CN102091111B - Saussurea cataplasm and production method thereof - Google Patents
Saussurea cataplasm and production method thereof Download PDFInfo
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Abstract
The invention relates to the technical field of medicines, and relates to a saussurea extract and saussurea cataplasm and a production method thereof. The saussurea extract contains syringin in an amount which is 6 times that of saussurea injection, chlorogenic acid in an amount which is 16 times that of the saussurea injection and rutin in an amount which is 200 times that of the saussurea injection. The saussurea cataplasm comprises the following raw materials in part by weight: the saussurea extract, an agglutinant, a humectant, a filler, a thickener, a cross-linking agent and a transdermal accelerator. Pharmacodynamic test results indicate that the saussurea cataplasm has the obvious effects of resisting pain caused by chemistry, inhibiting a harm reaction and resisting inflammatory, has the good effects on membrane residues, skin following performance, using comfort, discomfort symptoms in skin and pain due to uncovering and pulling, can be pulled and applied repeatedly, has high biocompatibility, affinity, air permeability and perspiration resistance, and avoids arousing allergy.
Description
The application is 200710203380.9 divides an application, and the applying date of original application is December in 2007 25 days, and the denomination of invention of original application is " Herba Saussureae Involueratae extract and saussurea involucrata catablasm and a production method thereof ".
Technical field
The present invention relates to medical technical field, is a kind of Herba Saussureae Involueratae extract and saussurea involucrata catablasm and production method thereof.
Background technology
Herba Saussureae Involueratae; It is the geographic important medicinal plants of the western high mountain of China; Herba Saussureae Involueratae is warm in nature, and mildly bitter flavor is gone into the liver,spleen,kidney warp; Have dispelling cold and removing dampness, promoting blood circulation to restore menstrual flow, functions such as strong muscle is supporing yang, anti-inflammatory and antalgic, contraction uterus, clinically be used to treat diseases such as rheumatic arthritis, women's cold and pain in the lower abdomen, amenorrhea, measles without adequate eruption, lung cold cough, sexual impotence, high mountain incompatibility.Herba Saussureae Involueratae has been carried out deep research both at home and abroad, mainly contained chemical constituents such as phenylpropyl alcohol element, flavone, alkaloid, terpenoid, lactone, polysaccharide, volatile oil, steroidal in the Herba Saussureae Involueratae, the modern pharmacology experiment shows that total flavones, phenylpropyl alcohol element are main active in the Herba Saussureae Involueratae.
Standard No. is to have put down in writing its preparation method in the Herba Saussureae Involueratae injection of WS3-B-3334-98: extract through 14 days alcohol dipping, through 1～3 month leave standstill, separate some macromolecular impurity.The effective ingredient of this method in to a certain extent can the extraction separation Herba Saussureae Involueratae; But the needed production cycle is oversize, and concerning Producer, this operation has brought very burden; Therefore, research invention extraction separation method new, the short time the right problem of demand side that is medical worker.
Publication number is that patent documentation that CN1634508A, name are called " Saussurea involucrata drop pill and preparation method thereof " only discloses and is the basis with Chinese traditional patent formulation saussurea involucrata oral liquid extraction process, and preparation technology is prepared from conjunction with drop pill.Though adopted alcohol reflux, shortened extraction time, extract is not further purified, and does not have clear and definite high performance liquid chromatogram controlling index.
Publication number is that the patent documentation that CN1500500A, name are called " a kind of be used for intravenous freeze-dry snow lotus powder agent and preparation method thereof " discloses following method: " extract with The suitable solvent, reuse different adsorption post separates ", this method is concise and to the point introduction; Do not point out why solvent of used solvent, how used adsorption column is operated, therefore; In actual production process, can't duplicate; And this patent only limits the effective ingredient total flavones, and limited range is 5mg to 20mg, the highest and minimumly differs from 4 times; Scope is wider, and the plain class of another effective ingredient phenylpropyl alcohol of Herba Saussureae Involueratae is not carried out the content qualification.
Publication number is that the patent documentation that CN1686357A, name are called " a kind of Saussurea involucrate powder injection and preparation method thereof " discloses following method: " extract purification from the Chinese medicine Herba Saussureae Involueratae and obtain effective site; control total flavones (in rutin, syringoside); control total alkaloids (in Colchicum autumnale) "; This control method is not too reasonable: 1. see that from compound structure rutin belongs to flavonoid; And syringoside belongs to plain type of phenylpropyl alcohol, and also has the plain active component chlorogenic acid of the higher phenylpropyl alcohol of another content not controlled in the Herba Saussureae Involueratae.2. consult the document of relevant Herba Saussureae Involueratae both at home and abroad, do not see to have from Herba Saussureae Involueratae, to separate to obtain the report that the colchicine structure is identified, measure with the HPLC multi-method and also do not detect colchicine, this patent is that the blank determination total alkali is unreasonable with the colchicine.3. the content of total alkali is very little in the bibliographical information Herba Saussureae Involueratae, and it is just bigger to adopt fluorescence spectrophotometer light method to measure the error of system own.
The dosage form of the clinical use of Herba Saussureae Involueratae mainly is an injection, and is evident in efficacy though drug administration by injection is rapid-action, and the snow lotus injection agent has serious muscle irritation, has shortcomings such as injection site pain, redness, use inconvenience, and patient's compliance is relatively poor.In order to make Herba Saussureae Involueratae bring into play clinical efficacy better, press for a kind of safe, easy to use and new formulation that compliance is good clinically.
For these reasons, and closely follow the forward position that modern medicinal agents develops, we have carried out the saussurea involucrata catablasm important function for of research.Cataplasma system is with medicine dissolution or be mixed in natural and the synthesizing water-solubility macromolecular material substrate; And the stand is applied on the back lining materials, supplies card to spread on the external preparation of skin, plays general action or local action through Transdermal absorption; Also belong to Percutaneously administrable prepn, its original shape is " poultice ".Because developing rapidly of fields such as modern fine chemistry industry and polymer material science provides the adjuvant of more superior performances for pharmaceutics.Therefore, cataplasma was at first succeeded in developing by Japan in the seventies in last century, in developed country such as American-European-Japanese a large amount of cataplasmas listings was arranged so far, received doctor and patient's favorable comment deeply.China began this dosage form is studied in the eighties in last century, but its development is slower, has only the product of minute quantity to appear on the market till now.
Summary of the invention
The invention provides a kind of Herba Saussureae Involueratae extract and saussurea involucrata catablasm and production method thereof; It has overcome the deficiency of above-mentioned prior art; The syringoside that the gained Herba Saussureae Involueratae extract contains, chlorogenic acid and rutin are higher, and the production method of this Herba Saussureae Involueratae extract is easy to operate, the gained saussurea involucrata catablasm have obvious antagonism chemistry pain caused, suppress shock reaction and antiinflammatory action; Easy to use, the production method of this saussurea involucrata catablasm is easy to operate.
One of technical scheme of the present invention obtains in the following manner: a kind of Herba Saussureae Involueratae extract, it contains 0.5% to 1.2% syringoside, 7% to 17% chlorogenic acid and 8% to 25% rutin by weight percentage.
Be further optimization and/or selection below to one of technique scheme:
This Herba Saussureae Involueratae extract obtains by following step:
(1) gets Herba Saussureae Involueratae, pulverize, put into extraction pot; Using concentration is that 6 to 12 times of amounts of ethanol of 60% to 90% are extracted 2 to 4 times, each 1 to 3 hour, and merge extractive liquid; Extracting liquid filtering, put coldly, centrifugal, supernatant concentration obtains every milliliter of concentrated solution that contains crude drug 0.1 gram to 0.5 gram;
(2) get above-mentioned concentrated solution; Last macroporous resin carries out purification; The macroporous resin type is one or more among AB-8, D101, HPD100, HPD400 and the HPD600; Fractional Collections effluent, effluent are concentrated to 20 ℃ of relative densities to be 1.05～1.20 thick paste or to process dried cream powder, promptly obtains Herba Saussureae Involueratae extract.
Getting above-mentioned concentrated solution adjust pH is 1 to 5, the macroporous resin column of one or more among last AB-8, D101, HPD100, HPD400 and the HPD600, and the post blade diameter length ratio is 1: 5 to 1: 9; Last appearance volume is 3BV to 6BV; Remove aqueous solution impurity with 3BV to 6BV sour water eluting, reuse 2BV to 6BV30% ethanol, 2BV to 6BV 50% ethanol is eluting respectively, merges eluent; Eluent reclaims ethanol and concentrate drying gets thick paste or dried cream powder, has promptly obtained Herba Saussureae Involueratae extract.(BV refers to the resin bed volume)
Two of technical scheme of the present invention obtains in the following manner: a kind of production method of Herba Saussureae Involueratae extract, and it is undertaken by following step:
(1) gets Herba Saussureae Involueratae, pulverize, put into extraction pot; Using concentration is that 6 to 12 times of amounts of ethanol of 60% to 90% are extracted 2 to 4 times, each 1 to 3 hour, and merge extractive liquid; Extracting liquid filtering, put coldly, centrifugal, supernatant concentration obtains every milliliter of concentrated solution that contains crude drug 0.1 gram to 0.5 gram;
(2) get above-mentioned concentrated solution; Last macroporous resin carries out purification; The macroporous resin type is one or more among AB-8, D101, HPD100, HPD400 and the HPD600; Fractional Collections effluent, effluent are concentrated to 20 ℃ of relative densities to be 1.05 to 1.20 thick paste or to process dried cream powder, promptly obtains Herba Saussureae Involueratae extract.
Be two further optimization and/or selection below to technique scheme:
Getting above-mentioned concentrated solution adjust pH is 1 to 5, the macroporous resin column of one or more among last AB-8, D101, HPD100, HPD400 and the HPD600, and the post blade diameter length ratio is 1: 5 to 1: 9; Last appearance volume is 3BV to 6BV; Remove aqueous solution impurity with 3BV to 6BV sour water eluting, reuse 2BV to 6BV30% ethanol, 2BV to 6BV 50% ethanol is eluting respectively, merges eluent; Eluent reclaims ethanol and concentrate drying gets thick paste or dried cream powder, has promptly obtained Herba Saussureae Involueratae extract.
Three of technical scheme of the present invention obtains in the following manner: more than one state the saussurea involucrata catablasm that Herba Saussureae Involueratae extract is one of raw material, and it consists of by parts by weight of raw materials: the transdermal enhancer of the filler of the sticker of the Herba Saussureae Involueratae extract of 1 weight portion to 8 weight portion, 4 weight portion to 15 weight portions, the wetting agent of 20 weight portion to 40 weight portions, 3 weight portion to 15 weight portions, the thickening agent of 1 weight portion to 10 weight portion, 0 weight portion to 2 parts by weight of cross-linking agent and 2 weight portion to 15 weight portions.
Four of technical scheme of the present invention obtains in the following manner: a kind of production method of saussurea involucrata catablasm; It obtains by following step: the employed substrate of ointment-containing body and adjuvant adopt the above any adjuvant or the substrate of preparation cataplasma of pharmaceutics, comprise in sticker, wetting agent, filler, cross-linking agent, transdermal enhancer, pH regulator agent, the cross-linking regulator one or more; The employed back lining materials of backing layer adopts a kind of in cotton, non-woven fabrics, the paper; The employed lid lining material of lid lining protecting film adopts a kind of in separate paper, plastic sheeting, polyester, aluminium foil-polyethylene composite film, the hard gauze.
Syringoside, chlorogenic acid and the rutin that gained Herba Saussureae Involueratae extract of the present invention contains is respectively 6 times, 16 times and 200 times of Herba Saussureae Involueratae injection, and the production method of this Herba Saussureae Involueratae extract is easy to operate.The results of pharmacodynamic test of gained saussurea involucrata catablasm of the present invention shows; Saussurea involucrata catablasm of the present invention have obvious antagonism chemistry pain caused, suppress shock reaction and antiinflammatory action; To film residual, skin tracing ability, comfort, skin malaise symptoms, take off that to pull pain all better, can take off repeatedly and pull and apply ointment or plaster, good to biocompatibility, affinity, breathability, the absorption of perspiration of skin; And being not easy allergy, the production method of this saussurea involucrata catablasm is easy to operate.
Description of drawings
Accompanying drawing 1 is the chromatogram that 257nm place syringoside reference substance is measured for wavelength.
Accompanying drawing 2 is that 257nm place chlorogenic acid, rutin mix the chromatogram that reference substance is measured for wavelength.
Accompanying drawing 3 is the chromatogram that 327nm place chlorogenic acid, control substance of Rutin are measured for wavelength.
Accompanying drawing 4 is the chromatogram of sample determination behind the 257nm place resin purification for wavelength.
Accompanying drawing 5 is the chromatogram of sample determination behind the 327nm place resin purification for wavelength.
Accompanying drawing 7 is the chromatogram of 327nm place Herba Saussureae Involueratae injection sample determination for wavelength.
The specific embodiment
The present invention does not receive the restriction of following embodiment, can confirm concrete embodiment according to the technical scheme and the practical situation of the invention described above.
Below in conjunction with embodiment the present invention is done further argumentation:
Embodiment 1, and this Herba Saussureae Involueratae extract contains 0.5% syringoside, 7% chlorogenic acid and 8% rutin by weight percentage.
Other legacy that also contains Herba Saussureae Involueratae at the Herba Saussureae Involueratae extract of the foregoing description 1 to 3.
The foregoing description 1 to 3 can obtain through following production method:
Embodiment 4, and the production method of this Herba Saussureae Involueratae extract is undertaken by following step: get Herba Saussureae Involueratae, pulverize; Put into extraction pot, using concentration is that 8 times of amounts of ethanol of 60% are extracted each 2 hours 2 times; Merge extractive liquid,, is put coldly, centrifugal at extracting liquid filtering, and supernatant concentration contains crude drug 0.2g to every milliliter.Getting above-mentioned concentrated solution accent pH is 4, last AB-8 type macroporous resin column, and the post blade diameter length ratio is 1: 6; Last appearance volume is 6BV; Remove aqueous solution impurity with 6BV sour water eluting, reuse 4BV 30% ethanol, 6BV 50% ethanol is eluting respectively, and eluent reclaims behind the ethanol drying under reduced pressure powder that gets dry extract; The drug effect part group that has promptly obtained Herba Saussureae Involueratae is a Herba Saussureae Involueratae extract, and wherein the rate of transform of syringoside is 89.4%, the chlorogenic acid rate of transform is 99.7%, the rutin rate of transform is 92.6%.
Embodiment 7, and the production method of this Herba Saussureae Involueratae extract is undertaken by following step: get Herba Saussureae Involueratae, pulverize; Put into extraction pot, using concentration is that 12 times of amounts of ethanol of 90% are extracted each 3 hours 2 times; Merge extractive liquid,, is put coldly, centrifugal at extracting liquid filtering, and supernatant concentration contains crude drug 0.4g to every milliliter.Getting above-mentioned concentrated solution accent pH is 5, last HPD100 type macroporous resin column, and the post blade diameter length ratio is 1: 9; Last appearance volume is 5BV; Remove aqueous solution impurity with 3BV sour water eluting, reuse 2BV30% ethanol, 5BV 50% ethanol is eluting respectively, and eluent reclaims behind the ethanol drying under reduced pressure powder that gets dry extract; The drug effect part group that has promptly obtained Herba Saussureae Involueratae is a Herba Saussureae Involueratae extract, and wherein the rate of transform of syringoside is 83.9%, the chlorogenic acid rate of transform is 85.2%, the rutin rate of transform is 96.7%.
In the present invention: crude drug is meant the raw medicinal material Herba Saussureae Involueratae.
Check and analysis method to syringoside, chlorogenic acid, rutin in the above-mentioned gained Herba Saussureae Involueratae extract is following:
Adopt HPLC check and analysis method,
Experimental apparatus: SPD-10AVP type high performance liquid chromatograph (institute is made in a day island proper Tianjin),
Experiment medicine: syringoside, chlorogenic acid and control substance of Rutin (all purchasing) in Nat'l Pharmaceutical & Biological Products Control Institute; Herba Saussureae Involueratae purification drug effect part group is above-mentioned Herba Saussureae Involueratae extract; Commercially available Herba Saussureae Involueratae injection (Western Regions, Xinjiang pharmaceutical factory).
Experimental technique:
Chromatographic conditions: column Kromasil? ODS-1 (250 × 4.6mm, 5 Jing); acetonitrile and 0.4% phosphoric acid as mobile phase gradient elution (acetonitrile: 0min to 13%, 15min to 13%, 16min 15% , 40min 15%); dual wavelength detection: 257nm (detection of lilac and rutin), 327nm (detection of chlorogenic acid); flow rate: 1mL · min
-1 ; the column temperature was 35 ℃; injection volume: 10 Teng.
The preparation of reference substance solution: precision takes by weighing syringoside, chlorogenic acid and control substance of Rutin and is respectively 6.38mg, 6.47mg, 6.57mg.Syringin dissolved in methanol and set the volume to 25mL volumetric flask, chlorogenic acid and rutin as reference substance dissolved in methanol and mixed volume to 25mL volumetric flask, respectively, a concentration of 255.2 He / mL, 258.8 He / mL and 262.8 He / mL in the control stock solution, shake, over 0.45 Jing membrane and set aside.
The preparation of need testing solution: 1. precision takes by weighing Herba Saussureae Involueratae purification drug effect part group 80mg, puts in the 50mL measuring bottle, with dissolve with methanol, is mixed with solution, and uses methanol constant volume, and 2. precision pipettes Herba Saussureae Involueratae injection 6mL and puts in the 10mL measuring bottle, with methanol constant volume to scale.
Assay: draw reference substance solution and need testing solution respectively,, calculate according to external standard method according to recording peak area.Measure syringoside, rutin at the 257nm place; Measure chlorogenic acid at the 327nm place; Chromatogram is seen accompanying drawing: the chromatogram (syringoside is seen peak 1) that accompanying drawing 1 is measured for 257nm place syringoside reference substance; Accompanying drawing 2 mixes the chromatogram (rutin sees peak 3) that reference substance is measured for 257nm place chlorogenic acid, rutin; Accompanying drawing 3 is the chromatogram (chlorogenic acid is seen peak 2) that 327nm place chlorogenic acid, control substance of Rutin are measured, accompanying drawing 4 for 257nm place resin purification after the chromatogram (syringoside and rutin see peak 1 and peak 3 respectively) of sample determination, accompanying drawing 5 for 327nm place resin purification after the chromatogram (chlorogenic acid is seen peak 2) of sample determination; Accompanying drawing 6 is the chromatogram (syringoside and rutin see peak 1 and peak 3 respectively) of 257nm place Herba Saussureae Involueratae injection sample determination, and accompanying drawing 7 is the chromatogram (chlorogenic acid is seen peak 2) of 327nm place Herba Saussureae Involueratae injection sample determination.
As a result, Herba Saussureae Involueratae purification drug effect part group be that syringoside accounts for total extractum amount in the Herba Saussureae Involueratae extract 0.5%～1.2%, chlorogenic acid accounts for 7%～17% of total extractum amount, rutin accounts for 8%～25% of total extractum amount.Simultaneously; The content of these three compositions in more commercially available Herba Saussureae Involueratae injection and the above-mentioned Herba Saussureae Involueratae extract; And being converted to same raw medicinal herbs amount to them, the result finds: the content of syringoside, chlorogenic acid and rutin is respectively 0.0568mg/g crude drug, 0.0853mg/g crude drug and 0.0419mg/g crude drug in the Herba Saussureae Involueratae injection; Syringoside, chlorogenic acid and rutin on average are respectively 0.3397mg/g crude drug, 1.3449mg/g crude drug and 8.0819mg/g crude drug in the above-mentioned Herba Saussureae Involueratae extract, are respectively 6 times, 16 times and 200 times of Herba Saussureae Involueratae injection approximately.
Embodiment 9, and saussurea involucrata catablasm and production method thereof are following:
Backing layer: non-woven fabrics
Lid lining: polyethylene film
Ointment-containing body layer component constitutes following by weight:
Method for preparing: take by weighing in tartaric acid, the EDTA adding 45g water by recipe quantity; Dissolving; Propylene glycol, dihydroxyaluminum aminoacetate, sodium polyacrylate, 30 POVIDONE K 30 BP/USP-90, polyvinylpolypyrrolidone XL-10 are repeatedly added in the glycerol successively on a small quantity, and heating in water bath makes abundant dissolving, Herba Saussureae Involueratae extract, azone is added again; At last above-mentioned water is added, get mastic.Be uniformly coated on then on the non-woven fabrics, cover polyethylene film, shear and promptly get saussurea involucrata catablasm.
Backing layer: non-woven fabrics
Lid lining: polyester film
Ointment-containing body layer component constitutes following by weight:
Method for preparing: by recipe quantity take by weighing sodium polyacrylate, Acritamer 940 adds purified water 42.5g; Dissolving; Propylene glycol, dihydroxyaluminum aminoacetate, 30 POVIDONE K 30 BP/USP-90, polyvinylpolypyrrolidone XL-10 are repeatedly added in the glycerol successively on a small quantity, and heating in water bath makes abundant dissolving, Herba Saussureae Involueratae extract, azone is added again; At last above-mentioned water is added, get mastic.Be uniformly coated on then on the non-woven fabrics, cover polyester film, shear and promptly get saussurea involucrata catablasm.
Embodiment 11, and saussurea involucrata catablasm and production method thereof are following:
Backing layer: non-woven fabrics
Lid lining: polyester film
Ointment-containing body layer component constitutes following by weight:
Method for preparing: take by weighing gelatin, sodium carboxymethyl cellulose, methylcellulose, sorbitol, add purified water 48g immersion by recipe quantity; The heating in water bath swelling; Other gets sodium polyacrylate, Kaolin, propylene glycol and mixes the back and add in the above-mentioned swelling solution, behind the stirring and evenly mixing, adds the suspension of Polyethylene Glycol-400 and Herba Saussureae Involueratae extract again; Stirred for several minute, mastic.Be uniformly coated on then on the non-woven fabrics, cover polyester film, shear and promptly get saussurea involucrata catablasm.
Embodiment 12, and saussurea involucrata catablasm and production method thereof are following:
Backing layer: artificial cloth
Lid lining: polypropylene film
Ointment-containing body layer component constitutes following by weight:
Method for preparing: take by weighing gelatin, sodium carboxymethyl cellulose, methylcellulose, polyvinylpyrrolidone (PVPK-90), sorbitol, add purified water 50g immersion by recipe quantity; The heating in water bath swelling; Other gets sodium polyacrylate, micropowder silica gel, propylene glycol and mixes the back and add in the above-mentioned swelling solution, behind the stirring and evenly mixing, adds the suspension of PEG400 and Herba Saussureae Involueratae extract again; Stirred for several minute, mastic.Be uniformly coated on then on the non-woven fabrics, cover polypropylene film, shear and promptly get saussurea involucrata catablasm.
Above-mentioned saussurea involucrata catablasm is through pharmacodynamics test, and its exercising result at antiinflammatory, ease pain is following:
(1) antiinflammatory action
Choose 50 of Kunming kind white mice, be divided into 5 groups at random, 10 every group.Every white mice buttocks loses hair or feathers with depilatory, sticks in the depilation district and is tried thing accordingly.1 group is pasted the saussurea involucrata catablasm high dose and contains extract powder 60mg/kg; Dosage contains extract powder 30mg//kg in 2 groups of subsides saussurea involucrata catablasms; 3 groups of subsides saussurea involucrata catablasm low dosages contain extract powder 15mg/kg, and 4 groups are pasted the positive drug QIZHENG ZHENTONG GAO, and 5 groups is not drug of blank matrix group.Behind the 24h with 5 seconds of xylene cotton balls contact mouse right ear; The post-tensioning neck was put to death in 15 minutes, the mice ears was downcut scales/electronic balance weighing with card punch with the position homalographic; With left ear is contrast; Left and right sides auricle weight difference calculates auris dextra inflammation swelling degree as the index of swelling degree, and the result carries out statistical procedures (like table 1).
Statistical result shows: basic, normal, high dose groups of saussurea involucrata catablasm and blank group relatively have significant differences (P＜0.01), and commercially available positive control drug QIZHENG ZHENTONG GAO group and blank group relatively have significant difference (P＜0.05).The result shows, the reaction that can both obviously reduce inflammation of basic, normal, high group of saussurea involucrata catablasm and QIZHENG ZHENTONG GAO group can find out that through the reduction of swelling degree its effect also is superior to commercially available QIZHENG ZHENTONG GAO like product.
(2) analgesic activity
Choose 50 of Kunming kind white mice, be divided into 5 groups at random, 10 every group.Every white mice buttocks loses hair or feathers with depilatory, sticks in the depilation district and is tried thing accordingly.1 group is pasted the saussurea involucrata catablasm high dose and contains extract powder 60mg/kg; Dosage contains extract powder 30mg/kg in 2 groups of subsides saussurea involucrata catablasms; 3 groups of subsides saussurea involucrata catablasm low dosages contain extract powder 15mg/kg, and 4 groups are pasted the positive drug QIZHENG ZHENTONG GAO, and 5 groups is not drug of blank matrix group.The 24h pneumoretroperitoneum is injected 0.7% acetic acid, every 10g body weight 0.1mL.Turn round the body number of times in the counting 15min, calculate suppression ratio, and carry out statistical procedures (like table 2) turning round body number of times result by following formula.
Statistical result shows: saussurea involucrata catablasm height, middle dose groups and blank group relatively have significant differences (P＜0.01); And saussurea involucrata catablasm low dose group, commercially available positive control drug QIZHENG ZHENTONG GAO group and blank group relatively have significant difference (P＜0.05); We can find out according to statistical result; The pain that the peritonitis that the saussurea involucrata catablasm Dichlorodiphenyl Acetate causes causes has the obvious suppression effect; Can find out with the blank group significant difference is arranged relatively through turning round the minimizing of body number of times, its effect also is superior to commercially available QIZHENG ZHENTONG GAO like product.
(3) mice formaldehyde shock reaction method (pain model of itching)
Choose 40 of Kunming kind white mice, be divided into 4 groups at random, 10 every group.Every white mice buttocks loses hair or feathers with depilatory, sticks in the depilation district and is tried thing accordingly.1 group of subsides saussurea involucrata catablasm high dose contains extract powder 60mg/kg, and dosage contains extract powder 30mg/kg in 2 groups of subsides saussurea involucrata catablasms, and 3 groups of subsides saussurea involucrata catablasm low dosages contain extract powder 15mg/kg, and 4 groups is not drug of blank matrix group.Inject 0.5% formaldehyde, 25 Ma in the right back foot of mice behind the 24h; And mice licks the reaction of stinging metapedes in the record 15min; Calculate the diversity between http://www.studa.net/pc/ and comparable group; Statistical result shows: saussurea involucrata catablasm height, middle dose groups and blank group relatively have significant differences (P＜0.01), and saussurea involucrata catablasm low dose group and blank group relatively have significant difference (P＜0.05).The result shows, licks behind the blank matrix group injection formaldehyde and stings the metapedes strong reaction, and whole body is restless, anxious.These article of giving can reduce mice to be licked and stings the metapedes time, and mice is comparatively quiet, and along with dosage increases and effect is strengthened, presents certain dose-effect relationship, sees table 3.
Results of pharmacodynamic test shows; Saussurea involucrata catablasm of the present invention has obvious antagonism chemistry pain caused (writhing method), suppresses shock reaction (mice formaldehyde method) and antiinflammatory action (the scorching method of caused by dimethylbenzene xylene); And presenting the dose-effect relationship mode, this test provides necessary pharmacodynamics foundation for saussurea involucrata catablasm is used for clinical antalgic and inflammation relieving.
(4) product irritant test of the present invention
The molding saussurea involucrata catablasm is affixed on 10 trial volunteer wrist backs, and to film residual, skin tracing ability, comfort, skin malaise symptoms, take off and pull pain etc. and estimate, the result sees table 4.
The result shows: product saussurea involucrata catablasm of the present invention to film residual, skin tracing ability, comfort, skin malaise symptoms, take off that to pull pain all better, can take off repeatedly and pull and apply ointment or plaster.The result discloses the present invention, and to produce the product saussurea involucrata catablasm good to biocompatibility, affinity, breathability, the absorption of perspiration of skin, and be not easy allergy.
Table 1 saussurea involucrata catablasm is to the influence (
n=10) of mice ear
| Group | Dosage (mg/kg) | Swelling degree (* 10 -4g) | The P value |
| The |
0 | 98.8±13.3 | ? |
| The pain that very just disappearing |
30 | 78.7±10.1 | ＜0.05 |
| The saussurea involucrata catablasm |
15 | 60.1±9.7 | ＜0.01 |
| Dose groups in the saussurea involucrata catablasm | 30 | 55.6±10.4 | ＜0.01 |
| The saussurea involucrata catablasm high dose group | 60 | 48.7±8.9 | ＜0.01 |
Table 2 saussurea involucrata catablasm is to the influence (
n=10) of mouse writhing reaction
The influence (
n=10) that table 3 saussurea involucrata catablasm is itched and reacted bitterly mice
Table 4 saussurea involucrata catablasm irritant test
Claims (6)
1. a saussurea involucrata catablasm is made up of backing layer, ointment-containing body layer and lid lining, it is characterized in that:
The ointment-containing body layer component consists of by parts by weight of raw materials:
Herba Saussureae Involueratae extract: 1 weight portion to 8 weight portion;
Sticker: 4 weight portion to 15 weight portions;
Wetting agent: 20 weight portion to 40 weight portions;
Filler: 3 weight portion to 15 weight portions;
Thickening agent: 1 weight fraction to 10 weight portion;
Cross-linking agent: 0 weight portion to 2 weight portion;
Transdermal enhancer: 2 weight portion to 15 weight portions;
Described Herba Saussureae Involueratae extract contains 0.5% to 1.2% syringoside, 7% to 17% chlorogenic acid and 8% to 25% rutin by weight percentage,
And described Herba Saussureae Involueratae extract obtains by following step:
(1) gets Herba Saussureae Involueratae, pulverize, put into extraction pot; Using concentration is that 6 to 12 times of amounts of ethanol of 60% to 90% are extracted 2 to 4 times, each 1 to 3 hour, and merge extractive liquid; Extracting liquid filtering, put coldly, centrifugal, supernatant concentration obtains every milliliter of concentrated solution that contains crude drug 0.1 gram to 0.5 gram;
(2) getting above-mentioned concentrated solution adjust pH is 1 to 5; Last macroporous resin carries out purification, and the macroporous resin type is a kind of among AB-8, D101, HPD100, HPD400 and the HPD600, and the post blade diameter length ratio is 1:5 to 1:9; Last appearance volume is 3BV to 6BV; Remove aqueous solution impurity with 3BV to 6BV sour water eluting, reuse 2BV to 6BV 30% ethanol, 2BV to 6BV 50% ethanol is eluting respectively, merges eluent; Eluent reclaims ethanol and concentrate drying to 20 ℃ relative density is 1.05～1.20 thick paste or processes dried cream powder, promptly obtains Herba Saussureae Involueratae extract.
2. according to the saussurea involucrata catablasm of claim 1, it is characterized in that:
The employed back lining materials of described backing layer is selected from a kind of in cotton, non-woven fabrics or the paper;
The employed lid lining material of described lid lining protecting film is selected from a kind of in separate paper, plastic sheeting, polyester, aluminium foil-polyethylene composite film or the hard gauze.
3. a saussurea involucrata catablasm is made up of backing layer, ointment-containing body layer and lid lining, it is characterized in that:
Backing layer: non-woven fabrics
Lid lining: polyethylene film
Ointment-containing body layer component constitutes following by weight:
And described Herba Saussureae Involueratae extract powder obtains by following step:
(1) gets Herba Saussureae Involueratae, pulverize, put into extraction pot; Using concentration is that 6 to 12 times of amounts of ethanol of 60% to 90% are extracted 2 to 4 times, each 1 to 3 hour, and merge extractive liquid; Extracting liquid filtering, put coldly, centrifugal, supernatant concentration obtains every milliliter of concentrated solution that contains crude drug 0.1 gram to 0.5 gram;
(2) getting above-mentioned concentrated solution adjust pH is 1 to 5; Last macroporous resin carries out purification; The macroporous resin type is a kind of among AB-8, D101, HPD100, HPD400 and the HPD600, and the post blade diameter length ratio is 1:5 to 1:9, and last appearance volume is 3BV to 6BV; Remove aqueous solution impurity with 3BV to 6BV sour water eluting; Reuse 2BV to 6BV 30% ethanol, 2BV to 6BV 50% ethanol is eluting respectively, merges eluent, and eluent reclaims ethanol and concentrate drying to 20 ℃ relative density is 1.05～1.20 thick paste or processes dried cream powder.
4. a saussurea involucrata catablasm is made up of backing layer, ointment-containing body layer and lid lining, it is characterized in that:
Backing layer: non-woven fabrics
Lid lining: polyester film
Ointment-containing body layer component constitutes following by weight:
And described Herba Saussureae Involueratae extract obtains by following step:
(1) gets Herba Saussureae Involueratae, pulverize, put into extraction pot; Using concentration is that 6 to 12 times of amounts of ethanol of 60% to 90% are extracted 2 to 4 times, each 1 to 3 hour, and merge extractive liquid; Extracting liquid filtering, put coldly, centrifugal, supernatant concentration obtains every milliliter of concentrated solution that contains crude drug 0.1 gram to 0.5 gram;
(2) getting above-mentioned concentrated solution adjust pH is 1 to 5; Last macroporous resin carries out purification, and the macroporous resin type is a kind of among AB-8, D101, HPD100, HPD400 and the HPD600, and the post blade diameter length ratio is 1:5 to 1:9; Last appearance volume is 3BV to 6BV; Remove aqueous solution impurity with 3BV to 6BV sour water eluting, reuse 2BV to 6BV 30% ethanol, 2BV to 6BV 50% ethanol is eluting respectively, merges eluent; Eluent reclaims ethanol and concentrate drying to 20 ℃ relative density is 1.05～1.20 thick paste or processes dried cream powder, promptly obtains Herba Saussureae Involueratae extract.
5. a saussurea involucrata catablasm is made up of backing layer, ointment-containing body layer and lid lining, it is characterized in that:
Backing layer: non-woven fabrics
Lid lining: polyester film
Ointment-containing body layer component constitutes following by weight:
And described Herba Saussureae Involueratae extract obtains by following step:
(1) gets Herba Saussureae Involueratae, pulverize, put into extraction pot; Using concentration is that 6 to 12 times of amounts of ethanol of 60% to 90% are extracted 2 to 4 times, each 1 to 3 hour, and merge extractive liquid; Extracting liquid filtering, put coldly, centrifugal, supernatant concentration obtains every milliliter of concentrated solution that contains crude drug 0.1 gram to 0.5 gram;
(2) getting above-mentioned concentrated solution adjust pH is 1 to 5; Last macroporous resin carries out purification, and the macroporous resin type is a kind of among AB-8, D101, HPD100, HPD400 and the HPD600, and the post blade diameter length ratio is 1:5 to 1:9; Last appearance volume is 3BV to 6BV; Remove aqueous solution impurity with 3BV to 6BV sour water eluting, reuse 2BV to 6BV 30% ethanol, 2BV to 6BV 50% ethanol is eluting respectively, merges eluent; Eluent reclaims ethanol and concentrate drying to 20 ℃ relative density is 1.05～1.20 thick paste or processes dried cream powder, promptly obtains Herba Saussureae Involueratae extract.
6. a saussurea involucrata catablasm is made up of backing layer, ointment-containing body layer and lid lining, it is characterized in that:
Backing layer: artificial cloth
Lid lining: polypropylene film
Ointment-containing body layer component constitutes following by weight:
And described Herba Saussureae Involueratae extract obtains by following step:
(1) gets Herba Saussureae Involueratae, pulverize, put into extraction pot; Using concentration is that 6 to 12 times of amounts of ethanol of 60% to 90% are extracted 2 to 4 times, each 1 to 3 hour, and merge extractive liquid; Extracting liquid filtering, put coldly, centrifugal, supernatant concentration obtains every milliliter of concentrated solution that contains crude drug 0.1 gram to 0.5 gram;
(2) getting above-mentioned concentrated solution adjust pH is 1 to 5; Last macroporous resin carries out purification, and the macroporous resin type is a kind of among AB-8, D101, HPD100, HPD400 and the HPD600, and the post blade diameter length ratio is 1:5 to 1:9; Last appearance volume is 3BV to 6BV; Remove aqueous solution impurity with 3BV to 6BV sour water eluting, reuse 2BV to 6BV 30% ethanol, 2BV to 6BV 50% ethanol is eluting respectively, merges eluent; Eluent reclaims ethanol and concentrate drying to 20 ℃ relative density is 1.05～1.20 thick paste or processes dried cream powder, promptly obtains Herba Saussureae Involueratae extract.
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| CN103083675A (en) * | 2011-11-02 | 2013-05-08 | 上海惠元医院有限公司 | Traditional Chinese medicine vertebral cataplasm substrate and preparation method thereof |
| CN102641371A (en) * | 2012-05-08 | 2012-08-22 | 辽宁中医药大学附属医院 | Cataplasma for treating body surface infectious diseases |
| CN103784524A (en) * | 2012-10-30 | 2014-05-14 | 天津药物研究院 | Preparation method and application of traditional Chinese medicine compound transdermal preparation capable of inhibiting inflammation and suppressing pains |
| CN104435043A (en) * | 2014-12-05 | 2015-03-25 | 新疆银朵兰维药股份有限公司 | Medicine for treating arthritis-induced arthralgia and preparation method thereof |
| CN105709189A (en) * | 2016-02-16 | 2016-06-29 | 广东泰宝医疗科技股份有限公司 | Method for preparing temperature sensitive physiotherapy analgesic |
| CN110063961B (en) * | 2019-06-02 | 2022-07-12 | 吉林农业大学 | New application of eleutheroside B |
| CN111184851A (en) * | 2019-10-09 | 2020-05-22 | 辽宁中医药大学附属医院 | Fujiubau cream and preparation method thereof |
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| CN101041653A (en) * | 2007-04-21 | 2007-09-26 | 中国科学院新疆理化技术研究所 | Method for extracting and enriching saussurea involucrate total flavone |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101041653A (en) * | 2007-04-21 | 2007-09-26 | 中国科学院新疆理化技术研究所 | Method for extracting and enriching saussurea involucrate total flavone |
Non-Patent Citations (1)
| Title |
|---|
| 张萍等.近五年中药巴布剂的研究进展.《中国现代中药》.2007,第9卷(第1期),30-32，35. * |
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