CN100398407C - Compound film rubber cork and its preparation method - Google Patents
Compound film rubber cork and its preparation method Download PDFInfo
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- CN100398407C CN100398407C CNB2005100218977A CN200510021897A CN100398407C CN 100398407 C CN100398407 C CN 100398407C CN B2005100218977 A CNB2005100218977 A CN B2005100218977A CN 200510021897 A CN200510021897 A CN 200510021897A CN 100398407 C CN100398407 C CN 100398407C
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Abstract
The present invention relates to a compound film rubber cork which is characterized in that a polymer film material layer which is close to the melting point of rubber is filmed at the surface of the rubber cork, wherein the film material is polyethylene, polypropylene, polyester, polystyrene, or compound materials of the polyethylene, the polypropylene, the polyester and the polystyrene; the tension rate of the film material is 7 to 20%; no adhesives exist between the compound film material of the compound film rubber cork and the rubber cork. Films are directly glued with the rubber cork by the method of the present invention through a physical method; the rubber cork and the films are tightly bonded; thereby, the direct contact of the rubber cork and liquid medicines is effectively avoided. Meanwhile, the films contact the rubber cork without gaps so that harmful substances can not exist. The rubber cork is once shaped by hot pressing at the melting point of the film material and rubber materials, so the problem that bubbles are generated in the rubber cork, and between the rubber cork and the films because of loose compounding can be avoided. The present invention has the advantages of high production efficiency, little pollution and simple technology; the present invention is favorable for industrialization.
Description
Technical field
The present invention relates to a kind of medical rubber plug and preparation method thereof, specifically a kind of Complex Membrane Rubber Stopper And Preparation Method.
Background technology
No. 462 files specify of State Food and Drug Administration, from January 1st, 2005, the same withdraw from use natural rubber of all drug packaging bottles bottle stopper, use butyl rubber bottle stopper instead or be coated with, compound film rubber cork.Why natural plug is thoroughly eliminated, just because of there is following shortcoming in it: 1, biological safety is relatively poor, and the moisture absorption is mouldy easily; 2, the foreign preteins of stripping is one of key factor that causes people's body heat source from natural plug; 3, easily carcinogenic, the teratogenesis of the pyridine compounds and their of stripping, mutagenesis; 4, chemical property is more active, and easy and medicine reacts to each other; 5, air-tightness is relatively poor; Has higher diffusibility for all gases; 6, in when sterilization, materials such as the heavy metal in a large amount of harmful residual chemical promoters, vulcanizator, the auxiliary material, protein are concentrated in the space of moving to plug footpath and pad film top, and direct intravasation vein through puncturing after endangers patient unawares.
The simple butyl rubber that uses but has following shortcoming:
1, lack of material, the whole world have only two tame overseas enterprises to produce, and form monopolization trend, and cost of material is too expensive, and domestic enterprise can't bear; 2, there is the particulate obscission, influences medicinal liquid clarity; 3, character is not absolute stability, reacts with some medicines, influences drug quality.
So simple popularization butyl rubber plug also has certain difficulty, this just makes the improvement work of plug become in the drug packaging reform urgent task.
Coated plug system adopts polymer composite to be sprayed on the purpose that the plug surface reaches the isolation plug.But spraying easily causes non-uniform film thickness even, and in spraying process, composite material liquefaction back easily reacts with plug, causes the control of plug difficult quality.
The CN1552301A patent application discloses a kind of medicinal compound film rubber cork preparation method, and the position that need answer film at molded plug is coated with adhesives, and heating scribbles the plug of adhesives, removes and desolvates; The film that High molecular material is made is heated to plastic, place on the plug of gluing, under vacuum condition with stock mould with compound sticking being pressed on the plug promptly of film.This method is owing to used adhesion agent, complex process, and adhesives particularly polyurethane binder itself certain toxicity is arranged, and the solvent that adds has volatility, at present, developed country such as America and Europe has prohibited in medicine and food pack and has adopted polyurethane binder.The safe and sanitary that sticks with glue agent about the soft compound package material of food detects, and each country all manages very sternly.The U.S. is made stipulations by FDA, as among the 21CFR § 1771390 about the adhesion agent of anti-121 ℃ or 135 ℃ thermophilic digestions, made the restriction of raw and auxiliary material, also to detect complex pocket, in the residual slag of evapo tranpiration that the control complex pocket is come by extracting behind thermophilic digestion, the part that can be dissolved in the chloroform can not be higher than 0.0016mg/cm
2Or 0.016mg/cm
2China is then detected from two aspects: one is to be undertaken by GB9683 " composite food package bag hygienic standard ", the content of its diaminotoluene must not be greater than 0.004mg/L, another is the wholesomeness of adhesion agent itself, detect by GBI5139 " toxicological evaluation of food safety procedure ".Present situation is, China limits because of the raw material to adhesion agent not, as the adhesion agent originating firm, all can detect by some program in this program, but great majority is only done the detection of a project of acute toxicity test, draw a LD
50Concrete numeral, just recommend to the user then with this report, say this adhesion agent safe and sanitary.This type of adhesive application is used in the plug in transfusion, and materials such as diluent ethyl acetate in the polyurethane and diaminotoluene can see through film permeation in soup, not only influence drug quality, also can directly be detrimental to health.
The patent application of the publication number CN1389334A of Japan Nipro Corp application discloses a kind of preparation method of laminated rubber plug, to handle through air plasma by the ethylene-tetrafluoroethylene of sex change type, make treated side and half finished rubber sheet lamination relatively, in mould, pressurize, add the shape of post forming for plug.Owing to do not obtain the security credential of poly-fluorine class material in China; the poly-fluorine class material of approval is not the interior packaging material of direct contact medicine; and employed film pulling experiment machine (Shanghai chemical machinery four factories; XLL-2500N); measure extensibility stretching rate of change and have only 5.5%, if with the compound film rubber cork breakage rate height of this method preparation.Use plasma technology to handle film surface treatment complexity in addition, cost is higher relatively, is unfavorable for industrialization.
Summary of the invention
The object of the present invention is to provide a kind of technology simple, utilize the preparation method of industrialized compound film rubber cork.
The objective of the invention is to implement by following technical scheme:
Multiple film rubber plug provided by the invention, it is characterized in that: it is under the rubber melting temperature, differs macromolecule member material less than 10 ℃ at the multiple film one deck in the surface of rubber plug and rubber fusing point.Described multiple film rubber plug is in the melting temperature pressurization, vacuumizes and obtain simultaneously.
Wherein, described membrane material is polyethylene, polypropylene, polyester, polyphenyl alkene, polytetrafluoroethylene or their composite material.Film preferred material extensibility is at 7-20%.
Preferably: fusing point is that 160 ± 10 ℃ transfusion is with natural plug and polypropylene, fusing point is that 120 ± 10 ℃ powder pin is with natural plug and polyethylene, fusing point is 110 ± 10 ℃ of polyisoprene plugs and polyester, or fusing point is that 115 ± 10 ℃ butyl rubber plug and polyethylene carry out multiple film at melting temperature and obtain.
Compound film rubber cork preparation method provided by the invention:
Method one may further comprise the steps:
The fusing point of a, mensuration sheet rubber, selection and rubber fusing point differ the macromolecule member material less than 10 ℃ then;
B, membrane material and unvulcanized film tightly are overlying on the mould of vacuum vulcanization machine, in mould, melting temperature pressurization down, heating, vacuumize and make the plug shape, wherein said pressure: 15～20Pa simultaneously; Temperature: 130～150 ℃.
The High molecular material of selecting for use is as polyethylene, polypropylene, polyester, polyphenyl alkene, polytetrafluoroethylene and their composite high-molecular material.Plug is because prescription is different, and fusing point is 110～180 ℃ of scopes, and the fusing point of each High molecular material is respectively 130 ℃ in polyphenyl alkene, 164～174 ℃ of polypropylene, 115～135 ℃ of polyethylenes, 110 ℃ of polyester.Can be deployed into appropriate melting point and corresponding plug heat seal according to each components in proportions through compound High molecular material.
Preferably transfusion is answered film with natural plug and polypropylene about 160 ℃; The powder pin is multiple film about 120 ℃ with natural plug and polyethylene; Polyisoprene plug and polyester be multiple film about 110 ℃; Butyl rubber plug and polyethylene be multiple film about 115 ℃.The High molecular material extensibility can be at 7-20%.
Method two
The inventive method also can be selected the membrane material close with the plug fusing point behind capsule forming, film is placed on the plug, is put in altogether in the mould, and melting temperature pressurizes down, heats, vacuumizes simultaneously, makes film be pressed on the plug bottom surface.Principal parameter: pressure: 15～20Pa; Temperature: 90～110 ℃.
The inventive method utilizes physical method directly bonding film and plug, and plug and film are combined closely, and has effectively avoided plug and soup direct contact, and film contacts with zero of plug simultaneously, and objectionable impurities can not be retained.Press mold is once hot-forming to plug, in membrane material and the moulding of elastomeric material fusing point, avoided plug inside, because of the compound problem that does not sternly produce bubble, simultaneously, avoid using plasma technique to handle the film surface between plug and the film, equipment and cost have been saved, and the production efficiency height, pollute few, be a kind of technology simple, be beneficial to industrialized method.
The specific embodiment
The preparation of embodiment 1 compound film rubber cork of the present invention
Polypropylene film and unvulcanized transfusion tightly are overlying on natural rubber sheet on the mould of vacuum vulcanization machine, and in mould, the 15～20Pa that pressurizes under 160 ℃ of temperature vacuumizes and makes the plug shape, and film is pressed on the plug bottom surface.Prune trimming.
The preparation of embodiment 2 compound film rubber corks of the present invention
Polyethylene foil and unvulcanized powder pin tightly are overlying on natural rubber sheet on the mould of vacuum vulcanization machine, and in mould, the 15～20Pa that pressurizes under 120 ℃ of temperature vacuumizes and makes the plug shape, and film is pressed on the plug bottom surface.Prune trimming.
The preparation of embodiment 3 compound film rubber corks of the present invention
Mylar and unvulcanized polyisoprene film tightly are overlying on the mould of vacuum vulcanization machine, and in mould, the 15～20Pa that pressurizes under 110 ℃ of temperature vacuumizes and makes the plug shape, and film is pressed on the plug bottom surface.Prune trimming.
The preparation of embodiment 4 compound film rubber corks of the present invention
Mylar is placed on the butyl rubber plug, be put in altogether in the mould, the 15～20Pa that pressurizes under 110 ℃ of temperature vacuumizes, and makes film be pressed on the plug bottom surface.
The preparation of embodiment 5 compound film rubber corks of the present invention
Polyethylene foil is placed on the butyl rubber plug, be put in altogether in the mould, the 15～20Pa that pressurizes under 110 ℃ of temperature vacuumizes, and makes film be pressed on the plug bottom surface.
Below by test the example form beneficial effect of the present invention is described in further detail, be limitation of the present invention but should not be construed as.
The comparative example
The comparative example makes plug according to file 02122272.X, and the membrane material of wherein selecting for use is sex change ETFE, and plasma process conditions is at 1.1KW second/cm
2The discharge process amount under carry out.
The extensibility of test example 1 membrane material
The polyethylene film that the film that makes according to file 02122272.X and this law are adopted, polypropylene screen, polyester film with the pulling experiment machine (Shanghai chemical machinery four factories, XLL-2500N), at specimen width 4mm, specimen length 25mm measures extensibility, the results are shown in following table:
Table 1
| Membrane material | Stretching rate of change (%) |
| Tetrafluoro ethylene polymer ETFE | 5.5 |
| Polythene PE | 11 |
| Polypropylene BOPP | 9 |
| Polyester BOPET | 10 |
Show that by test extensibility can not be lower than 5.5, cross low meeting and reduce yield rate that have only 4% plastic film as selecting extensibility, yield rate has only 70%; Extensibility is too high easily may to make multiple film inhomogeneous, influences the multiple film effect of product.
Test example 2 peel strengths
The plug that the present invention is made according to standard＜drug packaging with complex film, bag the peel strength of mechanical characteristics item test membrane and plug among the YBB00132002.The detect by an unaided eye breakage of bottom and the fissility (cohesiveness) of burr portion, the plug of embodiment 1-5 and the preparation of test example is not all peeled off, and does not break.The plug that the present invention is made according to standard＜drug packaging with complex film, bag the peel strength 〉=1.0N/15mm of mechanical characteristics item test membrane and plug among the YBB00132002.
With fusing point is 120 ℃ of polyethylene foils, fusing point is 164 ℃ a polypropylene film, fusing point is that 110 ℃ mylar tightly is overlying on the mould of vacuum vulcanization machine with natural rubber sheet (120 ± 10 ℃ of fusing points) with unvulcanized powder pin respectively, in mould, 15～20Pa pressurizes under 120 ℃ of temperature, vacuumize and make the plug shape, film is pressed on the plug bottom surface.Prune trimming.Measure peel strength by test example 2, see the following form:
Table 2
| Test material | Peel strength |
| Polyethylene | ≥1.0N/15mm |
| Polypropylene | ≤1.0N/15mm |
| Polyester | ≥1.0N/15mm |
As can be seen from the above table, the fusing point when selecting material between membrane material and the rubber differs can not be too big, should be less than ± 10 ℃, otherwise the peel strength of finished product can't reach requirement.
Test example 3 exfoliation rates
Get some plugs, add an amount of 2% sodium carbonate liquor, boiled 30 minutes, with potable water flush away alkalescence, the distilled water washing is neutral, dry for standby.With injection needle is No. 61/2, and the needle slope degree is that 14 ± § degree also should be smooth, and the edge does not have the burr and the rough surface of processing back.Inject 1/2 distilled water with medicine bottle.Get ten of plugs after the processing, plug is being marked with on the bottle of distilled water, with the regulation pinhead sleeve on the 5ml syringe, in acupuncture ring, sting to the water surface under vertical, and injection distilled water 1ml, take out syringe needle, bottle is placed under black background and the daylight lamp, with having or not the rubber scurf to fall (other suspended matter is disregarded) in the normal visual observation bottle.More than operation repeats 2 times, stings 3 pins altogether.The exfoliation rate does not answer 〉=60%, the results are shown in following table:
Table 3
| Sample | Natural powder pin plug | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | The comparative example |
| Exfoliation rate % not | 60 | 100 | 100 | 100 | 100 | 100 | 100 |
Plug more original natural gum on exfoliation rate index behind multiple film has been plugged with bigger raising, is fit to cartridge bag material requirement now more.
Test example 4 self sealss performances
Get 10 of 500ml infusion bottles, the 500ml water of packing into is built with pretreated plug respectively.Vertically thrust 3 pins (triangular in shape, the length of side is not less than 5mm) with No. 16 blood samplings or blood transfusion needle on every plug, every pin must penetrate.Pin is extracted, rapidly infusion bottle is inverted, static 120min, whether observe has water droplet to leak.The results are shown in following table:
Table 4
| Sample | Natural powder pin plug | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | The comparative example |
| First-time qualification rate % | 99 | 100 | 100 | 100 | 100 | 100 | 100 |
Plug more original natural gum on the self sealss performance behind multiple film has been plugged with bigger raising, thereby has improved the first-time qualification rate of product, is fit to suitability for industrialized production more.
In sum, the inventive method utilizes physical method directly bonding film and plug, and plug and film are combined closely, and have effectively avoided plug and soup direct contact, and film contacts with zero of plug simultaneously, and objectionable impurities can not be retained.The plug self sealss function admirable for preparing, suitable with the performance level that obtains plug through the plasma technique Processing of Preparation, and cost reduces greatly.The inventive method press mold is once hot-forming to plug, in membrane material and the moulding of elastomeric material fusing point, has avoided plug inside, between plug and the film because of the compound problem that does not sternly produce bubble, and the production efficiency height, pollute few, be a kind of technology simple, be beneficial to industrialized method.
Claims (8)
1. multiple film rubber plug is characterized in that: it is by the pressurization down of rubber melting temperature, the form that vacuumizes simultaneously, differs macromolecule member material less than 10 ℃ at the multiple film one deck in its surface and rubber fusing point.
2. multiple film rubber plug according to claim 1, it is characterized in that: described membrane material is polyethylene, polypropylene, polyester, polyphenyl alkene, polytetrafluoroethylene or their composite material.
3. multiple film rubber plug according to claim 2, it is characterized in that: described membrane material extensibility is at 7-20%.
4. want 3 described multiple film rubber plugs according to right, it is characterized in that: described multiple film rubber plug is: fusing point is that 160 ± 10 ℃ transfusion is with natural plug and polypropylene, fusing point is that 120 ± 10 ℃ powder pin is with natural plug and polyethylene, fusing point is 110 ± 10 ℃ of polyisoprene plugs and polyester, or fusing point be 115 ± 10 ℃ butyl rubber plug and polyethylene in the melting temperature pressurization, vacuumize multiple film simultaneously and obtain.
5. one kind prepares the described method of film rubber plug again of claim 1, it is characterized in that: may further comprise the steps:
The fusing point of a, mensuration sheet rubber, selection and rubber fusing point differ the macromolecule member material less than 10 ℃ then;
B, membrane material and unvulcanized film tightly are overlying on the mould of vacuum vulcanization machine, in mould, melting temperature pressurization down, heating, vacuumize and make the plug shape, wherein said pressure: 15～20Pa simultaneously; Temperature: 130～150 ℃.
6. the method for the multiple film rubber plug of preparation according to claim 5, it is characterized in that: described rubber fusing point is 110～180 ℃; Described High molecular material is polyethylene, polypropylene, polyester, polyphenyl alkene, polytetrafluoroethylene or their composite material; The High molecular material extensibility is at 7-20%.
7. the method for film rubber plug is answered in preparation according to claim 6, it is characterized in that: transfusion is answered films with natural plug and polypropylene at 160 ℃; The powder pin is answered films with natural plug and polyethylene at 120 ℃; Polyisoprene plug and polyester are at 110 ℃ of multiple films; Or butyl rubber plug and polyethylene are at 115 ℃ of multiple films.
8. one kind prepares the described method of film rubber plug again of claim 1, it is characterized in that: behind the capsule forming, selection and plug fusing point differ the membrane material less than 10 ℃, film is placed on the plug, be put in altogether in the mould, melting temperature pressurizes down, vacuumizes simultaneously, makes film be pressed on the plug bottom surface, wherein, pressure: 15～20Pa; Temperature: 90～110 ℃.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100218977A CN100398407C (en) | 2005-10-19 | 2005-10-19 | Compound film rubber cork and its preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100218977A CN100398407C (en) | 2005-10-19 | 2005-10-19 | Compound film rubber cork and its preparation method |
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| CN1751973A CN1751973A (en) | 2006-03-29 |
| CN100398407C true CN100398407C (en) | 2008-07-02 |
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101239019B (en) * | 2008-02-20 | 2011-12-28 | 广东雪龙药用包装材料有限公司 | Medicinal rubber bottle stopper studded with polymer material layer and stickup shaping method thereof |
| CN101560306B (en) * | 2008-04-14 | 2011-05-04 | 郑州市翱翔医药包装有限公司 | Surface processing method for medicinal rubber stopper |
| CN101953751B (en) * | 2010-10-11 | 2013-06-19 | 郑州市翱翔医药包装有限公司 | Fluorocarbon film rubber plug |
| CN103027889A (en) * | 2011-09-29 | 2013-04-10 | 山东新华制药股份有限公司 | Container-holding mesylate pazufloxacin aqueous solution and preparation method thereof |
| CN102702557B (en) * | 2012-06-04 | 2013-08-14 | 郑州市翱翔医药包装有限公司 | Preparation method of medical rubber stopper |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS595046A (en) * | 1982-06-30 | 1984-01-11 | Touritsu Kogyo:Kk | Production of medical rubber article |
| JPH05201456A (en) * | 1992-01-17 | 1993-08-10 | Nissho Corp | Rubber plug for medicine container |
| CN1552301A (en) * | 2003-06-04 | 2004-12-08 | 上海天汇化学有限公司 | Preparation of medicinal film coated rubber plug |
-
2005
- 2005-10-19 CN CNB2005100218977A patent/CN100398407C/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS595046A (en) * | 1982-06-30 | 1984-01-11 | Touritsu Kogyo:Kk | Production of medical rubber article |
| JPH05201456A (en) * | 1992-01-17 | 1993-08-10 | Nissho Corp | Rubber plug for medicine container |
| CN1552301A (en) * | 2003-06-04 | 2004-12-08 | 上海天汇化学有限公司 | Preparation of medicinal film coated rubber plug |
Non-Patent Citations (1)
| Title |
|---|
| 药用复膜丁基胶塞产品技术特征及其适用性. 隋玲玲，缪一鸣.中国包装，第6期. 2002 * |
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Assignee: Jiangsu Runde Medical Materials Co., Ltd. Assignor: Liu Yonghong Contract fulfillment period: 2006.4.25 to 2011.4.24 contract change Contract record no.: 2008320000837 Denomination of invention: Compound film rubber cork and its preparation method Granted publication date: 20060329 License type: Exclusive license Record date: 20081012 |
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