Degradation type disposable syringe and preparation method
Technical field
The present invention relates to the degradable disponsable medical instruments field, specifically, relate to degradation type disposable syringe and preparation method.
Background technology
At present, disposable syringe uses materials such as polrvinyl chloride, polyethylene and polypropylene to make mostly, and depleted syringe can not degrade in natural environment or destroy voluntarily, thereby becomes medical waste, contaminated environment, and the harm people's is healthy.Usually the ways that adopt concentrated burning to destroy are handled depleted syringe more, and this method is not only run counter to the principle of resources sustainable development.And after handling, can produce materials such as a large amount of black smokes, hydrogen chloride gas and supervirulent dioxin, serious environment pollution.On the other hand, because mismanagement of part medical institutions or interests are ordered about, disposable syringe is illegally reclaimed, is peddled and reused.The repeated use of syringe has stayed hidden danger to cross infection, causes pathophoresiss such as hepatitis B, acquired immune deficiency syndrome (AIDS).For this reason, the Chinese government endeavours to promote self-destructive syringe, but its complex structure, manufacturing cost height, promoting the use of of it has been subjected to restriction to a certain extent.For these reasons, the exploitation degradation type disposable syringe is not only avoided discarded syringe contaminated environment, and is economized on resources, and can also really realize the once use of disposable syringe.At present, about the research of degradation type disposable syringe with report less.Have only Chinese patent CN 2776433Y only to disclose the new construction of degradation-type self-destroyed syringe, this syringe needle is arranged on the overcoat front end, form integrative-structure with overcoat, piston is installed in the core bar front portion, the core bar front end flexibly connects conical the core of the card, the top is provided with the conical draw-in groove that cooperates with the core of the card in the overcoat, can realize with the back self-destruction.Syringe only is a carbon dioxide copolymer with base material in this patent, the preparation of unexposed corresponding base material, pelletize and syringe moulding process.
Summary of the invention
Innovation part of the present invention is: prepared complete degradation-type syringe, it is made of overcoat, core bar, needle stand and needle cap, and every performance of the degradation-type syringe that obtains meets national standard " disposable sterilized syringe (GB 15810-2001) " fully.The syringe preparation technology of this disclosure of the Invention is detailed rationally, and the Biodegradable syringe that obtains really possesses application prospect.
The present invention's first purpose provides degradation type disposable syringe.
The present invention's second purpose provides the preparation method of degradation type disposable syringe.
Degradation type disposable syringe provided by the invention, as shown in Figure 1, it constitutes needle cap 1, needle stand 2, core bar 3 and overcoat 4, all can degraded fully in natural environment.
Syringe jacket 4 or the needle stand 2 of being used for provided by the invention is made of the degradable base material, and this degradable base material is called for short base material a, and its composition and weight proportion are:
100 parts of degradable macromolecule major ingredients, plasticizer 0-8 part, stabilization aid 0-8 part.
Described degradable macromolecule major ingredient is: polylactic acid, PPDO, polybutylene succinate, polycaprolactone or polyhydroxy acid ester.
Described plasticizer is: triethyl citrate, acetyl triethyl citrate, tri-n-butyl citrate, ATBC, butyl stearate, octyl stearate, n-butyl sebacate, di-n-octyl sebacate, decanedioic acid di-sec-octyl, triacetyl glycerine, ethyl hexyl ester of epoxidized soybean oil or their blend.
Described stabilization aid is: epoxy soybean oil, sorbitol, glycerol, trimethylolpropane or their mixture.
Because syringe jacket, needle stand need to observe the medication level in it, are convenient to medical personnel's injection operation, the degradable base material needs the good transparency.Can contact with medicine during syringe jacket, needle stand use, should avoid using stabilizing agent as far as possible, few with stabilization aid and plasticizer.
Be used for syringe core rod 3, be made of the degradable base material, this degradable base material is called for short base material b, and its composition and weight proportion are:
100 parts of degradable macromolecule major ingredients, plasticizer 2-8 part, stabilizing agent 0.5-4 part, stabilization aid 2-8 part, filler 0-35 part.
Described degradable macromolecule major ingredient is: cellulose, starch, polyhydroxy acid ester, polybutylene succinate, polylactic acid, polycaprolactone, PPDO, poly-carbon dioxide resin or their blend.
Described plasticizer is: triethyl citrate, acetyl triethyl citrate, tri-n-butyl citrate, ATBC, butyl stearate, octyl stearate, n-butyl sebacate, di-n-octyl sebacate, decanedioic acid di-sec-octyl, triacetyl glycerine, ethyl hexyl ester of epoxidized soybean oil or their blend.
Described stabilizing agent is: calcium stearate, zinc stearate, two lauric acids, two positive fourth stannum, lauric acid dibutyltin maleate or their mixture.
Described stabilization aid is: epoxy soybean oil, sorbitol, glycerol, trimethylolpropane or their mixture.
Described filler is: white calcium carbonate, white Pulvis Talci, white silicon dioxide or white barium sulfate.
General syringe core rod does not directly contact with medicine, for increasing the stability of material in the course of processing, improves material property, introduces stabilizing agent, and increases stabilization aid and plasticizer consumption.Generally, syringe core rod requires for reducing cost, to improve the core bar physical property for milky, and the degradable macromolecule major ingredient can be formed by two or more degradable macromolecule blend, and adds filler, as: white calcium carbonate, white Pulvis Talci or silicon dioxide.
Be used for syringe needle head cap 2, be made of the degradable base material, this degradable base material is called for short base material c, and its composition and weight proportion are:
100 parts of degradable macromolecule major ingredients, plasticizer 2-8 part, stabilizing agent 0.5-4 part, stabilization aid 2-8 part.
Described degradable macromolecule major ingredient is: polylactic acid, PPDO, polybutylene succinate, polycaprolactone or polyhydroxy acid ester.
Described plasticizer is: triethyl citrate, acetyl triethyl citrate, tri-n-butyl citrate, ATBC, butyl stearate, octyl stearate, n-butyl sebacate, di-n-octyl sebacate, decanedioic acid di-sec-octyl, triacetyl glycerine, ethyl hexyl ester of epoxidized soybean oil or their blend.
Described stabilizing agent is: calcium stearate, zinc stearate, two lauric acids, two positive fourth stannum, lauric acid dibutyltin maleate or their mixture.
Described stabilization aid is: epoxy soybean oil, sorbitol, glycerol, trimethylolpropane or their mixture.
The invention provides the preparation method of degradation type disposable syringe, step and condition are as follows:
The first step: base material a, base material b or the base material c that will prepare by proportioning, send into height respectively and stir in the machine, rotating speed 600-800 rev/min, mixed 5-10 minute, make the compound of uniform base material a, base material b or base material c respectively;
Second step: base material a, base material b or base material c compound that the first step is made respectively; respectively under 50-100 ℃; vacuum drying 4-24 hour, to send in the single screw extrusion machine, temperature is controlled to be: feeding section 60-100 ℃; 90-130 ℃ of batch mixing section; fluxing zone 120-180 ℃, head 100-160 ℃, screw speed 30-50 rev/min; after the pelleter pelletizing, make the pellet of base material a, base material b or base material c respectively.
The invention provides the preparation method of degradation type disposable syringe, step and condition are as follows:
The first step:, under 50-100 ℃, vacuum drying 4-24 hour, stand-by the biodegradation base material pellet of above-mentioned base material a, base material b or base material c;
Second step: injection mo(u)lding: the pellet of oven dry is added injection machine, carry out the specification of needle cap 1, needle stand 2, core bar 3 and overcoat 4 and carry out injection mo(u)lding by needed syringe;
Barrel temperature is set at: charging aperture 20-60 ℃, and compression section 100-200 ℃, metering section 130-240 ℃, nozzle 130-220 ℃;
Mold temperature is: 20-50 ℃;
Injection pressure is: 40-200MPa;
Injection time is: 8-90 second;
Dwell time is: 0-5 second;
Screw speed is: 20-180 rev/min;
Through after the injection mo(u)lding, make degradation type disposable syringe needle cap 1, needle stand 2, core bar 3 and overcoat 4 respectively, then needle cap 1, needle stand 2, core bar 3 and overcoat 4 are assembled into degradation type disposable syringe.
The specific performance of syringe jacket 4, core bar 3, needle stand 2 and needle cap 1 requires difference to some extent, and the accessory shape and size differ greatly, so the syringe different accessories selects base material and Shooting Technique different.
Table 1, table 2 have provided part syringe biodegradation base material prescription.Wherein, prescription 1, prescription 2 and fill a prescription and 3 be used for syringe jacket 4 or needle stand 2; Prescription 4, prescription 5 are used for syringe core rod 3; Prescription 6, prescription 7, prescription 8 are used for syringe needle head cap 1.
Table 1
Table 2
Last degradation-type syringe encapsulation step is: after the assembling of syringe accessory, carry out Vacuum Package, through being up to the standards, stamp build date, get final product list marketing.
Beneficial effect: degradation-type syringe provided by the invention is that major ingredient is formulated with corresponding auxiliary material with the preferred polylactic acid of base material, polycaprolactone, starch, poly-carbon dioxide resin.This degradation type disposable syringe degradation speed is fast, safe and applicable, do not need shape, structure and the processing method of existing disposable syringe mould are made big change, and the production cost of syringe is lower.In addition, of paramount importancely be, the preparation technology of biological degradation type disposable syringe provided by the invention is detailed rationally, and its every index meets national standard fully, and " disposable sterilized syringe (GB 15810-2001) comprises syringe profile, color etc.Therefore, the degradation type disposable syringe of this disclosure of the Invention has real commercial application value.
Description of drawings
Fig. 1 is that degradation type disposable syringe of the present invention constitutes sketch map.Among the figure, needle cap 1, needle stand 2, core bar 3 and overcoat 4 are arranged, all can degraded fully in natural environment.This figure also is the accompanying drawing of summary.
The specific embodiment
The prescription that following examples adopted is the prescription of above-mentioned table 1 and table 2.
Embodiment 1 syringe jacket injection molding forming method
Adopt prescription 1 or 2 the degradable substrate material of filling a prescription, syringe jacket 4 injection molding forming methods are:
The first step will fill a prescription 1 or the pellet of 2 the degradable base material of filling a prescription under 80 ℃, vacuum drying is after 8 hours, and is stand-by.
The second step injection mo(u)lding: the pellet adding injection machine of the prescription 1 that will dry or 2 the degradable base material of filling a prescription, carry out injection mo(u)lding.Barrel temperature is set at: 30 ℃ of charging apertures, 1 95 ℃ of compression sections, 200 ℃ of metering sections, 185 ℃ at nozzle;
Mold temperature is: 30 ℃,
Injection pressure is: 110MPa,
Injection time is: 16 seconds,
Dwell time is: 3.0 seconds,
Screw speed is: 40 rev/mins,
Obtain adopting prescription 1 or the syringe jacket 4 of 2 the degradable base material of filling a prescription.
Embodiment 2 syringe jackets 4 injection molding forming methods
Adopt the degradable substrate material of prescription 3, syringe jacket 4 injection molding forming methods are:
The first step will be filled a prescription the pellet of syringe jacket 4 of 3 degradable base material under 60 ℃, and vacuum drying is after 24 hours, and is stand-by.
The second step injection mo(u)lding: the pellet of the syringe jacket 4 of the degradable base material of the prescription 3 that will dry adds injection machine, carries out injection mo(u)lding.Barrel temperature is set at: 30 ℃ of charging apertures, 145 ℃ of compression sections, 165 ℃ of metering sections, 155 ℃ at nozzle;
Mold temperature is: 30 ℃,
Injection pressure is: 100MPa,
Injection time is: 14 seconds,
Dwell time is: 2.6 seconds,
Screw speed is: 30 rev/mins,
Obtain adopting the syringe jacket 4 of the degradable base material of prescription 3.
Embodiment 3 syringe needle 2 injection molding forming methods
Adopt prescription 1 or 2 the degradable substrate material of filling a prescription, syringe needle 2 injection molding forming methods are:
The first step will fill a prescription 1 or the pellet of 2 the degradable base material of filling a prescription under 80 ℃, vacuum drying is after 8 hours, and is stand-by.
The second step injection mo(u)lding: the pellet of the syringe jacket of the prescription 1 that will dry or 2 the degradable base material of filling a prescription, the adding injection machine carries out injection mo(u)lding, and barrel temperature is set at: 30 ℃ of charging apertures, 180 ℃ of compression sections, 185 ℃ of metering sections, 170 ℃ at nozzle;
Mold temperature is: 30 ℃,
Injection pressure is: 95MPa,
Injection time is: 8.5 seconds,
Dwell time is: 1.6 seconds,
Screw speed is: 35 rev/mins,
Obtain adopting prescription 1 or the syringe needle 2 of 2 the degradable base material of filling a prescription.
Embodiment 4 syringe needle 2 injection molding forming methods
Adopt the degradable substrate material of prescription 3, syringe needle 2 injection molding forming methods are:
The first step will be filled a prescription the pellet of 3 degradable substrate material under 60 ℃, and vacuum drying is after 24 hours, and is stand-by.
The second step injection mo(u)lding: the pellet of the degradable substrate material of the prescription 3 that will dry, add injection machine, carry out injection mo(u)lding.Barrel temperature is set at: 30 ℃ of charging apertures, 115 ℃ of compression sections, 135 ℃ of metering sections, 130 ℃ at nozzle;
Mold temperature is: 30 ℃,
Injection pressure is: 90MPa,
Injection time is: 10.5 seconds,
Dwell time is: 2.0 seconds,
Screw speed is: 40 rev/mins,
Obtain adopting the syringe needle 2 of the degradable substrate material of prescription 3.
Embodiment 5 syringe core rods 3 injection molding forming methods
Adopt the degradable substrate material of prescription 4, syringe core rod 3 injection molding forming methods are:
The first step will be filled a prescription the pellet of 4 degradable substrate material under 80 ℃, and vacuum drying is after 8 hours, and is stand-by.
The second step injection mo(u)lding: the pellet of the degradable substrate material of the prescription 4 that will dry, add injection machine, carry out injection mo(u)lding.Barrel temperature is set at: 30 ℃ of charging apertures, 155 ℃ of compression sections, 175 ℃ of metering sections, 160 ℃ at nozzle;
Mold temperature is: 30 ℃,
Injection pressure is: 110MPa,
Injection time is: 14.0 seconds,
Dwell time is: 2.8 seconds,
Screw speed is: 35 rev/mins,
Obtain adopting the syringe core rod 3 of the degradable substrate material of prescription 4.
Embodiment 6 syringe core rods 3 injection molding forming methods
Adopt the degradable substrate material of prescription 5, syringe core rod 3 injection molding forming methods are:
The first step will be filled a prescription the pellet of 5 degradable substrate material under 60 ℃, and vacuum drying is after 24 hours, and is stand-by.
The second step injection mo(u)lding: the pellet of the degradable substrate material of the prescription 5 that will dry, add injection machine, carry out injection mo(u)lding.Barrel temperature is set at: 30 ℃ of charging apertures, 110 ℃ of compression sections, 125 ℃ of metering sections, 120 ℃ at nozzle;
Mold temperature is: 30 ℃,
Injection pressure is: 105MPa,
Injection time is: 14.0 seconds,
Dwell time is: 2.4 seconds,
Screw speed is: 45 rev/mins,
Obtain adopting the syringe core rod 3 of the degradable substrate material of prescription 5.
Embodiment 7 syringe needle head caps 1 injection molding forming method
Adopt prescription 6 or 7 the degradable substrate material of filling a prescription, syringe needle head cap 1 injection molding forming method is:
The first step will fill a prescription 6 or the pellet of 7 the degradable base material of filling a prescription under 80 ℃, vacuum drying is after 8 hours, and is stand-by.
The second step injection mo(u)lding: the pellet of the prescription 6 that will dry or 7 the degradable base material of filling a prescription, the adding injection machine carries out injection mo(u)lding.Barrel temperature is set at: 30 ℃ of charging apertures, 185 ℃ of compression sections, 190 ℃ of metering sections, 180 ℃ at nozzle;
Mold temperature is: 30 ℃,
Injection pressure is: 105MPa,
Injection time is: 10.2 seconds,
Dwell time is: 2.8 seconds,
Screw speed is: 30 rev/mins,
Obtain adopting prescription 6 or the syringe needle head cap 1 of 7 the degradable base material of filling a prescription.
Embodiment 8 syringe needle head caps 1 injection molding forming method
Adopt the degradable substrate material of prescription 8, syringe needle head cap 1 injection molding forming method is:
The first step will be filled a prescription the pellet of 8 degradable substrate material under 60 ℃, and vacuum drying is after 24 hours, and is stand-by.
The second step injection mo(u)lding: the pellet of the degradable substrate material of the prescription 8 that will dry, add injection machine, carry out injection mo(u)lding.Barrel temperature is set at: 30 ℃ of charging apertures, 135 ℃ of compression sections, 150 ℃ of metering sections, 140 ℃ at nozzle;
Mold temperature is: 30 ℃,
Injection pressure is: 90MPa,
Injection time is: 8.8 seconds,
Dwell time is: 2.6 seconds,
Screw speed is: 35 rev/mins,
Obtain adopting the syringe needle head cap 1 of the degradable substrate material of prescription 8.