CN111019254A - Brominated butyl rubber plug for alkali-resistant medicine and preparation method thereof - Google Patents
Brominated butyl rubber plug for alkali-resistant medicine and preparation method thereof Download PDFInfo
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- CN111019254A CN111019254A CN201911337675.4A CN201911337675A CN111019254A CN 111019254 A CN111019254 A CN 111019254A CN 201911337675 A CN201911337675 A CN 201911337675A CN 111019254 A CN111019254 A CN 111019254A
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- butyl rubber
- brominated butyl
- alkali
- rubber plug
- resistant
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- 239000003814 drug Substances 0.000 title claims abstract description 62
- 229920005557 bromobutyl Polymers 0.000 title claims abstract description 61
- 239000003513 alkali Substances 0.000 title claims abstract description 32
- 238000002360 preparation method Methods 0.000 title claims abstract description 13
- 238000004073 vulcanization Methods 0.000 claims abstract description 37
- 229920001971 elastomer Polymers 0.000 claims abstract description 35
- XLOMVQKBTHCTTD-UHFFFAOYSA-N Zinc monoxide Chemical group [Zn]=O XLOMVQKBTHCTTD-UHFFFAOYSA-N 0.000 claims abstract description 24
- 239000011787 zinc oxide Substances 0.000 claims abstract description 12
- BWGNESOTFCXPMA-UHFFFAOYSA-N Dihydrogen disulfide Chemical compound SS BWGNESOTFCXPMA-UHFFFAOYSA-N 0.000 claims abstract description 11
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 11
- 235000021355 Stearic acid Nutrition 0.000 claims abstract description 9
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims abstract description 9
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims abstract description 9
- 239000008117 stearic acid Substances 0.000 claims abstract description 9
- 239000012752 auxiliary agent Substances 0.000 claims abstract description 8
- 239000003086 colorant Substances 0.000 claims abstract description 8
- 239000000203 mixture Substances 0.000 claims abstract description 8
- 239000000945 filler Substances 0.000 claims abstract description 7
- 229940079593 drug Drugs 0.000 claims description 22
- 238000002156 mixing Methods 0.000 claims description 17
- 239000006229 carbon black Substances 0.000 claims description 14
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 13
- 238000004140 cleaning Methods 0.000 claims description 13
- 238000000465 moulding Methods 0.000 claims description 13
- 150000001875 compounds Chemical class 0.000 claims description 12
- 239000004636 vulcanized rubber Substances 0.000 claims description 10
- 239000005995 Aluminium silicate Substances 0.000 claims description 8
- 235000012211 aluminium silicate Nutrition 0.000 claims description 8
- 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 description 8
- 238000004806 packaging method and process Methods 0.000 claims description 8
- 239000002994 raw material Substances 0.000 claims description 8
- 239000004698 Polyethylene Substances 0.000 claims description 7
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 6
- 238000010382 chemical cross-linking Methods 0.000 claims description 6
- 238000001816 cooling Methods 0.000 claims description 6
- 238000005520 cutting process Methods 0.000 claims description 6
- 238000000034 method Methods 0.000 claims description 6
- -1 polyethylene Polymers 0.000 claims description 6
- 229920000573 polyethylene Polymers 0.000 claims description 6
- 238000004080 punching Methods 0.000 claims description 6
- 238000005096 rolling process Methods 0.000 claims description 6
- 239000004408 titanium dioxide Substances 0.000 claims description 6
- 239000002131 composite material Substances 0.000 claims description 2
- 241000764238 Isis Species 0.000 claims 1
- 239000000126 substance Substances 0.000 abstract description 11
- 230000002378 acidificating effect Effects 0.000 abstract description 6
- 230000001954 sterilising effect Effects 0.000 abstract description 4
- 238000004659 sterilization and disinfection Methods 0.000 abstract description 4
- 235000010215 titanium dioxide Nutrition 0.000 description 6
- 238000002347 injection Methods 0.000 description 5
- 239000007924 injection Substances 0.000 description 5
- 230000000052 comparative effect Effects 0.000 description 4
- NINIDFKCEFEMDL-UHFFFAOYSA-N Sulfur Chemical compound [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 description 3
- CMHURKNPNRMCAL-UHFFFAOYSA-N [O-2].O.[Mg+2].S Chemical compound [O-2].O.[Mg+2].S CMHURKNPNRMCAL-UHFFFAOYSA-N 0.000 description 3
- 229940063517 omeprazole sodium Drugs 0.000 description 3
- KNVABRFVZVESIL-UHFFFAOYSA-N sodium;6-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1h-benzimidazole Chemical compound [Na+].N=1C2=CC(OC)=CC=C2NC=1S(=O)CC1=NC=C(C)C(OC)=C1C KNVABRFVZVESIL-UHFFFAOYSA-N 0.000 description 3
- 239000011593 sulfur Substances 0.000 description 3
- 229910052717 sulfur Inorganic materials 0.000 description 3
- 239000012190 activator Substances 0.000 description 2
- 238000004132 cross linking Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 238000013508 migration Methods 0.000 description 2
- 230000005012 migration Effects 0.000 description 2
- 238000011056 performance test Methods 0.000 description 2
- 229920001568 phenolic resin Polymers 0.000 description 2
- 239000005011 phenolic resin Substances 0.000 description 2
- 229920005989 resin Polymers 0.000 description 2
- 239000011347 resin Substances 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- KXGFMDJXCMQABM-UHFFFAOYSA-N 2-methoxy-6-methylphenol Chemical compound [CH]OC1=CC=CC([CH])=C1O KXGFMDJXCMQABM-UHFFFAOYSA-N 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 239000002585 base Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 229920005549 butyl rubber Polymers 0.000 description 1
- 239000003183 carcinogenic agent Substances 0.000 description 1
- 229920005556 chlorobutyl Polymers 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000000806 elastomer Substances 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 229960003174 lansoprazole Drugs 0.000 description 1
- MJIHNNLFOKEZEW-UHFFFAOYSA-N lansoprazole Chemical compound CC1=C(OCC(F)(F)F)C=CN=C1CS(=O)C1=NC2=CC=CC=C2N1 MJIHNNLFOKEZEW-UHFFFAOYSA-N 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000001050 lubricating effect Effects 0.000 description 1
- 239000000395 magnesium oxide Substances 0.000 description 1
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 description 1
- 229940009953 magnesium oxide / zinc oxide Drugs 0.000 description 1
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 description 1
- 229910044991 metal oxide Inorganic materials 0.000 description 1
- 150000004706 metal oxides Chemical class 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- XKLJHFLUAHKGGU-UHFFFAOYSA-N nitrous amide Chemical compound ON=N XKLJHFLUAHKGGU-UHFFFAOYSA-N 0.000 description 1
- 229960004048 pantoprazole sodium Drugs 0.000 description 1
- YNWDKZIIWCEDEE-UHFFFAOYSA-N pantoprazole sodium Chemical compound [Na+].COC1=CC=NC(CS(=O)C=2[N-]C3=CC=C(OC(F)F)C=C3N=2)=C1OC YNWDKZIIWCEDEE-UHFFFAOYSA-N 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 239000012763 reinforcing filler Substances 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 150000003568 thioethers Chemical class 0.000 description 1
- 238000009966 trimming Methods 0.000 description 1
- 229940099259 vaseline Drugs 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
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
- C08K3/00—Use of inorganic substances as compounding ingredients
- C08K3/18—Oxygen-containing compounds, e.g. metal carbonyls
- C08K3/20—Oxides; Hydroxides
- C08K3/22—Oxides; Hydroxides of metals
- C08K2003/2296—Oxides; Hydroxides of metals of zinc
Landscapes
- Chemical & Material Sciences (AREA)
- General Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Chemistry (AREA)
- Polymers & Plastics (AREA)
- Organic Chemistry (AREA)
- Compositions Of Macromolecular Compounds (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Closures For Containers (AREA)
Abstract
The invention relates to the technical field of medicinal rubber plugs, in particular to a brominated butyl rubber plug for an alkali-resistant medicament and a preparation method thereof. The brominated butyl rubber plug for the alkali-resistant medicament comprises brominated butyl rubber, a vulcanizing agent, a vulcanization accelerator, stearic acid, a filler, an auxiliary agent and a coloring agent; the vulcanizing agent is alkylphenol disulfide, and the vulcanization accelerator is zinc oxide. The brominated butyl rubber plug for the alkali-resistant medicine solves the problem of poor alkali medicine tolerance of the brominated butyl rubber plug, avoids the phenomenon that micromolecule substances and acidic substances in the rubber plug can migrate into the medicine in an alkali environment to influence the turbidity of the medicine and cause medicine pollution, and ensures the tolerance of the brominated butyl rubber plug in wet heat sterilization; the invention also provides a preparation method of the composition.
Description
Technical Field
The invention relates to the technical field of medicinal rubber plugs, in particular to a brominated butyl rubber plug for an alkali-resistant medicament and a preparation method thereof.
Background
The alkaline drug is a drug with alkaline pH value, such as omeprazole sodium for injection, pantoprazole sodium for injection, lansoprazole sodium for injection and the like. Most of these drugs have a pH above 10 and are typically basic drugs. The alkaline medicine has strong activity, and is easy to generate migration adsorption reaction with the rubber plug, thereby influencing the quality of the medicine.
When a common rubber plug, such as a sulfur-vulcanized butyl rubber plug, is used for packaging an alkaline medicament, small molecular substances and acidic substances in the rubber plug can migrate into the medicament in an alkaline environment, so that the turbidity of the medicament is influenced, and the medicament pollution is caused.
Patent CN101427981 discloses a brominated butyl rubber plug for injection and a preparation method thereof, wherein the brominated butyl rubber plug for injection comprises 100 parts of brominated butyl rubber, and the ratio of each component is as follows: 100 parts of brominated butyl rubber, 10-100 parts of reinforcing filler, 3-5 parts of vulcanizing agent, 3-5 parts of activator, 1-5 parts of auxiliary agent and 0-5 parts of coloring agent; wherein the vulcanizing agent is brominated p-tert-octyl phenolic resin HY-2055I, and the activator is zinc oxide BA01-05 (type I).
The patent CN104744834A discloses a brominated butyl rubber plug and a preparation method thereof, wherein the brominated butyl rubber plug comprises 100 parts of domestic brominated butyl rubber in parts by weight: home-made brominated butyl rubber: 100, kaolin: 75-85, carbon black: 0.1, titanium dioxide: 3, vaseline: 3-6, active magnesium oxide: 5-6, sulfur: 0.1-0.3; wherein the vulcanization system is a sulfur-magnesium oxide system.
Patent CN109370070A discloses a brominated butyl rubber plug for a freeze-drying additive, which comprises the following components in parts by weight: BIIR 2030100 parts, calcined kaolin 60 parts, talcum powder 14-16 parts, PE wax 0.6-1 part, HY-2055 resin 0.4-1.5 parts, composite metal oxide 4.1-6.6 parts, sulfur 0.5-1 part and carbon black 4-5 parts. The brominated butyl rubber plug provided by the invention has a unique formula, and various raw materials in the formula are matched according to a certain proportion, so that the vulcanization efficiency and the crosslinking density of the brominated butyl rubber can be kept in a proper range, the sealing property of vulcanized rubber is improved, the internal lubricating property of the vulcanized rubber is increased, and the quantity of needle pricked scraps is reduced.
The vulcanization systems of the above patents are sulfur-magnesium oxide/zinc oxide systems, and the rubber plug vulcanized by the system can migrate into the medicine in an alkaline environment due to acidic substances such as sulfides generated in the vulcanization process, so that the pollution of the medicine is caused, and the quality of the medicine is influenced, in other words, the rubber plug produced by the sulfur-magnesium oxide system has poor tolerance to alkaline medicines; other curing systems, such as resin systems, are also less useful on brominated butyl rubber plugs due to their inherently poor drug compatibility.
Disclosure of Invention
Aiming at the defects of the prior art, the invention aims to provide the brominated butyl rubber plug for the alkali-resistant medicine, solves the problem of poor alkali medicine tolerance of the brominated butyl rubber plug, avoids the problem that micromolecule substances and acidic substances in the rubber plug can migrate into the medicine in an alkali environment to influence the turbidity of the medicine and cause medicine pollution, and ensures the tolerance of the brominated butyl rubber plug in wet heat sterilization; the invention also provides a preparation method of the composition.
The brominated butyl rubber plug for the alkali-resistant medicament comprises brominated butyl rubber, a vulcanizing agent, a vulcanization accelerator, stearic acid, a filler, an auxiliary agent and a coloring agent; the vulcanizing agent is alkylphenol disulfide, and the vulcanization accelerator is zinc oxide.
The brominated butyl rubber plug for the alkali-resistant medicine is composed of the following raw materials in parts by mass:
among them, brominated butyl rubber is an elastomer base material.
The alkylphenol disulfide and the zinc oxide are a vulcanization system, wherein the alkylphenol disulfide is a vulcanizing agent for crosslinking rubber molecules, and the zinc oxide is a vulcanization accelerator for improving the vulcanization efficiency and improving the performance of vulcanized rubber.
The filler is a mixture of calcined kaolin and white carbon black according to the mass ratio of 60-100: 5-10.
The auxiliary agent polyethylene wax is mainly used for improving the processing performance of the rubber material.
The colorant is a mixture of titanium dioxide and carbon black in a mass ratio of 2-3: 0.1-0.3.
The alkylphenol disulfide adopted by the invention is a novel sulfur donor, can improve the solubility of a vulcanized intermediate in rubber, and generates more monosulfur bonds in vulcanization, so that the vulcanized rubber has better moisture and heat resistance, acid and alkali resistance and the like, and no nitrosamine carcinogenic substance is generated in the using process.
The invention relates to a preparation method of a brominated butyl rubber plug for an alkali-resistant medicament, which comprises the following steps: raw material matching → mixing → preforming → vulcanization molding → removing edges → cleaning + packaging.
Specifically, the preparation method of the brominated butyl rubber plug for the alkali-resistant medicament comprises the following steps:
(1) mixing: mixing brominated butyl rubber, a vulcanizing agent, a vulcanization accelerator, stearic acid, a filler, an auxiliary agent and a coloring agent according to a formula, and then standing for 24-30h to obtain a rubber compound;
(2) preforming: sequentially extruding, rolling, cooling and cutting the rubber compound, and standing for 4-6h to obtain a preformed rubber sheet;
(3) and (3) vulcanization molding: placing the preformed rubber sheet into vulcanization equipment for chemical crosslinking and vulcanization molding;
(4) removing edges: punching the vulcanized rubber sheet to form a single product;
(5) cleaning; and cleaning, rinsing and packaging the product to obtain the brominated butyl rubber plug for the alkali-resistant medicament.
The mixing in the step (1) comprises banburying and open mixing.
The vulcanization temperature in the step (3) is 170-2。
Compared with the prior art, the invention has the following beneficial effects:
the invention takes the mixture of alkylphenol disulfide and zinc oxide as a vulcanization system, solves the problem of poor tolerance of alkaline drugs of the brominated butyl rubber plug, avoids the influence of the turbidity of drugs and the pollution of the drugs caused by the migration of small molecular substances and acidic substances in the rubber plug to the drugs in an alkaline environment, and ensures the tolerance of the brominated butyl rubber plug in wet heat sterilization.
Detailed Description
The present invention is further illustrated by the following examples, but the scope of the present invention is not limited thereto, and modifications of the technical solutions of the present invention by those skilled in the art should be within the scope of the present invention.
Example 1
The brominated butyl rubber plug for the alkali-resistant medicine is prepared according to the following raw material formula and method, and comprises the following steps:
(1) mixing: banburying and open mixing 100kg of brominated butyl rubber, 1kg of stearic acid, 2kg of alkylphenol disulfide, 5kg of zinc oxide, 80kg of calcined kaolin, 7kg of white carbon black, 3kg of polyethylene wax, 2.5kg of titanium dioxide and 0.2kg of carbon black, and then standing for 24 hours to obtain a rubber compound;
(2) preforming: sequentially extruding, rolling, cooling and cutting the rubber compound, and standing for 4 hours to obtain a preformed rubber sheet;
(3) and (3) vulcanization molding: placing the preformed film into a vulcanizing device for chemical crosslinking and vulcanization molding, wherein the temperature is 175 ℃, and the pressure is 130kg/cm2The time is 340 s;
(4) trimming, namely punching the vulcanized rubber sheet to form a single product;
(5) cleaning: and cleaning, rinsing and packaging the product to obtain the brominated butyl rubber plug for the alkali-resistant medicament.
Example 2
The brominated butyl rubber plug for the alkali-resistant medicine is prepared according to the following raw material formula and method, and comprises the following steps:
(1) mixing: banburying and open mixing 100kg of brominated butyl rubber, 2kg of stearic acid, 1kg of alkylphenol disulfide, 7kg of zinc oxide, 60kg of calcined kaolin, 5kg of white carbon black, 4kg of polyethylene wax, 3kg of titanium dioxide and 0.1kg of carbon black, and then standing for 28 hours to obtain a rubber compound;
(2) preforming: sequentially extruding, rolling, cooling and cutting the rubber compound, and standing for 6 hours to obtain a preformed rubber sheet;
(3) and (3) vulcanization molding: placing the preformed film into a vulcanizing device for chemical crosslinking and vulcanization molding, wherein the temperature is 170 ℃, and the pressure is 110kg/cm2The time is 360 s;
(4) removing edges: punching the vulcanized rubber sheet to form a single product;
(5) cleaning: and cleaning, rinsing and packaging the product to obtain the brominated butyl rubber plug for the alkali-resistant medicament.
Example 3
The brominated butyl rubber plug for the alkali-resistant medicine is prepared according to the following raw material formula and method, and comprises the following steps:
(1) mixing: banburying and open mixing 100kg of brominated butyl rubber, 1kg of stearic acid, 3kg of alkylphenol disulfide, 3kg of zinc oxide, 100kg of calcined kaolin, 5kg of white carbon black, 2kg of polyethylene wax, 2kg of titanium white and 0.3kg of carbon black, and then standing for 30 hours to obtain a rubber compound;
(2) preforming: sequentially extruding, rolling, cooling and cutting the rubber compound, and standing for 5 hours to obtain a preformed rubber sheet;
(3) and (3) vulcanization molding: placing the preformed film into a vulcanizing device for chemical crosslinking and vulcanization molding at 178 ℃ and 140kg/cm2Time 320 s;
(4) removing edges: punching the vulcanized rubber sheet to form a single product;
(5) cleaning: and cleaning, rinsing and packaging the product to obtain the brominated butyl rubber plug for the alkali-resistant medicament.
Comparative example 1
The brominated butyl rubber plug for the medicine is prepared according to the following raw material formula and method, and comprises the following steps:
(1) mixing: banburying and open mixing 100kg of brominated butyl rubber, 1kg of stearic acid, 2kg of phenolic resin, 5kg of zinc oxide, 80kg of calcined kaolin, 7kg of white carbon black, 3kg of polyethylene wax, 2.5kg of titanium dioxide and 0.2kg of carbon black, and then standing for 24 hours to obtain a rubber compound;
(2) preforming: sequentially extruding, rolling, cooling and cutting the rubber compound, and standing for 4 hours to obtain a preformed rubber sheet;
(3) and (3) vulcanization molding: placing the preformed film into a vulcanizing device for chemical crosslinking and vulcanization molding, wherein the temperature is 175 ℃, and the pressure is 130kg/cm2The time is 300 s;
(4) removing edges: punching the vulcanized rubber sheet to form a single product;
(5) cleaning: and cleaning, rinsing and packaging the product to obtain the brominated butyl rubber plug for the medicine.
The brominated butyl rubber stoppers for medicines prepared in examples 1 to 3 and comparative example 1 were subjected to performance tests according to the test standard YBB00052005-2015 of the State food and drug administration, and the test results are shown in Table 1.
TABLE 1 chlorinated butyl rubber stoppers for oral liquid bottles prepared in examples 1 to 3 and comparative example 1 Performance test results
| Item | Example 1 | Example 2 | Example 3 | Comparative example 1 |
| Tensile Strength (MPa) | 10.2 | 8.3 | 9.7 | 13.5 |
| Omeprazole sodium compatibility at 60 ℃ for 5 days | 0.5- | 0.5- | 0.5- | 0.5 |
| Omeprazole sodium compatibility at 60 ℃ for 15 days | 0.5- | 0.5 | 0.5- | 1+ |
As can be seen from Table 1, the mixture of alkylphenol disulfide and zinc oxide is used as a vulcanization system, so that the tolerance of the brominated butyl rubber plug to alkaline drugs is improved, the phenomenon that small molecular substances and acidic substances in the rubber plug can migrate into the drugs in an alkaline environment to affect the turbidity of the drugs and cause drug pollution is avoided, and the tolerance of the brominated butyl rubber plug to wet heat sterilization is ensured.
Claims (8)
1. The utility model provides an alkali-resistant is brominated butyl rubber buffer for medicine which characterized in that: comprises brominated butyl rubber, a vulcanizing agent, a vulcanization accelerator, stearic acid, a filler, an auxiliary agent and a coloring agent; the vulcanizing agent is alkylphenol disulfide, and the vulcanization accelerator is zinc oxide.
2. The brominated butyl rubber stopper for alkali-resistant drugs according to claim 1, which is characterized in that: the composite material consists of the following raw materials in parts by mass:
3. the brominated butyl rubber stopper for alkali-resistant drugs according to claim 1, which is characterized in that: the filler is a mixture of calcined kaolin and white carbon black according to the mass ratio of 60-100: 5-10.
4. The brominated butyl rubber stopper for alkali-resistant drugs according to claim 1, which is characterized in that: the auxiliary agent is polyethylene wax.
5. The brominated butyl rubber stopper for alkali-resistant drugs according to claim 1, which is characterized in that: the colorant is a mixture of titanium dioxide and carbon black in a mass ratio of 2-3: 0.1-0.3.
6. The preparation method of the brominated butyl rubber plug for the alkali-resistant medicine according to any one of claims 1 to 5, which is characterized in that: the method comprises the following steps:
(1) mixing: mixing brominated butyl rubber, a vulcanizing agent, a vulcanization accelerator, stearic acid, a filler, an auxiliary agent and a coloring agent according to a formula, and then standing for 24-30h to obtain a rubber compound;
(2) preforming: sequentially extruding, rolling, cooling and cutting the rubber compound, and standing for 4-6h to obtain a preformed rubber sheet;
(3) and (3) vulcanization molding: placing the preformed rubber sheet into vulcanization equipment for chemical crosslinking and vulcanization molding;
(4) removing edges: punching the vulcanized rubber sheet to form a single product;
(5) cleaning: and cleaning, rinsing and packaging the product to obtain the brominated butyl rubber plug for the alkali-resistant medicament.
7. The preparation method of the brominated butyl rubber stopper used for alkali-resistant drugs according to claim 6, which is characterized in that: the mixing in the step (1) comprises banburying and open mixing.
8. The preparation method of the brominated butyl rubber stopper used for alkali-resistant drugs according to claim 6, which is characterized in that: the vulcanization temperature in the step (3) is 170-178 ℃, the vulcanization time is 320-360s, and the vulcanization pressure isIs 110-140kg/cm2。
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| Application Number | Priority Date | Filing Date | Title |
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| CN201911337675.4A CN111019254A (en) | 2019-12-23 | 2019-12-23 | Brominated butyl rubber plug for alkali-resistant medicine and preparation method thereof |
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| CN201911337675.4A CN111019254A (en) | 2019-12-23 | 2019-12-23 | Brominated butyl rubber plug for alkali-resistant medicine and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112321957A (en) * | 2020-10-31 | 2021-02-05 | 山东省药用玻璃股份有限公司 | High-cleanness rubber plug |
| CN112409710A (en) * | 2020-11-03 | 2021-02-26 | 山东省药用玻璃股份有限公司 | Freeze-drying film-coated butyl rubber plug and preparation method thereof |
| CN115819897A (en) * | 2022-11-29 | 2023-03-21 | 湖北华强科技股份有限公司 | Brominated butyl/polyisoprene rubber gasket and production method thereof |
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| CN116144123A (en) * | 2023-02-22 | 2023-05-23 | 湖北辰诺医药包装科技有限公司 | Chlorinated butyl rubber plug for in-vitro diagnostic reagent and preparation method thereof |
| CN116144123B (en) * | 2023-02-22 | 2024-06-11 | 湖北辰诺医药包装科技有限公司 | Chlorinated butyl rubber plug for in-vitro diagnostic reagent and preparation method thereof |
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