Traditional Chinese medicine preparation for treating or improving cerebral thrombosis

Abstract

The invention provides a traditional Chinese medicine preparation for treating or improving cerebral thrombosis, and relates to the technical field of traditional Chinese medicine preparation. The traditional Chinese medicine preparation is prepared from lignum dalbergiae odoriferae, herba siegesbeckiae, rhodiola rosea, campsis grandiflora, radix rehmanniae praeparata, radix angelicae lateralis preparata, radix sophorae flavescentis, radix curcumae, peach kernels, dragon's blood, schizonepeta spike, radix ophiopogonis and liquorice, and has the effects of promoting blood circulation to remove blood stasis, activating meridians to stop pain, nourishing yin and clearing heat. The traditional Chinese medicine preparation has a good protection effect on experimental cerebral thrombosis mice, can well inhibit formation of cerebral thrombosis of cerebral thrombosis model rats, alleviate encephaledema conditions, effectively reduce platelet aggregation conditions, improve blood coagulation functions and alleviate cerebral thrombosis symptoms, and has a good treatment effect on the cerebral thrombosis model rats. When the traditional Chinese medicine preparation is used for treating cerebral thrombosis, the total effective rate of treatment can be remarkably increased, and the traditional Chinese medicine preparation has more advantages on improvement of nerve injury of a patient, improvement of ADL score and improvement of the blood coagulation function of the patient. The traditional Chinese medicine preparation provided by the invention has targeted treatment and improvement effects on cerebral thrombosis.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine pharmaceutical technology, and particularly relates to a traditional Chinese medicine preparation for treating or improving cerebral thrombosis. Background Art

[0002] Cerebral thrombosis is a cerebrovascular arterial disease. In the narrow or blocked blood vessel lumen, the formation of thrombus blocks will cause slow blood flow and interruption in the local cerebral blood supply area. Being in a state of hypoxia and ischemia for a long time and continuously, the patient's brain neurons are damaged, thereby triggering neurological symptoms and resulting in dysfunction in limb movement, cognition, etc. Clinically, Western medicine is generally used to treat cerebrovascular diseases. It adopts treatments such as thrombolysis, establishing collateral circulation, and antiplatelet aggregation, and has good treatment effects, but there are certain limitations. After Western medicine treatment, the patient's condition recovers relatively slowly, and the risks of complications and recurrence are relatively high.

[0003] With the gradual progress and development of traditional Chinese medicine, the treatment effect of traditional Chinese medicine for cerebral thrombosis is relatively ideal, and traditional Chinese medicine treatment has higher safety. On the basis of Western medicine treatment, the combined application of traditional Chinese medicine treatment methods can accelerate the recovery of patients with cerebral thrombosis and reduce the impact of complications and disease recurrence on the rehabilitation effect. Therefore, in the process of treating cerebral thrombosis, it is necessary to combine traditional Chinese medicine knowledge and Western medicine knowledge to achieve complementary and mutual assistance, jointly treat, and help patients improve nerve function, avoid repeated occurrence of cerebral thrombosis, and promote patients to return to normal life as soon as possible. Based on this, the present invention aims to provide a traditional Chinese medicine preparation with definite curative effect, which can significantly improve the clinical symptoms of patients with cerebral thrombosis and has a remarkable treatment effect. Summary of the Invention

[0004] (1) Technical Problems to be Solved

[0005] In view of the deficiencies of the prior art, the present invention provides a traditional Chinese medicine preparation and its application in the preparation of drugs for treating or improving cerebral thrombosis.

[0006] (2) Technical Solutions

[0007] To achieve the above objectives, the present invention is realized through the following technical solutions:

[0008] First of all, the present invention provides a traditional Chinese medicine preparation for treating or improving cerebral thrombosis. The traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 10 - 30 parts of Dalbergia odorifera, 5 - 25 parts of Siegesbeckia orientalis, 5 - 25 parts of Rhodiola rosea, 5 - 20 parts of Campsis grandiflora, 5 - 20 parts of Rehmannia glutinosa, 5 - 20 parts of Caulis Spatholobi, 5 - 20 parts of Sophora flavescens, 5 - 20 parts of Curcuma aromatica, 5 - 20 parts of Prunus persica, 5 - 20 parts of Sanguis draxonis, 1 - 15 parts of Schizonepeta tenuifolia, 1 - 15 parts of Ophiopogon japonicus, 1 - 10 parts of Glycyrrhiza uralensis.

[0009] Preferably, the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 15-25 parts of Dalbergia odorifera, 10-20 parts of Siegesbeckia orientalis, 10-20 parts of Rhodiola rosea, 5-15 parts of Campsis grandiflora, 5-15 parts of Rehmannia glutinosa, 5-15 parts of Angelica sinensis tail, 5-15 parts of Sophora flavescens, 5-15 parts of Curcuma aromatica, 5-15 parts of Prunus persica, 5-15 parts of Sanguis draxonis, 5-10 parts of Schizonepeta tenuifolia, 5-10 parts of Ophiopogon japonicus, 3-8 parts of Glycyrrhiza uralensis.

[0010] Preferably, the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 20 parts of Dalbergia odorifera, 15 parts of Siegesbeckia orientalis, 15 parts of Rhodiola rosea, 10 parts of Campsis grandiflora, 10 parts of Rehmannia glutinosa, 10 parts of Angelica sinensis tail, 10 parts of Sophora flavescens, 10 parts of Curcuma aromatica, 8 parts of Prunus persica, 8 parts of Sanguis draxonis, 6 parts of Schizonepeta tenuifolia, 6 parts of Ophiopogon japonicus, 4 parts of Glycyrrhiza uralensis.

[0011] The traditional Chinese medicine preparation provided by the present invention is used for preparing a drug for treating or improving cerebral thrombosis. The drug is made into an oral dosage form according to the conventional preparation method in medicine. The dosage form includes oral liquid, granule, powder, pill, plaster, decoction, and freeze-dried powder.

[0012] Dalbergia odorifera: Pungent in taste, warm in nature. It belongs to the liver and spleen meridians. Its main effects are promoting blood circulation to stop bleeding and regulating qi to relieve pain. It is mainly used for treating hypochondriac pain due to liver depression, chest pain, pain from falls and bruises, vomiting and abdominal pain, hematemesis, epistaxis, and traumatic bleeding.

[0013] Siegesbeckia orientalis: Pungent and bitter in taste, cold in nature. It belongs to the liver and kidney meridians. Its main effects are dispelling wind-dampness, promoting joint movement, and detoxifying. It is mainly used for treating rheumatic arthralgia, weakness of muscles and bones, soreness and weakness of the waist and knees, limb paralysis, hemiplegia, and rubella eczema.

[0014] Rhodiola rosea: Sweet and bitter in taste, neutral in nature. It belongs to the lung and heart meridians. Its main effects are replenishing qi and promoting blood circulation, dredging meridians and relieving asthma. It is mainly used for treating qi deficiency and blood stasis, chest pain, stroke and hemiplegia, and lassitude and asthma.

[0015] Campsis grandiflora: Sweet and sour in taste, cold in nature. It belongs to the liver and pericardium meridians. Its main effects are promoting blood circulation to dredge menstruation, cooling blood and dispelling wind. It is mainly used for treating irregular menstruation, amenorrhea and mass in the abdomen, rubella flushing, and skin itching.

[0016] Rehmannia glutinosa: Sweet in taste, slightly warm in nature. It belongs to the liver and kidney meridians. Its main effects are nourishing blood and yin, and replenishing essence and marrow. It is mainly used for treating sallow complexion due to blood deficiency, palpitation, irregular menstruation, metrorrhagia and metrostaxis, yin deficiency of the liver and kidney, soreness and weakness of the waist and knees, hectic fever, night sweating and spermatorrhea, internal heat and polydipsia, dizziness, tinnitus, and premature whitening of hair.

[0017] Angelica sinensis tail: Sweet and pungent in taste, warm in nature. It belongs to the liver, heart, and spleen meridians. Its main effects are nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and relaxing bowel movements. It is mainly used for treating sallow complexion due to blood deficiency, dizziness and palpitation, irregular menstruation, amenorrhea and dysmenorrhea, deficiency-cold abdominal pain, rheumatic arthralgia, pain from falls and bruises, carbuncles and sores, and intestinal dryness and constipation. Wine-processed Angelica sinensis promotes blood circulation to dredge menstruation. It is mainly used for treating amenorrhea and dysmenorrhea, rheumatic arthralgia, and pain from falls and bruises.

[0018] Sophora flavescens: Bitter in taste, cold in nature. It acts on the heart, liver, stomach, large intestine and bladder meridians. Its main effects are clearing heat and drying dampness, cooling blood. It is mainly used to treat qi stagnation in the heart and abdomen, masses and accumulations, calming the mind and tonifying essence, dysentery with bloody stools, jaundice with inhibited urination.

[0019] Curcuma aromatica Salisb.: Pungent and bitter in taste, cold in nature. It acts on the liver, heart and lung meridians. Its effects are promoting blood circulation to relieve pain, regulating qi and relieving depression, clearing the heart and cooling blood, promoting bile secretion and removing jaundice. It is mainly used to treat stabbing pain in the chest and hypochondrium, angina pectoris, amenorrhea and dysmenorrhea, breast distension and pain, coma due to febrile disease, epilepsy and mania, hematemesis and epistaxis due to blood heat.

[0020] Peach kernel: Bitter and sweet in taste, neutral in nature. It acts on the heart, liver and large intestine meridians. Its main effects are promoting blood circulation to remove stasis, relieving cough and asthma, moistening the intestines and promoting defecation. It is mainly used to treat masses and lumps, blood stasis accumulation due to febrile disease, lung abscess and intestinal abscess, amenorrhea and dysmenorrhea, traumatic injury, swelling and pain due to blood stasis, constipation due to blood dryness, cough and asthma.

[0021] Dragon's blood: Sweet and salty in taste, neutral in nature. It acts on the heart and liver meridians. Its main effects are promoting blood circulation to relieve pain, removing stasis and stopping bleeding, promoting tissue regeneration and astringing sores. It is mainly used to treat stabbing pain in the heart and abdomen, non-healing sores and ulcers, traumatic injury, external bleeding.

[0022] Spica Schizonepetae: Pungent in taste, slightly warm in nature. It acts on the lung and liver meridians. Its main effects are inducing sweating to disperse wind, promoting eruption, dissipating sores. It is mainly used to treat headache and cold, lockjaw due to stroke, hematemesis, epistaxis, carbuncle, sores and scabies, scrofula.

[0023] Radix Ophiopogonis: Sweet and slightly bitter in taste, slightly cold in nature. It acts on the heart, lung and stomach meridians. Its main effects are nourishing yin and moistening the lung, clearing the heart and relieving vexation, promoting the production of body fluid to benefit the stomach. It is mainly used to treat consumptive fever and restlessness, fluid injury due to febrile disease, dry cough due to lung dryness, hematemesis, hemoptysis, lung atrophy, lung abscess, thirst, dryness of the throat and mouth, constipation.

[0024] Licorice root: Sweet, neutral. It acts on the heart, lung, spleen and stomach meridians. Tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, alleviating spasm and pain, coordinating the properties of various drugs. It is used for weakness of the spleen and stomach, lassitude and fatigue, palpitation and shortness of breath, profuse phlegm and cough, abdominal pain and spasms in the abdomen and extremities, carbuncle and sore toxin, relieving the toxicity and potency of drugs.

[0025] (3) Beneficial effects

[0026] The present invention is based on the principle of traditional Chinese medicine syndrome differentiation and treatment, comprehensively considering the symptoms, causes and pathogenesis of patients, and provides a traditional Chinese medicine preparation for treating or improving cerebral thrombosis. The traditional Chinese medicine preparation is made from dalbergia odorifera, siegesbeckia herb, rhodiola rosea, campsis grandiflora, rehmannia glutinosa, angelica tail, sophora flavescens, curcuma aromatica, peach kernel, dragon's blood, schizonepeta spike, ophiopogon japonicus, and licorice. In the formula, dalbergia odorifera is used as the monarch drug, promoting qi and activating blood circulation, dissipating stasis and relieving pain. It directly enters the blood aspect, promotes the movement of qi and blood, dissipates stasis, enables the blood to circulate smoothly, and has the effect of dissipating stasis without damaging healthy qi; siegesbeckia herb dispels wind-dampness and dredges collaterals, and rhodiola rosea supplements qi and activates blood circulation. The two assist dalbergia odorifera and enhance the effect of activating blood circulation and dredging collaterals, and together they serve as ministerial drugs to assist dalbergia odorifera in improving problems such as collateral blockage and qi and blood stasis caused by cerebral thrombosis; campsis grandiflora cools blood and dissipates stasis, rehmannia glutinosa nourishes yin and replenishes blood, angelica tail promotes blood circulation and nourishes blood, sophora flavescens clears heat and dries dampness, curcuma aromatica can not only promote blood circulation and relieve pain but also promote qi and relieve depression, peach kernel promotes blood circulation and removes stasis, dragon's blood promotes blood circulation and relieves pain, schizonepeta spike dispels wind and induces sweating, guiding the medicine upward, ophiopogon japonicus nourishes yin and moistens dryness, and cooperates with rehmannia glutinosa to prevent the damage of yin fluid by blood-activating drugs during the process of dissipating stasis. The above herbs altogether serve as assistant drugs, synergistically acting from multiple aspects to further strengthen the power of promoting blood circulation and removing stasis in this formula, while taking into account nourishing yin and clearing heat, preventing the transformation of heat due to long-term stasis of blood stasis, and the potential harm of yin injury caused by blood-activating drugs; licorice serves as the envoy drug, harmonizing all the drugs, making the properties of the drugs in the whole formula coordinate with each other and better exerting the therapeutic effect. The traditional Chinese medicine preparation of the present invention uses blood-activating and stasis-removing drugs in combination with drugs for nourishing yin and clearing heat, expelling wind and dredging collaterals, taking into account both promoting dispersion and tonifying deficiency, and jointly achieving the effects of promoting blood circulation and removing stasis, dredging collaterals and relieving pain, nourishing yin and clearing heat, and realizing the effective treatment of cerebral thrombosis.

[0027] The traditional Chinese medicine preparation of the present invention has a good protective effect on experimental cerebral thrombosis mice, significantly delays the formation time of hemiplegia in experimental cerebral thrombosis mice, increases the survival time, and reduces the number of deaths. The traditional Chinese medicine preparation of the present invention can better inhibit the formation of cerebral thrombosis in cerebral thrombosis model rats caused by thrombus inducers, inhibit the increase of cerebrovascular permeability, reduce cerebral edema, and at the same time effectively reduce the platelet aggregation caused by thrombus inducers, significantly prolong the APTT, PT, and TT of cerebral thrombosis model rats, improve the blood coagulation function, relieve the symptoms of cerebral thrombosis, and has a good therapeutic effect on cerebral thrombosis model rats.

[0028] On the basis of conventional Western medicine treatment for cerebral thrombosis patients, using the traditional Chinese medicine preparation of the present invention to treat cerebral thrombosis can significantly improve the total effective rate of treatment, has a relatively greater improvement in the improvement of nerve injury and ADL score of patients, and at the same time has more advantages in improving the blood coagulation function of patients. The traditional Chinese medicine preparation provided by the present invention has a targeted treatment and improvement effect on cerebral thrombosis. Detailed implementation mode

[0029] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of them. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts belong to the scope of protection of the present invention.

[0030] Example 1

[0031] A traditional Chinese medicine preparation for treating or improving cerebral thrombosis, the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 20 parts of Dalbergia odorifera, 15 parts of Siegesbeckia orientalis, 15 parts of Rhodiola rosea, 10 parts of Campsis grandiflora, 10 parts of Rehmannia glutinosa, 10 parts of Angelica sinensis tail, 10 parts of Sophora flavescens, 10 parts of Curcuma aromatica, 8 parts of Prunus persica, 8 parts of Dragon's blood, 6 parts of Schizonepeta tenuifolia, 6 parts of Ophiopogon japonicus, 4 parts of Glycyrrhiza uralensis. The traditional Chinese medicine preparation is used for preparing a drug for treating or improving cerebral thrombosis, and the drug is made into an oral dosage form according to the conventional preparation methods in medicine, and the dosage form includes oral liquid, granule, powder, pill, plaster, decoction, and freeze-dried powder.

[0032] Example 2

[0033] A traditional Chinese medicine preparation for treating or improving cerebral thrombosis, the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 10 parts of Dalbergia odorifera, 5 parts of Siegesbeckia orientalis, 5 parts of Rhodiola rosea, 5 parts of Campsis grandiflora, 5 parts of Rehmannia glutinosa, 5 parts of Angelica sinensis tail, 5 parts of Sophora flavescens, 5 parts of Curcuma aromatica, 5 parts of Prunus persica, 5 parts of Dragon's blood, 3 parts of Schizonepeta tenuifolia, 3 parts of Ophiopogon japonicus, 3 parts of Glycyrrhiza uralensis.

[0034] Example 3

[0035] A traditional Chinese medicine preparation for treating or improving cerebral thrombosis, the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 30 parts of Dalbergia odorifera, 25 parts of Siegesbeckia orientalis, 25 parts of Rhodiola rosea, 20 parts of Campsis grandiflora, 20 parts of Rehmannia glutinosa, 20 parts of Angelica sinensis tail, 20 parts of Sophora flavescens, 20 parts of Curcuma aromatica, 20 parts of Prunus persica, 20 parts of Dragon's blood, 15 parts of Schizonepeta tenuifolia, 15 parts of Ophiopogon japonicus, 10 parts of Glycyrrhiza uralensis

[0036] Example 4

[0037] A traditional Chinese medicine preparation for treating or improving cerebral thrombosis, the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 12 parts of Dalbergia odorifera, 8 parts of Siegesbeckia orientalis, 8 parts of Rhodiola rosea, 5 parts of Campsis grandiflora, 5 parts of Rehmannia glutinosa, 5 parts of Angelica sinensis tail, 5 parts of Sophora flavescens, 5 parts of Curcuma aromatica, 5 parts of Prunus persica, 5 parts of Dragon's blood, 2 parts of Schizonepeta tenuifolia, 2 parts of Ophiopogon japonicus, 2 parts of Glycyrrhiza uralensis

[0038] Example 5

[0039] A traditional Chinese medicine preparation for treating or improving cerebral thrombosis, wherein the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 26 parts of dalbergia odorifera, 22 parts of siegesbeckia herb, 22 parts of rhodiola rosea, 16 parts of campsis grandiflora, 18 parts of prepared rehmannia root, 18 parts of caudate rehmannia root, 16 parts of sophora flavescens, 16 parts of curcuma aromatica, 16 parts of peach kernel, 16 parts of dragon's blood, 12 parts of schizonepeta spike, 12 parts of dwarf lilyturf tuber, 8 parts of liquorice

[0040] Example 6

[0041] A traditional Chinese medicine preparation for treating or improving cerebral thrombosis, wherein the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 15 parts of dalbergia odorifera, 10 parts of siegesbeckia herb, 10 parts of rhodiola rosea, 5 parts of campsis grandiflora, 5 parts of prepared rehmannia root, 5 parts of caudate rehmannia root, 5 parts of sophora flavescens, 5 parts of curcuma aromatica, 5 parts of peach kernel, 5 parts of dragon's blood, 5 parts of schizonepeta spike, 5 parts of dwarf lilyturf tuber, 3 parts of liquorice.

[0042] Example 7

[0043] A traditional Chinese medicine preparation for treating or improving cerebral thrombosis, wherein the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 25 parts of dalbergia odorifera, 20 parts of siegesbeckia herb, 20 parts of rhodiola rosea, 15 parts of campsis grandiflora, 15 parts of prepared rehmannia root, 15 parts of caudate rehmannia root, 15 parts of sophora flavescens, 15 parts of curcuma aromatica, 15 parts of peach kernel, 15 parts of dragon's blood, 10 parts of schizonepeta spike, 10 parts of dwarf lilyturf tuber, 8 parts of liquorice.

[0044] Example 8

[0045] A traditional Chinese medicine preparation for treating or improving cerebral thrombosis, wherein the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 18 parts of dalbergia odorifera, 14 parts of siegesbeckia herb, 16 parts of rhodiola rosea, 8 parts of campsis grandiflora, 10 parts of prepared rehmannia root, 10 parts of caudate rehmannia root, 12 parts of sophora flavescens, 12 parts of curcuma aromatica, 10 parts of peach kernel, 10 parts of dragon's blood, 8 parts of schizonepeta spike, 8 parts of dwarf lilyturf tuber, 6 parts of liquorice.

[0046] Example 9

[0047] A traditional Chinese medicine preparation for treating or improving cerebral thrombosis, wherein the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 22 parts of dalbergia odorifera, 16 parts of siegesbeckia herb, 18 parts of rhodiola rosea, 12 parts of campsis grandiflora, 10 parts of prepared rehmannia root, 12 parts of caudate rehmannia root, 10 parts of sophora flavescens, 12 parts of curcuma aromatica, 10 parts of peach kernel, 12 parts of dragon's blood, 9 parts of schizonepeta spike, 6 parts of dwarf lilyturf tuber, 5 parts of liquorice.

[0048] Test Example 1

[0049] Drug screening experiment

[0050] 1 Experimental drugs

[0051] Prescription 1: 20 parts of dalbergia odorifera, 15 parts of siegesbeckia herb, 15 parts of rhodiola rosea, 10 parts of campsis grandiflora, 10 parts of prepared rehmannia root, 10 parts of caudate rehmannia root, 10 parts of sophora flavescens, 10 parts of curcuma aromatica, 8 parts of peach kernel, 8 parts of dragon's blood, 6 parts of schizonepeta spike, 6 parts of dwarf lilyturf tuber, 4 parts of liquorice

[0052] Prescription 2: 15 parts of Siegesbeckia orientalis, 15 parts of Rhodiola rosea, 10 parts of Campsis grandiflora, 10 parts of Rehmannia glutinosa, 10 parts of Caulis Spatholobi, 10 parts of Sophora flavescens, 8 parts of Dragon's blood, 6 parts of Schizonepeta tenuifolia, 6 parts of Ophiopogon japonicus, 4 parts of Licorice

[0053] Prescription 3: 20 parts of Dalbergia odorifera, 10 parts of Campsis grandiflora, 10 parts of Rehmannia glutinosa, 10 parts of Caulis Spatholobi, 10 parts of Sophora flavescens, 10 parts of Curcuma aromatica, 8 parts of Persica, 6 parts of Schizonepeta tenuifolia, 6 parts of Ophiopogon japonicus, 4 parts of Licorice

[0054] Prescription 4: 20 parts of Dalbergia odorifera, 15 parts of Siegesbeckia orientalis, 15 parts of Rhodiola rosea, 10 parts of Campsis grandiflora, 10 parts of Caulis Spatholobi, 10 parts of Curcuma aromatica, 8 parts of Persica, 8 parts of Dragon's blood, 6 parts of Schizonepeta tenuifolia, 4 parts of Licorice

[0055] Prescription 5: 20 parts of Dalbergia odorifera, 15 parts of Siegesbeckia orientalis, 15 parts of Rhodiola rosea, 10 parts of Rehmannia glutinosa, 10 parts of Sophora flavescens, 10 parts of Curcuma aromatica, 8 parts of Persica, 8 parts of Dragon's blood, 6 parts of Ophiopogon japonicus, 4 parts of Licorice

[0056] Weigh each raw material according to the weight parts described in Prescriptions 1 - 5, wash them, soak them in 4 times the amount of water for 30 minutes, then decoct for 30 minutes, filter the medicinal liquid, add 3 times the amount of water and decoct for 30 minutes again. Combine the two decocted liquids and concentrate the drug content to 1 g / mL (equivalent to 1 g of crude drug content per 1 mL) to obtain Chinese medicine stock solutions 1 - 5, and store them at 4°C for later use.

[0057] 2 Experimental methods

[0058] Take 60 SPF - level KM mice, with body weight (20 ± 2) g, half male and half female. Randomly divide them into a model group and experimental groups 1 - 5, with 10 mice in each group. Mice in experimental groups 1 - 5 were intragastrically administered with Chinese medicine stock solutions 1 - 5 respectively, at a dose of 5 g / kg. The model group was intragastrically administered with an equal volume of normal saline. Mice in each group were continuously intragastrically administered for 7 days, once a day. 1 hour after the last administration, a mixture inducer of collagen and adrenaline (2.25 mg of collagen per mouse, 60 μg of adrenaline per mouse) was injected into the tail vein of the mice. Immediately after injection, observe the occurrence of hemiplegia, survival time and the number of dead mice in the mice within 15 minutes, and compare the protection rates of each group against experimental cerebral thrombosis mice.

[0059] 3 Experimental results

[0060] Compared with the model group, each administration group could prolong the hemiplegia formation time and survival time of experimental cerebral thrombosis mice to varying degrees, with significant differences (P < 0.05), and at the same time reduce the death number of experimental cerebral thrombosis mice; among them, compared with experimental groups 2 - 5, experimental group 1 (the traditional Chinese medicine preparation of the present invention) had the best effect in prolonging the hemiplegia formation time and survival time of experimental cerebral thrombosis mice, and the least number of dead mice. The above results indicate that the traditional Chinese medicine preparation of the present invention has excellent protective effects on experimental cerebral thrombosis mice compared with other traditional Chinese medicine prescriptions (prescriptions 2 - 5), significantly delays the hemiplegia formation time of experimental mice, increases the survival time, and reduces the death number. It is expected to be used as a drug for treating or improving cerebral thrombosis.

[0061] Table 1 Effects of different drugs on experimental cerebral thrombosis formation in mice

[0062] Group Hemiplegia formation time / s Survival time / s Number of deaths Model group 28.75±8.62 91.92±27.26 10 Experimental group 1 <![CDATA[44.17±10.05 * > <![CDATA[191.35±91.17 * > 6 Experimental group 2 <![CDATA[37.38±7.12 * > <![CDATA[169.48±79.50 * > 8 Experimental group 3 <![CDATA[39.63±9.87 * > <![CDATA[173.68±84.07 * > 7 Experimental group 4 <![CDATA[40.97±6.49 * > <![CDATA[185.03±101.05 * > 7 Experimental group 5 <![CDATA[40.71±11.30 * > <![CDATA[172.84±91.85 * > 7

[0063] Note: Different lowercase letters in the superscripts of the same column of data indicate significant differences, P < 0.05; the same lowercase letters in the superscripts of the same column of data indicate no significant differences, P > 0.05.

[0064] Test Example 2

[0065] 1 Materials and Methods

[0066] 1.1 Experimental animals

[0067] SPF - grade SD rats were selected, with a body weight of (220 ± 20) g, half male and half female, and were raised in an environment of 20 - 25 °C, 12 - hour light - dark cycle, 50% - 70% relative humidity, with sufficient food and water. The experiment started after 7 - day adaptive feeding.

[0068] 1.2 Drugs and preparations

[0069] The traditional Chinese medicine stock solution of the present invention is composed of 20 parts of Dalbergia odorifera, 15 parts of Siegesbeckia orientalis, 15 parts of Rhodiola rosea, 10 parts of Campsis grandiflora, 10 parts of Rehmannia glutinosa, 10 parts of Caulis Spatholobi, 10 parts of Sophora flavescens, 10 parts of Curcuma aromatica, 8 parts of Prunus persica, 8 parts of Sanguis draxonis, 6 parts of Schizonepeta tenuifolia, 6 parts of Ophiopogon japonicus, and 4 parts of Glycyrrhiza uralensis. Weigh each raw material according to the above weight parts, wash them, soak them in 4 times the amount of water for 30 minutes, then decoct for 30 minutes, filter the medicinal liquid, add 3 times the amount of water and decoct for 30 minutes again, combine the two decocted liquids, concentrate the drug content to 1 g / mL (equivalent to 1 g of crude drug content per 1 mL), and store at 4 °C for standby.

[0070] Aspirin, 50 mg / tablet.

[0071] 1.3 Methods

[0072] One hundred rats were divided into two major groups, and each major group was randomly divided into five groups, namely the blank group (distilled water), the model group (distilled water), the positive control group (aspirin, 13 mg / kg), the low-dose group of the traditional Chinese medicine preparation of the present invention (abbreviated as the low-dose group, 100 mg / kg of the original Chinese medicine solution), and the high-dose group of the traditional Chinese medicine preparation of the present invention (abbreviated as the high-dose group, 200 mg / kg of the original Chinese medicine solution). There were 10 rats in each group. Each group was given medicine by gavage once a day for 14 consecutive days, and medicine was given once 1 hour before modeling.

[0073] One hour after the last administration, a cerebral thrombosis formation experiment was carried out. During the experiment, the rats were anesthetized by intraperitoneal injection of 2% pentobarbital sodium (50 mg / kg). The left common carotid artery and the left external carotid artery were threaded for standby. First, the left external carotid artery was ligated, and then the proximal end of the left common carotid artery was ligated. A rat artery clamp was used to clamp about 1 cm away from the distal end of the ligation for reperfusion. A small incision was made between the ligation and the clamping of the left common carotid artery. A right-angled needle was inserted from the incision towards the head direction to inject a composite thrombus inducer. The artery clamp was opened to allow blood vessel reperfusion during injection, and the artery was clamped again after injection. Except for the blank group, the other groups were injected with 1 mL / kg of the composite thrombus inducer (adenosine diphosphate 1.25 mmol / L: thrombin 12,500 u / L: adrenaline 1 g / L = 100:200:5) from the cut of the left common carotid artery, and the blank group was injected with an equal amount of normal saline.

[0074] 1.4 Detection method

[0075] 1.4.1 Detection of the degree of cerebral thrombosis and the degree of cerebral edema

[0076] Ten minutes after injecting the composite thrombus inducer into the rats in the first major group, 5 mL / kg of 0.2% Evans blue was injected. Five minutes after the injection, the rats were quickly decapitated, and the brains were taken in ice. The residual blood was washed away with normal saline, blotted dry with filter paper, weighed on an analytical balance, cut into pieces, placed in an electric homogenizer, and a homogenate was prepared with 0.5% NaSO4:acetone = 3:7 (5 mL per gram of brain). The homogenate was poured into a capped test tube, sealed and placed at 4°C for 6 hours, centrifuged at 4000 rpm for 10 minutes, 3 mL of the supernatant was transferred into a test tube, and then centrifuged at 5000 rmp for 10 minutes. The supernatant was taken, zeroed with normal saline, and the absorbance (A) value was measured by a visible light spectrophotometer at 620 nm with a 1 cm light path for colorimetry. The content of Evans blue was expressed by the ratio of the optical density A of the embolized hemisphere (the left side is the infarction area and the right side is the control area) to its brain weight (A / wet weight of the left brain), and this was used to represent the severity of cerebral thrombosis. The degree of cerebral edema on the infarcted side was expressed by the ratio of the weight of the infarcted hemisphere (left side) to the weight of the control right hemisphere (left / right brain wet weight).

[0077] 1.4.2 Detection of blood coagulation function indexes

[0078] The second group of rats was injected with a composite thrombus inducer, and then the needle holes were ligated with sutures, the skin was sutured, and the rats were housed individually in cages. 24 hours after modeling, the rats were anesthetized by intraperitoneal injection, and blood was collected from the abdominal aorta using a disposable negative pressure sodium citrate (1:9) blood collection tube. The maximum platelet aggregation rate of the rats was detected using a platelet aggregometer. The coagulation function indexes of the rats were detected: PT, APTT, and TT.

[0079] 1.5 Statistical analysis

[0080] IBM SPSS Statistics 19.0 software was used for statistical processing. One-way analysis of variance was used for inter-group comparison. If the variances were homogeneous between groups, the statistical method used was LSD test; if the variances were not homogeneous, the Games Howell test was used. The results were expressed as mean ± standard deviation. Format. P < 0.05 was considered statistically significant.

[0081] 2 Results

[0082] 2.1 Effects of the traditional Chinese medicine preparation of the present invention on cerebral thrombosis and cerebral edema in experimental cerebral thrombosis rats

[0083] As shown in Table 2, compared with the blank group, the wet weight of the left brain and the ratio of the wet weight of the left brain to the right brain in the model group A were significantly increased, indicating that the cerebral thrombosis rat model was successfully constructed. Compared with the model group, the wet weight of the left brain and the ratio of the wet weight of the left brain to the right brain in each drug administration group decreased to varying degrees, and the difference was significant (P < 0.05); among them, the wet weight of the left brain in the high-dose group was comparable to that in the positive control group, and the ratio of the wet weight of the left brain to the right brain in the high-dose group was significantly lower than that in the positive control group. The above results indicate that the traditional Chinese medicine preparation of the present invention can better inhibit the formation of cerebral thrombosis caused by the thrombus inducer, inhibit the increase of cerebrovascular permeability, and reduce cerebral edema.

[0084] Table 2 Effects of the traditional Chinese medicine preparation of the present invention on the content of Evans blue in the brain tissue and the degree of cerebral edema in cerebral thrombosis rats

[0085] Group A / Left brain wet weight Left / Right brain wet weight Blank group 0.007±0.001 0.992±0.004 Model group <![CDATA[0.125±0.010 # > <![CDATA[1.117±0.009 # > Positive control group <![CDATA[0.065±0.008 * > <![CDATA[1.054±0.010 * > Low-dose group <![CDATA[0.081±0.009 * > <![CDATA[1.051±0.007 * > High-dose group <![CDATA[0.067±0.005 * > <![CDATA[1.035±0.008 * >

[0086] Note: Compared with the blank group, # P < 0.05; compared with the model group, *P < 0.05.

[0087] 2.2 Effects of the traditional Chinese medicine preparation of the present invention on platelet aggregation rate and coagulation function in experimental cerebral thrombosis rats

[0088] The results are shown in Table 3. Compared with the blank group, the platelet aggregation rate of rats in the model group was significantly increased, with a significant difference (P < 0.05). Compared with the model group, the platelet aggregation rates of rats in the positive control group, low-dose group, and high-dose group were all significantly decreased, with a significant difference (P < 0.05). The above results indicate that the traditional Chinese medicine preparation of the present invention can effectively reduce the platelet aggregation caused by thrombus inducers.

[0089] Table 3 Effects of the traditional Chinese medicine preparation of the present invention on the platelet aggregation rate of rats with cerebral thrombosis

[0090] Group Maximum aggregation rate (%) Blank group 44.19±8.39 Model group <![CDATA[56.38±7.03 # > Positive control group <![CDATA[45.27±5.12 * > Low-dose group <![CDATA[46.28±8.47 * > High-dose group <![CDATA[45.53±7.35 * >

[0091] Note: Compared with the blank group, # P < 0.05; compared with the model group, *P < 0.05.

[0092] APTT is the activated partial thromboplastin time. A shortened APTT indicates that there may be a hypercoagulable state or thromboembolic disease. PT is the prothrombin time. A shortened PT indicates that the blood has a hypercoagulable state and is prone to thrombosis. TT is the thrombin time, which reflects the time for fibrinogen in plasma to be converted into fibrin. A shortened TT indicates that there are microclots or calcium ions in the specimen.

[0093] As shown in Table 4, compared with the blank group, the APTT, PT, and TT of rats in the model group were all significantly shortened, with a significant difference (P < 0.05). Compared with the model group, the APTT and PT of the positive control group, low-dose group, and high-dose group were significantly increased, with a significant difference (P < 0.05). The TT of the positive control group and high-dose group was significantly increased, with a significant difference (P < 0.05). The TT of the low-dose group had an increasing trend, but there was no significant difference (P > 0.05). The above results indicate that the traditional Chinese medicine preparation of the present invention can significantly prolong the APTT, PT, and TT of rats with cerebral thrombosis models, improve the blood coagulation function, and relieve the symptoms of cerebral thrombosis.

[0094] Table 4 Effects of the traditional Chinese medicine preparation of the present invention on the blood coagulation function of rats with cerebral thrombosis

[0095] Group APTT (s) PT (s) TT (s) Blank group 25.00±2.58 14.03±1.28 37.22±1.46 Model group <![CDATA[21.47±2.06 # > <![CDATA[12.08±0.94 # > <![CDATA[34.17±0.99 # > Positive control group <![CDATA[24.48±2.31 * > <![CDATA[13.13±0.82 * > <![CDATA[36.65±0.70 * > Low-dose group <![CDATA[25.18±1.97 * > <![CDATA[13.27±1.12 * > 35.03±1.45 High-dose group <![CDATA[26.09±2.11 * > <![CDATA[13.96±1.63 * > <![CDATA[37.05±0.92 * >

[0096] Note: Compared with the blank group, # P < 0.05; compared with the model group, *P < 0.05.

[0097] Test Example 3

[0098] 1 Materials and Methods

[0099] 1.1 General Information

[0100] Select 96 patients with cerebral thrombosis admitted to the First Affiliated Hospital of Henan University of Chinese Medicine from January 2024 to December 2024 as the research objects. Using the random number table method, they were divided into a control group and an observation group, with 48 cases in each group. The patients or their legal guardians have been fully informed and consented to participate, and signed the corresponding informed consent form.

[0101] Inclusion criteria: (1) Meet the disease judgment criteria for cerebral thrombosis and be clearly diagnosed through relevant imaging examinations such as head CT; (2) Belong to a single lesion; (3) The patient has the first onset of cerebral thrombosis; (4) The time from the onset of the disease to admission does not exceed 72 hours; (5) Aged 40 - 80 years; (6) All relevant clinical data are complete and the medication compliance is good.

[0102] Exclusion criteria: (1) Those with combined cerebral hemorrhage or manifestations of hemorrhagic cerebral infarction; (2) Those with severe organ function disorders such as heart, lung, and kidney; (3) Those suffering from dementia, psychological diseases, or mental disorders; (4) Those with severe transfer or loss to follow - up.

[0103] Observation group: 26 males and 22 females, with an average age of (62.49 ± 7.01) years, an average course of disease of (19.77 ± 2.14) hours, 31 cases with < 3 comorbidities, and 17 cases with ≥ 3 comorbidities. Control group: 28 males and 20 females, with an average age of (64.11 ± 5.47) years, an average course of disease of (18.49 ± 2.57) hours, 29 cases with < 3 comorbidities, and 19 cases with ≥ 3 comorbidities. There were no statistically significant differences in the general data of the two groups of patients (P > 0.05).

[0104] 1.2 Methods

[0105] The control group received conventional treatment for cerebral thrombosis, mainly including anti - platelet aggregation, blood pressure regulation, improvement of nerve function, lipid - lowering, and improvement of microcirculation and other treatment interventions.

[0106] The observation group was treated with the traditional Chinese medicine preparation of the present invention on the basis of the control group, 1 dose per day, decocted in water for oral administration, taken twice in the morning and evening.

[0107] Both groups were treated continuously for 4 weeks, and the treatment recovery effects of the two groups were observed.

[0108] 1.3 Observation indicators

[0109] (1) The neurological function of both groups of patients was evaluated through the NIHSS stroke scale, ranging from 0 to 42 points. The evaluation content includes ataxia, eye movement, limb movement, consciousness status, etc. The higher the score, the more severe the neurological deficit.

[0110] (2) The activities of daily living (ADL) of the patients were evaluated using the ADL scale. The evaluation content included independent eating, body transfer, defecation, washing, etc., with a score range of 0 - 100 points. The higher the score, the lower the degree of dependence.

[0111] (3) The clinical efficacy of the two groups of patients was compared. Complete recovery: The NIHSS score decreased by 91% or more, and the physical disability level returned to grade 0; Marked improvement: The NIHSS score decreased by 46% - 90%, and the disability level returned to grade 1, 2, or 3; Effective: The NIHSS score decreased by 18% - 45%; Ineffective: The NIHSS score decreased by <18% or the condition deteriorated.

[0112] (4) The main coagulation function indexes of the two groups of patients were detected and compared, including TT, PT, and APTT.

[0113] 1.4 Statistical analysis

[0114] Analysis was performed using SPSS 21.0 statistical software. Measurement data were expressed as and t - test was used. Count data were expressed as (%) and χ 2 test was used. P < 0.05 was considered statistically significant.

[0115] 2 Results

[0116] 2.1 Comparison of clinical cure between the two groups of patients

[0117] The total effective rate of the observation group was 87.5%, and the total effective rate of the control group was 72.92%. The difference between the two groups was significant (P < 0.05). The results are shown in Table 5.

[0118] Table 5 Clinical cure effects of the two groups of patients [n(%)]

[0119] Group Basically cured Markedly effective Effective Ineffective Total effective Control group 21(43.75) 7(14.58) 5(10.42) 15(31.25) 35(72.92) Observation group 28(58.33) 8(16.67) 6(12.5) 6(12.5) 42(87.5) <![CDATA[χ 2 > — — — — 8.952 P — — — — 0.024

[0120] 2.2 Comparison of NIHSS and ADL scale scores between the two groups of patients

[0121] Before treatment, there was no significant difference in the NIHSS scores and ADL scores between the two groups of patients (P > 0.05). Compared with before treatment, the NIHSS scores of the control group and the observation group decreased significantly after treatment (P < 0.05), and the ADL scores increased significantly (P < 0.05); after treatment, the NIHSS score of the patients in the observation group was significantly lower than that of the control group (P < 0.05), and the ADL score was significantly higher than that of the control group (P < 0.05). The results are shown in Table 6.

[0122] Table 6 NIHSS and ADL scale scores of the two groups of patients (points)

[0123]

[0124] Note: Within each group, compared with before treatment, *P < 0.05; after treatment, compared with the control group, # P < 0.05.

[0125] 2.3 Comparison of coagulation function indexes between the two groups of patients

[0126] Before treatment, there was no significant difference in coagulation function indexes between the two groups of patients (P > 0.05). Compared with before treatment, the TT, PT, and APTT coagulation function indexes of the control group and the observation group were significantly increased after treatment (P < 0.05); after treatment, the TT, PT, and APTT coagulation function indexes of the patients in the observation group were significantly higher than those of the control group (P < 0.05).

[0127] Table 7 Results of coagulation function indexes of the two groups of patients

[0128]

[0129] Note: Within each group, compared with before treatment, *P < 0.05; after treatment, compared with the control group, # P < 0.05.

[0130] 3 Conclusion

[0131] On the basis of the conventional western medicine treatment for cerebral thrombosis patients, the use of the traditional Chinese medicine preparation of the present invention to treat cerebral thrombosis can significantly improve the total effective rate of treatment, has a relatively greater improvement in the improvement of nerve damage and ADL score of patients, and at the same time has more advantages in improving the coagulation function of patients. The traditional Chinese medicine preparation provided by the present invention has a targeted treatment and improvement effect on cerebral thrombosis.

[0132] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements for some of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A traditional Chinese medicine preparation for treating or improving cerebral thrombosis, characterized in that, The traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 10-30 parts of dalbergia odorifera, 5-25 parts of siegesbeckia orientalis, 5-25 parts of rhodiola rosea, 5-20 parts of campsis grandiflora, 5-20 parts of prepared rehmannia root, 5-20 parts of caudate rehmannia root, 5-20 parts of sophora flavescens, 5-20 parts of curcuma aromatica, 5-20 parts of peach kernel, 5-20 parts of dragon's blood, 1-15 parts of schizonepeta spike, 1-15 parts of dwarf lilyturf tuber, 1-10 parts of liquorice.

2. The traditional Chinese medicine preparation for treating or improving cerebral thrombosis according to claim 1, wherein The traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 15-25 parts of dalbergia odorifera, 10-20 parts of siegesbeckia orientalis, 10-20 parts of rhodiola rosea, 5-15 parts of campsis grandiflora, 5-15 parts of prepared rehmannia root, 5-15 parts of caudate rehmannia root, 5-15 parts of sophora flavescens, 5-15 parts of curcuma aromatica, 5-15 parts of peach kernel, 5-15 parts of dragon's blood, 5-10 parts of schizonepeta spike, 5-10 parts of dwarf lilyturf tuber, 3-8 parts of liquorice.

3. A traditional Chinese medicine preparation for treating or improving cerebral thrombosis according to claim 1, wherein, The traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 20 parts of dalbergia odorifera, 15 parts of siegesbeckia orientalis, 15 parts of rhodiola rosea, 10 parts of campsis grandiflora, 10 parts of prepared rehmannia root, 10 parts of caudate rehmannia root, 10 parts of sophora flavescens, 10 parts of curcuma aromatica, 8 parts of peach kernel, 8 parts of dragon's blood, 6 parts of schizonepeta spike, 6 parts of dwarf lilyturf tuber, 4 parts of liquorice.

4. Use of the traditional Chinese medicine preparation according to any one of claims 1 to 3 in the preparation of a drug for treating or improving cerebral thrombosis, characterized in that, The drug is prepared into an oral dosage form according to the conventional preparation method in medicine, and the dosage form includes oral liquid, granule, powder, pill, plaster, decoction, and freeze-dried powder.

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