CN1240658A - Quickly-acting antalgesic liniment and its preparing process - Google Patents
Quickly-acting antalgesic liniment and its preparing process Download PDFInfo
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Abstract
A quickly-acting antalgesic liniment for treating injury, fracture, sprain and joint pain is prepared from 6 Chinese-medicinal materials through mixing notoginseng, sapanwood, baked alum and borax, soaking in 70-80% alcohol for 60-85 hr, filtering, squeezing dregs, still standing the mixture of the squeezed liquid and leaching liquor, adding Dragon's blood and borneol, dissolving them in mixed liquid, addition 70-80% alcohol, deposition and filtering.
Description
The present invention relates to treat diseases such as traumatic injury, sprained ankle, soft tissue injury, anti-inflammatory analgetic, the external Chinese patent medicine of blood circulation promoting and blood stasis dispelling, particularly quickly-acting antalgesic liniment and preparation method thereof.
In the document of Chu Baning, retrieve the report of some Traditional Chinese medicine used as analgesic external curing traumatic injury, soft tissue injury at home.As: " Chinese orthopedics and traumatology of Chinese medicine " magazine the 3rd volume the 5th phase 1-5 page or leaf that nineteen ninety-five publishes, by the damage liquefaction film liniment of reports such as Hou Wei, main medicine consists of the Radix Angelicae Dahuricae, Radix Angelicae Sinensis, Flos Carthami, Radix Saposhnikoviae, Radix Notoginseng etc., has antiinflammatory, analgesic effect.256 pages of the 15th the 6th phases of volume of " the Shaanxi traditional Chinese medical science " magazine of publishing in 1994, " the red Radix Et Rhizoma Rhei liniment treated of Cape jasmine soft tissue injury 121 examples " by the report of comrade lieutenant colonel still, adopt its main medicine of the red Radix Et Rhizoma Rhei liniment of Cape jasmine to consist of: Fructus Gardeniae, Radix Et Rhizoma Rhei, Flos Carthami, Borneolum Syntheticum, the treatment cartilaginous tissue damages 121 examples, and total effective rate is 98.3%.This medicine has the effect of eliminating blood stasis swelling, alleviating pain, restore funcitons." the Shaanxi traditional Chinese medical science " magazine the 18th volume the 2nd phase 64-65 page or leaf of publishing in 1997, muscles and tendons relaxing to alleviate pain liquid treatment scapulohumeral periarthritis by the Chen Shuangquan report, its main medicine consists of: Semen Strychni (processed), Radix Aconiti, Radix Aconiti Kusnezoffii, Sanguis Draxonis, Agkistrodon, Lignum Sappan, Camphora, Borneolum Syntheticum etc., treatment scapulohumeral periarthritis 100 examples, total effective rate is 80%, and this medical instrument has effects such as blood circulation promoting and blood stasis dispelling, expelling wind and cold, removing obstruction in the collateral to relieve pain.
From the Traditional Chinese medicine used as analgesic external curing traumatic injury of above-mentioned domestic literature report, the argumentation of soft tissue injury, its externally applied liniment medicine composition has nothing in common with each other.
The purpose of this invention is to provide a kind of quickly-acting antalgesic liniment, sprain the disease of joint caused kindred pain, livid purple swelling in order to treatment traumatic injury, sprain and contusion, have the function that the analgesia of alleviating pain, anti-inflammation detumescence, blood circulation promoting and blood stasis dispelling, circulation of qi promoting are promoted blood circulation, prescription of the present invention is formed to form with existing disclosed externally applied liniment medicine and is had nothing in common with each other.
Content of the present invention is quickly-acting antalgesic liniment and preparation method thereof.Quickly-acting antalgesic liniment prescription scope is:
Radix Notoginseng: 24.5-25.5g dried Alumen: 37.0-38g Lignum Sappan: 24.5-25.5g
Sanguis Draxonis: 24.5-25.5g Borax: 24.5-25.5g Borneolum Syntheticum: the preferential prescription of selecting of 112-113g quickly-acting antalgesic liniment is:
Radix Notoginseng: 25.0g dried Alumen: 37.5g Lignum Sappan: 25.0g
Sanguis Draxonis: 25.0g Borax: 25.0g Borneolum Syntheticum: the preparation method of 112.5g quickly-acting antalgesic liniment is:
1. get Radix Notoginseng, Lignum Sappan (30 orders-60 purpose coarse powder) and Borax, dried Alumen (80 orders-100 purpose fine powder) mixing;
2. adding concentration is the ethanol 1000ml of 70-80%, soaks 60-85 hour;
3. filter, squeeze filtering remaining medicinal residues;
4. leachate and pressed liquor are mixed, leave standstill more than 24 hours;
5. in the mixed liquor of leachate and pressed liquor, add Sanguis Draxonis, Borneolum Syntheticum, and be dissolved in the mixed liquor;
6. the ethanol that adds concentration again and be 70-80% is to 1000ml, shakes up, clarification filtration, promptly.
(medicament sources) this preparation Chinese crude drug: Radix Notoginseng, Lignum Sappan, Sanguis Draxonis, Borneolum Syntheticum, Borax, dried Alumen are " Pharmacopoeia of People's Republic of China " standard.
1. Radix Notoginseng this product is the dry root of panax araliaceae plant Panax notoginseng (Burk) F.H.Chende.This product should meet " the pertinent regulations under 1995 editions one 8-9 page or leaf Radix Notoginseng item of Chinese pharmacopoeia.
2. Lignum Sappan this product is the dry core of leguminous plant Lignum Sappan Caesalpinin sappan L..This product should meet " the pertinent regulations under 1995 editions the 140th page of Lignum Sappan items of Chinese pharmacopoeia.
3. Sanguis Draxonis this product is that babassu black horse Lin exhausts the resin in Daemonnrops dracoBL fruit and the trunk, sees " 1995 editions one one of Chinese pharmacopoeia, 23 pages of appendix.
4. Borneolum Syntheticum this product is water white transparency or the crisp crystallization of white translucent lamellar.This product should meet " the pertinent regulations under 1995 editions the 122nd page of Borneolum Syntheticum items of Chinese pharmacopoeia.
5. Borax this product is the refining crystallization that forms of tincal warp, sees " 1995 editions one one of Chinese pharmacopoeia, 25 pages of appendix.
6. dried Alumen this product is that the Alumen that Sulfates mineral alunite processing refinement is made forms through calcining.This product should meet " the pertinent regulations under 1995 editions the 89th page of Alumen items of Chinese pharmacopoeia.By monarch, minister, help, make the principles of formulating prescriptions to analyze prescription compatibility of medicines:
Radix Notoginseng, returns liver, stomach warp at property sweet and slightly bitter taste, temperature.Compendium of Material Medica claims: Radix Notoginseng, " all canes are pounced on trauma, the dripping person of blood stasis, promptly ending of the mashed net for catching birds or fish of purt immediately, and bruise the person promptly dissipate." " book on Chinese herbal medicine is looked for the truth " title: " cause of disease blood stasis is then painful to be done, and the bitter temperature of Radix Notoginseng abnormal smells from the patient can be in its blood stasis of blood systemization.”
Skin infection gets that it is sour and astringent and receive also." " the Changsha medicine is separated " claim: " and Alumen, blood stasis dispelling is turbid, changes deteriorated blood and the painful abdominal mass whip that disappears, removing dampness gas and blood stasis dispelling corruption, drink the kind old expectorant place of telling down.The edge sputum condenses, and viscous is between last lower orifices tunnel, and the jail is not movable, and Alumen is collected and mopped up it, loses force from root, and internal organs are not allowed, and reality is non-tells the purgation thing also." institute of comprehensive above all families opinion, dried Alumen is can expectorant turbid, blood stasis dispelling is turbid, the deteriorated blood of dispelling, the painful abdominal mass that disappears are hard, can eliminate blood stasis, and it is turbid to dissolve expectorant again, is the good merchantable brand of the card of blood stasis dispelling expectorant treatment phlegm and blood stasis." Records of Tradition Chinese and Western Medicine in Combination " claims: " Radix Notoginseng is apt to blood stasis dispelling blood.If traumatic injury, in connect the internal organs meridians and do pain person, external application or take medicine orally, You Jie proves effective ".Go up according to this each tame institute opinion, Radix Notoginseng has the merit of blood circulation promoting and blood stasis dispelling, can blood stasis dispelling relieve the pain bitterly blood stasis dispelling dissipation bruise.
Sanguis Draxonis, property sweet-salty, flat, GUIXIN, Liver Channel." guiding principle ends " claims: interchannel Liu Shi cloud: " Sanguis Draxonis dehematize pain is for the panacea with blood is "." Bencao Jingshu " claims: " black horse Lin exhausts, the key medicine of dissipating blood stasis blood, tissue regeneration promoting blood, thus main removing mass blood, pain relieving.Lee Xun beats damage with it folding that cures the wound, and all pain, vim and vigour are stirred thorn "." book on Chinese herbal medicine meets former " claims: " Sanguis Draxonis is got to be in harmonious proportion vim and vigour, does not stop up the trouble of poison and have to be detained." go up each family comment according to this, Sanguis Draxonis tool dissipating blood stasis blood, the merit of removing mass blood is good at treatment wound pain due to blood stasis especially, and can QI and blood regulating and do not have to be detained and stop up the trouble of poison.
Lignum Sappan, the little suffering of property sweet-salty, flat, GUIXIN, liver, spleen channel." detailed outline " claims: Lignum Sappan, " few using then and blood, the then removing blood stasis of using " more." Bencao Jingshu " claims: Lignum Sappan, " salty master goes into blood, and suffering can be wandered away, and it is capable to lose the long-pending blood of the turbid stasis of blood, so all sluggish blood that stay knot of dispelling." " book on Chinese herbal medicine is looked for the truth " claim: Lignum Sappan, " function has the class Flos Carthami, few with then can and blood, many with then can removing blood stasis.So disease such as all sick injury from falling down, all should phase disease close and recuperate under medical treatment with its medicine." comprehensive above each tame institute opinion, the Lignum Sappan tool is invigorated blood circulation, the merit of removing blood stasis, can make that to lose the long-pending blood of the turbid stasis of blood capable, and the sluggish blood that stays knot of dispelling is used for the treatment of the blood stasis symptom of injury from falling down.
Borax, property sweet-salty, cold attach to the lung and stomach meridians." detailed outline " claims: Borax " can go the heat of the chest and diaphragm part of the body cavity above the diaphragm housing the heart and lungs, control expectorant heat." " Bencao Jingshu " title: " can separate the expectorant heat of part of the body cavity above the diaphragm housing the heart and lungs chest and diaphragm lung branch, broken crux is also for Borax." " gram is cut and is usefulness, is dissipated as energy, should attack and have a surplus." " book on Chinese herbal medicine converge with speech " claim: " the light Qinghua of oozing is as all sick belong to gas-tight, expectorant knot, fiery knot person, with this upright disappearing for Borax." comprehensive above each tame institute opinion, Borax can close in circulation of qi promoting, and clearing and dissipating phlegm-heat, broken crux are become what one is particularly good at the gram expectorant of cutting, dissipate.Report: grind superfine end with Borax(calcined) and put in ophthalmic and gv cave, and action activity waist such as do to bend over, turn round, squat down, to stand up, in order to the treatment pain of spraining one's back, most cases are fully recovered for 1-3 time.
Dried Alumen, nature and flavor are sour and astringent, cold, return lung, liver, spleen, large intestine channel." detailed outline " claims: " usefulness of Alumen, the sputum of vomiting and diarrhea wind heat are got its sour and bitter flavors can cause of vomiting and diarrhea also; Control all blood pains, proctoptosis, the prolapse of the uterus, skin infection, get that it is sour and astringent and receive also." " the Changsha medicine is separated " claim: " and Alumen, blood stasis dispelling is turbid, changes deteriorated blood and the painful abdominal mass whip that disappears, removing dampness gas and blood stasis dispelling corruption, drink the general old expectorant place of telling down.The edge sputum condenses, and viscous is between last lower orifices tunnel, and the jail is not movable, and Alumen is collected and mopped up it, loses force from root, and internal organs are not allowed, and reality is non-tells the purgation thing also." institute of comprehensive above all families opinion, dried Alumen is can expectorant turbid, blood stasis dispelling is turbid, the deteriorated blood of dispelling, the painful abdominal mass that disappears are hard, can eliminate blood stasis, and it is turbid to dissolve expectorant again, is the good merchantable brand of the card of blood stasis dispelling expectorant treatment phlegm and blood stasis.
Borneolum Syntheticum, nature and flavor are worked hard, are slightly cold, GUIXIN, spleen, lung meridian.Amplification on Canon of Materia Medica claims: " Borneolum Syntheticum, the big tonneau of this thing closes the heat of the diaphragm plug, and its delicate fragrance is that hundred medicines are earlier, and children's's adult wind saliva closes the heap soil or fertilizer over and around the roots usefulness of very helping." " herbal collection will " claim: " and Borneolum Syntheticum, Da Xin is apt to away, so can the tonneau stagnation of QI, get its hot diffusing also." " detailed outline " title: " fire stagnation is then sent out it, the method for contrary treatment, the hot main Gu Er that disperses.Can walk and can loose, make the energy that is jammed sharp, then the meridians bar reaches." " Bencao Jingshu " title: " Borneolum Syntheticum, property are apt to away scurry and are had one's ideas straightened out, and do not have toward not reaching; The gas of fragrance, it is evil to ward off a joint." " book on Chinese herbal medicine is stated " claim: " and Borneolum Syntheticum, it treats all diseases, closes heat of the diaphragm as the so-called tonneau of ancestor and stops up, and cuts the so-called heat radiation of vegetarian tonneau stagnation of QI, middle what is called is gas-tight gives birth to and ties up all diseases, act can be opened it, be its loose stop up, sharp knot, switching, treat not well.The method person of the contrary treatment is all thought in more all theory, and is very also not wrong.It is that all heap soil or fertilizer over and around the roots persons, knot person, the person of closing suffer from part and can loose blood also with it that this flavor had both been called hot loosing." " medical center bun will " claim: " and Borneolum Syntheticum, the gas-solid of hot perfume reaches invariably, and property is walked and is not kept, also can pain relieving." institute of comprehensive above all families opinion, the hot hardship of loosing of Borneolum Syntheticum is let out, energy tonneau stagnation of QI, and dismission is jammed, and bar reaches meridians, and walk to scurry and have one's ideas straightened out, the removing summer-heat accumulation of heat, the evil of avoiding evil spirits, blood and relieving pain can loose again.So all heap soil or fertilizer over and around the roots persons, knot person, the person of closing, switching is tied in can loose heaps soil or fertilizer over and around the roots, profit of Borneolum Syntheticum.
Ethanol, nature and flavor sweetness and bitterness suffering, temperature, GUIXIN, liver, lung, stomach warp." health preserving will collect " claims: " the wine person saves its minute agent and drinks it, suitable and hundred arteries and veins." " Mingyi Bielu " claim: " and big cold coagulation sea, only wine is not iced, and it is bright that it is hot, only Computer Associates International Inc. thing, medicine man pogoniasis is to go the medicine gesture." Materia Medica of Decoction claims: " it is more than that wine can be manageed it all warps." " Bencao Jingshu " claim: " and generation in wine, unexpectedly its priming is up, promptly calls its priming and goes into blood; Not saying capable medicine gesture, wouldn't be disease to be that medicine originally controls, and special its machine gesture is not opened, whereby with row? " comprehensive above each tame institute opinion, suitable and hundred arteries and veins of wine energy, all warps of row are more than, more significant feature is a row medicine gesture, promptly makes the therapeutical effect of its medicine be fully played by means of capacity for liquor.
In the quickly-acting antalgesic side, Radix Notoginseng blood-activating analgetic, detumescence, be used to fall pounce on turn round frustrate etc. that wound is joint caused, muscle pain due to blood stasis, its effect of livid purple swelling be excellent, so monarch drug in the side of being.Sanguis Draxonis can dissipating blood stasis blood, removing mass blood, and can prevent that the blood stasis heap soil or fertilizer over and around the roots of being detained is malicious, livid purple its effect of wound swelling and pain due to blood stasis is rather good with controlling; Lignum Sappan can be invigorated blood circulation, removing blood stasis and removing blood stasis, and can make that to lose the long-pending blood of the turbid stasis of blood capable, and can dispel stagnates stays the blood of knot, with Sanguis Draxonis mutually 5, helps the Radix Notoginseng blood-activating analgetic to subside a swelling, and is the ministerial drug in the side.The Borax circulation of qi promoting is closed, clearing away phlegm heat, broken crux, 2 gram expectorants knots; Dried Alumen is can expectorant turbid, blood stasis dispelling is turbid, the deteriorated blood of dispelling, the painful abdominal mass that disappears are hard, doubleization of the expectorant stasis of blood.Borax, dried Alumen two flavors are held concurrently with blood stasis dispelling based on expectorant, and the detumescence of the blood-activating analgetic of principal drug assistance is so be all adjuvant drug.The sharp stagnation of QI of Borneolum Syntheticum, loose and be jammed, the meridian dredging, separate accumulation of heat; Ethanol promoting blood circulation, all warps of row, row medicine heat, two flavors help the efficacy of a drug of monarch, minister, assistant with all strength, and row medicine gesture is gone into this two flavor and is messenger drug in the side in sick position.Seven flavor medicine in the side is by monarch, minister, help, make compatibility, each Si Qizhi, coordination cooperatively interacts again, bring out the best in each other, play the effect of blood circulation promoting and blood stasis dispelling, clearing and dissipating phlegm-heat, promote qi circulation opening meridians altogether, sprain the disease of joint caused kindred pain, livid purple swelling in order to treatment traumatic injury, sprain and contusion.Quickly-acting antalgesic liniment (prescription) Radix Notoginseng 25.0g dried Alumen 37.5g
Lignum Sappan 25.0g Sanguis Draxonis 25.0g
Borax 25.0g Borneolum Syntheticum 112.5g
(method for making) gets Radix Notoginseng, Lignum Sappan, Borax, dried Alumen, adds 75% soak with ethanol 84 hours, collects leachate, the squeezing medicinal residues, merge pressed liquor and leachate, leave standstill more than 24 hours, filter, add Sanguis Draxonis, Borneolum Syntheticum dissolving, add 75% ethanol again to 1000ml, clarification filtration, promptly.
(character) this product is the brownish red supernatant liquid.
(discriminating)
1. get this product 20ml, cold wind dries up, residue is with ether (50,50ml) and distilled water (60,60ml) alternately in the dissolving back immigration separatory funnel, jolting, standing demix, sucking-off upper strata ether solution, water layer continues with twice of extracted with diethyl ether (each 30ml), twice of water layer reuse ethyl acetate extraction (each 30ml), fling to residual ether and ethyl acetate in the water layer water-bath, put and be added in the macroporous adsorptive resins of handling well (internal diameter 1.0cm, long 15cm) after cold, at first use the 200ml distilled water flushing, discard water liquid; Carry out eluting with 50% ethanol 350ml then, get eluent 20ml, water bath method, residue dissolves with acetic anhydride, adds acetic anhydride concentrated sulphuric acid test solution 1-2 and drips displaing yellow, gradual change redness, cyan.
2. get this product 20ml, cold wind dries up, residue is with ether (50,50ml) and distilled water (60,60ml) alternately in the dissolving back immigration separatory funnel, jolting, standing demix discards water layer, and the ether layer continues with twice of distilled water wash (each 30ml), the water-bath of ether layer volatilizes, residue dissolves with 95% ethanol 10ml, filters, and gets filtrate 2ml and puts in the test tube, add rare HCl1ml, jolting, solution becomes yellow by redness, adds 10% sodium acetate 2-3ml again, jolting post-heating 2-3 minute, solution becomes redness by yellow again.
3. get arasaponin R
1Standard substance are an amount of, add solution that methanol makes 1mg/ml product solution in contrast; Get this product 20ml, cold wind dries up, residue is with ether (50,50ml) and distilled water (60,60ml) alternately in the dissolving back immigration separatory funnel, jolting, standing demix, sucking-off upper strata ether solution, water layer continues with twice of extracted with diethyl ether (each 30ml), twice of water layer reuse ethyl acetate extraction (each 30ml), fling to residual ether and ethyl acetate in the water layer water-bath, put and be added in the macroporous adsorptive resins of handling well (internal diameter 1.0cm, long 15cm) after cold, at first use the 200ml distilled water flushing, discard water liquid; Carry out eluting with 50% ethanol 350ml then, collect 50% ethanol elution, put evaporate to dryness in the water-bath, residue adds dissolve with methanol and is settled to 10ml, as need testing solution; Prepare negative control product solution according to need testing solution with the method operation.
According to thin layer chromatography (1995 editions one one of the Pharmacopoeia of the People's Republic of China, 35 pages of appendix) test, draw reference substance, test sample, each 5 μ l of negative control product solution, put respectively on the same silica gel g thin-layer plate that contains sodium carboxymethyl cellulose, with chloroform: methanol: water (6: 4: 1) is developing solvent, ascending development, take out airing, spray is with the vanillin-sulfuric acid test solution, the oven dry, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, the speckle that shows same color, the negative control product do not have this speckle.
4. get Sanguis Draxonis standard medical material 2.0g, add 95% ethanol 20ml, jolting is filtered, filtrate is added hydrochloric acid make it to separate out precipitation, filter, with a spot of acid rinsing precipitation, after the reuse 20%KOH washing, change to be dissolved in being the dracorubin chloroform solution in the chloroform, with the red rope chloroform solution of Sanguis Draxonis product solution in contrast; Get this product 20ml, cold wind dries up, residue is with ether (50,50ml) and distilled water (60,60ml) alternately in the dissolving back immigration separatory funnel, jolting, standing demix discards water layer, the ether layer continues with twice of distilled water wash (each 30m), the water-bath of ether layer volatilizes, and residue dissolves with chloroform, as need testing solution; Prepare negative control product solution according to need testing solution with the method operation.
According to thin layer chromatography (1995 editions one one of the Pharmacopoeia of the People's Republic of China, 35 pages of appendix) test, draw respectively 5 μ l of reference substance, test sample, negative control product solution, put respectively on the same silica gel g thin-layer plate that contains sodium carboxymethyl cellulose, with benzene: methanol (9: 1.5) is developing solvent, ascending development, taking-up dries up, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, the speckle that shows same color, the negative control product do not have this speckle.
(assay)
1. get this product 1.0ml, cold wind dries up, residue ether (30,30ml) and distilled water (40,40ml) alternately the dissolving back moves in the separatory funnel, jolting, standing demix, sucking-off upper strata ether solution, water layer continues with twice of extracted with diethyl ether (each 20ml), twice of water layer reuse ethyl acetate extraction (each 30ml), fling to residual ether and ethyl acetate in the water layer water-bath, put and be added to macroporous adsorptive resins (the internal diameter 1.0cm that has handled well after cold, long 15cm) in, at first use the 75ml distilled water flushing, discard water liquid, carry out eluting with 50% ethanol 125ml then, collect 50% ethanol elution, water bath method, residue, is got methanol solution 250ul and is put in the 10ml tool plug test tube in the 10ml volumetric flask with dissolve with methanol and standardize solution, flings to methanol in 5 minutes in boiling water bath (about 94 ℃) heating, taking-up is put cold, add freshly prepared 5% vanillin glacial acetic acid solution 0.2ml, perchloric acid 0.8ml was in 70 ℃ of water bath heat preservations 15 minutes, take out, have a shower with cold water immediately, add glacial acetic acid 5ml, mixing, placed 10 minutes, make blank with method, measure trap A in the 545nm place according to spectrophotography (1995 editions one one of the Pharmacopoeia of the People's Republic of China, 32 pages of appendix), substitution standard curve equation calculates content.
This product contains Radix Notoginseng total arasaponins must not be lower than 1.00mg/ml.
2. Borneolum Syntheticum is measured according to gas chromatography (an appendix VI of 95 editions pharmacopeia E).
The system suitability test: with methyl silicone rubber (SE-30) is fixative, coating concentration 5%, and 140 ± 10 ℃ of column temperatures, theoretical cam curve is calculated with the Borneolum Syntheticum peak should be greater than 450.
The preparation of reference substance solution: it is an amount of to get the Borneolum Syntheticum reference substance, and accurate the title decides, and adds ethanol and makes the solution that every 1ml contains 0.6mg, in contrast product solution.
The preparation of need testing solution: sample thief 1ml puts in the 25ml measuring bottle,, shakes up to scale with ethanol dilution, makes need testing solution
Algoscopy: precision is measured reference substance solution and need testing solution 0.5ul respectively, and inject gas chromatograph calculates, promptly.
This product contains Borneolum Syntheticum C
10H
13O should be not less than 20mg/ml.(inspection) 1. amount of alcohol presses 1995 editions one one of the Pharmacopoeia of the People's Republic of China, and the method that appendix is 56 pages is measured, and the ethanol content of this product should be between 60-70%.
2. other should meet 1995 editions one one of the Pharmacopoeia of the People's Republic of China, relevant every regulation under 10 pages of tincture items of appendix.
The Study on Preparation data
Quickly-acting antalgesic liniment is to be formed through the ethanol infusion by Radix Notoginseng, Sanguis Draxonis, Borneolum Syntheticum, Lignum Sappan, Borax, dried Alumen Six-element Chinese medicine, have effects such as spasmolysis and analgesia, antiinflammatory, detumescence, blood circulation promoting and blood stasis dispelling, be widely used in diseases such as rheumatic arthralgia, traumatic injury, fracture muscle and tendon injury.According to reported in literature, contain oside compound in this liniment, thereby serve as to investigate index with the content of Radix Notoginseng total arasaponins, adopt the best production technology of uniform experiment design screening quickly-acting antalgesic liniment.
One. assay
1. measure the selection of wavelength
It is an amount of to get the ginsenoside Rg1 standard substance, adds solution that methanol makes 1mg/ml product solution in contrast; Get extracting solution (Radix Notoginseng, Lignum Sappan, Borax, 75% alcohol leaching liquid of dried Alumen) 1.0ml, cold wind dries up, residue ether (30,30ml) and distilled water (40,40ml) alternately the dissolving back moves in the separatory funnel, jolting, standing demix, sucking-off upper strata ether solution, water layer continues with twice of extracted with diethyl ether (each 20ml), twice of water layer reuse ethyl acetate extraction (each 30ml), residual ether and ethyl acetate are flung in the water layer water-bath, put to be added in the macroporous adsorptive resins of handling well (internal diameter 1.0cm, long 15cm) after cold, at first use the 75ml distilled water flushing, discard water liquid; Reuse 50% ethanol 125ml carries out eluting, collects 50% ethanol elution, puts evaporate to dryness in the water-bath, and residue adds dissolve with methanol and is settled to 10ml, as need testing solution; Other gets negative medicinal liquid (75% alcohol leaching liquid of Lignum Sappan, Borax, dried Alumen) 1.0ml, makes negative control product solution according to need testing solution with the method operation.
Fig. 1 is the tracing of ginsenoside Rg1 standard substance, and Fig. 2 is the test sample scintigram, describes below in conjunction with accompanying drawing.Essence is got standard solution, test sample, negative control product solution 100,500,500ul, after pressing determination operation colour developing, in TU-1221 type UV/VIS spectrophotometer 400-900nm wave-length coverage interscan (seeing figure one, figure two), as can be seen from Figure: the ginsenoside Rg1 standard substance have a maximum absorption band at the 543nm place, Radix Notoginseng total arasaponins has a maximum absorption band at the 545nm place, and the negative control product are very little in this wavelength place interference, and therefore selected 545nm is the mensuration wavelength of Radix Notoginseng total arasaponins.
2. the preparation of standard curve
Precision is measured ginsenoside Rg1 titer (1mg/ml) 20,30,40,50,60,70ul places 10ml tool plug test tube, in boiling water bath (about 94 ℃), heat 5 minutes to fling to methanol, taking-up is put cold, add freshly prepared 5% vanillin glacial acetic acid solution 0.2ml, perchloric acid 0.8ml, in 70 ℃ of water bath heat preservations 15 minutes, take out, have a shower with cold water immediately, add glacial acetic acid 5ml, mixing was placed 10 minutes, did blank with method, measure trap A in the 545nm place, with trap A concentration C returned and can get the standard curve equation and be:
C＝28.39A-0.01359?r＝0.9993(P＜0.01)
3. sample determination
Get this product 1.0ml, cold wind dries up, residue ether (30,30ml) and distilled water (40,40ml) alternately the dissolving back moves in the separatory funnel, jolting, standing demix, sucking-off upper strata ether solution, water layer continues with twice of extracted with diethyl ether (each 20ml), twice of water layer reuse ethyl acetate extraction (each 30ml), fling to residual ether and ethyl acetate in the water layer water-bath, put and be added to macroporous adsorptive resins (the internal diameter 1.0cm that has handled well after cold, long 15cm) in, at first use the 75ml distilled water flushing, discard water liquid, carry out eluting with 50% ethanol 125ml then, collect 50% ethanol elution, water bath method, residue, is got methanol solution 250ul and is put in the 10ml tool plug test tube in the 10ml volumetric flask with dissolve with methanol and standardize solution, flings to methanol in 5 minutes in boiling water bath (about 94 ℃) heating, taking-up is put cold, add freshly prepared 5% vanillin glacial acetic acid solution 0.2ml, perchloric acid 0.8ml was in 70 ℃ of water bath heat preservations 15 minutes, take out, have a shower with cold water immediately, add glacial acetic acid 5ml, mixing, placed 10 minutes, make blank with method, measure trap A in the 545nm place according to spectrophotography (1995 editions one one of the Pharmacopoeia of the People's Republic of China, 32 pages of appendix), substitution standard curve equation calculates content.
Two. the even experimental design that total Saponin extracts
1. uniform Design
Contain multiple Saponin in the Radix Notoginseng, be soluble in ethanol according to Saponin, we adopt ethanol is to extract solvent, extracts total Saponin with cold-maceration.In experiment, be index with the content of Radix Notoginseng total arasaponins, investigate the influence of determining alcohol and two factors of soak time, and actual in conjunction with producing, each factor has been selected seven levels, and factor level sees Table 1.
The 65 70 75 80 85 90 95 merceration times of table 1 factor level table factor level concentration of alcohol (%) (hour) 12 24 36 48 60 72 84
2. experimental technique and data
Select U for use
7(7
6) table formulation experimental program, the results are shown in Table 2.Take by weighing Radix Notoginseng 2.5g, Lignum Sappan 2.5g, Borax 2.5g, dried Alumen 3.75g, add Different concentrations of alcohol 100ml and soak certain hour, press time-and-motion study content under the assay item then, calculate the content that contains Radix Notoginseng total arasaponins in the Radix Notoginseng.
Table 2U
7(7
6) content of watch test concentration of alcohol soak time Radix Notoginseng total arasaponins
(％)???????(h)???????????(mg/g)1?????????1(65)??????3(36)??????????45.852?????????2(70)??????6(72)??????????62.013?????????3(75)??????2(24)??????????52.484?????????4(80)??????5(60)??????????54.115?????????5(85)??????1(12)??????????37.276?????????6(90)??????4(48)??????????36.867?????????7(95)??????7(84)??????????21.76
3. date processing carries out multiple regression with experimental result with computer, tries to achieve regression equation: Y=-476.0739+14.108X
1+ 0.2069X
2-0.0951X
1X
2
X
1---concentration of alcohol, X
2---soak time, R=0.988, S=2.899,
F=42.309＞F
(0.1 3,3)=6.6054, F upchecks, and regression equation is meaningful.Optimal conditions is: concentration of alcohol---73.75%, and soak time---83.36 hours, predictive value=64.487 (mg/g) determined that in conjunction with producing actual analysis-by-synthesis optimum extraction conditions is: 75% ethanol, soaked 84 hours.
4. confirmatory experiment
Take by weighing three parts of Radix Notoginseng, Lignum Sappan, Borax, the dried Alumens of prescription ratio quintuple, the optimum extraction conditions according to the uniform Design screening soaks medical material respectively, and the gained medicinal liquid carries out assay, and measurement result sees Table 3.
The content of table 3 Radix Notoginseng total arasaponins (mg/g) lot number 123 X ± SD980104 62.28 64.74 64.74 63.92 ± 1.42980105 63.37 63.37 65.83 64.19 ± 1.42980106 62.55 63.37 65.55 63.82 ± 1.55
The content of above-mentioned three total Saponins of lot number medicinal liquid is carried out variance analysis and q check, the result shows: the total saponin content of three batches of medicinal liquids there are no significant difference (P＞0.05), more also there was no significant difference (P＞0.05) between lot number in twos, the medicinal liquid that extracts by optimum extraction conditions is described, its total saponin content approaches predictive value.According to the optimum extraction conditions of uniform Design screening, determine following production technology:
Get Radix Notoginseng, Lignum Sappan (coarse powder) and Borax, dried Alumen (fine powder) mixing, add 75% ethanol 1000ml and soaked 84 hours, collect leachate, the squeezing medicinal residues, merge pressed liquor and leachate, leave standstill more than 24 hours, filter, add Sanguis Draxonis, Borneolum Syntheticum dissolving, add 75% ethanol again to 1000ml, shake up, clarification filtration, promptly.
5. extraction ratio experiment
Take by weighing three parts of pseudo-ginseng 2.5g, put in the apparatus,Soxhlet's, complete with 75% alcohol reflux to extracting, filter, filtrate recycling ethanol, residue is dissolved in water, and measures item by total Saponin and stipulates to carry out time-and-motion study content down, calculating the content (mg/g) that contains Radix Notoginseng total arasaponins in the 1.0g pseudo-ginseng then is respectively: 87.49,86.81,88.17, and X ± SD=87.49 ± 0.68.By three batches of medicinal liquids of production technology preparation, measure total saponin content and calculate extraction ratio, the results are shown in Table 4.
The mensuration of table 4 extraction ratio
The extraction ratio of total saponin content (mg/g) 87.49 extraction ratios (%) 73.06 73.37 72.95 these production technologies can be used for producing in batches all more than 70% in 980,104 980,105 980106 medicinal liquid total saponin contents (mg/g), 63.92 64.19 63.82 pseudo-ginsengs.
The long-term toxicological test data of quickly-acting antalgesic liniment rabbit skin
Quickly-acting antalgesic liniment is mainly in order to the acute pain relieving of treatment traumatic injury, and can promote to heal recovery proper motion function.According to the three kind new medicine requirements of external Chinese medicine, carry out the research of skin long term toxicity.
Purpose is observed the rabbit intact skin and is contacted antalgesic liniment for a long time with damaged skin, and transdermal flux is to local and the toxic reaction of whole body generation and the recovery extent of reaction.
Healthy white rabbit is planted by animal and material New Zealand, body weight 2.12 ± 0.35kg, and male and female half and half, Xinjiang endemic diseases institute animal housing provides (producing certificate (94) No. 16001).Quickly-acting antalgesic liniment, peony clear liquid, 0.25g crude drug/ml, Xinjiang Medical College one attached doctor Zhang Hongfei of institute development.76% ethanol, this chamber autogamy.Sodium sulfide, analytical pure, the new Photochemical agents in Beijing factory produces.
Method and result get 30 of healthy white rabbit, male and female half and half, 6 every group, sub-cage rearing.Preceding 24 hours of administration with tame rabbit back spinal column both sides with 10%Na
2S solution depilation (about 150cm
2).Damaged skin is wiped skin with carpenter's fine sandpaper, with the slight evenly oozing of blood degree of being of skin
Be divided into the solvent matched group according to body weight and sex equilibrium and (only be coated with 76% ethanol 2.0ml/, quickly-acting antalgesic liniment intact skin low dose group (only being coated with 1.0ml/), quickly-acting antalgesic liniment high dose group (only being coated with 3.0ml/); Damaged skin low dose group and high dose group (two kinds of dosage of antalgesic liniment are with the intact skin group).Be coated with logotype 60 days every day 1 time.Behind the 60th day coating 6 hours, each group was got 4 (male and female half and half), and ear vein is got blood and made routine blood test and blood biochemical measurement.Put to death rabbit, bark fetching skin (coating place), the heart, liver, spleen, lung and kidney are done extremely to separate and histopathologic examination substantially, and calculate organ coefficient (internal organs weight/body weight).
Remaining 2 rabbit of each group continue after the drug withdrawal to raise for 2 weeks, and also extracting vein blood is made routine blood test and blood biochemical measurement, bark fetching skin (coating place), the heart, liver, spleen, lung and kidney, do cardinal principle and histopathologic examination, and calculate organ coefficient, to determine the recovery extent of toxic reaction.
As a result, none death of 4 groups of administration rabbit (contain reversibility and observe totally 10 of rabbit), ergasia state and food-intake are no abnormal, do not have any poisoning symptom.Day by day observe skin, the thin crust of damaged skin came off on 3rd, recovered normal fully on 5th.Respectively organize rabbit skin in 60 days and do not find macroscopic pathological lesion.The rabbit average weight was 2.61 ± 0.36kg when experiment finished, i.e. rabbit weight increase 0.49kg.
Organ coefficient, routine blood test, blood biochemical measurement and skin, the heart, liver, spleen, lung, the histological examination of nephropathy reason, administration group and solvent are given relatively, there is no any pathologic and change (see Table 5-7, the reversibility observed result sees Table 8-10).
The conclusion antalgesic liniment, rabbit skin 1.0ml/ only and 3.0ml/ only (be 0.25g crude drug and 0.75g crude drug /), two dosage, be coated with medication 60 days continuously, do not find any poisoning symptom, routine blood test, blood biochemical measurement and main organs histopathologic examination there is no any pathological change.Prompting, quickly-acting antalgesic liniment is coated with rabbit skin, no overt toxicity, dermatologic safety outside the prescribed dose scope.Table 5 quickly-acting antalgesic liniment is coated with the influence to the rabbit organ coefficient in 60 days outward.X±SD?n＝4
Organ coefficient (g/kg) group
3.44 ± 0.53*1.0ml/ .d 2.58 ± 0.05* of 3.03 ± 0.24*1.0ml/ .d 2.60 ± 0.26* of 2.46 ± 0.32 29.58 ± 2.98 0.53 ± 0.14 5.20 ± 1.53 2.94 ± 0.29 damaged skin 3.0ml/ .d 2.56 ± 0.13* 30.87 ± 3.44* 0.48 ± 0.19*, 5.97 ± 0.61* of conscience spleen lung kidney solvent control group, 29.36 ± 4.71*, 0.49 ± 0.15*, 5.14 ± 0.84*, 2.96 ± 0.30* intact skin 3.0ml/ .d 3.00 ± 0.20** 34.76 ± 7.14*, 0.57 ± 0.16*, 5.61 ± 2.04*, 29.06 ± 3.56*, 0.51 ± 0.16*, 5.84 ± 0.81*, 2.90 ± 0.26**P＞0.05; * P＜0.05 is coated with, 60 days outward to the impact of Peripheral Blood in Rabbits picture with solvent control group comparison sheet, 6 quick-acting ethoxybenzamide liniments. X ± SD n=4 group RBC HB HCT PLT WBC N L
(* 10
12/ L) (g/L) (%) (* 10
9/ L) (* 10
9/ L) (%) (%) 55.5 ± 10.4*1.0ml/ .d 5.73 ± 0.38* of 52.4 ± 11.0*1.0ml/ .d 6.09 ± 0.48* of solvent control group 6.34 ± 0.37 137.0 ± 6.0 44.8 ± 1.7 370.2 ± 46.1 8.4 ± 2.1 39.2 ± 2.9 60.9 ± 2.8 damaged skin 3.0ml/ .d 6.65 ± 0.36* 141.0 ± 12.1* 47.1 ± 2.9* 371.8 ± 9.8*, 8.2 ± 2.0*, 47.6 ± 11.0*, 130.0 ± 10.3*, 42.7 ± 4.0*, 384.5 ± 63.1*, 7.8 ± 2.2*, 47.0 ± 6.3*, 53.0 ± 6.3* intact skin 3.0ml/ .d 5.86 ± 0.61* 127.0 ± 12.5*, 40.1 ± 4.3*, 367.8 ± 88.6*, 7.7 ± 1.8*, 44.5 ± 10.4*, 136.0 ± 8.5*, 43.3 ± 2.5*, 365.6 ± 46.3 7.7 ± 1.1*, 37.1 ± 4.9*, 62.9 ± 4.9**P＞0.05 all is coated with 60 days outward to the impact of rabbit blood biochemistry with solvent control group comparison sheet 7 quickly-acting antalgesic liniments. X ± SD n=4 group CHO ALT AST TP GLU TRIG ALB BUN Cr
( mmol/L ) ( U/L ) ( U/L ) ( g/L ) ( mmol/L ) ( mmol/L ) ( g/L ) ( mmol/L ) ( um ) 1. 27±0.24 33.5±10.5 13.5±4.2 53.2±2.1 5.92±0.84 0.72±0.10 28.7±0.9 7.44±1.87 44.63.0ml/.d 1.00±0.22* 30.7±13.1* 14.8±3.4* 57.8±3.1* 5.87±0.33* 0.69±0.20* 29.2±0.6* 7.60±0.83* 39.71.0ml/.d 1.28±0.46* 38.2±17.1* 14.2±2.9* 57.7±4.1* 6.95±0.71* 0.66±0.23* 30.0±2.0* 5.69±1.10* 58.03.0ml/.d 0.93±0.28* 33.7±9.9* 15.2±4.2* 55.1±3.9* 6.35±0.68* 0.67±0.16* 29.3±1.2* 7.56±1.00* 58.31.0ml/.d 1.06±0.16* 36.5±7.9* 12.8±2.1* 52.2±4.8* 6.25±0.79* 0.67±0.08* 28.4±1.4* 6.00±1.03* 46.3*P＞0.0582。 X ± SD n=4
The dirty coefficient of device (g/kg) group
3.15 ± 0.79*1.0ml/ .d 2.57 ± 0.51* of 3.00 ± 0.29*1.0ml/ .d 2.50 ± 0.71* of 2.53 ± 0.22 30.01 ± 7.11 0.50 ± 0.13 5.70 ± 0.66 3.07 ± 0.31 damaged skin 3.0ml/ .d 2.49 ± 0.48* 29.00 ± 5.16* 0.51 ± 0.10*, 5.38 ± 0.89* of conscience spleen lung kidney solvent control group, 29.87 ± 2.14*, 0.54 ± 0.15*, 5.81 ± 0.90*, 2.99 ± 0.34* intact skin 3.0ml/ .d 2.61 ± 0.25* 29.59 ± 4.25*, 0.48 ± 0.17*, 5.90 ± 1.02*, 28.99 ± 5.71*, 0.51 ± 0.15*, 5.09 ± 0.48*, 2.97 ± 0.58**P＞0.05 is all with the afterwards variation of Peripheral Blood in Rabbits pictures of 2 weeks of 9 quickly-acting antalgesic liniment drug withdrawals of solvent control group comparison sheet. X ± SD n=4 group RBC HB HCT PLT WBC N L
(* 10
12/ L) (g/L) (%) (* 10
9/ L) (* 10
9/ L) (%) (%) 60.01 ± 18.20*1.0ml/ .d 5.72 ± 0.17* of 5417 ± 21.02*1.0ml/ .d 5.60 ± 0.23* of solvent control group 6.01 ± 0.29 136.5 ± 3.5 43.4 ± 1.6 375.0 ± 98.5 8.55 ± 2.1 40.25 ± 0.73 59.45 ± 8.32 damaged skin 3.0ml/ .d 5.91 ± 0.34* 134.5 ± 7.8* 45.1 ± 3.7* 381.2 ± 28.1*, 8.35 ± 0.21*, 45.87 ± 10.12*, 134.0 ± 1.4*, 44.8 ± 4.6*, 377.2 ± 108.2*, 7.80 ± 1.84*, 43.97 ± 8.29*, 58.25 ± 17.50* intact skin 3.0ml/ .d 5.95 ± 0.99* 132.5 ± 12.0*, 42.9 ± 2.8*, 370.2 ± 89.7*, 8.15 ± 0.07*, 44.12 ± 9.92*, 136.0 ± 5.7*, 43.9 ± 4.8*, 374.1 ± 90.1*, 7.85 ± 0.21*, 39.20 ± 5.68*, 61.12 ± 9.87**P＞0.05 is all with the variations of solvent control group comparison sheet rabbit blood biochemistry after 2 weeks of 10 quickly-acting antalgesic liniment drug withdrawals. X ± SD n=2 group CHO ALT AST TP GLU TRIG ALB BVN Crea
( mmol/L ) ( U/L ) ( U/L ) ( g/L ) ( mmol/L ) ( mmol/L ) ( g/L ) ( mmol/L ) ( umol/L ) 1.30±0.01 30.5±7.0 11.5±2.1 53.5±0.78 6.55±0.78 0.70±0.12 28.7±1.6 6.92±0.11 58.0±7.13.0ml/.d 1.00±0.18* 34.5±9.2* 11.8±2.1* 56.5±1.7* 6.20±0.14* 0.78±0.04* 30.3±1.2* 6.95±0.63* 52.0±5.7*1.0ml/.d 1.33±0.07* 29.0±2.8* 12.5±0.7* 54.2±5.7* 7.65±0.35* 0.81±0.07* 27.9±1.7* 5.80±0.93* 49.0±25.5*3.0ml/.d 1.30±0.08* 32.0±2.8* 10.2±5.7* 52.5±4.7* 6.90±1.24* 0.74±0.20* 28.6±1.3* 7.04±0.16* 52.5±7.8*1.0ml/.d 1.23±0.10* 31.8±7.9* 12.5±2.1* 52.7±1.2* 6.75±1.15* 0.70±0.10* 28.8±1.8* 6.07±0.13* 52.5±2.1**P＞0.05 ,
Quickly-acting antalgesic liniment skin acute toxicity test data
Quickly-acting antalgesic liniment is the new drug of Xinjiang Medical College one attached doctor Zhang Hongfei of institute development, is the pure Chinese medicine exterior-applied formulation made from Radix Notoginseng, Sanguis Draxonis, Borneolum Syntheticum etc.For understanding its toxicity size, special its skin acute toxicity of measuring.
Purpose is observed the animal intact skin and is contacted with the damaged skin short-term and tried the toxic reaction that thing-quickly-acting antalgesic liniment produces.
The healthy New Zealand of animal and material plants white family and exempts from, male and female half and half, and body is given birth to 2.04 ± 0.15kg, and Xinjiang endemic diseases institute animal housing provides (producing certificate (94) No. 16001).Antalgesic liniment, the peony clear liquid, 0.25g crude drug/ml newly cures attached doctor Zhang Hongfei of an institute development, and solvent is 76% ethanol.Sulfuration is received (depilation is used), analytical pure, and the new Photochemical agents in Beijing factory produces, lot number 920619.
Method and result choose 20 of white rabbit, are divided into matched group (only being coated with solvent 76% ethanol 2.0ml/), intact skin low dose group (only being coated with antalgesic liniment 1.0ml/), intact skin high dose group (only being coated with antalgesic liniment 3.0ml/) according to body weight and sex equilibrium.Damaged skin with carpenter's fine sandpaper wipe skin with the oozing of blood degree of being, only be coated with antalgesic liniment 3.0ml/).Damaged skin with carpenter's fine sandpaper wipe skin with the oozing of blood degree of being, be coated with low, high two the dosage groups of antalgesic liniment with above-mentioned intact skin group.Every group of 4 rabbit, preceding 24 hours of coating slough hair (the about 150cm that respectively organizes tame rabbit back spinal column both sides with the agent of slipping out of the hand (10% sodium sulfide solution)
2).Behind the coating 24 hours, with warm water remove skin residual tried thing, removal was tried behind the thing 1,24,48,72 hour to the 7th day, observed and the variation of body weight, skin and hair, eye and the mucosa of record animal situation and other poisoning manifestations such as breathing, central nervous system, extremity activity every day.
As a result, 4 groups of none death of coating rabbit after 7 days, the rabbit average weight is 2.23 ± 0.21kg during off-test.Hair is no abnormal, and skin does not have red and swollen no erythra, and it is normal that damaged skin recovers fully.Family's lagophthalmos and mucosa are also no abnormal.Breathe and the also no abnormal variation of extremity activity (seeing attached list 11)
The conclusion antalgesic liniment give rabbit intact skin, damaged skin be coated with 1.0 and 3.0ml/ only, (0.25g crude drug and 0.75g crude drug/only) observed 7 days continuously, every index is not seen significant change.So think quickly-acting antalgesic liniment no overt toxicity effect in used dosage range, drug safety.Subordinate list 11 quickly-acting antalgesic liniment rabbit skin acute toxicity table (1-7 day) group n dosage medication every day poisoning manifestations death toll (only)
The no damaged skin high dose 4 3.0 qd nothings of no damaged skin low dosage 4 1.0 qd of no intact skin high dose 4 3.0 qd of no intact skin low dosage 4 1.0 qd of (ml/ time) number of times matched group (solvent group) 4 2.0 qd
Quickly-acting antalgesic liniment skin anaphylactic test data
Quickly-acting antalgesic liniment is mainly used in the treatment of traumatic injury, and medicine according to the requirement of three class new Chinese medicines, is done the skin anaphylactic test research of this preparation repeatedly to contact skin during medication.
After purpose repeats to contact antalgesic liniment by rabbit skin, observe the reaction of body immune system on skin.
Animal and material albino guinea-pig, body weight 280 ± 15g, male and female half and half, Xinjiang endemic diseases institute animal housing supplies with (producing certificate (94) No. 16001).Antalgesic liniment, 0.25g crude drug/ml, Xinjiang Medical College one attached doctor Zhang Hongfei of institute development.76% ethanol, this chamber autogamy.Sodium sulfide (AR), the new Photochemical agents in Beijing factory product.2, the 4-dinitrochlorobenzene, reagent one factory in Shanghai produces.
Method and result choose 30 of healthy albino guinea-pigs, and 10 every group, male and female half and half.Be divided into the antalgesic liniment group according to body weight and sex equilibrium, 76% ethanol vehicle group and 2,4-dinitrochlorobenzene footpath between fields property matched group.Each Mus all sloughs spine's diamond wool (equal 9cm of every side with 109%NaS solution
2).
1. sensitization contact: quickly-acting antalgesic liniment group Cavia porcellus is coated with ethoxybenzamide 0.2ml in left side depilation district; The vehicle group Cavia porcellus is coated with 76% ethanol 0.2ml in homonymy depilation district; The positive controls Cavia porcellus is to be coated with 1%2 with the method homonymy, 4-dinitro-chlorine benzole soln 0.2ml.Cavia porcellus is divided equally cage and raises.At least continue 6 hours.Respectively repeated once with method in the 7th day and the 14th day, amount to 3 times.
2. excite contact: Yu Weici to give to be tried after the thing sensitization 14 days, with antalgesic liniment, 76% ethanol and 0.1%2, each 0.2ml of 4-dinitro-chlorine benzole soln, be coated with respectively and respectively organize depilation district, Cavia porcellus right side, eluting is tried thing after 6 hours, at once observe, and observed the skin allergy situation in 24,48 and 72 hours.Respectively organize time anaphylaxis score value by table 12 record, according to table 13 pair skin allergy with going out evaluation.
As a result, there is no erythema and edema each observing time of quickly-acting antalgesic liniment group, 76% ethanol vehicle group Cavia porcellus regulation, and score value is zero.And 2,4-dinitrochlorobenzene positive controls Cavia porcellus is erythema in various degree as seen, and the anaphylaxis incidence rate is 80～100% (tables 14).But 3 groups of Cavia porcelluss there is no severe allergic reaction symptoms such as asthma, astasia or shock.
The conclusion antalgesic liniment is outer and do not cause the guinea pig skin anaphylaxis, and 2, the 4-dinitrochlorobenzene has height to the utmost point to spend anaphylaxis to Cavia porcellus.
The standards of grading of table 12 skin allergy degree
Skin allergy situation score value erythema: no erythema 0
Slight erythema, inadequate visible 1
Moderate erythema, obvious visible 2
Severe erythema 3
The aubergine erythema also has eschar to form 4 edema: no edema 0
Mild edema, inadequate visible 1
Intermediate edema, obviously visible (edge exceeds surrounding skin) 2
The severe edema, cutaneous protuberance 1mm, profile clear 3
Serious oedema, skin are swelled more than the 1mm and expansion are arranged or have bubble or ulceration 4 highest point totals to be worth extremely sensitization table 14 ethoxybenzamide liniment allergic reaction on guinea pigs record sheet of 8 table 13 sensitization of skin evaluation criterion sensitization incidence (%) sensitization of skin evaluations, 0～10 no sensitization 11～30 slight sensitization 31～60 moderate sensitizations 61～80 height sensitizations 81～100
The antalgesic liniment group mean scores vehicle group mean scores dinitrochlorobenzene group mean scores date
Erythema edema sensitization rate, (%) erythema edema sensitization rate, (%) erythema edema sensitization rate, (%) 000000 1.8 0 1001 months 000000 1.8 0 1001 months 000000 1.7 0 901 months 22 days on the 21st on the 20th on the 19th 000000 1.4 0 80 January
The First Hospital Affiliated to Xinjiang Medical College's orthopaedics
The quickly-acting antalgesic liniment observation on Clinical Application
---attached 307 example reports
Quickly-acting antalgesic liniment (calling ethoxybenzamide in the following text) is a kind of pure Chinese medicine externally applied liniment, and it is very remarkable to obtain curative effect through clinical practice.Especially excellent with analgesic effect, simultaneously with detumescence, blood stasis dispelling function.This quick-acting similar medicine reports have been had not yet to see.
The present will be used ethoxybenzamide treatment case and be summarized as follows:
Physical data
Clinical practice 307 examples, wherein male 180 examples, women 127 examples.There is not age limit during medication.So do not add up the age.The sick kind of this group treatment is closed injury, in respect of:
Scapulohumeral periarthritis 12 examples, male 7 examples, women 5 examples.The degeneration knee joint, osteoarthritis 21 examples: male 8 examples, women 13 examples.Articular sprain 153 examples, male 107 examples, women 46 examples (wrist 46, knee joint 52, ankle 55) refer to (toe) damage 22 examples, male 10 examples, women 12 examples, soft tissue (trunk, extremity) damage 89 examples, male 41 examples, women 48 examples.
Administrated method: cotton swab dips in medicine obliterating affected part, and is each an amount of.Three times on the one, be four days the course of treatment.
Efficacy determination:
A. recovery from illness, pain disappears, and the movable normally no pressure pain point that recovers can recover original work.
B. produce effects, activity normally or normal substantially, the traumatic part tenderness is slight, the work life is unaffected, tired back idol has slightly aches.
C. effective, pain obviously alleviates, and limitation of activity significantly takes a turn for the better, and can participate in light work.
D. symptom and sign are improved less or are not had improvement.
Compare with medicine oil curative effect at prime
Medicine oil at prime is that Vinh Long Nan Yang group of Chinese's hall Pharma Inc. produces, and applies medicinal lotion or ointment in administrated method three parts every day.Case is chosen as every group 25 example of sprained ankle, and wrist closes act of violence sprains every group 12 example, because of selecting that at random degree of injury is not gone to divide, but all without fracture, always have observation see Table 15.16 both significant difference is arranged.Spraining of table 15 ankle joint
Table 16 is carpal to be sprained
| After applying medicinal lotion or ointment | ??????24h | ????????48h | ????72h | ||
| Pain | Safflower oil | No change | ??????← | ?????????← | Have slightly and alleviate |
| Ethoxybenzamide | 2 ' back disappears | ??????← | ?????????← | ????← | |
| Swelling | Safflower oil | No change | ??????← | ?????????← | Slightly alleviate |
| Ethoxybenzamide | No change | Most disappear | Continue to disappear | Slightly | |
| Ecchymosis | Safflower oil | No change | ??????← | ?????????← | Scope is dwindled |
| Ethoxybenzamide | No change | Dwindle | Continue to dwindle | The basic disappearance | |
| Joint motion | Safflower oil | Limited | Limited | Limited | Still limited |
| Ethoxybenzamide | Can stand | The companion that can walk aches | Walking is normal, discomfort in the time of for a long time | Normally | |
| After applying medicinal lotion or ointment | ?????24h | ?????48h | ????72h | ||
| Pain | Safflower oil | No change | ?????← | Alleviate | Take a turn for the better |
| Ethoxybenzamide | 2 ' back disappears | ?????← | ?????← | ?????← | |
| Swelling | Safflower oil | No change | ?????← | ?????← | Alleviate |
| Ethoxybenzamide | No change | Disappear | ?????← | ?????← | |
| Joint motion | Safflower oil | No change | ?????← | ?????← | Companion's pain |
| Ethoxybenzamide | Take, pain when carrying thing | Having acid to expand feels | Normally | ?????← | |
To some sick observation of curative effect of planting
Scapulohumeral periarthritis: after the medication 3 minutes first, pain obviously alleviated, and the shoulder joint movable amplitude increases thereupon.Medication every day that continues once, pain disappears after the medication 5 times, and is movable normal.Observed for 4 weeks and do not have recurrence.
The degeneration gonarthritis: 2 minutes pain disappears after the medication first, and the joint of only going downstairs does not have pain.Through the day a drug, observe after 5 medications; 6 examples are multiple pain after 7 days, and 8 examples are multiple pain after 12 days, and 7 examples are multiple pain after 14 days.Pain disappears after the medication once more, and is movable normal.
Sprain of carpal joint: 2 minutes pain disappears after the medication first, takes, do not have when carrying object pain.It is normal that three medications on the one recovered in 4 days, observes a week and do not have recurrence.
Ankle joint is turned round work, 2.5 minutes pain reliefs after the medication first, but Ambulatory Activity, three medications on the one after 3 days swollen and ecchymosis disappear substantially, activity is not limited, recovers normal after 4 days, observes a week and does not have recurrence.
Sprain of knee joint: 3 minutes pain disappears after the medication first.Pain obviously alleviated when one day posterior joint of three medications on the one was movable, and swelling alleviates, and slightly aching when walking does not two days later influence activity, after 3 days except that firmly the time joint have slightly uncomfortable normal substantially, the swelling disappearance, ecchymosis scope contractive color is light.Recover normal after 4 days fully, observe a week and do not have recurrence.
Soft tissue injury: it is main hitting, squeeze to hinder according to various vehicles, surplus for traumatic injury, weigh wounded with blunt and wound.The big person of injured area accounts for body surface area about 20%, and little person accounts for about 0.5%, heavy person three medications on the one 4 days, and local swelling in 2 days disappears, and the ecchymosis scope is dwindled, and recovers operate as normal after 3 days, and 1-2 medication of the lighter promptly recovers normal.The all disappearances in 2 minutes after medication of both pain.
Refer to (toe) damage, hinder that three medications on the one recover normal after 3 days to pound, to press, to squeeze.1.5 minutes pains of average medication disappear, and joint motion does not have pain.
But the still medication of person that has the skin injury, but pain relieving, hemostasis and anti-inflammation promotes wound healing.
Osteochondritis: pain disappearance after 1 minute after the pain medication that causes, run to jump and all recover normal.Three drug withdrawals two days later on the one are observed a week and are not had recurrence.
Through clinical observation, quickly-acting antalgesic liniment truly has its quick curative effect for pain, simultaneously swelling, ecchymosis is also had the promotion Absorption, and usage simple is wiped i.e. spirit, and without any side effects and taboo is old, few all suitable, can often join medicine for external use as family.
Concerning observing case, degeneration gonarthritis curative effect slightly is worse than other class damages, and this explanation ethoxybenzamide is the eliminate pain symptom only, can't make its elimination to degenerative disease takes place, regrettably fails degeneration is done late result observation.
Claims (4)
1. a quickly-acting antalgesic liniment comprises Radix Notoginseng, Borneolum Syntheticum, Sanguis Draxonis, Lignum Sappan, it is characterized in that the prescription scope is:
Radix Notoginseng: 24.5-25.5g dried Alumen: 37.0-38g Lignum Sappan: 24.5-25.5g
Sanguis Draxonis: 24.5-25.5g Borax: 24.5-25.5g Borneolum Syntheticum: 112-113g
2, a kind of preparation method of quickly-acting antalgesic liniment is characterized in that:
1. get Radix Notoginseng, Lignum Sappan (30 orders-60 purpose coarse powder) and Borax, dried Alumen (80 orders-100
The purpose fine powder) mixing;
2. adding concentration is the ethanol 1000ml of 70-80%, soaks 60-85 hour;
3. filter, squeeze filtering remaining medicinal residues;
4. leachate and pressed liquor are mixed, leave standstill more than 24 hours;
5. in the mixed liquor of leachate and pressed liquor, add Sanguis Draxonis, Borneolum Syntheticum, and be dissolved in the mixed liquor;
6. the ethanol that adds concentration again and be 70-80% is to 1000ml, shakes up, clarification filtration, promptly.
3. quickly-acting antalgesic liniment according to claim 1 is characterized in that the preferential prescription of selecting is:
Radix Notoginseng: 25.0g dried Alumen: 37.5g Lignum Sappan: 25.0g
Sanguis Draxonis: 25.0g Borax: 25.0g Borneolum Syntheticum: 112.5g
4. the preparation method of quickly-acting antalgesic liniment according to claim 2, its feature is 75% in concentration of ethanol, soaks 84 hours.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN98114662A CN1065764C (en) | 1998-06-29 | 1998-06-29 | Quickly-acting antalgesic liniment and its preparing process |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN98114662A CN1065764C (en) | 1998-06-29 | 1998-06-29 | Quickly-acting antalgesic liniment and its preparing process |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1240658A true CN1240658A (en) | 2000-01-12 |
| CN1065764C CN1065764C (en) | 2001-05-16 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN98114662A Expired - Fee Related CN1065764C (en) | 1998-06-29 | 1998-06-29 | Quickly-acting antalgesic liniment and its preparing process |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110522827A (en) * | 2018-05-23 | 2019-12-03 | 北京十力红方中医药研究院 | Quick-acting antalgesic external medicinal liquid and preparation method |
| CN110522828A (en) * | 2018-05-25 | 2019-12-03 | 北京十力红方中医药研究院 | Quick-acting antalgesic external medicinal liquid and preparation method |
| CN111450188A (en) * | 2020-05-09 | 2020-07-28 | 张良 | A topical Chinese medicinal liquid spray for treating male prostatitis |
| CN114949076A (en) * | 2022-06-28 | 2022-08-30 | 邝文达 | Traditional Chinese medicine composition for treating rheumatic arthralgia and preparation method thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1079152A (en) * | 1992-05-28 | 1993-12-08 | 杨应和 | A kind of preparation method of rapid-acting bone wound spirit |
-
1998
- 1998-06-29 CN CN98114662A patent/CN1065764C/en not_active Expired - Fee Related
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110522827A (en) * | 2018-05-23 | 2019-12-03 | 北京十力红方中医药研究院 | Quick-acting antalgesic external medicinal liquid and preparation method |
| CN110522828A (en) * | 2018-05-25 | 2019-12-03 | 北京十力红方中医药研究院 | Quick-acting antalgesic external medicinal liquid and preparation method |
| CN111450188A (en) * | 2020-05-09 | 2020-07-28 | 张良 | A topical Chinese medicinal liquid spray for treating male prostatitis |
| CN114949076A (en) * | 2022-06-28 | 2022-08-30 | 邝文达 | Traditional Chinese medicine composition for treating rheumatic arthralgia and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1065764C (en) | 2001-05-16 |
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