CN108938815B - Pharmaceutical composition for treating facial neuritis and preparation method and application thereof - Google Patents
Pharmaceutical composition for treating facial neuritis and preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition for treating facial neuritis and a preparation method and application thereof. The pharmaceutical composition is prepared from the following raw materials: 1.8 to 5.4 parts of schizonepeta, 1.8 to 5.4 parts of stiff silkworm, 1.8 to 5.4 parts of uncaria, 0.9 to 2.4 parts of liquorice, 1.8 to 5.4 parts of white peony root, 1.8 to 5.4 parts of divaricate saposhnikovia root, 0.3 to 1.5 parts of centipede, 1.8 to 5.4 parts of kudzu root, 1.8 to 5.4 parts of burdock, 1.8 to 5.4 parts of rehmannia, 0.9 to 2.4 parts of scorpion, 1.8 to 5.4 parts of angelica dahurica, 1.8 to 5.4 parts of peach kernel and 1.8 to 5.4 parts of scutellaria baicalensis. The pharmaceutical composition can effectively treat facial neuritis, and is safe to take and free of toxic and side effects.
Description
Technical Field
The invention relates to a pharmaceutical composition for treating facial neuritis, and also relates to a preparation method and application of the pharmaceutical composition.
Background
Facial neuritis is also called facial paralysis, which is peripheral facial nerve paralysis caused by nonspecific inflammation of the facial nerves in the foramen magnum. The pathogenesis has not been elucidated so far, and most of them are considered to be associated with viral infection. The disease can be developed at any age, and is mainly suitable for young and middle-aged patients. The acute onset usually manifests as facial distortion, salivation, speech air leakage, whistling or laughing. Different affected parts can be accompanied by different symptoms, such as involvement of femoral nerve, taste disturbance of the anterior tongue 2/3, stapedial muscular involvement, hyperacusis and excessive reverberation. Lesions of the geniculate ganglion may also cause dysesthesia of the auricle and external auditory meatus, herpes on the external auditory meatus and periosteum, and the like.
For the treatment of facial paralysis, western medicine uses hormone, antivirus, B vitamins, physical therapy, and even surgical therapy. Traditional Chinese medicine has a long history of treating facial paralysis. Facial paralysis belongs to the category of facial paralysis in traditional Chinese medicine. The book of "class syndrome management and cutting" is characterized in that: the mouth and eyes are kept clear, and the blood is dry and fails to nourish and moisten the meridians. Deficiency of both qi and blood is the root of the onset of facial paralysis. The pathogenic factors of exogenous wind and cold attacking meridians and collaterals cause qi and blood stagnation and malnutrition of meridians and collaterals, as in the theory of various etiologies: oblique wind ports are the weak wind and the wind enters the ribs of the nip. The "theory of disease origin, wind gap term" includes: wind pathogen enters the tendons of foot yangming and hand taiyang, and when it encounters cold, the tendons will lead to the cheek, so the mouth will be crooked. Therefore, it is mainly used for dispelling wind and dredging collaterals, and tonifying qi and activating blood circulation.
The Chinese patent application with the application number of 200810015329.X discloses a traditional Chinese medicine for treating facial neuritis, which comprises rhizoma typhonii, semen brassicae, honey locust, rhizoma arisaematis, rhizoma gastrodiae, uncaria, tribulus terrestris, earthworm, stiff silkworm, scorpion, centipede, herba schizonepetae, radix sileris, asarum, radix angelicae, ligusticum, magnolia flower, ginger, notopterygium root, fructus evodiae and raw liquorice. Chinese patent application No. 201510147140.6 discloses a traditional Chinese medicine wine for treating facial paralysis, which is prepared from the following raw materials in parts by weight: radix astragali, radix Angelicae Pubescentis, radix rehmanniae Preparata, radix rehmanniae, radix Gentianae Marcrophyllae, cortex Acanthopanacis, caulis Hederae sinensis, rhizoma Gastrodiae, ramulus Uncariae cum uncis, spina Gleditsiae, rhizoma Typhonii, Scorpio, Bombyx Batryticatus, semen Persicae, Carthami flos, radix Saposhnikoviae, herba Schizonepetae, radix Angelicae sinensis, rhizoma Ligustici Chuanxiong, Notopterygii rhizoma, radix Angelicae Dahuricae, periostracum Cicadae, radix Paeoniae alba, Achyranthis radix, ramulus Cinnamomi, Scorpio, Glycyrrhrizae radix and Chinese liquor of above 55 degree. The prescription contains up to 27 traditional Chinese medicines, and the medicinal liquor is narrow in adaptation population.
Therefore, a traditional Chinese medicine composition for treating facial neuritis with moderate prescription amount and wide applicable population is needed.
Disclosure of Invention
The first purpose of the invention is to provide a pharmaceutical composition which can effectively treat facial neuritis, and has moderate prescription amount and wide applicable population.
The second purpose of the invention is to provide a preparation method of the pharmaceutical composition.
The third purpose of the invention is to provide a medicinal preparation for treating facial neuritis.
The fourth purpose of the invention is to provide the pharmaceutical application of the pharmaceutical composition.
The purpose of the invention is realized by the following technical scheme.
In one aspect, the invention provides a pharmaceutical composition for treating facial neuritis, which is prepared from the following raw materials:
1.8 to 5.4 parts of schizonepeta, 1.8 to 5.4 parts of stiff silkworm, 1.8 to 5.4 parts of uncaria, 0.9 to 2.4 parts of liquorice, 1.8 to 5.4 parts of white peony root, 1.8 to 5.4 parts of divaricate saposhnikovia root, 0.3 to 1.5 parts of centipede, 1.8 to 5.4 parts of kudzu root, 1.8 to 5.4 parts of burdock, 1.8 to 5.4 parts of rehmannia, 0.9 to 2.4 parts of scorpion, 1.8 to 5.4 parts of angelica dahurica, 1.8 to 5.4 parts of peach kernel and 1.8 to 5.4 parts of scutellaria baicalensis.
The pharmaceutical composition according to the present invention is preferably prepared from the following raw materials: 2.1 to 4.5 parts of schizonepeta, 2.1 to 4.5 parts of stiff silkworm, 2.1 to 4.5 parts of uncaria, 1.2 to 2.1 parts of honey-fried licorice root, 2.1 to 4.5 parts of white peony root, 2.1 to 4.5 parts of divaricate saposhnikovia root, 0.6 to 1.2 parts of centipede, 2.1 to 4.5 parts of kudzuvine root, 2.1 to 4.5 parts of great burdock achene, 2.1 to 4.5 parts of rehmannia root, 1.2 to 2.1 parts of scorpion, 2.1 to 4.5 parts of dahurian angelica root, 2.1 to 4.5 parts of peach kernel and 2.1 to 4.5 parts of baical skullcap root.
The pharmaceutical composition according to the present invention is preferably prepared from the following raw materials:
3.6 parts of schizonepeta, 3 parts of stiff silkworm, 2.7 parts of uncaria, 1.8 parts of liquorice, 2.7 parts of white paeony root, 2.7 parts of divaricate saposhnikovia root, 0.6 part of centipede, 2.7 parts of kudzuvine root, 3.6 parts of great burdock achene, 3.6 parts of rehmannia, 1.8 parts of scorpion, 2.4 parts of angelica dahurica, 2.4 parts of peach kernel and 3 parts of baical skullcap root; or
3 parts of schizonepeta, 3 parts of stiff silkworm, 2.4 parts of uncaria, 1.8 parts of liquorice, 2.4 parts of white paeony root, 2.4 parts of divaricate saposhnikovia root, 0.6 part of centipede, 3 parts of kudzuvine root, 3.6 parts of great burdock achene, 3.6 parts of rehmannia, 1.8 parts of scorpion, 3 parts of angelica dahurica, 3 parts of peach kernel and 3 parts of baical skullcap root; or
2.7 parts of schizonepeta, 3 parts of stiff silkworm, 3 parts of uncaria, 1.8 parts of liquorice, 3 parts of white paeony root, 2.7 parts of divaricate saposhnikovia root, 0.6 part of centipede, 3 parts of kudzuvine root, 3 parts of great burdock achene, 3 parts of rehmannia, 1.8 parts of scorpion, 3 parts of dahurian angelica root, 3 parts of peach kernel and 3 parts of baical skullcap root.
In another aspect, the invention also provides a preparation method of the pharmaceutical composition.
A first preferred method of preparing a pharmaceutical composition according to the invention comprises the steps of:
(1) mixing the herba schizonepetae, the stiff silkworm, the uncaria, the liquorice, the white paeony root, the divaricate saposhnikovia root, the centipede, the kudzuvine root, the great burdock achene, the rehmannia root, the scorpion, the dahurian angelica root, the peach kernel and the baical skullcap root, and extracting by using water as a solvent to obtain an extracting solution;
(2) and concentrating, drying and crushing the extracting solution to obtain the pharmaceutical composition.
A second preferred method of preparing a pharmaceutical composition according to the invention comprises the steps of:
(1') a pulverization step: pulverizing herba Schizonepetae, radix Saposhnikoviae, Scorpio, Bombyx Batryticatus, Scolopendra, radix Angelicae Dahuricae and ramulus Uncariae cum uncis to obtain mixed medicinal powder;
(2') an extraction step: mixing the radix puerariae, the burdock, the rehmannia, the peach kernel, the radix scutellariae, the liquorice and the radix paeoniae alba to obtain a mixture, and extracting the mixture by using water as a solvent to obtain an extracting solution;
(3') a concentration step: concentrating the extracting solution to obtain a concentrated solution;
(4') a mixing step: and uniformly mixing the mixed medicinal powder and the concentrated solution, drying and crushing to obtain the medicinal composition.
In the second preferred preparation method, in the step (1'), the particle size of the mixed medicinal powder is preferably 65-100 mesh.
In the second preferred preparation method, preferably, in the step (2'), the mixture is soaked in water for 15 to 60 minutes before extraction; the extraction method is a heating reflux extraction method, the extraction times are 1-4 times, each extraction time is 0.5-2 hours, and the water addition amount is 1-8 times of the weight of the mixture.
In the second preferred preparation method, preferably, in the step (3'), the concentration temperature is 90 to 99 ℃, and the vacuum degree of concentration is-0.05 to-0.1 MPa.
In still another aspect, the present invention provides a pharmaceutical preparation for treating facial neuritis, which comprises the above pharmaceutical composition.
Preferably, the pharmaceutical formulation according to the present invention is a capsule.
In another aspect, the present invention provides the use of the above pharmaceutical composition for the preparation of a medicament for the treatment of facial neuritis.
The pharmaceutical composition has good effect on treating facial neuritis and is safe to take. The medicinal composition has moderate prescription amount and wide applicable population. In addition, the pharmaceutical composition of the invention has quick response.
Detailed Description
The present invention will be further described with reference to the following specific examples, but the scope of the present invention is not limited thereto.
< pharmaceutical composition >
The pharmaceutical composition is prepared from the following raw materials:
1.8 to 5.4 parts of schizonepeta, 1.8 to 5.4 parts of stiff silkworm, 1.8 to 5.4 parts of uncaria, 0.9 to 2.4 parts of liquorice, 1.8 to 5.4 parts of white peony root, 1.8 to 5.4 parts of divaricate saposhnikovia root, 0.3 to 1.5 parts of centipede, 1.8 to 5.4 parts of kudzu root, 1.8 to 5.4 parts of burdock, 1.8 to 5.4 parts of rehmannia, 0.9 to 2.4 parts of scorpion, 1.8 to 5.4 parts of angelica dahurica, 1.8 to 5.4 parts of peach kernel and 1.8 to 5.4 parts of scutellaria baicalensis.
In the present invention, preferably, the pharmaceutical composition is prepared from the following raw material drugs:
2.1 to 4.5 parts of schizonepeta, 2.1 to 4.5 parts of stiff silkworm, 2.1 to 4.5 parts of uncaria, 1.2 to 2.1 parts of honey-fried licorice root, 2.1 to 4.5 parts of white peony root, 2.1 to 4.5 parts of divaricate saposhnikovia root, 0.6 to 1.2 parts of centipede, 2.1 to 4.5 parts of kudzuvine root, 2.1 to 4.5 parts of great burdock achene, 2.1 to 4.5 parts of rehmannia root, 1.2 to 2.1 parts of scorpion, 2.1 to 4.5 parts of dahurian angelica root, 2.1 to 4.5 parts of peach kernel and 2.1 to 4.5 parts of baical skullcap root.
In the invention, more preferably, the pharmaceutical composition is prepared from the following raw material medicines:
3.6 parts of schizonepeta, 3 parts of stiff silkworm, 2.7 parts of uncaria, 1.8 parts of liquorice, 2.7 parts of white paeony root, 2.7 parts of divaricate saposhnikovia root, 0.6 part of centipede, 2.7 parts of kudzuvine root, 3.6 parts of great burdock achene, 3.6 parts of rehmannia, 1.8 parts of scorpion, 2.4 parts of angelica dahurica, 2.4 parts of peach kernel and 3 parts of baical skullcap root; or
3 parts of schizonepeta, 3 parts of stiff silkworm, 2.4 parts of uncaria, 1.8 parts of liquorice, 2.4 parts of white paeony root, 2.4 parts of divaricate saposhnikovia root, 0.6 part of centipede, 3 parts of kudzuvine root, 3.6 parts of great burdock achene, 3.6 parts of rehmannia, 1.8 parts of scorpion, 3 parts of angelica dahurica, 3 parts of peach kernel and 3 parts of baical skullcap root; or
2.7 parts of schizonepeta, 3 parts of stiff silkworm, 3 parts of uncaria, 1.8 parts of liquorice, 3 parts of white paeony root, 2.7 parts of divaricate saposhnikovia root, 0.6 part of centipede, 3 parts of kudzuvine root, 3 parts of great burdock achene, 3 parts of rehmannia, 1.8 parts of scorpion, 3 parts of dahurian angelica root, 3 parts of peach kernel and 3 parts of baical skullcap root.
In the invention, preferably, the licorice is prepared licorice, the white peony root is prepared radix paeoniae alba, and the rehmannia is prepared rehmannia.
In the present invention, it is preferable that the pharmaceutically active ingredient of the pharmaceutical composition is prepared from only the above-mentioned components in the weight ratio as described above. The pharmaceutically active ingredient of the pharmaceutical composition does not comprise other components.
Herba schizonepetae: 2, pungent taste; slightly bitter; mild in nature. Enter lung and liver meridians. Dispelling wind; relieving the exterior; promoting eruption; stopping bleeding. Mainly treating cold and fever; headache; itching eyes; cough; swollen and sore throat; measles; abscess and swelling; scabies and sores; bleeding; hematemesis; hematochezia; (ii) metrorrhagia and metrostaxis; postpartum anemic fainting. Can be used for treating common cold, headache, measles, rubella, and initial stage of pyocutaneous disease. Stir-baked into charcoal is indicated for hematochezia, metrorrhagia and metrostaxis and postpartum anemic fainting. Relieve exterior syndrome, dispel wind, promote eruption, eliminate sores and stop bleeding. Can be used for treating common cold, measles without adequate eruption, hematochezia, metrorrhagia, and epistaxis.
Stiff silkworm: bombyx Batryticatus, pungent in flavor and capable of dispelling wind, resolving phlegm and dredging collaterals, is usually combined with quan Xie and Bai Fu Zi. Dispel wind, arrest convulsion, resolve phlegm and dissipate nodulation. Can be used for treating convulsion, sore throat, submandibular lymphadenitis, facial paralysis, and skin pruritus.
Uncaria: clear heat and calm liver, extinguish wind and calm convulsion. Can be used for treating headache, vertigo, common cold, convulsion, epilepsy, and hypertension.
Honey-fried licorice root: radix Glycyrrhizae Preparata contains glycyrrhizin, glycyrrhetinic acid, and Glycyrrhiza polysaccharide, and has antiinflammatory, antiallergic, immunity regulating, antitumor, and analgesic effects. Therefore, the main effects of honey-fried licorice root are to harmonize the middle warmer, relieve urgency, moisten lung, remove toxicity, and harmonize the other drugs. It is commonly indicated for weakness of spleen and stomach, lassitude, palpitation and intermittent pulse, and can relieve subsidiary toxicity.
Raw white peony root: has analgesic, spasmolytic, blood stasis dispelling, and meridian dredging effects; bitter and sour in nature, slightly cold. It enters liver and spleen meridians. Nourish blood and astringe yin, soften liver and alleviate pain, pacify liver yang. Pacify liver and alleviate pain, nourish blood and regulate menstruation, astringe yin and check sweating. Can be used for treating headache, vertigo, hypochondriac pain, abdominal pain, limb spasm and pain, blood deficiency, sallow complexion, menoxenia, spontaneous perspiration, and night sweat.
Wind prevention: pungent and sweet in flavor, slightly warm in nature. It enters bladder, lung, spleen and liver meridians. Dispel wind and relieve exterior syndrome, subdue dampness and alleviate pain, stop spasm. Can be used for treating exterior syndrome due to exogenous pathogenic factor, rubella pruritus, rheumatalgia, tetanus, and spleen deficiency with excessive dampness.
Centipede: salty, pungent and warm. Is toxic. It enters liver, spleen and lung meridians. Dispel wind and relieve spasm. Can be used for treating spasm, convulsion, opisthotonus and trismus caused by acute and chronic infantile convulsion and tetanus, and has good effects of dispelling pathogenic wind and relieving spasm.
Kudzu root: expelling pathogenic factors from muscles and skin, allaying fever, promoting salivation, promoting eruption, invigorating yang, and relieving diarrhea. Can be used for treating fever, headache, neck and back pain, thirst, diabetes, and neck pain due to hypertension.
And (3) burdock: 2, pungent taste; bitter; is cold in nature. Entering the lung; the stomach meridian. Dispelling wind heat; clearing away heat and toxic materials and promoting eruption; to ventilate lung, relieve sore throat and disperse swelling.
Radix rehmanniae: sweet and cold in nature. It enters heart, liver and kidney meridians. Clear heat and cool blood, nourish yin, promote the production of body fluid. Can be used for treating fever with deep-red tongue, polydipsia, yin deficiency, internal heat, bone steaming, internal heat, diabetes, hematemesis, epistaxis, macula, and eruption.
Scorpion: pungent and mild; is toxic. It enters liver meridian. Extinguish wind and relieve spasm, counteract toxic pathogen and dissipate nodulation, dredge meridians to stop pain. Can be used for treating infantile convulsion, spasm, facial distortion due to apoplexy, hemiplegia, tetanus, rheumatism, headache, pyocutaneous disease, and lymphoid tuberculosis.
Radix angelicae: pungent and warm. Relieving exterior syndrome, dispelling cold, dispelling pathogenic wind, relieving pain, dredging nasal orifice, eliminating dampness, stopping leukorrhagia, relieving swelling, and expelling pus. It can be used for treating headache, supercilium pain, odontalgia, nasosinusitis, cold-dampness, abdominal pain, intestinal wind, hemorrhoid, leucorrhea with red and white discharge, carbuncle, skin ulcer, pruritus, scabies, and tinea.
Peach kernel: peach kernel, semen Persicae is bitter and sweet in taste and neutral in nature, can enter heart, liver and large intestine, has wide effects of promoting blood circulation and removing blood stasis, and can be used for treating various kinds of open symptoms of blood stasis. Clinically, it is good at treating internal abscess such as pulmonary abscess; each time of handling intestinal abscess is the essential herb, it has characteristic property . Much lipid and moist, it can moisten intestine and relax bowel, so it is used less often only in late clinic to moisten intestine and relax bowel.
Radix scutellariae: clear heat and dry dampness, purge fire and remove toxicity, stop bleeding, prevent abortion. Can be used for treating chest distress, nausea, damp-heat, dysentery, jaundice, cough due to lung heat, hyperpyrexia, polydipsia, hematemesis, carbuncle, swelling, sore, and threatened abortion.
The medicines are combined to treat both symptoms and root causes, and have the effects of tonifying qi and nourishing blood, promoting blood circulation to remove blood stasis, and dispelling wind and activating collaterals.
< preparation method of pharmaceutical composition >
The pharmaceutical compositions of the present invention can be prepared by a variety of methods.
According to a first preferred embodiment of the present invention, the process for the preparation of the pharmaceutical composition comprises the steps of:
(1) mixing the herba schizonepetae, the stiff silkworm, the uncaria, the liquorice, the white paeony root, the divaricate saposhnikovia root, the centipede, the kudzuvine root, the great burdock achene, the rehmannia root, the scorpion, the dahurian angelica root, the peach kernel and the baical skullcap root, and extracting by using water as a solvent to obtain an extracting solution;
(2) and concentrating, drying and crushing the extracting solution to obtain the pharmaceutical composition.
According to a second preferred embodiment of the present invention, the preparation method comprises the steps of:
(1') a pulverization step: pulverizing herba Schizonepetae, radix Saposhnikoviae, Scorpio, Bombyx Batryticatus, Scolopendra, radix Angelicae Dahuricae and ramulus Uncariae cum uncis to obtain mixed medicinal powder;
(2') an extraction step: mixing the radix puerariae, the burdock, the rehmannia, the peach kernel, the radix scutellariae, the liquorice and the radix paeoniae alba to obtain a mixture, and extracting the mixture by using water as a solvent to obtain an extracting solution;
(3') a concentration step: concentrating the extracting solution to obtain a concentrated solution;
(4') a mixing step: and uniformly mixing the mixed medicinal powder and the concentrated solution, drying and crushing to obtain the medicinal composition.
According to the preparation method of the invention, in the step (1'), the schizonepeta, the divaricate saposhnikovia root, the scorpion, the stiff silkworm, the centipede, the dahurian angelica root and the uncaria can be respectively crushed and then mixed to obtain the mixed medicinal powder; or mixing herba Schizonepetae, radix Saposhnikoviae, Scorpio, Bombyx Batryticatus, Scolopendra, radix Angelicae Dahuricae and ramulus Uncariae cum uncis, and pulverizing to obtain the mixed powder. The particle size of the mixed medicinal powder can be 65-100 meshes, preferably 70-90 meshes, and more preferably 80 meshes. When the mixed medicinal powder has the particle size, the subsequent preparation of a proper solid preparation is facilitated.
According to the preparation method of the present invention, in the step (2'), the pueraria root, the burdock, the rehmannia root, the peach kernel, the scutellaria root, the liquorice and the white paeony root can be fed in the form of decoction pieces, or can be fed after being pulverized, and there is no particular limitation. In one embodiment, the herbs are dosed in decoction pieces. Before the extraction process, the mixture can be soaked in water for 15-60 minutes, so that the medicinal materials are softened, and the subsequent extraction operation is facilitated. In the extraction step, the extraction method may be a water heating reflux extraction method or a water decoction method, and is preferably a water heating reflux extraction method. In the extraction procedure, the extraction times are 1-4 times, each extraction time is 0.5-2 hours, and the water addition amount is 1-8 times of the weight of the mixture. Preferably, in the extraction procedure, the extraction times are 2-3, each extraction time is 1-2 hours, and the water addition amount is 1-6 times of the weight of the mixture. According to a preferred embodiment of the present invention, the extraction method is a water heating reflux extraction method; the extraction times are 3, the extraction time is 1.5 hours, 1 hour and 1 hour respectively, and the water addition amount is 1-4 times of the weight of the mixture.
According to the preparation method of the invention, in the step (3'), the concentration temperature is 90-99 ℃, and preferably 95-99 ℃. The vacuum degree of concentration is-0.05 to-0.1 MPa, preferably-0.06 to-0.08 MPa. The temperature of the concentrate may be maintained above 60 c, preferably above 70 c, prior to the mixing step to prevent the concentrate from cooling and condensing, which could interfere with the subsequent mixing step.
According to the preparation method of the invention, in the step (4'), the concentrated solution and the mixed medicinal powder are uniformly mixed. Preferably, the mixing process is performed in a mixer-blender. The mixing time of the mixing process may be 20 to 45 minutes, preferably 25 to 40 minutes, so that the concentrated solution and the mixed powder are uniformly mixed. In the invention, the step of mixing the concentrated solution and the mixed medicinal powder is adopted, so that the mixed medicinal powder is favorably and uniformly dispersed in the concentrated solution, and the uniformly mixed material is easily formed. The drying step is preferably vacuum drying, and the drying temperature is preferably 60-70 ℃. The crushing step is to crush the mixture to a particle size of less than 50 meshes, preferably to a particle size of less than 60 meshes.
< preparation >
The invention also provides a pharmaceutical preparation for treating facial neuritis, which comprises the pharmaceutical composition and optionally pharmaceutically acceptable auxiliary materials. The pharmaceutical preparation may be in a form conventional in the art without limitation. Preferably, the pharmaceutical preparation is an oral dosage form, such as tablets, pills, capsules, granules, oral liquid, decoction, wine and the like. More preferably, the pharmaceutical formulation is an oral solid formulation. According to a preferred embodiment of the invention, the pharmaceutical formulation is a hard capsule.
In the present invention, the hard capsule comprises a pharmaceutical composition, which may or may not contain pharmaceutically acceptable excipients. When no auxiliary materials are contained, the pharmaceutical composition can be directly filled into a capsule shell to obtain a hard capsule. When the pharmaceutical composition contains the auxiliary materials, the pharmaceutical composition and the auxiliary materials can be uniformly mixed, and optionally, the mixture is granulated and filled into a capsule shell to obtain a hard capsule.
< pharmaceutical use >
The pharmaceutical composition can effectively treat facial neuritis, and therefore, the invention provides the application of the pharmaceutical composition in preparing a medicine for treating facial neuritis.
The embodiments of the present invention will be specifically described below with reference to specific examples.
Example 1
3.6kg of schizonepeta, 3kg of stiff silkworm, 2.7kg of uncaria, 1.8kg of honey-fried licorice root, 2.7kg of raw white paeony root, 2.7kg of divaricate saposhnikovia root, 0.6kg of centipede, 2.7kg of kudzuvine root, 3.6kg of great burdock achene, 3.6kg of rehmannia root, 1.8kg of scorpion, 2.4kg of dahurian angelica root, 2.4kg of peach kernel and 3kg of baical skullcap root, and the pharmaceutical composition is prepared by adopting the following method:
(1) mixing the herba schizonepetae, the stiff silkworm, the uncaria, the honey-fried licorice root, the raw white paeony root, the divaricate saposhnikovia root, the centipede, the kudzuvine root, the great burdock achene, the raw rehmannia root, the scorpion, the angelica dahurica, the peach kernel and the baical skullcap root, extracting for 3 times by using water as a solvent, wherein the water amount is 10 times, 10 times and 8 times of the total weight of the medicinal materials in sequence, and the extraction time is 1.5h, 1 h;
(2) and concentrating, drying and crushing the extracting solution to obtain the pharmaceutical composition.
Example 2
Taking 3kg of schizonepeta, 3kg of stiff silkworm, 2.4kg of uncaria, 1.8kg of honey-fried licorice root, 2.4kg of raw white paeony root, 2.4kg of divaricate saposhnikovia root, 0.6kg of centipede, 3kg of kudzuvine root, 3.6kg of great burdock achene, 3.6kg of rehmannia root, 1.8kg of scorpion, 3kg of dahurian angelica root, 3kg of peach kernel and 3kg of baical skullcap root, and preparing the pharmaceutical composition by adopting the following steps:
(1') a pulverization step: respectively crushing the schizonepeta, the divaricate saposhnikovia root, the scorpion, the stiff silkworm, the centipede, the dahurian angelica root and the uncaria into 80 meshes, and uniformly mixing to obtain mixed medicinal powder;
(2') an extraction step: mixing the kudzu root, the burdock, the radix rehmanniae, the peach kernel, the scutellaria baicalensis, the honey-fried licorice root and the raw white paeony root to obtain a mixture, soaking the mixture in water for 30 minutes, then adding water as a solvent, heating and refluxing for 2 times, wherein the water adding amount is 70kg and 70kg in sequence, and the extraction time is 2 hours and 2 hours in sequence to obtain an extracting solution;
(3') a concentration step: concentrating the extracting solution at 99 ℃ and under the vacuum degree of-0.07 MPa to obtain a concentrated solution, and keeping the temperature of the concentrated solution above 70 ℃;
(4') a mixing step: and (3) mixing the mixed medicinal powder and the concentrated solution in a mixing stirrer for 30 minutes, drying at 65 ℃, crushing, and sieving by a 60-mesh sieve to obtain the pharmaceutical composition.
Example 3
Taking 2.7kg of schizonepeta, 3kg of stiff silkworm, 3kg of uncaria, 1.8kg of honey-fried licorice root, 3kg of raw white paeony root, 2.7kg of divaricate saposhnikovia root, 0.6kg of centipede, 3kg of kudzuvine root, 3kg of great burdock achene, 3kg of rehmannia root, 1.8kg of scorpion, 3kg of dahurian angelica root, 3kg of peach kernel and 3kg of baical skullcap root, and preparing the pharmaceutical composition by adopting the following steps:
(1') a pulverization step: respectively crushing the schizonepeta, the divaricate saposhnikovia root, the scorpion, the stiff silkworm, the centipede, the dahurian angelica root and the uncaria into 80 meshes, and uniformly mixing to obtain mixed medicinal powder;
(2') an extraction step: mixing the kudzu root, the burdock, the radix rehmanniae, the peach kernel, the scutellaria baicalensis, the honey-fried licorice root and the raw white paeony root to obtain a mixture, soaking the mixture in water for 40 minutes, then adding water as a solvent, heating and refluxing for extraction for 3 times, wherein the water addition amount is 70kg, 60kg and 60kg in sequence, and the extraction time is 1.5 hours, 1.2 hours and 1 hour in sequence to obtain an extracting solution;
(3') a concentration step: concentrating the extracting solution at 99 ℃ and under the vacuum degree of-0.07 MPa to obtain a concentrated solution, and keeping the temperature of the concentrated solution above 70 ℃;
(4') a mixing step: and (3) mixing the mixed medicinal powder and the concentrated solution in a mixing stirrer for 35 minutes, drying at 65 ℃, crushing, and sieving by a 60-mesh sieve to obtain the pharmaceutical composition.
Example 4
The pharmaceutical composition of example 3 was placed in a pharmaceutical capsule filling machine for sub-packaging, and the sub-packaged capsules were polished in a polishing machine to obtain hard capsules with a specification of 0.3 g/capsule.
Experimental example 1
1. Observation object
1.1 case origin: 200 patients with simple facial paralysis as the main symptom in neurology department of central hospitals in Baotou city are continuously selected.
1.2 case entry criteria: patients with facial paralysis as the main symptom are selected, the diagnosis standard accords with 'Chinese idiopathic facial paralysis diagnosis and treatment guideline 2016', the age range is 18-80 years, and the attack time is within 72 hours.
1.3 case exclusion criteria: patients with facial paralysis due to cerebral infarction; severe dysfunction of other organs, such as acute myocardial infarction, heart failure, liver and kidney failure, severe infection, blood coagulation dysfunction, etc.; patients who cannot be co-treated and followed up; children and pregnant women; excluding facial paralysis caused by other reasons, such as tumor and Guillain-Barre syndrome.
2. Method of producing a composite material
2.1 grouping method: random control experimental design was used. The cases were divided into treatment groups and control groups using a random number table, and there was no significant difference between the two groups in terms of gender, age, and course of disease.
2.2 methods of treatment: the control group adopts basic treatment, hormone, vitamin B, physical therapy, antiviral treatment, etc.; the treatment group took the hard capsules of example 4 3 capsules 3 times daily on a basal regimen. 21 days is a course of treatment.
2.3 method for determining therapeutic effect and safety
2.3.1 therapeutic criteria: and (3) curing: the symptoms and physical signs basically disappear, eyelids are completely closed, the mouth is not obviously inclined, facial muscles basically move freely, and the examination function of a nervous system basically returns to normal; the method has the following advantages: symptoms and physical signs are improved to a certain extent, eyelids can not be completely closed, mouth is still slightly crooked, facial muscles are improved, and the recovery of nervous system examination function is poor; and (4) invalidation: symptoms and signs are not improved, and the examination function of the nervous system is not recovered.
2.3.2 method for evaluating safety of medication: before treatment, after 21 days of treatment, the safety of the medicine is tested and evaluated by testing and evaluating the liver and kidney functions, the hematuria routine, the electrocardiogram and the like of the patient.
2.4 statistical methods
Data were analyzed using SPSS15.0 statistical software. The measurement data is tested by t, and the counting data is expressed by mean +/-standard deviation. P <0.05 indicates statistical significance.
3. Results
The therapeutic effects of the two groups of patients are compared and shown in Table 1
TABLE 1 comparison of the treatment efficacy of two groups of patients
| Group of | Number of examples | Cure of disease | Is effective | Invalidation |
| Treatment group | 100 | 47 | 45 | 8 |
| Control group | 100 | 30 | 42 | 28 |
As can be seen from the table 1, the cure rate of the treatment group is 47%, and the total effective rate is 92%; the cure rate of the control group is 30 percent, the total effective rate is 72 percent, and the comparison difference of the two groups has statistical significance. The effect of the treatment group is better than that of the control group.
3.2 Observation of adverse events
The related physiological indexes of the two groups of patients after 21 days of treatment are analyzed, and no obvious abnormality is found, so that the medicine composition is safe to take.
4. Conclusion
The pharmaceutical composition can improve and cure facial neuritis, and has a definite curative effect; and the physiological index abnormality is not detected in the treatment process, so the medicine is safe to take. The pharmaceutical composition can effectively cure and improve facial neuritis symptoms, and is safe and effective.
The present invention is not limited to the above-described embodiments, and any variations, modifications, and substitutions which may occur to those skilled in the art may be made without departing from the spirit of the invention.
Claims (6)
1. The preparation method of the pharmaceutical composition for treating facial neuritis is characterized in that the pharmaceutical composition is prepared from the following raw material medicines:
2.7 parts of schizonepeta, 3 parts of stiff silkworm, 3 parts of uncaria, 1.8 parts of liquorice, 3 parts of white paeony root, 2.7 parts of divaricate saposhnikovia root, 0.6 part of centipede, 3 parts of kudzuvine root, 3 parts of great burdock achene, 3 parts of rehmannia, 1.8 parts of scorpion, 3 parts of dahurian angelica root, 3 parts of peach kernel and 3 parts of baical skullcap root;
the preparation method of the pharmaceutical composition comprises the following steps:
(1') a pulverization step: pulverizing herba Schizonepetae, radix Saposhnikoviae, Scorpio, Bombyx Batryticatus, Scolopendra, radix Angelicae Dahuricae and ramulus Uncariae cum uncis to obtain mixed medicinal powder;
(2') an extraction step: mixing the radix puerariae, the burdock, the rehmannia, the peach kernel, the radix scutellariae, the liquorice and the radix paeoniae alba to obtain a mixture, and extracting the mixture by using water as a solvent to obtain an extracting solution;
(3') a concentration step: concentrating the extracting solution to obtain a concentrated solution;
(4') a mixing step: and uniformly mixing the mixed medicinal powder and the concentrated solution, drying and crushing to obtain the medicinal composition.
2. The method according to claim 1, wherein in the step (1'), the particle size of the mixed medicinal powder is 65-100 mesh.
3. The method according to claim 1, wherein in the step (2'), the mixture is soaked in water for 15 to 60 minutes before the extraction; the extraction method is a heating reflux extraction method, the extraction times are 1-4 times, each extraction time is 0.5-2 hours, and the water addition amount is 1-8 times of the weight of the mixture.
4. The process according to claim 1, wherein in the step (3'), the concentration temperature is 90 to 99 ℃ and the vacuum degree of concentration is-0.05 to-0.1 MPa.
5. A pharmaceutical preparation for use in the treatment of facial neuritis, comprising a pharmaceutical composition prepared according to the method of any one of claims 1 to 4.
6. Use of a pharmaceutical composition prepared according to the process of any one of claims 1 to 4 for the preparation of a medicament for the treatment of facial neuritis.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101987148A (en) * | 2009-07-31 | 2011-03-23 | 天津市公博科技开发有限公司 | Chinese herbal medicine prescription for treating facial neuritis and preparation method thereof |
| JP2014133749A (en) * | 2014-04-03 | 2014-07-24 | Pola Chem Ind Inc | Autonomic nerve activator |
| CN104383173A (en) * | 2014-12-09 | 2015-03-04 | 任丰霞 | Traditional Chinese medicine decoction for treating facial paralysis |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101987148A (en) * | 2009-07-31 | 2011-03-23 | 天津市公博科技开发有限公司 | Chinese herbal medicine prescription for treating facial neuritis and preparation method thereof |
| JP2014133749A (en) * | 2014-04-03 | 2014-07-24 | Pola Chem Ind Inc | Autonomic nerve activator |
| CN104383173A (en) * | 2014-12-09 | 2015-03-04 | 任丰霞 | Traditional Chinese medicine decoction for treating facial paralysis |
Non-Patent Citations (1)
| Title |
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| 中西医结合治疗对急性面神经炎面肌功能恢复的观察(附53例分析);苏西云等;《现代康复》;19981231;第2卷(第05期);第495页 * |
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Effective date of registration: 20210930 Address after: 014040 Department of Neurology, Baotou Central Hospital, 61 Huancheng Road, Donghe District, Baotou City, Inner Mongolia Autonomous Region Patentee after: Liu Guorong Patentee after: Li Yuechun Patentee after: Wang Baojun Address before: 014040 Department of Neurology, Baotou Central Hospital, 61 Huancheng Road, Donghe District, Baotou City, Inner Mongolia Autonomous Region Patentee before: Wang Baojun |