A Chinese medicine composition for treating vascular neurosis headache

Abstract

The invention discloses a Chinese medicine composition for treating vascular neurosis headache, which is prepared from the following raw materials in parts by weight: 10-15 parts of earthworm, 10-20 parts of white peony root, 20-40 parts of stone cassia seed, 20-40 parts of calcined dragon bone, 20-40 parts of calcined oyster, 5-15 parts of gastrodia, 5-15 parts of scutellaria, 10-15 parts of chuanxiong, 10-30 parts of salvia miltiorrhiza, 10-15 parts of gardenia, 1-5 parts of liquorice, and 20-30 parts of millettia. The composition of the invention has the effects of calming the liver and nourishing blood, promoting blood circulation and relieving pain through specific medicinal flavors and dosages. In terms of treating vascular neurosis headache, the effect is better than the currently commonly used Western medicine ibuprofen, and has clinical practical promotion and application value.

Description

Technical Field

[0001] The invention specifically relates to a traditional Chinese medicine composition for treating vascular neurosis headache. Background Art

[0002] Vascular neurosis headache is a recurrent headache caused by vascular neuroregulation disorders in the head. Headaches can be aggravated by changes in body position, cold or heat stimulation, exertion, coughing, emotional changes, etc. Clinically, it is characterized by paroxysmal severe headaches on one or both sides, accompanied by blurred vision, nausea and vomiting. Most of them have a long course of illness and recurrent attacks, presenting as periodic, severe, throbbing pain, and clinical treatment is more difficult.

[0003] The prevalence of vascular neurosis headache in my country is 9.85‰, and the annual incidence is 0.797‰. At present, Western medicine mainly treats vascular neurosis headache symptomatically, using analgesics such as ibuprofen, etc. Traditional Chinese medicine has made gratifying progress in relieving short-term headaches through the treatment principles of promoting blood circulation and removing blood stasis, calming the liver and extinguishing wind, removing wind and dampness, unblocking meridians or resolving phlegm and opening the orifices, but it is not as good as Western medicine in completely eliminating headaches, and the long-term efficacy needs to be improved, which is far from meeting the needs of patients. Summary of the invention

[0004] To solve the above problems, the present invention provides a Chinese medicine composition for treating vascular neurosis headache, which is prepared from the following raw materials in parts by weight:

[0005] 10-15 parts of earthworms, 10-20 parts of white peony root, 20-40 parts of semen cassiae, 20-40 parts of dragon bones, 20-40 parts of oysters, 5-15 parts of gastrodia elata, 5-15 parts of scutellaria baicalensis, 10-15 parts of chuanxiong, 10-30 parts of salvia miltiorrhiza, 10-15 parts of gardenia jasminoides, 1-5 parts of liquorice, and 20-30 parts of millettia reticulata.

[0006] Furthermore, it is prepared from the following raw materials in parts by weight:

[0007] 12 parts of earthworms, 15 parts of white peony roots, 30 parts of semen cassiae, 30 parts of dragon bones, 30 parts of oysters, 10 parts of gastrodia elata, 15 parts of scutellaria baicalensis, 12 parts of ligusticum chuanxiong, 20 parts of salvia miltiorrhiza, 12 parts of gardenia jasminoides, 3 parts of liquorice, and 30 parts of millettia reticulata.

[0008] Furthermore, the dragon bone is a calcined dragon bone; and the oyster is a calcined oyster.

[0009] Furthermore, it is a preparation prepared from the powder of the raw material drug, or the water or organic solvent extract of the raw material drug as the active ingredient, and the addition of pharmaceutically acceptable excipients.

[0010] Furthermore, the preparation is an oral preparation.

[0011] Furthermore, the oral preparation is a solution, paste, granules, pills, tablets or powder.

[0012] The present invention also provides a method for preparing the aforementioned Chinese medicine composition, which comprises the following steps:

[0013] (1) Weigh the raw materials according to the above ratio;

[0014] (2) The raw material drug is ground into powder, or the water or organic solvent extract of the raw material drug is added with excipients or auxiliary ingredients commonly used in pharmaceuticals to obtain the powder.

[0015] The present invention also provides a use of the aforementioned traditional Chinese medicine composition in preparing a medicine for treating vascular neurosis headache.

[0016] Furthermore, the drug is a drug for treating migraine and / or orthosis.

[0017] Furthermore, the medicine is a medicine for treating migraine and / or headache caused by blood deficiency and blood stasis.

[0018] The Chinese medicine composition for treating vascular neurosis headache of the present invention comprises Rhizoma Dilonge which can soothe the liver, relieve pain, clear away heat and stop wind, and Radix Paeoniae Alba which can nourish blood, soothe the liver, and relieve pain as the main medicine; Semen Cassiae, Calcinated Dragon Bone, Calcinated Oyster which can soothe the liver, suppress yang, calm the nerves and calm the mind, and Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, and Rhizoma Spatholobi which can nourish blood and promote blood circulation as the assistant medicine; Radix Scutellariae and Fructus Gardeniae which can clear away heat, purge fire and cool blood as the assistant medicine; Radix Gastrodiae belongs to the liver meridian, leads all medicines to ascend to the head, and suppresses liver yang, dispels wind, dredges the meridians and relieves pain, and Radix Glycyrrhizae is used to harmonize all medicines. All medicines are used together to achieve the effects of nourishing yin and blood, dredge meridians and relieve pain, soothe the liver and extinguish wind, restore the functions of qi and blood of the internal organs, return yin and yang to balance, clear yang can rise, turbid yin can be strengthened, the brain meridians are unobstructed, the brain is nourished, and the headache disappears by itself, which embodies the principle of seeking the root cause of the disease.

[0019] Clinical trials have proven that the composition of the present invention has the effects of calming the liver and nourishing blood, promoting blood circulation and relieving pain through its specific medicinal flavor and dosage. In terms of treating vascular neurosis headache, its effect is better than the currently commonly used Western medicine ibuprofen, and has clinical reagent promotion and application value.

[0020] Obviously, according to the above contents of the present invention, in accordance with common technical knowledge and customary means in the art, without departing from the above basic technical ideas of the present invention, other various forms of modification, replacement or change may be made.

[0021] 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. DETAILED DESCRIPTION

[0022] Example 1 Preparation of the Chinese medicine composition of the present invention

[0023] Recipe: 12g earthworm, 15g white peony root, 30g stone cassia seed, 30g calcined dragon bone, 30g calcined oyster, 10g Gastrodia elata, 15g Scutellaria baicalensis, 12g Chuanxiong, 20g Salvia miltiorrhiza, 12g Gardenia jasminoides, 3g Licorice, 30g Millettia reticulata.

[0024] Preparation method: Weigh the medicinal ingredients according to the ratio, add 5 times the amount of water, soak for 30 minutes, then boil for 20 minutes, filter, and take the filtrate.

[0025] Example 2 Preparation of the Chinese medicine composition of the present invention

[0026] Recipe: 10g earthworm, 10g white peony root, 20g stone cassia seed, 20g dragon bone, 20g oyster, 5g gastrodia elata, 5g scutellaria baicalensis, 10g chuanxiong, 10g salvia miltiorrhiza, 10g gardenia, 1g licorice, 20g millettia reticulata.

[0027] Preparation method: Weigh the medicinal ingredients according to the ratio, add 4 times the amount of water, soak for 20 minutes, then boil for 30 minutes, filter, and take the filtrate.

[0028] Example 3 Preparation of the Chinese medicine composition of the present invention

[0029] Recipe: 15g earthworm, 20g white peony root, 40g limestone, 40g dragon bone, 40g oyster, 15g gastrodia, 15g scutellaria, 15g chuanxiong, 30g salvia miltiorrhiza, 15g gardenia, 5g licorice, 30g millettia reticulata.

[0030] Preparation method: Weigh the medicinal ingredients according to the ratio, add 8 times the amount of water, soak for 20 minutes, then boil for 20 minutes, filter, and take the filtrate.

[0031] The beneficial effects of the present invention are described below through test examples.

[0032] Test Example 1 Clinical Study

[0033] 1 Materials and methods

[0034] 1.1 General Information

[0035] From April 2020 to March 2022, 200 patients with vascular neurosis headache who visited the outpatient clinic of Xichang Traditional Chinese Medicine Hospital were randomly divided into a treatment group and a control group according to the order of their visits, with 100 cases in each group. The treatment group was aged 21-66 years old, with an average age of (41.14±5.83) years old, including 36 males and 64 females; the course of disease was 6-144 months, with an average course of disease of (56.32±6.18) months; the control group was aged 19-65 years old, with an average age of (40.93±6.02) years old; including 38 males and 62 females; the course of disease was 7-132 months, with an average course of disease of (55.97±5.96) months. There was no significant difference in baseline data between the groups, which was comparable (P>0.05).

[0036] 1.2 Inclusion and Exclusion Criteria

[0037] Inclusion criteria: meeting the relevant criteria set by the International Headache Society in 2004; complete clinical data; willing to cooperate with the study. Exclusion criteria: patients with severe heart, liver, and kidney diseases, malignant tumors, immune system diseases, mental disorders, physical conditions that are contraindicated or allergic to the drugs used in this study, and patients who are unwilling to cooperate with the study. This study was approved by the Medical Ethics Committee of this hospital, and the enrolled patients gave informed consent.

[0038] 1.3 Treatment methods

[0039] Treatment group: self-made Pinggan Yangxue decoction: earthworm 12g, white peony root 15g, stone cassia twig 30g, calcined dragon bone 30g, calcined oyster 30g, gastrodia 10g, scutellaria baicalensis 15g, chuanxiong 12g, salvia miltiorrhiza 20g, gardenia 12g, licorice 3g, millettia 30g. Decoction method: add 900ml of water to the above, soak for 30 minutes, boil for 20 minutes, take 450ml of juice, take 3 times, 1 dose per day, 7 doses as a course of treatment. Generally take 2 courses of treatment, avoid spicy food during medication.

[0040] Control group: Oral western medicine: Ibuprofen sustained-release capsules (National Medicine Standard H10900089) 300mg, 2 times / d; Oryzanol (National Medicine Standard H41022837) 10mg, 3 times / d; Vitamin B1 (National Medicine Standard H42020611) 10mg, 3 times / d; Flunarizine capsules (National Medicine Standard H10930003) 10mg, taken orally before bedtime. One week of medication is one course of treatment, and generally two courses of medication are taken.

[0041] 1.4 Observation indicators and evaluation criteria

[0042] The symptom scores of the two groups before and after treatment were compared, including headache severity, headache frequency and duration. Among them, the headache severity was divided into 0, 1, 2, 3 and 4, and the score was further quantified according to the pain intensity grading: the pain scale was 9 points for those with a value of >6.5 and ≤10, 6 points for those with a value of >3.5 and ≤6.5, 3 points for those with a value of >0 and ≤3.5, and 0 points for those without pain. The frequency and duration of headaches were quantitatively scored, with the frequency of headaches evaluated as 0, 3, 6 and 9 points, respectively, as no attack / month, ≤2 times / month, 3-4 times / month, and ≥5 times / month; the duration was evaluated as 0, 3, 6 and 9 points, respectively, as no attack, <12h, 12-48h, and >48h. The higher the score, the more severe the condition.

[0043] 1.5 Statistical analysis

[0044] SPSS 19.0 statistical software was used to analyze the data. The quantitative data were analyzed by variance analysis with multiple sample mean comparison. Indicates that the comparison between groups is done by X 2 test.

[0045] 2 Results

[0046] 2.1 Criteria for determining efficacy

[0047] The method was formulated with reference to the "Diagnostic basis, syndrome classification, and efficacy evaluation of head wind" in the "Standards for Diagnosis and Efficacy of TCM Diseases" issued by the State Administration of Traditional Chinese Medicine and the "Guidelines for Clinical Research of New Chinese Medicines". The more objective indicator, namely the symptom score, was used for comparison.

[0048] 2.2 Treatment outcomes

[0049] Table 1 Comparison of symptom scores between the two groups before treatment

[0050]

[0051] There was no significant difference between the two groups before treatment (P>0.05).

[0052] Table 2 Comparison of symptom scores between the two groups after treatment

[0053]

[0054]

[0055] After treatment, there was a significant difference between the two groups (X 2 =1.8436, P<0.05);

[0056] * There is a significant difference between the two groups (X 2 =1.9104, P<0.05);

[0057] # The two groups were compared and the difference was significant (X 2 =1.7825, P<0.05).

[0058] 3. Typical cases

[0059] Patient Li, female, 50 years old, had recurrent headaches on the left side for more than 6 years, which were triggered by cold, emotional fluctuations, fatigue, etc. She had been examined in many hospitals (brain CT and cerebral blood flow map, etc.), and organic lesions were excluded. She was diagnosed with vascular neurosis headache. She often took antipyretic and analgesic drugs for symptomatic treatment, and the headache was relieved, but it recurred. In the past month, the left-sided headache recurred. The treatment effect of oral analgesics and intravenous infusion of ligustrazine and other drugs was poor. She came to the clinic on January 12, 2021. She complained of severe pain in the left temporal region, mainly distending pain and throbbing pain, pain in the occipital region, accompanied by dizziness, irritability, insomnia, memory loss, etc. The tongue was red, the fur was thin and white, and the pulse was stringy. Cerebral blood flow map examination showed: low and flat waves on the left side, asymmetric amplitudes on both sides, and increased cerebral vascular tension. Diagnosed as vascular neurosis headache, the syndrome was blood deficiency and hyperactivity of the liver, and the treatment should be to calm the liver and nourish blood, and expel wind and dredge the collaterals. The patient was treated with Pinggan Yangxue Decoction (i.e. the decoction prepared in Example 1), 1 dose per day. After taking 2 doses in a row, the headache was significantly relieved. The original prescription was continued, and all symptoms disappeared after 1 course of treatment.

[0060] 4 Discussion

[0061] The cause of vascular neurosis headache is still unknown. Western medicine believes that this disease is caused by ischemic spasm of one or several cerebral arteries of unknown cause. Vascular neurosis headache is actually a Western medicine disease name. When Western medicine diagnoses this disease, it mainly evaluates its symptoms and imaging characteristics. For example, the symptoms may be a full headache, or a headache in the frontal and temporal areas, forehead, etc., or sitting back and forth from left to right, with more than 5 attacks, each lasting 5-72 hours, and the pain is mainly moderate or severe, and some are also accompanied by nausea and vomiting. At the same time, the disease has a hidden onset, or recurring, or continued aggravation, mostly due to fatigue or huge emotional fluctuations. Using imaging examinations, such as Doppler ultrasound or cerebral blood flow mapping, it can be seen that the cerebral artery is insufficiently supplied with blood or cerebral vasospasm. Based on these, the clinical diagnosis can basically be made.

[0062] Traditional Chinese medicine believes that all wind-induced dizziness and vertigo are related to the liver. Emotional injury, liver qi discomfort, depression and fire, disturbing the clear orifices and causing headaches. Long-term illness consumes qi and blood, blood deficiency generates wind, liver wind moves internally, disturbing the clear orifices, and the clear orifices are not nourished, which causes pain, and headaches. Pinggan Yangxue Decoction uses earthworms that calm the liver, dredge the meridians and relieve pain, clear away heat and stop wind, and white peony root that nourishes blood, calms the liver, softens the liver and relieves pain as the main medicine; stone cassia, calcined dragon bone, calcined oyster three flavors that calm the liver, suppress yang, calm the mind and calm the mind and salvia miltiorrhiza, chuanxiong, and millettia three flavors that nourish blood and activate blood circulation are the ministers; Scutellaria baicalensis and Gardenia jasminoides that clear heat, purge fire and cool blood are the adjuvants; Gastrodia elata belongs to the liver meridian, leading all the medicines to go up to the head, and calms the liver yang, dispels wind, dredges the meridians and relieves pain; licorice harmonizes all the medicines as the messenger. The combined use of these medicines can nourish yin and blood, relieve pain, calm the liver and extinguish wind, restore the functions of qi and blood in the internal organs, return yin and yang to balance, allow the clear yang to rise and the turbid yin to be led, and the brain meridians to be unobstructed. If the brain is nourished, the headache will disappear, reflecting the principle of treating the disease at its root.

[0063] Looking at the whole prescription, it can soothe the liver and nourish blood, activate blood circulation and relieve pain, which is an ideal method for treating vascular neurosis headache. Indications: It is used for hemiplegic and eustachian headaches caused by blood deficiency and blood stasis. Symptoms: migraine or vertex pain, dizziness, fixed pain, dull complexion, pale tongue with yellow coating, stringy and thin pulse, etc., which are symptoms of liver blood deficiency and blood stasis.

Claims

1. A Chinese medicine composition for treating partial and normal headaches caused by blood deficiency and blood stasis, characterized in that: It is prepared from the following raw materials by weight: 12 parts of earthworms, 15 parts of white peony roots, 30 parts of semen cassiae, 30 parts of calcined dragon bones, 30 parts of calcined oyster shells, 10 parts of gastrodia elata, 15 parts of scutellaria baicalensis, 12 parts of ligusticum chuanxiong, 20 parts of salvia miltiorrhiza, 12 parts of gardenia jasminoides, 3 parts of liquorice, and 30 parts of millettia reticulata.

2. The Chinese medicine composition according to claim 1, characterized in that: It is a preparation made from the powder of the raw material drug, or the water or organic solvent extract of the raw material drug as the active ingredient, plus pharmaceutically acceptable excipients.

3. The Chinese medicine composition according to claim 2, characterized in that: The preparation is an oral preparation.

4. The Chinese medicine composition according to claim 3, characterized in that: The oral preparation is a solution, paste, granule, pill, tablet or powder.

5. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: It includes the following steps: (1) Weighing the API according to the weight proportions described in claim 1; (2) The raw material drug is ground into powder, or the water or organic solvent extract of the raw material drug is added with excipients or auxiliary ingredients commonly used in pharmaceuticals to obtain the powder.

6. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for treating vascular neurosis headache, characterized in that: The medicine is a medicine for treating migraine and / or headache caused by blood deficiency and blood stasis.

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