CN114907650A - Special rubber plug suitable for sensitive medicine - Google Patents
Special rubber plug suitable for sensitive medicine Download PDFInfo
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- CN114907650A CN114907650A CN202210641909.XA CN202210641909A CN114907650A CN 114907650 A CN114907650 A CN 114907650A CN 202210641909 A CN202210641909 A CN 202210641909A CN 114907650 A CN114907650 A CN 114907650A
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- 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
- C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
- C08L23/18—Homopolymers or copolymers of hydrocarbons having four or more carbon atoms
- C08L23/20—Homopolymers or copolymers of hydrocarbons having four or more carbon atoms having four to nine carbon atoms
- C08L23/22—Copolymers of isobutene; Butyl rubber ; Homo- or copolymers of other iso-olefins
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J7/00—Chemical treatment or coating of shaped articles made of macromolecular substances
- C08J7/04—Coating
- C08J7/0427—Coating with only one layer of a composition containing a polymer binder
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J2323/00—Characterised by the use of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Derivatives of such polymers
- C08J2323/02—Characterised by the use of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Derivatives of such polymers not modified by chemical after treatment
- C08J2323/18—Homopolymers or copolymers of hydrocarbons having four or more carbon atoms
- C08J2323/20—Homopolymers or copolymers of hydrocarbons having four or more carbon atoms having four to nine carbon atoms
- C08J2323/22—Copolymers of isobutene; butyl rubber
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J2427/00—Characterised by the use of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Derivatives of such polymers
- C08J2427/02—Characterised by the use of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Derivatives of such polymers not modified by chemical after-treatment
- C08J2427/12—Characterised by the use of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Derivatives of such polymers not modified by chemical after-treatment containing fluorine atoms
- C08J2427/18—Homopolymers or copolymers of tetrafluoroethylene
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- 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
- C08K2003/2237—Oxides; Hydroxides of metals of titanium
- C08K2003/2241—Titanium dioxide
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2201/00—Properties
- C08L2201/08—Stabilised against heat, light or radiation or oxydation
Abstract
The invention discloses a special rubber plug suitable for sensitive medicines, which comprises the following raw materials in parts by weight: 89-92 parts of medical butyl rubber, 2.6-4.8 parts of carbon black, 20-40 parts of calcined kaolin, 2.6-6.1 parts of a cross-linking agent, 3.5-6.8 parts of titanium dioxide and 1.3-2.4 parts of polyethylene wax; according to the invention, the heterocyclic mercapto compound is used as the vulcanizing agent, and substances such as zinc oxide, sulfur or sulfur derivatives and the like are not used as the vulcanizing agent, so that the intrinsic cleanliness of the rubber plug is ensured, a zinc-free vulcanizing system can improve the quality of rubber plug products, the rubber plug can not release sulfur and paraffin during the freeze drying process, the rubber plug can not react with the medicine, and the change of effective component substances of the medicine is avoided.
Description
Technical Field
The invention relates to the technical field of medical rubber bottle stoppers, in particular to a special rubber stopper suitable for sensitive medicines.
Background
The rubber for producing the medical butyl rubber bottle stopper mainly comprises chlorinated medical butyl rubber and brominated medical butyl rubber, wherein the molecular structure of the rubber contains about 97-99% of isobutene and 1-3% of isoprene, and the molecular structure contains 1.8-2.2% of chlorine atoms or bromine atoms. When the vulcanizing agent is selected, the double bonds and halogen atoms with little content in the molecular structure of chlorinated medical butyl rubber and brominated medical butyl rubber are generally utilized for crosslinking, the types of the adopted vulcanizing agents are zinc oxide, sulfur derivatives, alkyl phenolic resin, magnesium oxide, amine compounds and the like, and the rubber and a matched vulcanizing system can still meet the requirements on some conventional partially insensitive medicines.
However, due to the complex formulation and the concentration gradient of the added raw materials, after the rubber plug is packaged with some drugs with stronger molecular activity, when the rubber plug is used for powder injection for injection, sulfur and paraffin are released in the freeze drying process, so that metal elements zinc and sulfur in the rubber plug can react with the drugs, the compatibility problem of the rubber plug and the drugs is generated, the substances of active ingredients of the drugs are changed, the stability of the drugs is reduced, and part of cephalosporins, part of infusion solutions and anticancer drugs are more prominent.
Disclosure of Invention
The invention aims to provide a special rubber plug suitable for sensitive medicines so as to solve the problem of compatibility of the rubber plug and medicines with stronger molecular activity.
In order to achieve the purpose, the invention provides the following technical scheme: the special rubber plug suitable for sensitive medicines comprises the following raw materials in parts by weight: 89-92 parts of medical butyl rubber, 2.6-4.8 parts of carbon black, 20-40 parts of calcined kaolin, 2.6-6.1 parts of cross-linking agent, 3.5-6.8 parts of titanium dioxide and 1.3-2.4 parts of polyethylene wax.
Preferably, the feed comprises the following raw materials in parts by weight: 89 parts of medical butyl rubber, 2.6 parts of carbon black, 30 parts of calcined kaolin, 2.6 parts of a cross-linking agent, 3.5 parts of titanium dioxide and 1.3 parts of polyethylene wax.
Preferably, the feed comprises the following raw materials in parts by weight: 89 parts of medical butyl rubber, 4.8 parts of carbon black, 20 parts of calcined kaolin, 6 parts of a cross-linking agent, 6.8 parts of titanium dioxide and 2.4 parts of polyethylene wax.
Preferably, the crosslinking agent is a heterocyclic mercapto compound.
The preparation method of the special rubber plug suitable for sensitive medicines comprises the following steps:
s1, mixing: the well-mixed medical butyl rubber, carbon black, calcined kaolin, a cross-linking agent, titanium dioxide and polyethylene wax are put into an internal mixer for internal mixing, the rubber material is discharged when the temperature of the rubber material is 110 +/-5 ℃, then the rubber material is put into an open mill for open mixing, and the left and right broaches are used for one time and are passed through for 5 times, and the mixed rubber is obtained after the rubber is crushed and turned over;
s2, preforming: putting the cooled rubber compound into an extruder, and calendering the extruded rubber compound by a calender to obtain rubber sheets with the required weight and size for vulcanization;
s3, vulcanization: vulcanizing and molding the cut rubber sheet under the condition of a vulcanizing machine under high-temperature and high-pressure equipment, wherein the vulcanization temperature is 175-180 ℃, and obtaining a molding semi-finished product;
s4, spraying: diluting the isolation coating with an ethyl acetate solvent, heating the vulcanized molded rubber plug by using an oven, uniformly spraying the diluted coating onto the heated rubber plug by using a high-pressure spray gun, and immediately feeding the rubber plug into the oven for heating and curing after the spraying is finished;
s5, removing edges: punching the sprayed rubber plug to form a single product;
s6, rinsing: and putting the rubber plug after edge removal into purified water, performing overflow rinsing for 30min, draining, adding an HCl solution, feeding steam, heating to the normal pressure of 80-100 ℃, treating for 20-40min, putting the purified water, performing overflow rinsing for 30min, and then performing unloading operation, thus finishing the preparation of the special rubber plug suitable for sensitive medicines.
Preferably, in step S4, the isolation coating includes the following raw materials in parts by weight: 80-95 parts of polytetrafluoroethylene, 1.3-3.6 parts of talcum powder, 0.2-0.8 part of slow-drying diluent and 0.3-1.4 parts of magnesium oxide.
Preferably, in the step S4, the mass ratio of the ethyl acetate solvent to the release coating is 4: 40.
Preferably, in the step S4, the heating temperature of the rubber plug is 130-150 ℃, the heating time is 7-11 min, the curing temperature of the coating is 140-160 ℃, and the curing time is 7-15 min.
Compared with the prior art, the invention has the beneficial effects that:
the invention uses heterocyclic mercapto compound as vulcanizing agent, and uses the heterocyclic mercapto compound as vulcanizing system of special rubber plug for sensitive medicine, which has good heat resistance, and does not use zinc oxide, sulfur or sulfur derivative as vulcanizing agent, thus ensuring the intrinsic cleanliness of the rubber plug, the zinc-free vulcanizing system can improve the quality of rubber plug products, so that the rubber plug can not release sulfur and paraffin during the freeze drying process, the rubber plug can not react with medicine, and avoid causing the change of effective component substances of the medicine, and an isolation protective layer can be formed outside the rubber plug by spraying isolation coating on the outside of the rubber plug, thereby preventing the rubber plug from releasing sulfur and paraffin under normal temperature environment, and further avoiding the change of effective component substances of the medicine caused by the precipitation (extraction) of the rubber plug.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The special rubber plug suitable for sensitive medicines comprises the following raw materials in parts by weight: 89-92 parts of medical butyl rubber, 2.6-4.8 parts of carbon black, 20-40 parts of calcined kaolin, 2.6-6.1 parts of a cross-linking agent, 3.5-6.8 parts of titanium dioxide and 1.3-2.4 parts of polyethylene wax.
The composite material comprises the following raw materials in parts by weight: 89 parts of medical butyl rubber, 2.6 parts of carbon black, 30 parts of calcined kaolin, 2.6 parts of a cross-linking agent, 3.5 parts of titanium dioxide and 1.3 parts of polyethylene wax.
The composite material comprises the following raw materials in parts by weight: 89 parts of medical butyl rubber, 4.8 parts of carbon black, 20 parts of calcined kaolin, 6 parts of a cross-linking agent, 6.8 parts of titanium dioxide and 2.4 parts of polyethylene wax.
Wherein the cross-linking agent is a heterocyclic mercapto compound.
The preparation method of the special rubber plug suitable for sensitive medicines comprises the following steps:
s1, mixing: the well-mixed medical butyl rubber, carbon black, calcined kaolin, a cross-linking agent, titanium dioxide and polyethylene wax are put into an internal mixer for internal mixing, the rubber material is discharged when the temperature of the rubber material is 110 +/-5 ℃, then the rubber material is put into an open mill for open mixing, and the left and right broaches are used for one time and are passed through for 5 times, and the mixed rubber is obtained after the rubber is crushed and turned over;
s2, preforming: putting the cooled rubber compound into an extruder, and calendering the extruded rubber compound by a calender to obtain rubber sheets with the required weight and size for vulcanization;
s3, vulcanization: vulcanizing and molding the cut rubber sheet under the condition of a vulcanizing machine under high-temperature and high-pressure equipment, wherein the vulcanization temperature is 175-180 ℃, and obtaining a molding semi-finished product;
s4, spraying: diluting the isolation coating with an ethyl acetate solvent, heating the vulcanized molded rubber plug by using an oven, uniformly spraying the diluted coating onto the heated rubber plug by using a high-pressure spray gun, and immediately feeding the rubber plug into the oven for heating and curing after the spraying is finished;
s5, removing edges: punching the sprayed rubber plug to form a single product;
s6, rinsing: and putting the rubber plug after edge removal into purified water, performing overflow rinsing for 30min, draining, adding an HCl solution, feeding steam, heating to the normal pressure of 80-100 ℃, treating for 20-40min, putting the purified water, performing overflow rinsing for 30min, and then performing unloading operation, thus finishing the preparation of the special rubber plug suitable for sensitive medicines.
In step S4, the isolation coating includes the following raw materials by weight: 80-95 parts of polytetrafluoroethylene, 1.3-3.6 parts of talcum powder, 0.2-0.8 part of slow-drying diluent and 0.3-1.4 parts of magnesium oxide.
In step S4, the mass ratio of the ethyl acetate solvent to the release coating is 4: 40.
In the step S4, the heating temperature of the rubber plug is 130-150 ℃, the heating time is 7-11 min, the curing temperature of the coating is 140-160 ℃, and the curing time is 7-15 min.
Example 1
The special rubber plug suitable for sensitive medicines comprises the following raw materials in parts by weight: 89 parts of medical butyl rubber, 2.6 parts of carbon black, 30 parts of calcined kaolin, 2.6 parts of a cross-linking agent, 3.5 parts of titanium dioxide and 1.3 parts of polyethylene wax.
The preparation method of the special rubber plug suitable for sensitive medicines comprises the following steps:
s1, mixing: the well-mixed medical butyl rubber, carbon black, calcined kaolin, a cross-linking agent, titanium dioxide and polyethylene wax are put into an internal mixer for internal mixing, the rubber material is discharged when the temperature of the rubber material is 110 +/-5 ℃, then the rubber material is put into an open mill for open mixing, and the left and right broaches are used for one time and are passed through for 5 times, and the mixed rubber is obtained after the rubber is crushed and turned over;
s2, preforming: putting the cooled rubber compound into an extruder, and calendering the extruded rubber compound by a calender to obtain rubber sheets with the required weight and size for vulcanization;
s3, vulcanization: vulcanizing and molding the cut rubber sheet under the condition of a vulcanizing machine under high-temperature and high-pressure equipment, wherein the vulcanization temperature is 175 ℃, and obtaining a molded semi-finished product;
s4, spraying: diluting the isolation coating by using an ethyl acetate solvent, wherein the mass ratio of the ethyl acetate solvent to the isolation coating is 4: 40, heating the vulcanized molded rubber plug by using an oven, wherein the heating temperature of the rubber plug is 140 ℃, the heating time is 8min, uniformly spraying the diluted coating on the heated rubber plug by using a high-pressure spray gun, immediately conveying the rubber plug into the oven for heating and curing after the spraying is finished, and the curing temperature of the coating is 150 ℃, and the curing time is 9 min;
s5, removing edges: punching the sprayed rubber plug to form a single product;
s6, rinsing: and putting the rubber plug after edge removal into purified water, performing overflow rinsing for 30min, draining, adding an HCl solution, feeding steam, heating to the normal pressure of 80-100 ℃, treating for 20-40min, putting the purified water, performing overflow rinsing for 30min, and then performing unloading operation, thus finishing the preparation of the special rubber plug suitable for sensitive medicines.
In step S4, the isolation coating includes the following raw materials by weight: 95 parts of polytetrafluoroethylene, 2.8 parts of talcum powder, 0.8 part of slow-drying diluent and 1.4 parts of magnesium oxide.
Example 2
The special rubber plug suitable for sensitive medicines comprises the following raw materials in parts by weight: 90 parts of medical butyl rubber, 2.6 parts of carbon black, 25 parts of calcined kaolin, 3.7 parts of a cross-linking agent, 3.5 parts of titanium dioxide and 1.3 parts of polyethylene wax.
The preparation method of the special rubber plug suitable for sensitive medicines comprises the following steps:
s1, mixing: the well-mixed medical butyl rubber, carbon black, calcined kaolin, a cross-linking agent, titanium dioxide and polyethylene wax are put into an internal mixer for internal mixing, the rubber material is discharged when the temperature of the rubber material is 110 +/-5 ℃, then the rubber material is put into an open mill for open mixing, and the left and right broaches are used for one time and are passed through for 5 times, and the mixed rubber is obtained after the rubber is crushed and turned over;
s2, preforming: putting the cooled rubber compound into an extruder, and calendering the extruded rubber compound by a calender to obtain rubber sheets with the required weight and size for vulcanization;
s3, vulcanization: vulcanizing and molding the cut rubber sheet under the condition of a vulcanizing machine under high-temperature and high-pressure equipment, wherein the vulcanization temperature is 175 ℃, and obtaining a molded semi-finished product;
s4, spraying: diluting the isolation coating by using an ethyl acetate solvent, wherein the mass ratio of the ethyl acetate solvent to the isolation coating is 4: 40, heating the vulcanized molded rubber plug by using an oven, wherein the heating temperature of the rubber plug is 140 ℃, the heating time is 8min, uniformly spraying the diluted coating on the heated rubber plug by using a high-pressure spray gun, immediately conveying the rubber plug into the oven for heating and curing after the spraying is finished, and the curing temperature of the coating is 150 ℃, and the curing time is 9 min;
s5, removing edges: punching the sprayed rubber plug to form a single product;
s6, rinsing: and putting the rubber plug after edge removal into purified water, performing overflow rinsing for 30min, draining, adding an HCl solution, feeding steam, heating to the normal pressure of 80-100 ℃, treating for 20-40min, putting the purified water, performing overflow rinsing for 30min, and then performing unloading operation, thus finishing the preparation of the special rubber plug suitable for sensitive medicines.
In step S4, the isolation coating includes the following raw materials by weight: 95 parts of polytetrafluoroethylene, 2.8 parts of talcum powder, 0.8 part of slow-drying diluent and 1.4 parts of magnesium oxide.
Example 3
The special rubber plug suitable for sensitive medicines comprises the following raw materials in parts by weight: 91 parts of medical butyl rubber, 2.6 parts of carbon black, 27 parts of calcined kaolin, 3.6 parts of a cross-linking agent, 3.5 parts of titanium dioxide and 1.3 parts of polyethylene wax.
The preparation method of the special rubber plug suitable for sensitive medicines comprises the following steps:
s1, mixing: the well-mixed medical butyl rubber, carbon black, calcined kaolin, a cross-linking agent, titanium dioxide and polyethylene wax are put into an internal mixer for internal mixing, the rubber material is discharged when the temperature of the rubber material is 110 +/-5 ℃, then the rubber material is put into an open mill for open mixing, and the left and right broaches are used for one time and are passed through for 5 times, and the mixed rubber is obtained after the rubber is crushed and turned over;
s2, preforming: putting the cooled rubber compound into an extruder, and calendering the extruded rubber compound by a calender to obtain rubber sheets with the required weight and size for vulcanization;
s3, vulcanization: vulcanizing and molding the cut rubber sheet under the condition of a vulcanizing machine under high-temperature and high-pressure equipment, wherein the vulcanization temperature is 175 ℃, and obtaining a molded semi-finished product;
s4, spraying: diluting the isolation coating by using an ethyl acetate solvent, wherein the mass ratio of the ethyl acetate solvent to the isolation coating is 4: 40, heating the vulcanized molded rubber plug by using an oven, wherein the heating temperature of the rubber plug is 140 ℃, the heating time is 8min, uniformly spraying the diluted coating on the heated rubber plug by using a high-pressure spray gun, immediately conveying the rubber plug into the oven for heating and curing after the spraying is finished, and the curing temperature of the coating is 150 ℃, and the curing time is 9 min;
s5, removing edges: punching the sprayed rubber plug to form a single product;
s6, rinsing: and putting the rubber plug after edge removal into purified water, performing overflow rinsing for 30min, draining, adding an HCl solution, feeding steam, heating to the normal pressure of 80-100 ℃, treating for 20-40min, putting the purified water, performing overflow rinsing for 30min, and then performing unloading operation, thus finishing the preparation of the special rubber plug suitable for sensitive medicines.
In step S4, the isolation coating includes the following raw materials by weight: 95 parts of polytetrafluoroethylene, 2.8 parts of talcum powder, 0.8 part of slow-drying diluent and 1.4 parts of magnesium oxide.
Example 4
The special rubber plug suitable for sensitive medicines comprises the following raw materials in parts by weight: 92 parts of medical butyl rubber, 4.8 parts of carbon black, 20 parts of calcined kaolin, 6 parts of a cross-linking agent, 6.8 parts of titanium dioxide and 2.4 parts of polyethylene wax.
The preparation method of the special rubber plug suitable for sensitive medicines comprises the following steps:
s1, mixing: the well-mixed medical butyl rubber, carbon black, calcined kaolin, a cross-linking agent, titanium dioxide and polyethylene wax are put into an internal mixer for internal mixing, the rubber material is discharged when the temperature of the rubber material is 110 +/-5 ℃, then the rubber material is put into an open mill for open mixing, and the left and right broaches are used for one time and are passed through for 5 times, and the mixed rubber is obtained after the rubber is crushed and turned over;
s2, preforming: putting the cooled rubber compound into an extruder, and calendering the extruded rubber compound by a calender to obtain rubber sheets with the required weight and size for vulcanization;
s3, vulcanization: vulcanizing and molding the cut rubber sheet under the condition of a vulcanizing machine under high-temperature and high-pressure equipment, wherein the vulcanization temperature is 175 ℃, and obtaining a molded semi-finished product;
s4, spraying: diluting the isolation coating by using an ethyl acetate solvent, wherein the mass ratio of the ethyl acetate solvent to the isolation coating is 4: 40, heating the vulcanized molded rubber plug by using an oven, wherein the heating temperature of the rubber plug is 140 ℃, the heating time is 8min, uniformly spraying the diluted coating on the heated rubber plug by using a high-pressure spray gun, immediately conveying the rubber plug into the oven for heating and curing after the spraying is finished, and the curing temperature of the coating is 150 ℃, and the curing time is 9 min;
s5, removing edges: punching the sprayed rubber plug to form a single product;
s6, rinsing: and (3) placing the rubber plug after edge removal into purified water, overflowing and rinsing for 30min, then draining, adding HCl solution, sending steam, heating to the normal pressure of 80-100 ℃, treating for 20-40min, then placing the purified water, overflowing and rinsing for 30min, and then carrying out unloading operation, thus finishing the preparation of the special rubber plug suitable for sensitive medicines.
In step S4, the isolation coating includes the following raw materials by weight: 95 parts of polytetrafluoroethylene, 2.8 parts of talcum powder, 0.8 part of slow-drying diluent and 1.4 parts of magnesium oxide.
Test example 1
In order to facilitate the understanding of the technical solutions of the present invention, the following is a further explanation of the present invention with reference to experimental data:
the special rubber plug suitable for sensitive drugs produced according to embodiment 4 of the present invention is sampled according to the specific requirements of "halogenated medical butyl rubber plug for YBB00042005 injection" issued by the national food and drug administration, and the detection results are as follows in table 1:
| inspection item | Technical index | The result of the detection |
| Adhesion Property | Should be sealed with the bottle without leakage | Without leakage |
| Volatile sulfur compounds | With Na 2 S/20cm2 is less than or equal to 50ug | 0 |
| Absorbance of ultraviolet | 220-360nm≤0.1 | 0.035 |
| Clarity of reaction | Grade 2 or below | Not more than 0.2 grade |
| Heavy metals | ≤1.0ppm | ＜0.05ppm |
| Zinc | ≤0.0003％ | 0 |
TABLE 1
The experimental data in table 1 show that the heterocyclic mercapto compound is used as the vulcanizing agent and is used as the vulcanizing system of the special rubber plug of the sensitive medicine, so that the rubber plug has good heat resistance, and substances such as zinc oxide, sulfur or sulfur derivatives and the like are not used as the vulcanizing agent, so that the inherent cleanliness of the rubber plug is ensured, the zinc-free vulcanizing system can improve the quality of rubber plug products, the rubber plug does not release sulfur and paraffin in the freeze drying process, the rubber plug does not react with the medicine, and the change of effective component substances of the medicine is avoided.
Comparative example 1:
the same procedure was followed as in example 4, except that in the preparation process, the plug was not subjected to the spray coating treatment.
Comparative example 2:
the same procedure as in example 4 was followed, except that no slow-drying diluent was added to the raw materials of the barrier coating in step S4.
Test example 2
In order to facilitate the understanding of the technical solutions of the present invention, the following is a further explanation of the present invention with reference to experimental data:
and (3) long-term test: the method comprises the steps of placing example 4, comparative example 1, comparative example 2 and a control group (the control group is halogenated medical butyl rubber for injection produced by hong sprout rubber plastic products Co., Ltd. in Jiangyin City), inverting, placing for 12 months under the conditions of the temperature of 25 ℃ and the relative humidity of 60%, taking out after 12 months, injecting 10mL of injection water to fully dissolve the medicine, and detecting the turbidity value (NTU value) by using a turbidity meter, wherein the results are shown in Table 2.
TABLE 2
The experimental data in table 2 show that, as can be seen from the test results of the 12-month long-term test, the gelatin plug has obvious advantages in the compatibility with the epirubicin hydrochloride medicine for injection, the effect of spraying the rubber plug is better than that of non-spraying, and the slow-drying diluent is added into the sprayed isolation coating, so that the drying speed of the isolation coating during curing can be inhibited, the isolation coating is not cracked outside the rubber plug, and the reaction between the rubber plug and the medicine can be further avoided.
It is noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.
Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (8)
1. The special rubber plug suitable for sensitive medicines is characterized in that: the feed comprises the following raw materials in parts by weight: 89-92 parts of medical butyl rubber, 2.6-4.8 parts of carbon black, 20-40 parts of calcined kaolin, 2.6-6.1 parts of cross-linking agent, 3.5-6.8 parts of titanium dioxide and 1.3-2.4 parts of polyethylene wax.
2. The special rubber plug suitable for sensitive medicines according to claim 1, characterized in that: the feed comprises the following raw materials in parts by weight: 89 parts of medical butyl rubber, 2.6 parts of carbon black, 30 parts of calcined kaolin, 2.6 parts of a cross-linking agent, 3.5 parts of titanium dioxide and 1.3 parts of polyethylene wax.
3. The special rubber plug suitable for sensitive medicines according to claim 1, characterized in that: the feed comprises the following raw materials in parts by weight: 89 parts of medical butyl rubber, 4.8 parts of carbon black, 20 parts of calcined kaolin, 6 parts of a cross-linking agent, 6.8 parts of titanium dioxide and 2.4 parts of polyethylene wax.
4. The special rubber plug suitable for sensitive medicines according to claim 1, characterized in that: the cross-linking agent is a heterocyclic mercapto compound.
5. The method for preparing the special rubber plug suitable for sensitive medicines according to any one of claims 1 to 4, characterized by comprising the following steps:
s1, mixing: the well-mixed medical butyl rubber, carbon black, calcined kaolin, a cross-linking agent, titanium dioxide and polyethylene wax are put into an internal mixer for internal mixing, the rubber material is discharged when the temperature of the rubber material is 110 +/-5 ℃, then the rubber material is put into an open mill for open mixing, and the left and right broaches are used for one time and are passed through for 5 times, and the mixed rubber is obtained after the rubber is crushed and turned over;
s2, preforming: putting the cooled rubber compound into an extruder, and calendering the extruded rubber compound by a calender to obtain rubber sheets with the required weight and size for vulcanization;
s3, vulcanization: vulcanizing and molding the cut rubber sheet under the condition of a vulcanizing machine under high-temperature and high-pressure equipment, wherein the vulcanization temperature is 175-180 ℃, and obtaining a molding semi-finished product;
s4, spraying: diluting the isolation coating with an ethyl acetate solvent, heating the vulcanized molded rubber plug by using an oven, uniformly spraying the diluted coating onto the heated rubber plug by using a high-pressure spray gun, and immediately feeding the rubber plug into the oven for heating and curing after the spraying is finished;
s5, removing edges: punching the sprayed rubber plug to form a single product;
s6, rinsing: and putting the rubber plug after edge removal into purified water, performing overflow rinsing for 30min, draining, adding an HCl solution, feeding steam, heating to the normal pressure of 80-100 ℃, treating for 20-40min, putting the purified water, performing overflow rinsing for 30min, and then performing unloading operation, thus finishing the preparation of the special rubber plug suitable for sensitive medicines.
6. The preparation method of the special rubber plug suitable for sensitive drugs according to claim 5, characterized in that: in the step S4, the isolation coating comprises the following raw materials in parts by weight: 80-95 parts of polytetrafluoroethylene, 1.3-3.6 parts of talcum powder, 0.2-0.8 part of slow-drying diluent and 0.3-1.4 parts of magnesium oxide.
7. The preparation method of the special rubber plug suitable for sensitive drugs according to claim 5, characterized in that: in the step S4, the mass ratio of the ethyl acetate solvent to the release coating is 4: 40.
8. The preparation method of the special rubber plug suitable for sensitive drugs according to claim 5, characterized in that: in the step S4, the heating temperature of the rubber plug is 130-150 ℃, the heating time is 7-11 min, the curing temperature of the coating is 140-160 ℃, and the curing time is 7-15 min.
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