CN100420726C - Hot-melt pressure-sensitive adhesive type matrix for medical use and its preparation - Google Patents
Hot-melt pressure-sensitive adhesive type matrix for medical use and its preparation Download PDFInfo
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- CN100420726C CN100420726C CNB2005100297574A CN200510029757A CN100420726C CN 100420726 C CN100420726 C CN 100420726C CN B2005100297574 A CNB2005100297574 A CN B2005100297574A CN 200510029757 A CN200510029757 A CN 200510029757A CN 100420726 C CN100420726 C CN 100420726C
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Abstract
The present invention relates to a hot-melt pressure-sensitive adhesive type matrix for medical use and the preparation method thereof, which provides one kind of hot-melt pressure-sensitive adhesive and the preparation method thereof. The hot-melt pressure-sensitive adhesive can be used as ointment preparation. The principal ingredients of the hot-melt pressure-sensitive adhesive comprises phenylethene thermoplastic elastomer SIS (phenylethene-isoprene-phenylethene three block copolymers) matched with adhesive resin (such as petroleum resin, terpenes polymer, polyisobutylene), softening oil (such as liquid paraffin), antioxidant (such as propyl gallate, BZ), etc. The hot-melt pressure-sensitive adhesive is transparent, has the advantages of fitness, no skin allergy and environmental protection and has good effects on ageing resistance and oxidative degradation. Administration ointment and medicine products made of the hot-melt pressure-sensitive adhesive has the advantages of big medicine carry amount and strong medicinal effect.
Description
Technical field
The present invention relates to hot-fusible pressure-sensitive adhesive, relate in particular to hot-fusible pressure-sensitive adhesive matrix and preparation thereof and medicinal use.
Background technology
Hot-fusible pressure-sensitive adhesive can produce splendid thermal viscosity under suitable high temperature, at the room temperature solid state, can produce then effect with finger or light pressure.
The hot-fusible pressure-sensitive adhesive that polar component is high can strengthen being followed the adsorptive power of object, improves then intensity simultaneously.Yet the higher chemical ingredients (element) of polarity has higher activity usually, and easy and oxygen effect produces catabiosis.
Consistency is poor between each composition of hot-fusible pressure-sensitive adhesive colloid of the prior art, oxidation takes place in the manufacturing processed easily, produce impurity; Prepared hot-fusible pressure-sensitive adhesive resistance to deterioration and cracked security are all bad.
In order to improve the medical hot melt pressure sensitive adhesive to the adhesion of skin with overcome inharmonious, puzzlement such as come off, all need the high element (composition) of the rational adsorptive power of additive.Usually add natural tackifier, as rosin, but natural tackifier polarity height causes allergic easily.Oil system is relatively poor because of the polar resin consistency, under heat effect chemical reaction can take place, and generating oxide compound influences tackiness.
Ideally, can alice when being affixed on the joint part bending motion, come off, but when then intensity is excessive, can cause skin pain when peeling off.For avoiding skin stimulated by colloid, the composition of medical hot melt pressure sensitive adhesive does not contain polar material usually, belongs to hydrophobic polymer.Therefore can't moisture absorbing and sweat releasing, have only and on colloid, get appropriate intervals punching or coating city breather hole.But general medical adhesive tape all can influence docile property when a large amount of perspire of skin.
The gasoline formulation of the rubber-emplastrum type of Chinese medicine use in the past is difficult to keep volatile matter; Use the solvent based pressure-sensitive adhesive can cause solvent contamination; Use stopping composition such as zinc oxide, drug loading is little, a little less than the drug effect.
Therefore this area press for provide a kind of ventilative, docile, do not cause allergic, have well anti-aging, oxygenolysis, the hot-fusible pressure-sensitive adhesive lotion of environmental protection, and need provide a kind of and can be used for containing volatile medicine, and drug loading is big, the transdermal administration plaster of strong drug action.
Summary of the invention
Purpose of the present invention just provide a kind of transparent, docile, do not cause allergic, environmental protection, and have hot-fusible pressure-sensitive adhesive lotion well anti-aging, the oxygenolysis effect; The method for making of this hot-fusible pressure-sensitive adhesive is provided simultaneously and this glue is used to prepare the ointment preparation.
One aspect of the present invention provides a kind of hot-fusible pressure-sensitive adhesive, and it comprises following main component:
(a) thermoplastic elastomer of 40-55 parts by weight, described thermoplastic elastomer are the segmented copolymers of styrene-isoprene-phenylethene;
(b) tackifier of 30-70 parts by weight, described tackifier are selected from petroleum resin, terpene polymer, polyisobutene, lanolin or its combination;
(c) tenderizer of 30-50 parts by weight, described tenderizer are selected from whiteruss, dimethyl phthalate, diethyl phthalate, Isopropyl myristate or its combination;
(d) antioxidant of 3-8 parts by weight and/or antiaging agent, described antioxidant and/or antiaging agent are selected from Microcrystalline Wax, Tenox PG, rubber accelerator or its combination.
The preferred 45-50 parts by weight of wherein said thermoplastic elastomer, the preferred 40-55 parts by weight of described tackifier, the preferred 40-45 parts by weight of described tenderizer, the preferred 4-5 parts by weight of described antioxidant and/or antiaging agent; Described hot-fusible pressure-sensitive adhesive is transparent.
Another aspect of the present invention provides the preparation method of above-mentioned hot-fusible pressure-sensitive adhesive, comprises step:
(a) thermoplastic elastomer of 40-55 parts by weight and the tenderizer of 15-30 parts by weight are mixed stirring;
(b) antioxidant of the tenderizer of 15-30 parts by weight and 2-6 parts by weight is dropped in the mixture of step (a) gained and be stirred to fusion;
(c) tackifier of 30 1 70 parts by weight and the antioxidant and/or the antiaging agent of 1-4 parts by weight are added in the mixture of step (b) gained.
Above-mentioned preparation method also comprises step (d): adding pharmaceutically active substance below 100 ℃, cooling off then, obtaining containing the hot-fusible pressure-sensitive adhesive of pharmaceutically active substance, i.e. lotion hot-fusible pressure-sensitive adhesive layer.
Wherein swelling is mixed with the segmented copolymer and the whiteruss of styrene-isoprene-phenylethene by the middle elder generation of step (a); Described pharmaceutically active substance preferred streams medicinal extract etc.
Another aspect of the present invention provides a kind of transdermal administration plaster product, and it comprises:
(a) backing;
(b) be positioned at lotion hot-fusible pressure-sensitive adhesive layer on the major surfaces of backing, described lotion hot-fusible pressure-sensitive adhesive layer contains the described hot-fusible pressure-sensitive adhesive of claim 1;
(c) be positioned at peelable layer on the lotion hot-fusible pressure-sensitive adhesive layer.
In another preference, the hot-fusible pressure-sensitive adhesive layer is formed by several layers, and has the other pressure-sensitive adhesive layer of non-activity material;
In another preference, between hot-fusible pressure-sensitive adhesive layer and pressure-sensitive adhesive layer, also contain the film that the control active substance discharges.
Described transdermal administration plaster product contains the lotion of transdermal agent.
In another aspect of this invention, provide the preparation method of described transdermal administration plaster product, comprise step:
(a) thermoplastic elastomer of 40-55 parts by weight and the tenderizer of 15-30 parts by weight are mixed stirring;
(b) antioxidant of the tenderizer of 15-30 parts by weight and 2-6 parts by weight is dropped in the mixture of step (a) gained and be stirred to fusion;
(c) tackifier of 30-70 parts by weight and the antioxidant and/or the antiaging agent of 1-4 parts by weight are added in the mixture of step (b) gained.
(d) add pharmaceutically active substance below 100 ℃, cooling off then, obtaining containing the hot-fusible pressure-sensitive adhesive of pharmaceutically active substance, i.e. lotion hot-fusible pressure-sensitive adhesive layer.
(e) the lotion hot-fusible pressure-sensitive adhesive is coated in earlier on the resistant to elevated temperatures separate-type paper, is transferred on the backing again.
The present invention also provides the application of described hot-fusible pressure-sensitive adhesive in the transparent traditional Chinese medicinal ointment of preparation.
Hot-fusible pressure-sensitive adhesive lotion provided by the invention is ventilative, docile, it is allergic not cause, and has well anti-aging, oxidative decomposition capacity, and environmental protection; Transdermal administration plaster provided by the invention can be used for containing volatile medicine, and drug loading is big, strong drug action.
Description of drawings
Fig. 1 has shown a kind of commercially available plaster (backing up).
Fig. 2 has shown a kind of commercially available plaster (its opaque medicine colloid up).
Fig. 3 has shown plaster (backing up) made in the one embodiment of the invention.
Fig. 4 has shown plaster (transparent pastille hot-fusible pressure-sensitive adhesive up) made in the one embodiment of the invention.
Embodiment
The inventor has found a kind of composite formula of hot-fusible pressure-sensitive adhesive through extensive and deep research, comprises the thermoplastic elastomer of (a) 40-55 parts by weight, and described thermoplastic elastomer is the segmented copolymer of styrene-isoprene-phenylethene; (b) tackifier of 20-60 parts by weight, described tackifier are selected from petroleum resin, terpene polymer, polyisobutene, lanolin or its combination; (c) tenderizer of 30-50 parts by weight, described tenderizer are selected from whiteruss, dimethyl phthalate, diethyl phthalate, Isopropyl myristate or its combination; (d) antioxidant of 3-8 parts by weight and/or antiaging agent, described antioxidant and/or antiaging agent are selected from Microcrystalline Wax, Tenox PG, rubber accelerator or its combination.The hot-fusible pressure-sensitive adhesive of this formula combination is transparent, docile, it is allergic not cause, environmental protection, and have well anti-aging, lytic effect; Use the transdermal administration plaster product that this hot-fusible pressure-sensitive adhesive obtains and can be used for volatile medicine, and can improve drug loading, strengthen drug effect.
Hot-fusible pressure-sensitive adhesive is 100% solid under room temperature state, is the thermoplastically tackiness agent that is substantially free of solvent and water, can be softening after being heated, even become molten mass.
Hot-fusible pressure-sensitive adhesive follow mode mainly by physical property absorption and machinery two kinds on anchor.Confirm that according to theory and actual test hot-fusible pressure-sensitive adhesive that polarity is high or quilt then thing can induce bigger interface polarity difference and absorption mutually, hot-fusible pressure-sensitive adhesive and the adherence of being followed between thing produce splendid adhesion.The combination of suitable visco-elasticity can make hot-fusible pressure-sensitive adhesive obtain best anchor effect and heat intensity.So the molecular weight of additives such as the visco-elasticity of hot-fusible pressure-sensitive adhesive and macromolecule resin, tackifier, softening oil, antioxidant (chemical element), composition ratio, consistency etc. have very big relation.
Select for use the high hot-fusible pressure-sensitive adhesive of polar component can strengthen, improve then intensity simultaneously being followed the adsorptive power of object.So desire improves adhesion, then need utilize the visco-elasticity of hot-fusible pressure-sensitive adhesive to remedy the deficiency of adsorptive power.
For hot-fusible pressure-sensitive adhesive has thermal safety well anti-aging, oxygenolysis, must add each composition of proper quantity of antioxidant and colloid must have in splendid intermiscibility and the manufacturing processed and will prevent oxidative phenomena, and impurity must be removed.
The main component of hot-fusible pressure-sensitive adhesive provided by the invention is vinylbenzene thermoplastic elastomer SIS, is equipped with tackifying resin (as petroleum resin, terpene polymer, polyisobutene) and softening oil (as whiteruss) and antioxidant (as Tenox PG, BZ) etc. and makes.
The thermoplastic elastomer (Sbc Stysenic Block Lopolymer) that the present invention uses provides pressure-sensitive, thermotolerance, intensity and force of cohesion.The preferred thermoplastic elastomer of the present invention (SIS:Stysenic Isoprene) is the segmented copolymer of styrene-isoprene-phenylethene, is better than SBS (Styrene Block Coploymer) in tackiness agent, hot-fusible pressure-sensitive adhesive field.The SIS modulus is low, and liquation viscosity and melt viscosity are little, and coating performance is good, and force of cohesion and adhesivity, flexibility, transparency properties are better than SBS.SIS and other additives have good consistency.Wherein preferred terpene polymer or low molecular polyisobutylene.
The tackifier that the present invention uses have synthetic resins, and described tackifier can improve adhesiveness, reduce rare denseness.Tackifier PetroChina Company Limited. resin, terpene polymer, polyisobutene, lanolin or its combination.Petroleum resin, terpene polymer are made tackifying resin, and acid number is low, look shallow, and softening temperature is low, antioxidant property is excellent; The molecular weight of polyisobutene is a lower molecular weight, belongs to thickening, tackifier, with other materials and be used for improving cohesive force, snappiness, ageing resistance and resistance to air loss.Preferred petroleum resin, terpene polymer, polyisobutene or its combination.
The softening agent that the present invention uses is softening oil (agent), can reduce rare denseness, hardness, improve winter hardiness, reduces cost.Wherein preferred liquid paraffin and compound phthalic acid dimethyl ester, phthalic acid diethyl ester and Isopropyl myristate or its combination.Can overcome shortcomings such as the big and easy crystallization of low temperature of volatility.
The antioxidant that the present invention uses, preferred Witcodur 272, Tenox PG, rubber accelerator ZDBC (BZ) or its combination.Described antioxidant can prevent or slow down tackiness agent because of being subjected to the oxidation that height is warm, mechanical shearing caused or wearing out.The preferred zinc dibutyl dithiocarbamate of rubber accelerator ZDBC (BZ) wherein.Described antioxidant is the compound antioxidant more preferably, can obtain best antiageing effect, anti-oxidation and thermolysis.
Hot-fusible pressure-sensitive adhesive provided by the present invention is transparent.
Among the preparation method of hot-fusible pressure-sensitive adhesive provided by the invention SIS synthetic rubber and whiteruss are mixed swelling, this method for making need not be soaked the SIS synthetic rubber, and temperature is descended, and fusing point reduces, and helps the low temperature glue.
Hot-fusible pressure-sensitive adhesive does not use solvent, can not produce environmental pollution, and the production efficiency height is becoming more and more important to this type of tackiness agent of society energy-conservation and that elimination environmental pollution cry increases now.
Adopted above-mentioned hot-fusible pressure-sensitive adhesive in the transdermal administration plaster product of plaster form provided by the present invention, volatile matter can be than the reservation of Duoing of vapour butyrous more than 20% like this.
On structure, transdermal administration plaster product is by to active substance and the auxiliary agent backing of impermeable basically, contain active substance from the stickiness polymer formulators and the protective membrane that needs to remove before use constitute.
The material of backing and protective membrane is well-known to those skilled in the art.In fact generally use the PETR release film, protective membrane also needs at least in its side silication that contacts with tackiness agent so that remove from plaster.
A kind of transdermal administration plaster product provided by the invention comprises backing, contains the hot-fusible pressure-sensitive adhesive layer and the removable protective layer of active substance lotion, and the described lotion hot-fusible pressure-sensitive adhesive layer that contains active substance is made by above-mentioned hot-fusible pressure-sensitive adhesive.
The component of hot-fusible pressure-sensitive adhesive paste layer can not see through backing.
In the method for making of transdermal administration plaster product provided by the invention the hot-fusible pressure-sensitive adhesive lotion is coated in earlier on the resistant to elevated temperatures separate-type paper, is transferred to again on base (cloth) material.
When the lotion hot-fusible pressure-sensitive adhesive in the transdermal administration plaster product provided by the invention is at first considered to add prescription drugs, the temperature of matrix should be prerequisite with the temperature that does not influence prescription drugs, then consider again matrix visco-elasticity, coating operation, stability, unlikelyly itch, characteristic such as docile and ventilative.
Lotion hot-fusible pressure-sensitive adhesive in the transdermal administration plaster product provided by the invention is based on the tackiness agent of thermoplastic polymer.Its hot-fusible pressure-sensitive adhesive must be operated under high speed, high temperature, and prescription drugs also should carry out in molten state.Contain volatile prescription drug, should keep low volatileness to carry out glue, coating, film-making as fluid extract etc.; Pack behind the cooling curing.
Major advantage of the present invention is:
1. the hot-fusible pressure-sensitive adhesive that is obtained is transparent, and is attractive in appearance, clean;
2. the transdermal administration plaster product drug loading that adopts hot-fusible pressure-sensitive adhesive lotion of the present invention to make is big, the drug effect height;
3. it is wide that the transdermal administration plaster product that adopts hot-fusible pressure-sensitive adhesive lotion of the present invention to make is suitable for the medicine scope;
4. hot-fusible pressure-sensitive adhesive of the present invention does not use solvent, can not produce environmental pollution, and the production efficiency height is becoming more and more important to this type of tackiness agent of society energy-conservation and that elimination environmental pollution cry increases now.
Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiment only to be used to the present invention is described and be not used in and limit the scope of the invention.The experimental technique of unreceipted actual conditions in the following example is usually according to the normal condition or the condition of advising according to manufacturer.
Embodiment 1-4
The preparation hot-fusible pressure-sensitive adhesive
| Embodiment | SIS synthetic rubber (gram) | Terpene polymer (gram) | Polyisobutene (gram) | Lanolin (gram) | Whiteruss (gram) | Dimethyl phthalate (gram) | Diethyl phthalate (gram) | Isopropyl myristate (gram) | Microcrystalline Wax (gram) | Tenox PG (gram) | Accelerant B Z (gram) |
| 1 | 40 | 32 | 8 | 5 | 28 | 1.5 | 1.5 | 3 | 2.5 | 0.2 | 0.3 |
| 2 | 45 | 35 | 12 | 6 | 30 | 1.8 | 1.8 | 3 | 2.8 | 0.2 | 0.3 |
| 3 | 50 | 40 | 12 | 6 | 34 | 1.9 | 1.9 | 3 | 3 | 0.2 | 0.3 |
| 4 | 55 | 40 | 12 | 7 | 35 | 2 | 2 | 4 | 3.5 | 0.25 | 0.45 |
With above-mentioned parts by weight, follow these steps to carry out;
(1) SIS synthetic rubber and whiteruss were mixed swelling more than 30 minutes, stir down, simultaneously inflated with nitrogen or under vacuum, carry out at 160-165 ℃;
(2) with diethyl phthalate, dimethyl phthalate, Isopropyl myristate and Microcrystalline Wax and terpene polymer; Drop in the mixture of step (1) gained in batches, be stirred to fusion, simultaneously inflated with nitrogen or under vacuum, carry out at 140 ℃;
(3) in the mixture of step (2) gained, add lanolin, polyisobutene, Tenox PG and accelerant B Z, 100 ℃ of stirrings, inflated with nitrogen or under vacuum, carry out promptly simultaneously.
Embodiment 5
The preparation SHEXIANG ZHUANGGU GAO
1, system pastille hot-fusible pressure-sensitive adhesive layer
(1) method with embodiment 1 makes hot-fusible pressure-sensitive adhesive;
(2) in the hot-fusible pressure-sensitive adhesive that makes, add 0.03 gram leopard bone, 3 gram borneols, stir at 90 ℃ and melt, simultaneously inflated with nitrogen;
(3) in the mixture of step (2) gained, add 3 gram camphors, 0.48 gram chondroitin sulfate, 0.6 gram Vena, 85 ℃ of whiles of temperature inflated with nitrogen;
(4) in the mixture of step (3) gained, add 2.55 gram wintergreen oils, 10 gram fluid extract mixings, 80～85 ℃ of whiles of temperature inflated with nitrogen;
(5) in the mixture of step (4) gained, add 0.024 gram Moschus mixed powder and 4 gram mentha camphor, 80 ℃ of whiles of temperature inflated with nitrogen;
(6) lotion is 80 ℃, and painting drum keeps being coated with 85 ℃ of temperature.
2, the above-mentioned lotion tackiness agent material that contains active substance is coated on the resistant to elevated temperatures separate-type paper, compound with backing then, itemize, section, packing, making the lotion hot-fusible pressure-sensitive adhesive glue spread that contains active substance is 1.7 gram/m
2Above SHEXIANG ZHUANGGU GAO.
Embodiment 6
Prepared ointment is transparent
See accompanying drawing 1,2,3,4.
Fig. 1, the 2nd, plaster on sale in the market, Fig. 1 be backing up, Fig. 2 be the pastille colloid up, see through colloid and can not see backing, be opaque; Fig. 3, the 4th, the plaster of preparation in the embodiment of the invention 5, Fig. 3 be backing up, Fig. 4 be the pastille hot-fusible pressure-sensitive adhesive up, can see backing through the pastille hot-fusible pressure-sensitive adhesive, be transparent.
Embodiment 7
Product test
Embodiment 5 prepared SHEXIANG ZHUANGGU GAO are carried out allergic, skin acute toxicity and skin irritation test.Following experimental data is checked by Shanghai Drug Control Inst.; Reference " new drug preclinical study governing principle ".
1, skin anaphylactic test
Preparation method: SHEXIANG ZHUANGGU GAO is cut into 3*3 centimetre of size, for test.
Positive control: 2,4-dinitro-chloro-benzene (chemical pure) is mixed with 1% solution with 95% ethanol, as sensitization liquid and exciting liquid.
Blank: (no pharmaceutical compositions) obedient cream
Experimental animal: get 250-300 and restrain 30 of healthy albino guinea-pigs, male and female half and half.Cavy was takeed on back wool in preceding 24 hours in coating and remove, the about 3*3 of unhairing scope centimetre.
Test method: cavy is divided into 3 groups at random, 10 every group, male and female half and half;
Tried the thing group: paste and tried thing (3*3 centimetre/mouse)
Negative control group: the obedient cream of no pharmaceutical compositions (3*3 centimetre/mouse)
Positive controls: 0.2ml/ mouse
Induce: with 75% ethanol cleaning guinea pig back unhairing district, tried the thing bone-strengthening musk and be affixed on unhairing district, left side respectively at getting in the 1st, 7,14, continue 6 hours, blank thing and positive control method are the same.
Excite: in induce finish after the 14th day, get and tried the thing bone-strengthening musk and be affixed on unhairing district, right side, remove after 6 hours and tried thing, observe at once, observed allergic situation then once more in 24,48,72 hours.Blank thing and positive control method are the same.
Result: see Table 1,2,3
Annotate: the ER erythema; ED oedema (down together)
Table 1 is tried thing group skin allergy and is marked
Sensitization rate: 0 sensitization intensity: weak sensitization
The scoring of table 2 blank group skin allergy
Sensitization rate: 0 sensitization intensity: weak sensitization
The scoring of table 3 positive controls skin allergy
Sensitization rate: 100% quick intensity: extreme sensitization
The result shows: this product was not met quick reaction through the guinea pig skin hypersensitive test.
2, skin acute toxicity test
The preparation method: getting an amount of medicinal extract, to add N.S an amount of, makes every ml and contain about 0.6g vehicle of medicinal extract or blank: 0.9% sodium chloride solution
Experimental animal:
Kind: new zealand rabbit sex: female body weight: 2.7-2.9
Test method:
Get 8 of above-mentioned animals, establish a dosage group, 4 every group, wherein intact skin and damaged skin half and half.With the back part of animal depilation, area was about 150 square centimeters in preceding 24 hours of administration.To be subjected to reagent thing (or vehicle) 2.0 evenly to be applied to the depilation zone: damaged skin then is coated with behind the broken skin of depilation zoning again and is tried thing (or vehicle), the same intact skin of dosage.Removed residual thing or the vehicle of being tried after the administration in 24 hours.
Observe every day, continuous 7 days. whole body poisoning manifestations and death condition behind the attention animals administer, and record.
The results are shown in Table 4.
Table 4
The result shows: this product is applied to tame rabbit back 2ml with 0.6/ml medicinal extract diluent, does not see part and whole body toxic reaction.
3, skin irritation test
The preparation method: it is an amount of to get medicinal extract, adds N.S and makes every ml and contain the about 0.6g diluent of medicinal extract.
Vehicle or blank:
Experimental animal:
Kind: new zealand rabbit sex: female body weight: 2.7-3.0kg
Test method:
Get 6 of above-mentioned animals, be divided into 2 groups, 3 every group, be respectively intact skin group and damaged skin group.In preceding 24 hours of administration back part of animal is lost hair or feathers.Each back part of animal is divided into and is tried thing district and contrast district (every district area is about 50 square centimeters), will be subjected to reagent thing, vehicle 1.0ml to be applied to aforementioned region respectively, every day 1 time, continuous 7 days.After the last administration, removed left drug in 24 hours, observe to remove and tried to smear the erythema at position and the recovery situation and the time of oedema situation and above-mentioned variation in 1,24,48 and 72 hour behind the thing.Every animal test results is carried out the irritant reaction scoring by table 1, and calculate mean scores evaluation stimulus intensity.
The results are shown in Table 5,6.
Table 5 intact skin group
Average mark=0 average mark=0
Table 6 damaged skin group
Average mark=0 average mark=0
Skin irritation intensity evaluation: nonirritant
The result shows: this product is applied to tame rabbit back 1.0ml with 0.6g/ml medicinal extract diluent, after continuous 7 days, does not see that there is irritant reaction the part.
Embodiment 8-10
The preparation SHEXIANG ZHUANGGU GAO
Repeat the method for embodiment 5, difference is to replace the hot-fusible pressure-sensitive adhesive of using embodiment 1 described method preparation with the hot-fusible pressure-sensitive adhesive of the described method preparation of embodiment 2-4.
The result:
The ointment that makes is transparent equally.
In addition, carry out skin anaphylactic test by embodiment 7 identical methods, the result shows that the SHEXIANG ZHUANGGU GAO of embodiment 8-10 preparation through the guinea pig skin hypersensitive test, do not meet quick reaction.
All quote in this application as a reference at all documents that the present invention mentions, just quoted as a reference separately as each piece document.Should be understood that in addition those skilled in the art can make various changes or modifications the present invention after having read above-mentioned teachings of the present invention, these equivalent form of values fall within the application's appended claims institute restricted portion equally.
Claims (7)
1. a hot-fusible pressure-sensitive adhesive is characterized in that, described hot-fusible pressure-sensitive adhesive is transparent, and described hot melt adhesive comprises following main component:
(a) thermoplastic elastomer of 40-55 parts by weight, described thermoplastic elastomer are the segmented copolymers of styrene-isoprene-phenylethene;
(b) tackifier of 30-70 parts by weight, described tackifier are low-molecular-weight polyisobutylene and the material that is selected from down group: petroleum resin, terpene polymer, lanolin or its combination;
(c) tenderizer of 30-50 parts by weight, described tenderizer are dimethyl phthalate, Isopropyl myristate and the material that is selected from down group: whiteruss, diethyl phthalate or its combination;
(d) antioxidant of 3-8 parts by weight, described antioxidant are Microcrystalline Wax and the material that is selected from down group: Tenox PG, rubber accelerator or its combination.
2. the preparation method of hot-fusible pressure-sensitive adhesive as claimed in claim 1 is characterized in that, comprises step:
(a) thermoplastic elastomer of 40-55 parts by weight and the tenderizer of 15-30 parts by weight are mixed stirring;
(b) antioxidant of the tenderizer of 15-30 parts by weight and 2-6 parts by weight is dropped in the mixture of step (a) gained and be stirred to fusion;
(c) tackifier of 30-70 parts by weight and the antioxidant of 1-4 parts by weight are added in the mixture of step (b) gained;
Above-mentioned steps (a) and (b) in the gross weight umber of the tenderizer that added, and above-mentioned steps (b) and (c) in the gross weight umber of the antioxidant that added, all in the described scope of claim 1.
3. preparation method as claimed in claim 2 is characterized in that, swelling is mixed with the segmented copolymer and the whiteruss of styrene-isoprene-phenylethene by elder generation in the step (a).
4. transdermal administration plaster product is characterized in that described product comprises:
(a) backing;
(b) be positioned at lotion hot-fusible pressure-sensitive adhesive layer on the major surfaces of backing, described lotion hot-fusible pressure-sensitive adhesive layer contains the described hot-fusible pressure-sensitive adhesive of claim 1;
(c) be positioned at peelable layer on the lotion hot-fusible pressure-sensitive adhesive layer.
5. transdermal administration plaster product as claimed in claim 4 is characterized in that, contains the lotion of transdermal agent.
6. the preparation method of claim 4 or 5 described transdermal administration plaster products is characterized in that, comprises step:
(a) thermoplastic elastomer of 40-55 parts by weight and the tenderizer of 15-30 parts by weight are mixed stirring;
(b) antioxidant of the tenderizer of 15-30 parts by weight and 2-6 parts by weight is dropped in the mixture of step (a) gained and be stirred to fusion;
(c) tackifier of 30-70 parts by weight and the antioxidant of 1-4 parts by weight are added in the mixture of step (b) gained;
Above-mentioned steps (a) and (b) in the gross weight umber of the tenderizer that added, and above-mentioned steps (b) and (c) in the gross weight umber of the antioxidant that added, all in the described scope of claim 1;
(d) add pharmaceutically active substance below 100 ℃, cooling off then, obtaining containing the hot-fusible pressure-sensitive adhesive of pharmaceutically active substance, i.e. lotion hot-fusible pressure-sensitive adhesive layer;
(e) the lotion hot-fusible pressure-sensitive adhesive is coated in earlier on the resistant to elevated temperatures separate-type paper, is transferred on the backing again.
7. the application of the described hot-fusible pressure-sensitive adhesive of claim 1 in the transparent traditional Chinese medicinal ointment of preparation.
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| CNB2005100297574A CN100420726C (en) | 2005-09-19 | 2005-09-19 | Hot-melt pressure-sensitive adhesive type matrix for medical use and its preparation |
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| CNB2005100297574A CN100420726C (en) | 2005-09-19 | 2005-09-19 | Hot-melt pressure-sensitive adhesive type matrix for medical use and its preparation |
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| CN100420726C true CN100420726C (en) | 2008-09-24 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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