CN103736060A - Lumbago plaster and preparation method thereof - Google Patents
Lumbago plaster and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a preparation method of a lumbago plaster, which is prepared from rhubarb, dried ginger, rhizoma kaempferiae, costus root, cortex periplocae, radix angelicae pubescentis, sandalwood, radix angelicae dahuricae, paniculate swallowwort root, ligusticum wallichii, clove, caulis kadsurae, teasel root, radix cyathulae and auxiliary materials; the lumbago plaster has the effects of diminishing inflammation, easing pain, warming and recuperating kidney yang, dispelling wind and relieving pain and the like, has exact curative effect on rheumatism lumbago, lumbar muscle strain, vertebra, spinal cord and other diseases, combines medicament treatment with physical therapy, and has the beneficial effects of quick response, good curative effect, less using amount of penetration enhancer and small side effect.
Description
Technical field
The present invention relates to a kind of lumbago plaster and preparation method thereof, belong to the field of medicine technology.
Technical background
Lumbago is the common disease of outpatient service, and 80% people can meet with lumbago in life, and in lumbago crowd, 24%～87% people there will be lumbago recurrence in 1 year.Lumbago is a kind of disease take waist one or both sides pain as cardinal symptom.Due to kidney disease, rheumatism, lumbar muscle strain, vertebra and the diseases of spinal cord etc. of doctor trained in Western medicine, mostly be chronic strain and and and aseptic inflammation cause.The traditional Chinese medical science thinks that pain in the lumbar region pain is many by insufficiency of kidney-YANG, cold coagulation dai channel, or dampness-heat of the liver is invaded and dai channel, and when row, a little less than yang deficiency gas, so that dai channel is depressed obstructed and occur pain; Or punching appoints a QI and blood to fill Sheng, thus dai channel stop up stagnant, damp and hot delay and pain.Main Therapeutic Method comprises conservative and two kinds of methods of operation now, and concrete can be divided into pharmacotherapy (oral pain alleviating or nonsteroidal anti inflammatory analgesic drug product), physiotherapy, minimally-invasive treatment, traditional operation.Now a lot of simple local anaesthesia drug injection and local anaesthetics and placebo of adopting, show but study, about the patient 60% of chronic back pain after injection 3～4 months just invalid.The application of radio-frequency (RF) ablation, intervertebral disc laser or interior electrothermal therapy, chamber mirror technology etc. can significantly reduce the wound of bringing because of open surgery, by increasing patient is accepted.But, because requirement difference, the impact in the operation visual field own and the restriction of admission passage of patient on treatment, and perform the operation and can bring all the time wound, treatment is got up neither be very convenient.Therefore, a curative effect is clear and definite, and rapidly, the less preparation of side effect will be well received in effect.
Summary of the invention:
Technical problem to be solved by this invention is to provide a kind of lumbago plaster and preparation method thereof.Described lumbago plaster has the effects such as antiinflammatory, analgesia, warming and recuperating the kidney-YANG, wind-expelling pain-stopping.For diseases such as treatment lumbago due to pathogenic wind-dampness, lumbar muscle strain, vertebra and spinal cords, there is definite curative effect.
For solving the problems of the technologies described above, the present invention realizes by the following technical solutions:
A kind of lumbago plaster, according to composition by weight, calculate, it is first made drug extract, then is prepared from adjuvant by Radix Et Rhizoma Rhei 100-200 part, Rhizoma Zingiberis 50-120 part, Rhizoma Kaempferiae 20-80 part, Radix Aucklandiae 10-30 part, Cortex Periplocae 10-30 part, Radix Angelicae Pubescentis 10-50 part, Lignum Santali Albi 10-30 part, Radix Angelicae Dahuricae 20-80 part, Radix Cynanchi Paniculati 20-80 part, Rhizoma Chuanxiong 10-30 part, Flos Caryophylli 10-30 part, Caulis et Radix Periplocae Forrestii 20-80 part, Radix Dipsaci 10-50 part, Radix Cyathulae 10-50 part.
Specifically, described lumbago plaster calculates according to composition by weight, it first makes drug extract by 32 parts of 160 parts of Radix Et Rhizoma Rhei, 80 parts of Rhizoma Zingiberiss, 56 parts of Rhizoma Kaempferiaes, 20 parts of the Radix Aucklandiae, 20 parts of Cortex Periplocaes, 32 parts of Radix Angelicae Pubescentiss, 20 parts, Lignum Santali Albi, 56 parts of the Radixs Angelicae Dahuricae, 56 parts of Radix Cynanchi Paniculatis, 20 parts of Rhizoma Chuanxiongs, 20 parts of Flos Caryophyllis, 64 parts of Caulis et Radix Periplocae Forrestii, 32 parts of Radix Dipsacis, Radix Cyathulae, then is prepared from adjuvant.
Aforesaid lumbago plaster, according to composition by weight, calculate, it is prepared from by described drug extract 2-6 part, SIS-81810-20 part, SBS-8115-10 part, C5 hydrogenation 20-40 part, naphthenic rubber oil 4-12 part, far-infrared powder 0.5-1 part, magnetic powder 5-10 part, antioxidant YD1680.2-0.8 part, antioxidant YD10100.1-0.5 part, potassium sorbate 0.05-0.2 part, penetrating agent 2-7 part.
Specifically, aforesaid lumbago plaster, according to composition by weight, calculate, it is prepared from by 5 parts of 4 parts of described drug extracts, SIS-81814 part, SBS-8117 part, 30 parts of C5 hydrogenation, 8 parts of naphthenic rubber oil, 0.88 part of far-infrared powder, 7.5 parts, magnetic powder, antioxidant YD1680.67 part, antioxidant YD10100.33 part, 0.1 part of potassium sorbate, penetrating agent.
Penetrating agent calculates according to components by weight percent, by 15 parts of 6 parts of Borneolum Syntheticums, 13 parts of Mentholums, 6 parts of natural camphors, 4 parts of methyl salicylate, azone, is mixed with and is formed.
Described lumbago plaster is external patch unguentum;
Described lumbago plaster carrier material used is non-woven fabrics or release paper.
Described drug extract is prepared like this: get the medical material of recipe quantity, be ground into coarse powder, add percolate pot, add the 3-5 of medical material amount doubly to measure 80%-95% ethanol, Jiang Guankou obturages, and infiltrates 24-72 hour, flood completely, receive the liquid of just filtering, during the due-in 60-70% that must drop into amount of alcohol; The 4-8 that drops into medical material amount doubly measures the ethanol of 80%-95%, and point 3-5 input, receives the liquid of filtering, during the due-in 70%-85% that must drop into ethanol total amount, by valve wide open, put only the extractum that when reclaiming ethanol and being concentrated into 60 ℃, relative density is 1.14-1.16, filter while hot, receive cream, obtain.
Specifically, described drug extract is prepared like this: the medical material of getting recipe quantity, be crushed to 40 object coarse powder, place backing net, by the order of leaf, powder, stem, add successively percolate pot, and use wooden stick tamping, by 4 times of medical material amount, measure 90% ethanol sprinkles on the medical material of percolate pot, 30 order stainless (steel) wires are placed on to even weighting material on medical material, with Polypropylence Sheet and sealing compound, filling mouthful is obturaged, infiltrate 48 hours, flood complete, by every kilogram of medical material 3～5mL per minute, receive the liquid of just filtering, during the due-in 60-70% that must drop into amount of alcohol; Drop into successively the ethanol of 6 times of amounts 90% of medical material amount, divide and add for four times, each 1.5 times, by every kilogram of medical material, 3～5mL per minute receives the liquid of filtering, due-in must drop into ethanol total amount 80% time by valve wide open, put clean, reclaim ethanol and be concentrated into the extractum that 60 ℃ of relative densities are 1.14～1.16 with spherical reclaim under reduced pressure concentration tank, with 200 mesh filter screens, filter while hot, receive cream, obtain.
Described external patch unguentum is prepared like this: C5 hydrogenation, naphthenic rubber oil are put into reactor heated and stirred 1-3 hour, add SIS-818, SBS-811 to stir 4-6 hour, temperature is all controlled at 130-140 ℃ during this time, adds antioxidant YD168, antioxidant YD1010, far-infrared powder, magnetic powder, stir 1-3 hour, add successively again potassium sorbate, drug extract, stir 30-80 minute, add penetrating agent, stir 5-20 minute, coating, section, obtains.
Specifically, described external patch unguentum is prepared like this: C5 hydrogenation, naphthenic rubber oil are put into reactor heated and stirred 2 hours, add SIS-818, SBS-811 to stir 5 hours, temperature is all controlled at 130-140 ℃ during this time, add antioxidant YD168, antioxidant YD1010, far-infrared powder, magnetic powder, stir 2 hours, then add successively potassium sorbate, drug extract, stir 50 minutes, add penetrating agent, stir 10 minutes, coating, section, obtains.
Lumbago plaster of the present invention is prepared from by Radix Et Rhizoma Rhei, Rhizoma Zingiberis, Rhizoma Kaempferiae, the Radix Aucklandiae, Cortex Periplocae, Radix Angelicae Pubescentis, Lignum Santali Albi, the Radix Angelicae Dahuricae, Radix Cynanchi Paniculati, Rhizoma Chuanxiong, Flos Caryophylli, Caulis et Radix Periplocae Forrestii, Radix Dipsaci, Radix Cyathulae and adjuvant.Radix Et Rhizoma Rhei bitter in the mouth, cold, warm in nature in side, heat and toxic materials clearing away, clearing away heat-fire, removing pathogenic heat from blood and toxic substance from the body, eliminating blood stasis and inducing menstruation, dampness removing jaundice eliminating.For the stagnant constipation of excess-heat, heat in blood is told nosebleed, conjunctival congestion pharyngeal swelling, carbuncle furuncle, abdominalgia with intestinal abscess, blood stasis amenorrhea, postpartum stagnation, traumatic injury, hygropyretic dysentery, yellow cellulitis dark coloured urine, stranguria, edema; Externally treating burns and scalds.Modern pharmacology proves that Radix Et Rhizoma Rhei has antiinflammatory action.Rhizoma Zingiberis is pungent, heat.Return spleen, stomach, kidney, the heart, lung meridian.Warming spleen and stomach for dispelling cold, recuperating depleted YANG is promoted blood circulation, warming the lung to resolve fluid-retention effect.For coldness and pain in the epigastrium, vomiting is had loose bowels, cold extremities faint pulse, and cold fluid-retention is breathed with cough.Modern pharmacology proves that Rhizoma Zingiberis has the pharmacological actions such as antalgic and inflammation relieving, antitumor, antipathogen.Rhizoma Kaempferiae acrid in the mouth, warm in nature.Return stomach warp.There is circulation of qi promoting warming middle-JIAO, help digestion, the function of pain relieving.For chest and diaphragm distension, coldness and pain in the epigastrium, diet does not disappear.The Radix Aucklandiae is pungent, bitter, temperature.Return spleen, stomach, large intestine, three warmers, gallbladder meridian.There are promoting the circulation of QI to relieve pain, strengthening the spleen to promote digestion function.For the breast side of body, abdominal distention, heavy after dysentery, food stagnation does not disappear, anorexia.Modern pharmacology proves that the Radix Aucklandiae has anthelmintic, antibacterial, analgesic biological activity.Cortex Periplocae is pungent, bitter, temperature; Poisonous.Return liver, kidney, heart channel.There is inducing diuresis to remove edema, wind-damp dispelling, the functions such as bone and muscle strengthening.For lower limb, float the middle of the month, shortness of breath and palpitation, anemofrigid-damp arthralgia, soreness of the waist and knees.Radix Angelicae Pubescentis is pungent, bitter in the mouth, tepor.Return kidney, urinary bladder channel.There is expelling wind and removing dampness, numbness relieving and pain relieving function.For anemofrigid-damp arthralgia, lumbocrural pain, few cloudy volt wind headache, wind and cold is held wet headache under the arm.Lignum Santali Albi nature and flavor are pungent, temperature.Return spleen, stomach, the heart, lung meridian.Tool circulation of qi promoting warming middle-JIAO, appetizing pain relieving.For QI stagnated by cold, chest and diaphragm does not relax, obstruction of qi in the chest and cardialgia, epigastric pain, vomiting lack of appetite.The Radix Angelicae Dahuricae is pungent, taste temperature.Return stomach, large intestine, lung meridian.There is the cold expelling of inducing sweat, wind-expelling pain-stopping, a surname's clearing the nasal passage, dampness leukorrhagia stopping, the function of detumescence and apocenosis.For headache due to common cold, eyebrow shuttle osteodynia, nasal obstruction watery nasal discharge, allergic rhinitis, nasal sinusitis, toothache, leukorrhagia, skin infection swells and ache.Modern pharmacology proof has the pharmacological action of easing pain and diminishing inflammation, activating blood circulation to dissipate blood stasis, spasmolytic, loose wind (trembling with fear), dehumidifying.Radix Cynanchi Paniculati nature and flavor are pungent, temperature.Return liver, stomach warp.Tool dispels the wind, removing dampness, pain relieving, antipruritic effect.For rheumatic arthralgia, stomachache distension, toothache, lumbago. fall and flutter the pain of injury, rubella, eczema etc.There is the pharmacological actions such as anti-inflammatory and antalgic, venom, antitumor.Rhizoma Chuanxiong acrid in the mouth, warm in nature.Return liver, gallbladder, pericardium channel.There is blood-activating and qi-promoting, the merits such as wind-expelling pain-stopping.For obstruction of qi in the chest and cardialgia, the twinge of the breast side of body, tumbling and swelling, menoxenia, amenorrhea dysmenorrhea ， mass in the abdomen stomachache, headache, the diseases such as rheumatic arthralgia.Flos Caryophylli property is pungent, temperature.Return spleen, stomach, lung, kidney channel.There is warming middle-JIAO to send down the adverse QI, reinforcing the kidney and supporting YANG function.For Deficiency and coldness of spleen and stomach, singultus vomiting, lack of appetite and vomiting, trusted subordinate's cold type of pain, impotence due to deficiency of the kidney.Caulis et Radix Periplocae Forrestii has the effect of stimulating the menstrual flow, invigorate blood circulation, detoxify, dispeling the wind, and cures mainly the diseases such as rheumatic arthritis, traumatic injury, menoxenia, is the diseases such as closed soft tissue injury, rheumatism and rheumatoid that are widely used in treating among the people.There is the effect of anticancer, antalgic and inflammation relieving, heart tonifying.Radix Dipsaci bitter in the mouth, sweet, pungent, tepor, returns liver, kidney channel.There is the effect of invigorating the liver and kidney, promoting the circulation of blood arteries and veins, reuniting the fractured tendons and bones; For soreness of waist and knee joint, rheumatism fraud pain, traumatic injury, fracture swells and ache.Radix Cyathulae sweet in the mouth, micro-hardship, flat.Return liver, kidney channel.Tool eliminating blood stasis and inducing menstruation, easing joint movement, the functions such as inducing diuresis for treating stranguria syndrome.For amenorrhea and mass in the abdomen, retention of placenta, injury from falling down, rheumatic arthralgia, flaccidity of the lower limbs clonic spasm of the muscle, the diseases such as hematuria stranguria with blood.The present invention is by common said medicine prescription, the effect of playing altogether antiinflammatory, analgesia, warming and recuperating the kidney-YANG, wind-expelling pain-stopping.For diseases such as treatment lumbago due to pathogenic wind-dampness, lumbar muscle strain, vertebra and spinal cords, there is definite curative effect.
Because emplastrum is percutaneous drug administration preparation, medicine need penetrate into body by keratodermatitis etc., generation effect, and therefore generally onset time is longer, conventionally adopts and adds penetrating agent to promote drug osmotic.But general chemical enhancers has certain side effect, life-time service may cause skin discomfort, lumbago plaster of the present invention adds far-infrared powder and magnetic powder in adjuvant, the far infrared that far-infrared powder produces claims again " life light wave ", approach with the frequency of vibration of human inner cell's molecule, after in it infiltrates body, just can cause the resonance of atom and the molecule of human body cell, seeing through sympathetic response absorbs, between molecule, frictional heat forms thermal response, impel subcutaneous deep temperature rise, and make Marjoram Extract, accelerate blood circulation, can promote the absorption of medicine, reduce penetrating agent consumption.
In addition, lumbago plaster of the present invention adds after far-infrared powder and magnetic powder in adjuvant, depths, the deep and thorough Li Keda muscle joint of far infrared, make body interior warm, relax one's muscles, drive the oxygen of capillary network and nutrient exchange, and it is interior swollen to eliminating to get rid of the aging refuses such as the tired material that accumulates in body and lactic acid, relaxes the effect brilliance of aching.Specific electromagnetic wave spectrum (TDP) wavelength that magnetic powder produces, at 2-25 micron, is easy to be absorbed by organism, and is free from side effects.Can also produce the biological effect useful to biology, thereby improve the activity of various enzymes in organism, improve the microcirculqtory system in organism, improve and transfer the immunologic function of organism self, produce more immune body fluid, alleviate pain disease.Far-infrared powder and magnetic powder can promote the quick absorption of medicine simultaneously, improve the utilization rate of medicine, thus make lumbago plaster onset of the present invention rapidly, good effect.
Compared with prior art, the present invention is with Radix Et Rhizoma Rhei, Rhizoma Zingiberis, Rhizoma Kaempferiae, the Radix Aucklandiae, the Radix Cynanchi Paniculati of antalgic and inflammation relieving, and the Cortex Periplocae of wind-expelling pain-stopping, Rhizoma Chuanxiong, Radix Cyathulae, Radix Angelicae Pubescentis, the Radix Angelicae Dahuricae, Heiguteng exract, help Radix Dipsaci, Lignum Santali Albi, Flos Caryophylli composition with warming the kidney to activate YANG.Both be good at the lumbago that chronic strain and aseptic inflammation cause, be good at again treating the arthralgia pain due to rheumatism.We have added far-infrared powder and magnetic powder in adjuvant simultaneously, the depths, the deep and thorough Li Keda muscle joint of far infrared that far-infrared powder produces, make body interior warm, relax one's muscles, drive oxygen and the nutrient exchange of capillary network, and it is interior swollen to eliminating to get rid of aging refuses such as accumulating tired material in body and lactic acid, the effect brilliance that mitigation is ached, far infrared can make subcutaneous deep skin temperature-elevating simultaneously, expansion blood capillary, blood circulation promoting, is conducive to the infiltration and usage of medicine.The specific electromagnetic wave spectrum that magnetic powder produces is easy to be absorbed by organism, the biological effect that generation is useful to biology, thereby the activity of various enzymes in raising organism, improve the microcirculqtory system in organism, improve and transfer the immunologic function of organism self, produce more immune body fluid, diminish inflammation and pain disease.
Applicant has carried out following experiment, and provable the present invention has effective effect;
Experimental example 1:
Medicine of the present invention adopts 90% ethanol for extracting solvent, and inventor finds through Related Experimental Study, uses cold-maceration to extract, and ethanol large usage quantity is extracted not exclusively, uses percolation to extract, and has ethanol consumption less, the advantage such as extracts more completely.Use the lumbago plaster outward appearance that lumbago plaster adjuvant of the present invention is write out a prescription and production technology is produced, the property pasted, uniformity etc. all better.
1, matrix optimization
The evaluation methodology of 1.1 emplastrum substrate
With indexs such as outward appearance, viscosity, stretchability, uniformity, fissilities, made emplastrum substrate is carried out to overall merit: outward appearance should be the paste that rare denseness is suitable; Viscosity is take skin as experimental subject, and stickiness should be larger; Stretchability should be easy to coating; It is consistent without granular sensation, exquisiteness, thin and thick when uniformity should be coated with on non-woven fabrics; Fissility is tackled plastic covering film and is easily peeled off, do not stick.All items is evaluated by index quality, 20 points of full marks, and defective is 5 points, obatained score summation is comprehensive grading.
The optimization of 1.2 emplastrum substrate prescriptions
According to emplastrum prescription and principal agent characteristic, by experiment of single factor, selecting C5 hydrogenation, naphthenic rubber oil, SIS-818 and SBS-811 is substrate constituent, inventor is take C5 hydrogenation, naphthenic rubber oil, SIS-818 and SBS-811 as investigation factor, each factor is established 3 levels, factor level, in Table 1, is selected L
9(3
4) orthogonal table experiment arrangement, with general comment, be divided into index optimization purifying process, the results are shown in following table 2.
Table 1 factor level table
Table 2 orthogonal array
Analyze conclusion: with general comment, be divided into index, by table 4 intuitive analysis, can obtain optimum extraction process is A
1b
2c
3d
2, extreme difference size is R
d>R
c>R
a>R
b, i.e. C5 hydrogenation >SIS-818>SBS-811GreatT.GreaT .GT naphthenic rubber oil, determines that substrate is: SBS-8117g, naphthenic rubber oil 8g, SIS-81814g, C5 hydrogenation 30g.
2, penetrating agent consumption is investigated
2.1 emodin contents are measured
Chromatographic condition and system suitability: octadecylsilane chemically bonded silica is filler; Take methanol-0.1% phosphoric acid solution (85:15) as mobile phase; Detection wavelength is 254nm.Number of theoretical plate calculates and should be not less than 3000 by emodin peak.
The preparation of reference substance solution: it is appropriate that precision takes emodin reference substance, adds methanol and makes respectively every lmL containing the each 80 μ g solution of emodin, obtains.
Algoscopy: accurate reference substance solution and the each 10 μ L of need testing solution of drawing respectively, injection liquid chromatography, measures, and obtains.
2.2 test sample skin permeation rates are measured: the lumbago plaster of the present invention of same homalographic and blank patch are affixed on respectively to 2 pretreated Corium Mus surfaces, paste powder and be installed on transdermal diffusion experiment instrument towards supply chamber, acceptable solution is normal saline.Setting bath temperature is (37 ± 0.5) ℃, mixing speed 100r/min, respectively at the the the 2nd, 4,6,8,12 and 24h sampling, take blank patch acceptable solution as blank, by " 5.3.1 ", measure, calculate the content that transdermal enters the emodin in absorption cell, and be calculated as follows test sample skin permeation rate, emodin in skin permeation rate (%)=absorption cell
aemodin total amount × 100% in content/lumbago plaster.
2.3 result
Add not commensurability penetrating agent to affect as table 3 emodin skin permeation rate:
Table 3 emodin skin permeation rate
2.4 conclusions: as seen from the above table, emodin skin permeation rate increases with penetrating agent consumption, when penetrating agent consumption exceedes after 5g, emodin skin permeation rate is almost constant, therefore penetrating agent consumption is 5g.
Experimental example 2: pharmacodynamic study
1, laboratory animal: Kunming kind Strains of Mouse (20 ± 2g) is female, Sprague Dawley (SD) strain rat (150 ± 20g) is male, and two kinds of animals are all purchased from Chongqing City's Experimental Animal Center.
2, Experimental agents:
2.1 preparations 1 of the present invention: according to the method preparation of embodiment 1 and embodiment 2.
2.2 preparations 2 of the present invention: according to the method preparation of embodiment 1 and embodiment 2, but do not add infrared powder and magnetic powder.
2.3 former technique preparations:
2.3.1 extract drugs
Prescription: Radix Et Rhizoma Rhei 160g, Rhizoma Zingiberis 80g, Rhizoma Kaempferiae 56g, Radix Aucklandiae 20g, Cortex Periplocae 20g, Radix Angelicae Pubescentis 32g, Lignum Santali Albi 20g, Radix Angelicae Dahuricae 56g, Radix Cynanchi Paniculati 56g, Rhizoma Chuanxiong 20g, Flos Caryophylli 20g, Caulis et Radix Periplocae Forrestii 64g, Radix Dipsaci 32g, Radix Cyathulae 32g.
Technique: the medical material of getting recipe quantity, be crushed to 40 object coarse powder, place backing net, by the order of leaf, powder, stem, add successively in extraction pot, add 6 times of amount 90% ethanol of medical material amount, with Polypropylence Sheet and sealing compound, filling mouthful is obturaged, infiltrate 48 hours, filter, filtering residue adds 4 times of amount 90% ethanol, infiltrate 48 hours, filter merging filtrate.With spherical reclaim under reduced pressure concentration tank, reclaim ethanol and be concentrated into relative density 1.14～1.16(60 ℃), with 200 mesh filter screens filtrations, receive cream, obtain.
2.3.2 preparation preparation
Formula: drug extract 4g, mixed-matrix (rubber: Colophonium: zinc oxide: lanoline: vaseline=5:7:6:1:1) 32g, penetrating agent (Borneolum Syntheticum: Mentholum: natural camphor: methyl salicylate: azone=6:13:6:4:15) 5g, far-infrared powder 0.88g, magnetic powder 7.5g.
Technique: get Borneolum Syntheticum, Mentholum, natural camphor, methyl salicylate, azone and be mixed and made into penetrating agent according to prescription ratio, standby; Separately get recipe quantity rubber, clean, at 50～60 ℃ of heat dryings or dry, be cut into bulk, in rubber mixing machine, plasticate and reticulate thin slice, eliminate static after 18～24 hours, be dipped in appropriate gasoline, after swelling, move in adhesive supplier, stir evenly, gradation adds vaseline, lanoline, zinc oxide, Colophonium, far-infrared powder and magnetic powder to make substrate, then adds the drug extract and the penetrating agent that make, stirs evenly, be coated with cream, reclaim gasoline, lid lining, section, obtains.
3, experimental technique
3.1 impacts on mice analgesic activity
3.1.1 experimental technique and result are placed in mice in special glass cylinder, and front half body is movable, and Mus tail passes in stopper one pomegranate after by cylinder, after mice peace and quiet, surveys pain.The mice of surveying pain as pain spot, is aimed at light tapping from l/3 under afterbody, and stopwatch records from the time that starts to irradiate whipping as the threshold of pain.Filter out the response time 40 of the animals of 3～12 seconds, be divided at random 4 groups (blank group, 1 group, preparation of the present invention, 2 groups, preparation of the present invention, former technique preparation groups).Each treated animal is done the method administration around Mus tail adhesive plaster except blank group, within 2,4,6,8 hours after administration, throws off cream sheet and measures the threshold of pain, measures.The results are shown in Table 4.
The impact of table 4 on mice analgesic activity (n=10, x ± s)
Note: with blank group comparison: * P < 0.05, * * P < 0.01.
With former technique preparation group comparison: #P < 0.05.
With 2 groups of comparisons of the present invention: △ P < 0.05.
3.1.2 conclusion
Above experimental studies results shows, 1 group, preparation of the present invention, and 2 groups, preparation of the present invention, former technique preparation group all can all can increase the mice threshold of pain; Wherein 1 group, preparation of the present invention, 2 groups, preparation of the present invention, all faster than the onset of former technique preparation group, better efficacy.And administration is after 6 hours, 1 group, preparation of the present invention is than 2 groups of better efficacy of the present invention preparation.
3.2 impacts that Ovum Gallus domesticus album is caused inflammation
3.2.1 experimental technique and result are got 40 of rats, be divided at random 4 groups (blank group, 1 group, preparation of the present invention, 2 groups, preparation of the present invention, former technique preparation groups), sufficient plantar subcutaneous injection lOO% Ovum Gallus domesticus album 0.05ml at Mus hind leg causes after inflammation, does immediately around Mus tail adhesive plaster.By capillary tube measurement by magnification method, measure respectively the volume of 1,2,4 hour sufficient sole of the foot before medicine, after medicine, observe the impact of each group of plaster on its swelling degree.The results are shown in Table 5.
Impact that table 5 causes inflammation on Ovum Gallus domesticus album (n=10, x ± s)
Note: with blank group comparison: * P < 0.05, * * P < 0.01.
With former technique preparation group comparison: #P < 0.05.
With 2 groups of comparisons of the present invention: △ P < 0.05.
3.2.2 conclusion
Above experimental studies results shows, 1 group, preparation of the present invention, and 2 groups, preparation of the present invention, former technique preparation group all can alleviate the caused swelling effect of Ovum Gallus domesticus album; Wherein 1 group, preparation of the present invention, 2 groups, preparation of the present invention, all faster than the onset of former technique preparation group, better efficacy.And administration is after 4 hours, 1 group, preparation of the present invention is than 2 groups of better efficacy of the present invention preparation.
Experimental example 3: performance study
10, preparation of the present invention is got in 1 far infrared wavelength test, removes lid lining, uses the inspection of far infrared detector, and preparation far infrared wavelength of the present invention is 10 μ m～14 μ m, and emissivity is 85.7%.
10, preparation of the present invention is got in 2 magnetic induction tests, removes lid lining, measures, and preparation maximum point magnetic induction of the present invention is 0.82Gs.
(preparation of the present invention and former technique preparation are compared, and preparation process of the present invention is with embodiment 1 and embodiment 2 in 3 property pasted tests; The preparation method of former technique preparation is shown in experimental example 2).
Hold the mensuration of viscous force and measure by < < Chinese Pharmacopoeia > 2010 editions one appendix X II E emplastrum adhesive force algoscopy of > (the second method is held the mensuration of viscous force), the results are shown in Table 6;
Peel strength is pressed < < Chinese Pharmacopoeia > 2010 editions one appendix X II E emplastrum adhesive force algoscopy of > (mensuration of the 3rd method peel strength) and is measured, and the results are shown in Table 6.
Table 6 property pasted
Conclusion: preparation of the present invention and the former technique preparation property pasted all meet the requirements, its Central Plains invention preparation viscosity is larger, peels off relatively difficulty, skin group zest is wanted to large, and the stickiness of preparation of the present invention is moderate, mastic plasticity is better, affinity is strong, less to skin irritation.
(preparation of the present invention and former technique preparation are compared, and preparation process of the present invention is with embodiment 1 and embodiment 2 for 4 irritation tests; The preparation method of former technique preparation is shown in experimental example 2).
Please 20 professionals carry out blank sensation scoring, hundred-mark system, gets geometrical mean.
Table 7 sensory evaluation scores reference listing
Preparation group of the present invention and former technique preparation group are marked as table 8:
The scoring of table 8 irritation test
Conclusion: preparation of the present invention and the comparison of former technique preparation, preparation of the present invention is less to the zest of skin.
Compared with prior art, lumbago plaster of the present invention has the beneficial effects such as onset is rapid, good effect, penetrating agent use amount is less, side effect is less, Drug therapy combines with physics physical therapy.Applicant adopted the preparation method of " former technique preparation " in experimental example 2 to be prepared in the past, but use the method for the invention instead in March, 2012, prepared lumbago plaster, and in March, 2013, income from sales has just increased by 29% on year-on-year basis.Reached goal of the invention.
The specific embodiment:
Embodiment 1: the preparation of drug extract
Prescription: Radix Et Rhizoma Rhei 160g, Rhizoma Zingiberis 80g, Rhizoma Kaempferiae 56g, Radix Aucklandiae 20g, Cortex Periplocae 20g, Radix Angelicae Pubescentis 32g, Lignum Santali Albi 20g, Radix Angelicae Dahuricae 56g, Radix Cynanchi Paniculati 56g, Rhizoma Chuanxiong 20g, Flos Caryophylli 20g, Caulis et Radix Periplocae Forrestii 64g, Radix Dipsaci 32g, Radix Cyathulae 32g.
Preparation technology: the medical material of getting recipe quantity, be crushed to 40 object coarse powder, place backing net, by the order of leaf, powder, stem, add successively percolate pot, and use wooden stick tamping, 4 times of medical material amount amount 90% ethanol sprinkles, on the medical material of percolate pot, are placed on medical material to evenly weighting material by 30 order stainless (steel) wires, filling mouth are obturaged with Polypropylence Sheet and sealing compound, infiltrate 48 hours, flood completely, by every kilogram of medical material, 3～5mL per minute receives the liquid of just filtering, during the due-in 60-70% that must drop into amount of alcohol; Drop into successively the ethanol of 6 times of amounts 90% of medical material amount, divide and add for four times, each 1.5 times, by every kilogram of medical material, 3～5mL per minute receives the liquid of filtering, due-in must drop into ethanol total amount 80% time by valve wide open, put clean, reclaim ethanol and be concentrated into the extractum that 60 ℃ of relative densities are 1.14～1.16 with spherical reclaim under reduced pressure concentration tank, with 200 mesh filter screens, filter while hot, receive cream, obtain.
Embodiment 2: the preparation of emplastrum
Prescription: drug extract 4g, SIS-81814g, SBS-8117g, C5 hydrogenation 30g, naphthenic rubber oil 8g, far-infrared powder 0.88g, magnetic powder 7.5g, antioxidant YD1680.67g, antioxidant YD10100.33g, potassium sorbate 0.1g, penetrating agent 5g.
Penetrating agent prescription: 15 parts of 6 parts of Borneolum Syntheticums, 13 parts of Mentholums, 6 parts of natural camphors, 4 parts of methyl salicylate, azone are mixed with and form.
Preparation technology: get Borneolum Syntheticum, Mentholum, natural camphor, methyl salicylate and azone, mix, standby; Separately C5 hydrogenation, naphthenic rubber oil are put into reactor heated and stirred 2 hours, add SIS-818, SBS-811 to stir 5 hours, temperature is all controlled at 130-140 ℃ during this time, adds antioxidant YD168, antioxidant YD1010, far-infrared powder, magnetic powder, stir 2 hours, add successively again potassium sorbate, drug extract, stir 50 minutes, add penetrating agent, stir 10 minutes, coating, section, obtains.
Claims (10)
1. a lumbago plaster, it is characterized in that: according to composition by weight, calculate, it is first made drug extract, then is prepared from adjuvant by Radix Et Rhizoma Rhei 100-200 part, Rhizoma Zingiberis 50-120 part, Rhizoma Kaempferiae 20-80 part, Radix Aucklandiae 10-30 part, Cortex Periplocae 10-30 part, Radix Angelicae Pubescentis 10-50 part, Lignum Santali Albi 10-30 part, Radix Angelicae Dahuricae 20-80 part, Radix Cynanchi Paniculati 20-80 part, Rhizoma Chuanxiong 10-30 part, Flos Caryophylli 10-30 part, Caulis et Radix Periplocae Forrestii 20-80 part, Radix Dipsaci 10-50 part, Radix Cyathulae 10-50 part.
2. lumbago plaster as claimed in claim 1, it is characterized in that: according to composition by weight, calculate, it first makes drug extract by 32 parts of 160 parts of Radix Et Rhizoma Rhei, 80 parts of Rhizoma Zingiberiss, 56 parts of Rhizoma Kaempferiaes, 20 parts of the Radix Aucklandiae, 20 parts of Cortex Periplocaes, 32 parts of Radix Angelicae Pubescentiss, 20 parts, Lignum Santali Albi, 56 parts of the Radixs Angelicae Dahuricae, 56 parts of Radix Cynanchi Paniculatis, 20 parts of Rhizoma Chuanxiongs, 20 parts of Flos Caryophyllis, 64 parts of Caulis et Radix Periplocae Forrestii, 32 parts of Radix Dipsacis, Radix Cyathulae, then is prepared from adjuvant.
3. lumbago plaster as claimed in claim 1 or 2, it is characterized in that: according to composition by weight, calculate, it is prepared from by described drug extract 2-6 part, SIS-81810-20 part, SBS-8115-10 part, C5 hydrogenation 20-40 part, naphthenic rubber oil 4-12 part, far-infrared powder 0.5-1 part, magnetic powder 5-10 part, antioxidant YD1680.2-0.8 part, antioxidant YD10100.1-0.5 part, potassium sorbate 0.05-0.2 part, penetrating agent 2-7 part.
4. lumbago plaster as claimed in claim 3, it is characterized in that: according to composition by weight, calculate, it is prepared from by 5 parts of 4 parts of described drug extracts, SIS-81814 part, SBS-8117 part, 30 parts of C5 hydrogenation, 8 parts of naphthenic rubber oil, 0.88 part of far-infrared powder, 7.5 parts, magnetic powder, antioxidant YD1680.67 part, antioxidant YD10100.33 part, 0.1 part of potassium sorbate, penetrating agent.
5. lumbago plaster as described in claim 3 or 4, is characterized in that: described penetrating agent calculates according to components by weight percent, by 15 parts of 6 parts of Borneolum Syntheticums, 13 parts of Mentholums, 6 parts of natural camphors, 4 parts of methyl salicylate, azone, is mixed with and is formed.
6. the lumbago plaster as described in as described in any one in claim 1-5, is characterized in that: described lumbago plaster is external patch unguentum; Described lumbago plaster carrier material used is non-woven fabrics or release paper.
7. the preparation method of lumbago plaster described in any one in preparation claim 1-4, it is characterized in that: described drug extract is prepared like this: the medical material of getting recipe quantity, be ground into coarse powder, add percolate pot, add the 3-5 of medical material amount doubly to measure 80%-95% ethanol, Jiang Guankou obturages, infiltrate 24-72 hour, flood completely, receive the liquid of just filtering, during the due-in 60-70% that must drop into amount of alcohol; The 4-8 that drops into medical material amount doubly measures the ethanol of 80%-95%, and point 3-5 input, receives the liquid of filtering, during the due-in 70%-85% that must drop into ethanol total amount, by valve wide open, put only the extractum that when reclaiming ethanol and being concentrated into 60 ℃, relative density is 1.14-1.16, filter while hot, receive cream, obtain.
8. the preparation method of lumbago plaster as claimed in claim 7, it is characterized in that: described drug extract is prepared like this: the medical material of getting recipe quantity, be crushed to 40 object coarse powder, place backing net, press leaf, powder, the order of stem adds percolate pot successively, and use wooden stick tamping, by 4 times of medical material amount, measure 90% ethanol sprinkles on the medical material of percolate pot, 30 order stainless (steel) wires are placed on to even weighting material on medical material, filling mouthful is obturaged with Polypropylence Sheet and sealing compound, infiltrate 48 hours, flood complete, by every kilogram of medical material 3～5mL per minute, receive the liquid of just filtering, during the due-in 60-70% that must drop into amount of alcohol, drop into successively the ethanol of 6 times of amounts 90% of medical material amount, divide and add for four times, each 1.5 times, by every kilogram of medical material, 3～5mL per minute receives the liquid of filtering, due-in must drop into ethanol total amount 80% time by valve wide open, put clean, reclaim ethanol and be concentrated into the extractum that 60 ℃ of relative densities are 1.14～1.16 with spherical reclaim under reduced pressure concentration tank, with 200 mesh filter screens, filter while hot, receive cream, obtain.
9. the preparation method of lumbago plaster as described in claim 7 or 8, it is characterized in that: described external patch unguentum is prepared like this: C5 hydrogenation, naphthenic rubber oil are put into reactor heated and stirred 1-3 hour, add SIS-818, SBS-811 to stir 4-6 hour, temperature is all controlled at 130-140 ℃ during this time, add antioxidant YD168, antioxidant YD1010, far-infrared powder, magnetic powder, stir 1-3 hour, add successively again potassium sorbate, drug extract, stir 30-80 minute, add penetrating agent, stir 5-20 minute, coating, section, obtains.
10. the preparation method of lumbago plaster as claimed in claim 9, it is characterized in that: described external patch unguentum is prepared like this: C5 hydrogenation, naphthenic rubber oil are put into reactor heated and stirred 2 hours, add SIS-818, SBS-811 to stir 5 hours, temperature is all controlled at 130-140 ℃ during this time, add antioxidant YD168, antioxidant YD1010, far-infrared powder, magnetic powder, stir 2 hours, add successively again potassium sorbate, drug extract, stir 50 minutes, add penetrating agent, stir 10 minutes, coating, section, obtains.
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| CN201410011319.4A CN103736060B (en) | 2014-01-09 | 2014-01-09 | Lumbago plaster and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104547989A (en) * | 2014-12-10 | 2015-04-29 | 天祝藏族自治县藏医院 | Tibetan paste for treating spondylodynia and using method thereof |
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| CN102552816A (en) * | 2012-02-15 | 2012-07-11 | 范云贤 | Plaster for treating pain and preparation method thereof |
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| CN1723935A (en) * | 2005-07-13 | 2006-01-25 | 河南羚锐制药股份有限公司 | Paste for removing obstruction in channels to relieve pain for treating osteoarthritis, and its prepn. method |
| CN1994430A (en) * | 2007-01-09 | 2007-07-11 | 北京市门头沟区中医医院 | Externally applied ointment for activating blood circulation and unblocking obstruction |
| CN102188673A (en) * | 2010-03-17 | 2011-09-21 | 赵贵凤 | Plaster for promoting muscles and bones, and preparation and application thereof |
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| CN104547989A (en) * | 2014-12-10 | 2015-04-29 | 天祝藏族自治县藏医院 | Tibetan paste for treating spondylodynia and using method thereof |
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| CN103736060B (en) | 2016-08-17 |
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