CN103073181B - Borosilicate glass sleeve for pen-type injector and preparation method thereof - Google Patents
Borosilicate glass sleeve for pen-type injector and preparation method thereof Download PDFInfo
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- CN103073181B CN103073181B CN201210574375.XA CN201210574375A CN103073181B CN 103073181 B CN103073181 B CN 103073181B CN 201210574375 A CN201210574375 A CN 201210574375A CN 103073181 B CN103073181 B CN 103073181B
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Abstract
The invention relates to a piece of medical glass, in particular to a borosilicate glass sleeve for a pen-type injector and a preparation method thereof. The borosilicate glass sleeve is characterized by comprising the following chemical compositions: SiO2, Al2O3, B2O3, K2O, Na20, CaO, MgO, BaO and Fe2O3. The method comprises the following steps: (1), forming the medical neutral borosilicate glass pipe through a forming machine; (2), allowing the formed glass sleeve to be subjected to annealing in an electric annealing furnace; (3), then allowing the glass sleeve to be subjected to an appearance test; (4), finally, packaging and putting in storage. The method has the advantages that the formula and the preparation method ensure that the glass performance reaches A-level water resistance requirement; the respective content of silicon dioxide, aluminium oxide, diboron trioxide is high; the content of alkali metal oxide is low; and the product is ensured to have higher chemical stability, thermal stability and mechanical strength.
Description
Technical field
The present invention relates to a kind of pharmaceutical glass, be specifically related to a kind of borosilicate glass sleeve for pen type syringe and preparation method thereof.
Background technology
All the time, the injection product that pharmaceutical manufacturer of China produces is all adopt Traditional Packing, pen-type injector is the injection packaging vessel of new generation just appearing at world market for 2002, emerging of it, meet the requirement of the easy to use and safe medication of people better, and will the epoch-making change of liquid drugs injection and the powder injection packing of product, clinical application mode be caused.
Traditional injection packaging existence two defects: one is patient medication security presence hidden danger.Before use, when ampoule is broken into pieces by operator, can produce tiny glass powder, these glass powders are likely mixed into medicament to injection, work the mischief to patient; Meanwhile, by the process of injection liquid inhalation syringe, liquid is exposed in air, easily causes particulate and microbial contamination.Two is that use procedure operation is complicated, and efficiency is low.As, use ampoule generally to need " drawing ", " striking ", " taking out " three actions; Powder pin is used then to need through five road programs: syringe needle thrusts the sucking liquid-intramuscular injection of mixing in solvent bottle-suctions solvent to syringe-injection solute bottle-in solute bottle or intravenous injection, instillation.
In addition, Traditional Packing also can cause some social concerns indirectly, and such as a large amount of plastic injector for temporary use can form white pollution, and there is the danger of the pathophoresiss such as acquired immune deficiency syndrome (AIDS) in use, recycling process.
And design pen-type injector ingenious, esy to use, safe and reliable, avoid the above-mentioned defect of Traditional Packing, the accuracy of administration, cleanliness and simplicity can be improved, its type self-destroyed packaging, can also avoid reusing.It is the earliest for genetically engineered drug, biological enzyme formulation, and in European countries such as Germany, the narcotic of dental operation uses pen-type injector to pack just more and more at large.Also the pen-style injection agent of multiple pen type injector package is allotted in American-European army.The application of pen-style injection agent comprises dual-use.Some preparation enterprises, while exploitation novel form, introduce or are introducing pen-type injector filling production lines.
Its range of application widely, can be used for following field: anti-biochemical first aid class, hemostasis and pain-relieving class, heart trouble first aid class, Regular Insulin, removing toxic substances class, antipyretic-antalgic class, anaesthetize calm class, microbiotic, Interferon, rabbit, transfer factor, solution drinks etc.
Borosilicate glass sleeve for pen type syringe is one of key fitment of pen-type injector, it is the main carriers of splendid attire medicine in pen-type injector, will with pen-type injector aluminium lid, pen-type injector halogenation (chlorination or bromination) isoprene-isobutylene rubber piston and pad with the use of, have higher requirement to aspects such as chemical stability, physical strength, smooth finish, cleanliness factor, conformabilities, therefore this product uses one-level water tolerance Glass tubing through thermo forming and forms through relevant treatment.One-level water tolerance Glass tubing has better chemical stability and physical strength than common low borosilicate glass tube, its oxide compound composition has strict requirement, according to State Food and Drug Administration's national drug packaging vessel (material) standard (trying) " classification of pharmaceutical glass composition and test method thereof " (YBB00342003) neutral glass compositional ranges is:
| Oxide components | SiO 2 | Al 2O 3 | B 2O 3 | K 2O+Na 2O | CaO+MgO+BaO |
| Oxide content (%) | ≈75 | 2-7 | 8-12 | 4-8 | ≈5 |
In one-level water tolerance glass oxide composition, the content of silicon-dioxide, boron trioxide and aluminium sesquioxide is higher than low borosilicate glass and common soda lime glass, and the content of potassium oxide and sodium oxide is lower than low borosilicate glass and common soda lime glass, this ensures that there one-level water tolerance glass and there is good chemical stability and low thermal expansivity, so one-level water tolerance glass is with its good material, performance, particularly excellent chemical stability and thermostability get a lot of applications in drug packaging field.
Borosilicate glass sleeve for pen type syringe adopts one-level water tolerance Glass tubing to be made, the material of one-level water tolerance glass ensure that the chemical stability of borosilicate glass sleeve for pen type syringe and low thermal expansivity, some component in glass just can be prevented like this by the medicine being contacted stripping or the mutual migration causing composition when long-time storage liquid preparation, also can prevent from being corroded by liquid long period of soaking causing flake, thus ensure that the quality of medicine.
State Food and Drug Administration's national drug packaging vessel (material) standard (trying) " borosilicate glass sleeve for pen type syringe " is divided into 8.65mm, 10.85mm, 10.95mm, 11.60mm, 14.00mm, 14.45mm and 18.25mm seven kinds of specifications according to glass tube external diameter.At present, specification market used is mainly 8.65mm, 10.85mm and 11.60mm.
Summary of the invention
The object of this invention is to provide a kind of borosilicate glass sleeve for pen type syringe and preparation method thereof, can either ensure that glass properties reaches the requirement of one-level water tolerance, can ensure that again product has very high chemical stability and thermostability and very high physical strength.
Borosilicate glass sleeve for pen type syringe of the present invention, comprises the chemical composition of following mass percent: SiO
275-79%, Al
2o
31.6-2.2%, B
2o
312.9-13.6%, K
2o0.05-0.1%, Na
2o5.2-8.6%, CaO1.2-1.5%, MgO0.03-0.05%, BaO0.08-0.1% and Fe
2o
30.02-0.03%.Amount less than 100% is inevitable customary impurities.
The preparation method of borosilicate glass sleeve for pen type syringe of the present invention, comprises the following steps:
(1) medicinal neutral boron silicate glass pipe is shaping by forming machine;
(2) the glass sleeve after forming does anneal in electric annealing furnace;
(3) again visual testing is carried out to glass sleeve;
(4) finally pack, put in storage.
Wherein, forming machine can adopt vertical equipment in step (1), and moulding process flow process is: upper pipe-fixed length-heating-cutting-heating-suitable for reading is shaping-and heating-end opening premolding-heating-finishing end opening-blanking.
Vertical equipment manufacturer is German AMBEG company, current state-of-the-art equipment in the world, this equipment adopts fuelled with natural gas, comburant oxygen, upper pipe, fixed length, heating, cutting, shaping, the process such as end opening is shaping suitable for reading are for complete continuously, the control key of quality is grasped the flame temperature of each station, grasps suitable for reading shaping.Machine speed generally adjusts according to produced specification, before upper pipe processing, first on glass-tube shelf, choose external diameter, visual appearance conformance with standard, the Glass tubing that length is consistent, should test to product by the requirement of borosilicate glass sleeve for pen type syringe inner quality standard in time after having inserted first Glass tubing, find that there is unacceptable product and take quarantine measures immediately.
In step (1), forming machine also can adopt horizontal equipment, moulding process flow process comprises Pipe Cutting and shaping two steps, wherein, Pipe Cutting is upper pipe-fixed length-heat-cut into short Glass tubing, be shaped to material loading-preheating round edge (revising the burr of Glass tubing during cutting)-heating-end opening premolding-heating-finishing end opening-upset-heating-suitable for reading shaping-blanking.
Horizontal equipment manufacturer is German LOWINGER company, and be equipment comparatively advanced in the world at present, this equipment cutting pipe and shaping two independent meanss, my company only have purchased molding device.Molding device adopts fuelled with natural gas, comburant oxygen, heating, cutting, shaping, the process such as end opening is shaping suitable for reading are for complete continuously, and the control key of quality is by the flame temperature adjusting Sweet natural gas, oxygen pressure grasps each station, grasp suitable for reading shaping.Machine speed generally adjusts according to produced specification.By the requirement of borosilicate glass sleeve for pen type syringe inner quality standard, product is tested at any time in production process, find that there is unacceptable product and take quarantine measures immediately.Pipe Cutting equipment and tube cutter, according to the specification of shaping borosilicate glass sleeve for pen type syringe, a long Glass tubing is cut into the short Glass tubing of many regular lengths, device fabrication producer is the ox pool, Wujin of Changzhou sunlight lamp foam material factory.
Molding procedure sends into natural wind by air-conditioning, smoke extraction duct is discharged to the waste gas produced in moulding process the Air quality ensureing molding procedure outside workshop, product introduction anneal after shaping, annealing furnace is electric annealing furnace, can ensure quality and the cleanliness factor of product.
Borosilicate glass sleeve for pen type syringe in the process made owing to being subject to fierce, uneven temperature variation, thus make it produce thermal stresses, this thermal stresses can reduce intensity and the thermostability of product, product even can be caused to break voluntarily, and annealing is exactly eliminate or reduce the heat treatment process of the thermal stresses in glass to permissible value.The quality of annealing is directly connected to the inner quality of borosilicate glass sleeve for pen type syringe, directly has influence on internal stress and whether interior surfaces of glass water tolerance is qualified, mainly realizes by controlling the temperature in each district of annealing furnace well.
The borosilicate glass sleeve for pen type syringe circulated from visual testing operation carries out packing, putting in storage at packaging process.This operation is that product is first loaded a plastics casing or other container, then plastics casing or other container heat that borosilicate glass sleeve for pen type syringe is housed is bundled into a hot bag dish, then carton is put in heat offer.Also can pack according to customer requirement.The major equipment that this operation uses is wrapping machine.Wrapping machine manufacturing firm is German B+S company.
Product correlated performance test of the present invention: product test divides routine inspection and type inspection two kinds.
Routine inspection is all tested to often criticizing product, and Interventions Requested mainly comprise: internal surface water tolerance, internal stress, thermotolerance; Body external diameter, body internal diameter, lower internal diameter, external diameter suitable for reading, neck internal diameter, upper internal diameter, mouth plane suitable for reading to the length of neck bottom, mouth plane suitable for reading to the length on lower edge suitable for reading, sealing face; Product surface should be bright and clean, smooth, and do not have obvious glass defect; Must not there be crackle at any position.
Type inspection is that every three months does once full item inspection to product, namely physicochemical property, specification and visual appearance are tested, Interventions Requested increase on the basis of routine inspection project: coefficient of linear thermal expansion, boron trioxide content, 121 DEG C of particle method water tolerance, arsenic, antimony, plumbous leaching content.
All carry out at the purifying factory building of GMP certification from visual testing operation, its cleanliness factor 300,000 grades, effectively ensure product high-cleanness, high.
The invention has the advantages that: glass properties reaches the requirement of one-level water tolerance to adopt formula of the present invention and preparation method ensure that, silicon-dioxide, aluminum oxide, boron trioxide content are high, alkali metal oxide content is low, ensure that product has very high chemical stability and thermostability and very high physical strength, the raw material used does not comprise heavy metal component and toxic substance, ensure that security and the wholesomeness requirement of product.What this formula also contemplated glass simultaneously founds factor, and the design gas rate of this formula is relatively low, can decrease volatility of raw material, decreases the pollution to air and wastage of material.
Embodiment
Below in conjunction with embodiment, the present invention will be further described.
Embodiment 1:
Formula:
Comprise the chemical composition of following mass percent: SiO
275%, Al
2o
32.2%, B
2o
312.9%, K
2o0.1%, Na
2o8.44%, CaO1.2%, MgO0.05%, BaO0.08% and Fe
2o
30.03%.
Preparation method:
Comprise the following steps: (1) is shaping by forming machine by medicinal neutral boron silicate glass pipe; (2) the glass sleeve after forming does anneal in electric annealing furnace; (3) again visual testing is carried out to glass sleeve; (4) finally pack, put in storage.
Wherein, forming machine can adopt vertical equipment in step (1), and moulding process flow process is: upper pipe-fixed length-heating-cutting-heating-suitable for reading is shaping-and heating-end opening premolding-heating-finishing end opening-blanking.
Vertical equipment manufacturer is German AMBEG company, current state-of-the-art equipment in the world, this equipment adopts fuelled with natural gas, comburant oxygen, upper pipe, fixed length, heating, cutting, shaping, the process such as end opening is shaping suitable for reading are for complete continuously, the control key of quality is grasped the flame temperature of each station, grasps suitable for reading shaping.Machine speed generally adjusts according to produced specification, before upper pipe processing, first on glass-tube shelf, choose external diameter, visual appearance conformance with standard, the Glass tubing that length is consistent, should test to product by the requirement of borosilicate glass sleeve for pen type syringe inner quality standard in time after having inserted first Glass tubing, find that there is unacceptable product and take quarantine measures immediately.
Molding procedure sends into natural wind by air-conditioning, smoke extraction duct is discharged to the waste gas produced in moulding process the Air quality ensureing molding procedure outside workshop, product introduction anneal after shaping, annealing furnace is electric annealing furnace, can ensure quality and the cleanliness factor of product.
Borosilicate glass sleeve for pen type syringe in the process made owing to being subject to fierce, uneven temperature variation, thus make it produce thermal stresses, this thermal stresses can reduce intensity and the thermostability of product, product even can be caused to break voluntarily, and annealing is exactly eliminate or reduce the heat treatment process of the thermal stresses in glass to permissible value.The quality of annealing is directly connected to the inner quality of borosilicate glass sleeve for pen type syringe, directly has influence on internal stress and whether interior surfaces of glass water tolerance is qualified, mainly realizes by controlling the temperature in each district of annealing furnace well.
The borosilicate glass sleeve for pen type syringe circulated from visual testing operation carries out packing, putting in storage at packaging process.This operation is that product is first loaded a plastics casing or other container, then plastics casing or other container heat that borosilicate glass sleeve for pen type syringe is housed is bundled into a hot bag dish, then carton is put in heat offer.Also can pack according to customer requirement.The major equipment that this operation uses is wrapping machine.Wrapping machine manufacturing firm is German B+S company.
Product correlated performance test of the present invention: product test divides routine inspection and type inspection two kinds.
Routine inspection is all tested to often criticizing product, and Interventions Requested mainly comprise: internal surface water tolerance, internal stress, thermotolerance; Body external diameter, body internal diameter, lower internal diameter, external diameter suitable for reading, neck internal diameter, upper internal diameter, mouth plane suitable for reading to the length of neck bottom, mouth plane suitable for reading to the length on lower edge suitable for reading, sealing face; Product surface should be bright and clean, smooth, and do not have obvious glass defect; Must not there be crackle at any position.
Type inspection is that every three months does once full item inspection to product, namely physicochemical property, specification and visual appearance are tested, Interventions Requested increase on the basis of routine inspection project: coefficient of linear thermal expansion, boron trioxide content, 121 DEG C of particle method water tolerance, arsenic, antimony, plumbous leaching content.
All carry out at the purifying factory building of GMP certification from visual testing operation, its cleanliness factor 300,000 grades, effectively ensure product high-cleanness, high.
Embodiment 2:
Formula:
Comprise the chemical composition of following mass percent: SiO
278%, Al
2o
31.6%, B
2o
313.6%, K
2o0.05%, Na
2o5.2%, CaO1.4%, MgO0.03%, BaO0.1% and Fe
2o
30.02%.
Preparation method:
Comprise the following steps: (1) is shaping by forming machine by medicinal neutral boron silicate glass pipe; (2) the glass sleeve after forming does anneal in electric annealing furnace; (3) again visual testing is carried out to glass sleeve; (4) finally pack, put in storage.
Wherein, forming machine can adopt vertical equipment in step (1), and moulding process flow process is: upper pipe-fixed length-heating-cutting-heating-suitable for reading is shaping-and heating-end opening premolding-heating-finishing end opening-blanking.
Vertical equipment manufacturer is German AMBEG company, current state-of-the-art equipment in the world, this equipment adopts fuelled with natural gas, comburant oxygen, upper pipe, fixed length, heating, cutting, shaping, the process such as end opening is shaping suitable for reading are for complete continuously, the control key of quality is grasped the flame temperature of each station, grasps suitable for reading shaping.Machine speed generally adjusts according to produced specification, before upper pipe processing, first on glass-tube shelf, choose external diameter, visual appearance conformance with standard, the Glass tubing that length is consistent, should test to product by the requirement of borosilicate glass sleeve for pen type syringe inner quality standard in time after having inserted first Glass tubing, find that there is unacceptable product and take quarantine measures immediately.
Molding procedure sends into natural wind by air-conditioning, smoke extraction duct is discharged to the waste gas produced in moulding process the Air quality ensureing molding procedure outside workshop, product introduction anneal after shaping, annealing furnace is electric annealing furnace, can ensure quality and the cleanliness factor of product.
Borosilicate glass sleeve for pen type syringe in the process made owing to being subject to fierce, uneven temperature variation, thus make it produce thermal stresses, this thermal stresses can reduce intensity and the thermostability of product, product even can be caused to break voluntarily, and annealing is exactly eliminate or reduce the heat treatment process of the thermal stresses in glass to permissible value.The quality of annealing is directly connected to the inner quality of borosilicate glass sleeve for pen type syringe, directly has influence on internal stress and whether interior surfaces of glass water tolerance is qualified, mainly realizes by controlling the temperature in each district of annealing furnace well.
The borosilicate glass sleeve for pen type syringe circulated from visual testing operation carries out packing, putting in storage at packaging process.This operation is that product is first loaded a plastics casing or other container, then plastics casing or other container heat that borosilicate glass sleeve for pen type syringe is housed is bundled into a hot bag dish, then carton is put in heat offer.Also can pack according to customer requirement.The major equipment that this operation uses is wrapping machine.Wrapping machine manufacturing firm is German B+S company.
Product correlated performance test of the present invention: product test divides routine inspection and type inspection two kinds.
Routine inspection is all tested to often criticizing product, and Interventions Requested mainly comprise: internal surface water tolerance, internal stress, thermotolerance; Body external diameter, body internal diameter, lower internal diameter, external diameter suitable for reading, neck internal diameter, upper internal diameter, mouth plane suitable for reading to the length of neck bottom, mouth plane suitable for reading to the length on lower edge suitable for reading, sealing face; Product surface should be bright and clean, smooth, and do not have obvious glass defect; Must not there be crackle at any position.
Type inspection is that every three months does once full item inspection to product, namely physicochemical property, specification and visual appearance are tested, Interventions Requested increase on the basis of routine inspection project: coefficient of linear thermal expansion, boron trioxide content, 121 DEG C of particle method water tolerance, arsenic, antimony, plumbous leaching content.
All carry out at the purifying factory building of GMP certification from visual testing operation, its cleanliness factor 300,000 grades, effectively ensure product high-cleanness, high.
Claims (4)
1. a borosilicate glass sleeve for pen type syringe, is characterized in that the chemical composition comprising following mass percent: SiO
275%, Al
2o
32.2%, B
2o
312.9%, K
2o0.1%, Na
2o8.44%, CaO1.2%, MgO0.05%, BaO0.08% and Fe
2o
30.03%.
2. a preparation method for borosilicate glass sleeve for pen type syringe according to claim 1, is characterized in that comprising the following steps:
(1) medicinal neutral boron silicate glass pipe is shaping by forming machine;
(2) the glass sleeve after forming does anneal in electric annealing furnace;
(3) again visual testing is carried out to glass sleeve;
(4) finally pack, put in storage.
3. the preparation method of borosilicate glass sleeve for pen type syringe according to claim 2, it is characterized in that forming machine adopts vertical equipment in step (1), moulding process flow process is: upper pipe-fixed length-heating-cutting-heating-suitable for reading is shaping-and heating-end opening premolding-heating-finishing end opening-blanking.
4. the preparation method of borosilicate glass sleeve for pen type syringe according to claim 2, it is characterized in that in step (1), forming machine adopts horizontal equipment, moulding process flow process comprises Pipe Cutting and shaping two steps, wherein, Pipe Cutting is upper pipe-fixed length-heat-cut into short Glass tubing, be shaped to material loading-preheating round edge-heating-end opening premolding-heating-finishing end opening-upset-heating-suitable for reading shaping-blanking.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210574375.XA CN103073181B (en) | 2012-12-26 | 2012-12-26 | Borosilicate glass sleeve for pen-type injector and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210574375.XA CN103073181B (en) | 2012-12-26 | 2012-12-26 | Borosilicate glass sleeve for pen-type injector and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN103073181A CN103073181A (en) | 2013-05-01 |
| CN103073181B true CN103073181B (en) | 2015-06-24 |
Family
ID=48149905
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201210574375.XA Active CN103073181B (en) | 2012-12-26 | 2012-12-26 | Borosilicate glass sleeve for pen-type injector and preparation method thereof |
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|---|---|
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108383379B (en) * | 2016-05-19 | 2020-09-01 | 林友富 | Improved manufacturing method of high-pressure-resistant borosilicate tube |
| CN109896741A (en) * | 2017-12-08 | 2019-06-18 | 辽宁省轻工科学研究院 | A kind of overlength, the preparation method of high-accuracy boron-containing glass pipe |
| CN113698078A (en) * | 2021-10-08 | 2021-11-26 | 无锡市爱尔德药用玻璃有限公司 | Processing technology for glass bottle production |
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| DE50108547D1 (en) * | 2001-06-12 | 2006-02-02 | Schott Ag | Process for the production of borosilicate glasses |
| DE102009038475B4 (en) * | 2009-08-21 | 2011-07-07 | Schott Ag, 55122 | Use of a glass for glass-metal connections |
| CN102515523B (en) * | 2011-12-29 | 2013-12-04 | 山东省药用玻璃股份有限公司 | Borosilicate glass sleeve for pen type syringe and preparation method of borosilicate glass sleeve |
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