Pharmaceutical composition for treating headache as well as preparation and application thereof

Abstract

The invention discloses a pharmaceutical composition for treating headache as well as a preparation and application thereof. The pharmaceutical composition comprises the following components in parts by weight: 10-30 parts of gastrodia elata, 5-20 parts of cassia twig, 10-30 parts of radix paeoniae alba, 10-30 parts of radix salviae miltiorrhizae, 5-20 parts of pseudo-ginseng, 10-20 parts of nux prinsepiae, 5-20 parts of processed rhizoma arisaematis, 10-30 parts of stiff silkworm, 10-30 parts of radix angelicae, 10-30 parts of ligusticum wallichii, 10-30 parts of ligusticum and 5-20 parts of liquorice. The pharmaceutical composition can be prepared into a preparation by adding pharmaceutically acceptable auxiliary materials. The pharmaceutical composition and the preparation can be used for treating headache.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceuticals, specifically relating to a pharmaceutical composition for treating headaches, its formulation, and its application. Background Technology

[0002] Headache is one of the most common clinical symptoms. It generally refers to pain localized to the upper half of the head, including the area above the line connecting the eyebrows, the upper edge of the auricle, and the external occipital protuberance. Headache is one of the most common neurological disorders, with numerous causes. It can be divided into primary and secondary headaches. Primary headaches refer to headaches of unknown cause and are the most common clinically, with tension headaches and migraines being the most frequent. Secondary headaches include headaches caused by various intracranial lesions, such as cerebrovascular diseases, intracranial infections, and head injuries, as well as systemic diseases such as fever, internal environment disorders, and the abuse of psychoactive drugs.

[0003] Western medicine treatment for headaches lacks personalized plans and typically focuses on relieving pain symptoms and nourishing nerves. Treatment often involves the use of painkillers such as ibuprofen and aspirin (nonsteroidal anti-inflammatory drugs). While these medications can quickly relieve headaches, they do not address the underlying cause, thus only treating the symptoms, not the root cause. Long-term use of painkillers can easily lead to various side effects, including gastrointestinal reactions and liver and kidney damage, and can also cause drug dependence.

[0004] Traditional Chinese medicine (TCM) treatment for headaches typically employs non-drug methods such as acupuncture and massage. While these methods have fewer side effects, the treatment course is relatively long, requiring high patient adherence for effectiveness. Furthermore, acupuncture and massage have limitations, necessitating hospital visits for treatment. TCM treatment emphasizes individualized diagnosis and treatment based on the patient's specific condition and constitution; inaccurate diagnosis and prescription will render the treatment ineffective. Summary of the Invention

[0005] To address the shortcomings of existing technologies, the present invention aims to provide a pharmaceutical composition for treating headaches, its formulation, and its application. The pharmaceutical composition of the present invention can be used to treat headaches, especially headaches caused by phlegm or blood stasis, and has a very good therapeutic effect.

[0006] The objective of this invention is achieved through the following technical solution: A pharmaceutical composition for treating headaches comprises the following components in parts by weight: 10-30 parts of Gastrodia elata, 5-20 parts of Cinnamomum cassia, 10-30 parts of Paeonia lactiflora, 10-30 parts of Salvia miltiorrhiza, 5-20 parts of Panax notoginseng, 10-20 parts of Prunus armeniaca seed, 5-20 parts of processed Arisaema heterophyllum, 10-30 parts of Bombyx mori, 10-30 parts of Angelica dahurica, 10-30 parts of Ligusticum chuanxiong, 10-30 parts of Ligusticum striatum, and 5-20 parts of Glycyrrhiza uralensis.

[0007] Preferably, the composition includes the following components in parts by weight: 15-25 parts of Gastrodia elata, 10-20 parts of Cinnamomum cassia, 15-30 parts of Paeonia lactiflora, 15-30 parts of Salvia miltiorrhiza, 10-20 parts of Panax notoginseng, 10-15 parts of Prunus armeniaca seed, 10-20 parts of processed Arisaema heterophyllum, 15-30 parts of Bombyx mori, 15-30 parts of Angelica dahurica, 15-30 parts of Ligusticum chuanxiong, 15-25 parts of Ligusticum striatum, and 10-20 parts of Glycyrrhiza uralensis.

[0008] Preferably, the composition includes the following components in parts by weight: 15-20 parts of Gastrodia elata, 10-15 parts of Cinnamomum cassia, 15-20 parts of Paeonia lactiflora, 15-25 parts of Salvia miltiorrhiza, 10-15 parts of Panax notoginseng, 10-15 parts of Prunus armeniaca seed, 10-15 parts of processed Arisaema heterophyllum, 15-20 parts of Bombyx mori, 15-20 parts of Angelica dahurica, 15-20 parts of Ligusticum chuanxiong, 15-20 parts of Ligusticum striatum, and 10-15 parts of Glycyrrhiza uralensis.

[0009] A formulation of the aforementioned pharmaceutical composition, wherein the pharmaceutical composition is prepared by adding pharmaceutically acceptable excipients to the pharmaceutical composition.

[0010] Preferably, the formulation is a decoction, granules, capsules or pills prepared according to conventional methods.

[0011] A method for preparing a pharmaceutical composition for treating headaches includes the following steps:

[0012] (1) Take Gastrodia elata, Cinnamomum cassia, Paeonia lactiflora, Salvia miltiorrhiza, Panax notoginseng, Angelica dahurica, Ligusticum chuanxiong and Ligusticum striatum, mix and grind them, pass through an 80-mesh sieve to obtain fine powder; put the fine powder into a mixer and mix for 35 minutes, then set aside.

[0013] (2) Take the seeds of the rhizome, silkworm, prepared arisaema, and licorice, add water and decoct three times, one hour each time. The amount of water added is 7-8 times the amount of the first decoction, 6-7 times the amount of the second decoction, and 6-7 times the amount of the third decoction. Filter the decoction, combine the filtrates, and concentrate under reduced pressure at below 80°C to obtain an extract with a relative density of 1.28-1.32 (about 60°C) for later use.

[0014] (3) Take the fine powder of the medicinal material, dilute the extract with boiling purified water to form pills, cover the surface with medicinal charcoal, dry in an oven below 80°C until the moisture content is qualified, polish, and you will get the product.

[0015] The pharmaceutical composition described herein is used to prepare a medicament for treating headaches.

[0016] The formulation of the pharmaceutical composition is used in the preparation of a medicament for treating headaches.

[0017] The beneficial effects of this invention are:

[0018] This invention uses Gastrodia elata to calm the liver, extinguish wind, unblock the meridians, and relieve pain, treating headaches caused by various reasons; processed Arisaema heterophyllum to resolve damp phlegm and dispel wind phlegm; and Ligusticum chuanxiong, a "key medicine for headaches in various meridians," to dispel wind, invigorate blood, and relieve pain. The three herbs combined serve as the principal herbs to calm the liver, extinguish wind, dispel wind, resolve phlegm, invigorate blood, unblock the meridians, and relieve pain. Cinnamomum cassia, Salvia miltiorrhiza, Panax notoginseng, Angelica dahurica, and Ligusticum striatum are used as the assistant herbs to warm and unblock the meridians, invigorate blood, remove blood stasis, dispel wind, and relieve pain, thus enhancing the effects of invigorating blood, unblocking the meridians, dispelling wind, and relieving pain. Paeonia lactiflora, Prunus armeniaca, and Bombyx batryticatus are used as adjuvant herbs to nourish yin and blood, dispel wind, relieve spasms, resolve phlegm, and dissipate nodules, taking into account different concurrent symptoms of headache and preventing the herbs from being too pungent and drying. Glycyrrhiza uralensis is used as the guiding herb to harmonize the properties of all the herbs.

[0019] Gastrodia elata: Sweet, neutral. Enters the Liver meridian. It calms wind and stops spasms, suppresses liver yang, dispels wind and unblocks the meridians. Used for infantile convulsions, epilepsy, tetanus, headache and dizziness, hemiplegia, numbness of limbs, and rheumatic pain. It mainly contains vanillin, gastrodin, gastrogenin, gastrodin ether, and gastrodia polysaccharides, etc., and has sedative, hypnotic, and analgesic effects. It can also improve microcirculation, dilate blood vessels, and lower blood pressure.

[0020] Cinnamon twig: pungent, sweet, and warm. It enters the heart, lung, and bladder meridians. It promotes sweating and relieves muscle tension, warms and unblocks the meridians, assists yang qi transformation, and calms and descends qi. It is used for amenorrhea due to blood stasis, joint pain, phlegm retention, edema, palpitations, and sudden abdominal pain. It mainly contains volatile oils that can dilate blood vessels, improve microcirculation, and have analgesic and anti-inflammatory effects.

[0021] White peony root: bitter, sour, slightly cold. It enters the liver and spleen meridians. It nourishes blood and regulates menstruation, astringes yin and stops sweating, softens the liver and relieves pain, and calms liver yang. It is used for blood deficiency and chlorosis, irregular menstruation, spontaneous sweating, night sweats, hypochondriac pain, abdominal pain, limb spasms, headache, and dizziness. It mainly contains paeoniflorin, paeonol, benzoylpaeoniflorin, volatile oil, and fatty oil, and has good antispasmodic and analgesic effects.

[0022] Purple Salvia miltiorrhiza: Bitter, slightly cold. Enters the Heart and Liver meridians. Invigorates blood circulation and removes blood stasis, regulates menstruation and relieves pain, clears the heart and eliminates irritability, cools the blood and reduces swelling. Used for chest pain, abdominal and hypochondriac pain, abdominal masses, painful arthralgia due to heat, insomnia, irregular menstruation, dysmenorrhea, amenorrhea, and sores and swelling. Mainly contains tanshinone, tanshinone, tanshinol, and tanshinone, etc., which have antiarrhythmic, coronary artery dilation, and coronary blood flow increasing effects, as well as certain sedative and analgesic effects.

[0023] Panax notoginseng: Sweet, slightly bitter, and warm in nature. It enters the liver and stomach meridians. It disperses blood stasis, stops bleeding, reduces swelling, and relieves pain. It is used for hemoptysis, hematemesis, epistaxis, hematochezia, metrorrhagia, traumatic bleeding, chest and abdominal pain, and swelling and pain from falls. It mainly contains ginsenosides and notoginsenosides, which shorten bleeding and clotting time, and have hematopoietic, analgesic, anti-inflammatory, and anti-tumor effects.

[0024] 蕤仁:Sweet, slightly cold. It acts on the liver meridian. It dispels wind and heat, nourishes the liver and improves eyesight. It is used for red and swollen eyes, erosion of the eyelid margin, and aversion to light due to dim eyesight. It contains components such as protein, fat, cellulose, kaempferol, isocorypalmine, diploptene, ursolic acid, daucosterol, β-sitosterol, vanillic acid, etc., and has the effects of reducing blood pressure, calming, antibacterial, and anti-inflammatory.

[0025] 制天南星:Bitter, pungent, warm; toxic. It acts on the lung, liver, and spleen meridians. It dries dampness and reduces phlegm, dispels wind and stops convulsions, and dissipates binds and reduces swelling. It is used for stubborn phlegm cough, wind-phlegm dizziness, wind-phlegm congestion in stroke, deviation of the mouth and eyes, hemiplegia, epilepsy, infantile convulsions, tetanus; externally used for carbuncles and snake and insect bites. It contains trace elements such as triterpenoid saponins, mannitol, benzoic acid, etc., and has obvious analgesic and sedative effects.

[0026] 僵蚕:Salty, pungent, flat. It acts on the liver, lung, and stomach meridians. It stops wind and relieves convulsions, dispels wind and relieves pain, and dissipates phlegm and binds. It is used for liver wind associated with phlegm, convulsions and twitching, infantile acute convulsions, tetanus, deviation of the mouth in stroke, wind-heat headache, red eyes and sore throat, rubella itching, and swelling and pain of the submandibular region. It contains protein and fat (palmitic acid, oleic acid, linoleic acid) and other trace elements, and has the effects of sedation, hypnosis, anticoagulation, anti-tumor, etc.

[0027] 白芷:Pungent, warm. It acts on the stomach, large intestine, and lung meridians. It relieves exterior syndrome and dispels cold, dispels wind and relieves pain, promotes nasal passage, dries dampness and stops leukorrhea, and reduces swelling and discharges pus. It is used for common cold headache, pain in the supraorbital bone, nasal congestion and discharge, allergic rhinitis, nasal sinusitis, toothache, leukorrhea, and swelling and pain of sores and ulcers. It mainly contains coumarin components and volatile oils, and has the effects of antipyretic, anti-inflammatory, analgesic, spasmolytic, and anti-cancer.

[0028] 川芎:Pungent, warm. It acts on the liver, gallbladder, and pericardium meridians. It promotes blood circulation and qi movement, dispels wind and relieves pain. It is used for chest pain due to chest impediment, stabbing pain in the chest and hypochondrium, swelling and pain from falls and bruises, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to mass in the abdomen, headache, and pain due to wind-dampness arthralgia.

[0029] 藁本:Pungent, warm. It acts on the bladder meridian. It dispels wind, disperses cold, eliminates dampness, and relieves pain. It is used for wind-cold common cold, headache at the vertex, and pain due to wind-dampness arthralgia. It contains volatile oils such as ligustilide, cnidilide, senkyunolide, etc., and alkaloids such as tetramethylpyrazine, and has the effects of dilating the coronary artery, increasing coronary blood flow, dilating the cerebral blood vessels, reducing vascular resistance, significantly increasing cerebral and limb blood flow, and improving microcirculation.

[0030] 甘草:Sweet, flat. It acts on the heart, lung, spleen, and stomach meridians. It invigorates the spleen and replenishes qi, clears heat and detoxifies, reduces phlegm and relieves cough, relieves spasm and pain, and harmonizes various herbs. It is used for weakness of the spleen and stomach, lassitude and weakness, palpitations and shortness of breath, cough with profuse phlegm, spasmodic pain in the epigastric and abdominal regions and limbs, carbuncles and sores, and relieving the toxicity and potency of drugs. It contains glycyrrhetinic acid and flavonoid components, and has the effects of anti-arrhythmia and spasmolysis. Detailed implementation manners

[0031] The present invention will be further described below in conjunction with embodiments, but the present invention is not limited to the embodiments.

[0032] Example 1

[0033] A pharmaceutical composition comprising the following components: 30g of Gastrodia elata, 20g of Cinnamomum cassia, 30g of Paeonia lactiflora, 30g of Salvia miltiorrhiza, 20g of Panax notoginseng, 20g of Prunus armeniaca seed, 20g of processed Arisaema heterophyllum, 30g of Bombyx mori, 30g of Angelica dahurica, 30g of Ligusticum chuanxiong, 30g of Ligusticum striatum, and 20g of Glycyrrhiza uralensis.

[0034] Example 2

[0035] A pharmaceutical composition comprising the following components: 10g of Gastrodia elata, 5g of Cinnamomum cassia, 10g of Paeonia lactiflora, 10g of Salvia miltiorrhiza, 5g of Panax notoginseng, 10g of Prunus armeniaca seed, 5g of processed Arisaema heterophyllum, 10g of Bombyx mori, 10g of Angelica dahurica, 10g of Ligusticum chuanxiong, 10g of Ligusticum striatum, and 5g of Glycyrrhiza uralensis.

[0036] Example 3

[0037] A pharmaceutical composition comprising the following components: 15g of Gastrodia elata, 10g of Cinnamomum cassia, 15g of Paeonia lactiflora, 15g of Salvia miltiorrhiza, 10g of Panax notoginseng, 15g of Prunus armeniaca seed, 15g of processed Arisaema heterophyllum, 15g of Bombyx mori, 15g of Angelica dahurica, 15g of Ligusticum chuanxiong, 15g of Ligusticum striatum, and 15g of Glycyrrhiza uralensis.

[0038] Example 4

[0039] A pharmaceutical composition comprising the following components: 20g of Gastrodia elata, 15g of Cinnamomum cassia, 20g of Paeonia lactiflora, 20g of Salvia miltiorrhiza, 15g of Panax notoginseng, 12g of Prunus armeniaca seed, 10g of processed Arisaema heterophyllum, 20g of Bombyx mori, 20g of Angelica dahurica, 20g of Ligusticum chuanxiong, 20g of Ligusticum striatum, and 10g of Glycyrrhiza uralensis.

[0040] Example 5

[0041] A pharmaceutical composition comprising the following components: 12g of Gastrodia elata, 9g of Cinnamomum cassia, 12g of Paeonia lactiflora, 12g of Salvia miltiorrhiza, 9g of Panax notoginseng, 10g of Prunus armeniaca seed, 9g of Arisaema heterophyllum, 12g of Bombyx mori, 12g of Angelica dahurica, 12g of Ligusticum chuanxiong, 12g of Ligusticum striatum, and 9g of Glycyrrhiza uralensis.

[0042] Example 6

[0043] A pharmaceutical composition comprising the following components: 25g Gastrodia elata, 12g Cinnamomum cassia, 25g Paeonia lactiflora, 25g Salvia miltiorrhiza, 18g Panax notoginseng, 18g Prunus armeniaca seed, 15g Arisaema heterophyllum, 25g Bombyx mori, 25g Angelica dahurica, 25g Ligusticum chuanxiong, 25g Ligusticum striatum, and 18g Glycyrrhiza uralensis.

[0044] Example 7

[0045] A formulation of a pharmaceutical composition is prepared by soaking the pharmaceutical composition described in any one of Examples 1-6 in water, decocting it twice, combining the decoctions, filtering, concentrating it into a thick paste, drying it, pulverizing it into a fine powder, adding an appropriate amount of dextrin, starch or other suitable excipients, mixing it well, and preparing it into tablets, powders, pills or other formulations.

[0046] Example 8

[0047] A formulation of a pharmaceutical composition is prepared according to the following steps:

[0048] (1) Weigh out the Chinese herbal medicine pieces according to the proportions of the pharmaceutical compositions described in any one of Examples 1-6;

[0049] (2) Take Gastrodia elata, Cinnamomum cassia, Paeonia lactiflora, Salvia miltiorrhiza, Panax notoginseng, Angelica dahurica, Ligusticum chuanxiong and Ligusticum striatum, mix and grind them, pass through an 80-mesh sieve to obtain fine powder; put the fine powder into a mixer and mix for 35 minutes, then set aside.

[0050] (3) Take the seeds of Rhizoma Achyranthis Bidentatae, Bombyx Batryticatus, processed Arisaema heterophyllum, and Glycyrrhizae Radix et Rhizoma, add water and decoct three times, one hour each time. The amount of water added is 7-8 times the amount of the seeds for the first time, 6-7 times the amount of the seeds for the second time, and 6-7 times the amount of the seeds for the third time. Filter the decoction, combine the filtrates, and concentrate them under reduced pressure below 80°C to obtain an extract with a relative density of 1.28-1.32 (about 60°C) for later use.

[0051] (4) Take the fine powder of the medicinal material, dilute the extract with boiled purified water to form pills, cover the surface with medicinal charcoal, dry in an oven below 80°C until the moisture content is qualified, polish, and you will get the product.

[0052] Application Examples - The pharmaceutical composition described in this invention is used to treat headaches.

[0053] I. Research Methods

[0054] Patients who meet the inclusion criteria of phlegm-dampness headache syndrome or blood stasis headache syndrome in traditional Chinese medicine within the past five years are selected and treated with the drug composition described in this invention. The clinical efficacy and adverse reactions are observed.

[0055] II. Research Subjects

[0056] Patients with phlegm-dampness headache syndrome or blood stasis headache syndrome.

[0057] III. Traditional Chinese Medicine Diagnostic Criteria

[0058] Referencing "Internal Medicine of Traditional Chinese Medicine" (11th Edition) and "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs"

[0059] 1. Phlegm-dampness headache syndrome

[0060] Main symptoms: headache feeling like a bandage, fullness and tightness in the chest and abdomen, vomiting of phlegm and saliva.

[0061] Secondary symptoms: bland taste in the mouth, poor appetite, swollen tongue with a white and greasy coating, and a wiry and slippery pulse.

[0062] Diagnosis: The patient must present with two or more of the main symptoms and at least three or more of the secondary symptoms, and the diagnosis can be made by combining the symptoms with the tongue and pulse.

[0063] 2. Headache due to blood stasis

[0064] Main symptom: A sharp, persistent headache that is fixed in one spot.

[0065] Secondary symptoms: The tongue is dark purple, or has ecchymosis or petechiae, the coating is thin and white, and the pulse is deep, thready or thready and hesitant.

[0066] Diagnosis: The patient must present with two or more of the main symptoms and at least three or more of the secondary symptoms, and the diagnosis can be made by combining the symptoms with the tongue and pulse.

[0067] IV. Western Medicine Diagnostic Criteria

[0068] Referencing the "Guidelines for the Diagnosis and Treatment of Migraine in China" (2022 Edition) and the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs"

[0069] 1. Common migraine without aura:

[0070] (1) At least 5 episodes.

[0071] (2) If left untreated, each episode lasts 4 to 72 hours.

[0072] (3) Having at least two of the following characteristics: ① Unilateral; ② Pulsating; ③ Moderate or severe (limited or stopped daily activities); ④ Headache aggravated by climbing stairs or other similar daily physical activities.

[0073] (4) At least one of the following is present during the attack: ① nausea and / or vomiting; ② photophobia and phonophobia.

[0074] (5) Having one of the following characteristics: ① The medical history and physical examination do not suggest evidence of organic disease; ② The medical history and physical examination suggest the possibility of a certain organic disease, but relevant laboratory tests have ruled it out; ③ Although there is a certain organic disease, the first onset of migraine is not closely related to the disease.

[0075] 2. Typical migraine with aura:

[0076] (1) Meets two of the following criteria and has had at least two episodes.

[0077] (2) Meets at least 3 of the following characteristics: ① has one or more aura symptoms with localized cortical and / or brainstem dysfunction; ② has at least one aura symptom that gradually develops and lasts for more than 4 minutes, or has two or more symptoms that occur in succession; ③ the duration of the aura symptom is less than 60 minutes; ④ there is no interval between the aura symptom and the headache attack.

[0078] (3) Having one of the following characteristics: ① Medical history and physical examination do not suggest evidence of organic disease; ② Medical history and physical examination suggest the possibility of a certain organic disease, but relevant laboratory tests have ruled it out; ③ Although there is a certain organic disease, the first onset of migraine is not closely related to the disease.

[0079] V. Inclusion Criteria

[0080] 1. Those who meet the diagnostic criteria of Western medicine for migraine without aura (common type) and migraine with aura (typical type);

[0081] 2. Those who meet the diagnostic criteria for headache syndrome with phlegm turbidity or headache syndrome with blood stasis in traditional Chinese medicine;

[0082] 3. Age 18 years and above to 70 years and below, gender not limited;

[0083] 4. Those whose CT or MRI head scan reports show no organic diseases.

[0084] VI. Exclusion Criteria

[0085] 1. Age under 18 or over 70; pregnant or breastfeeding women;

[0086] 2. Patients with hypertension, traumatic brain injury, or organic brain lesions;

[0087] 3. Special types of migraines, such as oculomotor migraine and hemiplegic migraine;

[0088] 4. Comorbid serious primary diseases of the cardiovascular, liver, kidney and hematopoietic systems;

[0089] 5. Mentally ill patients;

[0090] 6. Individuals allergic to the research drugs;

[0091] 7. Those who do not meet the inclusion criteria, do not take medication as prescribed, or whose efficacy cannot be determined or whose data is incomplete, thus affecting the assessment of efficacy or safety.

[0092] VII. Administration (Pills)

[0093] 1. Take 4 grams with warm water, twice a day, for one month as one course of treatment.

[0094] 2. Avoid spicy and pungent foods while taking this medication.

[0095] 3. Discontinue other medications during treatment.

[0096] VIII. Criteria for Evaluating Therapeutic Effect

[0097] Formulated with reference to the efficacy evaluation standards of the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs":

[0098] The efficacy index N = (pre-treatment score - post-treatment score) / pre-treatment score × 100% (nimodipine method)

[0099] Overall effective rate = (cured + significantly effective + effective) / total number of cases × 100%.

[0100] 1. Clinical cure: No recurrence of migraine symptoms after the course of treatment is completed, and no recurrence occurs for 1 month after stopping medication.

[0101] 2. Significant effect: Clinical symptoms are significantly improved, with 70% ≤ efficacy index < 95%.

[0102] 3. Effective: Clinical symptoms improved, with 30% ≤ efficacy index < 70%.

[0103] 4. Ineffective: No improvement in clinical symptoms, efficacy index <30%.

[0104] IX. Summary of Clinical Efficacy

[0105] This study observed a total of 95 valid cases. Among them, there were 20 male patients and 75 female patients; 35 patients were aged 18-30 years, 50 patients were aged 31-50 years, and 10 patients were aged 51-70 years.

[0106] In a study of 95 patients with headache treated with the pharmaceutical composition described in this application, after one course of treatment (1 month), 20 cases (21.05%) were cured, 30 cases (31.58%) showed significant improvement, 30 cases (31.58%) showed improvement, and 15 cases (15.79%) showed no improvement. After one month of treatment, the overall effective rate for the 95 patients was 84.21%. Clinical observation items are shown in the statistical table.

[0107] Clinical efficacy statistics table

[0108]

[0109] 10. Adverse Reactions

[0110] Clinical applications have shown no toxic side effects or adverse reactions.

[0111] XI. Typical Cases

[0112] 1. Patient Yin, female, 38 years old, presented on August 10, 2023, with a history of recurrent headaches for over 3 years. She reported experiencing unilateral headaches without any obvious cause recently. Before the headache, she experienced blurred vision and flashing lights in her vision for about an hour, followed by a unilateral headache. The pain was described as a heavy, radiating sensation to the ipsilateral eye socket and brow ridge, primarily throbbing. During the pain, she was unable to perform normal activities or work, and experienced chest tightness, nausea, and vomiting. She had previously been diagnosed with migraines at another hospital. Her current symptoms included poor mental state, loss of appetite, poor sleep, loose stools, clear and copious urine, pale tongue with a white, greasy coating, and a wiry, slippery pulse. Traditional Chinese medicine diagnosed her with "phlegm-dampness headache." She was prescribed pills prepared according to the method described in Example 8 of this invention, based on the drug composition of Example 5. After one course of treatment, she has not experienced a headache recurrence for nearly three months, her appetite and bowel movements are normal, and her sleep is good.

[0113] 2. Patient Zhang, female, 44 years old, presented on February 21, 2024, with a history of recurrent headaches for over 10 years, which had worsened in the past month. She reported frequent, one-sided headaches without any obvious cause over the past month, which had been somewhat relieved after taking ibuprofen. The headaches were primarily throbbing pain on the left side of her head, radiating to the left ear and eye socket, with each attack lasting approximately 3 hours. These attacks were accompanied by dizziness, nausea, dry heaving, and a desire to defecate. She had previously been diagnosed with migraines at another hospital. Her current symptoms included photophobia, preference for quiet, bland taste in the mouth, loss of appetite, frequent urination with clear urine, a pale tongue with a white, greasy coating, and a slippery pulse. Traditional Chinese medicine diagnosed her with "phlegm-dampness headache." She was prescribed pills prepared according to the method described in Example 8 of this invention, based on the drug composition of Example 5. After one course of treatment, the frequency of headaches decreased from 4 times per month to once per month, and the duration of pain was less than 1 hour. After continuing for two more courses of treatment, she has not experienced any headaches for nearly six months, and her diet and bowel movements have returned to normal.

[0114] 3. Patient Zhou, female, 66 years old, presented on February 19, 2024, with a history of recurrent unilateral headaches for over six months. She reported experiencing blurred vision and scotomas in one eye before each headache attack, lasting approximately one hour. The headache was characterized by a sharp, stabbing pain at the vertex, localized to a fixed location, intense and prolonged, accompanied by vomiting, photophobia, and cold intolerance. Self-administered painkillers were ineffective, prompting her to seek medical attention at a local hospital. Blood pressure and a head CT scan were normal. Current symptoms included fatigue, poor appetite, poor sleep, normal bowel movements, a purplish-dark tongue with prominent sublingual veins, a thin white coating, and a thready, hesitant pulse. The TCM diagnosis was "blood stasis headache." She was given pills prepared according to the method described in Example 8 of this invention, based on the pharmaceutical composition of Example 4. After one course of treatment, the headaches did not recur for nearly six months, and her mental state, sleep, appetite, and bowel movements improved.

[0115] 4. Patient Li, female, 53 years old, presented on February 1, 2024, with a history of recurrent headaches for over 10 years. She reported experiencing headaches 1-2 times per month. Previous treatments, including oral Chinese and Western medicine and acupuncture, had been ineffective. Recently, she experienced a headache attack following an argument, primarily a throbbing pain on the right side of her head, described as a "wrapped" headache, accompanied by chest tightness, nausea, and vomiting. The pain subsided after several hours, but self-administered painkillers proved ineffective. Current symptoms included poor mental state, poor sleep, loss of appetite, irritability, distension in the hypochondriac regions, a large, swollen tongue with a white, greasy coating, and a wiry, slippery pulse. The TCM diagnosis was "phlegm-dampness headache." She was prescribed pills prepared according to the method described in Example 8 of this invention, based on the drug composition of Example 5. After one course of treatment, the pain significantly decreased, with the duration of pain lasting approximately half an hour. She continued treatment for another course. A follow-up visit one month later revealed no headache recurrence, good sleep and appetite, and regular bowel movements.

[0116] 5. Patient Li, male, 42 years old, had suffered from recurrent headaches for over 8 years, with attacks occurring every half month. He came for consultation on October 7, 2023. The patient described the headache as sharp and stabbing, with severe pain, fixed on the right side, each episode lasting more than 2 hours. He had taken "flunarizine capsules, gastrodin tablets, and ibuprofen" on his own, which provided some relief, but the frequency and intensity of the attacks did not improve. He had previously been diagnosed with "migraine" at another hospital. Current symptoms included: fatigue, weakness, reluctance to speak, poor appetite, dark purple tongue, thin white tongue coating, thready and hesitant pulse, and normal bowel movements. The TCM diagnosis was "blood stasis headache". He was given pills prepared according to the preparation method of Example 8 of this invention, based on the drug composition of Example 4. After one course of treatment, the headache did not recur for nearly 3 months, his mental state was good, his appetite was good, and his bowel movements were normal.

[0117] 6. The above cases are only some of the cases observed in clinical practice, and the drug compositions used are only some of the drug compositions. In actual clinical use, the dosage of the specific drugs in the drug composition can be arbitrarily selected within the scope of this invention according to the different clinical symptoms of the patients.

Claims

1. A pharmaceutical composition for treating headaches, characterized in that, By weight, it consists of the following components: Gastrodia elata 10-30 parts, Cinnamomum cassia 5-20 parts, Paeonia lactiflora 10-30 parts, Salvia miltiorrhiza 10-30 parts, Panax notoginseng 5-20 parts, Prunus armeniaca 10-20 parts, Arisaema heterophyllum 5-20 parts, Bombyx mori 10-30 parts, Angelica dahurica 10-30 parts, Ligusticum chuanxiong 10-30 parts, Ligusticum striatum 10-30 parts, Glycyrrhiza uralensis 5-20 parts.

2. A formulation of the pharmaceutical composition according to claim 1, characterized in that, The pharmaceutical composition is formulated by adding pharmaceutically acceptable excipients.

3. A formulation of the pharmaceutical composition according to claim 2, characterized in that, The formulation is prepared in the form of decoction, granules, capsules or pills according to conventional methods.

4. A method for preparing a formulation of the pharmaceutical composition according to claim 2, characterized in that, Includes the following steps: (1) Take Gastrodia elata, Cinnamomum cassia, Paeonia lactiflora, Salvia miltiorrhiza, Panax notoginseng, Angelica dahurica, Ligusticum chuanxiong and Ligusticum striatum, mix and grind them, pass through an 80-mesh sieve to obtain fine powder; put the fine powder into a mixer and mix for 35 minutes, then set aside. (2) Take the seeds of the rhizome, the silkworm, the prepared arisaema, and the licorice root, add water and decoct three times, one hour each time. The amount of water added is 7-8 times the amount of the seed for the first time, 6-7 times the amount of the seed for the second time, and 6-7 times the amount of the seed for the third time. Filter the decoction, combine the filtrates, and concentrate them under reduced pressure at 80°C to an extract with a relative density of 1.28-1.32 for later use. (3) Take the fine powder from step (1), dilute the extract with boiled purified water to form pills, cover with pharmaceutical charcoal, dry in an oven below 80°C until the moisture content is qualified, polish, and you will get the product.

5. Use of the pharmaceutical composition of claim 1 in the preparation of a medicament for treating headache.

6. Use of a formulation of the pharmaceutical composition of claim 2 in the preparation of a medicament for treating headache.

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