kg of sesame oil, 5 kg of safflower seed oil, 3.5 kg of Scutellaria baicalensis, 3.5 kg of Citrus aurantium, 5 kg of Glycyrrhiza uralensis, 2.5 kg of Atractylodes macrocephala, and 2.5 kg of Poria cocos and put them into a reaction vessel. Heat the reaction vessel and when the temperature reaches 120°C, stop heating and keep it warm for 50 minutes. At the same time, stir thoroughly and filter thoroughly to remove the dregs. Keep the extract to make medicinal oil I.

[0071] The remaining preparation steps are the same as in Example 1.

[0072] Example 7: Preparation of a capsule drug for treating reflux esophagitis

[0073] The composition of the raw material composition is as follows: 95 kg of sesame oil, 5 kg of safflower seed oil, 5 kg of Scutellaria baicalensis, 2 kg of Citrus aurantium, 5 kg of licorice, 5 kg of Atractylodes macrocephala, and 7 kg of beeswax; wherein the mass ratio of sesame oil to safflower seed oil is 19:1, the mass ratio of Scutellaria baicalensis to Citrus aurantium is 2.5:1, and the mass ratio of Atractylodes macrocephala to licorice is 1:1.

[0074] Preparation process:

[0075] Purchase Scutellaria baicalensis slices, Glycyrrhiza uralensis slices, and Atractylodes macrocephala slices, and grind them into coarse granules for later use. Purchase sesame oil and safflower seed oil, filter them separately, and pour them into different storage tanks for later use. Purchase beeswax, refine it using the water boiling method, and set it aside for later use.

[0076] Take 95 kg of sesame oil, 5 kg of safflower seed oil, 3.5 kg of Scutellaria baicalensis, 3.5 kg of Citrus aurantium, 5 kg of Glycyrrhiza uralensis, and 5 kg of Atractylodes macrocephala and put them into a reaction vessel. Heat the reaction vessel and when the temperature reaches 120℃, stop heating and keep it warm for 50 minutes. At the same time, stir thoroughly and filter thoroughly to remove the dregs and keep the extract, which is the medicinal oil I.

[0077] The remaining preparation steps are the same as in Example 1.

[0078] Example 8: Preparation of a capsule drug for treating reflux esophagitis

[0079] The composition of the raw material composition is as follows: 95 kg of sesame oil, 5 kg of safflower seed oil, 5 kg of scutellaria baicalensis, 2 kg of immature bitter orange, 5 kg of licorice, 5 kg of poria cocos, and 7 kg of beeswax; wherein the mass ratio of sesame oil to safflower seed oil is 19:1, the mass ratio of scutellaria baicalensis to immature bitter orange is 2.5:1, and the mass ratio of poria cocos to licorice is 1:1.

[0080] Preparation process:

[0081] Purchase Scutellaria baicalensis slices, Glycyrrhiza uralensis slices, and Poria cocos slices, and grind them into coarse granules for later use. Purchase sesame oil and safflower seed oil, filter them separately, and pour them into different storage tanks for later use. Purchase beeswax, refine it using the water boiling method, and set it aside for later use.

[0082] Take 95 kg of sesame oil, 5 kg of safflower seed oil, 3.5 kg of Scutellaria baicalensis, 3.5 kg of Citrus aurantium, 5 kg of Glycyrrhiza uralensis, and 5 kg of Poria cocos and put them into a reaction vessel. Heat the reaction vessel and when the temperature reaches 120℃, stop heating and keep it warm for 50 minutes. At the same time, stir thoroughly and filter thoroughly to remove the dregs and keep the extract, which is the medicinal oil I.

[0083] The remaining preparation steps are the same as in Example 1.

[0084] Comparative Example 1: Preparation of a capsule drug for treating reflux esophagitis

[0085] Composition of raw material composition: 100 kg sesame oil, 5 kg Scutellaria baicalensis, 7 kg beeswax.

[0086] Preparation process:

[0087] Purchase Scutellaria baicalensis slices, grind them into coarse granules, and set aside. Purchase sesame oil, filter it, and pour it into an oil storage tank, and set aside. Purchase beeswax, refine it using the water boiling method, and set aside.

[0088] Take 100 kg of sesame oil and 5 kg of Scutellaria baicalensis, put them into a reaction vessel, heat the reaction vessel, and when the temperature reaches 120℃, stop heating and keep it warm for 50 minutes. At the same time, stir thoroughly, filter thoroughly, remove the dregs, and keep the extract to make medicinal oil I.

[0089] The remaining preparation steps are the same as in Example 1.

[0090] Test Example 1

[0091] 1. Cases and Grouping

[0092] Ninety patients with reflux esophagitis were included, aged 39–65 years, with a mean age of 49.7 years. There were 52 males and 38 females. All cases were confirmed by gastroscopy.

[0093] Based on the principle of voluntariness, 90 patients were divided into 10 groups. Treatment groups 1-8 were given the drugs prepared in Examples 1-8, 3g three times a day; treatment group 9 was given the drug in Comparative Example 1, 3g three times a day; and treatment group 10 was given omeprazole enteric-coated capsules, 40mg twice a day. The trial lasted for 8 weeks.

[0094] 2. Inspection

[0095] Before and after the experiment, venous blood was collected, plasma was separated, and plasma motilin was measured using radioimmunoassay.

[0096] A gastroscopy will be performed after the trial to assess the results.

[0097] 3. Results of plasma motilin assay

[0098] The results of plasma motilin assays are listed in Table 1.

[0099] Table 1. Plasma motilin assay results (ng / L)

[0100]

[0101]

[0102] Note*: P<0.05 after treatment compared to before treatment.

[0103] Compared with before treatment, plasma motilin levels were significantly increased in all groups after treatment (P<0.05). Increased plasma motilin levels can increase the pressure of the lower esophageal sphincter, promote gastric emptying, prevent acid reflux, and promote the recovery of reflux esophagitis. Furthermore, the treatment effects of treatment groups 1-8 and treatment group 10 were better than those of treatment group 9.

[0104] 4. Endoscopic observation results

[0105] The results of gastroscopy observations after the treatment are listed in Table 2. As can be seen from Table 2, except for treatment group 9, all other treatment groups showed good treatment effects.

[0106] Table 2. Overall Assessment of Patient Gastroscopy Results

[0107] Group get well Improvement invalid Treatment group 1 (n=9) 6 2 1 Treatment group 2 (n=9) 6 3 0 Treatment group 3 (n=9) 7 1 1 Treatment was administered to 4 groups (n=9) 7 2 0 Five treatment groups (n=9) 7 1 1 Six treatment groups (n=9) 8 1 0 Seven treatment groups (n=9) 8 0 1 Eight treatment groups (n=9) 8 0 1 Nine treatment groups (n=9) 5 2 3 Ten treatment groups (n=9) were treated. 6 1 2

[0108] Adverse reactions: No adverse reactions were observed in treatment groups 1-9. In treatment group 10, one patient experienced a mild adverse reaction, mainly anorexia and mild upper abdominal discomfort, which did not affect the course of treatment.

[0109] Test Example 2

[0110] I. Materials and Methods

[0111] 1. Animal housing environment

[0112] Temperature 24±2℃, relative humidity 50±10RH%, good ventilation, 12-hour light-dark cycle, free access to water. Rat cages are housed in stainless steel enclosures, with 3–5 rats per cage.

[0113] 2. Grouping, modeling, and administration of experimental animals

[0114] Eighty male SD rats, weighing 200–250 g, were used. After acclimatization for 7 days (fasting for 24 hours preoperatively, with free access to water), they were anesthetized by intraperitoneal injection of 1% pentobarbital (30–40 mg / kg). The rats were fixed on the operating table for surgery under strict aseptic conditions, with a midline abdominal incision. Ten rats in the sham-operated group underwent no other surgery; the abdominal cavity was directly sutured. In the other groups, the nerves and blood vessels of the lower esophagus were isolated, the cardia was ligated, and the esophagus was transected. The blood vessels around the stomach were isolated and ligated, and the duodenal stump was ligated and embedded in the stomach, preserving the entire stomach. The duodenal wall was longitudinally incised for about 0.5 cm at approximately 1 cm from the pylorus, and an esophagoduodenal anastomosis was performed with the lower end of the esophagus. Before closure, 1 mL of physiological saline and 20,000 IU of gentamicin sulfate were injected into the abdominal cavity. Three days after the operation, the rats were given levofloxacin for anti-inflammatory treatment, allowed free access to water, and fed 24 hours later. The rats' diet, feces, and activity were observed.

[0115] Three days after surgery, the animals were randomly divided into two groups after excluding the deceased rats: a model group (n=10), a low-dose group 1 (n=10), a low-dose group 2 (n=10), a high-dose group 1 (n=10), a high-dose group 2 (n=10), and a mosapride control group (n=10). The sham-operated and model groups were administered 2 mL of 0.9% sodium chloride injection by gavage once daily. The low-dose group 1 was administered 0.6 g of the drug prepared in Example 6 by gavage once daily; the low-dose group 2 was administered 0.6 g of the drug prepared in Example 1 by gavage once daily; the high-dose group 1 was administered 3.0 g of the drug prepared in Example 6 by gavage once daily; the high-dose group 2 was administered 3.0 g of the drug prepared in Example 1 by gavage once daily; and the mosapride control group was administered 2 mg / kg by gavage once daily.

[0116] 3. Detection of biochemical indicators in esophageal tissue

[0117] Rats in each group were administered the drug continuously for 3 weeks. After the last administration, the rats were fasted for 12 hours but allowed free access to water. They were then euthanized by decapitation, and a 2cm section of the esophagus was harvested from 0.5cm above the gastroesophageal junction toward the pharynx. The esophagus was longitudinally cut into two parts. One part was weighed and a 10% esophageal homogenate was prepared using physiological saline. The homogenate was centrifuged at 3500r / min (4℃) for 15min, and the supernatant was collected for analysis.

[0118] The activities of superoxide dismutase (SOD), lipid peroxidation (MDA), and glutathione peroxidase (GSH-PX) in tissue homogenates were determined by colorimetric methods. Results are expressed as amounts or activity units per milligram of protein.

[0119] 4. Histopathological examination

[0120] Another esophageal sample was observed with the naked eye, fixed with 10% formaldehyde, embedded in paraffin, sectioned, stained with hematoxylin and eosin (HE), and then observed for pathological changes under a light microscope.

[0121] 5. Statistical methods

[0122] The experimental results were analyzed using one-way ANOVA, and the t-test was used for intergroup comparisons.

[0123] Data are expressed as x±s. After testing for normality and homogeneity of variance, the F-test was used to compare the means of multiple groups. When the variances were unequal, the rank-sum test was used. p<0.05 indicates a significant difference, p<0.01 indicates a highly significant difference, and p>0.05 indicates no statistical difference.

[0124] 6. Results of rat esophageal tissue homogenization test

[0125] The results of the activity detection of SOD, MDA and GSH-PX in rat esophageal tissue homogenate are shown in Table 3.

[0126] Table 3. Activities of SOD, MDA and GSH-PX in rat esophageal tissue homogenate

[0127]

[0128] Note*: P < 0.05 compared to the model group.

[0129] Compared with sham surgery, the model group rats showed increased MDA content and decreased SOD and GSH-PX activities. Drug treatment increased SOD and GSH-PX activities and decreased MDA content. Compared with the model group, both high-dose group 1 and high-dose group 2 significantly reduced MDA content and increased SOD and GSH-PX activities (P<0.01).

[0130] 7. Pathological changes in rat esophageal tissue: The esophageal mucosa of rats in the sham-operated group appeared basically normal; in the model group, extensive lesions of the esophageal mucosa were observed by gross examination, with bark-like mucosal hyperplasia, most severe at the anastomosis site, gradually affecting upwards, reaching all segments of the esophageal mucosa, with significant thickening of the esophageal wall, irregular dilation of the lower segment, punctate or strip-like lesions, circumferential redness, erosion, or ulceration; punctate or strip-like lesions were observed in the esophageal mucosal fluid of rats in the low-dose group 1 and low-dose group 2, but the lesions were significantly milder; a few punctate or strip-like lesions were observed by gross examination of rats in the high-dose group 1, high-dose group 2, and mosapride group, which were significantly different from those in the model group.

[0131] The "Guidelines for the Diagnosis and Treatment of Reflux Esophagitis" issued by the Chinese Society of Digestive Endoscopy in 2003 were used as the basis for the gross examination scoring, as shown in Table 4.

[0132] Table 4. Gross Examination Scoring Table for Reflux Esophagitis

[0133]

[0134]

[0135] Based on the above scoring table, the results of gross examination of the esophagus of rats in each group are given, and the number of rats in each scoring level is listed in Table 5.

[0136] Table 5. Grading and Scoring of Visual Inspection

[0137] Grouping n Level 0 Class Ia Class Ib Level II Level III integral Sham surgery group 10 9 1 0 0 0 0.10±0.040 Model group 8 0 0 1 6 1 3.00±0.846 Low-dose group 1 8 0 1 4 3 0 2.25±0.504* Low-dose group 2 8 0 1 3 4 0 2.38±0.520* High-dose group 1 9 0 2 6 1 0 1.89±0.495* High-dose group 2 9 0 2 5 2 0 2.00±0.497* Mosapride group 9 0 2 6 1 0 1.89±0.495*

[0138] Compared with the model group, there were significant differences in the gross evaluation scores of the low-dose group 1, low-dose group 2, high-dose group 1, high-dose group 2 and mosapride group (P<0.05).

[0139] Under a light microscope, the model group showed inflammatory cell infiltration in the esophageal epithelium, papillary extension of the lamina propria, squamous epithelial hyperplasia, and mucosal erosion or ulceration. The high-dose group 1, high-dose group 2, and mosapride group basically recovered to normal, with significant differences (p < 0.05).

[0140] It should be noted that the embodiments described above are only for explaining this application and do not constitute any limitation on this application. This application has been described with reference to typical embodiments, but it should be understood that the terms used therein are descriptive and explanatory terms, not limiting terms. Modifications can be made to this application within the scope of the claims, and revisions can be made to the invention without departing from the scope and spirit of this application. Although the application described herein relates to specific methods, materials, and embodiments, it does not mean that this application is limited to the specific examples disclosed herein; on the contrary, this application can be extended to all other methods and applications with the same function.

Claims

1. A composition for treating reflux esophagitis, characterized in that, The composition comprises, by weight, the following components: 2-8 parts of Scutellaria baicalensis, 3-7 parts of Glycyrrhiza uralensis, 5-10 parts of beeswax, 80-120 parts of vegetable oil, 1-5 parts of Citrus aurantium, 1-3 parts of Atractylodes macrocephala, and 1-3 parts of Poria cocos; wherein the vegetable oil is a mixture of sesame oil and safflower seed oil, and the mass ratio of sesame oil to safflower seed oil is (10-20):

1.

2. The composition according to claim 1, characterized in that, The mass ratio of Scutellaria baicalensis to Citrus aurantium is (2~3):

1.

3. The composition according to claim 1, characterized in that, The total mass ratio of Atractylodes macrocephala and Poria cocos to the mass ratio of Glycyrrhiza uralensis is 1:(1~1.5).

4. A drug for treating reflux esophagitis, characterized in that, The drug comprises the composition as described in any one of claims 1-3.

5. The drug according to claim 4, characterized in that, The drug is in capsule form.

6. Use of the composition according to any one of claims 1-3 in the preparation of a medicament for treating reflux esophagitis.

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