Traditional Chinese medicine composition for treating chronic migraine and preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating chronic migraine and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine biology. On one hand, the invention provides a traditional Chinese medicine composition for treating chronic migraine, and the traditional Chinese medicine composition is prepared from the following raw material medicines: ligusticum wallichii, radix angelicae, radix bupleuri, rhizoma acori graminei, polygala tenuifolia, radix puerariae and ligusticum sinense; secondly, the invention provides a preparation method of the traditional Chinese medicine composition for treating chronic migraine. In the third aspect, the invention provides a preparation method of the Chinese thorowax root and Chinese ligusticum rhizome fermented freeze-dried powder. In the fourth aspect, the invention also provides application of the traditional Chinese medicine composition in preparation of medicines for treating chronic migraine.

Description

Technical Field

[0001] The present invention relates to the field of Chinese medicine biotechnology, and in particular to a Chinese medicine composition for treating chronic migraine, and a preparation method and application thereof. Background Art

[0002] The 2022 edition of the "Guidelines for the Diagnosis and Treatment of Migraine in China" points out that migraine is a common neurological disease, and its clinical symptoms are repeated attacks, paroxysmal throbbing headaches on one or both sides of the head, often accompanied by nausea, photophobia / phonophobia, vomiting and other symptoms. Migraine is mainly divided into two types: without aura and with aura. In my country, only 1 / 7 of patients experience aura symptoms before migraine, but most patients still have migraine without aura. According to the 2016 Global Burden of Disease (GBD) study, migraine is the second most common disabling neurological disease, and has a comorbid relationship with anxiety, depression, sleep disorders, etc. Some studies have also found that it may increase the risk of cognitive dysfunction and cardiovascular and cerebrovascular diseases.

[0003] Epidemiological surveys show that migraine is unevenly distributed and prevalent. The incidence is higher in Western countries, with 1,500 to 2,000 people per 100,000 in Europe and America and 732.1 people per 100,000 in China. The incidence in women is higher than that in men, with the ratio of male to female being 1.2:3 abroad and 1:4 in China. Migraine can occur at any age, but usually starts in childhood and adolescence, with a peak for the first attack around adolescence. The peak incidence is reached in young and middle-aged people (around 40 years old), and then gradually decreases. The age of the disease is more common in foreign countries between 25 and 45 years old, and in China between 20 and 45 years old.

[0004] The main goal of clinical treatment of migraine is to reduce or end the number of headache attacks, relieve its complications, and prevent recurrent headaches. Western medicine mainly uses antipyretic analgesics and sedatives to temporarily relieve pain, and gives symptomatic treatment such as antiemetics and gastric motility-promoting drugs, but long-term use of the above drugs is prone to adverse reactions. Traditional Chinese medicine believes that migraine belongs to the concepts of "head wind", "head wind" and "migraine wind" in the "Inner Canon of Medicine". The head is the "meeting place of all yang". If the qi in the head is light, clear and smooth, the mind will be smart and the spirit will be inward. When the meridians are blocked, the clear yang will not rise and the turbid yin will not fall, and head diseases will follow.

[0005] In the treatment of migraine, there is no special treatment drug for migraine patients in clinical practice at home and abroad, and most of them are mainly used to relieve or prevent headache attacks. Preventive treatment drugs include calcium ion antagonists such as flunarizine (relevant studies have pointed out that there is sufficient evidence for preventive treatment of migraine), antiepileptic drugs such as topiramate sodium valproate, beta-receptor blockers (among which the most sufficient evidence is metoprolol), antidepressants (amitriptyline), botulinum toxin type A, CGRP, and gempanides. New monoclonal antibodies to calcitonin gene-related polypeptides, such as eprenat beads, freeman beads, and gacanth beads, as well as rimegepant, are all used for subcutaneous and intravenous administration. It is reported that among these drugs, R imegepant has better efficacy in the acute attack period of migraine than others, and its adverse reactions are tolerable, but its price is high and it has not been widely used at this stage.

[0006] At present, the main methods of TCM for treating migraine include acupuncture, massage and Chinese medicine. Acupuncture for treating migraine is generally effective when it is treated at the beginning of the disease and before the pain is severe. In the clinic of chronic migraine, the classic prescriptions Chuanxiong Cha Tiao San, Chuanxiong Dingtong Yin, Sanpian Tang, Xuefu Zhuyu Tang, Tongqiao Huoxue Tang and Chinese patent medicines Zhengtian Wan, Tongtian Oral Liquid, Yangxue Qingnao Granules are commonly used, but there are few reports on migraine caused by wind evil disturbance and blood stasis in the brain. Therefore, the field of TCM urgently needs to develop preparations with precise clinical positioning, good compliance and generally acceptable prices to meet the clinical needs of the majority of patients.

[0007] In view of this, the present invention provides a Chinese medicine composition for treating chronic migraine and a preparation method and application thereof. Summary of the invention

[0008] The purpose of the present invention is to provide a Chinese medicine composition for treating chronic migraine and a preparation method and application thereof.

[0009] Migraine was called "head wind", "head wind" and "brain wind" in ancient times. The "Inner Canon of Medicine" says: "Only wind can reach the top of the mountain." The blockage of brain meridians is often attributed to the evil "wind". The nature of wind is clear and open, and it is easy to attack the yang position. It is good at moving and changing, and it can penetrate everywhere. The internal wind is caused by the disorder of qi mechanism and the hyperactivity and change of yang qi; the nature of wind is good at moving and not staying, and the wind and yang are everywhere. Qi is stagnant and stagnant, and the meridian qi is not smooth. If it is not smooth, it will cause pain; or qi is stagnant and stagnant, depressed and not released, and qi is reversed upwards, causing headaches. The meridians are stagnant, the blood flow is not smooth, and it is easy to leave blood stasis for a long time. Qi stagnation causes the meridians to stagnate, the qi mechanism is blocked, the blood flow is not smooth, and blood stasis is left; it blocks the blood vessels.

[0010] Chuanxiong was first recorded in Shennong's Herbal Classic, "It cures strokes in the brain, headaches, cold arthralgia, muscle spasms, slow and fast... It can eliminate coldness in the brain and wind on the face." Chuanxiong can go up to the head to relieve pain, go down to the water, enter the blood, and relieve depression. It is a blood-qi medicine and a holy medicine for headaches. In the treatment of headaches, since Chen Shiduo's "Differential Symptoms Records·Headache Chapter" proposed the use of Chuanxiong as much as 30g in Sanpian Decoction for migraine, many famous doctors in later generations have found that increasing the dosage of Chuanxiong has a significant effect on regulating depressed qi and removing deep blood stasis. Wang Qingren's Xuefu Zhuyu Decoction (15-30g) treats blood stasis headaches. The famous Chinese medicine professor Cui Yinglin uses 40g of Chuanxiong in combination with Angelica dahurica to strengthen the function of removing blood stasis.

[0011] In the present invention, Chuanxiong can dispel wind and relieve pain, promote blood circulation and promote qi, and is an essential medicine for treating headache. It is pungent, warm, fragrant, and does not stay, and it goes up to the top of the head, goes down to the sea of ​​blood, penetrates the skin and fur, and passes through the limbs. It is a blood-qi medicine, and is used for unblocking, and is used as the main medicine in the prescription. It is combined with Angelica dahurica and Bupleurum chinense. Angelica dahurica is pungent and warm, and can disperse the stagnant heat of the Yangming meridian, while Bupleurum chinense can disperse and reduce fever, soothe the liver and relieve depression, raise Yang Qi, and relieve the evil of Shaoyang; they dispel wind and promote blood circulation together.

[0012] Acorus calamus and Polygala tenuifolia are both adjuvant drugs, which complement each other and can connect the heart and kidney and wake up the mind and open the orifices.

[0013] Pueraria root and Ligusticum chuanxiong are guiding drugs. Ligusticum chuanxiong is used for pain in the top of the head, while Pueraria root is used for pain in the neck and back. The two can lead other drugs into the meridians. Ligusticum chuanxiong dispels wind and cold, removes dampness and relieves pain; Pueraria root relieves muscles and reduces fever, raises yang and stops diarrhea, dredges meridians and activates collaterals, and clears the evil heat of Yangming; Ligusticum chuanxiong dispels wind, removes dampness and relieves pain.

[0014] These medicines work together to dispel wind, promote blood circulation, resolve blood stasis and relieve pain, and can eliminate the symptoms of wind evil disturbing the brain and blood stasis blocking the brain vessels.

[0015] Through more than 60 years of medical practice and theoretical research, the applicant has gradually formed his own unique insights and theoretical system while exploring the essence of traditional medicine. The applicant uses drugs in an eclectic way, and the characteristics of his prescriptions are "few but fine flavors, large and surprising dosages", which is particularly evident in the prescriptions for treating migraine.

[0016] The present invention is based on clinical practice and combined with ancient books and documents, and reuses Chuanxiong as the main drug, and the daily dosage of the prescription is increased to 50g, Angelica dahurica and Bupleurum chinense are the ministerial drugs, Acorus calamus and Polygala tenuifolia are the adjuvant drugs, and Pueraria lobata and Ligusticum chuanxiong are the guiding drugs. All the drugs have the functions of dispelling wind and activating blood circulation, removing blood stasis and relieving pain, and are used for wind evil disturbance, blood stasis blocking brain collaterals, symptoms of repeated headaches, long-term non-healing, fixed pain, and pain like a cone. Chronic migraine, supraorbital neuralgia, and occipital neuralgia are seen in the above symptoms.

[0017] In order to achieve the above-mentioned purpose of the present invention, the following technical solutions are particularly adopted:

[0018] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating chronic migraine, wherein the traditional Chinese medicine composition for treating chronic migraine is made of the following raw materials: chuanxiong, angelica dahurica, bupleurum, calamus, polygala, kudzu root, and ligusticum chuanxiong.

[0019] Furthermore, in a preferred embodiment of the present invention, the Chinese medicine composition is made of the following raw materials in parts by weight: 40-60 parts of Chuanxiong, 5-20 parts of Angelica dahurica, 5-20 parts of Bupleurum, 2-10 parts of Acorus calamus, 2-10 parts of Polygala tenuifolia, 2-10 parts of Pueraria lobata, and 2-10 parts of Ligusticum chuanxiong.

[0020] Furthermore, in a preferred embodiment of the present invention, the Chinese medicine composition is made of the following raw materials in parts by weight: 50 parts of Chuanxiong, 10 parts of Angelica dahurica, 10 parts of Bupleurum, 5 parts of Acorus calamus, 5 parts of Polygala tenuifolia, 5 parts of Pueraria lobata, and 5 parts of Ligusticum chuanxiong.

[0021] In a second aspect, the present invention provides a method for preparing a traditional Chinese medicine composition for treating chronic migraine, the preparation method comprising the following steps: weighing slices of Chuanxiong, Angelica dahurica, Bupleurum chinense, Acorus calamus, Polygala tenuifolia, Pueraria lobata, and Ligusticum chuanxiong according to a weight ratio, adding 8 to 12 times the amount of water, decocting for 60 minutes, filtering, adding 7 to 9 times the amount of water to the residue, decocting for 60 minutes, filtering, combining the medicinal liquids, concentrating to a concentrated paste with a density of 1.2±0.05 (60°C), drying under reduced pressure at 65 to 75°C, crushing the dry paste and passing it through a 60-mesh sieve to obtain a composition powder.

[0022] Furthermore, in a preferred embodiment of the present invention, the amount of water added during the decoction is 10 times and 8 times respectively, and the reduced pressure drying temperature is 70°C.

[0023] The present invention also provides another method for preparing a Chinese medicine composition for treating chronic migraine, which comprises the following steps: weighing slices of Chuanxiong, Angelica dahurica, Bupleurum, Acorus calamus, Polygala tenuifolia, Pueraria lobata and Ligusticum chuanxiong according to a weight ratio, adding 8 to 12 times the amount of water to the slices except Bupleurum and Ligusticum chuanxiong, decocting for 60 minutes, filtering, adding 7 to 9 times the amount of water to the residue, decocting for 60 minutes, filtering, combining the medicinal liquids, concentrating to a concentrated paste with a density of 1.2±0.05 (60° C.), drying under reduced pressure at 65 to 75° C., and crushing the dried paste. Pass through a 60-mesh sieve to obtain an extraction powder; crush the bupleurum and Ligusticum chuanxiong slices into fine powder, add 6 to 8 times the weight of water, adjust the pH value to 6.9 to 7.3, sterilize at 121°C for 20 minutes, inoculate thermophilic streptococci at 46 to 50°C, culture in a closed manner for 2 to 4 days, then inactivate at 90°C for 10 minutes, centrifuge at 4000r / min for 20 minutes, collect the supernatant, concentrate under appropriate reduced pressure, and freeze-dry to obtain bupleurum and Ligusticum chuanxiong fermented freeze-dried powder; mix the above-mentioned extraction powder with the bupleurum and Ligusticum chuanxiong fermented freeze-dried powder to obtain a composite powder.

[0024] Furthermore, in a preferred embodiment of the present invention, in the preparation method, the amount of water added for decoction is 10 times and 8 times respectively, the reduced pressure drying temperature is 70°C; the amount of water added for fermentation is 7 times, the pH value is 7.1, the inoculation temperature is 48°C, and the closed culture time is 3d.

[0025] In a third aspect, the present invention also provides a method for preparing a freeze-dried powder of fermented bupleurum and Ligusticum chuanxiong, characterized in that the preparation method comprises the following steps: weighing bupleurum and Ligusticum chuanxiong slices according to a weight ratio, crushing them into fine powder, adding 6 to 8 times the weight of water, adjusting the pH value to 6.9 to 7.3, sterilizing at 121°C for 20 minutes, inoculating thermophilic Streptococcus at 46 to 50°C, culturing in a closed manner for 2 to 4 days, then inactivating at 90°C for 10 minutes, centrifuging at 4000r / min for 20 minutes, collecting the supernatant, appropriately reducing the pressure and concentrating, and freeze-drying to obtain the freeze-dried powder of fermented bupleurum and Ligusticum chuanxiong.

[0026] Furthermore, in a preferred embodiment of the present invention, in the preparation method, the fermentation water addition amount is 7 times, the pH value is 7.1, the inoculation temperature is 48° C., and the closed culture time is 3 days.

[0027] In a fourth aspect, the present invention also provides a use of the above composition in the preparation of a drug for treating chronic migraine.

[0028] Furthermore, the above-mentioned drug dosage form for treating chronic migraine is an oral preparation, and the oral preparation is selected from any one of granules, tablets, capsules, powders, decoctions or pills.

[0029] Compared with the prior art, the beneficial effects of the present invention include at least:

[0030] The pharmaceutical composition of the present invention is a pure Chinese medicine preparation, which has the effects of dispelling wind, activating blood circulation, removing blood stasis and relieving pain. It is used for wind evil disturbing the upper part, blood stasis blocking the brain meridian syndrome, with symptoms of repeated headaches, long-term unhealed, fixed pain, and pain like a cone. Chronic migraine, supraorbital neuralgia, occipital neuralgia with the above symptoms.

[0031] The pharmaceutical composition for treating chronic migraine of the present invention has the following advantages:

[0032] 1. The formula is unique, with a heavy use of Chuanxiong and the combination of various medicinal ingredients to fully exert the efficacy of the prescription, with definite therapeutic effects and no toxic side effects.

[0033] 2. The clinical positioning is clear, suitable for wind evil disturbing the brain, blood stasis blocking the brain meridians, with symptoms of repeated headaches, long-term non-healing, fixed pain, and pain like a needle. Chronic migraine, supraorbital neuralgia, occipital neuralgia with the above symptoms.

[0034] 3. The production method is simple, the medicinal taste is less, and it can be made into pharmaceutically acceptable dosage forms, such as granules, tablets, capsules, etc. Granules are convenient for clinical use, have a large drug loading capacity, and are easy to store and carry.

[0035] 4. Low cost and easy for patients to accept. DETAILED DESCRIPTION

[0036] The embodiments of the present invention will be described in detail below in conjunction with the examples, but it will be appreciated by those skilled in the art that the following examples are only used to illustrate the present invention and should not be construed as limiting the scope of the present invention. If specific conditions are not specified in the examples, they are carried out according to conventional conditions or conditions recommended by the manufacturer. If the manufacturer is not specified for the reagents or instruments used, they are all conventional products that can be purchased commercially.

[0037] The features and properties of the present invention are further described in detail below in conjunction with the embodiments:

[0038] Example 1

[0039] 4kg of Chuanxiong slices, 2.0kg of Angelica dahurica slices, 0.5kg of Bupleurum slices, 1.0kg of Acorus calamus slices, 0.2kg of Polygala tenuifolia slices, 1.0kg of Pueraria root slices, and 0.2kg of Ligusticum chuanxiong slices.

[0040] The above-mentioned pieces of medicinal material were added with 12 times the amount of water, boiled for 60 minutes, filtered, the residue was added with 7 times the amount of water, boiled for 60 minutes, filtered, the medicinal liquids were combined, concentrated to a concentrated paste with a density of about 1.2 (60°C), dried under reduced pressure at 75°C, and the dry paste was crushed and passed through a 60-mesh sieve to obtain a composite powder; the composite powder was added with auxiliary materials dextrin and stevia to granulate, dried, granulated, and bagged to obtain 3 kg of granules.

[0041] Example 2

[0042] 6kg of Chuanxiong slices, 0.5kg of Angelica dahurica slices, 2.0kg of Bupleurum slices, 0.2kg of Acorus calamus slices, 1.0kg of Polygala tenuifolia slices, 0.2kg of Pueraria root slices, and 1.0kg of Ligusticum chuanxiong slices.

[0043] Add 8 times the amount of water to the above-mentioned pieces, boil for 60 minutes, filter, add 9 times the amount of water to the residue, boil for 60 minutes, filter, combine the medicinal liquids, concentrate to a concentrated paste with a density of about 1.2 (60°C), dry under reduced pressure at 65°C, crush the dry paste and pass it through a 60-mesh sieve to obtain a composite powder; add auxiliary materials dextrin and stevia to the composite powder to granulate, dry, granulate, and bag to obtain 3 kg of granules.

[0044] Example 3

[0045] 5kg of Chuanxiong slices, 1kg of Angelica dahurica slices, 1kg of Bupleurum slices, 0.5kg of Acorus calamus slices, 0.5kg of Polygala tenuifolia slices, 0.5kg of Pueraria root slices, and 0.5kg of Ligusticum chuanxiong slices.

[0046] Add 10 times the amount of water to the above-mentioned pieces, boil for 60 minutes, filter, add 8 times the amount of water to the residue, boil for 60 minutes, filter, combine the medicinal liquids, concentrate to a concentrated paste with a density of about 1.2 (60°C), dry under reduced pressure at 70°C, crush the dry paste and pass it through a 60-mesh sieve to obtain a composite powder; add auxiliary materials dextrin and stevia to the composite powder to granulate, dry, granulate, and bag to obtain 3 kg of granules.

[0047] Example 4

[0048] 4kg of Chuanxiong slices, 2.0kg of Angelica dahurica slices, 0.5kg of Bupleurum slices, 1.0kg of Acorus calamus slices, 0.2kg of Polygala tenuifolia slices, 1.0kg of Pueraria root slices, and 0.2kg of Ligusticum chuanxiong slices.

[0049] Add 12 times the amount of water to the pieces except Bupleurum and Ligusticum chuanxiong, boil for 60 minutes, filter, add 7 times the amount of water to the residue, boil for 60 minutes, filter, combine the medicinal liquids, concentrate to a concentrated paste with a density of about 1.2 (60°C), dry under reduced pressure at 75°C, crush the dry paste and pass it through a 60-mesh sieve to obtain the extraction powder.

[0050] The preparation method of Bupleurum and Ligusticum chuanxiong fermented freeze-dried powder, the specific process is:

[0051] Crush the slices of Bupleurum and Ligusticum chuanxiong into fine powder, add 6 times the weight of water, adjust the pH value to 7.3, sterilize at 121°C for 20 min, inoculate thermophilic Streptococcus at 46°C, culture in a closed manner for 4 days, then inactivate at 90°C for 10 min, centrifuge at 4000r / min for 20 min, collect the supernatant, concentrate under appropriate reduced pressure, and freeze-dry to obtain Bupleurum and Ligusticum chuanxiong fermented freeze-dried powder.

[0052] The above-mentioned extract powder is mixed with Bupleurum and Ligusticum chuanxiong fermented freeze-dried powder to obtain a composite powder, and auxiliary materials dextrin and stevioside are added to granulate, dry, granulate, and bag to obtain 3 kg of granules.

[0053] Example 5

[0054] 6kg of Chuanxiong slices, 0.5kg of Angelica dahurica slices, 2.0kg of Bupleurum slices, 0.2kg of Acorus calamus slices, 1.0kg of Polygala tenuifolia slices, 0.2kg of Pueraria root slices, and 1.0kg of Ligusticum chuanxiong slices.

[0055] Add 8 times the amount of water to the pieces of medicine except Bupleurum and Ligusticum chuanxiong, boil for 60 minutes, filter, add 9 times the amount of water to the residue, boil for 60 minutes, filter, combine the medicinal liquids, concentrate to a concentrated paste with a density of about 1.2 (60°C), dry under reduced pressure at 65°C, crush the dry paste and pass through a 60-mesh sieve to obtain the extraction powder.

[0056] The preparation method of Bupleurum and Ligusticum chuanxiong fermented freeze-dried powder, the specific process is:

[0057] Crush the Radix Bupleuri and Radix Ligustici into fine powder, add 8 times the weight of water, adjust the pH value to 6.9, sterilize at 121°C for 20 min, inoculate thermophilic Streptococcus at 50°C, culture in a closed manner for 2 days, then inactivate at 90°C for 10 min, centrifuge at 4000r / min for 20 min, collect the supernatant, concentrate under appropriate reduced pressure, and freeze-dry to obtain the fermented freeze-dried powder of Radix Bupleuri and Radix Ligustici.

[0058] The above-mentioned extract powder is mixed with Bupleurum and Ligusticum chuanxiong fermented freeze-dried powder to obtain a composite powder, and auxiliary materials dextrin and stevioside are added to granulate, dry, granulate, and bag to obtain 3 kg of granules.

[0059] Example 6

[0060] 5kg of Chuanxiong slices, 1kg of Angelica dahurica slices, 1kg of Bupleurum slices, 0.5kg of Acorus calamus slices, 0.5kg of Polygala tenuifolia slices, 0.5kg of Pueraria root slices, and 0.5kg of Ligusticum chuanxiong slices.

[0061] Add 10 times the amount of water to the pieces except Bupleurum and Ligusticum chuanxiong, boil for 60 minutes, filter, add 8 times the amount of water to the residue, boil for 60 minutes, filter, combine the medicinal liquids, concentrate to a concentrated paste with a density of about 1.2 (60°C), dry under reduced pressure at 70°C, crush the dry paste and pass through a 60-mesh sieve to obtain the extraction powder.

[0062] The preparation method of Bupleurum and Ligusticum chuanxiong fermented freeze-dried powder, the specific process is:

[0063] Crush the slices of Radix Bupleuri and Radix Ligustici into fine powder, add 7 times the weight of water, adjust the pH value to 7.1, sterilize at 121°C for 20 min, inoculate thermophilic Streptococcus at 48°C, culture in a closed manner for 3 days, then inactivate at 90°C for 10 min, centrifuge at 4000r / min for 20 min, collect the supernatant, concentrate under appropriate reduced pressure, and freeze-dry to obtain the fermented freeze-dried powder of Radix Bupleuri and Radix Ligustici.

[0064] The above-mentioned extract powder, Bupleurum and Ligusticum chuanxiong fermented freeze-dried powder are mixed to obtain a composite powder, and auxiliary materials dextrin and stevioside are added to granulate, dry, granulate and bag to obtain 3 kg of granules.

[0065] Comparative Example 1

[0066] 5kg of Chuanxiong slices, 1kg of Angelica dahurica slices, 1kg of Bupleurum slices, 0.5kg of Acorus calamus slices, 0.5kg of Polygala tenuifolia slices, 0.5kg of Pueraria root slices, and 0.5kg of Ligusticum chuanxiong slices.

[0067] All the pieces of medicine were crushed into fine powder, 7 times the weight of water was added, the pH value was adjusted to 7.1, sterilized at 121°C for 20 min, inoculated with thermophilic Streptococcus at 48°C, cultured in a closed manner for 3 days, then inactivated at 90°C for 10 min, centrifuged at 4000 r / min for 20 min, the supernatant was collected, appropriately reduced pressure and concentrated, and freeze-dried to obtain the composite powder.

[0068] Add auxiliary materials dextrin and stevioside to granulate, dry, granulate and pack into bags to obtain 3 kg of granules.

[0069] Comparative Example 2

[0070] 5kg of Chuanxiong slices, 1kg of Angelica dahurica slices, 1kg of Bupleurum slices, 0.5kg of Acorus calamus slices, 0.5kg of Polygala tenuifolia slices, 0.5kg of Pueraria root slices, and 0.5kg of Ligusticum chuanxiong slices.

[0071] Add 10 times the amount of water to the pieces except Chuanxiong, boil for 60 minutes, filter, add 8 times the amount of water to the residue, boil for 60 minutes, filter, combine the medicinal liquids, concentrate to a concentrated paste with a density of about 1.2 (60°C), dry under reduced pressure at 70°C, crush the dry paste and pass it through a 60-mesh sieve to obtain the extraction powder.

[0072] The decoction pieces of Chuanxiong were crushed into fine powder, 7 times the weight of water was added, the pH value was adjusted to 7.1, sterilized at 121°C for 20 min, inoculated with thermophilic Streptococcus at 48°C, cultured in a closed manner for 3 days, then inactivated at 90°C for 10 min, centrifuged at 4000 r / min for 20 min, the supernatant was collected, appropriately reduced pressure and concentrated, and freeze-dried to obtain the fermented freeze-dried powder of Chuanxiong.

[0073] The above-mentioned extract powder and Chuanxiong fermented freeze-dried powder are mixed to obtain a composite powder, and auxiliary materials dextrin and stevioside are added to granulate, dry, granulate, and bag to obtain 3 kg of granules.

[0074] Comparative Example 3

[0075] 5kg of Chuanxiong slices, 1kg of Angelica dahurica slices, 1kg of Bupleurum slices, 0.5kg of Acorus calamus slices, 0.5kg of Polygala tenuifolia slices, 0.5kg of Pueraria root slices, and 0.5kg of Ligusticum chuanxiong slices.

[0076] Add 10 times the amount of water to the pieces except Angelica dahurica, boil for 60 minutes, filter, add 8 times the amount of water to the residue, boil for 60 minutes, filter, combine the medicinal liquids, concentrate to a concentrated paste with a density of about 1.2 (60°C), dry under reduced pressure at 70°C, crush the dry paste and pass it through a 60-mesh sieve to obtain the extraction powder.

[0077] The Angelica dahurica slices were crushed into fine powder, 7 times the weight of water was added, the pH value was adjusted to 7.1, sterilized at 121°C for 20 min, inoculated with thermophilic Streptococcus at 48°C, cultured in a closed environment for 3 days, then inactivated at 90°C for 10 min, centrifuged at 4000 r / min for 20 min, the supernatant was collected, appropriately reduced pressure and concentrated, and freeze-dried to obtain Angelica dahurica fermented freeze-dried powder.

[0078] The above-mentioned extract powder and Angelica dahurica fermented freeze-dried powder are mixed to obtain a composite powder, and auxiliary materials dextrin and stevioside are added to granulate, dry, granulate, and bag to obtain 3 kg of granules.

[0079] Comparative Example 4

[0080] 5kg of Chuanxiong slices, 1kg of Angelica dahurica slices, 1kg of Bupleurum slices, 0.5kg of Acorus calamus slices, 0.5kg of Polygala tenuifolia slices, 0.5kg of Pueraria root slices, and 0.5kg of Ligusticum chuanxiong slices.

[0081] Add 10 times the amount of water to the pieces except Bupleurum, boil for 60 minutes, filter, add 8 times the amount of water to the residue, boil for 60 minutes, filter, combine the medicinal liquids, concentrate to a concentrated paste with a density of about 1.2 (60°C), dry under reduced pressure at 70°C, crush the dry paste and pass it through a 60-mesh sieve to obtain the extraction powder.

[0082] The Bupleurum slices were crushed into fine powder, 7 times the weight of water was added, the pH value was adjusted to 7.1, sterilized at 121°C for 20 min, inoculated with thermophilic Streptococcus at 48°C, cultured in a closed manner for 3 days, then inactivated at 90°C for 10 min, centrifuged at 4000 r / min for 20 min, the supernatant was collected, appropriately reduced pressure and concentrated, and freeze-dried to obtain Bupleurum fermented freeze-dried powder.

[0083] The above-mentioned extract powder and Bupleurum fermentation freeze-dried powder are mixed to obtain a composite powder, and auxiliary materials dextrin and stevioside are added to granulate, dry, granulate, and bag to obtain 3 kg of granules.

[0084] Comparative Example 5

[0085] 5kg of Chuanxiong slices, 1kg of Angelica dahurica slices, 1kg of Bupleurum slices, 0.5kg of Acorus calamus slices, 0.5kg of Polygala tenuifolia slices, 0.5kg of Pueraria root slices, and 0.5kg of Ligusticum chuanxiong slices.

[0086] Add 10 times the amount of water to the pieces except Acorus calamus, boil for 60 minutes, filter, add 8 times the amount of water to the residue, boil for 60 minutes, filter, combine the medicinal liquids, concentrate to a concentrated paste with a density of about 1.2 (60°C), dry under reduced pressure at 70°C, crush the dry paste and pass it through a 60-mesh sieve to obtain the extraction powder.

[0087] The Acorus calamus slices were crushed into fine powder, 7 times the weight of water was added, the pH value was adjusted to 7.1, sterilized at 121°C for 20 min, inoculated with thermophilic Streptococcus at 48°C, cultured in a closed environment for 3 days, then inactivated at 90°C for 10 min, centrifuged at 4000 r / min for 20 min, the supernatant was collected, appropriately reduced pressure and concentrated, and freeze-dried to obtain Acorus calamus fermented freeze-dried powder.

[0088] The above-mentioned extract powder and Acorus calamus fermented freeze-dried powder are mixed to obtain a composite powder, and auxiliary materials dextrin and stevioside are added to granulate, dry, granulate, and bag to obtain 3 kg of granules.

[0089] Comparative Example 6

[0090] 5kg of Chuanxiong slices, 1kg of Angelica dahurica slices, 1kg of Bupleurum slices, 0.5kg of Acorus calamus slices, 0.5kg of Polygala tenuifolia slices, 0.5kg of Pueraria root slices, and 0.5kg of Ligusticum chuanxiong slices.

[0091] Add 10 times the amount of water to the pieces except Polygala tenuifolia, boil for 60 minutes, filter, add 8 times the amount of water to the residue, boil for 60 minutes, filter, combine the medicinal liquids, concentrate to a concentrated paste with a density of about 1.2 (60°C), dry under reduced pressure at 70°C, crush the dry paste and pass it through a 60-mesh sieve to obtain the extraction powder.

[0092] The Polygala root slices were crushed into fine powder, 7 times the weight of water was added, the pH value was adjusted to 7.1, sterilized at 121°C for 20 min, inoculated with thermophilic Streptococcus at 48°C, cultured in a closed manner for 3 days, and then inactivated at 90°C for 10 min, centrifuged at 4000 r / min for 20 min, the supernatant was collected, appropriately reduced pressure and concentrated, and freeze-dried to obtain Polygala root fermented freeze-dried powder.

[0093] The above-mentioned extract powder and Polygala fermented freeze-dried powder are mixed to obtain a composite powder, and auxiliary materials dextrin and stevioside are added to granulate, dry, granulate, and bag to obtain 3 kg of granules.

[0094] Comparative Example 7

[0095] 5kg of Chuanxiong slices, 1kg of Angelica dahurica slices, 1kg of Bupleurum slices, 0.5kg of Acorus calamus slices, 0.5kg of Polygala tenuifolia slices, 0.5kg of Pueraria root slices, and 0.5kg of Ligusticum chuanxiong slices.

[0096] Add 10 times the amount of water to the pieces except Pueraria root, boil for 60 minutes, filter, add 8 times the amount of water to the residue, boil for 60 minutes, filter, combine the medicinal liquids, concentrate to a concentrated paste with a density of about 1.2 (60°C), dry under reduced pressure at 70°C, crush the dry paste and pass it through a 60-mesh sieve to obtain the extraction powder.

[0097] The Pueraria root slices were crushed into fine powder, 7 times the weight of water was added, the pH value was adjusted to 7.1, sterilized at 121°C for 20 min, inoculated with thermophilic Streptococcus at 48°C, cultured in a closed manner for 3 days, then inactivated at 90°C for 10 min, centrifuged at 4000 r / min for 20 min, the supernatant was collected, appropriately reduced pressure and concentrated, and freeze-dried to obtain Pueraria root fermented freeze-dried powder.

[0098] The above-mentioned extract powder and Pueraria fermented freeze-dried powder are mixed to obtain a composite powder, and auxiliary materials dextrin and stevioside are added to granulate, dry, granulate, and bag to obtain 3 kg of granules.

[0099] Comparative Example 8

[0100] 5kg of Chuanxiong slices, 1kg of Angelica dahurica slices, 1kg of Bupleurum slices, 0.5kg of Acorus calamus slices, 0.5kg of Polygala tenuifolia slices, 0.5kg of Pueraria root slices, and 0.5kg of Ligusticum chuanxiong slices.

[0101] Add 10 times the amount of water to the pieces except Ligusticum chuanxiong, boil for 60 minutes, filter, add 8 times the amount of water to the residue, boil for 60 minutes, filter, combine the medicinal liquids, concentrate to a concentrated paste with a density of about 1.2 (60°C), dry under reduced pressure at 70°C, crush the dry paste and pass it through a 60-mesh sieve to obtain the extraction powder.

[0102] The Ligusticum chuanxiong slices were crushed into fine powder, 7 times the weight of water was added, the pH value was adjusted to 7.1, sterilized at 121°C for 20 min, inoculated with thermophilic Streptococcus at 48°C, cultured in a closed manner for 3 days, and then inactivated at 90°C for 10 min, centrifuged at 4000 r / min for 20 min, the supernatant was collected, appropriately reduced pressure and concentrated, and freeze-dried to obtain Ligusticum chuanxiong fermented freeze-dried powder.

[0103] The above-mentioned extract powder and Ligusticum chuanxiong fermentation freeze-dried powder are mixed to obtain a composite powder, and auxiliary materials dextrin and stevioside are added to granulate, dry, granulate, and bag to obtain 3 kg of granules.

[0104] Comparative Example 9

[0105] 5kg of Chuanxiong slices, 1kg of Angelica dahurica slices, 1kg of Bupleurum slices, 0.5kg of Acorus calamus slices, 0.5kg of Polygala tenuifolia slices, 0.5kg of Pueraria root slices, and 0.5kg of Ligusticum chuanxiong slices.

[0106] Add 10 times the amount of water to the pieces except Bupleurum and Ligusticum chuanxiong, boil for 60 minutes, filter, add 8 times the amount of water to the residue, boil for 60 minutes, filter, combine the medicinal liquids, concentrate to a concentrated paste with a density of about 1.2 (60°C), dry under reduced pressure at 70°C, crush the dry paste and pass through a 60-mesh sieve to obtain the extraction powder.

[0107] The preparation method of Bupleurum fermented freeze-dried powder, the specific process is:

[0108] The Bupleurum slices were crushed into fine powder, 7 times the weight of water was added, the pH value was adjusted to 7.1, sterilized at 121°C for 20 min, inoculated with thermophilic Streptococcus at 48°C, cultured in a closed manner for 3 days, then inactivated at 90°C for 10 min, centrifuged at 4000 r / min for 20 min, the supernatant was collected, appropriately reduced pressure and concentrated, and freeze-dried to obtain Bupleurum fermented freeze-dried powder.

[0109] The Ligusticum chuanxiong slices were crushed into fine powder, 7 times the weight of water was added, the pH value was adjusted to 7.1, sterilized at 121°C for 20 min, inoculated with thermophilic Streptococcus at 48°C, cultured in a closed manner for 3 days, and then inactivated at 90°C for 10 min, centrifuged at 4000 r / min for 20 min, the supernatant was collected, appropriately reduced pressure and concentrated, and freeze-dried to obtain Ligusticum chuanxiong fermented freeze-dried powder.

[0110] The above-mentioned extract powder, Bupleurum fermentation freeze-dried powder, and Ligusticum chuanxiong fermentation freeze-dried powder are mixed to obtain a composite powder, and auxiliary materials dextrin and stevioside are added to granulate, dry, granulate, and bag to obtain 3 kg of granules.

[0111] Comparative Example 10

[0112] 5kg of Chuanxiong slices, 1kg of Angelica dahurica slices, 1kg of Bupleurum slices, 0.5kg of Acorus calamus slices, 0.5kg of Polygala tenuifolia slices, 0.5kg of Pueraria root slices, and 0.5kg of Ligusticum chuanxiong slices.

[0113] Add 10 times the amount of water to the pieces except Bupleurum and Ligusticum chuanxiong, boil for 60 minutes, filter, add 8 times the amount of water to the residue, boil for 60 minutes, filter, combine the medicinal liquids, concentrate to a concentrated paste with a density of about 1.2 (60°C), dry under reduced pressure at 70°C, crush the dry paste and pass through a 60-mesh sieve to obtain the extraction powder.

[0114] Crush the Radix Bupleuri and Radix Ligustici Radix slices into fine powder, add 7 times the weight of water, adjust the pH value to 4.5, sterilize at 121°C for 20 min, inoculate Lactobacillus acidophilus at 37°C, culture in a closed manner for 3 days, then inactivate at 90°C for 10 min, centrifuge at 4000r / min for 20 min, collect the supernatant, concentrate under appropriate reduced pressure, and freeze-dry to obtain the fermented freeze-dried powder of Radix Bupleuri and Radix Ligustici.

[0115] The above-mentioned extract powder, Bupleurum and Ligusticum chuanxiong fermented freeze-dried powder are mixed to obtain a composite powder, and auxiliary materials dextrin and stevioside are added to granulate, dry, granulate and bag to obtain 3 kg of granules.

[0116] Comparative Example 11

[0117] 5kg of Chuanxiong slices, 1kg of Angelica dahurica slices, 1kg of Bupleurum slices, 0.5kg of Acorus calamus slices, 0.5kg of Polygala tenuifolia slices, 0.5kg of Pueraria root slices, and 0.5kg of Ligusticum chuanxiong slices.

[0118] Add 10 times the amount of water to the pieces except Bupleurum and Ligusticum chuanxiong, boil for 60 minutes, filter, add 8 times the amount of water to the residue, boil for 60 minutes, filter, combine the medicinal liquids, concentrate to a concentrated paste with a density of about 1.2 (60°C), dry under reduced pressure at 70°C, crush the dry paste and pass through a 60-mesh sieve to obtain the extraction powder.

[0119] Crush the Radix Bupleuri and Radix Ligustici into fine powder, add 7 times the weight of water, adjust the pH value to 6.8, sterilize at 121°C for 20 min, inoculate Lactobacillus helveticus at 37°C, culture in a closed environment for 3 days, then inactivate at 90°C for 10 min, centrifuge at 4000 r / min for 20 min, collect the supernatant, concentrate under appropriate reduced pressure, and freeze-dry to obtain the fermented freeze-dried powder of Radix Bupleuri and Radix Ligustici.

[0120] The above-mentioned extract powder, Bupleurum and Ligusticum chuanxiong fermented freeze-dried powder are mixed to obtain a composite powder, and auxiliary materials dextrin and stevioside are added to granulate, dry, granulate and bag to obtain 3 kg of granules.

[0121] Beneficial effects of the present invention:

[0122] 1. Materials

[0123] 1.1 Drugs Chinese herbal compound extracts (provided by Jiren Pharmaceutical Co., Ltd.)

[0124] Zhengtian Pills (China Resources Sanjiu Pharmaceutical Co., Ltd.)

[0125] Nitroglycerin (Beijing Yimin Pharmaceutical Co., Ltd.)

[0126] 1.2 Animals SPF healthy SD rats, half male and half female, weighing 200-220g. Rearing conditions: room temperature 22-24℃, humidity 40-60%, light / dark cycle 12h / 12h.

[0127] 2. Model establishment and drug administration

[0128] SD rats were adaptively fed for 3 days and randomly divided into a normal control group, a model control group, a positive control group (Zhengtian Pill 1.89g / kg), each group of Examples 1 to 6, each group of Comparative Examples 1 to 11 (0.85g / kg), and 12 rats in each group. Except for the normal control group, the rats in the other groups were subcutaneously injected with an equal volume of normal saline in the neck, and nitroglycerin (10mg / kg) was subcutaneously injected into the neck of the rats, once a week for three consecutive weeks. The model was given drugs at the same time. Except for the rats in the normal control group and the model group, which were gavaged with an equal volume of deionized water, the other rats were gavaged with drugs at 10ml / kg for 2 weeks, once a day, and 1h after the last injection, except for the normal group, the rats in the other groups were subcutaneously injected with nitroglycerin injection (10mg / kg) in the neck, inducing migraine symptoms such as scratching and shaking the head in the rats.

[0129] 3. Observation indicators

[0130] Behavioral observation, plantar pain threshold measurement, and 5-HT, NO, and ET-1 in rat brain tissue were measured.

[0131] 4. Results

[0132] 4.1 Effects of Chinese medicine on the behavior of rats with chronic migraine induced by nitroglycerin

[0133] Compared with the normal control group, after subcutaneous injection of nitroglycerin in the neck, the number of head scratching and head shaking of rats increased significantly (P<0.01). Compared with the model group, the number of head scratching and head shaking of rats in each group of the embodiment, comparative example 4, 8, 9 groups and positive drug Zhengtian pills decreased significantly (P<0.05 or P<0.01). The results are shown in Table 1.

[0134] Table 1 Effects of Chinese medicine on the behavior of rats with chronic migraine induced by nitroglycerin (n=12, mean±SEM)

[0135]

[0136]

[0137] 4.2 Effects of Chinese medicine on pain threshold in rats with chronic migraine induced by nitroglycerin

[0138] Compared with normal rats, subcutaneous injection of nitroglycerin in the neck can cause a significant decrease in the plantar pain threshold of rats (P<0.01). Compared with the model group, the plantar pain threshold of each group in the embodiment and the Zhengtian Pill group was significantly increased after the second and third injections of nitroglycerin (P<0.05 or P<0.01). The results are shown in Table 2.

[0139] Table 2 Effects of Chinese medicine on plantar pain threshold in rats with chronic migraine model induced by nitroglycerin (n=12, mean±SEM)

[0140] Grouping Before the experiment After the first injection After the second injection After the third injection Normal group 68.85±0.82 65.91±0.76 71.83±2.89 80.01±1.29 Model Group 68.82±0.57 65.45±0.76 57.77±1.94 50.35±1.40 Shotenmaru Group 68.59±0.56 65.17±0.94 76.89±2.49 76.59±2.76 Example 1 Group 69.16±0.53 67.03±0.85 75.63±2.12 76.32±2.97 Example 2 Group 68.60±0.71 65.48±0.80 75.91±2.50 76.26±2.75 Example 3 Group 68.83±0.59 66.32±0.87 76.83±2.52 77.02±2.61 Example 4 Group 68.93±0.62 65.51±0.79 78.52±1.39 78.74±1.50 Example 5 Group 68.71±0.68 65.72±0.81 78.90±1.43 78.52±1.41 Example 6 Group 68.86±0.70 65.63±0.78 79.65±1.48 79.83±1.53

[0141] 4.3 Effects of Chinese medicine on the contents of NO, ET-1 and 5-HT in brain tissue of rats with chronic migraine

[0142] Compared with the normal group, the NO content in the brain tissue of the rats in the nitroglycerin group was significantly increased (P<0.01), the ET-1 content was slightly increased, but there was no significant statistical difference, and the 5-HT content was significantly reduced. Compared with the model group rats, the serum NO and ET-1 contents of the rats in each group of Examples 1 to 3 were significantly reduced, but the effect of increasing the 5-HT content in the brain tissue was weaker than that of Zhengtian Pills. Zhengtian Pills did not significantly reduce the NO and ET-1 contents in the brain tissue of migraine rats. The indicators of each group of Examples 4 to 6 were relatively good. The results are shown in Table 3.

[0143] Table 3 Effects of Chinese medicine on NO, ET-1 and 5-HT in brain tissue of rats with chronic migraine model induced by nitroglycerin (n=12, mean±SEM)

[0144] Grouping NO (nmol / mgprot.) ET-1(ng / mgprot.) 5-HT (ng / mgprot.) Normal group 69.78±4.58 66.78±6.62 1.11±0.34 Model Group 92.03±6.48 74.36±8.12 0.40±0.08 Shotenmaru Group 88.48±4.52 73.07±6.46 1.07±0.28 Example 1 Group 68.41±5.19 50.65±2.12 0.57±0.11 Example 2 Group 69.80±5.03 52.03±2.67 0.56±0.12 Example 3 Group 68.25±4.37 51.95±2.34 0.60±0.14 Example 4 Group 70.34±5.63 51.80±2.53 0.96±0.29 Example 5 Group 69.50±5.26 52.48±2.36 0.99±0.26 Example 6 Group 68.75±4.06 51.09±2.25 1.03±0.30

[0145] 5. Conclusion

[0146] From the behavioral performance, it can be seen that the rats given Zhengtian Pills and the tested Chinese medicine are relatively quiet compared to the model group rats, showing a sedative effect, reducing the number of scratching or shaking the head. Combined with the results of the plantar pain threshold measurement, it can be seen that the tested Chinese medicine has a certain effect on improving nitroglycerin-induced migraine, which may be related to regulating the content of NO and ET-1 in brain tissue, stabilizing the balance of vasoconstriction and relaxation, and may also be related to enhancing the effect of 5-HT. However, compared with the positive drug Zhengtian Pills, the effects of each group of Examples 1 to 3 on brain tissue 5-HT are relatively weak, and the effects of Zhengtian Pills on NO and ET-1 that maintain the vascular state are not obvious. It can be inferred that the mechanisms of action of the two may be different, but both can have the effect of alleviating chronic migraine. The indicators of each group of Examples 4 to 6 are relatively good.

[0147] The links not described in detail in the present invention are all common knowledge that can be selected by ordinary technicians in the field. Although the present invention has been described in detail above with general descriptions and specific implementation schemes, it is obvious to ordinary technicians in the field that some modifications or improvements can be made on the basis of the present invention. Therefore, these modifications or improvements made on the basis of not departing from the spirit of the present invention all belong to the scope of protection claimed by the present invention.

Claims

1. A Chinese medicine composition for treating chronic migraine, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials: chuanxiong, angelica dahurica, bupleurum, calamus, polygala, kudzu root and ligusticum chuanxiong.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 40-60 parts of Chuanxiong, 5-20 parts of Angelica dahurica, 5-20 parts of Bupleurum, 2-10 parts of Acorus calamus, 2-10 parts of Polygala tenuifolia, 2-10 parts of Puerariae, and 2-10 parts of Ligusticum chuanxiong.

3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is prepared from the following raw materials in parts by weight: 50 parts of Chuanxiong, 10 parts of Angelica dahurica, 10 parts of Bupleurum, 5 parts of Acorus calamus, 5 parts of Polygala tenuifolia, 5 parts of Puerariae, and 5 parts of Ligusticum chuanxiong.

4. A method for preparing a Chinese medicine composition for treating chronic migraine, characterized in that: The preparation method comprises the following steps: weighing slices of Chuanxiong, Angelica dahurica, Bupleurum, Acorus calamus, Polygala tenuifolia, Pueraria lobata and Ligusticum chuanxiong according to a weight ratio, adding 8 to 12 times the amount of water, decocting for 60 minutes, filtering, adding 7 to 9 times the amount of water to the residue, decocting for 60 minutes, filtering, combining the medicinal liquids, concentrating to a concentrated paste with a density of 1.2±0.05 (60° C.), drying under reduced pressure at 65 to 75° C., crushing the dry paste and passing it through a 60-mesh sieve to obtain a composite powder.

5. The method for preparing the Chinese medicine composition according to claim 4, characterized in that: The amount of water added during decoction is 10 times and 8 times respectively, and the reduced pressure drying temperature is 70°C.

6. A method for preparing a Chinese medicine composition for treating chronic migraine, characterized in that: The preparation method comprises the following steps: weighing slices of chuanxiong, angelica dahurica, bupleurum, calamus calamus, polygala tenuifolia, kudzu root and ligusticum chuanxiong according to a weight ratio, adding 8 to 12 times the amount of water to the slices except bupleurum and ligusticum chuanxiong, decocting for 60 minutes, filtering, adding 7 to 9 times the amount of water to the residue, decocting for 60 minutes, filtering, combining the medicinal liquids, concentrating to a concentrated paste with a density of 1.2±0.05 (60° C.), drying under reduced pressure at 65 to 75° C., crushing the dry paste and passing it through a 60-mesh sieve to obtain an extract powder; bupleurum and ligusticum chuanxiong, The Ligusticum chuanxiong slices are crushed into fine powder, 6 to 8 times the weight of water is added, the pH value is adjusted to 6.9 to 7.3, sterilized at 121°C for 20 minutes, inoculated with thermophilic Streptococcus at 46 to 50°C, cultured in a closed manner for 2 to 4 days, and then inactivated at 90°C for 10 minutes, centrifuged at 4000 r / min for 20 minutes, the supernatant is collected, appropriately reduced pressure and concentrated, and freeze-dried to obtain Bupleurum and Ligusticum chuanxiong fermented freeze-dried powder; the above-mentioned extraction powder is mixed with Bupleurum and Ligusticum chuanxiong fermented freeze-dried powder to obtain a composite powder.

7. The method for preparing the Chinese medicine composition according to claim 6, characterized in that: The amount of water added during decoction is 10 times and 8 times respectively, and the reduced pressure drying temperature is 70° C.; the amount of water added during fermentation is 7 times, the pH value is 7.1, the inoculation temperature is 48° C., and the closed culture time is 3 days.

8. A method for preparing bupleurum and ligusticum fermented freeze-dried powder, characterized in that: The preparation method comprises the following steps: weighing radix bupleuri and radix ligusticum slices according to a weight ratio, crushing them into fine powder, adding 6 to 8 times the weight of water, adjusting the pH value to 6.9 to 7.3, sterilizing at 121°C for 20 minutes, inoculating thermophilic streptococci at 46 to 50°C, culturing in a closed manner for 2 to 4 days, then inactivating at 90°C for 10 minutes, centrifuging at 4000 r / min for 20 minutes, collecting the supernatant, concentrating under appropriate reduced pressure, and freeze-drying to obtain radix bupleuri and radix ligusticum fermented freeze-dried powder.

9. Use of the composition according to any one of claims 1 to 3 in the preparation of a medicament for treating chronic migraine.

10. The use according to claim 9, characterized in that: The dosage form of the drug for treating chronic migraine is an oral preparation, which is selected from any one of granules, tablets, capsules, powders, decoctions or pills.