A pharmaceutical composition for treating high fever with coma and inducing resuscitation and opening the mind

Abstract

A medicine composition for treating high fever coma and awakening the mind comprises the following raw materials by weight: 100-120g of benzoin, 60-100g of spiny jujube seeds, 100-120g of salvia miltiorrhiza, 60-100g of gastrodia elata, 60-100g of polygala tenuifolia, 20-40g of lotus seed core, 30-90g of rhizoma jasminoides, 60-100g of calamus, 60-100g of cypress seeds, 60-100g of bamboo shavings, 20-30g of borneol and 20-40g of acetaminophen as raw materials. The medicine composition has reasonable components, scientific compatibility, mutual support of components, rapid onset, small adverse reaction, high bioavailability, convenient carrying and taking, high cure rate, simple and easy operation of preparation method, low cost, is a major innovation in medicines for treating high fever convulsion and awakening the mind, and has huge economic and social benefits.

Description

Technical Field

[0001] The present invention relates to the field of medicine, and particularly to a pharmaceutical composition for treating high fever with coma and inducing resuscitation and awakening. Background Art

[0002] "High fever" is the main symptom of warm diseases and is also an inevitable manifestation of various warm diseases. During the development of warm diseases, "coma" and "high fever" are almost in a causal relationship. Whether the pathogenic warm factor is in the defensive phase or qi phase, or has entered the nutrient phase or blood phase, as long as "the pathogenic factor enters the pericardium" or "the heat sinks into the nutrient-blood aspect of the pericardium", symptoms such as "excessive heat with mania", "coma with delirium", "convulsion with coma" or "coma with qi exhaustion" will occur. "Warmth is the gradual stage of heat, and heat is the severe stage of warmth." Therefore, "high fever" is also the result of the struggle between the pathogenic factor and healthy qi in warm diseases, and "coma" is a critical "information" in warm diseases. If the clinical differentiation is unclear and the treatment is improper, it will either delay the pathogenesis or endanger life.

[0003] The main treatment methods of Western medicine for diseases such as coma, convulsion, and infection caused by high fever are physical cooling, application of antipyretics (such as non-steroidal drugs like carbasalate calcium, aspirin lysine, ibuprofen, paracetamol, naproxen, etc.) and antiviral and antibacterial drugs (such as acyclovir, amantadine, ribavirin, penicillin, etc.), as well as combined treatment with hormones. Although its effect is fast, it has large toxic and side effects. It can cause gastrointestinal reactions such as nausea, vomiting, upper abdominal discomfort or pain, which mostly disappear after stopping the drug. Gastrointestinal bleeding or ulcers may occur during long-term or large-dose application. Reversible tinnitus and hearing loss may occur after taking a certain course of treatment. Allergic reactions such as asthma, urticaria, angioneurotic edema or shock may occur in a few patients, and severe cases can be fatal. Liver and kidney function damage may occur when the dose is too large.

[0004] High fever with coma belongs to the category of "acute infantile convulsion" in modern traditional Chinese medicine theory. It is characterized by a rapid onset and excessive symptoms, belonging to yang syndrome, heat syndrome, and excess syndrome. Ancient physicians summarized this disease as the four syndromes of "phlegm, heat, fright, and wind". Although each has its own characteristics, they are closely related. Therefore, modern traditional Chinese medicine mostly treats high fever with coma with the principles of inducing resuscitation and awakening, suppressing fright and extinguishing wind, clearing heat and resolving phlegm. The cure rate is high, and most traditional Chinese medicine treatments have no toxic and side effects. However, its effect is slower than that of Western medicine treatment. Each of the Chinese and Western medicine treatments has its own advantages. If they can be combined for treatment, it will surely achieve good curative effects, but there has been no relevant public report so far. Summary of the Invention

[0005] In view of the above situation, to overcome the deficiencies of the prior art, the purpose of the present invention is to provide a pharmaceutical composition for treating high fever with coma and inducing resuscitation and awakening, which can effectively solve the problems of large toxic and side effects, low cure rate, and low bioavailability of existing drugs.

[0006] To achieve the above object, the technical solution provided by the present invention is a pharmaceutical composition for treating high fever coma and awakening the mind, comprising the following raw materials by weight: 100-120g of benzoin, 60-100g of spiny jujube seeds, 100-120g of salvia miltiorrhiza, 60-100g of gastrodia elata, 60-100g of polygala tenuifolia, 20-40g of lotus seed core, 30-90g of jasmine, 60-100g of calamus, 60-100g of cypress seeds, 60-100g of bamboo shavings, 20-30g of borneol and 20-40g of acetaminophen as raw materials, wherein:

[0007] (1) Grind the five medicinal materials of benzoin, spiny jujube seeds, gastrodia elata, rhizoma dahliae, and cypress seeds into powder, pass through a 75 μm sieve, sterilize at 115-130°C for 20-40 min, and mix them with borneol and acetaminophen in equal amounts in increasing amounts to form a fine powder for later use;

[0008] (2) Place the five raw materials of Danshen, Acorus calamus, lotus seed core, Polygala tenuifolia, and Rhizoma Anemarrhenae in an extraction tank, add water and boil twice, each time adding 6 to 8 times the total weight of the five raw materials, heat to boiling, then simmer for 1 to 2 hours each time, filter, combine the two filtrates, and concentrate to a concentrated solution with a relative density of 1.16 to 1.20 at 70 to 90°C;

[0009] (3) Mix the powder and concentrated solution evenly, add refined honey to make large honey pills.

[0010] The invention has reasonable components, scientific compatibility, mutual support of components, rapid onset of effect, small adverse reaction, high bioavailability, convenient carrying and taking, high cure rate, simple and easy operation in preparation method, low cost, and is a major innovation in drugs for treating high fever convulsions and awakening the mind, with huge economic and social benefits. DETAILED DESCRIPTION

[0011] The specific implementation modes of the present invention are described in detail below in conjunction with the embodiments.

[0012] The present invention can be specifically implemented by the following examples. Example 1

[0013] A pharmaceutical composition for treating high fever coma and awakening the mind, which is prepared from the following raw materials in parts by weight: 110g of benzoin, 80g of spiny jujube seeds, 110g of salvia miltiorrhiza, 80g of gastrodia elata, 80g of polygala tenuifolia, 30g of lotus seed core, 60g of jasmine, 80g of calamus, 80g of cypress seeds, 80g of bamboo shavings, 25g of borneol and 30g of acetaminophen, wherein:

[0014] (1) Grind the five medicinal materials of benzoin, spiny jujube seeds, gastrodia elata, radix dahurica and cypress seeds into powder, pass through a 75 μm sieve, sterilize at 120°C for 40 min, and mix them with borneol and acetaminophen in equal amounts in increasing amounts to form a fine powder for later use;

[0015] (2) Place the five raw materials of Danshen, Acorus calamus, lotus seed core, Polygala tenuifolia, and Rhizoma Anemarrhenae in an extraction tank, add water and boil twice, each time adding 8 times the total weight of the five raw materials, heat to boiling, then simmer for 1.5 h each time, filter, combine the two filtrates, and concentrate to a concentrate with a relative density of 1.18 at 80°C;

[0016] (3) Mix the powder and concentrated solution evenly, add refined honey to make large honey pills. Example 2

[0017] A pharmaceutical composition for treating high fever coma and awakening the mind, which is prepared from the following raw materials in parts by weight: 100g of benzoin, 60g of spiny jujube seeds, 100g of salvia miltiorrhiza, 60g of gastrodia elata, 60g of polygala tenuifolia, 20g of lotus seed core, 30g of jasmine, 60g of calamus, 60g of cypress seeds, 60g of bamboo shavings, 20g of borneol and 20g of acetaminophen, wherein:

[0018] (1) Grind the five medicinal materials of benzoin, spiny jujube seeds, gastrodia elata, rhizoma dahliae, and cypress seeds into powder, pass through a 75 μm sieve, sterilize at 115°C for 40 min, and mix them with borneol and acetaminophen in equal amounts in increasing amounts to form a fine powder for later use;

[0019] (2) Place the five raw materials of Danshen, Acorus calamus, lotus seed core, Polygala tenuifolia, and Rhizoma Anemarrhenae in an extraction tank, add water and boil twice, each time adding 6 times the total weight of the five raw materials, heat to boiling, then simmer for 1 hour each time, filter, combine the two filtrates, and concentrate to a concentrate with a relative density of 1.20 at 70°C;

[0020] (3) Mix the powder and concentrated solution evenly, add refined honey to make large honey pills. Example 3

[0021] A pharmaceutical composition for treating high fever coma and awakening the mind, which is prepared from the following raw materials in parts by weight: 120g of benzoin, 100g of spiny jujube seeds, 120g of salvia miltiorrhiza, 100g of gastrodia elata, 100g of polygala tenuifolia, 40g of lotus seed core, 90g of jasmine, 100g of calamus, 100g of cypress seeds, 100g of bamboo shavings, 30g of borneol and 40g of acetaminophen, wherein:

[0022] (1) Grind the five medicinal materials of benzoin, spiny jujube seeds, gastrodia elata, radix dahurica and cypress seeds into powder, pass through a 75 μm sieve, sterilize at 130°C for 20 min, and mix them with borneol and acetaminophen in equal amounts in increasing amounts to form a fine powder for later use;

[0023] (2) Place the five raw materials of Danshen, Acorus calamus, lotus seed core, Polygala tenuifolia, and Rhizoma Anemarrhenae in an extraction tank, add water and boil twice, each time adding 8 times the total weight of the five raw materials, heat to boiling, then simmer for 2 h each time, filter, combine the two filtrates, and concentrate to a concentrate with a relative density of 1.16 at 90°C;

[0024] (3) Mix the powder and concentrated solution evenly, add refined honey to make large honey pills. Example 4

[0025] A pharmaceutical composition for treating high fever coma and awakening the mind, which is prepared from the following raw materials in parts by weight: 105g of benzoin, 95g of spiny jujube seeds, 105g of salvia miltiorrhiza, 90g of gastrodia elata, 70g of polygala tenuifolia, 35g of lotus seed core, 40g of jasmine, 90g of calamus, 75g of cypress seeds, 75g of bamboo shavings, 23g of borneol and 35g of acetaminophen, wherein:

[0026] (1) Grind the five medicinal materials of benzoin, spiny jujube seeds, gastrodia elata, rhizoma dahliae, and cypress seeds into powder, pass through a 75 μm sieve, sterilize at 125°C for 25 min, and mix them with borneol and acetaminophen in equal amounts in increasing amounts to form a fine powder for later use;

[0027] (2) Place the five raw materials of Danshen, Acorus calamus, lotus seed core, Polygala tenuifolia, and Rhizoma Anemarrhenae in an extraction tank, add water and boil twice, each time adding 7 times the total weight of the five raw materials, heat to boiling, then simmer for 2 h each time, filter, combine the two filtrates, and concentrate to a concentrate with a relative density of 1.17 at 85°C;

[0028] (3) Mix the powder and concentrated solution evenly, add refined honey to make large honey pills. Example 5

[0029] A pharmaceutical composition for treating high fever coma and awakening the mind, which is prepared from the following raw materials in parts by weight: 115g of benzoin, 75g of spiny jujube seeds, 115g of salvia miltiorrhiza, 75g of gastrodia elata, 95g of polygala tenuifolia, 25g of lotus seed core, 85g of jasmine, 70g of calamus, 90g of cypress seeds, 70g of bamboo shavings, 28g of borneol and 23g of acetaminophen, wherein:

[0030] (1) Grind the five medicinal materials of benzoin, spiny jujube seeds, gastrodia elata, radix dahurica and cypress seeds into powder, pass through a 75 μm sieve, sterilize at 118°C for 38 min, and mix them with borneol and acetaminophen in equal amounts in increasing amounts to form a fine powder for later use;

[0031] (2) Place the five raw materials of Danshen, Acorus calamus, lotus seed core, Polygala tenuifolia, and Rhizoma Anemarrhenae in an extraction tank, add water and boil twice, each time adding 7.5 times the total weight of the five raw materials, heat to boiling, then simmer for 1.5 h each time, filter, combine the two filtrates, and concentrate to a concentrate with a relative density of 1.19 at 75°C;

[0032] (3) Mix the powder and concentrated solution evenly, add refined honey to make large honey pills.

[0033] Among the above drugs,

[0034] Benzoin: pungent, bitter, neutral. Enters the heart and spleen meridians. Refreshes the mind, promotes qi and blood circulation, relieves pain. Used for stroke, phlegm syncope, qi stagnation, coma, heart and stomach pain, postpartum blood fainting, and infantile convulsions.

[0035] It has the following functions:

[0036] 1. Eliminate filth and open the orifices: It can be used for stroke, qi syndrome, or the miasma of the season, or filthy qi that leads to qi stagnation and obstruction, blinding the mind, or qi disorder in the middle jiao, clear and turbid qi, and abnormal ascending and descending. The symptoms of plague are: sudden fainting, clenched jaws, unconsciousness; or diarrhea, abdominal pain, depression, dizziness, unconsciousness, etc., which are symptoms of blocked orifices and coma;

[0037] 2. Promote blood circulation, qi and relieve pain: used for abdominal pain, postpartum blood loss, infantile convulsions, rheumatic pain, etc.

[0038] 3. Expectorant effect: This product can stimulate the respiratory mucosa, increase its secretion, dilute sputum, and promote the discharge of sputum, thereby achieving the purpose of expectoration. Benzoin tincture is a stimulating expectorant. When placed in hot water and its steam is inhaled, it can directly stimulate the respiratory mucosa and increase its secretion; it can be used for bronchitis to promote the discharge of sputum. When inhaling, avoid excessive concentration of steam to avoid irritation to the eyes, nose, throat, etc.

[0039] 4. Antiseptic effect: In addition, it has an antiseptic effect. It can also be used as a topical preservative.

[0040] Ziziphus jujuba seed: sweet, sour, neutral. Enters the liver, gallbladder, and heart meridians. Nourishes the heart and liver, calms the mind and nerves, restrains sweat, and promotes body fluid production. Used for insomnia, palpitations, dreaminess, physical weakness, sweating, and thirst due to loss of body fluids.

[0041] It has the following functions:

[0042] 1. Sedative and hypnotic effect: Ziziphus jujuba seed decoction and its saponins, brass compounds, Ziziphus jujuba seed oil, etc., all have sedative and hypnotic effects;

[0043] 2. Anticonvulsant effect: When the water-soluble extract of Semen Ziziphi Spinosae was intragastrically administered to mice at a dose of 50 ml / kg, it could significantly counteract the number of clonic convulsions and the mortality rate of mice caused by pentylenetetrazol. For the convulsions induced by strychnine, it could only prolong the latent period and the death time of convulsions, but had no obvious effect on the mortality rate.

[0044] 3. Immune-enhancing effect: Experiments showed that the ethanol extract of Semen Ziziphi Spinosae could significantly increase the lymphocyte transformation rate of mice, increase the production of antibody hemolysin in mice, and significantly enhance the phagocytic function of mouse mononuclear macrophages. It could also significantly enhance the delayed hypersensitivity reaction of mice. When polysaccharide of Semen Ziziphi Spinosae was orally administered at a dose of 0.1 g / kg per day for 16 days, it could enhance the humoral immunity and cellular immunity of mice and had a certain protective effect on mice with radiation injury.

[0045] 4. Anti-arrhythmia: The water extract of Semen Ziziphi Spinosae could inhibit the heart rate of rabbits, and the effect of slowing down the heart rate was not related to the excitation of the vagus nerve and the β1 receptor blockade. The water extract of Semen Ziziphi Spinosae had an antagonistic effect on the arrhythmias induced by aconitine, chloroform, and barium chloride in experimental animals. The ethanol extract had an antagonistic effect on the arrhythmia induced by barium chloride in rats when intravenously injected.

[0046] 5. Anti-myocardial ischemia effect: Total flavonoids and total saponins of Semen Ziziphi Spinosae had anti-myocardial ischemia effects. Intravenous injection or intraperitoneal injection of the ethanol extract of Semen Ziziphi Spinosae had an antagonistic effect on the myocardial ischemia induced by pituitary posterior lobe hormone. It could improve the changes of ischemic EGC of the myocardium, reduce the release of LDH caused by hypoxia and glucose deficiency, and had a protective effect on myocardial cells.

[0047] Borneol: Pungent, bitter, slightly cold. It belongs to the heart, spleen, and lung meridians. It can resuscitate the patient from unconsciousness and relieve pain by clearing heat. It is used for coma due to febrile diseases, convulsions, syncope due to phlegm in stroke, sudden syncope due to qi stagnation, syncope due to pestilence, chest pain due to chest impediment, red eyes, oral ulcers, sore throat, and suppurative otitis media.

[0048] It has the following effects:

[0049] 1. Anti-bacterial and anti-fungal effects: Both natural borneol and synthetic borneol have antibacterial effects.

[0050] 2. Anti-inflammatory and sedative effects: Borneol has the effects of detumescence, anti-inflammation, and promoting wound healing. Clinically, it is often used to treat burns and scalds.

[0051] 3. Protective effect on the central nervous system (CNS): Borneol has a protective effect on the central nervous system (CNS). Borneol is a small molecule terpene compound, which is quickly absorbed in the body, easily penetrates the blood-brain barrier, and has a high drug accumulation and a long accumulation time in the brain tissue. The blood-brain barrier (BBB) is a physiological natural barrier between the blood and the brain tissue, which is used to prevent the free exchange of substances and is of great significance for maintaining the physiological stability of the brain tissue. Clinically, borneol can relieve pathological cerebral edema.

[0052] 4. Protective effect on the circulatory system: The mechanism of action is to slow down the heart rate, reduce the oxygen consumption of myocardial infarction, and increase the blood flow in the coronary sinus;

[0053] 5. Improve the bioavailability of other drugs: Borneol is commonly used as an adjuvant drug in the compatibility of traditional Chinese medicines, that is, it helps other drugs to exert their curative effects better. There is a saying that "it is weak when acting alone, but effective when used as an adjuvant or assistant". Modern pharmacological studies have shown that borneol helps other drugs to cross the blood-brain barrier and exert their pharmacological effects. Borneol is combined with benzoin. By studying the repair effect of this drug on ischemia and hypoxia in mice and its effect on the permeability of the blood-brain barrier, the effect of borneol on improving the bioavailability of other drugs is explored. Various studies have shown that borneol has a protective effect on mice with acute cerebral ischemia and can induce the opening of the blood-brain barrier under normal physiological conditions in mice.

[0054] Salvia miltiorrhiza: Bitter, slightly cold. It belongs to the heart and liver meridians. Promote blood circulation to remove stasis, dredge meridians and relieve pain, clear the heart and remove vexation, cool the blood and eliminate carbuncles. It is used for chest pain, epigastric and hypochondriac pain, mass accumulation, arthralgia pain due to heat, restlessness and insomnia, irregular menstruation, dysmenorrhea and amenorrhea, sores and carbuncles.

[0055] Salvia miltiorrhiza has the following effects:

[0056] 1. Effects on the cardiovascular system:

[0057] (1). Strengthen the heart, enhance myocardial contractility, improve heart function, and do not increase myocardial oxygen consumption;

[0058] (2). Effects on blood vessels: Dilate the coronary arteries, increase myocardial blood flow; dilate peripheral blood vessels, increase blood flow; reduce cerebral blood flow;

[0059] (3). Anti-thrombosis, improve the activity of plasmin, prolong bleeding and clotting time; inhibit platelet aggregation (increase the level of cAMP in platelets to inhibit the synthesis of TXA2); improve hemorheological properties (reduce blood viscosity, shorten the erythrocyte electrophoresis time);

[0060] (4). Improve microcirculation.

[0061] 2. Promote tissue repair and regeneration:

[0062] (1). Promote tissue repair and regeneration. Treatment with Salvia miltiorrhiza preparations: The necrotic myocardium is cleared quickly; the differentiation of fibroblasts and the formation of collagen fibers are more obvious; the granulation formation is relatively mature. Local congestion is reduced, blood circulation is improved, and the healing time is shortened;

[0063] (2). Inhibit excessive proliferation: It has an inhibitory effect on excessively proliferated fibroblasts.

[0064] 3. Protect the liver: Improve liver microcirculation.

[0065] 4. The antibacterial salvia preparation contains cryptotanshinone and dihydrotanshinone, which have inhibitory effects on staphylococcus, escherichia coli, and proteus in vitro.

[0066] Gastrodia elata: Sweet in taste, neutral in property; attributive to the liver meridian. It expels wind and stops convulsion, suppresses the hyperactive liver-yang, and dispels wind and dredges collaterals. Indications: 1. Endogenous wind stirring within the liver, epilepsy with convulsion: This herb mainly enters the liver meridian, functions to expel wind and stop convulsion, is sweet in taste, moist in nature, and mild in property. Therefore, it can be used to treat endogenous wind stirring within the liver, epilepsy with convulsion caused by various etiologies, regardless of cold, heat, deficiency or excess, and can be used in combination. 2. Dizziness, headache: This herb can both expel liver wind and suppress the hyperactive liver-yang, and is a key herb for treating dizziness and headache. Whether it is deficiency syndrome or excess syndrome, it can be used with different combinations. 3. Numbness of limbs, flaccidity of hands and feet, rheumatic arthralgia: This herb can also expel exogenous wind, dredge collaterals, and relieve pain. It is used to treat flaccidity of hands and feet, pain in muscles and bones; wind bi syndrome of women with flaccidity of hands and feet; rheumatic arthralgia, and limited flexion and extension of joints, etc.

[0067] It has the following effects:

[0068] Water, alcohol extracts and different preparations of Gastrodia elata can all significantly reduce the spontaneous activity of mice, and can prolong the sleeping time of mice induced by sodium barbital and cyclohexenobarbital. It can inhibit or shorten the seizure time of experimental epilepsy. Gastrodia elata can also reduce the resistance of peripheral blood vessels, cerebral blood vessels and coronary blood vessels, and has the effects of lowering blood pressure, slowing heart rate, analgesia and anti-inflammation. Gastrodia elata polysaccharide has immunological activity.

[0069] Polygala tenuifolia: Bitter, pungent, warm. Attributive to the heart, kidney and lung meridians. It has the effects of calming the mind and improving intelligence, connecting the heart and kidney, eliminating phlegm, and reducing swelling. It is used for insomnia, dreaminess, amnesia, palpitation, mental trance, cough with profuse phlegm that is difficult to expectorate, sores and ulcers, and breast swelling and pain caused by disharmony between the heart and kidney.

[0070] It has the following effects:

[0071] 1. Connecting the heart and kidney: Polygala tenuifolia can both open the heart qi to calm the mind and tranquilize the spirit, and dredge the kidney qi to strengthen the will and prevent amnesia. It is a drug for connecting the heart and kidney, calming the mind and tranquilizing the spirit, improving intelligence and strengthening memory, and is suitable for treating insomnia, dreaminess, amnesia, palpitation, mental trance and other symptoms caused by disharmony between the heart and kidney;

[0072] 2. Eliminating phlegm: Polygala tenuifolia is bitter, warm and dry in nature, and also enters the lung meridian, and can eliminate phlegm and relieve cough. Therefore, it can be used to treat cough with profuse, thick and sticky phlegm that is difficult to expectorate, etc., and is often used together with drugs for resolving phlegm, relieving cough and asthma to treat cough and asthma;

[0073] 3. Reducing swelling: Polygala tenuifolia has a pungent taste that can promote qi movement, a bitter taste that can purge, and a warm nature that can dredge. Therefore, it can dredge qi and blood stasis and disperse swelling and pain, and can be used to treat sores and ulcers, breast swelling and pain, etc.;

[0074] 4. Therapeutic and health-care effects: ① Polygala tenuifolia has sedative, hypnotic and anti-convulsive effects; the water decoction of Polygala tenuifolia has antioxidant, anti-aging, anti-cancer and other effects; the water extract of Polygala tenuifolia has a protective effect on the brain; the water extract of Polygala root has the effect of preventing various inflammatory encephalopathies. ② Polygala saponins have expectorant, antitussive, blood pressure-lowering effects, as well as effects of enhancing immunity, reducing myocardial contractility, slowing heart rate, antibacterial, antiviral, and hemolytic effects. ③ Polygala alcohol has analgesic effects. ④ The methanol extract of Polygala tenuifolia has hypoglycemic and hypolipidemic effects. ⑤ The crude extract of Polygala tenuifolia has cholagogic, diuretic and detumescent effects.

[0075] Plumula Nelumbinis: Bitter, cold. It belongs to the heart and kidney meridians. It has the effects of clearing the heart and calming the mind, connecting the heart and kidney, and astringing essence and stopping bleeding. It is used for heat invading the pericardium, coma and delirium, disharmony between the heart and kidney, insomnia and spermatorrhea, and hematemesis due to blood heat.

[0076] It has the following effects:

[0077] Plumula Nelumbinis can treat restlessness, delirium, spermatorrhea and emission caused by high fever, and can also treat symptoms such as hypertension, palpitation and insomnia. Plumula Nelumbinis has many effects. The contents of calcium, phosphorus and potassium in Plumula Nelumbinis are also very rich. In addition to being components that can form bones and teeth, it also promotes blood coagulation, activates certain enzymes, maintains nerve conductivity, has the effects of calming nerves, maintaining the elasticity of muscles and the rhythm of heartbeats, etc. Abundant phosphorus is also the main component of nuclear protein, which helps the body metabolize proteins, fats and carbohydrates, maintains acid-base balance, and also plays an important role in sperm formation.

[0078] Concretio Silicea Bambusae: Bitter, cold. It belongs to the heart and liver meridians. It has the effects of clearing heat and resolving phlegm, cooling the heart and calming convulsions. It is used for coma due to febrile diseases, stroke with phlegm obstruction, infantile convulsions, twitching and nocturnal crying.

[0079] It has the following effects:

[0080] 1. On the cardiovascular system: The water decocted extract of Concretio Silicea Bambusae can weaken the contractility of isolated frog hearts and slow down the heart rate. The effect is more intense at a concentration of 1*10 / -2g. It has a direct dilating effect on isolated rabbit ear blood vessels, manifested as an increase in perfusion volume, especially when the blood vessels are in a constricted state, this effect is more obvious. When mice were injected subcutaneously in the back with the water decocted extract of Concretio Silicea Bambusae at 3.0kg / kg, it had a very obvious inhibitory effect on the increase in skin capillary permeability caused by histamine;

[0081] 2. Effects on cardiovascular and plasma recalcification time: A concentration of 2*10 / -1g can significantly prolong the plasma recalcification time. In the blood coagulation experiment, this drug can prolong the coagulation time, which may be related to the prolongation of the recalcification time;

[0082] 3. Sedative and anti-inflammatory effects: Subcutaneous injection of the water decoction extract of Shiraia bambusicola at 2 - 3.1 kg / kg has a good analgesic effect on acetic acid-induced pain in mice. The crystalline substance Ⅲ (Shiraia baccata A) extracted from Shiraia bambusicola, when administered intragastrically at 100 mg / kg, can significantly increase the pain threshold of mice by the hot plate method. Its effect is superior to indomethacin (indocin) and is similar to pethidine (10 mg / kg); it can significantly reduce the number of writhing responses caused by acetic acid and can also significantly reduce the degree of foot swelling caused by egg white;

[0083] 4. Other effects: Preliminary pharmacological tests on the polysaccharides SBI and SB2 of Shiraia bambusicola show certain curative effects on hepatitis;

[0084] 5. Toxicity: When the water decoction extract of Shiraia bambusicola at 15 g / kg is administered intragastrically to mice, the mice move freely and have normal diet within 72 hours without adverse reactions.

[0085] Acorus tatarinowii: Pungent, bitter, warm. It has the effects of waking the mind and enhancing intelligence, and promoting digestion with aromatics. It is used for coma, epilepsy, amnesia, insomnia, tinnitus and deafness, fullness and discomfort in the epigastrium, and dysentery with locked jaws.

[0086] Acorus tatarinowii has the following effects:

[0087] 1. Effects on the central nervous system: Sedation, anti-convulsion, improvement of learning and memory, anti-depression;

[0088] 2. Antispasmodic effect: The water extract, total volatile oil, α-asarone, and β-asarone of Acorus tatarinowii have a certain relaxing effect on the spontaneous contraction of the isolated gastrointestinal muscle of rabbits;

[0089] 3. Cholagogic effect: Intra-duodenal administration of the total volatile oil of Acorus tatarinowii can promote bile secretion in rats, but the defatted extract has no promoting effect;

[0090] 4. Relaxing effect on tracheal smooth muscle: α-asarone and β-asarone can antagonize the contraction of guinea pig tracheal smooth muscle caused by histamine, acetylcholine, etc.;

[0091] 5. Anti-arrhythmic effect: Intraperitoneal injection of the volatile oil of Acorus tatarinowii can slow down the heart rate of rats and antagonize the arrhythmias induced by aconitine, adrenaline, and barium chloride.

[0092] Semen Platycladi: Sweet, mild in nature. It acts on the heart, kidney, and large intestine meridians. It has the effects of nourishing the heart and calming the mind, moistening the intestine and promoting defecation, and stopping sweating. It is used for insufficiency of yin and blood, restlessness and insomnia, palpitation, constipation due to intestinal dryness, and night sweats due to yin deficiency.

[0093] Semen Platycladi has the following pharmacological effects:

[0094] 1. Treatment of constipation: Semen Platycladi is a good tonic. Its kernels contain a large amount of vegetable oil and have a good effect of moistening the intestine and promoting defecation. Cooked with honey, rice, etc. into porridge, it tastes sweet and is suitable for constipation due to intestinal dryness caused by constitutional yin deficiency, senile debility, postpartum weakness, etc.;

[0095] 2. Tonifying deficiency and enriching blood: When combined with yin-nourishing drugs and consumed, Platycladi Semen has good curative effects on weakness and deficiency such as kidney deficiency and spleen deficiency. Moreover, Platycladi Semen is rich in nutrients, containing relatively more vegetable fatty oils, proteins, and mineral iron, which can promote the hematopoietic and blood-enriching functions of the bone marrow, and can tonify deficiency and enrich blood.

[0096] 3. Sedative and hypnotic effects: Both Platycladi Semen or pine and cypress trees have sedative and hypnotic effects. It is mainly because pine and cypress contain volatile vegetable oils, which have sedative and hypnotic effects, and are suitable for symptoms such as restlessness and less sleep, insomnia and dreaminess in the elderly.

[0097] 4. Treating palpitations: Platycladi Semen is neutral in nature, sweet in taste, and belongs to the heart, liver, and spleen meridians. This indicates that Platycladi Semen has the efficacy of nourishing the heart and calming the mind, and is suitable for symptoms such as palpitations and insomnia caused by heart yin deficiency and disharmony between the heart and kidney.

[0098] Bamboo Shavings: Sweet, slightly cold. Belong to the lung, stomach, heart, and gallbladder meridians. It has the functions of clearing heat and resolving phlegm, removing vexation, and stopping vomiting. It is used for phlegm-heat cough, phlegm caused by gallbladder fire, restlessness and uneasiness, vexed insomnia, stroke with phlegm obstruction, stiffness of the tongue and inability to speak, stomach-heat vomiting, pregnancy-induced nausea, and fetal movement restlessness.

[0099] Bamboo Shavings has the following effects:

[0100] 1. Detoxifying and clearing heat effect: Bamboo Shavings can help clear the heat toxins in the body and has the effect of detoxifying and clearing heat. Bamboo Shavings has good effects of stopping vomiting and reducing heat on vomiting caused by damp-heat and vomiting and hiccups caused by stomach deficiency-heat. Bamboo Shavings has the effect of detoxifying and clearing heat, which is beneficial for removing toxins in the body and can also relieve stomach heat.

[0101] 2. Effect of clearing heat and removing vexation: In addition to helping to clear the heat toxins in the body, Bamboo Shavings can also remove the residual heat after febrile diseases. It has good curative effects on symptoms such as restlessness and annoyance, vexation after childbirth, and vexed insomnia after serious illness. Bamboo Shavings can clear heat, detoxify, and remove vexation, which is beneficial for postpartum deficiency-heat and relieving depressive emotions.

[0102] 3. Effect of clearing the stomach and resolving turbidity: Bamboo Shavings has the effect of clearing the stomach and resolving turbidity. For symptoms such as excessive appetite, acid regurgitation, fullness and discomfort, greasy tongue coating, red tongue, dry mouth and desire for cold caused by unclear stomach turbidity, Bamboo Shavings can be used for treatment.

[0103] 4. Effect of clearing the lung and resolving phlegm: Bamboo Shavings can clear lung heat and can well relieve symptoms such as stagnation of phlegm-heat due to gallbladder deficiency, restlessness and uneasiness, and inability to sleep. Bamboo Shavings can resolve phlegm and has a good effect on relieving insomnia.

[0104] The effective combination of the above drugs is scientific and reasonable, dialectical treatment, and has good efficacy. It can quickly relieve the sudden loss of consciousness caused by high fever convulsions, head tilted back, forced or clonic contraction of the muscles of the face and limbs, fixed, upturned or squinting eyeballs, foaming at the mouth, clenched teeth, cyanosis, and incontinence. In the prescription, benzoin is used as the main drug to open the mind and wake up the spirit, promote qi and blood circulation; Ziziphus jujuba seeds and borneol are auxiliary drugs to assist in calming the mind; Salvia miltiorrhiza, lotus seed heart, cypress seed, Polygala tenuifolia, and Gastrodia elata are adjuvant drugs, which have the functions of promoting blood circulation and unblocking collaterals, clearing the heart and eliminating troubles, resolving phlegm, calming and tranquilizing the mind, and stopping wind and convulsions; Acorus calamus, Rhizoma Anemarrhenae, and Rhizoma Cibotii are used as the guiding drugs, which have the functions of removing dampness and appetizing, cooling the heart and calming the convulsions, and maintaining normal digestive function.

[0105] This prescription combines the theoretical basis of traditional Chinese medicine, treats according to syndrome differentiation, and has a scientific prescription. It has achieved very good beneficial technical effects through clinical trials. Taking Example 1 as an example, the relevant information is as follows:

[0106] 1. Case selection criteria

[0107] The clinical manifestations are high fever, coma, mania, hot body and burning hands, phlegm and shortness of breath, coughing and spitting out yellow phlegm, rough wheezing and restlessness, nasal flaring, thirst, and constipation. Anyone with the above symptoms will be used as the standard for case selection.

[0108] 2. Diagnostic Criteria

[0109] 2.1 Inclusion Criteria

[0110] Those with any of the above symptoms meet the diagnosis of febrile disease in traditional Chinese medicine and have a body temperature exceeding 39°C. All family members of the selected patients have signed informed consent.

[0111] 2.2 Exclusion criteria

[0112] Those who do not fall into this syndrome type; those who have transient ischemic attack; those who have serious primary diseases of the liver, kidney, hematopoietic system, endocrine system, etc. confirmed by examination; and those with mental illness.

[0113] 3. Treatment options

[0114] After obtaining informed consent, 85 confirmed coma patients were observed for efficacy and randomly divided into two groups. The treatment group had 43 cases, including 28 males and 15 females, aged 24 to 65 years old, and the control group had 42 cases, including 24 males and 18 females, aged 23 to 63 years old. All patients met the diagnostic criteria of traditional Chinese medicine for high fever and coma caused by febrile diseases. There was no significant difference in the average age, male-female ratio, condition and other clinical data of the two groups of patients, and they were comparable.

[0115] 1. Control group: only take Angong Niuhuang Pills, 1 pill each time, once a day. If the symptoms are well controlled, maintain the dosage. If the symptoms are not controlled, take 2 pills each time, once a day, until the symptoms are controlled. The treatment cycle is 7 days.

[0116] 2. Treatment group: Orally take the big honey pill prepared in Example 1 of the present invention, 1 pill each time, once a day. If the symptoms are well controlled, maintain the dosage. If the symptoms are not controlled, take 2 pills each time, once a day until the symptoms are controlled. The treatment cycle is 7 days.

[0117] IV. Efficacy evaluation criteria

[0118] Clinical cure: During the drug treatment, the consciousness changes from coma to fully awake, and the body temperature drops to normal.

[0119] Marked effect: During the drug treatment, the consciousness is slightly awake and the body temperature drops (still in the fever state).

[0120] Effective: During the drug treatment, the consciousness is still not awake, but the body temperature basically drops to normal.

[0121] Ineffective: During the drug treatment, there is still high fever and unconsciousness; or it is more serious.

[0122] Total effective rate = (number of clinically cured cases + number of markedly effective cases + number of effective cases) / total number of cases * 100%.

[0123] V. Statistical processing

[0124] Table 1 Comparison of treatment effects between two groups of patients

[0125] Group Number of cases Clinical cure (control) Marked effect Effective Ineffective Effective rate (%) Treatment group 43 20 13 4 6 86.0% Control group 42 14 10 4 14 66.7%

[0126] As can be seen from the above table, among the patients in the treatment group, 20 cases were clinically cured, 13 cases had marked effect, 4 cases were effective, and the total effective rate was 86.0%; among the patients in the control group, 14 cases were clinically cured, 10 cases had marked effect, 4 cases were effective, and the total effective rate was 66.7%. There was a significant difference in the treatment effects between the two groups. The treatment effect of the treatment group was significantly better than that of the control group (p < 0.05), indicating that the pharmaceutical composition for treating high fever and coma diseases of the present invention can control and improve the patient's consciousness, reduce the body temperature, and reduce the damage of high fever to the patient's brain.

[0127] While conducting the above experiments on Example 1 of the present invention, the same experiments were also conducted on Examples 2 - 5, and the same or similar results as those of Example 1 were obtained, indicating that the present invention has good effects, stable and reliable curative effects, which will not be listed one by one here.

[0128] VI. Conclusion

[0129] In summary, the components of the present invention are reasonable, the compatibility is scientific, the components support each other, the medication is safe, the curative effect is stable and reliable. The drug of the present invention is significantly superior to Angong Niuhuang Pills in clinical curative effect, has a high bioavailability, the active ingredients are more fully extracted, has a higher bioavailability, has a quick onset, few adverse reactions, and a low price. Compared with Angong Niuhuang Pills, it is more acceptable to ordinary patients, has a broad market prospect, is a major innovation in the treatment of high fever convulsions and resuscitating the patient from unconsciousness, and has great economic and social benefits.

[0130] It should be noted that the technical feature and the key of this application are the compatibility of the traditional Chinese medicine composition. The pill dosage form given above is only an example of a dosage form. Any technical solution that is essentially the same as this application made by using equivalent replacement means or various dosage forms suitable for taking prepared by using the traditional Chinese medicine composition of this application by conventional preparation methods, such as powder (powder for oral use), granule, capsule, decoction (decoction), oral liquid, tablet, etc., all belong to the protection scope of this application.

Claims

1. A pharmaceutical composition for treating high fever coma and awakening the mind, characterized in that: The invention is prepared from the following raw materials by weight: 100-120g of benzoin, 60-100g of spiny jujube seeds, 100-120g of salvia miltiorrhiza, 60-100g of gastrodia elata, 60-100g of polygala tenuifolia, 20-40g of lotus seed core, 30-90g of jasmine, 60-100g of calamus, 60-100g of cypress seeds, 60-100g of bamboo shavings, 20-30g of borneol and 20-40g of acetaminophen as raw materials, wherein: (1) Grind the five medicinal materials of benzoin, spiny jujube seeds, gastrodia elata, rhizoma dahliae, and cypress seeds into powder, pass through a 75 μm sieve, sterilize at 115-130°C for 20-40 min, and mix them with borneol and acetaminophen in equal amounts in increasing amounts to form a fine powder for later use; (2) Place the five raw materials of Danshen, Acorus calamus, lotus seed core, Polygala tenuifolia, and Rhizoma Anemarrhenae in an extraction tank, add water and boil twice, each time adding 6 to 8 times the total weight of the five raw materials, heat to boiling, then simmer for 1 to 2 hours each time, filter, combine the two filtrates, and concentrate to a concentrated solution with a relative density of 1.16 to 1.20 at 70 to 90°C; (3) Mix the powder and concentrated solution evenly, add refined honey to make large honey pills.

2. The pharmaceutical composition for treating high fever coma and awakening the mind according to claim 1, characterized in that: The following raw materials by weight are used as raw materials: 110g of benzoin, 80g of spiny jujube seeds, 110g of salvia miltiorrhiza, 80g of gastrodia elata, 80g of polygala tenuifolia, 30g of lotus seed core, 60g of jasmine, 80g of calamus, 80g of cypress seeds, 80g of bamboo shavings, 25g of borneol and 30g of acetaminophen, wherein: (1) Grind the five medicinal materials of benzoin, spiny jujube seeds, gastrodia elata, radix dahurica and cypress seeds into powder, pass through a 75 μm sieve, sterilize at 120°C for 40 min, and mix them with borneol and acetaminophen in equal amounts in increasing amounts to form a fine powder for later use; (2) Place the five raw materials of Danshen, Acorus calamus, lotus seed core, Polygala tenuifolia, and Rhizoma Anemarrhenae in an extraction tank, add water and boil twice, each time adding 8 times the total weight of the five raw materials, heat to boiling, then simmer for 1.5 h each time, filter, combine the two filtrates, and concentrate to a concentrate with a relative density of 1.18 at 80°C; (3) Mix the powder and concentrated solution evenly, add refined honey to make large honey pills.

3. The pharmaceutical composition for treating high fever coma and awakening the mind according to claim 1, characterized in that: The raw materials are as follows: 100g benzoin, 60g jujube seed, 100g salvia miltiorrhiza, 60g gastrodia elata, 60g polygala tenuifolia, 20g lotus seed core, 30g jasmine, 60g calamus, 60g cypress seed, 60g bamboo shavings, 20g borneol and 20g acetaminophen as raw materials, wherein: (1) Grind the five medicinal materials of benzoin, spiny jujube seeds, gastrodia elata, rhizoma dahliae, and cypress seeds into powder, pass through a 75 μm sieve, sterilize at 115°C for 40 min, and mix them with borneol and acetaminophen in equal amounts in increasing amounts to form a fine powder for later use; (2) Place the five raw materials of Danshen, Acorus calamus, lotus seed core, Polygala tenuifolia, and Rhizoma Anemarrhenae in an extraction tank, add water and boil twice, each time adding 6 times the total weight of the five raw materials, heat to boiling, then simmer for 1 hour each time, filter, combine the two filtrates, and concentrate to a concentrate with a relative density of 1.20 at 70°C; (3) Mix the powder and concentrated solution evenly, add refined honey to make large honey pills.

4. The pharmaceutical composition for treating high fever coma and awakening the mind according to claim 1, characterized in that: The following raw materials by weight are used as raw materials: 120g of benzoin, 100g of spiny jujube seeds, 120g of salvia miltiorrhiza, 100g of gastrodia elata, 100g of polygala tenuifolia, 40g of lotus seed core, 90g of jasmine, 100g of calamus, 100g of cypress seeds, 100g of bamboo shavings, 30g of borneol and 40g of acetaminophen, wherein: (1) Grind the five medicinal materials of benzoin, spiny jujube seeds, gastrodia elata, radix dahurica and cypress seeds into powder, pass through a 75 μm sieve, sterilize at 130°C for 20 min, and mix them with borneol and acetaminophen in equal amounts in increasing amounts to form a fine powder for later use; (2) Place the five raw materials of Danshen, Acorus calamus, lotus seed core, Polygala tenuifolia, and Rhizoma Anemarrhenae in an extraction tank, add water and boil twice, each time adding 8 times the total weight of the five raw materials, heat to boiling, then simmer for 2 h each time, filter, combine the two filtrates, and concentrate to a concentrate with a relative density of 1.16 at 90°C; (3) Mix the powder and concentrated solution evenly, add refined honey to make large honey pills.

5. The pharmaceutical composition for treating high fever coma and awakening the mind according to claim 1, characterized in that: The following raw materials by weight are used as raw materials: 105g benzoin, 95g jujube seeds, 105g salvia miltiorrhiza, 90g gastrodia elata, 70g polygala tenuifolia, 35g lotus seed core, 40g jasmine, 90g calamus, 75g cypress seeds, 75g bamboo shavings, 23g borneol and 35g acetaminophen as raw materials, wherein: (1) Grind the five medicinal materials of benzoin, spiny jujube seeds, gastrodia elata, rhizoma dahliae, and cypress seeds into powder, pass through a 75 μm sieve, sterilize at 125°C for 25 min, and mix them with borneol and acetaminophen in equal amounts in increasing amounts to form a fine powder for later use; (2) Place the five raw materials of Danshen, Acorus calamus, lotus seed core, Polygala tenuifolia, and Rhizoma Anemarrhenae in an extraction tank, add water and boil twice, each time adding 7 times the total weight of the five raw materials, heat to boiling, then simmer for 2 h each time, filter, combine the two filtrates, and concentrate to a concentrate with a relative density of 1.17 at 85°C; (3) Mix the powder and concentrated solution evenly, add refined honey to make large honey pills.

6. The pharmaceutical composition for treating high fever coma and awakening the mind according to claim 1, characterized in that: The following raw materials by weight are used as raw materials: 115g benzoin, 75g jujube seeds, 115g salvia miltiorrhiza, 75g gastrodia elata, 95g polygala tenuifolia, 25g lotus seed core, 85g jasmine, 70g calamus, 90g cypress seeds, 70g bamboo shavings, 28g borneol and 23g acetaminophen as raw materials, wherein: (1) Grind the five medicinal materials of benzoin, spiny jujube seeds, gastrodia elata, radix dahurica and cypress seeds into powder, pass through a 75 μm sieve, sterilize at 118°C for 38 min, and mix them with borneol and acetaminophen in equal amounts in increasing amounts to form a fine powder for later use; (2) Place the five raw materials of Danshen, Acorus calamus, lotus seed core, Polygala tenuifolia, and Rhizoma Anemarrhenae in an extraction tank, add water and boil twice, each time adding 7.5 times the total weight of the five raw materials, heat to boiling, then simmer for 1.5 h each time, filter, combine the two filtrates, and concentrate to a concentrate with a relative density of 1.19 at 75°C; (3) Mix the powder and concentrated solution evenly, add refined honey to make large honey pills.