A traditional Chinese medicine composition for reflux esophagitis and its application

Abstract

This invention provides a traditional Chinese medicine composition for reflux esophagitis, relating to the field of traditional Chinese medicine pharmaceutical technology. The composition comprises rose, Lithospermum erythrorhizon, Sargentodoxa cuneata, Rabdosia rubescens, honeysuckle, licorice, Evodia rutaecarpa, pearl, Coix seed, and Salvia miltiorrhiza. This composition is obtained through rational combination based on the principles of traditional Chinese medicine syndrome differentiation and treatment, with synergistic effects among the various herbs. This invention's composition exhibits significant anti-inflammatory effects and demonstrates significant repair and improvement effects on damaged esophageal mucosa. It shows significant efficacy in treating reflux esophagitis, significantly improving the treatment effectiveness and cure rate, significantly alleviating patient discomfort and pain. This invention's composition is a pure traditional Chinese medicine preparation, with no toxic side effects and no drug resistance.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for reflux esophagitis and application. BACKGROUND

[0002] Gastroesophageal reflux disease is a disease caused by the reflux of stomach and duodenum contents into the esophagus, which can be divided into three types: non-erosive reflux disease, reflux esophagitis and Barrett's esophagus. Among them, the incidence of reflux esophagitis (RE) is higher, accounting for 48-79% of gastroesophageal reflux disease. The typical symptoms of RE are mainly reflux and heartburn, and atypical symptoms include chronic cough, asthma, hoarseness, chronic laryngitis, chest pain, indigestion and nausea, etc. With the development of today's social economy and the change of people's eating habits, the incidence of RE shows an upward trend, and it is recurrent and lingering, which can cause pharyngitis, asthma, long-term inflammatory stimulation can lead to esophageal stenosis, and is more likely to evolve into esophageal adenocarcinoma and other complications, which seriously affects people's quality of life. Modern medicine mainly uses antacid drugs and acid suppressants in combination to treat this disease, but there are some shortcomings, such as recurrence after acid suppression treatment, long-term use can produce drug resistance and other adverse reactions.

[0003] Traditional Chinese medicine believes that the disease is located in the esophagus and stomach, and is closely related to the liver, spleen and other viscera. It is mainly caused by improper eating habits or food preference, which damages the spleen and stomach, and causes stagnation of evil qi such as water and phlegm in the middle jiao, and heat and fire due to long-term stagnation. The fire has the potential to inflame and cause stomach qi to ascend. Or because of excessive emotion or melancholy thinking, the liver qi fails to be discharged, the liver wood invades the spleen earth, and the function of qi movement is out of balance, causing stomach qi to ascend. Or because of long-term illness, the spleen is damaged, the disease is lingering and difficult to cure, the function of viscera is weak, the spleen and stomach are weak, the liver wood invades the earth, the function of qi movement is out of balance, and the stomach qi ascends. Traditional Chinese medicine has unique advantages in the treatment of RE based on long-term clinical practice and experience accumulation. Traditional Chinese medicine has the advantages of less adverse reactions, high safety, obvious improvement of symptoms, and a large number of studies have found that it can promote the healing of esophageal mucosa, reduce the release of inflammatory factors and reduce the incidence of complications. At present, many literatures and patents disclose many traditional Chinese medicine prescriptions for treating reflux esophagitis, such as CN10561728A and CN105497151A, which disclose traditional Chinese medicine for reflux esophagitis, but the traditional Chinese medicine components are numerous and the medicinal materials are rare, which has the problems of unclear pharmacological action and insignificant treatment effect. SUMMARY

[0004] (I) Technical problems to be solved

[0005] In view of the deficiencies of the prior art, the present application provides a traditional Chinese medicine composition for reflux esophagitis and application.

[0006] (II) Technical Solution

[0007] To achieve the above object, the present application is implemented by the following technical solution:

[0008] The present application provides a traditional Chinese medicine composition for treating reflux esophagitis, which is composed of rose, Chinese liquorice, radix sargentodoxae, rabdosia serra, two flowers, red ocher, licorice, evodia, pearl, coix seed and salvia miltiorrhiza.

[0009] Further, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: rose 5-25 parts, Chinese liquorice 10-30 parts, radix sargentodoxae 10-30 parts, rabdosia serra 5-20 parts, two flowers 5-20 parts, licorice 5-20 parts, evodia 5-20 parts, pearl 1-10 parts, coix seed 5-20 parts, and salvia miltiorrhiza 5-20 parts.

[0010] Further, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: rose 10-20 parts, Chinese liquorice 15-25 parts, radix sargentodoxae 15-25 parts, rabdosia serra 10-15 parts, two flowers 5-15 parts, licorice 5-15 parts, evodia 10-15 parts, pearl 5-10 parts, coix seed 5-15 parts, and salvia miltiorrhiza 10-15 parts.

[0011] Further, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: rose 15 parts, Chinese liquorice 20 parts, radix sargentodoxae 20 parts, rabdosia serra 12 parts, two flowers 9 parts, licorice 9 parts, evodia 12 parts, pearl 6 parts, coix seed 9 parts, and salvia miltiorrhiza 12 parts.

[0012] The traditional Chinese medicine composition provided by the present application is used for preparing a medicine for treating reflux esophagitis, and can be prepared into any oral dosage form acceptable in medicine, including but not limited to granules, oral liquid, decoction, powder, lyophilized powder, capsule, pill, etc.

[0013] The pharmacological effects of each raw material in the traditional Chinese medicine composition of the present application are as follows:

[0014] Rose: sweet, slightly bitter, warm; liver and spleen meridians; has the effects of promoting qi and relieving depression, and dispersing blood stasis; used for liver and stomach qi pain, poor appetite and vomiting, irregular menstruation, and contusion pain, etc.; rose contains flavonoids, volatile oils and aromatic compounds, polysaccharides, polyphenols, fatty acids and other effective active ingredients; modern pharmacological studies have shown that it has the pharmacological effects of antioxidant, antibacterial, hypolipidemic, hypoglycemic, and anti-tumor.

[0015] Lithospermum erythrorhizon: It has a sweet and salty taste and enters the heart and liver meridians; it has the effects of stopping bleeding and cooling blood; it can treat various diseases such as blood heat and toxicity, purplish-black rashes, measles that fail to erupt, febrile rashes, eczema, hematuria, bloody urine, bloody dysentery, constipation due to heat accumulation, sores, erysipelas, burns, malignant sores, and tinea; Lithospermum erythrorhizon contains a variety of effective ingredients such as naphthoquinones, monoterpenoid phenols and benzoquinones, phenolic acids and their salts, alkaloids, aliphatic and ester compounds, which have a variety of effects such as antibacterial, anti-inflammatory, anticancer, antiviral, hepatoprotective, antioxidant, antitumor and immunomodulatory effects.

[0016] *Sargentodoxa cuneata*: Bitter in taste, neutral in nature, and enters the large intestine and liver meridians; it has the effects of clearing heat and detoxifying, promoting blood circulation, dispelling wind and relieving pain. It is used for intestinal abscesses and abdominal pain, carbuncles due to heat toxins, amenorrhea, dysmenorrhea, traumatic swelling and pain, and rheumatic pain; it contains tannins, glycosides, cyclic polyphenols, triterpenoid saponins, lignans, flavonoids and other compounds; it has anti-inflammatory, antibacterial, and antiviral pharmacological effects.

[0017] Wintergreen herb: bitter and sweet in taste, slightly cold in nature, and enters the liver, stomach, and lung meridians; it has the effects of clearing heat and detoxifying, promoting blood circulation and relieving pain; it is used for sore throat, abdominal masses, snake and insect bites, etc.; it mainly contains terpenoids, alkaloids, flavonoids, volatile oils, sugars, steroids, amino acids, organic acids and other chemical components; modern pharmacological studies have shown that it has anti-tumor, antibacterial and anti-inflammatory, immune-enhancing and antioxidant effects.

[0018] Honeysuckle: also known as Lonicera japonica, Lonicera lycopersica, and Lonicera buergeriana; sweet in taste, cold in nature, and enters the lung and stomach meridians; it has the effects of clearing heat and detoxifying, reducing inflammation and swelling; it is used to treat various infectious diseases such as exogenous wind-heat or febrile diseases, heatstroke, dysentery due to heat toxin, carbuncles and boils, and sore throat; it mainly contains flavonoids, organic acids, volatile oils, iridoids and other effective components; modern pharmacological studies have shown that it has anti-inflammatory, antioxidant, anti-ultraviolet damage, lipid-lowering, blood sugar-lowering, and antiviral effects.

[0019] Licorice: Sweet in taste, neutral in nature, and enters the heart, spleen, lung, and stomach meridians; it has the effects of tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, relieving spasms and pain, and harmonizing various medicines; it is used for symptoms such as spleen and stomach weakness, fatigue, palpitations, shortness of breath, cough with excessive phlegm, carbuncles, and boils. Licorice is also good at harmonizing the properties of other medicines and reducing their toxicity. It contains total licorice flavonoids, glycyrrhizic acid, glycyrrhetinic acid, triterpenoids, glycyrrhizin, and other effective components, and has multiple effects such as anti-oxidation, anti-inflammatory and immunomodulatory effects, anti-ulcer effects, detoxification and anti-cancer effects, and anti-liver fibrosis effects.

[0020] Evodia rutaecarpa: pungent, bitter, and hot; slightly toxic; enters the liver, spleen, stomach, and kidney meridians; dispels cold and relieves pain, relieves nausea and vomiting, and helps yang and stops diarrhea; soothes the liver and relieves depression, warms the spleen and kidneys, dispels cold and dries dampness; modern research shows that it has the effects of inhibiting gastrointestinal spasms, anti-gastric ulcer, anti-diarrheal, anti-myocardial ischemia, anti-inflammatory, analgesic, and anti-thrombotic.

[0021] Pearl: It has a sweet and salty taste and enters the heart and liver meridians; it has the effects of calming the mind and soothing the nerves, nourishing yin and extinguishing wind, clearing heat and eliminating phlegm, removing corneal opacity and improving eyesight, detoxifying and promoting tissue regeneration; it is used to treat palpitations, anxiety, epilepsy, infantile convulsions, fever and thirst, sore throat and oral ulcers, corneal opacity, and sores that do not heal for a long time; pearl contains a variety of amino acids, biological calcium and trace elements and other effective ingredients, which have significant effects of central nervous system inhibition, delaying aging, promoting immunity, clearing microcirculation, protecting neurons and cells, and anti-inflammation.

[0022] Job's tears: sweet, bland, and cool; enters the spleen, stomach, and lung meridians; promotes diuresis and eliminates dampness, strengthens the spleen and stops diarrhea; modern research shows that it has anti-tumor, immune-regulating, blood sugar-lowering, blood calcium-lowering, anti-inflammatory, analgesic, antipyretic, and sedative effects.

[0023] Salvia miltiorrhiza: bitter in taste and slightly cold in nature, it enters the heart and liver meridians; it has the effects of promoting blood circulation and removing blood stasis, relieving dysmenorrhea and pain, clearing the heart and relieving irritability, cooling blood and reducing swelling; it is used to treat chest pain, abdominal and hypochondriac pain, abdominal masses, hot arthralgia, insomnia, irregular menstruation, dysmenorrhea and amenorrhea, sores and swelling; it has immunomodulatory effects on cytokines, antibodies and immune complexes and immune cells, and has multiple effects such as improving microcirculation, protecting the liver and reducing inflammation, promoting blood circulation and removing blood stasis, calming the mind and relieving pain, dilating blood vessels and lowering blood pressure.

[0024] (III) Beneficial Effects

[0025] In Traditional Chinese Medicine (TCM), reflux esophagitis falls under the categories of "esophageal nausea" and "acid reflux." Its primary pathogenesis involves impaired spleen and stomach function, leading to sluggish Qi circulation in the spleen and stomach. Over time, this results in impaired blood circulation, causing blood stasis in the stomach meridians, thus manifesting as Qi and blood stagnation. This invention provides a TCM composition for reflux esophagitis. The composition comprises rose, Lithospermum erythrorhizon, Sargentodoxa cuneata, Rabdosia rubescens, honeysuckle, licorice, Evodia rutaecarpa, pearl, coix seed, and Salvia miltiorrhiza. This composition is obtained through rational combination based on the principles of TCM syndrome differentiation and treatment, with synergistic effects among the individual herbs. The formula uses rose as the principal herb to regulate qi, relieve depression, and promote blood circulation and remove blood stasis. The assistant herbs, purple gromwell root, large spatholobus stem, and salvia root, are good at promoting blood circulation, activating blood and relieving pain. By promoting circulation, the disease can be cured by removing blood stasis. Evodia fruit dispels cold, warms the middle jiao, dries dampness and relieves depression. Honeysuckle flower is sweet and cold, clearing and draining. Evodia fruit is pungent and hot, guiding heat downward to soothe the liver and relieve depression. The combination of the two herbs clears the liver and stomach, neutralizes acid and descends rebellious qi. Winter jasmine clears heat and detoxifies, activates blood and relieves pain. Coix seed strengthens the spleen and promotes diuresis. Pearl nourishes yin, calms the mind and regulates sleep. Licorice root harmonizes the body. All the herbs have the function of promoting qi and blood circulation, clearing stomach fire and nourishing stomach yin. It emphasizes treating the liver and stomach at the same time and regulating the qi mechanism of the middle jiao. The herbal composition of this invention has a significant anti-inflammatory effect on rats with reflux esophagitis and a significant repairing and improving effect on damaged esophageal mucosa. The herbal composition of this invention has a significant therapeutic effect on reflux esophagitis, significantly improving the treatment efficacy and cure rate of the disease, significantly improving the patient's discomfort symptoms, and alleviating the patient's pain. The herbal composition of this invention is a pure traditional Chinese medicine preparation, with no toxic side effects on the human body and no drug resistance. Attached Figure Description

[0026] Figure 1 The pathological scores of esophageal mucosal damage in each group of rats are as follows. * Compared with the model group, P<0.05. Detailed Implementation

[0027] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0028] Example 1

[0029] A traditional Chinese medicine composition for reflux esophagitis, comprising the following raw materials in parts by weight: 5 parts rose petals, 10 parts Lithospermum erythrorhizon, 10 parts Sargentodoxa cuneata, 5 parts Rabdosia rubescens, 5 parts Lonicera japonica, 5 parts Glycyrrhiza uralensis, 5 parts Evodia rutaecarpa, 1 part pearl, 5 parts Coix lacryma-jobi, and 5 parts Salvia miltiorrhiza. This traditional Chinese medicine composition can be prepared into any medically acceptable oral dosage form, including but not limited to granules, oral liquids, decoctions, powders, lyophilized powders, capsules, and pills.

[0030] Example 2

[0031] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 25 parts of rose, 30 parts of Lithospermum erythrorhizon, 30 parts of Sargentodoxa cuneata, 20 parts of Rabdosia rubescens, 20 parts of Lonicera japonica, 20 parts of Glycyrrhiza uralensis, 20 parts of Evodia rutaecarpa, 10 parts of pearl, 20 parts of Coix lacryma-jobi, and 20 parts of Salvia miltiorrhiza.

[0032] Example 3

[0033] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 12 parts of rose, 18 parts of gromwell root, 26 parts of spatholobus stem, 8 parts of wintergreen, 8 parts of honeysuckle, 8 parts of licorice, 10 parts of evodia fruit, 4 parts of pearl, 6 parts of coix seed, and 8 parts of salvia root.

[0034] Example 4

[0035] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of rose, 15 parts of gromwell root, 15 parts of sarsaparilla, 10 parts of wintergreen, 5 parts of honeysuckle, 5 parts of licorice, 10 parts of evodia, 5 parts of pearl, 5 parts of coix seed, and 10 parts of salvia miltiorrhiza.

[0036] Example 5

[0037] The embodiment is different from embodiment 1 in that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: rose 20 parts, Chinese liquorice 25 parts, Sargentodoxa 25 parts, Rabdosia 15 parts, two flowers 15 parts, Radix et Rhizoma Glycyrrhizae 15 parts, Evodia 15 parts, pearl 10 parts, coix seed 15 parts, and Radix Salviae Miltiorrhizae 15 parts.

[0038] Embodiment 6

[0039] The embodiment is different from embodiment 1 in that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: rose 16 parts, Chinese liquorice 22 parts, Sargentodoxa 22 parts, Rabdosia 14 parts, two flowers 8 parts, Radix et Rhizoma Glycyrrhizae 6 parts, Evodia 14 parts, pearl 8 parts, coix seed 12 parts, and Radix Salviae Miltiorrhizae 14 parts.

[0040] Embodiment 7

[0041] The embodiment is different from embodiment 1 in that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: rose 15 parts, Chinese liquorice 20 parts, Sargentodoxa 20 parts, Rabdosia 12 parts, two flowers 9 parts, Radix et Rhizoma Glycyrrhizae 9 parts, Evodia 12 parts, pearl 6 parts, coix seed 9 parts, and Radix Salviae Miltiorrhizae 12 parts.

[0042] Test example 1

[0043] The traditional Chinese medicine composition in the application has reasonable compatibility, fully plays the role of each medicine, and the medicines jointly coordinate and increase the efficacy. In the application, the prescription is adjusted multiple times and experiments are conducted according to the experimental data, and only the influence of multiple groups of prescriptions on the reflux esophagitis model rats is listed and compared with the prescription of the application.

[0044] Prescription 1: rose 15 parts, Chinese liquorice 20 parts, Sargentodoxa 20 parts, Rabdosia 12 parts, two flowers 9 parts, Radix et Rhizoma Glycyrrhizae 9 parts, Evodia 12 parts, pearl 6 parts, coix seed 9 parts, and Radix Salviae Miltiorrhizae 12 parts.

[0045] Prescription 2: Chinese liquorice 20 parts, Sargentodoxa 20 parts, Rabdosia 12 parts, two flowers 9 parts, Radix et Rhizoma Glycyrrhizae 9 parts, Evodia 12 parts, and Radix Salviae Miltiorrhizae 12 parts.

[0046] Prescription 3: rose 15 parts, Rabdosia 12 parts, two flowers 9 parts, Radix et Rhizoma Glycyrrhizae 9 parts, Evodia 12 parts, pearl 6 parts, coix seed 9 parts, and Radix Salviae Miltiorrhizae 12 parts.

[0047] Prescription 4: rose 15 parts, Chinese liquorice 20 parts, Sargentodoxa 20 parts, two flowers 9 parts, Radix et Rhizoma Glycyrrhizae 9 parts, pearl 6 parts, coix seed 9 parts, and Radix Salviae Miltiorrhizae 12 parts.

[0048] Prescription 5: rose 15 parts, Chinese liquorice 20 parts, Sargentodoxa 20 parts, Rabdosia 12 parts, Evodia 12 parts, pearl 6 parts, and coix seed 9 parts.

[0049] The raw materials of each prescription were weighed according to the weight fraction, washed, dried, and ground, and then prepared into a traditional Chinese medicine stock solution according to the conventional decoction method. The concentration was 1 mL / g (1 g of raw medicinal materials per milliliter), and the stock solution was stored in a refrigerator at 0-4°C for standby use.

[0050] 1. Materials and Methods

[0051] 1.1 Test animals and modeling

[0052] Seventy SPF male rats weighing (200±20) g were selected, and the adaptive feeding lasted for one week before the experiment.

[0053] Ten of the 70 SD rats were selected as a sham operation group by using a random number table method, and the remaining 60 rats were a modeling group. The modeling was performed by using a cardia muscle incision + external partial ligation of the pylorus. Specifically, the rats were fasted for 24 h before modeling, the cardia muscle was incised, a metal rod with a diameter of 4 mm was placed outside the rat's pylorus, the metal rod was ligated together with the pylorus, and then the metal rod was removed. After the operation, the rats could drink sugar saline, and after fasting for 24 h, they were fed with half the amount (15 g / d) of granular feed for 3 days, and then with the full amount (30 g / d) for 4 days. After 7 days of feeding, the rats survived and had histological RE manifestations, which indicated that the modeling was successful.

[0054] 1.2 Animal grouping and administration

[0055] The 10 rats in the sham operation group were the blank control group, and the 60 model rats were divided into a model group and test groups 1-5 according to the random number table method, with 10 rats in each group. The administration was started on the day when the modeling was successful. The blank group and the model group were both given normal saline 5 mL; the test groups 1-5 were respectively given the traditional Chinese medicine stock solution prepared according to the prescription 1-5, with a dose of 4 g / kg. Each group was given the medicine once in the morning and once in the evening, for 14 consecutive days.

[0056] 1.3 Sample collection

[0057] After the last administration of each group of rats was completed, the rats were fasted for 24 h without water, anesthetized by intraperitoneal injection of 10% chloral hydrate (0.3 ml / 100 g), fixed in a supine position, and 5 ml of rat blood was collected by cardiac puncture. The blood was left to stand at room temperature for 2 h, centrifuged at 4°C and 3000 r / min for 15 min (centrifugation radius 4 cm), and the supernatant was taken and placed in an EP tube for cryopreservation at -20°C for detection. Then, the abdomen was opened routinely, and 1.5-2.0 cm of esophageal tissue was taken from the upper 0.5 cm of the gastroesophageal junction to the throat. The esophagus was first cut longitudinally, and the esophageal mucosa was observed macroscopically, and then cryopreserved at -80°C for detection.

[0058] 1.4 Observation indexes and methods

[0059] 1.4.1 Detection of IL-1β, IL-6, and IL-8 contents in serum and esophageal tissue by ELISA

[0060] The esophageal tissue and serum were operated according to the operation instruction of the ELISA kit. The esophageal tissue was washed with pre-cooled PBS, weighed, cut into pieces, added into a tissue grinder with a corresponding volume of PBS (9ml of PBS corresponding to 1g of tissue sample), and grinded in ice bath. Finally, the homogenate was centrifuged at 3000r / min for 10min at 4℃ (centrifugal radius 10cm), and the supernatant was detected.

[0061] 1.4.2 Esophageal tissue histopathology score

[0062] 1cm of lower esophageal sphincter tissue was taken, soaked and fixed in formaldehyde, embedded with paraffin and sliced, stained with hematoxylin, observed under an optical microscope, and scored for esophageal mucosa damage. According to whether there was squamous epithelial hyperplasia, mucosal proper layer papillary extension, inflammatory cell infiltration in epithelial cell layer, mucosal erosion, ulcer formation, Barrett esophagus change, it was divided into mild (1 point), moderate (2 points) and severe (3 points).

[0063] 1.5 Data statistics and analysis

[0064] The experimental data was analyzed by one-way ANOVA of SPSS25.0 software, and the results were represented by mean ± standard deviation, and the significant difference was represented by (P<0.05).

[0065] 2 Results

[0066] 2.1 Effect of the traditional Chinese medicine composition in the application on inflammatory factors in serum and esophageal tissue of rats

[0067] The results of the effect of the traditional Chinese medicine composition in the application on inflammatory factors in serum and esophageal tissue of rats are shown in Tables 1 and 2. Compared with the blank group, the contents of IL-1β, IL-6 and IL-8 in serum and esophageal tissue of the model group were significantly increased (P<0.05). Compared with the model group, the contents of IL-1β, IL-6 and IL-8 in serum and esophageal tissue of each group were significantly reduced after treatment in test groups 1-5, and the difference was significant (P<0.05). Among them, the contents of IL-1β, IL-6 and IL-8 in serum and esophageal tissue of the rats in test group 1 were significantly lower than those in test groups 2-5, and the difference was significant (P<0.05). Figure 1The pathological score results of esophageal mucosa injury of each group of rats show that the histological score of the model group is significantly higher than that of the blank group, the histological scores of the test groups 1-5 are significantly lower than that of the model group, and the histological score of the test group 1 is significantly lower than that of the test groups 2-5, and is equivalent to that of the blank group. The above results show that the traditional Chinese medicine composition has a significant anti-inflammatory effect on the reflux esophagitis model rats, and has a significant repair and improvement effect on the injured esophageal mucosa. Each traditional Chinese medicine in the traditional Chinese medicine composition is reasonably matched according to the principle of TCM dialectical therapy, and each drug has a synergistic effect, and the components in the formula are indispensable.

[0068] Table 1: Serum IL-1β, IL-6, IL-8 content of each group of rats (pg / mL)

[0069] Group Number (only) IL-1β IL-6 IL-8 Blank group 10 71.60±6.37 43.30±11.45 154.78±11.05 Model group 10 144.12 ± 10.76 ## ]] 56.9 ± 16.04 ## ]] 305.28 ± 27.64 ## ]] Test 1 group 10 72.83±5.96** 44.44±10.01* 156.40±12.71** Test 2 group 10 126.52±10.97* 53.32±10.17 253.87±25.51* Test 3 group 10 123.52±10.08* 53.05±10.93 261.06±25.83* Test 4 group 10 110.47±10.12** 51.79±10.48 234.01±11.24** Test 5 group 10 109.27±10.09** 50.88±10.33 236.51±12.68**

[0070] Note: # P<0.05, compared with the model group and the blank group; ## P<0.01, compared with the model group and the blank group; * P<0.05, compared with the model group and the blank group; **P<0.01, compared with the model group and the blank group; the same below.

[0071] Table 2: IL-1β, IL-6, IL-8 content in esophageal tissue of each group of rats (pg / mL)

[0072] Group Number (only) IL-1β IL-6 IL-8 Blank group 10 528.52±50.96 138.47±6.86 2.677±0.161 Model group 10 1464.41 ± 126.94 ## ]] 228.07 ± 6.11 ## ]] 4.081 ± 0.109 ## ]] Test 1 group 10 533.99±49.04** 138.13±6.12** 2.790±0.129** Test 2 group 10 1061.56±129.01* 195.13±6.10* 3.633±0.261* Test 3 group 10 1038.89±128.56* 190.27±6.46* 3.528±0.203* Test 4 group 10 993.15±60.98** 171.50±6.90** 3.327±0.128** Test 5 group 10 995.44±61.25** 172.60±6.65** 3.351±0.176**

[0073] Test Example 2

[0074] The following clinical application data is further to illustrate the treatment effect of the traditional Chinese medicine composition on reflux esophagitis.

[0075] 1. Clinical data

[0076] 1.1 Diagnosis standard

[0077] Referring to the diagnosis standard of reflux esophagitis combined with acid reflux in the "Chinese Medicine Diagnosis and Treatment Expert Consensus Opinion of Gastroesophageal Reflux Disease (2017)". With typical clinical symptoms such as acid reflux, heartburn, and retrosternal burning pain, and confirmed by gastroscopy.

[0078] 1.2 Syndrome differentiation standard

[0079] Referring to the diagnosis standard of reflux esophagitis in the "Consensus Opinion of Chinese and Western Medicine Combined Diagnosis and Treatment of Gastroesophageal Reflux Disease (2010)", the syndrome is liver-stomach disharmony. Main symptoms: acid regurgitation, heartburn, hiccups, belching, chest and abdominal distension; secondary symptoms: dry mouth, bitter taste, depression, constipation; tongue and pulse: red tongue, yellow and greasy fur, stringy pulse.

[0080] 1.3 Inclusion criteria

[0081] The patients met the above diagnostic and syndrome differentiation criteria; and the patients and their families gave informed consent to this study.

[0082] 1.4 Emission Standards

[0083] Patients with contraindications to the drugs used in this study; those with a history of gastrointestinal surgery; those with other serious organ dysfunction; those with malignant tumors; those with mental illnesses; and those with missing clinical data.

[0084] 1.5 General Information

[0085] All cases in this study were outpatients and inpatients of our hospital. A total of 140 patients with reflux esophagitis complicated by acid reflux were selected as the study subjects and randomly divided into two groups using a random number table. The control group consisted of 64 patients (38 males and 26 females), aged 20–60 years (mean age 37.13±7.28 years), with a disease duration of 0.5–5 years (mean duration 1.61±0.54 years). The observation group consisted of 76 patients (41 males and 33 females), aged 18–57 years (mean age 34.21±4.84 years), with a disease duration of 0.3–5 years (mean duration 1.13±0.61 years). There were no statistically significant differences in baseline characteristics between the two groups (P>0.05), indicating comparability.

[0086] 1.6 Methods

[0087] Control group: oral mosapride citrate tablets (5mg / time, 3 times / day) + pantoprazole enteric-coated tablets (40mg / time, 1 time / day).

[0088] Observation group: Based on the control group, the decoction of the traditional Chinese medicine composition of the present invention was prepared, with the following formula: 15g of rose, 20g of gromwell root, 20g of spatholobus stem, 12g of wintergreen, 9g of honeysuckle, 9g of licorice, 12g of evodia fruit, 6g of pearl, 9g of coix seed, and 12g of salvia root. One dose was prepared daily, with about 300mL of decoction obtained, and taken twice a day after meals.

[0089] Both groups of patients received treatment for a total of 3 weeks.

[0090] 1.7 Observation Indicators and Standards

[0091] 1.7.1 Clinical efficacy

[0092] The efficacy of the two groups was evaluated according to the reference symptoms and improvement of the erosion surface by electronic gastroscopy. According to the relevant standards of "Guidelines for Clinical Research of New Drugs of Traditional Chinese Medicine (Trial)", the evaluation was carried out. Cure: symptoms basically disappeared, syndrome score decreased by more than 95%; marked effect: erosion surface healed by more than 75% by electronic gastroscopy, and syndrome score decreased by 70%-95%; effectiveness: erosion surface healed by 50%-75% by electronic gastroscopy, and syndrome score decreased by 30%-69%; no effect: did not meet the above standards, or even the condition worsened.

[0093] 1.7.2 TCM syndrome score

[0094] The symptoms of hiccup belching, acid regurgitation, chest distention and fullness, and emotional depression were determined before and after treatment in the two groups. Each item was scored as 0, 2, 4, or 6 points according to no, mild, moderate, or severe. The higher the score, the more severe the symptoms.

[0095] 1.8 Data statistics and analysis

[0096] All data were analyzed using SPSS 25.0 statistical software. Count data was expressed as percentage (%) and analyzed by chi-square test. Measurement data was expressed as mean ± standard deviation and analyzed by two independent sample t-test or paired sample t-test. P<0.05 was considered statistically significant.

[0097] 2 Treatment results

[0098] 2.1 Comparison of clinical efficacy between the two groups

[0099] The results of the comparison of clinical efficacy between the two groups are shown in Table 4. The total effective rate of the observation group was 94.74%, and that of the control group was 71.88%. The total effective rate of the observation group was significantly higher than that of the control group, and the cure rate was also significantly higher.

[0100] Table 4 Comparison of clinical efficacy between the two groups (cases / %)

[0101] Group Example Cure Markedly effective Effective Ineffective Total effective Control group 64 24(37.50) 8(12.50) 14(21.88) 18(28.13) 46(71.88) Observation group 76 39(51.32) 20(26.32) 13(17.11) 4(10.53) 72(94.74)

[0102] 2.2 Comparison of TCM syndrome scores between the two groups before and after treatment

[0103] As shown in Table 5, there was no significant difference in TCM syndrome scores such as acid regurgitation, chest distention and fullness, hiccup belching, and emotional depression between the two groups before treatment (P>0.05). After treatment, the scores of the above-mentioned items in both groups decreased significantly compared with before treatment (P<0.05). The scores of the observation group were lower than those of the control group after treatment, and the difference was significant (P<0.05).

[0104] Table 5 Comparison of TCM syndrome scores between the two groups before and after treatment

[0105]

[0106] Note: * Compared with the treatment before the group, P<0.05; # Compared with the control group after treatment, P<0.05

[0107] 3Conclusion

[0108] The above results show that the traditional Chinese medicine composition provided by the present application can significantly improve the total effective rate and cure rate of the treatment of reflux esophagitis, and can significantly improve the symptoms of patients such as acid regurgitation, chest distention, hiccup, and depression.

[0109] The above examples are only used to illustrate the technical solutions of the present application, but not to limit it; although the present application has been described in detail with reference to the foregoing examples, those skilled in the art should understand that the technical solutions recorded in the foregoing examples can still be modified, or some technical features can be replaced by equivalents; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. A traditional Chinese medicine composition for reflux esophagitis, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: rose 5-25 parts, Chinese liquorice 10-30 parts, Sargentodoxa 10-30 parts, Rabdosia 5-20 parts, honeysuckle 5-20 parts, Glycyrrhiza 5-20 parts, Evodia 5-20 parts, pearl 1-10 parts, coix seed 5-20 parts, and salvia 5-20 parts.

2. The traditional Chinese medicine composition for reflux esophagitis according to claim 1, characterized by, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: rose 10-20 parts, Chinese liquorice 15-25 parts, Sargentodoxa 15-25 parts, Rabdosia 10-15 parts, honeysuckle 5-15 parts, Glycyrrhiza 5-15 parts, Evodia 10-15 parts, pearl 5-10 parts, coix seed 5-15 parts, and salvia 10-15 parts.

3. The traditional Chinese medicine composition for reflux esophagitis according to claim 1, characterized by, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: rose 15 parts, Chinese liquorice 20 parts, Sargentodoxa 20 parts, Rabdosia 12 parts, honeysuckle 9 parts, Glycyrrhiza 9 parts, Evodia 12 parts, pearl 6 parts, coix seed 9 parts, and salvia 12 parts.

4. The traditional Chinese medicine composition for reflux esophagitis according to any one of claims 1 to 3, characterized by, The traditional Chinese medicine composition is used for preparing a medicine for treating reflux esophagitis, and is prepared into any one of granules, oral liquid, water decoction, powder, lyophilized powder, capsule, and pill.

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