CN101288772B - Novel medical hot melt resin carrier gel matrix and its preparation method and application - Google Patents
Novel medical hot melt resin carrier gel matrix and its preparation method and application Download PDFInfo
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- CN101288772B CN101288772B CN2008100183810A CN200810018381A CN101288772B CN 101288772 B CN101288772 B CN 101288772B CN 2008100183810 A CN2008100183810 A CN 2008100183810A CN 200810018381 A CN200810018381 A CN 200810018381A CN 101288772 B CN101288772 B CN 101288772B
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Abstract
The invention provides a novel medicinal thermal melting resin vector adhesive matrix which is made from a thermoplastic elastomer, medical resin, softerner, skin transdermal enhancer and excipient which are mixed in a way of melting according to a certain percentage. The novel medicinal thermal melting resin adhesive prepared by the invention is a substitute for traditional black plaster, adhesive plasters, cataplasm and attached agent matrix excipient. The novel medicinal thermal melting resin vector adhesive matrix of the invention achieves the requirement of new medicinal excipient declared by SFDA in aspects of preparation process, production equipment, drug standard, pilot-scale study, drug stability, experimental storage, etc. Emplastrum as the matrix which is produced by the novel medicinal thermal melting resin vector adhesive of the invention has the characteristics of large drug loading, fast drug releasing rate, high stability, small skin irritation, short production cycle, high efficiency, safety, environmental protection, etc.
Description
Technical field
The invention belongs to medical technical field, relate to a kind of substrate (adjuvant) that is used to prepare external transdermal administration emplastrum, be particularly related to a kind of substrate of novel medical hot melt resin carrier glue, the present invention also relates to the preparation technology and the application in producing emplastrum of the substrate of this novel medical hot melt resin carrier glue simultaneously.
Background technology
Transdermal delivery system is a kind of with the pharmaceutical dosage form of skin as administration channel, have through the skin constant speed, discharge medicine enduringly and enter body circulation, avoid medicine in digestive tract, to decompose, reduce the infringement to the harmonization of the stomach liver, easy to use and advantage such as medication and drug withdrawal at any time, become one of direction of modern medicines preparation development.
Rubber-emplastrum in the emplastrum is being brought into play important effect as one of transdermal delivery system B-C post dosage form in medicine development and treatment lysis.But traditional rubber-emplastrum is owing to adopt natural rubber and substrate adjuvants such as natural rosin, thereby ubiquity the problem that zest is big, anaphylaxis is big, and rubber cream and easily aging, can not paste usefulness repeatedly.Have and report with the natural rubber to be that the anaphylaxis of emplastrum of substrate is up to 50%.In addition, in the production process of rubber-emplastrum, use a large amount of organic solvents,, and easily environment is polluted for production has brought unsafe factor.Often having adsorbed because of the storage of zinc oxide particle is improper when slurrying is filtered has water to bring in water or the industrial naptha bucket to cause filtration difficulty in the jar, and plant equipment is cleaned difficulty.Therefore, be the emplastrum of substrate with the natural rubber because complex process, to problems such as stimulating type, the sensitization of skin are serious, rare in the international market at present, its application prospect dimness.
Cataplasma in the emplastrum is a kind of novel form of percutaneous dosing, but because the substrate adjuvant is formed complexity, performance adjustment (especially structural adjustment) difficulty exists dehydration to wear out, stick problems such as skin adherence differences for a long time; And need add auxiliary agents such as multiple other binding agent, cross-linking agent during with compatibility of drugs, and need carry out a large amount of composition adjustment experiments, and mix the back and be difficult for carrying out the performance adjustment again, patch production controllability is poor, the domestic device fabrication that lacks such cataplasma.Therefore the development of this dosage form is restricted.
Summary of the invention
The purpose of this invention is to provide a kind of novel medical hot melt resin carrier gel matrix that is used to produce emplastrum.
Another object of the present invention provides a kind of preparation method of this novel medical hot melt resin carrier gel matrix.
Novel medical hot melt resin carrier gel matrix of the present invention is that the feedstock production by following weight portion forms:
10～80 parts of thermoplastic elastomers
5～60 parts of medical resins
1～70 part of softening agent
1～10 part of skin penetration enhancer
0.1～100 part of excipient
The preparation technology of novel medical hot melt resin carrier gel matrix of the present invention, be in reactor, to add thermoplastic elastomer successively by described weight portion, medical resin, softening agent, excipient, skin penetration enhancer, be heated to 80～240 ℃, evacuation mixed stirring after 30～240 minutes then, made novel medical hot melt resin carrier gel matrix of the present invention.
The thermoplastic elastomer that the present invention adopts be the thermoplastic elastomer that medicine is used always: as styrene butadiene styrene block copolymer (SBS), styrene isoprene styrene block copolymer (SIS) (SIS), styrene-isoprene-phenylethene radial block copolymer, and any in s-B-S radial block copolymer, hydrogenated butadiene block copolymer, styrene-propene butyl acrylate copolymer, the unformed polyolefin (APO).
The medical resin that the present invention adopts is a medicine medical resin commonly used: as aromatic hydrocarbons Petropols, ancient marlon resin, terpenoid resin, rosin based, Foral class, Colophonium esters, C
5Petropols, C
9Any in Petropols, styrene-maleic acid copolymer, maleic anhydride modified Colophonium and the rosin derivative.
The softening agent that the present invention adopts is a softening agent pharmaceutically commonly used, as, vaseline, phthalic acid dibutyl ester, almond oil, olive oil, Oleum Camelliae, Oleum Arachidis hypogaeae semen, Oleum sesami, Oleum Glycines, mink oil, cotton seed oil, Semen Maydis oil, safflower oil, Oleum Cocois, Oleum Ricini, oleic acid, liquid paraffin or the like.
The skin penetration enhancer that the present invention adopts is a skin penetration enhancer pharmaceutically commonly used.As pyrrole Lip river alkane ketone, azone, laurocapram and derivant thereof, dimethyl sulfoxide, decyl methyl sulfoxide, oleic acid, n-dodecanol, n-octyl alcohol, ethanol, isopropyl alcohol, isobutanol, propylene glycol, SEPA, Borneolum Syntheticum, Mentholum, methyl salicylate or the like.
The excipient that the present invention adopts is an excipient pharmaceutically commonly used, mainly contains lithopone, Kaolin, zinc oxide, clay, silica flour, carbon dust, titanium dioxide, calcium carbonate, aluminium oxide, graphite powder.
Adopt hot melt resin carrier gel matrix of the present invention to prepare the method for medicinal plaster agent, be that medical hot melt resin carrier gel matrix is heated to 75～115 ℃, the medicine that adds 0.05～1 times of medical hot melt resin carrier gel matrix amount, stirred 30～60 minutes, make medical resin and paste, then coating, peritoneum, cut and promptly get resin subsides finished product.
Medical hot melt resin carrier gel matrix of the present invention promptly can be used for the preparation of medicinal plaster agent such as Chinese medical concrete, Chinese medicine extract, Chinese medicine ultra-fine powder, chemical drugs.
Medical hot melt resin carrier gel matrix of the present invention, no matter product is aspects such as preparation technology, production equipment, drug standard, pilot scale research, medicine stability, experiment storage, has all reached SFDA and has declared the requirement of new drug with adjuvant.
The present invention compares in prior art and has the following advantages:
1, the medical hot melt resin carrier gel matrix of the present invention's preparation is little to the skin irritation type, does not have irritated phenomenon, pastes comfortable, convenient.
2, medical hot melt resin carrier gel matrix of the present invention pollution clothes not can use repeatedly.
3, the drug loading of medical hot melt resin carrier gel matrix of the present invention is big, medicine can reach 1: 20 with the ratio of substrate～and 1, with Chinese medicine and volatile medicine the good compatibility is arranged, colloid should not be damaged, finished product does not produce wire drawing and residual phenomena, thereby suits to add the resin subsides that various Chinese medical concretes, Chinese medicine extract, Chinese medicine ultra-fine powder, chemical drugs etc. are made.
4, medical hot melt resin carrier gel matrix stability of characteristics of the present invention; be produced on a large scale; new type resin patch production technology advanced person with the present technique making; processing and forming ability uniqueness; can be fit to different size, different elasticity, different dilatabilities; the processing and forming of the back lining materials of different pliabilitys can be processed into the different various plaster that paste with the position of human body.Its medium characteristics is stable, does not react with principal agent.For the succedaneum of traditional emplastrum substrate adjuvant, can realize suitability for industrialized production.Through the sealed packet dress, but long term storage, convenient transportation.
5, the prescription of medical hot melt resin carrier gel matrix of the present invention and preparation technology are simple, do not need organic solvent, safety, environmental protection.
6, to contain dose big for medical hot melt resin carrier gel matrix of the present invention: about 0.1 to 4 millimeter of the resin patch substrate thickness of making of present technique, and general emplastrum substrate and medicine layer thickness 0.1 millimeter only, compare the substrate that increased more than tens of times and the thickness of medicine layer, the appearance dose is increased exponentially, strengthen the topical administration amount, strengthened medication effect.
7, the stickup of medical hot melt resin carrier gel matrix of the present invention preparation is controlled, and adjusting medical hot melt resin carrier glue ratio according to the characteristic of medicine, can to reach viscosity moderate, can paste repeatedly, can the adhesive tape chaeta.
8, medical hot melt resin carrier gel matrix of the present invention according to and different Chinese medicine micropowder, Chinese medical concrete, Chinese medicine extract and chemical medicine preparation needs, can be modulated into fusing point and be lower than 100 degree or the resin glue substrate of low temperature more.
9, gluing speed is fast, the production efficiency height; System cream, to be coated with the cream equipment volume little, and floor space is a common emplastrum below 20%, the automaticity height, and several people's operations get final product, and labor intensity is low, the efficient height, energy consumption is little, has more economic benefit and social benefit.
The specific embodiment
Below by instantiation, medical hot melt resin carrier gel matrix of the present invention and preparation thereof, application are further specified.
Embodiment 1
In reactor, add 40 parts of styrene isoprene styrene block copolymer (SIS) successively (in weight portion, down together), 20 parts of liquid paraffin, 5 parts of rosin glyceride, 5 parts in lithopone, 2 parts of azones, be heated to 120 ℃, evacuation mixed stirring after 30 minutes then, made novel medical hot melt resin carrier gel matrix of the present invention.
Medical hot melt resin carrier gel matrix is heated to 115 ℃, the XIAOTONG TIEGAO extract that adds 0.05 times of hot melt resin carrier gel matrix amount, makes with QIZHENG XIAOTONG TIE cream prescription, stirred 50 minutes, and made the pain resin plaster that disappears, then coating, peritoneum, cut and promptly get resin plaster finished product.
Embodiment 2
In reactor, add 60 parts of styrene butadiene styrene block copolymer (SBS) successively, vaseline 20, C
55 parts of Petropols, 5 parts in lithopone, azone are heated to 240 ℃ for 2 parts, and evacuation mixed stirring after 90 minutes then, made novel medical hot melt resin carrier gel matrix of the present invention.
Medical hot melt resin carrier gel matrix is heated to 75 ℃, add 0.1 times of hot melt resin carrier gel matrix amount, press " the SHANGSHI ZHITONG GAO extractum that the SHANGSHI ZHITONG GAO prescription is made in the Chinese pharmacopoeia, stirred 30 minutes, make SHANGSHI ZHITONG GAO resin plaster, then coating, peritoneum, cut and promptly get resin and paste finished product.
Embodiment 3
In reactor, add 70 parts of s-B-S radial block copolymers successively, 40 parts of liquid paraffin, 30 parts of rosin glyceride, 2 parts in lithopone, azone are heated to 80 ℃ for 7 parts, evacuation mixed stirring after 60 minutes then, made novel medical hot melt resin carrier gel matrix of the present invention.
Medical hot melt resin carrier gel matrix is heated to 95 ℃, adds the Flos Carthami superfine powder of 0.5 times of hot melt resin carrier gel matrix amount, stirs and make Chinese medicine ultra-fine powder resin plaster after 45 minutes, then coating, peritoneum, cut and promptly get resin subsides finished product.
Embodiment 4
In reactor, add 80 parts of styrene-propene butyl acrylate copolymer, 60 parts of liquid paraffin, 50 parts of rosin glyceride, 8 parts in lithopone, azone successively and be heated to 90 ℃ for 1 part, evacuation mixed stirring after 120 minutes then, made novel medical hot melt resin carrier gel matrix of the present invention.
Medical hot melt resin carrier gel matrix is heated to 105 ℃, adds the menthol of getting of 0.5 times of hot melt resin carrier gel matrix amount, stirs and make menthol resin plaster after 30 minutes, then coating, peritoneum, cut and promptly get resin subsides finished product.
Claims (3)
1. novel medical hot melt resin carrier gel matrix is that the raw material melt compounding by following weight portion forms:
10～80 parts of thermoplastic elastomers
5～60 parts of medical resins
1～70 part of softening agent
1～10 part of skin penetration enhancer
0.1～100 part of excipient;
Described thermoplastic elastomer is the styrene-propene butyl acrylate copolymer;
Described medical resin is any of aromatic hydrocarbons Petropols, ancient marlon resin, C5 Petropols, C9 Petropols, Foral apoplexy due to endogenous wind;
Described softening agent is a vaseline;
Described skin penetration enhancer is any in pyrrole Lip river alkane ketone, dimethyl sulfoxide, ethanol, isopropyl alcohol, isobutanol, the propylene glycol;
Described excipient is any in lithopone, clay, silica flour, carbon dust, titanium dioxide, calcium carbonate, aluminium oxide, the graphite powder.
2. the preparation technology of medical hot melt resin carrier gel matrix according to claim 1, be in reactor, to add thermoplastic elastomer successively by described weight portion, medical resin, softening agent, excipient, skin penetration enhancer, be heated to 80～240 ℃, evacuation mixed stirring after 30～240 minutes then, made medical hot melt resin carrier gel matrix of the present invention.
3. the medical hot melt resin carrier gel matrix application in the emplastrum aborning according to claim 1, be that medical hot melt resin carrier gel matrix is heated to 75～115 ℃, the medicine that adds 0.05～1 times of medical hot melt resin carrier gel matrix amount, stirred 30～60 minutes, make medical resin and paste, then coating, peritoneum, cut and promptly get resin subsides finished product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008100183810A CN101288772B (en) | 2008-05-31 | 2008-05-31 | Novel medical hot melt resin carrier gel matrix and its preparation method and application |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008100183810A CN101288772B (en) | 2008-05-31 | 2008-05-31 | Novel medical hot melt resin carrier gel matrix and its preparation method and application |
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| Publication Number | Publication Date |
|---|---|
| CN101288772A CN101288772A (en) | 2008-10-22 |
| CN101288772B true CN101288772B (en) | 2011-02-02 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN2008100183810A Active CN101288772B (en) | 2008-05-31 | 2008-05-31 | Novel medical hot melt resin carrier gel matrix and its preparation method and application |
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Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103333650B (en) * | 2013-06-01 | 2015-11-18 | 黄山市休宁信德成化工有限公司 | A kind of melt pressure sensitive type plaster substrate glue |
| CN103333649B (en) * | 2013-06-01 | 2015-07-15 | 黄山市休宁信德成化工有限公司 | Hot-melt and pressure sensitive plaster matrigel and preparation method thereof |
| CN106221604A (en) * | 2016-09-20 | 2016-12-14 | 李国伦 | A kind of human body glue |
| CN114869864A (en) * | 2022-05-10 | 2022-08-09 | 黄山市信德成胶业有限公司 | Thermoplastic styrene-butadiene rubber system plaster matrix adhesive |
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