CN104922289A - Joint pain relieving gel and preparation method thereof - Google Patents

Joint pain relieving gel and preparation method thereof Download PDF

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CN104922289A
CN104922289A CN201510325222.5A CN201510325222A CN104922289A CN 104922289 A CN104922289 A CN 104922289A CN 201510325222 A CN201510325222 A CN 201510325222A CN 104922289 A CN104922289 A CN 104922289A
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ethanol
preparation
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fructus capsici
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刘道芳
刘海兵
谢红星
田湘玲
徐莉莉
廖华宁
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ANHUI ANKE YULIANGQING PHARMACEUTICAL CO LTD
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ANHUI ANKE YULIANGQING PHARMACEUTICAL CO LTD
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Abstract

The invention relates to the field of medicine, in particular to joint pain relieving gel. The joint pain relieving gel comprises, by weight, 160-240 parts of pepper fluid extracts, 90-140 parts of atropa belladonna fluid extracts, 30-50 parts of dementholized peppermint oil, 70-90 parts of methyl salicylate, 160-240 parts of camphor, 10-15 parts of diphenhydramine hydrochloride, 1-15 parts of polyvinyl alcohol, 2-30 parts of Carbomer, 1-3 parts of ethylparaben, 3-40 parts of hydroxypropyl methyl cellulose, 50-100 parts of glycerinum, 1-10 parts of triethanolamine, 1-10 parts of ethyl alcohol, 1-5 parts of azone and an appropriate amount of water. The part sum of all the raw material components is 1000. The invention further discloses a preparation method of the joint pain relieving gel. Compared with existing joint pain relieving plaster, the joint pain relieving gel has the advantages of being good in stability, good in rheological property, good in spreadability, convenient to use, small in skin irritation, good in curative effect and safe to produce.

Description

Arthralgia relief gel and preparation method thereof
Technical field
The present invention relates to field of medicaments, be specifically related to a kind of gel for arthralgia relief and preparation method thereof.
Background technology
Pain-relieving plaster for arthritis is a kind of listing Chinese patent medicine for many years, prescription comprises Fructus Capsici, Semen daturae, Oleum menthae, methyl salicylate, Camphora, diphhydramine hydrochloride Six-element, there is promoting blood circulation to remove blood stasis, warming the meridian analgesic function, clinically be used for the treatment of rheumatic arthritis caused by cold and damp stagnation meridians and articular sprain, evident in efficacy.Its quality standard refers to 2010 editions " Chinese Pharmacopoeias " 705 pages.But pain-relieving plaster for arthritis is rubber-emplastrum, it adopts natural rubber to be framework material, take Colophonium as viscosifier, these materials on skin have stronger zest and anaphylaxis, and adhesion is excessive, poor air permeability, make patient compliance poor, thus hinder the clinical practice of pain-relieving plaster for arthritis.In addition, because pain-relieving plaster for arthritis sticks in the often movable joint part of patient, when making patient activity like this, not only comfort level is low, and pain-relieving plaster for arthritis is easily wrinkling, causes drug effect to reduce.Moreover pain-relieving plaster for arthritis technological temperature is in process of production higher, causes the volatile loss of volatile oil component, affect clinical efficacy.The more important thing is, pain-relieving plaster for arthritis adopts gasoline to be solvent, there is certain potential safety hazard in process of production, and also can pollute environment.Therefore research and develop a kind of safety in production, good stability, facilitate medication, little to human body skin zest, transdermal release good arthralgia relief medicine for external use is significant.
Applicant's earlier application name is called the patent of invention (application number is 201310631458.2) of " promoting blood circulation and stopping pain gel and preparation method thereof ", above-mentioned defect is there is in use too just and proposes in this patent of invention based on traditional HUOXUE ZHITONG GAO, be referred from technical scheme disclosed in this patent, applicant attempts matrix components (the i.e. triethanolamine adopted with preparation promoting blood circulation and stopping pain gel by the medicine composition preparing pain-relieving plaster for arthritis, carbomer, ethyl hydroxybenzoate, hydroxypropyl emthylcellulose, glycerol, ethanol, azone and water) combine to prepare arthralgia relief gel, but test finds, after the drug extract adopting technique scheme to prepare mixes with substrate, centrifugal poor with heat stability, there is lamination.
Therefore, expect a kind of safety in production, good stability, facilitate medication, little to human body skin zest, the good arthralgia relief gel of transdermal release, need deep research.
Summary of the invention
Primary and foremost purpose of the present invention is to provide that a kind of good stability, rheological characteristic and stretchability are good, easy to use, little to skin irritation, good effect and the arthralgia relief gel that can keep the safety in production.
To achieve these goals, present invention employs following technical scheme: a kind of arthralgia relief gel, its raw materials comprises the component of following parts by weight: Fructus Capsici fluidextract 160-240 part, Semen daturae fluid extract 90-140 part, Oleum menthae 30-50 part, methyl salicylate 70-90 part, Camphora 160-240 part, diphhydramine hydrochloride 10-15 part, polyvinyl alcohol 1-15 part, carbomer 2-30 part, ethyl hydroxybenzoate 1-3 part, hydroxypropyl emthylcellulose 3-40 part, glycerol 50-100 part, triethanolamine 1-10 part, ethanol 1-10 part, azone 1-5 part, water is appropriate, described each raw material components amounts in 1000 parts.
Another object of the present invention is to provide a kind of preparation method of above-mentioned arthralgia relief gel, comprises the following steps:
A, take Oleum menthae, methyl salicylate, Camphora, diphhydramine hydrochloride, Fructus Capsici fluidextract and Semen daturae fluid extract, mixing stirs evenly, and obtains drug extract;
B, carbomer is sprinkled in 40-200 part water, places, stir after it is fully swelling, obtain carbomer gel A;
C, in hydroxypropyl emthylcellulose and polyvinyl alcohol, add 10-100 part water, heated and stirred, to dissolving, then adds glycerol, stirs evenly, obtain Colloidal fluid B;
D, take ethyl hydroxybenzoate and azone, adding 1-10 part mass fraction is the dissolve with ethanol of 85%-90%, and then obtained with step a drug extract mixes, and stirs evenly, obtains admixing medical solutions C;
E, carbomer gel A and Colloidal fluid B to be mixed, add 20-200 part water, stir evenly, then add admixing medical solutions C, stir evenly, then add triethanolamine, add water and supply weight, stir evenly, obtain arthralgia relief gel.
The arthralgia relief gel good stability prepared according to above technical scheme, rheological characteristic are good, stretchability is good, easy to use, little to skin irritation, have good biocompatibility, good effect and production safety.
Detailed description of the invention
A kind of arthralgia relief gel, its raw materials comprises the component of following parts by weight: in right amount, described each raw material components amounts in 1000 parts for Fructus Capsici fluidextract 160-240 part, Semen daturae fluid extract 90-140 part, Oleum menthae 30-50 part, methyl salicylate 70-90 part, Camphora 160-240 part, diphhydramine hydrochloride 10-15 part, polyvinyl alcohol 1-15 part, carbomer 2-30 part, ethyl hydroxybenzoate 1-3 part, hydroxypropyl emthylcellulose 3-40 part, glycerol 50-100 part, triethanolamine 1-10 part, ethanol 1-10 part, azone 1-5 part, water.This arthralgia relief gel good stability, rheological characteristic and stretchability be good, easy to use, little to skin irritation, have good biocompatibility, good effect and production safety.
As further preferred version, the parts by weight of described each raw material are: Fructus Capsici fluidextract 200 parts, Semen daturae fluid extract 120 parts, Oleum menthae 40 parts, methyl salicylate 80 parts, Camphora 200 parts, diphhydramine hydrochloride 13 parts, polyvinyl alcohol 3 parts, carbomer 5 parts, ethyl hydroxybenzoate 1 part, hydroxypropyl emthylcellulose 15 parts, glycerol 100 parts, triethanolamine 8 parts, ethanol 5 parts, azone 3 parts, water are appropriate.
The preparation method of above-mentioned arthralgia relief gel, comprises the following steps:
A, take Oleum menthae, methyl salicylate, Camphora, diphhydramine hydrochloride, Fructus Capsici fluidextract and Semen daturae fluid extract, mixing stirs evenly, and obtains drug extract;
B, carbomer is sprinkled in 40-200 part water, places, stir after it is fully swelling, obtain carbomer gel A;
C, in hydroxypropyl emthylcellulose and polyvinyl alcohol, add 10-100 part water, heated and stirred, to dissolving, then adds glycerol, stirs evenly, obtain Colloidal fluid B;
D, take ethyl hydroxybenzoate and azone, adding 1-10 part mass fraction is the dissolve with ethanol of 85%-90%, and then obtained with step a drug extract mixes, and stirs evenly, obtains admixing medical solutions C;
E, carbomer gel A and Colloidal fluid B to be mixed, add 20-200 part water, stir evenly, then add admixing medical solutions C, stir evenly, then add triethanolamine, add water and supply weight, stir evenly, obtain arthralgia relief gel.
More specifically scheme is: the preparation method of described Fructus Capsici fluidextract is as follows: take Fructus Capsici, be ground into coarse powder, in Fructus Capsici coarse powder, add 1-3 times of mass fraction is the ethanol of 85%-90%, dipping 1-3 days, percolation, collect percolate and filter, then under 25-30 DEG C of condition, concentrating filtrate to relative density is 1.25-1.30g/ml, obtains Fructus Capsici fluidextract;
The preparation method of the Semen daturae fluid extract in described step a is as follows: take Herba Belladonnae, be ground into Herba Belladonnae coarse powder, in Herba Belladonnae coarse powder, add 1-3 times of mass fraction is the ethanol of 85%-90%, dipping 2-3 days, percolation, collect percolate and filter, decompression recycling ethanol, naturally cool to room temperature, be separated removing chlorophyll, filter, concentrate filtrate to thick shape, then adding 8-10 times of mass fraction is the alcohol settling of 85%-90%, Aspirate supernatant, under 25-30 DEG C of condition, supernatant is evaporated to the thick paste that relative density is 1.25-1.30g/ml, then in thick paste, the ethanol that mass fraction is 85% is added, and dilute with water, until in atropine sulfate, alkaloid is wherein more than or equal to 6.6mg/ml, obtain Semen daturae fluid extract, in described thick paste, the interpolation quality of ethanol is 52%-66%.
More preferred scheme is: adding 3 times of mass fractions in described Fructus Capsici coarse powder is the ethanol of 90%, flood 3 days, the percolate collected is the Fructus Capsici fluidextract concentrating filtrate to relative density position 1.25g/ml under 25-30 DEG C of condition after filtering, in addition, adding 2 times of mass fractions in described Herba Belladonnae coarse powder is the ethanol of 85%, flood 3 days, in the process preparing Semen daturae fluid extract, described supernatant is that under 25-30 DEG C of condition, concentrate filtrate to relative density be 1.28g/ml, and in described thick paste, the interpolation quality of ethanol is 60%.
Prove through test, the present invention is implemented by above-mentioned technique and technical scheme that parameter limits thereof, can further improve stability and the result of use of arthralgia relief gel of the present invention self, concrete, arthralgia relief gel disclosed by the invention possesses the advantage of the following aspects:
(1) easily absorb: compared with the pain-relieving plaster for arthritis of prior art, containing a large amount of moisture in arthralgia relief gel of the present invention, keratodermatitis is easily softened, thus is conducive to the absorption of medicine.
(2) zest and the anaphylaxis of skin is reduced: containing plurality of impurities in natural rubber, and easily cause allergy, and arthralgia relief gel of the present invention abandon prior art adopt natural rubber make product as framework material, can effectively reduce skin irritation and anaphylaxis like this, use comfortable, improve the compliance of patient.
(3) drug effect is improved: traditional handicraft adopts gasoline to prepare pain-relieving plaster for arthritis as solvent, technological temperature during recycling design is higher, cause the effective volatile ingredient loss in medicine, affect drug effect, and the present invention adopts ethanol as solvent, required technological temperature during recovery is starkly lower than gasoline, effectively can reduce volatilization or the loss of effective ingredient like this, effectively improves the drug effect of arthralgia relief gel.
(4) environmental protect pollutes, improves production safety: gasoline is inflammable, explosive, therefore there is safety in production hidden danger when traditional handicraft adopts gasoline to prepare pain-relieving plaster for arthritis as solvent, and contaminated environment, by comparison, the present invention adopts ethanol to replace the petrolic solvent of prior art, effectively can improve the safety of production, and can directly be recycled ethanol in preparation process, not only reduce environmental pollution, and make resource be able to maximum using.
(5) easy to use: there is between arthralgia relief gel and skin good biocompatibility, easy painting exhibition and washing are removed, especially be used for each joint part in summer more convenient, can also use be massaged according to practical situation gel, advantageously in the fast treating in disease affected part.
(6) good stability: arthralgia relief gel of the present invention is placed in respectively 40 ± 1 DEG C, 25 ± 3 DEG C super constant temperature troughs and 5 ± 2 DEG C of refrigerators, the temperature of simulation different regions, observe 30 days, result shows that the viscosity of arthralgia relief gel of the present invention, color and luster and uniformity are all highly stable, is had no significant change by the wherein each item content's index of detection display.
(7) viscoelasticity is good: adopt the arthralgia relief gel that polyethylene, carbomer and hydroxypropyl emthylcellulose obtain as mixed type hydrophilic gel substrate, there is good viscoelasticity, elasticity is conducive to the stable of system, and viscosity is then conducive to production fill and smears.
Composition and the pharmacological action of the raw materials used middle key component of the present invention are as follows:
Fructus Capsici fluidextract: mainly containing terpenoid, alkaloids, steroid class, flavonoid, phenols, unsaturated fatty acid isoreactivity composition, wherein terpenoid comprises sesquiterpene, diterpene, tetraterpenes, alkaloids comprises capsaicin, dihydrocapsaicin, Nordihydrocapsaicin, homocapsaicin, Homodihydrocapsaicin etc., pharmaceutical research shows, after Fructus Capsici extract gastric infusion, obviously can extend the threshold of pain time of hot plate method in mice and heat radiation tail-flick method, have obvious inhibitory action to the ear swelling of mice dimethylbenzene induction, the foot swelling that can obviously suppress rat carrageenan to be induced, prompting has anti-inflammatory and analgesic effect, and in addition, capsaicin cream and diclofenac diethylamine emulgel all significantly can reduce arthralgia, improve the degree of tenderness and movable pain, overall efficiency is respectively 79.10%, 76.92%, but capsaicin cream is more rapid-action than diclofenac diethylamine emulgel, and the capsaicin cream outer used time has skin sends out red effect, thus makes the local vascular reflex dilatation of patient, promotion local blood circulation.
Semen daturae fluid extract: mainly containing compositions such as scopolamine, hyoscyamine, atropine, Semen Hyoscyami amine n-oxide, hyoscine N-oxide and flavonoids, for anticholinergic agent, Semen daturae fluid extract can remove smooth muscle spasm, suppress glandular secretion, especially to the smooth muscle being in hyperkinesia and spasticity, then spasmolysis is more obvious.
Oleum menthae: be aromatic drug, produces refrigerant sense, pain for skin or mucosa place, can promote local blood circulation.
Methyl salicylate: be the rubefacient of external, local is embrocated and can be produced the irritant reaction such as cutaneous vasodilation, the colour of skin be rubescent, and reflexive ground affects the skin of corresponding site, muscle, nerve and joint, play detumescence, antiinflammatory and analgesic activity, also have antipruritic effect, be mainly used in spraining, dampen, the disease such as lumbago, myalgia, neuralgia.
Camphora: belong to camphane compounds, main component is gum camphor, has orifice opening, qi stagnation removing, wards off foul, killing parasites for relieving itching, reducing swelling and alleviating pain effect, cure mainly the symptoms such as scabies pruritus, traumatic pain, toothache.
Diphhydramine hydrochloride: can multiple allergic symptom be eliminated, as urticaria, insect bite disease, remarkable to central inhibitory action, there is calmness, anti-cinetosis and emesis, cholinolytic effect, bronchial smooth muscle spasm can be alleviated.
In order to further illustrate technical scheme disclosed by the invention, 1-3 is described further by the following examples:
Embodiment 1: the preparation of arthralgia relief gel
1) Fructus Capsici is taken, be ground into coarse powder, the ethanol (in other words the interpolation quality of ethanol is 1 times of Fructus Capsici coarse powder) that 1 times of mass fraction is 85% is added in Fructus Capsici coarse powder, flood 2 days, percolation, collect percolate and filter, then under 30 DEG C of conditions, concentrating filtrate to relative density is 1.30g/ml, obtains Fructus Capsici fluidextract;
2) Herba Belladonnae is taken, be ground into Herba Belladonnae coarse powder, in Herba Belladonnae coarse powder, add 2 times of mass fractions is the ethanol of 85%, flood 2 days, percolation, collect percolate and filter, decompression recycling ethanol, naturally cool to room temperature, be separated removing chlorophyll, filter, concentrate filtrate to thick shape, then adding 10 times of mass fractions is the alcohol settling of 85%, Aspirate supernatant, under 30 DEG C of conditions, supernatant is evaporated to the thick paste that relative density is 1.25g/ml, then in thick paste, the ethanol that mass fraction is 85% is added, and dilute with water, until in atropine sulfate, alkaloid is wherein more than or equal to 6.6mg/ml, obtain Semen daturae fluid extract, in described thick paste, the interpolation quality of ethanol is 52%.
3) 30 parts of Oleum menthaes, 70 parts of methyl salicylate, 160 parts of Camphoras, 10 parts of diphhydramine hydrochlorides, 160 parts of steps 1 are taken) obtained Fructus Capsici fluidextract and step 2) 90 portions of obtained Semen daturae fluid extracts mix, stir evenly, obtain drug extract;
4) 2 parts of carbomers are sprinkled in 50 parts of water, place, stir after it is fully swelling, obtain carbomer gel A;
5) take 3 parts of hydroxypropyl emthylcelluloses and 1 part of polyvinyl alcohol, add 20 parts of water, heated and stirred, to dissolving, then adds 50 parts of glycerol, stirs evenly, obtain Colloidal fluid B;
6) take 1 part of ethyl hydroxybenzoate and 1 part of azone, adding 1 part of mass fraction is the dissolve with ethanol of 85%, then with step 3) obtained drug extract mixes, stirs evenly, obtain admixing medical solutions C;
7) carbomer gel A is mixed with Colloidal fluid B, add 20 parts of water, stir evenly, then add admixing medical solutions C, stir evenly, then add 1 part of triethanolamine, add water and supply weight, stir evenly, obtain arthralgia relief gel.
Embodiment 2: the preparation of arthralgia relief gel
1) take Fructus Capsici, be ground into coarse powder, in Fructus Capsici coarse powder, add 3 times of mass fractions is the ethanol of 85%, flood 3 days, percolation, collect percolate and filter, then under 25 DEG C of conditions, concentrating filtrate to relative density is 1.30g/ml, obtains Fructus Capsici fluidextract;
2) Herba Belladonnae is taken, be ground into Herba Belladonnae coarse powder, in Herba Belladonnae coarse powder, add 3 times of mass fractions is the ethanol of 85%, flood 3 days, percolation, collect percolate and filter, decompression recycling ethanol, naturally cool to room temperature, be separated removing chlorophyll, filter, concentrate filtrate to thick shape, then adding 10 times of mass fractions is the alcohol settling of 85%, Aspirate supernatant, under 30 DEG C of conditions, supernatant is evaporated to the thick paste that relative density is 1.30g/ml, then in thick paste, the ethanol that mass fraction is 85% is added, and dilute with water, until in atropine sulfate, alkaloid is wherein more than or equal to 6.6mg/ml, obtain Semen daturae fluid extract, in described thick paste, the interpolation quality of ethanol is 66%.
3) 50 parts of Oleum menthaes, 90 parts of methyl salicylate, 240 parts of Camphoras, 15 parts of diphhydramine hydrochlorides, 240 parts of steps 1 are taken) obtained Fructus Capsici fluidextract and step 2) 140 portions of obtained Semen daturae fluid extracts mix, stir evenly, obtain drug extract;
4) 30 parts of carbomers are sprinkled in 180 parts of water, place, stir after it is fully swelling, obtain carbomer gel A;
5) take 3 parts of hydroxypropyl emthylcelluloses and 3 parts of polyvinyl alcohol, add 100 parts of water, heated and stirred, to dissolving, then adds 100 parts of glycerol, stirs evenly, obtain Colloidal fluid B;
6) take 3 parts of ethyl hydroxybenzoates and 5 parts of azones, adding 10 parts of mass fractions is the dissolve with ethanol of 90%, then with step 3) obtained drug extract mixes, stirs evenly, obtain admixing medical solutions C;
7) carbomer gel A is mixed with Colloidal fluid B, add 180 parts of water, stir evenly, then add admixing medical solutions C, stir evenly, then add 10 parts of triethanolamine, add water and supply weight, stir evenly, obtain arthralgia relief gel.
Embodiment 3: the preparation of arthralgia relief gel
1) take Fructus Capsici, be ground into coarse powder, in Fructus Capsici coarse powder, add 1.5 times of mass fractions is the ethanol of 90%, flood 2 days, percolation, collect percolate and filter, then under 25 DEG C of conditions, concentrating filtrate to relative density is 1.27g/ml, obtains Fructus Capsici fluidextract;
2) Herba Belladonnae is taken, be ground into Herba Belladonnae coarse powder, in Herba Belladonnae coarse powder, add 1.5 times of mass fractions is the ethanol of 90%, flood 2 days, percolation, collect percolate and filter, decompression recycling ethanol, naturally cool to room temperature, be separated removing chlorophyll, filter, concentrate filtrate to thick shape, then adding 10 times of mass fractions is the alcohol settling of 85%, Aspirate supernatant, under 25 DEG C of conditions, supernatant is evaporated to the thick paste that relative density is 1.28g/ml, then in thick paste, the ethanol that mass fraction is 85% is added, and dilute with water, until in atropine sulfate, alkaloid is wherein more than or equal to 6.6mg/ml, obtain Semen daturae fluid extract, in described thick paste, the interpolation quality of ethanol is 60%.
3) 40 parts of Oleum menthaes, 80 parts of methyl salicylate, 200 parts of Camphoras, 13 parts of diphhydramine hydrochlorides, 200 parts of steps 1 are taken) obtained Fructus Capsici fluidextract and step 2) 120 portions of obtained Semen daturae fluid extracts mix, stir evenly, obtain drug extract;
4) 15 parts of carbomers are sprinkled in 50 parts of water, place, stir after it is fully swelling, obtain carbomer gel A;
5) take 20 parts of hydroxypropyl emthylcelluloses and 15 parts of polyvinyl alcohol, add 50 parts of water, heated and stirred, to dissolving, then adds 70 parts of glycerol, stirs evenly, obtain Colloidal fluid B;
6) take 2 parts of ethyl hydroxybenzoates and 3 parts of azones, adding 5 parts of mass fractions is the dissolve with ethanol of 85%, then with step 3) obtained drug extract mixes, stirs evenly, obtain admixing medical solutions C;
7) carbomer gel A is mixed with Colloidal fluid B, add 130 parts of water, stir evenly, then add admixing medical solutions C, stir evenly, then add 5 parts of triethanolamine, add water and supply weight, stir evenly, obtain arthralgia relief gel.
Embodiment 4: arthralgia relief gel is on the impact of mice caused by dimethylbenzene xylene inflammation
Choose male and healthy mice 36, be divided into 3 groups at random, be respectively matched group, pain-relieving plaster for arthritis group, arthralgia relief gel group, often organize 12, each experimental mice sticks ointment at auris dextra or smears administration 1 time, continuous 3 times every day, 1h after last administration, removing plaster or gel, auris dextra is only coated with dimethylbenzene 0.05mL/, and left ear compares, mice is put to death after 15min, with the card punch of diameter 7mm, ears are cut with position homalographic, weigh respectively, calculate auris dextra swelling.Result shows, and no significant difference between the pain-relieving plaster for arthritis of prior art and arthralgia relief gel group of the present invention is as shown in Table 1 below.
Table 1 on the impact of the scorching ear weight of mice caused by dimethylbenzene xylene (n=12, )
Compare with matched group: * p < 0.05
Embodiment 5: arthralgia relief gel is on the impact of mouse hot-plate induced pain
Regulate the temperature of thermostatic water-circulator bath at 55 DEG C ± 0.5 DEG C, by hot plate preheating 10min.Get female healthy mice, each 1 is placed on hot plate, and mice is from being placed on hot plate to occurring licking the pain threshold of metapedes required time (s) as this Mus.Allly lick the metapedes time and be less than 5s or be greater than 30s or leaper, give it up.Qualified 36 mices are divided into matched group, pain-relieving plaster for arthritis group, arthralgia relief gel group at random, often organize 12.Each experimental mice sticks ointment at back leg or smears administration 1 time, continuous 3 times, 1h after last administration every day, measures mice pain threshold.Result shows, and no significant difference between the pain-relieving plaster for arthritis of prior art and arthralgia relief gel group of the present invention is as shown in Table 2 below.
Table 2 on the impact of mouse hot-plate induced pain threshold of pain time (n=12, )
Compare with matched group: * p < 0.05
Embodiment 6: arthralgia relief gel Dichlorodiphenyl Acetate causes the impact of mouse writhing
Choose male and healthy mice 36, be divided into 3 groups at random, be respectively matched group, pain-relieving plaster for arthritis group, arthralgia relief gel group, often organize 12, shave off mouse web portion hair before experiment, in mouse web portion administration, after 1 hour, difference repeat administration once, then lumbar injection concentration is the acetum 0.1mL/10g of 0.6% immediately, observe the writhing response of mice, with typical hindlimb extension, abdominal part distortion, contraction of abdominal muscle is standard, the writhing number of times of each treated animal in record 15min.Result shows, and between pain-relieving plaster for arthritis and arthralgia relief gel group, no significant difference difference, as shown in Table 3 below.
Table 3 on the impact of mice acetic acid induced pain writhing number of times (n=12, )
Compare with matched group: * * p < 0.01
Conclusion: pain-relieving plaster for arthritis and the arthralgia relief gel of the present invention of prior art all have obvious anti-inflammatory and analgesic effect, but the latter's onset is faster.
Embodiment 7: arthralgia relief gel is to the irritant experiment of skin
Get healthy livid purple blue rabbit (2.3 ± 0.2kg) 24, male and female half and half, are divided into intact skin group and damaged skin group, 48 hours before administration, and lost hair or feathers back part of animal vertebra both sides with 6% sodium sulfide solution, every lateral area is about 50cm 2, within after unhairing 24 hours, check whether skin of unhairing has injured because of unhairing, being produced as follows of rabbit damaged skin: scratch with scalpel skin of unhairing being sterilized, the degree of being with oozing of blood, the damaged degree of control left and right sides skin is consistent substantially.
Test adopts consubstantiality left and right Self-control method: left and right sides unhairing district gives arthralgia relief gel, pain-relieving plaster for arthritis and blank respectively, smears every day once, successive administration 7 days; Within 1,24,48,72 hour after stopping administration, observe medicine-feeding part with or without the situation such as erythema and edema respectively, notice whether observe medicine-feeding part has the situations such as pigmentation, petechia, pachylosis simultaneously, result shows: the pain-relieving plaster for arthritis successive administration of prior art is after 5 days, the anaphylactic reactions such as the visible erythema of rabbit intact skin, edema, and damaged skin has obvious erythema, edema; Arthralgia relief gel successive administration of the present invention is after 7 days, and observed in 72 hours, rabbit intact skin has no the anaphylactic reaction such as erythema, edema.And damaged skin group has a small amount of erythema to be formed, erythema can disappear gradually after 72 hours or alleviate, and belongs to slight stimulation.As can be seen here, adopt arthralgia relief gel of the present invention to have no stimulation to rabbit intact skin, only have slight stimulation to damaged skin, its result of use is obviously better than the pain-relieving plaster for arthritis of prior art.

Claims (10)

1. an arthralgia relief gel, its raw materials comprises the component of following parts by weight: in right amount, described each raw material components amounts in 1000 parts for Fructus Capsici fluidextract 160-240 part, Semen daturae fluid extract 90-140 part, Oleum menthae 30-50 part, methyl salicylate 70-90 part, Camphora 160-240 part, diphhydramine hydrochloride 10-15 part, polyvinyl alcohol 1-15 part, carbomer 2-30 part, ethyl hydroxybenzoate 1-3 part, hydroxypropyl emthylcellulose 3-40 part, glycerol 50-100 part, triethanolamine 1-10 part, ethanol 1-10 part, azone 1-5 part, water.
2. arthralgia relief gel according to claim 1, is characterized in that: the parts by weight of described each raw material are: Fructus Capsici fluidextract 200 parts, Semen daturae fluid extract 120 parts, Oleum menthae 40 parts, methyl salicylate 80 parts, Camphora 200 parts, diphhydramine hydrochloride 13 parts, polyvinyl alcohol 3 parts, carbomer 5 parts, ethyl hydroxybenzoate 1 part, hydroxypropyl emthylcellulose 15 parts, glycerol 100 parts, triethanolamine 8 parts, ethanol 5 parts, azone 3 parts, water are appropriate.
3. a preparation method for arthralgia relief gel as claimed in claim 1 or 2, comprises the following steps:
A, take Oleum menthae, methyl salicylate, Camphora, diphhydramine hydrochloride, Fructus Capsici fluidextract and Semen daturae fluid extract, mixing stirs evenly, and obtains drug extract;
B, carbomer is sprinkled in 40-200 part water, places, stir after it is fully swelling, obtain carbomer gel A;
C, in hydroxypropyl emthylcellulose and polyvinyl alcohol, add 10-100 part water, heated and stirred, to dissolving, then adds glycerol, stirs evenly, obtain Colloidal fluid B;
D, take ethyl hydroxybenzoate and azone, adding 1-10 part mass fraction is the dissolve with ethanol of 85%-90%, and then obtained with step a drug extract mixes, and stirs evenly, obtains admixing medical solutions C;
E, carbomer gel A and Colloidal fluid B to be mixed, add 20-200 part water, stir evenly, then add admixing medical solutions C, stir evenly, then add triethanolamine, add water and supply weight, stir evenly, obtain arthralgia relief gel.
4. the preparation method of arthralgia relief gel according to claim 3, it is characterized in that: the preparation method of the Fructus Capsici fluidextract in described step a is as follows: take Fructus Capsici, be ground into coarse powder, in Fructus Capsici coarse powder, add 1-3 times of mass fraction is the ethanol of 85%-90%, dipping 1-3 days, percolation, collects percolate and filters, then under 25-30 DEG C of condition, concentrating filtrate to relative density is 1.25-1.30g/ml, obtains Fructus Capsici fluidextract.
5. the preparation method of arthralgia relief gel according to claim 3, it is characterized in that: the preparation method of the Semen daturae fluid extract in described step a is as follows: take Herba Belladonnae, be ground into Herba Belladonnae coarse powder, in Herba Belladonnae coarse powder, add 1-3 times of mass fraction is the ethanol of 85%-90%, dipping 2-3 days, percolation, collect percolate and filter, decompression recycling ethanol, naturally cool to room temperature, be separated removing chlorophyll, filter, concentrate filtrate to thick shape, then adding 8-10 times of mass fraction is the alcohol settling of 85%-90%, Aspirate supernatant, under 25-30 DEG C of condition, supernatant is evaporated to the thick paste that relative density is 1.25-1.30g/ml, then in thick paste, the ethanol that mass fraction is 85% is added, and dilute with water, until in atropine sulfate, alkaloid is wherein more than or equal to 6.6mg/ml, obtain Semen daturae fluid extract, in described thick paste, the interpolation quality of ethanol is 52%-66%.
6. the preparation method of arthralgia relief gel according to claim 4, is characterized in that: adding 3 times of mass fractions in described Fructus Capsici coarse powder is the ethanol of 90%, floods 3 days.
7. the preparation method of arthralgia relief gel according to claim 4, is characterized in that: described percolate is under 25-30 DEG C of condition, concentrate filtrate to the Fructus Capsici fluidextract that relative density is 1.25g/ml after filtering.
8. the preparation method of arthralgia relief gel according to claim 5, is characterized in that: in Herba Belladonnae coarse powder, add 2 times of mass fractions is the ethanol of 85%, floods 3 days.
9. the preparation method of arthralgia relief gel according to claim 5, is characterized in that: described supernatant is that under 25-30 DEG C of condition, concentrate filtrate to relative density be 1.28g/ml.
10. the preparation method of arthralgia relief gel according to claim 5, is characterized in that: in described thick paste, the interpolation quality of ethanol is 60%.
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