CN106084515A - One has puncture plug and preparation method - Google Patents
One has puncture plug and preparation method Download PDFInfo
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- CN106084515A CN106084515A CN201610528355.7A CN201610528355A CN106084515A CN 106084515 A CN106084515 A CN 106084515A CN 201610528355 A CN201610528355 A CN 201610528355A CN 106084515 A CN106084515 A CN 106084515A
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- plug
- parts
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- 238000002360 preparation method Methods 0.000 title claims abstract description 6
- 239000003814 drug Substances 0.000 claims abstract description 43
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 16
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims abstract description 16
- 229940079593 drug Drugs 0.000 claims abstract description 14
- 229920002545 silicone oil Polymers 0.000 claims abstract description 13
- 239000005995 Aluminium silicate Substances 0.000 claims abstract description 11
- 235000012211 aluminium silicate Nutrition 0.000 claims abstract description 11
- NLYAJNPCOHFWQQ-UHFFFAOYSA-N kaolin Chemical compound O.O.O=[Al]O[Si](=O)O[Si](=O)O[Al]=O NLYAJNPCOHFWQQ-UHFFFAOYSA-N 0.000 claims abstract description 11
- 239000000463 material Substances 0.000 claims abstract description 11
- NINIDFKCEFEMDL-UHFFFAOYSA-N Sulfur Chemical compound [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 claims abstract description 8
- 239000006229 carbon black Substances 0.000 claims abstract description 8
- 239000000395 magnesium oxide Substances 0.000 claims abstract description 8
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 claims abstract description 8
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 claims abstract description 8
- 239000000843 powder Substances 0.000 claims abstract description 8
- 239000011593 sulfur Substances 0.000 claims abstract description 8
- 229910052717 sulfur Inorganic materials 0.000 claims abstract description 8
- 239000004408 titanium dioxide Substances 0.000 claims abstract description 8
- 238000007789 sealing Methods 0.000 claims abstract description 6
- 238000000034 method Methods 0.000 claims description 24
- 238000012360 testing method Methods 0.000 claims description 22
- 238000001514 detection method Methods 0.000 claims description 16
- 238000002156 mixing Methods 0.000 claims description 15
- 238000004140 cleaning Methods 0.000 claims description 13
- 150000001875 compounds Chemical class 0.000 claims description 12
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 12
- 238000012216 screening Methods 0.000 claims description 9
- 238000002347 injection Methods 0.000 claims description 8
- 239000007924 injection Substances 0.000 claims description 8
- 238000005987 sulfurization reaction Methods 0.000 claims description 8
- 238000001816 cooling Methods 0.000 claims description 7
- 238000004299 exfoliation Methods 0.000 claims description 7
- 238000007689 inspection Methods 0.000 claims description 7
- 238000012546 transfer Methods 0.000 claims description 7
- 239000003292 glue Substances 0.000 claims description 6
- 238000009966 trimming Methods 0.000 claims description 6
- 239000002994 raw material Substances 0.000 claims description 5
- 238000004659 sterilization and disinfection Methods 0.000 claims description 5
- 239000011521 glass Substances 0.000 claims description 4
- 238000005303 weighing Methods 0.000 claims description 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 3
- 239000004411 aluminium Substances 0.000 claims description 3
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 3
- 229910052782 aluminium Inorganic materials 0.000 claims description 3
- 230000005540 biological transmission Effects 0.000 claims description 3
- 239000003153 chemical reaction reagent Substances 0.000 claims description 3
- 239000000470 constituent Substances 0.000 claims description 3
- 238000007670 refining Methods 0.000 claims description 3
- 238000004513 sizing Methods 0.000 claims description 3
- 230000001954 sterilising effect Effects 0.000 claims description 3
- 238000003860 storage Methods 0.000 claims description 3
- 238000004073 vulcanization Methods 0.000 claims description 3
- 238000001467 acupuncture Methods 0.000 claims description 2
- 210000000214 mouth Anatomy 0.000 claims description 2
- 210000003205 muscle Anatomy 0.000 claims description 2
- 239000004033 plastic Substances 0.000 claims description 2
- 238000007920 subcutaneous administration Methods 0.000 claims description 2
- XAQHXGSHRMHVMU-UHFFFAOYSA-N [S].[S] Chemical compound [S].[S] XAQHXGSHRMHVMU-UHFFFAOYSA-N 0.000 claims 1
- 238000005406 washing Methods 0.000 claims 1
- 239000000047 product Substances 0.000 abstract description 22
- 238000004519 manufacturing process Methods 0.000 abstract description 9
- 239000000203 mixture Substances 0.000 abstract description 4
- 238000005538 encapsulation Methods 0.000 abstract description 3
- 238000012856 packing Methods 0.000 abstract description 2
- 239000007795 chemical reaction product Substances 0.000 abstract 1
- 238000004806 packaging method and process Methods 0.000 description 9
- 239000000523 sample Substances 0.000 description 9
- 229920001971 elastomer Polymers 0.000 description 4
- 239000011265 semifinished product Substances 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 3
- 238000009472 formulation Methods 0.000 description 3
- 150000003463 sulfur Chemical class 0.000 description 3
- GLUUGHFHXGJENI-UHFFFAOYSA-N Piperazine Chemical compound C1CNCCN1 GLUUGHFHXGJENI-UHFFFAOYSA-N 0.000 description 2
- 229920005549 butyl rubber Polymers 0.000 description 2
- 230000003749 cleanliness Effects 0.000 description 2
- 238000007865 diluting Methods 0.000 description 2
- 238000009461 vacuum packaging Methods 0.000 description 2
- WKBOTKDWSSQWDR-UHFFFAOYSA-N Bromine atom Chemical compound [Br] WKBOTKDWSSQWDR-UHFFFAOYSA-N 0.000 description 1
- NCFTXMQPRQZFMZ-WERGMSTESA-M Cefoperazone sodium Chemical compound [Na+].O=C1C(=O)N(CC)CCN1C(=O)N[C@H](C=1C=CC(O)=CC=1)C(=O)N[C@@H]1C(=O)N2C(C([O-])=O)=C(CSC=3N(N=NN=3)C)CS[C@@H]21 NCFTXMQPRQZFMZ-WERGMSTESA-M 0.000 description 1
- YTPLMLYBLZKORZ-UHFFFAOYSA-N Divinylene sulfide Natural products C=1C=CSC=1 YTPLMLYBLZKORZ-UHFFFAOYSA-N 0.000 description 1
- NKZMPZCWBSWAOX-IBTYICNHSA-M Sulbactam sodium Chemical compound [Na+].O=S1(=O)C(C)(C)[C@H](C([O-])=O)N2C(=O)C[C@H]21 NKZMPZCWBSWAOX-IBTYICNHSA-M 0.000 description 1
- GDTBXPJZTBHREO-UHFFFAOYSA-N bromine Substances BrBr GDTBXPJZTBHREO-UHFFFAOYSA-N 0.000 description 1
- 229910052794 bromium Inorganic materials 0.000 description 1
- 238000003490 calendering Methods 0.000 description 1
- 229960002417 cefoperazone sodium Drugs 0.000 description 1
- AZZMGZXNTDTSME-JUZDKLSSSA-M cefotaxime sodium Chemical compound [Na+].N([C@@H]1C(N2C(=C(COC(C)=O)CS[C@@H]21)C([O-])=O)=O)C(=O)\C(=N/OC)C1=CSC(N)=N1 AZZMGZXNTDTSME-JUZDKLSSSA-M 0.000 description 1
- 229960002727 cefotaxime sodium Drugs 0.000 description 1
- 229960000479 ceftriaxone sodium Drugs 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000001427 coherent effect Effects 0.000 description 1
- 239000013068 control sample Substances 0.000 description 1
- FDRNWTJTHBSPMW-GNXCPKRQSA-L disodium;(6r,7r)-7-[[(2e)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(2-methyl-6-oxido-5-oxo-1,2,4-triazin-3-yl)sulfanylmethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate Chemical compound [Na+].[Na+].S([C@@H]1[C@@H](C(N1C=1C([O-])=O)=O)NC(=O)/C(=N/OC)C=2N=C(N)SC=2)CC=1CSC1=NC(=O)C([O-])=NN1C FDRNWTJTHBSPMW-GNXCPKRQSA-L 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000000686 essence Substances 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 239000010977 jade Substances 0.000 description 1
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000005096 rolling process Methods 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 238000004088 simulation Methods 0.000 description 1
- 229960000614 sulbactam sodium Drugs 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 229930192474 thiophene Natural products 0.000 description 1
- -1 thiophene oxime Chemical class 0.000 description 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
- C08L23/26—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers modified by chemical after-treatment
- C08L23/28—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers modified by chemical after-treatment by reaction with halogens or compounds containing halogen
- C08L23/283—Halogenated homo- or copolymers of iso-olefins
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/0078—Testing material properties on manufactured objects
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/44—Resins; Plastics; Rubber; Leather
- G01N33/445—Rubber
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Biochemistry (AREA)
- Immunology (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Food Science & Technology (AREA)
- Pathology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Polymers & Plastics (AREA)
- Organic Chemistry (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Compositions Of Macromolecular Compounds (AREA)
Abstract
The invention discloses a kind of plug with puncture and preparation method, belong to drug packing material field.Its formula composition by mass parts is: brombutyl 100 parts, Kaolin 72 85 parts, white carbon 35 parts, magnesium oxide 25 parts, methyl-silicone oil 13 parts, 0.3 0.6 parts of polymolecularity sulfur (S 80GE), titanium dioxide 3 parts, white carbon black 0.3 part.Advantages of the present invention is: the plug that the puncture resistance produced with formula of the present invention is good has good sealing, pliability, paracentesis resistance, can be used in encapsulating sterilized powder quasi drugs, particularly can meet the encapsulation requirement of in use strict to plug puncture-resistant performance requirement high-end product.The plug that puncture resistance is good can meet pharmaceutical production producer and walk confidential asking, and product is the most tacky, and good with the some drugs compatibility, meets the use requirement of pharmaceutical production producer and hospital.
Description
Technical field
The present invention relates to the plug formula that a kind of puncture resistance is good, belong to drug packing material field.
Background technology
Medical rubber plug is a kind of common sealing member matching used with glass bottle, because it is direct and drug contact, concerns people
The drug safety of the people, therefore do not require nothing more than that its cleanliness factor is high, good airproof performance is good with the medicine compatibility and in use has good
Good paracentesis resistance.
Although YBB standard has a clear and definite index request to medical rubber plug puncture resistance, but actually used during require more
Strictly, particularly hospital nurse, if being found to have plug exfoliation during making up a prescription surely can complain pharmaceutical factory, therefore invisible pressure is all
Transfer to plug manufacturer.Plug most critical of good performance is still formula, selects the fourth that cleanliness factor is high, sealing property is excellent
Base rubber, suitable filler and vulcanizing system, then it is equipped with the production technology of optimum, just can prepare the product met customer need
Product.
Summary of the invention
It is an object of the invention to provide a kind of plug with puncture, its formula includes the raw material of following mass parts:
Brombutyl 100 parts, Kaolin 72-85 part, white carbon 3-5 part, magnesium oxide 2-5 part, methyl-silicone oil 1-3
Part, modified sulfur 0.3-0.6 part, titanium dioxide 2-5 part, white carbon black 0.1-1 part.The most described prescription quality part is: bromine
Change butyl rubber 100 parts, Kaolin 76 parts, white carbon 4 parts, magnesium oxide 4 parts, methyl-silicone oil 1.5 parts, polymolecularity sulfur (S-
80GE) 0.5 part, titanium dioxide 3 parts, white carbon black 0.3 part.
The preparation method of the described plug with puncture, comprises the steps:
A, raw material prepare and coordinate
Load weighted various materials are placed in the container and place specified by the formula constituent weight according to recipe requirements；
B, mixing
The material that will work good, puts into banburying in banbury successively, and banburying process is finished, discharge, then is placed in mill
Machine, after the mill of 9-11 minute, bottom sheet hangs cooling, then is transported on transfer belt；
Banburying process: banburying first paragraph is mixing to be added and add the Kaolin of half quality in brombutyl, formula and carry out
Plasticate 4-5 minute, pressure: 0.5-0.7MPa；Banburying second segment is mixing adds second half Kaolin and white carbon, magnesium oxide, methyl
Silicone oil, modified sulfur, titanium dioxide, carry out plasticating 4-4.5 minute after white carbon black mixing, pressure: 0.5-0.7MPa；Dump temperature:
125-140℃；Mill technique: front roll temperature: 60-70 DEG C, rear roll temperature: 65-75 DEG C, after the cool glue of broaching tool, take out glue and add sulfur, will
Roll spacing is adjusted to 2-3mm, thin logical 5 times of sizing material, and upper blending device turns refining 3-5min, bottom sheet, and the air cooling time is not less than 5min, obtains
Elastomeric compound；
C, preforming cut-parts
Elastomeric compound on transfer transmission belt is fed in screw extruder, extruder temperature 40-80 DEG C, screw speed≤
45r/min, rolls through tri-roll press machine, cut-parts after cooler cooling, storage；
D, sulfuration
By the sulfuration process formulated according to elastomeric compound curing curve parameter, vulcanizer parameter is set, the film cut out is put
Enter in vulcanizer and vulcanize, vulcanization parameters: vacuum >=740mmHg, clamping pressure 12-20MPa, curing temperature 190 ± 3
DEG C, cure time 300 ± 30s.
E, flash trimming lamp inspection
Edge-removing process parameter: compressed air system pressure is not less than 0.5MPa, and operating pressure is 0.6MPa, the product after flash trimming
Product after screening machine screening, pack of weighing, the product after screening is carried out lamp inspection, rejects faulty goods；
F, cleaning
Series plug is loaded cleaning machine；Abluent consumption 3-5L/ pot, in cleaning process, rinsing times is no less than 3 times, adopts
The mode added by hand adds silicone oil, requires that silicone oil amount is 0.5-1.5ml/ ten thousand according to user；Baking temperature is at 90-120
Between DEG C, chilling temperature is not more than 70 DEG C, and cleaning total time is 210min, can prepare the plug with puncture.
The present invention also provides for some exfoliation method for testing performance by the plug with puncture obtained above, takes 10
Tested plug is placed in suitable glass container, and add water 200ml, puts in high pressure steam sterilizer, moist heat sterilization at 121 DEG C
After 30min, taking out, be cooled to room temperature, after 0～-10 DEG C are placed 48 hours, room temperature is placed 1 hour, is contained in matched appearance
On device, injecting the water of about half volume in a reservoir, the specification produced with Shanghai Ai Siai medical equipment Plastic Products Co., Ltd is
No. 16 angle draw points of 1.6*38SB vertically penetrate plug acupuncture position (this draw point for human body is subcutaneous, Intradermal, muscle, oral cavity
Injection), inject 2ml water with syringe before extracting syringe needle, every plug punctures 4 times, and a collection of plug sample uses same syringe needle,
The detection with the plug of puncture can be completed.
5, the plug with puncture prepared described in claim 3 and the detection method of the quick intermiscibility of medicine,
It is characterized in that,
On clean bench, shears, tweezers, sterile gloves test tool are all carried out disinfection standby with medical alcohol,
With the packaged clean plug of sterile bag after cleaning, being placed on clean bench for reagent product, that takes off on medicine is original-pack
Plug, after replacing with plug to be measured, seals up aluminium lid with manual capsuling machine, and every kind of medicine 3 bottles, it is bottled that dosage is 1.0g/, will envelope
The medicine installed is inverted, and pats medicated powder gently, allows medicated powder be fully contacted with plug to be measured, is inverted 3 bottles of original-pack medicines simultaneously and makees
For blank, it is 60 ± 2 DEG C that above-mentioned medicine is together put into temperature, humidity be 60-70% testing chamber for medicine stability in keep 5
My god,
Being taken out by medicine in testing chamber for medicine stability, after being cooled to room temperature, every bottle of filling 10ml injection water, to medicine
Carry out dissolving, diluting；Shake up, stand, after bubble collapse, detect with scopometer, record turbidity value, can complete to have
The plug of puncture and the detection of the quick intermiscibility of medicine.
Described plug quick adhesion test method is:
Take testing sample 500g in clean packaging, evacuation packaging, evacuated pressure on vacuum packing machine
0.085MPa, sealing line is all at same position.Sample after encapsulation is placed in 60 DEG C of climatic chambers, takes out after placing 5 days.
Observation packaging bag, with or without gas leakage (if any gas leakage, this sample cancels), naturally cools to room temperature, is all cut off by packaging bag edgewise,
Observe plug deformation and adhesion situation.
Accompanying drawing explanation
Fig. 1 is the preparation method process chart with puncture plug.
Detailed description of the invention
In order to make the purpose of the present invention, technical scheme and advantage clearer, below in conjunction with drawings and Examples, right
The present invention is further elaborated.Should be appreciated that specific embodiment described herein only in order to explain the present invention, not
For limiting the present invention.
The plug formula good in order to obtain a kind of puncture resistance of the present invention, its production technology illustrated below:
Description of the process
A, raw material prepare and coordinate
According to the formula constituent weight required in mixed card, weigh with suitable measurer respectively, by load weighted
Various materials are placed in the container and place specified.
B, mixing
According to calendering process card, set the parameter of correspondence, by rule of operation, the material that will work good, put into successively
Banburying in banbury, technique is finished, discharge, then is placed in mill, and after the mill of 9-11 minute, bottom sheet hangs cold
, then be transported on transfer belt but.
Banburying process: banburying first paragraph is mixing adds butyl rubber, half Kaolin is plasticated, 4-5 minute, pressure:
0.5-0.7MPa；Banburying second segment is mixing adds second half Kaolin and and white carbon, magnesium oxide, methyl-silicone oil, titanium dioxide, white carbon black
Banburying 4-4.5 minute after mixing, pressure: 0.5-0.7MPa；Dump temperature: 125-140 DEG C.Mill technique: front roll temperature: 60-
70 DEG C, rear roll temperature: 65-75 DEG C, after the cool glue of broaching tool, take out glue and add modified sulfur, roll spacing is adjusted to 2-3mm, sizing material thin logical 5
Time, upper blending device turns refining 3-5min, bottom sheet, and the air cooling time is not less than 5min.
Elastomeric compound becomes instrument (UR-2010 You Ken company limited manufacture) by sulfur and carries out curing curve detection, determines rear operation
Curing parameter.
C, preforming cut-parts
By the elastomeric compound on transfer transmission belt with certain speed feeding screw extruder (extruder temperature 40-80 DEG C,
Screw speed≤45r/min) in, rolling through tri-roll press machine, cooler cools down, and carries out cut-parts according to certain length and width, storage
Deposit.
D, sulfuration
By the sulfuration process formulated according to elastomeric compound curing curve parameter, vulcanizer parameter is set, the film cut out is put
Enter in vulcanizer and vulcanize.This process is a chemical reaction process, and curing temperature, pressure and time are to cause product the most abundant
The crucial three elements of sulfuration.Vulcanization parameters: vacuum >=740mmHg, clamping pressure 12-20MPa, curing temperature 190 ± 3
DEG C, cure time 300 ± 30s.
E, flash trimming lamp inspection
Edge-removing process parameter: compressed air system pressure is not less than 0.5MPa, and operating pressure is 0.6MPa.Product after flash trimming
Product after screening machine screening, pack of weighing.Product after screening is carried out lamp inspection, rejects faulty goods.
F, cleaning
By 20 series plugs once less than 150,000, load cleaning machine；Abluent consumption 3-5L/ pot, in cleaning process
Rinsing times is no less than 3 times, uses the mode being manually adding to add silicone oil, requires that silicone oil amount is 0.5-1.5ml/ ten thousand according to user
Only；Baking temperature is between 90-120 DEG C, and chilling temperature is not more than 70 DEG C, cleans total time about 210min.
G, packaging
Being packed by weighing products in the toilet of overall ten thousand grades of local laminar flows, stochastic sampling carries out outward appearance detection simultaneously.
Performance detects
Finished product, in addition to meeting YBB coherent detection standard, separately increases 1 semi-finished product detection and three finished product applicability detections.
1) semi-finished product elastomeric compound performance detection
For rubber, the physical and mechanical properties of semi-finished product elastomeric compound plays vital effect to finished product, pulls apart
Strongly, 300% stretches and elongation at break affects the manufacturability of product and the resilience of finished product surely；Proportion and hardness are inspection products
Whether soft durometer meets requirement, the committed step simultaneously confirmed the stability of product in production process, and concrete operations are such as
Under:
Vulcanizing press is set the temperature and time of technological requirement, weighs the lamellar semi-finished product elastomeric compound of 52 ± 2g, dress
Entering in vulcanizer, sulfuration makes test piece, after 16h is parked in test piece, is cut into sub-tinkling of pieces of jade test strip with the instrument of regulation, uses density
Instrument and durometer detect proportion and hardness, use omnipotent strength tester to carry out tension test, and result is as follows:
Pull apart strongly (MPa): 7.5；300% stretches (MPa) surely: 1.6；Elongation at break (%): 780；Proportion: 1.31, hard
Degree (Shao Er A): 46.Every testing result is satisfied by index request.
2) detection of exfoliation performance is punctured
Plug formula quality, puncturing exfoliation is one of performance the most intuitively, and the method for this research regulation is harsher, mainly
In order to preferably improve the performance of product, specific as follows:
Taking 10 tested plugs to be placed in suitable glass container, add water 200ml, puts in high pressure steam sterilizer, enters
After 121 DEG C of * 30min moist heat sterilizations of row, taking out, be cooled to room temperature, after 0～-10 DEG C are placed 48 hours, room temperature is placed 1 hour,
It is contained on matched container, injects the water of about half volume in a reservoir, vertically penetrate the pin of plug with No. 16 angle pins
Thorn position, injects 2ml water with syringe before extracting syringe needle, and every plug punctures 4 times, and a collection of plug sample uses same syringe needle,
Need before experiment to check syringe needle, it is ensured that impulse-free robustness.Total exfoliation number of 10 plugs must not cross 5.
50 plugs of detection as stated above, divide 5 batches and carry out, and detection exfoliation number is respectively 0,0,1,0,1, meet index and want
Ask.
3) detect with drug compatibility
Because different plug formula are different, inconsistent from different compatibility of drugss, therefore simulation plug and drug contact,
Contrast test it is accelerated under higher temperature and damp condition, specific as follows:
On clean bench, the test tools such as shears, tweezers, sterile gloves are all carried out disinfection standby with medical alcohol
With.With the packaged clean plug of sterile bag after cleaning, being placed on clean bench for reagent product, that takes off on medicine is former
Dress plug, after plug to be measured displacement, seals up aluminium lid with manual capsuling machine, and every kind of medicine 3 bottles, it is bottled that dosage is 1.0g/.Will
Packaged medicine is inverted, and pats medicated powder gently, allows medicated powder be fully contacted with plug to be measured, is inverted 3 bottles of original-pack medicines simultaneously
As blank.It is 60 ± 2 DEG C that above-mentioned medicine is together put into temperature, humidity be 60-70% testing chamber for medicine stability in protect
Hold 5 days.
Being taken out by medicine in testing chamber for medicine stability, after being cooled to room temperature, every bottle of filling 10ml injection water, to medicine
Carry out dissolving, diluting；Shake up, stand, after bubble collapse, detect with scopometer, record turbidity value.Inventive formulation system
Be 20A powder pin series plug as sample, select medicine be Lukang Medical Co., Ltd., Shandong ceftriaxone sodium for injection,
Cefotaxime sodium for injection and Suzhou Dawnrays Pharmaceutical Co., Ltd.'s cefoperazone sodium and sulbactam sodium for injection, equal 1.0g/ is bottled.
Table 1 and drug compatibility result
From upper table plug to be measured and three kinds of medicine quick compatibility results, inventive formulation plug relaxes with Qusong, piperazine
And thiophene oxime is the most blank more excellent.
4) tacky situation detection
Plug walks confidential asking during pharmaceutical production producer uses, if product has tacky hidden danger, can cause walking machine to add
During plug not smooth, cause empty bottle, jam etc., have a strong impact on the production efficiency of pharmaceutical production producer, thus carry out formula delete select time
Carry out Preliminary Identification by quick adhesion test, specifically comprise the following steps that
Take testing sample 500g in clean packaging, evacuation packaging, evacuated pressure on vacuum packing machine
0.085MPa, sealing line is all at same position.Sample after encapsulation is placed in 60 DEG C of climatic chambers, takes out after placing 5 days.
Observation packaging bag, with or without gas leakage (if any gas leakage, this sample cancels), naturally cools to room temperature, is all cut off by packaging bag edgewise,
Observe plug deformation and adhesion situation.In use control sample without adhesion situation is tested on year-on-year basis with known client,
Result is as follows:
The quick adhesion test result of table 2
Can obtain from the upper quick adhesion test result of table 2, inventive formulation plug adhesion situation is more excellent, does not the most affect plug
Factory normally uses.
The foregoing is only the preferred embodiments of the present invention, not in order to limit the present invention, all essences in the present invention
Any change, interpolation, equivalent and the improvement etc. made within god and principle, should be included in protection scope of the present invention it
In.
Claims (5)
1. a plug with puncture, it is characterised in that its formula includes the raw material of following mass parts:
Brombutyl 100 parts, Kaolin 72-85 part, white carbon 3-5 part, magnesium oxide 2-5 part, methyl-silicone oil 1-3 part, high
Dispersibility sulfur (S-80GE) 0.3-0.6 part, titanium dioxide 2-5 part, white carbon black 0.1-1 part.
The plug with puncture the most according to claim 1, it is characterised in that described prescription quality part is:
Brombutyl 100 parts, Kaolin 76 parts, white carbon 4 parts, magnesium oxide 4 parts, methyl-silicone oil 1.5 parts, polymolecularity sulfur
Sulphur (S-80GE) 0.5 part, titanium dioxide 3 parts, white carbon black 0.3 part.
3. the preparation method of the plug with puncture described in claim 1 or 2, it is characterised in that comprise the steps:
A, raw material prepare and coordinate
Load weighted various materials are placed in the container and place specified by the formula constituent weight according to recipe requirements；
B, mixing
The material that will work good, puts into banburying in banbury successively, and banburying process is finished, discharge, then is placed in mill, warp
After crossing the mill of 9-11 minute, bottom sheet hangs cooling, then is transported on transfer belt；
Banburying process: banburying first paragraph is mixing to be added and add the Kaolin of half quality in brombutyl, formula and plasticate
4-5 minute, pressure: 0.5-0.7MPa；Mixing second half Kaolin and the white carbon of adding of banburying second segment, magnesium oxide, methyl-silicone oil,
Titanium dioxide, carries out plasticating 4-4.5 minute after white carbon black mixing, pressure: 0.5-0.7MPa；Dump temperature: 125-140 DEG C；Mill work
Skill: front roll temperature: 60-70 DEG C, rear roll temperature: 65-75 DEG C, after the cool glue of broaching tool, take out glue and add polymolecularity sulfur (S-80GE),
Roll spacing is adjusted to 2-3mm, and thin logical 5 times of sizing material, upper blending device turns refining 3-5min, bottom sheet, and the air cooling time is not less than 5min, obtains
Elastomeric compound；
C, preforming cut-parts
Elastomeric compound on transfer transmission belt is fed in screw extruder, extruder temperature 40-80 DEG C, screw speed≤45r/
Min, rolls through tri-roll press machine, cut-parts after cooler cooling, storage；
D, sulfuration
By the sulfuration process formulated according to elastomeric compound curing curve parameter, vulcanizer parameter is set, the film cut out is inserted sulfur
Change machine vulcanizes, vulcanization parameters: vacuum >=740mmHg, clamping pressure 12-20MPa, curing temperature 190 ± 3 DEG C, sulfur
Change time 300 ± 30s.
E, flash trimming lamp inspection
Edge-removing process parameter: compressed air system pressure is not less than 0.5MPa, and operating pressure is 0.6MPa, the product warp after flash trimming
After screening machine screening, pack of weighing, the product after screening is carried out lamp inspection, rejects faulty goods；
F, cleaning
Series plug is loaded cleaning machine；Abluent consumption 3-5L/ pot, in cleaning process, rinsing times is no less than 3 times, uses hands
The mode that work adds adds silicone oil, requires that silicone oil amount is 0.5-1.5ml/ ten thousand according to user；Baking temperature 90-120 DEG C it
Between, chilling temperature is not more than 70 DEG C, and cleaning total time is 210min, can prepare the plug with puncture.
4. the exfoliation method for testing performance of the plug with puncture prepared described in claim 3, it is characterised in that take
10 tested plugs are placed in suitable glass container, and add water 200ml, put in high pressure steam sterilizer, damp and hot at 121 DEG C
After sterilizing 30min, taking out, be cooled to room temperature, after 0～-10 DEG C are placed 48 hours, room temperature is placed 1 hour, is contained in matched
Container on, inject the water of about half volume in a reservoir, with Shanghai Ai Siai medical equipment Plastic Products Co., Ltd produce rule
Lattice are the acupuncture position that No. 16 angle draw points of 1.6*38SB vertically penetrate plug, this draw point is subcutaneous for human body, Intradermal, muscle,
Oral cavity injection, injects 2ml water with syringe before extracting syringe needle, and every plug punctures 4 times, and a collection of plug sample uses same pin
Head, can complete the detection with the plug of puncture.
5. the plug with puncture prepared described in claim 3 and the detection method of the quick intermiscibility of medicine, it is special
Levy and be,
On clean bench, shears, tweezers, sterile gloves test tool are all carried out disinfection standby with medical alcohol, will be clear
With the packaged clean plug of sterile bag after washing, it is placed on clean bench for reagent product, takes off the original-pack plug on medicine,
After replacing with plug to be measured, sealing up aluminium lid with manual capsuling machine, every kind of medicine 3 bottles, it is bottled that dosage is 1.0g/, by packaged
Medicine be inverted, and pat medicated powder gently, allow medicated powder be fully contacted with plug to be measured, 3 bottles of original-pack medicines of inversion are as sky simultaneously
In vain, it is 60 ± 2 DEG C that above-mentioned medicine is together put into temperature, humidity be 60-70% testing chamber for medicine stability in keep 5 days,
Medicine in testing chamber for medicine stability is taken out, after being cooled to room temperature, every bottle of filling 10ml injection water, medicine is carried out
Dissolve, dilute；Shake up, stand, after bubble collapse, detect with scopometer, record turbidity value, can complete that there is puncture
Property the detection of plug and the quick intermiscibility of medicine.
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| CN201610528355.7A CN106084515A (en) | 2016-07-06 | 2016-07-06 | One has puncture plug and preparation method |
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| CN201610528355.7A CN106084515A (en) | 2016-07-06 | 2016-07-06 | One has puncture plug and preparation method |
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| CN106084515A true CN106084515A (en) | 2016-11-09 |
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| CN108034153A (en) * | 2017-12-29 | 2018-05-15 | 梅庆波 | A kind of preparation method of thermo oxidative aging endurance type yielding rubber |
| CN108559150A (en) * | 2018-04-03 | 2018-09-21 | 湖北华强科技有限责任公司 | A kind of soft high strength white butyl adhesive plaster rubber and its preparation method and application |
| CN109593280A (en) * | 2018-12-26 | 2019-04-09 | 湖北华强科技有限责任公司 | A kind of chlorinated butyl rubber bung formula and preparation method |
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| CN109593280A (en) * | 2018-12-26 | 2019-04-09 | 湖北华强科技有限责任公司 | A kind of chlorinated butyl rubber bung formula and preparation method |
| CN109705483A (en) * | 2018-12-28 | 2019-05-03 | 江阴市海华橡塑有限公司 | A kind of transfusion chlorinated butyl rubber plug and preparation method thereof |
| CN109705483B (en) * | 2018-12-28 | 2021-10-22 | 江阴市海华橡塑有限公司 | Transfusion chlorinated butyl rubber plug and preparation method thereof |
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