Compound composition for treating cerebral hemorrhage, preparation method, application and medicine

Abstract

The present invention provides a compound composition for treating cerebral hemorrhage and a preparation method, application and medicine, relating to the field of traditional Chinese medicine technology. The raw materials of the compound composition according to weight parts are: 10-30 parts of moutan bark, 2-10 parts of rhubarb, 5-15 parts of zedoaria root, 10-21 parts of kudzu root and 5-15 parts of luffa sponge;moutan bark, rhubarb, zedoaria root, kudzu root and luffa sponge are mixed and soaked in water;decoction is carried out twice, and the filtrate is combined to obtain a compound composition. The present invention adopts moutan bark, rhubarb, zedoaria root, kudzu root, luffa sponge five flavors, scientific compatibility, brings about the effect of significantly improving brain microcirculation, promoting hematoma absorption;It is also possible to significantly reduce hematoma volume, reduce inflammatory reaction, reduce brain tissue damage, and improve the treatment efficiency of cerebral hemorrhage.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and in particular relates to a compound composition for treating cerebral hemorrhage, a preparation method thereof, an application thereof and a medicine thereof. Background Art

[0002] Cerebrovascular disease is a common ailment that endangers human health. Cerebral hemorrhage is a type of cerebrovascular disease and the second most common cause of stroke after ischemic stroke. Therefore, acute treatment is crucial. Currently, Western medicine treatments for cerebral hemorrhage primarily fall into two categories: surgical treatment and comprehensive medical therapy. Surgical treatment, primarily reserved for patients with significant bleeding who are suitable for surgery, carries certain risks. Comprehensive medical therapy typically involves the use of dehydrating agents to reduce cerebral edema, antihypertensive medications to control blood pressure, prevent and treat infection, correct water, electrolyte, and acid-base imbalances, or neuronal function enhancers and calcium channel blockers. However, these treatments are less than ideal.

[0003] Traditional Chinese medicine has a certain application in the treatment of cerebral hemorrhage, including using Chinese herbs to improve symptoms and promote recovery. Chinese invention patent CN101721572A discloses a Chinese herbal compound preparation for treating hemorrhagic stroke. The preparation is prepared from the following raw materials in a weight ratio: 2-30g of rhubarb, 5-80g of water buffalo horn, 5-30g of red peony root, 3-30g of moutan bark, 5-50g of raw rehmannia, 3-30g of earthworm, 1-20g of ginseng and notoginseng, and 3-30g of calamus. In the formula, rhubarb and water buffalo horn are the main ingredients. Rhubarb clears heat and purges fire, cools blood and removes blood stasis, and clears the bowels and relieves heat. Water buffalo horn has the functions of clearing heat and cooling blood. The two herbs complement each other and can further enhance the cooling and blood-stasis-removing effects. Raw rehmannia, moutan bark, and red peony root are the auxiliary ingredients. The combination of the three herbs can better enhance the efficacy of the main ingredient. The earthworm and ginseng and notoginseng are used as auxiliary ingredients, and the calamus is used to open the mind and invigorate the body, guiding the herbs upward. The components of the medicines cooperate with each other to cool the blood and dissipate blood stasis, and clear the bowels and relieve heat. However, the preparation does not disclose the therapeutic effect of accelerating the reduction of hematoma volume.

[0004] Chinese invention patent CN101513491A discloses a Chinese patent medicine for treating cardiovascular and cerebrovascular diseases, which can treat arteriosclerosis, cerebral hemorrhage, and sequelae of cerebral thrombosis. The raw materials of the Chinese patent medicine include: 8-12g of pangolin slices, 10-14g of ground turtle, 3 golden-headed centipedes 5-7 inches long, 13-17g of earthworm, 2 white flower snakes 3-7 inches long, 25-35g of white ginseng, 15-25g of northern schisandra, 25-35g of ophiopogon, 25-35g of asparagus, 25-35g of elephant fritillary, 18-24g of bitter almond, 25-35g of dried scutellaria, 25-35g of Sichuan coptis root, 25-35g of gardenia, 25-35g of Qinglianxiang, 25-35g of Qinpi, 18-24g of Yiyuansan, 18-24g of lithospermum officinale, 18-24g of lithospermum officinale. 4g, gypsum 45-55g, talc 45-55g, weathered saltpeter 45-55g, raw golden rhubarb 25-35g, Chinese yew 25-35g, wild papaya 25-35g, cassia twig 25-35g, ephedra root 18-24g, liquorice 25-35g, whole angelica 13-17g, saffron 13-17g, notoginseng 13-17g, madder 18-22g, raw rehmannia 45-55g, powdered moutan bark 45-55g, red peony root 45-55g, sufang wood 35-45g, white tuckahoe 45-55g, and 2 liang of loofah. This Chinese patent medicine contains as many as 37 ingredients, and the formula is complex and may be toxic.

[0005] Chinese invention patent CN104189115A discloses a traditional Chinese medicine for the recovery phase of cerebral hemorrhage. The medicine comprises the following raw materials, by weight: 20-30 parts of salvia miltiorrhiza, 10-20 parts of chuanxiong rhizome, 10-20 parts of moutan bark, 10-20 parts of acanthopanax senticosus, 10-20 parts of rhubarb, 10-20 parts of leech, 20-30 parts of white snakehead, 15-20 parts of angelica sinensis, 10-20 parts of gentiana macrophylla, 10-20 parts of notopterygium root, 10-20 parts of siler, and 10-15 parts of breviscapus asarum. This medicine has some efficacy in the medium- to long-term treatment of cerebral hemorrhage, but is less effective in the acute phase.

[0006] The traditional Chinese medicine formulas currently used to treat cerebral hemorrhage are complex in composition, and most of them do not embody the effect of synergistic enhancement, resulting in a weak effect of reducing hematoma volume and clearing away heat and cooling blood. In addition, there are fewer traditional Chinese medicine formulas for treating acute cerebral hemorrhage caused by blood heat, and there are no reports of using Paeonia suffruticosa as a monarch drug to treat cerebral hemorrhage. Based on this, it is necessary to further study the types and proportions of components of traditional Chinese medicine formulas, and provide a simplified formula in which each component interacts and synergizes, significantly reducing hematoma volume, improving the efficacy of treating cerebral hemorrhage, and being safe and non-toxic. Summary of the Invention

[0007] The present invention addresses the problems existing in the prior art and provides a compound composition for treating cerebral hemorrhage, as well as a preparation method, application, and medicine. The present invention utilizes a scientific combination of five herbs: moutan bark, rhubarb, zedoaria root, kudzu root, and luffa sponge, to achieve the effects of clearing heat, cooling blood, activating blood circulation, and reducing swelling. The compound composition can improve cerebral microcirculation, promote hematoma absorption, significantly reduce hematoma volume, alleviate inflammatory reactions, reduce brain tissue damage, and improve treatment efficacy, particularly for acute cerebral hemorrhage.

[0008] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0009] First, the present invention provides a compound composition for treating cerebral hemorrhage. The raw materials are composed of the following ingredients in parts by weight: 10-30 parts of peony bark, 2-10 parts of rhubarb, 5-15 parts of zedoary root, 10-21 parts of kudzu root and 5-15 parts of loofah.

[0010] Preferably, the compound composition is composed of the following ingredients in parts by weight: 15-25 parts of peony bark, 3-8 parts of rhubarb, 8-12 parts of zedoary herb, 13-17 parts of kudzu root and 6-12 parts of loofah.

[0011] Further preferably, the compound composition is composed of the following ingredients in parts by weight: 20 parts of peony bark, 5 parts of rhubarb, 10 parts of zedoary herb, 15 parts of kudzu root and 9 parts of luffa.

[0012] Then, the present invention provides a method for preparing the above-mentioned compound composition, comprising the steps of:

[0013] (1) mixing peony bark, rhubarb, herba zedoariae, kudzu root and loofah, and soaking them in water to obtain a composition;

[0014] (2) First decoction: boiling the mixture from step (1), then decocting and filtering to obtain filtrate 1 and medicinal residue;

[0015] (3) Second decoction: add water to the medicinal residue from step (2), boil, then decoct, filter, and obtain filtrate 2;

[0016] (4) Combine filtrate 1 and filtrate 2 to obtain a compound composition.

[0017] Preferably, in step (1), the amount of water added for soaking is sufficient to cover the raw material components, and the soaking is carried out at room temperature for 30-60 minutes.

[0018] Further preferably, in step (1), the soaking time is 40-50 minutes.

[0019] More preferably, in step (1), the soaking time is 45 minutes.

[0020] Preferably, in step (2), the decocting time is 20-30 minutes.

[0021] Further preferably, in step (2), the decocting time is 25 minutes.

[0022] Preferably, in step (3), the decocting time is 15-25 minutes.

[0023] Further preferably, in step (3), the decocting time is 20 minutes.

[0024] Preferably, in step (2) and step (3), the filtration is performed while hot.

[0025] In the present invention, during the soaking and decocting process, the solid-liquid ratio of the Chinese medicinal raw material and water is controlled at 1:10-20 g / mL.

[0026] Furthermore, the present invention provides use of the above-mentioned compound composition in preparing a drug for treating cerebral hemorrhage.

[0027] Finally, the present invention provides a medicine for treating cerebral hemorrhage, comprising: the above compound composition.

[0028] Preferably, the medicine is specifically a medicine for treating heat syndrome occurring in the acute phase of cerebral hemorrhage.

[0029] Preferably, the drug is specifically a drug that promotes hematoma absorption and reduces hematoma volume.

[0030] More preferably, the drug is specifically a drug that promotes the absorption of cerebral hematoma and reduces the volume of cerebral hematoma.

[0031] Preferably, the components of the drug may further include a pharmaceutical carrier. The pharmaceutical carrier may be a solid, liquid, or gas. Examples of solid carriers include lactose, kaolin, sucrose, talc, gelatin, agar, pectin, gum arabic, magnesium stearate, and stearic acid. Examples of liquid carriers include syrup, peanut oil, olive oil, and water. Examples of gaseous carriers include carbon dioxide and nitrogen.

[0032] When preparing compositions for oral dosage forms, any convenient pharmaceutical medium can be used. For example, water, ethanol, oils, alcohols, flavoring agents, preservatives, colorants, and the like can be used to form oral liquid formulations, such as suspensions and solutions; while carriers, such as starches, sugars, microcrystalline cellulose, diluents, granulating agents, emulsifiers, lubricants, binders, and disintegrants can be used to form oral solid formulations, such as powders, capsules, and tablets. Tablets and capsules are preferred oral dosage units using solid pharmaceutical carriers due to their ease of administration. Tablets can be coated using standard aqueous or nonaqueous techniques.

[0033] Tablets containing the Chinese medicine composition or extract of the present invention can be prepared by tableting or molding, and one or more auxiliary ingredients or adjuvants can be used. The active ingredient can be compressed into a free-flowing form (such as powder or granules) in a suitable machine, and can be mixed with a binder, lubricant, inert diluent, surfactant or dispersant to prepare the compressed tablet. Molded tablets can be molded in a suitable machine, i.e., a powdered compound mixture moistened with an inert liquid diluent. Each tablet preferably contains about 0.05 mg to about 5 g of active ingredient, and each sachet or capsule preferably contains about 0.05 mg to about 5 g of active ingredient. For example, a preparation intended for oral administration to humans may contain about 0.5 mg to about 5 g of active drug, mixed with an appropriate and convenient carrier material, which may account for about 5% to 95% of the total composition. The unit dosage form usually contains about 1 mg to about 2 g of active ingredient, typically 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 800 mg or 1000 mg.

[0034] Pharmaceutical compositions suitable for parenteral administration of the present invention can be prepared as aqueous solutions or suspensions of the active compound. Suitable surfactants, such as hydroxypropylcellulose, can be included. Dispersions can also be prepared in glycerol, liquid polyethylene glycol, and oil mixtures thereof. In addition, preservatives can be added to prevent the harmful growth of microorganisms.

[0035] Medicine of the present invention can be the form that is suitable for topical use, for example aerosol, emulsifiable paste, ointment, lotion, powder or analogue.In addition, composition can be that suitable form is used for transdermal drug delivery device.Can use Chinese medicine composition of the present invention, prepare these prescriptions by conventional processing method.For example, by mixing hydrophilic material and water, and the compound of about 5wt% to about 10wt%, preparation has emulsifiable paste or ointment of required consistency.

[0036] The medicament of the present invention can be in a form suitable for rectal administration, wherein the carrier is a solid. It is best to prepare the mixture into unit dose suppositories. Suitable carriers include cocoa butter and other materials commonly used in the art. Suppositories can be prepared by first forming a composition containing a softened or melted carrier, followed by cooling and shaping in a mold.

[0037] In addition to the above-mentioned carrier components, the above-mentioned pharmaceutical preparations may include (if applicable) one or more additional carrier components, such as diluents, buffers, flavoring agents, binders, surfactants, thickeners, lubricants, preservatives (including antioxidants), etc. In addition, other excipients, such as lactose, starch, cellulose derivatives, magnesium stearate, stearic acid, etc., colorants and flavoring agents, etc., may be added. The preparation is made isotonic with the blood of the intended recipient. The components containing the Chinese medicine composition of the present invention can also be prepared in the form of a powder or concentrate.

[0038] Preferably, the dosage form of the drug is not limited to pills, capsules, granules, oral liquids, powders, tablets, lozenges, ointments and other dosage forms, and suitable drug carriers in the art can be selected for different dosage forms.

[0039] In the compound composition of the present invention, with Cortex Moutan as monarch drug, Radix Et Rhizoma Rhei as ministerial drug, Herba Lycopithecis and Radix Puerariae as adjuvant drug, and Fructus Luffae Fructus as guiding drug, the five herbs are combined and formed, has the effect of clearing away heat, cooling blood, promoting blood circulation and detumescence, and cures mainly the acute stage of cerebral hemorrhage caused by heat syndrome. The basic pathogenesis of cerebral hemorrhage is visceral dysfunction, imbalance of yin and yang, disorder of qi and blood, which invades the brain, and blood stasis overflows outside the brain vessels. The severe cases can block the clear orifices and blind the mind. The acute stage of cerebral hemorrhage is caused by different reasons, and "wind syndrome", "heat syndrome", "phlegm syndrome" and "Yin deficiency syndrome" are the basic syndromes of the acute stage of hemorrhagic stroke, and "wind syndrome" is the starting factor of morbidity. The acute stage is the most obvious with "heat syndrome", and "stasis syndrome" runs through the disease. The compound composition of the present invention is mainly used to treat heat syndrome in the acute stage of cerebral hemorrhage. It can unify the theory, method, prescription and medicine ideas for the symptoms of blood heat running wildly, invading the brain and bleeding outside the vessels. It can eliminate heat syndrome through the effects of clearing heat, cooling blood, activating blood circulation and reducing swelling, and treat concurrent symptoms at the same time.

[0040] Peony bark: Bitter, pungent, and slightly cold; it enters the heart, liver, and kidney meridians; it cools blood, dispels heat, and activates blood circulation and removes blood stasis. Modern research has shown that peony bark, primarily containing chemical components such as paeonol, has multiple pharmacological effects, including liver and kidney protection, anti-inflammatory, sedative, cooling, antipyretic, analgesic, and antispasmodic. It is primarily used to treat heat invading the blood, fever-induced rashes, hematemesis and epistaxis, night fever and morning chills, dryness without sweating, bone steaming, amenorrhea, dysmenorrhea, pain from falls, and carbuncles and sores. "Compendium of Materia Medica" states: "Peony bark treats latent heat in the blood of the Shaoyin and Jueyin meridians of the hands and feet." "Compendium of Materia Medica" states: "Peony bark tastes bitter and slightly pungent, and its qi is cold but non-toxic. Pungent can disperse lumps, while bitter and cold can remove blood heat and enter the blood. It is an essential medicine for cooling blood and heat. Cold and heat are symptoms of yin deficiency and blood heat. Stroke, spasms, convulsions, and epilepsy are all caused by yin deficiency, internal heat, and insufficient blood. When the heat is gone, the blood is cool, and when it is cool, new blood is generated and yin qi is restored. When yin qi is restored, the fire is not inflamed and there is no sign of wind caused by heat. Therefore, it is the main medicine for all of them. Carbuncle is caused by heat congestion and blood stasis." For the symptoms of hot blood in the acute stage of cerebral hemorrhage, peony bark can directly treat the cause by cooling blood, clearing heat, and promoting blood circulation and removing blood stasis. The present invention selects peony bark as the main medicine.

[0041] Rhubarb: Bitter in taste and cold in nature, it has the effects of purging, clearing away heat and purging fire, cooling blood and detoxifying, and removing blood stasis and promoting menstruation. It is mainly used to treat constipation caused by stagnation, vomiting and bleeding due to blood heat, red eyes and swollen throat, ulcers caused by heat toxins, burns and scalds, various symptoms of blood stasis, damp-heat dysentery, jaundice, and stranguria. According to the Shennong's Herbal Classic, it can dissipate blood stasis, resolve cold and heat due to blood stasis, dissolve lumps and masses, eliminate retained fluid and food, cleanse the intestines and stomach, eliminate the old and usher in the new, promote the flow of water and food, regulate the digestion of food, and soothe the five internal organs. Rhubarb can clear heat and purge fire, cool blood and detoxify, and complement the main ingredient, Cortex Moutan, to enhance its heat-clearing and blood-cooling efficacy, helping to alleviate the inflammatory response and heat-toxic symptoms in the acute phase of cerebral hemorrhage. Furthermore, rhubarb, through its purgative effect, helps expel blood stasis and toxins from the body, aiding in recovery. The present invention uses rhubarb as the auxiliary ingredient.

[0042] Ze Lan: bitter, pungent, slightly warm; enter the liver and spleen meridians; has the effects of promoting blood circulation and regulating menstruation, removing blood stasis and eliminating carbuncle, promoting diuresis and reducing swelling. Indications: irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to blood stasis after childbirth, sore carbuncle and swelling, edema and ascites. "Compendium of Materia Medica": nourishing nutrient qi, breaking up old blood, main women's fatigue and thinness, gynecology important medicine Ze Lan can assist the cortex moutan to strengthen the effect of promoting blood circulation and removing blood stasis. Considering that the acute phase of cerebral hemorrhage is often accompanied by edema, the effects of Ze Lan in removing blood stasis and eliminating carbuncle, promoting diuresis and reducing swelling are utilized to treat the concurrent symptoms of edema. The present invention selects Ze Lan as an adjuvant.

[0043] Pueraria root: sweet, spicy and cool; enters the spleen, stomach and lung meridians; has the effects of relieving muscles and reducing fever, clearing rashes, promoting fluid production and quenching thirst, raising yang and stopping diarrhea, promoting blood circulation and activating collaterals, and detoxifying alcohol. It is mainly used to treat exogenous fever and headache, stiff neck and back pain, thirst, polydipsia, measles that does not break out, dysentery, diarrhea, dizziness and headache, hemiplegia caused by stroke, chest pain and heart pain, and alcohol poisoning. "Compendium of Materia Medica" says: "Pueraria root is the main medicine for dispersing the heat evil of Yangming febrile disease, so it is used to treat polydipsia, high fever, and vomiting caused by heat congestion in the chest and diaphragm. It is dispersing and ascending, which is the nature of wind medicine, so it is used to treat various types of numbness." Pueraria root can lead the medicine upward to the head, strengthen the therapeutic effects of the main and auxiliary medicines on brain lesions, and also help to relieve the fever and headache symptoms of patients with cerebral hemorrhage and improve blood circulation in the brain. The present invention selects Pueraria root as an adjuvant.

[0044] Luffa: Sweet in flavor, neutral in nature; enters the stomach, lung, and liver meridians. It dispels wind, dredges the meridians, activates blood circulation, and promotes lactation. Indications: Pain and cramps in the arthralgia, chest and flank pain, milk blockage, and painful mastitis. "Compendium of Materia Medica" states: "Luffa enters the meridians and dispels pathogenic heat. Heat is eliminated, wind is dispelled, and fluid in the meridians is prevented from combining and forming phlegm, which can lead to swelling and toxins. Therefore, it is said to be a detoxifying agent." "Compendium of Materia Medica: New" states: "It dredges the meridians, harmonizes blood vessels, resolves phlegm, and soothes qi." Luffa, with its meridian-dredge properties, guides drugs directly to the affected area and harmonizes the various drugs, allowing the prescription to better exert its effects of clearing heat, cooling blood, activating blood circulation, and reducing swelling. Luffa is a guiding drug in the present invention's composition.

[0045] Compared with the prior art, the present invention has the following beneficial effects:

[0046] 1. The compound composition of the present invention is composed of peony bark as the main drug, rhubarb as the ministerial drug, herba zedoariae and kudzu root as the adjuvant drug, and luffa as the guiding drug. The above five herbs are compatible with each other, and the components interact with each other and complement each other. The prescription is streamlined and the composition is prepared with a specific ratio, bringing significant heat-clearing, blood-cooling, blood-activating and swelling-reducing effects. The compound composition of the present invention has a good therapeutic effect for the heat syndrome that occurs in the acute stage of cerebral hemorrhage, can promote hematoma absorption, and improve the pressure of hematoma on the surrounding brain tissue, thereby improving the patient's prognosis.

[0047] 2. The compound composition of the present invention is prepared by multiple decoctions, so that the active ingredients are fully dissolved, the content of the effective ingredients is increased, and the effect of significantly reducing the volume of the hematoma is achieved.

[0048] 3. The compound composition of the present invention is used to treat cerebral hemorrhage caused by heat syndrome and has a definite clinical efficacy. The compound composition of the present invention is different from other reported formulas for treating cerebral hemorrhage. The compound composition of the present invention can be used for the acute stage of cerebral hemorrhage caused by heat syndrome. Most of the traditional Chinese medicine formulas disclosed in the prior art are used for the recovery stage of cerebral hemorrhage. The compound composition of the present invention has a wider applicability. DETAILED DESCRIPTION

[0049] The following non-limiting examples are provided to enable those skilled in the art to more fully understand the present invention, but are not intended to limit the present invention in any way. The following contents are merely illustrative of the scope of the present invention, and those skilled in the art may make various changes and modifications to the present invention based on the disclosed contents, which should also fall within the scope of the present invention.

[0050] When numerical ranges are given in the examples, it should be understood that, unless otherwise specified herein, both endpoints of each numerical range and any value between the two endpoints may be selected. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the invention belongs.

[0051] The present invention will be further described below with reference to specific examples. Unless otherwise specified, the various chemical reagents and Chinese medicinal materials used in the examples of the present invention were obtained through conventional commercial channels.

[0052] Example 1

[0053] A compound composition for treating cerebral hemorrhage comprises the following raw materials in parts by weight: 20 parts of peony bark, 5 parts of rhubarb, 10 parts of zedoary herb, 15 parts of kudzu root and 9 parts of luffa sponge.

[0054] The preparation method of the compound composition is:

[0055] (1) Mix peony bark, rhubarb, zedoaria root, kudzu root and loofah, add water to cover the raw materials by 3-5 cm (solid-liquid ratio of 1:15 g / mL), and soak at room temperature for 45 minutes to obtain a mixture;

[0056] (2) First decoction: boil the mixture from step (1), then decoct for 25 min, filter while hot, and obtain filtrate 1 and medicinal residue;

[0057] (3) Second decoction: Add water to the medicinal residue from step (2) to cover the residue by 3-5 cm (solid-liquid ratio of 1:15 g / mL), boil, and then decoct for 20 min. Filter while hot to obtain filtrate 2;

[0058] (4) Combine filtrate 1 and filtrate 2 to obtain a compound composition.

[0059] Example 2

[0060] A compound composition for treating cerebral hemorrhage comprises the following raw materials in parts by weight: 15 parts of peony bark, 3 parts of rhubarb, 8 parts of zedoaria, 13 parts of kudzu root and 6 parts of luffa.

[0061] The rest are the same as in Example 1.

[0062] Example 3

[0063] A compound composition for treating cerebral hemorrhage comprises the following raw materials in parts by weight: 25 parts of peony bark, 8 parts of rhubarb, 12 parts of zedoary herb, 17 parts of kudzu root and 12 parts of luffa.

[0064] The rest are the same as in Example 1.

[0065] Example 4

[0066] A compound composition for treating cerebral hemorrhage comprises the following raw materials in parts by weight: 10 parts of peony bark, 2 parts of rhubarb, 5 parts of zedoaria, 10 parts of kudzu root and 5 parts of luffa.

[0067] The preparation method of the compound composition is:

[0068] (1) Mix peony bark, rhubarb, zedoaria root, kudzu root and loofah, add water to cover the raw materials by 3-5 cm (solid-liquid ratio of 1:15 g / mL), and soak at room temperature for 30 minutes to obtain a mixture;

[0069] (2) First decoction: boil the mixture from step (1), then decoct for 30 min, filter while hot, and obtain filtrate 1 and medicinal residue;

[0070] (3) Second decoction: Add water to the medicinal residue from step (2) to cover the residue by 3-5 cm (solid-liquid ratio of 1:15 g / mL), boil, and then decoct for 25 min. Filter while hot to obtain filtrate 2;

[0071] (4) Combine filtrate 1 and filtrate 2 to obtain a compound composition.

[0072] Example 5

[0073] A compound composition for treating cerebral hemorrhage comprises the following raw materials in parts by weight: 30 parts of peony bark, 10 parts of rhubarb, 15 parts of zedoaria, 21 parts of kudzu root and 15 parts of luffa.

[0074] The preparation method of the compound composition is:

[0075] (1) Mix peony bark, rhubarb, zedoaria root, kudzu root and loofah, add water to cover the raw materials by 3-5 cm (solid-liquid ratio of 1:15 g / mL), and soak at room temperature for 60 minutes to obtain a mixture;

[0076] (2) First decoction: boil the mixture from step (1), then decoct for 20 min, filter while hot, and obtain filtrate 1 and medicinal residue;

[0077] (3) Second decoction: Add water to the medicinal residue from step (2) to cover the residue by 3-5 cm (solid-liquid ratio of 1:15 g / mL), boil, and then decoct for 15 min. Filter while hot to obtain filtrate 2;

[0078] (4) Combine filtrate 1 and filtrate 2 to obtain a compound composition.

[0079] Comparative Example 1

[0080] The difference from Example 1 is that the adjuvant drug rhubarb is replaced by red peony root.

[0081] The compound composition comprises the following raw materials in parts by weight: 20 parts of peony bark, 5 parts of red peony root, 10 parts of zedoary herb, 15 parts of kudzu root and 9 parts of luffa sponge.

[0082] The preparation method of the compound composition is:

[0083] (1) Mix peony bark, red peony root, zedoary root, kudzu root and loofah, add water to cover the raw materials by 3-5 cm (solid-liquid ratio of 1:15 g / mL), and soak at room temperature for 45 minutes to obtain a mixture;

[0084] (2) First decoction: boil the mixture from step (1), then decoct for 25 min, filter while hot, and obtain filtrate 1 and medicinal residue;

[0085] (3) Second decoction: Add water to the medicinal residue from step (2) to cover the residue by 3-5 cm (solid-liquid ratio of 1:15 g / mL), boil, and then decoct for 20 min. Filter while hot to obtain filtrate 2;

[0086] (4) Combine filtrate 1 and filtrate 2 to obtain a compound composition.

[0087] Comparative Example 2

[0088] The difference from Example 1 is that the dosage ratios of the raw materials in the compound composition are different.

[0089] The raw materials of the compound composition are as follows: 8 parts of Paeonia suffruticosa, 1 part of Rhubarb, 25 parts of Herba Lycopodii, 22 parts of Radix Puerariae and 3 parts of Luffa Sponge. The preparation method of the compound composition is the same as that of Example 1.

[0090] Comparative Example 3

[0091] The difference from Example 1 is that the raw material components of the compound composition are different.

[0092] The compound composition comprises the following raw materials in parts by weight: 20 parts of peony bark, 5 parts of rhubarb and 9 parts of loofah.

[0093] The preparation method of the compound composition is:

[0094] (1) Mix peony bark, rhubarb and loofah, add water to cover the raw materials by 3-5 cm (solid-liquid ratio of 1:15 g / mL), and soak at room temperature for 45 minutes to obtain a mixture;

[0095] (2) First decoction: boil the mixture from step (1), then decoct for 25 min, filter while hot, and obtain filtrate 1 and medicinal residue;

[0096] (3) Second decoction: Add water to the medicinal residue from step (2) to cover the residue by 3-5 cm (solid-liquid ratio of 1:15 g / mL), boil, and then decoct for 20 min. Filter while hot to obtain filtrate 2;

[0097] (4) Combine filtrate 1 and filtrate 2 to obtain a compound composition.

[0098] Comparative Example 4

[0099] The difference from Example 1 is that the raw material components of the compound composition are different.

[0100] The compound composition comprises the following raw materials in parts by weight: 10 parts of Zedoariae rhizome and 15 parts of Puerariae root.

[0101] The preparation method of the compound composition is:

[0102] (1) Mix Zedoariae and Puerariae Radix, add water to cover the raw materials by 3-5 cm (solid-liquid ratio of 1:15 g / mL), and soak at room temperature for 45 minutes to obtain a mixture;

[0103] (2) First decoction: boil the mixture from step (1), then decoct for 25 min, filter while hot, and obtain filtrate 1 and medicinal residue;

[0104] (3) Second decoction: Add water to the medicinal residue from step (2) to cover the residue by 3-5 cm (solid-liquid ratio of 1:15 g / mL), boil, and then decoct for 20 min. Filter while hot to obtain filtrate 2;

[0105] (4) Combine filtrate 1 and filtrate 2 to obtain a compound composition.

[0106] Comparative Example 5

[0107] The difference from Example 1 is that the preparation method of the compound composition is different, specifically:

[0108] Mix peony bark, rhubarb, zedoaria root, kudzu root and loofah, add water to cover the raw materials by 3-5 cm (solid-liquid ratio of 1:15 g / mL), boil, then decoct for 45 minutes, filter while hot to obtain a filtrate.

[0109] Trial 1: Comparison of clinical efficacy

[0110] 110 patients with cerebral hemorrhage, aged 40-65 years (mean age 52.9 years), were randomly divided into 11 groups, with 10 patients in each group, namely: control group, Example 1 group, Example 2 group, Example 3 group, Example 4 group, Example 5 group, comparative example group 1 group, comparative example group 2 group, comparative example group 3 group, comparative example group 4 group, and comparative example group 5 group. All groups except the control group were experimental groups. There was no statistically significant difference in gender, age, comorbidities, etc. among the patients in the groups (P>0.05), indicating that the groups were comparable.

[0111] Inclusion criteria for patients with cerebral hemorrhage: (1) Patients with onset time less than 14 days (acute phase); (2) All patients underwent brain CT examination by imaging specialists, confirming varying degrees of intracranial hematoma; (3) No heart, liver, lung, kidney, blood system, or other serious primary diseases or mental illness; (4) All patients were consulted by surgical experts, and the condition was explained to the family members, the family members refused surgical treatment, and signed an informed consent form.

[0112] Experimental ethics number: Linyanshen

[2018] No. 075 (Ethics Committee of Xuanwu Hospital, Capital Medical University).

[0113] Patients in the control group did not take the relevant composite composition. Instead, they were given 20% mannitol injection (125 mL) for dehydration and intracranial pressure reduction. Patients in the Example and Comparative Example groups took the composite composition (filtrate) from each group, respectively. The filtrates obtained from each Example and Comparative Example were pressurized and concentrated to a concentration of 60g of the API in 400mL of the filtrate. Patients with cerebral hemorrhage drank 400mL of the composite composition (prepared using 60g of the API) daily.

[0114] 1. Comparison of hematoma size

[0115] Brain CT evaluation: Patients underwent hematoma volume measurement before treatment and after two weeks of continuous treatment with the compound composition. The comparison of hematoma volume before and after treatment is shown in Table 1.

[0116] SPSS 26.0 was used for statistics. Measurement data were expressed as mean ± standard error (x ± se). Paired sample t-test was used for intra-group comparison, and independent sample t-test was used for inter-group comparison. Chi-square test was used for enumeration data. P < 0.05 was considered statistically significant.

[0117] Table 1

[0118]

[0119] In Table 1, the data in the same column, the experimental group is compared with the control group. ## P<0.01, # P<0.05, statistically significant; data in the same row, after treatment compared with before treatment, && P<0.01, & P<0.05, showing statistical significance.

[0120] From the comparison of the technical effects in Table 1, it can be seen that the compound composition of the embodiment of the present invention can accelerate the reduction of hematoma volume, and the hematoma volume reduction effect is significantly better than that of the comparative example and the control group.

[0121] Comparative Example 1 uses Radix Paeoniae Rubra, which has the effect of clearing heat and cooling blood. Although it can play a certain role in alleviating edema in patients with cerebral hemorrhage in the clinic, compared with the compound composition of the embodiment of the present invention, Rhubarb can better assist the main drug Cortex Moutan to enhance its heat-clearing and blood-cooling efficacy. At the same time, Rhubarb can help alleviate the inflammatory response and heat-toxic symptoms of cerebral hemorrhage through its purgative effect. In the clinical results observation, the compound composition using Rhubarb as the ministerial drug can reduce the patient's hematoma volume faster.

[0122] Compared with Comparative Example 2 in which the formula ratio is changed, the formula of the embodiment can relieve the symptoms of clinical cerebral hemorrhage patients faster and absorb the hematoma faster.

[0123] Comparative Example 3 uses three ingredients to prepare the compound composition, while Comparative Example 4 uses two ingredients to prepare the compound composition. At the same dosage of the active pharmaceutical ingredients, even when the hematoma volume reduction effects of Comparative Example 3 and Comparative Example 4 are added together, the significant hematoma volume reduction effect described in the present invention is still not achieved. Therefore, the five ingredients of the present invention interact with each other and work synergistically to achieve a synergistic hematoma volume reduction effect.

[0124] Comparative Example 5 changes the preparation method of the compound composition. Although it has a certain effect of reducing hematoma volume, it still has a large difference compared with the examples.

[0125] 2. Comparison of NIHSS scores

[0126] Comparison of NIHSS Scores: Patients were assessed using the National Institutes of Health Stroke Scale (NIHSS) before treatment and after two weeks of continuous treatment with the combination. Scoring items include: level of consciousness, level of consciousness question, level of consciousness command, gaze, visual field, facial palsy, upper limb movement, lower limb movement, limb ataxia, sensation, language, dysarthria, and neglect. The NIHSS scoring criteria are shown in Table 2.

[0127] Table 2

[0128]

[0129] The NIHSS scores before and after treatment are shown in Table 3 , and the scores are expressed as mean ± standard error (x ± se).

[0130] Table 3

[0131]

[0132] In Table 3, the data in the same column are compared between the experimental groups and the control group. ## P<0.01, # P<0.05, statistically significant; data in the same row, after treatment compared with before treatment, && P<0.01, & P<0.05, showing statistical significance.

[0133] From the comparison of technical effects in Table 3, it can be seen that the compound composition of the embodiment of the present invention can significantly reduce the NIHSS score, and the score result is significantly better than that of the comparative example and the control group.

[0134] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A compound composition for treating cerebral hemorrhage, characterized in that: The raw materials are composed of the following components in parts by weight: 10-30 parts of peony bark, 2-10 parts of rhubarb, 5-15 parts of zedoaria, 10-21 parts of kudzu root and 5-15 parts of loofah.

2. The compound composition according to claim 1, characterized in that The raw materials are composed of the following components in parts by weight: 15-25 parts of peony bark, 3-8 parts of rhubarb, 8-12 parts of zedoary root, 13-17 parts of kudzu root and 6-12 parts of loofah.

3. The compound composition according to claim 2, characterized in that The raw materials are composed of the following components in parts by weight: 20 parts of peony bark, 5 parts of rhubarb, 10 parts of zedoary herb, 15 parts of kudzu root and 9 parts of loofah.

4. The method for preparing the compound composition according to any one of claims 1 to 3, characterized in that: Including steps: (1) Mix peony bark, rhubarb, zedoary root, kudzu root and loofah, and soak them in water to obtain a mixture; (2) First decoction: boiling the mixture from step (1), then decocting and filtering to obtain filtrate 1 and medicinal residue; (3) Second decoction: add water to the medicinal residue from step (2), boil, then decoct, filter, and obtain filtrate 2; (4) Combine filtrate 1 and filtrate 2 to obtain a compound composition.

5. The preparation method according to claim 4, characterized in that In step (1), the amount of water added for soaking is such that the raw material components are not covered, and the mixture is soaked at room temperature for 30-60 minutes.

6. The preparation method according to claim 4, characterized in that In step (2), the decocting time is 20-30 minutes; in step (3), the decocting time is 15-25 minutes.

7. Use of the compound composition in preparing a drug for treating cerebral hemorrhage, characterized in that: The compound composition used in the application is the compound composition described in any one of claims 1 to 3 or the compound composition prepared by the preparation method described in any one of claims 4 to 6.

8. A drug for treating cerebral hemorrhage, characterized in that: include: The compound composition according to any one of claims 1 to 3 or the compound composition prepared by the preparation method according to any one of claims 4 to 6.

9. The drug according to claim 8, characterized in that The medicine is specifically a medicine for treating fever syndrome in the acute stage of cerebral hemorrhage.

10. The drug according to claim 8, characterized in that The medicine is specifically a medicine that promotes hematoma absorption and reduces hematoma volume.

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