CN103263470B - Swelling-decreasing and pain-relieving traditional Chinese medicine gel and preparation method thereof - Google Patents
Swelling-decreasing and pain-relieving traditional Chinese medicine gel and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a swelling-decreasing and pain-relieving traditional Chinese medicine gel and a preparation method of the gel. The traditional Chinese preparation disclosed by the invention comprises pseudo-ginseng, safflower carthamus, ground beeltle, dipsacus asperoids, ligusticum wallichii, radix angelicae, angelica sinensis, menthol, and camphor in combination and has the functions of promoting Qi and blood circulation, dredging meridian, dispelling wind-damp, and relieving cold-aggravated arthralgia. The matrix of the gel disclosed by the invention is proper in fluidity, easy to apply, good in skin affinity, good in compatibility with a compound extracting solution of the traditional Chinese medicine, capable of slowly and stably releasing the medicine and favorable for improvement of the medicine bioavailability. Zoology test and clinical verification prove that the swelling-decreasing and pain-relieving traditional Chinese medicine gel disclosed by the invention has obvious functions of relieving pain, decreasing swelling and resolving stagnation. The preparation process of the swelling-decreasing and pain-relieving traditional Chinese medicine gel disclosed by the invention is simple, does not need a lot of equipment, only needs a high-speed mixer for mixing, is short in preparation process, does not need heating and dissolving operations, saves energy and friendly to the environment.
Description
Technical field
The invention belongs to medical technical field, particularly a kind of reducing swelling and alleviating pain Chinese medicine gel and preparation method thereof.
Background technology
Swelling, pain are by the caused unhappy sensation of reality or potential tissue injury, are also a kind of early warning mechanisms, prevent that body is subjected to oppression or further damage, are one of serious problems that perplex now human health.Now medical research shows, swelling is that intravascular fluid is seeped into due to interstice outward because capillary rupture, permeability hemorrhage and blood vessel wall increase; And pain is to stimulate local peripheral nerve to cause due to traumatic hematoma or inflammatory reaction thing.Should blood circulation promoting and blood stasis dispelling in treatment, regulating QI to relieve pain.At present, it is main clinically multiple acute and chronic pain being taked to western medicine more, and its curative effect is affirmed, but life-time service can cause the untoward reaction such as addiction.Therefore, find side effect and the little reducing swelling and alleviating pain Chinese medicine of dependency and become new trend.The Chinese medicine treatment pain card history of existing several thousand, in < < Huang di's Canon of Medicine > >, just the discussion of system has been carried out in the aspects such as the cause of disease of pain card, pathogenesis, sick position, syndrome, prognosis.Theory of Chinese medical science is thought " pain obstructed, general rule is not bitterly ", accordingly for Chinese medicine and the Chinese medicine compound of the various pain of main treatment is widely used in tcm clinical practice.
Gel, as the novel dosage form of a kind of medicine, is applicable to skin, mucosa, cavity/canal drug administration, not only can avoid oral first pass effect, can also alleviate the toxic and side effects of medicine, is favourably welcome in recent years.Gel means the semisolid with gel characteristic or the glop that extract and appropriate substrate are made.Gel has slow releasing function to drug release, and preparation technology is simple and appearance looks elegant is easy to coating use, and has the features such as easy absorption, pollution clothes, stability be not better after topical.Gel generally divides aqueous gel, oil-base gel agent, emulsion-type gel, prepare at present aqueous gel substrate and adopt Acritamer 940, polyvinyl alcohol, sodium carboxymethyl cellulose etc. more, but preparation technology all needs the swelling process of long period, technique is also more loaded down with trivial details, consuming time.
Gel is started to walk early abroad, development is fast, < < British Pharmacopoeia > > 1993 editions has recorded choline salicylate gel, lidocaine gel etc. for tooth, and < < American Pharmacopeia > > 1995 editions also records benzene azoles and plants gel because of gel, gel aluminum hydroxide etc. more than 30.At China's gel, be in development, raising stage, particularly Chinese medicine gel at home still in the starting stage.Chemicals gel because principal agent chemical composition is single, stable chemical nature, quality standard control existing a large amount of research datas, principal agent and the substrate compatibility are better, so preparation technology is relatively simple and ripe.Er China, because compound Chinese medicinal preparation complicated component, common Multiple components are brought into play therapeutical effect jointly, and dosage is generally larger, Chinese medicine ingredients stability is not strong, Chinese medicine ingredients and the substrate compatibility are not ideal enough, the Chinese medicine gel effect of making is desirable not as chemicals gel, and preparation technology is also not mature enough.Therefore, urgently research and development are good with the Chinese medicine extraction liquid compatibility, stretchability is good, with the good gel-type vehicle of skin affinity, for making Chinese medicine novel form, promote the development of China's Chinese medicine cause.
Summary of the invention
The object of the invention is to overcome the deficiencies in the prior art, a kind of reducing swelling and alleviating pain Chinese medicine gel and preparation method thereof is provided.
The technical solution used in the present invention is:
A kind of reducing swelling and alleviating pain Chinese medicine gel, comprise the active component of 430～550 parts by weight and the gel-type vehicle of 2530～2700 parts by weight, its active component is made by the raw material of following parts by weight: 500～650 parts of Radix Notoginseng, 340～450 parts, Flos Carthami, 500～650 parts of Eupolyphaga Seu Steleophagas, 500～650 parts of Radix Dipsacis, 500～650 parts of Rhizoma Chuanxiongs, 500～650 parts of the Radixs Angelicae Dahuricae, 500～650 parts of Radix Angelicae Sinensis, 43～58 parts of Mentholums, 20～32 parts of Camphoras.
Gel-type vehicle is made by the component of following parts by weight: 600～800 parts of 35～40 parts of the ethanol of 85～95 parts of gelatum skeleton materials, 470～490 parts of wetting agents, 7～12 parts of antiseptic, 3～8 parts of penetrating agents, 93～95v/v% and purified water.
Preferably, gelatum skeleton material is carbomer and Acrylic Acid Sodium Acrylate-acrylamide copolymer.
Preferably, gelatum skeleton material is the carbomer of 75～85 weight portions and the Acrylic Acid Sodium Acrylate-acrylamide copolymer of 10～12 weight portions.
Preferably, carbomer is carbomer U10.
Preferably, the relative molecular mass of Acrylic Acid Sodium Acrylate-acrylamide copolymer is 1,000 ten thousand～12,000,000.
Preferably, wetting agent is glycerol, and antiseptic is at least one in ethyl hydroxybenzoate, sodium benzoate, sorbic acid and its esters; Penetrating agent is at least one in azone, menthol, Borneolum Syntheticum.
Preferably, active component is made by the raw material of following parts by weight: 600 parts of Radix Notoginseng, 400 parts, Flos Carthami, 600 parts of Eupolyphaga Seu Steleophagas, 600 parts of Radix Dipsacis, 600 parts of Rhizoma Chuanxiongs, 600 parts of the Radixs Angelicae Dahuricae, 600 parts of Radix Angelicae Sinensis, 50 parts of Mentholums, 25 parts of Camphoras.
A preparation method for reducing swelling and alleviating pain Chinese medicine gel, comprises the following steps:
1) Radix Notoginseng, Flos Carthami, Eupolyphaga Seu Steleophaga, Radix Dipsaci, Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Radix Angelicae Sinensis are mixed, adopt decocting cooking method to extract, being concentrated into relative density is 1.02～1.07, obtains Chinese medicine extraction liquid;
2) Mentholum, Camphora are mixed and melted altogether, obtain mixed liquor a, seal standby;
3) carbomer is added in purified water, fully swelling; Add successively wetting agent, Chinese medicine extraction liquid, mixed liquor a, penetrating agent, mix homogeneously, obtains mixed liquor b;
4) antiseptic is dissolved in to the ethanol of 93～95v/v%, adds in mixed liquor b, mix, then add Acrylic Acid Sodium Acrylate-acrylamide copolymer, be stirred to and be uniformly dispersed, obtain swelling reducing and pain easing gel agent;
Wherein, each composition of swelling reducing and pain easing gel agent is as described in claim 1～8 any one.
Preferably, in step 3), first get 30～50% purified water and pour in container, evenly add carbomer, then add remaining purified water, fully swelling.
The invention has the beneficial effects as follows:
The effect that all medicine compatibilities of Chinese medicine preparation of the present invention are played qi and blood circulation promotion, the meridian dredging, wind-damp dispelling, stopping numbness pain altogether, through zoology test and clinical verification, reducing swelling and alleviating pain Chinese medicine gel of the present invention has obvious analgesia, detumescence, repercussive effect.
Gel substrate mobility of the present invention is suitable, be easy to be coated with exhibition, good with skin affinity, good with the traditional Chinese medicine compound extract compatibility, can slowly steadily discharge medicine, is conducive to improve the bioavailability of medicine.Reducing swelling and alleviating pain Chinese medicine gel of the present invention, to skin and mucosa nonirritant, can not cause skin allergy, uses safety, not pollution clothes.
The preparation technology of reducing swelling and alleviating pain Chinese medicine gel of the present invention is simple, without large number quipments, only need homogenizer to stir, and preparation time is short, in preparation process without heating for dissolving, energy savings, environmental friendliness.
The specific embodiment
The technical solution used in the present invention is:
A kind of reducing swelling and alleviating pain Chinese medicine gel, comprise the active component of 430～550 parts by weight and the gel-type vehicle of 2530～2700 parts by weight, its active component is made by the raw material of following parts by weight: 500～650 parts of Radix Notoginseng, 340～450 parts, Flos Carthami, 500～650 parts of Eupolyphaga Seu Steleophagas, 500～650 parts of Radix Dipsacis, 500～650 parts of Rhizoma Chuanxiongs, 500～650 parts of the Radixs Angelicae Dahuricae, 500～650 parts of Radix Angelicae Sinensis, 43～58 parts of Mentholums, 20～32 parts of Camphoras.
Gel-type vehicle is made by the component of following parts by weight: 600～800 parts of 35～40 parts of the ethanol of 85～95 parts of gelatum skeleton materials, 470～490 parts of wetting agents, 7～12 parts of antiseptic, 3～8 parts of penetrating agents, 93～95v/v% and purified water.
Preferred, this Chinese medicine gel comprises the active component of 500 parts by weight and the gel-type vehicle of 2626 parts by weight, and its active component is made by the raw material of following parts by weight: 600 parts of Radix Notoginseng, 400 parts, Flos Carthami, 600 parts of Eupolyphaga Seu Steleophagas, 600 parts of Radix Dipsacis, 600 parts of Rhizoma Chuanxiongs, 600 parts of the Radixs Angelicae Dahuricae, 600 parts of Radix Angelicae Sinensis, 50 parts of Mentholums, 25 parts of Camphoras; Gel-type vehicle is made by the component of following parts by weight: 650～700 parts of 35～40 parts of the ethanol of 85～92 parts of gelatum skeleton materials, 470～490 parts of wetting agents, 9 parts of antiseptic, 5 parts of penetrating agents, 95v/v% and purified water.
Preferably, gelatum skeleton material is carbomer and Acrylic Acid Sodium Acrylate-acrylamide copolymer.
Preferably, gelatum skeleton material is the carbomer of 75～85 weight portions and the Acrylic Acid Sodium Acrylate-acrylamide copolymer of 10～12 weight portions.
Preferably, carbomer is carbomer U10.
Preferably, the relative molecular mass of Acrylic Acid Sodium Acrylate-acrylamide copolymer is 1,000 ten thousand～12,000,000.
Preferably, wetting agent is glycerol, and antiseptic is at least one in ethyl hydroxybenzoate, sodium benzoate, sorbic acid and its esters; Penetrating agent is at least one in azone, menthol, Borneolum Syntheticum.
Preferably, active component is made by the raw material of following parts by weight: 600 parts of Radix Notoginseng, 400 parts, Flos Carthami, 600 parts of Eupolyphaga Seu Steleophagas, 600 parts of Radix Dipsacis, 600 parts of Rhizoma Chuanxiongs, 600 parts of the Radixs Angelicae Dahuricae, 600 parts of Radix Angelicae Sinensis, 50 parts of Mentholums, 25 parts of Camphoras.
A preparation method for reducing swelling and alleviating pain Chinese medicine gel, comprises the following steps:
1) Radix Notoginseng, Flos Carthami, Eupolyphaga Seu Steleophaga, Radix Dipsaci, Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Radix Angelicae Sinensis are mixed, adopt decocting cooking method to extract, being concentrated into relative density is 1.02～1.07, obtains Chinese medicine extraction liquid;
2) Mentholum, Camphora are mixed and melted altogether, obtain mixed liquor a, seal standby;
3) carbomer is added in purified water, fully swelling; Add successively wetting agent, Chinese medicine extraction liquid, mixed liquor a, penetrating agent, mix homogeneously, obtains mixed liquor b;
4) antiseptic is dissolved in to the ethanol of 93～95v/v%, adds in mixed liquor b, mix, then add Acrylic Acid Sodium Acrylate-acrylamide copolymer, be stirred to and be uniformly dispersed, obtain swelling reducing and pain easing gel agent;
Wherein, each composition of swelling reducing and pain easing gel agent is as described in claim 1～8 any one.
Preferably, in step 3), first get 30～50% purified water and pour in container, evenly add carbomer, then add remaining purified water, fully swelling.
Below in conjunction with embodiment, further set forth content of the present invention.
In following examples, carbomer used is provided by Bo Chang street, Boxing County Hong Tai supplementary material business department; Acrylic Acid Sodium Acrylate-acrylamide copolymer You Zhanqun Science and Technology Ltd. provides, and its relative molecular mass is 1,000 ten thousand～1,200 ten thousand.Unless otherwise noted, described in embodiment, umber is weight portion.
Embodiment 1
The selection of gelatum skeleton material:
(1) gel formula:
Carbomer is selected respectively Acritamer 940, Carbopol 941, carbomer U10, according to formula ratio, make gel substrate, the mouldability of substrate, hydrophilic, three indexs of carbomer swelling time are investigated, thereby optimized the carbomer model that can make at short notice stretchability, the good substrate of hydrophilic.The results are shown in Table 1.
The different carbomer models of table 1 are made the performance comparison of gel substrate
| Performance indications | Acritamer 940 | Carbopol 941 | Carbomer U10 |
| Mouldability | Good | Poor | Fine |
| Hydrophilic | By force | Stronger | Stronger |
| Swelling time (h) | 8 | 6 | 2 |
Mouldability classification: fine, good, general, poor; Hydrophilic classification: strong, strong, general, poor.
Visible, using carbomer U10 as gelatum skeleton material, the gel substrate mouldability of making, hydrophilic are all better than other two models, and swelling time is also relatively short.And experiment discovery, carbomer U10 is scattered in purified water, without waiting for complete swelling, stirs immediately and also can make the good substrate of quality, therefore can greatly shorten manufacturing cycle.
(2) gel formula:
According to formula ratio, wherein one group is added 11 parts of Acrylic Acid Sodium Acrylate-acrylamide copolymers, one group is not added Acrylic Acid Sodium Acrylate-acrylamide copolymer, make respectively two kinds of gel-type vehicles, in two kinds of gel-type vehicles, add Chinese medicine extraction liquid, stirring makes to be uniformly dispersed, and makes gel preparation.From viscous sense, year aqueous, three indexs of stretchability of preparation, investigate the impact of Acrylic Acid Sodium Acrylate-acrylamide copolymers on the quality of the pharmaceutical preparations.The results are shown in Table 2.
The impact of table 2 Acrylic Acid Sodium Acrylate-acrylamide copolymer on gel preparation
| Performance indications | Add terpolymer | Do not add terpolymer |
| Viscous sense | Nothing | Have |
| Water carrying capacity | 4 | 2 |
| Stretchability | Fine | Good |
1,2,3,4 grade of ascending minute of water carrying capacity.
Visible, be added with preparation viscous sense that the gel substrate of Acrylic Acid Sodium Acrylate-acrylamide copolymer makes, water carrying capacity, stretchability all good without adding the preparation that Acrylic Acid Sodium Acrylate-acrylamide copolymer makes.Acrylic Acid Sodium Acrylate-acrylamide copolymer is a kind of new functional macromolecule material, there is absorptance from the high absorbent function of heavy sensation of the body hundred times, and there is high rate of liquid aspiration and high liquid-keeping property, once imbibition, become hydrogel, even if pressurization is also difficult to water to separate.Therefore U10 is used in conjunction with carbomer, a large amount of Chinese medicine extraction liquid can be absorbed in wherein, greatly improve the drug loading of gel.
Embodiment 2
The preparation of reducing swelling and alleviating pain Chinese medicine gel preparation 1#.Said preparation comprises the active constituents of medicine of 500 parts by weight and the gel-type vehicle of 2626 parts by weight:
Wherein, active constituents of medicine formula is as follows:
Gel formula is as follows:
Preparation method:
1) by formula ratio, Radix Notoginseng, Flos Carthami, Eupolyphaga Seu Steleophaga, Radix Dipsaci, Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, the Radix Angelicae Sinensis seven taste prepared slices of Chinese crude drugs are soaked 30 minutes, decoct twice, decoct for the first time 2 hours, decoct for the second time 1 hour, merge decoction liquor, filter, being concentrated into relative density is 1.02～1.07, obtains Chinese medicine extraction liquid;
2) Mentholum, Camphora mix homogeneously are made to melt altogether, obtain mixed liquor a, seal standby;
3) first get 200 parts of purified water and pour in container, add carbomer U10, mix, then pour residue purified water into, mix, fully swelling; Add successively glycerol, Chinese medicine extraction liquid, mixed liquor a, azone, mix homogeneously, obtains mixed liquor b;
4) ethyl hydroxybenzoate being dissolved in to the ethanol of 95v/v%, adding in mixed liquor b, mix, then slowly add Acrylic Acid Sodium Acrylate-acrylamide copolymer, be stirred to and be uniformly dispersed, obtain swelling reducing and pain easing gel agent, is preparation 1#.
Embodiment 3
The preparation of reducing swelling and alleviating pain Chinese medicine gel preparation 2#.Said preparation comprises the active constituents of medicine of 430 parts by weight and the gel-type vehicle of 2530 parts by weight:
Wherein, active constituents of medicine formula is as follows:
Gel formula is as follows:
Preparation method:
1) by formula ratio, Radix Notoginseng, Flos Carthami, Eupolyphaga Seu Steleophaga, Radix Dipsaci, Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, the Radix Angelicae Sinensis seven taste prepared slices of Chinese crude drugs are soaked 30 minutes, decocted twice, decoct for the first time 2 hours, decoct for the second time 1 hour, merge decoction liquor, filter, being concentrated into relative density is 1.05, obtains Chinese medicine extraction liquid;
2) Mentholum, Camphora mix homogeneously are made to melt altogether, obtain mixed liquor a, seal standby;
3) first get 240 parts of purified water and pour in container, add carbomer U10, mix, then pour residue purified water into, mix, fully swelling; Add successively glycerol, Chinese medicine extraction liquid, mixed liquor a, azone, mix homogeneously, obtains mixed liquor b;
4) ethyl hydroxybenzoate being dissolved in to the ethanol of 93v/v%, adding in mixed liquor b, mix, then slowly add Acrylic Acid Sodium Acrylate-acrylamide copolymer, be stirred to and be uniformly dispersed, obtain swelling reducing and pain easing gel agent, is preparation 2#.
Embodiment 4
The preparation of reducing swelling and alleviating pain Chinese medicine gel preparation 3#.Said preparation comprises the active constituents of medicine of 450 parts by weight and the gel-type vehicle of 2700 parts by weight:
Wherein, active constituents of medicine formula is as follows:
Gel formula is as follows:
Preparation method:
1) by formula ratio, Radix Notoginseng, Flos Carthami, Eupolyphaga Seu Steleophaga, Radix Dipsaci, Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, the Radix Angelicae Sinensis seven taste prepared slices of Chinese crude drugs are soaked 30 minutes, decocted twice, decoct for the first time 2 hours, decoct for the second time 1 hour, merge decoction liquor, filter, being concentrated into relative density is 1.07, obtains Chinese medicine extraction liquid;
2) Mentholum, Camphora mix homogeneously are made to melt altogether, obtain mixed liquor a, seal standby;
3) first get 300 parts of purified water and pour in container, add carbomer U10, mix, then pour residue purified water into, mix, fully swelling; Add successively glycerol, Chinese medicine extraction liquid, mixed liquor a, azone, mix homogeneously, obtains mixed liquor b;
4) ethyl hydroxybenzoate being dissolved in to the ethanol of 95v/v%, adding in mixed liquor b, mix, then slowly add Acrylic Acid Sodium Acrylate-acrylamide copolymer, be stirred to and be uniformly dispersed, obtain swelling reducing and pain easing gel agent, is preparation 3#.
Test example 1
Animal experiment:
(1) reagent, reagent and experimental animal
Reagent: the swelling reducing and pain easing gel agent formulation 1#～3# of preparation a and embodiment 2～4 preparations.Wherein the preparation method of preparation a is as follows: 1. 600 parts of 600 parts of Radix Notoginseng, 400 parts, Flos Carthami, 600 parts of Eupolyphaga Seu Steleophagas, 600 parts of Radix Dipsacis, 600 parts of Rhizoma Chuanxiongs, 600 parts of the Radixs Angelicae Dahuricae, Radix Angelicae Sinensis are soaked 30 minutes, decoct twice, decoct for the first time 2 hours, decoct for the second time 1 hour, merge decoction liquor, filter, being concentrated into relative density is 1.02～1.07, obtains Chinese medicine extraction liquid; 2. 50 parts of Mentholums, 25 parts of mix homogeneously of Camphora are made to melt altogether, seal standby; 3. first get 200 parts of purified water and pour in container, add carbomer U1080 part, mix, then pour 500 parts of purified water into, mix, fully swelling; Add successively 480 parts of glycerol, Chinese medicine extraction liquid, step 2. 5 parts of gained mixed liquor, azones, mix homogeneously; 4. by 9 parts of ethanol that are dissolved in 40 parts of 95v/v% of ethyl hydroxybenzoate, add step 3. in mixed liquor, mix, be stirred to and be uniformly dispersed, obtain preparation a.
Reagent: 1% pentobarbital sodium inj, by Shanghai Xinya Pharmaceutical Industry Co. Ltd., produced.
Experimental animal: clean level SD rat, body weight 180g～220g, male and female dual-purpose.By Traditional Chinese Medicine University Of Guangzhou, provided.
(2) method and result
1) analgesic test
At ambient temperature, get mice, male and female dual-purpose, immerses mice tail end 3 ± 0.2cm in 48 ℃ of thermostat water baths, the incubation period of recording its whipping, surveys 2 times (interval 12min), asks its meansigma methods, and what get 5～30s incubation period is qualified Mus.After 24h, test, get 35 of qualified mices, be divided at random 5 groups, be i.e. blank group (not medication), 4 administration groups (preparation 1#, preparation 2#, preparation 3#, preparation a), every group of 7 mices.By in the thermostat water bath of 48 ℃ of mice tail end 3 ± 0.2cm immersions, first measure the basic incubation period of 5 treated animals, then 4 administration groups apply afterbody with preparation 1#, preparation 2#, preparation 3#, preparation a respectively, measure the variation respectively organize the TFL of mice after medication 30,60,90,120min, surpass 60s nonresponder, incubation period is by 60s.The results are shown in Table 3.
The impact of the different medication groups of table 3 on mice TFL
From table 3, to compare with matched group, medication group preparation 1#～3# group and preparation a group all can extend the whipping response latency of mice.With before administration, compare, preparation 1#～3# group and preparation a group all can improve the whipping response latency of mice, and increase rate is obvious.Preparation 1#～3# group is compared with preparation a group, acts on more remarkable.
Tail-flick method is that the whipping that stimulates the afterbody induced pain of mice to cause by hot water reacts.This result of the test shows, swelling reducing and pain easing gel agent of the present invention can make the mice whipping response latency extend, point out swelling reducing and pain easing gel agent of the present invention can play analgesic activity, and compared to the preparation a that does not add Acrylic Acid Sodium Acrylate-acrylamide copolymer component, preparation analgesic activity of the present invention is better.
2) hematoma repercussive test
1. modeling: choose rat, lumbar injection 1% pentobarbital sodium solution anesthesia (every 100g body weight 4mg pentobarbital sodium), after anaesthetizing successfully, with 6# syringe needle, carry out cardiac puncture, extract fresh intracardiac blood, from rear portion at the bottom of the sufficient sole of the foot to the subcutaneous injection 0.12ml of vola intermediate recess portion, cause a parapodum sole of the foot bottom hematoma.(at Hemorrhagic location coating preparation 1#, preparation 2#, preparation 3#, preparation a, coating in every 12 hours once respectively after modeling, to be divided at random blank group (not medication) and 4 medication groups.), 6 every group.2. the bottom hematoma swelling of the sufficient sole of the foot is measured: before modeling, with cursor micrometer caliper, measure every rat paw interior thickness value, after modeling respectively within 1,2,3,5,10,15 hour, surveying every group of rat paw interior thickness, before this value and modeling, the difference of thickness is hematoma swelling value, the results are shown in Table 4.3. after above-mentioned measurement completes, within every 10 hours, observe vola portion 1 time, to check every rat ecchymosis resolution time.Record the results are shown in Table 5.
The hematoma swelling comparison of table 4 different time foot sole of the foot portion
| Group | 1h | 2h | 3h | 5h | 10h | 15h |
| Matched group | 2.485±0.334 | 2.912±0.501 | 2.894±0.471 | 2.210±0.523 | 1.351±0.311 | 0.945±0.298 |
| Preparation 1# group | 1.825±0.511 | 1.981±0.381 | 1.899±0.341 | 1.602±0.340 | 0.703±0.246 | 0.467±0.310 |
| Preparation 2# group | 1.831±0.441 | 2.100±0.421 | 1.951±0.601 | 1.636±0.583 | 0.721±0.371 | 0.508±0.156 |
| Preparation 3# group | 1.819±0.328 | 1.977±0.342 | 1.933±0.421 | 1.647±0.215 | 0.709±0.382 | 0.451±0.212 |
| Preparation a group | 2.133±0.189 | 2.254±0.345 | 2.201±0.265 | 2.067±0.345 | 1.203±0.231 | 0.815±0.334 |
The ecchymosis regression time comparison of the sufficient sole of the foot of table 5 portion
| Group | Injection site | Diffuse to web portion between toe |
| Matched group | 75.12±10.01 | 86.23±10.35 |
| Preparation 1# group | 42.34±5.12 | 55.41±8.61 |
| Preparation 2# group | 43.05±4.42 | 54.13±9.11 |
| Preparation 3# group | 41.46±6.92 | 53.17±2.84 |
| Preparation a group | 50.08±7.98 | 59.97±6.18 |
After autologous whole blood injection, form local hematoma, there is rapidly aseptic inflammation reaction in Hemorrhagic location, shows as that local skin is rubescent, skin temperature rise, local organization swelling increase the weight of, and these are all obvious in 3 hours, disappear gradually later, the residual ecchymosis in sufficient sole of the foot bottom.From table 4, in 5 hours, (preparation 1#, preparation 2#, preparation 3#, preparation a) have obvious difference with blank group swelling value to 4 medication groups, show that medication group plays the effect of detumescence, and the detumescence speed of preparation 1#～～3# group is faster than preparation a group.In addition, sufficient sole of the foot portion hematoma disappears and spreads outward to toe web, and preparation a group hematoma ecchymosis resolution time (table 5) is short more than blank group, and preparation 1#～3# group hematoma ecchymosis resolution time shortens more than preparation a.
By above zoology test, verify, reducing swelling and alleviating pain Chinese medicine gel of the present invention has obvious analgesia, detumescence, repercussive effect.
Test example 2
Clinical trial:
1) case: 96 examples, male 53 examples; Female's 43 examples; At 7～68 years old age, be outpatient, and cardinal symptom is injury pain, swelling, limitation of activity etc.
2) method and result:
The preparation 1# of medicine for treatment: embodiment 2 preparations.
Usage and dosage: massage 2 to 3 times on the one after external application affected part or the drug of topical application.
Curative effect explanation: this organized 96 routine patient's drug of topical application after 2 weeks, and the state of an illness takes a turn for the better gradually, cardinal symptom is disappearance person's totally 90 examples completely, account for 93.8%; After the drug of topical application 1 week, disease makes rapid progress, cardinal symptom disappears substantially, is good therapeutic effect, and totally 17 examples, account for 17.7%; After the drug of topical application 3～4 weeks, cardinal symptom still exists, and the state of an illness alleviates, slowly, and for invalid, totally 2 examples, account for 2.1%.Visible, clinical efficacy and animal test results match.
Chinese medicine preparation side of the present invention separates: Radix Notoginseng, Flos Carthami stasis-dispelling and pain-killing; Eupolyphaga Seu Steleophaga removing blood stasis; Interrupted synthetism; Rhizoma Chuanxiong blood-activating and qi-promoting, wind-expelling pain-stopping; Radix Angelicae Dahuricae wind-expelling pain-stopping, dredging collateral detumescence; Chinese angelica blood supplementing is invigorated blood circulation, dispersing cold for relieving pain; Mentholum, the pain relieving of Camphora clearing heat for detumescence; All medicine compatibilities are played the effect of qi and blood circulation promotion, the meridian dredging, wind-damp dispelling, stopping numbness pain altogether, and QI and blood row unobstructed, the swollen pain that disappears of venation stops, thereby reaches therapeutic purposes.Can be used for traumatic injury, fracture-dislocation, the illness such as lumbago due to pathogenic wind-dampness.
Chinese medicine preparation of the present invention needs larger drug loading just can better bring into play curative effect, and gel-type vehicle of the present invention can absorb a large amount of Chinese medicine extraction liquid, forms stable gelinite, has greatly improved the drug loading of gel, thereby has improved the curative effect of reducing swelling and alleviating pain.And preparation technology of the present invention is simple, consuming time short, is easy to suitability for industrialized production.
Claims (8)
1. a reducing swelling and alleviating pain Chinese medicine gel, comprise the active component of 430～550 parts by weight and the gel-type vehicle of 2530～2700 parts by weight, its active component is made by the raw material of following parts by weight: 500～650 parts of Radix Notoginseng, 340～450 parts, Flos Carthami, 500～650 parts of Eupolyphaga Seu Steleophagas, 500～650 parts of Radix Dipsacis, 500～650 parts of Rhizoma Chuanxiongs, 500～650 parts of the Radixs Angelicae Dahuricae, 500～650 parts of Radix Angelicae Sinensis, 43～58 parts of Mentholums, 20～32 parts of Camphoras;
Gel-type vehicle is made by the component of following parts by weight: 600～800 parts of 35～40 parts of the ethanol of 85～95 parts of gelatum skeleton materials, 470～490 parts of wetting agents, 7～12 parts of antiseptic, 3～8 parts of penetrating agents, 93～95v/v% and purified water;
Gelatum skeleton material is carbomer and Acrylic Acid Sodium Acrylate-acrylamide copolymer.
2. reducing swelling and alleviating pain Chinese medicine gel according to claim 1, is characterized in that: gelatum skeleton material is the carbomer of 75～85 weight portions and the Acrylic Acid Sodium Acrylate-acrylamide copolymer of 10～12 weight portions.
3. reducing swelling and alleviating pain Chinese medicine gel according to claim 1 and 2, is characterized in that: carbomer is carbomer U10.
4. reducing swelling and alleviating pain Chinese medicine gel according to claim 1 and 2, is characterized in that: the relative molecular mass of Acrylic Acid Sodium Acrylate-acrylamide copolymer is 1,000 ten thousand～1,200 ten thousand.
5. reducing swelling and alleviating pain Chinese medicine gel according to claim 1 and 2, is characterized in that: wetting agent is glycerol, and antiseptic is at least one in ethyl hydroxybenzoate, sodium benzoate, sorbic acid and its esters; Penetrating agent is at least one in azone, menthol, Borneolum Syntheticum.
6. according to the reducing swelling and alleviating pain Chinese medicine gel described in claim 1 or 2, it is characterized in that: active component is made by the raw material of following parts by weight: 600 parts of Radix Notoginseng, 400 parts, Flos Carthami, 600 parts of Eupolyphaga Seu Steleophagas, 600 parts of Radix Dipsacis, 600 parts of Rhizoma Chuanxiongs, 600 parts of the Radixs Angelicae Dahuricae, 600 parts of Radix Angelicae Sinensis, 50 parts of Mentholums, 25 parts of Camphoras.
7. a preparation method for reducing swelling and alleviating pain Chinese medicine gel, comprises the following steps:
1) Radix Notoginseng, Flos Carthami, Eupolyphaga Seu Steleophaga, Radix Dipsaci, Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Radix Angelicae Sinensis are mixed, adopt decocting cooking method to extract, being concentrated into relative density is 1.02～1.07, obtains Chinese medicine extraction liquid;
2) Mentholum, Camphora are mixed and melted altogether, obtain mixed liquor a, seal standby;
3) carbomer is added in purified water, fully swelling; Add successively wetting agent, Chinese medicine extraction liquid, mixed liquor a, penetrating agent, mix homogeneously, obtains mixed liquor b;
4) antiseptic is dissolved in to the ethanol of 93～95v/v%, adds in mixed liquor b, mix, then add Acrylic Acid Sodium Acrylate-acrylamide copolymer, be stirred to and be uniformly dispersed, obtain swelling reducing and pain easing gel agent;
Wherein, each composition of swelling reducing and pain easing gel agent is as described in claim 1～6 any one.
8. preparation method according to claim 7, is characterized in that: in step 3), first get 30～50% purified water and pour in container, evenly add carbomer, then add remaining purified water, fully swelling.
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| CN110038035A (en) * | 2019-05-31 | 2019-07-23 | 厦门华言科技有限公司 | It is a kind of to treat pompholyx gel skin bacteriostatic agent and preparation method thereof |
| CN112315988A (en) * | 2020-11-25 | 2021-02-05 | 广州医科大学附属第五医院 | Radix Ilicis Pubescentis extract gel for promoting skin ulcer wound repair and its preparation method |
| CN112826845A (en) * | 2021-02-09 | 2021-05-25 | 宁夏医科大学 | Traditional Chinese medicine compound external gel for treating bone diseases and preparation method thereof |
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