Application of traditional Chinese medicine composition in preparation of medicine for preventing and / or treating migraine

Abstract

The invention relates to the technical field of traditional Chinese medicines, relates to new application of a traditional Chinese medicine composition, and in particular relates to application of the traditional Chinese medicine composition in preparation of a medicine for preventing and / or treating migraine. The traditional Chinese medicine composition is prepared from cassia twig, white peony root, honey-fried licorice root, ginger, jujube, ginseng, Chinese angelica, salted morinda officinalis and dwarf lilyturf tuber. The traditional Chinese medicine composition provided by the invention can obviously reduce serum NO and trigeminal nervous tissue SP content of migraine rats, increase trigeminal nervous tissue DA content, obviously improve head and face pain threshold and brain tissue DA content of the migraine rats and reduce brain tissue PGE2 content, and has a good treatment effect on migraine.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, and relates to a new use of a traditional Chinese medicine composition, in particular to application of the traditional Chinese medicine composition in preparation of a medicine for preventing and / or treating migraine. BACKGROUND

[0002] Migraine is the most common type of primary headache in clinic, and is mainly manifested as paroxysmal moderate to severe pulsating headache, which is usually unilateral and lasts for 4-72 hours, and is accompanied by nausea, vomiting, and the headache can be aggravated by light, sound stimulation or daily activities, and can be relieved by quiet environment and rest. Migraine is a common chronic neurovascular disease, which usually occurs in children and adolescence, and reaches the peak of incidence in young adulthood, and is more common in women, and the ratio of male to female patients is about 1:2-3, and the prevalence rate in the population is 5%-10%, and there is often a genetic background.

[0003] Frequent migraine attacks will affect the life and work of patients, and the most direct effect is on sleep, because of lack of sleep, people are not energetic during the day, and work is also greatly affected. Moreover, some patients often attack at work, which is very time-consuming. At the same time, people with long-term headache disease change their character, and often become irritable. Because of long-term treatment without effect, life is greatly affected, the psychology is fragile, and the confidence is lost, and over time, the heart and blood vessels of the person will be adversely affected, and brain thrombosis, hypertension and cerebral hemorrhage are also common after migraine attacks in clinic.

[0004] In view of the above problems, the field of traditional Chinese medicine should actively intervene in the prevention and treatment of schizophrenia, and develop a symptomatic prescription. Therefore, it has important practical significance to provide a traditional Chinese medicine composition for preventing and / or treating migraine. SUMMARY

[0005] Therefore, the present application provides application of a traditional Chinese medicine composition in preparation of a medicine for preventing and / or treating migraine.

[0006] In order to achieve the above-mentioned application purposes, the present application provides the following technical solutions:

[0007] The present application provides application of a traditional Chinese medicine composition in preparation of a medicine for preventing and / or treating migraine, and the main active ingredients, in terms of mass parts, include 10-25 parts of cassia twig, 10-25 parts of white peony root, 5-25 parts of licorice, 10-30 parts of fresh ginger, 15-30 parts of jujube, 10-30 parts of ginseng, 10-30 parts of angelica, 10-30 parts of radix morindae officinalis, and 10-30 parts of ophiopogon.

[0008] The prescription takes Ba Ji Tian of Foot-Shaoyin Channel and Renshen of Hand-Shaoyin Channel as the monarch drugs. Ba Ji Tian is sweet and warm, and it can tonify both fire and water without impairing the latter. It can promote the primordial yang from the bottom of the cauldron, and it can also consolidate essence and guard spirit. Renshen is sweet and bitter in taste, and it is slightly warm in nature. It enters Hand-Shaoyin Channel, and it can tonify five Zang organs, calm the spirit, and it can also calm the soul, stop palpitation, open the heart and benefit the intelligence, greatly tonify primordial qi, benefit qi and nourish blood, and nourish the heart and calm the spirit. The two drugs enter heart and kidney respectively, and they are one up and one down, one south and one north, and they communicate between heart and kidney. The assistant drugs, Dang Gui and Gui Zhi, can assist the monarch drugs, and they can also nourish liver blood, and they can also promote liver qi. At the same time, the assistant drugs, Mai Dong and Bai Shao, can also astringe lung metal, and Mai Dong can enter lung channel, and it can astringe lung metal, and it can also descend at night. Bai Shao can also astringe heart qi, and it can also descend at night. The two drugs are one left and one right, and one east and one west, and they can ascend liver and descend lung. The accompanying drugs, Sheng Jiang, Gan Cao, and Da Zao, can also turn the qi of middle-Jiao, and they can also make the ascending and descending coordinated, and they can also rotate the four aspects, and they can also nourish body fluid, and they can also transport the body fluid of spleen and stomach to the nutrient and defensive aspects. In the prescription, Renshen and Ba Ji Tian can jointly exert the function of "making the official strong and the skill excellent", and they can also promote the essence during the day, and Dang Gui and Bai Shao can also exert the function of "making the extreme stop", and they can also descend at night. The whole prescription can warm the middle-Jiao and tonify deficiency, ascend liver and descend lung, communicate between heart and kidney, regulate qi and blood, and lead yang into yin.

[0009] The raw materials of the prescription are as follows:

[0010] Gui Zhi: the dried tender branch of Cinnamomum cassia Presl of Lauraceae. It enters heart, lung, and bladder channels. It is pungent and sweet in taste, and it is warm in nature.

[0011] Bai Shao: the dried root of Paeonia lactiflora Pall. of Ranunculaceae. It enters liver and spleen channels. It is bitter and sour in taste, and it is cold in nature.

[0012] Gan Cao: the dried root of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L. of Leguminosae. It enters heart, lung, spleen, and stomach channels. It is sweet in taste, and it is neutral in nature. Zhi Gan Cao is the processed product of Gan Cao, and the processing method can be as follows: take the clean Gan Cao slices, add the honey and a little water, mix well, and then steam for a while. Fry until yellow to dark yellow, and then take out when it is not sticky. Cool down.

[0013] Sheng Jiang: the fresh rhizome of Zingiber officinale Rosc. of Zingiberaceae. It enters lung, spleen, and stomach channels. It is pungent in taste, and it is slightly warm in nature.

[0014] Da Zao: the dried mature fruit of Ziziphus jujuba Mill. var. inermis (Bunge) Rehd. of Rhamnaceae. It enters spleen and stomach channels. It is sweet in taste, and it is warm in nature.

[0015] Ginseng: the dried root of Panax ginseng C. A. Mey. of Araliaceae, the cultivated one is called "garden ginseng", the garden ginseng is dried by sunning or drying, and is called "raw sun-dried ginseng". It belongs to the meridians of spleen, lung and heart. It is sweet and slightly bitter in taste, and is flat.

[0016] Angelica: the dried root of Angelica sinensis (Oliv.) Diels of Umbelliferae. It belongs to the meridians of liver, heart and spleen. It is sweet and pungent, and is warm.

[0017] Morinda: the dried root of Morinda officinalis How of Rubiaceae. It belongs to the meridians of kidney and liver. It is sweet and pungent, and is slightly warm.

[0018] Ophiopogon: the dried tuber of Ophiopogon japonicus (Thunb.) Ker-Gawl. of Liliaceae. It belongs to the meridians of heart, lung and stomach. It is sweet, slightly bitter and cold.

[0019] In some specific embodiments of the present application, the main active ingredients include, in mass parts, 15 parts of Ramulus cinnamomi, 15 parts of Radix paeoniae alba, 12 parts of Glycyrrhiza uralensis, 18 parts of Zingiber officinale, 18 parts of Fructus jujubae, 10 parts of Panax ginseng, 15 parts of Angelica sinensis, 10 parts of Morinda officinalis and 10 parts of Ophiopogon japonicus.

[0020] In some specific embodiments of the present application, the Glycyrrhiza uralensis is Radix glycyrrhizae praeparata, and the Morinda officinalis is salt Morinda officinalis. Radix glycyrrhizae praeparata is sweet in taste and warm in nature, and has stronger effects of invigorating the spleen and tonifying qi, warming the middle and tonifying deficiency. Salt Morinda officinalis is warm but not dry, has relatively weak toxicity, and has stronger effects.

[0021] In some specific embodiments of the present application, the medicine further includes a medically acceptable excipient. Specifically, the excipient used is a carrier or excipient commonly used in the art, including but not limited to starch, lactose, glucose, sodium carboxymethyl cellulose, ethyl cellulose, methyl cellulose, malt, gelatin, polyhydric alcohols (such as propylene glycol, glycerol, mannitol), tablet pressing agents and the like, to help improve the stability or activity of the medicine, or produce an acceptable taste or smell in the case of oral administration.

[0022] In some specific embodiments of the present application, the dosage form of the medicine is a decoction, a tablet, a capsule, a granule, an oral liquid or a dripping pill. Thus, it is convenient for clinical administration.

[0023] In some specific embodiments of the present application, the preparation method of the traditional Chinese medicine composition includes: mixing the raw medicinal materials according to the ratio, adding water to decoct twice, adding 10 times the amount of water to decoct for 1.5 hours the first time, adding 8 times the amount of water to decoct for 1 hour the second time, combining the decoction, filtering, and concentrating the filtrate to a relative density of 1.10-1.20 (60°C) of extract, to obtain the traditional Chinese medicine composition.

[0024] In some embodiments of the present application, the preparation method of the medicine comprises: mixing each raw medicinal material according to the proportion, decocting twice with water, decocting for 1.5 hours with 10 times the amount of water the first time and decocting for 1 hour with 8 times the amount of water the second time, combining the decoction, filtering, concentrating the filtrate to a relative density of 1.10-1.20 (60°C), and mixing with excipients to obtain the medicine.

[0025] or mixing each raw medicinal material according to the proportion, adding 8-10 times the weight of water, water extracting twice, combining the water extracts, and concentrating to 1 gram of crude drug / mL.

[0026] In some embodiments of the present application, when the dosage form of the medicine is a decoction, the preparation method comprises the following steps:

[0027] mixing each raw medicinal material according to the proportion, decocting for 30-40 minutes with 8-10 times the weight of water, and obtaining the medicine.

[0028] In some embodiments of the present application, when the dosage form of the medicine is a tablet, a capsule, a granule, an oral liquid or a dripping pill, the preparation method comprises the following steps:

[0029] mixing each raw medicinal material according to the proportion, water extracting twice with 8-10 times the weight of water, combining the water extracts, concentrating to 1 gram of crude drug / mL, adding excipients, and preparing the corresponding dosage form according to the conventional method in the art to obtain the medicine.

[0030] In some embodiments of the present application, the prevention and / or treatment of migraine comprises:

[0031] (I) reducing the serum NO content and the SP content of the trigeminal nerve tissue of a migraine rat;

[0032] (II) increasing the DA content of the trigeminal nerve tissue;

[0033] (III) the head and face pain threshold of a migraine mouse and the DA content of the brain tissue; and / or

[0034] (IV) down-regulating the PGE2 content of the brain tissue.

[0035] The present application provides the use of a traditional Chinese medicine composition in the preparation of a medicine for treating migraine. The traditional Chinese medicine composition in the present application can significantly reduce the serum NO content and the SP content of the trigeminal nerve tissue of a migraine rat, increase the DA content of the trigeminal nerve tissue, significantly increase the head and face pain threshold of a migraine mouse and the DA content of the brain tissue, down-regulate the PGE2 content of the brain tissue, and has a good therapeutic effect on migraine. DETAILED DESCRIPTION

[0036] The application discloses application of a traditional Chinese medicine composition in preparation of a medicine for preventing and / or treating migraine. Those skilled in the art can refer to the content of the present application and appropriately improve process parameters to realize. It is particularly pointed out that all similar replacements and changes are obvious to those skilled in the art, and they are regarded as being included in the present application. The method and application of the present application have been described through preferred embodiments, and relevant personnel can obviously make changes or appropriate changes and combinations to the method and application described in the present application without departing from the content, spirit and scope of the present application, to realize and apply the present application technology.

[0037] Unless specific conditions are specified in the following experiments, the experiments are performed according to conventional conditions or manufacturer's recommended conditions, the raw materials or excipients used, and the reagents or instruments used are not specified by the manufacturer, and are conventional products that can be obtained by purchase. Unless otherwise specified, all percentages, ratios, proportions or parts are by weight.

[0038] Unless otherwise defined, all professional and scientific terms used herein have the same meanings as familiar to those skilled in the art. In addition, any method and material similar or equivalent to the described content can be applied to the present application.

[0039] The present application is further described below in conjunction with examples:

[0040] Example 1 Preparation of the traditional Chinese medicine composition granules in the present application

[0041] Take 250g of cassia twig, 250g of white peony root, 200g of fried licorice, 300g of raw ginger, 300g of jujube, 167g of ginseng, 250g of angelica, 167g of baijiatian, and 167g of ophiopogon japonicus. Add water and decoct twice. The first time, add 10 times the amount of water and decoct for 1.5 hours. The second time, add 8 times the amount of water and decoct for 1 hour. Combine the decoction, filter, and concentrate the filtrate to a relative density of 1.10-1.20 (60°C) of extract. Obtain the traditional Chinese medicine composition. Add 200g of maltodextrin, dry, and pulverize into fine powder. Add maltodextrin, mix well, and prepare granules. Dry to prepare 1000g.

[0042] Experimental Example 2 Therapeutic effect of the traditional Chinese medicine composition on the rat migraine model induced by nitroglycerin

[0043] 1.1 Animals

[0044] SD rats, male, SPF level, 36, body weight 200±20g, purchased from Hangzhou Medical College Experimental Animal Center, license number: SCXK(Zhe)2019-0002, feeding environment: room temperature 20-26℃, relative humidity control at 40-70%.

[0045] 1.2 Drugs

[0046] The traditional Chinese medicine composition prepared in Example 1, Jiangsu Kangyuan Pharmaceutical Co., Ltd.; Zolmitriptan tablets, Want Pharmaceutical (Hainan) Co., Ltd., batch number 20220204.

[0047] 1.3 Reagents

[0048] 0.9% sodium chloride injection, Heilongjiang Qitai Animal Health Products Co., Ltd., specification: 500ml / bottle, batch number: 230227A01 2; nitroglycerin solution, China Institute for Drug Control; coagulation blood collection tube, specification: 5mL, Liuyang Sanli Medical Technology Development Co., Ltd., batch number: 200911; disposable intravenous blood sample collection needle, Jiangsu Suyun Medical Instrument Co., Ltd., batch number: 20220208; PMSF, specification: 10mL, Biyun Tian Biotechnology Co., Ltd., item number: ST506, Lot: 113217180308; RIPA lysis buffer (strong), specification: 100ml, Biyun Tian Biotechnology Co., Ltd., batch number: ; isoflurane, Shenzhen Ruivode Life Science Co., Ltd., batch number: 20220101; nitric oxide (NO) kit, Nanjing Jiancheng Biological Engineering Institute, batch number: 20230411; substance P (SP) kit, Nanjing Jiancheng Biological Engineering Institute, batch number: 20230321; dopamine (DA) test kit, Nanjing Jiancheng Biological Engineering Institute, batch number: 20230703.

[0049] 1.4 Instruments

[0050] Electronic balance, Changzhou Lucky Electronic Equipment Co., Ltd., model: XY1000-1B; palm centrifuge, Haimen Qishengbel Instrument Manufacturing Co., Ltd., model: LX-100; refrigerated centrifuge, Beijing Baiyang Pharmaceutical Instrument Co., Ltd., model: BY-R20; low-temperature incubator, I-CVBE, model: FCI-280; frozen grinder, Shanghai Jingxin, model: Tissuelyser-24L; Perkin Elmer microplate reader, PerkinElmer Inc., model: Enspire.

[0051] 2. Dose design

[0052] The daily dose of the traditional Chinese medicine composition is 123g of crude drug per day. According to the body surface area conversion method, the equivalent dose of rats is 123g / 60kg*6.2=12.71g of crude drug / kg. According to the 1 / 2:1:2 administration method, the low dose is 6.36g of crude drug / kg, the medium dose is 12.71g of crude drug / kg, and the high dose is 25.44g of crude drug / kg. Gavage administration, 1mL / 100g, once a day. The daily dose of zolmitriptan tablets is 2.5mg per day. According to the body surface area conversion method, the equivalent dose of rats is 2.5mg / 60kg*6.2=0.26mg / kg.

[0053] 3. Experimental method

[0054] The SD rats were adaptively fed for 1 week, and free to eat feed and water. According to the body weight, they were randomly divided into normal control group, model control group, Zhengtian pill (positive control) group, traditional Chinese medicine composition low, medium and high dose groups, 6 rats in each group.

[0055] Each group of rats was given intragastric administration for 14 days, and the normal control group and the model control group were given the same dose of pure water. After the administration was completed, the rats were fasted for more than 12 hours without water in the afternoon of the 14th day. Except for the normal control group, the rats in the other groups were subcutaneously injected with 15 mg / kg of nitroglycerin on the 15th day to replicate the acute migraine model of rats, and the biological sample collection was performed 2 hours later.

[0056] After the rats were anesthetized with isoflurane, they were fixed in a supine position, the abdominal skin was cut, the abdominal aorta was separated, and the whole blood was collected in a vacuum blood collection tube. After standing on ice for 2 hours, the supernatant was collected after centrifugation at 3500 rpm for 10 minutes, and stored in a -80°C refrigerator.

[0057] Subsequently, the rats were executed by decapitation, the cervical vertebrae were cut, the head skin was peeled off, the skull was exposed, the skull was opened along the midline of the brain, and after gently prying the whole brain, a pair of white swollen structures stacked on the bottom left and right could be seen, which were the trigeminal ganglion. Carefully peel off the trigeminal nerve, try to take the complete nerve fiber bundle, peel off other tissues attached to the nerve bundle, rinse with physiological saline, and then absorb the water with filter paper, quickly put into liquid nitrogen for quick freezing or directly transfer to a negative eighty refrigerator for storage for standby.

[0058] Trigeminal nerve tissue and RIPA lysis buffer (containing PMSF) were homogenized at a ratio of 1:9 (such as 10 mg:90 μL), and the supernatant was collected after centrifugation at 3500 rpm for 10 minutes, and stored in a -80°C refrigerator.

[0059] Detection index: The contents of NO in rat serum and SP and DA in trigeminal nerve were detected, and the specific method referred to the instruction manual of the kit.

[0060] 4. Statistical method

[0061] The measurement data was expressed as mean ± standard deviation , using GraphPad prism9 statistical software, selecting single factor variance analysis (One-way ANOVA) test combined with Dunnett's multiple comparison test method for data statistical analysis, P<0.05 representing that the data had statistical significance.

[0062] 5. Experimental results

[0063] The results are shown in Table 1. After the rats were induced by nitroglycerin, compared with the normal control group, the contents of NO in serum and SP in trigeminal nerve tissue of the model control group were significantly increased, while the content of DA in trigeminal nerve tissue was significantly decreased, with statistical difference (P<0.01); compared with the model control group, the contents of NO and SP in the low, medium and high dose groups of the traditional Chinese medicine composition were significantly decreased, and the content of DA was significantly increased, with statistical difference (P<0.05, P<0.01).

[0064] Table 1: Therapeutic effect on nitroglycerin-induced acute migraine model in rats

[0065]

[0066] Note: Compared with the normal control group, ## P<0.01; compared with the model control group, *P<0.05, **P<0.01.

[0067] 6. Test conclusion

[0068] The traditional Chinese medicine composition 12.71, 25.44 g of crude drug / kg can significantly down-regulate the content of NO in serum and the content of SP in trigeminal nerve tissue of acute migraine rats, and up-regulate the content of DA in trigeminal nerve tissue, suggesting that the traditional Chinese medicine composition has a certain therapeutic effect on nitroglycerin-induced acute migraine in rats.

[0069] Protective effect of traditional Chinese medicine composition on reserpine-induced migraine in mice in Example 3

[0070] 1. Experimental materials

[0071] 1.1 Animal

[0072] ICR mice, male, SPF level, 36, body weight 17-19 g, from Hangzhou Medical College Experimental Animal Center, license number: SCXK(Zhe)2019-0002.

[0073] Rearing environment: room temperature 20-26℃, relative humidity controlled at 40-70%.

[0074] 1.2 Drug

[0075] Traditional Chinese medicine composition, prepared according to the method of Example 1, provided by Jiangsu Kangle Pharmaceutical Co., Ltd.; Zhengtian Pill (Hualuobenang Pharmaceutical Co., Ltd., batch number 2111009H).

[0076] 1.3 Reagent

[0077] Sodium chloride injection, Henan Kelun Pharmaceutical Co., Ltd., specification: 500 mL: 4.5 g, batch number: A21022302B; Reserpine injection, Tianjin Jinyao Amino Acid Co., Ltd., batch number: 220311; PGE2 (Prostaglandin E2) ELISA Kit, Wuhan Elyra Biotech Co., Ltd., item number: E-EL-0034; DA (Dopamine) ELISA Kit, Wuhan Elyra Biotech Co., Ltd., item number: E-EL-0046.

[0078] 1.4 Instruments

[0079] Von Frey filaments, Shanghai Yuren Scientific Instrument Co., Ltd., model number: NC12775-99 Touch-Test; electronic balance, Changzhou Lucky Electronic Equipment Co., Ltd., model number: XY1000-1B; palm centrifuge, Haimen Qilinbel Instrument Manufacturing Co., Ltd., model number: LX-100; refrigerated centrifuge, Beijing Baiyang Pharmaceutical Instrument Co., Ltd., model number: BY-R20; low-temperature incubator, I-CVBE, model number: FCI-280; frozen grinding instrument, Shanghai Jingxin, model number: Tissuelyser-24L; Perkin Elmer microplate reader, Perkin Elmer Inc., model number: Enspire.

[0080] 2. Dose design

[0081] The daily dose of the traditional Chinese medicine composition is 123g of crude drug per day. According to the body surface area conversion method, the equivalent dose of mice is 123g / 60kg*12.3 = 25.22g of crude drug / kg. According to the 1 / 2:1:2 administration method, the low dose is 12.61g of crude drug / kg, the medium dose is 25.22g of crude drug / kg, and the high dose is 50.44g of crude drug / kg. Intragastrically administered, 0.1mL / 10g, once a day.

[0082] The daily dose of Zhengtian Pills is 18g of pills per day. According to the body surface area conversion method, the equivalent dose of mice is 18g / 60kg*12.3 = 3.69g / kg.

[0083] 3. Experimental method

[0084] ICR mice were adaptively fed for 1 week, and free to eat feed and water. 36 mice were randomly divided into 6 groups according to body weight, namely: blank control group, model control group, Zhengtian pill group (positive control, 3.69 g / kg), the composition of the application low (12.61 g / kg), medium (25.22 g / kg), high (50.44 g / kg) dose group, 6 in each group. Except for the blank control group, the rest of the groups were subcutaneously injected with reserpine 0.25 mg / kg per day, for 12 consecutive days. On the 4th day of modeling, the corresponding groups were given intragastric administration once a day, for 7 consecutive days, and the blank control group and the model control group were given pure water by intragastric administration. 30 min after the last administration, the mouse head and face pain threshold was detected using Von Frey filaments, and then the mice were executed by decapitation, and the brain tissue was stored in a-80℃ refrigerator.

[0085] Detection index: ① Head and face pain threshold; ② ELISA kit to detect brain tissue PGE2, DA content.

[0086] 4. Statistical method

[0087] The measurement data is expressed as mean ± standard deviation , using GraphPad prism9 statistical software, selecting single factor variance analysis (One-way ANOVA) test combined with Dunnett's multiple comparison test method for data statistical analysis, P<0.05 represents that the data has statistical significance.

[0088] 5. Experimental results

[0089] 5.1 Effect on reserpine-induced head and face pain threshold in mice

[0090] As shown in Tables 2 and 3, compared with the normal control group, the head and face pain threshold of the model control group mice and the DA content in the brain tissue were significantly decreased, and the PGE2 content in the brain tissue was significantly increased (P<0.01); compared with the model control group, the head and face pain threshold of the Zhengtian pill group and the low, medium and high dose groups of the traditional Chinese medicine composition were significantly increased, and the PGE2 content was significantly decreased (P<0.05, P<0.01).

[0091] Table 2: Effect on reserpine-induced head and face pain threshold in mice with migraine

[0092]

[0093]

[0094] Note: compared with the normal control group, ## P<0.01; compared with the model control group, *P<0.05, **P<0.01.

[0095] Table 3: Effects of the Chinese medicine composition on PGE2 and DA in the brain tissue of migraine mice induced by reserpine

[0096]

[0097] Note: Compared with the normal control group, ## P<0.01; compared with the model control group, *P<0.05, **P<0.01.

[0098] 6. Test conclusion

[0099] The Chinese medicine composition 25.22, 50.44 g of crude drug / kg can obviously inhibit the decrease of the head and face pain threshold of migraine mice induced by reserpine and the content of DA in the brain tissue, and reduce the content of PGE2 in the brain tissue, which indicates that the Chinese medicine composition has a certain therapeutic effect on migraine mice induced by reserpine.

[0100] The above examples of the present application are only examples for clearly illustrating the present application, and are not intended to limit the embodiments of the present application. Based on the above description, other different forms of changes or variations can be made by those skilled in the art. Here, all the embodiments are not required to be exhausted. Any modification, equivalent replacement and improvement made within the spirit and principle of the present application shall be included in the protection scope of the claims of the present application.

Claims

1. The application of a traditional Chinese medicine composition in the preparation of a medicament for the prevention and / or treatment of migraines, characterized in that, The traditional Chinese medicine composition comprises, by weight:

2. The application as described in claim 1, characterized in that, The traditional Chinese medicine composition comprises, by weight:

3. The application as described in claim 1 or 2, characterized in that, The licorice mentioned is roasted licorice, and the Morinda officinalis mentioned is salt-processed Morinda officinalis.

4. The application as described in any one of claims 1 to 3, characterized in that, The drug includes the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

5. The application as described in any one of claims 1 to 4, characterized in that, The dosage form of the drug is one or more of the following: granules, decoction, tablets, capsules, oral liquid, or pills.

6. The application as described in any one of claims 1 to 5, characterized in that, The preparation method of the traditional Chinese medicine composition includes: mixing the raw medicinal materials according to the ratio, adding water and decocting twice. The first decoction is decocted with 10 times the amount of water for 1.5 hours, and the second decoction is decocted with 8 times the amount of water for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to an extract with a relative density of 1.10 to 1.20 (60°C).

7. The application as described in any one of claims 1 to 6, characterized in that, The preparation method of the drug includes: mixing the raw medicinal materials according to the ratio, adding water and decocting twice. The first decoction is decocted for 1.5 hours with 10 times the amount of water, and the second decoction is decocted for 1 hour with 8 times the amount of water. The decoctions are combined, filtered, and the filtrate is concentrated to an extract with a relative density of 1.10 to 1.20 (60°C). The extract is then mixed with excipients to obtain the final product. Alternatively, mix the raw medicinal materials according to the specified ratio, add 8 to 10 times the weight of water, extract twice with water, combine the water extracts, and concentrate to 1 gram of raw drug / mL.

8. The application as described in claim 7, characterized in that, When the dosage form of the drug is granules, its preparation method includes: mixing the raw medicinal materials according to the ratio, adding water and decocting twice, adding 10 times the amount of water for 1.5 hours for the first decoction, adding 8 times the amount of water for 1 hour for the second decoction, combining the decoctions, filtering, concentrating the filtrate to an extract with a relative density of 1.10 to 1.20 (60°C), adding maltodextrin, drying, pulverizing into fine powder, adding maltodextrin, mixing well, making granules, drying, and obtaining the drug. When the dosage form of the drug is a decoction, tablet, capsule, oral liquid or drop pill, its preparation method includes: mixing each raw medicinal material according to the ratio, adding 8 to 10 parts by weight of water, extracting twice with water, combining the water extracts, concentrating to 1 gram of crude drug / mL, adding excipients, and preparing the corresponding dosage form.

9. The application as described in any one of claims 1 to 8, characterized in that, The prevention and / or treatment of migraines includes: (I) Reduce serum NO and trigeminal nerve tissue SP content in migraine rats; (II) Increase the DA content in trigeminal nerve tissue; (III) Pain threshold in the head and face and DA content in brain tissue of migraine mice; and / or (IV) Downregulates PGE2 levels in brain tissue.

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