Traditional Chinese medicine extract for treating asthma and preparation method thereof

Abstract

The invention relates to a traditional Chinese medicine extract for treating asthma and a preparation method thereof, the traditional Chinese medicine extract comprises nidus vespae, ginger and mangnolia officinalis according to a weight ratio of 5: (2-3): (3-4); all the components have a synergistic effect, and the effect of treating asthma is remarkable.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine extraction, and more specifically, to a traditional Chinese medicine extract for treating asthma and its preparation method. Background Technology

[0002] Asthma (bronchial asthma) is a common chronic inflammatory airway disease, mainly characterized by recurrent episodes of wheezing, shortness of breath, chest tightness, or coughing, often occurring or worsening at night and in the early morning. The onset of asthma is related to both genetic and environmental factors. Genetic factors primarily determine a patient's predisposition, while environmental factors such as various allergens, air quality, smoking, and exercise are specific triggering factors. Common types of bronchial asthma include exercise-induced, drug-induced, occupational, and allergic asthma.

[0003] Currently, there is no cure for asthma, but medication can control the condition and improve quality of life. Commonly used medications are mainly divided into controller medications and reliever medications. The former are used for long-term disease control, such as inhaled corticosteroids; the latter are used to relieve acute attacks, such as short-acting β2-receptor agonists. These medications have many side effects with prolonged use, easily leading to osteoporosis, secondary infections, adrenal cortex suppression, nausea, and bitter taste in the mouth. In recent years, traditional Chinese medicine has achieved significant research results in the control and treatment of asthma, including research on compound extracts of Chinese herbal medicines, single herbs, and individual Chinese herbal components.

[0004] The honeycomb is made from fruit wasps, a type of wasp belonging to the Vespidae family. Polistes olivaceous (DeGeer), Japanese long-legged wasp Polistes japonicus Saussure or heteroceratops wasp Parapolybia varia Fabricius honeycomb has the effects of attacking poisons and killing insects, dispelling wind and relieving pain; it is often used for sores and carbuncles, mastitis, scrofula, stubborn skin diseases, tinea pedis, toothache, and rheumatic pain. Modern research shows that honeycomb extract contains flavonoids, amides, terpenes and high fatty acids, which have anti-inflammatory, analgesic, antithrombotic and blood vessel clearing, antipruritic and swelling-reducing and anti-tumor biological activities.

[0005] Beehive has a long history of medicinal use. The *Shennong Bencao Jing* (Shennong's Classic of Materia Medica) states that it is "bitter and neutral in nature, and treats epilepsy, convulsions, chills and fever, evil qi, mania, demonic possession, poisoning, and hemorrhoids." Currently, drugs developed using this method include Huzhen Qingfeng Capsules, Feixin Xiazhi Capsules, Musk Rheumatism Tablets, Cidan Capsules, and Xianglu Yiyang Capsules. Chinese patent CN109722354A discloses an antibacterial soap made from beehive extract and its preparation method, which shows inhibitory effects against Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa. Chinese patent CN113679742A discloses a method for preparing and applying an alcoholic extract of beehive, which has a uric acid-lowering effect and can be used to prevent and treat hyperuricemia and gout. Chinese patent CN106806477A discloses a method for preparing a decoction of bee honeycomb for treating rheumatic bone pain, which has therapeutic effects on rheumatic bone pain, joint pain, and lower back and leg pain, and can be applied to the development of related drugs; Chinese patent CN104474207A discloses a method for preparing and applying a traditional Chinese medicine composition containing wild bee honeycomb for treating sprains, which has a low-dose, high-activity therapeutic effect on sprain patients, and few side effects.

[0006] Ginger has a wide range of applications, not only as a spice to enhance the flavor of food, but also as an indispensable ingredient in traditional Chinese medicine prescriptions. In particular, ginger contains essential oil components such as borneol, cineole, citral, phenol, and alkaloids, which can remove unpleasant odors or tastes such as fishiness and stop central vomiting. As for the pungent components, gingerol and shogaol have a strong bactericidal effect against bacteria such as typhoid bacilli or cholerae.

[0007] Magnolia officinalis, a deciduous tree belonging to the genus Magnolia in the family Magnoliaceae. Its bark is thick, brown, does not crack, and is oily with a pungent taste; leaves are large, concentrated at the top of branches, oblong-obovate, with grayish soft hairs and a white bloom on the underside; flowers are white and fragrant; fruits are mostly oblong-ovate; seeds are triangular-obovate; flowering period is May-June, fruiting period is August-October. According to the *Compendium of Materia Medica*, Magnolia officinalis has the effects of warming the middle jiao (spleen and stomach), regulating qi, drying dampness, and resolving phlegm. It is mainly used to treat symptoms such as chest and abdominal fullness, distension and pain, nausea, and vomiting. Summary of the Invention

[0008] The purpose of this invention is to provide a traditional Chinese medicine extract for treating asthma with synergistic effects and its preparation method.

[0009] In a first aspect, the present invention provides a traditional Chinese medicine extract for treating asthma, wherein the traditional Chinese medicine comprises bee honeycomb, ginger and magnolia bark, and the ratio of bee honeycomb, ginger and magnolia bark by weight is 5:(2-3):(3-4).

[0010] In a preferred embodiment of the present invention, the traditional Chinese medicine is composed of bee honeycomb, ginger and magnolia bark, and the ratio of bee honeycomb, ginger and magnolia bark by weight is 5: (2-3): (3-4).

[0011] In a preferred embodiment of the present invention, the honeycomb, ginger, and magnolia bark are in a weight ratio of 5:(2.2-2.8):(3.3-3.7).

[0012] In a preferred embodiment of the present invention, the proportions of honeycomb, ginger, and magnolia bark by weight are 5:2.4:3.5.

[0013] In a preferred embodiment of the present invention, by combining extracts of honeycomb, ginger, and magnolia bark, the effects are synergistic and the therapeutic effect on asthma is significant.

[0014] Another aspect of the present invention is to provide a method for preparing extracts of traditional Chinese medicine.

[0015] An extract of a traditional Chinese medicine for treating asthma, the preparation method includes the following steps: Step (1): Clean the honeycomb, ginger and magnolia bark separately and let them dry. Grind the honeycomb and magnolia bark into powder.

[0016] Step (2): Cut the ginger into small cubes, place them in 90-100℃ steam for 30-60 minutes, remove and let them air dry.

[0017] Step (3): Take honeycomb, ginger and magnolia bark, add water at a weight ratio of 8-10, decoct 2-3 times, each time for 2.0-3.0 hours, combine the decoctions to obtain honeycomb, ginger and magnolia bark water extract, and the residue is honeycomb, ginger and magnolia bark extract powder 1.

[0018] Step (4): Take 1 part of honeycomb ginger and magnolia bark extract powder, add 5-6 times the weight of ethanol solution, extract at 50℃~70℃, and cycle the extraction for 5-10 min of stirring and 10-20 min of standing for a total of 300-360 min. After extraction, separate the solid and liquid to obtain honeycomb ginger and magnolia bark ethanol extract.

[0019] Step (5): Combine the aqueous extract of honeycomb ginger and magnolia bark obtained in step (3) and the ethanol extract of honeycomb ginger and magnolia bark obtained in step (4), add 2-4 times the amount of ethanol-n-heptane mixed solvent, stir for 3-4 hours, let stand for 10-12 hours, filter, freeze dry the filtrate to obtain the Chinese herbal extract for treating asthma.

[0020] In the above preparation method, the "times" mentioned in steps (3), (4), and (5) are based on the sum of the weights of honeycomb, ginger, and magnolia bark in step (1). For example, in step (1), the sum of the weights of honeycomb, ginger, and magnolia bark is 1 kg. In step (3), "adding water at a weight ratio of 8-10 times" means "adding water at a weight ratio of 8-10 kg". In step (4), "adding ethanol solution at a weight ratio of 5-6 times" means "adding ethanol solution at a weight ratio of 5-6 kg". In step (4), "adding ethanol-heptane mixed solvent at a weight ratio of 2-4 times" means "adding ethanol-heptane mixed solvent at a weight ratio of 2-4 kg".

[0021] In a preferred embodiment of the present invention, in step (4), the ethanol solution is an aqueous ethanol solution with a volume ratio of 40%-50%, preferably a 45% ethanol solution.

[0022] In step (5), the volume ratio of ethanol to n-heptane in the mixed solvent of ethanol and n-heptane is 2-3:1, preferably 2.5:1.

[0023] Another aspect of the present invention is to provide a pharmaceutical composition comprising the above-mentioned traditional Chinese medicine extract.

[0024] Furthermore, the pharmaceutical composition also includes pharmaceutically acceptable excipients.

[0025] Furthermore, the pharmaceutical composition is an oral pharmaceutical composition selected from oral lyophilized powder, granules, oral liquid, and tablets.

[0026] The pharmaceutically acceptable excipient can be any excipient in the art suitable for oral administration of pharmaceutical preparations.

[0027] Another object of the present invention is to provide the application of the above-mentioned Chinese herbal extracts and pharmaceutical compositions in the preparation of drugs for treating asthma.

[0028] Compared with the prior art, the present invention has the following beneficial effects: The herbal extract of this invention has a synergistic effect among its components, resulting in a significant therapeutic effect on asthma. Detailed Implementation

[0029] This invention discloses a traditional Chinese medicine extract for treating asthma and its preparation method. Those skilled in the art can refer to the content of this invention and, combined with the relevant principles of traditional Chinese medicine extraction and pharmaceutical preparation, appropriately modify the process parameters to achieve the desired result. It is particularly important to note that all similar substitutions and modifications are obvious to those skilled in the art and are considered to be included within the scope of this invention. The application of this invention has been described through preferred embodiments, and those skilled in the art can obviously make modifications or appropriate changes and combinations to the methods and applications described herein without departing from the content, spirit, and scope of this invention to realize and apply the technology of this invention.

[0030] To better understand the invention and not to limit its scope, all figures indicating amounts, percentages, and other numerical values ​​used in this application should, in all cases, be understood to be modified by the word "approximately." Each numerical parameter should at least be considered as obtained based on reported significant figures and through conventional rounding methods.

[0031] The present invention will be further illustrated by the following examples, but the examples do not limit the present invention in any way.

[0032] Example 1: Preparation of Traditional Chinese Medicine Extracts Step (1): Clean 5 kg of honeycomb, 2.4 kg of ginger, and 3.5 kg of magnolia bark, and let them dry. Grind the honeycomb and magnolia bark into powder.

[0033] Step (2): Cut the ginger into small cubes, place them in 90-100℃ steam for 45 minutes, remove and let them air dry.

[0034] Step (3): Take honeycomb, ginger and magnolia bark, add water at a weight ratio of 95 kg, decoct 3 times, 2.0 hours each time, combine the decoctions to obtain honeycomb, ginger and magnolia bark water extract, and the residue is honeycomb, ginger and magnolia bark extract powder 1.

[0035] Step (4): Take 1 part of honeycomb ginger and magnolia bark extract powder, add 60 kg of 45% ethanol solution, extract at 50℃~70℃, and cycle the extraction for 360 min by stirring for 8 min and standing for 16 min. After extraction, separate the solid and liquid to obtain honeycomb ginger and magnolia bark ethanol extract.

[0036] Step (5): Combine the aqueous extract of honeycomb ginger and magnolia bark obtained in step (3) and the ethanol extract of honeycomb ginger and magnolia bark obtained in step (4), add 33 kg of ethanol-heptane (ethanol to n-heptane volume ratio 2.5:1) mixed solvent, stir for 3.5 hours, let stand for 10.5 hours, filter, freeze dry the filtrate to obtain the Chinese herbal extract for treating asthma.

[0037] Example 2: Preparation of Traditional Chinese Medicine Extracts Step (1): Clean 5 kg of honeycomb, 2.4 kg of ginger, and 3.5 kg of magnolia bark, and let them dry. Grind the honeycomb and magnolia bark into powder.

[0038] Step (2): Cut the ginger into small cubes, place them in 90-100℃ steam for 30 minutes, remove and let them air dry.

[0039] Step (3): Take honeycomb, ginger and magnolia bark, add water at a weight ratio of 88 kg, decoct 3 times, 2.5 hours each time, combine the decoctions to obtain honeycomb, ginger and magnolia bark water extract, and the residue is honeycomb, ginger and magnolia bark extract powder 1.

[0040] Step (4): Take 1 part of honeycomb ginger and magnolia bark extract powder, add 50% ethanol solution with a weight ratio of 55Kg, extract at 50℃~70℃, and cycle the extraction for 300 minutes in total, stirring for 10 minutes and standing for 20 minutes. After extraction, separate the solid and liquid to obtain honeycomb ginger and magnolia bark ethanol extract.

[0041] Step (5): Combine the aqueous extract of honeycomb ginger and magnolia bark obtained in step (3) and the ethanol extract of honeycomb ginger and magnolia bark obtained in step (4), add 24 kg of ethanol-heptane (ethanol to n-heptane volume ratio 2.5:1) mixed solvent, stir for 4 hours, let stand for 12 hours, filter, freeze dry the filtrate to obtain the Chinese herbal extract for treating asthma.

[0042] Example 3: Preparation of Traditional Chinese Medicine Extracts Step (1): Clean 5 kg of honeycomb, 2.4 kg of ginger, and 3.5 kg of magnolia bark, and let them dry. Grind the honeycomb and magnolia bark into powder.

[0043] Step (2): Cut the ginger into small cubes, place them in 90-100℃ steam for 60 minutes, remove and let them air dry.

[0044] Step (3): Take honeycomb, ginger and magnolia bark, add water at a weight ratio of 105 kg, decoct twice, 3.0 hours each time, combine the decoctions to obtain honeycomb, ginger and magnolia bark water extract, and the residue is honeycomb, ginger and magnolia bark extract powder 1.

[0045] Step (4): Take 1 part of honeycomb ginger and magnolia bark extract powder, add 65 kg of 40% ethanol solution, extract at 50℃~70℃, and cycle the extraction for 330 min by stirring for 5 min and standing for 10 min. After extraction, separate the solid and liquid to obtain honeycomb ginger and magnolia bark ethanol extract.

[0046] Step (5): Combine the aqueous extract of honeycomb ginger and magnolia bark obtained in step (3) and the ethanol extract of honeycomb ginger and magnolia bark obtained in step (4), add 42 kg of ethanol-heptane (ethanol to n-heptane volume ratio 2.5:1) mixed solvent, stir for 3 hours, let stand for 10 hours, filter, freeze dry the filtrate to obtain the Chinese herbal extract for treating asthma.

[0047] Example 4: Preparation of Traditional Chinese Medicine Extracts Step (1): Clean 5 kg of honeycomb, 2.4 kg of ginger, and 3.5 kg of magnolia bark, and let them dry. Grind the honeycomb and magnolia bark into powder.

[0048] Step (2): Cut the ginger into small cubes and let them dry.

[0049] Step (3): Take honeycomb, ginger and magnolia bark, add water at a weight ratio of 95 kg, decoct 3 times, 2.0 hours each time, combine the decoctions to obtain honeycomb, ginger and magnolia bark water extract, and the residue is honeycomb, ginger and magnolia bark extract powder 1.

[0050] Step (4): Take 1 part of honeycomb ginger and magnolia bark extract powder, add 60 kg of 45% ethanol solution, extract at 50℃~70℃, and cycle the extraction for 360 min by stirring for 8 min and standing for 16 min. After extraction, separate the solid and liquid to obtain honeycomb ginger and magnolia bark ethanol extract.

[0051] Step (5): Combine the aqueous extract of honeycomb ginger and magnolia bark obtained in step (3) and the ethanol extract of honeycomb ginger and magnolia bark obtained in step (4), add 33 kg of ethanol-heptane (ethanol to n-heptane volume ratio 2.5:1) mixed solvent, stir for 3.5 hours, let stand for 10.5 hours, filter, freeze dry the filtrate to obtain the Chinese herbal extract for treating asthma.

[0052] Example 5: Preparation of Traditional Chinese Medicine Extracts Step (1): Clean 5 kg of honeycomb, 2.4 kg of ginger, and 3.5 kg of magnolia bark, and let them dry. Grind the honeycomb and magnolia bark into powder.

[0053] Step (2): Cut the ginger into small cubes, place them in 90-100℃ steam for 45 minutes, remove and let them air dry.

[0054] Step (3): Take honeycomb, ginger and magnolia bark, add water at a weight ratio of 95 kg, decoct 3 times, 2.0 hours each time, combine the decoctions to obtain honeycomb, ginger and magnolia bark water extract, and the residue is honeycomb, ginger and magnolia bark extract powder 1.

[0055] Step (4): Take the honeycomb ginger and magnolia bark water extract obtained in step (3), add 33 kg of ethanol and n-heptane (ethanol and n-heptane volume ratio 2.5:1) mixed solvent, stir for 3.5 hours, let stand for 10.5 hours, filter, freeze dry the filtrate to obtain the Chinese herbal extract for treating asthma.

[0056] Example 6: Preparation of Traditional Chinese Medicine Extracts Step (1): Clean 5 kg of honeycomb, 2.4 kg of ginger, and 3.5 kg of magnolia bark, and let them dry. Grind the honeycomb and magnolia bark into powder.

[0057] Step (2): Cut the ginger into small cubes, place them in 90-100℃ steam for 45 minutes, remove and let them air dry.

[0058] Step (3): Take honeycomb, ginger and magnolia bark, add 45% ethanol solution with a weight ratio of 60Kg, extract at 50℃~70℃, and cycle the extraction according to the following steps: stir for 8min and let stand for 16min as one cycle, for a total of 360min. After extraction, separate the solid and liquid to obtain honeycomb, ginger and magnolia bark ethanol extract.

[0059] Step (4): Take the honeycomb ginger and magnolia bark ethanol extract obtained in step (4), add 33 kg of ethanol-n-heptane (ethanol and n-heptane volume ratio 2.5:1) mixed solvent, stir for 3.5 hours, let stand for 10.5 hours, filter, freeze dry the filtrate to obtain the Chinese medicine extract for treating asthma.

[0060] Example 7: Preparation of Traditional Chinese Medicine Extracts Step (1): Clean 3.63 kg of honeycomb, 3.63 kg of ginger, and 3.63 kg of magnolia bark, and let them dry. Grind the honeycomb and magnolia bark into powder.

[0061] Step (2): Cut the ginger into small cubes, place them in 90-100℃ steam for 45 minutes, remove and let them air dry.

[0062] Step (3): Take honeycomb, ginger and magnolia bark, add water at a weight ratio of 95 kg, decoct 3 times, 2.0 hours each time, combine the decoctions to obtain honeycomb, ginger and magnolia bark water extract, and the residue is honeycomb, ginger and magnolia bark extract powder 1.

[0063] Step (4): Take 1 part of honeycomb ginger and magnolia bark extract powder, add 60 kg of 45% ethanol solution, extract at 50℃~70℃, and cycle the extraction for 360 min by stirring for 8 min and standing for 16 min. After extraction, separate the solid and liquid to obtain honeycomb ginger and magnolia bark ethanol extract.

[0064] Step (5): Combine the aqueous extract of honeycomb ginger and magnolia bark obtained in step (3) and the ethanol extract of honeycomb ginger and magnolia bark obtained in step (4), add 33 kg of ethanol-heptane (ethanol to n-heptane volume ratio 2.5:1) mixed solvent, stir for 3.5 hours, let stand for 10.5 hours, filter, freeze dry the filtrate to obtain the Chinese herbal extract for treating asthma.

[0065] Example 8: Preparation of Traditional Chinese Medicine Extracts Step (1): Clean 5 kg of honeycomb, 2.4 kg of ginger, and 3.5 kg of magnolia bark, and let them dry. Grind the honeycomb and magnolia bark into powder.

[0066] Step (2): Cut the ginger into small cubes, place them in 90-100℃ steam for 45 minutes, remove and let them air dry.

[0067] Step (3): Take honeycomb, ginger and magnolia bark, add water at a weight ratio of 95 kg, decoct 3 times, 2.0 hours each time, combine the decoctions to obtain honeycomb, ginger and magnolia bark water extract, and the residue is honeycomb, ginger and magnolia bark extract powder 1.

[0068] Step (4): Take 1 part of honeycomb ginger and magnolia bark extract powder, add 60 kg of 45% ethanol solution, extract at 50℃~70℃, and cycle the extraction for 360 min by stirring for 8 min and standing for 16 min. After extraction, separate the solid and liquid to obtain honeycomb ginger and magnolia bark ethanol extract.

[0069] Step (5): Combine the aqueous extract of honeycomb ginger and magnolia bark obtained in step (3) and the ethanol extract of honeycomb ginger and magnolia bark obtained in step (4), add 33 kg of anhydrous ethanol, stir for 3.5 hours, let stand for 10.5 hours, filter, freeze dry the filtrate to obtain the Chinese herbal extract for treating asthma.

[0070] Example 9: Preparation of Traditional Chinese Medicine Extracts Step (1): Clean 5 kg of honeycomb, 2.4 kg of ginger, and 3.5 kg of magnolia bark, and let them dry. Grind the honeycomb and magnolia bark into powder.

[0071] Step (2): Cut the ginger into small cubes, place them in 90-100℃ steam for 45 minutes, remove and let them air dry.

[0072] Step (3): Take honeycomb, ginger and magnolia bark, add water at a weight ratio of 95 kg, decoct 3 times, 2.0 hours each time, combine the decoctions to obtain honeycomb, ginger and magnolia bark water extract, and the residue is honeycomb, ginger and magnolia bark extract powder 1.

[0073] Step (4): Take 1 part of honeycomb ginger and magnolia bark extract powder, add 60 kg of 45% ethanol solution, extract at 50℃~70℃, and cycle the extraction for 360 min by stirring for 8 min and standing for 16 min. After extraction, separate the solid and liquid to obtain honeycomb ginger and magnolia bark ethanol extract.

[0074] Step (5): Combine the aqueous extract of honeycomb ginger and magnolia bark obtained in step (3) and the ethanol extract of honeycomb ginger and magnolia bark obtained in step (4), add 33 kg of n-heptane solvent, stir for 3.5 hours, let stand for 10.5 hours, filter, freeze dry the filtrate to obtain the Chinese herbal extract for treating asthma.

[0075] Example 10: Preparation of Traditional Chinese Medicine Extracts Step (1): Clean 5 kg of honeycomb and 5.9 kg of ginger, and let them dry. Grind the honeycomb into powder.

[0076] Step (2): Cut the ginger into small cubes, place them in 90-100℃ steam for 45 minutes, remove and let them air dry.

[0077] Step (3): Take honeycomb and ginger, add water at a weight ratio of 95 kg, decoct 3 times, 2.0 hours each time, combine the decoctions to obtain honeycomb and ginger water extract, and the residue is honeycomb and ginger extract powder 1.

[0078] Step (4): Take 1 part of honeycomb ginger extract powder, add 60 kg of 45% ethanol solution, extract at 50℃~70℃, and cycle the extraction for 360 min by stirring for 8 min and standing for 16 min. After extraction, separate the solid and liquid to obtain honeycomb ginger ethanol extract.

[0079] Step (5): Combine the honeycomb ginger water extract obtained in step (3) and the honeycomb ginger ethanol extract obtained in step (4), add 33 kg of ethanol-heptane (ethanol to n-heptane volume ratio 2.5:1) mixed solvent, stir for 3.5 hours, let stand for 10.5 hours, filter, freeze dry the filtrate to obtain the Chinese herbal extract for treating asthma.

[0080] Example 11: Preparation of Traditional Chinese Medicine Extracts Step (1): Clean 5 kg of honeycomb and 5.9 kg of magnolia bark separately and let them dry. Grind the honeycomb and magnolia bark into powder.

[0081] Step (2): Take honeycomb and magnolia bark, add water at a weight ratio of 95 kg, decoct 3 times, 2.0 hours each time, combine the decoctions to obtain honeycomb and magnolia bark water extract, and the residue is honeycomb and magnolia bark extract powder 1.

[0082] Step (3): Take 1 part of Magnolia officinalis extract powder and add 60 kg of 45% ethanol solution. The extraction temperature is 50℃~70℃. The extraction cycle is 8 min of stirring and 16 min of standing for a total of 360 min. After the extraction is completed, the solid and liquid are separated to obtain Magnolia officinalis ethanol extract.

[0083] Step (4): Combine the water extract of Magnolia officinalis obtained in step (3) and the ethanol extract of Magnolia officinalis obtained in step (4), add 33 kg of ethanol-heptane (ethanol to n-heptane volume ratio 2.5:1) mixed solvent, stir for 3.5 hours, let stand for 10.5 hours, filter, freeze dry the filtrate to obtain the Chinese herbal extract for treating asthma.

[0084] Example 12: Pharmacodynamic Trial for the Treatment of Asthma 1. Materials and Methods 1.1 Animals Male healthy guinea pigs (weighing 220-280g) should be acclimatized for one week at a room temperature of around 25℃ and a relative humidity of 40% to 70%.

[0085] 1.2 Test Drugs Examples 1-9 of this invention describe the preparation of traditional Chinese medicine extracts.

[0086] 1.3 Grouping and Modeling Mice were randomly divided into a model group and Example 1-9 groups, with 10 mice in each group. All mice were required to undergo modeling.

[0087] Modeling: Model group, Examples 1-9 groups, intraperitoneal injection of 30 mg / kg on the first day. -1 On the second day, 2 mg of ovalbumin and 100 mg of aluminum hydroxide were mixed and injected intraperitoneally in 1 ml suspension. 21 days later, 0.01 mg of ovalbumin and 100 mg of aluminum hydroxide were injected intraperitoneally again in 1 ml suspension. The purpose of the second injection was to induce sensitization in guinea pigs. The guinea pigs were then placed in a 4 L glass bell jar and nebulized with a 1% ovalbumin solution for 30 seconds to induce asthma.

[0088] 1.4 Administration method Starting on the first day after 1% ovalbumin solution was nebulized and inhaled to induce asthma in guinea pigs, groups 1-11 were given a dose of 30 mg / kg of traditional Chinese medicine extract once a day, while the model group was given the same dose of physiological saline by gavage for 10 consecutive days.

[0089] One hour after the last oral administration, 1% ovalbumin was used to stimulate asthma in guinea pigs, and the asthma latency period was recorded. The asthma latency period is the time required from each ovalbumin inhalation to the onset of asthma. Asthma was diagnosed by the occurrence of symptoms such as increased respiratory rate, head nodding during asthma breathing, nasal flaring, and convulsions.

[0090] 2. Experimental Results Note: Compared with the model group, #P<0.05, ##P<0.01; Compared with Example 1, △P<0.05, △△P<0.01.

[0091] ① Compared with the model control group, the traditional Chinese medicine extracts prepared in Examples 1-3 can significantly prolong the latency period of asthma, and all have very significant differences (P<0.01), indicating that the traditional Chinese medicine extracts prepared in Examples 1-3 can treat asthma.

[0092] ② Compared with the model control group, the herbal extract prepared in Example 4 significantly prolonged the latency period of asthma, showing a highly significant difference (P < 0.01). However, compared with Example 1, the latency period of asthma was significantly shortened, showing a significant difference (P < 0.05). This indicates that the herbal extract prepared in Example 4 can treat asthma, but its effect is significantly worse than that of Example 1. This further demonstrates that processing ginger using the specific method of this invention to extract three traditional Chinese medicines—bee honeycomb, magnolia bark, and ginger—results in a synergistic effect and significantly improves the treatment of asthma.

[0093] ③ Compared with the model control group, the herbal extract prepared in Example 7 significantly prolonged the latency period of asthma (P < 0.01), but significantly shortened the latency period compared with Example 1 (P < 0.05). This indicates that the herbal extract prepared in Example 7 can treat asthma, but its effect is significantly worse than that of Example 1. This further demonstrates that a specific weight ratio of bee honeycomb, magnolia bark, and ginger synergistically enhances the effect, resulting in a significant therapeutic effect on asthma.

[0094] ④ Compared with the model control group, the herbal extracts prepared in Examples 8-9 significantly prolonged the latency period of asthma, showing a very significant difference (P<0.01). However, compared with Example 1, the latency period of asthma was significantly shortened, showing a significant difference (P<0.05). This indicates that the herbal extracts prepared in Examples 8-9 can treat asthma, but the effect is significantly worse than that of Example 1. This further demonstrates that the specific method of this invention for extracting three traditional Chinese medicines—bee honeycomb, magnolia bark, and ginger—synergistically enhances their effects and significantly improves the treatment of asthma.

[0095] ⑤ Compared with the model control group, the Chinese herbal extracts prepared in Examples 5-6 significantly prolonged the latency period of asthma, showing a significant difference (P<0.05). However, compared with Example 1, the latency period of asthma was significantly shortened, showing a very significant difference (P<0.01). This indicates that the Chinese herbal extracts prepared in Examples 8-9 can treat asthma, but the effect is significantly worse than that of Example 1. This further illustrates that the specific method of the present invention extracts three Chinese herbal medicines, namely bee honeycomb, magnolia bark, and ginger, which have a synergistic effect and significantly improve the treatment effect of asthma.

[0096] ⑥ Compared with the model control group, the Chinese herbal extracts prepared in Examples 10-11 significantly prolonged the latency period of asthma, showing a significant difference (P<0.05). However, compared with Example 1, the latency period of asthma was significantly shortened, showing a very significant difference (P<0.01). This indicates that the Chinese herbal extracts prepared in Examples 10-11 can treat asthma, but the effect is significantly worse than that of Example 1. This further illustrates that the three Chinese herbal medicines, bee honeycomb, magnolia bark, and ginger, have a synergistic effect and a significant therapeutic effect on asthma.

Claims

1. A traditional Chinese medicine extract for treating asthma, wherein the traditional Chinese medicine comprises bee honeycomb, ginger, and magnolia bark, in a weight ratio of 5:2-3:3-4.

2. The traditional Chinese medicine extract as described in claim 1, characterized in that, The ratio of honeycomb, ginger, and magnolia bark is 5: 2.2-2.8: 3.3-3.

7.

3. The herbal extract as described in claim 1, characterized in that, The ratio of honeycomb, ginger, and magnolia bark is 5:2.4:3.

5.

4. The traditional Chinese medicine extract as described in claim 1, characterized in that, The preparation method includes the following steps: Step (1): Clean the honeycomb, ginger, and magnolia bark separately and let them dry; grind the honeycomb and magnolia bark into powder; Step (2): Cut the ginger into small cubes, place them in 90-100℃ steam for 30-60 minutes, remove and let them air dry; Step (3): Take honeycomb, ginger and magnolia bark, add water at a weight ratio of 8-10, decoct 2-3 times, each time for 2.0-3.0 hours, combine the decoctions to obtain honeycomb, ginger and magnolia bark water extract, and the residue is honeycomb, ginger and magnolia bark extract powder 1. Step (4): Take 1 part of honeycomb ginger and magnolia bark extract powder, add 5-6 times the weight of ethanol solution, extract at 50℃~70℃, and cycle the extraction for 5-10 min of stirring and 10-20 min of standing for a total of 300-360 min. After extraction, separate solid and liquid to obtain honeycomb ginger and magnolia bark ethanol extract. Step (5): Combine the aqueous extract of honeycomb ginger and magnolia bark obtained in step (3) and the ethanol extract of honeycomb ginger and magnolia bark obtained in step (4), add 2-4 times the amount of ethanol-n-heptane mixed solvent, stir for 3-4 hours, let stand for 10-12 hours, filter, freeze dry the filtrate to obtain the Chinese herbal extract for treating asthma.

5. The herbal extract as described in claim 4, characterized in that, In step (4), the ethanol solution is an aqueous solution of ethanol with a volume ratio of 40%-50%.

6. The herbal extract as described in claim 4, characterized in that, In step (4), the ethanol solution is an aqueous solution of ethanol with a volume ratio of 45%.

7. The herbal extract as described in claim 4, characterized in that, In step (3), the volume ratio of ethanol to n-heptane in the mixed solvent of ethanol and n-heptane is 2-3:

1.

8. The herbal extract as described in claim 4, characterized in that, In step (3), the volume ratio of ethanol to n-heptane in the mixed solvent of ethanol and n-heptane is 2.5:

1.

9. A pharmaceutical composition comprising any one of the traditional Chinese medicine extracts according to claims 1-8, characterized in that, It also includes pharmaceutically acceptable excipients.

10. The pharmaceutical composition according to claim 9, characterized in that, The pharmaceutical composition is an oral pharmaceutical composition selected from one of oral lyophilized powder, granules, oral liquid, and tablets.

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