CN116870111A - Traditional Chinese medicine composition for treating peripheral facial paralysis and preparation method and application thereof - Google Patents

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating peripheral facial paralysis, and a preparation method and application thereof. The Chinese medicinal composition comprises flos Lonicerae, fructus forsythiae, rhizoma Gastrodiae, radix Saposhnikoviae, rhizoma Typhonii, lumbricus, parched Bombyx Batryticatus, radix Angelicae Dahuricae, rhizoma Ligustici Chuanxiong, radix Angelicae sinensis, scutellariae radix, bupleuri radix, coicis semen, poria, alismatis rhizoma and Glycyrrhrizae radix, or semen Persicae, carthami flos, radix Angelicae sinensis, rehmanniae radix, radix Paeoniae alba, ramulus Cinnamomi, herba Speranskiae Tuberculatae, rhizoma corydalis, radix Clematidis, caulis Piperis Futokadsurae, radix Gentianae Marcrophyllae and herba Taxilli. The traditional Chinese medicine composition improves the treatment effect and the acceptance of patients, shortens the treatment time, and has good treatment effect on peripheral facial paralysis with symptoms of facial distortion, lacrimation of open eyes, large eye fission, shallow or vanishing frontal lines, facial muscle spasm, convulsion, linkage, lacrimation of eating and the like in the acute phase, the convalescence phase and the sequela phase.

Description

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

Technical field

The invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition for treating peripheral facial paralysis and its preparation method and application.

Background technique

Peripheral facial paralysis, also known as Bell's palsy or facial neuritis, is peripheral facial paralysis caused by non-specific inflammation of the facial nerve in the facial canal. The general symptom is that the mouth and eyes are skewed, and the inability to complete actions such as raising the eyebrows, closing the eyes, and puffing the mouth. It is a common and frequently-occurring disease that can occur at any age. The incidence rate is similar in men and women. Most cases are unilateral and rarely bilateral.

The existing TCM theory for the treatment of peripheral facial paralysis believes that the onset of peripheral facial paralysis is caused by insufficient righteousness, empty collaterals, and weak external defenses; exogenous evil invades the facial meridians, qi and blood are blocked, and the meridians are malnourished, resulting in muscle flaccidity. Not accepted. The head is the gathering of all Yangs and the sect of the Hundred Meridians. The yang meridian is easily invaded by external evils. Wind belongs to yang evil and has the effect of spreading upward and outward. Therefore, wind evil can easily invade the high parts of the human body.

At present, for the treatment of peripheral facial paralysis, Western medicine mostly focuses on glucocorticoids, antiviral drugs, vitamin B1, vitamin B12 and other drugs. However, taking hormone drugs and other Western drugs has certain side effects. It is also common to use traditional Chinese medicine (such as acupuncture) to treat peripheral facial paralysis. However, due to the inconvenience and unavoidable pain of multiple visits per week, many patients find it difficult to accept acupuncture treatment. The clinical acceptance is not ideal, and the effectiveness of the treatment needs to be improved. . At present, the treatment of peripheral facial paralysis with Chinese medicine alone mainly focuses on promoting blood circulation and unblocking collaterals, such as taking Naoxintong, Xuesaitong soft capsules, Nao'an capsules, scutellarin dropping pills or Dahuoluo capsules. However, wind evil is an important pathogenic evil in peripheral facial paralysis. Simply activating blood circulation and removing blood stasis cannot treat facial paralysis caused by wind evil invasion.

It would be extremely important to 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 therapeutic effect, but also avoid acupuncture treatment, improve patient acceptance, and shorten treatment time.

Contents of the invention

Invent the problem to be solved

In view of the deficiencies in the prior art, the present invention aims to provide a traditional Chinese medicine composition for treating peripheral facial paralysis and its preparation method and application. The traditional Chinese medicine composition can be combined with western medicine for treatment, and can improve the therapeutic effect and patient acceptance. Shorten treatment time.

solutions to problems

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

The first traditional Chinese medicine composition included: honeysuckle, forsythia, gastrodia elata, sapsroot, white aconite, earthworm, zombie, angelica, chuanxiong, angelica, skullcap, bupleurum, coix seed, poria, alisma and licorice.

Preferably, the traditional Chinese medicine composition is composed of honeysuckle, forsythia, gastrodia elata, saposhnikovia, white aconite, earthworm, Bombyx mori, angelica dahurica, chuanxiong, angelica, skullcap, bupleurum, coix seed, poria, alisma and licorice.

Preferably, in parts by weight, the traditional Chinese medicine composition includes: 10-30 parts of honeysuckle, 10-30 parts of Forsythia suspensa, 10-20 parts of Gastrodia elata, 10-20 parts of Fangfeng, 5-15 parts of White Aconite, and 10 parts of Dilong. -20 parts, 10-20 parts of Bombyx mori, 10-15 parts of Angelica dahurica, 5-10 parts of Chuanxiong, 10-20 parts of Chinese angelica, 10-20 parts of Scutellaria baicalensis, 10-20 parts of Bupleurum, 20-40 parts of Coix seed, Poria 10-30 parts, Alisma 5-15 parts and Licorice 5-15 parts.

More preferably, in parts by weight, the traditional Chinese medicine composition includes: 15-25 parts of honeysuckle, 15-25 parts of Forsythia suspensa, 12-17 parts of Gastrodia elata, 12-17 parts of Fangfeng, 8-12 parts of Aconite root, and Dilong. 12-17 parts of Bombyx mori, 10-13 parts of Angelica dahurica, 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, Poria cocos 15-25 parts, Alisma 8-12 parts and licorice 8-12 parts.

Further preferably, in parts by weight, the traditional Chinese medicine composition includes: 20 parts of honeysuckle, 20 parts of Forsythia suspensa, 15 parts of Gastrodia elata, 15 parts of Fangfeng, 9 parts of white aconite, 15 parts of Dilong, 15 parts of Bombyx mori, and 12 parts of Angelica dahurica. 7 parts of Chuanxiong, 15 parts of Angelicae Sinensis, 15 parts of Scutellaria baicalensis, 15 parts of Bupleurum, 30 parts of Coix Seed, 20 parts of Poria, 10 parts of Alisma and 10 parts of Licorice.

Preferably, the white aconite is a prepared white aconite.

Preferably, the zombie silkworm is fried zombie silkworm.

Preferably, the skullcap is wine-made skullcap (or wine-made skullcap).

Preferably, the Bupleurum is Bupleurum chinensis.

Preferably, the coix seed is fried coix seed.

The second traditional Chinese medicine composition includes: peach kernel, safflower, angelica root, rehmannia glutinosa, white peony root, cinnamon twig, clematis, Corydalis corydalis, clematis, sea breeze wisteria, genie and locust.

Preferably, the traditional Chinese medicine composition is composed of peach kernel, safflower, angelica root, rehmannia glutinosa, white peony root, cinnamon twig, clematis, Corydalis chinensis, clematis, sea breeze vine, rhizome, and mulberry.

Preferably, in parts by weight, the traditional Chinese medicine composition includes: 20-30 parts of peach kernel, 20-30 parts of safflower, 20-30 parts of angelica root, 20-30 parts of rehmannia glutinosa, 40-60 parts of white peony root, and 20 parts of cassia twig. -30 parts, 20-30 parts of Corydalis, 20-40 parts of Corydalis, 10-30 parts of Clematis, 10-30 parts of Sea Breeze Vine, 10-30 parts of Radix Gentiana and 20-30 parts of Lobra.

More preferably, in parts by weight, the traditional Chinese medicine composition includes: 23-28 parts of peach kernel, 23-28 parts of safflower, 23-28 parts of angelica root, 23-28 parts of rehmannia glutinosa, 45-55 parts of white peony root, and cassia twig. 23-28 parts, Corydalis cordata 23-28 parts, Corydalis 25-35 parts, Clematis 15-25 parts, Sea Breeze Vine 15-25 parts, Gentiana chinensis 15-25 parts and Loranthus 23-28 parts.

Further preferably, in parts by weight, the traditional Chinese medicine composition includes: 25 parts of peach kernel, 25 parts of safflower, 25 parts of Angelicae Sinensis, 25 parts of Rehmannia glutinosa, 50 parts of white peony root, 25 parts of cinnamon twigs, and 25 parts of Tienguicao , 30 parts of Corydalis Corydalis, 20 parts of Clematis, 20 parts of Sea Breeze Vine, 20 parts of Radix Gentiana and 25 parts of Lobra.

Preferably, the peach kernel is peach kernel.

Preferably, the Corydalis Corydalis is vinegar-made Corydalis Corydalis (or Corydalis Corydalis).

Preferably, the rehmannia glutinosa is Rehmannia glutinosa.

In a second aspect, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, which includes the steps of weighing and mixing each component in the traditional Chinese medicine composition.

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

Preferably, the pharmaceutical preparation is a decoction, oral liquid or oral solid preparation.

More preferably, the pharmaceutical preparation is a decoction.

Further, the oral solid preparation is a tablet, capsule, granule or powder.

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

Preferably, the peripheral facial paralysis is acute phase, recovery phase or sequela phase peripheral facial paralysis.

More preferably, the peripheral facial paralysis is acute phase Bell's palsy.

Preferably, the symptoms of peripheral facial paralysis include at least one of the following symptoms: deviated mouth and eyes, tearing from open eyes, enlarged eye fissures, shallow or disappeared forehead lines, spasm, twitching or synergy of facial muscles, and tearing during meals.

Effect of the invention

The traditional Chinese medicine composition for treating peripheral facial paralysis provided by the invention includes honeysuckle, forsythia, gastrodia elata, saposhnem, white aconite, earthworm, stir-fried silkworm, angelica, chuanxiong, angelica, skullcap, bupleurum, coix, poria, alisma. and licorice, or twelve herbs including peach kernel, safflower, angelica, rehmannia glutinosa, white peony root, cassia twig, clematis, Corydalis, clematis, sea breeze vine, rehmannia root, and locust. The traditional Chinese medicine composition can be used in combination or in combination with western medicine. The traditional Chinese medicine composition improves the therapeutic effect and patient acceptance, shortens the treatment time, and has no serious adverse reactions. The two traditional Chinese medicine compositions of the present invention are effective in the acute phase, recovery phase and sequela phase of patients with symptoms such as skewness of the mouth and eyes, tearing from the eyes, enlarged eye fissures, shallow or missing forehead lines, facial muscle spasms, twitching and linkage, and tears after eating. Peripheral facial paralysis has good therapeutic effects.

Detailed ways

Various exemplary embodiments, features, and aspects of the invention are described in detail below. The word "exemplary" as used herein means "serving as an example, example, or illustrative." Any embodiment described herein as "exemplary" is not necessarily to be construed as superior or superior to other embodiments.

In addition, in order to better explain the present invention, numerous specific details are given in the following detailed description. It will be understood by those skilled in the art that the present invention may be practiced without certain specific details. In other examples, methods, means, equipment and steps that are well known to those skilled in the art are not described in detail in order to highlight the gist of the present invention.

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

In this specification, the meaning of "can" includes both the meaning of performing certain processing and the meaning of not performing certain processing.

In this specification, references to "some specific/preferred embodiments", "other specific/preferred embodiments", "implementations", etc. refer to the specific elements described related to the embodiment (for example, Features, structures, properties and/or characteristics) are included in at least one embodiment described herein and may or may not be present in other embodiments. Additionally, it is to be understood that the described elements may be combined in various embodiments in any suitable manner.

In this specification, the numerical range represented by "numeric value A to numerical value B" refers to the range including the endpoint values A and B.

[Chinese medicine composition]

The combination of traditional Chinese medicine raw materials in the composition of the present invention is based on the traditional Chinese medicine belief that peripheral facial paralysis is caused by exogenous wind evil and dampness poison, attacking the three yang meridians of the head and face. In addition, the present invention also takes into account that the spleen controls blood circulation, and the spleen is not good at transporting blood. Without the source of Qi, the muscles will have no Qi to generate, the Qi and blood will not flow smoothly, and the meridians will be blocked by blood stasis. Therefore, traditional Chinese medicine prescriptions need to be considered in terms of dispelling wind, detoxifying, removing dampness, strengthening the spleen, and activating blood circulation and unblocking collaterals.

First of all, the first Chinese medicine composition for treating peripheral facial paralysis in the present invention includes the following components: honeysuckle, forsythia, gastrodia elata, saposhnem, white aconite, earthworm, Bombyx, angelica, chuanxiong, angelica, skullcap, bupleurum , Coix seed, Poria cocos, Alisma and licorice.

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

Forsythia suspensa (Thunb.) Vahl is the fruit of the plant Forsythia suspensa (Thunb.) Vahl in the family Oleaceae. It is produced in Northeast my country, North China, the Yangtze River Basin and Yunnan, and is found in both wild and domestic species. The first-ripe fruits are picked before the white dew and are still green in color, so they are called Qingqiao. If ripe fruits are picked before cold dew, they will turn yellow. After the Qingqiao is harvested, it is steamed and dried in the sun, and the seeds are sifted to be used as Forsythia suspensa. Qingqiao is the best and can be used raw. Forsythia suspensa is slightly cold in nature and bitter in taste. It returns to the lung, heart and gallbladder meridian. It has the effects of clearing away heat and detoxifying, eliminating carbuncle and dissipating stagnation.

Gastrodia elata is the tuber of the orchid family Gastrodia elata Bl., which is mainly produced in Sichuan, Yunnan, and Guizhou, and is widely distributed in the north and south of my country. Excavate from the beginning of winter to before Qingming Festival of the following year, wash immediately, steam thoroughly, open and dry at low temperature. Gastrodia elata is neutral in nature and sweet in taste, and returns to the liver meridian. It has the effects of calming wind and relieving spasm, calming liver yang, dispelling wind and unblocking collaterals.

Saposhnikovia divaricata (Turcz.) Schischk. is the root of Saposhnikovia divaricata (Turcz.) Schischk. Excavate in spring and autumn, remove the brown hairs on the reed heads, dry in the sun, moisten and slice into slices. Fangfeng is slightly warm in nature, pungent and sweet in taste, and returns to the bladder, liver, and spleen meridians. It has the effects of dispelling wind and relieving surface, eliminating dampness, relieving pain, and relieving spasm.

White aconite is the tuber of Typhonium giganteum Engl., a plant of the family Araceae, mainly produced in Henan, Shaanxi, Sichuan and Gansu provinces of my country. Excavate in autumn, remove residual stems, fibrous roots and outer skin, smoke with sulfur 1-2 times, and dry in the sun. White aconite is warm in nature, pungent and sweet in taste, and returns to the spleen and stomach meridians. It has the effects of drying dampness and resolving phlegm, dispelling wind and relieving spasm, detoxifying and resolving stagnation. "Preparation of white aconite" is a processed product of white aconite. Take the clean white aconite, separate into large and small pieces, soak, change the water 2 to 3 times a day, if sticky foam appears after a few days, add alum (per 100kg of white aconite) after changing the water. , use 2kg alum), soak for 1 day and then change the water until the taste is slightly numb and the tongue feels slightly numb, then take it out. Put the ginger slices and alum powder into a pot and add an appropriate amount of water. After boiling, pour in the white aconite and cook until there is no white core. Remove the ginger slices and let them dry until 60 to 70% dry. Cut into thick slices and dry (per 100kg of white aconite). Aconite, use 12.5kg each of ginger and alum).

Earthworm, the dried whole body of Pheretima aspergillum (E. Perrier, 1872) or Allolobophora caliginosa trapezoides (Duges, 1828). Earthworm is cold in nature and salty in taste. It belongs to the liver, spleen and lung meridians. It has the functions of clearing away heat and calming convulsion, calming the liver and extinguishing wind, relieving asthma, dredging collaterals and diuresis.

Bombyx mori Linnaeus is the dry whole body of the 4th to 5th instar larvae of the mulberry silkworm Bombyx mori Linnaeus that is killed due to infection (or artificial inoculation) with the fungus Beauveria bassiana of the Cordyceps family. Silkworm is mild in nature, salty and pungent in taste, and belongs to the liver, lung, and stomach meridians. It has the effects of expelling wind and relieving spasm, dispelling wind and relieving pain, resolving phlegm and dissipating stagnation. "Fried silkworm" is a processed product of zombie silkworm. Take the clean silkworm and fry it according to the bran frying method (refer to the General Chapter 0213 of the Four Parts of the Chinese Pharmacopoeia 2020 edition) until the surface is yellow.

Angelica dahurica is the root of Angelica dahurica Benth.et Hook. or A. anomala Lallem. and A. taiwaniana Boiss. Mainly produced in Zhejiang, Hubei, Liaoning, Sichuan and other places, and mostly cultivated. Excavate when the leaves turn yellow in summer and autumn, remove the fibrous roots, dry in the sun, moisten and slice. Angelica dahurica is warm in nature and pungent in taste. It returns to the lung and stomach meridians. It has the effects of relieving external symptoms, dispelling wind and dampness, reducing swelling and draining pus, and relieving pain.

Ligusticum chuanxiong is the dried rhizome of Ligusticum chuanxiong Hort., a plant belonging to the genus Apiaceae. It is mainly produced in Sichuan, Yunnan, Guizhou, Guangxi and other places. Ligusticum chuanxiong is warm in nature and pungent in taste. It returns to 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.

Angelica sinensis (Oliv.) Diels is the root of Angelica sinensis (Oliv.) Diels, a plant belonging to the family Apiaceae. It is mainly produced in Min County (Qinzhou) in southeastern Gansu Province. Secondly, it is also cultivated in Shaanxi, Sichuan, Yunnan, Hubei and other places. Excavate at the end of autumn, remove the reed heads and fibrous roots, wait until the water evaporates slightly, bundle them into small handfuls, and slowly smoke them to dry over low heat or smoke them with sulfur. Angelica sinensis is warm in nature, sweet and pungent in taste, and returns to the liver, heart, and spleen meridians. It has the functions of nourishing blood, activating blood circulation, relieving pain, and moisturizing the intestines.

Scutellaria baicalensis is the root of Scutellaria baicalensis Georgi, a plant belonging to the family Lamiaceae. Mainly produced in Hebei, Shanxi, Inner Mongolia, Henan and Shaanxi. Excavate in spring and autumn, remove residual stems and fibrous roots, and dry in the sun. Scutellaria baicalensis is cold in nature and bitter in taste. It belongs to the lung, gallbladder, stomach and large intestine meridians. It has the functions of clearing away heat and drying dampness, purging fire and detoxifying, stopping bleeding, and preventing miscarriage. "Scutellaria baicalensis slices" are processed products of scutellaria baicalensis. Take scutellaria baicalensis, remove impurities, boil it in boiling water for 10 minutes, take it out, suffocate it thoroughly, cut it into thin slices, and dry it; or steam it for half an hour, take it out, cut it into thin slices, and dry it (be careful to avoid exposure to the sun). "Wine-made Scutellaria baicalensis" or "Wine-made Scutellaria baicalensis" is a processed product of Scutellaria baicalensis. Take Scutellaria baicalensis slices and fry them dry according to the wine-grilling method (refer to Chinese Pharmacopoeia 2020 Edition Four General Principles 0213).

Bupleurum is the root or whole plant of Bupleurum chinense DC. or B. scorzonerifolium Willd. 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. Excavate in spring and autumn, dry in the sun and cut into short sections. Northern Bupleurum is cylindrical or long conical, 6 to 15 cm long and 0.3 to 0.8 cm in diameter. The root head is enlarged, 3 to 15 stem bases or short fibrous leaf bases remain at the top, and the lower branches are branched. The surface is dark brown or light brown, with longitudinal wrinkles, root marks and lenticels. It is hard and tough, not easy to break, the cross section is fibrous, the skin is light brown, and the wood is yellowish white. The smell is slightly fragrant and the taste is slightly bitter. The roots of Nanbupleuri root are thin and conical, with many fine hairy dead leaf fibers on the top, and the lower part is mostly unbranched or slightly branched. The surface is reddish brown or black brown, with many fine ring patterns near the root. The quality is slightly soft, easy to break, the cross section is slightly flat, and not fibrous. With bad oil and gas. Bupleurum is slightly cold in nature, bitter and pungent in taste, and returns to the heart envelope, liver, triple burner, and gallbladder meridian. It has the effects of relieving and reducing fever, soothing the liver and relieving stagnation, and promoting yang qi. The Bupleurum in the present invention can be Northern Bupleurum or Southern Bupleurum, and Northern Bupleurum is preferred.

Coix kernel is the mature seed kernel of Coix lacryma-jobi L., a plant belonging to the genus Coix of the family Poaceae. It is produced in most parts of my country, mainly in Fujian, Hebei, Liaoning and other places. In autumn, when the fruits are mature, the plants are harvested, sun-dried, the fruits are broken, and then sun-dried to remove the husks and seed coats. Coix seed is cool in nature, sweet and light in taste, and returns to the spleen, stomach, and lung meridians. It has the effects of diluting water and dampness, strengthening the spleen and stopping diarrhea, removing paralysis, clearing away heat and pus, detoxifying and dissipating stagnation. "Stir-fried coix seed with bran" is a processed product of coix seed. Take the clean coix seed and fry it according to the bran frying method (refer to Chinese Pharmacopoeia 2020 Edition Four General Principles 0213) until it is slightly yellow. "Fried coix seed" is a processed product of coix seed. Take the clean coix seed, place it in a preheated frying container, heat it over a slow fire, and stir-fry until the surface is slightly yellow, slightly bulging, and fragrant, then take it out and let it cool.

Poria cocos is the dried sclerotium of the Polyporaceae fungus Poria cocos (Schw.) Wolf. It is mostly parasitic on the roots of Pinaceae plants such as Scots pine or Masson pine. It is wild or cultivated and is mainly produced in Yunnan, Anhui, Hubei, Henan, Sichuan and other places. Excavate from July to September, remove the sediment, pile it up and "sweat", spread it out to dry until the surface is dry, and then "sweat" several times until wrinkles appear and most of the internal moisture is lost, then dry in the shade; or Cut fresh Poria cocos and dry it in the shade. Poria cocos is neutral in nature, sweet and light in taste, and is directed to the heart, spleen, and kidney meridians. It has the effects of diluting water and dampness, strengthening the spleen, and calming the nerves.

Alisma is the tuber of Alisma orientale (Sam.) Juzep., a plant of the genus Alismataceae, mainly produced in Fujian, Sichuan, Jiangxi and other places. In winter, excavate when the stems and leaves begin to wither, wash them, dry them over low heat, remove the fibrous roots and rough bark, moisten them with water, cut them into slices, and dry them in the sun. Alisma is cold in nature, sweet and light in taste, and returns to the kidney and bladder meridian. It has the effects of diluting water and dampness, releasing heat, resolving turbidity and lowering lipids.

Licorice is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. of the genus Leguminosae. It is mainly produced in Inner Mongolia, Shanxi, Gansu, Xinjiang and other places. Excavate in spring and autumn, remove residual stems and fibrous roots, or peel off the skin, slice into slices and dry in the sun. Licorice is mild in nature and sweet in taste, and it returns to the heart, lungs, spleen and stomach meridians. It has the functions of tonifying the spleen and replenishing qi, clearing heat and detoxifying, eliminating phlegm and relieving cough, relieving pain and relieving pain, and reconciling various medicines.

In some preferred embodiments, the first traditional Chinese medicine composition is composed of the following components: honeysuckle, forsythia, gastrodia elata, sapsroot, white aconite, earthworm, zombie, angelica, chuanxiong, angelica, skullcap, bupleurum, coix Kernel, Poria, Alisma and Licorice.

In some embodiments, in the first Chinese medicine composition, in parts by weight, the Chinese medicine composition includes: 10-30 parts of honeysuckle, 10-30 parts of Forsythia suspensa, 10-20 parts of Gastrodia elata, and 10-20 parts of Fangfeng , 5-15 parts of White Aconite, 10-20 parts of Earthworm, 10-20 parts of Bombyx mori, 10-15 parts of Angelica dahurica, 5-10 parts of Chuanxiong, 10-20 parts of Chinese angelica, 10-20 parts of Scutellaria baicalensis, 10-20 parts of Bupleurum. 20 parts of coix seed, 20-40 parts of coix seed, 10-30 parts of poria, 5-15 parts of Alisma and 5-15 parts of licorice.

In some preferred embodiments, in the first Chinese medicine composition, in parts by weight, the Chinese medicine composition includes: 15-25 parts of honeysuckle, 15-25 parts of Forsythia suspensa, 12-17 parts of Gastrodia elata, and 12-12 parts of Fangfeng. 17 parts, white aconite 8-12 parts, earthworm 12-17 parts, silkworm 12-17 parts, angelica dahurica 10-13 parts, chuanxiong 6-8 parts, angelica 12-17 parts, skullcap 12-17 parts, Bupleurum 12-17 parts, coix seed 25-35 parts, Poria 15-25 parts, Alisma 8-12 parts and licorice 8-12 parts.

In some more preferred embodiments, in the first Chinese medicine composition, in parts by weight, the Chinese medicine composition includes: 20 parts of honeysuckle, 20 parts of Forsythia suspensa, 15 parts of Gastrodia elata, 15 parts of Fangfeng, and 9 parts of White Aconite. , 15 parts of Dilong, 15 parts of Bombyx, 12 parts of Angelica dahurica, 7 parts of Chuanxiong, 15 parts of Angelicae, 15 parts of skullcap, 15 parts of Bupleurum, 30 parts of Coix seed, 20 parts of Poria, 10 parts of Alisma and 10 parts of licorice.

In some embodiments, the white aconite is a purpure aconite.

In some embodiments, the silkworm is fried silkworm.

In some embodiments, the skullcap is wine-made skullcap (or wine-made skullcap).

In some embodiments, the Bupleurum Bupleurum is Bupleurum Bupleurum.

In some embodiments, the coix seed is fried coix seed.

In the first Chinese medicine composition: honeysuckle has a light body and a fragrant smell, which can not only clear away the heat in the Qi, but also detoxify the blood; Forsythia is light and floats, good at moving up the burnt body to relieve heart fire, Breaks blood knots, dissipates Qi and eliminates carbuncles and swelling. Honeysuckle is combined with Forsythia suspensa. It is light and clear. It clears Qi and cools blood. It enhances the ability to clear away heat and detoxify. It can clear qi stagnation and blood coagulation in the twelve meridians. At the same time, modern pharmacology has found that the two medicines are effective against a variety of pathogenic bacteria. It has a broad-spectrum antibacterial effect and a certain antiviral effect, and both of them are considered monarch medicines.

White Aconite is pungent, warm and strong. It enters Yangming and travels to the head and face. It dispels wind and resolves phlegm, warms Yang and dissipates cold. It is especially good at treating wind on the head and face. Dilong unblocks the meridians and activates meridians. It is good at walking and guides various medicines directly into the meridians. The two are combined. , the effect of dispelling wind and dredging collaterals is more powerful. Angelica dahurica can be used on 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 aromatic. It can clear the nine orifices, dispel wind and relieve itching, unblock meridians and relieve pain, remove dampness and swelling, and stir-fried silkworms can remove stiffness. Wind relieves spasms, resolves phlegm and unblocks collaterals. Zhizhi silkworm is the best at clearing and transforming Qi. Its odor is thin and light and ascending. It dispels wind and clears away heat, calms wind and relieves spasms, resolves phlegm and dissipates stagnation, unblocks collaterals and relieves pain. The two medicines are used together, and when applied together, they can dispel wind and relieve pain, overcome dampness and stop bandages. Bupleurum is bitter and neutral, dispersing wind-heat and promoting yang energy; Scutellaria baicalensis is bitter and cold, clearing away heat and dampness, purging fire and detoxifying. Bupleurum purges half of external evils and half internal evils, Scutellaria baicalensis relieves half external and half internal evils, Bupleurum raises Qing Yang, and Scutellaria reduces turbid fire. The combination of the two medicines can enhance the clearness and reduce the turbidity, harmonize the exterior and interior, reconcile Shaoyang, and clear the evil heat of Shaoyang. Bupleurum is good at relieving depression, and Scutellaria baicalensis is good at releasing heat. The two medicines are used together, which can not only relax and regulate the qi of the liver and gallbladder, but also clear away the internal dampness and heat. To treat wind, treat blood first, then the wind will disappear on its own. Angelica sinensis is soft and moist in nature, nourishes blood and activates blood circulation, removes blood stasis and relieves pain; Ligusticum chuanxiong has a pungent and warm fragrance, promotes qi and activates blood circulation, dispels wind and relieves pain. Angelica sinensis is mainly for nourishing blood, and Ligusticum chuanxiong is mainly for promoting qi. The two medicines are used together to restrain each other's shortcomings and expand their longings, take into account both qi and blood, and enhance the power of nourishing blood and regulating menstruation, promoting qi and blood circulation, dispersing blood stasis and relieving pain. The above four groups of medicine pairs are all ministerial medicines, which can detoxify, dispel wind and activate blood circulation.

Coix seed clears away heat, removes dampness and removes paralysis, Poria cocos clears away heat and removes dampness and strengthens the spleen, Alisma removes water, removes dampness and purges heat. The three medicines are combined to clear away heat and remove dampness. Fangfeng, dispelling wind and relieving surface, eliminating dampness, relieving pain and relieving spasm. Gastrodia elata dispelling wind and dredging collaterals, expelling wind and relieving spasm. The combination of the two medicines enhances the effect of Aconite aconitifolia and Bombyx mori in dispelling wind and dredging collaterals. The above five flavors are all adjuvants.

Licorice harmonizes the middle and urgent symptoms, harmonizes various medicines, and serves as the herbal medicine.

The second traditional Chinese medicine composition for treating peripheral facial paralysis in the present invention includes the following components: peach kernel, safflower, angelica root, rehmannia glutinosa, white peony root, cinnamon twig, clematis, Corydalis, clematis, sea breeze vine, Gentiana and Sanji.

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 mature fruits from July to September, remove the pulp and core shell, take out the seeds and dry them in the sun. Peach kernels are neutral in nature and bitter in taste. They are directed to the heart, liver, lungs, and large intestine meridians. They have the functions of promoting blood circulation and removing blood stasis, moistening the intestines and laxative, relieving cough and asthma. "Burned peach kernels" are processed products of peach kernels. Take the clean peach kernels, peel them according to the burning method (refer to Chinese Pharmacopoeia 2020 Edition Four General Principles 0213), and mash them when used.

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

Angelica sinensis (Oliv.) Diels is the root of Angelica sinensis (Oliv.) Diels, a plant belonging to the family Apiaceae. It is mainly produced in Min County (Qinzhou) in southeastern Gansu Province. Secondly, it is also cultivated in Shaanxi, Sichuan, Yunnan, Hubei and other places. Excavate at the end of autumn, remove the reed heads and fibrous roots, wait until the water evaporates slightly, bundle them into small handfuls, and slowly smoke them to dry over low heat or smoke them with sulfur. Angelica sinensis is warm in nature, sweet and pungent in taste, and returns to the liver, heart, and spleen meridians. It has the functions of nourishing blood, activating blood circulation, relieving pain, and moisturizing the intestines.

Rehmannia glutinosa is the fresh or dried root tuber of Rehmannia glutinosa Libosch. Dig it in autumn, remove the reed heads, fibrous roots and sediment, and use it fresh; or slowly bake the rehmannia glutinosa until it is about 80% dry. The former is commonly called "fresh rehmannia glutinosa" and the latter is commonly called "raw rehmannia glutinosa". Fresh Rehmannia glutinosa is cold in nature, sweet and bitter in taste, and returns to the heart, liver, and kidney meridians. It has the effects of clearing away heat, promoting fluid production, cooling blood, and stopping bleeding. Rehmannia glutinosa is cold in nature and sweet in taste. It is directed to the heart, liver and kidney meridians. It has the effects of clearing away heat and cooling blood, nourishing yin and promoting fluid production. "Rehmannia glutinosa" is a processed product of raw rehmannia glutinosa. The processing method is: (1) Take raw rehmannia glutinosa and stew it with wine (refer to Chinese Pharmacopoeia 2020 Edition Four General Principles 0213) until the wine is exhausted, take it out, and dry it until the skin is slightly mucous. When dry, cut into thick slices or blocks and dry. For every 100kg of raw rehmannia glutinosa, 30-50kg of rice wine is used. (2) Take raw rehmannia glutinosa and steam it according to the steaming method (refer to Chinese Pharmacopoeia 2020 Edition Four General Chapters 0213) until it is black and moist, take it out, dry it in the sun until it is about 80% dry, cut it into thick slices or pieces, and dry it. Rehmannia glutinosa is slightly warm in nature and sweet in taste. It returns to the liver and kidney meridian and has the functions of nourishing blood and yin, replenishing essence and replenishing marrow. The rehmannia glutinosa in the present invention can be fresh rehmannia glutinosa, raw rehmannia glutinosa or cooked rehmannia glutinosa, preferably cooked rehmannia glutinosa.

White peony root is the root of Paeonia lactiflora Pall., a plant of the Ranunculaceae family, and is cultivated in Zhejiang, Anhui, Sichuan and other places. Dig in summer and autumn, remove soil and roots, peel, soak in boiling water or boil briefly until heated evenly, and dry in the sun. White peony root is slightly cold in nature, bitter and sour in taste, and returns to the liver and spleen meridians. It has the effects of nourishing blood and astringing yin, softening the liver and relieving pain, and calming liver yang.

Guizhi is the twig of Cinnamomum cassia Presl. of the Lauraceae family. It is mainly produced in Guangxi, Guangdong, Yunnan and other places. Usually the young branches are cut off in spring, dried in the sun or shade, and cut into thin slices or small sections. Guizhi is warm in nature, pungent and sweet in taste, and returns to the heart, lungs, and bladder meridians. It has the effects of producing sweat, relieving the surface, warming meridians, and unblocking yang.

Speranskia tuberculate (Bunge) Baill. is the whole plant of Speranskia tuberculate (Bunge) Baill. It is mainly produced in Liaoning, Jilin, Inner Mongolia, Hebei and other places. The herb is warm in nature and pungent in taste, and it belongs to the liver and kidney meridian. It has the functions of dispelling wind and removing dampness, relaxing muscles and activating blood circulation, dissipating blood stasis and reducing swelling, detoxifying and relieving pain.

Clematis intricata Bunge is the whole plant of Clematis intricata Bunge in the Ranunculaceae family. It has the functions of dispelling wind and dehumidification, unblocking collaterals and relieving pain.

Corydalis yanhusuo is the dried tuber of the Corydalis yanhusuo W.T.Wang plant in the Papaveraceae family. It is mainly produced in Hebei, Shandong, Jiangsu, Zhejiang and other places. Corydalis Corydalis is warm in nature, pungent and bitter in taste, and returns to the heart, liver, and spleen meridians. It has the effects of activating blood circulation, promoting qi, and relieving pain. "Vinegar Corydalis Corydalis" or "Vinegar Corydalis Corydalis" is a processed product of Corydalis Corydalis. Take the clean Corydalis Corydalis and fry it dry according to the vinegar method (refer to the General Chapter 0213 of the Chinese Pharmacopoeia 2020 Edition), or boil it with vinegar (refer to the General Chapter 0213 of the Chinese Pharmacopoeia 2020 Edition). 0213) Cook until the vinegar is absorbed, cut into thick slices or mash when used.

Clematis is the dry root and rhizome of Clematis chinensis Osbeck, Clematis hexapetala Pall. or Clematis manshurica Rupr. of the Ranunculaceae family. It is mainly produced in Jiangsu, Anhui, and Zhejiang and other places. Dig in autumn, remove sediment and dry in the sun. Clematis is warm in nature, pungent and salty in taste, and belongs to the bladder meridian. It has the functions of dispelling rheumatism, dredging meridians, relieving paralysis and pain, and treating bone diseases.

Sea breeze vine is the cane of Piper kadsura Sieb., a plant of the genus Pepper in the family Piperaceae. It is mainly produced in Guangdong, Fujian, Taiwan, Zhejiang and other places. Harvest in summer and autumn, remove roots and leaves, and dry in the sun. Hai Feng Teng is slightly warm in nature, pungent and bitter in taste, and returns to the liver meridian. It has the effects of dispelling rheumatism, dredging meridians, and relieving paralysis and pain.

Gentiana is the dry root of Gentiana macrophulla Pall., Gentiana straminea Maxim. or Gentiana crassicaulis Duthie ex Burk., mainly produced in Shaanxi, Sichuan, Yunnan, Tibet and other places. Genji is neutral in nature, pungent and bitter in taste, and returns to the stomach, liver, and gallbladder meridians. It has the effects of dispelling wind and removing dampness, clearing away heat and relieving numbness.

Loranthus is the leafy stem and branch of Viscum coloratum (Komar.) Nakai or Loranthus parasiticus (L.) Merr. of the family Lorantaceae. The former is mainly produced in Hebei, Liaoning, Jilin, Inner Mongolia, and Anhui. , Zhejiang, Hunan, Henan and other places, the latter is mainly produced in Guangdong, Guangxi and other places. Harvest from winter to spring, remove thick stems, cut into sections, dry, or steam and then dry. Mulberry is mild in nature, bitter and sweet in taste, and returns to the liver and kidney meridian. It has the effects of dispelling rheumatism, nourishing the liver and kidneys, strengthening bones and muscles, and preventing miscarriage.

In some embodiments, the second Chinese medicine composition consists of the following components: peach kernel, safflower, angelica root, rehmannia glutinosa, white peony root, cinnamon twig, clematis root, Corydalis corydalis, clematis, sea breeze wisteria, rhizome, and Mulberry.

In some embodiments, in the second Chinese medicine composition, in parts by weight, the Chinese medicine composition includes: 20-30 parts of peach kernel, 20-30 parts of safflower, 20-30 parts of Angelica sinensis, and 20-30 parts of Rehmannia glutinosa. , 40-60 parts of white peony root, 20-30 parts of cinnamon twig, 20-30 parts of Corydalis cordata, 20-40 parts of Corydalis Corydalis, 10-30 parts of Clematis, 10-30 parts of Sea Breeze Vine, 10-30 parts of Radix Gentiana. 20-30 servings and mulberry.

In some preferred embodiments, in the second traditional Chinese medicine composition, in parts by weight, the traditional Chinese medicine composition includes: 23-28 parts of peach kernel, 23-28 parts of safflower, 23-28 parts of angelica root, 23-28 parts of rehmannia glutinosa. 28 parts, 45-55 parts of white peony root, 23-28 parts of cinnamon twig, 23-28 parts of Corydalis cordata, 25-35 parts of Corydalis Corydalis, 15-25 parts of Clematis, 15-25 parts of Sea Breeze Vine, 15 parts of Radix Gentiana. -25 servings and lollipop 23-28 servings.

In some more preferred embodiments, in the second traditional Chinese medicine composition, in parts by weight, the traditional Chinese medicine composition includes: 25 parts of peach kernel, 25 parts of safflower, 25 parts of angelica root, 25 parts of rehmannia glutinosa, and 50 parts of white peony root. , 25 parts of Cinnamon twig, 25 parts of Corydalis cordata, 30 parts of Corydalis Corydalis, 20 parts of Clematis, 20 parts of Sea Breeze Vine, 20 parts of Gentianae and 25 parts of Lobra.

In some embodiments, the peach kernel is peach kernel.

In some embodiments, the Corydalis corydalis is acetic Corydalis corydalis (or Corydalis acetate).

In some embodiments, the Rehmannia glutinosa is Rehmannia glutinosa.

In the second Chinese medicine composition: Taohong Siwu Decoction is the main ingredient, peach kernel and safflower mainly enter the blood component, unblock the meridians and straighten them, and relieve the stagnant blood components. According to "treat wind first, treat blood" to make blood flow and wind flow. self-destruction. The prescription uses powerful blood-breaking products, peach kernel and safflower as the monarch drugs, which focus on activating blood circulation and removing blood stasis; peach kernel breaks blood and removes blood stasis; safflower activates blood circulation and stimulates menstruation, removes blood stasis and relieves pain. Peach kernel has strong power to break blood stasis, while safflower has strong blood circulation power. The two medicines are used together to promote each other and enhance the power of promoting blood circulation, dredging menstruation, removing blood stasis and regenerating new energy.

Rehmannia glutinosa, which is sweet and warm, nourishes blood and nourishes the liver; Angelica sinensis nourishes yin and nourishes blood, promoting blood circulation and relieving pain; peony nourishes yin and nourishes nutrients to increase the power of blood. The three medicines are used in combination to nourish yin and nourish blood. Guizhi nourishes blood, nourishes nutrients, warms and unblocks meridians. White peony nourishes blood and astringes yin without stagnating evil, while cinnamon twig combines with nutrients to relieve muscles without damaging yin. The two are combined, dispersing and astringing, and can be used together with cold and temperature to harmonize yin and qi, regulate qi and blood, balance yin and yang, and work together to provide warmth. It has the function of activating blood circulation and removing blood stasis, dredging meridians, activating collaterals and eliminating paralysis. The four medicines are all ministerial medicines.

Corydalis Corydalis promotes qi, activates blood circulation and relieves pain. Corydalis Corydalis is pungent in taste 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 is pungent, salty, warm in nature, enters the bladder meridian, dispels rheumatism, and unblocks meridians. Sea Breeze Vine is pungent and bitter in taste, slightly warm in nature, and returns to the liver meridian. It can dispel rheumatism, dredge meridians, and relieve paralysis and pain. Genji is pungent, bitter, and neutral in nature. It returns to the liver, gallbladder, and stomach meridians. It can dispel rheumatism, clear away dampness and heat, relax muscles and collaterals, and relieve paralysis and pain. Mulberry tastes bitter, sweet, and has a neutral nature. It enters the liver and kidney meridians and can dispel rheumatism, nourish the liver and kidneys, and strengthen muscles and bones. The combined use of these six herbs has the effect of dispelling wind, removing dampness and unblocking meridians.

[Preparation method of traditional Chinese medicine composition]

The present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, which includes the steps of weighing and mixing each component in the traditional Chinese medicine composition.

[Pharmaceutical preparations]

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

In some embodiments, the pharmaceutical formulation is a decoction, oral liquid, or oral solid formulation.

In some preferred embodiments, the pharmaceutical formulation is a decoction.

In some embodiments, the oral solid formulation is a tablet, capsule, granule or powder.

The first traditional Chinese medicine composition for treating peripheral facial paralysis in the present invention can be made into decoction, oral liquid or oral solid preparation.

The second traditional Chinese medicine composition for treating peripheral facial paralysis in the present invention can be made into granules or powders. In some embodiments, the granules or powders can be used topically.

In the present invention, "decoction" refers to a liquid preparation made by decoction of traditional Chinese medicine pieces or coarse particles with water, removing residue and extracting juice.

In the present invention, the preparation process flow of "oral liquid" is extraction-refining-liquid preparation-filling-sterilization. Appropriate preservatives, antioxidants, flavoring agents, solubilizers, etc. can be added as needed. Oral liquid It should be sterilized at 100℃ for 30 minutes.

[Application of traditional Chinese medicine compositions or pharmaceutical preparations]

First, the present invention provides the use of the above-mentioned traditional Chinese medicine composition or the above-mentioned pharmaceutical preparation in the preparation of drugs for preventing and/or treating peripheral facial paralysis.

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

In some embodiments, when applied to the prevention and/or treatment of 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: to administer the above-mentioned Chinese medicine The composition or the above-mentioned pharmaceutical preparations are mainly used, and western medicine treatment is supplemented.

In some embodiments, the peripheral facial paralysis is acute phase, convalescent phase, or sequela phase peripheral facial paralysis.

In some embodiments, the peripheral facial palsy is acute phase Bell's palsy.

In some embodiments, the symptoms of peripheral facial paralysis include at least one of the following symptoms: deviation of the mouth and eyes, tearing of the eyes, enlarging eye fissures, shallowing or disappearance of forehead lines, spasm, twitching or synergy of facial muscles, and tearing after eating. .

Example

The present invention will be further described below through the description of specific embodiments, but this is not a limitation of the present invention. 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 deviate from the basic idea of the present invention, ideas are within the scope of the present invention. If the specific conditions are not specified in the examples, the conditions should be carried out according to the conventional conditions or the conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments used is not indicated, they are all conventional products that can be purchased commercially. The raw materials used in the present invention are all commercially available.

Example 1

The steps for preparing the traditional Chinese medicine composition (TCM prescription) for treating peripheral facial paralysis of the present invention into a decoction are as follows:

The first recipe:

Prescription: 20g honeysuckle, 20g forsythia, 15g gastrodia elata, 15g Fangfeng, 9g prepared white aconite, 15g earthworm, 15g fried silkworm, 12g angelica, 7g chuanxiong, 15g angelica, 15g wine skullcap, 15g northern bupleurum, fried coix kernels 30g, Poria cocos 20g, Alisma 10g, licorice 10g.

Preparation steps:

Take the prescription 20g of honeysuckle, 20g of forsythia, 15g of Gastrodia elata, 15g of Fangfeng, 9g of prepared white aconite, 15g of Dilong, 15g of fried silkworm, 12g of Angelica dahurica, 7g of Chuanxiong, 15g of Chinese angelica, 15g of wine skullcap, 15g of Bupleurum, stir-fried 30g of coix seed, 20g of poria, 10g of Alisma and 10g of licorice, add water and decoct twice. The first time, add 6 times the amount of water and decoct for 40 minutes. Store the decoction in a separate container. The second time, add 6 times the amount of water and decoct for 30 minutes. , combine the two decoction liquids, filter and concentrate to 100-200ml.

The second recipe:

Prescription: 25g peach kernel, 25g safflower, 25g angelica, 25g rehmannia glutinosa, 50g white peony root, 25g cinnamon twig, 25g clematis, 30g vinegar, 20g clematis, 20g sea breeze vine, 20g rhinoplasty, 25g locust. .

Preparation steps:

Take the prescription: 25g peach kernel, 25g safflower, 25g angelica, 25g rehmannia glutinosa, 50g white peony root, 25g cinnamon twig, 25g clematis, 30g vinegar, clematis 20g, 20g sea breeze vine, 20g rhinoplasty, and loranthema. 25g, add water and decoct twice. For the first time, add 8 times the amount of water and decoct for 60 minutes. Store the decoction in a separate container. For the second time, add 6 times the amount of water and decoct for 30 minutes. Combine the two decoctions, filter and concentrate the filtrate to 100 -150ml, ready to go.

Example 2

The steps of preparing the granules of the traditional Chinese medicine composition (TCM prescription) for treating peripheral facial paralysis of the present invention are as follows:

The first recipe:

Prescription: 20g honeysuckle, 20g forsythia, 15g gastrodia elata, 15g Fangfeng, 9g prepared white aconite, 15g earthworm, 15g fried silkworm, 12g angelica, 7g chuanxiong, 15g angelica, 15g wine skullcap, 15g northern bupleurum, fried coix kernels 30g, Poria cocos 20g, Alisma 10g, licorice tablets 10g.

Preparation steps:

Take the prescription 20g of honeysuckle, 20g of forsythia, 15g of Gastrodia elata, 15g of Fangfeng, 9g of prepared white aconite, 15g of Dilong, 15g of fried silkworm, 12g of Angelica dahurica, 7g of Chuanxiong, 15g of Chinese angelica, 15g of wine skullcap, 15g of Bupleurum, stir-fried 30g of coix seed, 20g of poria, 10g of Alisma and 10g of licorice, add water and boil twice. The first time, add 10 times the amount of water and boil for 60 minutes. Store the decoction in a separate container. The second time, add 8 times the amount of water and boil for 30 minutes. , combine the two decoction liquids, filter, and concentrate the filtrate to a clear paste with a relative density of 1.15-1.20 (60°C). Add auxiliary materials, granulate, dry, and mix to obtain.

The second recipe:

Prescription: 25g peach kernel, 25g safflower, 25g angelica, 25g rehmannia glutinosa, 50g white peony root, 25g cinnamon twig, 25g clematis, 30g vinegar, 20g clematis, 20g sea breeze vine, 20g rhinoplasty, 25g locust. .

Preparation steps:

Take the prescription: 25g peach kernel, 25g safflower, 25g angelica, 25g rehmannia glutinosa, 50g white peony root, 25g cinnamon twig, 25g clematis, 30g vinegar, clematis 20g, 20g sea breeze vine, 20g rhinoplasty, and loranthema. 25g, add water and decoct twice. The first time is to add 10 times the amount of water and decoct for 60 minutes. The decoction is stored in a separate container. The second time is to add 8 times the amount of water and decoct for 45 minutes. Combine the two decoctions, filter, and concentrate the filtrate to a relative Make a clear paste with a density of 1.15-1.20 (60℃), add auxiliary materials, granulate, dry and mix to get it.

Example 3: Clinical study on Zhengyan decoction combined with external application of traditional Chinese medicine in the treatment of acute phase Bell's facial palsy

1. Method

1. Source of cases

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

2. Subject

2.1 Diagnostic criteria:

Referring to the "China Guidelines for the Diagnosis and Treatment of Idiopathic Facial Nerve Paralysis" issued by the Neurology Branch of the Chinese Medical Association in 2016, the clinical diagnostic criteria for facial nerve paralysis are as follows:

(1) Acute onset, usually reaching the peak in about 3 days;

(2) Unilateral peripheral facial paralysis, paralysis of facial muscles on the affected side, disappearance of forehead lines, closed eyes, bulging cheeks, weakness in showing teeth, shallow nasolabial grooves, skewed and drooping corners of the mouth, air leakage when whistling, leakage when brushing teeth, and water leakage when eating Food retention, with or without pain behind the ears, loss of taste in front of the tongue, hyperacusis, abnormal tear or saliva secretion;

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

2.2 Inclusion criteria:

(1) Meet the above diagnostic criteria;

(2) Aged 18-60 years old, no gender limit;

(3) Patients in the acute phase, the course of disease is 1 to 7 days;

(4) Sign the informed consent form.

2.3 Exclusion criteria:

(1) Facial nerve palsy caused by Hunter syndrome and other confirmed disease causes, such as Guillain-Barré syndrome, multiple sclerosis, sarcoidosis, Mobius syndrome, diabetic peripheral neuropathy, encephalitis (fungus, virus, bacteria) , human immunodeficiency virus infection, Lyme disease, otitis media, herpes zoster virus infection, syphilis, brainstem stroke, facial nerve tumors, skin tumors, parotid gland tumors and facial nerve trauma, etc.;

(2) Combined with serious diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system;

(3) Suffering from severe mental illness and incapacitated;

(4) Coagulation dysfunction;

(5) Pregnant and lactating women;

(6) Acute local skin infection

3. Randomization and blinding

Eligible subjects were randomly assigned to receive treatment from experimental group 1, experimental group 2, experimental group 3, or control group, with the ratio of the four groups being 1:1:1:1. Block randomization was used, and the block size was 8. Outcome assessors and statisticians were blinded.

4.Interventions

Control group: received western medicine treatment, and the treatment plan was in accordance with the "China Guidelines for the Diagnosis and Treatment of Idiopathic Facial Nerve Paralysis" promulgated by the Neurology Branch of the Chinese Medical Association in 2016. The treatment course was 10 days. Specific plan: In the acute phase, ① oral prednisone/prednisolone (1 mg per kilogram of body weight) 30 mg to 60 mg per day for 5 days, and then gradually reduce the dose to discontinuation within 5 days; ② oral acyclovir each time 0.8g, 5 times a day for 10 days; ③ Methylcobalamin tablets are taken orally at 0.5 mg each time, 3 times a day. Follow up to 12 weeks.

Experimental group 1: On the basis of the control group, Zhengyan decoction was added. The prescription of Zhengyan Decoction is as follows: 20g honeysuckle, 20g forsythia, 15g gastrodia elata, 15g Fangfeng, 9g prepared white aconite, 15g earthworm, 15g stir-fried silkworm, 12g angelica, 7g chuanxiong, 15g angelica, 15g wine skullcap, 15g bupleurum , fried coix seed 30g, Poria cocos 20g, Alisma 10g, licorice slices 10g. Take 1 dose of the above medicines per day, decoct and filter to 200mL of concoction, and take 100mL orally in the morning and evening. The course of treatment is 12 weeks.

Experimental group 2: On the basis of the control group, external application of traditional Chinese medicine was added. The prescription of traditional Chinese medicine for external application is as follows: 25g peach kernel, 25g safflower, 25g angelica, 25g rehmannia glutinosa, 50g white peony root, 25g cinnamon twig, 25g clematis, 30g vinegar, 20g clematis, 20g sea breeze vine, 20g rhizome, Lollipop 25g. Grind the above medicine into powder, mix it with rice wine or vinegar into a paste, and apply it on the affected side of the face, once/day, 30min-1h/time. The course of treatment is 12 weeks.

Experimental group 3: On the basis of the control group, Zhengyan decoction combined with external application of traditional Chinese medicine was added. The method of using Zhengyan decoction and traditional Chinese medicine for external application is the same as above. The course of treatment is 12 weeks.

5. Outcome indicators

House-Brackmann (H-B) facial nerve function classification: Facial nerve function is divided into 6 levels. Grade I: normal function; Grade II: mild dysfunction (when observed carefully, mild weakness of facial muscles can be detected, the eyelids can be completely closed with gentle force, slight facial asymmetry, and barely detectable joints when smiling forcefully) Movement, no contracture or spasm); Grade III: Moderate dysfunction (obvious facial muscle weakness, but no damage to the face, may be unable to raise eyebrows, eyelids can be completely closed when exerting force, mouth movements are strong but asymmetrical, with Obvious synkinesis or spasm); Grade IV: Moderate to severe dysfunction (obvious facial muscle weakness, disfigurement, inability to raise eyebrows, inability to completely close the eyelids when exerting force, asymmetry of oral movements, severe synkinesis or spasm) ); Grade V: Severe functional impairment (insufficient eye closing that can be detected, 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, no synkinesis, contractures, and spasticity). The patients were recorded before treatment and for 12 weeks of treatment.

Efficacy evaluation: total effective rate = (recovery + marked effect + effective) / total number of cases × 100%. Recovery: All clinical manifestations on the affected side of the face disappeared compared to before, and the H-B classification was grade I (ie, no facial paralysis). Significant effect: The patient's face is bilaterally symmetrical at rest; facial synkinesis still exists during movement, slight lip asymmetry, eyes can be completely closed, forehead movement is moderate, H-B grade II. Effective: The face is basically symmetrical when still; it is asymmetrical during movement, there is slight synkinesis or spasm in the facial nerve, the lips are obviously asymmetrical, and the eyes can only be closed by force, H-B grade III. Invalid: There is obvious bilateral asymmetry when the face is at rest, there is no forehead movement, it is difficult to close the eyes, and only slight lip movement is possible. The symptoms have no obvious change compared with before treatment, H-B grade IV-IV.

6. Statistical methods

The main results were analyzed according to the intentionality principle. Measurement data are expressed as mean ± standard deviation Or median (interquartile range) (Median[IQR]); count data is expressed as frequency or composition ratio. If the measurement data conforms to the normal distribution and the variances are homogeneous, the independent sample t test is used; if the measurement data does not conform to the normal distribution, the non-parametric test is used. Count data were analyzed using ^χ2 test. Missing values are processed and analyzed using the last carry forward method. Statistical testing adopts two-sided testing, and the significance level of difference is α=0.05. P<0.05 indicates that the difference is statistically significant. The statistical software uses SPSS25.0 version.

2. Results

1.General information

A total of 400 patients with Bell's palsy in the acute stage were included, 100 in each group. General information such as gender, age, and course of disease of the two groups of patients were statistically analyzed and the differences were not statistically significant, and the baselines were comparable (see Table 1).

Table 1 Patient baseline characteristics

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

2.Comparison of total effective efficiency

There was a statistical difference in the total effective rate among the four groups after treatment (P<0.05). The results of pairwise comparison 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 all statistically significant (P <0.05); the total effective rate of experimental group 2 (81%) was higher than that of experimental group 1 (76%) and the control group (70%), and the differences were statistically significant (P<0.05); the total effective rate of experimental group 1 The efficiency (76%) was higher than that of the control group (70%), and the difference was statistically significant (P<0.05). See Table 2.

Table 2 Total effective rates of the four groups after treatment

Note: a Comparing test group 3 with test group 2, P<0.05; b Comparing test group 3 with test group 1, P<0.05; c Comparing test group 3 with control, P<0.05; d Test group 2 with test group 1 Comparison, P<0.05; eComparison between test group 2 and control group, P<0.05; fComparison between test group 1 and control group, P<0.05.

3.Safety comparison

In the control group, 3 cases had headaches and dizziness, which disappeared after stopping the drug; in the experimental group 1, 2 cases had abdominal pain and vomiting, which disappeared after the drug was stopped; in the experimental group 2, 2 cases had abnormal sensations, which disappeared after the drug was stopped; in the experimental group 3, 4 cases Increased appetite occurs. There were no serious adverse reactions in any of the four groups.

Claims (9)

1. A traditional Chinese medicine composition, which includes: honeysuckle, forsythia, gastrodia elata, saposhnikovia, white aconite, earthworm, silkworm, angelica dahurica, chuanxiong, angelica, skullcap, bupleurum, coix seed, poria, alisma and licorice; Preferably, the traditional Chinese medicine composition is composed of honeysuckle, forsythia, gastrodia elata, saposhnikovia, white aconite, earthworm, Bombyx mori, angelica dahurica, chuanxiong, angelica, skullcap, bupleurum, coix seed, poria, alisma and licorice. 2. The traditional Chinese medicine composition according to claim 1, characterized in that, in parts by weight, the traditional Chinese medicine composition includes: 10-30 parts of honeysuckle, 10-30 parts of Forsythia suspensa, 10-20 parts of Gastrodia elata, and 10 parts of Fangfeng. -20 parts, 5-15 parts of Aconite, 10-20 parts of Earthworm, 10-20 parts of Bombyx mori, 10-15 parts of Angelica dahurica, 5-10 parts of Chuanxiong, 10-20 parts of Angelica sinensis, 10-20 parts of Scutellaria baicalensis, Chai Chai 10-20 parts of coix seed, 20-40 parts of coix seed, 10-30 parts of poria, 5-15 parts of Alisma and 5-15 parts of licorice; Preferably, in parts by weight, the traditional Chinese medicine composition includes: 15-25 parts of honeysuckle, 15-25 parts of Forsythia suspensa, 12-17 parts of Gastrodia elata, 12-17 parts of Fangfeng, 8-12 parts of White Aconite, and 12 parts of Dilong. -17 parts, Bombyx mori 12-17 parts, Angelica dahurica 10-13 parts, Ligusticum chuanxiong 6-8 parts, Angelica sinensis 12-17 parts, Scutellaria baicalensis 12-17 parts, Bupleurum 12-17 parts, Coix seed 25-35 parts, Poria cocos 15-25 parts, Alisma 8-12 parts and Licorice 8-12 parts; More preferably, in parts by weight, the traditional Chinese medicine composition includes: 20 parts of honeysuckle, 20 parts of Forsythia suspensa, 15 parts of Gastrodia elata, 15 parts of Fangfeng, 9 parts of white aconite, 15 parts of Dilong, 15 parts of Bombyx mori, and 12 parts of Angelica dahurica. 7 parts of Chuanxiong, 15 parts of Angelicae Sinensis, 15 parts of Scutellaria baicalensis, 15 parts of Bupleurum, 30 parts of Coix Seed, 20 parts of Poria, 10 parts of Alisma and 10 parts of Licorice. 3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that the traditional Chinese medicine composition satisfies at least one of the following conditions: The said white aconite is prepared from white aconite; The zombie silkworm is fried zombie silkworm; The said Scutellaria baicalensis is Scutellaria baicalensis made with wine; The Bupleurum Bupleurum is Bupleuri Bupleurum; and The coix seed is fried coix seed. 4. A traditional Chinese medicine composition, which includes: peach kernel, safflower, angelica root, rehmannia glutinosa, white peony root, cinnamon twig, clematis, Corydalis, clematis, sea breeze vine, rhizome, and mulberry; Preferably, the traditional Chinese medicine composition is composed of peach kernel, safflower, angelica root, rehmannia glutinosa, white peony root, cinnamon twig, clematis, Corydalis chinensis, clematis, sea breeze vine, rhizome, and mulberry. 5. The traditional Chinese medicine composition according to claim 4, characterized in that, in parts by weight, the traditional Chinese medicine composition includes: 20-30 parts of peach kernel, 20-30 parts of safflower, 20-30 parts of angelica root, and 20 parts of rehmannia glutinosa. -30 parts, 40-60 parts of white peony root, 20-30 parts of cinnamon twig, 20-30 parts of Tiengucao, 20-40 parts of Corydalis, 10-30 parts of Clematis, 10-30 parts of Sea Breeze Vine, and Radix Gentiana 10-30 servings and 20-30 servings of lollipop; Preferably, in parts by weight, the traditional Chinese medicine composition includes: 23-28 parts of peach kernel, 23-28 parts of safflower, 23-28 parts of Angelica sinensis, 23-28 parts of Rehmannia glutinosa, 45-55 parts of white peony root, and 23 parts of Guizhi. -28 parts, 23-28 parts of Corydalis, 25-35 parts of Corydalis, 15-25 parts of Clematis, 15-25 parts of Sea Breeze Vine, 15-25 parts of Radix Gentiana and 23-28 parts of Locust; More preferably, in parts by weight, the traditional Chinese medicine composition includes: 25 parts of peach kernel, 25 parts of safflower, 25 parts of Angelica sinensis, 25 parts of Rehmannia glutinosa, 50 parts of white peony root, 25 parts of cinnamon twigs, and 25 parts of Tienguicao , 30 parts of Corydalis Corydalis, 20 parts of Clematis, 20 parts of Sea Breeze Vine, 20 parts of Radix Gentiana and 25 parts of Lobra. 6. The traditional Chinese medicine composition according to claim 4 or 5, characterized in that the traditional Chinese medicine composition satisfies at least one of the following conditions: The peach kernels are peach kernels; The Corydalis Corydalis is a vinegar-made Corydalis Corydalis; and The rehmannia glutinosa is cooked rehmannia glutinosa. 7. The preparation method of the traditional Chinese medicine composition according to any one of claims 1 to 6, which includes the steps of weighing and mixing each component in the traditional Chinese medicine composition. 8. A pharmaceutical preparation made from the traditional Chinese medicine composition according to any one of claims 1-6; Preferably, the pharmaceutical preparation is a decoction, oral liquid or oral solid preparation, preferably a decoction; Further, the oral solid preparation is a tablet, capsule, granule or powder. 9. Application of the traditional Chinese medicine composition according to any one of claims 1 to 7 or the pharmaceutical preparation according to claim 8 in the preparation of medicines for preventing and/or treating peripheral facial paralysis; Preferably, the peripheral facial paralysis is acute phase, recovery phase or sequela phase peripheral facial paralysis, preferably acute phase Bell's palsy; Preferably, the symptoms of peripheral facial paralysis include at least one of the following symptoms: deviated mouth and eyes, tearing from open eyes, enlarged eye fissures, shallow or disappeared forehead lines, spasm, twitching or synergy of facial muscles, and tearing during meals.