Anti-nodule composition containing ganoderma lucidum spore oil as well as preparation method and application of anti-nodule composition
Through the synergistic effect of Ganoderma lucidum spore oil with Chinese herbal compositions such as 营营营, atomized preparation was prepared into atomized preparation, which solved the shortcomings of lung nodules in the prior art, and achieved significant reduction of lung nodules and improved drug targeting.
Patent Information
- Application Number
- CN202510529384.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-04-25
- Publication Date
- 2025-07-08
AI Technical Summary
The existing technology lacks effective drugs for the treatment of lung nodules. Traditional Chinese medicine treatment mostly relies on syndrome differentiation and treatment, and lacks drugs that directly act on lung nodules.
The swelling of lung nodules is synchronized by using Chinese medicine compositions such as Ganoderma lucidum, swelling of the lung nodules through the form of CO2 supercritical extraction and atomization preparation, and is prepared into atomized preparation to improve targeting and efficacy.
It significantly reduces and even eliminates lung nodules, improves the targeting of drugs and reduces side effects, and achieves effective treatment of lung nodules.
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Abstract
Description
Technical Field
[0001] The present invention relates to the field of traditional Chinese medicine, in particular to an anti-nodule composition containing ganoderma spore oil, a preparation method thereof and an application thereof. Background Art
[0002] Traditional Chinese medicine believes that the cause of nodules is the obstruction of the circulation of body fluids, abnormal distribution, stagnation of water and dampness. If it is not removed for a long time, it will lead to the formation of phlegm turbidity and internal retention in the lungs. The lungs govern all vessels and are in charge of regulation. The lungs can assist the heart in promoting blood circulation and play a role in promoting and regulating the blood circulation. The dysfunction of the ascending and descending movements of the lungs, adverse qi movement, and unsmooth blood circulation will form stasis. In addition, the internal retention of phlegm turbidity and pathogenic toxins affects blood circulation and forms stasis over time.
[0003] Lung nodules refer to soft tissue shadows with clear boundaries, a diameter ≤ 3 cm and surrounded by lung tissue. Traditional Chinese medicine treats lung nodules by the method of syndrome differentiation and treatment in combination with the patient's tongue coating and facial features, giving traditional Chinese medicines for resolving phlegm, relieving cough, softening hard masses and promoting blood circulation to remove stasis, and cooperating with dredging the meridians obstructed in the lungs to eliminate the nodules in the lungs, so that lung nodule patients can avoid surgery.
[0004] The market needs a drug for effectively treating lung nodules, and the present invention solves such problems. Summary of the Invention
[0005] To solve the deficiencies of the prior art, the purpose of the present invention is to provide an anti-nodule composition containing ganoderma spore oil, a preparation method thereof and an application thereof. The spore oil, schizonepeta tenuifolia and dioscorea nipponica Makino synergistically inhibit the swelling of lung nodules, reduce or even eliminate lung nodules, and have good medicinal effects. The present invention solves such problems.
[0006] To achieve the above object, the present invention adopts the following technical solutions: An anti-nodule composition containing ganoderma spore oil, including by mass: 15 - 35 parts of schizonepeta tenuifolia, 30 - 40 parts of astragalus membranaceus, 4 - 16 parts of dioscorea nipponica Makino, 6 - 14 parts of ganoderma spores.
[0007] The above-mentioned anti-nodule composition containing ganoderma spore oil, including by mass: 25 parts of schizonepeta tenuifolia, 35 parts of astragalus membranaceus, 10 parts of dioscorea nipponica Makino, 10 parts of ganoderma spores.
[0008] The above-mentioned anti-nodule composition containing ganoderma spore oil further includes: 15 - 35 parts of poria cocos, 7 - 13 parts of laminaria japonica, 7 - 13 parts of licorice.
[0009] The above-mentioned anti-nodule composition containing ganoderma spore oil further includes: 25 parts of poria cocos, 10 parts of laminaria japonica, 10 parts of licorice.
[0010] The preparation method of the above-mentioned anti-nodule composition containing ganoderma spore oil includes the following steps: Step 1: Wash, filter, dry and sterilize 6 - 14 parts of Ganoderma lucidum spores, crush them by low-temperature airflow wall-breaking, and then obtain Ganoderma lucidum spore oil and residues by CO2 supercritical extraction; Step 2: Crush and mix the residues with other traditional Chinese medicines in the formula, add 8 times the weight of water, decoct once according to the decoction steps, and filter to obtain filter cakes and the first filtrate; Step 3: Decoct the obtained filter cakes once according to the decoction steps and filter to obtain the second filtrate; Step 4: Mix the first filtrate and the second filtrate and perform rotary evaporation to obtain an extract.
[0011] For the preparation method of the anti-nodule composition containing Ganoderma lucidum spore oil described above, the decoction steps in Steps 2 and 3 are: decoct at 120°C for 30 min and then decoct at 70°C for 15 min.
[0012] For the application of the anti-nodule composition containing Ganoderma lucidum spore oil described above, when applied to the preparation of an aerosol preparation, it includes the following steps: Step A: Take the extract and add cyclodextrin for inclusion to obtain an inclusion liquid; Step B: Mix the inclusion liquid, Ganoderma lucidum spore oil, and pharmaceutical excipients evenly, adjust the pH to 6.6 - 7.8 with a pH regulator, filter and sterilize; Step C: Use a medical aerosol device to make it in the form of an aerosol for use.
[0013] For the application of the anti-nodule composition containing Ganoderma lucidum spore oil described above, the cyclodextrin is hydroxypropyl-β-cyclodextrin with an average degree of substitution of 2.0 - 10.0.
[0014] For the application of the anti-nodule composition containing Ganoderma lucidum spore oil described above, the pH regulator is selected from one or more of sodium hydroxide, potassium hydroxide, and sodium bicarbonate.
[0015] For the application of the anti-nodule composition containing Ganoderma lucidum spore oil described above, the pharmaceutical excipient is a fragrance.
[0016] The advantages of the present invention are as follows: The present invention discovers that there is a synergistic effect between spore oil, Speranskia tuberculata, and Dioscorea nipponica in inhibiting the swelling of lung nodules, and the medicine of the formula of the present invention can shrink or even eliminate lung nodules with good efficacy; The present invention adopts an aerosol preparation, which improves the targeting, enhances the drug efficacy, and reduces the side effects. Detailed Embodiments
[0017] The present invention will be specifically introduced below in combination with specific embodiments.
[0018] Pharmacology: Glandweed: Nature and flavor: sweet, pungent, warm; Meridians entered: the lung and liver meridians. Efficacy and indications: 1. Expel wind and remove dampness. This herb is pungent and warm. Pungency can promote dispersion, and warmth can overcome cold and dampness. Entering the liver meridian, it can expel wind and remove dampness. As stated in Compendium of Materia Medica, glandweed "treats all rheumatic pains and contractions of muscles and bones." If limb pain, numbness, and restricted flexion and extension are caused by invasion of the limb meridians by wind-cold-damp pathogens, this herb can be selected to expel wind, dispel cold, and remove dampness. Once the pathogenic factors are removed, all symptoms will naturally subside. 2. Soothe tendons and activate collaterals. This herb is pungent, dispersing, warm, and dredging, and enters the liver meridian, and the liver governs the tendons. Therefore, this herb has the efficacy of soothing tendons and activating collaterals. For externally contracted wind-cold pathogens with qi of meridians failing to disperse, manifested as contraction and spasm of limb tendons and inability to stretch and rotate freely, glandweed can be selected to expel wind and cold and soothe tendons and activate collaterals for treatment. For example, Gansu, Ningxia, Qinghai and Shaanxi Chinese Herbal Medicines Selection selects this herb to treat tendon contracture. 3. Promote blood circulation and relieve pain. This herb is pungent, dispersing, warm, and dredging, and enters the blood aspect of the liver meridian, so it can promote blood circulation and relieve pain. For various pains in the whole body, including the heart, abdomen, waist, and knees, both internal and external, this herb can be selected for treatment, taking advantage of its properties of being pungent, warm, good at moving, promoting blood circulation, and regulating qi. When qi and blood circulate smoothly, there will be no pain. 4. Detoxify and resolve skin rashes. Lingmi Dan Yao Jian states: "Treats heat toxin." Yangcheng's Experience Formula selects this herb to treat the initial stage of swelling toxin. Gansu, Ningxia, Qinghai and Shaanxi Chinese Herbal Medicines Selection uses this herb to treat scrotal eczema and sores and ulcers. Therefore, it can be considered that glandweed treats sores, tinea, swelling toxin, and scrotal eczema, usually by decocting and washing externally. Because washing with this herb externally also has the characteristics of guiding the herb to penetrate into the meridians and blood vessels, and expelling wind, promoting blood circulation, and relieving pain.
[0019] Astragalus membranaceus: Taste: sweet; Nature: slightly warm; Meridians entered: the spleen and lung meridians. Efficacy: Invigorate the spleen and replenish the middle, elevate yang and lift prolapse, benefit the defensive qi and consolidate the exterior, promote diuresis, and support detoxification and generate flesh.
[0020] Dioscorea nipponica: Taste: sweet and bitter; Nature: warm; Meridians entered: the liver, kidney, and lung meridians; Efficacy: Has the effects of expelling wind and removing dampness, soothing tendons and activating collaterals, promoting blood circulation and relieving pain, and relieving cough and asthma.
[0021] Ganoderma lucidum spores: The chemical constituents of Ganoderma lucidum spores can be divided into the following categories: proteins and amino acids, glycoproteins, vitamins, carotenoids, sterols, triterpenoids, alkaloids, fatty acids, lactones, and inorganic ions, etc. The protein content in Ganoderma lucidum spores reaches 18%. Among them, the content of essential amino acids such as isoleucine, leucine, lysine, valine, methionine, and phenylalanine is very rich, all reaching 10 g / kg. The vitamins are mainly vitamin E (VE). In every 100 g of spores, the VE content exceeds 60 mg. In addition, a small amount of vitamin C is also contained. Ganoderma lucidum spores are rich in polysaccharides and oligosaccharides. The contents of disaccharides, trisaccharides, and tetrasaccharides are 1.94, 1.67, and 2.5 mg / g respectively. The sterols include ergosta-7,22-diene-3-ol and β-sitosterol. Some triterpenoid compounds have also been isolated from the acidic extract of Ganoderma lucidum spore powder, which are ganosporeic acid A, B, C, E and ganodenn anon-Trol. And new triterpenoid substances are constantly being discovered in Ganoderma lucidum spores, and these substances have good biological activities. The fatty acids in Ganoderma lucidum spores include tetracosanoic acid, stearic acid, palmitic acid, docosanoic acid, etc. Its lactones belong to pentacyclic triterpene lactones, including Ganoderma lucidum spore lactone A and B. The alkaloids include choline, betaine, and thiotriazoline methylamine salt. The inorganic elements include calcium, phosphorus, iron, magnesium, sodium, zinc, germanium, selenium, etc.
[0022] Poria cocos: Sweet in taste, light in flavor, neutral in property. It acts on the heart, lung, spleen, and kidney meridians. Promotes diuresis and percolates dampness, strengthens the spleen, and calms the mind. It is used for oliguria with edema, dizziness and palpitation due to phlegm-fluid retention, poor appetite due to spleen deficiency, loose stools and diarrhea, restlessness of the mind, palpitations, and insomnia.
[0023] Laminaria japonica: Salty in taste, cold in nature. It acts on the liver, stomach, and kidney meridians. Its effects are: softening hardness and dissipating nodules, resolving phlegm, and promoting diuresis. It is used for goiter, scrofula, swelling and pain of the testicles, and edema due to phlegm-fluid retention.
[0024] Licorice root: Sweet in taste, neutral in property; it acts on the heart, lung, spleen, and stomach meridians; its effects are: invigorating the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, alleviating pain by relaxing muscles, and coordinating the actions of various drugs. Licorice root has been recorded in Chinese materia medica books of all dynasties. Licorice root is not only a good medicine but also has the laudatory name of "the king of all medicines". Dingchuan Decoction (Ephedra, Ginkgo biloba, Morus alba root bark, Perilla seed, Apricot kernel, Scutellaria baicalensis, Tussilago farfara, Pinellia ternata, Licorice root) in "She Sheng Zhong Miao Fang" in the Ming Dynasty has a certain curative effect on the treatment of chronic bronchitis and asthmatic bronchitis.
[0025] Prepare samples according to the formula of the following examples Example 1: 35 g of Speranskia tuberculata, 30 g of Astragalus membranaceus, 4 g of Dioscorea nipponica, 14 g of Ganoderma lucidum spores; Example 2: 25 g of Speranskia tuberculata, 35 g of Astragalus membranaceus, 10 g of Dioscorea nipponica, 10 g of Ganoderma lucidum spores; Example 3: 15 g of Speranskia tuberculata, 40 g of Astragalus membranaceus, 16 g of Dioscorea nipponica, 6 g of Ganoderma lucidum spores; Example 4: 35 g of Speranskia tuberculata, 30 g of Astragalus membranaceus, 4 g of Dioscorea nipponica, 14 g of Ganoderma lucidum spores, 15 parts of Poria cocos, 13 parts of Ecklonia kurome, 13 parts of Glycyrrhiza uralensis; Example 5: 25 g of Speranskia tuberculata, 35 g of Astragalus membranaceus, 10 g of Dioscorea nipponica, 10 g of Ganoderma lucidum spores, 25 parts of Poria cocos, 10 parts of Ecklonia kurome, 10 parts of Glycyrrhiza uralensis; Example 6: 15 g of Speranskia tuberculata, 40 g of Astragalus membranaceus, 16 g of Dioscorea nipponica, 6 g of Ganoderma lucidum spores, 35 parts of Poria cocos, 7 parts of Ecklonia kurome, 7 parts of Glycyrrhiza uralensis; Comparative Example 1: 35 g of Astragalus membranaceus, 10 g of Dioscorea nipponica, 10 g of Ganoderma lucidum spores; lacking Speranskia tuberculata compared with Example 2; Comparative Example 2: 25 g of Speranskia tuberculata, 10 g of Dioscorea nipponica, 10 g of Ganoderma lucidum spores; lacking Astragalus membranaceus compared with Example 2; Comparative Example 3: 25 g of Speranskia tuberculata, 35 g of Astragalus membranaceus, 10 g of Ganoderma lucidum spores; lacking Dioscorea nipponica compared with Example 2; Comparative Example 4: 25 g of Speranskia tuberculata, 35 g of Astragalus membranaceus, 10 g of Dioscorea nipponica; lacking Ganoderma lucidum spores compared with Example 2; Examples 1-6 and Comparative Examples 1-3 were prepared according to the following preparation method, including the following steps: Step 1: After washing, filtering, dry sterilization, and low-temperature airflow wall-breaking and pulverizing 6-14 parts of Ganoderma lucidum spores, Ganoderma lucidum spore oil and residues were obtained by CO2 supercritical extraction; Step 2: The residues and other traditional Chinese medicines in the formula were stirred and mixed, 8 times the weight of water was added, and it was decocted at 120 °C for 30 min, then decocted at 70 °C for 15 min, and filtered to obtain filter cakes and the first filtrate; Step 3: The obtained filter cakes were decocted once again, and filtered to obtain the second filtrate; Step 4: The first filtrate and the second filtrate were mixed and rotary evaporated to obtain an extract.
[0026] The preparation of the atomization preparation includes the following steps: Step 1: Take the extract and add cyclodextrin for inclusion to obtain an inclusion liquid; the cyclodextrin selected is hydroxypropyl-β-cyclodextrin with an average degree of substitution of 2.0-10.0.
[0027] Step 2: Mix the inclusion liquid, Ganoderma lucidum spore oil, and 0.6 ml of essence, mix evenly, adjust the pH to 6.6-7.8 with a pH regulator, filter and sterilize; the pH regulator selected is sodium bicarbonate.
[0028] The preparation method of Comparative Example 4 includes the following steps: Step 1: Crush and mix the traditional Chinese medicines in the formula, add 8 times the weight of water, decoct at 120 °C for 30 min, then decoct at 70 °C for 15 min, and filter to obtain a filter cake and the first filtrate. Step 3: Repeat the decoction of the obtained filter cake once, filter to obtain the second filtrate. Step 4: Mix the first filtrate and the second filtrate and perform rotary evaporation to obtain an extract.
[0029] The preparation of the atomization preparation includes the following steps: Step 1: Take the extract and add cyclodextrin for inclusion to obtain an inclusion liquid; the cyclodextrin is hydroxypropyl-β-cyclodextrin with an average degree of substitution of 2.0 - 10.0.
[0030] Step 2: Mix the inclusion liquid and 0.6 ml of essence, mix evenly, adjust the pH to 6.6 - 7.8 with a pH regulator, filter and sterilize; the pH regulator is 5% sodium bicarbonate.
[0031] Experiment 1: Inhibition rate of pulmonary nodule swelling Select 110 male SD rats, 10 rats in each group; divide into 11 groups. 1 group is the blank group and is raised normally. 10 groups of model groups are modeled according to the following modeling method. After successful modeling, take 2 ml of each sample and mix it with 16 ml of normal saline, and use a medical atomizer to act on the rats. The medication lasts for 60 days. After the administration is completed, the rats in each group are anesthetized and sacrificed, the weight of the rat lung tissue is weighed, and the inhibition rate of pulmonary nodule swelling is calculated. The results are shown in Table 1.
[0032] Modeling method: Intraperitoneally inject a 4.5% sodium pentobarbital solution (dose: 40 mg / kg body weight) into the rats in each group. Cut open the neck of the rats to separate the muscles, expose the trachea, and use the non-exposed tracheal intubation method for poisoning. Inject 200 μL of a 250 g / L silicon dioxide suspension into the trachea at one time.
[0033] Inhibition rate of pulmonary nodule swelling = (lung swelling system of the administration group - lung swelling coefficient of the blank group) / (lung swelling coefficient of the model group - lung swelling coefficient of the blank group) × 100% Table 1 It can be seen from the above results that the products prepared in the examples of the present invention all have excellent inhibition rates of pulmonary nodule swelling. From the comparison of Examples 1 - 6 and Comparative Examples 1, 3, and 4, it is found that the present invention discovers that there is a synergistic effect between spore oil, schizonepeta root, and dioscorea nipponica in inhibiting pulmonary nodule swelling.
[0034] II. Clinical study of pulmonary nodules According to the "Chinese Expert Consensus on the Diagnosis and Treatment of Pulmonary Nodules (2018 Edition)", pulmonary nodules refer to round or irregular lesions in the lungs with a diameter less than or equal to 2 cm, and the imaging manifestation is a shadow with increased density.
[0035] The samples of each example correspond to a treatment group, with 10 people in each group. One person undergoes atomization treatment once in the morning and once in the evening. For each sample, 6 ml is mixed with 24 ml of normal saline, and an atomizer is used for atomization treatment. The long diameter × short diameter before treatment, 1 month after treatment, and 2 months after treatment are recorded in the image, and the average reduction amount in mm compared to before treatment is calculated. The average results are shown in Table 2: Table 2 It can be concluded from the above that after taking the traditional Chinese medicine composition provided by the present invention for 2 months, the pulmonary nodules can basically be reduced by more than 3 mm, and the drug of the formula of the present invention has a good effect on reducing pulmonary nodules.
[0036] The above shows and describes the basic principles, main features and advantages of the present invention. Those skilled in the art should understand that the above embodiments do not limit the present invention in any form, and any technical solutions obtained by using equivalent substitution or equivalent transformation fall within the protection scope of the present invention.
Claims
1. An anti-nodule composition containing ganoderma spore oil, characterized in that, By mass parts, it includes: 15 - 35 parts of Speranskia tuberculata, 30 - 40 parts of Astragalus membranaceus, 4 - 16 parts of Dioscorea nipponica, 6 - 14 parts of Ganoderma lucidum spores.
2. The anti-nodule composition containing ganoderma spore oil according to claim 1, characterized in that, By mass parts, it includes: 25 parts of Speranskia tuberculata, 35 parts of Astragalus membranaceus, 10 parts of Dioscorea nipponica, 10 parts of Ganoderma lucidum spores.
3. The anti-nodule composition containing ganoderma spore oil according to claim 1, characterized in that, It also includes: 15 - 35 parts of Poria cocos, 7 - 13 parts of Ecklonia kurome, 7 - 13 parts of Glycyrrhiza uralensis.
4. The anti-nodule composition containing ganoderma spore oil according to claim 3, characterized in that, It also includes: 25 parts of Poria cocos, 10 parts of Ecklonia kurome, 10 parts of Glycyrrhiza uralensis.
5. The preparation method of an anti-nodule composition containing ganoderma spore oil according to claim 1, characterized in that, It includes the following steps: Step 1: After washing, filtering, dry sterilizing, and low - temperature airflow wall - breaking and pulverizing 6 - 14 parts of Ganoderma lucidum spores, then extracting with CO2 supercritical fluid to obtain Ganoderma lucidum spore oil and residues. Step 2: Pulverize and mix the residues with other traditional Chinese medicines in the formula, add 8 times the weight of water, and decoct once according to the decocting steps, then filter to obtain filter cakes and the first filtrate. Step 3: Decoct the obtained filter cakes once according to the decocting steps and filter to obtain the second filtrate. Step 4: Mix the first filtrate and the second filtrate and perform rotary evaporation to obtain the extract.
6. The preparation method of an anti-nodule composition containing ganoderma spore oil according to claim 5, characterized in that, The decocting steps in Steps 2 and 3 are: decoct at 120°C for 30 min, and then decoct at 70°C for 15 min.
7. Use of an anti-nodule composition containing ganoderma spore oil according to claim 5, characterized in that, When applied to the preparation of an aerosol preparation, it includes the following steps: Step A: Take the extract and add cyclodextrin for inclusion to obtain the inclusion liquid. Step B: Mix the inclusion liquid, Ganoderma lucidum spore oil, and pharmaceutical excipients, mix evenly, adjust the pH to 6.6 - 7.8 with a pH regulator, filter and sterilize. Step C: Use a medical aerosol device to make it into an aerosol form for use.
8. Use of an anti-nodule composition containing ganoderma spore oil according to claim 7, characterized in that, The cyclodextrin is hydroxypropyl - β - cyclodextrin with an average degree of substitution of 2.0 - 10.
0.
9. Use of an anti-nodule composition containing ganoderma spore oil according to claim 7, characterized in that, The pH regulator is selected from one or more of sodium hydroxide, potassium hydroxide, and sodium bicarbonate.
10. Use of an anti-nodule composition containing ganoderma spore oil according to claim 7, characterized in that, The pharmaceutical excipient is a fragrance.