CN103263470A - 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, also are 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.Medical research now shows that swelling is that intravascular fluid is seeped into due to the interstice outward owing to capillary rupture, permeability hemorrhage and blood vessel wall increase; And pain is because traumatic hematoma or inflammatory reaction thing stimulate local peripheral nerve to cause.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 western medicine more, and its curative effect has obtained certainly, but life-time service can cause untoward reaction such as addiction.Therefore, seek side effect and the little reducing swelling and alleviating pain Chinese medicine of dependency and become new trend.The history in existing several thousand of Chinese medicine treatment pain card in Huangdi's Internal Classics, has just been carried out the argumentation of system to aspects such as the cause of disease of pain card, pathogenesis, disease position, syndrome, prognosis.Theory of Chinese medical science is thought " pain then obstructed, general rule is not bitterly " be widely used accordingly for Chinese medicine and the Chinese medicine compound of the various pain of main treatment in tcm clinical practice.
Gel is applicable to skin, mucosa, cavity/canal drug administration as the novel dosage form of a kind of medicine, 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 an amount of 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 characteristics such as easy absorption, pollution clothes, stability be not better behind the topical.Gel generally divides aqueous gel, oil-base gel agent, emulsion-type gel, preparation aqueous gel substrate adopts Acritamer 940, polyvinyl alcohol, sodium carboxymethyl cellulose etc. more at present, but preparation technology all needs the swelling process of long period, and technology is also more loaded down with trivial details, consuming time.
Gel is started to walk early abroad, and development is fast, and " British Pharmacopoeia " 1993 editions put down in writing the choline salicylate tooth with gel, lidocaine gel etc., and " American Pharmacopeia " 1995 editions also records the benzene azoles because of kind of gel surplus gel, the gel aluminum hydroxide etc. 30.Be in development, raising stage, particularly Chinese medicine gel at China's gel and still be in the starting stage at home.The chemicals gel is because the principal agent chemical constituent is single, chemical property is stable, the existing a large amount of research datas of quality standard control, and principal agent and matrix phase capacitive are better, so preparation technology is simple relatively and ripe.And in China, because compound Chinese medicinal preparation complicated component, common multiple composition are brought into play therapeutical effect jointly, and dosage is general bigger, Chinese medicine ingredients stability is not strong, Chinese medicine ingredients and matrix phase capacitive are not ideal enough, the Chinese medicine gel effect of making is not as chemicals gel ideal, and preparation technology is also not mature enough.Therefore, demand urgently researching and developing good with the Chinese medicine extraction liquid compatibility, stretchability is good, with the good gel-type vehicle of skin affinity, be used for making the Chinese medicine novel form, promote the development of China's Chinese medicine cause.
Summary of the invention
The objective 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 on 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 following compositions in weight portion: 600～800 parts of 35～40 parts of the ethanol of 85～95 parts of gel 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, the gel skeleton material is carbomer and Acrylic Acid Sodium Acrylate-acrylamide copolymer.
Preferably, the gel skeleton material is carbomer and 10～12 parts by weight of acrylic-sodium acrylate-acrylamide copolymer of 75～85 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 a in ethyl hydroxybenzoate, sodium benzoate, sorbic acid and its esters; Penetrating agent is at least a in azone, menthol, the Borneolum Syntheticum.
Preferably, active component is made by the raw material of following parts by weight: 600 parts of Radix Notoginseng, 400 parts on 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 kind of preparation method of reducing swelling and alleviating pain Chinese medicine gel may further comprise the steps:
1) Radix Notoginseng, Flos Carthami, Eupolyphaga Seu Steleophaga, Radix Dipsaci, Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Radix Angelicae Sinensis are mixed, adopt the decocting cooking method to extract, being concentrated into relative density is 1.02～1.07, gets Chinese medicine extraction liquid;
2) Mentholum, Camphora mixing are melted altogether, get mixed liquor a, seal standby;
3) carbomer is added in the purified water, fully swelling; Add wetting agent, Chinese medicine extraction liquid, mixed liquor a, penetrating agent successively, mix homogeneously gets mixed liquor b;
4) antiseptic is dissolved in the ethanol of 93～95v/v%, adds among the mixed liquor b, mixing adds Acrylic Acid Sodium Acrylate-acrylamide copolymer then, is stirred to be uniformly dispersed, and obtains the swelling reducing and pain easing gel agent;
Wherein, each composition of swelling reducing and pain easing gel agent is as described in any one of the claim 1～8.
Preferably, in the step 3), get 30～50% purified water earlier and pour in the container, evenly add carbomer, add remaining purified water again, 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 tangible analgesia, detumescence, repercussive effect.
Gel substrate flowability of the present invention suits, is easy to be coated with exhibition, good with the skin affinity, and is good with the traditional Chinese medicine compound extract compatibility, can slowly steadily discharge medicine, is conducive to improve bioavailability of medicament.Reducing swelling and alleviating pain Chinese medicine gel of the present invention can not cause skin allergy to skin and mucosa nonirritant, uses safety, not pollution clothes.
The preparation technology of reducing swelling and alleviating pain Chinese medicine gel of the present invention is simple, need not large number quipments, only need homogenizer to stir and get final product, and preparation time is short, need not heating for dissolving in the preparation process, 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 on 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 following compositions in weight portion: 600～800 parts of 35～40 parts of the ethanol of 85～95 parts of gel 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 on 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 following compositions in weight portion: 650～700 parts of 35～40 parts of the ethanol of 85～92 parts of gel skeleton materials, 470～490 parts of wetting agents, 9 parts of antiseptic, 5 parts of penetrating agents, 95v/v% and purified water.
Preferably, the gel skeleton material is carbomer and Acrylic Acid Sodium Acrylate-acrylamide copolymer.
Preferably, the gel skeleton material is carbomer and 10～12 parts by weight of acrylic-sodium acrylate-acrylamide copolymer of 75～85 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 a in ethyl hydroxybenzoate, sodium benzoate, sorbic acid and its esters; Penetrating agent is at least a in azone, menthol, the Borneolum Syntheticum.
Preferably, active component is made by the raw material of following parts by weight: 600 parts of Radix Notoginseng, 400 parts on 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 kind of preparation method of reducing swelling and alleviating pain Chinese medicine gel may further comprise the steps:
1) Radix Notoginseng, Flos Carthami, Eupolyphaga Seu Steleophaga, Radix Dipsaci, Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Radix Angelicae Sinensis are mixed, adopt the decocting cooking method to extract, being concentrated into relative density is 1.02～1.07, gets Chinese medicine extraction liquid;
2) Mentholum, Camphora mixing are melted altogether, get mixed liquor a, seal standby;
3) carbomer is added in the purified water, fully swelling; Add wetting agent, Chinese medicine extraction liquid, mixed liquor a, penetrating agent successively, mix homogeneously gets mixed liquor b;
4) antiseptic is dissolved in the ethanol of 93～95v/v%, adds among the mixed liquor b, mixing adds Acrylic Acid Sodium Acrylate-acrylamide copolymer then, is stirred to be uniformly dispersed, and obtains the swelling reducing and pain easing gel agent;
Wherein, each composition of swelling reducing and pain easing gel agent is as described in any one of the claim 1～8.
Preferably, in the step 3), get 30～50% purified water earlier and pour in the container, evenly add carbomer, add remaining purified water again, fully swelling.
Below in conjunction with embodiment, further set forth content of the present invention.
Used carbomer is provided by the grand safe supplementary material in Bo Chang street, Boxing County business department in following examples; Acrylic Acid Sodium Acrylate-acrylamide copolymer is provided by Zhan Qun Science and Technology Ltd., and its relative molecular mass is 1,000 ten thousand～1,200 ten thousand.Unless otherwise noted, umber is weight portion described in the embodiment.
Embodiment 1
The selection of gel skeleton material:
(1) gel prescription:
Carbomer is selected Acritamer 940, Carbopol 941, carbomer U10 respectively for use, make gel substrate according to formula ratio, three indexs of mouldability, hydrophilic, carbomer swelling time to substrate are investigated, and can make stretchability, the hydrophilic carbomer model of substrate preferably at short notice thereby optimize.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 | Difference | Fine |
| Hydrophilic | By force | Stronger | Stronger |
| Swelling time (h) | 8 | 6 | 2 |
Mouldability classification: fine, good, general, poor; Hydrophilic classification: strong, strong, general, poor.
As seen, as the gel skeleton material, the gel substrate mouldability of making, hydrophilic are all better than other two models with carbomer U10, and swelling time is also shorter relatively.And experiment finds that carbomer U10 is scattered in the purified water, need not to wait for complete swelling, stirs immediately and also can make quality substrate preferably, therefore can shorten manufacturing cycle greatly.
(2) gel prescription:
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 two kinds of gel-type vehicles respectively, add Chinese medicine extraction liquid in two kinds of gel-type vehicles, stirring makes and is uniformly dispersed, and makes the gel preparation.Investigate Acrylic Acid Sodium Acrylate-acrylamide copolymer to the influence of the quality of the pharmaceutical preparations from viscous sense, year aqueous, three indexs of stretchability of preparation.The results are shown in Table 2.
Table 2 Acrylic Acid Sodium Acrylate-acrylamide copolymer is to the influence of gel preparation
| Performance indications | Add terpolymer | Do not add terpolymer |
| The viscous sense | Do not have | Have |
| Water carrying capacity | 4 | 2 |
| Stretchability | Fine | Good |
The ascending branch 1 of water carrying capacity, 2,3,4 grades.
As seen, be added with the sense of preparation viscous, water carrying capacity, stretchability that the gel substrate of Acrylic Acid Sodium Acrylate-acrylamide copolymer makes and do not have all that to add the preparation that Acrylic Acid Sodium Acrylate-acrylamide copolymer makes good.Acrylic Acid Sodium Acrylate-acrylamide copolymer is a kind of new functional macromolecule material, has absorptance from the high absorbent function of heavy sensation of the body hundred times, and have high rate of liquid aspiration and high liquid-keeping property, in case when imbibition becomes hydrogel, even pressurization also is difficult to separated form water is come out.So U10 is used with carbomer, a large amount of Chinese medicine extraction liquid can be absorbed in wherein, improve the drug loading of gel greatly.
Embodiment 2
The preparation of reducing swelling and alleviating pain Chinese medicine gel preparation 1#.Said preparation comprises the gel-type vehicle of 500 parts of medicines by weight active component and 2626 parts by weight:
Wherein, the active constituents of medicine prescription is as follows:
The gel prescription 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 flavor prepared slices of Chinese crude drugs were soaked 30 minutes, decoct twice, decocted 2 hours for the first time, decocted 1 hour for the second time, merge decoction liquor, filter, being concentrated into relative density is 1.02～1.07, gets Chinese medicine extraction liquid;
2) Mentholum, Camphora mix homogeneously are made altogether and melt, get mixed liquor a, seal standby;
3) get 200 parts of purified water earlier and pour in the container, add carbomer U10, mixing is poured the residue purified water again into, mixing, fully swelling; Add glycerol, Chinese medicine extraction liquid, mixed liquor a, azone successively, mix homogeneously gets mixed liquor b;
4) ethyl hydroxybenzoate is dissolved in the ethanol of 95v/v%, adds among the mixed liquor b, mixing slowly adds Acrylic Acid Sodium Acrylate-acrylamide copolymer then, is stirred to be uniformly dispersed, and obtains the 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 gel-type vehicle of 430 parts of medicines by weight active component and 2530 parts by weight:
Wherein, the active constituents of medicine prescription is as follows:
The gel prescription 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 flavor prepared slices of Chinese crude drugs were soaked 30 minutes, decocted twice, decocted 2 hours for the first time, decocted 1 hour for the second time, merge decoction liquor, filter, being concentrated into relative density is 1.05, gets Chinese medicine extraction liquid;
2) Mentholum, Camphora mix homogeneously are made altogether and melt, get mixed liquor a, seal standby;
3) get 240 parts of purified water earlier and pour in the container, add carbomer U10, mixing is poured the residue purified water again into, mixing, fully swelling; Add glycerol, Chinese medicine extraction liquid, mixed liquor a, azone successively, mix homogeneously gets mixed liquor b;
4) ethyl hydroxybenzoate is dissolved in the ethanol of 93v/v%, adds among the mixed liquor b, mixing slowly adds Acrylic Acid Sodium Acrylate-acrylamide copolymer then, is stirred to be uniformly dispersed, and obtains the 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 gel-type vehicle of 450 parts of medicines by weight active component and 2700 parts by weight:
Wherein, the active constituents of medicine prescription is as follows:
The gel prescription 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 flavor prepared slices of Chinese crude drugs were soaked 30 minutes, decocted twice, decocted 2 hours for the first time, decocted 1 hour for the second time, merge decoction liquor, filter, being concentrated into relative density is 1.07, gets Chinese medicine extraction liquid;
2) Mentholum, Camphora mix homogeneously are made altogether and melt, get mixed liquor a, seal standby;
3) get 300 parts of purified water earlier and pour in the container, add carbomer U10, mixing is poured the residue purified water again into, mixing, fully swelling; Add glycerol, Chinese medicine extraction liquid, mixed liquor a, azone successively, mix homogeneously gets mixed liquor b;
4) ethyl hydroxybenzoate is dissolved in the ethanol of 95v/v%, adds among the mixed liquor b, mixing slowly adds Acrylic Acid Sodium Acrylate-acrylamide copolymer then, is stirred to be uniformly dispersed, and obtains the 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 Radix Notoginseng, 400 parts on 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 were soaked 30 minutes for 600 parts, decoct twice, decocted 2 hours for the first time, decocted 1 hour for the second time, merge decoction liquor, filter, being concentrated into relative density is 1.02～1.07, gets Chinese medicine extraction liquid; 2. 50 parts of Mentholums, 25 parts of mix homogeneously of Camphora are made altogether and melt, seal standby; 3. get 200 parts of purified water earlier and pour in the container, add carbomer U1080 part, mixing is poured 500 parts of purified water again into, mixing, fully swelling; Add 480 parts of glycerol, Chinese medicine extraction liquid, step 2. 5 parts of gained mixed liquor, azones successively, mix homogeneously; 4. with 9 parts of ethanol that are dissolved in 40 parts of 95v/v% of ethyl hydroxybenzoate, add step 3. in the mixed liquor, mixing is stirred to and is uniformly dispersed, and obtains preparation a.
Reagent: 1% pentobarbital sodium inj, produced by Shanghai Xinya Pharmaceutical Industry Co. Ltd..
Experimental animal: cleaning level SD rat, body weight 180g～220g, male and female dual-purpose.Provided by Traditional Chinese Medicine University Of Guangzhou.
(2) method and result
1) analgesic test
At ambient temperature, get mice, the male and female dual-purpose immerses mice tail end 3 ± 0.2cm in 48 ℃ of thermostat water baths, surveys 2 times (12min at interval) incubation period of recording its whipping, asks its meansigma methods, gets the qualified Mus that is of 5～30s incubation period.Test behind the 24h, get 35 of qualified mices, be divided into 5 groups at random, be i.e. blank group (not medication), 4 administration groups (preparation 1#, preparation 2#, preparation 3#, preparation a), every group of 7 mices.In the thermostat water bath with 48 ℃ of mice tail end 3 ± 0.2cm immersions, at first measure the basic incubation period of 5 treated animals, 4 administration groups apply afterbody with preparation 1#, preparation 2#, preparation 3#, preparation a respectively then, measure the variation respectively organize the TFL of mice behind medication 30,60,90, the 120min, surpass the 60s nonresponder, incubation period is by 60s.The results are shown in Table 3.
The different medication groups of table 3 are to the influence of mice TFL
By table 3 as seen, compare with matched group, medication group preparation 1#～3# group and preparation a group all can prolong the whipping response latency of mice.With compare before the administration, preparation 1#～3# group and preparation a group all can improve the whipping response latency of mice, and the raising rate is obvious.Preparation 1#～3# group is compared with preparation a group, acts on more remarkable.
Tail-flick method is to stimulate the afterbody of mice to cause the whipping reaction that pain causes by hot water.This result of the test shows, swelling reducing and pain easing gel agent of the present invention can make the mice whipping response latency prolong, 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, carry out cardiac puncture with the 6# syringe needle, extract fresh intracardiac blood, parapodum sole of the foot bottom hematoma is caused to the subcutaneous injection 0.12ml of vola intermediate recess portion in the rear portion at the bottom of the sufficient sole of the foot.(at hematoma position coating preparation 1#, preparation 2#, preparation 3#, preparation a, coating in per 12 hours once respectively to be divided into blank group (not medication) and 4 medication groups after the modeling at random.), 6 every group.2. sufficient sole of the foot bottom hematoma swelling is measured: measure every rat paw interior thickness value with the vernier micrometer callipers before the modeling, after the modeling respectively at surveying every group of rat paw interior thickness in 1,2,3,5,10,15 hour, the difference of thickness is hematoma swelling value before this value and the modeling, the results are shown in Table 4.3. after above-mentioned measurement is finished, observed vola portion 1 time in per 10 hours, to check every rat ecchymosis resolution time.Record the results are shown in Table 5.
The hematoma swelling of table 4 different time foot sole of the foot portion relatively
| 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 sufficient sole of the foot of table 5 portion ecchymosis regression time relatively
| Group | The 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 |
Through after the injection of body whole blood, forming local hematoma, aseptic inflammation reaction appears rapidly in the hematoma position, 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 the residual ecchymosis in sufficient sole of the foot bottom later on gradually.By table 4 as seen, in 5 hours, 4 medication groups (preparation 1#, preparation 2#, preparation 3#, preparation a) have tangible difference with blank group swelling value, show that the medication group plays the effect of detumescence, and preparation 1#～～the detumescence speed of 3# group is faster than preparation a group.In addition, sufficient sole of the foot portion hematoma disappears and spreads outward to the toe web, and preparation a group hematoma ecchymosis resolution time (table 5) is short more than the blank group, and preparation 1#～3# group hematoma ecchymosis resolution time shortens more than preparation a.
By above zoology test checking, reducing swelling and alleviating pain Chinese medicine gel of the present invention has tangible analgesia, detumescence, repercussive effect.
Test example 2
Clinical trial:
1) case: 96 examples, male 53 examples; Woman's 43 examples; 7～68 years old age was the 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.
The curative effect explanation: after this organized for 96 routine 2 weeks of patient's drug of topical application, the state of an illness took a turn for the better gradually, and cardinal symptom complete obiteration person is totally 90 examples, accounts for 93.8%; After 1 week of the drug of topical application, the state of an illness takes a turn for the better rapidly, and cardinal symptom disappears substantially, is better curative effect, and totally 17 examples account for 17.7%; After 3～4 weeks of the drug of topical application, cardinal symptom still exists, and the state of an illness alleviates, slowly, and for invalid, totally 2 examples account for 2.1%.As seen, 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; The 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, collateral dredging 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 then unobstructed, the swollen pain that disappears of venation ends, thereby reaches therapeutic purposes.Can be used for traumatic injury, fracture-dislocation, illness such as lumbago due to pathogenic wind-dampness.
Chinese medicine preparation of the present invention needs bigger 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 the stabilizing gel body, has improved the drug loading of gel greatly, thereby has improved the curative effect of reducing swelling and alleviating pain.And simple, the consuming time weak point of preparation technology of the present invention is easy to suitability for industrialized production.
Claims (10)
1. 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 on 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.
2. reducing swelling and alleviating pain Chinese medicine gel according to claim 1, it is characterized in that: gel-type vehicle is made by following compositions in weight portion: 600～800 parts of 35～40 parts of the ethanol of 85～95 parts of gel 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.
3. reducing swelling and alleviating pain Chinese medicine gel according to claim 2, it is characterized in that: the gel skeleton material is carbomer and Acrylic Acid Sodium Acrylate-acrylamide copolymer.
4. reducing swelling and alleviating pain Chinese medicine gel according to claim 3, it is characterized in that: the gel skeleton material is carbomer and 10～12 parts by weight of acrylic-sodium acrylate-acrylamide copolymer of 75～85 weight portions.
5. according to claim 3 or 4 described reducing swelling and alleviating pain Chinese medicine gel, it is characterized in that: carbomer is carbomer U10.
6. according to claim 3 or 4 described reducing swelling and alleviating pain Chinese medicine gel, it is characterized in that: the relative molecular mass of Acrylic Acid Sodium Acrylate-acrylamide copolymer is 1,000 ten thousand～1,200 ten thousand.
7. according to any described reducing swelling and alleviating pain Chinese medicine gel of claim 2～4, it is characterized in that: wetting agent is glycerol, and antiseptic is at least a in ethyl hydroxybenzoate, sodium benzoate, sorbic acid and its esters; Penetrating agent is at least a in azone, menthol, the Borneolum Syntheticum.
8. according to any described reducing swelling and alleviating pain Chinese medicine gel of claim 1～4, 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 on 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.
9. the preparation method of a reducing swelling and alleviating pain Chinese medicine gel may further comprise the steps:
1) Radix Notoginseng, Flos Carthami, Eupolyphaga Seu Steleophaga, Radix Dipsaci, Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Radix Angelicae Sinensis are mixed, adopt the decocting cooking method to extract, being concentrated into relative density is 1.02～1.07, gets Chinese medicine extraction liquid;
2) Mentholum, Camphora mixing are melted altogether, get mixed liquor a, seal standby;
3) carbomer is added in the purified water, fully swelling; Add wetting agent, Chinese medicine extraction liquid, mixed liquor a, penetrating agent successively, mix homogeneously gets mixed liquor b;
4) antiseptic is dissolved in the ethanol of 93～95v/v%, adds among the mixed liquor b, mixing adds Acrylic Acid Sodium Acrylate-acrylamide copolymer then, is stirred to be uniformly dispersed, and obtains the swelling reducing and pain easing gel agent;
Wherein, each composition of swelling reducing and pain easing gel agent is as described in any one of the claim 1～8.
10. preparation method according to claim 1 is characterized in that: in the step 3), get 30～50% purified water earlier and pour in the container, evenly add carbomer, add remaining purified water again, fully swelling.
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| 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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| 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 |
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