A traditional Chinese medicine composition for the recovery period of cerebral thrombosis

Abstract

This invention discloses two traditional Chinese medicine compositions, namely, Composition I and Composition II, for use in the recovery period of cerebral thrombosis, and their medicinal uses. Composition I comprises 400-700 parts by weight of Astragalus membranaceus, 200-400 parts by weight of Panax notoginseng, 100-350 parts by weight of Hirudo medicinalis, and 1-10 parts by weight of Borneol. Composition II comprises 50-120 parts by weight of Astragalus membranaceus extract, 20-40 parts by weight of total Panax notoginseng saponins, 20-50 parts by weight of Hirudo medicinalis extract, and 1-10 parts by weight of Borneol. This invention also provides a drug comprising Composition I or Composition II, its preparation method, and its medicinal uses.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine and medicine, and specifically relates to a traditional Chinese medicine composition for the recovery period of cerebral thrombosis. Background Technology

[0002] Cerebral thrombosis is a type of ischemic cerebrovascular disease, mostly occurring after the age of 50, with slightly more men than women. The most common cause of cerebral thrombosis is arteriosclerosis. Due to arteriosclerosis, the inner lining of cerebral arteries becomes rough and the lumen narrows. Under certain conditions, such as decreased blood pressure, slow blood flow, increased blood viscosity, or increased platelet aggregation, clotting factors coagulate into clots within the lumen, forming thrombi that block blood vessels, interrupt blood flow, and cause ischemia, hypoxia, softening, and necrosis of the brain tissue supplied by the vessel. Cerebral thrombosis can occur in any segment of cerebral blood vessels, but clinically, thrombi formed in branches of the internal carotid artery, anterior cerebral artery, and middle cerebral artery are more common. The location of the cerebral thrombosis determines the clinical symptoms and severity; mild cases often present with unilateral limb weakness, sensory dullness, and aphasia, while severe cases can lead to coma, incontinence, and even death. Cerebral thrombosis is divided into acute and recovery phases based on its course. The principle of acute phase treatment is to improve blood circulation in the ischemic area of ​​the brain and promote the recovery of nerve function as soon as possible; the principle of recovery phase treatment is to continue to strengthen the functional exercise of paralyzed limbs and speech function training, while preventing recurrence.

[0003] According to a report in The Lancet in March 2019, ischemic cerebrovascular disease has become one of the leading causes of death worldwide.

[0004] Traditional Chinese medicine (TCM) has certain advantages in treating cerebral thrombosis, generally focusing on invigorating qi and promoting blood circulation. For example, Chinese invention patent application CN101244245A (published August 20, 2008) discloses a TCM composition with blood-activating and stasis-removing effects for treating cerebral thrombosis, cerebral infarction, and hemiplegia. The raw materials include 31 medicinal herbs such as Angelica sinensis, Ligusticum chuanxiong, Salvia miltiorrhiza, Polygonum multiflorum, Boswellia carterii, Commiphora myrrha, Curcuma longa, Atractylodes macrocephala, Chaenomeles speciosa, Achyranthes bidentata, Citrus aurantium, Carthamus tinctorius, Pheretima aspergillum, Cistanche deserticola, Amber, Poria cocos, Phyllanthus emblica, Pangolin scales, Hirudo medicinalis, Typha orientalis, Prunus persica, Gastrodia elata, Astragalus membranaceus, Panax notoginseng, Arisaema cum bile, Acorus tatarinowii, Bungarus fasciatus, Euphorbia humifusa, Rheum palmatum, Codonopsis pilosula, and Pueraria lobata. For example, Chinese invention patent CN101085229A (published on December 12, 2007) discloses an oral medication for treating cerebral thrombosis, composed of danshen, sanqi, leech, gastrodia, white snake, astragalus, musk, silkworm, earthworm, achyranthes, chuanxiong, and borneol in a specific weight ratio. These traditional Chinese medicine compositions are generally complex, containing anywhere from a dozen to dozens of ingredients; this not only increases the burden on patients but also makes preparation inconvenient. Summary of the Invention

[0005] To overcome the shortcomings of existing technologies, this invention provides a traditional Chinese medicine composition for the recovery period of cerebral thrombosis. The traditional Chinese medicine composition of this invention has a simple formulation but definite curative effect; it provides a new option to meet clinical treatment needs.

[0006] To achieve the above-mentioned objectives, the present invention adopts the following technical solution:

[0007] A traditional Chinese medicine composition I for the recovery period of cerebral thrombosis, comprising the following raw materials in parts by weight:

[0008] Astragalus membranaceus 400-700 parts by weight, Panax notoginseng 200-400 parts by weight, Hirudo medicinalis 100-350 parts by weight, Borneol 1-10 parts by weight.

[0009] Preferably, the raw materials of the traditional Chinese medicine composition I include the following traditional Chinese medicinal materials in parts by weight:

[0010] Astragalus membranaceus 450-650 parts by weight, Panax notoginseng 200-350 parts by weight, Hirudo medicinalis 200-350 parts by weight, Borneol 3-8 parts by weight.

[0011] More preferably, the raw materials of the traditional Chinese medicine composition I include the following traditional Chinese medicinal materials in parts by weight:

[0012] Astragalus membranaceus 500-600 parts by weight, Panax notoginseng 200-300 parts by weight, Hirudo medicinalis 300-350 parts by weight, Borneol 5-7 parts by weight.

[0013] As a preferred embodiment, the present invention provides a traditional Chinese medicine composition I for the recovery period of cerebral thrombosis, the raw materials of which are composed of Astragalus membranaceus, Panax notoginseng, leech and borneol, and the weight parts of each medicinal material are as defined above.

[0014] This invention also provides a traditional Chinese medicine composition II for the recovery period of cerebral thrombosis, comprising the following raw materials in parts by weight:

[0015] Astragalus extract 50-120 parts by weight, total saponins of Panax notoginseng 20-40 parts by weight, leech extract 20-50 parts by weight, borneol 1-10 parts by weight;

[0016] The Astragalus extract is prepared by the following method:

[0017] Take Astragalus membranaceus, add water and decoct three times, adding 5-10 times the weight of Astragalus membranaceus each time, and decoct for 1-2 hours each time; filter while hot, combine the filtrates, and concentrate the filtrate to 1-2g of Astragalus membranaceus per ml; add ethanol to make the alcohol content 75%, refrigerate for 12 hours, take the supernatant, filter, recover the ethanol from the filtrate and concentrate until there is no alcohol taste, add dextrin to make the relative density of the extract 1.03-1.05 (40℃), spray dry to obtain Astragalus membranaceus extract;

[0018] The total saponins of Panax notoginseng were prepared by the following method:

[0019] Take Panax notoginseng, grind it appropriately, and extract it twice with 90% ethanol. For the first extraction, add 2.5 times the weight of Panax notoginseng in 90% ethanol and reflux for 10 hours. For the second extraction, add twice the amount of 90% ethanol and extract for 5 hours. Filter while hot, combine the filtrates, recover the ethanol until there is no ethanol odor, add an appropriate amount of water to dilute the solution to 0.25 g (crude drug) / ml, stir well, let stand, and filter. Pass the filtrate through a macroporous adsorption resin column, wash with water, and then elute with 80% ethanol. Collect the eluent, recover the ethanol under reduced pressure, concentrate to a thick paste, dry, and grind to obtain total saponins of Panax notoginseng.

[0020] The leech extract was prepared by the following method:

[0021] Take leeches, add water and decoct twice, adding 5-10 times the weight of water of the leeches each time, for 1-2 hours each time, filter while hot, and combine the filtrates; concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (35-40℃), vacuum dry, and when the extract becomes viscous, add 20% of the weight of corn starch of the leeches, mix, dry, pulverize, and pass through an 80-mesh sieve to obtain the leech extract.

[0022] Preferably, in the preparation of the total saponins of Panax notoginseng, the macroporous resin is D101 macroporous resin, and the amount of resin used is 4 / 3 times the weight of Panax notoginseng.

[0023] Preferably, in the preparation of the total saponins of Panax notoginseng, the volume ratio of rinsing water to macroporous resin is 2-4 ml:1 g, more preferably 3 ml:1 g.

[0024] More preferably, in the preparation of the total saponins of Panax notoginseng, the volume ratio of 80% ethanol to the weight ratio of macroporous resin is 1-2 ml:1 g, more preferably 1 ml:1 g.

[0025] Preferably, the traditional Chinese medicine composition II comprises the following raw materials in parts by weight:

[0026] The extract consists of 60-100 parts by weight of Astragalus membranaceus extract, 20-35 parts by weight of total Panax notoginseng saponins, 25-50 parts by weight of Hirudo medicinalis extract, and 3-8 parts by weight of borneol.

[0027] More preferably, the traditional Chinese medicine composition II comprises the following raw materials in parts by weight:

[0028] The extract consists of 70-90 parts by weight of Astragalus membranaceus extract, 20-30 parts by weight of total Panax notoginseng saponins, 30-50 parts by weight of leech extract, and 5-7 parts by weight of borneol.

[0029] As a preferred embodiment, the present invention provides a traditional Chinese medicine composition II for the recovery period of cerebral thrombosis, the raw materials being composed of the Astragalus membranaceus extract, the total saponins of Panax notoginseng, the leech extract, and borneol, the weight parts of each raw material being as defined above.

[0030] Another object of the present invention is to provide a medicine comprising the above-mentioned traditional Chinese medicine composition I or the above-mentioned traditional Chinese medicine composition II, and may or may not include pharmaceutically acceptable excipients.

[0031] The drug is any clinically acceptable formulation, preferably an oral formulation.

[0032] Preferably, the oral preparation is selected from one or more of decoctions, powders, capsules, tablets, honey pills, water-honey pills, water pills, concentrated pills, paste pills, wax pills, granules, oral liquids, and drop pills, more preferably granules, tablets, and / or capsules, and most preferably granules and / or capsules.

[0033] The present invention also provides a method for preparing the above-mentioned drug, comprising preparing each Chinese medicinal material or raw material according to the said weight parts, and preparing a clinically acceptable formulation by adding or not adding pharmaceutically acceptable excipients according to conventional methods in the art.

[0034] The pharmaceutically acceptable excipients described in this invention include, but are not limited to: (1) diluents, such as starch, powdered sugar, dextrin, lactose, pregelatinized starch, microcrystalline cellulose, inorganic calcium salts (such as calcium sulfate, calcium hydrogen phosphate, pharmaceutical calcium carbonate, etc.), mannitol, vegetable oil, polyethylene glycol, etc.; (2) binders, such as distilled water, ethanol, starch paste, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose and ethyl cellulose, hydroxypropyl methyl cellulose, etc.; (3) disintegrants, such as dry starch, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, croscarmellose, croscarmellose sodium, etc.; (4) lubricants, such as magnesium stearate, micronized silica gel, talc, hydrogenated vegetable oil, polyethylene glycol, magnesium lauryl sulfate, etc.

[0035] As a preferred embodiment, the present invention provides a method for preparing granules for the recovery period of cerebral thrombosis, comprising the following operations:

[0036] Prepare Astragalus membranaceus, Panax notoginseng, Hirudo medicinalis, and borneol according to the aforementioned Chinese herbal composition I; pulverize the borneol into a fine powder; decoct the remaining three herbs 1-3 times with water, adding 5-10 times the total weight of the herbs each time, and decoct for 1-2 hours each time; filter while hot and combine the filtrates; concentrate the filtrate to a relative density of 1.05-1.10 (60℃), add a portion of dextrin, mix well, spray dry, then add the remaining dextrin and borneol powder, mix well, and granulate by dry method to obtain the final product; wherein the total weight of dextrin is 50%-60% of the total weight of the herbs.

[0037] Preferably, the astragalus, notoginseng and leech are decocted twice with water. For the first decoction, 10 times the total weight of the herbs are added and the decoction is decocted for 1 hour. For the second decoction, 8 times the total weight of the herbs are added and the decoction is decocted for 1 hour.

[0038] As a preferred embodiment, the present invention provides a method for preparing a capsule for the recovery period of cerebral thrombosis, comprising the following steps:

[0039] Prepare the Astragalus extract, Panax notoginseng total saponins, leech extract and borneol according to the aforementioned Chinese medicine composition II; pulverize the borneol in the specified weight proportions into fine powder, pass it through an 80-mesh sieve, mix it evenly with the Astragalus extract, Panax notoginseng total saponins and leech extract, add pharmaceutically acceptable excipients, mix evenly, dry granulate, and encapsulate to obtain the final product.

[0040] Furthermore, another objective of this invention is to provide the application of the above-mentioned traditional Chinese medicine composition I, the above-mentioned traditional Chinese medicine composition II, the above-mentioned drug, the above-mentioned granules and the above-mentioned capsules in the preparation of a drug for treating the recovery period of cerebral thrombosis.

[0041] In this instruction manual, the "parts by weight" for each Chinese medicinal herb refers to the dosage ratio between the herbs, not an actual unit of mass. Depending on the actual situation, a unit of weight can be any mass, such as 1g, 500g, or 1kg, or even 15g, 30g, etc.

[0042] Unless otherwise specified, all concentrations of "ethanol" in this specification are volume percentage concentrations, and "ethanol" refers to ethanol with a volume percentage concentration of 95%–100%. For solutions other than ethanol, such as 40% sodium hydroxide solution and 10% hydrochloric acid solution, the concentrations are mass percentage concentrations.

[0043] In this specification, "purified water" refers to water that has undergone treatment such as distillation and deionization. Attached Figure Description

[0044] The present invention will be further described below with reference to the accompanying drawings.

[0045] Figure 1 The images shown are HE-stained micrographs of carotid artery sections from rats in the control group of Study 4, with image A on the left magnified 40 times and image B on the right magnified 200 times.

[0046] Figure 2 The images shown are HE-stained micrographs of the common carotid artery sections from the model control group rats in Study 4, with Image A on the left magnified 40 times and Image B on the right magnified 200 times.

[0047] Figure 3The images shown are HE-stained micrographs of carotid artery sections from rats in the positive control group of Study 4. Image A on the left is magnified 40 times, and image B on the right is magnified 200 times.

[0048] Figure 4 The images shown are HE-stained micrographs of carotid artery sections from rats in the high-dose group of Study 4. Image A on the left is magnified 40 times, and image B on the right is magnified 200 times.

[0049] Figure 5 The images shown are HE-stained micrographs of carotid artery sections from rats in the medium-dose group of Experiment 8 in Study 4. Image A on the left is magnified 40 times, and image B on the right is magnified 200 times.

[0050] Figure 6 The images shown are HE-stained micrographs of carotid artery sections from the low-dose group of rats in Study 4. Image A on the left is magnified 40 times, and image B on the right is magnified 200 times. Detailed Implementation

[0051] The present invention will be described below with reference to specific embodiments. Those skilled in the art will understand that these embodiments are for illustrative purposes only and do not limit the scope of the invention in any way.

[0052] Unless otherwise specified, the experimental methods used in the following examples are conventional methods. Unless otherwise specified, all medicinal materials and reagents used in the following examples are commercially available products.

[0053] The purchase details of some reagents and medicinal materials are as follows:

[0054] Astragalus: The dried root of *Astragalus membranaceus* (Fisch.) Bge. var. *mongholicus* (Bge.) Hsiao, a plant belonging to the Fabaceae family. Purchased from Bozhou Shennonggu Traditional Chinese Medicine Holding Co., Ltd.

[0055] Panax notoginseng: The dried root of Panax notoginseng (Burk.) FHChen, a plant of the Araliaceae family. Purchased from Bozhou Shennonggu Traditional Chinese Medicine Holding Co., Ltd.

[0056] Leech: The dried whole body of *Whitmania pigra* Whitman, a leech belonging to the family Hirudinidae. Purchased from Anhui Henian Tang Chinese Herbal Medicine Co., Ltd.

[0057] Borneol: Purchased from Tongling Borneol Factory in Anhui Province.

[0058] Example 1 A traditional Chinese medicine composition for the recovery period of cerebral thrombosis I

[0059] The composition of the traditional Chinese medicine composition I described in this embodiment is (1 part by weight = 1g):

[0060] Astragalus membranaceus 650 parts by weight, Panax notoginseng 400 parts by weight, leech 100 parts by weight, borneol 10 parts by weight.

[0061] Example 2 A traditional Chinese medicine composition for the recovery period of cerebral thrombosis I

[0062] The composition of the traditional Chinese medicine composition I described in this embodiment is (1 part by weight = 1g):

[0063] Astragalus membranaceus 450 parts by weight, Panax notoginseng 350 parts by weight, leech 200 parts by weight, borneol 3 parts by weight.

[0064] Example 3 A traditional Chinese medicine composition for the recovery period of cerebral thrombosis I

[0065] The composition of the traditional Chinese medicine composition I described in this embodiment is (1 part by weight = 1g):

[0066] Astragalus membranaceus 600 parts by weight, Panax notoginseng 200 parts by weight, leech 350 parts by weight, borneol 7 parts by weight.

[0067] Example 4 A traditional Chinese medicine composition for the recovery period of cerebral thrombosis I

[0068] The composition of the traditional Chinese medicine composition I described in this embodiment is (1 part by weight = 1g):

[0069] Astragalus membranaceus 500 parts by weight, Panax notoginseng 300 parts by weight, Hirudo medicinalis 300 parts by weight, Borneol 5 parts by weight.

[0070] Example 5. A traditional Chinese medicine composition for the recovery period of cerebral thrombosis I

[0071] The composition of the traditional Chinese medicine composition I described in this embodiment is (1 part by weight = 1g):

[0072] Astragalus membranaceus 550 parts by weight, Panax notoginseng 250 parts by weight, Hirudo medicinalis 330 parts by weight, Borneol 6 parts by weight.

[0073] Example 6 A granule for the recovery period of cerebral thrombosis

[0074] Take the traditional Chinese medicine composition I described in Example 5; pulverize borneol into a fine powder; decoct the remaining three ingredients twice with water. For the first decoction, add 10 times the total weight of the medicinal materials and decoct for 1 hour, then filter. For the second decoction, add 8 times the total weight of the medicinal materials and decoct for 1 hour, then filter. Combine the filtrates and concentrate them to a relative density of 1.05–1.10 (60°C). Add 5% dextrin by weight, mix well, and spray dry to obtain spray-dried powder. Add dextrin and the above-mentioned borneol fine powder, mix well, and dry granulate to produce 1000g of product, which is then packaged into 2g bags.

[0075] Example 7 Preparation of extracts

[0076] 1. Preparation of Astragalus Extract

[0077] Take Astragalus membranaceus, add water and decoct three times. For the first decoction, add 8 times the weight of Astragalus membranaceus water, soak for 30 minutes, and decoct for 1.5 hours. For the second decoction, add 6 times the weight of Astragalus membranaceus water and decoct for 1.5 hours. For the third decoction, add 5 times the total weight of Astragalus membranaceus water and decoct for 1.5 hours. Filter while hot and combine the filtrates. Concentrate the filtrate to 1-2g of Astragalus membranaceus per ml (relative density: 1.14-1.23 (40℃)). Add ethanol to make the alcohol content 75%. Refrigerate for 12 hours, take the supernatant and filter. Recover the ethanol from the filtrate and concentrate until there is no alcohol odor. Add about 10% of the total weight of Astragalus membranaceus dextrin to make the relative density of the extract 1.03-1.05 (40℃). Spray dry to obtain Astragalus membranaceus extract.

[0078] 2. Preparation of total saponins from Panax notoginseng

[0079] Take Panax notoginseng, grind it appropriately, and extract it twice with 90% ethanol. For the first extraction, add 2.5 times the weight of Panax notoginseng in 90% ethanol and reflux for 10 hours. For the second extraction, add twice the amount of 90% ethanol and extract for 5 hours. Filter while hot, combine the filtrates, recover the ethanol until there is no ethanol odor, add an appropriate amount of water to dilute the solution to 0.25g (crude drug) / ml, stir well, let stand, and filter. Pass the filtrate through a D101 macroporous adsorption resin column, rinse the macroporous resin column with water at a ratio of 3ml water per 1g macroporous resin, and then elute with 80% ethanol (1ml 80% ethanol per 1g macroporous resin). Collect the eluent, recover the ethanol under reduced pressure, concentrate to a thick paste, dry, and grind to obtain total saponins of Panax notoginseng.

[0080] 3. Preparation of leech extract

[0081] Take leeches and decoct them twice with water. For the first decoction, add 10 times the weight of water as the leeches, soak for 30 minutes, decoct for 2 hours, and filter. For the second decoction, add 8 times the weight of water as the leeches, soak for 1 hour, filter, and combine the filtrates. Concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (35-40℃), and continue to dry under vacuum at 70℃. When the extract becomes viscous, add about 20% of the weight of corn starch as the leeches, mix, dry, pulverize, and pass through an 80-mesh sieve to obtain the leech extract.

[0082] Example 8 A traditional Chinese medicine composition II for the recovery period of cerebral thrombosis

[0083] The composition of the traditional Chinese medicine composition II described in this embodiment is (1 part by weight = 1g):

[0084] Astragalus extract 80 parts by weight, total saponins of Panax notoginseng 25 parts by weight, leech extract 40 parts by weight, borneol 6 parts by weight;

[0085] Each extract was prepared according to the method described in Example 7.

[0086] Example 9 A traditional Chinese medicine composition II for the recovery period of cerebral thrombosis

[0087] The composition of the traditional Chinese medicine composition II described in this embodiment is (1 part by weight = 1g):

[0088] Astragalus extract 90 parts by weight, total saponins of Panax notoginseng 20 parts by weight, leech extract 50 parts by weight, borneol 5 parts by weight;

[0089] Each extract was prepared according to the method described in Example 7.

[0090] Example 10 A traditional Chinese medicine composition II for the recovery period of cerebral thrombosis

[0091] The composition of the traditional Chinese medicine composition II described in this embodiment is (1 part by weight = 1g).

[0092] Astragalus extract 70 parts by weight, total saponins of Panax notoginseng 30 parts by weight, leech extract 30 parts by weight, borneol 7 parts by weight

[0093] Each extract was prepared according to the method described in Example 7.

[0094] Example 11 A traditional Chinese medicine composition II for the recovery period of cerebral thrombosis

[0095] The composition of the traditional Chinese medicine composition II described in this embodiment is (1 part by weight = 1g):

[0096] Astragalus extract 120 parts by weight, total saponins of Panax notoginseng 35 parts by weight, leech extract 25 parts by weight, borneol 3 parts by weight;

[0097] Each extract was prepared according to the method described in Example 7.

[0098] Example 12 A traditional Chinese medicine composition II for the recovery period of cerebral thrombosis

[0099] The composition of the traditional Chinese medicine composition II described in this embodiment is (1 part by weight = 1g):

[0100] Astragalus extract 50 parts by weight, total saponins of Panax notoginseng 40 parts by weight, leech extract 20 parts by weight, borneol 10 parts by weight;

[0101] Each extract was prepared according to the method described in Example 7.

[0102] Example 13 A capsule for use in the recovery period of cerebral thrombosis

[0103] Take the traditional Chinese medicine composition II described in Example 8; pulverize borneol into a fine powder and pass it through an 80-mesh sieve; mix it evenly with approximately 149g of the Astragalus extract, the total saponins of Panax notoginseng, the leech extract and microcrystalline cellulose, dry granulate to obtain 300g of granules, encapsulate them to make 1000 capsules, 0.3g / capsule, aluminum-plastic packaging, and an outer composite film bag.

[0104] Comparative Example 1 A traditional Chinese medicine composition A

[0105] The composition of the traditional Chinese medicine composition described in this comparative example is (1 part by weight = 1g):

[0106] Astragalus membranaceus 800 parts by weight, Panax notoginseng 150 parts by weight, Hirudo medicinalis 350 parts by weight, Borneol 5 parts by weight.

[0107] Comparative Example 2 A traditional Chinese medicine composition B

[0108] The composition of the traditional Chinese medicine composition described in this comparative example is (1 part by weight = 1g):

[0109] Astragalus extract 40 parts by weight, total saponins of Panax notoginseng 50 parts by weight, leech extract 50 parts by weight, borneol 8 parts by weight;

[0110] Each extract was prepared according to the method described in Example 7.

[0111] Comparative Example 3 A traditional Chinese medicine composition C

[0112] The composition of the traditional Chinese medicine composition described in this comparative example is as follows:

[0113] Leech extract 20g, Panax notoginseng extract 20g.

[0114] The traditional Chinese medicine composition C in this comparative example was prepared according to the following method:

[0115] 1) Take the whole leech and prepare leech extract according to the method described in Example 1 of Chinese Patent Application No. 200510088789.1;

[0116] 2) Take Panax notoginseng and prepare Panax notoginseng extract according to the method described in Example 1 of Chinese Patent Application No. 200510088789.1;

[0117] 3) Take the leech extract and Panax notoginseng extract prepared above, mix them evenly, and you will get the product.

[0118] Comparative Example 4 A traditional Chinese medicine composition D

[0119] The composition of the traditional Chinese medicine composition D described in this comparative example is as follows:

[0120] Leech 20g, Astragalus 60g, Panax notoginseng 60g.

[0121] The traditional Chinese medicine composition D in this comparative example was prepared according to the following method:

[0122] 1) Take leeches and prepare the active ingredients of leeches according to the description of Example 1 in Chinese Invention Patent Application No. 200910136744.5;

[0123] 2) Take Astragalus membranaceus and prepare the active ingredients of Astragalus membranaceus according to the description of Example 1 in Chinese Invention Patent Application No. 200910136744.5;

[0124] 3) Take Panax notoginseng and prepare Panax notoginseng saponins according to the description in Example 6 of Chinese Invention Patent Application No. 200910136744.5;

[0125] 4) Take the prepared leech active ingredients, astragalus active ingredients and notoginseng saponins, pulverize them separately, mix them evenly, and you will get the product.

[0126] Study Example 1 The effect of the traditional Chinese medicine composition of the present invention on the coagulation time of rats (capillary glass tube method)

[0127] Sixty SPF-grade SD rats, half male and half female, weighing 230g-250g, were purchased from Liaoning Changsheng Biotechnology Co., Ltd., Animal Use License No.: SYXK(Heilongjiang) 2018-007, Animal Production License No.: SCXK(Liaoning) 2020-0001. They were randomly divided into 16 groups, with 10 rats in each group (half male and half female). These groups were designated as a blank control group, a positive drug group, experimental groups 1-10, and control groups 1-4. Each group was administered the following drugs by gavage:

[0128] Blank control group: distilled water, 10 ml / kg body weight;

[0129] Positive drug group: Naoan capsules (product batch number 221002, Anhui Lei Yunshang Pharmaceutical Co., Ltd.), 0.170g / kg body weight per dose, with a dosing volume of 10ml / kg body weight;

[0130] Experimental Groups 1-5: The traditional Chinese medicine compositions of Examples 1-5 were prepared as spray-dried powders according to the method of Example 6, and then each was mixed with an appropriate amount of borneol powder; each time, 1.262g of raw drug / kg body weight was administered, and the volume was 10ml / kg body weight.

[0131] Experimental groups 6-10: The traditional Chinese medicine composition of Examples 8-12, 0.162g / kg body weight per dose, with a dosage volume of 10ml / kg;

[0132] Comparative Group 1: The spray-dried powder of the traditional Chinese medicine composition of Comparative Example 1 was prepared according to the method of Example 6, and then an appropriate amount of borneol powder was added and mixed evenly; each time, 1.262g of raw drug / kg body weight was administered, and the volume of administration was 10ml / kg body weight.

[0133] Comparison Groups 2-4: The traditional Chinese medicine composition prepared in Comparative Examples 2-4 was administered at a dose of 0.162 g / kg body weight per dose, with a dosage volume of 10 ml / kg body weight.

[0134] Each group was given the medication once a day for 10 consecutive days.

[0135] One hour after the last administration, blood was collected from the orbital cavity of rats. The capillary tube (produced by West China Medical University Instrument Factory) was broken every 15 seconds until blood streaks appeared. The time from when the capillary tube was filled with blood to when blood streaks appeared was recorded as the clotting time.

[0136] Statistical analysis was performed using IBM SPSS 26.0 software. All data are expressed as mean ± standard deviation (±s). One-way ANOVA was used to compare multiple groups that conformed to a normal distribution and had homogeneous variances. A p-value < 0.05 was considered statistically significant.

[0137] The results are shown in Table 1.

[0138] Table 1. Effects of the herbal composition of the present invention on coagulation time in rats.

[0139]

[0140]

[0141] Note: Compared with the blank control group, * P < 0.05 **P < 0.01; compared with experimental group 6, # P < 0.05.

[0142] The data in Table 1 show that the various traditional Chinese medicine compositions of the present invention can significantly prolong the coagulation time of rats (P<0.01), and their effects are stronger than those of the control group and the positive control group, with significant differences (P<0.05).

[0143] Study Example 2 Effects of the traditional Chinese medicine composition of the present invention on thrombosis in rats

[0144] Seventy SPF-grade SD rats, half male and half female, weighing 230g-250g, were purchased from Liaoning Changsheng Biotechnology Co., Ltd., Animal Use License No.: SYXK(Heilongjiang) 2018-007, Animal Production License No.: SCXK(Liaoning) 2020-0001. They were randomly divided into 7 groups, with 10 rats in each group (half male and half female). These groups were designated as a blank control group, positive control group, experimental group, and control groups 1-4. Each group was administered the following drugs by gavage:

[0145] Blank control group: distilled water, 10 ml / kg body weight;

[0146] Positive control group: Nao'an capsules (product batch number 221002, Anhui Lei Yunshang Pharmaceutical Co., Ltd.), 0.170g / kg body weight per dose, with a dosing volume of 10ml / kg body weight;

[0147] Experimental group: The traditional Chinese medicine composition of Example 8 was administered at a dose of 0.162 g / kg body weight per dose, with a dosage volume of 10 ml / kg body weight.

[0148] Comparative Group 1: The spray-dried powder of the traditional Chinese medicine composition of Comparative Example 1 was prepared according to the method of Example 6, and then an appropriate amount of borneol powder was added and mixed evenly; each time, 1.262g of raw drug / kg body weight was administered, and the volume was 10ml / kg body weight.

[0149] Comparison Groups 2-4: The traditional Chinese medicine composition prepared in Comparative Examples 2-4 was administered at a dose of 0.162 g / kg body weight per dose, with a dosage volume of 10 ml / kg body weight.

[0150] Each group was given the medication once a day for 10 consecutive days.

[0151] One hour after the last administration, anesthesia was administered via intraperitoneal injection of chloral hydrate (batch number: 20201215, Tianjin Damao Chemical Reagent Factory). The right common carotid artery and left external jugular vein were separated. A 6 cm long No. 4 surgical suture was inserted into the middle of a three-segment polyethylene tube, and the tube lumen was filled with heparin (batch number: FS208A, Sanofi Pharmaceuticals) and normal saline solution (12.5 U / ml). After one end of the tube was inserted into the left external jugular vein, the other end was inserted into the right common carotid artery. The arterial clamp was released, and blood flowed from the right common carotid artery through the polyethylene tube back to the left external jugular vein. After 20 minutes of blood flow, the flow was interrupted, and the suture was quickly removed and weighed. The wet weight of the thrombus was the total weight minus the weight of the suture. The inhibition rate was calculated using the following formula:

[0152] Inhibition rate = (Thrombus weight in blank control group - Thrombus weight in treatment group) / Thrombus weight in blank control group × 100%.

[0153] Statistical analysis was performed using IBM SPSS 26.0 software. All data are expressed as mean ± standard deviation (±s). One-way ANOVA was used to compare multiple groups that conformed to a normal distribution and had homogeneous variances. A p-value < 0.05 was considered statistically significant.

[0154] The results are shown in Table 2.

[0155] Table 2. Effects of the traditional Chinese medicine composition of the present invention on thrombosis in rats.

[0156] Group Animal number Dosage (g / kg) Blood clot weight Thrombosis inhibition rate (%) Blank control group 10 - 52.32±3.60 - Positive control group 10 0.170 <![CDATA[37.35±5.04 ## ]]> 28.6 experimental group 10 0.162 <![CDATA[45.60±9.36 # ]]> 12.8 Comparison Group 1 10 1.262 49.30±4.28 5.8 Comparison of 2 groups 10 0.162 49.11±6.24 6.1 Comparison of 3 groups 10 0.162 49.75±7.56 4.9 Comparison of 4 groups 10 0.162 49.68±8.32 5.0

[0157] Note: Compared with the blank control group ## P < 0.01 # P < 0.05.

[0158] Table 2 shows that, compared with the blank control group, the thrombus weight in the positive control group and the experimental group was significantly reduced (P<0.01, P<0.05). The thrombus weight in the control group showed a decreasing trend, but the difference was not significant. This indicates that the traditional Chinese medicine composition of Example 8 of the present invention can inhibit thrombus formation and has a stronger effect than the control groups.

[0159] Study Example 3 The effect of the composition of the present invention on a blood stasis model (anticoagulant effect)

[0160] Eighty SPF-grade SD rats, half male and half female, weighing 230g-250g, were purchased from Liaoning Changsheng Biotechnology Co., Ltd., Animal Use License No.: SYXK(Heilongjiang) 2018-007, Animal Production License No.: SCXK(Liaoning) 2020-0001. They were randomly divided into 8 groups, with 10 rats in each group (half male and half female). These groups were designated as a blank control group, model control group, positive control group, experimental group, and control groups 1-4. Each group was administered the following drugs by gavage:

[0161] Blank control group and model control group: distilled water, 10 ml / kg body weight;

[0162] Positive control group: Nao'an capsules (product batch number 221002, Anhui Lei Yunshang Pharmaceutical Co., Ltd.), 0.170g / kg body weight per dose, with a dosing volume of 10ml / kg body weight;

[0163] Experimental group: The traditional Chinese medicine composition of Example 8 was administered at a dose of 0.162 g / kg body weight per dose, with a dosage volume of 10 ml / kg body weight.

[0164] Comparative Group 1: The spray-dried powder prepared according to Example 6 of the traditional Chinese medicine composition of Comparative Example 1 was then mixed with an appropriate amount of borneol powder and mixed evenly; each time, 1.262g of raw drug / kg body weight was administered, and the volume was 10ml / kg body weight.

[0165] Comparison Groups 2-4: The traditional Chinese medicine composition prepared in Comparative Examples 2-4 was administered at a dose of 0.162 g / kg body weight per dose, with a dosage volume of 10 ml / kg body weight.

[0166] Model preparation: Except for the blank control group, the rats in the other groups were continuously bathed in ice water for 14 days, 10 minutes each time. On the 15th day, the blank control group was injected with physiological saline, while the other 7 groups of rats were injected subcutaneously with adrenaline hydrochloride injection (62302142, Suicheng Pharmaceutical Co., Ltd.) (0.8 ml / kg). 2 hours after the injection, the rats (except for the blank control group) were bathed in ice water for another 10 minutes. 2 hours after the end of the ice water bath, the same dose of adrenaline hydrochloride was injected again.

[0167] During the modeling process, each group was given medication by gavage once a day for 15 consecutive days.

[0168] After the last administration, rats were anesthetized by intraperitoneal injection of 0.3 ml / 100 g body weight of 10% chloral hydrate solution. Blood was collected from the abdominal aorta using a heparin sodium blood collection tube (product batch number: 20210420, Shandong Chengwu County Medical Products Factory) and a blood collection needle. Blood rheological parameters were directly measured within 4 hours after abdominal aortic blood collection using an LB-2A fully automated hemorheology analyzer (Tianjin Tangyu Medical Instrument Technology Development Co., Ltd.).

[0169] Statistical analysis was performed using IBM SPSS 26.0 software. All data are expressed as mean ± standard deviation (±s). One-way ANOVA was used to compare multiple groups that conformed to a normal distribution and had homogeneous variances. A p-value < 0.05 was considered statistically significant.

[0170] The results are shown in Table 3.

[0171] Table 3. Effects of the herbal composition of the present invention on whole blood viscosity and reduced whole blood viscosity in rats.

[0172]

[0173] Note: Compared with the blank control group ### P < 0.001; compared with the model group, ** P < 0.01 * P < 0.05.

[0174] Table 3 shows that the whole blood viscosity and reduced whole blood viscosity of the model control group rats were significantly higher than those of the blank control group (P<0.001), indicating successful model establishment. The whole blood viscosity and reduced whole blood viscosity of the experimental group rats were significantly lower than those of the model control group (P<0.01, P<0.05), suggesting that the traditional Chinese medicine composition of this invention has a significant anticoagulant effect, which is stronger than that of the control groups.

[0175] Study Example 4 Therapeutic effect of the composition of the present invention on rats with carotid atherosclerosis

[0176] Sixty SPF-grade SD rats, half male and half female, weighing 230g-250g, were purchased from Liaoning Changsheng Biotechnology Co., Ltd., Animal Use License No.: SYXK(Heilongjiang) 2018-007, Animal Production License No.: SCXK(Liaoning) 2020-0001. They were randomly divided into 6 groups of 10 rats each, half male and half female: blank control group, model control group, positive control group, high-dose experimental group, medium-dose experimental group, and low-dose experimental group.

[0177] Animal model preparation: A carotid atherosclerosis model was established by combining a high-fat diet with vitamin D3 injection and carotid artery clamping. Each group of rats received an intraperitoneal injection of vitamin D3 (batch number: 20230401, Harbin Daowai District Hongda Animal Pharmaceutical Factory) at 300,000 IU / kg, once daily for 3 days. After the injections, the rats were fed a high-fat diet (3% cholesterol, 0.5% sodium cholate, 5% egg yolk powder, 15% lard, 5% white sugar, 0.2% propylthiouracil, 71.3% basal diet) for 12 weeks. Vitamin D3 was injected at 100,000 IU / kg at 1, 3, and 5 weeks after the start of feeding. After 4 weeks of high-fat diet feeding, carotid artery clamping was performed on rats in all groups except the blank control group. Carotid artery clamping: Experimental animals were fasted for 12 hours before surgery, but water was allowed. They were anesthetized with an intraperitoneal injection of 0.3 ml / 100 g chloral hydrate, and their fur and skin were removed (lower midline of the neck). They were then fixed supine on the operating table. The skin of the rat's neck was disinfected, and an incision of approximately 5.0 cm was made along the midline of the neck. The left common frontal artery was dissected 3.0 cm downwards at the level of the thyroid cartilage. One side of the common carotid artery was clamped using a self-made vascular clamp for a clamp length of 1.5 cm, a clamping strength of one lock, and a clamping time of 20 minutes. The skin was then sutured. The blank control group received no treatment.

[0178] Simultaneously with membrane formation, each treatment group was administered the corresponding drug via gavage. The high, medium, and low dose groups were administered the traditional Chinese medicine composition of Example 8 via gavage at doses of 0.648 g / kg body weight, 0.324 g / kg body weight, and 0.162 g / kg body weight, respectively. The positive control group was administered the contents of Nao'an capsules at a dose of 0.170 g / kg body weight via gavage. The administration volume was 10 ml / kg body weight for all groups. The blank control group and the model control group were given the same volume of distilled water. Administration was once daily for 12 consecutive weeks.

[0179] After the last administration, rats were anesthetized by intraperitoneal injection of 0.3 ml / 100 g body weight of 10% chloral hydrate solution. (1) Blood was collected from the abdominal aorta using disposable vacuum blood collection tubes (product batch number: 21097004, Hebei Xinle Medical Instrument Technology Co., Ltd.) and blood collection needles. After blood collection, the rats were centrifuged at low temperature for 10 min at about 4000×g. The supernatant was carefully aspirated with a pipette and dispensed into 2 ml centrifuge tubes and stored at -80℃ for later use. The lipid metabolism of rats was detected using a Chemray 240 fully automated biochemical analyzer (Shenzhen Leidu Life Science Co., Ltd.). (2) The common carotid artery was quickly separated. A 1 cm long common carotid artery was taken, rinsed with physiological saline, and fixed in 10% neutral formalin fixative (batch number: 20220805, Beijing Yili Fine Chemicals Co., Ltd.). After HE staining, the pathological changes of the carotid intima were observed using an Eclipse Ci-L upright white light microscope (Nikon (Japan)).

[0180] Statistical analysis was performed using IBM SPSS 26.0 software. All data are expressed as mean ± standard deviation (±s). One-way ANOVA was used to compare multiple groups that conformed to a normal distribution and had homogeneous variances. A p-value < 0.05 was considered statistically significant.

[0181] (1) The results of lipid metabolism test are shown in Table 4.

[0182] Table 4 shows that, compared with the blank control group, the serum TC, TG, LDL, and HDL levels of rats in the model control group were significantly higher than those in the blank control group, indicating successful model establishment. Although the serum lipid levels of rats in the positive control group and each experimental group showed a decreasing trend compared with the model control group, the differences were not significant.

[0183] Table 4. Effects of the composition of the present invention on serum lipid levels in rats

[0184]

[0185] Note: Compared with the blank control group ### P < 0.001 ## P < 0.05.

[0186] (2) Effects on pathological changes in the carotid intima

[0187] Micrographs of carotid artery sections from each group of rats after HE staining are shown below. Figures 1-6 .

[0188] Figure 1 As shown, the common carotid artery tissue of the blank group rats showed a small number of missing intima endothelial cells (indicated by the arrow in the figure), the internal elastic lamina was intact, continuous, and regularly arranged without obvious breakage, the media was composed of multiple layers of circularly arranged smooth muscle, the adventitia was thinner, and no obvious inflammatory cell infiltration was observed.

[0189] Figure 2 As shown, in the model control group rats, the common carotid artery vascular tissue showed extensive fibrous plaque formation, protruding into the lumen, with a large number of tightly packed collagen fibers leading to complete luminal obstruction (indicated by arrow 1 in the figure), accompanied by a large amount of lymphocyte infiltration (indicated by arrow 2 in the figure), many foam cells (indicated by arrow 3 in the figure), and occasional elastic lamina rupture (indicated by arrow 4 in the figure). The media showed edema of smooth muscle cells, loose elastic lamina, and irregular arrangement (indicated by arrow 5 in the figure). The adventitia was thin and showed no obvious abnormalities.

[0190] Figure 3As shown, in the positive control group rats, the common carotid artery tissue showed a small number of missing intima endothelial cells (indicated by arrow 1 in the figure), extensive mild proliferation of collagen fibers protruding into the lumen (indicated by arrow 2 in the figure), the internal elastic lamina was intact and continuous, irregularly arranged, without obvious breakage, occasional edema of the smooth muscle in the media was observed, the elastic lamina was loose and irregularly arranged (indicated by arrow 3 in the figure), the adventitia was thin, and no obvious inflammatory cell infiltration was observed.

[0191] Figure 4 As shown, in the high-dose group of rats in Example 8, a small number of intimal endothelial cells were missing (indicated by arrow 1 in the figure), moderate collagen fiber hyperplasia protruded into the lumen to form fibrous plaques (indicated by arrow 2 in the figure), a very small number of lymphocytes were visible below the fibrous cap (indicated by arrow 3 in the figure), the subendothelial layer was loose, the internal elastic lamina was intact and continuous, irregularly arranged, without obvious breakage, occasional edema of the smooth muscle in the media was observed, the elastic lamina was loose and irregularly arranged (indicated by arrow 4 in the figure), the adventitia was thin, and no obvious inflammatory cell infiltration was observed.

[0192] Figure 5 As shown, in Example 8, the carotid artery tissue of rats in the medium dose group showed a large number of missing intima endothelial cells (indicated by arrow 1 in the figure), mild intimal hyperplasia, increased cell number, and protrusion into the lumen (indicated by arrow 2 in the figure). The internal elastic lamina was intact and continuous, irregularly arranged, and without obvious breakage. Edema of the smooth muscle in the media was common, and the elastic lamina was loose and irregularly arranged (indicated by arrow 3 in the figure). The adventitia was thin, and a small number of lymphocytes were infiltrated around it (indicated by arrow 4 in the figure).

[0193] Figure 6 As shown, in the low-dose group of rats in Example 8, a large amount of collagen fiber proliferation was observed in the common carotid artery tissue, which protruded into the lumen to form fibrous plaques. The collagen fibers were tightly arranged and covered the intima, resulting in moderate stenosis of the lumen (indicated by arrow 1 in the figure), accompanied by a very small amount of lymphocyte infiltration (indicated by arrow 2 in the figure). Intima endothelial cells were mostly absent (indicated by arrow 3 in the figure). The internal elastic lamina was intact, continuous, irregularly arranged, and without obvious breakage. Occasionally, edema of the smooth muscle in the media was observed, and the elastic lamina was loose and irregularly arranged (indicated by arrow 4 in the figure). The adventitia was thin and no obvious abnormalities were observed.

[0194] The above experimental results prove that the experimental model is successful; compared with the model control group, the positive drug group and the high, medium and low dose drug groups all have an effect on improving the intimal damaged cells, and the number of lymphocytes is relatively reduced.

[0195] Study Example 5 Security research

[0196] Acute toxicity test: Using the maximum dose method, rats were administered 1.245 g / ml of the contents of the capsules from Example 13 via gavage. The maximum gavage volume for rats was 20 ml / kg body weight. Rats were administered the drug once daily, and toxic reactions and mortality were observed for 14 consecutive days. The results showed that the maximum dose of the capsules from Example 13 was 24.9 g / kg body weight, equivalent to 153.8 times the clinically intended dose. From the day of administration to the end of the observation period, all rats were in good general condition, with smooth and shiny fur, normal activity and diet, and formed feces. No animals died. Although there were occasional abnormalities in body weight, the overall weight showed an increasing trend, indicating that gavage administration of the capsules from Example 13 did not affect the growth of the test animals. The day after the experiment, no changes in the volume, color, or texture of animal organs were observed by visual inspection. No hemorrhage, congestion, exudation, ulceration, perforation, or inflammation was observed in important organs such as the brain, heart, liver, spleen, lungs, and kidneys. There was no effusion in the pleural cavity, abdominal cavity, or pericardial cavity.

[0197] Three-month toxicity study: Following the "Technical Guidelines for Repeated-Dose Toxicity Testing of Drugs" issued by the State Food and Drug Administration in May 2014, rats were administered three doses (10, 30, and 60 times the clinical dose in Example 13) and distilled water via gavage for three consecutive months. Results: Rats in all treatment groups exhibited normal activity, lively behavior, and glossy fur, with no significant differences or abnormal changes. During the treatment and recovery periods, the average food intake and average body weight of rats in each dose group differed from the control group, but these differences were only observed at individual time points, lacking regularity or trend, and indicating no dose-response relationship. Preliminary assessment suggests these differences are not toxicologically significant. Compared with the control group, some hematological and blood biochemical indicators in each group showed abnormal changes, but no dose-response correlation was observed, suggesting these may be transient reactions. Urine routine indicators showed no dose-response correlation abnormalities compared to the control group. At the end of the treatment and recovery periods, all organ coefficients showed no toxicologically significant abnormalities, and no microscopic examination of any tissues or organs revealed dose-toxicity relationships or delayed toxic reactions. Under the experimental conditions, rats were repeatedly administered the capsules of Example 13 by gavage for three months at a dose of 9.714 g / kg / day (approximately 60 times the clinical dose), and no definite target organs or toxic reactions were found.

Claims

1. A traditional Chinese medicine composition I for the recovery period of cerebral thrombosis, comprising the following raw materials in parts by weight: Astragalus membranaceus 450-650 parts by weight, Panax notoginseng 200-350 parts by weight, Hirudo medicinalis 200-350 parts by weight, Borneol 3-8 parts by weight.

2. The traditional Chinese medicine composition I according to claim 1, characterized in that, The raw materials of the traditional Chinese medicine composition I are composed of the following traditional Chinese medicinal materials in parts by weight: Astragalus membranaceus 500-600 parts by weight, Panax notoginseng 200-300 parts by weight, Hirudo medicinalis 300-350 parts by weight, Borneol 5-7 parts by weight.

3. A traditional Chinese medicine composition II for the recovery period of cerebral thrombosis, comprising the following raw materials in parts by weight: Astragalus extract 50-120 parts by weight, total saponins of Panax notoginseng 20-40 parts by weight, leech extract 20-50 parts by weight, borneol 1-10 parts by weight; The Astragalus extract is prepared by the following method: Take Astragalus membranaceus, add water and decoct three times, adding 5-10 times the weight of Astragalus membranaceus each time, and decoct for 1-2 hours each time; filter while hot, combine the filtrates, and concentrate the filtrate to 1-2g of Astragalus membranaceus per ml; add ethanol to make the alcohol content 75%, refrigerate for 12 hours, take the supernatant, filter, recover the ethanol from the filtrate and concentrate until there is no alcohol taste, add dextrin to make the relative density of the extract 1.03-1.05 at 40℃, spray dry to obtain Astragalus membranaceus extract; The total saponins of Panax notoginseng were prepared by the following method: Take Panax notoginseng, grind it appropriately, and extract it twice with 90% ethanol. For the first extraction, add 2.5 times the weight of Panax notoginseng in 90% ethanol and reflux for 10 hours. For the second extraction, add twice the amount of 90% ethanol and extract for 5 hours. Filter while hot, combine the filtrates, recover the ethanol until there is no ethanol odor, add an appropriate amount of water to dilute the solution to 0.25g crude drug / ml, stir well, let stand, and filter. Pass the filtrate through a macroporous adsorption resin column, wash with water, and then elute with 80% ethanol. Collect the eluent, recover the ethanol under reduced pressure, concentrate to a thick paste, dry, and grind to obtain total saponins of Panax notoginseng. The leech extract was prepared by the following method: Take leeches, add water and decoct twice, adding 5-10 times the weight of water of the leeches each time, for 1-2 hours each time, filter while hot, and combine the filtrates; concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 at 35-40℃, vacuum dry, and when the extract becomes viscous, add 20% of the weight of corn starch of the leeches, mix, dry, pulverize, and pass through an 80-mesh sieve to obtain the leech extract.

4. The traditional Chinese medicine composition II according to claim 3, characterized in that, In the preparation of the total saponins of Panax notoginseng, the macroporous resin is D101 macroporous resin, and the amount of resin used is 4 / 3 times the weight of Panax notoginseng.

5. The traditional Chinese medicine composition II according to claim 3 or 4, characterized in that, In the preparation of the total saponins of Panax notoginseng, the volume ratio of rinsing water to macroporous resin is 2-4 ml: 1 g.

6. The traditional Chinese medicine composition II according to claim 5, characterized in that, In the preparation of the total saponins of Panax notoginseng, the volume ratio of rinsing water to macroporous resin is 3 ml: 1 g.

7. The traditional Chinese medicine composition II according to claim 3 or 4, characterized in that, In the preparation of the total saponins of Panax notoginseng, the volume ratio of 80% ethanol to macroporous resin is 1-2 ml: 1 g.

8. The traditional Chinese medicine composition II according to claim 7, characterized in that, In the preparation of the total saponins of Panax notoginseng, the volume ratio of 80% ethanol to macroporous resin is 1 ml: 1 g.

9. The traditional Chinese medicine composition II according to claim 3, characterized in that, The traditional Chinese medicine composition II is composed of the following raw materials in parts by weight: The extract consists of 60-100 parts by weight of Astragalus membranaceus extract, 20-35 parts by weight of total Panax notoginseng saponins, 25-50 parts by weight of Hirudo medicinalis extract, and 3-8 parts by weight of borneol.

10. The traditional Chinese medicine composition II according to claim 9, characterized in that, The traditional Chinese medicine composition II is composed of the following raw materials in parts by weight: The extract consists of 70-90 parts by weight of Astragalus membranaceus extract, 20-30 parts by weight of total Panax notoginseng saponins, 30-50 parts by weight of leech extract, and 5-7 parts by weight of borneol.

11. A medicament for the recovery period of cerebral thrombosis, comprising the traditional Chinese medicine composition I as described in claim 1 or 2 or the traditional Chinese medicine composition II as described in any one of claims 3 to 10, and pharmaceutically acceptable excipients.

12. The medicament according to claim 11, characterized in that, The drug is any clinically acceptable formulation.

13. The medicament according to claim 12, characterized in that, The drug is an oral preparation.

14. The medicament according to claim 13, characterized in that, The oral preparation is selected from one or more of the following: decoction, powder, capsule, tablet, honey pill, water-honey pill, water pill, concentrated pill, paste pill, wax pill, granule, oral liquid, and drop pill.

15. The medicament according to claim 14, characterized in that, The oral preparation is in the form of granules, tablets, or capsules.

16. The medicament according to claim 15, characterized in that, The oral preparation is in the form of granules or capsules.

17. A method for preparing a drug according to any one of claims 11 to 16, comprising preparing each Chinese medicinal material or raw material according to the said weight parts, adding pharmaceutically acceptable excipients according to conventional methods in the art, and preparing a clinically acceptable formulation.

18. A method for preparing granules for the recovery period of cerebral thrombosis, comprising the following steps: According to the traditional Chinese medicine composition I described in claim 1 or 2, prepare Astragalus membranaceus, Panax notoginseng, Hirudo medicinalis, and borneol; pulverize borneol into a fine powder; decoct the remaining three ingredients with water 1-3 times, adding 5-10 times the total weight of the medicinal materials each time, and decoct for 1-2 hours each time; filter while hot and combine the filtrates; concentrate the filtrate to a relative density of 1.05-1.10 at 60℃, add a portion of dextrin, mix well, spray dry, then add the remaining dextrin and borneol powder, mix well, and granulate by dry method to obtain the final product; wherein the total weight of dextrin is 50%-60% of the total weight of the medicinal materials.

19. The preparation method according to claim 18, characterized in that, Add water to Astragalus membranaceus, Panax notoginseng and leech and decoct twice. For the first decoction, add 10 times the total weight of the herbs and decoct for 1 hour. For the second decoction, add 8 times the total weight of the herbs and decoct for 1 hour.

20. A method for preparing a capsule for the recovery period of cerebral thrombosis, comprising the following steps: Prepare the Astragalus extract, Panax notoginseng total saponins, leech extract and borneol according to the traditional Chinese medicine composition II according to any one of claims 3 to 10; pulverize the borneol in the specified weight parts into fine powder, pass it through an 80-mesh sieve, mix it evenly with the Astragalus extract, Panax notoginseng total saponins and leech extract in the specified weight parts, add pharmaceutically acceptable excipients, mix evenly, dry granulate, and encapsulate to obtain the final product.

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