Traditional Chinese medicine composition for treating yang deficiency syndrome of stroke

Abstract

The invention discloses a traditional Chinese medicine composition for treating stroke yang deficiency syndrome, relates to the technical field of traditional Chinese medicines, and is technically characterized in that the traditional Chinese medicine composition is prepared from the following components in parts by weight: 8-12g of ginseng, 13-17g of radix aconiti lateralis preparata, 13-17g of cassia twig, 13-17g of rhizoma acori graminei, 8-12g of lumbricus, 13-17g of radix rehmanniae recen, 8-12g of radix saposhnikoviae, 8-12g of herba epimedii, 8-12g of radix morindae officinalis and 8-12g of ligusticum wallichii. The traditional Chinese medicine composition can greatly tonify primordial qi, warm yang for dispelling cold, enhance the yang warming capacity, reduce phlegm, promote blood circulation and dredge collaterals, effectively aims at the pathogenesis of the yang deficiency syndrome of the stroke, can fully retain effective components, guarantee the medicine quality and meet the requirements of different patients in preparation, in addition, a plurality of auxiliary components for enhancing the medicine effect are added and cooperate with main medicines to enhance the treatment effect, and the traditional Chinese medicine composition is suitable for clinical application. The taste can be improved, the medication compliance is improved, the stroke symptom of a patient can be improved on the whole, the balance of yin and yang of the body is adjusted, the viscera function is enhanced, disease relapse is prevented, and the life quality of the patient is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and more specifically, to a traditional Chinese medicine composition for treating yang deficiency syndrome of stroke. Background Art

[0002] Stroke is a cerebrovascular disease that seriously threatens human health, characterized by high incidence, high disability rate and high mortality rate. Among them, yang deficiency syndrome of stroke is relatively common in clinical practice, and its pathogenesis is complex, which has brought great impacts on the quality of life and health of patients.

[0003] Modern medicine mainly focuses on thrombolysis, antiplatelet aggregation, improving cerebral circulation and other treatment means in the treatment of stroke, but these methods have certain limitations. For example:

[0004] 1. Thrombolytic therapy is strictly limited by the time window, and many patients often miss the best treatment opportunity;

[0005] 2. Antiplatelet drugs may increase the risk of bleeding, and some patients have resistance, and the curative effect is not ideal.

[0006] 3. The existing treatment means still need to be improved in terms of improving the yang deficiency constitution of stroke patients, promoting the comprehensive recovery of nerve function and preventing recurrence.

[0007] In view of this situation, the present application provides a traditional Chinese medicine composition for treating yang deficiency syndrome of stroke. Summary of the Invention

[0008] The purpose of the present invention is to overcome the above-mentioned defects of the prior art and provide a traditional Chinese medicine composition for treating yang deficiency syndrome of stroke.

[0009] To achieve the above purpose, the present invention provides the following technical solutions:

[0010] On the one hand, the present invention provides a traditional Chinese medicine composition for treating yang deficiency syndrome of stroke, which is made of the following components in parts by weight:

[0011] Ginseng 8 - 12g, prepared aconite root 13 - 17g, cassia twig 13 - 17g, acorus tatarinowii 13 - 17g, earthworm 8 - 12g, rehmannia glutinosa 13 - 17g, ledebouriella seseloides 8 - 12g, epimedium 8 - 12g, morinda officinalis 8 - 12g, and chuanxiong rhizome 8 - 12g.

[0012] Further, the traditional Chinese medicine composition is made of the following components in parts by weight:

[0013] Ginseng 10g, prepared aconite root 15g, cassia twig 15g, acorus tatarinowii 15g, earthworm 10g, rehmannia glutinosa 15g, ledebouriella seseloides 10g, epimedium 10g, morinda officinalis 10g, and chuanxiong rhizome 10g.

[0014] On the other hand, the solution of the present invention provides a preparation method of a traditional Chinese medicine composition for treating yang deficiency syndrome of stroke, comprising the following steps:

[0015] S1. Pretreatment of medicinal materials: Remove impurities, mildew and non-medicinal parts from ginseng, prepared aconite root, cassia twig, acorus tatarinowii, earthworm, raw rehmannia root, ledebouriella root, epimedium herb, morinda officinalis root and chuanxiong rhizome. After washing the ginseng, cut it into thin slices. Soak the prepared aconite root in clean water, change the water 2 - 3 times a day, soak for 3 - 5 days until there is no pungent and numbing taste when tasted, and then take it out. Wash and dry the remaining medicinal materials respectively. Cut the chuanxiong rhizome into slices with a thickness of 2 - 3 mm to increase the contact area during extraction.

[0016] S2. Crushing and mixing: Crush the pretreated ginseng, prepared aconite root, cassia twig, acorus tatarinowii, earthworm, raw rehmannia root, ledebouriella root, epimedium herb, morinda officinalis root and chuanxiong rhizome respectively, with a crushing particle size of 80 - 100 mesh. Put the crushed medicinal materials into a mixing container according to the proportion within the above weight range and stir evenly.

[0017] S3. Extraction: Take the mixed medicinal materials, add 10 - 12 times the total weight of the medicinal materials of water, soak for 2 - 3 h, and use supercritical CO 2 fluid extraction to extract some volatile components. The extraction pressure is 20 - 30 MPa, the temperature is 40 - 50 °C, and the time is 1 - 2 h. Collect the extract. For the medicinal residues after supercritical extraction, use the decoction method for extraction. First, bring to a boil with strong fire, then turn to slow fire and decoct for 1.5 - 2.5 h, and then filter out the decoction. Add 8 - 10 times the amount of water to the medicinal residues and repeat the above decoction process. Combine the two decoctions and the supercritical extract.

[0018] S4. Concentration and drying: Concentrate the combined decoction and extract under reduced pressure, control the temperature at 60 - 80 °C to concentrate the decoction to a clear paste with a relative density of 1.15 - 1.25 at 60 °C. Use the vacuum freeze-drying method to dry the clear paste. The pre-freezing temperature is -40 - -30 °C, and the time is 2 - 3 h. Then dry at a vacuum degree of 10 - 20 Pa and a temperature of -20 - -10 °C for 12 - 24 h to obtain dry powder.

[0019] S5. Forming: According to needs, make the dry powder into dosage forms such as pills, tablets, capsules or powders.

[0020] Further, in step S5, when making pills, if the total weight of the dry powder is 100 g, add 20 g of honey and 4 g of ganoderma spore powder as binders, and among them, the mass ratio of honey to ganoderma spore powder is 5:1.

[0021] When made into tablets, magnesium stearate accounting for 0.5%-1% of the total tablet weight, microcrystalline cellulose accounting for 20%-30% of the total tablet weight, and 8 g of salvia miltiorrhiza extract are added as lubricant, filler and adjuvant therapeutic ingredient respectively, wherein the salvia miltiorrhiza extract accounts for 5%-10% of the total tablet weight;

[0022] When made into capsules, appropriate amount of starch and 10 g of astragalus membranaceus extract are added as filler. The astragalus membranaceus extract accounts for 8%-12% of the total weight of the capsule content. If 100 capsules are made and the weight of each capsule content is 0.5 g, the addition amount of starch is 40-42 g;

[0023] When made into powder, 0.5 g of menthol is added as flavoring agent.

[0024] Furthermore, it also includes one or more auxiliary ingredients for enhancing drug efficacy. The auxiliary ingredients include one or more of astragalus membranaceus, angelica sinensis, salvia miltiorrhiza, carthamus tinctorius, wolfberry fruit, cistanche deserticola, eucommia ulmoides, taxillus chinensis and pilose antler, and the total weight of the auxiliary ingredients accounts for 2%-10% of the total weight of the traditional Chinese medicine composition.

[0025] Furthermore, when the auxiliary ingredients include astragalus membranaceus and angelica sinensis, the weight ratio of astragalus membranaceus to angelica sinensis is 2:1 to 3:1; when the auxiliary ingredients include salvia miltiorrhiza and carthamus tinctorius, the weight ratio of salvia miltiorrhiza to carthamus tinctorius is 3:1 to 4:1.

[0026] Furthermore, in step S3, an ultrasonic-assisted extraction method is adopted. Specifically, the medicinal materials are ultrasonically treated for 30-60 min before decocting, and the ultrasonic frequency is 20-40 kHz.

[0027] Furthermore, it also includes one or more flavoring agents for regulating the taste of the drug. The flavoring agents are selected from one or more of licorice root, Chinese date, maltose, sucrose, and the total addition amount of the flavoring agents does not exceed 5% of the total weight of the drug.

[0028] Compared with the prior art, the present invention has the following beneficial effects:

[0029] 1. In the present invention, ginseng and processed aconite root are used as the monarch drugs, and cinnamon twig, epimedium and morinda officinalis are used as the assistant drugs, accurately compatible with yang-warming medicinal materials to invigorate yang qi, warm and dredge meridians, tonify kidney yang and strengthen muscles and bones, improve yang deficiency symptoms, and promote the recovery of limb function. Acorus tatarinowii, earthworm and ligusticum wallichii are used as the minister drugs to resolve phlegm and open orifices, dredge collaterals and relieve pain, synergistically enhance the effect, remove phlegm-dampness, dredge meridians, improve qi and blood stasis, and relieve sequelae of stroke. Rehmannia glutinosa and ledebouriella seseloides are used as assistants to regulate and reconcile, clear heat and nourish yin, restrict dryness and warmth, disperse wind pathogen, balance the medicinal properties, stabilize healthy qi, ensure the operation of qi and blood meridians, and improve the treatment effect;

[0030] 2. The supercritical CO 2Fluid extraction combined with decoction method and ultrasonic-assisted extraction retains multiple effective components such as volatile, fat-soluble, and water-soluble components of the medicinal materials, enhances the overall curative effect, optimizes the processes of vacuum concentration and vacuum freeze-drying to ensure the drug stability and activity, improves the bioavailability, lays a foundation for the drug quality and clinical application, and is made into various dosage forms such as pills, tablets, capsules, and powders, each with its own advantages, meeting the needs of different patients, and improving the medication compliance;

[0031] 3. The auxiliary components of the present invention, such as Astragalus membranaceus and Angelica sinensis, synergize with the main drug, act on multiple targets, enhance the body function, improve blood circulation, restore kidney function, greatly replenish vital energy, accelerate recovery, and flavoring agents such as Glycyrrhiza glabra and Chinese date improve the taste, enhance the medication compliance, ensure the implementation of treatment, assist the drug to play its role, overall regulate the balance of yin and yang of the body, enhance the viscera function, improve the immunity and resistance, prevent the recurrence of stroke, and ensure long-term health and quality of life. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 It is the overall preparation flow chart of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0033] Example 1: This example provides a traditional Chinese medicine composition for treating yang deficiency syndrome of stroke. Weigh the following medicinal materials by weight: 8g of ginseng, 13g of prepared aconite, 13g of cinnamon twig, 13g of acorus tatarinowii, 8g of earthworm, 13g of rehmannia glutinosa, 8g of saposhnikovia divaricata, 8g of epimedium, 8g of morinda officinalis, 8g of ligusticum wallichii;

[0034] Select 2g of salvia miltiorrhiza and 0.5g of safflower as auxiliary components (the weight ratio of salvia miltiorrhiza to safflower is about 4:1), and the total weight accounts for about 2% of the total weight of the traditional Chinese medicine composition;

[0035] Select 3g of Chinese date as the flavoring agent, and the total addition amount accounts for about 3% of the total weight of the drug (assuming the total weight of the finally prepared drug is about 100g).

[0036] This example also provides a preparation method of the traditional Chinese medicine composition. The specific preparation steps are as follows:

[0037] Step 1. Medicinal material pretreatment: strictly screen all medicinal materials, remove impurities, mildew, and non-medicinal parts, wash the ginseng and cut it into thin slices; soak the prepared aconite in clear water, change the water 2 - 3 times a day, soak for 3 - 5 days until there is no pungent and numbing feeling when tasting, and then take it out; wash and air-dry the remaining medicinal materials, cut the ligusticum wallichii into slices with a thickness of 2 - 3mm;

[0038] Step 2. Crushing and mixing: crush the processed medicinal materials to 80 - 100 meshes respectively, and mix the medicinal materials evenly according to the proportion;

[0039] Step 3. Extraction: take the mixed medicinal materials, add 10 times the amount of water, soak for 2h, perform ultrasonic-assisted extraction for 30min, the ultrasonic frequency is 20kHz, supercritical CO2 Extract volatile components by fluid extraction, with an extraction pressure of 20 MPa, a temperature of 40 °C, and a time of 1 h. Collect the extract, decoct the medicinal residues, bring to a boil over high heat and then switch to low heat for 1.5 h, and filter out the medicinal liquid; add 8 times the amount of water to the medicinal residues and repeat the decoction, and combine the decocted liquid and the extract.

[0040] Step Four: Concentration and drying. Concentrate under reduced pressure at a temperature of 60 °C until the relative density reaches 1.15 to obtain a clear paste at 60 °C. Then, perform vacuum freeze-drying. Pre-freeze at -40 °C for 2 h, with a vacuum degree of 10 Pa and a temperature of -20 °C, and dry for 12 h to obtain dry powder.

[0041] Step Five: Shaping. Make pills: Add 20 g of honey and 4 g of Ganoderma lucidum spores powder (5:1) to 100 g of dry powder to make pills. Make tablets: Add 0.5% magnesium stearate, 20% microcrystalline cellulose, and 2 g of Salvia miltiorrhiza extract (accounting for about 5% of the tablets) to make tablets. Make capsules: Add about 42 g of appropriate starch and 2 g of Salvia miltiorrhiza extract (accounting for about 8% of the capsule content) to make capsules. Make powder: Add 0.5 g of menthol and 3 g of Chinese dates to make powder.

[0042] Example 2: The implementation plan of a traditional Chinese medicine composition for treating yang deficiency syndrome of stroke provided in this Example 2 is as follows: Weigh the medicinal materials by weight: 12 g of ginseng, 17 g of prepared aconite root, 17 g of cinnamon twig, 17 g of acorus tatarinowii, 12 g of earthworm, 17 g of rehmannia root, 12 g of ledebouriella root, 12 g of epimedium herb, 12 g of morinda officinalis root, 12 g of chuanxiong rhizome.

[0043] The auxiliary components are selected as 8 g of astragalus membranaceus and 4 g of angelica sinensis (2:1), accounting for about 8% of the total weight.

[0044] The flavoring agent is 4 g of maltose, accounting for about 4% (assuming the total weight of the drug is about 100 g).

[0045] This Example 2 also provides a preparation method for the above traditional Chinese medicine composition, and the steps are as follows:

[0046] Step One: Pretreatment of medicinal materials. Select and process the medicinal materials. The operations of slicing ginseng and soaking prepared aconite root are the same as in Example 1, and slice and process chuanxiong rhizome.

[0047] Step Two: Crushing and mixing. Crush the medicinal materials to 80 - 100 mesh and then mix.

[0048] Step Three: Extraction. Add 12 times the amount of water, soak for 3 h, perform ultrasonic treatment for 60 min at a frequency of 40 kHz, perform supercritical extraction with a pressure of 30 MPa, a temperature of 50 °C, and a time of 2 h, collect the extract, decoct the medicinal residues, bring to a boil over high heat and then switch to low heat for 2.5 h, repeat adding water for decoction, and combine.

[0049] Step 4: Concentration and drying. Concentrate under reduced pressure at 60 - 80°C to a clear extract with a relative density of 1.25, and then perform vacuum freeze-drying. Pre-freeze at -30°C for 3 h, with a vacuum degree of 20 Pa and a temperature of -10°C, and dry for 24 h to obtain a powder.

[0050] Step 5: Shaping. Pills: Add honey and ganoderma spore powder to 100 g of the powder to make pills. Tablets: Add 1% magnesium stearate, 30% microcrystalline cellulose, and 10 g of astragalus root extract (about 10%) to make tablets. Capsules: Add about 40 g of starch and 10 g of astragalus root extract (about 12%) to make capsules. Powder: Add 0.5 g of menthol and 4 g of maltose to make powder.

[0051] Example 3: The implementation plan of a traditional Chinese medicine composition for treating yang deficiency syndrome of stroke provided in this Example 3 is as follows: Weigh the medicinal materials by weight: 10 g of ginseng, 15 g of prepared aconite root, 15 g of cinnamon twig, 15 g of acorus tatarinowii, 10 g of earthworm, 15 g of rehmannia root, 10 g of ledebouriella root, 10 g of epimedium, 10 g of morinda officinalis, 10 g of chuanxiong rhizome;

[0052] The auxiliary components are selected as 3 g of wolfberry fruit, 3 g of desertliving cistanche, 2 g of eucommia bark, 2 g of taxillus chinensis, totaling 10 g, accounting for about 10% of the total weight;

[0053] The flavoring agent is selected as 5 g of sucrose, accounting for about 5% (assuming the total weight of the drug is about 100 g).

[0054] This Example 3 also provides a preparation plan for the traditional Chinese medicine composition, and the specific steps are as follows:

[0055] Step 1: Pretreatment of medicinal materials. Process the medicinal materials, slice the ginseng, soak the prepared aconite root, wash and air-dry the rest, and slice the chuanxiong rhizome;

[0056] Step 2: Crushing and mixing. Crush to 80 - 100 meshes and then mix;

[0057] Step 3: Extraction. Add 11 times the amount of water, soak for 2.5 h, perform ultrasonic treatment for 45 min at a frequency of 30 kHz, perform supercritical extraction at a pressure of 25 MPa and a temperature of 45°C for 1.5 h, collect the extract, decoct the medicinal residues, decoct with strong fire and then turn to slow fire for 2 h, repeat adding water for decoction, and combine;

[0058] Step 4: Concentration and drying. Concentrate under reduced pressure at 70°C to a clear extract with a relative density of 1.20, and then perform vacuum freeze-drying. Pre-freeze at -35°C for 2.5 h, with a vacuum degree of 15 Pa and a temperature of -15°C, and dry for 18 h to obtain a powder.

[0059] Step 5: Shaping. Pills: Add honey and ganoderma spore powder to 100 g of the powder to make pills. Tablets: Add 0.8% magnesium stearate, 25% microcrystalline cellulose, and 10 g of wolfberry fruit extract (about 8%) to make tablets. Capsules: Add about 41 g of starch and 10 g of desertliving cistanche extract (about 10%) to make capsules. Powder: Add 0.5 g of menthol and 5 g of sucrose to make powder.

[0060] The above embodiments of the present invention are based on the syndrome differentiation and treatment of yang deficiency syndrome of stroke in traditional Chinese medicine theory and the synergistic effect of traditional Chinese medicine compatibility. By rationally combining multiple Chinese medicinal materials with different effects, and adopting a specific preparation process, the drug components synergize with each other to exert effects such as warming yang and dredging collaterals, so as to improve the symptoms of patients with yang deficiency syndrome of stroke and achieve the purpose of treating diseases. At the same time, in the preparation process, modern advanced extraction, concentration, drying and other technical means are combined to retain the effective components of the drug to the greatest extent, improve the stability and bioavailability of the drug, and enhance the overall treatment effect. The specific effects of each Chinese medicine component are as follows:

[0061] Ginseng: It tastes sweet and slightly bitter, is slightly warm in nature, and belongs to the spleen, lung, heart, and kidney meridians. It has the effects of greatly tonifying primordial qi, restoring pulse and arresting collapse, invigorating the spleen and benefiting the lung, promoting fluid production and nourishing blood, and calming the mind and improving intelligence. In this composition, it is used in combination with ginseng and prepared aconite root to mainly play the role of warming yang and replenishing qi, helping to supplement the healthy qi of the human body, improving the weakness state of the body caused by yang deficiency, and laying a foundation for subsequent effects such as dredging collaterals;

[0062] Prepared aconite root: It is pungent, sweet, and extremely hot, toxic, and belongs to the heart, kidney, and spleen meridians. It can return yang and rescue from collapse, tonify fire and assist yang, and disperse cold and relieve pain. When paired with ginseng, it enhances the power of warming yang, can effectively improve the yang deficiency situation of patients with yang deficiency syndrome, helps disperse cold pathogens, makes the yang qi of the body excited, promotes qi and blood circulation, and has an improving effect on symptoms such as limb coldness and weakness caused by yang deficiency after stroke;

[0063] Cinnamon twig: It is pungent, sweet, and warm, and belongs to the heart, lung, and bladder meridians. It has the functions of inducing sweating to relieve the exterior syndrome, warming and dredging the meridians, assisting yang to transform qi, and calming the adverse qi rushing upward. In the prescription, it works together with acorus tatarinowii and earthworm to play the role of "warming the meridians, resolving phlegm, and promoting blood circulation". By warming and dredging the meridians, it helps to disperse pathological products such as cold pathogens and phlegm dampness in the meridians, promotes the normal circulation of qi and blood in the meridians, and improves the situation of limb movement disorders caused by stroke;

[0064] Acorus tatarinowii: It is pungent, bitter, and warm, and belongs to the heart and stomach meridians. It can open the orifices and resolve phlegm, awaken the mind and improve intelligence, and promote digestion by removing dampness. Its effect of resolving phlegm and opening orifices helps to remove phlegm dampness in the body, open the clear orifices, and has a relieving effect on symptoms such as unconsciousness and speech disorders that may occur after stroke due to phlegm dampness blocking the clear orifices. At the same time, it synergistically works with cinnamon twig and other drugs to assist in warming and dredging the meridians, resolving phlegm and promoting blood circulation;

[0065] Earthworm: It is salty, cold, and belongs to the liver, spleen, and bladder meridians. It can clear heat and calm convulsions, dredge collaterals, relieve asthma, and promote diuresis. In the composition, it mainly plays the role of dredging collaterals, can dredge stasis in the meridians, promote qi and blood circulation, improve stroke sequelae such as limb numbness and hemiplegia caused by meridian obstruction, and its cold nature can also, to a certain extent, assist in checking the warm and dry nature that other warm drugs may bring;

[0066] Rehmannia glutinosa: Sweet, cold, attributing to the heart, liver and kidney meridians. It has the effects of clearing heat and cooling blood, nourishing yin and promoting the production of body fluid. It plays the role of clearing heat and nourishing yin in the formula, can assist in controlling the warm and dry nature of drugs such as ginseng and prepared aconite root, prevent adverse reactions such as internal heat due to excessive use of yang-warming drugs, and at the same time nourish the body fluid by nourishing yin and promoting the production of body fluid, achieving seeking yang from yin, making yin and yang tend to balance, and being beneficial to the improvement of the overall condition;

[0067] Saposhnikovia divaricata: Pungent, sweet, slightly warm, attributing to the bladder, liver and spleen meridians. It can dispel wind and relieve exterior syndrome, resolve dampness and relieve pain, and stop convulsions. It can make pathogenic factors go away and there is no external disturbance, disperse wind pathogens, avoid the re-invasion of exogenous wind into the human body, and help relieve discomfort symptoms such as muscle spasm and pain that may occur after stroke, and cooperate with other drugs to strengthen the healthy qi of the body and ensure the smooth operation of qi and blood in the meridians of the body;

[0068] Epimedium brevicornum: Pungent, sweet, warm, attributing to the liver and kidney meridians. It has the functions of tonifying kidney yang, strengthening tendons and bones, and dispelling wind and dampness. It further enhances the power of warming and tonifying kidney yang to help improve yang deficiency syndrome. Especially for the situation of insufficient yang qi in the kidney, it helps to enhance the body's yang qi and strengthen the body's functions, and has an improvement effect on manifestations such as soreness and weakness of the waist and knees and limb weakness caused by yang deficiency in stroke patients;

[0069] Morinda officinalis: Sweet, pungent, slightly warm, attributing to the kidney and liver meridians. It can tonify kidney yang, strengthen tendons and bones, and dispel wind and dampness. It acts synergistically with Epimedium brevicornum to strengthen the effect of warming and tonifying kidney yang, improve the body's yang deficiency state, and at the same time its function of strengthening tendons and bones also helps stroke patients recover limb strength and promote the rehabilitation of limb functions;

[0070] Ligusticum chuanxiong: Pungent, warm, attributing to the liver, gallbladder and pericardium meridians. It has the effects of promoting blood circulation and qi movement, dispelling wind and relieving pain. In the formula, it promotes blood circulation and qi movement, strengthens the circulation of qi and blood, enables qi and blood to flow smoothly in the meridians, eliminates various stroke symptoms caused by qi and blood stasis, such as limb pain and numbness, and can assist other drugs to better play the overall effect of warming yang and dredging meridians;

[0071] In addition, auxiliary components such as astragalus membranaceus, angelica sinensis, salvia miltiorrhiza, carthamus tinctorius, wolfberry fruit, cistanche deserticola, eucommia ulmoides, taxillus chinensis and pilose antler (if added) also have their corresponding effects, such as astragalus membranaceus replenishing qi and ascending yang, angelica sinensis nourishing blood and promoting blood circulation, salvia miltiorrhiza promoting blood circulation and removing stasis, etc. They further enhance the overall therapeutic effect and cooperate with the main drug to improve the condition of stroke yang deficiency syndrome from multiple angles; while flavoring agents such as licorice, jujube, maltose and sucrose mainly play the role of adjusting the taste of the drug and improving the compliance of patients taking medicine.

[0072] In order to prove that the implementation scheme of the present invention has good efficacy in the treatment of stroke yang deficiency syndrome, the following experiments and tests are carried out on the traditional Chinese medicine composition for treating stroke yang deficiency syndrome prepared in the above Examples 1-3, specifically as follows:

[0073] Experiment 1. Effect on the recovery of nerve function in rats with stroke yang deficiency syndrome

[0074] I. Experimental animals and grouping

[0075] Clean-grade male SD rats weighing 200 - 250 g were selected and randomly divided into a normal control group, a model control group, a drug group of Example 1, a drug group of Example 2, and a drug group of Example 3, with 10 rats in each group.

[0076] II. Modeling method

[0077] The middle cerebral artery occlusion (MCAO) model of rats was made by the suture method, and after the operation, the rats were raised in a low-temperature environment to induce the yang deficiency syndrome model (the success of the yang deficiency syndrome model establishment can be determined by detecting indicators such as the rectal temperature and serum thyroxine of the rats).

[0078] III. Administration method

[0079] The normal control group and the model control group were given intragastric administration of normal saline with equal volume, and the drug groups of Example 1, Example 2, and Example 3 were respectively given the drug preparations prepared in the corresponding examples (administered by intragastric administration after equivalent dose conversion), once a day for 28 consecutive days.

[0080] IV. Detection indicators and methods

[0081] 1. Neurological deficit score: The neurological deficit score of the rats was measured by the Longa scoring method on the 1st, 7th, 14th, 21st, and 28th days after modeling (0 - 4 points, the higher the score, the more severe the neurological deficit);

[0082] 2. Determination of cerebral infarction volume: At the end of the experiment, the rats were sacrificed, the brain was taken, and the cerebral infarction volume was measured by the TTC staining method, and the percentage of cerebral infarction volume was calculated (cerebral infarction volume / total brain volume × 100%).

[0083] The experimental data table is as follows:

[0084]

[0085]

[0086] Experiment 2. Effects on hemorheological indexes of rats with stroke yang deficiency syndrome

[0087] I. Experimental animals and grouping

[0088] Same as Experiment 1.

[0089] II. Modeling and administration methods

[0090] Same as Experiment 1.

[0091] III. Detection indicators and methods

[0092] At the end of the experiment, abdominal aortic blood of rats was collected, and hemorheological indexes such as high shear viscosity of whole blood, low shear viscosity of whole blood, and plasma viscosity were detected using a blood rheometer.

[0093] The experimental data table is as follows:

[0094]

[0095] Experiment 3. Effects on Serum Inflammatory Factor Levels in Rats with Yang Deficiency Syndrome of Stroke

[0096] I. Experimental Animals and Grouping

[0097] Same as Experiment 1.

[0098] II. Modeling and Drug Administration Methods

[0099] Same as Experiment 1.

[0100] III. Detection Indexes and Methods

[0101] At the end of the experiment, rat serum was collected, and the levels of inflammatory factors such as tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6) in the serum were detected using the enzyme-linked immunosorbent assay (ELISA) method.

[0102] The experimental data table is as follows:

[0103] TNF-α (pg / ml) IL-1β (pg / ml) IL-6 (pg / ml) Normal control group 10.2±1.5 5.5±0.8 15.0±2.0 Model control group 35.5±3.0 18.0±2.5 45.0±3.5 Drug group of Example 1 25.0±2.5 12.0±1.8 30.0±3.0 Drug group of Example 2 22.5±2.2 10.5±1.5 26.0±2.8 Drug group of Example 3 20.0±2.0 9.0±1.2 22.0±2.5

[0104] In summary, it can be seen from the above experimental data that compared with the model control group, the drug groups of Examples 1, 2, and 3 all had varying degrees of improvement in nerve function recovery, specifically manifested as a gradual decrease in the nerve function deficit score and a reduction in the percentage of cerebral infarction volume; in terms of hemorheological indexes, they were able to reduce the high shear viscosity of whole blood, low shear viscosity of whole blood, and plasma viscosity; in terms of serum inflammatory factor levels, they could also reduce the levels of inflammatory factors such as TNF-α, IL-1β, and IL-6.

[0105] This indicates that the traditional Chinese medicine composition prepared in Examples 1-3 may promote nerve function recovery by improving hemorheological characteristics, reducing inflammatory responses, etc., thus proving that the traditional Chinese medicine composition of the present invention has a certain effect in the treatment of yang deficiency syndrome of stroke.

[0106] The above are only the preferred embodiments of the present invention and are not used to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating Yang deficiency syndrome of stroke, characterized in that: The Chinese medicine composition is made of the following components in parts by weight: Ginseng 8-12g, processed aconite 13-17g, cinnamon twig 13-17g, calamus 13-17g, earthworm 8-12g, raw rehmannia glutinosa 13-17g, siler 8-12g, epimedium 8-12g, Morinda officinalis 8-12g and ligusticum 8-12g.

2. The Chinese medicine composition for treating Yang deficiency syndrome of stroke according to claim 1, characterized in that: The Chinese medicine composition is made of the following components in parts by weight: Ginseng 10g, processed aconite 15g, cinnamon twig 15g, calamus 15g, earthworm 10g, raw rehmannia glutinosa 15g, siler 10g, epimedium 10g, Morinda officinalis 10g and ligusticum 10g.

3. The Chinese medicine composition for treating Yang deficiency syndrome of stroke according to any one of claims 1-2, characterized in that: The preparation method of the Chinese medicine composition comprises the following steps: S1. Pretreatment of medicinal materials: remove impurities, mildew and non-medicinal parts of ginseng, processed aconite root, cinnamon twig, calamus, earthworm, raw rehmannia root, saposhnikovia root, epimedium, Morinda officinalis and chuanxiong. Wash ginseng and cut it into thin slices. Soak processed aconite root in clean water, change the water 2-3 times a day, soak for 3-5 days until there is no spicy feeling in the mouth, then take it out. Wash and dry the other medicinal materials respectively. Slice chuanxiong with a thickness of 2-3 mm to increase the contact area during extraction. S2, crushing and mixing, crushing the pretreated ginseng, prepared aconite root, cinnamon twig, calamus, earthworm, raw rehmannia root, siler, epimedium, Morinda officinalis and ligusticum chuanxiong respectively, the crushing particle size is 80-100 mesh, and the crushed medicinal materials are placed in a mixing container according to the above weight range ratio, and stirred evenly; S3, extraction, take the mixed medicinal materials, add 10-12 times the total weight of the medicinal materials in water, soak for 2-3h, use supercritical CO2 fluid extraction to extract some volatile components, the extraction pressure is 20-30MPa, the temperature is 40-50°C, the time is 1-2h, collect the extract, and extract the residue after supercritical extraction by decoction method, first boil with high heat, then turn to low heat and decoct for 1.5-2.5h, then filter out the medicinal liquid, add 8-10 times the amount of water to the residue, repeat the above decoction process, and combine the two decoctions with the supercritical extract; S4, concentration and drying, the combined decoction and extract are concentrated under reduced pressure, the temperature is controlled at 60-80°C, the liquid medicine is concentrated to a relative density of 1.15-1.25, 60°C clear paste, the clear paste is dried by vacuum freeze drying, the pre-freezing temperature is -40--30°C, the time is 2-3h, and then dried at a vacuum degree of 10-20Pa and a temperature of -20--10°C for 12-24h to obtain a dry powder; S5. Molding: the dry powder is made into the dosage form of pills, tablets, capsules or powders as required.

4. The Chinese medicine composition for treating Yang deficiency syndrome of stroke according to claim 3, characterized in that: In step S5, when making pills, if the total weight of the dry powder is 100 g, 20 g of honey and 4 g of Ganoderma lucidum spore powder are added as a binder, wherein the mass ratio of honey to Ganoderma lucidum spore powder is 5:1; When the tablets are made, 0.5%-1% of magnesium stearate, 20%-30% of microcrystalline cellulose and 8g of salvia miltiorrhiza extract are added as lubricants, fillers and auxiliary therapeutic ingredients, respectively, wherein the salvia miltiorrhiza extract accounts for 5%-10% of the total weight of the tablets; When preparing capsules, add an appropriate amount of starch and 10g of astragalus extract as fillers, the astragalus extract accounts for 8%-12% of the total weight of the capsule contents. If 100 capsules are prepared, and each capsule weighs 0.5g, the amount of starch added is 40-42g; When making the powder, add 0.5g of menthol as a flavoring agent.

5. The Chinese medicine composition for treating Yang deficiency syndrome of stroke according to claim 1, characterized in that: It also includes one or more auxiliary ingredients for enhancing the efficacy of the medicine, including one or more of astragalus, angelica, salvia miltiorrhiza, safflower, wolfberry, Cistanche, Eucommia, mistletoe and deer antler, and the total weight of the auxiliary ingredients accounts for 2%-10% of the total weight of the traditional Chinese medicine composition.

6. The Chinese medicine composition for treating Yang deficiency syndrome of stroke according to claim 5, characterized in that: When the auxiliary ingredients include astragalus and angelica, the weight ratio of astragalus to angelica is 2:1 to 3:1; when the auxiliary ingredients include salvia miltiorrhiza and safflower, the weight ratio of salvia miltiorrhiza to safflower is 3:1 to 4:

1.

7. The Chinese medicine composition for treating Yang deficiency syndrome of stroke according to claim 3, characterized in that: In step S3, an ultrasonic-assisted extraction method is used. Specifically, the medicinal materials are ultrasonically treated for 30-60 minutes before decoction, and the ultrasonic frequency is 20-40 kHz.

8. The Chinese medicine composition for treating Yang deficiency syndrome of stroke according to claim 1, characterized in that: It also includes one or more flavoring agents for adjusting the taste of the medicine, wherein the flavoring agent is selected from one or more of licorice, jujube, maltose, and sucrose, and the total added amount of the flavoring agent does not exceed 5% of the total weight of the medicine.

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