CN101757522A - 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 Chinese medicine 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 the 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.According to the substrate difference, gel is divided into aqueous gel and oil-base gel again, 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 that substrate, preparing gel also often adds following adjuvant type: pH regulator 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 the 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 ".Chinese medicine gel has the drug level height, and is not volatile, acts on persistent 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 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 Chinese medicine gel preparation that repercussive and analgesic tincture prepares after process modification.The main forming matrix of this Chinese medicine gel preparation is selected from adjuvants such as sodium carboxymethyl cellulose (CMC-Na), hydroxypropyl emthylcellulose (HPMC), carbomer, belong to aqueous Chinese medicine gel preparation, external preparation for skin, the performance local action, function is a 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 a national standard Chinese traditional patent formulation preparation, and quality standard derives from the 12nd of Ministry of Public Health issuing standard " Chinese traditional patent formulation preparation ".Repercussive and analgesic tincture is made up 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 action, 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 the prescription and the preparation method of repercussive and analgesic tincture, and except that Mentholum and Camphora employing dissolve with ethanol, other medical material mainly adopts alcohol dipping to extract the ethanol extract that obtains them, and the two mixing obtains 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 that Mentholum and Camphora with repercussive and analgesic tincture to be mixed as active ingredient with Mentholum and Camphora and makes unguentum.
CN1315521 discloses extractum that the percolation of prescription other former medicinal extractum of writing out a prescription except that Mentholum and Camphora of repercussive and analgesic tincture obtains and Mentholum and Camphora and has been mixed and made into membrane.
The former medicine prescription that CN1698817 discloses with repercussive and analgesic tincture is a raw material, and extractum that will the percolation acquisition of other former medicinal extractum of writing out a prescription except that 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 that Mentholum and Camphora mixes as active ingredient with Mentholum and Camphora makes cataplasma.
At present the repercussive and analgesic tincture that uses clinically is liquid preparation, has certain defective, and for example tincture is at transportation, glass container rapid wear when carrying, and bottle stopper produces muddy or precipitation sometimes, thereby influences product quality and curative effect if the bad sealing solvent is volatile.And membrane, cataplasma and the aerosol of the preparation of the former medicine prescription of the employing repercussive and analgesic tincture of patent disclosure, its actual complicated process of preparation, cost is higher.And gel preparation technology is simple, and transportation and easy to use helps guaranteeing constant product quality.For this reason, the inventor has finished the former medicine prescription of employing repercussive and analgesic tincture and has prepared 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%, and CMC-Na and HPMC all need not to add and carry out the pH regulator agent, the gel cross-linking agent is because of containing Camphora in the former tincture prescription, Mentholum, contain ethanol in the preparation, so can not add transdermal enhancer, in keeping the preparation gel sample, contain the alcohol amount 30% when above, can not add the antiseptic and inhibiting bacteria function agent, and the adjuvant of selecting for use 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 substrate preparation, its sample has certain flowability, the bubble that produces in the whipping process can be discharged by nature, so production equipment even need not to reduce pressure 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 technology has following advantage: 1. avoid volatile ingredient to cause damage because of volatilization; 2. avoid heat-sensitive ingredients to damage, and in hot conditions chemical reaction takes place mutually between the composition because of high-temperature heating; 3. liquid preparation semisolidization, composition disperses more even, can not produce muddy and precipitation; 4. the obstructed pH of overregulating carries out crosslinked, thereby avoids active ingredient to be subjected to the soda acid variable effect; 5. medicine holdup time on skin long, keep drug effect lastingly, the performance long-acting.So 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 is grouped into by following one-tenth: Chinese medicine active ingredient 5%～95% (weight), hydrophilic gel substrate 0.5%～5.0% (weight) and other suitable pharmaceutic adjuvant, wherein, the Chinese medicine active ingredient 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 is formed.The weight portion here can be unit of weights such as g, kg.
Gel of the present invention, the percentage by weight of said Chinese medicine active ingredient 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 the 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 for use: one or more in laurocapram and homologue thereof, dimethyl sulfoxide, oleic acid, propylene glycol, the ethanol etc.; Wetting agent (wetting agent) can be selected for use: one or more in glycerol, propylene glycol, the ethanol etc.; The antiseptic and inhibiting bacteria function agent can be selected for use: one or more in benzoic acid, sodium benzoate, parabens, sorbic acid, the ethanol etc.; Acid-base modifier can be selected one or more of triethanolamine, sodium hydroxide, sodium carbonate, sodium bicarbonate, hydrochloric acid etc. for use.Also can add PEG200-600 in addition in case of necessity 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 following medicinal materials in part by weight: 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 promptly is 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 Chinese medicine active ingredient can be the repercussive and analgesic tincture medicinal liquid that goes on the market at present, also the raw material of above-mentioned weight portion can be extracted by taking alcohol dipping, percolation except that the raw medicinal material Camphora, the Mentholum, the extracting solution that obtains directly or through partly or entirely reclaim ethanol concentrated after, being dissolved in alcoholic acid solution with Camphora, Mentholum mixes, obtain admixing medical solutions, as the Chinese medicine active ingredient.
Said Chinese medicine active ingredient among the present invention, its ethanol content is 0-65%, preferred 20-65%.
Gel of the present invention, wherein, the Chinese medicine active ingredient also can be by record and disclosed method acquisitions 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 Chinese medicine active ingredient of gel of the present invention.
More than the dipping, the method for percolation of ethanol extract of these Chinese medicine active ingredients all be the Chinese medicine extraction method of this area routine, referring to " M medicated wine, N tincture, O fluid extract and the extractum of an appendix I of Chinese pharmacopoeia version in 2005 etc. are the medical material extracting method down.
The gel of the invention described above, said Chinese medicine active ingredient, preferably without spissated ethanol extract (containing Camphora, Mentholum), to prevent that the volatile ingredient in the former medicine from losing because of concentrating, influence the curative effect of gel, wherein, alcoholic acid content is no more than 55% in the gel, preferred 20-45%, more preferably 35-45%.
Swelling reducing and pain easing gel of the present invention is to improve the aqueous Chinese medicine gel preparation that is prepared from, external preparation for skin, performance local action by existing preparation repercussive and analgesic tincture prescription is carried out dosage form, function is a 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 by weighing gel-type vehicle such as CMC-Na, add the alcoholic solution of Chinese medicine active ingredient gradually, and constantly stir, slowly add purified water again, stir and make into gel, add other suitable pharmaceutic adjuvant again, divide unit dose package, promptly to ormal weight.
Wherein, in the said method, said Chinese medicine active ingredient is meant said Chinese medicine active ingredient in the gel preparation of the invention described above, it promptly can be the former tincture medicinal liquid of repercussive and analgesic tincture, also can be to take alcohol percolation method or infusion process to extract by the crude drug except that Camphora, Mentholum, partly or entirely reclaim the concentrated medicament or the extractum of gained behind the ethanol, mix the medicinal liquid that obtains then with the alcoholic solution of Camphora, Mentholum.The alcoholic solution of said Chinese medicine active ingredient, its ethanol content are 20-65%.
Second kind of method for preparing the swelling reducing and pain easing gel preparation provided by the invention, its process comprises:
A) take by weighing 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) in the substrate dispersion liquid in last step, add the Chinese medicine active ingredient, stir and make into gel, add an amount of purified water and regulate the gel stickiness, add other suitable pharmaceutic adjuvant again, divide unit dose package, promptly.
Wherein, in the said method, said Chinese medicine active ingredient is meant in the 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 that Camphora, Mentholum, partly or entirely reclaims the concentrated medicament or the extractum of gained behind the ethanol.
Provided by the invention the third prepares the method for swelling reducing and pain easing gel preparation, and its process comprises:
A) take by weighing gel-type vehicle such as CMC-Na, add an amount of ethanol, stir; Or gel-type vehicle added in wetting agent (glycerol, the propylene glycol etc.) solution, grind, gel-type vehicle is fully disperseed, stir, obtain the substrate dispersion liquid;
B) the Chinese medicine active ingredient is slowly joined in the above-mentioned substrate dispersion liquid, stir and make into gel, add an amount of purified water and regulate the gel stickiness, add other suitable pharmaceutic adjuvant again, divide unit dose package, promptly.
Wherein, in the said method, said Chinese medicine active ingredient is meant said Chinese medicine active ingredient in the gel preparation of the invention described above, it promptly can be the former tincture medicinal liquid of repercussive and analgesic tincture, also can be to take alcohol percolation method or infusion process to extract by the crude drug except that Camphora, Mentholum, partly or entirely reclaim the concentrated medicament or the extractum of gained behind the ethanol, mix the medicinal liquid that obtains then 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 for use, 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 the prescription, ethanol content is too high, and preparations shaping is difficult more, ethanol content is low excessively, and then Zhi Bei gel sample stability is poor more, and sample is muddy because of precipitation occurring, clarity is poor, and ethanol content proportion in preparation is 35%～45% in the optimizing prescriptions.
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 Chinese pharmacopoeia fluid extract of version in 2005 and the extractum item, make solvent with 53% ethanol, flood after 28 hours, with the speed of the about 3ml of per minute percolation slowly, collect percolate 5300g, device is preserved in addition; After getting Camphora, Mentholum and adding ethanol and make dissolving in right amount, 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 leave standstill, and filter, and obtain the repercussive and analgesic tincture original liquid;
B) swelling reducing and pain easing gel preparations shaping: get gel-type vehicle and add in the above reducing swelling and alleviating pain tincture original liquid, the limit edged stirs, and is constantly slowly adding suitable quantity of water under the stirring condition again, make thickening molding gradually, can add other adjuvant (also can not adding) as required, mixing, the single dose packing is promptly.
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 Chinese pharmacopoeia fluid extract of version in 2005 and the extractum item, make solvent with 53% ethanol, flood after 28 hours, with the speed of the about 3ml of per minute percolation slowly, collect percolate 5300g, device is preserved in addition;
B) concentrating of medical material percolate: the percolate of getting 19 flavor medical materials such as the Radix Aucklandiae, Radix Saposhnikoviae, reclaim ethanol, concentrate to reduce amount of liquid medicine, the unsuitable overrich of spissated 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 ethanol makes dissolving in right amount;
D) swelling reducing and pain easing gel preparations shaping: get that gel-type vehicle camphorates, in the Mentholum alcoholic solution, stir and make dispersion, the material concentrated solution of getting it filled again slowly adds in the above solution down in continuous stirring, make thickening molding gradually,, add other adjuvant according to arts demand, mixing, the single dose packing promptly.
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 Chinese pharmacopoeia fluid extract of version in 2005 and the extractum item, make solvent with 53% ethanol, flood after 28 hours, with the speed of the about 3ml of per minute percolation slowly, collect percolate 5300g, device is preserved in addition;
B) concentrating of medical material percolate: the percolate of getting 19 flavor medical materials such as the Radix Aucklandiae, Radix Saposhnikoviae, reclaim ethanol, concentrate to reduce amount of liquid medicine, the unsuitable overrich of spissated 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 grinds and disperses: 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 ethanol makes dissolving in right amount;
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 the above solution down in continuous stirring, makes thickening molding gradually, and is last, according to arts demand, add other adjuvant (also can not adding), mixing, the single dose packing is promptly.
Because of inventing related main adjuvant is hydrophilic materials, so the gel of being invented is the water-soluble base gel.Chinese medicine active ingredient among the present invention, gel-type vehicle, ethanol, must mix with certain proportion, ethanol content influences the preparations shaping and the sample stability of gel, ethanol content is low excessively, part composition in the extracting solution (mainly being the ester soluble components) can change because of dissolubility, and separate out precipitation, ethanol content is too high, then is difficult to molding.
For guaranteeing that ingredient does not change selection process flow process 1 described preparation method.Technological process 1 is that with respect to technological process 2,3 maximum differences herbal extract is without the heating concentration, so have following advantage: 1. ingredient can not degraded because of being subjected to heat damage; 2. avoid volatile ingredient to wave the loss of loosing because of being heated; 3. avoid taking place mutually between the composition under the heating condition chemical reaction; 4. can not produce deposit because of ethanol reclaims; In addition, 5. technology is simple, and is workable; 6. streamlining need not reclaim concentrator, does not consume energy, and saves production cost.
And technological process 2,3 described preparation methoies, the advantage that has is: can significantly reduce amount of liquid medicine, dosage can be reduced to 1/5 of former dosage.
Stability test:
Prescription 1:CMC-Na 15g, glycerol 25ml, PEG40012.5ml, repercussive and analgesic tincture 375ml, purified water 62.5ml
Method for making: take by weighing CMC-Na, add in the mixed liquor of glycerol and PEG400, grinding fully disperses CMC-Na, adds the repercussive and analgesic tincture agent solution again, stirs, and adds purified water at last gradually to ormal weight, stirs and makes into gel, promptly.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 by weighing CMC-Na, add the repercussive and analgesic tincture agent solution, stir, constantly stirring and the slow purified water that adds make into gel, promptly to ormal weight.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 the low temperature freezing-thawing test in 3 cycles simultaneously, each sample is that index is estimated its quality with character variation, change color, precipitate generation etc.
Result of the test:
Conclusion (of pressure testing): under the condition of investigating, outward appearances such as the character of sample, color do not have significant change, and deposit-free generates in 10 days, shows that the sample physical stability is good.
Quicken 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 shows that 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 orange-yellow, brownish red, brownish black respectively according to the liquor strength difference; Special odor with Mentholum and Camphora; The quality clear does not have muddy; Certain flowability and stickiness are arranged; PH is neutral or near neutral; The strong lasting skin wet that keeps of lock aqueous, the skin comfort is good.
Swelling reducing and pain easing gel of the present invention preferably is the sample that substrate makes with CMC-Na, 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 regulator agent, gel cross-linking agent, because of containing Camphora, Mentholum in the former tincture prescription, contain ethanol in the preparation, so can not add transdermal enhancer, in keeping the preparation gel sample, contain the alcohol amount 30% when above, 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 concentrates, possessing stirring and evenly mixing equipment can produce, the gel sample of preparation has certain flowability, the bubble that produces in the whipping process can be discharged by nature, so production equipment even need not to reduce pressure 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 last table shows, can make gel preferably with carbomer, CMC-Na, HPMC as gel-type vehicle, other several gel-type vehicles are made very difficulty of 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, best as carbomer skin comfort level, appearance character is best, but stability is not good enough slightly, 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 to its shaping influence minimum, 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 poor slightly.These shortcomings can overcome by adding relevant adjuvant, can go into antiseptic or antibacterial as stability, and mouldability solves by Chang Fangfa such as control ethanol contents.
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 by weighing CMC-Na, add the repercussive and analgesic tincture agent solution, stir, constantly stirring and the slow purified water that adds make into gel to ormal weight, make 7500g, packing, promptly.
Embodiment 2:
Prescription: CMC-Na250g, glycerol 500g, PEG400300g, repercussive and analgesic tincture medicinal liquid 6000g, purified water 1050g
Preparation method:
Take by weighing CMC-Na, add in the mixed liquor of glycerol and PEG400, grinding fully disperses CMC-Na, adds the repercussive and analgesic tincture agent solution again, stirs, and adds purified water at last gradually to ormal weight, stirs and makes into gel, makes 8100g, packing, promptly.
Embodiment 3:
Prescription: CMC-Na45g, ethanol 125g, repercussive and analgesic tincture medical material percolate 5300ml, Camphora 55g, Mentholum 55g, purified water are an amount of
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 the prescription 19 flavor pulverizing medicinal materials and become coarse powder, according to " the percolation under Chinese pharmacopoeia fluid extract of version in 2005 and the extractum item, make solvent with 53% ethanol, flood after 28 hours, with the speed of the about 3ml of per minute percolation slowly, collect percolate 5300ml;
B) the swollen analgesic tincture medical material percolate of cancellation reclaims ethanol, is evaporated to about 1000g, and is as the medical material concentrated solution, standby; Camphora, Mentholum are dissolved in the 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 the above solution down in continuous stirring, makes thickening molding gradually, adds purified water at last and regulates denseness, and mixing is made 1300g, packing, promptly.
Embodiment 4:
Prescription: CMC-Na75g, ethanol 215g, propylene glycol 215g, repercussive and analgesic tincture medical material percolate 5300ml, Camphora 55g, Mentholum 55g, an amount of, the ethylparaben 2.0g of purified water
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 about 1000g, and is as the medical material concentrated solution, standby; Camphora, Mentholum are dissolved in the 215g ethanol, standby; Get ethylparaben and CMC-Na and add in the propylene glycol, grind evenly, form dispersion; Camphora, Mentholum alcoholic solution are added in the above dispersion, stir; Again the medical material concentrated solution is slowly added under constantly stirring, mix, stir and make into gel, add an amount of purified water at last and regulate gel consistency, make 2200g, packing, promptly.
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 an amount of
Preparation method:
Make the sepage of repercussive and analgesic tincture medical material and filter by implementing 3 medical material prescription and method, the cancellation analgesic tincture medical material percolate that swells, partially recycled ethanol, to the about 2100g of medicine liquid volume,, standby as the medical material concentrated solution; Camphora, Mentholum are added in the above concentrated medicament, stir and make dissolving; Get CMC-Na again and add, mix; It is an amount of slowly to add purified water under constantly stirring, and makes thickening gradually make gel; Add benzoic acid at last, stirring and evenly mixing is made 2600g, packing, promptly.
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 the dehydrated alcohol, mix, get HPMC again and add in the above solution, add the repercussive and analgesic tincture medicinal liquid again, mix, last constantly the stirring slowly adds purified water down, makes thickening gradually make gel, adds sorbitol again, mixing is made 27000g, packing, promptly.
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 about 1000g, and is as the medical material concentrated solution, standby; Camphora, Mentholum are dissolved in the ethanol, standby; Getting HPMC and sodium benzoate puts in the glycerol to grind to make and is uniformly dispersed; With above alcoholic solution, add substrate and disperse to stir in the thing; Under constantly stirring, slowly add the medical material concentrated solution at last, make thickening gradually make gel, make 1400g, packing, promptly.
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 stirring and the slow purified water that adds make into gel to ormal weight, make 8000g, packing, promptly.
Embodiment 9:
Prescription: Acritamer 940 12g, repercussive and analgesic tincture medical material percolate 5300ml, Camphora 55g, Mentholum 55g, ethanol 170g, an amount of, the sorbic acid 3g of triethanolamine
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 about 1000g, put cold, filtration, filtrate is as the medical material concentrated solution, and is standby; Camphora, Mentholum and above filtration filtering residue are dissolved in the ethanol, standby; Get carbomer and put in the above medical material concentrated solution, left standstill 24 hours, reuse high-shear homogenizer breast is even; Add alcoholic solution, stirring and evenly mixing; Last constantly the stirring down added triethanolamine, makes thickening gradually make gel, adds sorbic acid again, and mixing is made 1300g, packing, promptly.
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) an amount of, 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 about 1000g, and is as the medical material concentrated solution, standby; Camphora, Mentholum are dissolved in the ethanol, with the propylene glycol mixing, standby again; Get carbomer and put in the 8400g purified water, make abundant swelling, high speed homogenization is as substrate; In substrate, add alcoholic solution and medical material concentrated solution successively, stirring and evenly mixing; Constantly stir down, slowly add NaOH solution, make thickening gradually make gel, add remaining 8400g purified water more gradually, add butoben at last, mixing is made 21000g, packing, promptly.
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: Chinese medicine active ingredient 5%～95%, gel-type vehicle 0.5%～5.0% and other suitable pharmaceutic adjuvant, wherein, the Chinese medicine active ingredient 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 is formed.
2. according to the gel of claim 1, said Chinese medicine active ingredient is by following medicinal materials in 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 yellow Tengs, 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 the gel of claim 2, said Chinese medicine active ingredient is the former tincture solution of repercussive and analgesic tincture.
4. according to the gel of claim 1～3, ethanol content is 0%～65% in the said Chinese medicine active ingredient.
5. according to the gel of claim 1, said gel-type vehicle is selected from: one or more in sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose, the carbomer, preferably carboxymethyl cellulose sodium.
6. according to the gel of claim 5, 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 the gel of claim 5 or 6, said sodium carboxymethyl cellulose, its range of viscosities are 300～1200mPa.S (2% aqueous solution), preferred 800～1200mPa.S (2% aqueous solution).
8. according to the gel of claim 1, said other suitable pharmaceutic adjuvant comprises water, transdermal enhancer, wetting agent, antiseptic, acid-base modifier, antioxidant or their mixture.
9. the preparation method of the swelling reducing and pain easing gel preparation of a claim 1, its process comprises:
Take by weighing gel-type vehicle, add the alcoholic solution of Chinese medicine active ingredient gradually, and constantly stir, slowly add purified water again, stir and make into gel, add other suitable pharmaceutic adjuvant again, divide unit dose package, promptly to ormal weight; Wherein, the alcoholic solution of Chinese medicine active ingredient, its ethanol content are 20-65%.
10. the preparation method of the swelling reducing and pain easing gel preparation of a claim 1, its process comprises:
A) take by weighing 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) in the substrate dispersion liquid in last step, add the Chinese medicine active ingredient, stir and make into gel, add an amount of purified water and regulate the gel stickiness, add other suitable pharmaceutic adjuvant again, divide unit dose package, promptly.
11. the preparation method of the swelling reducing and pain easing gel preparation of a claim 1, its process comprises:
A) take by weighing gel-type vehicle, add an amount of ethanol, stir; Or gel-type vehicle added in wetting agent (glycerol, the propylene glycol etc.) solution, grind, gel-type vehicle is fully disperseed, stir, obtain the substrate dispersion liquid;
B) the Chinese medicine active ingredient is slowly joined in the above-mentioned substrate dispersion liquid, stir and make into gel, add an amount of purified water and regulate the gel stickiness, add other suitable pharmaceutic adjuvant again, divide unit dose package, promptly.
12. the described arbitrary method of claim 9-11, gel-type vehicle are in sodium carboxymethyl cellulose (CMC-Na), hydroxypropyl emthylcellulose (HPMC), the carbomer one or more, preferably carboxymethyl cellulose sodium (CMC-Na).
13. gel according to claim 1, said Chinese medicine active ingredient can be the former tincture medicinal liquid of repercussive and analgesic tincture, or take alcohol percolation method or dipping to extract by the crude drug except that Camphora, Mentholum, partly or entirely reclaim the concentrated medicament or the extractum of gained behind the ethanol, mix the medicinal liquid that obtains then with the alcoholic solution of Camphora, Mentholum.
14. as the described arbitrary swelling reducing and pain easing gel preparation of claim 1～8, it is characterized in that: in this gel sample preparation, the percentage ratio that ethanol accounts for whole weight of formulation is no more than 55%, and preferred weight percent is 35%～45%.
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| CN103417880A (en) * | 2013-07-24 | 2013-12-04 | 广西梧州三鹤药业有限公司 | TCM composition and preparation method thereof |
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| 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 |
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| CN100444887C (en) * | 2005-05-09 | 2008-12-24 | 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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| CN103417880A (en) * | 2013-07-24 | 2013-12-04 | 广西梧州三鹤药业有限公司 | TCM composition and preparation method thereof |
| 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 |
| CN104435931A (en) * | 2014-12-13 | 2015-03-25 | 山西省肿瘤研究所 | Pain relieving patch 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 |
| CN106138190A (en) * | 2016-08-08 | 2016-11-23 | 林湧博 | A kind of external-use gel preparation, preparation method and its usage |
| 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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