Pharmaceutical composition and application

Abstract

The invention discloses a pharmaceutical composition and application, and belongs to the technical field of traditional Chinese medicines. The invention discloses a pharmaceutical composition for treating dizziness. The pharmaceutical composition comprises the following raw materials: rhizoma pinellinae praeparata, rhizoma atractylodis macrocephalae fried with bran, gastrodia elata, uncaria, rhizoma cimicifugae, radix bupleuri, platycodon grandiflorum, ligusticum wallichii and radix cyathulae. The pharmaceutical composition takes rhizoma atractylodis macrocephalae stir-fried with bran as a monarch drug and has the effects of invigorating spleen and replenishing qi; rhizoma gastrodiae has the effects of calming liver wind and activating meridians to stop pain, and rhizoma pinellinae praeparata and rhizoma gastrodiae serve as ministerial drugs; the rhizoma chuanxiong has the effects of pungent temperature rising, qi promoting, blood activating, peripheral blood vessel expanding and microcirculation disturbance improving, the radix cyathulae has the effects of promoting blood circulation, removing blood stasis and descending sexual capacity, and the rhizoma chuanxiong and the radix cyathulae are mutually used and are increased and decreased, so that qi and blood circulatory flow is realized, and no blood stasis is caused; uncaria can clear heat, calm liver and clear head and eyes; in addition, a small amount of cimicifugae foetidae and radix bupleuri are used for lifting the clear yang to clear the head and eyes, and the five medicines are used as adjuvant drugs. The platycodon grandiflorum is used as the medicine and leads the medicine to move upwards to directly reach the head surface; the traditional Chinese medicine is used as a conductant drug. All the medicines are combined to lift clear yang, circulatory flow of qi and blood, both symptoms and root causes are taken into consideration, wind-phlegm is treated, and qi and blood are regulated together.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a pharmaceutical composition and application thereof. Background Art

[0002] Vertigo is a complex condition, and its pathogenesis involves multiple physiological systems and neural pathways. First, the vestibular system is an important part of the pathogenesis of vertigo. The vestibular organs in the inner ear are responsible for sensing the position, movement, and balance of the head. However, abnormalities in the granular material in the inner ear can cause benign paroxysmal positional vertigo, leading to abnormal vestibular system function. In addition, blood circulation problems are also a key aspect of the pathogenesis of vertigo. The normal function of the brain and inner ear requires adequate blood supply. Insufficient constriction or dilation of blood vessels can lead to insufficient blood supply, which can cause headaches, dizziness, and vertigo. Abnormalities of the central nervous system, such as stroke, brain injury, or neurodegenerative diseases, can interfere with these functions and cause vertigo. Visual problems can also cause vertigo. Visual information interacts with balance and positioning information. When this interaction is disturbed, vertigo occurs. Nerve conduction problems are also part of the pathogenesis of vertigo. Problems in the transmission of neural signals can lead to interference with balance perception and spatial positioning, which in turn causes vertigo. Drugs and chemicals also have an impact on the pathogenesis of vertigo. Some drugs, chemicals, or drug side effects can interfere with the normal function of the nervous system and cause vertigo. Mental state, emotions and psychological factors, such as anxiety and depression, can affect the way the brain processes, thus causing vertigo. It can be seen that the pathogenesis of vertigo involves the complex synergy of multiple physiological systems. Therefore, the complexity of vertigo makes its diagnosis and treatment a challenge in the medical field.

[0003] At present, there are many Chinese and Western medicines that can treat vertigo on the market, but drugs specifically used for the treatment of vertigo are extremely rare. Chemical drug treatment mainly relieves the symptoms of vertigo. Although it works quickly, it has large toxic side effects and can easily affect the patient's endocrine, heart, liver and kidney functions. In addition, it cannot treat the physical symptoms related to the disease and often relapses. For example, it is difficult to control the recurrence of Meniere's syndrome with current drugs. Summary of the invention

[0004] In order to solve the problems existing in the prior art, the purpose of the present invention is to provide a pharmaceutical composition and application, so as to provide a new method for treating vertigo.

[0005] The technical solution of the present invention to solve the above technical problems is as follows: a pharmaceutical composition is provided, comprising the following raw materials in parts by weight: 6-9 parts of French Pinellia, 15 parts of fried Atractylodes macrocephala with bran, 9 parts of Gastrodia elata, 15-30 parts of Uncaria rhynchophylla, 3 parts of Cimicifuga heracleifolia, 6 parts of Bupleurum, 6 parts of Platycodon grandiflorum, 9-15 parts of Chuanxiong, and 20-30 parts of Cyathula capitata.

[0006] Furthermore, the pharmaceutical composition includes the following raw materials in parts by weight: 9 parts of French Pinellia, 15 parts of fried Atractylodes macrocephala, 9 parts of Gastrodia elata, 30 parts of Uncaria rhynchophylla, 3 parts of Cimicifuga heracleifolia, 6 parts of Bupleurum, 6 parts of Platycodon grandiflorum, 15 parts of Chuanxiong, and 30 parts of Cyathula capitata.

[0007] The present invention provides an application of the above-mentioned pharmaceutical composition in preparing a preparation for treating vertigo.

[0008] Furthermore, the vertigo may be vestibular vertigo, non-vestibular vertigo or vertigo caused by headache.

[0009] Furthermore, vestibular vertigo is divided into central vestibular vertigo and peripheral vestibular vertigo.

[0010] Furthermore, non-vestibular vertigo includes ocular vertigo, vertigo caused by cardiovascular system diseases, vertigo caused by blood system diseases, and vertigo caused by endocrine system diseases.

[0011] Furthermore, headaches include migraine, vascular neurosis headache, tension-type headache, trigeminal autonomic headache, hypertensive headache, other primary headaches, secondary headaches, painful cranial neuropathy and other types of headaches.

[0012] The present invention also provides a preparation for treating vertigo, which comprises the above-mentioned pharmaceutical composition.

[0013] Furthermore, the preparation is an oral preparation.

[0014] Further, the preparations include decoctions, granules, capsules, tablets, oral liquids, pills, tinctures and syrups.

[0015] The present invention has the following beneficial effects: the pharmaceutical composition of the present invention uses bran-fried Atractylodes macrocephala as the main drug, which can invigorate the spleen and replenish qi. Clear yang does not rise, turbid yin does not fall, the soil is weak and the wood is insulted, and wind and phlegm disturb the upper part, so the Banxia is used to dry dampness and resolve phlegm, and the Gastrodia elata is used to calm the liver and extinguish wind, dredge the meridians and relieve pain, and the two are the ministerial drugs; the clear orifices are not nourished, and the wind evil takes advantage of it, so it is indispensable to dispel wind and dissipate evil, Chuanxiong is pungent, warm and floating, promotes qi and activates blood circulation, can dilate peripheral blood vessels and improve microcirculation disorders, and Chuanxiong is used to activate blood circulation and remove blood stasis, and is good at descending, and the two drugs are used in conjunction with each other, one rises and the other falls, so that qi and blood circulate without the risk of blood stasis; Uncaria rhynchophylla clears heat and calms the liver, clears and benefits the head; a small amount of Cimicifugae and Bupleurum are used to lift the clear yang to clear and benefit the head, and these five drugs are the adjuvant drugs. Platycodon grandiflorum is the boat of the medicine, which leads the medicine upward to the head and face; it is used as the guiding medicine. The combination of these medicines can raise the clear yang, circulate the qi and blood, take into account both the symptoms and the root cause, treat both wind and phlegm, and harmonize the qi and blood, thus achieving a good therapeutic effect and improving the patient's vertigo symptoms. DETAILED DESCRIPTION

[0016] The principles and features of the present invention are described below in conjunction with the examples, which are only used to explain the present invention and are not intended to limit the scope of the present invention. If no specific conditions are specified in the examples, the conditions are carried out according to conventional conditions or the conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments is not specified, they are all conventional products that can be purchased commercially.

[0017] Pinellia tuber: Drying dampness and dissolving phlegm. The ancients said that "all diseases are accompanied by phlegm". Many difficult and serious chronic diseases are closely related to "phlegm". Stir-fried Atractylodes macrocephala: warm in nature and sweet in taste. Its effects are: strengthening the spleen and replenishing qi, dispelling dampness and stopping diarrhea, and diuresis. Studies have found that Atractylodes macrocephala significantly inhibits platelet aggregation and has a vasodilatory effect. Gastrodia elata: Gastrodia elata is a medicine for the qi of the liver meridian. It is sweet, flat and moist. It is good at calming the liver and stopping wind and stopping dizziness. The disease is mainly located in the brain and liver. Small and medium arteriosclerosis is the key pathogenesis of cerebral artery insufficiency and is closely related to internal wind. It is often treated with calming the liver and relieving muscles, dispelling wind and activating blood circulation as the treatment principle. Gastrodia elata is good at improving cerebral blood supply and protecting nerve function. It is combined with Chuanxiong to relax muscles and relieve muscles, activate blood circulation and dispel wind, and promote qi and relieve pain. The three medicines can be used together to improve cerebral blood supply and treat dizziness.

[0018] Chuanxiong: It is a blood Qi medicine, which helps to clear Yang and relieve depression. For those with depression in the middle burner, Chuanxiong must be used. It can open and lift Qi to raise it, and then the depression will naturally fall. It is the messenger of blood and Qi of Yin and Yang. Chuanxiong can promote blood circulation and remove blood stasis, dispel wind and dampness. It is combined with Chuanxiong to regulate the rise and fall, and treat Qi and blood together. Combined with the pathological characteristics of vertigo, the fall is greater than the rise, and it mainly plays the role of promoting Qi and blood. Cimicifuga: It has the effects of relieving the exterior and raising Yang, clearing away heat and detoxifying. When doctors in all dynasties used Qi-tonifying and Yang-raising agents, the dosage of Cimicifuga was relatively small. Bupleurum: A small amount of Bupleurum is used in combination with Cimicifuga, and the left and right are complementary, and the two rise and complement each other, exerting their power to raise Yang and lift the sunken. Bupleurum leads the liver Qi from the left to the top, and Cimicifuga leads the stomach Qi from the right to the top. Small doses can play the role of raising Yang Qi. "Compendium of Materia Medica" says that it can "lead the Shaoyang clear Qi to go up" and raise the liver Yang Qi. Because Bupleurum has the properties of ascending and dispersing, it belongs to the category of wind medicine. Wind medicine cannot ascend unless it is light and clear. If it is to play its purpose of ascending liver yang, it should follow the nature of yang ascending and floating, and be used in small doses. Uncaria rhynchophylla: sweet in taste, cool in nature, enters the liver and pericardium meridians, has the effects of calming wind and relieving convulsions, clearing heat and calming the liver.

[0019] Platycodon grandiflorum: relieves sore throat and relieves nasal congestion; it can benefit the diaphragm and treat lung abscess; it is a vessel for all medicines; it is a meridian for the lungs. The heart and lungs are located in the upper part of the body. If you want the medicine to reach the upper part of the body or the head and face, Platycodon grandiflorum can be a vessel for all medicines to float up.

[0020] Embodiment 1: A pharmaceutical composition comprising the following raw materials in parts by weight: 9 parts of French Pinellia, 15 parts of fried Atractylodes macrocephala with bran, 9 parts of Gastrodia elata, 30 parts of Uncaria rhynchophylla, 3 parts of Cimicifuga heracleifolia, 6 parts of Bupleurum, 6 parts of Platycodon grandiflorum, 15 parts of Ligusticum chuanxiong, and 30 parts of Cyathula capitata.

[0021] Embodiment 2: A pharmaceutical composition comprising the following raw materials in parts by weight: 8 parts of French Pinellia, 15 parts of bran-fried Atractylodes, 9 parts of Gastrodia, 20 parts of Uncaria, 3 parts of Cimicifuga, 6 parts of Bupleurum, 6 parts of Platycodon, 12 parts of Chuanxiong, and 25 parts of Cyathula.

[0022] Embodiment 3: A pharmaceutical composition comprising the following raw materials in parts by weight: 6 parts of French Pinellia, 15 parts of fried Atractylodes macrocephala with bran, 9 parts of Gastrodia elata, 15 parts of Uncaria rhynchophylla, 3 parts of Cimicifuga heracleifolia, 6 parts of Bupleurum, 6 parts of Platycodon grandiflorum, 9 parts of Ligusticum chuanxiong, and 20 parts of Cyathula capitata.

[0023] Comparative Example: The kudzu root and gastrodia elata soup comprises the following raw materials in parts by weight: 10 parts of Gastrodia elata, 30 parts of Pueraria root, 15 parts of Uncaria rhynchophylla, 30 parts of Millettia spatholobi, 10 parts of Angelica sinensis, 15 parts of Ligusticum chuanxiong, 10 parts of Pheretima, 10 parts of Ligusticum chuanxiong, 15 parts of Salvia miltiorrhiza, 10 parts of Alismatis and 6 parts of Panax notoginseng.

[0024] Test example: (1) Test method A total of 20 patients with vertigo were included in the study for grouping (the trial time was July 2024-August 2024). The grouping method was the random number table method, and they were evenly divided into a control group of 10 cases and a test group of 10 cases, including 7 females and 3 males in the control group, aged 39-60 years old, with a course of 1-8 years; the test group: 5 females and 5 males, aged 21-59 years old, with a course of 1-7 years. Comparison of clinical data of patients in each group, P>0.05. The patients in the control group were all treated with Gegen Tianma Decoction, and the patients in the test group were all treated with the pharmaceutical composition in Example 1 of the present invention. Observe the clinical data of patients in each group, including: clinical efficacy before and after treatment, and changes in traditional Chinese medicine symptoms (vertigo, headache, palpitations, chest tightness, heartache, insomnia) of patients before and after treatment.

[0025] (2) Diagnostic criteria ① TCM diagnosis: in accordance with the diagnostic criteria for vertigo in TCM Internal Medicine, including liver yang hyperactivity syndrome, qi and blood deficiency syndrome, kidney essence deficiency syndrome, phlegm turbidity obstruction syndrome, etc. Patients with liver yang hyperactivity are prone to symptoms such as irritability, irritability, headache, and dizziness; patients with qi and blood deficiency are prone to symptoms such as dizziness, insomnia, and pale complexion; patients with kidney essence deficiency are prone to symptoms such as soreness of waist and knees, tinnitus, and dizziness; patients with phlegm turbidity obstruction are prone to symptoms such as dizziness, nausea, vomiting, and chest tightness.

[0026] ② Western medicine diagnosis: in accordance with the diagnostic criteria for vertigo in Practical Internal Medicine, that is, patients have symptoms of vertigo, manifested as a sense of rotation, lifting or tilting of surrounding objects or themselves, accompanied by symptoms such as nausea and vomiting; changes in body position may induce or aggravate vertigo, such as turning the head, bending over, getting up, etc.; patients often have symptoms such as tinnitus and hearing loss. And agree to accept this treatment plan and can adhere to the treatment and follow-up.

[0027] (3) Inclusion and exclusion criteria Inclusion criteria: ① Patients aged between 20 and 60 years old; ② Both male and female patients are accepted; ③ Patients understand the study, voluntarily join, and sign the agreement; ④ Ethical approval for this study.

[0028] Exclusion criteria: ① patients with secondary vertigo; ② pregnant women and breastfeeding patients; ③ patients with drug allergies and Chinese medicine treatment; ④ patients with mental illness; ⑤ patients with psychological illness; ⑥ patients unable to communicate and patients with compliance problems, etc.

[0029] (4) Elimination, falling off and termination criteria ① Those with poor compliance or misadmission will be excluded; ② Those who withdraw voluntarily or are lost to follow-up, or die but the cause of death is not related to this study will be considered as dropouts; ③ Those whose condition worsens or serious adverse reactions occur will have the trial terminated.

[0030] (5) Medication treatment Patients in both the control group and the experimental group received Chinese medicine treatment for 2 weeks. One dose was decocted twice and then mixed and taken orally in 2 doses, 1 dose per day.

[0031] (6) Observation indicators 1. Efficacy: According to the evaluation criteria for vertigo efficacy in the "Guidelines for Clinical Research of New Chinese Medicines", ① clinical cure: vertigo and other symptoms disappear; ② marked effect: vertigo and other symptoms are significantly improved, there is still slight dizziness, but it does not affect daily work and life; ③ effective: vertigo is alleviated, there is still a slight sense of rotation of oneself and scenery, which has a certain impact on daily life or work; ④ ineffective: symptoms are not relieved or even aggravated. Compare the clinical cure rates of the two groups; 2. Dizziness score: Refer to the Dizziness Handicap Inventory (DHI): Evaluate the severity of vertigo before treatment and 7 and 14 days after treatment. The scale includes 25 questions in three dimensions: physical disorder (DHIP), emotional disorder (DHIE), and functional disorder (DHIF). The full score is 100 points. The higher the score, the more severe the patient's vertigo disability.

[0032] 3. Adverse reactions: Observe the adverse reactions of the two groups during the treatment.

[0033] (7) Statistical methods SPSS 23.0 was used to perform statistical analysis on the data. The measurement data were first analyzed for normality. The data in this study were all in accordance with the normal distribution and were expressed as (x±s). The paired sample t test was used for comparison before and after treatment within the group, and the independent sample t test was used for comparison between groups. The count data were expressed as percentage (%), and the difference between groups was expressed as x. 2 If P < 0.05, the difference was statistically significant.

[0034] (8) Test results ①Comparison of clinical cure rates between the two groups The clinical cure rates of the experimental group and the control group were 80.00% and 60.00%, respectively, and the difference was statistically significant ( P <0.05), see Table 1 for details.

[0035] Table 1 Comparison of clinical cure rates between the two groups

[0036] After treatment, the TCM syndrome scores of the experimental group were lower than those of the control group, and the difference was statistically significant ( P <0.05), see Table 2 for details.

[0037] Table 2 Comparison of TCM syndrome scores between the two groups of patients

[0038] ③Vertigo score As shown in Table 3, compared with the control group, the vertigo score of the patients treated with the pharmaceutical composition of Example 1 of the present invention was significantly reduced, indicating that the Chinese medicine composition of the present invention can effectively relieve the symptom of vertigo.

[0039] Table 3 Comparison of vertigo scores between the two groups of patients before and after treatment (mean values)

[0040] The above results show that the effective rate of the pharmaceutical composition of the present invention is higher, and the TCM syndrome score is lower, which further illustrates that the Chinese medicine composition of the present invention can raise the clear yang, circulate qi and blood, take care of both the symptoms and the root causes, treat wind and phlegm, and regulate qi and blood, achieving good therapeutic effects. In summary, the Chinese medicine composition of the present invention can be used to treat patients with vertigo, which can effectively improve the symptoms of patients and can be used and promoted in clinical practice.

[0041] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A pharmaceutical composition, characterized in that The invention comprises the following raw materials in parts by weight: 6-9 parts of French pinellia, 15 parts of bran-fried atractylodes, 9 parts of gastrodia, 15-30 parts of uncaria, 3 parts of cimicifuga, 6 parts of bupleurum, 6 parts of platycodon, 9-15 parts of ligusticum chuanxiong and 20-30 parts of cyathula.

2. The pharmaceutical composition according to claim 1, characterized in that The invention comprises the following raw materials in parts by weight: 9 parts of French pinellia, 15 parts of bran-fried atractylodes, 9 parts of gastrodia, 30 parts of uncaria, 3 parts of cimicifuga, 6 parts of bupleurum, 6 parts of platycodon, 15 parts of ligusticum chuanxiong and 30 parts of cyathula.

3. Use of the pharmaceutical composition according to any one of claims 1 to 2 in the preparation of a preparation for treating vertigo.

4. The use according to claim 3, characterized in that: The vertigo is vestibular vertigo, non-vestibular vertigo or vertigo caused by headache.

5. The use according to claim 4, characterized in that: The vestibular vertigo includes central vestibular vertigo and peripheral vestibular vertigo.

6. The use according to claim 4, characterized in that: The non-vestibular vertigo mentioned above includes ocular vertigo, vertigo caused by cardiovascular system diseases, vertigo caused by blood system diseases and vertigo caused by endocrine system diseases.

7. A preparation for treating vertigo, characterized in that: The preparation comprises the pharmaceutical composition according to claim 1 or 2.

8. The preparation for treating vertigo according to claim 7, characterized in that: The preparation is an oral preparation.

9. The preparation for treating vertigo according to claim 8, characterized in that The preparations include decoctions, granules, capsules, tablets, oral liquids, pills, tinctures and syrups.

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