CN103110787B - Compound trauma cream and preparation method thereof - Google Patents
Compound trauma cream and preparation method thereof Download PDFInfo
- Publication number
- CN103110787B CN103110787B CN201310070884.3A CN201310070884A CN103110787B CN 103110787 B CN103110787 B CN 103110787B CN 201310070884 A CN201310070884 A CN 201310070884A CN 103110787 B CN103110787 B CN 103110787B
- Authority
- CN
- China
- Prior art keywords
- parts
- radix
- sodium
- cream
- cataplasma
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a compound trauma cream. The compound trauma cream is cataplasmata which is prepared from murraya paniculata, largespike woodnettle root, toddalia, pink reineckea herb, oxalidaceae, alangium chinense harms, giant knotweed, pseudo-ginseng, methyl salicylate, camphor, borneol, menthol, glycerin, polyacrylate sodium, sodium carboxymethyl cellulose, glutin, sodium carbonate and pure water. According to the compound trauma cream and the preparation method thereof disclosed by the invention, a water-soluble high-molecular compound is used as a substrate and refined with the traditional Chinese medicine extract to form the cataplasmata; the cataplasmata not only can improve the compatibility and the affinity of the medicine and the skin and can improve the transdermal absorbing capacity, but also is large in drug loading capacity, high in bioavailability, long in moisture preserving period, strong in perspiration resistance, capable of being repeatedly pasted, small in thrill and not capable of causing skin allergy.
Description
Technical field
The present invention relates to a kind of compound recipe Shangfuninggao and preparation method thereof, belong to the field of medicine technology.
Background technology
Traumatic injury is in daily life for seemingly homely food of some people, Chinese traditional treatment traumatic injury has the history of several thousand, ancient claim that " traumatic injury " is the introduction of all wounds, how because of External Force Acting, or overexert and cause in the situation of self fault.The traditional Chinese medical science so that internal organs are impaired etc., is referred to as traumatic injury all muscles and bones traumas causing in human body because of External Force Acting, swelling and pain due to blood stasis, disharmony between QI and blood, blockage of main and collateral channels.It is stagnant that its main pathology is that congestion is stopped up, and the blood resistance of holding one's breath, therefore taking pain, swelling as main manifestations.Treat mainly with promoting blood circulation to remove obstruction in the collateral, relaxing muscles and tendons and promoting circulation of QI, reducing swelling and alleviating pain is method, curative effect is also comparatively obvious.
Compound recipe Shangfuninggao is prepared from by Caulis et folium gaultheriae yunnanensis, largespike woodnettle root, Radix Toddaliae Asiaticae, Herba Reineckeae Carneae, Vat slurry grass, Radix Alangii, Rhizoma Polygoni Cuspidati, Radix Notoginseng, methyl salicylate, Camphora, Borneolum Syntheticum, Mentholum and adjuvant.Modern pharmacological research proves, compound recipe Shangfuninggao has blood circulation promoting and blood stasis dispelling, effect of reducing swelling and alleviating pain, the limbs pain causing for various traumatic injury has definite curative effect, the method of existing production compound recipe Shangfuninggao be generally adopt drug standard (WS-10989(ZD-0989)-2002) on method, the preparation that above-mentioned standard is recorded is rubber-emplastrum, the rubber-emplastrum that described method is made easily produces pain in the time peeling off, skin is had to certain zest and anaphylaxis, especially can not use especially for the patient who has wound, above drawbacks limit the clinical practice of compound recipe Shangfuninggao.If it is long to be changed system into the moisturizing phase, absorption of perspiration is strong, can repeatedly notice, without sensitization and irritating preparation be patient in the urgent need to.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of compound recipe Shangfuninggao and preparation method thereof.Compound recipe Shangfuninggao of the present invention is cataplasma, and the moisturizing phase is long, and absorption of perspiration is strong, can repeatedly notice, without sensitization and zest.
For solving the problems of the technologies described above, the present invention realizes by the following technical solutions:
A kind of compound recipe Shangfuninggao, calculate according to composition by weight, it is by Caulis et folium gaultheriae yunnanensis 162-800 part, 800 parts of largespike woodnettle root 162-, Radix Toddaliae Asiaticae 130-600 part, Herba Reineckeae Carneae 162-800 part, Vat starches careless 130-600 part, Radix Alangii 97.5-450 part, Rhizoma Polygoni Cuspidati 162-800 part, Radix Notoginseng 162-800 part, methyl salicylate 32.5-150 part, Camphora 21.12-100 part, Borneolum Syntheticum 35.75-170 part, Mentholum 27.62-130 part, 7600 parts of glycerol, sodium polyacrylate 266-1250 part, sodium carboxymethyl cellulose 88-450 part, gelatin 133-650 part, sodium carbonate 22-120 part, purified water 1333-6200 part is prepared from.
Specifically, aforesaid compound recipe Shangfuninggao calculates according to composition by weight, is prepared from by 6000 parts of 737 parts of Caulis et folium gaultheriae yunnanensiss, 737 parts of largespike woodnettle roots, 592 parts of Radix Toddaliae Asiaticaes, Herba Reineckeae Carneae 737 592 parts of Fen, Vat slurry grass, 444 parts of Radix Alangiis, 737 parts of Rhizoma Polygoni Cuspidati, 737 parts of Radix Notoginseng, 148 parts of methyl salicylate, 96 parts of Camphoras, 163 parts of Borneolum Syntheticums, 126 parts of Mentholums, 7600 parts of glycerol, 1200 parts of sodium polyacrylate, 400 parts of sodium carboxymethyl cellulose, 600 parts, gelatin, 100 parts of sodium carbonate, purified water.
The preparation method of aforesaid compound recipe Shangfuninggao is: above-mentioned raw materials and adjuvant are prepared into cataplasma according to common process.
Specifically, such preparation of described cataplasma:
1. Caulis et folium gaultheriae yunnanensis, largespike woodnettle root, Radix Toddaliae Asiaticae, Herba Reineckeae Carneae, Vat slurry grass, Radix Alangii, Rhizoma Polygoni Cuspidati and Radix Notoginseng powder are broken into coarse powder, with 90% ethanol extraction secondary, each 1.5h, filters, decompression filtrate recycling ethanol the extractum that relative density is 1.28 while being concentrated into 40 DEG C;
2. Borneolum Syntheticum, Mentholum, Camphora are pulverized after and methyl salicylate miscible, stir evenly;
3. step solution and step extractum 1. is 2. mixed;
4. sodium carbonate is poured in purified water and dissolved, gelatin is poured in the aqueous solution of sodium carbonate, naturally swelling in 50 DEG C of water-baths;
5. sodium polyacrylate, sodium carboxymethyl cellulose and glycerol mix, and pour in step mixture 3., stir;
6. 4. step is put into and stirred together with step solution 5., obtain colloid, be coated with cream, cutting, lid serves as a contrast, cuts into slices, packs and get final product.
The present invention is prepared from by Caulis et folium gaultheriae yunnanensis, largespike woodnettle root, Radix Toddaliae Asiaticae, Herba Reineckeae Carneae, Vat slurry grass, Radix Alangii, Rhizoma Polygoni Cuspidati, Radix Notoginseng, methyl salicylate, Camphora, Borneolum Syntheticum, Mentholum and adjuvant.Wherein: Caulis et folium gaultheriae yunnanensis is the stem and leaf of ericad Yunnan Gaultheria, being distributed in the ground such as Yunnan, Sichuan, Guizhou, Guangxi, is traditional Miao Ethnomedicine.Cure mainly Fengshi Guanjie pain, traumatic injury.Its main medicinal chemical composition is methyl salicylate, emergence therapeutic for soft tissue injury, as sprain, myalgia etc.Largespike woodnettle root is the dry herb of contrayerva bulbil Chinese mugwort fiber crops, is Guizhou minority nationality medication, is mainly distributed in Guizhou, has effect of expelling wind and removing dampness, blood circulation promoting and blood stasis dispelling.Its ethanol extract has obvious analgesic activities.Radix Toddaliae Asiaticae is the root of rutaceae Radix Toddaliae Asiaticae, is mainly distributed in the ground such as Yunnan, Sichuan, Guizhou, Guangxi, is Guizhou traditional national medicine.Be used for the treatment of dissipating blood stasis hemostasis, expelling wind and removing dampness, subduing swelling and detoxicating.Main active is the Alcohol soluble compositions such as Coumarins and alkaloids.Herba Reineckeae Carneae has another name called Premna microphylla Turez, is that Liliaceae Herba Reineckeae Carneae belongs to the green herbaceous plant of perennation, is mainly distributed in Southwestern China area, and Miao Ethnomedicine external is mashed wine stir-fry and applied, for cooling blood for hemostasis, injury from falling down.Herba Reineckeae Carneae mainly contains the chemical composition such as steroid saponin, sapogenin, has the effect such as relieving cough and resolving phlegm, anti-inflammatory.Vat slurry Cao, Wei the fresh or dry herb of Vat slurry Cao Ke Vat slurry grass, all has distribution all over China, is Minority Nationalities in Guizhou medication.For clearing away heat-damp and promoting diuresis, removing heat from blood detumescence, removing toxic substances scattered silt.Radix Alangii is the dry thin fibrous root of Alangiaceae plant Radix Alangii and melon wood.Mainly being distributed in Guizhou, is Guizhou characteristic ethnic drug, can expelling wind and removing dampness, soothing the channels and quicking the network vessels, eliminating stasis to stop pain.Rhizoma Polygoni Cuspidati main active is resveratrol and emodin, and resveratrol has effect of expelling wind and removing dampness, eliminating stasis to stop pain, and emodin has very strong antibacterial activity.Radix Notoginseng primary treatment treating swelling and pain by traumatic injury, traumatic hemorrhage.Methyl salicylate is esters medicine, is usually used in, in external preparation, having the effects such as inflammation-resisting itch-stopping.Camphora is applied to skin gentle stimulation and antisepsis.Have refrigerant sense, have dehumidifying parasite killing, warming and odynolysis, has one's ideas straightened out and wards off dirty effect.Cure mainly scabies pruritus, traumatic pain, toothache.Borneolum Syntheticum chemical composition is mainly Borneolum Syntheticum.There is antibacterial, antiinflammatory, analgesia and promote the effect of Drug Percutaneous Absorption.Mentholum is colourless needle-like or prism-shaped crystallization or white crystalline powder, there is the special aroma of Herba Menthae, taste is just scorching hot rear refrigerant, alcoholic solution is aobvious neutral anti-straight, its preparation optionally sense of cold Meng receiver of chafe or mucosa produces sense of cold reflection, cause mucocutaneous vasoconstriction, there is antipruritic, pain relieving, anticorrosion refrigerant effect.Camphora, Borneolum Syntheticum, Mentholum, methyl salicylate promote the function of Transdermal absorption in addition.
The present invention, on the basis of existing compound recipe Shangfuninggao standard, changes system into cataplasma by it by rubber-emplastrum, starts with from preparation aspect, reduces zest and the sensitization of medicine.In side, Borneolum Syntheticum, Mentholum, Camphora are containing volatile ingredient, and the merit of a short infiltration and the meridians of living, is ground rear and methyl salicylate is miscible, stir evenly, without enclose, direct and clear paste mixes and makes its volatile ingredient infiltration reach maximum, to improve the Transdermal absorption function of cataplasma; Sodium carbonate will be dissolved by purified water in addition, then gelatin be poured in the aqueous solution of sodium carbonate, naturally fully swelling with for subsequent use in 50 DEG C of water-baths, the method has improved the swelling rate of gelatin, shortens swelling time.
Compared with prior art, cataplasma tool of the present invention has the following advantages:
1, cataplasma made by medicine by the present invention, starts with from preparation aspect, reduced zest and the sensitization of medicine;
2, the present invention selects hydrophilic matrix, comprises the material without uv absorption such as sodium polyacrylate, sodium carboxymethyl cellulose, gelatin, glycerol, does not affect the assay of medicine.Add sodium carbonate to increase system alkali environment, not only can soften skin, be easy to the effective ingredient in absorbing the drug, can increase the viscosity of sodium polyacrylate simultaneously.
3, the present invention is taking water-soluble high-molecular compound as substrate, close through refining the emplastrum forming with Chinese medicine extract, the compatibility and the affinity of medicine and skin are not only improved, improve Transdermal absorption amount, and drug loading is large, bioavailability is high, it is long to have the moisturizing phase, absorption of perspiration is strong, can repeatedly notice, and zest is little, can not cause skin allergy.
4, technique simple possible of the present invention, easy operating, in production process to Producer without injury, do not need organic solvent exposure, production safety coefficient high, without the three wastes and three-waste free discharge, can be to environment.
Applicant has carried out following experiment, and provable the present invention has effective effect.
experimental example 1: the research of medicinal material extract technique
1. medicinal material extract technical study
Primary standard technique: medical material adopts and is ground into after coarse powder, with 90% ethanol extraction secondary, each 2h, filtration, filtrate recycling ethanol and to be concentrated into relative density be 1.28(40 DEG C) extractum.
The present invention adopts L
9(3
4) experiment of orthogonal trial factor level, adopting emodin in Rhizoma Polygoni Cuspidati is index, preferably optimum extraction process.
Table 1 factor level table
Table 2 L
9(3
4) orthogonal table
The variance analysis of table 3 emodin
F
1-0.1(2,2)=9.00 F
1-0.05(2,2)=19.00
Shown by the results of analysis of variance, the impact of the extraction ratio of A factor on emodin is comparatively remarkable, and D factor also has impact in this experimental design, and B, C are to the experimental result indifference opposite sex, according to table 3 intuitive analysis and table 4 the results of analysis of variance, selected optimum extraction process is A
3b
3c
2d
2.90% concentration of alcohol is measured alcohol reflux 2 times with 12 times, and each extraction time is 1.5h.
Ethanol reclaims and the concentration time of medicinal liquid has content to have a significant effect to methyl salicylate, former rubber paste production technology is that filtrate recycling ethanol is concentrated into relative density 1.28(40 DEG C) fluid extract, when its main cause is that density is low, its moisture is too high, on the impact that forms of rubber paste, and reduce its active constituent content, as density is greater than 1.28(40 DEG C), fluid extract is too dense, cannot mix with substrate, viscous force after molding is had to considerable influence, also reduced the content of methyl salicylate simultaneously.So we keep relative density consistent with former technique in the process of dosage changing form.
2. preferably extraction process checking
For investigating the stability of above-mentioned selection process, extract by above-mentioned research optimum process condition, parallel 3 samples, each experiment is consistent with orthogonal experiment extraction process, and 90% concentration of alcohol is measured alcohol reflux 2 times with 12 times, and each extraction time is 1.5h.Extracting solution concentrates laggard HPLC, measures emodin content.
Table 4
3. other become divisional processing
Camphora, Borneolum Syntheticum, Mentholum, methyl salicylate are the medicine of the transdermal enhancing effect that emplastrum is conventional, owing to all thering is volatility, so adopt crude drug directly to join in preparation, this technique can retain the effumability compositions such as Camphora, Mentholum, Borneolum Syntheticum, methyl salicylate preferably.
experimental example 2: substrate prescription optimization experiment
In the present invention, binding agent is selected sodium polyacrylate, sodium carboxymethyl cellulose and gelatin; Wetting agent is selected glycerol; Filler is Chinese medicine extraction extractum.Add a certain amount of gelatin can make cataplasma there is good elasticity.
1. adjuvant just screens
The screening of 1.1 stickers:
At present conventional sticker mainly comprises: the macromolecular material class taking gelatin, arabic gum as the natural glue of representative, taking carbomer and sodium polyacrylate as representative.The present invention has mainly investigated the impact on bar cloth cream viscous force of gelatin, carbomer, sodium polyacrylate, arabic gum and their different proportionings, thereby selects best adhesion strength prescription.
Whether method: respectively gelatin, sodium polyacrylate, arabic gum and the two are share mutually, same to CMC-Na, glycerol, extractum, water mix, investigate after its molding cohesiveness, viscosity and permeate for judge index, selects best stickum.The results are shown in Table 5.
The impact of table 5 sticker kind on cataplasma performance
Better as sticker effect by gelatin+sodium polyacrylate system as seen by table 5.
The selection of 1.2 cross-linking agent: with reference to Japanese lignocaine cataplasma prescription, its cross-linking agent is selected tartaric acid and dihydroxy aluminum glycinate, and aluminium ion is wherein combined with macromolecule polyacrylic acid sodium, strengthens its cohesiveness.This experiment selects aluminum chloride and tartaric acid as cross-linking agent.Result show cohesiveness strengthen, but viscous force reduce, add carbamide to viscous force without any change.
The selection of 1.3 filleies: bar cloth cream filler can be selected kaolin and kieselguhr, and because this prescription is prescriptions of Chinese medicine, methyl salicylate amount is excessive, has reducing effect to viscous force after adding filler, and when after filling dose increase, cataplasma is without viscous force.Therefore test taking Chinese medical concrete as filler.
The selection of 1.4 wetting agents: wetting agent is selected propylene glycol and glycerol, result shows that propylene glycol can significantly reduce mastic viscous force and cohesiveness as wetting agent, bar cloth cream and skin adhesion are little, easily come off.And glycerol can have good viscous force and cohesiveness with skin as wetting agent.The two mixed effect is not as alone glycerol in addition.So it is wetting agent that this preparation is selected glycerol.
In sum, finally we to select sodium polyacrylate, sodium carboxymethyl cellulose and gelatin be binding agent; Glycerol is as wetting agent; Filler is Chinese medicine extraction extractum.
2. orthogonal experiment
2.1 orthogonals: by preliminary experiment, selecting glycerol, sodium polyacrylate, CMC-Na, binding agent, water is investigation factor, carry out five factor 4 level experiments, and orthogonal factor level is in table 6.
Table 6 horizontal factor table
Prescription compound method: by the amount of recipe design, 1. phase: sodium polyacrylate, glycerol, CMC-Na, fluid extract are miscible; 2. phase: binding agent, water heating for dissolving.1.+and 2. at water-soluble 40 DEG C after stirring and evenly mixing, on self-control bar cloth cream coating instrument, being coated with, 37 DEG C, baking oven is dried 6h, to obtain final product.
The selection of control indexes: because cataplasma quality control index is more, cannot carry out comprehensive orthogonal investigation, and a lot of index is relevant with people's subjective judgment, there is no objectivity.Its objective evaluation is mainly viscosity and cohesiveness, and we select initial bonding strength and hold the Chinese medicine index that viscous force is its quality standard of evaluation for this reason.
Initial bonding strength is measured: adopt version pharmacopeia annex XII E emplastrum adhesion algoscopy slope spin in 2010 to measure, being about to a stainless steel ball rolls across from the test sample adhesive faces being placed in hang plate, the biggest ball steel ball that can cling according to test sample adhesive faces, evaluates its initial bonding strength.Concrete grammar is for getting 3 of test samples, be placed in (by 30 °, the inclination angle specifying under each kind item) inclination version central authorities, cream is towards upper, top, inclined-plane 10cm and bottom 15cm cover with the thick mylar of 0.025mm, centre reserves 5cm cream face, and the steel ball specifying under each kind item is freely rolled down from beveled top end.Finally average.Taking the maximum steel ball of adhered to as index, mobile spin position finding 3 times, averages.(meansigma methods/50) * 100% are initial bonding strength score value.
Holding viscous force measures: adopt version pharmacopeia annex XII E emplastrum in 2010 to hold amylograph and measure.Sample is removed test sample packaging material, room temperature is placed after 2h, test sample is cut into 5*7cm area, and adhesive faces sticks on brassboard, vertically places, on test sample, carry out rollback three times with pressure roller, after test sample is pasted onboard, place 20min, be fixed on experiment frame, the counterweight that below hangs 1kg quality, records test sample and slides onto the time coming off.(persistent period/50/20) * 100% is holds viscous force score value.
Consider the initial bonding strength of bar cloth cream and hold viscous force to be equal to importantly, therefore get equal weight coefficient, above-mentioned two scores are added, calculating integrate score, as the quantizating index of prescription screening in cataplasma.
Orthogonal experiment results: prepare the multiple peaceful cataplasma of compound recipe wound according to orthogonal table, room temperature is placed after 48h, in 37 DEG C of baking 6h of baking oven.Subsequently to sample initial bonding strength with hold viscous force and measure.Experimental result is in table 7, and variance analysis is in table 8.
Table 7 Orthogonal experiment results
Note: general comment is initial bonding strength and holds viscous force sum.
Table 8 variance analysis 8
Note:
f 0.05(3,3)=9.28
Shown by intuitive analysis and the results of analysis of variance, in 5 factors, glycerol and binding agent have appreciable impact to result.Determine that thus best prescription condition is A
1b
3c
4d
3e
2, i.e. glycerol: sodium polyacrylate: CMC-Na: binding agent: water=7.6:1.2:0.4:0.6:6.
2.2 formulation and technology checkings
Prepare 3 batches of compound recipe Shangfuninggaos according to best prescription technique, utilize above method measure initial bonding strength and hold viscous force, investigate the heavy linear of formulation and technology, the results are shown in following table.
Table 9 confirmatory experiment result
The result shows, orthogonal preferred result is reliable, has good predictability, and simple to operate being convenient to controlled.
3 discuss
Cataplasma is that a kind of novel externally applied transdermal absorbs unguentum, and its main judge index is viscosity and cohesiveness.Traditional Chinese medicine cataplasma and chemical medicine cataplasma by comparison, due to the complexity of its composition, the more difficult proportioning of substrate, viscosity is lower.In order more to embody a concentrated reflection of the multiple peaceful cataplasma quality of wound, we in screening process mainly around the initial bonding strength of cataplasma with hold viscous force and investigate.
In cataplasma preparation process, will strictly control technical process, except the kind and consumption of adjuvant, different addition sequences also can make cataplasma mass parameter change.Sodium polyacrylate should be first and glycerol mix, prevent its quick moisture absorption, the materials such as gelatin and water are fully swelling, otherwise can cause substrate inequality.
Cataplasma should be controlled its water content, and water content height not only can affect the adhesion property of plaster, can promote keratodermatitis softening simultaneously, is conducive to the absorption of medicine.
4. checking:
In prescription, adding sodium carbonate is the alkalescence in order to strengthen mastic, and under alkali condition, sodium polyacrylate viscosity strengthens.The amount that experiment adds sodium carbonate and sodium bicarbonate compares.And control the oven for drying time.
Obtain optimised process prescription by orthogonal experiment, get respectively blank, sodium carbonate 0.1,0.2,0.3g and sodium bicarbonate 0.14,0.2,0.3, the mono-factor of 0.4g is investigated, result demonstration adds sodium carbonate and sodium bicarbonate and negative control more all to increase viscous force, 0.1,0.2g sodium carbonate has good viscous force and cohesiveness, and 0.14,0.2g sodium bicarbonate has good viscous force and cohesiveness.The results are shown in following table:
Table 10
experimental example 3: comparative study
1. the rubber-emplastrum check item research comparative test that the cataplasma that the inventive method is made and primary standard are made
1.1 test materials: corrosion resistant plate, shears, different size steel ball, 2kg pressure roller, wrist-watch, spring scale etc.
1.2 test methods: the first viscous force of the rubber-emplastrum that the cataplasma that (1) just viscous force test is made according to " Chinese Pharmacopoeia " 2010 editions () annex XII E emplastrum adhesive force algoscopy first algoscopy mensuration the inventive method and primary standard are made.(2) cataplasma of the present invention is cut to 4cm × 10cm specification by peel strength, sticks on corrosion resistant plate, carrys out rollback press 3 times with heavy 2kg pressure roller on cataplasma, places 20min; About 1cm is opened in cataplasma one end, clamp with spring scale, become 180 with corrosion resistant plate
odirection is slowly peeled off, and does not have 2cm to record single reading, calculates 3 times reading meansigma methods.Be measured in the same method the peel strength of the unguentum that primary standard makes.
1.3 result of the tests:
Test and obtain following result according to test method, in table 11.
Just viscous force, peel strength research of table 11 relatively
As seen from the results in Table 3, the first viscous force of cataplasma of the present invention is the first viscous force 1.98g that 2.07g is greater than primary standard rubber-emplastrum; And the peel strength 4.44N of cataplasma of the present invention is less than primary standard rubber-emplastrum 4.95N, the relative primary standard rubber-emplastrum of cataplasma of the present invention is described, glutinous viscosity is good, easily peels off, and peels off the pain of generation while avoiding patient to change cream.
The zest of the rubber-emplastrum that the cataplasma that 2 the inventive method are made and primary standard are made, anaphylaxis contrast experiment's research
2.1 experiment materials: (1) medicine: primary standard rubber-emplastrum (specification 5cm × 6.5cm), cataplasma of the present invention, be cut to 5cm × 6.5cm specification.(2) reagent: DNFB (Tianjin Ke Miou, 20101201).(3) animal: male and female white big ear rabbit, 2～3kg; Albino guinea-pig, 210～230g, male and female half and half, are purchased from Guiyang Medical College.(4) other: shears, shaver.
2.2 experimental technique
2.2.1 irritation test
Get 8 of white big ear rabbits, divide two groups at random by body weight, intact skin group and damaged skin group, every group 4, before administration, centered by the vertebra of back, lose hair or feathers in both sides, depilation scope is respectively 3 cm × 3 cm, and damaged group firmly scratches skin with shaver after depilation, taking mild to moderate oozing of blood as degree.After 24h, primary standard glue cream is pasted in left side, right side loses money in a business and invents bar cloth cream, attach after 6 h, removing drug combination warm water cleans, in removing 1,24,48,72 h after medicine, observe and record the situation of change of rabbit skin, result is carried out irritant reaction scoring by table 12, calculate mean scores, carry out stimulus intensity evaluation by table 13.
Table 12 skin irritation reaction grade form
2.2.2 skin hypersensitivity experiment
40 of extracting waste Cavia porcelluss, divide 4 groups at random by body weight, 24h left side back depilation before administration, depilation scope 3cm × 3cm.Every group 10, blank group, sticks blank bar cloth cream; The 2nd group of positive matched group, smears positive sensitizer DNFB, and induced concentration is 1%, and exciting concentration is 0.1%; The 3rd group is that the present invention is subject to reagent group, sticks the multiple Ning Babu cream of compound recipe wound of the present invention; The 4th group is that primary standard is subject to reagent group, sticks the multiple peaceful rubber paste of primary standard compound recipe wound.Induction exposure: the 0th day by blank cling to cloth cream, 1% 2,4-dinitrochlorobenzene, the multiple Ning Babu cream of compound recipe of the present invention wound and the multiple peaceful rubber paste of primary standard compound recipe wound, impose on respectively depilation district, left side, time of contact 6h, remove afterwards each tested material, warm water is cleaned, and the 7th day and the 14th day, respectively with same method reprocessing, amount to 3 times and induce.Excite contact: the 28th day by blank cling to cloth cream, 1% 2,4-dinitrochlorobenzene, the multiple Ning Babu cream of compound recipe of the present invention wound and the multiple peaceful rubber paste of primary standard compound recipe wound are for depilation district, right side, after contact 6h, remove each tested material, warm water is cleaned, observe immediately, and in 24,48h observed and recorded skin allergy situation again.Result of the test is pressed the scoring of skin allergy standards of grading, according to the difference of test group and the performance of matched group guinea pig skin, judges the degree of tested material to skin allergy by table 14, judges its sensitization rate, and its hypersensitive is made to evaluation by table 15.
Table 14 skin allergy standards of grading
Note: sensitization rate=occur number of animals/animal subject number × 100% of erythema or edema.
2.3 result of the test
The zest of two kinds of cataplasmas, anaphylaxis experimental studies results are in table 16,17.
Table 16 irritant reaction complete to rabbit and damaged skin of back is marked
Shown by table 8 result, no matter cataplasma of the present invention is to integrity skin or the equal nonirritant of destructive skin; And primary standard rubber-emplastrum produces stimulation to intact skin, damaged skin is produced to serious stimulation.
Table 17 skin allergy test result
From table 9 result of the test: cataplasma of the present invention and blank cataplasma thereof to skin all without sensitization; Primary standard cataplasma has certain sensitization to skin, and in this test, its sensitization is up to 17.5%.
3, conclusion
The relative primary standard of the present invention, taking water-soluble high-molecular compound as substrate, close through refining the emplastrum forming with Chinese medicine extract, the cataplasma that the present invention makes not only has the principal advantages with skin with common cataplasmas such as the good compatibility, affinity and drug loading are large, bioavailability is high, and to skin nonirritant, do not cause skin allergy, glutinous viscosity is good and can take off the advantages such as cloth is good.Be better than the made rubber-emplastrum of former technique.
detailed description of the invention:
Embodiment 1:
Prescription: Caulis et folium gaultheriae yunnanensis 737g, largespike woodnettle root 737g, Radix Toddaliae Asiaticae 592g, Herba Reineckeae Carneae 737g, Vat starch careless 592g, Radix Alangii 444g, Rhizoma Polygoni Cuspidati 737g, Radix Notoginseng 737g, methyl salicylate 148g, Camphora 96g, Borneolum Syntheticum 163g, Mentholum 126g, glycerol 7600g, sodium polyacrylate 1200g, sodium carboxymethyl cellulose 400g, gelatin 600g, sodium carbonate 100g, purified water 6000g.
Technique:
1. Caulis et folium gaultheriae yunnanensis, largespike woodnettle root, Radix Toddaliae Asiaticae, Herba Reineckeae Carneae, Vat slurry grass, Radix Alangii, Rhizoma Polygoni Cuspidati and Radix Notoginseng powder are broken into coarse powder, with 90% ethanol extraction secondary, each 1.5h, filters, decompression filtrate recycling ethanol the extractum that relative density is 1.28 while being concentrated into 40 DEG C;
2. Borneolum Syntheticum, Mentholum, Camphora are pulverized after and methyl salicylate miscible, stir evenly;
3. step solution and step extractum 1. is 2. mixed;
4. sodium carbonate is poured in purified water and dissolved, gelatin is poured in the aqueous solution of sodium carbonate, naturally swelling in 50 DEG C of water-baths;
5. sodium polyacrylate, sodium carboxymethyl cellulose and glycerol mix, and pour in step mixture 3., stir;
6. 4. step is put into and stirred together with step solution 5., obtain colloid, be coated with cream, cutting, lid serves as a contrast, cuts into slices, packs and get final product.
Usage and consumption: external, paste affected part.
Claims (2)
1. a compound recipe Shangfuninggao, it is characterized in that: calculate according to composition by weight, it is by Caulis et folium gaultheriae yunnanensis 162-800 part, largespike woodnettle root 162-800 part, Radix Toddaliae Asiaticae 130-600 part, Herba Reineckeae Carneae 162-800 part, Vat starches careless 130-600 part, Radix Alangii 97.5-450 part, Rhizoma Polygoni Cuspidati 162-800 part, Radix Notoginseng 162-800 part, methyl salicylate 32.5-150 part, Camphora 21.12-100 part, Borneolum Syntheticum 35.75-170 part, Mentholum 27.62-130 part, 7600 parts of glycerol, sodium polyacrylate 266-1250 part, sodium carboxymethyl cellulose 88-450 part, gelatin 133-650 part, sodium carbonate 22-120 part, purified water 1333-6200 part is prepared from, above-mentioned raw materials and adjuvant are prepared into cataplasma according to common process, : such preparation of described cataplasma:
1. Caulis et folium gaultheriae yunnanensis, largespike woodnettle root, Radix Toddaliae Asiaticae, Herba Reineckeae Carneae, Vat slurry grass, Radix Alangii, Rhizoma Polygoni Cuspidati and Radix Notoginseng powder are broken into coarse powder, with 90% ethanol extraction secondary, 1.5h at every turn, filtration, decompression filtrate recycling ethanol the extractum that relative density is 1.28 while being concentrated into 40 DEG C;
2. Borneolum Syntheticum, Mentholum, Camphora are pulverized after and methyl salicylate miscible, stir evenly;
3. step solution and step extractum 1. is 2. mixed;
4. sodium carbonate is poured in purified water and dissolved, gelatin is poured in the aqueous solution of sodium carbonate, naturally swelling in 50 DEG C of water-baths;
5. sodium polyacrylate, sodium carboxymethyl cellulose and glycerol mix, and pour in step mixture 3., stir;
6. 4. step is put into and stirred together with step solution 5., obtain colloid, be coated with cream, cutting, lid serves as a contrast, cuts into slices, packs and get final product.
2. compound recipe Shangfuninggao as claimed in claim 1, it is characterized in that: calculate according to composition by weight, it is prepared from by 6000 parts of 737 parts of Caulis et folium gaultheriae yunnanensiss, 737 parts of largespike woodnettle roots, 592 parts of Radix Toddaliae Asiaticaes, Herba Reineckeae Carneae 737 592 parts of Fen, Vat slurry grass, 444 parts of Radix Alangiis, 737 parts of Rhizoma Polygoni Cuspidati, 737 parts of Radix Notoginseng, 148 parts of methyl salicylate, 96 parts of Camphoras, 163 parts of Borneolum Syntheticums, 126 parts of Mentholums, 7600 parts of glycerol, 1200 parts of sodium polyacrylate, 400 parts of sodium carboxymethyl cellulose, 600 parts, gelatin, 100 parts of sodium carbonate, purified water.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310070884.3A CN103110787B (en) | 2013-03-06 | 2013-03-06 | Compound trauma cream and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310070884.3A CN103110787B (en) | 2013-03-06 | 2013-03-06 | Compound trauma cream and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN103110787A CN103110787A (en) | 2013-05-22 |
| CN103110787B true CN103110787B (en) | 2014-07-23 |
Family
ID=48409193
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310070884.3A Active CN103110787B (en) | 2013-03-06 | 2013-03-06 | Compound trauma cream and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN103110787B (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104689273B (en) * | 2015-03-02 | 2018-02-16 | 贵州苗康医药科技有限公司 | A kind of external preparation of wind-expelling pain-stopping and preparation method thereof |
-
2013
- 2013-03-06 CN CN201310070884.3A patent/CN103110787B/en active Active
Non-Patent Citations (9)
| Title |
|---|
| 中药巴布剂亲水性基质的研究进展;赵斌等;《中华中医药学刊》;20080630;第26卷(第6期);1276-1278 * |
| 中药巴布剂及其生产设备研究进展;王艳艳等;《中国制药装备》;20111130(第32期);6-12、36 * |
| 中药巴布剂的研究进展;沈静等;《时珍国医国药》;20051231;第16卷(第1期);52-54 * |
| 中药巴布剂的研究进展;王雪等;《中医儿科杂志》;20070331;第3卷(第2期);54-57 * |
| 国家药品监督管理局编.复方伤复宁膏.《国家药品监督管理局 国家中成药标准汇编(中成药地方标准上升国家标准部分) 骨伤科分册》.2002,150-153. * |
| 沈静等.中药巴布剂的研究进展.《时珍国医国药》.2005,第16卷(第1期),52-54. |
| 王艳艳等.中药巴布剂及其生产设备研究进展.《中国制药装备》.2011,(第32期),6-12、36. |
| 王雪等.中药巴布剂的研究进展.《中医儿科杂志》.2007,第3卷(第2期),54-57. |
| 赵斌等.中药巴布剂亲水性基质的研究进展.《中华中医药学刊》.2008,第26卷(第6期),1276-1278. |
Also Published As
| Publication number | Publication date |
|---|---|
| CN103110787A (en) | 2013-05-22 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN105688166A (en) | Medical cold compress paster and preparation method thereof | |
| CN100542585C (en) | A kind of externally-applied medicinal composition with analgesia and antiinflammatory action | |
| CN109394737A (en) | Medical cold application and preparation method thereof | |
| CN1947739B (en) | Traditional Chinese medicine composition for treating dermal titillation and chronic eczema and its preparation method | |
| CN103041173A (en) | Traditional Chinese medicine external preparation for curing dermatitis and eczema and preparing method thereof | |
| CN101773551B (en) | External-use medicine composition of traditional Mongolian medicine for curing soft tissue injury | |
| CN102380015B (en) | Medicinal composition for treating rheumatoid arthritis and preparation method and application thereof | |
| CN104274546B (en) | A kind of external medicine composition, traditional Chinese medicine for outer use and its preparation method and application | |
| CN104147533A (en) | Blood-activating, stasis-resolving and pain-relieving cream and preparation method thereof | |
| CN104983989A (en) | Traditional Chinese medicine drug for treating dysmenorrheal and gel paste and preparation method thereof | |
| Kolhe | Evaluation of polyherbal ointment for wound healing activity in Wistar rats | |
| CN108578465A (en) | A kind of Chinese medicine composition and its preparation method and application | |
| CN103110787B (en) | Compound trauma cream and preparation method thereof | |
| CN104173591A (en) | Puer tea essential oil hydrogel patch and preparation method thereof | |
| CN103083520B (en) | Traditional Chinese cataplasm for traumatic injury as well as preparation method thereof | |
| CN110787261A (en) | Ointment for clearing heat, cooling blood, stopping bleeding, relieving swelling and promoting wound healing and preparation method thereof | |
| CN103800841A (en) | Pure traditional Chinese medicine drug for treating women mammary gland proliferation and preparation method thereof | |
| CN103356827A (en) | Cattail pollen adhesive bandage and preparation method thereof | |
| CN104940302A (en) | External traditional Chinese medicine for relieving pain and preparation method of external traditional Chinese medicine | |
| CN108403932A (en) | A kind of Chinese medicine compound prescription external preparation and its preparation method and application for treating steroid dependent dermatitis | |
| CN108567852A (en) | A kind of pharmaceutical composition of prevention diabetic neuropathy | |
| CN104523977A (en) | Anti-inflammatory analgesic ointment and preparation method thereof | |
| CN113730088A (en) | Thin-sheet type self-heating body eye patch and preparation process thereof | |
| CN105582060B (en) | A kind of pharmaceutical composition and its preparation method and application of anti-treating respiratory system disease | |
| CN102205091B (en) | Pharmaceutical composition for treating pain syndrome or arthralgia syndrome and preparation method and application thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |