Use of a herbal composition in preparing a medicament for treating neurogenic pulmonary edema

JP2024533770A5Active Publication Date: 2025-06-18SHANDONG NEW TIME PHARMA CO LTD
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Patent Information

Application Number
JP2024519249
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2021-09-30
Filing Date
2022-09-29
Publication Date
2025-06-18
Estimated Expiration
2042-09-29

AI Technical Summary

Technical Problem

Neurogenic pulmonary edema, caused by brain injury or central nervous system disease, lacks effective treatments in traditional Chinese medicine and modern clinical practices, leading to severe symptoms and potential respiratory failure.

Method used

A novel Chinese herbal medicine composition comprising Jinghuan, Windproof, Qianghu, Dokkatsu, Chaihu, Qianhu, Senkyu, Conchihu, Boulei, and Bellflower, formulated into various oral preparations, is developed to reduce lung edema and improve lung tissue pathology.

Benefits of technology

The herbal composition significantly reduces lung index and wet weight, alleviating pulmonary edema and improving lung tissue pathology in animal models of neurogenic pulmonary edema, offering a safer alternative to modern treatments.

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Abstract

Provided is a traditional Chinese medicine composition for treating neurogenic pulmonary edema. The traditional Chinese medicine composition is mainly prepared with Qiang Huo, Angelica Root, Poria Cocos, Fangfeng, Scutellaria Baicalensis, Cnidium Root, Platycodon Root, Bupleurum Root, Qianhu, Citrus Fruit Root, Licorice Root, and Licorice Root. The traditional Chinese medicine composition can improve the lung index and lung wet weight / dry weight of rats with neurogenic pulmonary edema, and has a therapeutic effect on neurogenic pulmonary edema.
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Description

[Technical field]

[0001] The present invention belongs to the technical field of medicine, and relates to a new use of a traditional Chinese medicine composition, particularly to the use of the traditional Chinese medicine composition in preparing a medicament for treating neurogenic pulmonary edema, which comprises Scutellaria Baicalensis, Fangfeng Root, Qianhuo Root, Angelica Root, Bupleurum Root, Qianhuo Root, Cnidium Root, Zingiber officinale, Poria Root, Platycodon Root, and Licorice Root. [Background technology]

[0002] Pulmonary edema is caused by fluid accumulation in the pulmonary interstitium or alveoli, resulting in increased pulmonary extravascular fluid volume and / or increased intracapillary pressure. The main clinical symptoms of acute pulmonary edema include dyspnea, cyanosis, coughing, colorless or pink foam, and diffuse pulmonary rales, which can lead to respiratory failure and death in severe cases. Pulmonary edema is a common and severe disease with a high incidence and poor prognosis.

[0003] Pulmonary edema can be divided into cardiogenic pulmonary edema and noncardiogenic pulmonary edema, among which, cardiogenic pulmonary edema is caused by a sudden increase in blood return volume and right ventricular output due to heart disease, or a sudden decrease in left ventricular output, which causes a large amount of blood to accumulate in the pulmonary circulation, leading to a sudden increase in pulmonary capillary venous pressure. When the pressure in the pulmonary capillaries exceeds the colloidal osmotic pressure, the hemodynamics in the capillaries changes, causing congestion in the pulmonary circulation, increasing the permeability of the pulmonary capillary walls, and allowing liquid to filter through the capillary walls, resulting in pulmonary edema.

[0004] There are many causes of noncardiogenic pulmonary edema, but its etiology is primarily due to elevated alveolar-capillary pressure, increased alveolar-capillary permeability, decreased plasma oncotic pressure, or other factors such as impaired pulmonary lymphatic reflux and increased negative pressure within the tissue compartment.Neurogenic pulmonary edema refers to a clinical syndrome of acute pulmonary edema caused by acute interstitial and alveolar fluid leakage caused by brain injury or central nervous system disease, despite the absence of primary cardiac or pulmonary disease.

[0005] In clinical practice, pulmonary edema is treated with antibiotics, corticosteroids, diuretics, vasodilators, etc. depending on the cause of the pulmonary edema. However, these medications have side effects to varying degrees; for example, vasodilators can cause a drop in blood pressure, and diuretics can cause electrolyte imbalance.

[0006] The name of the disease pulmonary edema did not exist in ancient medical texts, nor is it recorded in ancient medical texts of traditional Chinese medicine, but the symptoms of pulmonary edema are similar to those of traditional Chinese medicine, such as "dysentery," "asthma," "lung swelling," "watery air," and "upper air cough." According to the main clinical symptoms of pulmonary edema and ancient understanding and modern clinical practice, there are three causes of pulmonary edema: external evil spirits attacking the lungs, heart disease and lung disease, and weakening due to chronic diseases.

[0007] Jingfang Granules are a combination of Jingjiang, Fangfeng, Qianghuo, Angelica Root, Bupleurum Root, Quercus Root, Cnidium Root, Zingiber officinale, Poria Cocos, Platycodon Root, and Licorice. They have a diaphoretic effect, relieve surface symptoms, dispel wind and phlegm, purify the lungs, and relieve coughs. They are known to be very effective in treating a series of symptoms caused by exogenous wind and cold, and are safe with almost no side effects. Summary of the Invention

[0008] The present invention provides a new herbal composition for treating neurogenic pulmonary edema, which is prepared with Scutellaria Baicalensis, Fangfeng, Qianhuo, Angelica Root, Bupleurum Root, Qianhuo, Cnidium Officinale, Zi Hua, Poria Cocos, Platycodon Grandiflorum, and Licorice.The present invention is based on the conventional product Scutellaria Baicalensis Granule and further develops its use, and based on the feedback of clinical use, the inventors have researched and developed a new use of Scutellaria Baicalensis Granule and its prescription.The experimental research results show that Scutellaria Baicalensis Granule can significantly reduce the lung index and lung wet weight / dry weight of rats with oleic acid-induced neurogenic pulmonary edema, improve the pathological state of rat lung tissue, and reduce the degree of lung tissue edema. The Jingfang Granules prepared with the herbal medicine composition of the present invention can also significantly reduce the lung wet weight / dry weight of mice with neurogenic pulmonary edema induced by spinal cord injury, improve the pathological state of mouse lung tissue, and reduce the degree of edema of lung tissue, thereby increasing the number of drugs for the clinical treatment of neurogenic pulmonary edema.

[0009] Scutellaria: Scutellaria is warm and has the effect of relieving stimulating heat and superficial wind, and can be widely used for patients with wind-chill and wind-heat, as well as patients with no obvious cold or fever. Scutellaria also plays a role in curing rashes and relieving sores, and has a certain therapeutic effect on diseases such as sores, rubella, and measles, and can also relieve itching. In addition, when Scutellaria is fried over charcoal, its properties change from hot and spicy to bitter and mild, and it has a certain hemostatic effect, and can improve symptoms such as bloody stools, postpartum bleeding, and uterine bleeding.

[0010] Fengfeng: Fengfeng has pungent and warming properties, and has the effect of dispelling wind and relieving surface symptoms, and has a certain effect on headaches, anasthenia, fever, etc. caused by colds due to wind and chills. Fengfeng also has the effect of dispelling dampness and relieving pain, and can relieve rheumatic joint pain, joint pain, and other symptoms. In addition, Fengfeng has an antispasmodic effect and can improve the symptoms of hand and foot spasms. Modern pharmacological research has shown that Fengfeng has sedative, analgesic, and antispasmodic effects, and is often used as an auxiliary treatment for tetanus.

[0011] Qiang Huo: In traditional Chinese medicine, Qiang Huo is considered to have the properties of pungent, bitter and warming, and to act on the bladder and kidneys, relieving surface symptoms, clearing cold, clearing wind and dampness, and relieving pain. First, Qiang Huo has a pungent taste, has the effects of dissipating and promoting, and can relieve surface symptoms. In addition, it has the properties of warming the body, so it can treat the wind-chill symptoms of cold. In addition, Qiang Huo has the properties of warming and drying, and has the effect of clearing dampness. In addition to the function of relieving surface symptoms, it also has the function of clearing wind and overcoming dampness, and can treat wind-chill and dampness in the upper body. Qiang Huo also has an analgesic effect and can be used externally or internally. Modern pharmacological research has shown that the volatile oil of Qiang Huo has obvious antipyretic and analgesic effects and has the effect of inhibiting skin fungi.

[0012] Euonymus ulmoides: Euonymus ulmoides has the effect of harmonizing the meridians, improving the flow of qi and blood, and clearing wind and dampness, and relieving symptoms such as joint pain, decreased joint flexion and extension, and paralysis of the hands and feet caused by wind-cold dampness. Euonymus ulmoides can also be used to relieve symptoms such as toothache caused by wind and fire and headache caused by wind. It is commonly used in clinical practice to treat diseases such as rheumatoid arthritis, chronic rheumatoid arthritis, sciatica, cervical spondylosis, and frozen shoulder.

[0013] Bupleurum Root: Bupleurum Root acts on the liver, releasing liver qi stagnation and promoting liver qi circulation, and has a certain regulating effect on symptoms such as chest and hypochondrium pain, menstrual irregularities, mental depression, and pain due to breast expansion. Bupleurum Root has a slight cooling property and antipyretic effect, and can relieve fever caused by diseases such as acute bronchitis, acute tracheitis, and viral pneumonia. Bupleurum Root also has the effect of strengthening yang, and can improve symptoms such as qi deficiency and organ prolapse. Pharmacological studies have shown that Bupleurum Root has sedative and analgesic effects, and has the effect of protecting the liver and reducing liver damage.

[0014] Qianhu: Qianhu is bitter, pungent and slightly cold in nature, and acts on the lungs. It is effective for coughing with yellow phlegm, a lot of phlegm or sticky phlegm, fever, dry mouth, shortness of breath, and other diseases caused by accumulation of phlegm and heat in the lungs and impaired function of dispersing and lowering the lungs. It can eliminate the fire in the lungs, ease the upward movement of the lung qi, and help reduce the fire, and is also useful for treating infectious diseases such as bronchitis and pneumonia. Qianhu also has the effect of dispersing wind and clearing heat, making it suitable for patients with exogenous wind-heat, dispersing wind-heat, and relieving symptoms such as headache, irritability, and insomnia.

[0015] Cnidium officinalis: Cnidium officinalis is a herbal medicine commonly used in clinical Chinese medicine. It mainly grows in mild climates and has mild properties, acting on the liver, gallbladder and pericardium. For patients with chest and flank pain, wind-induced numbness, menstrual irregularity and pain from falling, it has the effects of promoting blood circulation, removing congestion, clearing wind and relieving pain, so as to relieve pain and regularize menstruation. In addition, the volatile oil components contained in Cnidium officinalis have a certain inhibitory effect on brain activity, preventing excessive excitement in the human body and providing a sedative effect.

[0016] Citrus Fruit: In traditional Chinese medicine, Citrus Fruit has a bitter taste and is believed to have the effect of improving the flow of qi, restoring the normal circulation of qi, relieving stagnation, and relieving abdominal distension. Citrus Fruit is the unripe dried fruit of oranges, and its properties and meridian properties are similar to Citrus Fruit, but its effects are relatively milder, improving the flow of qi, restoring the normal circulation of qi, and relieving bloating, so it can be used to treat qi stagnation, chest and hypochondria, bloating and pain, food indigestion, flatulence, and sagging. Citrus Fruit is widely used in diet therapy, mainly used to strengthen the spleen and digestion, and can relieve symptoms of bloating and discomfort. The latest pharmacological research has shown that Citrus Fruit has the effect of regulating gastrointestinal motility and stimulating intestinal smooth muscles.

[0017] Poria cocoon: Poria cocoon has a gentle nature and acts on the spleen. When steeped in water and drunk, it strengthens the spleen and has a certain regulating effect on spleen deficiency, loss of appetite, loose stools, and diarrhea. Poria cocoon also acts on the heart and has a calming effect, relieving symptoms such as panic, insomnia, and anxiety, and helping to improve the quality of sleep. In addition, when steeped in water and drunk, it has a diuretic and moistening effect, which can relieve symptoms such as edema, oliguria, and difficulty urinating.

[0018] Platycodon grandiflorum: Platycodon grandiflorum has a bitter, pungent, and mild nature and acts on the lungs. Platycodon grandiflorum is usually used to treat conditions such as cough with excess phlegm, chest tightness, sore throat, hoarseness, lung abscess, and vomiting of pus. Platycodon grandiflorum water has the effect of lowering blood lipids and blood sugar levels.

[0019] Licorice: Licorice has a sweet and flat taste, and acts on the heart, lungs, spleen and stomach. It has the effect of replenishing qi and invigorating the pulse, and after honey roasting, the ability to replenish qi is enhanced. It can be used to treat heart energy deficiency, palpitations and slow pulse. It can clear heat and detoxify. Licorice has a sweet and cool taste, and can clear heat and detoxify. It can be used to help treat sore throat and epilepsy. Licorice has a gentle nature, has mild medicinal properties, can clear phlegm, stop cough, replenish qi and moisturize the lungs. It can be used to treat wind-cold cough, wind-heat cough, cold phlegm cough, wet phlegm cough and dry cough. When licorice acts on the upper abdomen, it has the effect of strengthening the spleen and stomach, relieving pain and relieving pain. It can also be used to treat spleen and stomach qi deficiency, fatigue, loss of appetite, loose stools, abdominal distension and acute pain in the hands and feet.

[0020] The present invention provides a specific composition of the above-mentioned herbal medicine composition, which mainly comprises:

[0021] It is prepared using 5 to 30 parts by weight of sedge and 5 to 30 parts by weight of windbreaker as raw materials.

[0022] The herbal medicine composition mainly comprises:

[0023] It is prepared using 10-20 parts by weight of sedge and 15-25 parts by weight of windbreaker as raw materials.

[0024] The herbal medicine composition mainly comprises:

[0025] 5~30 parts by weight of Jinghuan, 5~30 parts by weight of windbreak, 5~30 parts by weight of Qinghui

[0026] It is prepared using 5 to 30 parts by weight of Angelica Root, 3 to 25 parts by weight of Bupleurum Root, and 3 to 25 parts by weight of Qing Hua Hua as raw materials.

[0027] The herbal medicine composition mainly comprises:

[0028] 5~30 parts by weight of Jinghuan, 5~30 parts by weight of windbreak, 5~30 parts by weight of Qinghui

[0029] Dokatsu 5-30 parts by weight, Saiku 3-25 parts by weight, Qianhu 3-25 parts by weight

[0030] 5 to 30 parts by weight of Chinese cabbage, 3 to 25 parts by weight of Mantis annua, 5 to 30 parts by weight of Bokum

[0031] It is prepared using 3 to 25 parts by weight of Platycodon grandiflorum as the raw material.

[0032] The herbal medicine composition mainly comprises:

[0033] 5~30 parts by weight of Jinghuan, 5~30 parts by weight of windbreak, 5~30 parts by weight of Qinghui

[0034] Dokatsu 5-30 parts by weight, Saiku 3-25 parts by weight, Qianhu 3-25 parts by weight

[0035] 5 to 30 parts by weight of Chinese cabbage, 3 to 25 parts by weight of Mantis annua, 5 to 30 parts by weight of Bokum

[0036] It is prepared using 3 to 25 parts by weight of Platycodon grandiflorum and 1 to 10 parts by weight of Licorice as raw materials.

[0037] The herbal medicine composition mainly comprises:

[0038] 10~20 parts by weight of Jinghu, 10~20 parts by weight of windbreak, 10~20 parts by weight of Qinghui

[0039] Dokatsu 10-20 parts by weight, Saiku 5-20 parts by weight, Qianhu 5-20 parts by weight

[0040] 10 to 20 parts by weight of Cucumber, 5 to 20 parts by weight of Mantis annua, 10 to 20 parts by weight

[0041] It is prepared using 5 to 20 parts by weight of Platycodon grandiflorum and 3 to 10 parts by weight of Licorice as raw materials.

[0042] The herbal medicine composition mainly comprises:

[0043] Jingku 12-18 parts by weight, Windproof 12-18 parts by weight, Qianghu 12-18 parts by weight

[0044] Dokatsu 12-18 parts by weight, Saiku 10-18 parts by weight, Qianhu 10-20 parts by weight

[0045] 10 to 20 parts by weight of Cucumber, 10 to 20 parts by weight of Mantis chinensis, 10 to 20 parts by weight of Bulong

[0046] It is prepared using 10 to 20 parts by weight of Platycodon grandiflorum and 3 to 8 parts by weight of Licorice as raw materials.

[0047] The herbal medicine composition mainly comprises:

[0048] 15 parts by weight of Jinghuan, 15 parts by weight of windbreak, 15 parts by weight of Qianghu

[0049] Dokatsu 15 parts by weight, Saiku 15 parts by weight, Zenhu 15 parts by weight

[0050] 15 parts by weight of Cucumber, 15 parts by weight of Mantis annua, 15 parts by weight of Bulong

[0051] It is prepared using 15 parts by weight of Platycodon grandiflorum and 5 parts by weight of licorice as raw materials.

[0052] The herbal medicine composition mainly comprises:

[0053] 15 parts by weight of Jinghuan, 15 parts by weight of windbreak, 15 parts by weight of Qianghu

[0054] Dokatsu 15 parts by weight, Saiba 15 parts by weight, Qianhu 10 parts by weight

[0055] 10 parts by weight of Cucumber, 10 parts by weight of Mantis annua, 10 parts by weight of Bulong

[0056] It is prepared using 10 parts by weight of Platycodon grandiflorum and 5 parts by weight of licorice as raw materials.

[0057] The present invention provides a method for preparing the above-mentioned herbal medicine composition, which mainly includes the steps of firstly distilling Scutellaria Baicalensis, Fangfeng, Qiang Huo, Angelica Root, Qianhuo, Cnidium Officinale and Citrus Fruit Rind to extract volatile oils for use, preparing the distilled drug residue, distilled Cnidium Officinale and Citrus Fruit Rind aqueous solution for use, and then carrying out other operations.

[0058] Specifically, the preparation method mainly comprises:

[0059] Step A is to distill Scutellaria Baicalensis, Fangfeng, Qiang Huo, Angelica Root, Qianhuo, Cnidium Officinalis, and Citrus Fruit Root to extract volatile oils for use, and prepare the distilled drug residue, distilled Cnidium Officinalis, and Citrus Fruit Root aqueous solution for use;

[0060] Step B is to prepare the distilled aqueous solution of Cnidium officinalis and Cnidium husk obtained in step A into a 10-40% ethanol solution for use;

[0061] Step C is to mix the Poria cocos, the distilled Cnidium officinalis and the residue of the husk obtained in step A, and extract the mixture by infusing it with the ethanol solution obtained in step B, and prepare the infuse liquid for use;

[0062] Step D is to add water to the Bupleurum Root, Platycodon Root, Licorice Root, and the distilled Scutellaria Root, Bouquet, Qiang Huo, Angelica Root, and Chinese Husk Root residue obtained in step A, and boil them, concentrating the decoction for use;

[0063] and step E, mixing and concentrating the infusion liquid obtained in step C and the decoction obtained in step D, and adding the volatile oil obtained in step A to obtain a herbal medicine composition.

[0064] Furthermore, the preparation method mainly comprises:

[0065] Step A is to distill Scutellaria Baicalensis, Fangfeng, Qiang Huo, Angelica Root, Qianhuo, Cnidium Officinalis, and Citrus Fruit Root to extract volatile oils for use, and prepare the distilled drug residue, distilled Cnidium Officinalis, and Citrus Fruit Root aqueous solution for use;

[0066] Step B is to prepare the distilled aqueous solution of Cnidium officinalis and Cnidium husk obtained in step A into a 15-30% ethanol solution for use;

[0067] Step C is to mix Poria cocos, Cnidium officinalis after distillation and Citrus pulp residue obtained in step A, and extract the extract by infiltration with the ethanol solution obtained in step B, and prepare the infiltration liquid for use;

[0068] Step D is to add water to the Bupleurum Root, Platycodon Root, Licorice Root, and the distilled Scutellaria Root, Bouquet, Qiang Huo, Angelica Root, and Oryza Root medicinal residue obtained in step A, and boil them. The boiled liquid is concentrated into a thick paste, which is then prepared for use.

[0069] and step E, mixing the infusion liquid obtained in step C and the ointment obtained in step D, concentrating them to form a ointment, and adding the volatile oil obtained in step A to obtain a herbal medicine composition.

[0070] The fourth object of the present invention is to provide a herbal medicine preparation containing the above-mentioned herbal medicine composition, which is an oral preparation acceptable for clinical treatment;

[0071] The pharmaceutical compositions of the present invention can be prepared by conventional formulation techniques using conventional pharmaceutical auxiliary substances.

[0072] Typical pharmaceutical auxiliary substances are one or more selected from excipients, lubricants, binders, emulsifiers, disintegrants, stabilizers, and flavoring agents.

[0073] The excipient is one or more selected from lactose, sucrose, glucose, mannitol sugar, sorbitol sugar, starch, dextrin, crystalline cellulose, gum arabic, and dextran.

[0074] The lubricant is one or more selected from magnesium stearate, calcium stearate, talc powder, fine silica gel, boric acid, and sodium lauryl sulfate.

[0075] The binder is one or more selected from hydroxypropyl cellulose, hydroxypropyl methyl cellulose, polyvinylpyrrolidone, and polyethylene glycol.

[0076] The disintegrant is one or more selected from low-substituted hydroxypropyl cellulose, carboxymethyl cellulose, sodium carboxymethyl starch, and cross-linked polyvinylpyrrolidone.

[0077] The emulsifier is one or more selected from bentonite, magnesium hydroxide, aluminum hydroxide, and sodium lauryl sulfate.

[0078] The stabilizer is one or more selected from methylparaben, benzyl alcohol, phenethyl alcohol, phenol, sorbic acid, and dehydroacetic acid.

[0079] The flavoring agent is one or more selected from sucrose, flavorings, aspartame, and cyclodextrin.

[0080] Furthermore, the clinically acceptable oral formulation is one or more of a pill, a capsule, a tablet, a granule, a combination drug, or an oral liquid;

[0081] Furthermore, the oral formulation is a granule or a combination formulation.

[0082] The present invention also provides a use of the above herbal composition in preparing a medicament for treating neurogenic pulmonary edema.

[0083] Neurogenic pulmonary edema (NPE) is a clinical syndrome characterized by acute pulmonary edema following central nervous system injury. NPE is primarily seen in patients with central nervous system lesions, such as spinal cord injury, intracranial hemorrhage, status epilepticus, meningitis, subarachnoid hemorrhage, and medullary lesions, and usually occurs within 24 to 72 hours after the onset of the above central nervous system lesions.

[0084] Neurogenic pulmonary edema is different from acute respiratory distress syndrome in that the patient does not have cardiac or pulmonary dysfunction, but instead suffers from central nervous system damage, which leads to increased pulmonary extravascular hydrostatic pressure and impaired oxygenation. The common feature of neurogenic pulmonary edema is acute and severe central nervous system damage, characterized by a sudden and rapid increase in intracranial pressure, which leads to brain tissue compression, ischemia and other damage, which causes extreme excitation of the sympathetic nervous system, releases catecholamines, and causes an abnormal increase in pulmonary extravascular hydrostatic pressure, resulting in pulmonary edema.

[0085] Furthermore, the neurogenic pulmonary edema is pulmonary edema caused by brain injury or central nervous system disease.

[0086] Neurogenic pulmonary edema is a syndrome caused by damage to the central nervous system, such as the medulla oblongata or hypothalamus, which leads to increased extrapulmonary hydrostatic pressure and impaired oxygenation, resulting in a series of lung lesions. It is clinically classified into two subtypes: acute and chronic.

[0087] Acute dyspnea and progressive hypoxemia are the most important clinical symptoms of neurogenic pulmonary edema, because the clinical symptoms are not specific and can be easily confused with other lung diseases. In the early stages of neurogenic pulmonary edema, only nonspecific symptoms such as shortness of breath, elevated blood pressure, and elevated pulse rate may be observed, but in the later stages of neurogenic pulmonary edema, typical symptoms include dyspnea or shortness of breath, tachycardia, cyanosis, pink frothy sputum, pulmonary crepitus and rales, which resemble respiratory distress syndrome, and oxygen therapy is generally ineffective.

[0088] Furthermore, the neurogenic pulmonary edema is one or more selected from pulmonary edema caused by head trauma, surgery, subarachnoid hemorrhage, cerebral embolism, cerebral hemorrhage, brain stem infarction, intracerebral tumor, acute cerebral edema, epilepsy, and viral infection accompanied by central nervous system lesions.

[0089] Neurogenic pulmonary edema (PE) is pulmonary edema caused by brain lesions such as cerebrovascular disease, brain tumors, brain trauma, and grand mal epilepsy, and is also called encephalogenic pulmonary edema. It is a clinical syndrome characterized by acute pulmonary edema after injury to the central nervous system.

[0090] Head trauma refers to trauma that occurs to the head and is a common injury, with injuries caused by falls and collisions being the most common, followed by contusions. Head trauma often occurs in disasters, wars, and traffic accidents. It is important for injuries throughout the body. Head trauma can be classified into three categories: soft tissue (scalp) injury, skull injury (fracture), and intracranial tissue (cerebral blood vessels and meninges) injury.

[0091] The surgery refers to a neurosurgery procedure.

[0092] The subarachnoid hemorrhage refers to a clinical syndrome caused by the rupture of a diseased blood vessel at the base or surface of the brain, causing blood to flow directly into the subarachnoid space, and is also called primary subarachnoid hemorrhage.

[0093] The cerebral embolism refers to a condition in which various emboli (such as a cardiac mural thrombus, atherosclerotic plaque, fat, tumor cells, fibrocartilage, or air) in the bloodstream enter a cerebral artery and block the blood vessel. The collateral circulation cannot compensate, and this causes ischemic necrosis of the brain tissue in the blood supply area of ​​the artery, resulting in localized neurological deficits.

[0094] The cerebral hemorrhage refers to hemorrhage caused by non-traumatic rupture of blood vessels in the brain parenchyma, and its cause is closely related to cerebrovascular disease, i.e., hyperlipidemia, diabetes, hypertension, vascular aging, smoking, etc. Patients with cerebral hemorrhage often suddenly develop symptoms due to emotional excitement or strenuous exercise, and the early mortality rate is very high, and most of the survivors are left with sequelae such as motor disorders, cognitive disorders, speech disorders, and swallowing disorders, although to different degrees.

[0095] Brain stem infarction, also called brain stem embolism, is a type of cerebral infarction and is the most serious type. Brain stem infarction is caused by arteriosclerosis, embolism, spasm, inflammation, etc. of the vertebral basilar artery and its branched blood vessels, which causes stenosis or occlusion of the above arteries, leading to ischemia of the midbrain, pons, and medulla oblongata, resulting in corresponding neurological symptoms and signs.

[0096] The intracerebral tumor refers to a brain tumor including a primary brain tumor occurring in the brain parenchyma and a secondary brain tumor metastasized to the brain from another part of the body.

[0097] Epilepsy, commonly known in China as "sheep horn wind" or "sheep den wind", is a chronic disease in which neurons in the brain suddenly discharge abnormally, causing temporary brain dysfunction.

[0098] Furthermore, the neurogenic pulmonary edema is one or more selected from pulmonary edema caused by head trauma, surgery, subarachnoid hemorrhage, cerebral embolism, cerebral hemorrhage, brain stem infarction, intracerebral tumor, acute cerebral edema, and viral infection accompanied by central nervous system lesions.

[0099] Furthermore, the neurogenic pulmonary edema is one or more selected from pulmonary edema caused by head trauma, surgery, subarachnoid hemorrhage, cerebral embolism, cerebral hemorrhage, brain stem infarction, intracerebral tumor, acute cerebral edema, and epilepsy.

[0100] Furthermore, the neurogenic pulmonary edema is one or more selected from pulmonary edema caused by head trauma, surgery, subarachnoid hemorrhage, cerebral embolism, cerebral hemorrhage, brain stem infarction, intracerebral tumor, and acute cerebral edema.

[0101] Furthermore, the neurogenic pulmonary edema is one or more selected from pulmonary edema caused by head trauma, surgery, subarachnoid hemorrhage, cerebral embolism, cerebral hemorrhage, brain stem infarction, and intracerebral tumor.

[0102] Furthermore, the neurogenic pulmonary edema is one or more selected from pulmonary edema caused by head trauma, surgery, subarachnoid hemorrhage, cerebral embolism, cerebral hemorrhage, and brain stem infarction.

[0103] Furthermore, the neurogenic pulmonary edema is one or more selected from pulmonary edema caused by head trauma, surgery, subarachnoid hemorrhage, cerebral embolism, and cerebral hemorrhage.

[0104] Furthermore, the neurogenic pulmonary edema is one or more selected from pulmonary edema caused by head trauma, surgery, subarachnoid hemorrhage, and cerebral embolism.

[0105] Furthermore, the neurogenic pulmonary edema is one or more selected from pulmonary edema caused by head trauma, surgery, and subarachnoid hemorrhage.

[0106] Furthermore, the neurogenic pulmonary edema is one or more selected from pulmonary edema induced by head trauma and surgery.

[0107] Further, the neurogenic pulmonary edema is selected from pulmonary edema caused by head trauma.

[0108] Pharmacological experiments show that the Jingfang granule prepared by the herbal composition of the present invention can significantly reduce the lung index and lung wet weight / dry weight of rats with neurogenic pulmonary edema caused by oleic acid, improve the pathological state of the rat's lungs, and reduce the degree of edema of the lung tissue.Pharmacological experiments show that the Jingfang granule can significantly reduce the lung wet weight / dry weight of mice with neurogenic pulmonary edema induced by spinal cord injury, improve the pathological state of mouse lung tissue, and reduce the degree of edema of the lung tissue.The herbal composition of the present invention can increase the drug for clinical treatment of neurogenic pulmonary edema. [Brief description of the drawings]

[0109] [Figure 1] 1 shows lung tissue images of rats in each group in the oleic acid-induced acute pulmonary edema model. [Diagram 2] 1 shows lung tissue images of rats in each group of a neurogenic pulmonary edema model induced by spinal cord injury. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0110] Example 1 Preparation of Granules

[0111] Prescription

[0112] Jinghui 75g, Windproof 75g, Qianghu 75g, Dokatsu 75g, Saihu 75g, Qianhu 75g, Senkyu 75g, Beetroot husk 75g, Bouling 75g, Bellflower 75g, Licorice 25g

[0113] Preparation method

[0114] Step A: Distilling Scutellaria Baicalensis, Fangfeng, Qiang Huo, Angelica Root, Quan Huo, Cnidium Officinalis, and Citrus Fruit Root separately to extract the volatile oil for use; distilled drug residue, distilled Cnidium Officinalis, and Citrus Fruit Root aqueous solution for use.

[0115] Step B: The distilled aqueous solution of Cnidium officinalis and Cnidium husk obtained in Step A was prepared into a 25% ethanol solution for use.

[0116] Step C: Poria cocos, the distilled Cnidium officinalis obtained in step A, and the residue of the husk of the stalk were mixed, and extracted by percolation with the ethanol solution obtained in step B, and the percolation liquid was prepared for use.

[0117] Step D: Add water to the Bupleurum Root, Platycodon Root, Licorice Root, and the distilled Scutellaria Root, Bougainvillea Root, Qiang Huo, Angelica Root, and Qianhu Root Medicinal Residue obtained in Step A, and decoct them twice for 1.5 hours each. The two decoctions are combined, filtered, and concentrated into a paste for use.

[0118] Step E: The impregnated liquid obtained in step C and the ointment obtained in step D are mixed, allowed to stand, filtered, and concentrated into a ointment with a relative density of 1.30 (80-85°C). 6 parts of sucrose powder are added to 1 part of the ointment, mixed uniformly, granulated, dried, and the volatile oil obtained in step A is added, mixed uniformly, and granules are obtained.

[0119] Example 2 Preparation of Granules

[0120] Prescription

[0121] Jinghui 50g, Windproof 100g, Chikatsu 50g, Solitary Katsu 100g, Saihu 15g, Qianhu 100g, Senkyu 50g, Kikhu 100g, Bouling 50g, Bellflower 100g, Licorice 5g

[0122] The preparation method was the same as in Example 1.

[0123] Example 3 Preparation of Granules

[0124] Prescription

[0125] Jingju 100g, Windproof 50g, Qianghu 100g, Dokatsu 50g, Saihu 100g, Qianhu 15g, Senkyu 100g, Kihu 125g, Boului 125g, Bellflower 15g, Licorice 40g

[0126] The preparation method was the same as in Example 1.

[0127] Preparation Example 4 Preparation of oral liquid

[0128] Prescription

[0129] Jinghui 75g, Windproof 75g, Qianghu 75g, Dokatsu 75g, Saihu 75g, Qianhu 75g, Senkyu 75g, Beetroot husk 75g, Bouling 75g, Bellflower 75g, Licorice 25g

[0130] Preparation method

[0131] Step A: Distilling Scutellaria Baicalensis, Fangfeng, Qiang Huo, Angelica Root, Quan Huo, Cnidium Officinalis, and Citrus Fruit Root separately to extract the volatile oil for use; distilled drug residue, distilled Cnidium Officinalis, and Citrus Fruit Root aqueous solution for use.

[0132] Step B: The distilled aqueous solution of Cnidium officinalis and Cnidium husk obtained in Step A was prepared into a 10% ethanol solution for use.

[0133] Step C: Poria cocos, the distilled Cnidium officinalis obtained in step A, and the residue of the husk of the stalk were mixed, and extracted by percolation with the ethanol solution obtained in step B, and the percolation liquid was prepared for use.

[0134] Step D: Add water to the Bupleurum Root, Platycodon Root, Licorice Root, and the distilled Scutellaria Root, Bougainvillea Root, Qiang Huo, Angelica Root, and Qianhu Root Medicinal Residue obtained in Step A, and decoct them twice for 1.5 hours each. The two decoctions are combined, filtered, and concentrated into a paste for use.

[0135] Step E: The infusion liquid obtained in step C and the ointment obtained in step D are mixed, left to stand and filtered, concentrated into a ointment, an appropriate amount of sucrose is added and mixed uniformly, the volatile oil obtained in step A is added and mixed uniformly, and water is added until the total volume is 1000ml to obtain an oral liquid.

[0136] Example 5 Preparation of syrup

[0137] Prescription

[0138] Jinghui 75g, Windproof 75g, Qianghu 75g, Dokatsu 75g, Saihu 75g, Qianhu 75g, Senkyu 75g, Beetroot husk 75g, Bouling 75g, Bellflower 75g, Licorice 25g

[0139] Preparation method

[0140] Step A: Distilling Scutellaria Baicalensis, Fangfeng, Qiang Huo, Angelica Root, Quan Huo, Cnidium Officinalis, and Citrus Fruit Root separately to extract the volatile oil for use; distilled drug residue, distilled Cnidium Officinalis, and Citrus Fruit Root aqueous solution for use.

[0141] Step B: The distilled aqueous solution of Cnidium officinalis and Cnidium husk obtained in Step A was prepared into a 40% ethanol solution for use.

[0142] Step C: Poria cocos, the distilled Cnidium officinalis obtained in step A, and the residue of the husk of the stalk were mixed, and extracted by percolation with the ethanol solution obtained in step B, and the percolation liquid was prepared for use.

[0143] Step D: Add water to the Bupleurum Root, Platycodon Root, Licorice Root, and the distilled Scutellaria Root, Bougainvillea Root, Qiang Huo, Angelica Root, and Qianhu Root Medicinal Residue obtained in Step A, and decoct them twice for 1.5 hours each. The two decoctions are combined, filtered, and concentrated into a paste for use.

[0144] Step E: The impregnated liquid obtained in step C and the ointment obtained in step D are mixed, allowed to stand, filtered, concentrated into a ointment, an appropriate amount of sucrose is added, mixed uniformly, 500ml of the volatile oil and simple syrup obtained in step A are added, mixed uniformly, allowed to stand, filtered, and water is added until the total volume is 1000ml to obtain a syrup.

[0145] Example 6 Preparation of tablets

[0146] Prescription

[0147] Jinghui 75g, Windproof 75g, Qianghu 75g, Dokatsu 75g, Saihu 75g, Qianhu 75g, Senkyu 75g, Beetroot husk 75g, Bouling 75g, Bellflower 75g, Licorice 25g

[0148] Preparation method

[0149] Step A: Distilling Scutellaria Baicalensis, Fangfeng, Qiang Huo, Angelica Root, Quan Huo, Cnidium Officinalis, and Citrus Fruit Root separately to extract the volatile oil for use; distilled drug residue, distilled Cnidium Officinalis, and Citrus Fruit Root aqueous solution for use.

[0150] Step B: The distilled aqueous solution of Cnidium officinalis and Cnidium husk obtained in Step A was prepared into a 15% ethanol solution for use.

[0151] Step C: Poria cocos, the distilled Cnidium officinalis obtained in step A, and the residue of the husk of the stalk were mixed, and extracted by percolation with the ethanol solution obtained in step B, and the percolation liquid was prepared for use.

[0152] Step D: Add water to the Bupleurum Root, Platycodon Root, Licorice Root, and the distilled Scutellaria Root, Bougainvillea Root, Qiang Huo, Angelica Root, and Qianhu Root Medicinal Residue obtained in Step A, and decoct them twice for 1.5 hours each. The two decoctions are combined, filtered, and concentrated into a paste for use.

[0153] Step E: The infusion liquid obtained in step C and the ointment obtained in step D are mixed, left to stand, filtered, concentrated into a ointment, an appropriate amount of sucrose is added, mixed uniformly, granulated and dried, the volatile oil obtained in step A is added, mixed uniformly, granulated, an appropriate amount of auxiliary materials are added, mixed uniformly, tableted to obtain tablets.

[0154] Example 7 Preparation of capsules

[0155] Prescription

[0156] Jinghui 75g, Windproof 75g, Qianghu 75g, Dokatsu 75g, Saihu 75g, Qianhu 75g, Senkyu 75g, Beetroot husk 75g, Bouling 75g, Bellflower 75g, Licorice 25g

[0157] Step A: Distilling Scutellaria Baicalensis, Fangfeng, Qiang Huo, Angelica Root, Quan Huo, Cnidium Officinalis, and Citrus Fruit Root separately to extract the volatile oil for use; distilled drug residue, distilled Cnidium Officinalis, and Citrus Fruit Root aqueous solution for use.

[0158] Step B: The distilled aqueous solution of Cnidium officinalis and Cnidium husk obtained in Step A was prepared into a 30% ethanol solution for use.

[0159] Step C: Poria cocos, the distilled Cnidium officinalis obtained in step A, and the residue of the husk of the stalk were mixed, and extracted by percolation with the ethanol solution obtained in step B, and the percolation liquid was prepared for use.

[0160] Step D: Add water to the Bupleurum Root, Platycodon Root, Licorice Root, and the distilled Scutellaria Root, Bougainvillea Root, Qiang Huo, Angelica Root, and Qianhu Root Medicinal Residue obtained in Step A, and decoct them twice for 1.5 hours each. The two decoctions are combined, filtered, and concentrated into a paste for use.

[0161] Step E: The infusion liquid obtained in step C and the ointment obtained in step D are mixed, allowed to stand, filtered, concentrated into a ointment, an appropriate amount of sucrose is added, mixed uniformly, granulated, and dried, the volatile oil obtained in step A is added, mixed uniformly, granulated, and dried, crushed, and packed into capsules to obtain capsules.

[0162] Example 8 Preparation of pills

[0163] Prescription

[0164] Jinghui 75g, Windproof 75g, Qianghu 75g, Dokatsu 75g, Saihu 75g, Qianhu 75g, Senkyu 75g, Beetroot husk 75g, Bouling 75g, Bellflower 75g, Licorice 25g

[0165] Preparation method

[0166] Step A: Distilling Scutellaria Baicalensis, Fangfeng, Qiang Huo, Angelica Root, Quan Huo, Cnidium Officinalis, and Citrus Fruit Root separately to extract the volatile oil for use; distilled drug residue, distilled Cnidium Officinalis, and Citrus Fruit Root aqueous solution for use.

[0167] Step B: The distilled aqueous solution of Cnidium officinalis and Cnidium husk obtained in Step A was prepared into a 25% ethanol solution for use.

[0168] Step C: Poria cocos, the distilled Cnidium officinalis obtained in step A, and the residue of the husk of the stalk were mixed, and extracted by percolation with the ethanol solution obtained in step B, and the percolation liquid was prepared for use.

[0169] Step D: Add water to the Bupleurum Root, Platycodon Root, Licorice Root, and the distilled Scutellaria Root, Bougainvillea Root, Qiang Huo, Angelica Root, and Qianhu Root Medicinal Residue obtained in Step A, and decoct them twice for 1.5 hours each. The two decoctions are combined, filtered, and concentrated into a paste for use.

[0170] Step E: The infusion liquid obtained in step C and the ointment obtained in step D are mixed, left to stand, filtered, concentrated into a ointment, an appropriate amount of sucrose is added, mixed uniformly, granulated and dried, the volatile oil obtained in step A is added, mixed uniformly, dried, pulverized, sieved, 40~60g of refined honey and an appropriate amount of water pan pills are added, dried, and pills are obtained.

[0171] Example 9 Preparation of ointment

[0172] Prescription

[0173] Jinghui 75g, Windproof 75g, Qianghu 75g, Dokatsu 75g, Saihu 75g, Qianhu 75g, Senkyu 75g, Beetroot husk 75g, Bouling 75g, Bellflower 75g, Licorice 25g

[0174] Preparation method

[0175] Step A: Distilling Scutellaria Baicalensis, Fangfeng, Qiang Huo, Angelica Root, Quan Huo, Cnidium Officinalis, and Citrus Fruit Root separately to extract the volatile oil for use; distilled drug residue, distilled Cnidium Officinalis, and Citrus Fruit Root aqueous solution for use.

[0176] Step B: The distilled aqueous solution of Cnidium officinalis and Cnidium husk obtained in Step A was prepared into a 25% ethanol solution for use.

[0177] Step C: Poria cocos, the distilled Cnidium officinalis obtained in step A, and the residue of the husk of the stalk were mixed, and extracted by percolation with the ethanol solution obtained in step B, and the percolation liquid was prepared for use.

[0178] Step D: Add water to the Bupleurum Root, Platycodon Root, Licorice Root, and the distilled Scutellaria Root, Bougainvillea Root, Qiang Huo, Angelica Root, and Qianhu Root Medicinal Residue obtained in Step A, and decoct them twice for 1.5 hours each. The two decoctions are combined, filtered, and concentrated into a paste for use.

[0179] Step E: The impregnated liquid obtained in step C and the ointment obtained in step D were mixed, left to stand and filtered to concentrate into a ointment, and the volatile oil obtained in step A was added and mixed uniformly to obtain a ointment.

[0180] In order to verify the effect of the herbal composition of the present invention in the treatment of neurogenic pulmonary edema, the inventors have carried out relevant pharmacodynamic test studies. It should be noted that the medicines selected in the following pharmacodynamic tests are medicines obtained by the representative formulations and preparation methods of the present invention. The inventors have also carried out pharmacodynamic experiments on medicines obtained by other formulations and preparation methods included in the present invention. The experimental results show that medicines obtained by other formulations and preparation methods have the same or similar effects, but due to space limitations, they are not listed here comprehensively. In addition, in the following pharmacodynamic experiments, only some representative animal models are used to verify the effect of the present invention.

[0181] In addition, all of the following experimental studies have been conducted after the safety of the drugs has been demonstrated through acute and long-term toxicity tests, and all doses administered in the experimental studies are within the safe dosage range.

[0182] Oleic acid is a highly toxic fatty acid that, when injected intravenously, stimulates vasoconstriction, causes an increase in pulmonary arterial pressure, damages vascular endothelial cells, increases the permeability of the alveolar-capillary membrane, induces pulmonary interstitial and alveolar edema, reduces lung compliance, decreases functional residual capacity, and forms alveolar occlusion membranes. Oleic acid is a mature and commonly used tool to model pulmonary edema.

[0183] Performing laminectomy in rats to cause spinal injury and inducing pulmonary edema in rats are typical methods for modeling neurogenic pulmonary edema animal models, and this method is simple and easy to implement, with a high success rate of modeling.

[0184] Example of Efficacy 1: Effect of Keibo Granules on Acute Pulmonary Edema Model Caused by Oleic Acid in Rats

[0185] 1 material

[0186] 1.1 Animals

[0187] Wista rats, male, 6-8 weeks old, weighing 200-220 g. The experimental animals were provided by Lunan Pharmaceutical Co., Ltd. and were allowed to adapt for one week before the experiment.

[0188] 1.2 Drugs and Reagents

[0189] 1.2.1 Drugs

[0190] Example 1 of the present invention Granules,

[0191] Oleic Acid

[0192] 1.2.2 Rat Dosage

[0193] Example 1 Granules: 4 g / kg (low dose), 8 g / kg (medium dose), 16 g / kg (high dose).

[0194] 2. Experimental process

[0195] 2.1 Animal Grouping, Modeling, and Dosing

[0196] 60 rats were randomly divided into blank group, model group, Example 1 low dose group, Example 1 medium dose group, and Example 1 high dose group, 12 rats each. The blank group and model group were intragastrically administered with 10ml / kg purified water, and the Example 1 low dose group, Example 1 medium dose group, and Example 1 high dose group were intragastrically administered with 4g / kg, 8g / kg, and 16g / kg Jingbo granules, respectively, with an administration volume of 10ml / kg, once a day for two consecutive days. 30min after the completion of the administration on the third day, the rats in the remaining groups, except for the blank group, were injected with 0.2ml / kg oleic acid via tail vein immediately after the time was measured, and after 6h, the rats were anesthetized and killed, the lungs were removed to observe the lung tissue, and their weights were measured, and the lung index and lung wet weight / dry weight were calculated according to lung index=lung weight / body weight. The weight of the lower left lung was measured to obtain the wet lung weight, and the lower left lung was baked at 70°C for 48 hours until it reached the specified weight, after which it was weighed to obtain the dry lung weight.

[0197] 2.2 Statistical processing

[0198] Statistical processing was performed using SPSS17.0 software, and the measurement data

[0199]

number

[0200] Comparisons between groups were performed using one-way analysis of variance, and comparisons between both groups were performed using t-tests. P<0.05 was considered to indicate a statistically significant difference.

[0201] 3. Results and Conclusions

[0202] Observing the overall shape of the lungs of each group, the lung tissue of the rats in the blank group was normal, with a smooth surface, no congestion, and light pink color, while the lung tissue of the rats in the model group was significantly enlarged, with congestion and bleeding spots, dark red color, and pink bubbles overflowed when the trachea was cut. Compared with the model group, the congestion was greatly reduced in the lungs of the rats in the low, medium and high dose groups of Example 1, and there was a small amount of bubbles in the trachea or no obvious bubbles. The experimental results show that the Jingfang Granules of the present invention can effectively alleviate pulmonary edema and pathological changes in tissues, and have a clear therapeutic effect on pulmonary edema.

[0203] Compared with the blank group, the lung index and lung wet weight / dry weight were significantly increased in the model group (P<0.05); compared with the model group, the lung index was significantly decreased in the Example 1 low dose group, Example 1 medium dose group, and Example 1 high dose group (P<0.05, P<0.01), and the lung wet weight / dry weight was significantly decreased in the Example 1 medium dose group and Example 1 high dose group (P<0.05). The results are shown in Table 1. The experimental results showed that Jingbo Granules could significantly improve the pulmonary edema symptoms in rats.

[0204] [Table 1]

[0205] Note: Compared with the normal group, *P<0.05; **P<0.01; compared with the model group, #P < 0.05, ## P<0.01.

[0206] Example 2: Effect of Keibo Granules on a rat model of neurogenic pulmonary edema induced by oleic acid

[0207] 1.Material

[0208] 1.1 Animals

[0209] SD rats, male, 6-8 weeks old, weighing 200-220 g. The experimental animals were provided by Lunan Pharmaceutical Co., Ltd. and were allowed to adapt for one week before the experiment.

[0210] 1.2 Drugs

[0211] Example 1 of the present invention Granules

[0212] Oleic Acid

[0213] 1.2.2 Dosage in rats

[0214] Example 1 Granules: 4 g / kg (low dose), 8 g / kg (medium dose), 16 g / kg (high dose).

[0215] 2. Experimental process

[0216] 2.1 Animal Grouping, Modeling, and Dosing

[0217] 50 rats were randomly divided into blank group, model group, low dose group of Example 1, medium dose group of Example 1, and high dose group of Example 1, with one rat per group. The normal group and model group were intragastrically administered purified water, while the low dose group of Example 1, medium dose group of Example 1, and high dose group of Example 1 were intragastrically administered 4 g / kg, 8 g / kg, and 16 g / kg of granules of Example 1, respectively. The granules were diluted with purified water, and the administration volume was 10 ml / kg, once a day for two consecutive days. On the third day, 30 minutes after the administration was completed, the animals were anesthetized and fixed, the skin of the parietal bone was cut, and a No. 7 needle was inserted vertically about 6 mm into the center of the parietal bone. When blood disappeared when aspirating, 0.2 ml / kg of oleic acid was slowly injected, and timing was started. After 10 minutes, the rats were killed, the lungs were taken, and the lung tissue was observed and weighed, and the lung index and lung wet weight / dry weight were calculated according to the formula: lung index = lung weight / body weight. The weight of the left lower lung lobe was weighed to obtain the lung wet weight, and the left lower lung lobe was baked at 70°C for 48 hours until it reached a predetermined weight, which was then weighed to obtain the lung dry weight, and the lung wet weight / dry weight was calculated.

[0218] 2.2 Statistical processing

[0219] Statistical processing was performed using SPSS17.0 software, and the measurement data was

[0220]

number

[0221] Comparisons between groups were performed using one-way analysis of variance, and comparisons between both groups were performed using t-tests. P<0.05 was considered to indicate a statistically significant difference.

[0222] 3. Results and Conclusions

[0223] Observation of the lung tissue of rats in each group showed that the lungs of rats in the blank group were full, smooth and pink in color, while the lungs of rats in the model group were significantly enlarged, dark red in color, and a large amount of foam overflowed after tracheotomy.Compared with the model group, the lesion severity was significantly reduced in the low, medium and high dose groups of Example 1.The experimental results show that the Jingfang Granules of the present invention can effectively alleviate pulmonary edema and pathological changes in tissues, and have a clear therapeutic effect on pulmonary edema.

[0224] Compared with the blank group, the lung index and lung wet weight / dry weight in the model group increased significantly (P<0.01), indicating that the model was successfully created. Compared with the model group, the lung index and lung wet weight / dry weight in the medium dose group and the high dose group of Example 1 Granules decreased significantly (P<0.05, P<0.01), and the results are shown in Table 2. The experimental results showed that Jingbo Granules could significantly improve neurogenic pulmonary edema in rats.

[0225] [Table 2]

[0226] Note: *P<0.05 compared with blank group, **P<0.01 compared with model group # P < 0.05, ## P<0.01.

[0227] Example 2: Effect of Keibo Granules on a rat model of neurogenic pulmonary edema caused by spinal cord injury

[0228] 1.Material

[0229] 1.1 Animals

[0230] ICR mice, male, 4-6 weeks old, weighing 23-25 ​​g. Experimental animals were provided by Lunan Pharmaceutical Co., Ltd. and were allowed to adapt for one week prior to the experiment.

[0231] 1.2 Drugs

[0232] Example 1 of the present invention Granules

[0233] Dexamethasone

[0234] 2. Experimental process

[0235] 2.1 Animal Grouping, Modeling, and Dosing

[0236] Forty mice were randomly divided into a sham operation group, a model group, a dexamethasone group, an Example 1 granule group, and a dexamethasone + Example 1 granule group, eight mice per group. The sham operation group underwent laminectomy but no spinal cord injury, while the model group and each administration group underwent laminectomy and spinal cord injury. 24 hours after modeling, the sham operation group and the model group were intramuscularly injected with saline (10 ml / kg) and intragastrically administered with purified water (10 ml / kg), the Example 1 granule group was intragastrically administered with Example 1 granule (18 g / kg), the dexamethasone group was intramuscularly injected with dexamethasone injection (0.025 mg / kg), and the dexamethasone + Example 1 granule group was intragastrically administered with Example 1 granule (18 g / kg) and intramuscularly injected with dexamethasone injection (0.025 mg / kg). The animals were administered the drug for two consecutive days. On the third day after modeling, the animals were anesthetized and killed, and the lungs were removed and their wet weights were measured. They were then dried in a 60°C oven for 48 hours, removed, and their dry weights were measured to calculate the wet / dry weight ratio.

[0237] 2.2 Statistical processing

[0238] Statistical processing was performed using SPSS17.0 software, and the measurement data was

[0239]

number

[0240] Comparisons between groups were performed using one-way analysis of variance, and comparisons between both groups were performed using t-tests. P<0.05 was considered to indicate a statistically significant difference.

[0241] 3. Results and Discussion

[0242] Compared with the sham operation group, the model group showed a significant increase in lung wet weight / dry weight (P<0.001), indicating that the modeling was successful. Compared with the model group, the Example 1 Granule group and the Dexamethasone + Example 1 Granule group showed a significant decrease in lung wet weight / dry weight (P<0.001), and the effect was superior to that of the Dexamethasone group (P<0.01), and the results are shown in Table 3. The experimental results showed that Jingbang Granule had a significant protective effect against neurogenic pulmonary edema caused by spinal cord injury, and its efficacy was far superior to that of dexamethasone.

[0243] [Table 3]

[0244] NOTE: Compared with the sham-operated group, *** P<0.001, compared with the model group; # P < 0.05, ## P < 0.01, ### P<0.001 compared with the dexamethasone group. && P < 0.01, &&& P<0.001.

Claims

1. Use of a traditional Chinese medicine composition consisting of Schizonepeta tenuifolia, Saposhnikovia divaricata, Notopterygium incisum, Angelica pubescens, Bupleurum chinense, Peucedanum praeruptorum, Senecio scandens, Aurantii Fructus Immaturus, Poria cocos, Platycodon grandiflorum, and Glycyrrhiza glabra in the preparation of a drug for preventing or treating neurogenic pulmonary edema, wherein the traditional Chinese medicine composition comprises 5 to 30 parts by weight of Schizonepeta tenuifolia, 5 to 30 parts by weight of Saposhnikovia divaricata, 5 to 30 parts by weight of Notopterygium incisum, 5 to 30 parts by weight of Angelica pubescens, 3 to 25 parts by weight of Bupleurum chinense, 3 to 25 parts by weight of Peucedanum praeruptorum, 5 to 30 parts by weight of Senecio scandens, 3 to 25 parts by weight of Aurantii Fructus Immaturus, 5 to 30 parts by weight of Poria cocos, 3 to 25 parts by weight of Platycodon grandiflorum, and 1 to 10 parts by weight of Glycyrrhiza glabra and is prepared using the above as raw materials. Use of the traditional Chinese medicine composition, characterized in that.

2. The neurogenic pulmonary edema is pulmonary edema caused by brain injury or central nervous system diseases. Use according to claim 1, characterized in that.

3. The neurogenic pulmonary edema is one or more selected from pulmonary edema caused by head trauma, surgery, subarachnoid hemorrhage, cerebral embolism, cerebral hemorrhage, brainstem infarction, intracranial tumor, acute cerebral edema, epilepsy, and viral infections accompanied by central nervous system lesions. Use according to claim 1, characterized in that.

4. The traditional Chinese medicine composition is prepared using 15 parts by weight of Schizonepeta tenuifolia, 15 parts by weight of Saposhnikovia divaricata, 15 parts by weight of Notopterygium incisum, 15 parts by weight of Angelica pubescens, 15 parts by weight of Bupleurum chinense, 15 parts by weight of Peucedanum praeruptorum, 15 parts by weight of Senecio scandens, 15 parts by weight of Aurantii Fructus Immaturus, 15 parts by weight of Poria cocos, 15 parts by weight of Platycodon grandiflorum, and 5 parts by weight of Glycyrrhiza glabra as raw materials. Use according to claim 1, characterized in that.

5. The traditional Chinese medicine composition is prepared into tablets, capsules, pills, granules, or oral liquids by adding one or more pharmaceutically acceptable pharmaceutical adjuvants. Use according to any one of claims 1 to 4, characterized in that.

6. The use according to claim 5, characterized in that the traditional Chinese medicine composition is prepared into granules by adding one or more pharmaceutically acceptable pharmaceutical adjuvants.