Flavored fructus evodiae soup as well as preparation method and application thereof

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly discloses modified fructus evodiae soup as well as a preparation method, application and a pharmaceutical composition thereof. The decoction is prepared from a plurality of traditional Chinese medicinal materials such as fructus evodiae, fried codonopsis pilosula, Chinese dates, dried ginger and the like according to a specific proportion, and is mainly used for treating Jueyin headache or headache caused by cerebral ischemia injury. The preparation method comprises the following steps: soaking the medicinal materials, decocting, filtering, combining and the like, and selectively adding the steps of concentrating, packaging and storing. In addition, the invention further provides a pharmaceutical composition containing the modified fructus evodiae decoction and the ibuprofen for treating headache, the pharmaceutical composition aims at achieving the synergistic effect of medicines in a mode of combining traditional Chinese medicine and western medicine, reducing the dosage of the western medicine, reducing side effects and improving the curative effect, and the content of the modified fructus evodiae decoction and the content of the ibuprofen in the composition are both in a clear range. Therefore, the treatment effect and the safety are ensured.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and specifically discloses a flavored Evodia rutaecarpa decoction and a preparation method thereof. Background Art

[0002] Migraine belongs to the category of "headache" in traditional Chinese medicine. The symptom description was first seen in "Lingshu•Juebing Pian", which was "half cold pain in the head". The name of migraine was first proposed in "Dongyuan Shishu". The head is the "meeting place of all yang", "the place of clear yang", and the location of the sea of ​​marrow. It is located at the highest position in the human body. The blood of the five internal organs and the clear yang of the six bowels are all injected into the head. If the external evil invades the brain, blocks the clear yang, blocks the meridians, and blocks the meridian qi, then pain will occur if it is blocked. If the qi and blood are both deficient, the liver and kidney are insufficient, the head orifices are not nourished, and pain will occur if they are not nourished. All of these can cause headaches. Migraine is a headache that occurs in the two temporal areas. Through long-term clinical practice, it is found that migraine belongs to the category of internal injury headaches among "headaches", and its disease is related to liver imbalance. If it is caused by hyperactivity of liver yang, the treatment should be to calm the liver and suppress yang, unblock the meridians and relieve pain; if it is caused by blood stasis blocking the meridians, the treatment should be to activate blood circulation and remove blood stasis, unblock the meridians and open the orifices; if it is caused by wind-phlegm blocking the meridians, the treatment should be to extinguish wind and resolve phlegm, unblock the meridians and relieve pain; if it is caused by deficiency of both qi and blood, and deficiency of yin and yang, the treatment should be to nourish qi and blood, raise yang and unblock the meridians; if it is caused by deficiency of liver and kidney, the treatment should be to nourish the liver and kidney, invigorate the essence and activate the meridians. Wuzhuyu Decoction is the 5th prescription included in the first batch of "Catalogue of Ancient Classic Prescriptions (First Batch)", and comes from Article 378 of "Treatise on Febrile Diseases and Miscellaneous Diseases" by Zhang Zhongjing of the Han Dynasty: "Dry retching, spitting of saliva, and headache should be treated with Wuzhuyu Decoction." It is a headache caused by liver and stomach deficiency and cold, turbid yin rising up, and rushing up to the head orifices along the meridians. Because the Liver Meridian and the Governor Vessel meet at the top of the head, headache at the top of the head can be seen. The liver and gallbladder are mutually exterior and interior, and if the liver fails to release, the gallbladder will not be able to regulate itself. The gallbladder meridian runs through the temporal part of the head on both sides, so migraine can also be seen.

[0003] At present, there are still many limitations in the treatment of migraine with Western medicine. Wuzhuyu Decoction is a commonly used traditional Chinese medicine prescription for the treatment of migraine. As a traditional Chinese medicine prescription, Wuzhuyu Decoction has significant effects in warming the middle and replenishing deficiency, reducing adverse reactions and stopping vomiting, but it also has shortcomings such as slow onset of action and unclear efficacy in the treatment of migraine, and it is in urgent need of research and improvement. Summary of the invention

[0004] In order to solve the above problems, the present invention discloses a modified Evodia rutaecarpa decoction and a preparation method and application thereof. The modified Evodia rutaecarpa decoction is derived from Evodia rutaecarpa decoction by adding 5 medicinal materials with the main effects of calming the liver and extinguishing wind, and dispelling wind and relieving pain, thereby providing a more comprehensive and effective treatment plan for the various causes and pathogenesis of migraine.

[0005] The technical solution of the present invention is as follows: A flavored Evodia rutaecarpa decoction, prepared from the following ingredients: Evodia rutaecarpa, stir-fried Codonopsis pilosula, jujube, dried ginger, Ligusticum chuanxiong, Angelica dahurica, Gastrodia elata, Uncaria rhynchophylla, and Semen Cassiae.

[0006] Furthermore, the above-mentioned flavored Evodia rutaecarpa decoction is prepared from the following raw materials by weight: 5-10 parts of Evodia rutaecarpa, 5-10 parts of stir-fried Codonopsis pilosula, 3-6 parts of jujube, 3-6 parts of dried ginger, 2-6 parts of Chuanxiong, 2-4 parts of Angelica dahurica, 1-3 parts of Gastrodia elata, 1-3 parts of Uncaria rhynchophylla, and 1-2 parts of Semen Cassiae.

[0007] Furthermore, in the above-mentioned flavored Evodia rutaecarpa decoction, the raw materials are in the form of Chinese herbal medicine slices.

[0008] The present invention also discloses a preparation method of the flavored Evodia rutaecarpa decoction, comprising the following steps: 1) Accurately weigh each ingredient according to the prescription ratio to ensure that all ingredients are dry and free of impurities; 2) Place all the Chinese medicinal materials except Semen Cassiae in a suitable container, add enough cold water to make the cold water 2-3 cm above the surface of the medicine, and soak for 30-60 minutes to allow the medicinal materials to absorb water and swell, thus promoting the dissolution of the active ingredients; 3) Pour the soaked herbs and the soaking liquid into a casserole or stainless steel pot, boil over high heat, then simmer over low heat, keeping it at a slight boil for 30-60 minutes, stirring appropriately during the process to prevent the bottom from getting stuck; add the stone cassia seed 5-10 minutes before the end of the low heat; 4) Filter out the medicinal liquid with gauze or filter mesh. This is the first decoction. Add appropriate amount of clean water to the residue again and repeat the decoction process from 2) to 3) to obtain the second decoction. Combine the two decoctions to obtain the flavored Evodia rutaecarpa decoction.

[0009] Furthermore, the above-mentioned flavored Evodia rutaecarpa decoction also includes the following step 5) after decoction and merging, concentrating over low heat.

[0010] Furthermore, the aforementioned flavored Evodia rutaecarpa decoction further comprises the following step 6) after the medicinal liquid is cooled to room temperature, it is packaged and stored.

[0011] The invention also discloses the use of the modified Wuzhuyu decoction in preparing medicine for treating headache.

[0012] Furthermore, in the above use, the headache is Jueyin headache or headache caused by cerebral ischemia injury (i.e. migraine).

[0013] The invention also discloses a medicine composition for treating headache, which contains the modified Wuzhuyu decoction and ibuprofen.

[0014] Furthermore, in the above-mentioned pharmaceutical composition for treating headache, the content of the modified Evodia rutaecarpa decoction is 5-10 mL, and the content of ibuprofen is 0.05-0.3 g.

[0015] Compared with the prior art, the present invention has the following beneficial effects: The invention discloses a flavored Wuzhuyu decoction and a preparation method and application thereof. Wuzhuyu is used as the main drug in the prescription. Wuzhuyu is mainly used for its warming ability to warm the liver and its pungent nature to promote yang, so as to eliminate the evil of liver cold and turbid yin, dredge the liver meridian and relieve headache, and is the main drug for relieving migraine. Dried ginger is used instead of fresh ginger to achieve the effects of warming the middle and dispelling cold, restoring yang and unblocking meridians, warming the lungs and transforming phlegm, thereby enhancing the yang-warming effect of the whole prescription, helping Wuzhuyu to promote yang and dispel cold, and also relieving the nausea and vomiting symptoms associated with migraine. Stir-fried Codonopsis pilosula is used to replace ginseng. Codonopsis pilosula is sweet in taste and neutral in nature. Although its qi-tonifying effect is not as strong as that of ginseng, it has the effects of nourishing qi and blood, and together with jujube, it can nourish qi and blood and nourish the head orifices. This recipe adds Chuanxiong, Angelica dahurica, Gastrodia elata, Uncaria rhynchophylla and Semen Cassiae. Chuanxiong can invigorate blood circulation, dispel blood stasis and relieve pain, and can ascend to the top of the head, descend to the blood sea, promote blood and qi inside, and disperse wind and cold outside. It is an important medicine for treating headaches; Angelica dahurica is pungent, warm in nature, and slippery in texture, which can keep blood vessels from drying up and has a good analgesic effect; Gastrodia elata is sweet, slow in nature, moist in texture, nourishing, and can dispel wind and relieve pain, soothe the liver, extinguish wind and stop spasms. It complements Chuanxiong, one descends and the other ascends, dispels depression, soothes swelling and reverses, and is easy to clear qi and raise reverse, so that the qi is unblocked, and the qi and blood are unblocked and pain is relieved. At the same time, Gastrodia elata can control the pungent and warm nature of Chuanxiong and Angelica dahurica, and Chuanxiong and Angelica dahurica can help Gastrodia elata ascend to the top of the head and relieve various headaches. In addition, Uncaria rhynchophylla can clear the liver, calm wind and stop dizziness, and Semen Cassiae Cassiae is good at calming the liver and suppressing yang, and it can be used with Gastrodia elata to calm the liver and calm wind. According to the etiology and pathogenesis of migraine headache caused by liver wind disturbance leading to headache and dizziness, the Wuzhuyu headache prescription adds 5 medicinal materials with the main effects of calming the liver and extinguishing wind, dispelling wind and relieving pain, and provides a more comprehensive and effective treatment plan for the various etiologies and pathogenesis of migraine. Furthermore, the present invention also proposes a pharmaceutical composition for treating headache, which not only contains the flavored Wuzhuyu decoction, but also combines the western medicine ibuprofen, realizing the treatment concept of combining traditional Chinese and western medicine. This combination can exert the synergistic effect of the two drugs, improve the treatment effect, and at the same time may reduce the dosage and side effects of a single drug. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 The preparation process of the flavored Evodia rutaecarpa decoction of the present invention; Figure 2 Test Example 1 is for the evaluation of the efficacy of migraine; Figure 3 Test Example 2 is an evaluation of the efficacy of the drug for migraine. DETAILED DESCRIPTION

[0017] A flavored Evodia rutaecarpa decoction is prepared from the following raw materials by weight: 5-10 parts of Evodia rutaecarpa, 5-10 parts of stir-fried Codonopsis pilosula, 3-6 parts of jujube, 3-6 parts of dried ginger, 2-6 parts of Chuanxiong, 2-4 parts of Angelica dahurica, 1-3 parts of Gastrodia elata, 1-3 parts of Uncaria rhynchophylla, 1-2 parts of Semen Cassiae; The raw materials are in the form of Chinese herbal medicine slices; The preparation method of the above-mentioned flavored Evodia rutaecarpa decoction is as follows: Figure 1As shown, the following steps are included: 1) Accurately weigh each ingredient according to the prescription ratio to ensure that all ingredients are dry and free of impurities; 2) Place all the Chinese medicinal materials except Semen Cassiae in a suitable container, add enough cold water to make the cold water 2-3 cm above the surface of the medicine, and soak for 30-60 minutes to allow the medicinal materials to absorb water and swell, thus promoting the dissolution of the active ingredients; 3) Pour the soaked herbs and the soaking liquid into a casserole or stainless steel pot, boil over high heat, then simmer over low heat, keeping it at a slight boil for 30-60 minutes, stirring appropriately during the process to prevent the bottom from getting stuck; add the stone cassia seed 5-10 minutes before the end of the low heat; 4) Filter out the medicinal liquid with gauze or filter, this is the first decoction, add appropriate amount of clean water to the residue again, repeat 2)-3) decoction process to get the second decoction, the two decoctions are combined to get the flavored Wuzhuyu Decoction; 5) After decoction and merging, concentrate over low heat until the density reaches between 1.05-1.1 g / mL, then stop concentrating; 6) Wait for the drug solution to cool to room temperature and then package it for storage.

[0018] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0019] Example 1 A flavored Evodia rutaecarpa decoction is prepared from the following raw materials by weight: Evodia rutaecarpa 5g, stir-fried Codonopsis pilosula 10g, jujube 3g, dried ginger 6g, chuanxiong 2g, angelica dahurica 4g, Gastrodia elata 1g, Uncaria rhynchophylla 3g, Semen cassiae 2g; The raw materials are in the form of Chinese herbal medicine slices; The preparation method of the modified Evodia rutaecarpa decoction comprises the following steps: 1) Accurately weigh each ingredient according to the prescription ratio to ensure that all ingredients are dry and free of impurities; 2) Place all the Chinese medicinal materials except Semen Cassiae in a suitable container, add enough cold water to make the cold water 2-3 cm above the surface of the medicine, and soak for 30-60 minutes to allow the medicinal materials to absorb water and swell, thus promoting the dissolution of the active ingredients; 3) Pour the soaked herbs and the soaking liquid into a casserole or stainless steel pot, boil over high heat, then simmer over low heat, keeping it at a slight boil for 30-60 minutes, stirring appropriately during the process to prevent the bottom from getting stuck; add the stone cassia seed 5-10 minutes before the end of the low heat; 4) Filter out the medicinal liquid with gauze or filter, this is the first decoction, add appropriate amount of clean water to the residue again, repeat 2)-3) decoction process to get the second decoction, the two decoctions are combined to get the flavored Wuzhuyu Decoction; 5) After decoction and combination, concentrate over low heat until the density reaches 1.05 g / mL, then stop concentrating; 6) Wait for the drug solution to cool to room temperature and then package it for storage.

[0020] Example 2 A flavored Evodia rutaecarpa decoction is prepared from the following raw materials by weight: Evodia rutaecarpa 7g, stir-fried Codonopsis pilosula 7g, jujube 4g, dried ginger 5g, chuanxiong 4g, angelica dahurica 3g, Gastrodia elata 2g, Uncaria rhynchophylla 2g, Semen cassiae 1.5g; The raw materials are in the form of Chinese herbal medicine slices; The preparation method of the modified Evodia rutaecarpa decoction comprises the following steps: 1) Accurately weigh each ingredient according to the prescription ratio to ensure that all ingredients are dry and free of impurities; 2) Place all the Chinese medicinal materials except Semen Cassiae in a suitable container, add enough cold water to make the cold water 2-3 cm above the surface of the medicine, and soak for 30-60 minutes to allow the medicinal materials to absorb water and swell, thus promoting the dissolution of the active ingredients; 3) Pour the soaked herbs and the soaking liquid into a casserole or stainless steel pot, boil over high heat, then simmer over low heat, keeping it at a slight boil for 30-60 minutes, stirring appropriately during the process to prevent the bottom from getting stuck; add the stone cassia seed 5-10 minutes before the end of the low heat; 4) Filter out the medicinal liquid with gauze or filter, this is the first decoction, add appropriate amount of clean water to the residue again, repeat 2)-3) decoction process to get the second decoction, the two decoctions are combined to get the flavored Wuzhuyu Decoction; 5) After decoction and combination, concentrate over low heat until the density reaches 1.05 g / mL, then stop concentrating; 6) Wait for the drug solution to cool to room temperature and then package it for storage.

[0021] Example 3 A flavored Evodia rutaecarpa decoction is prepared from the following raw materials by weight: Evodia rutaecarpa 10g, stir-fried Codonopsis pilosula 5g, jujube 6g, dried ginger 3g, chuanxiong 6g, angelica dahurica 2g, gastrodia elata 3g, Uncaria rhynchophylla 1g, Semen cassiae 2g; The raw materials are in the form of Chinese herbal medicine slices; The preparation method of the modified Evodia rutaecarpa decoction comprises the following steps: 1) Accurately weigh each ingredient according to the prescription ratio to ensure that all ingredients are dry and free of impurities; 2) Place all the Chinese medicinal materials except Semen Cassiae in a suitable container, add enough cold water to make the cold water 2-3 cm above the surface of the medicine, and soak for 30-60 minutes to allow the medicinal materials to absorb water and swell, thus promoting the dissolution of the active ingredients; 3) Pour the soaked herbs and the soaking liquid into a casserole or stainless steel pot, boil over high heat, then simmer over low heat, keeping it at a slight boil for 30-60 minutes, stirring appropriately during the process to prevent the bottom from getting stuck; add the stone cassia seed 5-10 minutes before the end of the low heat; 4) Filter out the medicinal liquid with gauze or filter, this is the first decoction, add appropriate amount of clean water to the residue again, repeat 2)-3) decoction process to get the second decoction, the two decoctions are combined to get the flavored Wuzhuyu Decoction; 5) After decoction and combination, concentrate over low heat until the density reaches 1.05 g / mL, then stop concentrating; 6) Wait for the drug solution to cool to room temperature and then package it for storage.

[0022] Comparative Example 1 A flavored Evodia rutaecarpa decoction is prepared from the following raw materials by weight: Evodia rutaecarpa 7g, stir-fried Codonopsis pilosula 7g, jujube 4g, ginger 5g, chuanxiong 4g, angelica dahurica 3g, Gastrodia elata 2g, Uncaria rhynchophylla 2g, Semen cassiae 1.5g; The raw materials are in the form of Chinese herbal medicine slices; The preparation method of the modified Evodia rutaecarpa decoction comprises the following steps: 1) Accurately weigh each ingredient according to the prescription ratio to ensure that all ingredients are dry and free of impurities; 2) Place all the Chinese medicinal materials except Semen Cassiae in a suitable container, add enough cold water to make the cold water 2-3 cm above the surface of the medicine, and soak for 30-60 minutes to allow the medicinal materials to absorb water and swell, thus promoting the dissolution of the active ingredients; 3) Pour the soaked herbs and the soaking liquid into a casserole or stainless steel pot, boil over high heat, then simmer over low heat, keeping it at a slight boil for 30-60 minutes, stirring appropriately during the process to prevent the bottom from getting stuck; add the stone cassia seed 5-10 minutes before the end of the low heat; 4) Filter out the medicinal liquid with gauze or filter, this is the first decoction, add appropriate amount of clean water to the residue again, repeat 2)-3) decoction process to get the second decoction, the two decoctions are combined to get the flavored Wuzhuyu Decoction; 5) After decoction and merging, concentrate over low heat until the density reaches between 1.05-1.1 g / mL, then stop concentrating; 6) Wait for the drug solution to cool to room temperature and then package it for storage.

[0023] Comparative Example 1 uses fresh ginger instead of dried ginger, and the rest is the same as Example 2.

[0024] Comparative Example 2 A flavored Evodia rutaecarpa decoction is prepared from the following raw materials by weight: Evodia rutaecarpa 7g, stir-fried Codonopsis pilosula 7g, jujube 4g, dried ginger 5g, chuanxiong 4g, angelica dahurica 3g, gastrodia elata 2g, Uncaria rhynchophylla 2g; The raw materials are in the form of Chinese herbal medicine slices; The preparation method of the modified Evodia rutaecarpa decoction comprises the following steps: 1) Accurately weigh each ingredient according to the prescription ratio to ensure that all ingredients are dry and free of impurities; 2) Place all the Chinese medicinal materials in a suitable container, add enough cold water to make the cold water 2-3 cm above the surface of the medicine, and soak for 30-60 minutes to allow the medicinal materials to absorb water and swell, thus promoting the dissolution of the active ingredients; 3) Pour the soaked herbs and the soaking liquid into a casserole or stainless steel pot, boil over high heat, then simmer over low heat, keeping it at a slight boil for 30-60 minutes, stirring appropriately during this time to prevent the bottom from getting sticky; 4) Filter out the medicinal liquid with gauze or filter, this is the first decoction, add appropriate amount of clean water to the residue again, repeat 2)-3) decoction process to get the second decoction, the two decoctions are combined to get the flavored Wuzhuyu Decoction; 5) After decoction and merging, concentrate over low heat until the density reaches between 1.05-1.1 g / mL, then stop concentrating; 6) Wait for the drug solution to cool to room temperature and then package it for storage.

[0025] Comparative Example 2 does not contain Semen Cassiae, and the other contents are the same as those of Example 2.

[0026] Comparative Example 3 A flavored Evodia rutaecarpa decoction is prepared from the following raw materials by weight: Evodia rutaecarpa 7g, stir-fried Codonopsis pilosula 7g, jujube 4g, dried ginger 5g, Semen Cassiae 1.5g; The raw materials are in the form of Chinese herbal medicine slices; The preparation method of the modified Evodia rutaecarpa decoction comprises the following steps: 1) Accurately weigh each ingredient according to the prescription ratio to ensure that all ingredients are dry and free of impurities; 2) Place all the Chinese medicinal materials except Semen Cassiae in a suitable container, add enough cold water to make the cold water 2-3 cm above the surface of the medicine, and soak for 30-60 minutes to allow the medicinal materials to absorb water and swell, thus promoting the dissolution of the active ingredients; 3) Pour the soaked herbs and the soaking liquid into a casserole or stainless steel pot, boil over high heat, then simmer over low heat, keeping it at a slight boil for 30-60 minutes, stirring appropriately during the process to prevent the bottom from getting stuck; add the stone cassia seed 5-10 minutes before the end of the low heat; 4) Filter out the medicinal liquid with gauze or filter, this is the first decoction, add appropriate amount of clean water to the residue again, repeat 2)-3) decoction process to get the second decoction, the two decoctions are combined to get the flavored Wuzhuyu Decoction; 5) After decoction and merging, concentrate over low heat until the density reaches between 1.05-1.1 g / mL, then stop concentrating; 6) Wait for the drug solution to cool to room temperature and then package it for storage.

[0027] Comparative Example 3 does not contain Chuanxiong, Angelica dahurica, Gastrodia elata and Uncaria rhynchophylla, and the rest is the same as Example 2.

[0028] Comparative Example 4 Comparative Example 4 is traditional Evodia rutaecarpa decoction, which includes 9g Evodia rutaecarpa, 18g ginger, 9g ginseng, and twelve jujubes (100g).

[0029] The preparation method of the traditional Evodia rutaecarpa decoction comprises the following steps: 1) Accurately weigh each ingredient according to the prescription ratio to ensure that all ingredients are dry and free of impurities; 2) Place all the Chinese medicinal materials in a suitable container, add enough cold water to make the cold water 2-3 cm above the surface of the medicine, and soak for 30-60 minutes to allow the medicinal materials to absorb water and swell, thus promoting the dissolution of the active ingredients; 3) Pour the soaked herbs and the soaking liquid into a casserole or stainless steel pot, boil over high heat, then simmer over low heat, keeping it at a slight boil for 30-60 minutes, stirring appropriately during this time to prevent the bottom from getting sticky; 4) Filter out the medicinal liquid with gauze or filter, this is the first decoction, add appropriate amount of clean water to the medicinal residue again, repeat 2)-3) decoction process to get the second decoction, the two decoctions are combined to get the traditional Evodia rutaecarpa decoction; 5) After decoction and merging, concentrate over low heat until the density reaches between 1.05-1.1 g / mL, then stop concentrating; 6) Wait for the drug solution to cool to room temperature and then package it for storage.

[0030] Comparative Example 5 Ibuprofen tablets (0.2g).

[0031] Comparative Example 6 Placebo group, starch tablets.

[0032] Test Example 1 The therapeutic effect of the improved Zhi Ke Gan Cao decoction described in the present invention was tested.

[0033] This study was approved by the Medical Ethics Committee of Kunshan Hospital of Traditional Chinese Medicine. A total of 90 patients diagnosed with migraine were recruited from the Department of Neurosurgery and the Department of Neurosurgery of Kunshan Hospital of Traditional Chinese Medicine, and informed consent was signed with the patients.

[0034] Inclusion criteria: 1) Patients diagnosed with migraine; 2) Patients with risk of allergy and adverse reactions to Chinese medicines were excluded; 3) Patients with no serious abnormalities in blood lipids, coagulation function, liver and kidney function and those with severe diseases of other organs were excluded; 4) Patients with other intracranial lesions such as stroke were excluded by imaging examination.

[0035] Dosage: (flavored) Evodia rutaecarpa decoction, 10 mL each morning and evening, ibuprofen tablets once each morning and evening. Evaluation method: VAS scores were performed on the patients in the test group (Examples 1-3, comparative examples 1-5, 10 people in each group) and the control group (Comparative example 6, 10 people in the placebo group) before, 7 days and 21 days after taking the medicine. The visual analogue scale (VAS) is used to evaluate pain. When used clinically, the side with the scale is facing away from the patient, and the patient is asked to mark the corresponding position on the ruler that can represent the degree of pain. The physician scores the patient according to the position marked by the patient. The clinical assessment is divided into "0-2" as "excellent", "3-5" as "good", "6-8" as "acceptable", and > "8" as "poor". The same method can be used before and after clinical treatment to make a more objective score and to evaluate the effect of pain treatment more objectively. The results are shown in Tables 1 and Figure 2 , the score is accumulated by the people in the group.

[0036] Table 1 Evaluation of efficacy for migraine 7 days before taking the medicine 7 days after taking the medicine 21 days after taking the medicine Example 1 82 45 24 Example 2 76 43 21 Example 3 81 39 25 Comparative Example 1 83 48 29 Comparative Example 2 75 55 35 Comparative Example 3 84 62 36 Comparative Example 4 82 65 38 Comparative Example 5 85 39 28 Comparative Example 6 83 75 70 From the results in Table 1, it can be seen that the flavored Wuzhuyu decoction prepared in Examples 1-3 of the present invention can have a good symptom-relieving effect on migraine. From the comparison between Example 2 and Comparative Example 1, it can be seen that the use of dried ginger instead of ginger can warm the middle and dispel cold, restore yang and dredge the meridians, warm the lungs and transform phlegm, enhance the warming yang effect of the whole prescription, and can help Wuzhuyu to dispel yang and dispel cold, and further relieve migraine. From the comparison between Example 2 and Comparative Example 2, it can be seen that Semen Cassiae is good at calming the liver and suppressing yang, and can be used together with Gastrodia elata to calm the liver and stop wind. Without Semen Cassiae, the effect is not good. Decrease; From the comparison of Example 2 and Comparative Example 3, Chuanxiong, Angelica dahurica, Gastrodia elata and Uncaria rhynchophylla have a significant effect on this prescription. Chuanxiong can promote blood circulation, dispel blood stasis and relieve pain, and can ascend to the top of the head, go down to the sea of ​​blood, promote blood qi inside, and disperse wind and cold outside, which is the main medicine for treating headache; Angelica dahurica is pungent, warm in nature, and slippery in texture, which can prevent blood vessels from drying up, and has a good analgesic effect; Gastrodia elata is sweet, slow, moist and nourishing, and can dispel wind and relieve pain, soothe the liver, extinguish wind and stop spasms, and complement Chuanxiong, one descends and one rises, dispersing depression, flattening and rising, and easily clearing qi and ascending, so that the qi mechanism is unblocked, and the qi and blood can be unblocked to relieve pain. At the same time, Gastrodia elata can process Chuanxiong and Angelica dahurica, which are pungent and warm, and Chuanxiong and Angelica dahurica can help Gastrodia elata ascend to the top of the head, relieving various types of headaches; From Example 2 and Comparative Example 4, that is, traditional Evodia rutaecarpa decoction, it can be seen that this prescription has the advantages of faster onset and better headache relief effect compared with traditional Evodia rutaecarpa decoction. From Example 2 and Comparative Example 5, it can be seen that the therapeutic effect of the modified Evodia rutaecarpa decoction of the present invention is equivalent to that of the western medicine ibuprofen tablets (0.2 g).

[0037] Test Example 2 The effect of the combined use of the modified Evodia rutaecarpa decoction of the present invention and ibuprofen was tested.

[0038] This study was approved by the Medical Ethics Committee of Kunshan Hospital of Traditional Chinese Medicine. A total of 90 patients diagnosed with migraine were recruited from the Department of Neurosurgery and the Department of Neurosurgery of Kunshan Hospital of Traditional Chinese Medicine, and informed consent was signed with the patients.

[0039] Inclusion criteria: 1) Patients diagnosed with migraine; 2) Patients with risk of allergy and adverse reactions to Chinese medicines were excluded; 3) Patients with no serious abnormalities in blood lipids, coagulation function, liver and kidney function and those with severe diseases of other organs were excluded; 4) Patients with other intracranial lesions such as stroke were excluded by imaging examination.

[0040] Dosage: Experimental Example 1: Example 2 prepared flavored Wuzhuyu decoction 10mL taken once in the morning and evening (ie, Example 2 in Test Example 1); Experimental Example 2: Example 2 prepared flavored Wuzhuyu decoction 10mL and ibuprofen tablets (0.05g) were taken once in the morning and evening; Experimental Example 3: 10 mL of the modified Wuzhuyu decoction prepared in Example 2 and ibuprofen tablets (0.1 g) were taken once in the morning and evening; Experimental Example 4: Example 2 prepared flavored Wuzhuyu decoction 10mL and ibuprofen tablets (0.2g) were taken once in the morning and evening; Experimental Example 5: Comparative Example 4 prepared traditional Evodia rutaecarpa decoction 10mL and ibuprofen tablets (0.2g) were taken once in the morning and evening; Experimental Example 6: Ibuprofen tablets (0.05 g) were taken once in the morning and once in the evening; Experimental Example 7: Ibuprofen tablets (0.1 g) were taken once in the morning and once in the evening; Experimental Example 8: Ibuprofen tablets (0.2 g) were taken once in the morning and once in the evening, i.e., Comparative Example 5 in Test Example 1; Experimental Example 9: Placebo group, i.e., Comparative Example 6 in Test Example 1.

[0041] The evaluation method is the same as that of Test Example 1, and the results are shown in Tables 2 and Figure 3 , the score is accumulated by the people in the group.

[0042] Table 2 Test of the effect of the combination of the modified Wuzhuyu decoction of the present invention and ibuprofen 7 days before taking the medicine 7 days after taking the medicine 21 days after taking the medicine Experimental Example 1 76 43 21 Experimental Example 2 81 31 18 Experimental Example 3 83 27 16 Experimental Example 4 77 28 17 Experimental Example 5 79 35 26 Experimental Example 6 84 61 39 Experimental Example 7 81 48 34 Experimental Example 8 85 39 28 Experimental Example 9 83 75 70 From Table 2 above and Figure 3 It can be seen from the results that the combination of the flavored Evodia rutaecarpa decoction of the present invention and low-dose ibuprofen (0.05-0.1 g, Experimental Examples 2 and 3) has a good synergistic effect, and the effect is greatly improved compared with the use of 0.2 g ibuprofen alone (Experimental Example 8), while the traditional Evodia rutaecarpa decoction does not have a similar beneficial effect.

[0043] It can be seen from the above embodiment data that the present invention discloses a preparation method and application of a flavored Wuzhuyu Decoction. The flavored Wuzhuyu Decoction has a significant therapeutic effect on headache (migraine) caused by Jueyin headache or cerebral ischemic injury by scientifically combining a variety of Chinese medicinal materials, such as Wuzhuyu, stir-fried Codonopsis, and jujube. These medicinal materials work together to reconcile qi and blood, warm the middle and dispel cold, dispel wind and relieve pain, thereby effectively alleviating and treating related symptoms. The flavored Wuzhuyu Decoction can not only be used for headache caused by Jueyin headache and cerebral ischemic injury, but can also be used in combination with other drugs (such as ibuprofen) according to the specific condition to form a more targeted pharmaceutical composition. This flexibility makes the scheme have a wider adaptability and higher therapeutic effect in clinical applications. The above are only a limited number of preferred embodiments of the present invention, and the description is relatively specific and detailed, but it cannot be understood as a limitation on the scope of the patent of the present invention. It should be pointed out that for ordinary technicians in this field, without departing from the concept of the present invention, several variations and improvements can be made, which all belong to the protection scope of the present invention.

Claims

1. A flavored Evodia rutaecarpa decoction, characterized in that: Made from the following ingredients: Evodia rutaecarpa, stir-fried Codonopsis pilosula, jujube, dried ginger, Ligusticum chuanxiong, Angelica dahurica, Gastrodia elata, Uncaria rhynchophylla, and Semen Cassiae.

2. The flavored Evodia rutaecarpa decoction according to claim 1, characterized in that: Calculated by weight, it is made from the following raw materials: 5-10 parts of Evodia rutaecarpa, 5-10 parts of stir-fried Codonopsis pilosula, 3-6 parts of jujube, 3-6 parts of dried ginger, 2-6 parts of Chuanxiong, 2-4 parts of Angelica dahurica, 1-3 parts of Gastrodia elata, 1-3 parts of Uncaria rhynchophylla, and 1-2 parts of Semen Cassiae.

3. The flavored Evodia rutaecarpa decoction according to claim 1, characterized in that: The raw materials are in the form of Chinese herbal medicine slices.

4. The method for preparing the flavored Evodia rutaecarpa decoction according to any one of claims 1 to 3, characterized in that: The following steps are involved: 1) Accurately weigh each ingredient according to the prescription ratio to ensure that all ingredients are dry and free of impurities; 2) Place all the Chinese medicinal materials except Semen Cassiae in a suitable container, add enough cold water to make the cold water 2-3 cm above the surface of the medicine, and soak for 30-60 minutes to allow the medicinal materials to absorb water and swell, thus promoting the dissolution of the active ingredients; 3) Pour the soaked herbs and the soaking liquid into a casserole or stainless steel pot, boil over high heat, then simmer over low heat, keeping it at a slight boil for 30-60 minutes, stirring appropriately during the process to prevent the bottom from getting stuck; add the stone cassia seed 5-10 minutes before the end of the low heat; 4) Filter out the medicinal liquid with gauze or filter mesh. This is the first decoction. Add appropriate amount of clean water to the residue again and repeat the decoction process from 2) to 3) to obtain the second decoction. Combine the two decoctions to obtain the flavored Evodia rutaecarpa decoction.

5. The method for preparing the flavored Evodia rutaecarpa decoction according to claim 4, characterized in that: The step 5) is also included: after decoction and combination, concentrating over low heat.

6. The method for preparing the modified Evodia rutaecarpa decoction according to claim 5, characterized in that: The method also includes the following step 6) when the drug solution is cooled to room temperature, packaging and storage.

7. Use of the modified Evodia rutaecarpa decoction as described in any one of claims 1 to 3 in the preparation of a medicine for treating headache.

8. The use according to claim 7, characterized in that The headache is a Jueyin headache or a headache caused by cerebral ischemic injury.

9. A pharmaceutical composition for treating headache, characterized in that: Contains the flavored Evodia rutaecarpa decoction as described in any one of claims 1 to 3 and ibuprofen.

10. A pharmaceutical composition for treating headache according to claim 9, characterized in that: The content of the modified Evodia rutaecarpa decoction is 5-10 mL, and the content of ibuprofen is 0.05-0.3 g.

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