CN106798791A

CN106798791A - A kind of external traditional Chinese medicinal application of facial paralysis

Info

Publication number: CN106798791A
Application number: CN201710131697.XA
Authority: CN
Inventors: 屈相玲; 朴春梅; 周训蓉; 高永跃; 夏于芬; 代欣; 刘安莉
Original assignee: No 2 Affiliated Hospital of Guiyang College of Traditional Chinese Medicine
Current assignee: No 2 Affiliated Hospital of Guiyang College of Traditional Chinese Medicine
Priority date: 2017-03-07
Filing date: 2017-03-07
Publication date: 2017-06-06

Abstract

The invention discloses a kind of external traditional Chinese medicinal application of facial paralysis, it is made up of the Chinese medicine material of following mass fraction：5~15 parts of pseudo-ginseng, 5~15 parts of prepared RADIX ET RHIZOMA RHEI, 10~20 parts of Chinese violet, 5~15 parts of the bark of official magnolia, 0.3~1 part of borneol.More than each medicine share to play and effectively improve pain after ear, ischemic, the oedema mitigated in facial canal etc., so as to mitigate the infringement of facial nerve.

Description

A kind of external traditional Chinese medicinal application of facial paralysis

Technical field

The present invention relates to technical field of Chinese medicine, and in particular to a kind of external traditional Chinese medicinal application of facial paralysis.

Background technology

Facial paralysis is a kind of acute peripheral facial paralysis caused by the nonsuppurative inflammation of facial nerve.It is mainly shown as patient facial region Expression myoparalysis, i.e. distortion of commissure, the category traditional Chinese medical science mouthful out-of-the-way (apoplex involving the channels and collaterals card).《Interior warp》Middle title mouth fish sticking its mouth out of the water, mouth it is out-of-the-way, and think facial paralysis The mainly lesion of the stomach channel of foot-Yang-ming.It is bright《Jing Yue's complete work miliaria wind》Point out：" mouth eye fish sticking its mouth out of the water tiltedly have distinguishing for fever and chills ... but vim and vigour Without losing, though then heat may not muscular atonia, though it is cold may not muscular contracture, also always understood by declining for vim and vigour." at present, this disease being thought middle medical circles more By positive unsaturated vapor, interspaces of skin and muscles being loose, weakened defensive QI, collaterals being void and defenceless, ailment said due to cold or exposure is taken advantage of a weak point in opponent's defence the facial channels and collaterals of invasion and attack, facial Stomach Muscle Channel lose in Foster, qi and blood numbness resistance is moistened, so that muscle is indulged to delay does not receive caused.But there are fever and chills not, there is face to suffer from cold factor, heat type facial paralysis more sympotoms caused by cold factors The multifactor body overabundance of yang, cold-evil enter innerization heat, thermal resistance sun is bright, shaoyang meridians network, cause stagnant through vapour lock, and muscles along the regular meridians loses and support and send out in moistening.Facial paralysis The treatment of early stage is very crucial, and whether early treatment is appropriate, directly affects recovery in the future.Hormone being given current early treatment more To mitigate the compression of facial nerve oedema, slow down facial nerve denaturation.Early stage anemopyretic patient is more with infection, so antiviral, antibacterial The use of element is also very necessary.External treatment of tcm treatment bell paralysis is evident in efficacy, and most researchers are matched somebody with somebody Close acupuncture.

Peripheral facial paralysis acute stage, is most commonly seen in clinic, while acute stage is also when treating the gold of peripheral facial paralysis Section, focuses on the treatment of this phase and nurses, and can play the curative effect got half the result with twice the effort.Using Chinese medicine external compound preparation, clinically merge Acupuncture treatment, is a feasible program for treating peripheral facial paralysis.This treatment method can make the direct skin permeation of medicine, drug effect Through focus, can promote Doppler flow mapping to set up, and mitigate local inflammation and ooze out and oedema, improve neural surrounding microcirculation, with rush Enter regional flow, improve neurotrophic effect.With instant effect, short treating period, effect be good, advantage without side reaction.Therefore, research and develop A kind of external traditional Chinese medicinal application of facial paralysis is extremely necessary.

The content of the invention

It is an object of the invention to provide a kind of external traditional Chinese medicinal application for treating peripheral facial paralysis, to overcome prior art It is not enough.

The technical scheme is that such：

The external traditional Chinese medicinal application of facial paralysis of the invention, it is made up of the bulk drug of following parts by weight：Pseudo-ginseng 5~15 Part, 5~15 parts of prepared RADIX ET RHIZOMA RHEI, 10~20 parts of Chinese violet, 5~15 parts of the bark of official magnolia, 0.3~1 part of borneol.

It is further preferred that it is made up of the Chinese medicine material of following mass fraction：It is 10 parts of pseudo-ginseng, 10 parts of prepared RADIX ET RHIZOMA RHEI, pale reddish brown 15 parts of Chinese violet, 10 parts of the bark of official magnolia, 0.5 part of borneol.

The present invention is made up of pseudo-ginseng, prepared RADIX ET RHIZOMA RHEI, the bark of official magnolia, Chinese violet, the taste medicinal material of borneol 5, though flavour of a drug are few, heat-clearing disappears Swollen, work(promoting blood circulation and removing obstruction in channels is standby.In component of the present invention, pseudo-ginseng and prepared RADIX ET RHIZOMA RHEI are altogether monarch drug in a prescription, and prepared RADIX ET RHIZOMA RHEI heat-clearing is malicious, scattered stasis detumescence, Pseudo-ginseng is the key medicine of detumescence ding-tong promoting blood circulation and removing blood stasis, and with removing blood stasis and hemostasis, the effect of analgesic therapy of invigorating blood circulation, modern pharmacological research shows, pseudo-ginseng Energy removing blood stasis for promoting tissue regeneration, reduces capillary permeability, suppresses inflammatory and oozes out, and the effect of promotion organization wound repair, the party takes its work Blood, swelling and pain relieving, the effect of anti-inflammatory.Chinese violet is ministerial drug, is that treatment is swollen and ache, the common medicine of carbuncle sore tumefacting virus, with heat-clearing solution Poison, the work(of carbuncle that disappears dissipating bind,；Bark of official magnolia promoting the circulation of qi, eliminating dampness, borneol clearing away heat to and alleviating pain, penetration is strong, and two medicines are altogether for assistant is allowed to medicine.

More than each medicine share to play and effectively improve pain after ear, ischemic, the oedema mitigated in facial canal etc. so that Mitigate the infringement of facial nerve.

The preparation method of this external traditional Chinese medicinal application of the invention is such：By 5~15 parts of pseudo-ginseng, 5~15 parts of prepared RADIX ET RHIZOMA RHEI, 10~20 parts of Chinese violet, 5~15 parts of the bark of official magnolia, 0.3~1 part of borneol are assorted, in addition to borneol, the four traditional Chinese medicine material such as pseudo-ginseng, prepared RADIX ET RHIZOMA RHEI Through 60 DEG C of drying under reduced pressure 3 hours, most fine powder is ground into；Borneol is finely ground, and with above-mentioned powder facing-up, sieving, mixing is dispensed, i.e., .

The present invention is analyzed according to prescription ingredients active ingredient and pharmacological research Information integration, by product agent of the invention Type is set to powder, for convenience of describing, product of the invention is named as facial paralysis is just dissipating again, clinically acupuncture and sticks, with facial paralysis It is multiple just to dissipate scattered stasis detumescence, in combination with acupuncture treatment with dredging the channel, so as to improve local inflammation after the god's inflammation ear of face, promote its work( Can recover, and Shorten the Treatment Process.Prescription drug physicochemical property and pharmacological research：

Pseudo-ginseng [dry root and rhizome of panax araliaceae plant Panax notoginseng (Burk.) F.H.Chen] changes Study and point be summed up following a few classes：(1) saponins：It is one of principle active component of pseudo-ginseng.These saponin monomer compositions Mainly 20 (the S)-protopanaxadiol-types [20 (S)-protopanaxadio1] of dammarane and 20 (S)-Protopanaxatriol types [20 (S)-protopanaxatrio1] tetracyclic triterpene saponin.20 (R)-ginsenoside Rh 1s, Ginsenoside Ng-R2, ginsenoside Rg1, notoginsenoside R, Ginsenoside Rh4,3beta,6alpha,12beta-Trihydroxydammar-20(21),24-diene-6-O-beta-D-glucopyranoside, ginseng sapoglycoside Rg 3, ginsenoside Rd, notoginsenoside k, ginseng Saponin(e Rb1, ginsenoside Rb3, ginsenoside Rb2, ginsenoside Rg2, Ginsenoside Rc, GF2, Panax Notoginseng saponin R 3, Arasaponin R4, Panax Notoginseng saponin R 5, arasaponin R6, notoginsenoside Fa, notoginsenoside Fc, N-Fe, seven leaf courage glycosides. (2) flavonoids：Kaempferol -3-O- galactolipin-O- glucose (pseudo-ginseng flavonoid glycoside), pseudo-ginseng flavones B, Quercetin etc..(3) carbohydrate： Sanchinan-A, sucrose.(4) volatile oil：Ketone alkene, cycloalkane, sesquiterpenoids, fatty vinegar class, benzene substituent etc..(5) other Composition：All multicomponents such as including carbene alcohol component, Nao alcohol composition, alkaloid, protein, fat oil, amino acid.

Pseudo-ginseng is sweet, slight bitter, warm in nature, Return liver, stomach, with dissipate stasis of blood hemostasis, the effect of swelling and pain relieving.Clinically commonly use In spit blood, spit blood, have blood in stool, collapse blood, traumatism and bleeding, fall fall forward swell and ache etc. disease treatment and angina pectoris, a hat atherosclerotic The angiocardiopathies such as heart disease high fat of blood, ICVD, dizziness, dizzy, headache, failure of memory, incoordination Preventing and treating and treatment with cranial vascular disease.

Modern pharmacological research data shows：Pseudo-ginseng has anti-inflammatory and antalgic, antitumor, anti-arrhythmia, anti-thrombus function, tune The effects such as section is immune, anti-aging, anti-oxidant, liver protection.The capillary permeability that pseudo-ginseng can suppress acute inflammation increases, inflammatory Hyperplasia, tissue edema, leukoplania, granulation tissue hyperplasia are controlled so as to traditional pseudo-ginseng such as anti-inflammatory, detumescence, analgesic occur Therapeutic effect.The mechanism of pseudo-ginseng anti-inflammatory properties is increased by preventing free calcium level in inflammatory cell, suppresses thromboxane A in perfusate Activity, and then reduction dinoprostone must discharge relevant, be finally reached anti-inflammatory purpose.Guangxi Medical Uneversity Cancer Hospital was once Stomatitis is prevented through application pseudo-ginseng, is as a result shown, the use of the stomatitis incidence of pseudo-ginseng preventer is than not pre- Anti- person significantly reduces, and further demonstrate that pseudo-ginseng has certain resist inflammation on repercussive function.Pseudo-ginseng is also directly caused a disease to some simultaneously Bacterium, table are shallow and deep fungal has bacteriostasis.

Prepared RADIX ET RHIZOMA RHEI (is the processed product of rheum officinale, rheum officinale is polygonum rheum palmatum Rheum palmatum L., Tang Gute The dry root of rheum officinale Rheumtanguticum Maxim, ex Balf. or Rheum officinale Rheum officinale Baill. and Rhizome) chemical composition has been summed up following a few classes (1) Anthraquinones：It is Rhein, rheum emodin, chrysaron, aloe-emodin, big Flavine methyl ether, isoemodin, Chrysophanol, Physcione-monoglucoside, aloe-emodin monoglucoside, rheum emodin glucose Glycosides, chrysophanol monoglucoside etc..(2) anthrone class：Reidin A, B, C, the palm leaf dianthrone A, B, C and Sennoside A~F etc.. (3) diphenylethylene：3,4,3', 5'- tetrahydroxy Stilbene -3- glucosides, 4,3', 5'- trihydroxy stilbene -4- glucosides.(4) it is many Carbohydrate：Two kinds of acidic polysaccharoses of DHP-I and DHP-2.(5) tannin class：Epicatechin-3-O-gallate, no d- catechins, food Sub- acid, tetrarin acid.(6) other：Palmitic acid, linoleic acid, lauric acid/dodecanoic acid, malic acid, butanedioic acid, oxalic acid, lactic acid, cassia bark Acid, isobutyl enedioic acid, citric acid.

Prepared RADIX ET RHIZOMA RHEI bitter, cold in nature, returns spleen, stomach, large intestine, pericardium channel, with heat and toxic materials clearing away, clearing heat-fire, removing pattogenic heat from the blood and toxic material from the body, by The effect of stasis of blood is stimulated the menstrual flow.Research shows that prepared RADIX ET RHIZOMA RHEI discharge function relaxes, the relieving side effects of stomachache, and can strengthen promoting blood circulation Effect.Clinic is mainly used in the diseases such as pathogenic fire,toxin and furuncles.

Modern pharmacology research shows：Rheum officinale mainly has regulation gastrointestinal function, anti-inflammatory, protection cardiovascular and cerebrovascular, antitumor, guarantor Liver cholagogic and anti-aging, resisting pathogenic microbes, resisiting influenza virus, rubella virus, hepatitis viruse, epidemic hemorrhagic fever virus etc. are more Plant the pharmacological actions such as virus.

Chinese violet (Violaceae Chinese violet viola yedoensis Makino's dries herb) chemical composition It has been summed up following a few classes：(1) flavone compound：Kaempferol -3-O- sandlwoods the pyranose,-C- α-L- of apiolin 6,8- bis- Arabopyranose glycosides, 6-C- α-L- arabopyranose base -8-C- β-D- glucopyranosides, apiolin 6-C- β-D- glycopyranosyls -8- C- α-L- arabopyranoses, apiolin 6-C- β-D- glycopyranosyl -8-C- β-L- arabopyranoses glycosides, apiolin, apiolin 6-C- α-L- arabopyranose base -8-C- β-D- xylopyranoses glucosides, apiolin 6-C- β-D- xylopyranosyl -8-C- α-L- arabopyranoses, Cyanidenon (5,7,3', 4'- kaempferol), cyanidenon 6-C- β-D- glucopyranosides etc..(2) Coumarins chemical combination Thing：Aesculetin, cichoriin, early keng rice glycosides, Scopoletin, aesculin, Isoscopoletin, double leaf aesculetin, 5- methoxies Base -7- methytal coumarins, 7,8- escoparones etc..(3) volatile oil：1-OCOL, 2- amyl groups-furans, D- lemons Lemon alkene, eucalyptol, phenylacetaldehyde, 3,7- dimethyl -1,6- octadiene -3- alcohol, 2,6- dimethyl-ring alcohol, benzyl carbinol etc..(4) Organic acid compound：Palmitic acid, P-hydroxybenzoic acid, succinic acid, trans p hydroxycinnamic acid.(5) trace element：Contain The trace elements such as Ca, Na, K, Mg, Cu, Fe, Mn, Zn, Si, P.(6) other compounds：Violyedoenamide, 6,7- Dihydroxycoumarin, cupreol, daucosterol, myricyl alcohol, stearic acid and soft-methyl ester.

Chinese violet bitter, pungent, cold in nature, the thoughts of returning home, Liver Channel are clearing heat and detoxicating with anti-inflammation, the effect of cool blood detumescence, Can be used to treat and treat pyogenic infections from tumour or sore, ulcer carbuncle on the back, erysipelas, snake venom bites.Clinically it is used for treatment furuncle swelling toxin, urinary tract sense Dye, cellulitis, mammitis, pharyngitis, dysentery, jaundice, red eye, swell pain etc.；It is outer to be applied to treatment carbuncle swells, traumatic injury and poison Snake bite etc.；It is among the people to be widely used in the skin diseases such as treatment eczema, itch and acne.

Modern pharmacological research data shows, Chinese violet has antibacterial, and anti-inflammatory, antiendotoxin, anti-AIDS, regulation is exempted from Epidemic disease, it is anti-oxidant to wait effect.Chinese violet water extract and butanol extract (3.0,9.0g/kg) paraxylene cause mice ear and angle Fork dish glue causes mouse foot swelling to be respectively provided with significant inhibitory action, and can to some extent reduce the scorching mice serum of carrageenan cause The β of interleukins (interleukin, IL) -1, TNF (tumor necrosis factor, TNF)-α and inflammatory The content of PGE2 (prostaglandin E2, PGE) in tissue；Coumarins composition is that it mainly resists in Chinese violet Bacterium active component, the aesculetin in cumarin, 6,7- diformazan butylcoumariiis, scopolactone and 5- methoxyl group -7- hydroxyl methoxies Butylcoumariii to staphylococcus aureus, Escherichia coli, Streptococcusagalactiae, salmonella etc. all have different degrees of suppression and Organic acid and flavonoid glycoside composition in bactericidal activity, and Chinese violet also have very strong antibacterial, bactericidal action.

The bark of official magnolia (Magnoliacea plant bark of official magnolia Magnolia officinalis Rehd.et Wils or Magnolia bilola Magnolia officinalis Rehd.etWils.Var.biloba Rehd.et Wils.'s dries dry hide, root skin and branch Skin) chemical composition has been summed up following a few classes：(1) phenols：Magnolol, honokiol, tetrahydromagnolol, iso-agnolol, dragon Brain base magnolol, peppery menthyl magnolol, peppery menthyl honokiol, two peppery menthyl magnolols, bark of official magnolia lignanoid A~I, thickness Plain triol, bark of official magnolia aldehyde B~E, Taiwan sassafrases aldehyde, 2,2'- dihydroxy -5- pi-allyls-biphenyl -5- methacrylaldehyde, syringaresinol, 2, 2', 5'- trihydroxy -5- allyls connect hexichol, syringaresinol 4'-O- β-D- glucopyranosides, 6'-O- methyl honokiol, 8, 9- dihydroxy dihydros honokiol, 8,9- dihydroxy -7- melonia honokiols etc..(2) alkaloids：Magnocurarine, wood Magnoflorine, magnosprengerine, michelalbine, magnocurarine, oxoushinsunine N-nornuciferine, anonaine, the goose palm Chinese catalpa alkali, roemerine, reticuline, aporphine alkaloid etc..(3) volatile oil：Eucalyptol, 1- methyl -4- isopropyl-phenols, γ-pine Oily alkene, imperial kneecap olefine aldehydr, pepper alkene, o- isopropyl-phenol γ-Yilan worm alkene, Bronyl acetate, acetic acid linalool ester, carypohyllene, perfume (or spice) Orange alkene, alloaromadendrene, elemol, guaiol, hinesol etc..(4) trace element：Ca、Na、K、Me、Fe、Mn、Zn.(5) its He：Double-O- β-D- the Portugals of margarone, cupreol, coated split leather glycosides, arachidic acid, hexacosanol, daucosterol, syringaresinol 4,4'- Polyglycoside, rosin element 4-O- β-D- glucopyranosides etc..

Bark of official magnolia bitter, pungent, tepor.Returns spleen, stomach, lung, large intestine channel, have functions that promoting qi circulation to remove dampness, relieving asthma, and clinic is main It is used for damp retention in middle-jiao, the vexed abdominal distension of gastral cavity caused by the stagnation of the circulation of vital energy is unfavorable, stomachache is vomitted inverse, also can be used for the abdominal fullness and distention of gastrointestinal retention, greatly Constipation knot, stagnation of QI due to dyspepsia of breathing with cough etc.；Various ulcer erysipelas are applied to outward.

Modern pharmacology research shows that the bark of official magnolia has broad-spectrum antiseptic, antitumor, anti-inflammatory and antalgic, liver protection, protection heart and brain blood The effects such as pipe, promotion digestive juice secretion, adjustment gastrointestinal motility function, antiulcer and anticoagulation.Bark of official magnolia ethanol extract is to vinegar The mouse peritoneal capillary permeability that acid causes is raised, and auricular concha swelling caused by dimethylbenzene, the foot swelling that carrageenan causes is equal There is obvious inhibitory action, stimulate whipping to react writhing response caused by mouse acetic acid and heat pain and inhibitory action is presented, shows second Alcohol extracting thing has preferable anti-inflammatory and analgesic activity.

Borneol, also known as piece brain, tangerine piece, kapur, MEIHUA BINGPIAN, plum blossom brain, borneol brain, Mei Bing etc., it is canella camphor tree The fresh branch of Cinnamomum camphora (L.) Presl, leaf is extracted is processed into.Borneol point borneol, L-Borneol and conjunction It is the fat-soluble Monoterpenes of small molecule into borneol；Product of the invention is the hexagonal crystal of white translucent, as camphor Smell, is dissolved in ethanol, ether and benzene.

Borneol is cool in nature, be slightly cold, taste is pungent, hardship, the thoughts of returning home, spleen, lung channel.With inducing resuscitation of having one's ideas straightened out, clearing away heat to and alleviating pain, myogenic effect.With In pyreticosis coma, convulsions, apoplexy coma due to blocking of the respiratory system, bstruction of the circulation of vital energy is fainted cruelly, middle evil is gone into a coma, chest impediment and cardialgia, hot eyes, aphtha, abscess of throat, duct stream Purulence.《Amplification on Materia Medica》Think that its action character is " then gesture of walking alone is weak, and assistant makes then active ".Clinic is usually used in treating exedens oral cavity Inflammation, otitis media suppurative, chronic bronchitis, chronic nasal cavity inflammation, pediatric burn etc..

Pharmacological research data shows：Borneol has anti-inflammatory and antalgic, antibacterial, antiviral, protection heart and brain, bidirectional modulation nerveous system The effects such as system, raising other drugs biological utilisation.Caused by 5% borneol or isoborneol emulsion apply ear to 2% croton oil mixture painting ear Mouse inflammatory reaction has inhibitory action, and wherein isoborneol effect is notable.5% borneol or isoborneol emulsion 3.5ml/kg intraperitoneal injections Effect is significantly inhibited to rat egg white pedal swelling.Additionally, borneol is to staphylococcus aureus, hemolytic hammer Bacterium, Streptococcus viridans, streptococcus pneumonia and Escherichia coli etc., in vitro there is obvious antibacterial action, and antibacterial action phase Seemingly, low concentration is antibacterial, and high concentration is sterilized.Borneol also has inhibitory action to hog cholera vibrios.

Technique effect of the invention is as follows：

The facial paralysis prepared by technical scheme is just being dissipated by pseudo-ginseng, prepared RADIX ET RHIZOMA RHEI, the bark of official magnolia, Chinese violet, the taste of borneol 5 again Medicinal material is constituted, though flavour of a drug are few, clearing heat for detumescence, work(promoting blood circulation and removing obstruction in channels are standby.Pseudo-ginseng and prepared RADIX ET RHIZOMA RHEI are altogether monarch drug in a prescription, prepared RADIX ET RHIZOMA RHEI in side Heat-clearing poison, scattered stasis detumescence, pseudo-ginseng are the key medicine of detumescence ding-tong promoting blood circulation and removing blood stasis, with removing blood stasis and hemostasis, the effect of analgesic therapy of invigorating blood circulation, modern medicine Reason research shows that pseudo-ginseng energy removing blood stasis for promoting tissue regeneration reduces capillary permeability, suppresses inflammatory and oozes out, promotion organization wound repair Effect, the party takes its promoting blood circulation, swelling and pain relieving, the effect of anti-inflammatory.Chinese violet is ministerial drug, be treatment swell and ache, carbuncle sore tumefacting virus it is normal Medication, with clearing heat and detoxicating, the work(of carbuncle that disappears dissipating bind,；Bark of official magnolia promoting the circulation of qi, eliminating dampness, borneol clearing away heat to and alleviating pain, penetration is strong, and two medicines are altogether assistant It is allowed to medicine.Modern medicine thinks that facial paralysis is the virus infection in stylomastoid foramen, causes tissue edema or periostitis with pressure surface god Through；Or because of local nutrient vessel spasm, cause nerve fiber ischemic, oedema, compression and benumb；Also have and think local organization oedema Caused by may belonging to immune response.Modern pharmacological research confirms that pseudo-ginseng, prepared RADIX ET RHIZOMA RHEI, the bark of official magnolia, Chinese violet, borneol have reduces hair The release of thin vasopermeability and the medium that reduces inflammation, produces obvious antiinflammatory action.Each medicine is shared and can played effectively above Pain, ischemic, the oedema mitigated in facial canal etc. after improvement ear, so as to mitigate the infringement of facial nerve.

Brief description of the drawings

Fig. 1 is the process chart of preparation method of the invention；

Fig. 2 is that facial paralysis of the invention just dissipates moisture equilibrium at dry side curve again；

Fig. 3 is critical relative moisture sucting wet curve figure of the invention；

Fig. 4 is the thin layer discriminating figure of pseudo-ginseng of the invention；In figure, 1, pseudo-ginseng control medicinal material；2nd, notoginsenoside R and ginseng Saponin(e Rg1 and ginsenoside Rb1's mixing reference substance；3~5, facial paralysis just dissipates test sample (lot number again：20160311,20160312, 20160313)；6th, negative test sample (scarce pseudo-ginseng)；

Fig. 5 is the thin layer discriminating figure of prepared RADIX ET RHIZOMA RHEI；In figure：1st, prepared RADIX ET RHIZOMA RHEI control medicinal material；2~4, facial paralysis just dissipates test sample again (lot number：20160311,20160312,20160313)；5th, negative test sample (lacking prepared RADIX ET RHIZOMA RHEI medicinal material)；

Fig. 6 is the thin layer discriminating figure of Chinese violet；In figure, 1, Chinese violet control medicinal material；2~4, facial paralysis is just being dissipated for examination again Product (lot number：20160311,20160312,20160313)；5th, negative test sample (lacking Chinese violet medicinal material)；

Fig. 7 is the thin layer discriminating figure of the bark of official magnolia；In figure, 1, bark of official magnolia control medicinal material；2~4, facial paralysis just dissipates test sample (lot number again： 20160311,20160312,20160313)；5th, negative test sample (scarce magnolia medicament).

Specific embodiment

The present invention is described in further detail with reference to the accompanying drawings and examples, but protection scope of the present invention is not received Any limitation of specific embodiment, but be defined in the claims.

Embodiment 1：

1st, prescription composition：Pseudo-ginseng 10g prepared RADIX ET RHIZOMA RHEI 10g Chinese violet 15g bark of official magnolia 10g borneols 0.5g.

2nd, preparation method：Technological process as shown in Figure 1, the above five tastes are assorted by 23 times of amounts of prescription, in addition to borneol, The four traditional Chinese medicine such as pseudo-ginseng, prepared RADIX ET RHIZOMA RHEI material was ground into most fine powder through 60 DEG C of drying under reduced pressure 3 hours；Borneol is finely ground, match somebody with somebody with above-mentioned powder Grind, sieve, mixing, packing is obtained final product.

3rd, indication：It is clearing heat for detumescence, promoting blood circulation and removing obstruction in channels.For peripheral facial paralysis acute stage and partial gall patient.

4th, usage and dosage：External application, according to the state of an illness, external application, apply part acupuncture point, per cave is mixed well from vaseline, grease etc. One patch, once a day, January is 1 course for the treatment of.Needed that the course for the treatment of can be repeated according to the state of an illness.

The prescription of the present embodiment is derived from the Empirical formula of No. 2 Affiliated Hospital of Guiyang College of Traditional Chinese Medicine's department of acupuncture and moxibustion long-term clinical practice, Its clinical efficacy is and flavour of a drug selected by the present invention very certainly, all record into《Chinese Pharmacopoeia》2015 editions one, and base Source stabilization, aboundresources.Product of the invention is analyzed according to prescription ingredients active ingredient and pharmacological research Information integration, will The product formulation is set to powder, clinically acupuncture and sticks, and scattered stasis detumescence is just dissipated again with facial paralysis, in combination with acupuncture treatment dredging Channels and collaterals, so as to improve local inflammation after the god's inflammation ear of face, promote its functional rehabilitation, and Shorten the Treatment Process.Therefore, original is being kept to face as far as possible On the premise of bed administration features, the process route of product of the invention is defined below：The above five tastes, are matched somebody with somebody by 23 times of amounts of prescription Together, in addition to borneol, pseudo-ginseng, prepared RADIX ET RHIZOMA RHEI, Chinese violet, bark of official magnolia four traditional Chinese medicine material are individually ground into most fine powder → borneol is finely ground, with Above-mentioned powder facing-up, sieving → mixing → sub-dose packaging → finished product.

5 medicinal material pre-treating technologies are studied：

The prepared slices of Chinese crude drugs meet in prescription of the present invention《Chinese Pharmacopoeia》2015 editions ministerial standards, by Guiyang College of Traditional Chinese Medicine second Affiliated hospital Korea Spro rosy clouds professor of pharmacy identifies.

Pseudo-ginseng product of the invention should meet photograph《Chinese Pharmacopoeia》One 11-12 pages of version in 2015 and《Guizhou Province processes rule Model》2005 editions 8-9 pages of pseudo-ginseng regulations.

Prepared RADIX ET RHIZOMA RHEI product of the invention should meet photograph《Chinese Pharmacopoeia》One 23-24 pages of version in 2015 and《Guizhou Province processes Specification》2005 editions 17-18 pages of prepared RADIX ET RHIZOMA RHEI regulations.

Chinese violet product of the invention should meet photograph《Chinese Pharmacopoeia》One 337-338 pages of version in 2015 and《Guizhou Province Concocted specification》The 2005 editions Chinese violet of page 249 regulations.

Bark of official magnolia product of the invention should meet photograph《Chinese Pharmacopoeia》One 251-252 pages of version in 2015 and《Guizhou Province processes Specification》The 2005 editions bark of official magnolia of page 185 regulations.

Borneol product of the invention should meet photograph《Chinese Pharmacopoeia》Version one borneols of page 146 regulation in 2015.

Test example 1：The screening of process conditions

(1) drying process research

Pseudo-ginseng, prepared RADIX ET RHIZOMA RHEI, the bark of official magnolia, Chinese violet medicinal material water content are determined using moisture teller, respectively： 9.37%th, 8.67%, 8.50%, 8.57%, meet《Chinese Pharmacopoeia》2015 editions requirements an of regulation, but it is direct by its Obtained powder moisture does not meet between 8.54%~9.10%《Chinese Pharmacopoeia》2015 editions four powders of general rule 0115 Requirement under to moisture.It is therefore desirable to be pulverized and mixed after being dried treatment to crude drug.Conventional drying side Method has constant pressure and dry and drying under reduced pressure.This experiment is with water content in powder and ginsenoside Rg₁Content is evaluation index, investigates 80 DEG C constant pressure and dry, 70 DEG C of constant pressure and dries and 60 DEG C of decompressions different drying times, preferably optimum drying condition.Three are taken in prescription ratio 7th, prepared RADIX ET RHIZOMA RHEI, the bark of official magnolia, the taste medicinal material of Chinese violet 4, are respectively adopted above-mentioned different drying means, on the rocks facing-up mixing after crushing After determine ginsenoside Rg₁The water content of content and powder, each parallel 2 sample of experiment.The results are shown in Table 1.

Influence (n=2) of the different drying means of table 1 to Determination of Content of Ginsenoside Rg_1 and water content

As shown in Table 1,60 DEG C of drying under reduced pressure 3 hours and 70 DEG C of constant pressure and dries water content of 3 hours and ginsenoside Rg₁Contain Amount is suitable, 60 DEG C of drying under reduced pressure 6 hours and 80 DEG C of constant pressure and dries water content of 2 hours and ginsenoside Rg₁Content is suitable.But examine Consider that drying temperature is too high and the drying time long change for being possible to cause other active ingredients in sample, therefore do not adopt.Cause The drying process of this medicinal material is set to：60 DEG C of drying under reduced pressure 3 hours.

(2) disintegrating process research

By former technique in addition to borneol, the four traditional Chinese medicine material co-grinding such as pseudo-ginseng, prepared RADIX ET RHIZOMA RHEI, but result shows, due to each taste The difference of quality, composition, water content, requirement, the condition of crushing of medicinal material etc. so that cannot more accurately reach prescription requirements Ratio, while pseudo-ginseng belongs to expensive thin medicinal material in prescription, more should be by the way of individually crushing.Other Chinese medicine borneol easily distils, It is oxidizable in atmosphere to be changed into camphor.Therefore, should be tried one's best in powder production and shorten the time that borneol participates in preparation, the system of powder It is standby, need to be through drying, crushing, mixing.Borneol should be added upon mixing, therefore can not be with other medicinal powder co-grindings.Therefore said preparation Disintegrating process is set in addition to borneol, and the four traditional Chinese medicine such as pseudo-ginseng, prepared RADIX ET RHIZOMA RHEI material mixes after individually pulverizing and sieving, and borneol is finely ground, and upper State powder facing-up.

(3) hybrid technique research

Mixture homogeneity is the important indicator of powder quality, particularly the powder containing costly medicine, in order to ensure component The uniformity of mixing, herein with ginsenoside Rg₁Uniformity of dosage units is inspection target, and using stirring mixing method, stirring, sieving are mixed Powder obtained by legal 2 kinds of different mixing modes is sampled in 5 different orientation, by the system of quality standard draft test sample Preparation Method prepares sample, determines ginsenoside Rg₁Content, the results are shown in Table 2.

Ginsenoside Rg1 (μ g/g) content investigates result in the different mixing modes of table 2 gained powder

Result shows, stirs, mixing method of sieving can guarantee that ginsenoside Rg₁Uniformity of dosage units, therefore facial paralysis is just scattered again Hybrid technique is set to stirring, sieving mixing method.

(4) preparations shaping technical study

1st, dosage form selection foundation

Peripheral facial paralysis acute stage, is most commonly seen in clinic, while acute stage is also when treating the gold of peripheral facial paralysis Section, focuses on the treatment of this phase and nurses, and can play the curative effect got half the result with twice the effort.Product-facial paralysis of the invention is just being dissipated by pseudo-ginseng, ripe again The medicinal materials such as rheum officinale, Chinese violet, the bark of official magnolia are constituted.Clinically outer being coated with is mixed well from vaseline, grease etc. according to conditions of patients to disappear The swollen scattered stasis of blood, in combination with acupuncture treatment with dredging the channel, so as to improve local inflammation after the god's inflammation ear of face, promotes its functional rehabilitation. Dosage form selection of the invention is powder, and said preparation is prepared simply, and technique productions are feasible, steady quality, and clinical efficacy is definite, because This, selection powder is more rational.

2. the measure of critical relative moisture

The measure of 2.1 moisture equilibrium at dry side times

Take the glass desicator that bottom fills NaCl supersaturated solutions, the built-in measuring cup (5 × 3cm) of drier, 25 Constant weight is reached in DEG C thermostatic drying chamber.Sample about 1g is taken, is put in the measuring cup of constant weight, jog makes it be evenly distributed, precision claims It is fixed, weigh the cap is opened, drier top is put into, in being preserved in 25 DEG C of thermostatic drying chambers, respectively at 1,2,4,8,12,24, 36,48,72h weigh once, calculate the hydroscopicity of different time.Computing formula：Hydroscopicity=(total before gross weight-moisture absorption after moisture absorption Powder amount × 100% before/moisture absorption again).Result of the test shows that 3 kinds of sample lots are tested respectively, and experimental result numerical value is close, The average value list of result is now taken to be analyzed.The moisture equilibrium at dry side time of powder is shown in Table 3, and moisture equilibrium at dry side curve is shown in Fig. 2.

3 moisture equilibrium at dry side time of table (n=3)

From table 3, Fig. 2, product of the invention moisture absorption after 48h basically reaches balance, and hydroscopicity is no longer significantly increased, The moisture equilibrium at dry side time of the medicinal powder is 48h.

The measure of 2.2 powder critical relative moistures

Packing ambient humidity is very big on powder packing influence, it is necessary to determine the critical relative moisture of powder.Prepare KNO₃, KCl, NaCl, NaBr, Zn (NO₃)₂, CaCl₂, the supersaturated solutions of the different salt of 7 kinds of KAc are respectively placed in the dry device of glass thousand, 25 Make to reach balance inside it after constant temperature 24h in DEG C constant incubator, determined under drier sealed environment using humidometer RH, now relative humidity is respectively in each drier：92.5%, 84.3%, 74.3%, 58.7%, 42.3%, 31.5%, 20.0%.

7 parts of sample is taken, every part of about 1g is accurately weighed, be placed at the weighing up to constant weight and numbering in 25 DEG C of thermostatic drying chambers In bottle, uniformly sprawl, thickness is about 2mm, accurately weighed, open weigh the cap, be respectively put into the glass of above-mentioned different relative humidity In glass drier, 48h is placed in 25 DEG C of thermostatic drying chambers, take out measuring cup, add a cover rear accurately weighed, the weight of determination sample Change, calculates hydroscopicity (being shown in Table 4).With hydroscopicity as ordinate, relative humidity RH is that abscissa draws RH- hydroscopicity curves. Make tangent line respectively from curve two ends, the corresponding abscissa of two points of intersection of tangents is critical relative moisture.Critical relative moisture moisture absorption Curve is shown in Fig. 3.

The powder critical relative moisture of table 4 is determined

As seen from Figure 3, the critical relative moisture of powder is about 57%.The water absorption rate of relative humidity medicinal powder below 57% compared with It is small, and medicinal powder hygroscopicity substantially increases more than 57%, therefore, answer control ring during storage, packing etc. after powder shaping Border relative humidity below 57%, to reduce influence of the moisture to pharmaceutical properties and stability.

(5) three batches of sample lab scale craft confirmatory experiments

In order to verify the accuracy and reappearance of the technological parameter condition that the studies above determines, therefore carry out proving test. The medicinal materials such as pseudo-ginseng, prepared RADIX ET RHIZOMA RHEI, the bark of official magnolia are taken, 60 DEG C of drying under reduced pressure are prepared after 3 hours by the best conditions of preparation pr ocess, prepare 3 batches, Determine ginsenoside Rg₁Content, as a result shows (be shown in Table 5)：Ginsenoside Rg₁Average value is 6.19%, RSD=1.93%, explanation Process stabilizing is feasible.

The lab scale craft checking test of table 5

(6) three batches of sample pilot scale researches

Three batches of amplifications, 10 times of productions are carried out by preparation process condition is worked out, comprehensive assessment is carried out to production technology index, it is right Medicinal material and finished product carry out performance rating, investigate the reasonability of product preparation process of the invention.By data display in table 6, by institute The theory that feeds intake should produce 1744 bags of (6g/ bags) finished product meters, and powder finished product net yield is not less than 85%.Technique productions condition meets The big production requirement of factory, operability is stronger, and medicinal material, final product quality are controllable, final product quality stabilization.Scale up test technological parameter and Pilot product Quality Checkout Data is shown in Table 6.

The scale up test technological parameter of table 6 and pilot product quality testing data

Show through three batches of scale up test results, product items technical parameter of the invention is identical with technique optimum condition, and Stable process conditions, illustrate feasible process, are adapted to batch production.

Certainly, it is more than the concrete application example of invention, the present invention also has other implementation methods, all use is equally replaced Change or equivalent transformation formed technical scheme, all fall within protection domain of the presently claimed invention.

Claims

1. a kind of external traditional Chinese medicinal application of facial paralysis, it is characterised in that：It is made up of the Chinese medicine material of following mass fraction：Pseudo-ginseng 5~15 parts, 5~15 parts of prepared RADIX ET RHIZOMA RHEI, 10~20 parts of Chinese violet, 5~15 parts of the bark of official magnolia, 0.3~1 part of borneol.

2. the external traditional Chinese medicinal application of facial paralysis according to claim 1, it is characterised in that：It is by following mass fraction Medicine raw material is made：10 parts of pseudo-ginseng, 10 parts of prepared RADIX ET RHIZOMA RHEI, 15 parts of Chinese violet, 10 parts of the bark of official magnolia, 0.5 part of borneol.

3. the external traditional Chinese medicinal application of facial paralysis according to claim 1 and 2, it is characterised in that：It is common with pseudo-ginseng and prepared RADIX ET RHIZOMA RHEI It is monarch drug in a prescription, Chinese violet is ministerial drug, and the bark of official magnolia and the medicine of borneol two are altogether for assistant is allowed to medicine.