CN101757522B - Swelling reducing and pain easing gel and preparation method thereof - Google Patents
Swelling reducing and pain easing gel and preparation method thereof Download PDFInfo
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Abstract
The invention relates to swelling reducing and pain easing gel and preparation method thereof. The gel mainly contains swelling reducing and pain easing tincture liquid medicine, gel substrate and other pharmaceutical adjuvant and has the characteristics of small dosage of the adjuvant and good stability. The gel acts locally, has the functions of stimulating blood circulation and causing the muscles and joints to relax, reducing swelling and easing pain, and is used for curing injuries from falls, rheumatism, unknown swelling and toxin, and parotitis swelling. The gel has the advantages of long dwell time, durable effect, simple formulation process, low production cost and strong operability in industrial production.
Description
Technical field
The invention belongs to the Chinese medicine preparation technical field, relate to a kind of Traditional Chinese medicinal gel preparation, be specifically related to repercussive and analgesic tincture and be prepared into swelling reducing and pain easing gel by process modification.
Background technology
Gel (Gel) means latex glop or the semi-solid preparation of homogeneous, suspendible or emulsion-type that medicine and the adjuvant that can form gel are made.Gel can be divided into whole body gel and local with gel two classes, and present most of topical gels agent is the skin gel.Different according to substrate, gel is divided into again aqueous gel and oil-base gel, and the main matrix of aqueous gel is generally carbomer, cellulose derivative, alginate, tragacanth, pectin, gelatin, xanthan gum, agar, non-cellulosic polysaccharide such as chitin, ethene polymers, acrylic resin, polyvinyl alcohol and carbopol etc.; The main matrix of oil-base gel agent is made of liquid paraffin and polyoxyethylene or fatty oil colloid silicon or lead soap, zinc soap.Except substrate, the gel preparation also often adds following adjuvant type: pH adjusting agent, wetting agent, antiseptic, stabilizing agent, cosolvent, solubilizing agent and Percutaneous absorption enhancer etc.
Chinese medicine gel is a kind of novel external preparation, be applicable to skin, mucosa and tract, can the long period with the site of action tight adhesion, bioadhesive is preferably arranged, the first-pass effects such as enzyme, acid in gastrointestinal tract that oral administration exists have not only been avoided, and the untoward reaction that can alleviate medicine, meet the theory of " inner disease outer treat ".It is high, not volatile that Chinese medicine gel has a drug level, acts on lasting characteristics, improves medicine local concentration, the release of prolong drug or the purpose of diffusion process thereby reach.Chinese medicine gel is usually used in the aspects such as anti-inflammatory and antalgic, antiviral, pain relieving, and method for making is simple, use is comfortable.
Swelling reducing and pain easing gel involved in the present invention is the Traditional Chinese medicinal gel preparation that repercussive and analgesic tincture prepares after process modification.The main forming matrix of this Traditional Chinese medicinal gel preparation is selected from the adjuvants such as sodium carboxymethyl cellulose (CMC-Na), hydroxypropyl emthylcellulose (HPMC), carbomer, belong to the aqueous Traditional Chinese medicinal gel preparation, external preparation for skin, the performance local action, function is relaxing muscles and tendons and activating QI and blood in the collateral, reducing swelling and alleviating pain, be used for traumatic injury, rheumatic ostalgia, innominate toxic swelling, parotitis swells and ache.
Repercussive and analgesic tincture is the national standard Traditional Chinese medicine historical preparation, and quality standard derives from the 12nd of Ministry of Public Health issuing standard " Traditional Chinese medicine historical preparation ".Repercussive and analgesic tincture is comprised of the Radix Angelicae Dahuricae, Mentholum, Lignum Aquilariae Resinatum, Rhizoma Chuanxiong, DALUOSAN, Rhizoma Curcumae, Radix Saposhnikoviae, Ramulus Cinnamomi, Radix seu Caulis Parabarii, yellow Teng, Herba Schizonepetae, Radix Zanthoxyli, the Radix Aucklandiae, Radix Achyranthis Bidentatae, rhizoma sparganic, Cortex Acanthopancis, Herba Asari, Radix Ardisiae punctatae, Radix Cynanchi Paniculati, Camphora, Fructus Gardeniae 21 flavor Chinese medicines, the tincture of its prescription can oral or external, embrocate the affected part and play local effect, relaxing muscles and tendons and activating QI and blood in the collateral, reducing swelling and alleviating pain is used for osteopatia sprain, rheumatic ostalgia, innominate toxic swelling, parotitis swells and ache.
CN1660355 discloses prescription and the preparation method of repercussive and analgesic tincture, and except Mentholum and Camphora employing dissolve with ethanol, other medical material mainly adopts alcohol dipping to extract the ethanol extract that obtains them, both is mixed to get repercussive and analgesic tincture or makes Emulsion, water preparation.
CN1698815 discloses prescription extractum that other prescription medical material adopts alcohol percolation method to obtain except Mentholum and Camphora with repercussive and analgesic tincture to be mixed as active ingredient with Mentholum and Camphora and makes unguentum.
The extractum that the percolation of the prescription that CN1315521 discloses repercussive and analgesic tincture former medicinal extractum of other prescription except Mentholum and Camphora obtains and Mentholum and Camphora are mixed and made into membrane.
CN1698817 discloses former medicine prescription take repercussive and analgesic tincture as raw material, and extractum that will the percolation acquisition of the former medicinal extractum of other prescription except Mentholum and Camphora mixes with Mentholum and Camphora, makes aerosol as active ingredient and solvent and impelling.
The prescription that CN101099864 discloses repercussive and analgesic tincture extractum that other prescription medical material adopts alcohol percolation method to obtain except Mentholum and Camphora mixes as active ingredient with Mentholum and Camphora makes cataplasma.
The repercussive and analgesic tincture that uses clinically at present is liquid preparation, has certain defective, and for example tincture at transportation, glass container rapid wear when carrying, if bottle stopper bad sealing solvent is volatile, sometimes produces muddy or precipitation, thereby affects product quality and curative effect.And membrane, cataplasma and the aerosol of the former medicine formula preparation of the disclosed employing repercussive and analgesic tincture of patent, its actual complicated process of preparation, cost is higher.And gel preparation technology is simple, and transportation and easy to use is conducive to guarantee constant product quality.For this reason, the inventor has completed the former medicine formula preparation of employing repercussive and analgesic tincture and has gone out its gel.
in view of above reason, the present invention carries out formulation and technology to former reducing swelling and alleviating pain tincture and improves, analyze from formulation and technology, a kind of swelling reducing and pain easing gel that the present invention relates to, its prescription is simple, supplementary product consumption is few, main matrix CMC-Na accounts for the prescription ratio and is no more than 5.0%, CMC-Na and HPMC all need not to add and carry out pH adjusting agent, the gel cross-linking agent, because containing Camphora in former tincture prescription, Mentholum, contain ethanol in preparation, therefore can not add transdermal enhancer, contain the alcohol amount 30% when above in keeping the preparation gel sample, can not add the antiseptic and inhibiting bacteria function agent, and the adjuvant of selecting does not react with principal agent, can not disturb index components to detect, preparation technology is simple to operation, extremely low to equipment requirements, possessing stirring and evenly mixing equipment can produce, adopting CMC-Na and HPMC is the swelling reducing and pain easing gel of matrix composition, its sample has certain fluidity, the bubble meeting Natural excrement that produces in whipping process is therefore production equipment even need not decompression or vacuum, preparation technology's good production feasibility.Analysis-by-synthesis, by the swelling reducing and pain easing gel that the formulation and technology that the present invention relates to is produced, its production cost reduces greatly.
The inventor is through prescription screening and technical study repeatedly, and the swelling reducing and pain easing gel by the development of optimizing prescriptions technique has following advantage: 1. avoid volatile ingredient to cause damage because of volatilization; 2. avoid heat-sensitive ingredients to damage because of high-temperature heating, and in hot conditions, chemical reaction occurs mutually between composition; 3. liquid preparation semisolidization, composition disperses more even, can not produce muddy and precipitation; 4. the obstructed pH of overregulating carry out crosslinked, thereby avoid active ingredient to be subjected to the soda acid variable effect; 5. medicine holdup time on skin long, keep lastingly drug effect, the performance long-acting.Therefore the swelling reducing and pain easing gel after improving is safer, effective, stable.
Summary of the invention
the invention provides a kind of swelling reducing and pain easing gel preparation, it is characterized in that, this gel preparation consists of the following composition: active Chinese drug component composition 5%～95% (weight), hydrophilic gel substrate 0.5%～5.0% (weight) and other suitable pharmaceutic adjuvant, wherein, the active Chinese drug component composition is by the ethanol extraction of following weight portion medical material: Radix Aucklandiae 20-55 part, Radix Saposhnikoviae 40-50 part, Herba Schizonepetae 40-80 part, Herba Asari 35-70 part, Cortex Acanthopancis 35-70 part, Ramulus Cinnamomi 20-50 part, Radix Achyranthis Bidentatae 35-60 part, Rhizoma Chuanxiong 25-60 part, Radix Cynanchi Paniculati 35-55 part, Radix Angelicae Dahuricae 50-150 part, Rhizoma Curcumae 30-70 part, Radix seu Caulis Parabarii 60-150 part, DALUOSAN 80-250 part, Radix Ardisiae punctatae 60-120 part, Radix Zanthoxyli 90-300 part, yellow Teng 70-200 part, Fructus Gardeniae 80-300 part, rhizoma sparganic 50-120 part, Lignum Aquilariae Resinatum 20-50 part, and Camphora 30-80 part, Mentholum 45-90 part forms.The weight portion here can be the unit of weights such as g, kg.
Gel of the present invention, the percentage by weight of said active Chinese drug component composition is preferably 20-90%, more preferably 50-85%.
said gel-type vehicle is selected from sodium carboxymethyl cellulose (CMC-Na), hydroxypropyl emthylcellulose (HPMC), a kind of in carbomer or two kinds, its content is respectively 0.5%～5.0%, 1.0%～4.0%, 0.5%～3.5%, preferably carboxymethyl cellulose sodium (CMC-Na), wherein, the range of viscosities of sodium carboxymethyl cellulose is 300～1200mPa.S (2% aqueous solution), preferred 800～1200mPa.S (2% aqueous solution), other suitable pharmaceutic adjuvant comprises water, transdermal enhancer, wetting agent, antiseptic, acid-base modifier, antioxidant or their mixture.Wherein, transdermal enhancer can be selected: one or more in laurocapram and homologue thereof, dimethyl sulfoxide, oleic acid, propylene glycol, ethanol etc.; Wetting agent (wetting agent) can be selected: one or more in glycerol, propylene glycol, ethanol etc.; The antiseptic and inhibiting bacteria function agent can be selected: one or more in benzoic acid, sodium benzoate, parabens, sorbic acid, ethanol etc.; Acid-base modifier can be selected one or more of triethanolamine, sodium hydroxide, sodium carbonate, sodium bicarbonate, hydrochloric acid etc.Also can add in case of necessity in addition PEG200-600 to increase dispersibility, add poly yamanashi esters and make solubilising stability.
In some specific embodiments, gel of the present invention, its Chinese medicine active ingredient is by the ethanol extract of the medical material of following weight portion: Radix Aucklandiae 47g, Radix Saposhnikoviae 47g, Herba Schizonepetae 47g, Herba Asari 47g, Cortex Acanthopancis 47g, Ramulus Cinnamomi 47g, Radix Achyranthis Bidentatae 47g, Rhizoma Chuanxiong 47g, Radix Cynanchi Paniculati 47g, Radix Angelicae Dahuricae 70g, Rhizoma Curcumae 47g, Radix seu Caulis Parabarii 70g, DALUOSAN 100g, Radix Ardisiae punctatae 70g, Radix Zanthoxyli 100g, yellow Teng 95g, Fructus Gardeniae 100g, rhizoma sparganic 70g, Lignum Aquilariae Resinatum 32.5g, and Camphora 55g, Mentholum 55g form.The former medicine of this group weight portion is namely the crude drug component of repercussive and analgesic tincture, and the repercussive and analgesic tincture medicinal liquid is the solution with medical active that adopts the ethanol extraction preparation.
Above-mentioned active Chinese drug component composition can be the repercussive and analgesic tincture medicinal liquid that goes on the market at present, also can be with the raw material of above-mentioned weight portion by the raw medicinal material except Camphora, Mentholum being taked alcohol dipping, percolation extract, the extracting solution that obtains is directly or after partly or entirely reclaiming ethanol and concentrating, the solution that is dissolved in ethanol with Camphora, Mentholum mixes, obtain admixing medical solutions, as the active Chinese drug component composition.
Said active Chinese drug component composition in the present invention, its ethanol content is 0-65%, preferred 20-65%.
Gel of the present invention, wherein, the active Chinese drug component composition also can be by record and the acquisitions of disclosed method such as Chinese patent CN1660355, CN1698815, CN1315521, CN1698817, CN101099864, as ethanol extract or the concentrated extract that obtains by the method for these patents, being dissolved in alcoholic solution with Camphora, Mentholum again mixes, obtain admixing medical solutions, also can be used as the active Chinese drug component composition of gel of the present invention.
The dipping of the ethanol extract of above these active Chinese drug component compositions, the method for percolation are all the Traditional Chinese medicine extraction methods of this area routine, referring to " the lower medical material extracting method of the item such as the M medicated wine of an appendix I of Chinese Pharmacopoeia 2005 version, N tincture, O fluid extract and extractum.
The gel of the invention described above, said active Chinese drug component composition, preferably without concentrated ethanol extract (containing Camphora, Mentholum), to prevent that the volatile ingredient in former medicine from losing because of concentrated, affect the curative effect of gel, wherein, in gel, the content of ethanol is no more than 55%, preferred 20-45%, more preferably 35-45%.
Swelling reducing and pain easing gel of the present invention is to improve by existing preparation repercussive and analgesic tincture prescription is carried out dosage form, the aqueous Traditional Chinese medicinal gel preparation that is prepared from, external preparation for skin, performance local action, function is relaxing muscles and tendons and activating QI and blood in the collateral, and reducing swelling and alleviating pain is used for traumatic injury, rheumatic ostalgia, innominate toxic swelling, parotitis swells and ache.
Another purpose of the present invention provides a kind of preparation method of swelling reducing and pain easing gel preparation, and its process comprises:
Take gel-type vehicle such as CMC-Na, add gradually the alcoholic solution of active Chinese drug component composition, and constantly stir, more slowly add purified water to ormal weight, stir and make into gel, then add other suitable pharmaceutic adjuvant, minute unit dose package, and get final product.
Wherein, in said method, said active Chinese drug component composition refers to said active Chinese drug component composition in the gel preparation of the invention described above, it can be namely the former tincture medicinal liquid of repercussive and analgesic tincture, can be also to take alcohol percolation method or infusion process to extract by the crude drug except Camphora, Mentholum, partly or entirely reclaim concentrated medicament or the extractum of gained after ethanol, then mix the medicinal liquid that obtains with the alcoholic solution of Camphora, Mentholum.The alcoholic solution of said active Chinese drug component composition, its ethanol content are 20-65%.
The second provided by the invention prepares the method for swelling reducing and pain easing gel preparation, and its process comprises:
A) take gel-type vehicle such as CMC-Na, the alcoholic solution with Mentholum of camphorating stirs, and gel-type vehicle is uniformly dispersed, and obtains the substrate dispersion liquid;
B) added the active Chinese drug component composition in the substrate dispersion liquid in upper step, stir and make into gel, add appropriate purified water to regulate the gel stickiness, then add other suitable pharmaceutic adjuvant, minute unit dose package, and get final product.
Wherein, in said method, said active Chinese drug component composition refers in gel preparation of the present invention, and the crude drug of above-mentioned weight portion takes alcohol percolation method or infusion process to extract except Camphora, Mentholum, partly or entirely reclaims concentrated medicament or the extractum of gained after ethanol.
Provided by the invention the third prepares the method for swelling reducing and pain easing gel preparation, and its process comprises:
A) take gel-type vehicle such as CMC-Na, add appropriate ethanol, stir; Or gel-type vehicle is added in wetting agent (glycerol, propylene glycol etc.) solution, grind, gel-type vehicle is fully disperseed, stir, obtain the substrate dispersion liquid;
B) the active Chinese drug component composition is slowly joined in above-mentioned substrate dispersion liquid, stir and make into gel, add appropriate purified water to regulate the gel stickiness, then add other suitable pharmaceutic adjuvant, minute unit dose package, and get final product.
Wherein, in said method, said active Chinese drug component composition refers to said active Chinese drug component composition in the gel preparation of the invention described above, it can be namely the former tincture medicinal liquid of repercussive and analgesic tincture, can be also to take alcohol percolation method or infusion process to extract by the crude drug except Camphora, Mentholum, partly or entirely reclaim concentrated medicament or the extractum of gained after ethanol, then mix the medicinal liquid that obtains with Camphora, Mentholum or its alcoholic solution.
Gel of the present invention is the forming matrix of swelling reducing and pain easing gel when selecting sodium carboxymethyl cellulose, and its consumption is 0.5%～5.0%, and the model preferred viscosity ranges is 800～1200mPa.S (2% aqueous solution); Contain certain density ethanol in prescription, ethanol content is too high, and preparations shaping is more difficult, ethanol content is too low, and the gel sample stability of preparation is poorer, and sample is muddy because precipitation occurring, clarity is poor, and in optimizing prescriptions, ethanol content proportion in preparation is 35%～45%.
The present invention realizes in the following way:
The invention provides following three preparation technology's flow processs, see accompanying drawing.
By technological process Fig. 1, the concrete preparation process of a kind of swelling reducing and pain easing gel is:
A) preparation of repercussive and analgesic tincture original liquid: get the prescription medical material, 19 flavors such as the Radix Aucklandiae, Radix Saposhnikoviae are ground into coarse powder, according to " the percolation under fluid extract of Chinese Pharmacopoeia 2005 version and extractum item, make solvent with 53% ethanol, flood after 28 hours, with the speed of approximately 3ml per minute percolation slowly, collect percolate 5300g, another device is preserved; After getting Camphora, Mentholum and adding appropriate amount of ethanol and make dissolving, with the above-mentioned liquid mixing of filtering, perhaps Camphora, Mentholum need not dissolve with ethanol and directly add mixing in the above-mentioned liquid of filtering, and be standing, filters, and obtains the repercussive and analgesic tincture original liquid;
B) swelling reducing and pain easing gel preparations shaping: get gel-type vehicle and add in above reducing swelling and alleviating pain tincture original liquid, the limit edged stirs, constantly slowly adding suitable quantity of water under stirring condition again, make thickening molding gradually, can add as required other adjuvant (also can not adding), mixing, single dose packing and get final product.
By technological process Fig. 2, the concrete preparation process of a kind of swelling reducing and pain easing gel is:
A) the medical material percolation extracts: get the prescription medical material, 19 flavors such as the Radix Aucklandiae, Radix Saposhnikoviae are ground into coarse powder, according to " the percolation under fluid extract of Chinese Pharmacopoeia 2005 version and extractum item, make solvent with 53% ethanol, flood after 28 hours, with the speed of approximately 3ml per minute percolation slowly, collect percolate 5300g, another device is preserved;
B) the medical material percolate is concentrated: the percolate of getting the 19 flavor medical materials such as the Radix Aucklandiae, Radix Saposhnikoviae, reclaim ethanol, concentrated to reduce amount of liquid medicine, the unsuitable overrich of concentrated medicinal liquid, the medicinal liquid overrich can cause the liposoluble constituent precipitation, thereby cause the loss of part composition, the concentrated solution relative density should remain on below 1.05;
C) preparation of Camphora, Mentholum alcoholic solution: get Camphora, Mentholum adds appropriate amount of ethanol makes dissolving;
D) swelling reducing and pain easing gel preparations shaping: get that gel-type vehicle camphorates, in the Mentholum alcoholic solution, stirring makes dispersion, the material concentrated solution of getting it filled again slowly adds in above solution under continuous stirring, make thickening molding gradually, according to the technique needs, add other adjuvant, mixing, single dose packing and get final product.
By technological process Fig. 3, the concrete preparation process of a kind of swelling reducing and pain easing gel is:
A) the medical material percolation extracts: get the prescription medical material, 19 flavors such as the Radix Aucklandiae, Radix Saposhnikoviae are ground into coarse powder, according to " the percolation under fluid extract of Chinese Pharmacopoeia 2005 version and extractum item, make solvent with 53% ethanol, flood after 28 hours, with the speed of approximately 3ml per minute percolation slowly, collect percolate 5300g, another device is preserved;
B) the medical material percolate is concentrated: the percolate of getting the 19 flavor medical materials such as the Radix Aucklandiae, Radix Saposhnikoviae, reclaim ethanol, concentrated to reduce amount of liquid medicine, the unsuitable overrich of concentrated medicinal liquid, the medicinal liquid overrich can cause the liposoluble constituent precipitation, thereby cause the loss of part composition, the concentrated solution relative density should remain on below 1.05;
C) gel-type vehicle grinding distribution: get the grinding of gel-type vehicle and adjuvant and make dispersion, described adjuvant comprises glycerol, Polyethylene Glycol, propylene glycol etc.;
D) preparation of Camphora, Mentholum alcoholic solution: get Camphora, Mentholum adds appropriate amount of ethanol makes dissolving;
E) swelling reducing and pain easing gel preparations shaping: with Camphora, Mentholum alcoholic solution, add in the gel-type vehicle dispersion, stir, the material concentrated solution of getting it filled again slowly adds in above solution under continuous stirring, makes thickening molding gradually, and is last, according to the technique needs, add other adjuvant (also can not adding), mixing, single dose packing and get final product.
Be hydrophilic materials because inventing related major auxiliary burden, therefore the gel of inventing is the water-soluble base gel.Active Chinese drug component composition in the present invention, gel-type vehicle, ethanol, must mix with certain proportion, ethanol content affects preparations shaping and the sample stability of gel, ethanol content is too low, part composition in extracting solution (being mainly the ester soluble components) can change because of dissolubility, and separate out precipitation, ethanol content is too high, is difficult to molding.
For guaranteeing that ingredient does not change, the described preparation method of selection process flow process 1.Technological process 1 is distinguished and is with respect to technological process 2,3 maximums, and herbal extract is without the heating concentration, therefore have following advantage: 1. ingredient can not degraded because being subjected to heat damage; 2. avoid volatile ingredient to wave loose loss because being heated; 3. avoid mutually occuring between composition under heating condition chemical reaction; 4. can not produce deposit because ethanol reclaims; In addition, 5. technique is simple, and is workable; 6. streamlining, need not reclaim concentrator, do not consume energy, and saves production cost.
And technological process 2,3 described preparation methoies, the advantage that has is: can greatly reduce amount of liquid medicine, dosage can be reduced to 1/5 of former dosage.
Stability test:
Prescription 1:CMC-Na 15g, glycerol 25ml, PEG400 12.5ml, repercussive and analgesic tincture 375ml, purified water 62.5ml
Method for making: take CMC-Na, add in the mixed liquor of glycerol and PEG400, grinding fully disperses CMC-Na, then adds the repercussive and analgesic tincture agent solution, stirs, and adds gradually at last purified water to ormal weight, stirs and makes into gel, and get final product.Sample is distributed into 6 bottles with vial, and rubber stopper is built, the sealing compound sealing.
Prescription 2:CMC-Na 15g, repercussive and analgesic tincture 400ml, purified water 85ml
Method for making: take CMC-Na, add the repercussive and analgesic tincture agent solution, stir, constantly stir and slowly add purified water to ormal weight, make into gel, and get final product.Sample is distributed into 6 bottles with vial, and rubber stopper is built, the sealing compound sealing.
Influence factor's test method: sample thief carries out influence factor's test in 10 days under 40 ℃ of high temperature, 92% high humidity, 4500LX ± 500LX high light condition, carried out simultaneously the low temperature freezing-thawing test in 3 cycles, each sample is estimated its quality take character variation, change color, precipitate generation etc. as index.
Result of the test:
Conclusion (of pressure testing): under the condition of investigating, the outward appearances such as the character of sample, color are without significant change, and in 10 days, deposit-free generates, and shows that the sample physical stability is good.
Accelerate and long-term stable experiment: sample thief is at 40 ± 2 ℃, humidity is to carry out accelerated test under RH65 ± 5% condition, in 25 ± 2 ℃, humidity is to carry out long term test under RH60 ± 10% condition, investigate 6 months, the result demonstration, prepared sample physical behavior is good, and the stability sample physical stability is good.
By the gel sample of preparation method of the present invention preparation, be respectively orange-yellow, brownish red, brownish black according to the liquor strength difference; Special odor with Mentholum and Camphora; The quality clear is without muddy; Certain fluidity and stickiness are arranged; PH is neutral or near neutral; The strong lasting skin wetness that keeps of lock aqueous, the skin comfort is good.
The sample that swelling reducing and pain easing gel of the present invention preferably makes take CMC-Na as substrate, its prescription is simple, supplementary product consumption is few, main matrix CMC-Na accounts for the prescription ratio and is no more than 5.0%, and need not to carry out pH adjusting agent, gel cross-linking agent, because containing Camphora, Mentholum in former tincture prescription, contain ethanol in preparation, therefore can not add transdermal enhancer, contain the alcohol amount 30% when above in keeping the preparation gel sample, can not add the antiseptic and inhibiting bacteria function agent, and adjuvant do not react with principal agent, can not disturb index components to detect.Preparation technology is simple to operation, extremely low to equipment requirements, need not heating concentrated, possessing stirring and evenly mixing equipment can produce, the gel sample of preparation has certain fluidity, the bubble meeting Natural excrement that produces in whipping process is therefore production equipment even need not decompression or vacuum, preparation technology's good production feasibility.Analysis-by-synthesis, by the swelling reducing and pain easing gel that the formulation and technology that the present invention relates to is produced, its production cost reduces greatly.
Description of drawings:
Fig. 1 is technological process Fig. 1;
Fig. 2 is technological process Fig. 2;
Fig. 3 is technological process Fig. 3.
The specific embodiment:
After planning various gel-type vehicles formation gels, test their performance indications separately, specific as follows:
(1) prescription
(2) test result of the technical specification of the gel of each substrate is as follows:
Result from upper table shows, can make gel preferably with carbomer, CMC-Na, HPMC as gel-type vehicle, it is very difficult that other several gel-type vehicles are made gel, therefore, the preferred carbomer of the present invention, CMC-Na, HPMC are as the substrate of gel of the present invention, and the gel of three kinds of substrate respectively has quality, as best in carbomer skin comfort level, appearance character is best, but stability is slightly not good enough, and concentration of alcohol is obvious to its shaping influence; The CMC-Na good stability need not to carry out acid-alkali accommodation, and good forming ability is produced workablely, and ethanol content is to forming certain influence; HPMC ethanol is minimum to its shaping influence, but prepare high concentration of alcohol sample, need not to regulate soda acid, stability still can, mouldability still can, though the skin comfort level not as carbomer, but still can be accepted, appearance character is slightly poor.These shortcomings can overcome by adding relevant adjuvant, can enter antiseptic or antibacterial as stability, and mouldability solves by controlling the Chang Fangfa such as ethanol content.
Below in conjunction with specific embodiment, the invention will be further described.
Embodiment:
Embodiment 1:
Prescription: CMC-Na 225g, repercussive and analgesic tincture medicinal liquid 6000g, purified water 1275g
Preparation method:
Take CMC-Na, add the repercussive and analgesic tincture agent solution, stir, constantly stir and slowly add purified water to ormal weight, make into gel, make 7500g, packing, and get final product.
Embodiment 2:
Prescription: CMC-Na250g, glycerol 500g, PEG400 300g, repercussive and analgesic tincture medicinal liquid 6000g, purified water 1050g
Preparation method:
Take CMC-Na, add in the mixed liquor of glycerol and PEG400, grinding fully disperses CMC-Na, then adds the repercussive and analgesic tincture agent solution, stirs, and adds gradually at last purified water to ormal weight, stirs and makes into gel, makes 8100g, packing, and get final product.
Embodiment 3:
Prescription: CMC-Na45g, ethanol 125g, repercussive and analgesic tincture medical material percolate 5300ml, Camphora 55g, Mentholum 55g, purified water are appropriate
Repercussive and analgesic tincture medical material percolate prescription:
Radix Aucklandiae 47g, Radix Saposhnikoviae 47g, Herba Schizonepetae 47g, Herba Asari 47g, Cortex Acanthopancis 47g, Ramulus Cinnamomi 47g, Radix Achyranthis Bidentatae 47g, Rhizoma Chuanxiong 47g, Radix Cynanchi Paniculati 47g, Radix Angelicae Dahuricae 70g, Rhizoma Curcumae 47g, Radix seu Caulis Parabarii 70g, DALUOSAN 100g, Radix Ardisiae punctatae 70g, Radix Zanthoxyli 100g, yellow Teng 95g, Fructus Gardeniae 100g, rhizoma sparganic 70g, Lignum Aquilariae Resinatum 32.5g
Preparation method:
A) preparation of repercussive and analgesic tincture medical material percolate: get in prescription 19 flavor pulverizing medicinal materials and become coarse powder, according to " the percolation under fluid extract of Chinese Pharmacopoeia 2005 version and extractum item, make solvent with 53% ethanol, flood after 28 hours, with the speed of approximately 3m1 per minute percolation slowly, collect percolate 5300ml;
B) cancel swollen analgesic tincture medical material percolate, reclaim ethanol, be evaporated to approximately 1000g, as the medical material concentrated solution, standby; Camphora, Mentholum are dissolved in 125g ethanol, standby; Get that CMC-Na camphorates, in the Mentholum alcoholic solution, stir and make dispersion; The material concentrated solution of getting it filled again slowly adds in above solution under continuous stirring, makes thickening molding gradually, adds at last purified water to regulate denseness, and mixing is made 1300g, packing, and get final product.
Embodiment 4:
Prescription: CMC-Na75g, ethanol 215g, propylene glycol 215g, repercussive and analgesic tincture medical material percolate 5300ml, Camphora 55g, Mentholum 55g, purified water are appropriate, ethylparaben 2.0g
Preparation method:
Make the sepage of repercussive and analgesic tincture medical material and filter by implementing 3 medical material prescription and method, the material percolate of getting it filled, recovery ethanol is evaporated to approximately 1000g, and is as the medical material concentrated solution, standby; Camphora, Mentholum are dissolved in 215g ethanol, standby; Get ethylparaben and CMC-Na and add in propylene glycol, grind evenly, form dispersion; Camphora, Mentholum alcoholic solution are added in above dispersion, stir; Again the medical material concentrated solution is slowly added under constantly stirring, mix, stir and make into gel, add at last appropriate purified water and regulate gel consistency, make 2200g, packing, and get final product.
Embodiment 5:
Prescription: CMC-Na 65g, repercussive and analgesic tincture medical material percolate 5300ml, Camphora 55g, Mentholum 55g, benzoic acid 8.0g, purified water are appropriate
Preparation method:
Make the sepage of repercussive and analgesic tincture medical material and filter by implementing 3 medical material prescription and method, cancel the analgesic tincture medical material percolate that swells, partially recycled ethanol, to the about 2100g of medicine liquid volume, as the medical material concentrated solution, standby; Camphora, Mentholum are added in above concentrated medicament, be stirred to dissolve; Get again CMC-Na and add, mix; Slowly add purified water appropriate under constantly stirring, make thickening gradually make gel; Add at last benzoic acid, stirring and evenly mixing is made 2600g, packing, and get final product.
Embodiment 6:
Prescription: HPMC 820g, dehydrated alcohol 5500g, glycerol 1360g, repercussive and analgesic tincture medicinal liquid 6000ml, purified water add to ormal weight, sorbitol 40.0g
Preparation method:
Glycerol is added in dehydrated alcohol, mix, then get HPMC and add in above solution, then add the repercussive and analgesic tincture medicinal liquid, mix, slowly add purified water under last continuous the stirring, make thickening gradually make gel, then add sorbitol, mixing is made 27000g, packing, and get final product.
Embodiment 7:
Prescription: HPMC 27g, dehydrated alcohol 200g, glycerol 60g, repercussive and analgesic tincture medical material percolate 5300ml, Camphora 55g, Mentholum 55g, sodium benzoate 3.0g
Preparation method:
Make the sepage of repercussive and analgesic tincture medical material and filter by implementing 3 medical material prescription and method, the material percolate of getting it filled, recovery ethanol is evaporated to approximately 1000g, and is as the medical material concentrated solution, standby; Camphora, Mentholum are dissolved in ethanol, standby; Getting HPMC and sodium benzoate puts in glycerol to grind to make and is uniformly dispersed; With above alcoholic solution, add in the substrate dispersion, stir; Slowly add the medical material concentrated solution at last under constantly stirring, make thickening gradually make gel, make 1400g, packing, and get final product.
Embodiment 8:
Prescription: CMC-Na 200g, HPMC 80g, repercussive and analgesic tincture medicinal liquid 6000ml, purified water add to ormal weight
Preparation method:
Get CMC-Na and HPMC, add reducing swelling and alleviating pain tincture medicinal liquid while grinding, stir, constantly stir and slowly add purified water to ormal weight, make into gel, make 8000g, packing, and get final product.
Embodiment 9:
Prescription: Acritamer 940 12g, repercussive and analgesic tincture medical material percolate 5300ml, Camphora 55g, Mentholum 55g, ethanol 170g, triethanolamine are appropriate, sorbic acid 3g
Preparation method:
Make the sepage of repercussive and analgesic tincture medical material and filter by implementing 3 medical material prescription and method, the material percolate of getting it filled reclaims ethanol, is evaporated to approximately 1000g, let cool, and filtration, filtrate is as the medical material concentrated solution, and is standby; Camphora, Mentholum and above filtration filtering residue are dissolved in ethanol, standby; Get carbomer and put in above medical material concentrated solution, standing 24 hours, then use the high-shear homogenizer breast even; Add alcoholic solution, stirring and evenly mixing; Under last constantly stirring, add triethanolamine, make thickening gradually make gel, then add sorbic acid, mixing is made 1300g, packing, and get final product.
Embodiment 10:
Prescription: Acritamer 940 105g, repercussive and analgesic tincture medical material percolate 5300ml, Camphora 55g, Mentholum 55g, ethanol 420g, propylene glycol 1680g, NaOH (1mol/L) are appropriate, purified water 16800g, butoben 10.0g
Preparation method:
Make the sepage of repercussive and analgesic tincture medical material and filter by implementing 3 medical material prescription and method, the material percolate of getting it filled, recovery ethanol is evaporated to approximately 1000g, and is as the medical material concentrated solution, standby; Camphora, Mentholum are dissolved in ethanol, then with the propylene glycol mixing, standby; Get carbomer and put in the 8400g purified water, make abundant swelling, high speed homogenization is as substrate; Add successively alcoholic solution and medical material concentrated solution in substrate, stirring and evenly mixing; Under constantly stirring, slowly add NaOH solution, make thickening gradually make gel, then add gradually remaining 8400g purified water, add at last butoben, mixing is made 21000g, packing, and get final product.
Claims (14)
1. swelling reducing and pain easing gel preparation, it is characterized in that, this gel preparation is grouped into by following one-tenth: active Chinese drug component composition 5%～95%, be selected from sodium carboxymethyl cellulose, gel-type vehicle 0.5%～5.0% and other suitable pharmaceutic adjuvant of hydroxypropyl emthylcellulose and carbomer, wherein, the active Chinese drug component composition is by the ethanol extraction of following weight portion medical material: Radix Aucklandiae 20-55 part, Radix Saposhnikoviae 40-50 part, Herba Schizonepetae 40-80 part, Herba Asari 35-70 part, Cortex Acanthopancis 35-70 part, Ramulus Cinnamomi 20-50 part, Radix Achyranthis Bidentatae 35-60 part, Rhizoma Chuanxiong 25-60 part, Radix Cynanchi Paniculati 35-55 part, Radix Angelicae Dahuricae 50-150 part, Rhizoma Curcumae 30-70 part, Radix seu Caulis Parabarii 60-150 part, DALUOSAN 80-250 part, Radix Ardisiae punctatae 60-120 part, Radix Zanthoxyli 90-300 part, Caulis Fibraureae 70-200 part, Fructus Gardeniae 80-300 part, rhizoma sparganic 50-120 part, Lignum Aquilariae Resinatum 20-50 part, and Camphora 30-80 part, form with Mentholum 45-90 part, wherein, the percentage ratio that ethanol accounts for whole weight of formulation is 35%～45%.
2. according to claim 1 gel, said active Chinese drug component composition is by the medical material of following weight portion: 47 parts of the Radix Aucklandiae, 47 parts of Radix Saposhnikoviaes, 47 parts of Herba Schizonepetae, 47 parts of Herba Asaris, 47 parts of Cortex Acanthopanciss, 47 parts of Ramulus Cinnamomi, 47 parts of Radix Achyranthis Bidentataes, 47 parts of Rhizoma Chuanxiongs, 47 parts of Radix Cynanchi Paniculatis, 70 parts of the Radixs Angelicae Dahuricae, 47 parts of Rhizoma Curcumae, 70 parts of Radix seu Caulis Parabarii, 100 parts of DALUOSAN, 70 parts of Radix Ardisiae punctatae, 100 parts of Radix Zanthoxylis, 95 parts of Caulis Fibraureaes, 100 parts of Fructus Gardeniaes, 70 parts of rhizoma sparganic, 32.5 parts of ethanol extractions of Lignum Aquilariae Resinatum, and 55 parts of Camphoras, 55 parts of compositions of Mentholum.
3. according to claim 2 gel, said active Chinese drug component composition is the former tincture solution of repercussive and analgesic tincture.
4. according to claim 1～3 arbitrary gels, in said active Chinese drug component composition, ethanol content is 0%～65%.
5. according to claim 1 gel, said gel-type vehicle is sodium carboxymethyl cellulose.
6. according to claim 1 gel, said sodium carboxymethyl cellulose, its content are 0.5%～5.0%; Said hydroxypropyl emthylcellulose, its content are 1.0%～4.0%; Said carbomer, its content are 0.5%～3.5%.
7. according to claim 5 or 6 gel, said sodium carboxymethyl cellulose, the range of viscosities of its 2% aqueous solution are 300～1200mPa.S.
8. according to claim 7 gel, said sodium carboxymethyl cellulose, the range of viscosities of its 2% aqueous solution are 800～1200mPa.S.
9. according to claim 1 gel, said other suitable pharmaceutic adjuvant comprises water, transdermal enhancer, wetting agent, antiseptic, acid-base modifier, antioxidant or their mixture.
10. the preparation method of the swelling reducing and pain easing gel preparation of a claim 1, its step comprises:
Take the gel-type vehicle that is selected from sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose and carbomer, the alcoholic solution that adds gradually the active Chinese drug component composition, and constantly stir, slowly add again purified water to ormal weight, stirring makes into gel, add again other suitable pharmaceutic adjuvant, minute unit dose package, and get final product; Wherein, the alcoholic solution of active Chinese drug component composition, its ethanol content are 20-65%.
11. the preparation method of the swelling reducing and pain easing gel preparation of a claim 1, its step comprises:
A) take the gel-type vehicle that is selected from sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose and carbomer, the alcoholic solution with Mentholum of camphorating stirs, and gel-type vehicle is uniformly dispersed, and obtains the substrate dispersion liquid;
B) added other active Chinese drug component composition except Camphora and Mentholum in the substrate dispersion liquid in upper step, stir and make into gel, add appropriate purified water to regulate the gel stickiness, then add other suitable pharmaceutic adjuvant, minute unit dose package, and get final product.
12. the preparation method of the swelling reducing and pain easing gel preparation of a claim 1, its step comprises:
A) take the gel-type vehicle that is selected from sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose and carbomer, add appropriate ethanol, stir, obtain the substrate dispersion liquid;
B) the active Chinese drug component composition is slowly joined in above-mentioned substrate dispersion liquid, stir and make into gel, add appropriate purified water to regulate the gel stickiness, then add other suitable pharmaceutic adjuvant, minute unit dose package, and get final product.
13. the arbitrary described method of claim 10-12, gel-type vehicle is sodium carboxymethyl cellulose.
14. gel according to claim 1, said active Chinese drug component composition is the former tincture medicinal liquid of repercussive and analgesic tincture, or take alcohol percolation method or dipping to extract by the crude drug except Camphora, Mentholum, partly or entirely reclaim concentrated medicament or the extractum of gained after ethanol, then mix the medicinal liquid that obtains with the alcoholic solution of Camphora, Mentholum.
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| CN103417880B (en) * | 2013-07-24 | 2015-09-02 | 广西梧州三鹤药业有限公司 | Chinese medicine composition and preparation method thereof |
| CN104435931B (en) * | 2014-12-13 | 2017-08-29 | 山西省肿瘤研究所 | One kind analgesic patch and preparation method thereof |
| CN104606642A (en) * | 2015-02-09 | 2015-05-13 | 山东大学齐鲁医院 | Gel for treating traumatic injury and preparation method of gel |
| CN104971076A (en) * | 2015-05-25 | 2015-10-14 | 北京中医药大学 | Stable bee venom gel agent and preparation method thereof |
| CN106138190B (en) * | 2016-08-08 | 2020-03-31 | 浙江奕箔生物科技有限公司 | External gel preparation, preparation method and application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1698817A (en) * | 2005-06-07 | 2005-11-23 | 广西花红药业有限责任公司 | Swelling-reducing pain-easing aerosol and its preparation method |
| CN1698816A (en) * | 2005-06-07 | 2005-11-23 | 广西花红药业有限责任公司 | Coating film preparation for dispelling swelling and relieving pain and its preparation method |
| CN1698815A (en) * | 2005-06-07 | 2005-11-23 | 广西花红药业有限责任公司 | Chinese medicinal composite ointment, its preparation process, cataplasm thereof and method for preparing the same |
| CN1861184A (en) * | 2005-05-09 | 2006-11-15 | 广西花红药业有限责任公司 | Application of composition for preparing medicine to treat chilblain disease |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1861184A (en) * | 2005-05-09 | 2006-11-15 | 广西花红药业有限责任公司 | Application of composition for preparing medicine to treat chilblain disease |
| CN1698817A (en) * | 2005-06-07 | 2005-11-23 | 广西花红药业有限责任公司 | Swelling-reducing pain-easing aerosol and its preparation method |
| CN1698816A (en) * | 2005-06-07 | 2005-11-23 | 广西花红药业有限责任公司 | Coating film preparation for dispelling swelling and relieving pain and its preparation method |
| CN1698815A (en) * | 2005-06-07 | 2005-11-23 | 广西花红药业有限责任公司 | Chinese medicinal composite ointment, its preparation process, cataplasm thereof and method for preparing the same |
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