CN108485273A - The production method of disposable syringe self-lubricating piston - Google Patents
The production method of disposable syringe self-lubricating piston Download PDFInfo
- Publication number
- CN108485273A CN108485273A CN201810349582.2A CN201810349582A CN108485273A CN 108485273 A CN108485273 A CN 108485273A CN 201810349582 A CN201810349582 A CN 201810349582A CN 108485273 A CN108485273 A CN 108485273A
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- Prior art keywords
- parts
- medical
- self
- production method
- disposable syringe
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L83/00—Compositions of macromolecular compounds obtained by reactions forming in the main chain of the macromolecule a linkage containing silicon with or without sulfur, nitrogen, oxygen or carbon only; Compositions of derivatives of such polymers
- C08L83/04—Polysiloxanes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C35/00—Heating, cooling or curing, e.g. crosslinking or vulcanising; Apparatus therefor
- B29C35/02—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0222—Materials for reducing friction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2205/00—Polymer mixtures characterised by other features
- C08L2205/02—Polymer mixtures characterised by other features containing two or more polymers of the same C08L -group
- C08L2205/025—Polymer mixtures characterised by other features containing two or more polymers of the same C08L -group containing two or more polymers of the same hierarchy C08L, and differing only in parameters such as density, comonomer content, molecular weight, structure
Abstract
The invention belongs to the field of medical instrument technology, more particularly to a kind of disposable syringe production method of self-lubricating piston.In terms of parts by weight, 100 parts of medical grade silicon rubber is weighed, 38 parts of medical dimethicone, 0.5 1 parts of 10 30 parts of fume colloidal silica and vulcanizing agent are spare；Medical grade silicon rubber is set uniformly to be mixed with rubber compound with medical dimethicone, fume colloidal silica and vulcanizing agent by mechanism；By in the rubber compound merging film-discharging machine of preparation, film is made；Manufactured film is placed in molding die, and mold is put into vulcanizer and is vulcanized, semi-finished product are made；Manufactured semi-finished product are rushed into overlap with particular manufacturing craft and punching machine；Cleaning, drying, after the assay was approved packaging and storage.The syringe that the present invention prepares is good with self-lubricating piston appearance, and hardness height is low with pressure permanent set, and biology performance index is excellent.
Description
Technical field
The invention belongs to the field of medical instrument technology, more particularly to a kind of disposable syringe self-lubricating piston
Production method.
Background technology
The prior art reduces in syringe frictional resistance between piston and cylinder inboard wall using lubricant, it is common to use
A kind of lubricant is silicone oil, but using this lubricant and unwelcome, because this lubricant disperse or can be dissolved in liquid
In, to make liquid be contaminated, therefore people once attempt explore not with lubricator and syringe piston remains to leakproof and makes work
The method that plug is easy sliding, this trial includes with a variety of different piston profiles.
In process of production, it in order to ensure that syringe is used with excellent sliding capability, needs to piston and syringe
Inner cylinder carries out silication；This silication is carried out by two steps, first, silication is carried out in piston production process, second is that syringe group
Silication is carried out during dress.It is more or less in the silicatization process twice of product since the ability of each corporate environment management and control is different
There are pollution problems.
Invention content
It is an object of the invention to overcome the deficiencies of the prior art and provide a kind of disposable syringes to be lived with self-lubricating
The production method of plug.The production method is simple for process, reasonable, reduces pollution of the external environment to product to the full extent；System
For the syringe gone out is high with self-lubricating piston biological safe performance, appearance is good, rubber plug bottom is without yellowing, hardness height and its presses forever
Long deformation rate is low.
The disposable syringe of the present invention production method of self-lubricating piston, specifically includes following steps：
(1) dispensing：In terms of parts by weight, 100 parts of medical grade silicon rubber is weighed, medical dimethicone 3-8 parts, vapor phase method is white
0.5-1 parts of 10-30 parts of carbon black and vulcanizing agent are spare；
(2) it is kneaded：Make medical grade silicon rubber and medical dimethicone, fume colloidal silica and vulcanizing agent by mechanism
Uniformly it is mixed with rubber compound；
Rubber compound is to be added in twin-screw extruder or closed kneader to be gradually added into vapor phase method by medical grade silicon rubber (raw rubber)
White Carbon black, medical dimethicone and vulcanizing agent and other auxiliary agents are refined repeatedly.The fast roller of twin-screw extruder is higher rear
Speed ratio causes to be kneaded faster, and low speed can make film smooth than then；Roller must be connected with cooling water, melting temperature preferably 40 DEG C with
Under, to prevent the volatilization loss of incipient scorch or vulcanizing agent.It is smaller (1~5mm) to start roll spacing when mixing, then gradually amplifies.It is kneaded
Time is that (twin-screw extruder specification was in 20~40 minutes)。
(3) glue piece：In the rubber compound merging film-discharging machine that will be prepared through step (2), film is made；
(4) vulcanize：Film made of step (3) is placed in molding die, and mold is put into vulcanizer and carries out sulphur
Change, semi-finished product are made；
(5) overlap is repaiied：Semi-finished product made of step (4) are rushed into overlap with particular manufacturing craft and punching machine；
(6) cleaning, drying, after the assay was approved packaging and storage.
Wherein：
Vulcanizing agent described in step (1) is -2,5- pairs-(t-butyl peroxy) hexane of 2,5- dimethyl.
Mixing described in step (2) uses twin-screw extruder or closed kneader；It feeds and operates in mixing process and is suitable
Sequence is：Medical grade silicon rubber → fume colloidal silica → medical dimethicone → vulcanizing agent → thin logical 5 times → blanking.
40 DEG C of melting temperature ＜, time 20-40min in step (2).
Mold being put into vulcanizer described in step (4) vulcanizes, 155~165 DEG C of curing temperature, and the time 160~
240s。
Drying temperature described in step (6) is 100-120 DEG C, drying time 1-3 hours.
The invention has the advantages that：
(1) disposable syringe self-lubricating piston prepared by the present invention, biology performance index is excellent, whole skills
Art index complies fully with《YY/T0243-2016 disposable sterilized syringe pistons》The requirement of medical device industry standard,
The vitro cytotoxicity index of product reaches 0 grade, fully meets GB/T16886.5 standards i.e. ISO10993 medical instruments biology
Evaluate the associated specifications of international standard.
(2) production method is simple for process, reasonable, reduces pollution of the external environment to product to the full extent；It prepares
The syringe gone out is high with self-lubricating piston biological safe performance, appearance is good, and rubber plug bottom is without yellowing, hardness height and the permanent change of pressure
Form quotient is low.
Specific implementation mode
The invention will be further described with reference to embodiments.
Embodiment 1
The disposable syringe of the present invention production method of self-lubricating piston, specifically includes following steps：
(1) dispensing：In terms of parts by weight, 100 parts of medical grade silicon rubber, 8 parts of medical dimethicone, vapor phase method hard charcoal are weighed
Black 30 parts and vulcanizing agent 2,5- dimethyl -2,5- double -1 part of (t-butyl peroxy) hexanes are spare；
(2) it is kneaded：Make medical grade silicon rubber and medical dimethicone, fume colloidal silica and vulcanizing agent by mechanism
Uniformly it is mixed with rubber compound；
Rubber compound is to be added in twin-screw extruder or closed kneader to be gradually added into vapor phase method by medical grade silicon rubber (raw rubber)
White Carbon black, medical dimethicone and vulcanizing agent and other auxiliary agents are refined repeatedly.The fast roller of twin-screw extruder is higher rear
Speed ratio causes to be kneaded faster, and low speed can make film smooth than then；Roller must be connected with cooling water, melting temperature preferably 40 DEG C with
Under, to prevent the volatilization loss of incipient scorch or vulcanizing agent.It is smaller (5mm) to start roll spacing when mixing, then gradually amplifies；Mixing time
For 40 minutes, (twin-screw extruder specification was)。
(3) glue piece：In the rubber compound merging film-discharging machine that will be prepared through step (2), film is made；
(4) vulcanize：Film made of step (3) is placed in molding die, and mold is put into vulcanizer and carries out sulphur
Change, 165 DEG C of curing temperature, time 160s；Semi-finished product are made；
(5) overlap is repaiied：Semi-finished product made of step (4) are rushed into overlap with particular manufacturing craft and punching machine；
(6) cleaning, drying, drying temperature are 110 DEG C, drying time 2 hours, after the assay was approved packaging and storage.
Performance detection is carried out with self-lubricating piston to the disposable syringe of preparation, appearance surfaces are without bloom, nothing
Bubble, flawless, uniform color, hardness are Shao Er (A types) 62, meet YY/T0243-2003 standard specifications；Rubber plug bottom
Without yellowing phenomenon, permanent set 20% is pressed, YY/T0243-2016 standard specifications are met；Degradation post-tensioning intensity
Change rate≤± 15%.
Embodiment 2
The disposable syringe of the present invention production method of self-lubricating piston, specifically includes following steps：
(1) dispensing：In terms of parts by weight, 100 parts of medical grade silicon rubber, 3 parts of medical dimethicone, vapor phase method hard charcoal are weighed
Black 10 parts and vulcanizing agent 2,5- dimethyl -2,5- double -0.5 part of (t-butyl peroxy) hexanes are spare；
(2) it is kneaded：Make medical grade silicon rubber and medical dimethicone, fume colloidal silica and vulcanizing agent by mechanism
Uniformly it is mixed with rubber compound；
Rubber compound is to be added in twin-screw extruder or closed kneader to be gradually added into vapor phase method by medical grade silicon rubber (raw rubber)
White Carbon black, medical dimethicone and vulcanizing agent and other auxiliary agents are refined repeatedly.The fast roller of twin-screw extruder is higher rear
Speed ratio causes to be kneaded faster, and low speed can make film smooth than then；Roller must be connected with cooling water, melting temperature preferably 40 DEG C with
Under, to prevent the volatilization loss of incipient scorch or vulcanizing agent.It is smaller (1mm) to start roll spacing when mixing, then gradually amplifies；Mixing time
For 20 minutes, (twin-screw extruder specification was)。
(3) glue piece：In the rubber compound merging film-discharging machine that will be prepared through step (2), film is made；
(4) vulcanize：Film made of step (3) is placed in molding die, and mold is put into vulcanizer and carries out sulphur
Change, 155 DEG C of curing temperature, time 240s；Semi-finished product are made；
(5) overlap is repaiied：Semi-finished product made of step (4) are rushed into overlap with particular manufacturing craft and punching machine；
(6) cleaning, drying, drying temperature are 110 DEG C, drying time 2 hours, after the assay was approved packaging and storage.
Performance detection is carried out with self-lubricating piston to the disposable syringe of preparation, appearance surfaces are without bloom, nothing
Bubble, flawless, uniform color, hardness are Shao Er (A types) 57, meet YY/T0243-2003 standard specifications；Rubber plug bottom
Without yellowing phenomenon, permanent set 27% is pressed, YY/T0243-2016 standard specifications are met；Degradation post-tensioning intensity
Change rate≤± 20%.
Embodiment 3
The disposable syringe of the present invention production method of self-lubricating piston, specifically includes following steps：
(1) dispensing：In terms of parts by weight, 100 parts of medical grade silicon rubber is weighed, 6.5 parts of medical dimethicone, vapor phase method is white
20 parts of carbon black and -2,5- pairs -0.75 part of (t-butyl peroxy) hexane of vulcanizing agent 2,5- dimethyl are spare；
(2) it is kneaded：Make medical grade silicon rubber and medical dimethicone, fume colloidal silica and vulcanizing agent by mechanism
Uniformly it is mixed with rubber compound；
Rubber compound is to be added in twin-screw extruder or closed kneader to be gradually added into vapor phase method by medical grade silicon rubber (raw rubber)
White Carbon black, medical dimethicone and vulcanizing agent and other auxiliary agents are refined repeatedly.The fast roller of twin-screw extruder is higher rear
Speed ratio causes to be kneaded faster, and low speed can make film smooth than then；Roller must be connected with cooling water, melting temperature preferably 40 DEG C with
Under, to prevent the volatilization loss of incipient scorch or vulcanizing agent.It is smaller (3mm) to start roll spacing when mixing, then gradually amplifies；Mixing time
For 30 minutes, (twin-screw extruder specification was)。
(3) glue piece：In the rubber compound merging film-discharging machine that will be prepared through step (2), film is made；
(4) vulcanize：Film made of step (3) is placed in molding die, and mold is put into vulcanizer and carries out sulphur
Change, 160 DEG C of curing temperature, time 200s；Semi-finished product are made；
(5) overlap is repaiied：Semi-finished product made of step (4) are rushed into overlap with particular manufacturing craft and punching machine；
(6) cleaning, drying, drying temperature are 110 DEG C, drying time 2 hours, after the assay was approved packaging and storage.
Performance detection is carried out with self-lubricating piston to the disposable syringe of preparation, appearance surfaces are without bloom, nothing
Bubble, flawless, uniform color, hardness are Shao Er (A types) 59, meet YY/T0243-2003 standard specifications；Rubber plug bottom
Without yellowing phenomenon, permanent set 24% is pressed, YY/T0243-2016 standard specifications are met；Degradation post-tensioning intensity
Change rate≤± 20%.
Claims (6)
1. a kind of disposable syringe production method of self-lubricating piston, it is characterised in that：Specifically include following steps：
(1) dispensing：In terms of parts by weight, 100 parts of medical grade silicon rubber is weighed, medical dimethicone 3-8 parts, fume colloidal silica
10-30 parts spare with 0.5-1 parts of vulcanizing agent；
(2) it is kneaded：Keep medical grade silicon rubber and medical dimethicone, fume colloidal silica and vulcanizing agent uniform by mechanism
It is mixed with rubber compound；
(3) glue piece：In the rubber compound merging film-discharging machine that will be prepared through step (2), film is made；
(4) vulcanize：Film made of step (3) is placed in molding die, and mold is put into vulcanizer and is vulcanized, is made
At semi-finished product；
(5) overlap is repaiied：Semi-finished product made of step (4) are rushed into overlap with particular manufacturing craft and punching machine；
(6) cleaning, drying, after the assay was approved packaging and storage.
2. the disposable syringe according to claim 1 production method of self-lubricating piston, it is characterised in that：Step
Suddenly the vulcanizing agent described in (1) is -2,5- pairs-(t-butyl peroxy) hexane of 2,5- dimethyl.
3. the disposable syringe according to claim 1 production method of self-lubricating piston, it is characterised in that：Step
Suddenly the mixing described in (2) uses twin-screw extruder or closed kneader；Charging and operation order are in mixing process：Medical silicon
Rubber → fume colloidal silica → medical dimethicone → vulcanizing agent → thin logical 5 times → blanking.
4. the disposable syringe according to claim 1 production method of self-lubricating piston, it is characterised in that：Step
Suddenly 40 DEG C of melting temperature ＜, time 20-40min in (2).
5. the disposable syringe according to claim 1 production method of self-lubricating piston, it is characterised in that：Step
Suddenly mold being put into vulcanizer described in (4) vulcanizes, 155~165 DEG C of curing temperature, 160~240s of time.
6. the disposable syringe according to claim 1 production method of self-lubricating piston, it is characterised in that：Step
Suddenly the drying temperature described in (6) is 100-120 DEG C, and drying time is 1-3 hours.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810349582.2A CN108485273A (en) | 2018-04-18 | 2018-04-18 | The production method of disposable syringe self-lubricating piston |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810349582.2A CN108485273A (en) | 2018-04-18 | 2018-04-18 | The production method of disposable syringe self-lubricating piston |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN108485273A true CN108485273A (en) | 2018-09-04 |
Family
ID=63313239
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810349582.2A Pending CN108485273A (en) | 2018-04-18 | 2018-04-18 | The production method of disposable syringe self-lubricating piston |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN108485273A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110183855A (en) * | 2019-06-06 | 2019-08-30 | 杭州师范大学 | A kind of fuel-displaced silica gel and its preparation method and application |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH05131029A (en) * | 1991-05-30 | 1993-05-28 | Top:Kk | Syringe |
| CN101696302A (en) * | 2009-10-29 | 2010-04-21 | 广州市合诚化学有限公司 | Self-lubricating polypropylene compound material for manufacturing medical injectors |
| CN103189085A (en) * | 2010-10-01 | 2013-07-03 | 莫门蒂夫性能材料股份有限公司 | Self-lubricating pharmaceutical syringe stoppers |
| CN103957966A (en) * | 2011-09-27 | 2014-07-30 | 贝克顿迪金森法国公司 | Use of plasma treated silicone oil as a coating in a medical injection device |
| CN104387629A (en) * | 2014-11-28 | 2015-03-04 | 丹阳市金晟医用橡塑制品有限公司 | Piston for disposable sterile syringe and manufacturing method of piston |
-
2018
- 2018-04-18 CN CN201810349582.2A patent/CN108485273A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH05131029A (en) * | 1991-05-30 | 1993-05-28 | Top:Kk | Syringe |
| CN101696302A (en) * | 2009-10-29 | 2010-04-21 | 广州市合诚化学有限公司 | Self-lubricating polypropylene compound material for manufacturing medical injectors |
| CN103189085A (en) * | 2010-10-01 | 2013-07-03 | 莫门蒂夫性能材料股份有限公司 | Self-lubricating pharmaceutical syringe stoppers |
| CN103957966A (en) * | 2011-09-27 | 2014-07-30 | 贝克顿迪金森法国公司 | Use of plasma treated silicone oil as a coating in a medical injection device |
| CN104387629A (en) * | 2014-11-28 | 2015-03-04 | 丹阳市金晟医用橡塑制品有限公司 | Piston for disposable sterile syringe and manufacturing method of piston |
Non-Patent Citations (1)
| Title |
|---|
| 向珍阳: "药物注射包部件的硅烷化", 《中国医疗器械信息》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110183855A (en) * | 2019-06-06 | 2019-08-30 | 杭州师范大学 | A kind of fuel-displaced silica gel and its preparation method and application |
| CN110183855B (en) * | 2019-06-06 | 2021-03-30 | 杭州师范大学 | Oil-yielding silica gel and preparation method and application thereof |
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Application publication date: 20180904 |
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