Traditional Chinese medicine composition for treating peripheral facial paralysis and its preparation method and application

Abstract

The present invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a Chinese medicine composition for treating peripheral facial paralysis, and a preparation method and application thereof. The Chinese medicine composition comprises honeysuckle, forsythia, gastrodia, siler, rhizoma leucodermi, earthworm, fried silkworm, angelica dahurica, ligusticum chuanxiong, angelica, scutellaria baicalensis, bupleurum, coix seed, tuckahoe, rhizoma alismatis and liquorice, or comprises peach kernel, safflower, angelica, rehmannia root, white peony root, cassia twig, clematis root, corydalis, clematis root, caulis yangfeng, gentiana macrophylla and parasitic plant. The Chinese medicine composition of the present invention improves the therapeutic effect and the patient's acceptance, shortens the treatment time, and has a good therapeutic effect on peripheral facial paralysis in the acute stage, recovery stage and sequela stage with symptoms such as facial paralysis, eye tearing, enlarged palpebral fissure, shallow or disappeared forehead wrinkles, facial muscle spasm, twitch, linkage, and tears during meals.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating peripheral facial paralysis and a preparation method and application thereof. Background Art

[0002] Peripheral facial palsy, also known as Bell's palsy or facial neuritis, is a peripheral facial muscle paralysis caused by nonspecific inflammation of the facial nerve in the facial nerve canal. The general symptoms are facial paralysis, inability to raise eyebrows, close eyes, puff mouth, etc. It is a common and frequently occurring disease that can occur at any age. The incidence rate is similar between men and women. Most cases are unilateral, and bilateral cases are rare.

[0003] The existing TCM theory for the treatment of peripheral facial paralysis believes that the onset of peripheral facial paralysis is due to insufficient positive energy, empty collaterals, and weak defense; exogenous evil invades the facial meridians, qi and blood are blocked, and the meridians are not nourished, resulting in muscle relaxation. The head is the meeting point of all yang and the ancestor of all meridians. Yang meridians are easily invaded by exogenous evils. Wind belongs to yang evil, which has the effect of radiating upward and outward, so wind evil hurts people and easily invades the high position of the human body.

[0004] At present, for the treatment of peripheral facial paralysis, Western medicine mainly uses glucocorticoids, antiviral drugs, vitamin B1, vitamin B12 and other drugs. However, taking Western medicines such as hormone drugs has certain side effects. It is also common to use traditional Chinese medicine (such as acupuncture) to treat peripheral facial paralysis, but due to the inconvenience of multiple visits a week and the inevitable pain, many patients find it difficult to accept acupuncture treatment, the clinical acceptance is not ideal, and the effectiveness of treatment needs to be improved. At present, the treatment of peripheral facial paralysis with Chinese medicine alone is mainly based on promoting blood circulation and unblocking collaterals, such as taking Naoxintong, Xuesaitong soft capsules, Naoan capsules, Dengzhanhuasu dripping pills or Dahuoluo capsules. However, wind evil is an important pathogenic evil in peripheral facial paralysis, and simply promoting blood circulation and removing blood stasis cannot treat facial paralysis caused by wind evil invasion.

[0005] It would be of great significance if we could develop a Chinese medicine that can be used in combination with Western medicine to treat peripheral facial paralysis, and it can not only improve the treatment effect, but also avoid acupuncture treatment, increase patient acceptance, and shorten the treatment time. Summary of the invention

[0006] Problem that the invention aims to solve

[0007] In view of the deficiencies in the prior art, the present invention aims to provide a Chinese medicine composition for treating peripheral facial paralysis and a preparation method and application thereof. The Chinese medicine composition can be used in combination with Western medicine for treatment, which can improve the treatment effect and patient acceptance and shorten the treatment time.

[0008] Solutions for solving problems

[0009] In a first aspect, the present invention provides two Chinese medicine compositions for treating peripheral facial paralysis.

[0010] The first Chinese medicine composition includes: honeysuckle, forsythia, gastrodia, siler, white aconite, earthworm, bombyx batryticatus, angelica dahurica, ligusticum chuanxiong, angelica sinensis, scutellaria baicalensis, bupleurum, coix seed, tuckahoe, oriental water plantain and liquorice.

[0011] Preferably, the Chinese medicine composition consists of honeysuckle, forsythia, gastrodia, siler, white aconite, earthworm, bombyx batryticatus, angelica dahurica, ligusticum chuanxiong, angelica sinensis, scutellaria baicalensis, bupleurum, coix seed, tuckahoe, oriental water plantain and liquorice.

[0012] Preferably, the Chinese medicine composition comprises, by weight: 10-30 parts of honeysuckle, 10-30 parts of forsythia, 10-20 parts of gastrodia, 10-20 parts of siler, 5-15 parts of white aconite, 10-20 parts of earthworm, 10-20 parts of bombyx batryticatus, 10-15 parts of angelica dahurica, 5-10 parts of ligusticum chuanxiong, 10-20 parts of angelica sinensis, 10-20 parts of scutellaria baicalensis, 10-20 parts of bupleurum, 20-40 parts of coix seed, 10-30 parts of poria, 5-15 parts of oriental rhizome and 5-15 parts of liquorice.

[0013] More preferably, in parts by weight, the Chinese medicine composition comprises: 15-25 parts of honeysuckle, 15-25 parts of forsythia, 12-17 parts of gastrodia, 12-17 parts of siler, 8-12 parts of white aconite, 12-17 parts of earthworm, 12-17 parts of bombyx batryticatus, 10-13 parts of angelica, 6-8 parts of ligusticum chuanxiong, 12-17 parts of angelica sinensis, 12-17 parts of scutellaria baicalensis, 12-17 parts of bupleurum, 25-35 parts of coix seed, 15-25 parts of poria, 8-12 parts of oriental rhizome and 8-12 parts of liquorice.

[0014] Further preferably, the Chinese medicine composition comprises, by weight: 20 parts of honeysuckle, 20 parts of forsythia, 15 parts of gastrodia, 15 parts of siler, 9 parts of white aconite, 15 parts of earthworm, 15 parts of bombyx batryticatus, 12 parts of angelica dahurica, 7 parts of ligusticum chuanxiong, 15 parts of angelica sinensis, 15 parts of scutellaria baicalensis, 15 parts of bupleurum, 30 parts of coix seed, 20 parts of poria, 10 parts of oriental water plantain and 10 parts of liquorice.

[0015] Preferably, the Radix et Rhizoma Whiteheads is processed Radix et Rhizoma Whiteheads.

[0016] Preferably, the silkworm pupae are fried silkworm pupae.

[0017] Preferably, the radix scutellariae is wine-processed radix scutellariae (or wine radix scutellariae).

[0018] Preferably, the Bupleurum is Bupleurum chinense.

[0019] Preferably, the coix seeds are fried coix seeds.

[0020] The second Chinese medicine composition includes: peach kernel, safflower, angelica, rehmannia root, white peony root, cinnamon twig, iron wire radix poriae, corydalis, clematis, sea wind vine, gentiana macrophylla and mistletoe.

[0021] Preferably, the traditional Chinese medicine composition consists of peach kernel, safflower, angelica, rehmannia root, white peony root, cinnamon twig, herba scutellariae, corydalis, clematis, kadzuvine root, gentiana macrophylla and mistletoe.

[0022] Preferably, in parts by weight, the Chinese medicine composition comprises: 20-30 parts of peach kernel, 20-30 parts of safflower, 20-30 parts of angelica, 20-30 parts of rehmannia root, 40-60 parts of white peony root, 20-30 parts of cassia twig, 20-30 parts of iron wire stalk grass, 20-40 parts of Corydalis, 10-30 parts of clematis, 10-30 parts of Piper mesenteriae, 10-30 parts of Gentiana macrophylla and 20-30 parts of mistletoe.

[0023] More preferably, in parts by weight, the Chinese medicine composition comprises: 23-28 parts of peach kernel, 23-28 parts of safflower, 23-28 parts of angelica, 23-28 parts of rehmannia root, 45-55 parts of white peony root, 23-28 parts of cassia twig, 23-28 parts of iron wire stalk grass, 25-35 parts of Corydalis, 15-25 parts of Clematis, 15-25 parts of Piper mesenteriae, 15-25 parts of Gentiana macrophylla and 23-28 parts of mistletoe.

[0024] Further preferably, the Chinese medicine composition comprises, by weight: 25 parts of peach kernel, 25 parts of safflower, 25 parts of angelica, 25 parts of rehmannia root, 50 parts of white peony root, 25 parts of cinnamon twig, 25 parts of iron wire stalk grass, 30 parts of Corydalis yanhusuo, 20 parts of clematis, 20 parts of kadzu vine, 20 parts of gentiana macrophylla and 25 parts of mistletoe.

[0025] Preferably, the peach kernels are stewed peach kernels.

[0026] Preferably, the Corydalis yanhusuo is vinegar-processed Corydalis yanhusuo (or vinegar Corydalis yanhusuo).

[0027] Preferably, the Rehmannia root is Rehmannia root prepared.

[0028] In a second aspect, the present invention provides a method for preparing the above-mentioned Chinese medicine composition, which comprises the steps of weighing and mixing the various components in the Chinese medicine composition.

[0029] In a third aspect, the present invention provides a pharmaceutical preparation, which is prepared from the above-mentioned traditional Chinese medicine composition.

[0030] Preferably, the pharmaceutical preparation is a decoction, an oral liquid or an oral solid preparation.

[0031] More preferably, the pharmaceutical preparation is a decoction.

[0032] Furthermore, the oral solid preparation is a tablet, capsule, granule or powder.

[0033] In a fourth aspect, the present invention provides use of the above-mentioned Chinese medicine composition or the above-mentioned pharmaceutical preparation in the preparation of a drug for preventing and / or treating peripheral facial paralysis.

[0034] Preferably, the peripheral facial paralysis is peripheral facial paralysis in the acute stage, recovery stage or sequelae stage.

[0035] More preferably, the peripheral facial palsy is acute Bell's palsy.

[0036] Preferably, the symptoms of peripheral facial paralysis include at least one of the following symptoms: facial deviation, tearing, enlarged palpebral fissure, shallow or disappearing forehead wrinkles, facial muscle spasms, twitches or linkages, and tears while eating.

[0037] Effects of the Invention

[0038] The Chinese medicine composition for treating peripheral facial paralysis provided by the present invention comprises 16 medicinal materials including honeysuckle, forsythia, gastrodia, siler, rhizoma leucodermi, earthworm, fried silkworm, angelica dahurica, ligusticum chuanxiong, angelica, scutellaria, bupleurum, coix seed, tuckahoe, rhizoma alismatis and liquorice, or comprises 12 medicinal materials including peach kernel, safflower, angelica, rehmannia root, white peony root, cassia twig, herba scutellariae, corydalis, radix clematis, spatholobi, gentiana macrophyllae and parasitic plant. The Chinese medicine composition can be used in combination or in combination with western medicine. The Chinese medicine composition improves the therapeutic effect and the patient's acceptance, shortens the treatment time, and has no serious adverse reactions. The two Chinese medicine compositions of the present invention have good therapeutic effects on peripheral facial paralysis in the acute stage, recovery stage and sequela stage with symptoms such as facial paralysis, eye tearing, enlarged palpebral fissure, shallow or disappeared forehead wrinkles, facial muscle spasm, twitching, linkage, and tears during eating. DETAILED DESCRIPTION

[0039] Various exemplary embodiments, features and aspects of the present invention will be described in detail below. The word "exemplary" used here means "used as an example, embodiment or illustrative". Any embodiment described here as "exemplary" is not necessarily interpreted as being superior or better than other embodiments.

[0040] In addition, in order to better illustrate the present invention, numerous specific details are provided in the following specific embodiments. It should be understood by those skilled in the art that the present invention can be implemented without certain specific details. In other examples, methods, means, equipment and steps well known to those skilled in the art are not described in detail in order to highlight the subject matter of the present invention.

[0041] Unless otherwise stated, the units used in this specification are all international standard units, and the numerical values ​​and numerical ranges appearing in the present invention should be understood to include the inevitable systematic errors in industrial production.

[0042] In this specification, the word "may" means both performing a certain process and not performing a certain process.

[0043] In this specification, the references to "some specific / preferred embodiments", "other specific / preferred embodiments", "embodiments", etc., mean that the specific elements (e.g., features, structures, properties and / or characteristics) described in connection with the embodiments are included in at least one embodiment described herein, and may or may not exist in other embodiments. In addition, it should be understood that the elements may be combined in various embodiments in any suitable manner.

[0044] In this specification, the numerical range expressed using "a numerical value A to a numerical value B" means a range including the endpoints numerical values ​​A and B.

[0045] [Chinese medicine composition]

[0046] The combination of Chinese medicinal raw materials in the composition of the present invention is based on the fact that Chinese medicine believes that peripheral facial paralysis is caused by exogenous wind evil with dampness and toxins, and the sudden attack on the three yang meridians of the head and face. In addition, the present invention also considers that the spleen is responsible for blood transportation, and if the spleen fails to transport blood and has no source of qi, the muscles will have no qi to live, qi and blood will not flow smoothly, and the meridians will be blocked. Therefore, it is necessary to comprehensively consider the Chinese medicine prescription from the aspects of dispelling wind, detoxifying, dispelling dampness and strengthening the spleen, and promoting blood circulation and unblocking collaterals.

[0047] First, the first Chinese medicine composition for treating peripheral facial paralysis in the present invention comprises the following components: honeysuckle, forsythia, gastrodia, siler, white aconite, earthworm, bombyx batryticatus, angelica dahurica, ligusticum chuanxiong, angelica sinensis, scutellaria baicalensis, bupleurum, coix seed, tuckahoe, oriental water plantain and liquorice.

[0048] Honeysuckle is the flower bud of Lonicera japonica Thunb., a plant of the Caprifoliaceae family. It is distributed throughout the north and south of my country. It is picked in early summer when the flowers are in bud, dried in the shade, and used raw or made into a dew. Honeysuckle is cold in nature, sweet in taste, and enters the lung, stomach, and large intestine meridians, and has the effects of clearing heat and detoxifying.

[0049] Forsythia suspensa (Thunb.) Vahl, a plant of the genus Forsythia in the family Oleaceae, is produced in Northeast my country, North China, the Yangtze River Basin to Yunnan, and is found both in the wild and in domesticated plants. The first-ripened fruits are harvested before the White Dew, and are still green in color, called Qingqiao. The ripe fruits are harvested before the Cold Dew, and are called Huangqiao. After harvesting, Qingqiao is steamed and dried, and the seeds are sieved out to be used as the heart of the forsythia. Qingqiao is preferred and is used raw. Forsythia is slightly cold in nature, bitter in taste, and enters the lung, heart, and gallbladder meridians. It has the effects of clearing away heat and detoxifying, eliminating carbuncle and dispersing knots.

[0050] Gastrodia elata is the tuber of Gastrodia elata Bl., a plant of the Orchidaceae Gastrodia genus. It is mainly produced in Sichuan, Yunnan, and Guizhou, and is widely distributed in the north and south of my country. It is dug from the beginning of winter to before Qingming the following year, washed immediately, steamed thoroughly, and dried at low temperature. Gastrodia elata is mild in nature, sweet in taste, and enters the liver meridian. It has the effects of calming wind and relieving spasm, calming liver yang, and dispelling wind and unblocking collaterals.

[0051] Saposhnikovia divaricata (Turcz.) Schischk. is a plant of the genus Saposhnikovia in the family Apiaceae. It is mainly produced in Heilongjiang, Jilin and Liaoning. It is harvested in spring and autumn, the brown hair on the reed head is removed, dried in the sun, and sliced ​​thoroughly. Saposhnikovia is slightly warm in nature, pungent and sweet in taste, and enters the bladder, liver and spleen meridians. It has the effects of dispelling wind and relieving exterior symptoms, eliminating dampness, relieving pain and relieving spasms.

[0052] White aconite is the tuber of Typhonium giganteum Engl., a plant of the genus Typhonium of the family Araceae. It is mainly produced in Henan, Shaanxi, Sichuan and Gansu provinces in my country. It is dug in autumn, the residual stems, fibrous roots and outer skin are removed, and it is fumigated with sulfur 1-2 times and dried in the sun. White aconite is warm in nature, pungent and sweet in taste, and enters the spleen and stomach meridians. It has the effects of drying dampness and resolving phlegm, dispelling wind and stopping spasm, and detoxifying and dispersing knots. "Processed white aconite" is a processed product of white aconite. Take clean white aconite, separate large and small pieces, soak, and change the water 2-3 times a day. If sticky foam appears after a few days, add alum after changing the water (2kg of alum is used for every 100kg of white aconite), soak for 1 day, and then change the water again until there is a slight numbness in the tongue when tasting, and then take it out. Put ginger slices and alum powder in a pot, add appropriate amount of water, boil, pour in white aconite and cook until there is no white core, remove from the pot, remove the ginger slices, dry until 60% to 70% dry, cut into thick slices, and dry (for every 100kg of white aconite, use 12.5kg of ginger and 12.5kg of alum).

[0053] Earthworm is the dried whole body of Pheretima aspergillum (E.Perrier, 1872) of the family Lumbricidae or Allolobophora caliginosa trapezoides (Duges, 1828) of the family Lumbricidae. Earthworm is cold in nature, salty in taste, and enters the liver, spleen, and lung meridians. It has the effects of clearing away heat and calming the nerves, calming the liver and extinguishing wind, stopping asthma, unblocking meridians, and promoting urination.

[0054] Bombyx mori Linnaeus is the dried whole body of the 4th to 5th instar larvae of the silkworm Bombyx mori Linnaeus of the Bombycidae family, which died from infection (or artificial inoculation) with the fungus Beauveria bassiana of the Cordyceps family. Bombyx mori is flat in nature, salty and pungent in taste, and enters the liver, lung, and stomach meridians. It has the effects of calming wind and relieving spasms, dispelling wind and relieving pain, and resolving phlegm and dispersing nodules. "Stir-fried Bombyx mori" is a processed product of Bombyx mori. Take the clean Bombyx mori and stir-fry it according to the bran stir-frying method (refer to the 2020 edition of the Chinese Pharmacopoeia, Part IV, General Rules 0213) until the surface turns yellow.

[0055] Angelica dahurica is the root of Angelica dahurica Benth.et Hook. or A.anomala Lallem. and A.taiwaniana Boiss. of the Apiaceae family. It is mainly produced in Zhejiang, Hubei, Liaoning and Sichuan, and is mostly cultivated. It is dug when the leaves turn yellow in summer and autumn, the fibrous roots are removed, dried in the sun, and sliced ​​thoroughly. Angelica dahurica is warm in nature, pungent in taste, and enters the lung and stomach meridians. It has the effects of dispelling exterior pathogens, dispelling wind and dampness, reducing swelling and draining pus, and relieving pain.

[0056] Chuanxiong is the dried rhizome of the plant Ligusticum chuanxiong Hort. of the Apiaceae family. It is mainly produced in Sichuan, Yunnan, Guizhou, Guangxi, etc. Chuanxiong is warm in nature, pungent in taste, and enters the liver, gallbladder, and pericardium meridians. It has the effects of promoting qi and relieving depression, dispelling wind and dampness, promoting blood circulation and relieving pain.

[0057] Angelica sinensis is the root of Angelica sinensis (Oliv.) Diels, a plant of the Apiaceae family. It is mainly produced in Minxian (Qinzhou) in southeastern Gansu, and is also cultivated in Shaanxi, Sichuan, Yunnan, Hubei and other places. It is dug up in late autumn, and the reed head and fibrous roots are removed. After the water evaporates slightly, it is tied into small bundles and slowly smoked with a low fire or smoked with sulfur. Angelica sinensis is warm in nature, sweet and spicy in taste, and enters the liver, heart and spleen meridians. It has the effects of nourishing blood, promoting blood circulation, relieving pain, and moistening the intestines.

[0058] Scutellaria baicalensis is the root of Scutellaria baicalensis Georgi, a plant of the genus Scutellaria in the Lamiaceae family. It is mainly produced in Hebei, Shanxi, Inner Mongolia, Henan and Shaanxi. It is dug in spring and autumn, and the residual stems and fibrous roots are removed and dried in the sun. Scutellaria baicalensis is cold in nature and bitter in taste. It enters the lung, gallbladder, stomach and large intestine meridians. It has the effects of clearing heat and dampness, purging fire and detoxifying, stopping bleeding and calming the fetus. "Scutellaria baicalensis slices" are processed products of Scutellaria baicalensis. Take Scutellaria baicalensis, remove impurities, boil in boiling water for 10 minutes, take out, simmer thoroughly, cut into thin slices, and dry; or steam for half an hour, take out, cut into thin slices, and dry (be careful to avoid exposure to the sun). "Wine Scutellaria baicalensis" or "Wine-processed Scutellaria baicalensis" is a processed product of Scutellaria baicalensis. Take Scutellaria baicalensis slices and fry them dry according to the wine roasting method (refer to the General Rules of the Fourth Part of the 2020 Edition of the Chinese Pharmacopoeia 0213).

[0059] Bupleurum chinense DC. or B.scorzonerifolium Willd. of the genus Bupleurum in the family Apiaceae. The former is mainly produced in Liaoning, Gansu, Hebei, Henan and other places, while the latter is mainly produced in Hubei, Jiangsu, Sichuan and other places. It is dug up in spring and autumn, dried in the sun, and cut into short sections. Bupleurum chinense DC. is cylindrical or oblong-conical, 6 to 15 cm long and 0.3 to 0.8 cm in diameter. The root head is swollen, with 3 to 15 stem bases or short fibrous leaf bases remaining at the top, and branches at the bottom. The surface is dark brown or light brown, with longitudinal wrinkles, root scars and lenticels. It is hard and tough, not easy to break, and the cross section is fibrous, with light brown cortex and yellow-white wood. It has a slight fragrance and a slightly bitter taste. The root of southern Bupleurum chinense is thinner, conical, with many fine hair-like dead leaf fibers at the top, and the bottom is mostly unbranched or slightly branched. The surface is reddish brown or dark brown, with many fine rings near the root head. It is slightly soft, easy to break, and the cross section is slightly flat, not fibrous. It has a rancid oily smell. Bupleurum is slightly cold in nature, bitter and pungent in taste, and enters the pericardium, liver, triple burner, and gallbladder meridians. It has the effects of resolving fever, soothing the liver and relieving depression, and raising yang energy. The Bupleurum in the present invention can be Bupleurum chinense or Bupleurum chinense, preferably Bupleurum chinense.

[0060] Job's tears are the mature kernels of Coix lacryma-jobi L., a plant of the genus Coix in the Poaceae family. It is produced in most parts of my country, mainly in Fujian, Hebei, Liaoning and other places. In autumn, the plants are harvested when the fruits are ripe, dried in the sun, the fruits are beaten, and then dried in the sun, and the shells and seed coats are removed. Job's tears are cool in nature, sweet and light in taste, and enter the spleen, stomach, and lung meridians. They have the effects of promoting diuresis and infiltrating dampness, strengthening the spleen and stopping diarrhea, removing numbness, clearing heat and discharging pus, and detoxifying and dispersing nodules. "Stir-fried coix seeds with bran" is a processed product of coix seeds. Take the clean coix seeds and stir-fry them according to the bran frying method (refer to the general rules of the fourth part of the 2020 edition of the Chinese Pharmacopoeia 0213) until they are slightly yellow. "Fried coix seeds" is a processed product of coix seeds. Take the clean coix seeds, place them in a preheated frying container, heat them over low heat, and fry until the surface is slightly yellow, slightly bulging, and has an aroma, then take them out and let them cool.

[0061] Poria cocos is the dried sclerotium of the Polyporaceae fungus Poria cocos (Schw.) Wolf. It is mostly parasitic on the roots of Pinus densiflora or Pinus massoniana, and is wild or cultivated. It is mainly produced in Yunnan, Anhui, Hubei, Henan, Sichuan and other places. It is mostly dug from July to September, and the sand is removed. After being piled up to "sweat", it is spread out to dry on the surface, and then "sweated" again. This is repeated several times until wrinkles appear and most of the internal moisture is lost, and then dried in the shade; or fresh Poria cocos can be cut and dried in the shade. Poria cocos is flat in nature, sweet and light in taste, and enters the heart, spleen, and kidney meridians. It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen, and calming the nerves.

[0062] Alisma orientale (Sam.) Juzep. is a tuber of the Alisma orientale plant of the Alisma genus of the Alismataceae family. It is mainly produced in Fujian, Sichuan, Jiangxi and other places. It is dug up in winter when the stems and leaves begin to wither, washed, dried over a low fire, and then the fibrous roots and rough skin are removed, sliced ​​and dried in the sun. Alisma orientale is cold in nature, sweet and light in taste, and enters the kidney and bladder meridians. It has the effects of promoting diuresis and removing dampness, relieving heat, clearing turbidity and reducing fat.

[0063] Licorice is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. of the genus Glycyrrhiza in the Leguminosae family. It is mainly produced in Inner Mongolia, Shanxi, Gansu, Xinjiang and other places. It is dug in spring and autumn, and the residual stems and fibrous roots are removed, or the outer skin is removed, sliced ​​and dried. Licorice is flat in nature, sweet in taste, and enters the heart, lung, spleen and stomach meridians. It has the effects of tonifying the spleen and replenishing qi, clearing away heat and detoxifying, removing phlegm and relieving cough, relieving acute pain and harmonizing various medicines.

[0064] In some preferred embodiments, the first Chinese medicine composition consists of the following components: honeysuckle, forsythia, gastrodia, siler, white aconite, earthworm, bombyx batryticatus, angelica dahurica, ligusticum chuanxiong, angelica sinensis, scutellaria baicalensis, bupleurum, coix seed, poria, oriental water plantain and liquorice.

[0065] In some embodiments, the first traditional Chinese medicine composition includes, by weight, 10-30 parts of honeysuckle, 10-30 parts of forsythia, 10-20 parts of gastrodia, 10-20 parts of siler, 5-15 parts of white aconite, 10-20 parts of earthworm, 10-20 parts of bombyx batryticatus, 10-15 parts of angelica dahurica, 5-10 parts of ligusticum chuanxiong, 10-20 parts of angelica sinensis, 10-20 parts of scutellaria baicalensis, 10-20 parts of bupleurum, 20-40 parts of coix seed, 10-30 parts of poria, 5-15 parts of oriental rhizome and 5-15 parts of liquorice.

[0066] In some preferred embodiments, the first traditional Chinese medicine composition includes, by weight, 15-25 parts of honeysuckle, 15-25 parts of forsythia, 12-17 parts of gastrodia, 12-17 parts of siler, 8-12 parts of white aconite, 12-17 parts of earthworm, 12-17 parts of bombyx batryticatus, 10-13 parts of angelica, 6-8 parts of ligusticum chuanxiong, 12-17 parts of angelica sinensis, 12-17 parts of scutellaria baicalensis, 12-17 parts of bupleurum, 25-35 parts of coix seed, 15-25 parts of poria, 8-12 parts of oriental rhizome and 8-12 parts of liquorice.

[0067] In some more preferred embodiments, the first Chinese medicine composition includes, by weight, 20 parts of honeysuckle, 20 parts of forsythia, 15 parts of gastrodia, 15 parts of siler, 9 parts of white aconite, 15 parts of earthworm, 15 parts of bombyx batryticatus, 12 parts of angelica dahurica, 7 parts of ligusticum chuanxiong, 15 parts of angelica sinensis, 15 parts of scutellaria baicalensis, 15 parts of bupleurum, 30 parts of coix seed, 20 parts of poria, 10 parts of oriental water plantain and 10 parts of liquorice.

[0068] In some embodiments, the Radix Whiteheada is processed Radix Whiteheada.

[0069] In some embodiments, the Bombyx batryticatus is stir-fried Bombyx batryticatus.

[0070] In some embodiments, the radix scutellariae is wine-processed radix scutellariae (or wine radix scutellariae).

[0071] In some embodiments, the Bupleurum chinense is Bupleurum chinense.

[0072] In some embodiments, the coix seeds are fried coix seeds.

[0073] In the first Chinese medicine composition: honeysuckle is light and fragrant, which can clear the heat of qi and detoxify blood; forsythia is light and floating, good at going up to the upper part of the body, so as to relieve heart fire, break blood stasis, disperse qi accumulation, and eliminate carbuncle. Honeysuckle and forsythia are combined and go up, light and clear, floating and dispersing, clearing qi and cooling blood, enhancing the ability of clearing heat and detoxifying, and dredging qi stagnation and blood stasis in the twelve meridians. At the same time, modern pharmacology has found that the two drugs have broad-spectrum antibacterial effects on a variety of pathogens and have certain antiviral effects. The two are both monarch drugs.

[0074] Processed white aconite is pungent, warm, and dry. It enters the Yangming meridian and moves to the head and face, dispelling wind and resolving phlegm, warming the yang and dispersing cold. It is especially good at treating wind in the head and face. Earthworms can dredge the meridians and activate the collaterals. They are good at moving and lead all the other medicines directly to the collaterals. The combination of the two can dispel wind and dredge the collaterals more effectively. Angelica dahurica can reach the face and face, and is good at dispersing wind, cold, and dampness in the Yangming meridian. Angelica dahurica is white in color, warm in nature, and has a strong aroma. It can dredge the nine orifices, dispel wind and relieve itching, dredge the collaterals and relieve pain, and remove dampness and reduce swelling. Stir-fried silkworm can dispel wind and stop spasms, resolve phlegm and dredge the collaterals. Processed silkworm can get the most clear and transformed qi. Its smell is light and floating, and it can dispel wind and clear heat, stop wind and relieve spasms, resolve phlegm and resolve knots, and dredge the collaterals and relieve pain. The two medicines are used together and move upward, and their power to dispel wind and relieve pain, overcome dampness and stop leukorrhea is more prominent. Bupleurum is bitter and flat, dispersing wind and heat, and raising yang qi; wine-scutellaria is bitter and cold, clearing heat and drying dampness, purging fire and detoxifying. Bupleurum purifies the external evil that is half superficial and half internal, while Scutellaria baicalensis purifies the internal evil that is half superficial and half internal. Bupleurum purifies the clear Yang, while Scutellaria baicalensis purifies the turbid fire. The combination of the two medicines can raise the clear and lower the turbid, reconcile the exterior and interior, and reconcile the Shaoyang, clearing the evil heat of the Shaoyang. Bupleurum purifies the liver and gallbladder, and can clear the internal dampness and heat. To treat wind, you must first treat the blood, and the blood will extinguish the wind. Angelica sinensis is soft and moist, nourishes blood and activates blood circulation, removes blood stasis and relieves pain; Chuanxiong is pungent, warm, fragrant and penetrating, promotes qi and activates blood circulation, removes wind and relieves pain. Angelica sinensis mainly nourishes blood, while Chuanxiong mainly promotes qi. The two medicines are used together to restrain each other's shortcomings and develop their strengths, taking into account both qi and blood, and enhancing the power of nourishing blood and regulating menstruation, promoting qi and activating blood circulation, and dispersing blood stasis and relieving pain. The above four groups of medicines are all ministers, and they have the functions of detoxification, dispelling wind and activating blood circulation.

[0075] Coix seeds clear away heat, dispel dampness and eliminate numbness, Poria promotes diuresis, infiltrates dampness and strengthens the spleen, and Alisma orientalis promotes diuresis, infiltrates dampness and eliminates heat. The three herbs work together to clear away heat and dispel dampness. Saposhnikovia dispels wind and relieves exterior symptoms, overcomes dampness, relieves pain and stops spasms, and Gastrodia dispels wind and dredges the meridians, calms the wind and stops spasms. The two herbs work together to enhance the functions of Rhizoma Aconiti Lateralis and Bombyx Batryticatus in dispelling wind and dredging the meridians. The above five herbs are adjuvants.

[0076] Licorice can harmonize the middle, relieve urgency, and coordinate various medicines, and is used as a guiding drug.

[0077] The second Chinese medicine composition for treating peripheral facial paralysis in the present invention comprises the following components: peach kernel, safflower, angelica, rehmannia root, white peony root, cassia twig, clematis root, corydalis, clematis root, kadzuvine root, gentiana macrophylla and mistletoe.

[0078] Peach kernel is the seed kernel of Prunus persica (L.) Batsch or Prunus davidiana (Carr.) Franch. of the genus Prunus in the Rosaceae family. It is produced in most parts of the country, mainly in Sichuan, Shaanxi, Hebei, Shandong, Guizhou and other places. Pick the ripe fruits from July to September, remove the pulp and shell, take out the seeds, and dry them in the sun. Peach kernel is flat in nature, bitter in taste, and enters the heart, liver, lung, and large intestine meridians. It has the effects of promoting blood circulation and removing blood stasis, moistening the intestines and relieving constipation, and relieving cough and asthma. "Simmered peach kernel" is a processed product of peach kernel. Take the clean peach kernel, peel it according to the stewing method (refer to the general rules of the fourth part of the 2020 edition of the Chinese Pharmacopoeia 0213), and crush it when used.

[0079] Safflower is the tubular corolla of Carthamus tinctorius L., a plant of the genus Carthamus in the Asteraceae family. It is produced in Henan, Hubei, Sichuan, Yunnan, Zhejiang and other places, and is cultivated. It blooms in summer and is picked when the color of the flower changes from yellow to bright red and dried in the shade. Safflower is warm in nature, pungent in taste, and enters the heart and liver meridians. It has the effects of promoting blood circulation, removing blood stasis, and promoting menstruation.

[0080] Angelica sinensis is the root of Angelica sinensis (Oliv.) Diels, a plant of the Apiaceae family. It is mainly produced in Minxian (Qinzhou) in southeastern Gansu, and is also cultivated in Shaanxi, Sichuan, Yunnan, Hubei and other places. It is dug up in late autumn, and the reed head and fibrous roots are removed. After the water evaporates slightly, it is tied into small bundles and slowly smoked with a low fire or smoked with sulfur. Angelica sinensis is warm in nature, sweet and spicy in taste, and enters the liver, heart and spleen meridians. It has the effects of nourishing blood, promoting blood circulation, relieving pain, and moistening the intestines.

[0081] Rehmannia glutinosa is the fresh or dried root of Rehmannia glutinosa Libosch. of the Scrophulariaceae family. It is dug in autumn, and the root, fibrous roots and mud are removed, and used fresh; or the Rehmannia glutinosa is slowly baked until it is about 80% dry. The former is commonly known as "fresh Rehmannia glutinosa" and the latter is commonly known as "raw Rehmannia glutinosa". Fresh Rehmannia glutinosa is cold in nature, sweet and bitter in taste, and enters the heart, liver, and kidney meridians. It has the effects of clearing heat and promoting fluid production, cooling blood, and stopping bleeding. Raw Rehmannia glutinosa is cold in nature, sweet in taste, and enters the heart, liver, and kidney meridians. It has the effects of clearing heat and cooling blood, nourishing yin and promoting fluid production. "Prepared Rehmannia glutinosa" is a processed product of raw Rehmannia glutinosa. The processing method is as follows: (1) Take raw Rehmannia glutinosa and stew it according to the wine stewing method (refer to the 2020 edition of the Chinese Pharmacopoeia, Part Four, General Rules 0213) until the wine is absorbed, take it out, dry it in the sun until the mucus on the outer skin is slightly dry, cut it into thick slices or pieces, and dry it. For every 100kg of raw Rehmannia root, use 30-50kg of yellow wine. (2) Take raw Rehmannia root, steam it according to the steaming method (refer to 0213 of the four parts of the 2020 edition of the Chinese Pharmacopoeia) until it is black and moist, take it out, and dry it in the sun until it is about 80% dry, cut it into thick slices or blocks, and dry it. Rehmannia root is slightly warm in nature, sweet in taste, and enters the liver and kidney meridians. It has the effects of nourishing blood and yin, replenishing essence and filling marrow. The Rehmannia root in the present invention can be fresh Rehmannia root, raw Rehmannia root or cooked Rehmannia root, preferably cooked Rehmannia root.

[0082] White peony root is the root of Paeonia lactiflora Pall., a plant of the genus Paeonia in the family Ranunculaceae. It is cultivated in Zhejiang, Anhui, Sichuan and other places. It is dug in summer and autumn, the soil and branch roots are removed, the skin is peeled, and it is soaked in boiling water or boiled briefly until it is evenly heated, and then dried. White peony root is slightly cold in nature, bitter and sour in taste, and enters the liver and spleen meridians. It has the effects of nourishing blood and restraining yin, softening the liver and relieving pain, and calming liver yang.

[0083] Cinnamon twigs are the young branches of Cinnamomum cassia Presl., a plant of the Lauraceae family. They are mainly produced in Guangxi, Guangdong, and Yunnan. The young branches are usually cut in spring, dried in the sun or in the shade, and cut into thin slices or small pieces. Cinnamon twigs are warm in nature, pungent and sweet in taste, and enter the heart, lung, and bladder meridians. They have the effects of sweating, relieving exterior symptoms, warming the meridians, and promoting yang.

[0084] Speranskia tuberculate (Bunge) Baill. is the whole herb of Speranskia tuberculate (Bunge) Baill. of the Euphorbiaceae family. It is mainly produced in Liaoning, Jilin, Inner Mongolia, Hebei, etc. Speranskia tuberculate is warm in nature, pungent in taste, and enters the liver and kidney meridians. It has the effects of dispelling wind and dampness, relaxing muscles and activating blood circulation, dispersing blood stasis and reducing swelling, detoxifying and relieving pain.

[0085] Clematis intricata Bunge is the whole herb of Clematis intricata Bunge, a plant of the Ranunculaceae family. It has the effects of dispelling wind and dampness, unblocking meridians and relieving pain.

[0086] Corydalis yanhusuo is the dried tuber of Corydalis yanhusuo WTW, a plant of the genus Corydalis of the family Papaveraceae. It is mainly produced in Hebei, Shandong, Jiangsu, Zhejiang and other places. Corydalis yanhusuo is warm in nature, pungent and bitter in taste, and enters the heart, liver and spleen meridians. It has the effects of promoting blood circulation, promoting qi circulation and relieving pain. "Vinegar Corydalis" or "Vinegar-processed Corydalis yanhusuo" is the processed product of Corydalis yanhusuo. Take clean Corydalis yanhusuo, stir-fry it dry according to the vinegar roasting method (refer to the general rule 0213 of the fourth part of the 2020 edition of the Chinese Pharmacopoeia), or boil it according to the vinegar boiling method (refer to the general rule 0213 of the fourth part of the 2020 edition of the Chinese Pharmacopoeia) until the vinegar is absorbed, cut into thick slices or mash it when used.

[0087] Clematis chinensis Osbeck, Clematis hexapetala Pall. or Clematis manshurica Rupr. of the genus Clematis in the Ranunculaceae family are dried roots and rhizomes. They are mainly produced in Jiangsu, Anhui, Zhejiang and other places. They are dug in autumn, the sand is removed and they are dried in the sun. Clematis chinensis is warm in nature, pungent and salty in taste, and belongs to the bladder meridian. It has the effects of removing rheumatism, unblocking meridians, relieving pain and curing bone stagnation.

[0088] Kadsura sissa is the vine stem of Piper kadsura Sieb., a plant of the Piperaceae family. It is mainly produced in Guangdong, Fujian, Taiwan, Zhejiang and other places. It is harvested in summer and autumn, and the roots and leaves are removed and dried in the sun. Kadsura sissa is slightly warm in nature, pungent and bitter in taste, and enters the liver meridian. It has the effects of removing rheumatism, unblocking meridians, and relieving pain.

[0089] Gentiana macrophulla Pall., Gentiana straminea Maxim. or Gentiana crassicaulis Duthie ex Burk., are dried roots of Gentianaceae, and are mainly produced in Shaanxi, Sichuan, Yunnan, Tibet, etc. Gentiana macrophulla Pall. is flat in nature, pungent and bitter in taste, and enters the stomach, liver, and gallbladder meridians, and has the effects of dispelling wind and dampness, clearing heat and relieving numbness.

[0090] Mulberry is the leafy stems and branches of the evergreen shrub Viscum coloratum (Komar.) Nakai or Loranthus parasiticus (L.) Merr. of the Loranaceae family. The former is mainly produced in Hebei, Liaoning, Jilin, Inner Mongolia, Anhui, Zhejiang, Hunan, Henan and other places, while the latter is mainly produced in Guangdong, Guangxi and other places. It is harvested from winter to the next spring, the thick stems are removed, cut into sections, dried, or steamed and dried. Mulberry is flat in nature, bitter and sweet in taste, and enters the liver and kidney meridians. It has the effects of removing rheumatism, nourishing the liver and kidney, strengthening the bones and tendons, and calming the fetus.

[0091] In some embodiments, the second traditional Chinese medicine composition consists of the following components: peach kernel, safflower, angelica, rehmannia root, white peony root, cinnamon twig, iron wire radix, corydalis, clematis, kadzuvine root, gentiana macrophylla and mistletoe.

[0092] In some embodiments, the second traditional Chinese medicine composition includes, by weight, 20-30 parts of peach kernel, 20-30 parts of safflower, 20-30 parts of angelica, 20-30 parts of rehmannia root, 40-60 parts of white peony root, 20-30 parts of cassia twig, 20-30 parts of iron wire radix scutellariae, 20-40 parts of Corydalis yanhusuo, 10-30 parts of clematis, 10-30 parts of sea wind vine, 10-30 parts of gentiana macrophylla and 20-30 parts of mistletoe.

[0093] In some preferred embodiments, the second traditional Chinese medicine composition includes, by weight: 23-28 parts of peach kernel, 23-28 parts of safflower, 23-28 parts of angelica, 23-28 parts of rehmannia root, 45-55 parts of white peony root, 23-28 parts of cassia twig, 23-28 parts of iron wire radix scutellariae, 25-35 parts of Corydalis yanhusuo, 15-25 parts of clematis, 15-25 parts of kadzu vine, 15-25 parts of gentiana macrophylla and 23-28 parts of mistletoe.

[0094] In some more preferred embodiments, the second Chinese medicine composition includes, by weight, 25 parts of peach kernel, 25 parts of safflower, 25 parts of angelica, 25 parts of rehmannia root, 50 parts of white peony root, 25 parts of cinnamon twig, 25 parts of iron wire radix, 30 parts of Corydalis yanhusuo, 20 parts of clematis, 20 parts of sea wind vine, 20 parts of gentiana macrophylla and 25 parts of mistletoe.

[0095] In some embodiments, the peach kernel is steamed peach kernel.

[0096] In some embodiments, the Corydalis yanhusuo is vinegar-processed Corydalis yanhusuo (or vinegar Corydalis yanhusuo).

[0097] In some embodiments, the Rehmannia root is Rehmannia root prepared.

[0098] In the second Chinese medicine composition: Taohong Siwu Decoction is the main ingredient, peach kernel and safflower are mainly used to enter the blood, mainly to dredge the meridians and straighten the body, and relieve blood stasis, following the principle of "treating wind by treating blood first", so that blood can flow and wind will be eliminated. The formula uses strong blood-breaking ingredients, peach kernel and safflower as the main ingredients, and focuses on promoting blood circulation and removing blood stasis; peach kernel breaks blood and removes blood stasis; safflower promotes blood circulation and menstruation, removes blood stasis and relieves pain. Peach kernel has strong blood stasis-breaking power, and safflower has better blood circulation power. The two medicines are used together to promote each other, and the power of promoting blood circulation and menstruation, removing blood stasis and promoting new blood is enhanced.

[0099] The sweet and warm Rehmannia root nourishes the blood and liver; the Chinese angelica nourishes the yin, nourishes the blood, harmonizes the blood, and relieves pain; the peony nourishes the blood, benefits the yin, and harmonizes the blood, so as to enhance the blood-tonifying power. The three herbs are used together to enhance the effect of nourishing the yin and blood. Cinnamon twig nourishes the blood and harmonizes the blood, warms and dredges the meridians. White peony nourishes the blood, restrains the yin, and does not stagnate the evil. Cinnamon twig harmonizes the blood and relieves the muscles without hurting the yin. The combination of the two is both dispersing and restraining, and is used with both cold and warming effects, so that the blood and the body are in harmony, the qi and blood are regulated, and the yin and yang are balanced, and the four herbs are used together to warm the meridians, activate blood circulation, remove blood stasis, dredge the meridians, activate the collaterals, and eliminate numbness. The four herbs are collectively the minister herbs.

[0100] Corydalis yanhusuo promotes qi and blood circulation and relieves pain. Herba scutellariae is pungent and warm in nature. It enters the lung, spleen, liver and kidney meridians and has the function of dispelling wind, activating blood circulation and unblocking collaterals. Clematis chinensis is pungent and salty in nature and warm in nature. It enters the bladder meridian and dispels rheumatism and dredges the meridians. Herba scutellariae is pungent and bitter in nature and slightly warm in nature. It enters the liver meridian and can dispel rheumatism, dredge the meridians and relieve arthralgia. Herba gentianae is pungent and bitter in taste and neutral in nature. It enters the liver, gallbladder and stomach meridians and can dispel rheumatism, clear dampness and heat, relax the tendons and tendons and relieve arthralgia. Herba scutellariae is bitter and sweet in taste and neutral in nature. It enters the liver and kidney meridians and can dispel rheumatism, tonify the liver and kidney and strengthen the tendons and bones. The six herbs are used together to dispel wind, dampness and dredge the collaterals.

[0101] [Preparation method of Chinese medicine composition]

[0102] The present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, which comprises the steps of weighing and mixing the various components in the traditional Chinese medicine composition.

[0103] [Drug preparations]

[0104] The present invention provides a pharmaceutical preparation, which is prepared from the above-mentioned traditional Chinese medicine composition.

[0105] In some embodiments, the pharmaceutical preparation is a decoction, an oral liquid, or an oral solid preparation.

[0106] In some preferred embodiments, the pharmaceutical preparation is a decoction.

[0107] In some embodiments, the oral solid dosage form is a tablet, capsule, granule or powder.

[0108] The first Chinese medicinal composition for treating peripheral facial paralysis of the present invention can be prepared into a decoction, an oral liquid or an oral solid preparation.

[0109] The second Chinese medicine composition for treating peripheral facial paralysis of the present invention can be prepared into granules or powders. In some embodiments, the granules or powders can be applied externally.

[0110] In the present invention, "decoction" refers to a liquid preparation prepared by decocting Chinese herbal medicine pieces or coarse granules with water, removing the residue and extracting the juice.

[0111] In the present invention, the preparation process of the "oral liquid" is extraction-purification-liquid preparation-filling-sterilization. Suitable preservatives, antioxidants, flavoring agents, solubilizers, etc. can be added as needed. The oral liquid should be sterilized at 100°C for 30 minutes.

[0112] [Application of Chinese medicine composition or pharmaceutical preparation]

[0113] Firstly, the present invention provides the use of the above-mentioned Chinese medicine composition or the above-mentioned pharmaceutical preparation in preparing a drug for preventing and / or treating peripheral facial paralysis.

[0114] Secondly, the present invention provides a method for preventing and / or treating peripheral facial paralysis, which comprises administering an effective amount of the above-mentioned Chinese medicine composition or the above-mentioned pharmaceutical preparation to a patient.

[0115] In some embodiments, when used to prevent and / or treat peripheral facial paralysis, the above-mentioned Chinese medicine composition or the above-mentioned pharmaceutical preparation can be administered alone or in combination with other treatment methods (such as Western medicine treatment), for example: the above-mentioned Chinese medicine composition or the above-mentioned pharmaceutical preparation is administered mainly, and Western medicine treatment is used as a supplement.

[0116] In some embodiments, the peripheral facial palsy is acute, recovery or sequelae peripheral facial palsy.

[0117] In some embodiments, the peripheral facial palsy is acute Bell's palsy.

[0118] In some embodiments, the symptoms of peripheral facial paralysis include at least one of the following symptoms: facial deviation, tearing, enlarged palpebral fissures, shallow or disappearing forehead wrinkles, facial muscle spasms, twitches or linkages, and tearing while eating.

[0119] Example

[0120] The present invention will be further described below by the description of specific embodiments, but this is not limitation of the present invention, and those skilled in the art can make various modifications or improvements according to the basic idea of ​​the present invention, but as long as they do not depart from the basic idea of ​​the present invention, they are all within the scope of the present invention. If specific conditions are not specified in the examples, they are carried out according to the conditions recommended by normal conditions or manufacturers. If the manufacturer is not specified in the reagents or instruments used, they are all conventional products that can be obtained commercially. Raw materials used in the present invention are all commercially available.

[0121] Example 1

[0122] The Chinese medicine composition (Chinese medicine prescription) for treating peripheral facial paralysis of the present invention is prepared into a decoction by the following steps:

[0123] The first prescription:

[0124] Prescription: 20g honeysuckle, 20g forsythia, 15g gastrodia, 15g siler, 9g processed white aconite, 15g earthworm, 15g stir-fried bombyx batryticatus, 12g angelica, 7g chuanxiong, 15g angelica, 15g wine-cooked scutellaria, 15g bupleurum, 30g stir-fried coix seed, 20g poria, 10g oriental rhizome, and 10g liquorice.

[0125] Preparation steps:

[0126] Take 20g of honeysuckle, 20g of forsythia, 15g of gastrodia, 15g of siler, 9g of processed white aconite, 15g of earthworm, 15g of stir-fried bombyx batryticatus, 12g of angelica dahurica, 7g of chuanxiong, 15g of angelica sinensis, 15g of wine-cooked scutellaria, 15g of northern bupleurum, 30g of stir-fried coix seed, 20g of poria, 10g of oriental medicine, and 10g of liquorice, add water and boil twice, add 6 times the amount of water for the first time and boil for 40 minutes, store the decoction in a separate container, add 6 times the amount of water for the second time and boil for 30 minutes, combine the two decoctions, filter, and concentrate to 100-200ml.

[0127] The second prescription:

[0128] Prescription: 25g of stewed peach kernel, 25g of safflower, 25g of angelica, 25g of rehmannia root, 50g of white peony root, 25g of cinnamon twig, 25g of iron wire pelargonium, 30g of vinegar Corydalis, 20g of Clematis, 20g of Piper melongena, 20g of Gentiana macrophylla, and 25g of mistletoe.

[0129] Preparation steps:

[0130] Take 25g of stewed peach kernel, 25g of safflower, 25g of angelica, 25g of rehmannia, 50g of white peony root, 25g of cinnamon twig, 25g of iron wire pelargonium, 30g of vinegar Corydalis, 20g of Clematidis, 20g of Piper melongena, 20g of Gentiana macrophylla, and 25g of Viscum album in the prescription, add water and boil twice, add 8 times the amount of water for the first time and boil for 60 minutes, and keep the decoction in another container, add 6 times the amount of water for the second time and boil for 30 minutes, combine the two decoctions, filter, and concentrate the filtrate to 100-150ml.

[0131] Example 2

[0132] The Chinese medicine composition (Chinese medicine prescription) for treating peripheral facial paralysis of the present invention is prepared into granules by the following steps:

[0133] The first prescription:

[0134] Prescription: 20g honeysuckle, 20g forsythia, 15g gastrodia, 15g siler, 9g processed white aconite, 15g earthworm, 15g stir-fried bombyx batryticatus, 12g angelica dahurica, 7g chuanxiong, 15g angelica, 15g wine-cooked scutellaria, 15g bupleurum, 30g stir-fried coix seed, 20g poria, 10g oriental rhizome, 10g licorice tablets.

[0135] Preparation steps:

[0136] Take 20g of honeysuckle, 20g of forsythia, 15g of gastrodia, 15g of siler, 9g of processed white aconite, 15g of earthworm, 15g of stir-fried bombyx batryticatus, 12g of angelica dahurica, 7g of chuanxiong, 15g of angelica sinensis, 15g of wine-soaked scutellaria, 15g of northern bupleurum, 30g of stir-fried coix seed, 20g of poria, 10g of oriental medicine, and 10g of liquorice, add water and boil twice, add 10 times the amount of water for the first time and boil for 60 minutes, and store the decoction in a separate container, add 8 times the amount of water for the second time and boil for 30 minutes, combine the two decoctions, filter, and concentrate the filtrate to a clear paste with a relative density of 1.15-1.20 (60℃), add auxiliary materials, granulate, dry, and mix.

[0137] The second prescription:

[0138] Prescription: 25g of stewed peach kernel, 25g of safflower, 25g of angelica, 25g of rehmannia root, 50g of white peony root, 25g of cinnamon twig, 25g of iron wire pelargonium, 30g of vinegar Corydalis, 20g of Clematis, 20g of Piper melongena, 20g of Gentiana macrophylla, and 25g of mistletoe.

[0139] Preparation steps:

[0140] Take 25g of stewed peach kernel, 25g of safflower, 25g of angelica, 25g of rehmannia, 50g of white peony root, 25g of cinnamon twig, 25g of iron wire pelargonium, 30g of vinegar Corydalis, 20g of Clematidis, 20g of Piper melongena, 20g of Gentiana macrophylla, and 25g of Viscum album in the prescription, add water and boil twice, add 10 times the amount of water for the first time and boil for 60 minutes, and keep the decoction in another container, add 8 times the amount of water for the second time and boil for 45 minutes, combine the two decoctions, filter, concentrate the filtrate to a clear paste with a relative density of 1.15-1.20 (60℃), add auxiliary materials, granulate, dry, and mix to obtain.

[0141] Example 3: Clinical study on the treatment of acute Bell's palsy with Zhengyan Decoction combined with external application of traditional Chinese medicine

[0142] 1. Methods

[0143] 1. Source of cases

[0144] The study cases were from 400 patients with acute Bell's palsy in the Acupuncture Department of Dongzhimen Hospital of Beijing University of Chinese Medicine. The enrollment period was from January 2019 to December 2022, for a period of 3 years.

[0145] 2. Subjects

[0146] 2.1 Diagnostic criteria:

[0147] Refer to the clinical diagnostic criteria for facial nerve paralysis in the "Guidelines for the Diagnosis and Treatment of Idiopathic Facial Paralysis in China" issued by the Chinese Society of Neurology and others in 2016:

[0148] (1) Acute onset, usually reaching its peak in about 3 days;

[0149] (2) Unilateral peripheral facial paralysis, paralysis of facial muscles on the affected side, disappearance of forehead wrinkles, weakness in closing eyes, puffing cheeks, and showing teeth, shallow nasolabial grooves, crooked and drooping corners of the mouth, air leakage when whistling, water leakage when brushing teeth, food retention when eating, with or without pain behind the ear, decreased taste in front of the tongue, hyperacusis, and abnormal tear or saliva secretion;

[0150] (3) Exclude secondary causes (lesions in other parts of the nervous system, especially the cerebellopontine angle and brainstem; ear diseases; space-occupying lesions, trauma, etc.).

[0151] 2.2 Inclusion criteria:

[0152] (1) Meet the above diagnostic criteria;

[0153] (2) Aged 18-60, regardless of gender;

[0154] (3) Acute patients, the course of illness is 1 to 7 days;

[0155] (4) Sign the informed consent form.

[0156] 2.3 Exclusion criteria:

[0157] (1) Facial nerve palsy caused by Hunter syndrome and other confirmed diseases, such as Guillain-Barré syndrome, multiple sclerosis, sarcoidosis, Mobius syndrome, diabetic peripheral neuropathy, encephalitis (fungal, viral, bacterial), human immunodeficiency virus infection, Lyme disease, otitis media, herpes zoster virus infection, syphilis, brainstem stroke, facial nerve tumor, skin tumor, parotid gland tumor and facial nerve trauma;

[0158] (2) Having serious diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic system;

[0159] (3) Suffering from severe mental illness and lacking capacity for conduct;

[0160] (4) Coagulation disorders;

[0161] (5) Pregnant and lactating women;

[0162] (6) Local acute skin infection

[0163] 3. Randomization and blinding

[0164] Eligible subjects were randomly assigned to receive treatment in experimental group 1, experimental group 2, experimental group 3 or control group, with the ratio of 1:1:1:1. Block randomization was used, and the block size was 8. The outcome assessors and statisticians were blinded.

[0165] 4. Intervention measures

[0166] Control group: received western medicine treatment, and the treatment plan was based on the "Guidelines for the Diagnosis and Treatment of Idiopathic Facial Paralysis in China" issued by the Chinese Medical Association Neurology Branch in 2016. The course of treatment was 10 days. Specific plan: in the acute phase, ① prednisone / prednisolone was taken orally (1 mg per kg of body weight) 30 mg to 60 mg per day for 5 consecutive days, and then gradually reduced to stop within 5 days; ② acyclovir was taken orally 0.8 g each time, 5 times a day, for a total of 10 days; ③ methylcobalamin tablets were taken orally 0.5 mg each time, 3 times a day. Follow-up was until 12 weeks.

[0167] Experimental group 1: On the basis of the control group, Zhengyan Decoction was added. The prescription of Zhengyan Decoction is as follows: 20g of honeysuckle, 20g of forsythia, 15g of gastrodia, 15g of siler, 9g of processed white aconite, 15g of earthworm, 15g of fried silkworm, 12g of angelica, 7g of chuanxiong, 15g of angelica, 15g of wine-soaked scutellaria, 15g of northern bupleurum, 30g of fried coix seed, 20g of tuckahoe, 10g of oriental rhizome, 10g of licorice tablets. Take the above drugs once a day, decoct and filter to 200mL of juice, and take 100mL orally in the morning and evening. The course of treatment is 12 weeks.

[0168] Experimental group 2: On the basis of the control group, Chinese medicine was applied externally. The prescription of Chinese medicine for external application is as follows: 25g of boiled peach kernel, 25g of safflower, 25g of angelica, 25g of rehmannia root, 50g of white peony root, 25g of cassia twig, 25g of iron wire piercing bone grass, 30g of vinegar corydalis, 20g of clematis, 20g of sea wind vine, 20g of gentiana macrophylla, 25g of mistletoe. Grind the above medicines into powder, mix them into a paste with rice wine or aged vinegar, and apply them to the affected side of the face, once a day, 30min-1h / time. The course of treatment is 12 weeks.

[0169] Experimental group 3: Based on the control group, Zhengyan decoction combined with Chinese medicine external application was added. The use of Zhengyan decoction and Chinese medicine external application was the same as above. The course of treatment was 12 weeks.

[0170] 5. Outcome indicators

[0171] House-Brackmann (HB) facial nerve function grading: Facial nerve function is divided into 6 grades. Grade I: normal function; Grade II: mild dysfunction (when carefully observed, mild weakness of facial muscles can be detected, eyelids can be completely closed with slight force, slight asymmetry of the face when smiling hard, just perceptible synkinesis, no contracture or spasm); Grade III: moderate dysfunction (facial muscles are obviously weak, but the face is not damaged, eyebrows cannot be raised, eyelids can be completely closed when force is applied, mouth movements are strong but asymmetrical when force is applied, and there are obvious synkinesis or spasm); Grade IV: moderate to severe dysfunction (facial muscles are obviously weak, which damages the face, eyebrows cannot be raised, eyelids cannot be completely closed when force is applied, mouth movements are asymmetrical, and there are severe synkinesis or spasm); Grade V: severe dysfunction (just perceptible incomplete eye closure, only slight movement of the corners of the mouth, usually no synkinesis, contracture and spasm); Grade VI: complete paralysis (facial muscles cannot move, tension disappears, and there is no synkinesis, contracture and spasm). The patients were recorded before treatment and 12 weeks after treatment.

[0172] Efficacy evaluation: Total effective rate = (cured + markedly effective + effective) / total number of cases × 100%. Cured: The clinical manifestations on the affected side of the face disappeared completely compared with before, and the HB grade was grade I (i.e. no facial paralysis). Markedly effective: The patient's face was bilaterally symmetrical at rest; there was still facial synkinesis during movement, slight synkinesis of the lips, the eyes could be completely closed, and the forehead movement was moderate, HB grade II. Effective: The face was basically symmetrical at rest; it was asymmetrical during movement, there was slight synkinesis or spasm of the facial nerve, the lips were obviously asymmetrical, and they could only be closed by closing the eyes, HB grade III. Ineffective: The face was obviously bilaterally asymmetrical when it was at rest, there was no forehead movement, it was difficult to close the eyes, only slight lip movement could be achieved, and there was no significant change in symptoms compared with before treatment, HB grade IV-IV.

[0173] 6. Statistical methods

[0174] The main results were analyzed according to the intention-to-treat principle. The data were expressed as median (interquartile range) (Median [IQR]); count data were expressed as frequency or composition ratio. If the measurement data conformed to normal distribution and variance was homogeneous, the independent sample t test was used; if it did not conform to normal distribution, nonparametric test was used. Count data were analyzed by χ 2 The missing values ​​were processed and analyzed by the last-carry-forward method. The statistical test was a two-sided test, with a significant difference level of α = 0.05, and P < 0.05 indicating that the difference was statistically significant. SPSS 25.0 version was used for statistical software.

[0175] 2. Results

[0176] 1. General Information

[0177] A total of 400 patients with acute Bell's palsy were included, 100 in each group. The general data of the two groups of patients, such as gender, age, and course of disease, were statistically analyzed and found to have no statistically significant difference, and the baselines were comparable (see Table 1).

[0178] Table 1 Baseline characteristics of patients

[0179]

[0180] Note: Data are median (IQR) or number of patients (%).

[0181] 2. Comparison of total effective rate

[0182] After treatment, the total effective rates of the four groups were statistically different (P<0.05). Pairwise comparison results showed that the total effective rate of test group 3 (88%) was higher than that of test group 2 (81%), test group 1 (76%) and control group (70%), and the differences were statistically significant (P<0.05); the total effective rate of test group 2 (81%) was higher than that of test group 1 (76%) and control group (70%), and the differences were statistically significant (P<0.05); the total effective rate of test group 1 (76%) was higher than that of control group (70%), and the difference was statistically significant (P<0.05). See Table 2.

[0183] Table 2 Total effective rate of the four groups after treatment

[0184]

[0185] Note: a Comparison between experimental group 3 and experimental group 2, P<0.05; b Comparison between experimental group 3 and experimental group 1, P<0.05; c Comparison between experimental group 3 and control, P<0.05; d Comparison between experimental group 2 and experimental group 1, P<0.05; e Comparison between experimental group 2 and control group, P<0.05; f Comparison between experimental group 1 and control group, P<0.05.

[0186] 3. Security comparison

[0187] In the control group, 3 cases had headache and dizziness, which disappeared after drug withdrawal; in the experimental group 1, 2 cases had abdominal pain and vomiting, which disappeared after drug withdrawal; in the experimental group 2, 2 cases had paresthesia, which disappeared after drug withdrawal; in the experimental group 3, 4 cases had increased appetite. There were no serious adverse reactions in the four groups.

Claims

1. A Chinese medicine composition, which consists of 15-25 parts of honeysuckle, 15-25 parts of forsythia, 12-17 parts of gastrodia, 12-17 parts of siler, 8-12 parts of white aconite, 12-17 parts of earthworm, 12-17 parts of bombyx batryticatus, 10-13 parts of angelica, 6-8 parts of ligusticum chuanxiong, 12-17 parts of angelica sinensis, 12-17 parts of scutellaria baicalensis, 12-17 parts of bupleurum, 25-35 parts of coix seeds, 15-25 parts of tuckahoe, 8-12 parts of orientalis and 8-12 parts of liquorice in parts by weight; The Chinese medicine composition is used for preventing and / or treating peripheral facial paralysis, wherein the peripheral facial paralysis is acute stage Bell's palsy; The Chinese medicine composition is used orally; The white aconite root is processed white aconite root; The silkworm is fried silkworm; The radix scutellariae is wine-processed radix scutellariae; The radix bupleuri is radix bupleuri; The coix seeds are fried coix seeds.

2. The Chinese medicine composition according to claim 1, characterized in that In parts by weight, the Chinese medicine composition consists of 20 parts of honeysuckle, 20 parts of forsythia, 15 parts of gastrodia, 15 parts of siler, 9 parts of white aconite, 15 parts of earthworm, 15 parts of bombyx batryticatus, 12 parts of angelica dahurica, 7 parts of ligusticum chuanxiong, 15 parts of angelica sinensis, 15 parts of scutellaria baicalensis, 15 parts of bupleurum, 30 parts of coix seeds, 20 parts of poria, 10 parts of oriental water plantain and 10 parts of liquorice.

3. A Chinese medicine composition, which consists of 23-28 parts of peach kernel, 23-28 parts of safflower, 23-28 parts of angelica, 23-28 parts of rehmannia root, 45-55 parts of white peony root, 23-28 parts of cassia twig, 23-28 parts of clematis root, 25-35 parts of corydalis, 15-25 parts of clematis root, 15-25 parts of kelp, 15-25 parts of gentiana macrophylla and 23-28 parts of mistletoe; The Chinese medicine composition is used for preventing and / or treating peripheral facial paralysis, wherein the peripheral facial paralysis is acute stage Bell's palsy; The Chinese medicine composition is applied externally; The peach kernel is a stewed peach kernel; The Corydalis yanhusuo is vinegar-processed Corydalis yanhusuo; The Rehmannia root is Rehmannia root prepared.

4. The Chinese medicine composition according to claim 3, characterized in that: In parts by weight, the Chinese medicine composition consists of 25 parts of peach kernel, 25 parts of safflower, 25 parts of angelica, 25 parts of rehmannia root, 50 parts of white peony root, 25 parts of cassia twig, 25 parts of iron wire radix, 30 parts of Corydalis, 20 parts of clematis, 20 parts of Piper melongena, 20 parts of Gentiana macrophylla and 25 parts of mistletoe.

5. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, comprising the steps of weighing and mixing the various components in the Chinese medicine composition.

6. A pharmaceutical preparation, which is made from the Chinese medicine composition according to any one of claims 1 to 4; The pharmaceutical preparation is used for preventing and / or treating peripheral facial paralysis, which is Bell's palsy in the acute stage.

7. The pharmaceutical preparation according to claim 6, characterized in that When the traditional Chinese medicine composition consists of 15-25 parts of honeysuckle, 15-25 parts of forsythia, 12-17 parts of gastrodia, 12-17 parts of siler, 8-12 parts of white aconite, 12-17 parts of earthworm, 12-17 parts of bombyx batryticatus, 10-13 parts of angelica, 6-8 parts of ligusticum chuanxiong, 12-17 parts of angelica sinensis, 12-17 parts of scutellaria baicalensis, 12-17 parts of bupleurum, 25-35 parts of coix seeds, 15-25 parts of poria, 8-12 parts of oriental rhizome and 8-12 parts of liquorice, the pharmaceutical preparation is a decoction, an oral liquid or an oral solid preparation.

8. The pharmaceutical preparation according to claim 6, characterized in that When the traditional Chinese medicine composition consists of 15-25 parts of honeysuckle, 15-25 parts of forsythia, 12-17 parts of gastrodia, 12-17 parts of siler, 8-12 parts of white aconite, 12-17 parts of earthworm, 12-17 parts of bombyx batryticatus, 10-13 parts of angelica, 6-8 parts of ligusticum chuanxiong, 12-17 parts of angelica sinensis, 12-17 parts of scutellaria baicalensis, 12-17 parts of bupleurum, 25-35 parts of coix seed, 15-25 parts of poria, 8-12 parts of oriental rhizome and 8-12 parts of liquorice, the pharmaceutical preparation is a decoction.

9. The pharmaceutical preparation according to claim 7, characterized in that The oral solid preparation is a tablet, capsule, granule or powder.

10. Use of the Chinese medicine composition according to any one of claims 1 to 4 or the pharmaceutical preparation according to any one of claims 6 to 9 in the preparation of a medicament for preventing and / or treating peripheral facial paralysis; The peripheral facial palsy is Bell's palsy in the acute stage.

11. The use according to claim 10, characterized in that: The symptoms of the acute phase of Bell's palsy include at least one of the following symptoms: facial deviation, tearing, enlarged palpebral fissures, shallow or disappearing forehead wrinkles, facial muscle spasms, twitches or linkages, and tears while eating.

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