CN103071134B - External preparation for treating rheumatic arthrodynia and traumatic pain and swelling and preparation method thereof - Google Patents
External preparation for treating rheumatic arthrodynia and traumatic pain and swelling and preparation method thereof Download PDFInfo
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Abstract
The invention relates to an external medicine, in particular to an external preparation for treating rheumatic arthrodynia and traumatic pain and swelling. The preparation is characterized in that every 1000ml external preparation is prepared from the following principal raw materials by weight: 26-46 g of gnetum montanum, 10-30 g of pine pen, 5-25 g of fructus schizandrae, 5-25 g of gaultheria yunnanensis, 14-34 g of radix zanthoxyli, 5-20 g of safflower, 5-20 g of camphanone, 5-20 g of elecampane inula root, 5-25 g of menispermum dauricum, 5-25 g of cochinchina raspberry root or leaf, 5-25 g of rhizoma zingiberis and 5-25 g of menthol. The preparation can promote blood circulation, dissipate blood stasis, disperse the swelling, relieve the pain, expel wind and remove dampness, is obvious in treatment effect, quick in effect and safe, and has no toxic or side effects; and the variety of the traditional Chinese medicine for treating the rheumatic arthrodynia, arthritis, the traumatic pain and swelling, and acute sprain and contusion is enriched.
Description
Technical field
The present invention relates to a kind of Chinese medicine for outer use, particularly a kind of external preparation medicine for the treatment of Fengshi Guanjie pain and treating swelling and pain by traumatic injury.
Background technology
Fengshi Guanjie pain causes muscle or organizes needed nutrition to carry by blood circulation because blood circulation is obstructed, muscle lacks nutrition and accelerated ageing becomes stiff, the chronic pain that causes patient joint and soft tissue around thereof to produce.According to " China's rheumatic four diseases Survey on epidemiological features ", rheumatism is l 4% at Chinese general population sickness rate, and special trade (weaving, steel machinery, chemical industry, mine oil, harbour, army) is up to 23.1%; The main ill crowd of rheumatic four diseases is in 40-60 year; Current China estimates at 1.82 hundred million people and suffers from rheumatism, and more than 40 years old patient accounts for 9,464 ten thousand people.Wind-warm syndrome causes handicapped in daily life and work to patient, and disability rate is high, and the physiology on patient, psychology cause very big impact, form burden greatly to society.
The generation for the treatment of swelling and pain by traumatic injury bruise not only injures limbs but also injure QI and blood, occurs stagnation of QI leukemia phenomenon, because crazy blood is the not broken and interior damage person of skin, mostly is blood circulating out of vessels and gathers in a place, can not dissipate for the moment in vivo and flesh table occurs swelling and ache livid purple, and painful area is fixed.Chinese medicine is thought stagnation of QI and blood may bring about pain, no matter the stagnation of QI or leukemia are all obstructed, the cause of disease of this explanation osteopatia sprain is due to external force, and pathogenesis is stagnation of QI leukemia.Rheumatic arthralgia and bruise are commonly encountered diseases, frequently-occurring disease, and it has a strong impact on and produces and life.Although there is clinically the Chinese medicine preparation of many treatment traumatic injury, rheumatic bone carbuncle at present, as Chinese patent: Wound dispelling swell dispersing tincture and preparation method thereof, application number 200510066151.8, publication number CN 1686414A, applicant: Haiwang Jinxiang Chinese Medicine Pharmaceutical Co., Ltd., Fuzhou City, address: Jin, Fuzhou, Fujian Province peace Qu Kuiqi, inventor: Xu Yanhe.Summary: a kind of Wound dispelling swell dispersing acid anhydride and preparation method thereof, 56-84 parts of Mentholums, Borneolum Syntheticum 48-72 part, Radix Zanthoxyli 48-72 part, Caulis et folium stauntoniae 36-54 part, Herba Glechomae 24-36 part, Fructus Gardeniae 24-36 part, join beans grass 24-36 part, Camphora 24-36 part, Radix Aconiti Kusnezoffii 16-24 part, vegetables art 14-22 part, Ramulus Cinnamomi 14-22 part, Flos Carthami 12-18 part, Radix Clematidis 12-18 part, Herba Droserae Lunatae 12-18 part, Caulis Piperis Kadsurae 12-18 part, CHUANSHAO l0-14 part, Radix Wikstroemae l0-14 part, Rhizoma Arisaematis l0-14 part, white positive l0-14 part, Sanguis Draxonis 2-4 part is made, be used for the treatment of traumatic injury, acute jerk contused wound, crazy hematoma pain, detumescence, pain relieving is fast, curative effect is high, easy to use.And for example Chinese patent: a kind of Chinese medicinal ointment compositions, its preparation method, its cataplasma and preparation method thereof, application number 200510075043.7, publication number CN 1698815A, applicant: Huahong Pharmaceutical Co., Ltd., Guangxi, address: No. 74, Hongguang Road ,Liuzhou City ,Guangxi Zhuang Autonomousnationality District, inventor: Wei Feiyan, summary: a kind of Chinese medicinal ointment compositions, its preparation method, its cataplasma and preparation method thereof, comprise active component, penetration enhancer and substrate.Described active component take Radix Saposhnikoviae, Herba Schizonepetae, Herba Asari, Radix Achyranthis Bidentatae, CHUANSHAO, Radix Cynanchi Paniculati, vegetables art, DALUOSAN, Radix Ardisiae punctatae, Radix Zanthoxyli, Rhizoma Sparganii, Ramulus Cinnamomi, in vain just, Radix seu Caulis Parabarii, the Radix Aucklandiae, Caulis Fibraureae, Cortex Acanthopancis, Fructus Gardeniae and Lignum Aquilariae Resinatum extract with oozing the method for spattering as raw material, concentrated formation extractum, then extractum and Camphora, Mentholum are mixed and made into active component.The preparation method that this invention also relates to this Chinese medicinal ointment compositions with and cataplasma and preparation method thereof.Cataplasma can be used for treating anemofrigid-damp arthralgia, scapulohumeral periarthritis, acute jerk contused wound, innominate toxic swelling, parotid gland swelling and pain and have advantages of evident in efficacy, effect rapidly, have no side effect.For another example Chinese patent: a kind of external-use tincture medicine for the treatment of rheumatic arthralgia and acute jerk contused wound disease and preparation method thereof, application number: 200810073697.X, publication number CN 101336993A, applicant: Yuan An Tang Pharmaceutical Co., Ltd., Guangxi, address: Zhong Sha town, Guiping City, Guangxi Zhuang Autonomous Region, inventor: Mo Zhaoqin, summary: a kind of external acid anhydride agent medicine for the treatment of rheumatic arthralgia and acute jerk contused wound disease, is characterized in that often making the required primary raw material of the tincture dose medicament of 1000ml by weight ratio: Radix Ardisiae Crenatae 18～28g; Caulis et Folium piperis 18～28g; Cortex Periplocae 18～28g; Radix Zanthoxyli 18～28g; Herba Sarcandrae 18～28g; Camphora 0.5～0.8g; Rhizoma Polygoni Cuspidati 12～19g; Five tastes rattan 6～10g; Borneolum Syntheticum 0.5～0.8g.This product has that expelling wind and cold, Huoxue San " are crazy, effect of reducing swelling and alleviating pain, its curative effect and bone-setting liquor are suitable, but its raw material source is wide, be easy to obtain, and can effectively extract and preserve the main active of respectively hiding medical material in formula, and product is without obvious toxic-side effects, uses safety, convenient, has enriched the types of drugs to treatment rheumatic arthralgia and acute jerk contused wound disease.
The external-use tincture medicine of above-mentioned disclosed treatment Fengshi Guanjie pain and treating swelling and pain by traumatic injury respectively has feature, but some ingredients are more complicated, and some crude drug sources are few, and clinical effectiveness is each has something to recommend him.
Summary of the invention
The object of the present invention is to provide a kind of evident in efficacy, effect rapidly, promoting blood circulation to remove blood stasis, reducing swelling and alleviating pain, expelling wind and removing dampness, safe without toxic side effect, easy to use be used for the treatment of Fengshi Guanjie pain, arthralgia due to cold,, Chinese medicine composition for the treatment of swelling and pain by traumatic injury, acute jerk contused wound and preparation method thereof.
Technical scheme of the present invention is as follows:
The external preparation for the treatment of Fengshi Guanjie pain and treating swelling and pain by traumatic injury, makes the required primary raw material of the external preparation medicine of 1000ml by following weight proportion: Caulis Gneti 26-46g, a pinaster 10-30g, five tastes rattan 5-25g, Caulis et folium gaultheriae yunnanensis 5-25g, Radix Zanthoxyli 14-34g, Flos Carthami 5-20g, Camphora 5-20g, Radix Inulae 5-20g, Caulis menispermi 5-25g, Radix seu Folium Rubi Cochinchinensis 5-25g, Rhizoma Zingiberis 5-25g, lotus brain 5-25g; Described external preparation comprises tincture and spray.
The preparation method of described tincture is:
(1) weigh by weight crude drug: Caulis Gneti, pinaster pen, five tastes rattan, Caulis et folium gaultheriae yunnanensis, Radix Zanthoxyli, Flos Carthami, Radix Inulae, Caulis menispermi, Radix seu Folium Rubi Cochinchinensis and ginger powder are broken into coarse powder;
(2) former step (1) coarse powder medicine is shone to the percolation under fluid extract and extractum item, make solvent with volumetric concentration 60-80% ethanol, flood after 48 hours, with the slowly percolation of speed of approximately 1～2ml per minute, collect the about 800ml of liquid that just filters, preserve;
(3) continue percolation to till 12 times of weight of medical material amount, collect the continuous liquid of filtering, reclaim ethanol, under 40-70 ℃ of condition, be concentrated into relative density and be 1.03～1.05 clear paste, let cool, be incorporated to the liquid of just filtering;
(4) separately get Camphora, Mentholum, add ethanol 50ml and make to dissolve, add in above-mentioned solution, add ethanol to ormal weight, shake up, leave standstill 24 hours, filter, bottling, obtains product.
The described method of preparing spray is:
(1) weigh by weight crude drug: Caulis Gneti, pinaster pen, five tastes rattan, Caulis et folium gaultheriae yunnanensis, Radix Zanthoxyli, Flos Carthami, Radix Inulae, Caulis menispermi, Radix seu Folium Rubi Cochinchinensis and ginger powder are broken into coarse powder;
(2) former step (1) coarse powder medicine is shone to the percolation under fluid extract and extractum item, make solvent with 70% ethanol, flood after 48 hours, with the slowly percolation of speed of approximately 1～2ml per minute, collect the about 800ml of liquid that just filters, preserve;
(3) continue percolation to till 12 times of amounts of medical material amount, collect the continuous liquid of filtering, reclaim ethanol, under 40-70 ℃ of condition, be concentrated into relative density and be 1.03～1.05 clear paste, let cool, be incorporated to the liquid of just filtering;
(4) separately get Camphora, Mentholum, add propylene glycol 50ml and make to dissolve, add in above-mentioned solution, and add surfactant tween or the span of 0.1-10 gram, the flavouring agent of 0.5-1 gram, adds ethanol to ormal weight, shakes up, and leaves standstill 24 hours, filter, pack in spray bottle, obtain spray product.
The above pulverizing medicinal materials can adopt the conventional method such as independent pulverizing, co-grinding, dry pulverization process, waterproof pulverization.
Performance and effect of various medical materials of the present invention are as follows:
Caulis Gneti: be Gnetaceae plant Caulis Gneti Gnetum montanum Markgr. or the dry rattan of Caulis Gneti Parvifolii Gnetum parvifolinm (warb) C.Y. cheng.Nature and flavor and function: bitter, warm, return Liver Channel.Expelling wind and removing dampness, promoting blood circulation to remove blood stasis.For rheumatic ostalgia, soreness of bones and muscles, traumatic injury, venom, 6～9 grams of usual amounts.Suitable amount used externally, fresh goods is mashed wine and is adjusted, and applies a hot compress to the affected part.1. " Luchuan book on Chinese herbal medicine ": " stem and leaf: reuniting the fractured tendons and bones.Control traumatic injury, the fracture injury of tendon and muscle." 2. " Guangxi medicine is planted register ": " stem and leaf: synthetism, detumescence, pain relieving.Dispelling the wind and dampness pathogens osteodynia.Root: control the arthroncus of knee." 3. Guangzhou army " conventional Chinese herbal medicine handbook ": " rattan is dispelled wind and removed dampness, promoting blood circulation to remove blood stasis.Treating rheumatic lumbago and skelalgia, soreness of bones and muscles, traumatic injury, venom." for oral administration: to decoct soup, 2～3 money (0.5～1 liang of fresh person).External: smash deposited or mash wine and fry deposited.
Pinaster pen: be the sprout tip of pinaceae plant Pinus massoniana Lamb Pinus massoniana Lamb..
Five tastes rattan: be the dry Herb of milk wort Radix securidacae Alyxia Levinei Merr.[Latin plant animal mineral name] Securidaca inapfondiculata Hassk. ［ S.tavoyana Wall.ex Benn ］, [another name] Ramulus et Folium Claoxyli, Corium elephatis rattan, rub disappear, five horses are patrolled city, cicada's wings wood.[nature and flavor] are pungent; Bitter; Cool.[effect] expelling wind and removing dampness; Eliminating stasis to stop pain.[curing mainly] traumatic injury; Rheumatic ostalgia; Acute gastroenteritis; Allergic dermatitis.
Caulis et folium gaultheriae yunnanensis: be dry root and the stem of apocynaceae plant muscle rattan Alyxia levinei Merr.Caulis et folium gaultheriae yunnanensis Latin plant animal mineral name: Gaultheriayunnanensis(Franch.) Rehd.[G.CrenulataKurzi; VacciniumyunnanenseFranch.], another name: Herba speranskiae tuberculatae, MANSHANXIANG, Radix scopoliae sinensis, coal.[nature and flavor] are pungent, temperature.1. " the southern regions of the Yunnan Province book on Chinese herbal medicine ": warm in nature, acrid in the mouth is peppery, slightly poisonous.2. " Kweiyang medicinal herbs among the people ": pungent, temperature, nontoxic.3. " Yunnan Chinese herbal medicine ": pungent, flat.[effect of cure mainly-Caulis et folium gaultheriae yunnanensis of function] expelling wind and removing dampness, promoting blood circulation to remove obstruction in the collateral.Dispelling the wind and dampness pathogens arthralgia, water spreads, traumatic injury, toothache, eczema.1. " the southern regions of the Yunnan Province book on Chinese herbal medicine ": control phlegm-fire, bones and muscles pain, steeps in wine good with it.Its stalk, wash anemofrigid-damp arthralgia, bones and muscles pain, and warm bone is diathermanous, endures washing.2. " Kweiyang medicinal herbs among the people ": dispelling the wind and dampness pathogens arthralgia, traumatic injury.3. " Guangxi medicine is planted register ": circulation of qi promoting, detumescence, relieving cough and resolving phlegm.Control toothache, impairment caused by overstrain, snakebite, rheumatism, eruptive disease, skin sufferings.4. " Guizhou medical herbs ": expelling wind and removing dampness, relaxing muscles and tendons to promote blood circulation.5. " Kunming conventional medical herbs among the people ": active deep.
Radix Zanthoxyli: be rutaceae Radix Zanthoxyli Zanthoxylum nitidum (Roxb.) DC. or Radix Zanthoxyli Zanthoxylum nitidum var, the dry Herb of fastuosum How ex Huang.Another name another name: under Radix Zanthoxyli, red heart Zanthoxylum nitidum (Roxb.) DC, the red le of falling hook, Radix Zanthoxyli, two-sided pin, Zanthoxylum nitidum (Roxb.) DC, leaf, thread a needle, great Ye cat branch le, the tiger that goes up a hill, Radix Phytolaccae, Pericarpium Zanthoxyli, nature and flavor: bitter, pungent, put down; Slightly poisonous.Gui Jing: return liver, stomach warp.Function cures mainly: promoting the circulation of QI to relieve pain, blood circulation promoting and blood stasis dispelling, dispelling wind and removing obstruction in the collateral.The traumatic injury, rheumatic arthralgia, stomachache, the toothache that cause for qi depression to blood stasis, venom; The burning hot wound of external treatment soup.
Flos Carthami: be the dried floral of feverfew Flos Carthami Carthamus tinctorius L..Another name shuteria pampaniniana, thorn Flos Carthami, Flos Carthami, golden red flower.Warm in nature, acrid in the mouth, the latus rectum of invigorating blood circulation, eliminating stasis to stop pain.For amenorrhea, dysmenorrhea, lochia, lump in the abdomen mass in the abdomen, traumatic injury.When ancients often have what blood in vivo, often add Flos Carthami tate.Bundle is boiled available one day twice foot bath, is suitable for various varicosis, peripheral neuritis, and blood circulation is bad, lower limb numbness or the congestion such as livid purple.
Radix Inulae: the dry root of feverfew Radix Inulae Inula helenium L. or total shape Radix Inulae Inula racemosa Hook. f..[another name]: Radix Aristolochiae, Qi Muxiang, Radix Inulae, agate slave (Tibetan language), property of medicine classification]: temporary unfiled nature and flavor with return through: pungent, bitter, temperature.Return liver, spleen channel.[function with cure mainly]: invigorating the spleen and regulating the stomach, promoting the flow of QI for relieving the stagnancy, pain relieving is antiabortive.For the breast side of body, abdominal distention, vomiting dysentery, the breast side of body is dampened, and feels a pain in the chest when breathing and has a pain, frequent fetal movement.
Caulis menispermi: be the dry root and rhizome of vitaceae Caulis seu folium ampelopsis brevipedunculatae (Caulis Ampelopsis Brevipedunculae) Ampelopsis sinica (Miq) W.T.Wang.[meridian distribution of property and flavor] light, put down into kidney channel [effect] enriching yin and nourishing kidney.Control lumbago, scrofula.Chinese medicine bitter in the mouth, cold in nature.Slightly poisonous.Heat-clearing and toxic substances removing, throat, reducing swelling and alleviating pain, anticancer.Chinese medicine is controlled laryngopharynx swelling and pain, cough due to lung-heat, aphtha, gingivitis, jaundice, enteritis, dysentery, pyelonephritis, mumps, carbuncle pyogenic infections from tumour or sore, worm venom, esophageal carcinoma, gastric cancer.Mongolian medicine is controlled heat in blood, " association day " heat, and bone heat, hot " Xi Wu element " disease, erysipelas, thirsty, feel sick, vomiting, dermatosis." detailed outline is picked up any lost article from the road ": control lumbago.Scrofula.Caulis menispermi has good flesh pine effect, and its interaction property and curare are same.Sinomenine also has the effect of flesh pine.The sinomenine of high dose has contraction to cat bronchus, and this effect is relevant with its release histamine.Dauricine has spasmolysis to intestinal smooth muscle.Sinomenine and sinomenine all have hypotensive effect, and this effect may be due to its direct blood vessel dilating.Dauricine also has hypotensive effect, and its principle is central, simultaneously also relevant with block nerves joint with direct blood vessel dilating.Dauricine has stronger inhibitory action to streptococcus pneumoniae, hemophilus influenza.Sinomenine and Sinomenium acutum have tuberculosis effect, and dysentery bacterium and ameba are all had to inhibitory action; And all can suppress or kill in vivo and in vitro the cell of ehrlich ascites carcinoma.Sinomenine and sinomenine also have antiinflammatory, analgesia and stimulate the effect of mice reticuloendothelial system phagocytic function.Dauricine has antiinflammatory and Antitussive and Expectorant Effect.
Radix seu Folium Rubi Cochinchinensis: be dry root and the rhizome of rosaceous plant salem-rose Rubus rosaefolius smith.[another name] little fierce tiger, chicken aciculum, [nature and flavor] hardship; Pungent; Temperature [return through] liver; Kidney channel [function cures mainly] expelling wind and removing dampness, promoting the circulation of QI to relieve pain.Main air pain of dampness syndrome, traumatic pain, lumbago and skelalgia [usage and dosage] is for oral administration: decoct soup, 6-18g.[each discussion] " Chinese herbal medicine handbook is commonly used in Hainan Island ": wind dispelling, dehumidifying, circulation of qi promoting.Control lumbago and skelalgia, extremity arthralgia pain, rheumatic ostalgia.
Camphora: be the dry branch of canella Cinnamomum camphora (L) sied., leaf and root.Another name: splendid brain, camphor, brain, oily brain, tree brain.Gui Jing: the heart, spleen channel.Effect: orifice opening; Qi stagnation removing; Ward off foul; Killing parasites for relieving itching; Reducing swelling and alleviating pain
Mentholum: a kind of chemical agent, Mentholum is to be extracted by institute in the leaf of Herba Menthae and stem, white crystal, molecular formula C10H20O, is the main component in Herba Menthae and lavender quintessence oil.In the world, China and Brazil is main natural Herba Menthae manufacturing country, and the annual production of Oleum menthae all reaches 2000-3000t.Mentholum and racementhol all can be used as toothpaste; Perfume; The odorant of beverage and confection etc.As excitants, act on skin or mucosa pharmaceutically, have refrigerant itching-relieving action; The carminative that can be used as for oral administration, for headache and nose; Pharynx; Laryngitis etc.Its ester is for spice and medicine.
Rhizoma Zingiberis: the dry rhizome of zingiber Zingiber officinale Rosc..[nature and flavor, return through] acrid in the mouth, hot in nature.Return spleen, stomach, the heart, lung meridian.[effect] warming spleen and stomach for dispelling cold, recuperating depleted YANG is promoted blood circulation, dampness expectorant, warming the lung to resolve fluid-retention.[curing mainly] coldness and pain in the epigastrium; Vomiting; Have loose bowels, YANG-depletion is fainted contrary; Cold fluid-retention is breathed with cough; Arthralgia due to cold-dampnes.
Prescription Caulis Gneti of the present invention: nature and flavor hardship, temperature, return Liver Channel, expelling wind and removing dampness, promoting blood circulation to remove blood stasis; Pinaster pen; Five tastes rattan: nature and flavor are pungent, bitter, cool, expelling wind and removing dampness; Eliminating stasis to stop pain; Caulis et folium gaultheriae yunnanensis: nature and flavor are pungent, temperature, expelling wind and removing dampness, promoting blood circulation to remove obstruction in the collateral; Radix Zanthoxyli: nature and flavor hardship, pungent, flat, return liver, stomach warp, promoting the circulation of QI to relieve pain, blood circulation promoting and blood stasis dispelling, dispelling wind and removing obstruction in the collateral; Flos Carthami: warm in nature, acrid in the mouth, the latus rectum of invigorating blood circulation, eliminating stasis to stop pain; Radix Inulae: pungent, bitter, temperature, returns liver, spleen channel, and pain relieving, controls contusion; Caulis menispermi: nature and flavor are light, flat, enter kidney channel, and enriching yin and nourishing kidney, control lumbago, heat-clearing and toxic substances removing, reducing swelling and alleviating pain, Caulis menispermi also has good flesh pine effect; Radix seu Folium Rubi Cochinchinensis: nature and flavor hardship, pungent, warm, return liver, kidney channel, expelling wind and removing dampness, promoting the circulation of QI to relieve pain; Rhizoma Zingiberis: acrid in the mouth, hot in nature, return spleen, stomach, the heart, lung meridian, warming spleen and stomach for dispelling cold, recuperating depleted YANG is promoted blood circulation; Camphora: return through the heart, spleen channel, orifice opening, antipruritic, reducing swelling and alleviating pain; Mentholum: act on skin or mucosa, have refrigerant itching-relieving action.All medicines join five through science above promoting blood circulation to remove blood stasis, reducing swelling and alleviating pain, and wind dispelling dredging collateral, cold relieving removing dampness effect, be used for the treatment of Fengshi Guanjie pain, arthralgia due to cold, treating swelling and pain by traumatic injury, acute jerk contused wound.The using method of product of the present invention is: suitable amount used externally, wipe affected part 10 minutes, 3 times on the one at every turn.
The invention has the beneficial effects as follows:
1, the external-use tincture medicine that the present invention treats Fengshi Guanjie pain and treating swelling and pain by traumatic injury has that expelling wind and cold, Huoxue San " are crazy, effect of reducing swelling and alleviating pain, and the common sympton due to treatment rheumatic arthralgia and acute jerk contused wound is significantly improved to effect;
2, it is wide that the present invention treats the external-use tincture medicine material source of Fengshi Guanjie pain and treating swelling and pain by traumatic injury, easily obtains;
3, the external-use tincture pharmaceutical preparation that the present invention treats Fengshi Guanjie pain and treating swelling and pain by traumatic injury can extract and preserve the main active of ingredients in formula effectively;
4, the external-use tincture medicine that the present invention treats Fengshi Guanjie pain and treating swelling and pain by traumatic injury has no side effect, and uses safety, convenient, has enriched treatment Fengshi Guanjie pain and treating swelling and pain by traumatic injury patient's the medication range of choice.
5, Fengshi Guanjie pain is mostly due to wind-cold damp pathogen invasion and attack human body, impatency meridians, due to QI-blood circulation is not smooth, and traumatic injury can cause Yu Xue Bi resistance meridians, these two kinds of situations cause clinically conventionally with muscle, muscles and bones, ache in joint, numb, swelling, the symptoms such as joint stuffiness, therefore, the inventor is according to " general rule is not sick, pain obstructed " theory of Chinese medical science, for the upper pathogensis of crossing disease, formulate " reducing swelling and alleviating pain, blood circulation promoting and blood stasis dispelling, wind dispelling dredging collateral, cold relieving removing dampness " Therapeutic Principle, filter out prescription of the present invention, the Chinese medicine preparation of preparation is to traumatic injury thus, Fengshi Guanjie pain has significant curative effect, clinically applicable to for example Fengshi Guanjie pain, treating swelling and pain by traumatic injury, acute jerk contused wound, scapulohumeral periarthritis, the diseases such as innominate toxic swelling.
The discriminating of product of the present invention: can adopt following several method:
1, the thin layer differential method of Rhizoma Zingiberis,
Get this product 30ml, evaporate to dryness, residue adds dehydrated alcohol 3ml and petroleum ether (60～90 ℃) 9ml makes to dissolve, filter,, filtrate evaporate to dryness, residue adds dehydrated alcohol 1ml, makes to dissolve, as need testing solution.The negative sample 30ml that separately gets scarce Rhizoma Zingiberis is made in the same way of negative controls, then gets Rhizoma Zingiberis control medicinal material 1g, adds methanol 10ml, and reflux 30 minutes filters, filtrate evaporate to dryness, and residue adds methanol 1ml to be made to dissolve, medical material solution in contrast.Test according to thin layer chromatography (appendix VI B of Chinese Pharmacopoeia version in 2005), draw the each 5 μ l of above-mentioned three kinds of solution, put respectively on the same silica gel g thin-layer plate take sodium carboxymethyl cellulose as adhesive, take hexane-acetone-methanol (9:2.5:1) as developing solvent, launch, take out, dry, put under ultra-violet lamp (365nm) and inspect.In test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, the fluorescence speckle of aobvious same color.
2, Mentholum counter point,
Get Mentholum reference substance, add methanol and make the solution of 1ml containing 2mg, product solution in contrast.Test according to thin layer chromatography (appendix VI B of Chinese Pharmacopoeia version in 2000), draw need testing solution 10 μ l and above-mentioned reference substance solution 2 μ l under the item of [discriminating] (1), put respectively on the same silica gel g thin-layer plate take sodium carboxymethyl cellulose as adhesive, take normal hexane-ethyl acetate (8.5:1.5) as developing solvent, launch, take out, dry, spray, with vanillin sulphuric acid test solution, is heated to speckle colour developing at 105 ℃ clear.In test sample chromatograph, with the corresponding position of reference substance on, the speckle of aobvious same color.
Determination of menthol algoscopy is calculated: accurate reference substance solution and the each 1ml of need testing solution of drawing respectively, inject gas chromatograph, measures, and calculates, and to obtain final product.The every 1ml of this product must not be lower than 9.0mg containing Mentholum (C10H20O).
3, Camphora relative method,
Get this product 2ml, add 60% ethanol dilution to 10ml, as need testing solution.Separately get negative sample 2ml and be made in the same way of negative sample solution, then get Camphora reference substance 201mg, add 60% ethanol 10ml and make to dissolve, product solution in contrast.According to gas chromatography, appendix VI E test of Chinese Pharmacopoeia version in 2005, take Polyethylene Glycol (PEG)-20M as immobile phase, coating concentration is 10%; Column temperature 150+10 ℃, draws respectively above-mentioned three kinds of solution 1-2 μ l, and inject gas chromatograph, presents the chromatographic peak identical with reference substance retention time in test sample chromatograph respectively.
4, Radix Inulae differential method
Radix Inulae medical material is differentiated and is tested: method is, get this product 30ml, adding petroleum ether jolting extracts 2 times, each 20ml, merge petroleum ether liquid extracting solution, evaporate to dryness, residue adds ethyl acetate 1ml, make to dissolve, as need testing solution, separately get negative sample 30ml and be made in the same way of negative sample solution, get again Radix Aristolochiae control medicinal material 1g, adding petroleum ether 2ml dipping spends the night, filter, filtrate is medical material solution in contrast, test according to thin layer chromatography (appendix VI B of Chinese Pharmacopoeia version in 2005), draw the each 10 μ l of above-mentioned 3 kinds of solution, put respectively on the same silica gel g thin-layer plate take sodium carboxymethyl cellulose as adhesive, take petroleum ether-ethyl acetate (8.5:1.5) as developing solvent, launch, take out, dry.Spray is with 2-4-dinitrophenylhydrazine test solution, in test sample chromatograph, with the corresponding position of control medicinal material on the speckle of aobvious same color.
The specific embodiment
Embodiment 1:
(1) often make the required primary raw material of the external-use tincture medicine of 1000ml by following weight proportion:
Caulis Gneti 30g, a pinaster 20g, five tastes rattan 10g, Caulis et folium gaultheriae yunnanensis 15g, Radix Zanthoxyli 10g, Flos Carthami 15g, Camphor tree, brain 15g, Radix Inulae 10g, Caulis menispermi 10g, Radix seu Folium Rubi Cochinchinensis 15g, Rhizoma Zingiberis 15g, Mentholum 15g;
(2) the present invention treats the preparation method of the external-use tincture medicine of Fengshi Guanjie pain and treating swelling and pain by traumatic injury and is:
A: the crude drug described parts by weight: Caulis Gneti, pinaster pen, five tastes rattan, Caulis et folium gaultheriae yunnanensis, Radix Zanthoxyli, Flos Carthami, Radix Inulae, Caulis menispermi, Radix seu Folium Rubi Cochinchinensis, Rhizoma Zingiberis, is ground into coarse powder;
B: former step a coarse powder medicine is shone to the percolation (appendix I O of Chinese Pharmacopoeia version in 2000) under fluid extract and extractum item, make solvent with 70% ethanol, flood after 48 hours, with the slowly percolation of speed of approximately 1～2ml per minute, collect the about 800ml of liquid that just filters, another device is preserved;
C: continue percolation to till 12 times of amounts of medical material amount, collect the continuous liquid of filtering, reclaim ethanol, be concentrated into relative density under 40-70 ℃ of condition and be 1.03～1.05 clear paste, let cool, be incorporated to the liquid of just filtering;
D: separately get Camphora, Mentholum, add ethanol 50ml and make to dissolve, add in above-mentioned solution, add ethanol to ormal weight, shake up, leave standstill 24 hours, filter, obtain the finished product five pines of the present invention tincture that swells and ache.
(3) the above pulverizing medicinal materials can adopt the conventional method such as independent pulverizing, co-grinding, dry pulverization process, waterproof pulverization.
Embodiment 2:
(1) often make the required primary raw material of the external-use tincture medicine of 1000ml by following weight proportion:
Caulis Gneti 36g, a pinaster 20g, five tastes rattan 15g, Caulis et folium gaultheriae yunnanensis 15g, Radix Zanthoxyli 24g, Flos Carthami 10g, Camphora 10g, Radix Inulae 10g, Caulis menispermi 15g, Radix seu Folium Rubi Cochinchinensis 15g, Rhizoma Zingiberis 15g, Mentholum 15g;
(2) the present invention treats the preparation method of the external-use tincture medicine of Fengshi Guanjie pain and treating swelling and pain by traumatic injury and is:
A: the crude drug described parts by weight: Caulis Gneti, pinaster pen, five tastes rattan, Caulis et folium gaultheriae yunnanensis, Radix Zanthoxyli, Flos Carthami, Radix Inulae, Caulis menispermi, Radix seu Folium Rubi Cochinchinensis, Rhizoma Zingiberis, is ground into coarse powder;
B: former step a coarse powder medicine is shone to the percolation (appendix I O of Chinese Pharmacopoeia version in 2000) under fluid extract and extractum item, make solvent with 70% ethanol, flood after 48 hours, with the slowly percolation of speed of approximately 1～2ml per minute, collect the about 800ml of liquid that just filters, another device is preserved; C: continue percolation to till 12 times of amounts of medical material amount, collect the continuous liquid of filtering, reclaim ethanol, be concentrated into relative density under 40-70 ℃ of condition and be 1.03～1.05 clear paste, let cool, be incorporated to the liquid of just filtering;
D: separately get Camphora, Mentholum, add ethanol 50ml and make to dissolve, add in above-mentioned solution, add ethanol to ormal weight, shake up, leave standstill 24 hours, filter, obtain the finished product five pines of the present invention tincture that swells and ache.
(3) the above pulverizing medicinal materials can adopt the conventional method such as independent pulverizing, co-grinding, dry pulverization process, waterproof pulverization.
Embodiment 3:
(1) often make the required primary raw material of the external-use tincture medicine of 1000ml by following weight proportion:
Caulis Gneti 30g, a pinaster 15g, five tastes rattan 12g, Caulis et folium gaultheriae yunnanensis 12g, Radix Zanthoxyli 20g, Flos Carthami 10g, Camphora 10g, Radix Inulae 10g, Caulis menispermi 15g, Radix seu Folium Rubi Cochinchinensis 15g, Rhizoma Zingiberis 15g, Mentholum 15g
(2) the present invention treats the preparation method of the external-use tincture medicine of Fengshi Guanjie pain and treating swelling and pain by traumatic injury and is:
A: the crude drug described parts by weight: Caulis Gneti, pinaster pen, five tastes rattan, Caulis et folium gaultheriae yunnanensis, Radix Zanthoxyli, Flos Carthami, Radix Inulae, Caulis menispermi, Radix seu Folium Rubi Cochinchinensis, Rhizoma Zingiberis, is ground into coarse powder;
B: former step a coarse powder medicine is shone to the percolation (appendix I O of Chinese Pharmacopoeia version in 2000) under fluid extract and extractum item, make solvent with 70% ethanol, flood after 48 hours, with the slowly percolation of speed of approximately 1～2ml per minute, collect the about 800ml of liquid that just filters, another device is preserved; C: continue percolation to till 12 times of amounts of medical material amount, collect the continuous liquid of filtering, reclaim ethanol, be concentrated into relative density under 40-70 ℃ of condition and be 1.03～1.05 clear paste, let cool, be incorporated to the liquid of just filtering;
D: separately get Camphora, Mentholum, add ethanol 50ml and make to dissolve, add in above-mentioned solution, add ethanol to ormal weight, shake up, leave standstill 24 hours, filter, obtain the finished product five pines of the present invention tincture that swells and ache.
(3) the above pulverizing medicinal materials can adopt the conventional method such as independent pulverizing, co-grinding, dry pulverization process, waterproof pulverization.
Embodiment 4, spray preparation (1000ml):
Caulis Gneti 25g, a pinaster 10g, five tastes rattan 5g, Caulis et folium gaultheriae yunnanensis 5g, Radix Zanthoxyli 14g, Flos Carthami 5g, Camphora 5g, Radix Inulae 5g, Caulis menispermi 5g, Radix seu Folium Rubi Cochinchinensis 5g, Rhizoma Zingiberis 5g, lotus brain 5g;
(1) weigh by weight crude drug: Caulis Gneti, pinaster pen, five tastes rattan, Caulis et folium gaultheriae yunnanensis, Radix Zanthoxyli, Flos Carthami, Radix Inulae, Caulis menispermi, Radix seu Folium Rubi Cochinchinensis and ginger powder are broken into coarse powder;
(2) former step (1) coarse powder medicine is shone to the percolation under fluid extract and extractum item, make solvent with 70% ethanol, flood after 48 hours, with the slowly percolation of speed of approximately 1～2ml per minute, collect the about 800ml of liquid that just filters, preserve;
(3) continue percolation to till 12 times of amounts of medical material amount, collect the continuous liquid of filtering, reclaim ethanol, under 40-70 ℃ of condition, be concentrated into relative density and be 1.03～1.05 clear paste, let cool, be incorporated to the liquid of just filtering;
(4) separately get Camphora, Mentholum, add propylene glycol 50ml and make to dissolve, add in above-mentioned solution, and add surfactant tween or the span of 0.1-10 gram, the flavouring agent of 0.5-1 gram, adds ethanol to ormal weight, shakes up, and leaves standstill 24 hours, filter, pack in spray bottle, obtain spray product.
Embodiment 5, spray preparation (1000ml):
Caulis Gneti 30g, a pinaster 20g, five tastes rattan 14g, Caulis et folium gaultheriae yunnanensis 10g, Radix Zanthoxyli 18g, Flos Carthami 8g, Camphora 9g, Radix Inulae 10g, Caulis menispermi 15g, Radix seu Folium Rubi Cochinchinensis 15g, Rhizoma Zingiberis 15g, lotus brain 15g;
(1) weigh by weight crude drug: Caulis Gneti, pinaster pen, five tastes rattan, Caulis et folium gaultheriae yunnanensis, Radix Zanthoxyli, Flos Carthami, Radix Inulae, Caulis menispermi, Radix seu Folium Rubi Cochinchinensis and ginger powder are broken into coarse powder;
(2) former step (1) coarse powder medicine is shone to the percolation under fluid extract and extractum item, make solvent with 70% ethanol, flood after 48 hours, with the slowly percolation of speed of approximately 1～2ml per minute, collect the about 800ml of liquid that just filters, preserve;
(3) continue percolation to till 12 times of amounts of medical material amount, collect the continuous liquid of filtering, reclaim ethanol, under 40-70 ℃ of condition, be concentrated into relative density and be 1.03～1.05 clear paste, let cool, be incorporated to the liquid of just filtering;
(4) separately get Camphora, Mentholum, add propylene glycol 50ml and make to dissolve, add in above-mentioned solution, and add surfactant tween or the span of 0.1-10 gram, the flavouring agent of 0.5-1 gram, adds ethanol to ormal weight, shakes up, and leaves standstill 24 hours, filter, pack in spray bottle, obtain spray product.
Clinical verification:
Five pines are swollen and ache tincture system according to the ethnic drug preparation of Guangxi Minority experience and traditional Chinese medical theory development, have the cold expelling of invigorating blood circulation, and effect of reducing swelling and alleviating pain, expelling wind and removing dampness, for limbs joint pain, the acute jerk contused wound etc. of anemofrigid-damp arthralgia.In order to verify its effect, with reference to " guideline of clinical investigations of new Chinese medicine treatment numbness disease " [1] and " guideline of clinical investigations of new Chinese medicine treatment acute soft tissue injury " [2], the first Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi (120 example), Guangxi Chinese medicine the second Affiliated Hospital (100 example) and The People's Hospital, Guangxi Zhuang Autonomous Region's (100 example) carried out clinical trial to the five pines tincture that swells and ache before 3 years, and result is summarized as follows:
1, treatment group obvious effective rate, effective percentage are respectively 64.2%, 21.7%, and total effective rate is 85.8%; Matched group obvious effective rate, effective percentage are respectively 57.5%, 25.8%, and total effective rate is 83.3%.Two groups relatively without significance.To numbness, sick and acute jerk contused wound all has good analgesic effect to tincture to point out five pines to swell and ache, with to contrast medicine similar.
2, the different sick efficacy results of planting are distinguished, and two groups to disadvantage and the equal no significant difference of acute jerk contused wound analgesic effect.
3, clinical symptoms efficacy result shows, after two groups of curative effects, the symptoms such as the conscious pain of patient, tenderness, swelling moving obstacle all have clear improvement.But two groups of comparisons, no significant difference.Point out the five pines tincture that swells and ache can obviously improve disadvantage and acute jerk contused wound patient's clinical symptoms, with to contrast medicine similar.
4, after treatment, pain relief, extinction time comparative result show, the five pines relieving pain of tincture to disadvantage and acute jerk contused wound that swell and ache, with to contrast medicine similar.
5, this research to 200 routine patients carried out blood, just conventional teaching notes are poor, the heart, liver, kidney function test, all do not find obvious adverse reaction and toxic and side effects.Prompting this product is clinical safe and reliable.
The swell and ache tincture stability test report of five pines
" technical requirement of study of tcm new drug " of promulgating by National Drug Administration and the five pines tincture that swells and ache is produced and this product three batch samples has been carried out to stability test with drug standard (trying), and result is as follows:
1 test specimen: the large pharmaceutcal corporation, Ltd of Guangxi Yulin great Jin produces, lot number 030104,030112,030118.
2 investigation projects: character, discriminating, inspection, assay, limit test of microbe.
3 test methods: sample is going on the market with under terms of packing, in room temperature (8～30 ℃), under relative humidity 40～95% states, preserve, investigate by the five pines tincture quality standard that swells and ache, limit test of microbe project is by microorganism limit examine method check of " Chinese Pharmacopoeia " version in 2000.Except of that month (0 month) once, the 3rd month, the 6th month, the 12nd month and each examination in 18th month once, are investigated this product character identification, inspection, assay and limit test of microbe project.
4 result of the tests: in table 1,2,3.
5 conclusions: " the study of tcm new drug technical requirement " that this product is promulgated by National Drug Administration and the five pines tincture that swells and ache is produced and all conformed with the regulations with character, discriminating, inspection, the assay of drug standard (trying) three batch samples.Limit test of microbe bacterial population is all less than 100/ml, and mycete is all less than 100/ml,, escherichia coli, the demodicid mite that lives all do not detect.Be that pass the test all conforms with the regulations.Showing that this product is under listing drug packaging condition, preserve 18 months drug qualities stable under room temperature (8～30 ℃), relative humidity 40～95% conditions, is 2 years therefore determine this product shelf-life.
Drug standard of the present invention also can use the thin layer of Rhizoma Zingiberis to differentiate.Method is: get this product 30ml, and evaporate to dryness, residue adds dehydrated alcohol 3ml and petroleum ether (60～90 ℃) 9ml makes to dissolve, filter, filtrate evaporate to dryness, residue adds dehydrated alcohol 1ml, makes to dissolve, as need testing solution.The negative sample 30ml that separately gets scarce Rhizoma Zingiberis is made in the same way of negative controls, then gets Rhizoma Zingiberis control medicinal material 1g, adds methanol 10ml, and reflux 30 minutes filters, filtrate evaporate to dryness, and residue adds methanol 1ml to be made to dissolve, medical material solution in contrast.Test according to thin layer chromatography (appendix VI B of Chinese Pharmacopoeia version in 2005), draw the each 5 μ l of above-mentioned three kinds of solution, put respectively on the same silica gel g thin-layer plate take sodium carboxymethyl cellulose as adhesive, take hexane-acetone-methanol (9:2.5:1) as developing solvent, launch, take out, dry, put under ultra-violet lamp (365nm) and inspect.In test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, the fluorescence speckle of aobvious same color.
(2) within the tentative phase, prove this discrimination method basic feasible solution, therefore revise.
(3) this discrimination method is the discrimination method of Camphora medical material newly-increased within the tentative phase.Get this product 2ml, add 60% ethanol dilution to 10ml, as need testing solution.Separately get negative sample 2ml and be made in the same way of negative sample solution, then get Camphora reference substance 201mg, add 60% ethanol 10ml and make to dissolve, product solution in contrast.According to gas chromatography (appendix VI E of Chinese Pharmacopoeia version in 2005) test, take Polyethylene Glycol (PEG)-20M as immobile phase, coating concentration is 10%; Column temperature 150+10 ℃, draws respectively above-mentioned three kinds of solution 1-2 μ l, and inject gas chromatograph, presents the chromatographic peak identical with reference substance retention time in test sample chromatograph respectively.This test method favorable reproducibility, specificity is strong, negative noiseless, therefore income text.
Claims (3)
1. an external preparation for the treatment of Fengshi Guanjie pain and treating swelling and pain by traumatic injury, is characterized in that: the external preparation of 1000ml is made up of the crude drug of following weight: Caulis Gneti 26-46g, a pinaster 10-30g, five tastes rattan 5-25g, Caulis et folium gaultheriae yunnanensis 5-25g, Radix Zanthoxyli 14-34g, Flos Carthami 5-20g, Camphora 5-20g, Radix Inulae 5-20g, Caulis menispermi 5-25g, Radix seu Folium Rubi Cochinchinensis 5-25g, Rhizoma Zingiberis 5-25g, Mentholum 5-25g; Described external preparation comprises tincture and spray.
2. the external preparation for the treatment of Fengshi Guanjie pain according to claim 1 and treating swelling and pain by traumatic injury, is characterized in that: the preparation method of tincture is:
(1) weighting raw materials by weight: Caulis Gneti, pinaster pen, five tastes rattan, Caulis et folium gaultheriae yunnanensis, Radix Zanthoxyli, Flos Carthami, Radix Inulae, Caulis menispermi, Radix seu Folium Rubi Cochinchinensis and ginger powder are broken into coarse powder;
(2) the coarse powder of step (1), make solvent with volumetric concentration 60-80% ethanol, flood after 48 hours, with the slowly percolation of speed of 1～2ml per minute, collect the about 800ml of liquid that just filters, preserve;
(3) till continuing percolation to percolate and being 12 times of weight of medical material amount, collect the continuous liquid of filtering, reclaim ethanol, under 40-70 ℃ of condition, be concentrated into relative density and be 1.03～1.05 clear paste, let cool, be incorporated to the liquid of just filtering;
(4) separately get Camphora, Mentholum, add ethanol 50ml and make to dissolve, add in the solution that step (3) obtains, add ethanol to ormal weight, shake up, leave standstill 24 hours, filter, bottling, obtains product.
3. the external preparation for the treatment of Fengshi Guanjie pain according to claim 1 and treating swelling and pain by traumatic injury, is characterized in that: the method for preparing spray is:
(1) weighting raw materials by weight: Caulis Gneti, pinaster pen, five tastes rattan, Caulis et folium gaultheriae yunnanensis, Radix Zanthoxyli, Flos Carthami, Radix Inulae, Caulis menispermi, Radix seu Folium Rubi Cochinchinensis and ginger powder are broken into coarse powder;
(2) the coarse powder of step (1), make solvent with 70% ethanol, flood after 48 hours, with the slowly percolation of speed of 1～2ml per minute, collect the about 800ml of liquid that just filters, preserve;
(3) till continuing percolation to percolate and being 12 times of amounts of medical material amount, collect the continuous liquid of filtering, reclaim ethanol, under 40-70 ℃ of condition, be concentrated into relative density and be 1.03～1.05 clear paste, let cool, be incorporated to the liquid of just filtering;
(4) separately get Camphora, Mentholum, adding propylene glycol 50ml makes to dissolve, add in the solution that step (3) obtains, and add surfactant tween or the span of 0.1-10 gram, the flavouring agent of 0.5-1 gram, add ethanol to ormal weight, shake up, leave standstill 24 hours, filter, pack in spray bottle, obtain spray product.
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