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Protective cap for pre-filled syringe and manufacturing method of protective cap

A syringe and prefilling technology, which is applied in the direction of hypodermic injection devices, devices introduced into the body, needles, etc., can solve the problems of prefilled syringe performance impact, manpower, material and financial resources, etc., and achieve high cleanliness and radiation performance excellent effect

Active Publication Date: 2020-09-22
郑州翱翔医药科技股份有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The introduction of these measures will not only have a certain impact on the performance of other components of the prefilled syringe, but also require some additional manpower, material and financial resources for medical device factories or pharmaceutical factories

Method used

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  • Protective cap for pre-filled syringe and manufacturing method of protective cap

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] A luer lock protective cap for prefilled syringes, prepared from the following raw materials in parts by mass: 50 parts of rubber A polyisoprene rubber, 50 parts of rubber B bromobutyl rubber; vulcanizing agent 2,5-dimethyl 0.8 parts of -2,5-bis(tert-butylperoxy)hexane, 0.4 parts of sulfur; 1.2 parts of co-curing agent trimethylolpropane trimethacrylate, 2 parts of magnesium oxide; 65 parts of filler calcium carbonate, 10 parts of white carbon black; 3 parts of pigment titanium dioxide, 0.3 parts of carbon black.

[0017] The manufacturing method is as follows:

[0018] (1) Compounding: Weigh each material according to the formula.

[0019] (2) Kneading: Knead and mix the weighed materials on the internal mixer and the open mixer respectively.

[0020] (3) Vulcanization: Vulcanize at 180°C for 7 minutes using a protective cap vulcanization mold.

[0021] (4) Punching: Punch and trim the vulcanized protective cap film on a punching machine.

[0022] (5) Cleaning and ...

Embodiment 2

[0026] A needle shield for prefilled syringes, prepared from the following raw materials in parts by mass: 70 parts of rubber A polyisoprene rubber; 30 parts of rubber B EPDM rubber; vulcanizing agent 1, 1-2 1 part of tert-butylperoxy-3,3,5-trimethylcyclohexane, 0.5 part of tert-octylphenol formaldehyde resin; 1.2 parts of triallyl cyanurate, 1 part of zinc oxide; filler carbonic acid Calcium 50 parts, kaolin 15 parts, white carbon black 10 parts; pigment titanium dioxide 3 parts, carbon black 0.3 parts.

[0027] Manufacturing method is the same as embodiment 1.

[0028] The reference standard "YBB00102004-2015 Polyisoprene Rubber Needle Protective Cap for Prefilled Syringes" of the piston product produced by the above method was tested, and the results are shown in Table 1.

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PUM

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Abstract

The invention discloses a protective cap for a pre-filled syringe and a manufacturing method of the protective cap. The protective cap is prepared from the following raw materials in parts by mass: 100 parts of a rubber composition, 0.5-4 parts of a vulcanizing agent, 0.5-5 parts of an auxiliary vulcanizing agent, 20-90 parts of filler and 0.1-5 parts of pigment. The rubber composition is preparedfrom 30-70 parts by mass of rubber A and 30-70 parts by mass of rubber B, wherein the rubber A is one of polyisoprene rubber, butadiene styrene rubber or butadiene rubber; and the rubber B is one ofchlorinated butyl rubber, brominated butyl rubber, silicone rubber or ethylene propylene terpolymer. The protective cap provided by the invention has excellent dimensional stability, heat resistance,oxygen resistance, radiation resistance, extremely low dissolution and extractable substances and appropriate gas permeability, and is suitable for various sterilization forms such as irradiation, steam, ethylene oxide and the like.

Description

technical field [0001] The invention belongs to the field of rubber fittings for prefilled syringes, and in particular relates to a production method for a protective cap for prefilled syringes. Background technique [0002] The protective cap is one of the prefilled syringe assemblies, which belongs to the seal of the syringe. It can be used for the needle seal of the syringe with a needle or the injection port of the syringe without a needle. When used for the seal of the needle, the needle will pierce into the cap. [0003] With the continuous popularization and use of prefilled syringes, the functional requirements for protective caps are also increasing. In addition to rigid requirements such as tightness and compatibility of liquid medicines, the need to meet various process and use requirements of prefilled syringes and maintain long-term stability has become increasingly prominent. Prefilled syringes have to go through two or more sterilization procedures from the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08L9/00C08L23/28C08L23/16C08L61/08C08K13/04C08K5/14C08K3/22C08K3/26C08K7/26C08K3/04C08K3/06C08K3/34A61M5/32
CPCC08L9/00C08L23/283A61M5/3202C08L2201/08C08L2205/03C08L2312/00C08K2003/2241C08K2003/265C08K2003/222C08K13/04C08K5/14C08K3/22C08K3/26C08K7/26C08K3/04C08K3/06C08L23/16C08L61/06C08K3/346
Inventor 刘梅玲李亚珂杨明真李志会陈帅立
Owner 郑州翱翔医药科技股份有限公司
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