External traditional Chinese medicine composition for treating migraine

Abstract

The invention relates to the technical field of traditional Chinese medicines, and particularly discloses an external traditional Chinese medicine composition for treating migraine, which comprises the following components in parts by weight: 2 parts of jasmine root and 8 parts of vaseline, the jasmine root is dry powder which is dug from September to December every year, and the impurity rate of the dry powder is not more than 3%, and the vaseline is uniformly mixed. The traditional Chinese medicine has a remarkable and quick effect on migraine patients, and over half of patients can be obviously relieved after being smeared for 2 hours. The composition thought of the traditional Chinese medicine composition is that the traditional Chinese medicine composition is prepared according to classic medicines and a large amount of clinical experience, the problems of clinical migraine and other acute pain stages can be solved, and an effective and safe traditional Chinese medicine formula for external use is provided. The traditional Chinese medicine has the characteristics of good curative effect, convenience in use, low cost and high acceptance degree.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, in particular to an external Chinese medicine for treating migraine, and specifically to an external Chinese medicine composition for treating migraine. Background Art

[0002] Migraine is a common chronic neurovascular disease characterized by paroxysmal, mostly unilateral, moderate to severe, throbbing headaches that generally last 4-72 hours and may be accompanied by nausea and vomiting. Headaches can be aggravated by light, sound or activity, and can be relieved by resting in a quiet environment. Epidemiological surveys show that the prevalence of migraine in my country is 9.3%, with a female to male ratio of about 3:1. With the improvement of economic level and the increase of social pressure, the incidence and consultation rate of migraine are increasing year by year, and the economic losses caused by migraine worldwide can be as high as 13 billion US dollars each year. The results of the World Health Organization's 2016 Global Burden of Disease Survey show that about 1.04 billion people suffer from migraine, of which 45.1 million are disabled. Migraine has become the second largest disease in terms of loss of life due to disability.

[0003] Migraine belongs to the category of "headache" and "disease" in traditional Chinese medicine. Doctors of all dynasties have accumulated a lot of experience in the treatment of migraine. At present, there are Chinese patent medicines for the treatment of migraine, such as Yangxueqingnao granules, Zhengtian pills and Tianshu capsules. Western medicine has no specific treatment for migraine. In clinical practice, there are only drugs for the acute treatment of migraine, such as non-steroidal anti-inflammatory drugs, triptans and opioids. Although they can relieve pain and alleviate accompanying symptoms, they have poor long-term effects and obvious adverse reactions. Therefore, it is of great significance to discover drugs for the prevention and treatment of migraine that take both the symptoms and the root cause into consideration, are highly effective and have low toxicity from the treasures of traditional Chinese medicine.

[0004] Western medicine believes that the etiology of migraine is complex and its pathogenesis is still unclear. The dominant theories include vascular origin theory, neurogenic theory, trigeminal neurovascular theory, immune factors, genetic factors, biochemical factors, etc. At present, the treatment of migraine in Western medicine is still in the exploratory stage, and the treatment of its attack period is mainly based on triptan and ergotamine. Although drugs such as ergotamine and triptan can significantly improve the clinical symptoms of migraine, they often have side effects such as dizziness, nausea, drowsiness, gastrointestinal reactions, and paresthesia. Long-term or frequent use of certain analgesics can cause analgesic nephropathy and produce drug-dependent migraine. Internationally, the release of the "Migraine Evidence-Based Guidelines" has given recommendations for neuroimaging examinations of migraine, drug treatment during acute attacks, drug prevention, and non-drug prevention and treatment. However, the high cost of treatment, more side effects, and unsatisfactory long-term efficacy make the effect of Western medicine in treating migraine unsatisfactory. Therefore, further strengthening the clinical research of migraine, improving clinical efficacy, and reducing social losses have become one of the issues that the medical community urgently needs to solve.

[0005] Traditional Chinese medicine has a unique understanding of migraine. This disease is often referred to as "head wind", "brain wind", "head wind pain", "head hemiplegia" and "hemiplegia wind" in traditional Chinese medicine literature. The understanding of migraine by predecessors is closely related to the liver, spleen and kidney. Those who are true, those caused by wind include both external wind and internal wind. Those invaded by external wind often carry cold, dampness and heat evil, blocking the meridians. Headache caused by internal wind may be due to hyperactivity of liver yang, disorder of qi and blood; or due to blood stasis and blockage of brain vessels; or due to internal generation of phlegm and turbidity, blocking the clear orifices. Those who are weak may be due to deficiency of both qi and blood, loss of meridians; or due to emptiness of brain marrow and insufficiency of clear orifices. Modern Chinese medicine scientists have made further progress on the basis of inheriting the understanding of the etiology and pathogenesis of migraine by predecessors. Emphasizing the complex pathogenesis of wind, fire, blood stasis, phlegm, and deficiency, it is believed that wind evil blocking the collaterals, blood stasis, and liver yang hyperactivity are the basic pathogenesis of migraine. The treatment method adopts a combination of several methods, mainly to dispel wind and relieve pain, calm the liver and extinguish wind, search for wind and dredge the collaterals, and activate blood circulation and remove blood stasis. In terms of efficacy, traditional Chinese medicine can prevent migraine attacks and reduce the severity of attacks, and it has no obvious toxic and side effects, and is not easy to produce dependence and drug resistance. However, using the traditional oral administration method, the drug is slowly absorbed in the gastrointestinal tract, which is easy to increase the gastrointestinal burden. In addition, due to the first-pass effect of the liver and the obstruction of the blood-brain barrier, the effective ingredients reach the lesion site slowly and in very small quantities, thus affecting the rapid effect. Summary of the invention

[0006] In order to solve the problem of migraine, the present application provides an external Chinese medicine composition for treating migraine, which is used to solve the problem of migraine.

[0007] In order to achieve the above-mentioned purpose, the technical solution adopted in this application is: a Chinese medicine composition for external use for treating migraine, comprising 2 parts of jasmine root and 8 parts of vaseline by weight, wherein the jasmine root is dug from September to December each year, and the dry powder with an impurity rate not exceeding 3% is evenly mixed with the vaseline.

[0008] Jasmine root is warm, bitter and poisonous. It has analgesic, anesthetic and hypnotic effects. It is used to treat sprained bones, tooth decay, headaches, insomnia, etc.

[0009] In order to optimize the drug effect, it is further determined that the Chinese medicine composition can be prepared into a pharmaceutically acceptable dosage form.

[0010] In order to optimize the drug effect, it is further determined that the pharmaceutically acceptable dosage form is selected from ointment.

[0011] Beneficial effects:

[0012] The invention has a significant effect on patients with migraine and a rapid effect. More than half of the patients can be significantly relieved within 2 hours of application treatment. The composition idea of ​​the Chinese medicine composition is to formulate a prescription based on classical medicines and a large amount of clinical experience, which can solve the problems of clinical migraine and other acute pains, and provide an effective and safe external Chinese medicine prescription. It has the characteristics of good efficacy, easy use, low cost and high acceptance. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 The present invention affects the serum 5-HT, IL-6 and IL-1β in migraine rats.

[0014] Figure 2 The present invention affects 5-HT, IL-6 and IL-1β in TNC tissue of migraine rats. DETAILED DESCRIPTION

[0015] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the compositions and effects in the embodiments of the present application will be described clearly and completely in combination with examples. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Those skilled in the art can also add other beneficial components for synergistic effect. For example, new existing components can be added by reducing the proportion of vaseline to improve the duration of action and the effect of action.

[0016] Preferred embodiment:

[0017] A Chinese medicinal composition for external use for treating migraine is prepared from the following Chinese medicinal materials in parts by weight: 20 g of jasmine root and 80 g of vaseline.

[0018] The preparation method of the medicine of the present invention comprises the following steps:

[0019] ①Use the uniformly purchased medicinal materials to grind each Chinese medicine into powder according to the prescription ratio, such as jasmine root;

[0020] ② Equipped with centrally purchased auxiliary materials, such as vaseline;

[0021] The specific contents and mass ratio of the experimental group ingredients are: 20% jasmine root, 80% vaseline. Taking the total amount of 10g / can as an example, it contains 2g jasmine root and 8g vaseline.

[0022] ③Preparation of head wind ointment

[0023] Take 20% of the powder in ①, add vaseline and mix evenly into a paste to make a head wind ointment.

[0024] The method of use of the present invention is as follows: when a migraine attack occurs, apply the head wind massage ointment to the Fengchi acupoint and the temple twice, and massage for more than 30 seconds.

[0025] This drug has been used in animals and clinically as follows:

[0026] Part I: Animal Experiments

[0027] At present, there is no research exploring the role of topical preparations related to Toufeng Ointment (jasmine root preparation) in central sensitization of migraine. This part of the experiment aims to clarify whether the effect of Toufeng Ointment on migraine is related to immune inflammatory function; observe the number of times migraine rats scratch their heads and climb cages, and use enzyme-linked immunosorbent assay to detect the expression and release of cellular inflammation-related substances.

[0028] The results showed that the behavioral test results showed that after NTG administration, the model group rats scratched their heads and climbed the cage more frequently, showing hyperalgesia. After the intervention of Toufeng Mo Gao, the number of head scratching and cage climbing of migraine rats decreased significantly, as shown in Table 1 and Table 2. The ELISA results showed that the inflammatory factors TNF-α and IL-6 in the model group increased significantly, as shown in Table 1 and Table 2. Figure 1 , Figure 2 .

[0029] Table 1 Effect of Toufengmo ointment on the number of head scratching in migraine rats

[0030]

[0031] Table 2 Effect of Toufengmo ointment on the number of cage climbing in migraine rats

[0032]

[0033] Part II: About the clinical part

[0034] The present invention uses migraine patients visiting the Department of Neurology of Dongzhimen Hospital of Beijing University of Chinese Medicine as research subjects, conducts a randomized, controlled study, and observes the clinical efficacy of head wind ointment in treating migraine patients.

[0035] During the study, the subjects were patients with migraine (migraine with typical aura or migraine without aura) diagnosed by Western medicine. They were treated with medication during the attack period. The treatment group used external Toufengmo ointment, and the control group used external Toufengmo powder for clinical treatment. The effect indicators were to observe and compare the proportion of respondents in each group who had an effective effect after medication, and to record the proportion of people in each group who had a 50% relief from headache 2 hours after completing the treatment, VAS score, pain intensity grading, headache symptom score, effectiveness assessment, 24h headache relief and recurrence. The clinical efficacy of this prescription on migraine patients was comprehensively analyzed. A total of 40 subjects were recruited, 20 in the treatment group and 20 in the control group.

[0036] 1. Research results

[0037] 1. General Information

[0038] 1.1 Gender distribution

[0039] There were 5 males and 15 females in the treatment group, and 7 males and 13 females in the control group. There was no statistically significant difference in gender between the two groups (P>0.05). (See Table 1-1)

[0040] Table 1-1 Gender distribution (%)

[0041]

[0042] 1.2 Age distribution

[0043] The youngest patient in the treatment group was 21 years old and the oldest was 57 years old, while the youngest patient in the control group was 25 years old and the oldest was 49 years old. The average ages of the two groups were 31.51±3.42 years old and 34.15±4.05 years old, respectively. There was no statistical difference in age distribution between the two groups (P>0.05). (See Table 1-2)

[0044] Table 1-2 Age distribution

[0045]

[0046]

[0047] 2. Observation indicators before treatment

[0048] Before treatment, there was no significant difference in the baseline observation indexes between the two groups of patients (P>0.05). (See Table 2-1) Table 2-1 Comparison of baseline observation indexes between the two groups of patients

[0049]

[0050] 3. Observation indicators after treatment

[0051] 3.1 Main indicators

[0052] After treatment, the number of patients in the two groups whose headaches were relieved by 50% 2 hours after medication was statistically significant (P < 0.05), and was higher than that in the control group (P < 0.05). (See Table 3-1)

[0053] Table 3-1 Comparison of LVEF between the two groups before and after treatment

[0054]

[0055] 3.2 Secondary indicators

[0056] 3.2.1 Comparison of VAS scores

[0057] After treatment, the VAS scores of the two groups showed a downward trend. The VAS scores of the two groups at 1.0h and 2.0h after treatment were statistically significant (P < 0.05), while there was no statistical significance at other observation time points (P > 0.05) (see Table 3-2).

[0058] Table 3-2 Comparison of VAS scores between the two groups after treatment

[0059]

[0060]

[0061] 3.2.2 Comparison of headache intensity levels after treatment

[0062] After treatment, the headache intensity level was a multi-group unidirectional ordered data, and Ridit analysis was used. There was no statistical difference in the headache intensity level between the two groups at each observation point after treatment (P>0.05). (See Table 3-4)

[0063] Table 3-4 Comparison of pain intensity levels between the two groups of patients after treatment

[0064]

[0065] 3.2.3 Scoring of headache symptoms after treatment

[0066] After treatment, there was no statistical difference in the headache intensity between the two groups at each observation point (P>0.05) (see Table 3-5)

[0067] Table 3-5 Comparison of headache symptom scores between the two groups after treatment

[0068]

[0069] 4. Adverse reactions

[0070] All subjects showed no adverse effects on normal physiological indicators such as consciousness, pulse, heart rate, and respiration after treatment.

[0071] External treatment in traditional Chinese medicine has a long history and rich content. Wu Shiji once said: "The principle of external treatment is the principle of internal treatment, and the medicine for external treatment is also the medicine for internal treatment. The difference is the method." It can be seen that external treatment and internal treatment have different paths but the same goal. And external treatment has its unique advantages. By applying the drug to the body surface, the drug property can penetrate the skin and hair and reach the internal organs, so as to eliminate pathogenic factors, adjust the yin and yang of the internal organs and treat the disease. Therefore, Wu Shiji said: "Treat the disease by treating the disease, the skin is separated and the hair pores are open, and the internal organs are not seen, and the internal organs are directly reached." In addition, the drug is not absorbed through the gastrointestinal tract, which avoids the effect of the drug on liver and kidney function, and the treatment is relatively safe. However, there are few studies on the treatment of migraine with external treatment at present, which are mostly empirical treatments, and a systematic theoretical system has not yet been formed. In addition, many treatment methods are complicated to operate, the dosage form is complicated to make, and the scope of medication is wide, which brings many inconveniences to the treatment. Therefore, it is urgent to develop external treatments and drugs that are both effective and convenient to use, and to formulate objective efficacy standards.

[0072] Jasmine root is warm, bitter, and poisonous. It has analgesic, anesthetic, and hypnotic effects. It is used to treat sprained bones, tooth decay, headaches, insomnia, and other symptoms. Professor Zhou Shaohua has conducted research on jasmine root and found that jasmine root liquid is a central nervous system depressant with a sedative and hypnotic effect.

[15] Therefore, jasmine root was developed into an external ointment for the treatment of acute migraine, and achieved certain therapeutic effects.

[0073] In summary, based on the etiology and pathogenesis of migraine, applying Toufengmo powder into an ointment on the corresponding acupuncture points on the head to relieve migraine has the advantages of rapid onset, simple operation, and economic convenience. The drug is applied to the acupuncture points on the body surface, can penetrate the skin and directly reach the diseased area, dredge the meridians and perfuse the whole body, adjust the functions of the internal organs to strengthen the body and eliminate evil. In addition, external medicines can be selected from vigorous medicines, which have fewer concerns than internal medicines, so the medicinal properties are strong and take effect quickly, and there are other advantages. Applying Toufengmo ointment to the affected area to treat migraine can improve the clinical efficacy of migraine, relieve acute attacks of migraine, and improve the quality of life of patients.

[0074] Toufengmogao can improve the VAS score of pain in patients with migraine, and the number of patients whose headaches are relieved by 50% after 2 hours of treatment is superior to that of the control group (Toufengmosan).

[0075] The above description is only the preferred embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A Chinese medicine composition for external use for treating migraine, characterized in that: The invention comprises 2 parts of jasmine roots and 8 parts of vaseline by weight, wherein the jasmine roots are dug from September to December each year, and dry powder with an impurity rate of no more than 3% is uniformly mixed with the vaseline.

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