Formula and production process of locally-coated pre-encapsulated piston

Abstract

The invention relates to the technical field of injector film-coated pistons, and provides a formula and a production process of a locally-coated pre-filled piston. The locally coated pre-encapsulated piston is prepared from the following components in percentage by mass: 100 parts of brominated butyl rubber, 60 to 90 parts of calcined kaolin, 0.3 to 0.5 part of soluble sulfur, 5 to 8 parts of active magnesium oxide, 2 to 3 parts of titanium dioxide, 0.1 to 0.3 part of carbon black and 1 to 3 parts of polyethylene wax. The production and preparation process comprises the steps of raw material matching, mixing, pre-forming, film pasting, vulcanization forming, edge removing, cleaning and packaging. The pre-potting piston is produced in a two-stage mixing mode, so that in the production and preparation process, rubber materials are prevented from self-sulfuration and even scorching, meanwhile, the dispersion uniformity of various powder materials is improved, and under the action of a sulfuration technology, the materials form a cross-linked structure, better tensile strength, elasticity and aging resistance are obtained, and the service life of the piston is prolonged. The service life of the pre-encapsulation piston is greatly prolonged, and the durability of the pre-encapsulation piston is improved.

Description

Technical Field

[0001] The invention relates to the technical field of syringe film-coated pistons, in particular to a formula and production process of a partially film-coated prefilled piston. Background Art

[0002] Prefilled syringes are a new type of liquid drug packaging that integrates drug storage and injection functions. It is a practical injection dosage form with high technical content. At present, prefilled syringes are the first choice for many vaccines, biological preparations and other products. Especially in the packaging field of small-dose, high-value-added drugs, gradually replacing ampoules and vials will become a future trend.

[0003] The prefilled piston is one of the important components of the prefilled syringe and has a vital impact on the safety of the packaged drug. When using an ordinary prefilled piston, since the piston is in direct contact with sensitive drugs, compatibility problems may occur due to the interaction between the piston and the drug. The coated piston shields the contact between the piston and the drug by adding a barrier plastic film on the surface of the piston, which can effectively reduce the absorption, adsorption, leaching and penetration between the piston and the drug, thereby effectively reducing or delaying the occurrence and development of compatibility problems and improving the long-term stability of the drug.

[0004] In the prior art, the piston is generally in direct contact with the drug, which will cause compatibility problems due to the interaction between the piston and the drug, resulting in drug deterioration and failure. Therefore, a pre-filled piston formula and production process with a partial coating is needed. Summary of the invention

[0005] In view of the deficiencies in the prior art, the present invention provides a partially coated prefilled piston formula and production process, which solves the problem that after the piston comes into direct contact with the drug, the compatibility problem will occur due to the interaction between the piston and the drug, resulting in drug deterioration and failure.

[0006] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0007] A formula for a partially coated prefilled piston, the weight percentage of which is as follows: 100 parts of brominated butyl rubber, 60-90 parts of calcined kaolin, 0.3-0.5 parts of soluble sulfur, 5-8 parts of active magnesium oxide, 2-3 parts of titanium dioxide, 0.1-0.3 parts of carbon black and 1-3 parts of polyethylene wax.

[0008] A production process for a partially coated prefilled piston comprises the following steps:

[0009] Step 1: Mixing: prepare 100 parts of bromobutyl rubber, 60-90 parts of calcined kaolin, 0.3-0.5 parts of soluble sulfur, 5-8 parts of active magnesium oxide, 2-3 parts of titanium dioxide, 0.1-0.3 parts of carbon black and 1-3 parts of polyethylene wax as raw materials, mix the ingredients according to the formula, mix the raw materials by internal mixing and open mixing, and produce by two-stage mixing method;

[0010] Step 2: Preforming: the mixed rubber is stored after being extruded, calendered, cooled and cut into pieces;

[0011] Step 3: The fluorine film material is evenly pasted on the surface of the preformed film;

[0012] Step 4: Vulcanization molding: put the preformed film with the film material attached into a vulcanizer for vulcanization molding.

[0013] Step 5: Remove the edges and punch the vulcanized film to form a single product;

[0014] Step 6: Cleaning: Clean the product to improve its cleanliness;

[0015] Step 7: Dry the product and then package it.

[0016] Preferably, the specific steps of the two-stage mixing in step one are:

[0017] S1, adding all raw materials except soluble sulfur in a mixing stage;

[0018] S2. Add soluble sulfur in the second stage of mixing.

[0019] Preferably, the fluorine film material used in step three is selected from any one of ETFE or FEP films.

[0020] Preferably, in step 4, the vulcanization molding conditions include:

[0021] Vulcanization temperature: 160-180℃;

[0022] Curing time 200-400S;

[0023] Vulcanization pressure: 100-150kg / cm2.

[0024] The present invention provides a partial film-coated pre-filled piston formula and production process, which has the following beneficial effects:

[0025] The present invention adopts a two-stage mixing method to produce the pre-filled piston, so that in the production and preparation process, the rubber material is prevented from self-sulfurization or even scorching, and the dispersion uniformity of various powders is improved. Through the action of the vulcanization process, the material forms a cross-linked structure to obtain better tensile strength, elasticity and aging resistance, which greatly prolongs the service life of the pre-filled piston and increases its durability. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 It is a schematic diagram of the process flow of the present invention;

[0027] Figure 2 The figure is a schematic diagram of the coating part of the prefilled piston prepared by the present invention. DETAILED DESCRIPTION

[0028] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0029] Please see attached Figure 1 and attached Figure 2 , the present invention provides the following embodiments:

[0030] Embodiment 1:

[0031] As one aspect of the present application, a partially coated prefilled piston formula is provided, wherein the mass percentages of the partially coated prefilled piston are as follows: 100 parts of brominated butyl rubber, 65 parts of calcined kaolin, 0.3 parts of soluble sulfur, 6 parts of active magnesium oxide, 3 parts of titanium dioxide, 0.15 parts of carbon black and 2 parts of polyethylene wax.

[0032] Based on the above-mentioned partially coated prefilled piston formula, as another aspect of the present invention, a partially coated prefilled piston production process comprises the following steps:

[0033] Step 1: Mixing: prepare the raw materials of 100 parts of bromobutyl rubber, 65 parts of calcined kaolin, 0.3 parts of soluble sulfur, 6 parts of active magnesium oxide, 3 parts of titanium dioxide, 0.15 parts of carbon black and 2 parts of polyethylene wax, mix the raw materials according to the formula, mix the raw materials by internal mixing and open mixing, and adopt a two-stage mixing method, wherein all raw materials except soluble sulfur are added in the first stage of mixing, and soluble sulfur is added in the second stage of mixing;

[0034] Step 2: Preforming: the mixed rubber is stored after being extruded, calendered, cooled and cut into pieces;

[0035] Step 3: The fluorine film material is evenly pasted on the surface of the preformed film, and the fluorine film material is ETFE film;

[0036] Step 4: vulcanization molding: put the preformed film with the film material attached into the vulcanizer for vulcanization molding. The molding environment is: vulcanization temperature: 165°C; vulcanization time 400S; vulcanization pressure: 105kg / cm2.

[0037] Step 5: Remove the edges and punch the vulcanized film to form a single product;

[0038] Step 6: Cleaning: Clean the product to improve its cleanliness;

[0039] Step 7: Dry the product and then package it.

[0040] Embodiment 2:

[0041] As one aspect of the present application, a partially coated prefilled piston formula is provided, wherein the mass percentages of the partially coated prefilled piston are as follows: 100 parts of brominated butyl rubber, 75 parts of calcined kaolin, 0.45 parts of soluble sulfur, 7 parts of active magnesium oxide, 2 parts of titanium dioxide, 0.2 parts of carbon black and 3 parts of polyethylene wax.

[0042] Based on the above-mentioned partially coated prefilled piston formula, as another aspect of the present invention, a partially coated prefilled piston production process comprises the following steps:

[0043] Step 1: Mixing: prepare the raw materials of 100 parts of bromobutyl rubber, 75 parts of calcined kaolin, 0.45 parts of soluble sulfur, 7 parts of active magnesium oxide, 2 parts of titanium dioxide, 0.2 parts of carbon black and 3 parts of polyethylene wax, mix the raw materials according to the formula, mix the raw materials by internal mixing and open mixing, and adopt a two-stage mixing method, wherein all raw materials except soluble sulfur are added in the first stage of mixing, and soluble sulfur is added in the second stage of mixing;

[0044] Step 2: Preforming: the mixed rubber is stored after being extruded, calendered, cooled and cut into pieces;

[0045] Step 3: The fluorine film material is evenly pasted on the surface of the preformed film, the fluorine film material FEP film;

[0046] Step 4: vulcanization molding: put the preformed film with the film material attached into the vulcanizer for vulcanization molding. The molding environment is: vulcanization temperature: 180°C; vulcanization time: 200S; vulcanization pressure: 150kg / cm2.

[0047] Step 5: Remove the edges and punch the vulcanized film to form a single product;

[0048] Step 6: Cleaning: Clean the product to improve its cleanliness;

[0049] Step 7: Dry the product and then package it.

[0050] Embodiment three:

[0051] As one aspect of the present application, a partially coated prefilled piston formula is provided, wherein the mass percentages of the partially coated prefilled piston are as follows: 100 parts of brominated butyl rubber, 80 parts of calcined kaolin, 0.35 parts of soluble sulfur, 6 parts of active magnesium oxide, 2 parts of titanium dioxide, 0.1 parts of carbon black and 3 parts of polyethylene wax.

[0052] Based on the above-mentioned partially coated prefilled piston formula, as another aspect of the present invention, a partially coated prefilled piston production process comprises the following steps:

[0053] Step 1: Mixing: prepare the raw materials of 100 parts of bromobutyl rubber, 80 parts of calcined kaolin, 0.35 parts of soluble sulfur, 6 parts of active magnesium oxide, 2 parts of titanium dioxide, 0.1 parts of carbon black and 3 parts of polyethylene wax, mix the raw materials according to the formula, mix the raw materials by internal mixing and open mixing, and adopt a two-stage mixing method, wherein all raw materials except soluble sulfur are added in the first stage of mixing, and soluble sulfur is added in the second stage of mixing;

[0054] Step 2: Preforming: the mixed rubber is stored after being extruded, calendered, cooled and cut into pieces;

[0055] Step 3: The fluorine film material is evenly pasted on the surface of the preformed film, and the fluorine film material is ETFE film;

[0056] Step 4: vulcanization molding: put the preformed film with the film material attached into the vulcanizer for vulcanization molding. The molding environment is: vulcanization temperature: 175°C; vulcanization time 350S; vulcanization pressure: 125kg / cm2.

[0057] Step 5: Remove the edges and punch the vulcanized film to form a single product;

[0058] Step 6: Cleaning: Clean the product to improve its cleanliness;

[0059] Step 7: Dry the product and then package it.

[0060] Embodiment 4:

[0061] As one aspect of the present application, a partially coated prefilled piston formula is provided, wherein the mass percentages of the partially coated prefilled piston are as follows: 100 parts of brominated butyl rubber, 60-90 parts of calcined kaolin, 0.45 parts of soluble sulfur, 5 parts of active magnesium oxide, 2 parts of titanium dioxide, 0.2 parts of carbon black and 2 parts of polyethylene wax.

[0062] Based on the above-mentioned partially coated prefilled piston formula, as another aspect of the present invention, a partially coated prefilled piston production process comprises the following steps:

[0063] Step 1: Mixing: prepare the raw materials of 100 parts of bromobutyl rubber, 60-90 parts of calcined kaolin, 0.45 parts of soluble sulfur, 5 parts of active magnesium oxide, 2 parts of titanium dioxide, 0.2 parts of carbon black and 2 parts of polyethylene wax, mix the raw materials according to the formula, mix the raw materials by internal mixing and open mixing, and adopt a two-stage mixing method, wherein all raw materials except soluble sulfur are added in the first stage of mixing, and soluble sulfur is added in the second stage of mixing;

[0064] Step 2: Preforming: the mixed rubber is stored after being extruded, calendered, cooled and cut into pieces;

[0065] Step 3: The fluorine film material is evenly pasted on the surface of the preformed film, the fluorine film material FEP film;

[0066] Step 4: vulcanization molding: put the preformed film with the film material attached into the vulcanizer for vulcanization molding. The molding environment is: vulcanization temperature: 170°C; vulcanization time 300S; vulcanization pressure: 130kg / cm2.

[0067] Step 5: Remove the edges and punch the vulcanized film to form a single product;

[0068] Step 6: Cleaning: Clean the product to improve its cleanliness;

[0069] Step 7: Dry the product and then package it.

[0070] In each of the above embodiments, a two-stage mixing method is adopted to produce the pre-filled piston, so that during the production and preparation process, the rubber material is prevented from self-sulfurization or even scorching, while the dispersion uniformity of various powders is improved. Through the action of the vulcanization process, the material forms a cross-linked structure to obtain better tensile strength, elasticity and aging resistance, which greatly extends the service life of the pre-filled piston and increases its durability.

[0071] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A partially coated prefilled piston formulation, characterized in that: The mass percentage composition of the partially coated pre-filled piston is as follows: 100 parts of brominated butyl rubber, 60-90 parts of calcined kaolin, 0.3-0.5 parts of soluble sulfur, 5-8 parts of active magnesium oxide, 2-3 parts of titanium dioxide, 0.1-0.3 parts of carbon black and 1-3 parts of polyethylene wax.

2. A production process for a partially coated prefilled piston, using a partially coated prefilled piston formula as claimed in claim 1, characterized in that: The following steps are involved: Step 1: Mixing: prepare 100 parts of bromobutyl rubber, 60-90 parts of calcined kaolin, 0.3-0.5 parts of soluble sulfur, 5-8 parts of active magnesium oxide, 2-3 parts of titanium dioxide, 0.1-0.3 parts of carbon black and 1-3 parts of polyethylene wax as raw materials, mix the ingredients according to the formula, mix the raw materials by internal mixing and open mixing, and produce by two-stage mixing method; Step 2: Preforming: the mixed rubber is stored after being extruded, calendered, cooled and cut into pieces; Step 3: The fluorine film material is evenly pasted on the surface of the preformed film; Step 4: Vulcanization molding: put the preformed film with the film material attached into a vulcanizer for vulcanization molding. Step 5: Remove the edges and punch the vulcanized film to form a single product; Step 6: Cleaning: Clean the product to improve its cleanliness; Step 7: Dry the product and then package it.

3. The process for producing a partially coated prefilled piston according to claim 2, characterized in that: The specific steps of the two-stage mixing in step one are: S1, adding all raw materials except soluble sulfur in a mixing stage; S2. Add soluble sulfur in the second stage of mixing.

4. The process for producing a partially coated prefilled piston according to claim 2, characterized in that: The fluorine film material used in step three is selected from any one of ETFE or FEP films.

5. The process for producing a partially coated prefilled piston according to claim 2, characterized in that: In the step 4, the vulcanization molding conditions include: Vulcanization temperature: 160-180℃; Curing time 200-400S; Vulcanization pressure: 100-150kg / cm2.

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