CN101780169A - Traumatic injury analgesic cataplasm preparation and preparation method thereof - Google Patents
Traumatic injury analgesic cataplasm preparation and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a traumatic injury analgesic cataplasm and a preparation method thereof, the traumatic injury analgesic cataplasm is produced by formula raw materials of traumatic injury analgesic paste according to the process of the cataplasm and comprises a hydrophilic gel matrix, a non-woven fabric back-up material and a traumatic injury analgesic paste drug, and the traumatic injury analgesic paste drug consists of ground beetle, crude kusnezoff monkshood, nux vomica (stir-fried), rhubarb, rosewood heart wood, shinyleaf pricklyash root, baical skullcap root, amur corktree bark, giant knotweed rhizome, borneol, camphor, menthol, peppermint oil and methyl salicylate. The soluble matrix of the cataplasm has good compatibility with water-soluble and fat-soluble drugs, and the drug loading of the matrix is great, thereby being very applicable to medication features of multiple components and large dose of traditional Chinese medicine; compared with an adhesive plaster agent, the cataplasm is easier to soften the horny layer of skin, is conductive to transdermal absorption of the drug and has better air permeability, adhesion to the skin and moisture retention, thereby having the advantages of comfortable use, small irritation to the skin, repeated tearing and pasting, no pollution of clothes, no residue, no pain when tearing after the use and the like.
Description
Technical field
The present invention relates to a kind of cataplasma preparation, be specifically related to a kind of traumatic injury analgesic cataplasm preparation and preparation method thereof, belong to medical technical field.
Background technology
DIEDA ZHENTONG GAO is Baiyunshan Pharmaceutics Stock-sharing Co., Ltd., Guangzhou City White Cloud Mountain kind that the metric system pharmaceutical factory produced of how helping, this product dosage form is a rubber-emplastrum, go on the market in January, 1970, has promoting blood circulation and stopping pain, dissipating blood stasis for subsidence of swelling, the effect of expelling wind and dampness, be used for acute and chronic bruise, chronic lambago and skelalgia, rheumatic arthritis etc., its curative effect is accepted by extensive patients deeply.The DIEDA ZHENTONG GAO standard is recorded in " 631 pages in text of Chinese pharmacopoeia version in 2005, this rubber-emplastrum feeds intake with the medical material powder and is used as medicine, and medical material comprises Eupolyphaga Seu Steleophaga, Radix Aconiti Kusnezoffii, Semen Strychni (stir-fry), Radix Et Rhizoma Rhei, Lignum Dalbergiae Odoriferae, Radix Zanthoxyli, Radix Scutellariae, Cortex Phellodendri, Rhizoma Polygoni Cuspidati, Borneolum Syntheticum, Oleum menthae, Camphora, methyl salicylate, Mentholum etc.Former dosage form is a rubber-emplastrum, and preparation technology is simple, is after Chinese crude drug is ground into fine powder merely, adds adjuvants such as rubber, Colophonium and mix, and is coated in and makes on the cotton, and it is big to have zest, is attached to the adhesion hair of tearing on the skin, and shortcomings such as pain are arranged.In order to inherit and excavate traditional Chinese patent medicine, improve the international competitiveness of product, be necessary to improve the preparation method of the dosage form of original DIEDA ZHENTONG GAO.
Cataplasma is a kind of exterior-applied formulation that grows up on the basis of poultice, and the seventies at first occurs in Japan.Cataplasma is main matrix with the water-soluble high-molecular material, compare with traditional Chinese medicine patch unguentum, its host material can better can absorb and carry multiple water solublity and fat-soluble medicine and penetrating agent, and exist with the state of similar gels, helps the infiltration of medicine; Its substrate drug loading is big, is fit to very much the medication characteristics of Chinese medicine multicomponent, heavy dose; Cataplasma is softening than the easier keratodermatitis that makes of rubber-emplastrum, improves its bioavailability; The cataplasma breathability, skin tackness, moisture retention etc. all obviously are better than traditional rubber-emplastrum, thereby have use comfortable, little to skin irritation, can take off repeatedly and pull and apply ointment or plaster, pollution clothes, is not taken off after using and is pulled advantages such as not having pain at noresidue, more avoided plumbous to the harm of human body and the pollution of environment, not having three industrial wastes in the production, be particularly suitable for the modern production of Chinese medicine, is a kind of tool exterior-applied formulation with broad prospects for development.
The present invention is prepared into traumatic injury analgesic cataplasm with the DIEDA ZHENTONG GAO dosage changing form, and each raw medicinal herbs of former rubber-emplastrum is used as medicine with medicinal powder, and bioavailability is low, and is existing so that most of medical material is used as medicine after extracting purification, improves its bioavailability greatly; Former rubber-emplastrum contains rubber, Colophonium etc. and has the skin irritation material, now changes the cataplasma made from the water-soluble base adjuvant into, avoids the influence of zest adjuvant, thereby has improved patient's compliance.
Summary of the invention
The objective of the invention is to be made into a kind of novel formulation-Chinese medicine patcher, and the preparation method of this Chinese medicine patcher is provided with the prescription of original DIEDA ZHENTONG GAO.
In order to address the above problem, the technical solution adopted in the present invention is:
Traumatic injury analgesic cataplasm of the present invention is made up of as back lining materials etc. medicine, hydrophilic gel substrate, non-woven fabrics, and to achieve the object of the present invention, the technical scheme that is adopted is every 70cm
2Cataplasma be coated with adhesive plaster 8～15g, the composition percentage by weight of its plaster is: medicine 8～25%, hydrophilic gel substrate 75～92%.
The composition percentage by weight of above-mentioned traumatic injury analgesic cataplasm plaster is preferably: medicine 12～20%, hydrophilic gel substrate 80～88%.
The composition of said traumatic injury analgesic cataplasm medicine and quantity are:
Eupolyphaga Seu Steleophaga 48g, Radix Aconiti Kusnezoffii 48g, Semen Strychni (stir-fry) 48g, Radix Et Rhizoma Rhei 48g, Lignum Dalbergiae Odoriferae 48g, Radix Zanthoxyli 48g, Radix Scutellariae 48g, Cortex Phellodendri 48g, Rhizoma Polygoni Cuspidati 15g, Borneolum Syntheticum 24g, Camphora 60g, Mentholum 30g, Oleum menthae 30g, methyl salicylate 60g.
The hydrophilic gel substrate prescription of said traumatic injury analgesic cataplasm forms and quantity is:
The part in and sodium polyacrylate NP-700 (adhesive agent) 4.50～7.00%
30 POVIDONE K 30 BP/USP-90 (adhesive agent) 1.50～2.50%
Carbomer 980 (adhesive agent) 1.15～2.20%
Glycerol (wetting agent) 25～40%
Dihydroxyaluminum aminoacetate (cross-linking agent) 0.18～0.30%
EDTA-2Na (cross-linking regulator) 0.02～0.10%
Tartaric acid (PH regulator) 0.05～0.15%
Tween-80 (surfactant) 1.15～2.20%
Micropowder silica gel (filler) 1.15～2.20%
Purified water 42～65%
Another object of the present invention provides the preparation method of above-mentioned traumatic injury analgesic cataplasm, and its step is as follows:
(1) ten four Chinese medicine materials in the prescription are got mixed dissolutions such as Camphora 60g, Oleum menthae 30g, Borneolum Syntheticum 24g, Mentholum 30g and methyl salicylate 60g and are become fluid, and fluid is 1. standby;
(2) get Lignum Dalbergiae Odoriferae 48g and Eupolyphaga Seu Steleophaga 48g is ground into fine powder, the medical material powder is 2. standby;
(3) all the other medical materials are got Radix Aconiti Kusnezoffii 48g, Semen Strychni (stir-fry) 48g, Radix Zanthoxyli 48g and Cortex Phellodendri 48g four Chinese medicine material and are added 50%～80% ethanol extraction secondary, filter, merging filtrate, reclaim ethanol, be condensed into relative density and be 1.10～1.15/60 ℃ thick paste 3., standby;
(4) get Radix Et Rhizoma Rhei 48g, Radix Scutellariae 48g and Rhizoma Polygoni Cuspidati 15g three flavor medical materials and add 50%～80% ethanol extraction secondary, filter, merging filtrate reclaims ethanol, be condensed into relative density and be 1.10～1.15/60 ℃ thick paste 4., standby.
(5) get carbomer 980 and add in the water of about 20 times of amounts, the limit edged stirs, and 5. swelling is spent the night, standby;
(6) get tartaric acid and Tween-80 and add remaining purified water, stirring and dissolving adds 30 POVIDONE K 30 BP/USP-90 again, stirs, and 6. dissolving fully, standby;
(7) get fluid 1., add micropowder silica gel and stir, add medical material powder such as Lignum Dalbergiae Odoriferae 2. with dihydroxyaluminum aminoacetate and NP-700, stir, add glycerol, 7. dispersed with stirring is even, standby;
(8) after 5. and 6. mixing, add 7. in the colloid, stir, add successively thick paste such as Radix Aconiti Kusnezoffii 3. with thick paste such as Radix Et Rhizoma Rhei 4., stir, adjust coating thickness, coating at last, cutting, pack, sealing is placed and is solidified, promptly.
In the preparation method of above-mentioned traumatic injury analgesic cataplasm, add 6 times of amount ethanol in the step (3) for the first time, add 5 times of amount ethanol for the second time, extracted 2 hours at every turn.
In the preparation method of above-mentioned traumatic injury analgesic cataplasm, add 6 times of amount ethanol in the step (4) for the first time, add 5 times of amount ethanol for the second time, extracted 2 hours at every turn.
Hydrophilic gel substrate is made up of adhesive agent, cross-linking agent, cross-linking regulator, pH value regulator, wetting agent, filler, surfactant, purified water etc.Adhesive agent can be in sodium polyacrylate FA200, the part and the combination of one or more materials among the sodium polyacrylate NP-700,30 POVIDONE K 30 BP/USP-90, sodium carboxymethyl cellulose, carbomer 980, polyvinyl alcohol, gelatin; Cross-linking agent is not limited to dihydroxyaluminum aminoacetate, can also be aluminium hydroxide, aluminum chloride, aluminium oxide etc.; The pH regulator agent is not limited to tartaric acid, can also select citric acid or lactic acid; Wetting agent is not limited to glycerol, can also be propylene glycol, PEG400 etc.; Filler is not limited to micropowder silica gel, can also be Kaolin, polyvinylpolypyrrolidone; Surfactant is selected from Tween-80, sodium lauryl sulphate etc.By sodium polyacrylate FA200 and the part in and sodium polyacrylate NP-700 be the adhesive agent of substrate, dihydroxyaluminum aminoacetate discharges trivalent aluminium ion as cross-linking agent under tartaric acid condition, both react and form the ring-type complex, by in the adjustment member and the ratio of sodium polyacrylate and dihydroxyaluminum aminoacetate, can regulate the cross-link intensity and the cohesiveness of catablasm base material.
Usage and dosage: traumatic injury analgesic cataplasm can be pasted the affected part.
Storage: airtight, put shady and cool place and preserve.
The present invention with respect to the beneficial effect of prior art is:
Compare with existing commercially available DIEDA ZHENTONG GAO, the present invention has the following advantages:
(1) cataplasma water-soluble base and water solublity, fat-soluble medicine intermiscibility are good, and the substrate drug loading is big, are fit to very much Chinese medicine multicomponent, heavy dose of medication characteristics.
(2) cataplasma is softening than the easier keratodermatitis that makes of rubber-emplastrum, causes its cell hydration to expand, and helps the Transdermal absorption of medicine.
(3) the cataplasma breathability, skin tackness, moisture retention all obviously are better than traditional rubber-emplastrum, thereby have and use comfortablely, little to skin irritation, can take off repeatedly and pull and apply ointment or plaster, not pollution clothes, take off after noresidue, the use and pull advantages such as not having pain, thereby bigger use prospect is arranged.
The specific embodiment
Below by embodiment the present invention is described in further details, these embodiment only are used for illustrating the present invention, do not limit the scope of the invention.
Embodiment 1
[medical material prescription]
Eupolyphaga Seu Steleophaga 48g, Radix Aconiti Kusnezoffii 48g, Semen Strychni (stir-fry) 48g, Radix Et Rhizoma Rhei 48g, Lignum Dalbergiae Odoriferae 48g, Radix Zanthoxyli 48g, Radix Scutellariae 48g, Cortex Phellodendri 48g, Rhizoma Polygoni Cuspidati 15g, Borneolum Syntheticum 24g, Camphora 60g, Mentholum 30g, Oleum menthae 30g, methyl salicylate 60g.
[substrate prescription]
The part in and sodium polyacrylate NP-700 175g 30 POVIDONE K 30 BP/USP-90 70g
Carbomer 980 60g glycerol 1000g
Dihydroxyaluminum aminoacetate 7.5g EDTA-2Na 1.7g
Micropowder silica gel 50g tartaric acid 3g
Tween-80 50g purified water is an amount of
Be adjusted to 3410g
Preparation method:
(1) ten four Chinese medicine materials in the prescription are got mixed dissolutions such as Camphora, Oleum menthae, Borneolum Syntheticum, Mentholum, methyl salicylate and are become fluid, and fluid is 1. standby;
(2) get Lignum Dalbergiae Odoriferae, Eupolyph aga sinesis Walker is broken into fine powder, the medical material powder is 2. standby;
(3) all the other medical materials, get Radix Aconiti Kusnezoffii, Semen Strychni (stir-fry), Radix Zanthoxyli, Cortex Phellodendri four Chinese medicine material and add 60% ethanol extraction secondary, add for the first time 6 times of amount ethanol, add for the second time 5 times of amount ethanol, extracted 2 hours at every turn, filter, merging filtrate, reclaim ethanol, be condensed into relative density and be 1.10～1.15/60 ℃ thick paste 3., standby;
(4) get Radix Et Rhizoma Rhei, Radix Scutellariae, Rhizoma Polygoni Cuspidati three flavor medical materials and add 60% ethanol extraction secondary, add 6 times of amount ethanol for the first time, add 5 times of amount ethanol for the second time, the each extraction 2 hours filters merging filtrate, reclaim ethanol, be condensed into relative density and be 1.10～1.15/60 ℃ thick paste 4., standby;
(5) get carbomer 980 and add in the water of about 20 times of amounts, the limit edged stirs, and 5. swelling is spent the night, standby;
(6) get tartaric acid, Tween-80 adds remaining purified water, stirring and dissolving adds 30 POVIDONE K 30 BP/USP-90 again, stirs, 6. dissolving fully, standby;
(7) get the volatility raw material 1., add micropowder silica gel and stir, add medical material powder such as Lignum Dalbergiae Odoriferae 2., dihydroxyaluminum aminoacetate and NP-700, stir, add glycerol, 7. dispersed with stirring is even, standby;
(8) after 5. and 6. mixing, add 7. in the colloid, stir, add successively thick paste such as Radix Aconiti Kusnezoffii 3., thick paste such as Radix Et Rhizoma Rhei 4., stir, adjust coating thickness, coating at last, cutting, about 341 paste, every subsides 70cm
2, pack, sealing is placed and is solidified, promptly.
Embodiment 2
[medical material prescription] is with embodiment 1
[substrate prescription] is with embodiment 1
Preparation method is with embodiment 1, and coating is at last cut, and about 425 paste every subsides 70cm
2
Embodiment 3
[medical material prescription] is with embodiment 1
[substrate prescription] is with embodiment 1
Preparation method is with embodiment 1, and coating is at last cut, and about 230 paste every subsides 70cm
2
Embodiment 4
[medical material prescription]
Eupolyphaga Seu Steleophaga 32g, Radix Aconiti Kusnezoffii 32g, Semen Strychni (stir-fry) 32g, Radix Et Rhizoma Rhei 32g, Lignum Dalbergiae Odoriferae 32g, Radix Zanthoxyli 32g, Radix Scutellariae 32g, Cortex Phellodendri 32g, Rhizoma Polygoni Cuspidati 10g, Borneolum Syntheticum 16g, Camphora 40g, Mentholum 20g, Oleum menthae 20g, methyl salicylate 40g.
[substrate prescription] is with embodiment 1
Preparation method is with embodiment 1
Embodiment 5
[medical material prescription]
Eupolyphaga Seu Steleophaga 64g, Radix Aconiti Kusnezoffii 64g, Semen Strychni (stir-fry) 64g, Radix Et Rhizoma Rhei 64g, Lignum Dalbergiae Odoriferae 64g, Radix Zanthoxyli 64g, Radix Scutellariae 64g, Cortex Phellodendri 64g, Rhizoma Polygoni Cuspidati 20g, Borneolum Syntheticum 32g, Camphora 80g, Mentholum 40g, Oleum menthae 40g, methyl salicylate 80g.
[substrate prescription] is with embodiment 1
Preparation method is with embodiment 1
Embodiment 6
[medical material prescription] is with embodiment 1
[substrate prescription]
The part in and sodium polyacrylate NP-700 175g 30 POVIDONE K 30 BP/USP-90 70g
Carbomer 980 50g glycerol 1000g
Dihydroxyaluminum aminoacetate 7g EDTA-2Na 1.7g
Micropowder silica gel 50g tartaric acid 3g
Tween-80 50g purified water is an amount of
Preparation method is with embodiment 1.
Embodiment 7
[medical material prescription] is with embodiment 1
[substrate prescription]
The part in and sodium polyacrylate NP-700 175g 30 POVIDONE K 30 BP/USP-90 70g
Carbomer 980 50g glycerol 1000g
Dihydroxyaluminum aminoacetate 7g EDTA-2Na 1.7g
Micropowder silica gel 50g tartaric acid 3g
Tween-80 40g purified water is an amount of
Preparation method is with embodiment 1.
Embodiment 8
[medical material prescription] is with embodiment 1
[substrate prescription]
Sodium polyacrylate FA-200 175g 30 POVIDONE K 30 BP/USP-90 70g
Carbomer 980 60g glycerol 1000g
Aluminium hydroxide 7.5g EDTA-2Na 1.7g
Kaolin 50g tartaric acid 3g
Tween-80 50g purified water is an amount of
Preparation method is with embodiment 1.
Embodiment 9
[medical material prescription] is with embodiment 1
[substrate prescription]
Sodium polyacrylate FA-200 175g polyvinyl alcohol 70g
CMC-Na 60g glycerol 1000g
Aluminium hydroxide 7.5g EDTA-2Na 1.7g
Kaolin 50g tartaric acid 3g
Tween-80 50g purified water is an amount of
Preparation method is with embodiment 1.
Embodiment 10
[medical material prescription] is with embodiment 1
[substrate prescription]
The part in and sodium polyacrylate NP-700 285g 30 POVIDONE K 30 BP/USP-90 115g
Carbomer 980 95g glycerol 1660g
Dihydroxyaluminum aminoacetate 12.5g EDTA-2Na 3g
Micropowder silica gel 80g tartaric acid 4g
Tween-80 80g purified water is an amount of
Preparation method is with embodiment 1.
Experimental example 11
Sense index: with the outward appearance of cataplasma and comfort and the tracing ability that is attached on the skin is sense index.The skin comfort is normally carried out hand test to stickiness, draftability and the recovery of mastic, and is big with stickiness, have preferably draftability and answer speed soon for well.The skin tracing ability is to use for reference the method that Japan estimates cataplasma, is about to the molding cataplasma and is affixed on the wrist back, firmly gets rid of adeciduate method 10 times.The sensation index can be judged the product quality situation rapidly, but emphasizes subjective feeling, and factor restricts to be subjected to that individual variation influences etc., is difficult to objectively respond product quality comprehensively.
Experimental example 12
Adhesion test (mensuration of first viscous force): adopt the slope spin to measure, be about to a stainless steel ball and roll across,, estimate the size of its original viscosity according to the biggest ball steel ball that test sample stickiness face can cling from placing the test sample stickiness face on the hang plate.
Before the algoscopy test, remove the test sample packaging material, make non-overlapping copies place more than 2 hours in room temperature.
Get 3 of traumatic injury analgesic cataplasms, place the 15 ° of hang plate central authorities in inclination angle, cream is towards last, top, inclined-plane 10cm and bottom 15cm cover with the thick mylar of 0.025mm, 5cm cream face is reserved in the centre, and the steel ball with each kind item is stipulated down freely rolls down from beveled top end.
3 cataplasmas should have 2 or 2 clinging steel ball on test section, can not cling if any 1, and the less ball test of reuse should be able to cling.As have only 1 can cling steel ball, and in addition 2 can only cling less No. one steel ball, then should get 3 retrials in addition, 3 all should be able to cling steel ball is up to specification.
Experimental example 13
Plastic property: get 1 of traumatic injury analgesic cataplasm, put in 37 ℃, the constant humidity cabinet of relative humidity 64% 30 minutes, take out, with clip test sample is fixed on the smooth steel plate, the inclination angle of steel plate and horizontal plane is 60 °, places 24 hours, and the cream face should not have the trickling phenomenon.
Experimental example 14
Heat resistant test: can be with reference to version " operation under an appendix II of the Chinese pharmacopoeia item emplastrum item in 2005, traumatic injury analgesic cataplasm is removed the lid lining, place 120 ℃ of constant temperature oven heating 0.5 hour, taking-up is put to room temperature, back lining materials should not have the mastic phenomenon of osmosis, cream face still gloss is even, and hands has touched stickiness, adhesion requirement up to specification.
Experimental example 15
Acid-base value test: it is an amount of to get total compound, adds distilled water, stirs to make to be made into 5% suspension, fixed with the Accurate pH instrumentation, record data.
Experimental example 16 effect experiments
Be pharmacological actions such as the antiinflammatory of observing traumatic injury analgesic cataplasm of the present invention, analgesia, blood circulation promoting and blood stasis dispelling, use the test of mice caused by dimethylbenzene xylene ear swelling, carrageenin and cause the experiment of increasing that rat paw edema experiment and acetic acid cause the mouse peritoneal capillary permeability, show that traumatic injury analgesic cataplasm of the present invention has the obvious suppression effect to acute non-special inflammation, and can suppress the formation of granuloma induced by implantation of cotton pellets, certain anti-chronic inflammatory disease effect is arranged; By using the experiment of hot plate method and writhing method, the invention traumatic injury analgesic cataplasm can suppress glacial acetic acid induced mice writhing response as a result, improves mice hot plate pain threshold; And good microcirculation improvement effect arranged.
Experimental example 17 acute toxicity tests
The application rat carries out acute toxicity testing and shows: rat normal skin, damaged skin give the 10.59g crude drug/kg of traumatic injury analgesic cataplasm local application of maximum concentration, one day 2 times, maximum dosage-feeding is 21.18g crude drug/kg/d, be that the daily consumption of clinical adult (observed continuously 14 days by 720 times of 0.0294g crude drug/kg).The result shows that each treated animal general reaction is all no abnormal, ingests, the drinking-water activity is all normal, and none animal dead, rat intact skin and damaged skin all do not have the acute absorption toxicity of skin.Point out this medicine acute toxicity low, clinical drug safety.
Experimental example 18 skin irritations and sensitivity test
This test with the rabbit be object observed traumatic injury analgesic cataplasm of the present invention to normal skin and damaged skin the irritative response behind single and multiple dosing, with the Cavia porcellus is the skin allergy test that object has been observed traumatic injury analgesic cataplasm, the result shows: traumatic injury analgesic cataplasm does not see that to skin zest and anaphylactic reaction are arranged, and points out this medicine clinical administration method safety.
Experimental example 19 long term toxicity tests
Select 128 of SD rats for use, be divided into 4 groups at random by body weight, promptly matched group, traumatic injury analgesic cataplasm of the present invention low (0.588g crude drug/kg), in (1.765g crude drug/kg), high dose group (5.295g crude drug/kg), 32 every group, male and female half and half.Each administration group is smeared every day is subjected to reagent once, successive administration 1 month.Matched group, each 16 rat of basic, normal, high dosage group, totally 64, male and female half and half are put to death in administration respectively after 1 month and after convalescent period (2 weeks of drug withdrawal).Duration of test is observed outward appearance, general behavior, body weight change, the amount of drinking water of ingesting of animal, administration after 1 month and convalescent period (2 weeks of drug withdrawal) cut open extremely animal is carried out index inspections such as hematology's (RBC, HCT, MCV, MCH, MCHC, HB, PLT, CT, WBC and classification, reticulocyte, clotting time etc.) and serum biochemistry (AST, ALT, ALP, Glu, BUN, Crea, TP, T.BIL, ALB, GLOB, A/G, TG, CHOL etc.), organ coefficient, histopathology.Result of the test shows: each treated animal general state is good, all no abnormal variation of outward appearance sign, behavioral activity, body weight gain; Three dosage groups and matched group are learned and are checked all in normal range not have significant difference between group at administration 1 month and the hematological examination after 2 weeks of drug withdrawal, blood biochemical; Each is organized main organs and organizes and do not see that pathology relevant with medicine change.Show according to result of the test: give the SD rat skin and smear continuous 1 month of 20,60,180 times the basic, normal, high dosage of traumatic injury analgesic cataplasm of the present invention that is equivalent to clinical dosage, do not find its to animal appearance, behavioral activity, body weight, food ration, amount of drinking water, hematology, blood is biochemical and each organ index, histopathology produce unusual influence, drug withdrawal convalescent period is not seen the retardance toxic reaction yet, points out the dosage safety of traumatic injury analgesic cataplasm clinical practice of the present invention higher.
Claims (5)
1. a traumatic injury analgesic cataplasm is that the prescription raw material of DIEDA ZHENTONG GAO is made by the technology of cataplasma, is made up of hydrophilic gel substrate, non-woven fabrics back lining materials and traumatic injury analgesic cream drug, it is characterized in that every 70cm
2Cataplasma coating traumatic injury analgesic plaster 8～15g, the composition percentage by weight of plaster is: medicine 8～25%, hydrophilic gel substrate 75～92%; Described hydrophilic gel substrate is made up of adhesive agent, wetting agent, cross-linking agent, cross-linking regulator, PH regulator, surfactant, filler and purified water; Described adhesive agent is in sodium polyacrylate FA200, the part and the combination of one or more materials in sodium polyacrylate NP-700,30 POVIDONE K 30 BP/USP-90, sodium carboxymethyl cellulose, carbomer 980, polyvinyl alcohol or the gelatin; Described cross-linking agent is dihydroxyaluminum aminoacetate, aluminium hydroxide, aluminum chloride or aluminium oxide; Described pH regulator agent is tartaric acid, citric acid or lactic acid; Described wetting agent is glycerol, propylene glycol or PEG400; Described filler is micropowder silica gel, Kaolin, polyvinylpolypyrrolidone; Described surfactant is selected from Tween-80 or sodium lauryl sulphate;
The following components in weight percentage of described hydrophilic gel matrix optimization is formed:
The part in and sodium polyacrylate 4.50-7.00%, polyvidone 1.50～2.50%, carbomer 1.15～2.20%, glycerol 25～40%, dihydroxyaluminum aminoacetate 0.18～0.30%, EDTA-2Na 0.02～0.10%, tartaric acid 0.05～0.15%, Tween-80 1.15～2.20%, micropowder silica gel 1.15～2.20%, purified water 42～65%;
The medicine of described traumatic injury analgesic plaster consists of:
Eupolyphaga Seu Steleophaga 48g, Radix Aconiti Kusnezoffii 48g, Semen Strychni (parched) 48g, Radix Et Rhizoma Rhei 48g, Lignum Dalbergiae Odoriferae 48g, Radix Zanthoxyli 48g, Radix Scutellariae 48g, Cortex Phellodendri 48g, Rhizoma Polygoni Cuspidati 15g, Borneolum Syntheticum 24g, Camphora 60g, Mentholum 30g, Oleum menthae 30g, methyl salicylate 60g.
2. a kind of traumatic injury analgesic cataplasm according to claim 1 is characterized in that the composition percentage by weight of described plaster is preferably: medicine 12～20%, hydrophilic gel substrate 80～88%.
3. a preparation method that is used to prepare the described traumatic injury analgesic cataplasm of claim 1 is characterized in that comprising the steps:
(1) get Camphora 60g, Oleum menthae 30g, Borneolum Syntheticum 24g, Mentholum 30g and methyl salicylate 60g mixed dissolution and become fluid 1., standby;
(2) get Lignum Dalbergiae Odoriferae 48g and Eupolyphaga Seu Steleophaga 48g is ground into fine powder, 2. standby as the medical material powder;
(3) all the other medical materials are got Radix Aconiti Kusnezoffii 48g, Semen Strychni (parched) 48g, Radix Zanthoxyli 48g and Cortex Phellodendri 48g four Chinese medicine material and are added 50%～80% ethanol extraction secondary, filter, and merging filtrate reclaims ethanol, be condensed into relative density and be 1.10～1.15/60 ℃ thick paste 3., standby;
(4) get Radix Et Rhizoma Rhei 48g, Radix Scutellariae 48g and Rhizoma Polygoni Cuspidati 15g three flavor medical materials and add 50%～80% ethanol extraction secondary, filter, merging filtrate reclaims ethanol, be condensed into relative density and be 1.10～1.15/60 ℃ thick paste 4., standby;
(5) get carbomer 980 and add in the water of about 20 times of amounts, the limit edged stirs, and 5. swelling is spent the night, standby;
(6) get tartaric acid and Tween-80 and add remaining purified water, stirring and dissolving adds 30 POVIDONE K 30 BP/USP-90 again, stirs, and 6. dissolving fully, standby;
(7) get fluid 1., add micropowder silica gel and stir, add medical material powder such as Lignum Dalbergiae Odoriferae 2. with dihydroxyaluminum aminoacetate and sodium polyacrylate NP-700, stir, add glycerol, 7. dispersed with stirring is even, standby;
(8) after 5. and 6. mixing, add 7. in the colloid, stir, add successively thick paste such as Radix Aconiti Kusnezoffii 3., thick paste such as Radix Et Rhizoma Rhei 4., stir, adjust coating thickness, coating at last, cutting, pack, sealing is placed and is solidified, promptly.
4. in the preparation method of traumatic injury analgesic cataplasm according to claim 3, it is characterized in that adding for the first time in the step (3) 6 times of amount ethanol, add 5 times of amount ethanol for the second time, extracted 2 hours at every turn.
5. in the preparation method of traumatic injury analgesic cataplasm according to claim 3, it is characterized in that adding for the first time in the step (4) 6 times of amount ethanol, add 5 times of amount ethanol for the second time, extracted 2 hours at every turn.
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