Traditional Chinese medicine composition for treating headache due to blood stasis and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine preparation for treating blood stasis headache and a preparation method thereof. The medicine is technically characterized by consisting of traditional Chinese medicinal materials and pharmaceutic adjuvants, the traditional Chinese medicinal materials comprise ligusticum wallichii, radix angelicae, peach kernel, safflower, radix paeoniae rubra, trogopterus dung and the like according to a specific proportion; the pharmaceutic adjuvants comprise honey, starch, ethanol, cane sugar, potassium sorbate and cane sugar powder. The medicine is suitable for treating dizziness, headache which is not healed for a long time, pains such as astringent spines and fixed pains, or amnesia, insomnia, palpitation, gloomy complexion, purple and dark tongue or spots and fine and astringent pulse symptoms, and has the effects of promoting blood circulation to remove blood stasis and relieving pains.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine compositions, and in particular to a medicine for treating blood stasis headache and a preparation method thereof. Background Art

[0002] Headache is a common symptom in clinical practice, which refers to the feeling of pain in the whole or part of the head, and it occurs in a variety of acute and chronic diseases. There are many causes of headache. Traditional Chinese medicine discusses headache as two types: exogenous and endogenous. Stasis headache is one of the headaches. Its symptoms include dizziness and swelling, severe tingling pain in the head, pain in a fixed place, intermittent, lingering and unhealed, petechiae or dark purple on the tongue, and sluggish pulse. It is mostly caused by long-term illness, qi stagnation and blood stasis or sequelae of trauma. The clinical characteristics of stasis headache are high incidence, accounting for about 1 / 2 of headaches, dizziness and swelling, tingling or throbbing pain on one or both sides, the pain in a fixed place, reduced by pressing, intermittent, often due to emotional fluctuations, dysmenorrhea or breast pain, thin white or thin yellow tongue coating, dark tongue or ecchymosis or petechiae, stringy and slow pulse, positive reactions in the head-down pain test and the jugular vein compression test, which seriously affects the patient's physical health and normal life.

[0003] Western medicine believes that blood stasis headache is related to blood circulation disorders, which may be caused by head trauma, vascular disease or long-term diseases. Examination requires CT scan and MRI of the head and neck, and neurological examination. Analgesics, anti-inflammatory drugs, antidepressants, and anti-epileptic drugs can be used for intervention. In severe cases, nerve blocks can be used to remove diseased tissue. However, the current cure rate of Western medicine is low, and surgical treatment has potential risks such as local anesthetic toxicity, syncope, nerve damage, and total spinal anesthesia.

[0004] Traditional Chinese medicine usually uses the Tongqiao Huoxue and Xuefu Zhuyu Decoction to treat headaches caused by blood stasis. For severe pain, scorpion, centipede, earthworm, angelica dahurica and other drugs should be added; for patients with qi deficiency, astragalus should be added. In the prescription, the dosage of red and white peony root and Chuanxiong should be slightly larger. It is precisely because of the problems in the treatment formula and dosage that the efficacy of the drugs for treating headaches caused by blood stasis in the prior art is not satisfactory, and the headaches are not cured for a long time.

[0005] The discomfort caused by blood stasis headache seriously hinders the patient's physical health and daily activities, and the existing technology has poor efficacy and high recurrence rate. Therefore, it is extremely important to seek drugs to treat ischemic femoral head necrosis. Summary of the invention

[0006] In order to solve the above problems, the present invention provides a Chinese medicine composition for treating blood stasis headache and a preparation method thereof.

[0007] In order to achieve the above object, the technical solution of the present invention is as follows:

[0008] The first object of the present invention is to provide a Chinese medicine composition for treating blood stasis headache, the Chinese medicine composition comprising the following components in parts by weight:

[0009] 12-18 weight parts of Chuanxiong 12-18 weight parts of Angelica dahurica

[0010] Peach kernel 7-15 weight parts Safflower 7-15 weight parts

[0011] 12-18 parts by weight of red peony root and 7-15 parts by weight of Ophiopogon japonicus.

[0012] In a preferred embodiment, the Chinese medicine composition comprises the following components in parts by weight:

[0013] 14-16 weight parts of Chuanxiong and 14-16 weight parts of Angelica dahurica

[0014] Peach kernel 8-12 weight parts Safflower 8-12 weight parts

[0015] 14-16 parts by weight of red peony root and 8-12 parts by weight of Ophiopogon japonicus.

[0016] In another preferred embodiment, the Chinese medicine composition comprises the following components in parts by weight:

[0017] 15-16 weight parts of Chuanxiong and 15-16 weight parts of Angelica dahurica

[0018] Peach kernel 9-11 parts by weight Safflower 9-11 parts by weight

[0019] 15-16 parts by weight of red peony root and 9-11 parts by weight of Ophiopogon japonicus.

[0020] In the most preferred embodiment, the Chinese medicine composition comprises the following components in parts by weight:

[0021] 15 weight parts of Chuanxiong and 15 weight parts of Angelica dahurica

[0022] Peach kernel 10 weight parts Safflower 10 weight parts

[0023] 15 parts by weight of red peony root and 10 parts by weight of Ophiopogon japonicus.

[0024] The second object of the present invention is to provide a Chinese medicine composition preparation for treating headache caused by blood stasis, wherein the pharmaceutical excipients are conventional pharmaceutical excipients.

[0025] Preferably, the pharmaceutical preparation is an oral preparation, preferably one of tablets, hard capsules, oral liquids, decoctions, granules or pellets.

[0026] Specifically, the Chinese medicine composition preparation is prepared from the Chinese medicine composition and pharmaceutical excipients, and the pharmaceutical excipients include one or more of honey, starch, ethanol, sucrose, potassium sorbate and sucrose powder.

[0027] The preparation method of the Chinese medicine composition for treating headache caused by blood stasis according to the third object of the present invention specifically comprises the following steps:

[0028] (1) Weigh each medicinal material according to the prescribed amount and crush it into coarse powder;

[0029] (2) mixing and decocting all the crude powders of the medicinal materials obtained in step (1) for three times, filtering, combining the decoctions, and concentrating them into an extract;

[0030] (3) The extract obtained in step (2) is mixed with pharmaceutical excipients to prepare different pharmaceutical preparations.

[0031] Furthermore, the above steps also include the step of extracting volatile oil:

[0032] (1) Weigh each medicinal material according to the prescribed amount and crush it into coarse powder;

[0033] (2) adding ten times the amount of 70-85% ethanol to all the crude powder of the medicinal materials obtained in step (1), immersing and refluxing for 3-5 hours, then adding 0.2-0.6 times the weight of β-cyclodextrin of the original medicinal materials and continuing to reflux for 2-3 hours, filtering, separating the filtrate and the filter residue, and drying the filtrate at low temperature to obtain a volatile oil inclusion compound;

[0034] (3) adding 2-3 times the amount of water to the Chinese medicine residue in step (2), mixing and decocting for 3 times, filtering, combining the decoction, and concentrating into an extract;

[0035] (4) The volatile oil inclusion compound and extract obtained in steps (2) and (3) are mixed with pharmaceutical excipients to prepare different pharmaceutical preparations.

[0036] If it is prepared into an oral liquid, its preparation method comprises the following steps:

[0037] (1) Add an appropriate amount of sucrose to boiling water to make it dissolve evenly, filter it, and make a monosaccharide syrup;

[0038] (2) Weighing each medicinal material according to the prescribed amount and crushing the medicinal materials into coarse powder;

[0039] (3) adding ten times the amount of 70-85% ethanol to all the crude powder of the medicinal materials obtained in step (1), immersing and refluxing for 3-5 hours, then adding 0.2-0.6 times the weight of β-cyclodextrin of the original medicinal materials and continuing to reflux for 2-3 hours, filtering, separating the filtrate and the filter residue, and drying the filtrate at low temperature to obtain a volatile oil inclusion compound;

[0040] (4) adding 2-3 times the amount of water to the Chinese medicine residue in step (2), mixing and decocting for 3 times, filtering, combining the decoction, and concentrating into an extract;

[0041] (5) adding the monosaccharide syrup obtained in step (1) to the volatile oil inclusion compound and extract obtained in steps (2) and (3), and adding purified water;

[0042] (6) Add potassium sorbate to the mixture obtained in step (5), mix well, and fill to obtain an oral solution.

[0043] Furthermore, if the granules are prepared, the preparation method comprises the following steps:

[0044] (1) Weigh each medicinal material according to the prescribed amount and crush it into coarse powder;

[0045] (2) adding ten times the amount of 70-85% ethanol to all the crude powder of the medicinal materials obtained in step (1), immersing and refluxing for 3-5 hours, then adding 0.2-0.6 times the weight of β-cyclodextrin of the original medicinal materials and continuing to reflux for 2-3 hours, filtering, separating the filtrate and the filter residue, and drying the filtrate at low temperature to obtain a volatile oil inclusion compound;

[0046] (3) adding 2-3 times the amount of water to the Chinese medicine residue in step (2), mixing and decocting for 3 times, filtering, combining the decoction, and concentrating into an extract;

[0047] (4) The volatile oil inclusion compound and extract obtained in steps (2) and (3) are mixed with pharmaceutical excipients to prepare granules.

[0048] If it is prepared into a decoction, its preparation method comprises the following steps:

[0049] (1) Weigh each medicinal material according to the prescribed amount and crush it into coarse powder;

[0050] (2) adding ten times the amount of 70-85% ethanol to all the crude powder of the medicinal materials obtained in step (1), immersing and refluxing for 3-5 hours, then adding 0.2-0.6 times the weight of β-cyclodextrin of the original medicinal materials and continuing to reflux for 2-3 hours, filtering, separating the filtrate and the filter residue, and drying the filtrate at low temperature to obtain a volatile oil inclusion compound;

[0051] (3) adding 2-3 times the amount of water to the Chinese medicine residue in step (2), mixing and decocting for 3 times, filtering, combining the decoction, and concentrating into an extract;

[0052] (4) The volatile oil inclusion compound, extract and honey obtained in steps (2) and (3) are heated and mixed, and concentrated to obtain a decoction.

[0053] Furthermore, if a hard capsule is prepared, the preparation method comprises the following steps:

[0054] (1) Weigh each medicinal material according to the prescribed amount and crush it into coarse powder;

[0055] (2) adding ten times the amount of 70-85% ethanol to all the crude powder of the medicinal materials obtained in step (1), immersing and refluxing for 3-5 hours, then adding 0.2-0.6 times the weight of β-cyclodextrin of the original medicinal materials and continuing to reflux for 2-3 hours, filtering, separating the filtrate and the filter residue, and drying the filtrate at low temperature to obtain a volatile oil inclusion compound;

[0056] (3) adding 2-3 times the amount of water to the Chinese medicine residue in step (2), mixing and decocting for 3 times, filtering, combining the decoction, and concentrating into an extract;

[0057] (4) drying the extract obtained in step (3) under reduced pressure to obtain a dry extract;

[0058] (5) crushing the volatile oil inclusion compound and dry extract obtained in steps (2) and (4), adding starch and mixing evenly;

[0059] (6) The mixture obtained in step (5) is granulated with ethanol, dried, granulated, and filled into capsules to obtain hard capsules.

[0060] The fourth object of the present invention is to provide the use of the traditional Chinese medicine composition, specifically: the use of the traditional Chinese medicine composition in the preparation of a medicine for treating blood stasis headache.

[0061] Furthermore, pharmacological experiments have confirmed that the Chinese medicine preparation can promote blood circulation, relieve pain and improve blood circulation.

[0062] Furthermore, the Chinese medicine preparation can be used in combination with other blood-activating and analgesic drugs in the preparation of drugs for treating headache caused by blood stasis.

[0063] The pharmacology or coordination mechanism of some of the raw materials in the above formula of the present invention is:

[0064] The main active ingredient in Chuanxiong, ligustrazine, can inhibit the contraction of vascular smooth muscle, dilate coronary arteries, increase brain and limb blood flow, and reduce peripheral vascular resistance. The decoction of Chuanxiong has a sedative effect on the central nervous system of animals and has a hypotensive effect. The root of Angelica dahurica is used as medicine, which has the functions of removing diseases and dampness, draining pus and promoting muscle growth, promoting blood circulation and relieving pain. It is mainly used to treat colds, headaches, rhinitis, and toothaches. It can treat leucorrhea, painful boils, swellings, and other symptoms. Its decoction and effective ingredients have anti-inflammatory, antipyretic, analgesic, spasmodic, hypotensive, and antibacterial effects. Peach kernel enters the heart, liver, and large intestine meridians. It is bitter, sweet, and flat. It has the effects of breaking blood and removing blood stasis, moistening dryness and lubricating the intestines. It is mainly used to treat amenorrhea, abdominal masses, blood accumulation due to febrile diseases, rheumatism, malaria, traumatic injuries, blood stasis and swelling, and constipation due to blood dryness. The alcohol extract of peach kernel has an anticoagulant effect and a weak hemolytic effect. It has a hypotensive effect on normal rats. Safflower is the dried flower of Carthamus tinctorius L., a plant of the Asteraceae family. It can promote blood circulation and menstruation, remove blood stasis and relieve pain. It is mainly used to treat amenorrhea, abdominal masses, dystocia, stillbirth, postpartum lochia, blood stasis and pain, carbuncle, and injury from falls. It has the effects of lowering blood pressure, inhibiting the heart, analgesia, sedation, and anti-inflammatory. Red peony root has the effects of clearing heat and cooling blood, dispersing blood stasis and relieving pain. It is used for fever and rashes, vomiting blood and epistaxis, red and swollen eyes, liver depression and hypochondria, amenorrhea and dysmenorrhea, abdominal pain from abdominal masses, injury from falls, carbuncle, and ulcer. It has the effects of anti-thrombosis, lowering blood lipids, anti-atherosclerosis, and analgesia. Wulingzhi is the dried feces of the orange-footed flying squirrel and flying squirrel of the family Squirrelidae. It has the effects of promoting blood circulation and dispersing blood stasis, and charcoal-frying to stop bleeding. It is used for blood stasis and pain in the heart and abdomen, dysmenorrhea, blood stasis and amenorrhea, and abdominal pain from blood stasis after childbirth. It can increase arterial blood flow, reduce vascular resistance, and relieve smooth muscle spasm.

[0065] Traditional Chinese medicine believes that injuries from falls, emotional distress, and phlegm-dampness disturbance are common causes of headaches caused by blood stasis. "Pain due to blockage" and "pain due to lack of nourishment" are the core pathogenesis. Phlegm and blood stasis are intertwined, causing the clear yang to not rise, the turbid yin to not descend, and the clear orifices to be blocked, resulting in "pain due to blockage"; endogenous blood stasis prevents the essence, qi, and blood from filling the brain veins, causing the clear orifices to lose nourishment and the meridians to be lack of nourishment, which leads to "pain due to lack of nourishment". Therefore, traditional Chinese medicine treatment of headaches caused by blood stasis is mainly to resolve blood stasis and relieve pain. All medicines are used together to achieve the effect of promoting blood circulation and relieving pain.

[0066] Pharmacological experiments have confirmed that the Chinese medicine composition of the present invention has a determined efficacy and can effectively improve the cerebral blood rheology, brain weight and brain tissue water content of a rat model of congestion headache, and at the same time has a more obvious therapeutic effect on headache; clinical cases have confirmed that for patients with congestion headache, the Chinese medicine composition of the present invention has a short treatment time and a low probability of recurrence.

[0067] Compared with the prior art, this solution has the following beneficial effects:

[0068] (1) The Chinese medicine composition of the present invention has a small dosage, a quick effect, a short treatment time and a low recurrence rate during treatment;

[0069] (2) The Chinese medicine composition of the present invention is a pure Chinese medicine preparation without any toxic side effects, and is particularly applicable to adolescents with a high incidence of the disease;

[0070] (3) The Chinese medicinal materials used in the Chinese medicine composition of the present invention are all conventional medicinal materials, and there are no special requirements for the preparation method. The overall cost is low and it has the value of popularization and application. BRIEF DESCRIPTION OF THE DRAWINGS

[0071] Figure 1 The effect of the Chinese medicine composition of the present invention on cerebral blood flow in rats with acute congestion model (compared with the normal control group: P < 0.01 ** Compared with the model control group, P<0.01 was used ## express);

[0072] Figure 2 The effect of the Chinese medicine composition of the present invention on the brain weight of rats with acute congestion model (compared with the normal control group: P < 0.01 ** Compared with the model control group, P<0.01 was used ## express);

[0073] Figure 3 The effect of the Chinese medicine composition of the present invention on the water content of brain tissue in rats with acute congestion model (compared with the normal control group: P < 0.01 ** Compared with the model control group, P<0.01 was used ## express). DETAILED DESCRIPTION

[0074] The above contents of the present invention are further described in detail below through specific implementation methods in the form of embodiments. However, this should not be understood as the scope of the above subject matter of the present invention being limited to the following examples. All technologies realized based on the above contents of the present invention belong to the scope of the present invention.

[0075] Similar modifications, replacements or changes made to the technical solution of the present invention based on the routine selection and industry experience of those skilled in the art are all within the protection scope of the present invention.

[0076] Example 1 Preparation of oral liquid

[0077] Formula:

[0078] Chuanxiong 12g Angelica dahurica 12g

[0079] Peach kernel 7g safflower 7g

[0080] Red peony root 12g, octyldophylla 7g;

[0081] The preparation method is:

[0082] Weigh each medicinal material according to the prescribed amount, and crush the medicinal materials into coarse powder; mix all the medicinal materials, and boil them for 3 times, boil them for 2.5 hours with 15 times the amount of water for the first time, boil them for 1.5 hours with 10 times the amount of water for the second time, and boil them for 1 hour with 6 times the amount of water for the third time, filter, combine the decoctions, and concentrate them into an extract with a relative density of 1.10-1.15 at 80°C, take sucrose and add it to the boiling water to dissolve it evenly, filter it, and make a monosyrup, add the monosyrup to the above-mentioned drug filtrate to make the final sugar content 20-60%, add purified water to the full amount, and then add 0.2% of the prepared amount of potassium sorbate, mix them evenly, and fill them to obtain the oral solution.

[0083] Example 2 Preparation of Decoction

[0084] Formula:

[0085] Chuanxiong 12g Angelica dahurica 18g

[0086] Peach kernel 7g safflower 15g

[0087] Red peony root 18g, cinnamomum officinale 15g;

[0088] Weigh each medicinal material according to the prescribed amount and crush it into coarse powder; mix all the medicinal materials and boil them three times, using 15 times the amount of water for the first time and boiling for 2.5 hours, using 10 times the amount of water for the second time and boiling for 1.5 hours, using 6 times the amount of water for the third time and boiling for 1 hour, filter, combine the decoctions, and concentrate to an extract with a relative density of 1.10-1.15 at 65°C, then add 50% of the amount of honey to the extract, heat and mix, and concentrate to an extract with a relative density of 1.3-1.35 at 65°C to obtain a decoction.

[0089] Example 3 Preparation of granules

[0090] Formula:

[0091] Chuanxiong 18g Angelica dahurica 18g

[0092] Peach kernel 15g safflower 15g

[0093] Red peony root 18g, cinnamomum officinale 15g;

[0094] The preparation method is:

[0095] Weigh each medicinal material according to the prescribed amount and crush it into coarse powder; add ten times the amount of 85% ethanol and reflux for extraction for 3 hours, then add β-cyclodextrin of 0.6 times the weight of the original medicinal material and continue to reflux for 3 hours, filter, separate the filtrate and the residue, and dry the filtrate at 60°C and 0.01Mpa to obtain a volatile oil inclusion compound; take the residue and add 3 times the amount of water, mix and boil for 3 times, filter, combine the decoction, and concentrate to an extract with a relative density of 1.20-1.25 at 65°C; mix the volatile oil inclusion compound, the extract and pharmaceutical excipients to prepare granules.

[0096] Example 4 Preparation of granules

[0097] Formula:

[0098] Chuanxiong 14g Angelica dahurica 14g

[0099] Peach kernel 8g safflower 12g

[0100] Red peony root 14g, octyldophylla 12g;

[0101] The preparation method is the same as that of Example 3.

[0102] Example 5 Preparation of granules

[0103] Formula:

[0104] Chuanxiong 16g Angelica dahurica 16g

[0105] Peach kernel 12g safflower 8g

[0106] Red peony root 16g, octyldophylla chinensis 8g;

[0107] The preparation method is the same as that of Example 3.

[0108] Example 6 Preparation of granules

[0109] Formula:

[0110] Chuanxiong 16g Angelica dahurica 15g

[0111] Peach kernel 11g safflower 8g

[0112] Red peony root 16g, Ophiopogon japonicus 9g;

[0113] The preparation method is the same as that of Example 3.

[0114] Example 7 Preparation of granules

[0115] Formula:

[0116] Chuanxiong 15g Angelica dahurica 16g

[0117] Peach kernel 9g safflower 11g

[0118] Red peony root 15g, cinnamon bark 11g;

[0119] The preparation method is the same as that of Example 3.

[0120] Example 8 Preparation of granules

[0121] Formula:

[0122] Chuanxiong 15g Angelica dahurica 15g

[0123] Peach kernel 10g safflower 10g

[0124] Red peony root 15g, Ophiopogon japonicus 10g; the preparation method is the same as that of Example 3.

[0125] Preparation of Comparative Example 1 Granules

[0126] Formula:

[0127] Chuanxiong 15g Angelica dahurica 15g

[0128] Peach kernel 10g safflower 10g

[0129] Red peony root 15g, Ophiopogon japonicus 10g; the preparation method is the same as that of Example 3.

[0130] Preparation of Comparative Example 1 Granules

[0131] Formula:

[0132] Chuanxiong 5g Angelica dahurica 40g

[0133] Peach kernel 5g safflower 10g

[0134] Red Peony Root 15g, Ophiopogon japonicus 5g; the preparation method is the same as that of Example 3.

[0135] Preparation of Comparative Example 2 Granules

[0136] Formula:

[0137] Chuanxiong 20g Angelica dahurica 2g

[0138] Peach kernel 20g safflower 20g

[0139] Red Peony Root 5g, Ophiopogon japonicus 10g; the preparation method is the same as that of Example 3.

[0140] Preparation of Comparative Example 3 Granules

[0141] Formula:

[0142] Chuanxiong 25g Angelica dahurica 25g

[0143] Peach kernel 20g Red peony root 5g

[0144] Ophiopogon japonicus 5g;

[0145] Preparation of Comparative Example 4 Granules

[0146] Formula:

[0147] 30g safflower, 15g magnolia

[0148] Peach kernel 10g Red peony root 15g

[0149] Panax notoginseng 5g;

[0150] The preparation method is the same as that of Example 3.

[0151] Preparation of Comparative Example 5 Granules

[0152] Formula:

[0153] Chuanxiong 5g Qianghuo 25g

[0154] Peach kernel 5g safflower 5g

[0155] Gardenia 25g, Ophiopogon japonicus 25g;

[0156] The preparation method is the same as that of Example 3.

[0157] Experimental Example 1 Effect of the Chinese medicine composition of the present invention on acute blood stasis model rats

[0158] 1 Materials and methods

[0159] 1.1 Experimental animals and husbandry

[0160] Healthy male SPF SD rats, weight: 200-220 g. Animal license number: SYXK (Lu) 2018-0008.

[0162] The experiment began after the animals were acclimatized to the laboratory for 1 week.

[0163] 1.2 Experimental methods

[0164] Rats were randomly divided into normal control group, model group, high-dose group of Example 3, low-dose group of Example 3, Example 6 group, comparative example 3 group, comparative example 5 group and positive control drug group, with 10 rats in each group.

[0165] Each group was gavaged with the corresponding Chinese medicine composition preparation, wherein the low-dose group of Example 3 and the high-dose group of Example 3 were gavaged with the Chinese medicine composition in sequence, with a raw drug content of 8g / kg / d and 32g / kg / d, the Example 2 group, the Comparative Example 2 group, and the Comparative Example 6 group were administered with a raw drug content of 8g / kg / d, the positive control drug group was aspirin 20mg / kg, for 7 consecutive days, and the normal control group and the model group were gavaged with an equal volume of 0.5% sodium carboxymethyl cellulose solution. After 6 days of administration, except for the model group, each rat was subcutaneously injected with 0.1% epinephrine 0.15ml / 200g, and injected again in the same way 4h later, and the rats were immersed in 8°C cold water for 5min between the two injections, and fasted after treatment.

[0166] 1.3 Detection indicators

[0167] 1.3.1 Rat blood rheology test

[0168] On the 7th day after administration, 5 mL of blood was collected from the rat's carotid artery and centrifuged at 4°C to obtain the supernatant for measuring plasma viscosity.

[0169] 1.3.2 Detection of rat cerebral blood flow

[0170] Half an hour after administration on the 7th day, the rats were anesthetized with 20% urethane, the scalp was cut open to expose the pia mater tissue, and the cerebral blood flow was tested with a Doppler laser probe.

[0171] 1.3.3 Detection of rat brain weight and brain tissue water content

[0172] After administration on the 7th day, the rats were killed, the brains were removed, the wet weight was measured, and then the brains were dried at 110°C to calculate the brain water content. The calculation formula is:

[0173] Brain water content = [(wet weight - dry weight) / wet weight × 100%]

[0174] 2 Experimental results

[0175] 2.1 Daily observation of animals:

[0176] After modeling, rats in each group showed abnormal agitation to varying degrees, some of them showed restlessness such as grabbing the cage with both feet, and their food and water intake decreased. Among them, the agitation of rats in the high-dose group of Example 3 was lower than that in other groups, and the agitation of rats in the model group was the most obvious.

[0177] 2.2 Effects on hemorheological parameters in rats

[0178] The results are shown in Table 1. As can be seen from the table, compared with the blank control group, the plasma viscosity of the model group changed significantly, and the difference was statistically significant (P < 0.01). Compared with the model group, the plasma viscosity of rats in each example group was improved, among which the differences in the high-dose group of Example 3, the low-dose group of Example 3, the Example 6 group, and the positive control drug group were statistically significant (P < 0.01).

[0179] Table 1 Low, medium and high shear rates

[0180]

[0181]

[0182] Note: Compared with the normal control group: P < 0.01 ** Compared with the model control group, P<0.01 was used ## express.

[0183] 2.3 Effects on cerebral blood flow in rats

[0184] The results are as follows Figure 1 As shown. Figure 1It can be seen that compared with the model group, the cerebral blood flow of rats in each embodiment group was improved, among which the differences in the high-dose group of Example 3, the low-dose group of Example 3, the Example 6 group, and the positive control drug group were statistically significant (P < 0.01), while the differences between the comparative embodiment 3 group and the comparative embodiment 5 group and the model group were not significant (P > 0.05), indicating that the Chinese medicine composition of the present invention can improve the cerebral blood flow of rats with acute congestion headache model, increase the cerebral blood perfusion of rats, and then improve the degree of cerebral ischemia and hypoxia in rats.

[0185] 2.4 Effects on brain weight and water content in rats

[0186] The results of the effect of the Chinese medicine composition of the present invention on the brain weight and brain tissue water content of rats are as follows: Figure 2 , 3 As shown. Figure 2 , Figure 3 It can be seen that compared with the normal control group, the brain weight and brain tissue water content of the rats in the model group were significantly increased (P < 0.01), indicating that the acute blood stasis model of the rats in the model group was successfully established. Compared with the model group, the brain weight and brain tissue water content of the rats in each embodiment group were reduced to varying degrees, among which, the differences between the high-dose group of Example 3, the low-dose group of Example 3, the Example 6 group, the positive control drug group and the model group were statistically significant (P < 0.01), while the differences between the comparative implementation group 3 and the comparative embodiment 5 group and the model group were not significant (P > 0.05).

[0187] Experimental Example 2 Effect of the Chinese medicine composition of the present invention on headache rats

[0188] 1 Materials and methods

[0189] 1.1 Experimental animals and husbandry

[0190] Healthy SPF SD rats, half male and half female, weight: 220-260 g. Animal license number: SYXK (Lu) 2018-0008.

[0191] The experiment began after the animals were acclimatized to the laboratory for 1 week.

[0192] 1.2 Experimental methods

[0193] SD rats were randomly divided into a model group, a high-dose group of Example 3, a low-dose group of Example 3, an Example 6 group, a comparative example 3 group, a comparative example 5 group, and a positive control drug group, with 10 rats in each group.

[0194] Each group was gavaged with the corresponding Chinese medicine composition preparation, wherein the low-dose group of Example 3 and the high-dose group of Example 3 were gavaged with the Chinese medicine composition in sequence, with the combined raw drug content of 8g / kg / d and 32g / kg / d, the Example 2 group, the Comparative Example 2 group, and the Comparative Example 6 group were gavaged with the combined raw drug content of 8g / kg / d, and the positive control drug group was aspirin 20mg / kg.

[0195] After the experiment started, 1 ml / 100 g nitroglycerin injection was subcutaneously injected into the rats in each group 30 minutes after administration, and the behavior of the rats was observed and recorded. The model group was injected with an equal amount of normal saline. The above operation was repeated for five consecutive days.

[0196] 2 Experimental results

[0197] 2.1 Animal Observation:

[0198] After the experimental headache model was induced by injection of nitroglycerin injection, rats in each group showed abnormal agitation to varying degrees, with some rats scratching the cage with both feet, screaming, shaking their heads, and scratching their faces with their hind limbs. The specific manifestations are shown in Table 2:

[0199] Table 2 Effects on headache model test in rats

[0200]

[0201] Note: Compared with the normal control group: P < 0.01 ** Compared with the model control group, P<0.01 was used ## express.

[0202] It can be seen that the high-dose group of Example 3 of the present invention significantly shortened the pain reaction time of rats, reduced the pain of rats within 90 minutes, and significantly reduced the duration.

[0203] Clinical cases:

[0204] 1. Liu XX, male, 42 years old, had tingling pain on one side of his head for several days, which was relieved by pressing, accompanied by irritability, insomnia, and neck discomfort. Western medicine diagnosed it as "vascular tension headache". He was given 16g of Chuanxiong, 18g of Angelica dahurica, 10g of Peach Kernel, 10g of Carthamus tinctorius, 14g of Paeonia lactiflora, and 10g of Ophiopogon japonicus, decocted in water, once a day. He said that his headache was relieved after taking the medicine, and after taking 3 more doses, the headache symptoms disappeared. He has been well so far in follow-up.

[0205] 2. Zhao XX, female, 33 years old, had tingling sensation on the top of the head for 1 year, was irritable and angry, had dark red tongue with ecchymosis, thin white tongue coating, and slow pulse. She was treated with 15g of Chuanxiong, 15g of Angelica dahurica, 10g of Peach Kernel, 10g of Carthamus tinctorius, 15g of Red Peony Root, and 10g of Ophiopogon japonicus, decocted in water to 300ml, and taken warm in the morning, noon, and evening. After 1 week of treatment, the headache was completely relieved, and after taking it for another 2 weeks, she was cured. There was no recurrence in the 3-year follow-up.

[0206] 3. Li XX, female, 65 years old, dizziness, throbbing pain on both sides, pain relief when pressing, poor sleep, emotional agitation, decocted with 18g of Chuanxiong, 18g of Angelica dahurica, 15g of Peach Kernel, 15g of Safflower, 18g of Red Peony Root, and 15g of Ophiopogon japonicus, and taken warm in the morning, noon, and evening. After 2 weeks, all symptoms were cured, and there was no recurrence during the 2-year follow-up.

Claims

1. A Chinese medicine preparation for treating blood stasis headache, characterized in that: The Chinese medicine preparation is composed of a Chinese medicine composition and pharmaceutical excipients. In parts by weight, the Chinese medicine composition includes the following components in parts by weight: 12-18 weight parts of Chuanxiong 12-18 weight parts of Angelica dahurica Peach kernel 7-15 weight parts Safflower 7-15 weight parts 12-18 parts by weight of red peony root, 7-15 parts by weight of Ophiopogon japonicus; The pharmaceutical excipients are conventional pharmaceutical excipients.

2. The Chinese medicine preparation according to claim 1, characterized in that: The Chinese medicine composition comprises the following components in parts by weight: 14-16 weight parts of Chuanxiong and 14-16 weight parts of Angelica dahurica Peach kernel 8-12 weight parts Safflower 8-12 weight parts 14-16 parts by weight of red peony root and 8-12 parts by weight of Ophiopogon japonicus.

3. The Chinese medicine preparation according to claim 1, characterized in that: The Chinese medicine composition comprises the following components in parts by weight: 15-16 weight parts of Chuanxiong and 15-16 weight parts of Angelica dahurica Peach kernel 9-11 parts by weight Safflower 9-11 parts by weight 15-16 parts by weight of red peony root and 9-11 parts by weight of Ophiopogon japonicus.

4. The Chinese medicine preparation according to claim 1, characterized in that: The Chinese medicine composition comprises the following components in parts by weight: 15 weight parts of Chuanxiong and 15 weight parts of Angelica dahurica Peach kernel 10 weight parts Safflower 10 weight parts 15 parts by weight of red peony root and 10 parts by weight of Ophiopogon japonicus.

5. The Chinese medicine preparation according to claim 1, characterized in that: The pharmaceutical excipients include one or more of honey, starch, ethanol, sucrose, potassium sorbate and sucrose powder.

6. The Chinese medicine preparation according to claim 1, characterized in that: The Chinese medicine preparation is an oral preparation. Preferably, the oral preparation is a tablet, a hard capsule, an oral liquid, a decoction, a granule or a pellet.

7. The Chinese medicine preparation according to claim 1, characterized in that: The preparation method of the Chinese medicine composition is as follows: (1) Weigh each medicinal material according to the prescribed amount and crush it into coarse powder; (2) mixing and decocting all the crude powders of the medicinal materials obtained in step (1) for three times, filtering, combining the decoctions, and concentrating them into an extract; (3) The extract obtained in step (2) is mixed with pharmaceutical excipients to prepare a pharmaceutical preparation, wherein the pharmaceutical preparation is a tablet, a hard capsule, an oral liquid, a decoction, a granule or a pellet.

8. The Chinese medicine preparation according to claim 7, characterized in that: The preparation method of the Chinese medicine composition further comprises a volatile oil extraction step: (1) Weigh each medicinal material according to the prescribed amount and crush it into coarse powder; (2) adding ten times the amount of 70-85% ethanol to all the crude powder of the medicinal materials obtained in step (1), immersing and refluxing for 3-5 hours, then adding 0.2-0.6 times the weight of β-cyclodextrin of the original medicinal materials and continuing to reflux for 2-3 hours, filtering, separating the filtrate and the filter residue, and drying the filtrate at low temperature to obtain a volatile oil inclusion compound; (3) adding 2-3 times the amount of water to the Chinese medicine residue in step (2), mixing and decocting for 3 times, filtering, combining the decoction, and concentrating into an extract; (4) The volatile oil inclusion compound and extract obtained in steps (2) and (3) are mixed with pharmaceutical excipients to prepare different pharmaceutical preparations.

9. Use of the Chinese medicine preparation according to claim 1 in preparing a medicament for removing blood stasis and relieving pain.

10. The use according to claim 9, characterized in that The Chinese medicine preparation is used in combination with other blood stasis-removing and analgesic drugs in the preparation of drugs for treating headache caused by blood stasis.

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