CN104825559B - A kind of drug gel patch for treating acute soft tissue injury and preparation method thereof - Google Patents
A kind of drug gel patch for treating acute soft tissue injury and preparation method thereof Download PDFInfo
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- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of drug gel patch for treating acute soft tissue injury and preparation method thereof, the raw material of following parts by weight is included：Pseudo-ginseng 10 50, lamiophlomis rotata 6 12, charred RADIX ET RHIZOMA RHEI 10 50, Asian puccoon 10 50, borneol 19 and gel-type vehicle 30 85；Wherein, gel-type vehicle includes gelatin 10 20, silica 5 15, Sodium Polyacrylate 5 15, PVP 5 15, sodium carboxymethylcellulose 38, carbomer 13, aluminium hydroxide 13, ethyl hydroxy benzoate 0.1 0.5 and glycerine 150 260.Pseudo-ginseng, lamiophlomis rotata, charred RADIX ET RHIZOMA RHEI and Asian puccoon are extracted with ethanol and are concentrated to give thick paste；After gelatin is diluted and dissolved, mixed with thick paste and silica, obtain decoction；After borneol is mixed with preparing the other components of gel-type vehicle, the decoction is added, insulated and stirred obtains drug gel, and drug gel is coated with and produces the drug gel patch.
Description
Technical field
The present invention relates to treatment soft tissue injury external used medicine field, more particularly to one kind can efficiently treat it is acute soft
Gel patch of the traditional Chinese medicine ingredients of tissue damage and preparation method thereof.
Background technology
Soft tissue injury is the common disease of surgery, and at present, general treatment soft tissue injury is using Chinese medicine percutaneous administration system
Agent, traditional Chinese medicine percutaneous drug-delivery preparation is with a long history, various in style, is such as used for the external-applied ointment of smearing or pastes outside skin
The common patch in portion, still, external-applied ointment is not easy to keep, easy pollution clothes, and the common patch of in general, such as damp-affection and pain relieving
Cream, it is mostly that biology is beaten powder and is used as medicine and makes mud shape paste, it is poor and easy to aging with gas permeability, moisture retention, skin is also easy to produce
The drawbacks such as irritation effect.
With the application of the progress of pharmaceutical technology and medicinal new accessories particularly macromolecule medicinal materials, develop
Percutaneous dosing novel form, both gel patch, still, the several kinds of Chinese medicinal materials for being used to treating soft tissue injury at present there has been no extraction
The report of Styling Gel patch is prepared into after active ingredient.
In addition, currently used for treat soft tissue injury external used medicine in, on the one hand influenceed by drug ingedient used, separately
One side dosage is inaccurate, and generally existing therapeutic effect is bad or the drawbacks such as certain toxic side effect be present.
The content of the invention
It is an object of the invention to solve at least the above and/or defect, and provide at least will be described later it is excellent
Point.
It is a further object of the invention to provide a kind of drug gel patch for being used to treat acute soft tissue injury, energy
Enough rapid, effective treatment acute soft tissue injuries.
It is a yet further object of the present invention to provide a kind of prepare the Chinese medicine composition that can effectively treat soft tissue injury
For the method for gel patch.
It is a yet further object of the present invention to provide a kind of can effectively treat soft tissue injury and without in toxic side effect
Drug composition.
Adopted the following technical scheme that to achieve the above object with some other purposes, the present invention：
A kind of drug gel patch for treating acute soft tissue injury, include the raw material of following parts by weight：
Pseudo-ginseng 10-50, lamiophlomis rotata 6-12, charred RADIX ET RHIZOMA RHEI 10-50, Asian puccoon 10-50, borneol 1-9 and gel-type vehicle 30-85；
Wherein, the gel-type vehicle includes several in following parts by weight of component：Gelatin 10-20, silica 5-15, gather
PAA 5-15, PVP 5-15, sodium carboxymethylcellulose 3-8, carbomer 1-3, aluminium hydroxide 1-3, ethyl hydroxy benzoate 0.1-
0.5 and glycerine 150-260.
Preferably, in the drug gel patch of described treatment acute soft tissue injury, the original of following parts by weight is included
Material：Pseudo-ginseng 20-40, lamiophlomis rotata 8-12, charred RADIX ET RHIZOMA RHEI 20-40, Asian puccoon 20-40, borneol 4-8 and gel-type vehicle 45-65.
Preferably, in the drug gel patch of described treatment acute soft tissue injury, the original of following parts by weight is included
Material：Pseudo-ginseng 30, lamiophlomis rotata 10, charred RADIX ET RHIZOMA RHEI 30, Asian puccoon 30, borneol 5 and gel-type vehicle 50-55.
Preferably, in the drug gel patch of described treatment acute soft tissue injury, the gel-type vehicle include with
The component of lower parts by weight：Gelatin 15, silica 10, Sodium Polyacrylate 10, PVP 10, sodium carboxymethylcellulose 5, carbomer
2nd, aluminium hydroxide 2, ethyl hydroxy benzoate 0.3 and glycerine 200.
Preferably, in the drug gel patch of described treatment acute soft tissue injury, in addition to following parts by weight are former
One or more in material：
Halite 10-18, aspongopus 6-10, dried lacquer 8-12, charred HERBA CIRSII JAPONICI 20-30, acute turpinia leaf 15-25, radix cyathulae 10-
15th, callicarpa kwangtungensis Chun 12-20 or field thistle 10-15.
A kind of preparation method for the drug gel patch for treating acute soft tissue injury, comprises the following steps：
Step 1: pseudo-ginseng, lamiophlomis rotata, charred RADIX ET RHIZOMA RHEI and Asian puccoon are extracted to obtain into extract solution with ethanol, extract solution is concentrated to give
Thick paste；
Step 2: after 5-15 times of gelatin is diluted and dissolved, mixed with gained thick paste and silica, obtain decoction；
Step 3: by borneol, Sodium Polyacrylate, PVP, sodium carboxymethylcellulose, carbomer, aluminium hydroxide, oxybenzene second
After ester and glycerine mixing, the decoction is added, is kept for 45-60 DEG C and stirs to obtain drug gel, drug gel is coated with and produced
The gel patch.
Preferably, in the preparation method of the drug gel patch of described treatment acute soft tissue injury, in step 1
The alcohol extraction procedure is：
1.1 levigations, crossed after pseudo-ginseng, lamiophlomis rotata, charred RADIX ET RHIZOMA RHEI and Asian puccoon are ground and be not less than 100 mesh sieves, obtain drug powder；
1.2 are once extracted, and gained drug powder is mixed with the 60-80% ethanol of 6-8 times of volume, soak 1.5-3 hours
Refluxing extraction 0.5-2 hours afterwards, obtain an extract solution；
1.3 second extractions, secondary raffinate is mixed with the 60-80% ethanol of 5-7 times of volume, refluxing extraction 0.5-2 is small
When, obtain secondary raffinate；
1.4 mixing concentrations, after extract solution of gained is merged with secondary raffinate, recovery ethanol, will extremely without ethanol flavor
Extract solution concentration densities after recovery ethanol reach 1.15-1.20, produce the thick paste.
Preferably, in the preparation method of the drug gel patch of described treatment acute soft tissue injury, in step 2,
The diluent dissolving method of gelatin is：Gelatin and the water of 10 times of volumes are mixed, stand 1.5-3 hours, after gelatin swelling
40-60 DEG C is heated to Gelatin.
Preferably, in the preparation method of the drug gel patch of described treatment acute soft tissue injury, in step 3,
Pulverize and cross before borneol is mixed and be not less than 100 mesh sieves；
Add after decoction and persistently stir 0.5-1.5 hours with 8-15 revs/min, decoction is mixed into medicine with gel-type vehicle
Gel.
Preferably, in the preparation method of the drug gel patch of described treatment acute soft tissue injury, in step 3,
The drug gel coating thickness is 1.2-1.5mm, coating bonnet lining, in the ring of 25 ± 2 DEG C of temperature, relative humidity 50 ± 5%
Dried in the air under border 20-30 hours, produce the gel patch.
The present invention comprises at least following beneficial effect：First, there is the pseudo-ginseng in Chinese medicine material formula of the present invention the scattered stasis of blood to stop
The effect of blood, detumescence ding-tong, for various interior external hemorrhages or treating swelling and pain by traumatic injury；Lamiophlomis rotata has promoting blood circulation, swelling and pain relieving, is used for
Traumatic injury has special efficacy；Asian puccoon has removing toxic substances promoting eruption effect；Borneol being capable of swelling and pain relieving；And charred RADIX ET RHIZOMA RHEI is rheum officinale Preparation process
Product, the not only effect with cooling blood and removing stasis, hemostasis, and after processing, compared to the main component in rhubarb, in charred RADIX ET RHIZOMA RHEI
Gallic acid content increases by 2.4 times, and phenyl propyl ketone content is 1.4 times of content in rhubarb, and the content of anthraquinone aglycone improves 46%；
And it is only 18% of content in rhubarb that anthraquinone glycoside content, which reduces by 95%, Stibene-glucoside content, phenyl propyl ketone glycosides component content shows
Writing reduces.Obtained by research, the methods of glycosides in rheum officinale is the representative composition of rheum officinale discharge function, and it is formed and quantity relative ratio relationship
Change be directly connected to for rheum officinale " under bitter cold is rushed down " property of medicine change analysis.Charred RADIX ET RHIZOMA RHEI using gallic acid, anthraquinone aglycone as
Main, methods of glycosides significantly reduces, and causes its discharge function to disappear substantially, refrigeration function decrease, and adds work promoting blood circulation and removing blood stasis
With, being detected by experiment, charred RADIX ET RHIZOMA RHEI maximal non-toxic dosage is behaved 152 times of clinical research on maximum utilized quantity 30g/d, relative to rhubarb,
Be greatly improved the quantity of charred RADIX ET RHIZOMA RHEI, so as to significantly improve effect promoting blood circulation and removing blood stasis, and can avoid rhubarb due to
The drawbacks of bitter cold causes by force, there is obvious attenuation.
Secondly, the present invention is prepared as gel patch by the way that Chinese medical extract is combined with gel-type vehicle, relative to conventional pastes
Patch, the present invention have drugloading rate is big, transdermal effect is good, moisture retention is strong, it is non-stimulated to skin, it is good with skin-friendliness, it is ageing-resistant,
The advantages of dosage is accurate, and balanced by experiment detection, blood concentration without peak valley phenomenon, toxic side effect is significantly reduced,
And polluted in the industrial production without organic solvents, meet environmental requirement.
Finally, the present invention is counted by clinical observation, using 96 trouble of drug gel patch of the present invention treatment
In person, fully recover 81, effective 10, effective 3, invalid 2, cure rate 84.5%, total effective rate reaches 97.9%；And use
In 70 patients of common shangshi zhitong plaster, shangshi zhitong gao treatment, to fully recover 41, cure rate 58.5%, total effective rate is only 84.3%,
The drug gel patch for the treatment of acute soft tissue injury of the present invention improves compared to common shangshi zhitong plaster, shangshi zhitong gao cure rate
26% or so, total effective rate raising more than 13% is evident in efficacy to be better than common shangshi zhitong plaster, shangshi zhitong gao.
Further advantage, target and the feature of the present invention embodies part by following explanation, and part will also be by this
The research and practice of invention and be understood by the person skilled in the art.
Embodiment
The present invention is elaborated with reference to embodiment, after making those of ordinary skill in the art refer to this specification
It can implement according to this.
A kind of drug gel patch for treating acute soft tissue injury, include the Chinese medicine of following parts by weight：Pseudo-ginseng 10-50,
Lamiophlomis rotata 6-12, charred RADIX ET RHIZOMA RHEI 10-50, Asian puccoon 10-50 and borneol 1-9.Pseudo-ginseng in formula has dissipate stasis of blood hemostasis, detumescence ding-tong
Effect, for various interior external hemorrhages or treating swelling and pain by traumatic injury；Lamiophlomis rotata has promoting blood circulation, swelling and pain relieving, has for traumatic injury
Special efficacy；Asian puccoon has removing toxic substances promoting eruption effect；Borneol being capable of swelling and pain relieving.Charred RADIX ET RHIZOMA RHEI is formed by rheum officinale Preparation process, slight bitter, is had
Cooling blood and removing stasis, the effect of hemostasis.Charred RADIX ET RHIZOMA RHEI is used in the present invention, it is more more excellent than having with general without the rheum officinale of processing
Effect.Front and rear constituent analysis is processed to rheum officinale to learn, removed in rhubarb containing a variety of anthraquinone glycosides, two by high performance liquid chromatography
Outside the methods of glycosides such as styrene glycosides, phenyl propyl ketone glycosides, while also contain a large amount of condensed tannin constituents, it is rheum officinale that rhubarb, which is processed,
After charcoal, methods of glycosides and condensed tannin peak area significantly reduce, and the content of gallic acid and anthraquinone aglycone substantially increases.Tool
Body analysis result is as follows：
The changes of contents of anthraquinone component before and after 1. rheum officinale processes：
Process is significantly reduced for anthraquinone glycoside component content after charred RADIX ET RHIZOMA RHEI, and 95% is reduced compared with rhubarb.Anthraquinone glycoside
With anthraquinone glycoside composition antithesis, compared with rhubarb, charred RADIX ET RHIZOMA RHEI anthraquinone aglycone total amount adds the changes of contents of first constituents
46%.
2. the change of phenyl propyl ketone constituents before and after processing：
Also there occurs more significant change before and after phenyl propyl ketone and its methods of glycosides processing, and by different concocting methods
It is also different to influence its intensity of variation.Process as after charred RADIX ET RHIZOMA RHEI, 4 '-hydroxy-2-butanone is that the content of phenyl propyl ketone dramatically increases,
About 1.4 times of rhubarb.
3. the change of talan glycoside and tannin constituents before and after processing
The content of talan glycoside and catechin is higher in rhubarb, processes as after charred RADIX ET RHIZOMA RHEI, Stibene-glucoside
Total amount is only the 18% of rhubarb.The content of catechin is higher in rhubarb, but processes and destroyed completely for the composition after charred RADIX ET RHIZOMA RHEI,
On the contrary, the content of gallic acid adds 2.4 times.
Anthraquinone glycoside composition is the representative composition of rheum officinale discharge function, and it is formed and the change of quantity relative ratio relationship is directly connected to
For the analysis of rheum officinale " under bitter cold is rushed down " property of medicine change.Under the rushing down of rheum officinale and the glycoside such as refrigeration function and anthraquinone glycoside, phenyl propyl ketone glycosides
The content of composition is closely related.Traditional Chinese medicine theory thinks that the property of rhubarb bitter cold is very strong, and it is charred RADIX ET RHIZOMA RHEI then bitter cold to process
Property it is little.The property of bitter cold with rush down under, refrigeration function intensity it is consistent, meanwhile, under rushing down, refrigeration function again with methods of glycosides and contracting
The changes of contents trend for closing tannin is consistent.And charred RADIX ET RHIZOMA RHEI, based on gallic acid, anthraquinone aglycone, methods of glycosides significantly reduces, and leads
Cause its discharge function to disappear substantially, refrigeration function decrease, and add effect promoting blood circulation and removing blood stasis.
Rhubarb is processed as that after charred RADIX ET RHIZOMA RHEI, can significantly improve maximal non-toxic concentration, and charred RADIX ET RHIZOMA RHEI maximal non-toxic dosage is behaved
152 times of clinical research on maximum utilized quantity 30g/d.In addition, it is demonstrated experimentally that charred RADIX ET RHIZOMA RHEI have to tetrahymena it is obvious suppress growth, its
Inhibiting rate is 21.28%, shows that rheum officinale processing has certain attenuation.
In the drug gel patch for the treatment of acute soft tissue injury of the present invention, in addition to gel-type vehicle 30-85 weights
Part is measured, the gel-type vehicle includes several in following parts by weight of component：Gelatin 10-20, silica 5-15, Sodium Polyacrylate
5-15, PVP 5-15, sodium carboxymethylcellulose 3-8, carbomer 1-3, aluminium hydroxide 1-3, ethyl hydroxy benzoate 0.1-0.5 and sweet
Oily 150-260.Formed by the extract of described several Chinese medicines and by water-soluble high-molecular compound or hydroaropic substance
Matrix uniformly after mixing, is coated on back lining materials and both can be made into drug gel patch, belong to Chinese medicine percutaneous drug-delivery preparation.Tradition
Chinese medicine percutaneous drug-delivery preparation it is with a long history, various in style, and gel patch be on the basis of traditional Chinese medicine plaster is inherited,
The application of progress and medicinal new accessories, particularly macromolecule medicinal materials with pharmaceutical technology, the Chinese medicine warp developed
Novel form is administered in skin, with drugloading rate is big, transdermal effect is good, moisture retention is strong, non-stimulated to skin, good, resistance to skin-friendliness
The advantages that aging, accurate dosage, and can constant release, curative effect long lasting and stable, drug action it is strong, blood concentration balance, nothing
Peak valley phenomenon, toxic side effect is small, is polluted in the industrial production without organic solvents, meets environmental requirement.
In the drug gel patch of described treatment acute soft tissue injury, the raw material of following parts by weight is included：Pseudo-ginseng 20-
40th, lamiophlomis rotata 8-12, charred RADIX ET RHIZOMA RHEI 20-40, Asian puccoon 20-40, borneol 4-8 and gel-type vehicle 45-65.
In the drug gel patch of described treatment acute soft tissue injury, the raw material of following parts by weight is included：Pseudo-ginseng 30,
Lamiophlomis rotata 10, charred RADIX ET RHIZOMA RHEI 30, Asian puccoon 30, borneol 5 and gel-type vehicle 50-55.This formula is optimum formula, and gel-type vehicle is with
The mass ratio control of medicine is 1: 2.
In the drug gel patch of described treatment acute soft tissue injury, the gel-type vehicle includes following parts by weight
Component：Gelatin 15, silica 10, Sodium Polyacrylate 10, PVP 10, sodium carboxymethylcellulose 5, carbomer 2, aluminium hydroxide
2nd, ethyl hydroxy benzoate 0.3 and glycerine 200.
In the drug gel patch of described treatment acute soft tissue injury, in addition to one kind in following raw material
It is or several：Halite 10-18, aspongopus 6-10, dried lacquer 8-12, charred HERBA CIRSII JAPONICI 20-30, acute turpinia leaf 15-25, radix cyathulae 10-15,
Callicarpa kwangtungensis Chun 12-20 or field thistle 10-15.Halite has the effect of clearing heat and cooling blood；Aspongopus regulating qi-flowing for relieving pain, middle benefit gas is supporing yang, uses
In soreness of waist and knee joint；Dried lacquer broken stasis of blood is stimulated the menstrual flow, for hemostasis；Charred HERBA CIRSII JAPONICI cool blood, hemostasis, for traumatism and bleeding；Acute turpinia leaf promoting blood circulation stops
Bitterly, for the pain of injury caused by falling and tumbling；Radix cyathulae dispelling stasis of blood and stimulating the menstrual flow, it is easing joint movement, for injury from falling down, arthralgia pain due to rheumatism；Callicarpa kwangtungensis Chun convergence stops
Blood, dissipate the stasis of blood, be clearing heat and detoxicating, for traumatism and bleeding；Field thistle cooling blood and hemostasis, for traumatism and bleeding.
A kind of preparation method for the drug gel patch for treating acute soft tissue injury, comprises the following steps：
Step 1: pseudo-ginseng, lamiophlomis rotata, charred RADIX ET RHIZOMA RHEI and Asian puccoon are extracted to obtain into extract solution with ethanol, extract solution is concentrated to give
Thick paste；
Step 2: by gelatin 5-15 times dilute, gelatin is fully swelled, heating be allowed to dissolving after, with gained thick paste and two
Silica mixes, and obtains decoction；
Step 3: by borneol, Sodium Polyacrylate, PVP, sodium carboxymethylcellulose, carbomer, aluminium hydroxide, oxybenzene second
After ester and glycerine mixing, the decoction is added, is kept for 45-60 DEG C and stirs to obtain drug gel, drug gel is coated with and produced
The gel patch.
In the preparation method of the drug gel patch of described treatment acute soft tissue injury, ethanol carries described in step 1
The method is taken to be：
1.1 levigations, crossed after pseudo-ginseng, lamiophlomis rotata, charred RADIX ET RHIZOMA RHEI and Asian puccoon are ground and be not less than 100 mesh sieves, obtain drug powder；
1.2 are once extracted, and gained drug powder is mixed with the 60-80% ethanol of 6-8 times of volume, soak 1.5-3 hours
Refluxing extraction 0.5-2 hours afterwards, obtain an extract solution；
1.3 second extractions, secondary raffinate is mixed with the 60-80% ethanol of 5-7 times of volume, refluxing extraction 0.5-2 is small
When, obtain secondary raffinate；
1.4 mixing concentrations, after extract solution of gained is merged with secondary raffinate, recovery ethanol, will extremely without ethanol flavor
Extract solution concentration densities after recovery ethanol reach 1.15-1.20, produce the thick paste.
In the preparation method of the drug gel patch of described treatment acute soft tissue injury, in step 2, gelatin it is dilute
Releasing agent dissolving method is：Gelatin and the water of 10 times of volumes are mixed, stand 1.5-3 hours, 40-60 DEG C adds after gelatin swelling
Heat is to Gelatin.
In the preparation method of the drug gel patch of described treatment acute soft tissue injury, in step 3, borneol is mixed
Pulverize and cross before closing and be not less than 100 mesh sieves；
Add after decoction and persistently stir 0.5-1.5 hours with 8-15 revs/min, decoction is mixed into medicine with gel-type vehicle
Gel.
In the preparation method of the drug gel patch of described treatment acute soft tissue injury, in step 3, the medicine
Gel coating thickness is 1.2-1.5mm, and coating bonnet lining, dry in the air 20- in the environment of 25 ± 2 DEG C of temperature, relative humidity 50 ± 5%
30 hours, the gel patch is produced, 9 grams are weighed per note.
Embodiment 1
One kind treats acute soft tissue injury drug gel patch, and gel is made by the Chinese medicine material of following proportion by weight
Patch：30 parts of pseudo-ginseng, 10 parts of lamiophlomis rotata, 30 parts of charred RADIX ET RHIZOMA RHEI, 30 parts of Asian puccoon, 5 parts of borneol.Also contain gel-type vehicle, the gel
The mass ratio of matrix and Chinese medicine material is 1: 2, and the gelatin substrate is by gelatin, silica, Sodium Polyacrylate, PVP, carboxylic
Sodium carboxymethylcellulose pyce, carbomer, aluminium hydroxide, ethyl hydroxy benzoate, glycerine are 15: 10: 10: 10: 5: 2: 2: 0.3: 200 in mass ratio
Mixing is formed.
It is prepared by following step：
(1) grind, take pseudo-ginseng, lamiophlomis rotata, charred RADIX ET RHIZOMA RHEI and Asian puccoon, smash, cross 120 mesh sieves, obtain drug powder, it is standby
With；
(2) extract, extract for the first time, drug powder plus 7 times of 70% ethanol of amount soak 2 hours, refluxing extraction 1 hour,
Second of extraction plus 6 times of 70% ethanol of amount, refluxing extraction 1 hour, merge extract solution twice, and recovery ethanol continues to without alcohol taste
The thick paste that relative density is under the conditions of 60 DEG C 1.15~1.20 is concentrated into, it is standby；Gelatin is taken to add 10 times of amount water dilutions, stirring is
It is even, place 2 hours, gelatin is fully swelled, 50 DEG C of heating are allowed to dissolve, and add thick paste, stir evenly, add silica, stir
It is even, decoction is obtained, it is standby.
(3) it is molded, takes borneol and grinding into fine powder, excessively 120 mesh sieves, it is standby；Separately take Sodium Polyacrylate, 30 POVIDONE K 30 BP/USP 90, carboxylic first
Base sodium cellulosate, carbomer, aluminium hydroxide and ethyl hydroxy benzoate mixing, are added in glycerine, stir jointly together with borneol powder,
Decoction is added, under 50 DEG C of insulations, is persistently stirred 1 hour with 10 revs/min, with 15 revs/min of coatings, coating thickness is
1.4mm, lid lining, dries in the air 24 hours in the environment of 25 DEG C ± 2 DEG C of temperature, relative humidity 50 ± 5%, cuts into slices, and packaging, is prepared into and controls
Acute soft tissue injury drug gel patch is treated, often pastes weight 9g.
Embodiment 2
Exemplified by producing drug gel patch 1000 of the present invention and paste, Chinese medicine material used and auxiliary material and its quality proportioning
For：
The preparation method of drug gel patch of the present invention comprises the following steps：
(1) levigation.Pseudo-ginseng 3000g, lamiophlomis rotata 1000g, charred RADIX ET RHIZOMA RHEI 3000g, Asian puccoon 3000g are taken, is smashed, crosses 120
Mesh sieve, it is standby to obtain drug powder；
(2) extract.Extract for the first time, drug powder plus 7 times of 70% ethanol of amount soak 2 hours, refluxing extraction 1 hour,
Second plus 6 times of 70% ethanol of amount, refluxing extraction 1 hour, merge extract solution, recovery ethanol continues to be concentrated into phase to without alcohol taste
It is the thick paste of 1.15~1.20 (60 DEG C of surveys) to density, it is standby；Gelatin 300g is taken, adds 10 times of amount water, stirs, it is small to place 2
When, gelatin is fully swelled, 50 DEG C of heating make dissolving, add decoction, stir evenly, add silica 200g, stir evenly to obtain decoction,
It is standby；
(3) it is molded.Borneol 500g is taken, is ground into fine powder, crosses 120 mesh sieves, it is standby；Sodium Polyacrylate 200g separately is taken, gathers dimension
Ketone K90200g, sodium carboxymethylcellulose 100g, carbomer 40g, aluminium hydroxide 40g, ethyl hydroxy benzoate 6g are common together with borneol powder
It is added in 4000g glycerine, stirs, add decoction, under 50 DEG C of insulations, is persistently stirred 1 hour with 10 revs/min, with
15 revs/min of coatings, coating thickness 1.4mm, lid lining, dried in the air in the environment of 25 DEG C ± 2 DEG C of temperature, relative humidity 50 ± 5%
24 hours, cut into slices, packaging is prepared into treatment acute soft tissue injury gel patch, often pastes weight 9g.
In the proportioning of the present embodiment, the mass parts of effective medicinal components each component are：
Embodiment 3
Exemplified by producing drug gel patch 1000 of the present invention and paste, Chinese medicine material used and auxiliary material and its quality proportioning
For：
Its preparation method is identical with embodiment 1,2, is prepared into treatment acute soft tissue injury gel patch, often pastes weight 9g.
In the proportioning of the present embodiment, the mass parts of effective medicinal components each component are：
Embodiment 4
Exemplified by producing drug gel patch 1000 of the present invention and paste, Chinese medicine material used and auxiliary material and its quality proportioning
For：
Its preparation method is identical with embodiment 1,2, is prepared into treatment acute soft tissue injury gel patch, often pastes weight 9g.
In the proportioning of the present embodiment, the mass parts of effective medicinal components each component are：
Embodiment 5
Exemplified by producing drug gel patch 1000 of the present invention and paste, Chinese medicine material used and auxiliary material and its quality proportioning
For：
Its preparation method is identical with embodiment 1,2, is prepared into treatment acute soft tissue injury gel patch, often pastes weight 9g.
In the proportioning of the present embodiment, the mass parts of effective medicinal components each component are：
Embodiment 6
Exemplified by producing drug gel patch 1000 of the present invention and paste, Chinese medicine material used and auxiliary material and its quality proportioning
For：
Its preparation method is identical with embodiment 1,2, is prepared into treatment acute soft tissue injury gel patch, often pastes weight 9g.
In the proportioning of the present embodiment, the mass parts of effective medicinal components each component are：
In order to verify therapeutic effect of the medicine of the present invention to treatment acute soft tissue injury, using medicine of the present invention
Gel patch has carried out 96 clinical observation experiments, and experimental result statistics is as follows：
1st, clinical data
Experimental group be used as using drug gel patch of the present invention treatment, entitled blood used determines gel cream bitterly during experiment
Patch.In 96 patients for the treatment of：Male 56, women 40；Age is minimum 10 years old, maximum 76 years old；Average age 40 years old；Damage
Position：Neck 5,3, chest, 12, waist, shoulder joint 4, ancon 10, wrist hand 16, knee 10, ankle and foot 36
Example.This group of patient has obvious trauma history or joint sprain history, local red and swollen heat pain, dysfunction, limitation of activity, x-ray inspection
Look into and be less than 3 without fracture, dislocation and osteopathy, the course of disease.Using common shangshi zhitong plaster, shangshi zhitong gao as a control group, 70 patients for the treatment of
In, male 36, women 34, the age is minimum 9 years old, maximum 70 years old, average age 43 years old, damage location：Neck 4, chest 4
Example, 12, waist, shoulder joint 6, ancon 8, wrist hand 10, knee 7, ankle and foot 19.This group of patient has substantially
Trauma history or joint sprain history, local red and swollen heat pain, dysfunction, limitation of activity, x-ray inspection without fracture, dislocation and osteopathy,
The course of disease is less than 3.
2nd, diagnostic criteria
According to《New Chinese medicine guideline of clinical investigations》[1] relevant acute soft tissue injury diagnostic criteria is worked out.
Doctor trained in Western medicine diagnosis category soft tissue bruise person：
1. there is obvious trauma history, sharp ache, local rapid swelling, limb activity dysfunction；
2. injury tenderness is obvious, local livid purple ecchymosis is may occur in which, severe patient may occur in which subcutaneous hematoma, the fluctuation sign positive.
Belong to joint sprain person：
1. there is obvious strain history in early days, sharp ache after wound is local different degrees of swelling, ecchymosis, joint work occur
Dynamic dysfunction.
Chinese medical discrimination category qi stagnation and blood stasis type：Local swelling, shouting pain, fixed pain, the livid purple ecchymosis in injury or hemotoncus, joint are lived
Dynamic limited, tongue nature is purple dim or has ecchymosis, stringy and hesitant pulse.
3rd, treatment method
Experimental group：Drug gel patch of the present invention is taken, weight 9g is often pasted, per adhesion medicine content 10.9g.Drug application face is placed in trouble
Place or the most obvious position of pain, application are firm.First day used, is gently rubbed with the hands at the topical application of drug with hand every 4-5 hours, makes it
Heating is advantageous to Transdermal absorption.Every dressing in 24 hours 1 time, 7 times are a course for the treatment of, treat 2 courses for the treatment of.
Control group：Treated using shangshi zhitong plaster, shangshi zhitong gao, treatment method is identical with experimental group, every dressing in 24 hours 1 time, is for 7 times
One course for the treatment of, treat 2 courses for the treatment of.
4th, criterion of therapeutical effect
With reference to State Administration of Traditional Chinese Medicine in 1994《Criterion of therapeutical effect is treated in the diagnosis of traditional Chinese medical science pain》
Recovery from illness：Red, swollen, hot, pain disappears, and accompanying or adjacent joints activity is freely；It is effective：Red, swollen, hot disappearance, slightly
Ache, accompanying or adjacent joints activity is substantially unrestricted；Effectively：Red, swollen, hot, pain mitigates, accompanying or adjacent joints activity
It is slight limited；It is invalid；It is red, swollen, hot, be limited bitterly without improvement, joint motion.
5th, treatment results and analysis
In 96 patients of experimental group, fully recover 81, effective 10, effective 3, invalid 2, cure rate 84.5%, always have
Efficiency reaches 97.9%；In 70 patients of control group, fully recover 41, effective 10, effective 8, invalid 11, cure rate is
58.5%, total effective rate 84.3%.Two groups for the treatment of results are counted using Chi-square Test (2 × c contingency tables independence test)
Handle, and significant difference (p ＜ 0.05) between as a result finding two groups be present, illustrates the effect of present invention treats acute soft tissue injury
Better than shangshi zhitong plaster, shangshi zhitong gao.
The drug gel patch for the treatment of acute soft tissue injury of the present invention is extracted to be prepared into, and treatment standard is high,
Drug action is strong, is mainly used in local swelling caused by acute soft tissue injury, pain, ecchymosis, limbs or joint movement function
Obstacle, Chinese medical discrimination belong to blood-stasis syndrome type patient, have promoting blood circulation and hemostasis, stagnation resolvation analgesic therapy, the effect of clearing heat for detumescence, also can use
Osteoarthritis in positions such as treatment shoulder, elbow, waists.
The application method of drug gel patch of the present invention is：Patch is taken out, directly drug application face is placed in drug application face
The most obvious position of affected part or pain is placed in, application is firm.First day used, the topical application of drug is gently rubbed with the hands with hand every 4-5 mouse
Place, makes its heating be advantageous to Transdermal absorption.Every dressing in 24 hours 1 time, 7 times are a course for the treatment of, treat 2 courses for the treatment of.
Although embodiment of the present invention is disclosed as above, it is not restricted in specification and embodiment listed
With it can be applied to various suitable the field of the invention completely, can be easily for those skilled in the art
Other modification is realized, therefore under the universal limited without departing substantially from claim and equivalency range, it is of the invention and unlimited
In specific details and shown here as the embodiment with description.
Claims (6)
1. a kind of drug gel patch for treating acute soft tissue injury, it is characterised in that include the raw material of following parts by weight：
Pseudo-ginseng 30, lamiophlomis rotata 10, charred RADIX ET RHIZOMA RHEI 30, Asian puccoon 30, borneol 5 and gel-type vehicle 50-55；
Wherein, the gel-type vehicle includes several in following parts by weight of component：Gelatin 10-20, silica 5-15, polypropylene
Sour sodium 5-15, PVP 5-15, sodium carboxymethylcellulose 3-8, carbomer 1-3, aluminium hydroxide 1-3, ethyl hydroxy benzoate 0.1-0.5 with
And glycerine 150-260；
The preparation method of the drug gel patch of described treatment acute soft tissue injury, comprises the following steps：
Step 1: pseudo-ginseng, lamiophlomis rotata, charred RADIX ET RHIZOMA RHEI and Asian puccoon are extracted to obtain into extract solution with ethanol, extract solution is concentrated to give thick paste；
Step 2: after 5-15 times of gelatin is diluted and dissolved, mixed with gained thick paste and silica, obtain decoction；
Step 3: by borneol, Sodium Polyacrylate, PVP, sodium carboxymethylcellulose, carbomer, aluminium hydroxide, ethyl hydroxy benzoate with
And after glycerine mixing, the decoction is added, kept for 45-60 DEG C and stir to obtain drug gel, drug gel is coated with described in producing
Gel patch.
2. the drug gel patch for the treatment of acute soft tissue injury as claimed in claim 1, it is characterised in that the gel base
Matter includes the component of following parts by weight：Gelatin 15, silica 10, Sodium Polyacrylate 10, PVP 10, sodium carboxymethylcellulose
5th, carbomer 2, aluminium hydroxide 2, ethyl hydroxy benzoate 0.3 and glycerine 200.
3. the drug gel patch for the treatment of acute soft tissue injury as claimed in claim 1, it is characterised in that institute in step 1
Stating alcohol extraction procedure is：
1.1 levigations, crossed after pseudo-ginseng, lamiophlomis rotata, charred RADIX ET RHIZOMA RHEI and Asian puccoon are ground and be not less than 100 mesh sieves, obtain drug powder；
1.2 are once extracted, and gained drug powder is mixed with the 60-80% ethanol of 6-8 times of volume, are returned after soaking 1.5-3 hours
Stream extraction 0.5-2 hours, obtain an extract solution；
1.3 second extractions, secondary raffinate is mixed with the 60-80% ethanol of 5-7 times of volume, refluxing extraction 0.5-2 hours, obtained
To secondary raffinate；
1.4 mixing concentrations, after extract solution of gained is merged with secondary raffinate, recovery ethanol will reclaim to without ethanol flavor
Extract solution concentration densities after ethanol reach 1.15-1.20, produce the thick paste.
4. the drug gel patch for the treatment of acute soft tissue injury as claimed in claim 1, it is characterised in that in step 2,
The diluent dissolving method of gelatin is：Gelatin and the water of 10 times of volumes are mixed, stand 1.5-3 hours, after gelatin swelling
40-60 DEG C is heated to Gelatin.
5. the drug gel patch for the treatment of acute soft tissue injury as claimed in claim 1, it is characterised in that in step 3,
Pulverize and cross before borneol is mixed and be not less than 100 mesh sieves；
Add after decoction and persistently stir 0.5-1.5 hours with 8-15 revs/min, decoction is mixed into medicine with gel-type vehicle and coagulate
Glue.
6. the drug gel patch for the treatment of acute soft tissue injury as claimed in claim 1, it is characterised in that in step 3,
The drug gel coating thickness is 1.2-1.5mm, coating bonnet lining, in the ring of 25 ± 2 DEG C of temperature, relative humidity 50 ± 5%
Dried in the air under border 20-30 hours, produce the gel patch.
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| 冰片外用方药简介;张晓峰等;《中国临床医生》;20031231;第31卷(第1期);49-51 * |
| 独一味胶囊治疗急性软组织损伤的临床疗效;王晓钟;《吉林医学》;20111130;第32卷(第31期);6616-6617 * |
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