Low-temperature medical delivery tube and preparation method thereof

Abstract

The invention belongs to the technical field of transmission pipe production, and particularly relates to a low-temperature medical transmission pipe and a preparation method thereof, and the preparation method comprises five steps of mixing, forming, activating, coating and drying. The low-temperature composite organic phase change energy storage material is used as a coating liquid to coat the surface of a crude product of the transmission tube, and the prepared transmission tube is relatively stable in thermal performance, non-toxic and capable of being used for low-temperature transmission of medicines. And the preparation scheme is low in cost, simple in preparation process and convenient to operate, overcomes material loss caused by thermocuring, is suitable for batch production, and has a great application prospect in low-temperature transmission of medicine preparation.

Description

Technical Field

[0001] The invention belongs to the technical field of transmission tube production, and specifically relates to a transmission tube for low-temperature medicine and a preparation method thereof. Background Art

[0002] Silicone tube is a network elastic body formed by curing and cross-linking raw rubber. Its chemical stability and thermal stability are stronger than those of ordinary organic polymer materials. It can withstand repeated high-pressure sterilization and dry heat sterilization, so it has a wide range of applications in the medical field. Because silicone tube has good tissue compatibility and blood compatibility, it has little stimulation to the human body during use and no foreign body sensation, so silicone tube has been widely used in various implant / interventional medical devices such as various pump catheters, in-vivo catheters and drainage tubes.

[0003] In addition to having good compatibility, silicone tubes also have stable physical and chemical properties. In the field of pharmaceutical production, if the transmission pipeline is not selected properly, it may cause the migration, adsorption and even chemical reactions of the drug liquid components, change the properties of the drug, affect the efficacy of the drug, and even cause serious side effects. In order to ensure the safety, effectiveness and uniformity of the drug, silicone tubes with stable physical and chemical properties must be selected as transmission pipelines during the production of drug liquid filtration, filling and other processes. In order to ensure that during the production, storage and transportation of drugs, especially when involving low-temperature environments, the transmission tube will not break, deform or affect the quality of the drug due to excessively low temperatures, the development of a silicone tube as a low-temperature medical transmission tube is on the agenda. Summary of the invention

[0004] In view of the problems existing in the background technology, the present invention provides a transmission tube for low-temperature medicine and a preparation method thereof. The prepared transmission tube is non-toxic and tasteless, soft, elastic, resistant to kinking, deformation, cracking, and has a long service life, which is achieved by the following technical solutions: The preparation of cryogenic medical transmission tubes includes the following steps: Step (1): weighing each raw material in portions and mixing them to obtain a blank; Step (2): placing the mixed material in a silicone extruder for extrusion molding to obtain a crude transmission tube; Step (3): activating the crude product in the transfer tube; Step (4): coating the raw transmission pipe product with the synthesized heat-curing transmission pipe coating liquid; Step (5): placing the coated transmission tube in an oven for heat curing to obtain a low-temperature medical transmission tube.

[0005] Preferably, the raw materials are as follows: 60-70 parts of methyl vinyl silicone rubber, 6-10 parts of epoxy resin, 10-15 parts of polyvinyl pyrrolidone, 3-7 parts of silane coupling agent, and 5-12 parts of polyethylene glycol.

[0006] Preferably, during the mixing in step (1), the speed of the high mixer is 30-50 r / min, and the mixing time is 1-2 hours.

[0007] Preferably, in step (2), the extrusion temperature of the extruder is 180° C. to 210° C., and the extrusion speed is 0.3 to 0.6 M / min.

[0008] Preferably, the activation step is: immersing the crude transmission tube prepared in step (2) in a 1 mol / L nitric acid solution for 6 hours for surface pretreatment, then taking it out and washing it twice with deionized water and once with anhydrous ethanol for standby use.

[0009] Preferably, the coating step is: placing the activated crude transmission tube in the coating liquid, then heating it to 90° C., stirring it continuously for 1 to 2 hours, and then taking it out.

[0010] Further preferably, the preparation step of the coating liquid is: stirring tetradecane and dodecanol at 25° C. at a rotation speed of 10,000 rpm for 4 minutes to form a tetradecane-dodecanol binary blend mixture with a particle size of nanometer level.

[0011] Preferably, the thermal curing in step (5) is as follows: the transmission tube obtained in step (4) is placed in an oven at 80-110° C. and dried for 4-8 hours to obtain a low-temperature medical transmission tube.

[0012] The present invention has the following beneficial effects: Through the above technical scheme, compared with the existing technology, the present invention provides a low-temperature medicine transmission tube and preparation method. The phase transition temperature of dodecanol and tetradecane is lower than the phase transition temperature of the binary eutectic mixture, the phase transition latent heat is large, the thermal performance is relatively stable, non-toxic, and can be used for low-temperature transmission of medicine. In addition, the preparation scheme has low cost, simple preparation process, convenient operation, overcomes the material loss caused by thermal curing, is suitable for batch production, and has great application prospects in low-temperature transmission of drug preparation. DETAILED DESCRIPTION

[0013] The following embodiments of the technical solution of the present invention are described in detail in conjunction with the embodiments. The following embodiments are only used to more clearly illustrate the technical solution of the present invention, and are therefore only used as examples, and cannot be used to limit the protection scope of the present invention.

[0014] It should be noted that the experimental methods used in the implementation examples are all conventional methods unless otherwise specified; the materials, reagents, etc. used, unless otherwise specified, can be obtained from commercial channels.

[0015] In the present invention, unless otherwise specified, all "parts" and percentages (%) refer to percentages by weight.

[0016] In the present invention, unless otherwise specified, the sum of all percentages in all compositions is 100%.

[0017] In the present invention, unless otherwise specified, the numerical range "a-b" represents an abbreviation of any real number combination between a-b, where a and b are real numbers. For example, the numerical range "0-5" means that all real numbers between "0-5" are listed in this document, and "0-5" is just an abbreviation of these numerical combinations.

[0018] In the present invention, unless otherwise specified, all embodiments and preferred embodiments mentioned herein can be combined with each other to form a new technical solution.

[0019] In the present invention, unless otherwise specified, all the steps mentioned herein may be performed sequentially or randomly, but are preferably performed sequentially; for example, the method includes steps (a) and (b), which means that the method may include steps (a) and (b) performed sequentially, or may include steps (b) and (a) performed sequentially; for example, the method may further include step (c), which means that step (c) may be added to the method in any order, for example, the method may include steps (a), (b) and (c), or may include steps (a), (c) and (b), or may include steps (c), (a) and (b), etc.

[0020] In the present invention, unless otherwise specified, the specific numerical values ​​and specific substances in the embodiments of the present invention may be combined with other features of the description part of the present invention; for example, if the specification mentions that the reaction temperature is 10~100°C, and the embodiment mentions that the reaction temperature is 20°C, then it can be considered that the present invention has specifically disclosed the range of 10~20°C, or the range of 20~100°C, and this range can be combined with other features of the description part to form a new technical solution. Embodiment 1;

[0021] (1) Weigh 65 parts of methyl vinyl silicone rubber, 7 parts of epoxy resin, 13 parts of polyvinyl pyrrolidone, 5 parts of silane coupling agent, and 10 parts of polyethylene glycol, and mix them in a high-speed mixer for 1 hour; (2) placing the mixed material in a silicone extruder and extruding it at an extrusion temperature of 180° C. and an extrusion speed of 0.3 M / min to obtain a crude transmission tube; (3) The crude transmission tube prepared in step (2) was immersed in a 1 mol / L nitric acid solution for 6 hours for surface pretreatment, and then taken out and washed twice with deionized water and once with anhydrous ethanol for standby use; (4) Stir tetradecane and dodecanol at 10,000 rpm at 25°C for 4 minutes to form a tetradecane-dodecanol binary blend with nanometer particle size, i.e., the coating liquid. Place the activated crude transfer tube in the coating liquid, then heat to 90°C, continue stirring for 2 hours, and take it out; (5) The transmission tube obtained in step (4) is placed in an oven at 110° C. and dried for 6 hours to obtain a low-temperature medical transmission tube. Embodiment 2;

[0022] (1) Weigh 60 parts of methyl vinyl silicone rubber, 10 parts of epoxy resin, 15 parts of polyvinyl pyrrolidone, 6 parts of silane coupling agent, and 9 parts of polyethylene glycol, and mix them in a high-speed mixer for 1 hour; (2) placing the mixed material in a silicone extruder, and extruding the mixed material at an extrusion temperature of 190° C. and an extrusion speed of 0.3 to 0.6 M / min to obtain a crude transmission tube; (3) The crude transmission tube prepared in step (2) was immersed in a 1 mol / L nitric acid solution for 6 hours for surface pretreatment, and then taken out and washed twice with deionized water and once with anhydrous ethanol for standby use; (4) Stir tetradecane and dodecanol at 10,000 rpm at 25°C for 4 minutes to form a tetradecane-dodecanol binary blend with nanometer particle size, i.e., the coating liquid. Place the activated crude transfer tube in the coating liquid, then heat to 90°C, continue stirring for 1 hour, and take it out; (5) The transmission tube obtained in step (4) is placed in an oven at 110° C. and dried for 4 hours to obtain a low-temperature medical transmission tube. Embodiment 3;

[0023] (1) Weigh 65 parts of methyl vinyl silicone rubber, 7 parts of epoxy resin, 13 parts of polyvinyl pyrrolidone, 5 parts of silane coupling agent, and 10 parts of polyethylene glycol, and mix them in a high-speed mixer for 1 hour; (2) placing the mixed material in a silicone extruder and extruding it at an extrusion temperature of 200° C. and an extrusion speed of 0.5 M / min to obtain a crude transmission tube; (3) The crude transmission tube prepared in step (2) was immersed in a 1 mol / L nitric acid solution for 6 hours for surface pretreatment, and then taken out and washed twice with deionized water and once with anhydrous ethanol for standby use; (4) Stir tetradecane and dodecanol at 10,000 rpm at 25°C for 4 minutes to form a tetradecane-dodecanol binary blend with nanometer particle size, i.e., the coating liquid. Place the activated crude transfer tube in the coating liquid, then heat to 90°C, continue stirring for 2 hours, and take it out; (5) The transmission tube obtained in step (4) is placed in an oven at 110° C. and dried for 8 hours to obtain a low-temperature medical transmission tube. Embodiment 4;

[0024] (1) Weigh 70 parts of methyl vinyl silicone rubber, 7 parts of epoxy resin, 10 parts of polyvinyl pyrrolidone, 4 parts of silane coupling agent, and 9 parts of polyethylene glycol, and mix them in a high-speed mixer for 1 hour; (2) placing the mixed material in a silicone extruder and extruding it at an extrusion temperature of 180° C. and an extrusion speed of 0.4 M / min to obtain a crude transmission tube; (3) The crude transmission tube prepared in step (2) was immersed in a 1 mol / L nitric acid solution for 6 hours for surface pretreatment, and then taken out and washed twice with deionized water and once with anhydrous ethanol for standby use; (4) Stir tetradecane and dodecanol at 10,000 rpm at 25°C for 4 minutes to form a tetradecane-dodecanol binary blend with nanometer particle size, i.e., the coating liquid. Place the activated crude transfer tube in the coating liquid, then heat to 90°C, continue stirring for 2 hours, and take it out; (5) The transmission tube obtained in step (4) is placed in an oven at 110° C. and dried for 5 hours to obtain a low-temperature medical transmission tube. Embodiment 5;

[0025] (1) Weigh 63 parts of methyl vinyl silicone rubber, 7 parts of epoxy resin, 12 parts of polyvinyl pyrrolidone, 5 parts of silane coupling agent, and 13 parts of polyethylene glycol, and mix them in a high-speed mixer for 1 hour; (2) placing the mixed material in a silicone extruder and extruding it at an extrusion temperature of 180° C. and an extrusion speed of 0.4 M / min to obtain a crude transmission tube; (3) The crude transmission tube prepared in step (2) was immersed in a 1 mol / L nitric acid solution for 6 hours for surface pretreatment, and then taken out and washed twice with deionized water and once with anhydrous ethanol for standby use; (4) Stir tetradecane and dodecanol at 10,000 rpm at 25°C for 4 minutes to form a tetradecane-dodecanol binary blend with nanometer particle size, i.e., the coating liquid. Place the activated crude transfer tube in the coating liquid, then heat to 90°C, continue stirring for 2 hours, and take it out; (5) The transmission tube obtained in step (4) is placed in an oven at 100° C. and dried for 5 hours to obtain a low-temperature medical transmission tube. Embodiment 6;

[0026] Performance Testing Leak rate test About 0.5 g of each sample was placed on filter paper at room temperature for 12 h, and part of the binary eutectic mixture of low-temperature composite organic phase change energy storage material may leak and penetrate the filter paper. The mass loss percentage is defined as the mass difference between the initial mass and the residual mass on the filter paper after 12 h.

[0027] Table 1

[0028] There is no obvious oil mark around the examples 1 to 5 after the static treatment, indicating that the tetradecane dodecanol binary eutectic mixture is well adhered. No leakage occurred during the static treatment, and the adsorption effect was good. It can be seen from Table 1 that the mass loss percentage before and after static treatment is less than 1%, which may be caused by operation and measurement errors.

[0029] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein by equivalents. These modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention, and they should all be included in the scope of the claims and specification of the present invention.

Claims

1. A method for preparing a low-temperature medical transmission tube, comprising the following steps: Step (1): weighing each raw material in portions and mixing them to obtain a blank; Step (2): placing the mixed material in a silicone extruder for extrusion molding to obtain a crude transmission tube; Step (3): activating the crude product in the transfer tube; Step (4): coating the raw transmission pipe product with the synthesized heat-curing transmission pipe coating liquid; Step (5): placing the coated transmission tube in an oven for heat curing to obtain a low-temperature medical transmission tube.

2. The method for preparing a cryogenic medical transmission tube according to claim 1, characterized in that: The raw material portions are: 60-70 portions of methyl vinyl silicone rubber, 6-10 portions of epoxy resin, 10-15 portions of polyvinyl pyrrolidone, 3-7 portions of silane coupling agent, and 5-12 portions of polyethylene glycol.

3. The method for preparing a cryogenic medical transmission tube according to claim 1, characterized in that: During the mixing in step (1), the speed of the high speed mixer is 30-50 r / min, and the mixing time is 1-2 hours.

4. The method for preparing a low-temperature medical transmission tube according to claim 1, characterized in that: In step (2), the extrusion temperature of the extruder is 180°C to 210°C, and the extrusion speed is 0.3 to 0.6 M / min.

5. The method for preparing a cryogenic medical transmission tube according to claim 1, characterized in that: The activation operation in step (3) is as follows: immerse the crude transmission tube prepared in step (2) in a 1 mol / L nitric acid solution for 6 hours for surface pretreatment, then take it out and wash it twice with deionized water and once with anhydrous ethanol for standby use.

6. The method for preparing a cryogenic medical transmission tube according to claim 1, characterized in that: The coating steps are as follows: placing the activated transmission tube crude product in the coating liquid, then heating it to 90° C., stirring it continuously for 1 to 2 hours, and then taking it out.

7. The method for preparing a cryogenic medical transmission tube according to claim 6, characterized in that: The coating liquid was prepared by stirring tetradecane and dodecanol at 10,000 rpm at 25° C. for 4 minutes to form a tetradecane-dodecanol binary blended mixture with nanometer particle size.

8. The method for preparing a cryogenic medical transmission tube according to claim 1, characterized in that: The step (5) of heat curing is as follows: placing the transmission tube obtained in the step (4) in an oven at 80-110° C. and drying for 4-8 hours to obtain a low-temperature medical transmission tube.

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