A Gualou Xiebai Banxia Decoction with the effects of promoting yang and resolving stagnation, eliminating phlegm and relieving chest and a preparation method thereof
By combining modified Pinellia ternata with anti-inflammatory agents, a decoction of Trichosanthes kirilowii, Allium macrostemon, and Pinellia ternata was prepared, which solved the treatment problem of airway inflammatory diseases such as allergic asthma. It achieved significant effects in inhibiting airway inflammation and relieving cough and phlegm, and achieved the therapeutic goals of promoting yang, dispersing stagnation, eliminating phlegm, and relieving chest congestion.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- SHANGHAI GUO CHUANG PHARM CO LTD
- Filing Date
- 2026-04-15
- Publication Date
- 2026-06-12
AI Technical Summary
Current technologies are insufficient to effectively treat airway inflammatory diseases such as allergic asthma, especially in the early stages of an attack, such as sneezing, runny nose, coughing, and chest tightness, and conventional drug treatments are not very effective.
Modified Pinellia ternata was prepared by combining modified Pinellia ternata with anti-inflammatory agents through alcohol extraction and fermentation extraction processes. It was then combined with other Chinese medicinal herbs such as Trichosanthes kirilowii and Allium macrostemon to prepare Trichosanthes kirilowii, Allium macrostemon and Pinellia ternata decoction. Lycopene and other ingredients were added to form an anti-inflammatory agent with the functions of promoting yang, dispersing stagnation, eliminating phlegm and relieving chest congestion.
It significantly inhibits airway inflammation, increasing the airway inflammation inhibition rate to 89%, and significantly relieves cough and expectoration, achieving the therapeutic effects of promoting yang, dispersing nodules, eliminating phlegm, and relieving chest congestion.
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Abstract
Description
Technical Field
[0001] This invention relates to Gualou Xiebai Banxia Decoction and its preparation method, specifically to a Gualou Xiebai Banxia Decoction with the effects of promoting yang, dispersing nodules, resolving phlegm, and relieving chest congestion, an anti-inflammatory agent, modified Banxia, and their preparation method. Background Technology
[0002] Gualou Xiebai Banxia Decoction is a classic Chinese medicine formula, originating from the *Synopsis of Prescriptions of the Golden Chamber*, created by Zhang Zhongjing. This formula is primarily used to treat chest pain (similar to chest pain symptoms in modern medicine such as coronary heart disease and angina pectoris), possessing the effects of relieving chest pain, promoting yang energy, resolving phlegm, and dissipating nodules. Its concise formula and exquisite combination make it one of the representative formulas for treating chest pain in traditional Chinese medicine. Gualou Xiebai Banxia Decoction is a classic Chinese medicine formula for treating chest pain, possessing the effects of relieving chest pain, promoting yang energy, resolving phlegm, and dissipating nodules. Its refined formula and significant efficacy have led to its widespread application in modern clinical practice for the treatment of cardiovascular and respiratory diseases. By harmonizing qi and resolving phlegm and unblocking the meridians, this formula can effectively alleviate chest pain symptoms and improve patients' quality of life.
[0003] Allergic asthma is a relatively stubborn disease that often begins in infancy and early childhood. If left untreated, it can persist throughout life. Most asthma patients have allergies or allergic rhinitis. Asthma patients with allergic rhinitis may experience sneezing, runny nose, itchy nose, itchy eyes, and tearing as early warning signs of an attack.
[0004] Allergic asthma attacks are often preceded by warning symptoms such as sneezing, runny nose, coughing, and chest tightness. If left untreated, these symptoms can worsen due to bronchial obstruction, leading to severe asthma attacks. In severe cases, patients may be forced to sit upright or adopt an orthopneic posture, experiencing a dry cough or expectoration of large amounts of white frothy sputum, and even cyanosis. Atypical asthma also exists clinically, such as cough-variant asthma, where patients experience a cough for more than two months without any obvious trigger, often occurring at night and in the early morning, and exacerbated by exercise or cold air. Airway reactivity testing shows high reactivity, and treatment with antibiotics or antitussives and expectorants is often ineffective. Allergic asthma and other inflammatory respiratory diseases require effective anti-inflammatory treatment. Summary of the Invention
[0005] Purpose of the invention: The purpose of this invention is to provide a Gualou Xiebai Banxia Decoction, an anti-inflammatory agent, and a preparation method that have good effects of promoting yang, dispersing stagnation, eliminating phlegm, and relieving chest congestion.
[0006] Technical solution: The present invention provides an anti-inflammatory agent, characterized in that it comprises the following raw materials in parts by weight: 5-9 parts lycopene, 7-11 parts Arisaema cum Bile, 5-9 parts Ophiopogon japonicus, 6-11 parts Cirsium japonicum, 8-14 parts Prunus armeniaca, 6-10 parts Prunus armeniaca, 5-7 parts Cinnamomum cassia, and 4-9 parts Phyllanthus urinaria.
[0007] Furthermore, the anti-inflammatory agent is prepared as follows: (1) Preparation of the extractant: The extractant is prepared by mixing purified water and ethanol in a weight ratio of 8-15:4-6; (2) Take 7-11 parts of Arisaema cum Bile, 5-9 parts of Ligusticum striatum, 6-11 parts of Cirsium japonicum, 8-14 parts of Prunus armeniaca, 6-10 parts of Prunus armeniaca, 5-7 parts of Cinnamomum cassia, 4-9 parts of Polygonum multiflorum, and 9-20 parts of water, mix them together to obtain mixed Chinese herbal medicines. (3) Add 2500 to 4500 mL of extractant to the mixed herbs in step (2) and vacuum extract at 100 to 150°C for 240 to 260 min to obtain the mixed herbal extract; (4) Concentrate 2000-2500 mL of the mixed herbal extract from step (3) at 50-70°C; (5) Add 5-9 parts of lycopene to the concentrate in step (4), stir, and obtain an anti-inflammatory agent.
[0008] A method for preparing modified Pinellia ternata, comprising the following modification steps: A. Alcohol extraction (1) Take 7-9 parts of ginger and Pinellia ternata, wash, dry, crush, and pass through a 150-200 mesh sieve after processing; (2) Mix the treated ginger pinellia with 60-75% ethanol at a mass ratio of 1:1.5-2, stir for 10-20 min to soak and expand, then put it into a pressure percolation device, add 10-12 parts of 55-60% ethanol solvent to the percolation device, set the pressure to 6-8 MPa, the percolation flow rate to 5-9 mL / min, and collect the filtrate through the percolation device. (3) Then perform water bath heating at 75-80℃ for 35-40 min. After the ethanol evaporates, add it to the microwave device and add 2-4 parts of modifier at the same time. Set the temperature to 50-55℃ and the microwave power to 15-20w. After reacting for 15-20 min, the first filtrate is obtained. B. Fermentation Extraction (1) Preparation of compound bacterial solution: Mix the additives and water to obtain a solvent. The weight ratio of additives to water is 4-6 parts: 50-60 parts. Then add 2-4 parts of lactic acid bacteria, 2-3 parts of yeast, and 2-4 parts of acetic acid bacteria, stir, and obtain a mixed bacterial solution. (2) Place the first filtrate in the mixed bacterial solution and ferment for 3-4 days at 50-55℃ and pH=5-7 to obtain the second filtrate by filtration and sterilization. (3) Use ultrasonic treatment with a power of 100-150w for 40-60min. After the treatment, return to room temperature to obtain the third filtrate. (4) Add an equal amount of distilled water to the third filtrate, seal and shake for 20-30 minutes, let stand for 2-3 hours, filter, concentrate and dry to obtain modified Pinellia ternata powder extract.
[0009] Furthermore, the modifier is acetylcysteine.
[0010] Furthermore, the additive is L-lysine hydrochloride.
[0011] A modified Pinellia ternata extract was prepared by the method described above.
[0012] Another aspect of the present invention provides a method for preparing the Trichosanthes kirilowii, Allium macrostemon, and Pinellia ternata decoction, which has the effects of promoting yang, dispersing stagnation, resolving phlegm, and relieving chest congestion, comprising the following steps: (1) Modify Pinellia ternata according to the aforementioned method to prepare an anti-inflammatory agent; (2) Take Trichosanthes kirilowii, wash and cut into pieces; wash Allium macrostemon and coarsely crush; weigh 10-17 parts of Trichosanthes kirilowii, 9-13 parts of Allium macrostemon, 11-14 parts of modified Pinellia ternata, 1300-1500 parts of rice wine, and 8-15 parts of anti-inflammatory agent according to the proportion; (3) Mix the raw materials from step (2), heat to boiling, maintain a gentle boil for 1.5-2.0 hours, stop heating, filter with a 200-300 mesh sieve, remove impurities from the filtrate by high-speed centrifugation, and obtain the extract; (4) The extract from step (3) is concentrated under reduced pressure and low temperature until the relative density of the concentrate is 1.15-1.20. The reduced pressure and low temperature conditions are: pressure ≤0.07MPa and temperature ≤60℃, to obtain the decoction.
[0013] A decoction of Trichosanthes kirilowii, Allium macrostemon, and Pinellia ternata with the effects of promoting yang, dispersing stagnation, eliminating phlegm, and relieving chest congestion is prepared by the method described above.
[0014] Raw material source: (1) The “Fu Ling” mentioned in this application refers to the Chinese medicinal material Poria cocos (Schw.) Wolf, which is the dried sclerotium of the fungus Poria cocos of the Polyporaceae family. Poria cocos is a commonly used Chinese medicinal material included in the Pharmacopoeia of the People’s Republic of China.
[0015] (2) The “longevity fruit” mentioned in this application refers to the fruit or seed of Hovenia dulcis Thunb., a plant of the Rhamnaceae family, which has a fleshy pedicel and is commonly known as “raisin fruit” or “hovenia seed”.
[0016] (3) The “wood pear” mentioned in this application is the dried, nearly mature fruit of Chaenomeles sinensis (Thouin) Koehne, a plant of the Rosaceae family, and is the same species as the “papaya” recorded in the Pharmacopoeia of the People’s Republic of China.
[0017] Compared with the prior art, the beneficial effects of the present invention are as follows: The anti-inflammatory agent provided by this invention has a significant inhibitory effect on airway inflammation, with an airway inflammation inhibition rate of up to 89% (as shown in Table 3). The modified Pinellia ternata provided by this invention has a high content of organic acids and total alkaloids, and has a significant antitussive and expectorant effect (as shown in Tables 1 and 2). The preparation method of the Trichosanthes kirilowii, Allium macrostemon, and Pinellia ternata decoction of this invention has clear steps and readily available raw materials. Those skilled in the art can reproduce the technical solution according to this method to prepare a decoction with the effects of promoting yang, dispersing stagnation, eliminating phlegm, and relieving chest congestion.
[0018] The Trichosanthes kirilowii, Allium macrostemon, and Pinellia ternata decoction of the present invention contains modified Pinellia ternata and an anti-inflammatory agent. The modified Pinellia ternata has significant antitussive and expectorant effects (as shown in Table 2, experimental data), and the anti-inflammatory agent has significant airway inflammation-inhibiting effects (as shown in Table 3, experimental data). Those skilled in the art can reasonably expect that the Trichosanthes kirilowii, Allium macrostemon, and Pinellia ternata decoction containing the above-mentioned modified Pinellia ternata and anti-inflammatory agent will also have antitussive, expectorant, and anti-inflammatory effects, achieving the therapeutic goal of "promoting yang and dispersing stagnation, eliminating phlegm and relieving chest congestion." Attached Figure Description
[0019] Figure 1 This is the product of the present invention. Detailed Implementation
[0020] To make the objectives, technical solutions, and advantages of the present invention clearer, the technical solutions of the present invention will be further described below.
[0021] (I) Pretreatment of raw materials and components related to this experiment (1) Modification of Pinellia ternata: Preparation Example 1 The Pinellia ternata extraction method of this preparation example includes the following steps: A. Alcohol extraction (1) Take 8g of ginger and Pinellia ternata, wash, dry, crush, and pass through a 150-200 sieve after processing; (2) Mix the treated ginger pinellia with 70% ethanol solvent at a mass ratio of 1g:1.5g, stir for 15min to soak and expand, then put it into a pressure percolation device, add 11g of 56% ethanol solvent into the percolation device, set the pressure to 7MPa, the percolation flow rate to 7mL / min, and collect the filtrate through the percolation device. (3) The percolation equipment is heated in a water bath at a temperature of 78°C for 38 minutes. After the ethanol evaporates, it is added to the microwave equipment along with 3g of acetylcysteine. The temperature is set to 53°C and the microwave power is set to 18W. After reacting for 18 minutes, the first filtrate is obtained. B. Fermentation Extraction (1) Preparation of compound bacterial solution: Mix L-lysine hydrochloride and water to obtain a solvent. The weight ratio of L-lysine hydrochloride to water is 5g:55g. Then add 3g of lactic acid bacteria, 3g of yeast and 5g of acetic acid bacteria, stir to obtain a mixed bacterial solution. (2) Place the first filtrate in the mixed bacterial solution and ferment for 3 days at 58°C and pH=6 to obtain the second filtrate by filtration and sterilization. (3) Ultrasonic treatment was performed with an ultrasonic power of 120w and a reaction time of 50min. After the reaction was completed, the mixture was returned to room temperature to obtain the third filtrate. (4) Place the third filtrate into a sealed bottle, add an equal amount of distilled water, shake in a shaker for 20-30 minutes, and let stand for 3 hours. Filter again with filter paper, and concentrate the filtrate to dryness using a rotary evaporator to obtain the modified Pinellia ternata powder extract.
[0022] Preparation Example 2 The Pinellia ternata extraction method of this embodiment includes the following steps: A. Alcohol extraction (1) Take 9g of ginger and Pinellia ternata, wash, dry, crush, and pass through a 180-sieve after processing; (2) Mix the treated ginger pinellia with 75% ethanol solvent at a mass ratio of 1g:2g, stir for 20min to soak and expand, then load it into a pressure percolation device, add 12g of 60% ethanol solvent into the percolation device, set the pressure to 15MPa, the percolation flow rate to 9mL / min, and collect the filtrate through the percolation device. (3) The percolation equipment is heated in a water bath at a temperature of 80°C for 40 minutes. After the ethanol evaporates, it is added to the microwave equipment along with 4g of acetylcysteine. The temperature is set to 55°C and the microwave power is set to 20W. After reacting for 20 minutes, the first filtrate is obtained. B. Fermentation Extraction (1) Preparation of compound bacterial solution: Mix L-lysine hydrochloride and water to obtain a solvent. The weight ratio of L-lysine hydrochloride to water is 6g:60g. Then add 4g of lactic acid bacteria, 3g of yeast and 4g of acetic acid bacteria, stir to obtain a mixed bacterial solution. (2) Place the first filtrate in the mixed bacterial solution and ferment for 4 days at 50°C and pH=6 to obtain the second filtrate by filtration and sterilization. (3) Ultrasonic treatment was performed with an ultrasonic power of 150w and a reaction time of 60min. After the reaction was completed, the mixture was returned to room temperature to obtain the third filtrate. (4) Place the third filtrate into a sealed bottle, add an equal amount of distilled water, shake in a shaker for 30 minutes, and let stand for 3 hours. Filter again with filter paper, and concentrate the filtrate to dryness using a rotary evaporator to obtain the modified Pinellia ternata powder extract.
[0023] Preparation Example 3 The Pinellia ternata extraction method of this embodiment includes the following steps: A. Alcohol extraction (1) Take 7g of ginger-processed Pinellia ternata, wash, dry, crush, and pass through a 150-200 sieve; (2) Mix the treated ginger pinellia with 60% ethanol solvent at a mass ratio of 1:1.5, stir for 10 min to soak and expand, then put it into a pressure percolation device, add 10g of 55% ethanol solvent into the percolation device, set the pressure to 6Mpa, the percolation flow rate to 5mL / min, and collect the filtrate through the percolation device. (3) The percolation equipment is heated in a water bath at a temperature of 75°C for 35 minutes. After the ethanol evaporates, it is added to the microwave equipment along with 2g of acetylcysteine. The temperature is set to 50°C and the microwave power is set to 15W. After reacting for 15 minutes, the first filtrate is obtained. B. Fermentation Extraction (1) Preparation of compound bacterial solution: Mix L-lysine hydrochloride and water to obtain a solvent. The weight ratio of L-lysine hydrochloride to water is 4g:50g. Then add 2g of lactic acid bacteria, 2g of yeast and 2g of acetic acid bacteria, stir to obtain a mixed bacterial solution. (2) Place the first filtrate in the mixed bacterial solution and ferment for 3 days at 55℃ and pH=6 to obtain the second filtrate by filtration and sterilization. (3) Ultrasonic treatment was performed with an ultrasonic power of 100W and a reaction time of 40min. After the reaction was completed, the mixture was returned to room temperature to obtain the third filtrate. (4) Place the third filtrate into a sealed bottle, add an equal amount of distilled water, shake in a shaker for 20-30 minutes, and let stand for 2-3 hours. Filter again with filter paper, and concentrate the filtrate to dryness using a rotary evaporator to obtain the modified Pinellia ternata powder extract.
[0024] Comparative Example 1 The difference from Preparation Example 1 is that: pressure control, water bath, and microwave treatment are not performed in the alcohol extraction step, and the following steps are removed: "Set the pressure to 7 MPa, the percolation flow rate to 8 mL / min, and collect the filtrate through the percolation equipment of the filter; (3) the percolation equipment is heated in a water bath at a temperature of 79°C for 38 min. After the ethanol evaporates, it is added to the microwave equipment, and 3 parts of acetylcysteine are added at the same time. The temperature is set to 54°C and the microwave power is set to 18 W." After reacting for 18 min, the first filtrate is obtained. Other operations are the same as in Example 1.
[0025] Comparative Example 2 The difference from Example 1 is that there is no fermentation extraction step, and the following steps are removed: "B. Fermentation extraction (1) Preparation of compound bacterial solution: L-lysine hydrochloride and water are mixed and stirred to obtain a solvent. The weight ratio of L-lysine hydrochloride to water is 4g:50g. Then add 2g of lactic acid bacteria, 2g of yeast, and 2g of acetic acid bacteria, stir, and obtain a mixed bacterial solution; (2) Place the first filtrate in the mixed bacterial solution and ferment for 3 days at 55℃ and pH=6 to obtain the second filtrate; (3) Use ultrasonic treatment with an ultrasonic power of 100w and a reaction time of 40min. After the reaction is completed, return to room temperature to obtain the third filtrate;", and other operations are the same as in Example 1.
[0026] Comparative Example 3 The difference from Preparation Example 1 is that no modifier is added, and the rest of the operation is the same as in Example 1.
[0027] Comparative Example 4 The difference from Preparation Example 1 is that no additives are added, and the rest of the operation is the same as in Example 1.
[0028] Comparative Example 5 The difference from Preparation Example 1 is that the pressure and temperature of the mixed bacteria are increased simultaneously, that is, the pressure is 10 MPa during alcohol extraction and the first filtrate is placed in the mixed bacterial solution at 60°C during fermentation.
[0029] Comparative Example 6 The difference from Preparation Example 1 is that the pressure and temperature of the mixed bacteria are reduced simultaneously, that is, the pressure is 4 MPa during alcohol extraction and the first filtrate is placed in the mixed bacterial solution at 50°C during fermentation.
[0030] Comparative Example 7 The difference from Preparation Example 1 is that the pressure is increased and the temperature of the mixed bacteria is decreased, that is, the pressure is 10 MPa during alcohol extraction and the first filtrate is placed in the mixed bacterial solution at 50°C during fermentation.
[0031] Following the method for content determination under the "Pinellia" section of the 2010 edition of the Chinese Pharmacopoeia, the content of organic acids in modified Pinellia was determined by potentiometric titration. Using ephedrine hydrochloride as a reference standard, the absorbance was measured by acidic dye colorimetry, and the content was calculated according to a regression equation. The content of alkaloids was also determined by using D-anhydrous glucose as a reference standard, followed by absorbance measurement using a spectrophotometer after sulfuric acid-phenol color development. The content of polysaccharides was then determined and calculated according to a regression equation. The results are shown in Table 1.
[0032] Table 1. Content of organic acids and total alkaloids in modified Pinellia ternata ( (n=5)
[0033] The data in the table above show that the modified Pinellia ternata prepared in Examples 1-3 has a higher content of organic acids and total alkaloids, indicating that the modification process and formulation of Pinellia ternata in this invention can increase the content of organic acids and total alkaloids in Pinellia ternata.
[0034] Comparative Example 1 investigated the effects of pressure control, water bath, and microwave treatment processes on the content of organic acids and total alkaloids in Pinellia ternata. The data showed that removing these processes reduced the content of organic acids and total alkaloids in Pinellia ternata, indicating that pressure control, water bath, and microwave treatment significantly affected the extraction of these components. Pressure treatment allows ethanol solvent to penetrate the herb tissue more easily, dissolving its internal components, increasing the concentration of substances within the tissue, and accelerating outward diffusion, thus promoting component extraction. Subsequent microwave treatment, through the combined effects of heat and physical processes, further accelerated the dissolution of active ingredients, improved utilization, and promoted drug absorption.
[0035] Comparative Example 2 investigated the effect of fermentation on the content of organic acids and total alkaloids in Pinellia ternata. The data showed that removing the fermentation treatment reduced the content of organic acids and total alkaloids in Pinellia ternata, indicating that fermentation has a significant impact on the extraction of these components. Fermentation facilitates the decomposition of cell walls, making the cell wall structure looser and even partially ruptured, thereby promoting the release of organic acids and total alkaloids and increasing their extraction content.
[0036] Comparative Example 3 investigated the effect of the modifier acetylcysteine of this invention on the content of organic acids and total alkaloids in Pinellia ternata. The data showed that the content of organic acids and total alkaloids in Pinellia ternata decreased after the addition of the modifier, indicating that the modifier acetylcysteine has a significant impact on the extraction of organic acids and total alkaloids. This is because acetylcysteine contains sulfhydryl groups, which can disrupt the disulfide bonds and other connecting structures between Pinellia ternata cells, making the intercellular connections looser. Simultaneously, it can also act on the cell membrane, increasing cell membrane permeability, allowing organic acids and alkaloids inside the cell to be more easily released outside the cell, thereby improving extraction efficiency. The sulfhydryl groups of acetylcysteine can form hydrogen bonds with organic acids and alkaloids in Pinellia ternata. This interaction can change the state of organic acids and alkaloids within the cell, making them more easily dissociated from their binding sites within the cell, and thus dissolved and extracted by the extraction solvent.
[0037] Comparative Example 4 investigated the effect of the additive L-lysine hydrochloride of the present invention on the content of organic acids and total alkaloids in Pinellia ternata. The data show that the content of organic acids and total alkaloids in Pinellia ternata decreased after the addition of the additive L-lysine hydrochloride, indicating that the additive L-lysine hydrochloride has a significant impact on the extraction of organic acids and total alkaloids. The reason is that L-lysine hydrochloride is an amphoteric electrolyte that can dissociate into ions in solution. Its cationic portion can interact with the negative charge on the surface of Pinellia ternata cells, changing the charge distribution on the cell surface, thereby increasing the electrostatic repulsion between cells and widening the intercellular spaces. Simultaneously, it may interact with components such as phospholipids on the cell membrane, making the cell membrane structure looser and increasing permeability, which is conducive to the diffusion of organic acids and alkaloids from inside the cell to outside, thus improving the extraction content. The amino and carboxyl groups of L-lysine hydrochloride can form complexes with organic acids and alkaloids in Pinellia ternata through hydrogen bonds, ionic bonds, or coordinate bonds. The formation of such complexes can change the physicochemical properties of organic acids and alkaloids, increasing their solubility in the extraction solvent. It also helps to dissociate them from their binding sites within cells, thereby improving extraction efficiency.
[0038] Comparative Examples 5-7 investigated the effects of pressure during alcohol extraction and temperature of the mixed bacterial solution during fermentation on the content of organic acids and total alkaloids in Pinellia ternata. The data show that, compared to Example 1, pressure during alcohol extraction and temperature of the mixed bacterial solution during fermentation have a significant impact on the content of organic acids and total alkaloids in Pinellia ternata. This is because these pressure and temperature conditions can prevent structural changes or degradation of organic acids or alkaloids during extraction due to high temperatures, strong acids, or strong bases, thus better protecting the structure and activity of organic acids and increasing the content of the extracted product. Simultaneously, the microorganisms are treated at the optimal temperature, which is conducive to the exertion of their activity. Therefore, the pressure and temperature should be maintained within a certain range.
[0039] Experiments on the antitussive and expectorant effects of modified Pinellia ternata extract: 1. Cough suppression experiment: KM mice were randomly divided into groups. Each experimental group was administered 0.5 mL of modified Pinellia ternata filtrate by gavage once daily for 5 consecutive days. One hour after the last administration, the mice were placed in an ammonia-induced cough device to establish a cough model. After spraying for 15 seconds, the mice were immediately removed, and the cough latency period (from the start of the ammonia spray to the first cough of the mouse) and the number of coughs within 3 minutes were recorded.
[0040] 2. Expectorant Experiment: KM mice were randomly divided into groups. Each experimental group was administered 0.5 mL of modified Pinellia ternata filtrate by gavage once daily for 5 consecutive days. Thirty minutes after the last administration, the mice were intraperitoneally injected with 0.2 mL (10 g) of 0.5% phenol red and 0.9% sodium chloride solution. -1Thirty minutes after injection, the mice were euthanized by dislocation. They were then fixed in a supine position on a surgical board, the skin in the middle of the neck was cut open, the trachea was separated, and 0.5 mL of 5% NaHCO₃ solution was injected into the trachea with a syringe. The respiratory tract was irrigated three times through the needle, and the irrigating fluid was collected. The fluid was centrifuged at 2000 rpm for 5 min, and the supernatant was collected. The optical density (OD value) of the supernatant was measured at a wavelength of 558 nm using a spectrophotometer. The concentration of phenol red was calculated according to the regression equation of the phenol red standard curve.
[0041] 3. Statistical methods: Data were analyzed using one-way ANOVA in SPSS 13.0 software. Data are expressed as follows: x±s )express.
[0042] Table 2. Experimental results of modified Pinellia ternata on antitussive and expectorant effects ( )
[0043] Note: Compared with the blank control group, * P <0.05.
[0044] Table 2 shows that the modified Pinellia ternata in Preparations 1-3 exhibited significant expectorant and antitussive effects, and significantly increased phenol red excretion. Comparative Examples 1-7 showed much weaker effects than Preparations 1-3, with no significant antitussive effect.
[0045] (2) Preparation method and efficacy determination of anti-inflammatory agents: Preparation Example 1: (1) Preparation of the extractant: The extractant was prepared by mixing purified water and ethanol in a weight ratio of 11:5; (2) Take 8g of Arisaema cum Bile, 6g of Ligusticum striatum, 8g of Cirsium japonicum, 12g of Lysimachia christinae, 8g of Pyrus pyrifolia, 6g of Cinnamomum cassia, 6g of Polygonum multiflorum, and 14g of water, mix them together to obtain mixed Chinese herbal medicines; (3) Add 3500 mL of extractant to the mixed herbs in step (2) and vacuum extract at 130°C for 250 min to obtain the mixed herbal extract; (4) Concentrate 2300 mL of the mixed herbal extract from step (3) at 60°C in a low-temperature vacuum concentrator; (5) Add 7g of lycopene to the concentrate in step (4), stir well, and the anti-inflammatory agent is obtained.
[0046] Preparation Example 2: (1) Preparation of the extractant: The extractant was prepared by mixing purified water and ethanol at a weight ratio of 15g:6g; (2) Take 11g of Arisaema cum Bile, 9g of Ligusticum striatum, 11g of Cirsium japonicum, 14g of Lysimachia christinae, 10g of Pyrus pyrifolia, 7g of Cinnamomum cassia, 9g of Polygonum multiflorum, and 20g of water, mix them together to obtain mixed Chinese herbal medicines; (3) Add 4500 mL of extractant to the mixed herbs in step (2) and vacuum extract at 150°C for 260 min to obtain the mixed herbal extract; (4) Concentrate 2500 mL of the mixed herbal extract from step (3) at 70°C in a low-temperature vacuum concentrator; (5) Add 9g of lycopene to the concentrate in step (4), stir well, and the anti-inflammatory agent is obtained.
[0047] Preparation Example 3: (1) Preparation of the extractant: The extractant was prepared by mixing purified water and ethanol in a weight ratio of 8:4; (2) Take 7g of Arisaema cum Bile, 5g of Ligusticum striatum, 6g of Cirsium japonicum, 8g of Lysimachia christinae, 6g of Pyrus pyrifolia, 5g of Cinnamomum cassia, 4g of Polygonum multiflorum, and 9g of water, mix them together to obtain mixed Chinese herbal medicines; (3) Add 2500 of the extractant to the mixed herbs in step (2) and extract under vacuum at 100°C for 240 min to obtain the mixed herbal extract; (4) Concentrate 2000 mL of the mixed herbal extract from step (3) at 50°C in a low-temperature vacuum concentrator; (5) Add 5 parts of lycopene to the concentrate in step (4), stir well, and the anti-inflammatory agent is obtained.
[0048] Preparation Example 4: (1) Preparation of the extractant: The extractant was prepared by mixing purified water and ethanol in a weight ratio of 9:5; (2) Take 8g of Arisaema cum Bile, 6g of Ligusticum striatum, 7g of Cirsium japonicum, 9g of Prunus armeniaca, 9g of Prunus armeniaca, 6g of Cinnamomum cassia, 5g of Polygonum multiflorum, and 11g of water, mix them together to obtain mixed Chinese herbal medicines; (3) Add 2800 mL of extractant to the mixed herbs in step (2) and vacuum extract at 120°C for 245 min to obtain the mixed herbal extract; (4) Concentrate 2200 mL of the mixed herbal extract from step (3) at 55°C in a low-temperature vacuum concentrator; (5) Add 7g of lycopene to the concentrate in step (4), stir well, and the anti-inflammatory agent is obtained.
[0049] Preparation Example 5: (1) Preparation of the extractant: The extractant was prepared by mixing purified water and ethanol at a weight ratio of 13g:5g; (2) Take 10g of Arisaema cum Bile, 8g of Ligusticum striatum, 9g of Cirsium japonicum, 11g of Lysimachia christinae, 8g of Pyrus pyrifolia, 6g of Cinnamomum cassia, 7g of Polygonum multiflorum, and 12g of water, mix them together to obtain mixed Chinese herbal medicines; (3) Add 3000 mL of extractant to the mixed herbs in step (2) and vacuum extract at 140°C for 250 min to obtain the mixed herbal extract; (4) Concentrate 2400 mL of the mixed herbal extract from step (3) at 65°C in a low-temperature vacuum concentrator; (5) Add 8g of lycopene to the concentrate in step (4), stir well, and the anti-inflammatory agent is obtained.
[0050] Comparative Example 1: The difference from Preparation Example 1 is that lycopene is not added, but the rest of the operation is the same as Preparation Example 1.
[0051] Performance testing: Airway inflammation suppression test 1.1 Selection of Laboratory Animals Animal species: C57BL / 6 mice, 6 weeks old, weighing 18-22g.
[0052] Divide into groups of 3: Control group: No inflammation induction, no drug treatment.
[0053] Inflammation model group: Inflammation induced, no drug treatment.
[0054] Drug treatment group: Inflammation induction + drug treatment.
[0055] 1.2 Inflammation Induction Inducer: Ovalbumin (OVA): 20 µg / animal, sensitized by intraperitoneal injection in combination with adjuvant aluminum hydroxide, followed by challenge by nebulized inhalation of OVA (1% w / v).
[0056] Induction time: After sensitization for 2 weeks, nebulization stimulation for 3-5 days, once a day.
[0057] 1.3 Drug treatment Intraperitoneal injection: 8 mg / kg, once daily for 5 days. Detection indicator: Eosinophil count in BALF.
[0058] Inhibition rate (%) = [(Model group index - Drug treatment group index) / (Model group index - Control group index)] × 100 Table 3 Airway inflammation suppression rate (%)
[0059] The data in the table above show that Preparation Examples 1-5 exhibited a high airway inflammation inhibition rate, reaching as high as 89%, achieving unexpected therapeutic effects. This demonstrates that the anti-inflammatory agent of the present invention has the effect of inhibiting airway inflammation and can be used as a therapeutic agent or anti-inflammatory agent for respiratory diseases. Compared with Preparation Examples 1-5 containing the combined components, Comparative Example 1 without added lycopene showed a significantly lower inhibition rate, demonstrating that lycopene plays an important role in the anti-inflammatory effect of the agent, promoting the synergistic effect among Arisaema cum Bile, Ophiopogon japonicus, Cirsium japonicum, Lysimachia christinae, Pyrus pyrifolia, Cinnamomum cassia, and Phragmites communis, thereby enhancing the anti-inflammatory effect.
[0060] Arisaema cum Bile has the effects of clearing heat and resolving phlegm. Lycopene's antioxidant and anti-inflammatory effects can synergistically work with Arisaema cum Bile to reduce heat symptoms and phlegm obstruction during the inflammatory process, helping to alleviate symptoms such as local swelling caused by inflammation. Ophiopogon japonicus has the effects of nourishing yin and moistening dryness. Lycopene can synergistically work with Ophiopogon japonicus to protect tissue cells while improving the local internal environment of the inflamed area through nourishing yin and moistening dryness, thus enhancing the body's anti-inflammatory ability. Thistle has the effects of cooling blood and stopping bleeding. Lycopene synergistically works with this herb to reduce inflammation and help improve local bleeding and ecchymosis that may accompany inflammation, promoting the resolution of inflammation. Herbs such as Prunus armeniaca, Pyrus pyrifolia, and Cinnamomum cassia may have their own effects of regulating bodily functions and improving blood circulation. Lycopene synergistically works with these herbs to regulate the body's internal environment as a whole, enhancing the anti-inflammatory effect of the formula. For example, by improving blood circulation, the inflamed area receives better nutrition and metabolic waste excretion, which is beneficial for the recovery of inflammation.
[0061] (II) Preparation method and efficacy evaluation of Gualou Xiebai Banxia Decoction, which has the effects of promoting yang, dispersing stagnation, eliminating phlegm, and relieving chest tightness, according to this embodiment. Example 1 The preparation method of Gualou Xiebai Banxia Decoction, which has the effects of promoting yang, dispersing stagnation, resolving phlegm, and relieving chest congestion, according to this embodiment, includes the following steps: (1) Take Trichosanthes kirilowii, wash and cut into pieces; wash Allium macrostemon and coarsely crush; weigh 15g of Trichosanthes kirilowii, 11g of Allium macrostemon, 13g of modified Pinellia ternata from Preparation Example 1, 1400g of rice wine, and 9g of anti-inflammatory agent from Preparation Example 1 according to the proportion; (2) Mix the raw materials from step (1), heat to boiling, maintain a gentle boil for 1.8 hours, stop heating, filter with a 250-mesh sieve, remove impurities from the filtrate by high-speed centrifugation, and obtain the extract; (3) The extract from step (2) is concentrated under reduced pressure and low temperature until the relative density of the concentrate is 1.15-1.20. The reduced pressure and low temperature conditions are: pressure ≤0.07MPa and temperature ≤60℃, to obtain the decoction.
[0062] Example 2 The preparation method of Gualou Xiebai Banxia Decoction, which has the effects of promoting yang, dispersing stagnation, resolving phlegm, and relieving chest congestion, according to this embodiment, includes the following steps: (1) Take Trichosanthes kirilowii, wash and cut into pieces; wash Allium macrostemon and coarsely crush; weigh 10g of Trichosanthes kirilowii, 9g of Allium macrostemon, 11g of modified Pinellia ternata from Preparation Example 1, 1300g of rice wine, and 8g of anti-inflammatory agent from Preparation Example 1 according to the proportion; (2) Mix the raw materials from step (1), heat to boiling, maintain a gentle boil for 1.5 hours, stop heating, filter with a 200-mesh sieve, remove impurities from the filtrate by high-speed centrifugation, and obtain the extract; (3) The extract from step (2) is concentrated under reduced pressure and low temperature until the relative density of the concentrate is 1.15-1.20. The reduced pressure and low temperature conditions are: pressure ≤0.07MPa and temperature ≤60℃, to obtain the decoction.
[0063] Example 3 The preparation method of Gualou Xiebai Banxia Decoction, which has the effects of promoting yang, dispersing stagnation, resolving phlegm, and relieving chest congestion, according to this embodiment, includes the following steps: (1) Take Trichosanthes kirilowii, wash and cut into pieces; wash Allium macrostemon and coarsely crush; weigh 17g of Trichosanthes kirilowii, 13g of Allium macrostemon, 14g of modified Pinellia ternata from Preparation Example 1, 1500g of rice wine, and 15g of anti-inflammatory agent from Preparation Example 1 according to the proportion; (2) Mix the raw materials from step (1), heat to boiling, maintain a gentle boil for 2.0 hours, stop heating, filter with a 300-mesh sieve, remove impurities from the filtrate by high-speed centrifugation, and obtain the extract; (3) The extract from step (2) is concentrated under reduced pressure and low temperature until the relative density of the concentrate is 1.15-1.20. The reduced pressure and low temperature conditions are: pressure ≤0.07MPa and temperature ≤60℃, to obtain the decoction.
[0064] The Trichosanthes kirilowii, Allium macrostemon, and Pinellia ternata decoction of this invention contains modified Pinellia ternata and an anti-inflammatory agent. The modified Pinellia ternata has significant antitussive and expectorant effects (as shown in Table 2, experimental data), and the anti-inflammatory agent has significant airway inflammation-inhibiting effects (as shown in Table 3, experimental data). The Trichosanthes kirilowii, Allium macrostemon, and Pinellia ternata decoction containing the modified Pinellia ternata and anti-inflammatory agent also possesses antitussive, expectorant, and anti-inflammatory effects, achieving the therapeutic goal of "promoting yang and dispersing stagnation, eliminating phlegm and relieving chest congestion."
[0065] The above are merely preferred embodiments of the present invention and do not constitute any limitation on the present invention. Any equivalent substitutions or modifications made by those skilled in the art to the technical solutions and content disclosed in the present invention without departing from the scope of the present invention shall be deemed to have remained within the protection scope of the present invention.
Claims
1. An anti-inflammatory agent, characterized in that, The ingredients include the following parts by weight: 5-9 parts lycopene, 7-11 parts Arisaema cum Bile, 5-9 parts Ophiopogon japonicus, 6-11 parts Cirsium japonicum, 8-14 parts Prunus armeniaca, 6-10 parts Prunus armeniaca, 5-7 parts Cinnamomum cassia, and 4-9 parts Phyllanthus urinaria.
2. The anti-inflammatory agent according to claim 1, characterized in that, The preparation method is as follows: (1) Preparation of the extractant: The extractant is prepared by mixing purified water and ethanol in a weight ratio of 8-15:4-6; (2) Take 7-11 parts of Arisaema cum Bile, 5-9 parts of Ligusticum striatum, 6-11 parts of Cirsium japonicum, 8-14 parts of Prunus armeniaca, 6-10 parts of Prunus armeniaca, 5-7 parts of Cinnamomum cassia, 4-9 parts of Polygonum multiflorum, and 9-20 parts of water, mix them together to obtain mixed Chinese herbal medicines. (3) Add 2500 to 4500 mL of extractant to the mixed herbs in step (2) and vacuum extract at 100 to 150°C for 240 to 260 min to obtain the mixed herbal extract; (4) Concentrate 2000-2500 mL of the mixed herbal extract from step (3) at 50-70°C; (5) Add 5-9 parts of lycopene to the concentrate in step (4), stir, and obtain an anti-inflammatory agent.
3. A method for preparing modified Pinellia ternata, characterized in that, The Pinellia ternata mentioned is ginger-processed Pinellia ternata, modified by the following method: A. Alcohol extraction (1) Take 7-9 parts of ginger and Pinellia ternata, wash, dry, crush, and pass through a 150-200 mesh sieve after processing; (2) Mix the treated ginger pinellia with 60-75% ethanol at a mass ratio of 1:1.5-2, stir for 10-20 min to wet and expand, then put it into a pressure percolation device, add 10-12 parts of 55-60% ethanol solvent, set the pressure to 6-8 MPa, the percolation flow rate to 5-9 mL / min, and collect the filtrate. (3) Then perform water bath heating at 75-80℃ for 35-40 min. After the ethanol evaporates, add it to the microwave device and add 2-4 parts of modifier at the same time. Set the temperature to 50-55℃ and the microwave power to 15-20w. After reacting for 15-20 min, the first filtrate is obtained. B. Fermentation Extraction (1) Preparation of compound bacterial solution: Mix the additives and water to obtain a solvent. The weight ratio of additives to water is 4-6 parts: 50-60 parts. Then add 2-4 parts of lactic acid bacteria, 2-3 parts of yeast, and 2-4 parts of acetic acid bacteria, stir, and obtain a mixed bacterial solution. (2) Place the first filtrate in the mixed bacterial solution and ferment for 3-4 days at 50-55℃ and pH=5-7 to obtain the second filtrate by filtration and sterilization. (3) Ultrasonic treatment, with a power of 100-150w and a time of 40-60min. After the treatment, return to room temperature to obtain the third filtrate. (4) Add an equal amount of distilled water to the third filtrate, seal and shake for 20-30 minutes, let stand for 2-3 hours, filter, concentrate and dry to obtain modified Pinellia ternata powder extract.
4. The method for preparing modified Pinellia ternata according to claim 3, characterized in that, The modifier is acetylcysteine.
5. The method for preparing modified Pinellia ternata according to claim 3, characterized in that, The additive is L-lysine hydrochloride.
6. A modified Pinellia ternata extract, prepared by the preparation method according to any one of claims 3-5.
7. A method for preparing Gualou Xiebai Banxia Decoction, which has the effects of promoting Yang, dispersing stagnation, resolving phlegm, and relieving chest congestion, characterized in that... Includes the following steps: (1) Prepare modified Pinellia ternata according to the method of claim 3, and prepare an anti-inflammatory agent according to the method of claim 2; (2) Take Trichosanthes kirilowii, wash and cut into pieces; wash Allium macrostemon and coarsely crush; weigh 10-17 parts of Trichosanthes kirilowii, 9-13 parts of Allium macrostemon, 11-14 parts of modified Pinellia ternata, 1300-1500 parts of rice wine, and 8-15 parts of anti-inflammatory agent according to the proportion; (3) Mix the raw materials from step (2), heat to boiling, maintain a gentle boil for 1.5-2.0 hours, stop heating, filter with a 200-300 mesh sieve, remove impurities from the filtrate by high-speed centrifugation, and obtain the extract; (4) The extract from step (3) is concentrated under reduced pressure and low temperature until the relative density of the concentrate is 1.15-1.
20. The reduced pressure and low temperature conditions are: pressure ≤0.07MPa and temperature ≤60℃, to obtain the decoction.
8. A Gualou Xiebai Banxia Decoction with the effects of promoting yang, dispersing stagnation, eliminating phlegm, and relieving chest congestion, prepared by the method described in claim 7.