CN114470093B

CN114470093B - Traditional Chinese medicine preparation for treating gastroesophageal reflux disease and preparation method and application thereof

Info

Publication number: CN114470093B
Application number: CN202210298127.0A
Authority: CN
Inventors: 王彦刚
Original assignee: Individual
Current assignee: Individual
Priority date: 2022-03-25
Filing date: 2022-03-25
Publication date: 2023-05-02
Anticipated expiration: 2042-03-25
Also published as: CN114470093A

Abstract

The invention provides a traditional Chinese medicine preparation for treating gastroesophageal reflux disease, which comprises the following raw materials in parts by weight: 20-40 parts of gypsum, 9-15 parts of immature bitter orange, 5-9 parts of magnolia officinalis, 5-10 parts of baical skullcap root, 10-30 parts of rabdosia rubescens, 3-6 parts of oroxylum indicum, 6-9 parts of blackberry lily, 8-12 parts of thunberg fritillary bulb, 8-12 parts of cuttlebone, 15-30 parts of concha arcae powder, 5-9 parts of purified pinellia tuber and 10-15 parts of silktree albizia bark. Compared with the existing acid inhibiting medicine, the traditional Chinese medicine preparation can obviously improve the clinical symptoms of heartburn, acid regurgitation, pharyngalgia, pharyngeal obstruction, abdominal distention and the like of patients suffering from gastroesophageal reflux. Obviously improves the damaged state of the esophageal mucosa under the gastroscope of the gastroesophageal reflux patient and improves the healing rate of the esophageal mucosa. Reducing the recurrence rate of gastroesophageal reflux disease.

Description

Traditional Chinese medicine preparation for treating gastroesophageal reflux disease and preparation method and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine preparation for treating gastroesophageal reflux disease, and a preparation method and application of the traditional Chinese medicine preparation.

Background

Gastroesophageal reflux disease (GERD) is a clinically common condition with heartburn and reflux as typical symptoms. Epidemiological investigation based on population in China shows that the prevalence rate of at least 1 heart burn symptom per week is 1.9% -7.0%. Treatment of gastroesophageal reflux disease Proton Pump Inhibitors (PPI) are the preferred agents, and severe and refractory gastroesophageal reflux disease can be treated endoscopically or surgically. The current treatment of gastroesophageal reflux disease mainly has the following disadvantages:

1. the treatment time is long. At present, the treatment course of acid inhibition treatment mainly using PPI medicines is 4-8 weeks, but the healing rate of the esophageal mucosa of a patient with the treatment course of 8 weeks is obviously higher than that of a patient with the treatment course of 4 weeks.

2. High recurrence rate and maintenance therapy. The recurrence rate of 15mg 1 times/d 24 weeks of lansoprazole taken by a patient with gastroesophageal reflux was 25.5%. After stopping the treatment, patients with severe esophagitis are more likely to relapse, and only 58% of patients in the on-demand treatment group can still maintain the healing state of the esophageal mucosa after 6 months of treatment.

3. Adverse reactions of long-term acid-inhibiting treatment. Long term use of PPI, elevated intragastric pH, may lead to excessive bacterial growth, increasing the chance of clostridium difficile infection. Some studies suggest that long treatment periods and/or high dose use may increase the risk of hypomagnesemia, osteoporosis, vitamin B12 deficiency, anemia, pulmonary and intestinal infections, increased polyp formation, community-acquired pneumonia, gastric cancer, and chronic kidney disease.

4. Refractory gastroesophageal reflux disease for which acid suppression treatment is ineffective. Up to 30% of patients, treated with double standard doses of antacid for 8 weeks, have no significant improvement in symptoms such as reflux, heartburn, etc., defined as refractory GERD. Treatment of such patients is typically to optimize PPI use, with some patients undergoing endoscopic or surgical treatment.

Therefore, in order to overcome the drawbacks of the existing treatment techniques for gastroesophageal reflux disease, a new treatment means is needed to shorten the treatment time of gastroesophageal reflux disease and reduce the recurrence rate of gastroesophageal reflux disease.

In view of this, the present invention has been made.

Disclosure of Invention

The first aim of the invention is to provide a traditional Chinese medicine preparation for treating gastroesophageal reflux disease, which can remarkably improve the clinical symptoms of heartburn, acid regurgitation, pharyngalgia, pharyngeal blocking, abdominal distension and the like of gastroesophageal reflux patients, remarkably improve the state of damaged esophageal mucosa of the gastroesophageal reflux patients, improve the healing rate of the esophageal mucosa and reduce the recurrence rate of the gastroesophageal reflux disease.

The second aim of the invention is to provide a preparation method of the traditional Chinese medicine preparation.

In order to achieve the above purpose, the technical scheme of the invention is as follows:

the invention relates to a traditional Chinese medicine preparation for treating gastroesophageal reflux disease, which comprises the following raw materials in parts by weight: 20-40 parts of gypsum, 9-15 parts of immature bitter orange, 5-9 parts of magnolia officinalis, 5-10 parts of baical skullcap root, 10-30 parts of rabdosia rubescens, 3-6 parts of oroxylum indicum, 6-9 parts of blackberry lily, 8-12 parts of thunberg fritillary bulb, 8-12 parts of cuttlebone, 15-30 parts of concha arcae powder, 5-9 parts of purified pinellia tuber and 10-15 parts of silktree albizia bark.

Preferably, the traditional Chinese medicine preparation comprises the following raw materials in parts by weight: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of magnolia officinalis, 9 parts of baical skullcap root, 15 parts of rabdosia rubescens, 6 parts of oroxylum indicum, 9 parts of blackberry lily, 12 parts of fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of purified pinellia tuber and 15 parts of cortex albiziae.

The principle of the traditional Chinese medicine preparation for realizing the functions is as follows:

gastroesophageal reflux disease belongs to the categories of symptoms such as 'oesophagitis', 'acid regurgitation', 'noisy', and the like in traditional Chinese medicine, and the symptoms are located in the oesophagus and the stomach, closely related to the liver, the spleen and the lung, and the nuclear heart disease machine is summarized as stagnation of heat and upward reverse of stomach qi. The most typical clinical manifestations of gastroesophageal reflux disease are reflux and heartburn. The gastroesophageal reflux disease is caused by liver depression and qi stagnation, or abnormal ascending and descending of spleen and stomach qi movement, qi stagnation, long-term fire transformation, heat depression and internal generation, and febrile inflammation due to unsmooth emotion, improper diet and other reasons, so that stomach qi is reversed, and the disease is seen. Yuan-Zhu Danxi (Danxi heart method-six depression) is as follows: the qi and blood flow are harmonized, so that all diseases are generated without generating any disease, and all diseases are generated so as to generate qi stagnation, so that all diseases of human body are generated by the stagnation. The more the depression should be accumulated, the more the ascending person should not ascend, the descending person should not descend, and the changing person should not change. "Qing dynasty He Mengyao" medical advance & depression "has the following meaning: the patients with the stagnation of the cover are not fire, and the patients with the stagnation of the fire are not fire. The heat can cause depression, and the depression and the heat are combined, so that the depression heat is formed, and the heart is feverish and acid is reversed. As in the book of Nei Jing, "vomit acid … … all belong to heat". The stomach is descending, and the physiological function of the stomach depends on the general descending of stomach qi. The stomach qi is not reduced, spleen qi is difficult to rise, so turbid pathogen is not separated, liver qi is in disorder, qi stagnation is caused, heat is transformed into depression, and liver and stomach depression heat is formed, so that symptoms such as pain after sternum, dysphagia and the like are caused. Liver failing to reach the top, stomach failing to descend, lung failing to disperse and descend, lung qi stagnating and heat transforming into lung and stomach stagnating heat in the long term, and throat is the portal of lung and stomach, so symptoms such as pharyngalgia, throat blockage, throat dryness and the like appear.

The traditional Chinese medicine preparation is prepared according to the treatment method of clearing, benefiting, regulating and nourishing according to the core pathogenesis of the stomach qi upward reversal caused by stagnation of heat.

Clearing heat, namely clearing stagnated heat, has the process of transforming heat into acid in the pathogenesis of gastroesophageal reflux disease, and can lead acid to be free from transformation, thereby relieving the acid regurgitation symptom, reducing gastric acid secretion and eliminating pathological factors. In the recipe, gypsum is used, is pungent and sweet in taste, has a large cold nature, enters lung and stomach meridians, and has bitter taste, heat-clearing and fire-purging properties, and pungent flavor can be announced thoroughly, so it is an essential herb for clearing lung and stomach fire-stagnation. So it is a monarch drug.

Bai Huang is bitter in flavor, cold in nature, enters lung, stomach and biliary large intestine meridians, and is the key herb for clearing heat, drying dampness and relieving distension and fullness. Ben Cao Jing Shu (materia Medica): baical skullcap root, radix Scutellariae, has the effect of clearing and descending, so it eliminates pathogenic factors; bitter taste and dry dampness; cold in yin can dispel heat, so it governs heat. For those with heat, pathogenic heat and damp-heat are also indicated. Rabdosia rubescens is sweet and bitter in taste and slightly cold in nature, has the effects of clearing heat and detoxicating, diminishing inflammation and relieving pain, resisting tumor and the like, and is clinically used for treating diseases such as sore throat, tonsillitis, snake and insect bites, esophageal cancer and the like. Modern pharmacological researches have found that the main chemical component of Rabdosia rubescens is diterpenoid, and the expression of inflammatory mediators can be regulated and controlled by influencing the transcription capacity of nuclear transcription factor kB, so that the Rabdosia rubescens has anti-inflammatory activity, is even effective on various tumors, and has obvious curative effect on treating early esophageal cancer. The two medicines are combined to strengthen the effects of clearing heat, relieving sore throat and removing toxin.

Immature bitter orange, magnolia officinalis lowers turbid qi of spleen and stomach. Zhi Shi can break qi and relieve distension and fullness, remove food retention and resolve phlegm, enter spleen and stomach meridians. "Bencao Xin Ji" cloud: zhi Shi is also good at summer-time for its nature … …. Spleen is also suitable for summer-qi because it can descend and push and shake accumulation in spleen. Modern pharmacological research shows that immature bitter orange can regulate gastrointestinal movement and has the functions of promoting gastric movement and accelerating gastric emptying. Magnolia officinalis has the bitter taste of being bitter, and can reduce qi, remove food retention and remove fullness, and can dry dampness and phlegm, and is described in Changsha Yao Jie (Changsha Jie): magnolia officinalis, cortex Magnolia officinalis, radix Angelicae sinensis, herba Pogostemonis, radix Magnolia officinalis, herba Pogostemonis, radix Angelicae sinensis, cortex Magnolia officinalis, herba Po. The two medicines are used together to regulate spleen and stomach qi, and recover stomach qi and dredge and reduce physiological functions.

Semen Oroxyli, bitter in taste, sweet in flavor, cool in nature, enters lung, liver and stomach meridians, and can clear heat of the lung and stomach, treat sore throat, sooth liver and stomach, and smooth emotion, so as to help recover liver failing to dredge.

Blackberry lily has bitter taste, cold property, enters lung meridian, and has the effects of clearing heat, detoxicating, resolving phlegm and relieving sore throat. The "Ben Cao gang mu" records that Belamcanda rhizome can reduce pathogenic fire, and is the key herb for palsy of throat and sore throat in ancient times Fang Zhi. Modern pharmacological researches have found that blackberry lily is rich in flavonoid substances and has various pharmacological activities including antioxidation, anti-inflammatory, anticancer, intestinal flora regulation and the like.

The pharynx is the "gate" of the stomach and the "exterior condition" of the stomach. In the circulation of the meridians, the pharynx belongs to the stomach system, and the person who is supported by the pharynx is presented from the front of the head to the throat and enters the basin. Studies have shown that both pharyngeal and gastrointestinal motility is limited by the sympathetic and vagus nerves, and that gastrointestinal dyskinesias, sympathetic and vagus dysfunction, and involvement of the pharyngeal plexus, can present with pharyngeal symptoms. At the same time, uncomfortable irritation of the pharynx can cause vomiting reflex, so that intra-abdominal pressure is increased, at the same time, pylorus is closed, cardia and esophagus are relaxed, gastric acid and other gastric contents are reversed into the esophagus, and damage to the esophagus mucosa is caused. Therefore, the three medicines of rabdosia rubescens, oroxylum indicum and blackberry lily can clear and relieve the sore throat, thus relieving the symptoms outside the esophagus and relieving the repeated irritation of pathological factors to the esophageal mucosa.

Zhe Bei mu is bitter in flavor, cold in nature, enters heart and lung meridians. Has the effects of clearing lung-heat, resolving phlegm, resolving masses and detumescence. Cuttlebone and concha arcae powder inhibit acid. Modern researches have shown that cuttlebone has the effects of neutralizing gastric acid, protecting mucous membrane and resisting ulcer. Corrugated powder has salty taste and mild nature, enters lung, stomach and liver meridians, and has the effects of relieving hyperacidity and pain, and resolving phlegm and removing blood stasis. Zhejiang fritillary bulb, together with cuttlebone, is named Wubei san, and is the proved recipe for preparing acid.

Purified pinellia tuber, rhizoma Pinelliae, with pungent and warm nature, can dry dampness and phlegm, reduce adverse flow of qi and arrest vomiting, and relieve distension and fullness and dissipate nodulation. The term "elsewhere" means that: "resolving phlegm heat in the chest, abdomen and diaphragm, cough with upward qi, and sudden pain and fullness in the chest, chest and abdomen, vomiting. The recipe is used to strengthen the stomach and reduce adverse qi.

Modern research has shown that psycho-psychological factors play an important role in the development and progression of gastroesophageal reflux disease, and that psycho-social factors may exacerbate symptoms by inducing relaxation of the lower esophageal sphincter. And the disease has longer disease course and repeated symptoms, and patients are easy to generate anxiety states and aggravate the disease. Therefore, the albizia bark is selected from the formula, and is sweet in quality, enters heart and liver channels, has the effect of tranquillizing, and is used for treating uneasiness, insomnia and dysphoria, mild in effect and remarkable in effect. "Shennong Ben Cao Jing" say he huanpi "mainly tranquilize five zang organs and mind, make people happy and careless. Therefore, the cortex albiziae can relieve the emotion of a patient and promote the improvement of gastroesophageal reflux disease.

In conclusion, the prescription takes gypsum as principal drug, baikal skullcap root, rabdosia rubescens, immature bitter orange and magnolia officinalis as ministerial drug, oroxylum indicum, blackberry lily, fritillary bulb, cuttlebone, corrugated powder, purified pinellia tuber and cortex albiziae as adjuvant drug, and has the effects of clearing Xuan Yure, relieving sore throat, regulating qi and nourishing heart and mind. The whole formula has strict compatibility, special medicine profile and definite curative effect aiming at the nuclear heart disease machine.

The invention also relates to a preparation method of the traditional Chinese medicine preparation for treating gastroesophageal reflux disease, which comprises the following steps:

(1) Extracting: mixing the raw materials, soaking in water, heating for extraction, and filtering to obtain extractive solution;

preferably, the extraction is carried out in an extraction tank, the weight ratio of the mixed raw materials to water is 1 (5-10), the soaking time is 1-2 hours, the heating extraction time is 0.5-1 hour, the heating temperature is 80-100 ℃, and the repeated extraction can be carried out for 2-3 times.

(2) Concentrating: concentrating the extract under reduced pressure to obtain extract;

preferably, the reduced pressure concentration is performed in a multi-effect energy-saving evaporation concentration device, wherein the temperature is 80-85 ℃ for the first effect, 75-80 ℃ for the second effect and 65-75 ℃ for the third effect; the vacuum degree is one effect-0.04 to-0.05 MPa, the two effect-0.05 to-0.06 MPa, the three effect-0.06 to-0.07 MPa and the steam pressure is 0.2 to 0.5MPa, the relative density of the extract at 55 ℃ is 1.08 to 1.10 (the density of water at 4 ℃ is 1g/cm < 3 > as the reference density).

(3) Spray drying: and (3) spray drying the extract to obtain the traditional Chinese medicine preparation.

Preferably, the spray drying is performed in a spray dryer, the inlet air temperature of the spray drying is 130-160 ℃, and the exhaust air temperature is 80-100 ℃.

The invention also relates to application of the traditional Chinese medicine preparation in preparation of medicines for treating gastroesophageal reflux disease, and specific clinical effects are shown in the embodiment.

The invention has the beneficial effects that:

aiming at the defects of the prior treatment technology of gastroesophageal reflux disease, the invention provides a traditional Chinese medicine preparation for treating gastroesophageal reflux disease, which can achieve the following technical effects:

1. significantly improves the clinical symptoms of patients with gastroesophageal reflux disease. Compared with the pure administration of rabeprazole, the combination of the preparation can obviously improve the clinical symptoms of heartburn, acid regurgitation, pharyngalgia, pharyngeal blocking, abdominal distention and the like.

2. Remarkably improves the state of the esophageal mucosa of patients with gastroesophageal reflux, and improves the healing rate of the esophageal mucosa. After the preparation is treated by being combined with rabeprazole for 8 weeks, the effective rate of improving the esophageal mucosa under the gastroscope of a patient is 83.33%, and the healing rate is 60.00%. The effective rate of the rabeprazole taken alone in the same period is 73.33 percent, and the healing rate is 33.33 percent.

3. Reducing the recurrence rate of gastroesophageal reflux disease. After stopping the medicine, the symptom recurrence rate is 11.11% at 4 weeks, and the symptom recurrence rate of the rabeprazole taken alone at the same time is 34.78.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be described in detail below. It will be apparent that the described embodiments are only some, but not all, embodiments of the invention. All other embodiments, based on the examples herein, which are within the scope of the invention as defined by the claims, will be within the scope of the invention as defined by the claims.

Examples

The traditional Chinese medicine preparation for treating gastroesophageal reflux disease comprises the following components in parts by weight: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of magnolia officinalis, 9 parts of baical skullcap root, 15 parts of rabdosia rubescens, 6 parts of oroxylum indicum, 9 parts of blackberry lily, 12 parts of fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of purified pinellia tuber and 15 parts of cortex albiziae.

The preparation method of the traditional Chinese medicine preparation comprises the following steps:

(1) Extracting: mixing the raw materials, placing into an extraction tank, adding water, soaking for 1 hr, heating and extracting at 90deg.C for 40 min with the weight ratio of the mixed raw materials to water being 1:8, repeatedly extracting for 2 times, and filtering to obtain extractive solution;

(2) Concentrating: concentrating the extracting solution in a multi-effect energy-saving evaporation concentration device under reduced pressure, wherein the temperature is 80-85 ℃ for the first effect, 75-80 ℃ for the second effect and 65-75 ℃ for the third effect; vacuum degree is-0.04 to-0.05 MPa, double effect is-0.05 to-0.06 MPa, triple effect is-0.06 to-0.07 MPa, steam pressure is 0.2 to 0.5MPa, and extract is obtained, and relative density of the extract at 55 ℃ is 1.08 to 1.10;

(3) Spray drying: spray drying the extract in spray dryer, setting air inlet temperature at 150deg.C and air exhaust temperature at 90deg.C to obtain Chinese medicinal preparation.

The clinical efficacy observations of the traditional Chinese medicine preparation of the example are as follows:

1. clinical data

1.1 general clinical data

60 patients selected in the study were diagnosed with reflux esophagitis from 12 months 2020 to 7 months 2021 in Ming's hospital in Hebei province. Patients were numbered in order of visit, and were divided into 2 groups of 30 persons each using a random number table method.

1.2 case selection

1.2.1 Western diagnostic criteria reference "expert consensus on gastroesophageal reflux disease in China" 2020:

clinical manifestations (one)

(1) Typical symptoms: heartburn and reflux

(2) Atypical symptoms: chest pain (excluding heart-derived chest pain), upper abdominal pain, upper abdominal distention, belch, nausea and other digestive tract symptoms; symptoms outside esophagus, such as asthma, cough, pharyngolaryngitis, dental erosion, foreign body sensation or blockage sensation in pharynx, hoarseness after waking up, otitis media, and the like;

(II) upper gastrointestinal endoscope

The upper gastrointestinal endoscope found reflux esophagitis, the severity of which was classified as los Angeles, as follows:

clinical condition responders may be initially diagnosed with reflux esophagitis, and endoscopy responders may be clearly diagnosed with reflux esophagitis.

1.2.2 inclusion criteria

(1) Meets the Western diagnosis standard of reflux esophagitis;

(2) Age between 18-65 years old, unlimited in sex;

(3) No drug or non-drug treatment for reflux esophagitis and no drug to alter gastrointestinal function was taken within approximately 2 weeks;

(4) Voluntarily participate in the research survey, sign the informed consent form, follow the doctor's advice, the reliability is high.

2. Research method

2.1 methods of treatment

2.1.1 basal therapy

Education two groups of subjects attach importance to diet, emotion, lifestyle adjustments, such as: avoiding eating before sleep, avoiding strong tea, coffee, chocolate, mint, spicy or acidic foods, high-fat diet, etc.; the bad emotional states such as anxiety, dysphoria and the like are avoided for a long time; weight loss, elevation of bed head, withdrawal (restriction) of cigarettes, withdrawal (restriction of wine), etc.

2.1.2 pharmaceutical treatment

Control group: rabeprazole sodium enteric-coated tablets: each tablet is taken once before breakfast, 10 mg, 1 tablet for 1 time and 1 day for 1 time. [ production Unit ] Jiangsu Haoshen pharmaceutical Co., ltd; [ approved literature ] national drug standard H20020330.

Treatment group: based on the treatment of the control group, the formula of the traditional Chinese medicine preparation (granule of the example 1) is: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of magnolia officinalis, 9 parts of baical skullcap root, 15 parts of rabdosia rubescens, 6 parts of oroxylum indicum, 9 parts of blackberry lily, 12 parts of fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of purified pinellia tuber and 15 parts of cortex albiziae. The usage method is as follows: daily 1 dose, taken with boiled water, 200 ml each in the morning and evening.

According to the national gastroesophageal reflux disease expert consensus in 2020, 8 weeks were determined as 1 course of treatment, and the subjects of the upper 2 groups were subjected to standard treatment for 8 weeks.

2.2 observations index

2.2.1 general index: gender, age, course of disease, etc.

2.2.2 therapeutic efficacy index

(1) The Chinese medicine syndromes are integrated: the principal symptoms in the integral table of the symptoms of the traditional Chinese medicine are respectively 0, 2, 4 and 6 according to the degree of absence, light, medium and heavy, and the secondary symptoms are respectively 0, 1, 2 and 3 according to the degree of absence, light, medium and heavy, and the integral before and after treatment is recorded.

(2) The RDQ scale score records the frequency and severity of four symptoms of heartburn, reflux, non-heart chest pain, and acid regurgitation occurring over the past four weeks, each divided into 0-5 points, with a total score of over 12 positive. The pre-treatment and post-treatment scores were recorded.

(3) Changes in the submucosal mucosa before and after treatment.

(4) Recurrence of patients with drug withdrawal for 4 weeks

2.2.3 Security indicators

Electrocardiographic examination; three general methods of blood, urine and feces; liver and kidney function; adverse drug reactions.

2.3 efficacy assessment criteria

2.3.1 evaluation criteria for efficacy of Chinese medical Condition

Reference to "guidelines for clinical research of New traditional Chinese medicine" (2002 edition), calculation using nimodipine method: efficacy index = (pre-treatment integral-post-treatment integral)/pre-treatment integral x 100%

Principle of judging effect of syndrome of traditional Chinese medicine

2.3.2 RDQ integral efficacy evaluation

With reference to the "gastroesophageal reflux disease chinese and western medicine combined diagnosis and treatment consensus" formulated in 2017, the efficacy is assessed according to the total score ratio method, the total percentage= (pre-treatment integral-post-treatment integral)/pre-treatment integral×100%, and the specific criteria are as follows:

RDQ integral efficacy evaluation

2.3.3 judging the curative effect according to the integral of gastroscopy review:

(1) And (3) healing: the endoscopic score was 0 minutes after treatment.

(2) The effect is shown: the endoscopic integration was reduced by 2 minutes.

(3) The method is effective: the endoscopic integration was reduced by 1 minute.

(4) Invalidation: there is no change or increase in the endoscopic integration. The specific criteria are as follows:

2.3.4 evaluation of long-term efficacy

The RDQ questionnaire is filled in after 4 weeks of telephone follow-up after treatment, and the score is larger than the score at the end of the treatment course and is more than 12 minutes, thus the recurrence is obtained.

2.3.5 adverse reactions

If adverse reaction occurs in the research process, recording the occurrence time, the ending time, the specific conditions and the treatment measures of the adverse reaction, and if the adverse reaction is determined to be related to the test drug, exiting the research.

2.3.6 statistical analysis method

All data in the study are statistically analyzed by SPSS 26.0 statistical software, and the metering data are expressed by mean ± standard deviation (X ± S); paired sample t test is adopted before and after the same group treatment, independent sample t test is adopted for comparison among different groups, and P is less than 0.05 and is a significant difference, so that the method has statistical significance; p > 0.05 is no significant difference and comparable.

3. Therapeutic results

3.1 comparison of the two Pre-treatment groups of base data

3.1.1 two sets of gender comparisons

Table 1 two sets of patient gender comparison tables

As shown in Table 1, the gender comparison of the two groups uses chi-square test ² =0.300, p=0.584, p > 0.05, indicating no statistical difference in gender for the two groups of patients, and comparability.

3.1.2 age comparisons of two groups

Table 2 two groups of patient age distribution tables

As shown in table 2, the ages of the two groups of patients did not follow normal distribution, and with rank sum test, z= -0.533, p=0.594, p > 0.05, indicating no significant difference in ages of the two groups of patients, a comparison can be made.

3.1.3 comparison of two sets of disease courses

Table 3 two groups of patient course comparison tables

As shown in table 3, neither of the two sets of disease course times obeyed normal distribution, and with the rank sum test, z= -0.187, p=0.852, p > 0.05, and the difference between the two sets of disease course was statistically significant and comparable.

3.2 comparison of therapeutic Effect

3.2.1 total integral comparison of symptoms in TCM before and after treatment

Table 4 comparison table of total integral of symptoms in chinese medicine for two groups of patients before and after treatment

Note that: p < 0.05 in comparison before and after treatment in group; compared with the control group, the additive has P less than 0.05.

As shown in table 4, the total integral of symptoms in the traditional Chinese medicine of both the patients before and after treatment accords with the normal distribution and the variance is uniform, so the t test is adopted. Through t-test, the total integral of symptoms in the traditional Chinese medicine of the two groups of patients before treatment is not statistically different, and the two groups of patients are comparable (t=1.116, p=0.269, p > 0.05). After treatment, the total integral of the traditional Chinese medicine symptoms of the two groups of patients is obviously reduced compared with that before treatment, and the difference has statistical significance (P is less than 0.05). The total integral of symptoms in the two groups of patients after treatment is significantly lower than that in the control group, and the difference is statistically significant (t=7.393, p=0.00, p < 0.05).

3.2.2 integral comparison of symptoms in TCM before and after treatment

Table 5 comparison table of Chinese medicine symptom scores for two groups of patients before and after treatment

Note that: p < 0.05 compared to prior to treatment in the same group; compared with the control group, the additive has P less than 0.05.

As shown in table 5, the scores of the symptoms of each traditional Chinese medicine in the two groups of patients before and after treatment do not conform to the normal distribution, so rank sum test is adopted. After rank sum test, the Chinese medicine symptom scores of the two groups of patients before treatment are not statistically different and are comparable. The loose stool scores of the patients in the control group are not obviously different after the traditional Chinese medicine symptom score treatment compared with the patients before the treatment (P is more than 0.05). The scores of the other symptoms are obviously reduced, and the difference is statistically significant (P is less than 0.05). The Chinese medicine symptoms of the patients in the treatment group are obviously reduced after scoring treatment compared with before treatment, and the difference is statistically significant (P is less than 0.05). After the two groups of patients are treated, the symptoms of heartburn, acid regurgitation, pharyngalgia, pharyngeal obstruction, abdominal distension, tiredness and hypodynamia in the treatment group are obviously smaller than those in the control group, the difference has statistical significance (P is less than 0.05), and the symptoms of chest distress and anorexia have no obvious difference (P is more than 0.05).

3.2.3 comparison of the efficacy of the symptoms of traditional Chinese medicine before and after treatment

Table 6 comparison of the efficacy of the symptoms in the two groups of patients after treatment

As shown in table 6, the therapeutic effects of the traditional Chinese medicine symptoms of the two groups of patients after treatment are tested by rank and sum, z= -2.779, p=0.005, and p < 0.05, and the difference is statistically significant. The total effective rate of the treatment group is 93.33 percent higher than that of the control group by 83.33 percent.

3.2.4 comparison of RDQ scores before and after treatment

Table 7 RDQ scores for both pre-and post-treatment groups of patients

As shown in table 7, the RDQ scores were consistent with a normal distribution and a uniform variance before and after treatment for both groups of patients, so a t-test was used. By t-test, there was no statistical significance (P > 0.05) for the difference in RDQ scores between the two groups of patients before treatment, indicating that there was no significant difference in scores between the two groups before treatment, and a comparison could be made. The RDQ scores of both groups of patients were significantly reduced after treatment compared to those before treatment, and the differences were statistically significant (P < 0.05). The RDQ scores after treatment of both groups of patients were significantly lower in the treated group than in the control group, the differences were statistically significant (t=5.839, p < 0.05).

3.2.5 RDQ integral efficacy comparison before and after treatment

Table 8 RDQ integral efficacy for two groups of patients

As shown in table 8, the RDQ integrated efficacy of the two groups of patients after treatment was tested by rank summation, z= -2.440, p=0.015, p < 0.05, and the difference was statistically significant. The total effective rate of the treatment group is 90.00 percent higher than that of the control group by 76.67 percent.

3.2.6 comparison of gastroscopic efficacy before and after treatment

Table 9 comparison of the efficacy of two sets of gastroscopies

As shown in table 9, the gastroscope effect showed that the total effective rate of the treatment group was 83.33% and the total effective rate of the control group was 73.33%. Through rank sum test, Z= -2.039, P=0.041, P < 0.05, and the difference has statistical significance.

3.2.7 comparison of gastroscopic grading before and after treatment

Table 10 gastroscopic grading before and after treatment for two groups of patients

As shown in Table 10, the gastroscope grade versus grade data, a rank sum test was used. There was no obvious difference in gastroscopic grading between the two groups of patients before treatment, no statistical significance (z= -0.779, p=0.436, p > 0.05), and comparability. After treatment, the gastroscopic grading of both groups of patients was different from that before treatment, and the differences were statistically significant (control group: z= -4.125, p=0.000, p < 0.05; treatment group: z= -4.769, p=0.000, p < 0.05). After treatment, the gastroscopic grade of the treated group was significantly lower than that of the control group, the differences were statistically significant (z= -2.131, p=0.033, p < 0.05).

3.2.8 recurrence rate comparison after treatment

Table 11 comparison of recurrence rates after 4 weeks of treatment in both groups

As shown in Table 11, the treatment group had 3 persons with recurrence rate 11.11%, the control group had 8 persons with recurrence rate 34.78% following 4 weeks after withdrawal, and the treatment group had chi by continuous chi-square test ² P=4.056, p=0.044, p < 0.05, the difference being statistically significant.

The amounts of Rabdosia rubescens, oroxyli and Belamcanda rhizome added were changed on the basis of examples to obtain comparative examples 1 to 3. Rabdosia rubescens was replaced with Prunella spike to obtain comparative example 4.

Comparative example 1

A traditional Chinese medicine preparation for treating gastroesophageal reflux disease comprises the following raw materials in parts by weight: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of magnolia officinalis, 12 parts of baical skullcap root, 20 parts of rabdosia rubescens, 9 parts of oroxylum indicum, 6 parts of blackberry lily, 12 parts of fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of purified pinellia tuber and 15 parts of cortex albiziae, and the preparation method is the same as that of example 1.

Comparative example 2

A traditional Chinese medicine preparation for treating gastroesophageal reflux disease comprises the following raw materials in parts by weight: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of magnolia officinalis, 9 parts of baical skullcap root, 20 parts of rabdosia rubescens, 9 parts of oroxylum indicum, 9 parts of blackberry lily, 12 parts of fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of purified pinellia tuber and 15 parts of cortex albiziae, and the preparation method is the same as that of example 1.

Comparative example 3

A traditional Chinese medicine preparation for treating gastroesophageal reflux disease comprises the following raw materials in parts by weight: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of magnolia officinalis, 12 parts of radix scutellariae, 15 parts of rabdosia rubescens, 6 parts of semen oroxyli, 6 parts of blackberry lily, 12 parts of fritillaria thunbergii, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of purified pinellia ternate and 15 parts of cortex albiziae. The preparation method is the same as in example 1.

Comparative example 4

A traditional Chinese medicine preparation for treating gastroesophageal reflux disease comprises the following raw materials in parts by weight: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of magnolia officinalis, 9 parts of baical skullcap root, 15 parts of common selfheal fruit-spike, 6 parts of oroxylum seed, 9 parts of blackberry lily, 12 parts of thunberg fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of purified pinellia tuber and 15 parts of silktree albizia bark. The preparation method is the same as in example 1.

For the traditional Chinese medicine preparations of examples and comparative examples, clinical trials were repeated in the same steps as the traditional Chinese medicine preparations of the previous examples. The clinical effect observation results of the traditional Chinese medicine preparation of the comparative example are as follows:

1. clinical data

1.1 general clinical data

90 patients selected in the comparative study were diagnosed with reflux esophagitis from 6 months 2020 to 10 months 2020 at the Ming Yitang of the Hospital in Hebei province. Patients were numbered in order of visit, and were divided into 6 groups of 15 persons each using a random number table method.

1.2 case selection

Section 1.2 of the observation of clinical efficacy of the traditional Chinese medicine preparation in the embodiment.

2. Research method

2.1 methods of treatment

2.1.1 basal therapy

Section 2.1.1 of the observation of clinical efficacy of the traditional Chinese medicine preparation in the example.

2.1.2 pharmaceutical treatment

Comparative example 1 group: based on the treatment of the control group, the formula of the traditional Chinese medicine preparation (granule of comparative example 1) is given: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of magnolia officinalis, 12 parts of radix scutellariae, 20 parts of rabdosia rubescens, 9 parts of semen oroxyli, 6 parts of blackberry lily, 12 parts of fritillaria thunbergii, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of purified pinellia ternate and 15 parts of cortex albiziae. The usage method is as follows: daily 1 dose, taken with boiled water, 200 ml each in the morning and evening.

Comparative example 2 group: based on the treatment of the control group, the formula of the traditional Chinese medicine preparation (granule of comparative example 2) is given: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of magnolia officinalis, 9 parts of baical skullcap root, 20 parts of rabdosia rubescens, 9 parts of oroxylum indicum, 9 parts of blackberry lily, 12 parts of fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of purified pinellia tuber and 15 parts of cortex albiziae. The usage method is as follows: daily 1 dose, taken with boiled water, 200 ml each in the morning and evening.

Comparative example 3 group: based on the treatment of the control group, the formula of the traditional Chinese medicine preparation (granule of comparative example 3) is given: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of magnolia officinalis, 12 parts of radix scutellariae, 15 parts of rabdosia rubescens, 6 parts of semen oroxyli, 6 parts of blackberry lily, 12 parts of fritillaria thunbergii, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of purified pinellia ternate and 15 parts of cortex albiziae. The usage method is as follows: daily 1 dose, taken with boiled water, 200 ml each in the morning and evening.

Comparative example 4 group: based on the treatment of the control group, the formula of the traditional Chinese medicine preparation (granule of comparative example 4) is given: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of magnolia officinalis, 9 parts of baical skullcap root, 15 parts of common selfheal fruit-spike, 6 parts of oroxylum seed, 9 parts of blackberry lily, 12 parts of thunberg fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of purified pinellia tuber and 15 parts of silktree albizia bark. The usage method is as follows: daily 1 dose, taken with boiled water, 200 ml each in the morning and evening.

Group of examples: based on the treatment of the control group, the formula of the traditional Chinese medicine preparation (granule of the embodiment) is: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of magnolia officinalis, 9 parts of baical skullcap root, 15 parts of rabdosia rubescens, 6 parts of oroxylum indicum, 9 parts of blackberry lily, 12 parts of fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of purified pinellia tuber and 15 parts of cortex albiziae. The usage method is as follows: daily 1 dose, taken with boiled water, 200 ml each in the morning and evening.

2.2 observations index

(2) Changes in the submucosal mucosa before and after treatment.

3 results

Table 12 comparison table of total points of symptoms in chinese medicine for each group of patients before and after treatment

Note that: p < 0.05 in comparison before and after treatment in group; as compared with the control group, P is less than 0.05; compared with the comparative examples 1-4, the additive has P less than 0.05.

As shown in table 12, the total integral of symptoms in the traditional Chinese medicine of each group of patients before and after treatment accords with the normal distribution and has uniform variance, so the t test is adopted. Through t test, the total integral of Chinese medicine symptoms of each group of patients before treatment has no statistical difference and has comparability (P is more than 0.05). After treatment, the total integral of the traditional Chinese medicine symptoms of each group of patients is obviously reduced compared with that before treatment, and the differences have statistical significance (P is less than 0.05). The total integral of the symptoms of the traditional Chinese medicine of the patients in the groups 1-4 after treatment is obviously smaller than that of the control group, and the difference has statistical significance (P is less than 0.05). The total integral of the symptoms of the traditional Chinese medicine of the patients in the example group after treatment is obviously smaller than that of the patients in the control group and the proportion 1-4 groups, and the difference has statistical significance (P is less than 0.05).

Table 13 comparison of gastroscopic efficacy of each group

As shown in table 13, the gastroscopic effect showed that the example group had better effect than the control group, and the difference had statistical significance (z= -2.083, p=0.037, p < 0.05). The treatment effect of the example group is better than that of the comparative examples 1-4, and the difference has clinical significance and no statistical significance (P is more than 0.05). The treatment effect of the groups of comparative examples 1-4 is superior to that of the control group, and the difference has clinical significance and no statistical significance (P is more than 0.05).

The results of the above comparative examples show that the total effective rate is reduced to different degrees by changing the amounts or ingredients of the raw materials in each ingredient of the present invention.

The foregoing is merely illustrative of the present invention, and the present invention is not limited thereto, and any person skilled in the art will readily recognize that variations or substitutions are within the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. The traditional Chinese medicine preparation for treating gastroesophageal reflux disease is characterized by comprising the following raw materials in parts by weight: 20-40 parts of gypsum, 9-15 parts of immature bitter orange, 5-9 parts of magnolia officinalis, 5-10 parts of radix scutellariae, 10-30 parts of rabdosia rubescens, 3-6 parts of oroxylum indicum, 6-9 parts of blackberry lily, 8-12 parts of fritillary bulb, 8-12 parts of cuttlebone, 15-30 parts of concha arcae powder, 5-9 parts of purified pinellia ternate and 10-15 parts of cortex albiziae.

2. The traditional Chinese medicine preparation for treating gastroesophageal reflux disease according to claim 1, wherein the traditional Chinese medicine preparation comprises the following raw materials in parts by weight: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of magnolia officinalis, 9 parts of baical skullcap root, 15 parts of rabdosia rubescens, 6 parts of oroxylum indicum, 9 parts of blackberry lily, 12 parts of fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of purified pinellia tuber and 15 parts of cortex albiziae.

3. The method for preparing a traditional Chinese medicine preparation for treating gastroesophageal reflux disease according to claim 1 or 2, characterized in that the method comprises the following steps:

4. The method of claim 3, wherein in the step (1), the weight ratio of the mixed raw material to water is 1 (5-10).

5. The method according to claim 3, wherein in the step (1), the soaking time is 1 to 2 hours, the heat extraction time is 0.5 to 1 hour, and the heating temperature is 80 to 100 ℃.

6. The method of claim 3, wherein in step (1), the extraction is repeated 2 to 3 times.

7. A method of producing according to claim 3, wherein in step (2), the reduced pressure concentration is performed in a multi-effect energy-saving evaporation concentration device.

8. The preparation method according to claim 7, wherein in the step (2), the first effect temperature is 80-85 ℃, the second effect temperature is 75-80 ℃, and the third effect temperature is 65-75 ℃; the primary vacuum degree is-0.04 to-0.05 MPa, the secondary vacuum degree is-0.05 to-0.06 MPa, the tertiary vacuum degree is-0.06 to-0.07 MPa, and the steam pressure is 0.2 to 0.5MPa.

9. The method according to claim 3, wherein in the step (3), the air inlet temperature of the spray drying is 130-160 ℃ and the air outlet temperature is 80-100 ℃.

10. Use of a Chinese medicinal preparation according to claim 1 or 2 for the preparation of a medicament for the treatment of gastroesophageal reflux disease.