CN104645054A - Traditional Chinese medicine preparation for treating facioplegia and preparation process thereof - Google Patents

Abstract

The invention discloses a traditional Chinese medicine preparation for treating facioplegia, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine preparation is prepared from such medicinal materials as cinnamon, rhizome chuanxiong, angelica, centipedes, cicada slough, uncaria, scorpion, leeches, apiary, bulbus fritillariae cirrhosae, bighead atractylodes rhizome, astragalus, rhizoma bletillae, rhizoma coptidis, longicorn, divaricate saposhnikovia root, earthworms, licorice, etc. The traditional Chinese medicine preparation disclosed by the invention is not only good in remarkable curative effect on facioplegia, but also stable in preparation process, small in individual difference of preparation efficacy, simple, easy and feasible in preparation method and equipment, and is easy to promote and apply.

Description

One treats prosopoplegic Chinese medicine preparation and preparation technology thereof

Technical field

The invention belongs to tcm field, relate to one and treat prosopoplegic Chinese medicine preparation and preparation technology thereof.

Technical background

Facial paralysis (facial neuritis, Bell's palsy are commonly called as " facial paralysis ", " wapperijaw bar ", " facial paralysis ") is a kind of commonly encountered diseases that is principal character with facial expression muscle group dyskinesia.General symptom is facial hemiparalysis.It is a kind of commonly encountered diseases, frequently-occurring disease, and it is not by age limit.Patient is often the most basic to lift the actions such as eyebrow, eye closing, drum mouth and all cannot complete.

Facial paralysis is the peripheral facial paralysis (abbreviation facial paralysis) because facial neuritis causes.Be principal character with facial hemiparalysis clinically, mostly be Unilateral, it is few that bilateral is fallen ill simultaneously.Onset is anxious, and sick side surface part histrionic muscles paralysis, forehead line disappears, and eyebrow is sagging, blepharodiastasis, and nasolabial fold is smooth, ptosis of labial angle, and face is led to strong side.Primary disease is commonly encountered diseases, the frequently-occurring disease of Neurological Clinics, and any age all can fall ill, but the most common with 20-40 year.Any season all can fall ill.Facial paralysis the lighter, and treat in time, prognosis is better; The facial paralysis persistent period is longer, and prognosis is poorer.The facial paralysis traditional Chinese medical science claims " facial paralysis ", " mouth is out-of-the-way " etc., belongs to " apoplexy " category.

It is relatively empty in interior that the prosopoplegic cause of disease is mainly " healthy energy ", caused by the heresy invasion and attack that Head And Face is had a cold, causes muscle arteries and veins to lose and support and cause primary disease.

Pathological change is patient when tired and physically-draining, and healthy energy is relatively empty in interior, and venation is hollow, the heresy invasion and attack that Head And Face is had a cold, and causes blockage of meridian, and QI and blood numbness resistance meridians, the mistake of muscle arteries and veins is foster, and sees all diseases of facial hemiparalysis.The traditional Chinese medical science is to prosopoplegic differentiation of symptoms and signs for classification of syndrome:

1, ailment said due to cold or exposure enters network type: often after night has a cold or is subject to humidity, morning next day rises and namely finds facial paralysis, facial hemiparalysis, or has headache, white and thin fur, floating pulse.Syndrome analysis: healthy energy relative deficiency, venation is hollow, the heresy be affected by the cold, invasion and attack women's head-ornaments, and muscle BI-syndrome involved the blood vessels hinders, therefore facial paralysis is do, facial hemiparalysis; The evil external beam of wind and cold, therefore headache, white and thin fur, floating pulse.The rule for the treatment of: expelling wind and activating blood circulation, and battalion's dredging collateral.

2, QIXUELIANGXU type: facial hemiparalysis, with the passing of time not multiple, dizzy weak, poor appetite anorexia, cardiopalmus dim eyesight, thin fur, thready pulse.

Syndrome analysis: positive QI-insufficiency, after the heresy be affected by the cold, blockage of meridian, the resistance of QI and blood numbness is unfavorable, and muscle arteries and veins loses supports, therefore facial hemiparalysis, with the passing of time not multiple; Sick not multiple for a long time, cause QI and blood deficiency, therefore dizzy weak dim eyesight; Blood failing to tonify the heart, therefore cardiopalmus battle array is done; The unstrong fortune of board, then poor appetite anorexia; Thin fur, thready pulse is levying of insufficiency of vital energy and blood.The rule for the treatment of: benefiting vital QI and blood, dispelling wind and removing obstruction in the collateral.

3, obstruction by phlegm type: facial hemiparalysis, headache, numb limbs and tense tendons, dizzy, spiritlessness and weakness, indigestion and loss of appetite.Body of the tongue is dim, greasy and thin fur, thready and rolling pulse or carefully puckery.

Syndrome analysis: insufficiency of vital energy and blood, venation is hollow, evil people's network of wind and cold, folder expectorant folder arthralgia due to blood stasis resistance meridians, therefore facial hemiparalysis and cause facial paralysis; Obstruction of collaterals by blood stasis, clear key is unfavorable, therefore headache limb fiber crops; Insufficiency of vital energy and blood, thus dizzy, spiritlessness and weakness; Strong fortune mistake department dam u is indigestion and loss of appetite; Body of the tongue is dim, greasy and thin fur, thready and rolling pulse or carefully puckery be blood stagnancy due to deficiency of QI, resembling of obstruction by phlegm.The rule for the treatment of: benefiting QI for activating blood circulation, disease of dispelling dredging collateral.

Summary of the invention

The technical problem to be solved in the present invention is a kind of Chinese medicine facial paralysis being had to better therapeutic effect of invention, and this Chinese medicine will adapt to the demand of modern clinic.

For solving the problems of the technologies described above, inventor is according to traditional Chinese medicine theory and oneself experience of practising medicine for many years, again compatibility medical material, invent a brand-new Chinese prescription, and with reference to modern pharmaceutical technology and preparation process, the consumption of each medical material of further adjustment prescription, makes finished product preparation when ensureing drug effect by Chinese prescription, said preparation treatment facial paralysis Be very effective.The Chinese prescription of final formation is (with parts by weight):

Cortex Cinnamomi 7-17 part, Rhizoma Chuanxiong 9-21 part, Radix Angelicae Sinensis 10-22 part, Scolopendra 5-8 part, Periostracum Cicadae 9-19 part, Ramulus Uncariae Cum Uncis 11-23 part, Scorpio 5-9 part, Hirudo 4-7 part, Nidus Vespae 3-6 part, Bulbus Fritillariae Cirrhosae 8-20 part, Rhizoma Atractylodis Macrocephalae 12-24 part, Radix Astragali 12-26 part, Pseudobulbus Bletillae (Rhizoma Bletillae) 8-18 part, Rhizoma Coptidis 13-27 part, Anoplophorae seu Aprionae 5-9 part, Radix Saposhnikoviae 10-20 part, Pheretima 11-23 part, Radix Glycyrrhizae 8-14 part.

In practice process, preferred two proportionings with optimum therapeuticing effect are out:

Preferably 1: Cortex Cinnamomi 12 parts, Rhizoma Chuanxiong 15 parts, Radix Angelicae Sinensis 16 parts, Scolopendra 6 parts, Periostracum Cicadae 14 parts, Ramulus Uncariae Cum Uncis 17 parts, Scorpio 7 parts, Hirudo 5 parts, 5 parts, Nidus Vespae, Bulbus Fritillariae Cirrhosae 14 parts, the Rhizoma Atractylodis Macrocephalae 18 parts, the Radix Astragali 19 parts, Pseudobulbus Bletillae (Rhizoma Bletillae) 13 parts, Rhizoma Coptidis 20 parts, Anoplophorae seu Aprionae 7 parts, Radix Saposhnikoviae 15 parts, Pheretima 17 parts, 11 parts, Radix Glycyrrhizae.

Preferably 2: Cortex Cinnamomi 13 parts, Rhizoma Chuanxiong 17 parts, Radix Angelicae Sinensis 17 parts, Scolopendra 5 parts, Periostracum Cicadae 15 parts, Ramulus Uncariae Cum Uncis 18 parts, Scorpio 6 parts, Hirudo 5 parts, 4 parts, Nidus Vespae, Bulbus Fritillariae Cirrhosae 13 parts, the Rhizoma Atractylodis Macrocephalae 17 parts, the Radix Astragali 18 parts, Pseudobulbus Bletillae (Rhizoma Bletillae) 14 parts, Rhizoma Coptidis 22 parts, Anoplophorae seu Aprionae 8 parts, Radix Saposhnikoviae 16 parts, Pheretima 18 parts, 12 parts, Radix Glycyrrhizae.

The preparation technology of Chinese medicine preparation of the present invention is following steps:

(1) take the ingredientss such as Cortex Cinnamomi, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Scolopendra, Periostracum Cicadae, Ramulus Uncariae Cum Uncis, Scorpio, Hirudo, Nidus Vespae, Bulbus Fritillariae Cirrhosae, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Pseudobulbus Bletillae (Rhizoma Bletillae), Rhizoma Coptidis, Anoplophorae seu Aprionae, Radix Saposhnikoviae, Pheretima, Radix Glycyrrhizae respectively by Chinese prescription, pulverize respectively, for subsequent use;

(2) medical materials such as Cortex Cinnamomi, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Uncariae Cum Uncis, Bulbus Fritillariae Cirrhosae, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Pseudobulbus Bletillae (Rhizoma Bletillae), Rhizoma Coptidis, Radix Saposhnikoviae, Radix Glycyrrhizae are added the distilled water of initial medical material 6-12 times weight, soak 12-24 hour, backflow decocts 1-5 hour, filter, add the purified water of initial weight 4-9 times weight again, backflow decocts 1-3 hour, filters and retains filtering residue, merging filtrate, being concentrated into 65 DEG C of relative densities is that the concentrated solution of 1.15-1.20 is for subsequent use;

(3) filtering residue of the medical materials such as Scolopendra, Periostracum Cicadae, Scorpio, Hirudo, Nidus Vespae, Anoplophorae seu Aprionae, Pheretima and step (2) is mixed, add the ethanol of the concentration 55-80% of 5-8 times of weight, reflux, extract, 2 times, each 2-6 hour, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 65 DEG C of relative densities be that the concentrated solution of 1.20-1.25 is for subsequent use;

(4) merged by the concentrated solution of step (2) and (3) gained, continuing to be concentrated into 65 DEG C of relative densities is the Chinese medical concrete of 1.28-1.33, for subsequent use;

(5) suitable adjuvant is added, the Chinese medical concrete utilizing modern general Chinese medicine preparation technology step (4) to be obtained, makes finished dosage forms dosage forms such as () such as pill, tablet, capsule, granule, syrup, ointment, patch, powder, tinctures of clinical needs.

Source, the nature and flavor of Chinese crude drug involved in Chinese prescription of the present invention, return through and special efficacy:

Cortex Cinnamomi: this product is the dry bark of canella Cortex Cinnamomi.Acrid in the mouth, sweet, extremely hot in nature; Return kidney, spleen, the heart, Liver Channel; Mend fire supporing yang, let the fire back to its origin, dispersing cold for relieving pain, promoting blood circulation to restore menstrual flow.

Rhizoma Chuanxiong: this product is the dry rhizome of samphire Rhizoma Chuanxiong.Acrid in the mouth, warm in nature; Return liver, gallbladder, pericardium channel; Blood-activating and qi-promoting, wind-expelling pain-stopping.

Radix Angelicae Sinensis: this product is the dry root of umbelliferae angelica.Sweet in the mouth, pungent, warm in nature; Return liver, the heart, spleen channel; Enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.

Scolopendra: this product is the dry body of Scolopendridae animal Scolopendpa Subspinipes Mutilans L. KOCH.Acrid in the mouth, warm in nature; Return Liver Channel; Endogenous wind stopping spasmolytic, merit poison eliminating stagnation, removing obstruction in the collateral to relieve pain.

Periostracum Cicadae: exuviae shell when this product is the larva emergence of cicada Cryptotympana atrata Fabr..Sweet in the mouth, cold in nature; Return lung, Liver Channel; Loose wind heat extraction, sore-throat relieving, rash, nebula removing, spasmolytic.

Ramulus Uncariae Cum Uncis: this product is the dry stem and branch with belt hook of Maguireothamnus speciosus Ramulus Uncariae Cum Uncis, Ramulus Uncariae macrophyllae, Ramulus Uncariae Cum Uncis, Uncaria sinensis (Oliv.) Havil. or stockless fruit Ramulus Uncariae Cum Uncis.Sweet in the mouth, cool in nature; Return liver, pericardium channel; Heat clearing away suppressing the hyperactive liver, dispelling wind and relieving convulsion.

Scorpio: this product is the dry body of Buthidae animal Scorpio.Acrid in the mouth, property is put down; Return Liver Channel; Endogenous wind stopping spasmolytic, dispersing pathogen accumulation, removing obstruction in the collateral to relieve pain.

Hirudo: this product is the dry body of Hirudinidae animal whitmania, Hirudo or Folium Salicis Babylonicae Hirudo.Salty in the mouth, hardship, property is put down; Return Liver Channel; Removing blood stasis, removing blood stasis, stimulates the menstrual flow.

Nidus Vespae: this product is the nest of Vespidae insecticide fruit hornet, Japanese long foot wasp or different abdomen wasp.Sweet in the mouth, property is put down; Return stomach warp; Dispel the wind, merit poison, parasite killing, pain relieving.

Bulbus Fritillariae Cirrhosae: this product is the dry bulb of liliaceous plant Bulbus Fritillariae Cirrhosae, Fritillaria unibracteata, Gansu Bulbus Fritillariae Uninbracteatae or Bulbus Fritillariae cirrhosae.Bitter in the mouth, sweet, cold nature; Return lung, heart channel; Clearing heat and moistening lung, preventing phlegm from forming and stopping coughing.

The Rhizoma Atractylodis Macrocephalae: this product is the dry rhizome of the feverfew Rhizoma Atractylodis Macrocephalae.Bitter in the mouth, sweet, warm in nature; Return spleen, stomach warp; Invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive.

The Radix Astragali: this product is the dry root of leguminous plant Radix Astagali or Radix Astragali.Sweet in the mouth, warm in nature; Return lung, spleen channel; Invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.

Pseudobulbus Bletillae (Rhizoma Bletillae): this product is the dry tuber of orchid Pseudobulbus Bletillae (Rhizoma Bletillae).Bitter in the mouth, sweet, puckery, cold nature; Return lung, liver, stomach warp; Astringing to arrest bleeding, detumescence and promoting granulation.

Rhizoma Coptidis: this product is the dry rhizome of ranunculaceae plant Rhizoma Coptidis, Coptis deltoidea C.Y.Cheng et Hsiao or Coptis Teeta Wall.Bitter in the mouth, cold in nature; GUIXIN, spleen, stomach, liver, gallbladder, large intestine channel; Heat clearing and damp drying, eliminating fire and detoxication.

Anoplophorae seu Aprionae: be the Scorpio of Cerambycidae longicorn beetle, mulberry borer or other nearly edge insecticides.Sweet in the mouth; Warm in nature; GUIXIN; Spleen channel; Promoting blood circulation to restore menstrual flow, eliminating stasis to stop pain; Removing toxic substances and promoting subsidence of swelling.

Radix Saposhnikoviae: this product is the dry root of umbelliferae Saposhnikovia divaricata.Acrid in the mouth, sweet, warm in nature; Return bladder, liver, spleen channel; Inducing diaphoresis to dispel wind, victory is wet, relieving convulsion.

Pheretima: this product is the dry body of Ju Yin section animal Pheretima aspergillum, popular Pheretimatschiliensis, power simulation or the blind Pheretimatschiliensis of comb.Salty in the mouth, cold in nature; Return liver, spleen, urinary bladder channel; Heat clearing away is calmed the frightened, and dredging collateral, relievings asthma, diuresis.

Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume, Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L..Sweet in the mouth, property is put down; GUIXIN, lung, spleen, stomach warp; Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.

The prescription analysis of Chinese medicine preparation of the present invention Chinese prescription used:

This prescription is with the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Rhizoma Coptidis, Ramulus Uncariae Cum Uncis, Pheretima for monarch drug, and dampness diuretic, diuresis poison holding, eliminating fire and detoxication, dispelling wind and relieving convulsion, dredging collateral are relievingd asthma; With Radix Angelicae Sinensis, Rhizoma Chuanxiong, Periostracum Cicadae, Radix Saposhnikoviae, Pseudobulbus Bletillae (Rhizoma Bletillae) for ministerial drug, menstruction regulating and pain relieving, circulation of qi promoting of dispeling the wind, rash spasmolytic, inducing diaphoresis to dispel wind, detumescence and promoting granulation; With Scolopendra, Scorpio, Hirudo, Anoplophorae seu Aprionae for adjuvant drug, removing obstruction in the collateral to relieve pain, dispersing pathogen accumulation, eliminating blood stasis and inducing menstruation, removing toxic substances and promoting subsidence of swelling; With Cortex Cinnamomi, Nidus Vespae, Bulbus Fritillariae Cirrhosae for making medicine, let the fire back to its origin, merit of dispeling the wind poison, clearing heat and moistening lung; With Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, make all medicine synergism, negative and positive each other, jointly reach the effects such as eliminating fire and detoxication, dispelling wind and relieving convulsion, inducing diaphoresis to dispel wind, removing obstruction in the collateral to relieve pain, dispersing pathogen accumulation, to facial paralysis, there is very significant therapeutic effect.

Compared with prior art, Chinese medicine preparation of the present invention has following technical advantage:

1, instant effect, therapeutic effect is good, not easily recurs, and has no side effect, and conditioning combines with treatment;

2, little, the formulation method of invention formulation process stabilizing, preparation drug effect individual variation and simple equipments easy, be easy to apply.

Detailed description of the invention

Embodiment 1

Granule is produced in the ratio of the preferred prescription proportioning 1 of the present invention and the optimal procedure parameters of invention formulation process:

(1) Cortex Cinnamomi 1200g, Rhizoma Chuanxiong 1500g, Radix Angelicae Sinensis 1600g, Scolopendra 600g, Periostracum Cicadae 1400g, Ramulus Uncariae Cum Uncis 1700g, Scorpio 700g, Hirudo 500g, Nidus Vespae 500g, Bulbus Fritillariae Cirrhosae 1400g, Rhizoma Atractylodis Macrocephalae 1800g, Radix Astragali 1900g, Pseudobulbus Bletillae (Rhizoma Bletillae) 1300g, Rhizoma Coptidis 2000g, Anoplophorae seu Aprionae 700g, Radix Saposhnikoviae 1500g, Pheretima 1700g, Radix Glycyrrhizae 1100g is taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

(2) medical materials such as Cortex Cinnamomi, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Uncariae Cum Uncis, Bulbus Fritillariae Cirrhosae, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Pseudobulbus Bletillae (Rhizoma Bletillae), Rhizoma Coptidis, Radix Saposhnikoviae, Radix Glycyrrhizae are added the distilled water of initial medical material 9 times of weight, soak 16 hours, backflow decoction 2 hours, filter, add the purified water of initial weight 6 times of weight again, backflow decoction 2 hours, filters and retains filtering residue, merging filtrate, being concentrated into 65 DEG C of relative densities is that the concentrated solution of 1.15-1.20 is for subsequent use;

(3) filtering residue of the medical materials such as Scolopendra, Periostracum Cicadae, Scorpio, Hirudo, Nidus Vespae, Anoplophorae seu Aprionae, Pheretima and step (2) is mixed, add the ethanol of the concentration 70% of 7 times of weight, reflux, extract, 2 times, each 3 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 65 DEG C of relative densities be that the concentrated solution of 1.20-1.25 is for subsequent use;

(4) merged by the concentrated solution of step (2) and (3) gained, continuing to be concentrated into 65 DEG C of relative densities is the Chinese medical concrete of 1.28-1.33, for subsequent use;

(5) add suitable adjuvant, utilize the Chinese medical concrete that step (4) obtains by modern general Chinese medicine preparation technology, make granule, specification is: amount to 0.5g crude drug/g granule.

Embodiment 2

Granule is produced in the ratio of the preferred prescription proportioning 2 of the present invention and the optimal procedure parameters of invention formulation process:

(1) Cortex Cinnamomi 1300g, Rhizoma Chuanxiong 1700g, Radix Angelicae Sinensis 1700g, Scolopendra 500g, Periostracum Cicadae 1500g, Ramulus Uncariae Cum Uncis 1800g, Scorpio 600g, Hirudo 500g, Nidus Vespae 400g, Bulbus Fritillariae Cirrhosae 1300g, Rhizoma Atractylodis Macrocephalae 1700g, Radix Astragali 1800g, Pseudobulbus Bletillae (Rhizoma Bletillae) 1400g, Rhizoma Coptidis 2200g, Anoplophorae seu Aprionae 800g, Radix Saposhnikoviae 1600g, Pheretima 1800g, Radix Glycyrrhizae 1200g is taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

(2) medical materials such as Cortex Cinnamomi, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Uncariae Cum Uncis, Bulbus Fritillariae Cirrhosae, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Pseudobulbus Bletillae (Rhizoma Bletillae), Rhizoma Coptidis, Radix Saposhnikoviae, Radix Glycyrrhizae are added the distilled water of initial medical material 9 times of weight, soak 16 hours, backflow decoction 2 hours, filter, add the purified water of initial weight 6 times of weight again, backflow decoction 2 hours, filters and retains filtering residue, merging filtrate, being concentrated into 65 DEG C of relative densities is that the concentrated solution of 1.15-1.20 is for subsequent use;

(3) filtering residue of the medical materials such as Scolopendra, Periostracum Cicadae, Scorpio, Hirudo, Nidus Vespae, Anoplophorae seu Aprionae, Pheretima and step (2) is mixed, add the ethanol of the concentration 70% of 7 times of weight, reflux, extract, 2 times, each 3 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 65 DEG C of relative densities be that the concentrated solution of 1.20-1.25 is for subsequent use;

(4) merged by the concentrated solution of step (2) and (3) gained, continuing to be concentrated into 65 DEG C of relative densities is the Chinese medical concrete of 1.28-1.33, for subsequent use;

(5) add suitable adjuvant, utilize the Chinese medical concrete that step (4) obtains by modern general Chinese medicine preparation technology, make granule, specification is: amount to 0.5g crude drug/g granule.

Embodiment 3

Granule is produced by the minimum scale of Chinese prescription scope of the present invention and the optimized parameter of invention formulation process:

(1) Cortex Cinnamomi 700g, Rhizoma Chuanxiong 900g, Radix Angelicae Sinensis 1000g, Scolopendra 500g, Periostracum Cicadae 900g, Ramulus Uncariae Cum Uncis 1100g, Scorpio 500g, Hirudo 400g, Nidus Vespae 300g, Bulbus Fritillariae Cirrhosae 800g, Rhizoma Atractylodis Macrocephalae 1200g, Radix Astragali 1200g, Pseudobulbus Bletillae (Rhizoma Bletillae) 800g, Rhizoma Coptidis 1300g, Anoplophorae seu Aprionae 500g, Radix Saposhnikoviae 1000g, Pheretima 1100g, Radix Glycyrrhizae 800g is taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

(2) medical materials such as Cortex Cinnamomi, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Uncariae Cum Uncis, Bulbus Fritillariae Cirrhosae, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Pseudobulbus Bletillae (Rhizoma Bletillae), Rhizoma Coptidis, Radix Saposhnikoviae, Radix Glycyrrhizae are added the distilled water of initial medical material 9 times of weight, soak 16 hours, backflow decoction 2 hours, filter, add the purified water of initial weight 6 times of weight again, backflow decoction 2 hours, filters and retains filtering residue, merging filtrate, being concentrated into 65 DEG C of relative densities is that the concentrated solution of 1.15-1.20 is for subsequent use;

(3) filtering residue of the medical materials such as Scolopendra, Periostracum Cicadae, Scorpio, Hirudo, Nidus Vespae, Anoplophorae seu Aprionae, Pheretima and step (2) is mixed, add the ethanol of the concentration 70% of 7 times of weight, reflux, extract, 2 times, each 3 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 65 DEG C of relative densities be that the concentrated solution of 1.20-1.25 is for subsequent use;

(4) merged by the concentrated solution of step (2) and (3) gained, continuing to be concentrated into 65 DEG C of relative densities is the Chinese medical concrete of 1.28-1.33, for subsequent use;

(5) add suitable adjuvant, utilize the Chinese medical concrete that step (4) obtains by modern general Chinese medicine preparation technology, make granule, specification is: amount to 0.5g crude drug/g granule.

Embodiment 4

Granule is produced by the maximum ratio of Chinese prescription scope of the present invention and the optimal procedure parameters of invention formulation process:

(1) Cortex Cinnamomi 1700g, Rhizoma Chuanxiong 2100g, Radix Angelicae Sinensis 2200g, Scolopendra 800g, Periostracum Cicadae 1900g, Ramulus Uncariae Cum Uncis 2300g, Scorpio 900g, Hirudo 700g, Nidus Vespae 600g, Bulbus Fritillariae Cirrhosae 2000g, Rhizoma Atractylodis Macrocephalae 2400g, Radix Astragali 2600g, Pseudobulbus Bletillae (Rhizoma Bletillae) 1800g, Rhizoma Coptidis 2700g, Anoplophorae seu Aprionae 900g, Radix Saposhnikoviae 2000g, Pheretima 2300g, Radix Glycyrrhizae 1400g is taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

(2) medical materials such as Cortex Cinnamomi, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Uncariae Cum Uncis, Bulbus Fritillariae Cirrhosae, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Pseudobulbus Bletillae (Rhizoma Bletillae), Rhizoma Coptidis, Radix Saposhnikoviae, Radix Glycyrrhizae are added the distilled water of initial medical material 9 times of weight, soak 16 hours, backflow decoction 2 hours, filter, add the purified water of initial weight 6 times of weight again, backflow decoction 2 hours, filters and retains filtering residue, merging filtrate, being concentrated into 65 DEG C of relative densities is that the concentrated solution of 1.15-1.20 is for subsequent use;

(3) filtering residue of the medical materials such as Scolopendra, Periostracum Cicadae, Scorpio, Hirudo, Nidus Vespae, Anoplophorae seu Aprionae, Pheretima and step (2) is mixed, add the ethanol of the concentration 70% of 7 times of weight, reflux, extract, 2 times, each 3 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 65 DEG C of relative densities be that the concentrated solution of 1.20-1.25 is for subsequent use;

(4) merged by the concentrated solution of step (2) and (3) gained, continuing to be concentrated into 65 DEG C of relative densities is the Chinese medical concrete of 1.28-1.33, for subsequent use;

(5) add suitable adjuvant, utilize the Chinese medical concrete that step (4) obtains by modern general Chinese medicine preparation technology, make granule, specification is: amount to 0.5g crude drug/g granule.

Embodiment 5

Granule is produced by the optimal procedure parameters of the arbitrary proportion within the scope of Chinese prescription of the present invention and invention formulation process:

(1) Cortex Cinnamomi 700g, Rhizoma Chuanxiong 2100g, Radix Angelicae Sinensis 2200g, Scolopendra 500g, Periostracum Cicadae 1900g, Ramulus Uncariae Cum Uncis 1100g, Scorpio 900g, Hirudo 400g, Nidus Vespae 600g, Bulbus Fritillariae Cirrhosae 800g, Rhizoma Atractylodis Macrocephalae 2400g, Radix Astragali 1200g, Pseudobulbus Bletillae (Rhizoma Bletillae) 1800g, Rhizoma Coptidis 1300g, Anoplophorae seu Aprionae 900g, Radix Saposhnikoviae 1000g, Pheretima 2300g, Radix Glycyrrhizae 800g is taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

(2) medical materials such as Cortex Cinnamomi, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Uncariae Cum Uncis, Bulbus Fritillariae Cirrhosae, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Pseudobulbus Bletillae (Rhizoma Bletillae), Rhizoma Coptidis, Radix Saposhnikoviae, Radix Glycyrrhizae are added the distilled water of initial medical material 9 times of weight, soak 16 hours, backflow decoction 2 hours, filter, add the purified water of initial weight 6 times of weight again, backflow decoction 2 hours, filters and retains filtering residue, merging filtrate, being concentrated into 65 DEG C of relative densities is that the concentrated solution of 1.15-1.20 is for subsequent use;

(3) filtering residue of the medical materials such as Scolopendra, Periostracum Cicadae, Scorpio, Hirudo, Nidus Vespae, Anoplophorae seu Aprionae, Pheretima and step (2) is mixed, add the ethanol of the concentration 70% of 7 times of weight, reflux, extract, 2 times, each 3 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 65 DEG C of relative densities be that the concentrated solution of 1.20-1.25 is for subsequent use;

(4) merged by the concentrated solution of step (2) and (3) gained, continuing to be concentrated into 65 DEG C of relative densities is the Chinese medical concrete of 1.28-1.33, for subsequent use;

(5) add suitable adjuvant, utilize the Chinese medical concrete that step (4) obtains by modern general Chinese medicine preparation technology, make granule, specification is: amount to 0.5g crude drug/g granule.

The toxicity test of embodiment 6, Chinese medicine preparation of the present invention

(1) acute toxicity test

1, tested medicine: the granule manufactured by embodiment of the present invention 1-5, adding distil water is modulated into magma, for subsequent use.

2, experimental animal: regular grade NIH mice, body weight 21g ± 3g, male and female half and half, female mice is all without pregnant.

3, to mouse stomach Chinese medicine granules of the present invention, when given low reaches 631.8g crude drug/kg dosage, after administration, mice occurs that light activity reduces, 1 hours recovers normal, Continuous Observation 7 days after administration, none animal dead, its overall health of patients, diet, take the photograph water, urine and body weight increase all normal.

4, result of the test shows: the maximum dosage-feeding of mouse stomach granule of the present invention is 631.8g crude drug/kg/d(LD ₅₀> 631.8g crude drug/kg).Chinese medicine clinical application every day total amount of the present invention is 0.25g crude drug/kg/d; By weighing machine, the dosis tolerata of mouse stomach capsule of the present invention is 2527.2 times of clinical patient.Point out this medicine acute toxicity extremely low, clinical drug safety.

(2), long term toxicity test

1, test objective: the toxic reaction of viewing test animal after long-term edible Chinese medicine preparation of the present invention, assesses the basic security of Chinese medicine preparation of the present invention.

2, test material:

(1) animal: select adult healthy SD rat 180, original body mass 217 ± 11g, male and female half and half, female rats is all without pregnant.

(2) medicine: the granule manufactured by embodiment of the present invention 1-5, adding distil water is modulated into magma, for subsequent use.Per weight dosage is by 20 times of calculating (clinical application amount foundation Pharmacopoeia of the People's Republic of China version in 2010) of clinical application amount, and dosage is 5.0g crude drug/kg/d.

3, test method

(1) 180 SD rats are divided into 6 groups, often organize 30, male and female half and half.Experimental animal male and female sub-cage rearing, 5, every cage, quantitative feeding (every cage 1300-1500g/ week), normal feedstuff is experimental mouse full-valence pellet feed, freely drinks water.Experimental temperature (22 ± 2) DEG C, humidity 60%-80%.The natural lighting light and shade cycle.After SD rat is bought, under this laboratory rearing condition, adapt to 2 weeks, observe general behavior performance.Test pre-test animal ingestion amount, selects qualified rat.

(2) medication

With the magma of the made granule modulation of embodiment 1-5, respectively to wherein 5 groups of SD rat oral gavages administration, every day 2 times, each volume is 0.2ml/10g body weight, successive administration 26 weeks.Remaining one group is matched group, by same method gavage normal saline.Experimental animal is weighed weekly 1 time, according to body weight change adjustment dosage.24h after administration in the 13rd week, often organize execution 10, male and female half and half, observe and detect indices; Remaining continuation administration was observed to 26 weeks, and 24h after last 1 administration, often organizes and put to death 10 again, male and female half and half, observe and detect indices; Remaining 10 are carried out 8 week convalescent period and observe.

(3) test item and the time

General inspection: the general status observing animal every day, as the mental status, dynamic response, behavioral activity, the change of dietary amount, defecation situation, eyes and duct secretions, hair color, cleannes etc.Body weight change situation and food ration measure weekly 1 time.

Hematological examination: after administration, the 13rd, 26 week and drug withdrawal recover the end of term (the 34th week) and detect following index respectively: packed cell volume (HCT), red blood cell count(RBC) (RBC), content of hemoglobin (HGB), numeration of leukocyte (WBC), lymphocyte comparative counting (LY), platelet count (PLT), neutrophilic granulocyte comparative counting (NE), mononuclear cell comparative counting (Mon) and clotting time (CT).

Blood parameters check: after administration the 13rd, 26 week and drug withdrawal recovery the end of term (the 34th week) detect following index respectively: alanine aminotransferase (ALT), alkali phosphatase (AST), Lomefloxacin aspartate injection (AST), total bilirubin (TB), albumin (ALB), gross protein (TP), blood glucose (GLU), blood urea nitrogen (BUN), T-CHOL (TC), creatinine (Crea), uric acid (UA), blood sodium (Na ⁺), blood potassium (K ⁺), blood calcium (Ca ⁺) and β ₂-microglobulin.

Urinate biochemical and urine routine: after administration, the 13rd, 26 week and drug withdrawal recover the end of term (the 34th week) each survey 1 time.Animal metabolism cage list cage is raised and is collected 24h urine, overnight fasting before test, detects urine bilirubin (BIL), glucose (GLU), ketoboidies (KET), protein, pH value, urobilinogen (URO), urine is occulted blood (BLO), nitrite (NIT), proportion and leukocyte (WBC); Quantitative determination of radioimmunoassay urine β ₂-MG(renal tubular function obstacle sensitive indicator).

System postmortem and histopathologic examination: macroscopy is carried out to each internal organs, the organs such as heart, liver, lungs, kidney, spleen, brain, adrenal gland, thymus, thyroid, pancreas, uterus, ovary, testis, prostate are taken out and weighs, calculate organ coefficient (organ weights/body weight).With light microscopic, histological examination is carried out to above-mentioned internal organs and spinal cord, thymus, bladder, bone marrow (breastbone), duodenum, stomach, ileum, pancreas, hypophysis cerebri, optic nerve, lymph node, coton and rectal etc.

4, result of the test

The all rats of overview all do not show any abnormal conditions; Hematological examination, blood parameters inspection, urinate biochemical, urine routine, system postmortem and histopathologic examination, indices, compared with control animals, does not all have obvious difference.Therefore, Chinese medicine granules of the present invention to SD rat without any toxic action, in view of 20 times of ratios of its behaviour dose, so can infer that to take be safe to this granule for patient.

The clinical trial of embodiment 7, Chinese medicine preparation of the present invention

1, physical data

The subjects of this clinical trial provides by certain the People's Hospital of city Neurology Department, these section office have accepted prosopoplegic patient 382 for medical treatment altogether from year June in March, 2011 to 2014, therefrom select 210 to be applicable to and the patient being ready to participate in this clinical trial, wherein man 75, female 135, age 31-69 year, course of disease 2-105 days, all patients are divided into 3 groups, often organize 70 people, be respectively matched group, test A, test B group, during grouping, make the age of patient between each group, sex, the course of disease etc. possess comparability on statistical significance.

2, trial drug

Contrast medicine: methylcobalamin tablet, registration certificate X20010195, Japanese Eisai Co., Ltd;

Investigational agent: the granule that the embodiment of the present invention 1, embodiment 2 are produced, specification is: amount to 0.5g crude drug/g granule.

3, test method

The oral methylcobalamin tablet of matched group, every day 3 times, each 500ug; The Chinese medicine preparation that test A and the not oral embodiment of the present invention 1 of test B component, embodiment 2 are produced, every day 3 times, each 10g; Within 3 weeks, be a course for the treatment of, treat 3 courses for the treatment of continuously.

4, curative effect judgment criteria

Cure: facial paralysis symptom disappears completely, catacleisis is good, and bicker is without crooked, and facial muscle functional rehabilitation is normal, symmetrical.And make a definite diagnosis through doctor and fully recover;

Effective: symptom disappears substantially, better, facial muscle motion slightly weakens or has slight sensory disturbance, and function is normal for Ipsilateral facial muscle sensation and motor function recovery;

Take a turn for the better: sings and symptoms disappears substantially, facial muscle funtion part is recovered normal or is made moderate progress;

Invalid: facial all symptoms are without any improvement, even more serious.

5, therapeutic outcome statistics and analysis

(1) in process of the test, matched group has 11 routine patients to occur the untoward reaction such as inappetence in various degree, nausea,vomiting,diarrhea, allergy, erythra, and test A group and test B group all do not occur untoward reaction.

(2) test data statistical analysis is as shown in table 1:

Table 1 test data statistical analysis table

6, conclusion

Compared with contrast medicine, the untoward reaction rate of matched group is 15.7%, and a routine untoward reaction does not appear in Chinese medicine preparation of the present invention, fully shows the technical advantage of Chinese medicine when disease therapy; No matter the display of test data statistical analysis table is cure rate or total effective rate, and two test group are all far away higher than matched group; To sum up, Chinese medicine preparation of the present invention relatively has very significant technical advantage with prior art, achieves breakthrough progress treating in facial paralysis.

Claims (5)

1. treat a prosopoplegic Chinese medicine preparation, it is characterized in that being made up of the raw material of following weight portion: Cortex Cinnamomi 7-17 part, Rhizoma Chuanxiong 9-21 part, Radix Angelicae Sinensis 10-22 part, Scolopendra 5-8 part, Periostracum Cicadae 9-19 part, Ramulus Uncariae Cum Uncis 11-23 part, Scorpio 5-9 part, Hirudo 4-7 part, Nidus Vespae 3-6 part, Bulbus Fritillariae Cirrhosae 8-20 part, Rhizoma Atractylodis Macrocephalae 12-24 part, Radix Astragali 12-26 part, Pseudobulbus Bletillae (Rhizoma Bletillae) 8-18 part, Rhizoma Coptidis 13-27 part, Anoplophorae seu Aprionae 5-9 part, Radix Saposhnikoviae 10-20 part, Pheretima 11-23 part, Radix Glycyrrhizae 8-14 part.

2. the prosopoplegic Chinese medicine preparation for the treatment of as claimed in claim 1, is characterized in that being made up of the raw material of following weight portion: Cortex Cinnamomi 12 parts, Rhizoma Chuanxiong 15 parts, Radix Angelicae Sinensis 16 parts, Scolopendra 6 parts, Periostracum Cicadae 14 parts, Ramulus Uncariae Cum Uncis 17 parts, Scorpio 7 parts, Hirudo 5 parts, 5 parts, Nidus Vespae, Bulbus Fritillariae Cirrhosae 14 parts, the Rhizoma Atractylodis Macrocephalae 18 parts, the Radix Astragali 19 parts, Pseudobulbus Bletillae (Rhizoma Bletillae) 13 parts, Rhizoma Coptidis 20 parts, Anoplophorae seu Aprionae 7 parts, Radix Saposhnikoviae 15 parts, Pheretima 17 parts, 11 parts, Radix Glycyrrhizae.

3. the prosopoplegic Chinese medicine preparation for the treatment of as claimed in claim 1, is characterized in that being made up of the raw material of following weight portion: Cortex Cinnamomi 13 parts, Rhizoma Chuanxiong 17 parts, Radix Angelicae Sinensis 17 parts, Scolopendra 5 parts, Periostracum Cicadae 15 parts, Ramulus Uncariae Cum Uncis 18 parts, Scorpio 6 parts, Hirudo 5 parts, 4 parts, Nidus Vespae, Bulbus Fritillariae Cirrhosae 13 parts, the Rhizoma Atractylodis Macrocephalae 17 parts, the Radix Astragali 18 parts, Pseudobulbus Bletillae (Rhizoma Bletillae) 14 parts, Rhizoma Coptidis 22 parts, Anoplophorae seu Aprionae 8 parts, Radix Saposhnikoviae 16 parts, Pheretima 18 parts, 12 parts, Radix Glycyrrhizae.

4. prepare as arbitrary in claim 1-3 as described in the method for the prosopoplegic Chinese medicine preparation for the treatment of, it is characterized in that comprising following processing step:

(1) take the ingredientss such as Cortex Cinnamomi, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Scolopendra, Periostracum Cicadae, Ramulus Uncariae Cum Uncis, Scorpio, Hirudo, Nidus Vespae, Bulbus Fritillariae Cirrhosae, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Pseudobulbus Bletillae (Rhizoma Bletillae), Rhizoma Coptidis, Anoplophorae seu Aprionae, Radix Saposhnikoviae, Pheretima, Radix Glycyrrhizae respectively by Chinese prescription, pulverize respectively, for subsequent use;

(2) medical materials such as Cortex Cinnamomi, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Ramulus Uncariae Cum Uncis, Bulbus Fritillariae Cirrhosae, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Pseudobulbus Bletillae (Rhizoma Bletillae), Rhizoma Coptidis, Radix Saposhnikoviae, Radix Glycyrrhizae are added the distilled water of initial medical material 6-12 times weight, soak 12-24 hour, backflow decocts 1-5 hour, filter, add the purified water of initial weight 4-9 times weight again, backflow decocts 1-3 hour, filters and retains filtering residue, merging filtrate, being concentrated into 65 DEG C of relative densities is that the concentrated solution of 1.15-1.20 is for subsequent use;

(3) filtering residue of the medical materials such as Scolopendra, Periostracum Cicadae, Scorpio, Hirudo, Nidus Vespae, Anoplophorae seu Aprionae, Pheretima and step (2) is mixed, add the ethanol of the concentration 55-80% of 5-8 times of weight, reflux, extract, 2 times, each 2-6 hour, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 65 DEG C of relative densities be that the concentrated solution of 1.20-1.25 is for subsequent use;

(4) merged by the concentrated solution of step (2) and (3) gained, continuing to be concentrated into 65 DEG C of relative densities is the Chinese medical concrete of 1.28-1.33, for subsequent use;

(5) add suitable adjuvant, the Chinese medical concrete utilizing modern general Chinese medicine preparation technology step (4) to be obtained, makes the finished dosage forms of clinical needs.

5. the one as described in as arbitrary in claim 1-3 treats prosopoplegic Chinese medicine preparation, it is characterized in that: described Chinese medicine preparation can be made into pill, tablet, capsule, granule, syrup, ointment, patch, powder and tincture.