Macromolecular double-cavity pre-filled syringe and preparation method thereof

Abstract

According to the high-molecular double-cavity pre-filled syringe, before injection is prepared, pushing force is applied to the push rod and transmitted to the liquid medicine sealing plug through the push rod, the push rod pushes liquid medicine and the middle sealing plug to move forwards together, and when the end face of the rear end of the middle sealing plug is separated from the plane where the rear end of the liquid medicine channel is located, the liquid medicine channel is closed. Liquid medicine flows into the medicine powder loading chamber from the liquid medicine loading chamber through the liquid medicine channel. After liquid medicine enters the medicine powder loading chamber from the liquid medicine loading chamber, the injector is slightly beaten and shaken left and right, so that the medicine powder and the liquid medicine are fully mixed. After blending is completed, the liquid medicine sealing plug continues to be pushed and injected, the space of the medicine powder loading chamber is compressed, the powder sealing plug is moved to the sealing lock cap, at the moment, the liquid medicine flows out of the liquid discharging groove to the injection needle, and the injection process is completed. Quick mixing of medicine powder and liquid medicine is achieved, and the powder and liquid medicine dispensing mode is more efficient and safer. The invention further provides a preparation method of the high-molecular double-cavity pre-filled syringe. The preparation method comprises the steps of burdening, injection molding, silicification of the blending tube and assembly of a finished product.

Description

Technical Field

[0001] The invention belongs to the technical field of medical packaging, and in particular relates to a polymer double-chamber prefilled syringe and a preparation method thereof. Background Art

[0002] Traditional syringes have some limitations in use. For example, powder injection preparations need to be prepared in advance, and they are used with multiple accessories such as vials and disposable sterile syringes. The use process is complicated and cumbersome, and the secondary aspiration and puncture of sterile syringes are prone to contamination. The manual preparation process is not only time-consuming and laborious, but also has certain risks. It may cause drug waste or inaccurate dosage during the operation.

[0003] Meanwhile, syringes on the market are mostly made of glass and plastic materials, suitable for various medical occasions. According to regulations, syringes must meet certain quality standards, including colorless and transparent, low expansion coefficient, excellent heat resistance, low melting point and easy sealing, no bubbles, pits and sand particles, sufficient physical strength and high chemical stability. However, these standards are not completely applicable to all types of drugs, especially those sensitive preparations that have special requirements for syringe materials.

[0004] For example, patent CN202410211063.5 discloses an implantable prefilled syringe for solid preparations and a preparation method thereof. The syringe recorded therein can be used to prefill solid preparations, but not to prefill liquid preparations. Patent CN202011224737.3 discloses a preparation process for a polymer prefilled syringe. The syringe recorded therein can be used to prefill liquid preparations, but not to prefill powder preparations. Traditional prefilled syringes have the disadvantage that they can only be filled with liquid preparations or solid preparations, but not with powder preparations and liquid preparations at the same time. In addition, prefilled syringes made of glass are not tolerant to alkaline preparations, nor are they tolerant to protein powders and alkaline liquids.

[0005] Meanwhile, in the existing public technologies, such as patents CN114470421A and CN1750852A, a dual-chamber prefilled syringe is described, but the preparation method of the syringe and how to prepare the components are not described.

[0006] Therefore, the present invention discloses a double-chamber prefilled syringe for achieving powder-liquid blending, and a method for manufacturing the components of the double-chamber prefilled syringe. Summary of the invention

[0007] In order to solve the above technical problems, the present invention provides a polymer double-chamber prefilled syringe, comprising a blending tube, a sealing lock cap, an injection needle, a push rod, a powder sealing plug, a middle sealing plug and a liquid medicine sealing plug;

[0008] The front end of the blending tube is connected to the rear end of the sealing lock cap, and the rear end has an opening for inserting the push rod, the front end outer wall of the blending tube is provided with an annular protrusion, and the rear end inner wall of the sealing lock cap is provided with a plurality of annular sealing grooves for cooperating with the annular protrusion;

[0009] The powder sealing plug, the middle sealing plug and the liquid medicine sealing plug are respectively located at the front end, the middle part and the rear end of the blending tube, and are all freely slidable in the blending tube. The blending tube forms a powder loading chamber and a liquid medicine loading chamber between the powder sealing plug and the middle sealing plug, and between the middle sealing plug and the liquid medicine sealing plug;

[0010] The side wall of the blending tube protrudes outward to form a protrusion, the axial length of the protrusion is greater than the axial length of the middle sealing plug, and when the middle sealing plug is completely moved to the position of the blending tube where the protrusion is located, the drug liquid begins to flow, and the protrusion is a drug liquid channel to achieve communication between the drug powder loading chamber and the drug liquid loading chamber;

[0011] The injection needle is arranged at the front end of the sealing locking cap, and a drainage groove is arranged on the inner wall of the sealing locking cap. The axial length of the drainage groove is greater than the axial length of the powder sealing plug. When the powder sealing plug is completely moved to the position of the drainage groove of the sealing locking cap, the drainage groove can connect the powder loading chamber and the injection needle.

[0012] The present invention also provides a method for preparing a polymer double-chamber prefilled syringe, using the polymer double-chamber prefilled syringe in the above embodiment, the method comprising:

[0013] Ingredients: prepare the materials of each component of the polymer double-chamber prefilled syringe respectively, wherein the blending tube is made of cycloolefin polymer or cycloolefin copolymer, the sealing lock cap is made of homopolymer polypropylene, the injection needle is a disposable sterile injection needle, the push rod is made of homopolymer polypropylene, and the powder sealing plug, the middle sealing plug and the liquid sealing plug are all made of brominated butyl rubber;

[0014] Injection molding, respectively performing injection molding on the materials required for the blending tube, the sealing lock cap and the push rod in the polymer double-chamber prefilled syringe to obtain the blending tube, the sealing lock cap and the push rod;

[0015] Siliconizing the blended tube, using an automatic siliconizing machine to siliconize the inner wall of the blended tube;

[0016] Finished product assembly: the obtained blending tube, the sealing lock cap, the injection needle, the push rod, the powder sealing plug, the middle sealing plug and the liquid medicine sealing plug are assembled to obtain the polymer double-chamber prefilled syringe.

[0017] Optionally, in the above preparation method, the powder sealing plug, the middle sealing plug and the liquid medicine sealing plug adopt a surface coating process, the film layer is ethylene-tetrafluoroethylene copolymer, and the friction coefficient of the film layer is in the range of 0.20-0.30;

[0018] And / or, the powder sealing plug, the middle sealing plug and the liquid sealing plug are all made of brominated butyl rubber, and the mass fraction of water in the brominated butyl rubber is 0.05%-0.1%, and the mass fraction of ash is 40%-50%.

[0019] Optionally, in the above preparation method, during the siliconization of the blended tube, an automatic siliconizing machine is used to spray silicone oil on the inner wall of the blended tube, the viscosity range of the silicone oil is 900cst-1000cst, the mass fraction range of the silicone oil is 99.5-99.9%, the spray pressure range of the silicone oil is 0.4MPa-0.6MPa, and the spray time range of the silicone oil is 0.4s-0.6s.

[0020] Optionally, in the above preparation method, the blended tube is injection molded by using a cycloolefin polymer or a cycloolefin copolymer, and the cycloolefin polymer or the cycloolefin copolymer used in the blended tube has a shrinkage of ≤0.80%, a water absorption of <0.020%, a tensile modulus of >2700MPa, a heat deformation temperature of ≥125°C, and a transmittance of ≥90%;

[0021] And / or, the Rockwell hardness of the polypropylene used in the sealing lock cap is ≥90, the yield strength is >15MPa, the bending modulus is >700MPa, and the heat deformation temperature is ≥80°C;

[0022] And / or, the push rod is injection molded by polypropylene, and the polypropylene used in the push rod has a yield strength of ≥30MPa, a bending modulus of >1570MPa, and a heat deformation temperature under load of >100°C;

[0023] And / or, the flexural modulus of the sealing lock cap is lower than the flexural modulus of the blending tube.

[0024] Optionally, in the above preparation method, the steps of the blended tube injection molding method include drying treatment, injection molding and pressure holding and shaping in sequence;

[0025] The drying temperature in the drying process of the blending tube material is 90°C-100°C, and the drying time is 1.5h-2h;

[0026] The barrel temperature in the injection molding of the blended tube is 280°C-300°C, the fixed mold temperature is 170°C-180°C, the movable mold temperature is 55°C-65°C, and the injection pressure is 400bar-500bar; the pressure holding switching in the pressure holding molding of the blended tube is time switching, the injection to pressure holding switching time is 2s-4s, and the pressure holding pressure is 200bar-300bar.

[0027] Optionally, in the above preparation method, during the production process of the blended tube, demolding adopts a two-step parting method, and the gate adopts a double injection point design, the two-step parting method includes a fixed mold base plate and a movable mold base plate, the fixed mold base plate is provided with a heating device, and the movable mold base plate is provided with a cooling device.

[0028] Optionally, in the above preparation method, in the two-step parting, the first-step parting is the sleeve mold opening of the blending tube, the movable mold base plate drives the blending tube to be ejected from the fixed mold base plate, and the parting surface is located at the mid-vertical line of the sleeve; the second-step parting is the sleeve ejection, the blending tube is cored out, and the blending tube is ejected from the movable mold base plate, and the parting surface is located at the bottom of the sleeve flange of the blending tube.

[0029] Optionally, in the above preparation method, the double injection points are arranged on both side walls of the rear end of the blending tube, and the core is arranged at the rear end of the blending tube.

[0030] The invention provides a polymer double-chamber prefilled syringe and a preparation method thereof, and its beneficial effects are: providing a polymer double-chamber prefilled syringe and a preparation method thereof, which can achieve rapid mixing of drug powder and drug liquid, and obtain a more efficient and safe powder-liquid dispensing method.

[0031] The polymer double-chamber prefilled syringe can realize the steps of dispensing medicine powder and liquid medicine, specifically including the mixing and injection process: before preparing for injection, a driving force is applied to the push rod, and the driving force is transmitted to the liquid medicine sealing plug through the push rod. The push rod pushes the liquid medicine and the middle sealing plug to move forward together. When the rear end face of the middle sealing plug is separated from the plane where the rear end of the liquid medicine channel is located, the liquid medicine flows into the powder loading chamber from the liquid medicine loading chamber through the liquid medicine channel. After the liquid medicine enters the powder loading chamber from the liquid medicine loading chamber, gently tap and shake the syringe left and right to fully mix the powder and liquid medicine. After the blending is completed, continue to push the liquid medicine sealing plug to compress the space of the powder loading chamber, so that the powder sealing plug moves to the sealing lock cap. At this time, the liquid medicine can flow out from the drain groove to complete the injection process. The above arrangement can realize the rapid mixing of powder and liquid medicine, and obtain a more efficient and safe powder-liquid dispensing method. In order to realize the above-mentioned dispensing method, the present invention provides a method for preparing each component of the polymer double-chamber prefilled syringe, with the focus on the method for making the blending tube that directly contacts the liquid medicine. In order to achieve the corresponding role of the component in the assembly, the present invention also provides material selection requirements that can achieve the performance of the component and the performance that the selected material needs to achieve. Through these means, the operation of the polymer double-chamber prefilled syringe is realized. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the prior art descriptions are briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention, and for ordinary technicians in this field, other drawings can be obtained based on the provided drawings without creative work.

[0033] Figure 1 A schematic diagram of the structure of a polymer double-chamber prefilled syringe provided by an embodiment of the present invention;

[0034] Figure 2 A front view of a blending tube provided in an embodiment of the present invention;

[0035] Figure 3 A side view of a blending tube provided in an embodiment of the present invention;

[0036] Figure 4 A front view of a sealing lock cap provided in an embodiment of the present invention.

[0037] In the above picture:

[0038] 100-mixing tube; 110-medicine liquid channel; 120-powder loading chamber; 130-medicine liquid loading chamber; 140-handle;

[0039] 200-sealed lock cap;

[0040] 300-Injection needle;

[0041] 410-powder sealing plug; 420-auxiliary liquid blending plug; 430-liquid blending plug; 440-liquid sealing plug;

[0042] 500-Putter. DETAILED DESCRIPTION

[0043] Embodiments of the present invention are described in detail below, examples of which are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and cannot be understood as limiting the present invention.

[0044] The core of the present invention is to provide a polymer double-chamber prefilled syringe and a preparation method thereof, which can achieve rapid mixing of drug powder and drug liquid, and obtain a more efficient and safe powder-liquid dispensing method.

[0045] In order to enable those skilled in the art to better understand the technical solution provided by the present invention, the present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments.

[0046] Specifically, please refer to Figure 1-Figure 4 The present invention provides a polymer double-chamber prefilled syringe, which includes a blending tube 100, a sealing lock cap 200, an injection needle 300, a push rod 500, a powder sealing plug 410, a middle sealing plug and a liquid medicine sealing plug 440.

[0047] The front end of the blending tube 100 is connected to the rear end of the sealing lock cap 200, and the rear end has an opening for inserting the push rod 500, and the interior thereof has a storage space for containing medicine powder and medicine liquid. The rear end of the blending tube 100 is turned outward to form a handle 140. The inner wall of the blending tube 100 is siliconized, so that the syringe can obtain better sliding performance. At the same time, the siliconization parameters adopted in the above embodiment can reduce the powder absorption of the wall of the blending tube 100 while obtaining better sliding performance. Specifically, the front end outer wall of the blending tube 100 is provided with an annular protrusion, and the rear end inner wall of the sealing lock cap 200 is provided with a plurality of annular sealing grooves for cooperating with the annular protrusion of the blending tube 100. The cross-section of the annular protrusion is semicircular. The annular sealing groove can be provided with multiple channels along the axial direction. Installation in different positions can be achieved. Such as Figure 2 As shown, the rear end inner wall of the sealing lock cap 200 adopts a triple annular sealing groove structure, which is interference fit with the annular protrusion of the blending tube 100. This can not only ensure the sealing after assembly and effectively prevent the entry of impurities such as particles, but also ensure that the sealing lock cap 200 will not rotate.

[0048] The powder sealing plug 410, the middle sealing plug and the liquid medicine sealing plug 440 are respectively located at the front end, the middle part and the rear end of the blending tube 100, and are all free to slide in the blending tube 100. The blending tube 100 forms a powder loading chamber 120 and a liquid medicine loading chamber 130 between the powder sealing plug 410 and the middle sealing plug, and between the middle sealing plug and the liquid medicine sealing plug 440. The blending tube 100 plays the role of loading powder, liquid medicine and blending powder and liquid medicine, and is divided into a liquid medicine loading chamber 130, a powder loading chamber 120 and a liquid medicine channel 110. The liquid medicine channel 110 is arranged in the middle of the blending tube 100, and allows the liquid medicine to flow from the liquid medicine loading chamber 130 through the liquid medicine channel 110 into the powder loading chamber 120 to obtain a blended liquid medicine. A handle 140 is provided at the rear end of the blending tube 100 , and a push rod 500 is inserted into the rear end of the blending tube 100 . By pressing the push rod 500 and the handle 140 , injection can be achieved.

[0049] The powder sealing plug 410, the middle sealing plug and the liquid medicine sealing plug 440 are used together in the blending tube 100, and can be fluid-tightly attached to the inner wall of the blending tube 100 and slidably connected. The powder sealing plug 410 and the liquid medicine sealing plug 440 are respectively at the front end and the rear end of the blending tube 100 to play a sealing role. The middle sealing plug plays a role in separating and long-term sealing of liquid medicine and powder medicine before the medicines are blended.

[0050] The side wall of the blending tube 100 bulges outward to form a bulge, and the axial length of the bulge is greater than the axial length of the middle sealing plug. When the middle sealing plug is completely moved to the position of the bulge in the blending tube 100, the medicine begins to flow. The bulge is the medicine liquid channel 110 to achieve the connection between the medicine powder loading chamber 120 and the medicine liquid loading chamber 130.

[0051] The injection needle 300 is a disposable sterile injection needle. The inner wall of the sealing lock cap 200 is provided with a drainage groove. The axial length of the drainage groove is greater than the axial length of the powder sealing plug 410. When the powder sealing plug 410 is completely moved to the position of the drainage groove of the sealing lock cap 200, the drainage groove can connect the powder loading chamber 120 and the injection needle 300. Among them, the injection needle 300 plays an injection role, and the sealing lock cap 200 plays a sealing role and a connecting role, and the injection is completed together. The sealing lock cap 200 adopts the design of the Luer lock, and the injection needle 300 is tightly connected. Through the interference fit between the sealing lock cap 200 and the blending tube 100, the two can produce a small elastic deformation when in contact, and can be in close contact without causing stress cracking. Thereby ensuring that the blended liquid does not leak from the sealing lock cap 200. The drainage grooves arranged around the sealing lock cap 200, the blended liquid can be discharged from the drainage groove, and partially injected into the patient's body through the injection needle 300.

[0052] The present invention provides a polymer double-chamber prefilled syringe, and the mixing and injection process of drug powder and drug liquid specifically includes: before preparing for injection, applying a driving force to the push rod 500, and the driving force is transmitted to the drug liquid sealing plug 440 through the push rod 500, and the push rod 500 pushes the drug liquid and the middle sealing plug to move forward together, and when the rear end surface of the middle sealing plug is separated from the plane where the rear end of the drug liquid channel 110 is located, the drug liquid flows into the drug powder loading chamber 120 from the drug liquid loading chamber 130 through the drug liquid channel 110. After the drug liquid enters the drug powder loading chamber 120 from the drug liquid loading chamber 130, the syringe is gently tapped and shaken left and right to fully mix the drug powder and the drug liquid. After the blending is completed, the drug liquid sealing plug 440 is continued to be pushed, the space of the drug powder loading chamber 120 is compressed, and the powder sealing plug 410 is moved to the sealing lock cap 200, and the drug liquid can flow out from the drainage groove at this time, and the injection process is completed. The above arrangement can achieve rapid mixing of medicine powder and medicine liquid, and obtain a more efficient and safe powder-liquid dispensing method.

[0053] In addition, the present invention also provides a method for preparing a polymer double-chamber prefilled syringe, using the polymer double-chamber prefilled syringe in the above specific embodiment, the method comprising:

[0054] Ingredients: prepare the materials of each component in the polymer double-chamber prefilled syringe separately, wherein the blending tube 100 is made of cycloolefin polymer or cycloolefin copolymer, the sealing lock cap 200 is made of homopolymer polypropylene, the injection needle 300 is a disposable sterile injection needle, the push rod 500 is made of homopolymer polypropylene, and the powder sealing plug 410, the middle sealing plug and the liquid sealing plug 440 are made of brominated butyl rubber.

[0055] Injection molding: the materials required for the blending tube 100, the sealing lock cap 200 and the push rod 500 in the polymer double-chamber prefilled syringe are respectively injection molded to obtain the blending tube 100, the sealing lock cap 200 and the push rod 500.

[0056] The blending tube is siliconized by using an automatic siliconizing machine to siliconize the inner wall of the blending tube 100 to ensure the sliding of the powder sealing plug 410, the middle sealing plug and the liquid medicine sealing plug 440.

[0057] Finished product assembly: the obtained blending tube 100, sealing lock cap 200, injection needle 300, push rod 500, powder sealing plug 410, middle sealing plug and liquid sealing plug 440 are assembled to obtain a polymer double-chamber prefilled syringe.

[0058] Obviously, the polymer double-chamber prefilled syringe product prepared by the above-mentioned preparation method has stability when in contact with drug powder and drug liquid, ensuring biosafety and drug compatibility, and can achieve rapid mixing of drug powder and drug liquid, making the powder-liquid dispensing process more efficient and safe.

[0059] This solution does not require major changes to the shape and structure of the existing syringe. It only requires selecting a suitable material, improving the preparation method, and selecting a suitable range of process parameters to obtain a product with high molding processing precision.

[0060] In a specific embodiment, the blending tube 100 is injection molded by cycloolefin polymer or cycloolefin copolymer, and has excellent low temperature resistance. The blending tube 100 is open at both ends, and the upper end can be filled, freeze-dried and plugged, and the lower end can be filled with injection liquid, replacing glass, and can withstand sodium bicarbonate injection drugs.

[0061] The sealing lock cap 200 is injection molded from polypropylene homopolymer.

[0062] The powder sealing plug 410, the middle sealing plug and the liquid medicine sealing plug 440 can be made of brominated butyl rubber. The powder sealing plug 410, the middle sealing plug and the liquid medicine sealing plug 440 are coated with a film layer of a fluoropolymer, and the film layer is preferably ethylene-tetrafluoroethylene copolymer or polytetrafluoroethylene. The piston coating technology can effectively ensure the lubricity of the sealing plug, reduce the use of silicone oil, and thus reduce the retention of insoluble particles in the patient's body. The surface film layer can block the contact between the powder and the liquid medicine and the piston, prevent the powder from sticking, and reduce the starting force. The friction coefficient of the film layer ranges from 0.20 to 0.30 (including two endpoint values, i.e., 0.20 and 0.30).

[0063] The push rod 500 is injection molded from polypropylene.

[0064] In a specific embodiment, the powder sealing plug 410, the middle sealing plug and the liquid medicine sealing plug 440 are all brominated butyl rubber pistons. The mass fraction of water in the brominated butyl rubber is 0.05%-0.1% (including two endpoint values, i.e., 0.05% and 0.1%), and the mass fraction of ash in the brominated butyl rubber is 40%-50% (including two endpoint values, i.e., 40% and 50%). The middle sealing plug includes an auxiliary liquid medicine blending plug 420 and a liquid medicine blending plug 430.

[0065] It should be noted that all parts involving numerical ranges in the claims and the specification of this scheme include the two end values ​​of the numerical range and will not be repeated one by one later.

[0066] For the injection molding method, specifically, the injection molding steps of the blending tube 100 include drying treatment, injection molding and pressure holding and shaping in sequence. Before starting the injection molding process, the mold and injection molding machine of the injection molding process can be preheated in advance. In the drying treatment of the blending tube 100 material, the drying temperature is 90°C-100°C, and the drying time is 1.5h-2h. In the injection molding step of the blending tube 100, the injection starting position is 70mm-80mm, the barrel temperature is 280°C-300°C, the fixed mold temperature is 170°C-180°C, the movable mold temperature is 55°C-65°C, and the injection pressure is 400bar-500bar. In the pressure holding and shaping step of the blending tube 100, the pressure holding switch is a time switch, the injection to pressure holding switch time is 2s-4s, and the pressure holding pressure is 200bar-300bar. Appropriate holding time and holding pressure can effectively reduce the crystallization of the melt during cooling, thereby reducing the overall crystallinity, making the product have isotropic optical properties as a whole, and thus obtaining a more transparent appearance. The injection molding process can be used with a fully electric injection molding machine, with a mold opening stroke of 400mm-600mm, a clamping force greater than 1000kN, a maximum injection speed of 350mm / s, and a screw diameter of 32mm.

[0067] The specific finished product assembly process includes the assembly of the powder sealing plug 410, the liquid medicine blending plug 430, the auxiliary liquid medicine blending plug 420, the liquid medicine sealing plug 440 and the blending tube 100, and the assembly of the semi-finished product and the cone head.

[0068] (1) The assembly process of the powder sealing plug 410, the liquid medicine blending plug 430, the auxiliary liquid medicine blending plug 420, the liquid medicine sealing plug 440 and the blending tube 100 is as follows: first, the liquid medicine blending plug 430 and the auxiliary liquid medicine blending plug 420 are placed in the lower end of the bypass passage of the blending tube 100, and freeze-dried or directly filled powder can be selected according to needs. Then, the powder sealing plug 410 is inserted into the front end opening of the blending tube 100, the syringe is turned over, and vacuum is drawn. Under the vacuum state, the liquid medicine sealing plug 440 is inserted to obtain an assembled semi-finished product.

[0069] (2) The assembly process of the semi-finished product and the cone head is as follows: the top seal of the semi-finished product and the sealing lock cap 200 are sealed by mechanical flat pressing using a snap mechanism, and then the injection needle 300 and the push rod 500 are screwed on to obtain a polymer double-chamber prefilled syringe.

[0070] In a specific embodiment, the powder sealing plug 410, the middle sealing plug and the liquid sealing plug 440 are coated with a fluorine-containing polymer, and the friction coefficient of the fluorine-containing polymer film layer is in the range of 0.20-0.30.

[0071] The powder sealing plug 410, the middle sealing plug and the liquid sealing plug 440 are all made of brominated butyl rubber, the moisture content of the brominated butyl rubber is in the range of 0.05%-0.1%, and the ash content of the brominated butyl rubber is in the range of 40%-50%.

[0072] The specific process parameters of the siliconization of the blended tube are: using an automatic siliconization machine to spray silicone oil on the inner wall of the blended tube 100, the viscosity of the silicone oil ranges from 900cst to 1000cst, the mass fraction of the silicone oil ranges from 99.5 to 99.9%, the injection pressure of the silicone oil ranges from 0.4MPa to 0.6MPa, and the injection time of the silicone oil ranges from 0.4s to 0.6s. The silicon spraying speed is 60mm / s to 100mm / s.

[0073] The blended tube 100 is injection molded with cycloolefin polymer or cycloolefin copolymer and has excellent low temperature resistance. Among them, the index parameters are shrinkage rate ≤ 0.80%, water absorption rate < 0.020%, tensile modulus > 2700MPa, heat deformation temperature ≥ 125°C, and transmittance ≥ 90%. Specifically, the blended tube 100 material is dried before the injection molding process, the drying temperature is 90°C-100°C, and the drying time is 1.5h-2h. By drying the raw materials, the bubbles and shrinkage caused by water evaporation in the raw materials during the injection molding process are reduced to control the product appearance of the blended tube 100.

[0074] During the production of the blending tube 100, demoulding adopts a two-step parting, and the gate adopts a double injection point design. The two-step parting is achieved through the cooperation of the fixed mold base plate and the movable mold base plate. A heating device is provided at the fixed mold base plate to prevent the melt from cooling in the flow channel and causing normal injection. At the same time, a blending tube core is provided on the fixed mold base plate, which can be removed from the movable mold when the mold is opened; a cooling device is provided on the movable mold base plate to quickly shape the melt after it contacts the template and control product shrinkage. The injection molding process parameters of the blending tube 100 are detailed in Table 1.

[0075] Table 1 Blended tube injection molding process parameters

[0076]

[0077] Furthermore, the semi-hot runner mold used in the blending tube 100 is demolded by a two-step parting method. In the two-step parting step, the first step is to open the sleeve mold of the blending tube 100, and the movable mold base plate drives the blending tube 100 to be ejected from the fixed mold base plate, and the parting surface is located at the mid-vertical line of the sleeve. The second step is to eject the sleeve, and the blending tube 100 is cored out of the tube, so that the blending tube 100 is ejected from the movable mold base plate, and the parting surface is located at the bottom of the sleeve flange (i.e., the handle 140) of the blending tube 100. The demolding direction is from the rear end of the blending tube 100 to the front end. Double injection point injection molding, the injection points are set on the two side walls of the rear end of the blending tube 100 (at the two flanges formed by the handle 140), the core is set at the rear end of the blending tube 100, and the demolding pressure is 35MPa-45MPa.

[0078] Double injection points are arranged on the two side walls of the rear end of the blending tube 100, and the core is arranged at the rear end of the blending tube 100. The double injection points are arranged so that the melt can be filled into the mold more quickly, and the product production process can be more easily controlled. By adopting the above-mentioned injection molding process, the handle 140 on the blending tube 100 can be formed into an integrated structure with the body of the blending tube 100. In addition, reinforcing ribs can be designed at the connection between the handle 140 and the rear end of the blending tube 100, and cracking can be effectively prevented by thickening. At the same time, the wide edge design is adopted, which is more suitable for mechanized filling.

[0079] The sealing lock cap 200 is injection molded by polypropylene homopolymer, wherein the index parameters are Rockwell hardness ≥ 90, yield strength > 15MPa, bending modulus > 700MPa, and heat deformation temperature ≥ 80°C. Specifically, the sealing lock cap 200 is integrally injection molded by a semi-hot runner mold, and the semi-hot runner mold includes a movable mold and a fixed mold. The movable mold is used for heating and can be heated by an external heating device. The fixed mold is used for cooling and can be set in cooling water. The injection port of the sealing lock cap 200 is set at the bottom of the movable mold. The injection molding process parameters of the sealing lock cap 200 are detailed in Table 2.

[0080] Table 2 Sealing lock cap injection molding process parameters

[0081]

[0082] The injection molding process of the blending tube 100 and the sealing lock cap 200 both adopts a multi-cavity hot runner mold, which has the advantage of saving energy and raw materials, reducing product deformation, and improving product precision. At the same time, it is assisted by the injection molding optimization process, relying on the relevant parameters of the material, optimizing the influence of parameters such as temperature and pressure on the specific volume of the raw material, conducting mold flow analysis, analyzing the changes in pressure, density, and temperature during the injection molding process, analyzing the causes of defect curves during the processing process, and further optimizing the optimal process parameters to produce products with high molding processing precision.

[0083] In order to improve the sealing performance of the product, the bending modulus of the sealing lock cap 200 is lower than that of the blending tube 100. After being compressed, the deformation can be stored, and contact pressure is generated at the same time, and the leakage channel is blocked, so as to effectively achieve sealing and block the invasion of dust and bacteria.

[0084] The powder sealing plug 410, the middle sealing plug and the liquid medicine sealing plug 440 are coated with a fluorine-containing polymer film layer. The powder sealing plug 410, the middle sealing plug and the liquid medicine sealing plug 440 are all brominated butyl rubber pistons. The index parameters of the brominated butyl rubber piston are moisture content <0.3% and ash content <50%. Preferably, the mass fraction of moisture is 0.05%-0.1%, and the mass fraction of ash is 40%-50%.

[0085] The push rod 500 is made of polypropylene injection molding, and its index parameters are yield strength ≥ 30MPa, bending modulus > 1570MPa, and heat deformation temperature under load > 100°C. The injection molding process parameters of the push rod 500 are shown in Table 3.

[0086] Table 3 Push rod injection molding process parameters

[0087]

[0088] The injection molding process using the above parameters has the characteristics of rapid injection molding and high production efficiency. Each component is made of the above materials, which has higher chemical compatibility and can be applied to more drugs.

[0089] In the description of the embodiments of the present application, unless otherwise specified, " / " means or, for example, A / B can mean A or B; "and / or" in this article is only a description of the association relationship of associated objects, indicating that there can be three relationships, for example, A and / or B can mean: A exists alone, A and B exist at the same time, and B exists alone. In addition, in the description of the embodiments of the present application, "multiple" means two or more than two.

[0090] The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other.

[0091] The principles and implementation methods of the present invention are described in this article using specific examples. The description of the above embodiments is only used to help understand the method and core ideas of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made to the present invention without departing from the principles of the present invention, and these improvements and modifications also fall within the scope of protection of the claims of the present invention.

Claims

1. A polymer double-chamber prefilled syringe, characterized in that: It comprises a blending tube (100), a sealing lock cap (200), an injection needle (300), a push rod (500), a powder sealing plug (410), a middle sealing plug and a liquid medicine sealing plug (440); The front end of the blending tube (100) is connected to the rear end of the sealing lock cap (200), and the rear end has an opening for inserting the push rod (500); the front end outer wall of the blending tube (100) is provided with an annular protrusion, and the rear end inner wall of the sealing lock cap (200) is provided with a plurality of annular sealing grooves for cooperating with the annular protrusion; The powder sealing plug (410), the middle sealing plug and the liquid medicine sealing plug (440) are respectively located at the front end, the middle part and the rear end of the blending tube (100), and are all able to slide freely in the blending tube (100); the blending tube (100) forms a powder loading chamber (120) and a liquid medicine loading chamber (130) between the powder sealing plug (410) and the middle sealing plug, and between the middle sealing plug and the liquid medicine sealing plug (440); The side wall of the blending tube (100) protrudes outward to form a protrusion, the axial length of the protrusion is greater than the axial length of the middle sealing plug, and when the middle sealing plug is completely moved to the position of the blending tube (100) where the protrusion is located, the drug liquid begins to flow, and the protrusion is a drug liquid channel (110) to achieve communication between the drug powder loading chamber (120) and the drug liquid loading chamber (130); The injection needle (300) is arranged at the front end of the sealing lock cap (200), and a drainage groove is arranged on the inner wall of the sealing lock cap (200). The axial length of the drainage groove is greater than the axial length of the powder sealing plug (410). When the powder sealing plug (410) moves to the position of the drainage groove of the sealing lock cap (200), the drainage groove can connect the powder loading chamber (120) and the injection needle (300).

2. A method for preparing a polymer double-chamber prefilled syringe, characterized in that: Using the polymer double-chamber prefilled syringe according to claim 1, the method comprises: Ingredients are prepared respectively for the materials of the components of the polymer double-chamber prefilled syringe, wherein the blending tube (100) is made of cycloolefin polymer or cycloolefin copolymer, the sealing lock cap (200) is made of homopolymer polypropylene, the injection needle (300) is a disposable sterile injection needle, the push rod (500) is made of homopolymer polypropylene, and the powder sealing plug (410), the middle sealing plug and the liquid sealing plug (440) are all made of brominated butyl rubber; Injection molding, respectively performing injection molding on the materials required for the blending tube (100), the sealing lock cap (200), and the push rod (500) in the polymer double-chamber prefilled syringe to obtain the blending tube (100), the sealing lock cap (200), and the push rod (500); Siliconizing the blending tube, using an automatic siliconizing machine to siliconize the inner wall of the blending tube (100); Finished product assembly: the obtained blending tube (100), the sealing lock cap (200), the injection needle (300), the push rod (500), the powder sealing plug (410), the middle sealing plug and the liquid medicine sealing plug (440) are assembled to obtain the polymer double-chamber prefilled syringe.

3. The preparation method according to claim 2, characterized in that: The powder sealing plug (410), the middle sealing plug and the liquid medicine sealing plug (440) are coated on the surface, the film layer is ethylene-tetrafluoroethylene copolymer, and the friction coefficient of the film layer is in the range of 0.20-0.30; And / or, the powder sealing plug (410), the middle sealing plug, and the liquid medicine sealing plug (440) are all made of brominated butyl rubber, and the mass fraction of water in the brominated butyl rubber is 0.05%-0.1%, and the mass fraction of ash is 40%-50%.

4. The preparation method according to claim 2, characterized in that: During the siliconization of the blended tube, an automatic siliconizing machine is used to spray silicone oil onto the inner wall of the blended tube (100), wherein the viscosity of the silicone oil is in the range of 900 cst-1000 cst, the mass fraction of the silicone oil is in the range of 99.5-99.9%, the spraying pressure of the silicone oil is in the range of 0.4 MPa-0.6 MPa, and the spraying time of the silicone oil is in the range of 0.4 s-0.6 s.

5. The preparation method according to claim 2, characterized in that: The blended tube (100) is injection molded using a cycloolefin polymer or a cycloolefin copolymer, and the cycloolefin polymer or the cycloolefin copolymer used in the blended tube (100) has a shrinkage of ≤0.80%, a water absorption of <0.020%, a tensile modulus of >2700 MPa, a heat deformation temperature of ≥125°C, and a transmittance of ≥90%; And / or, the polypropylene used in the sealing lock cap (200) has a Rockwell hardness of ≥90, a yield strength of >15 MPa, a bending modulus of >700 MPa, and a heat deformation temperature of ≥80°C; And / or, the push rod (500) is injection molded with polypropylene, and the polypropylene used in the push rod (500) has a yield strength of ≥30 MPa, a bending modulus of >1570 MPa, and a heat deformation temperature under load of >100°C; And / or, the bending modulus of the sealing lock cap (200) is lower than the bending modulus of the blending tube (100).

6. The preparation method according to claim 2, characterized in that: The injection molding method of the blended tube (100) comprises the following steps in sequence: drying treatment, injection molding and pressure-maintaining shaping; The drying temperature in the drying process of the material in the blending tube (100) is 90°C-100°C, and the drying time is 1.5h-2h; The barrel temperature of the blending tube (100) during injection molding is 280°C-300°C, the fixed mold temperature is 170°C-180°C, the movable mold temperature is 55°C-65°C, and the injection pressure is 400bar-500bar; the pressure holding switching during pressure holding molding of the blending tube (100) is time switching, the injection-to-pressure holding switching time is 2s-4s, and the pressure holding pressure is 200bar-300bar.

7. The preparation method according to claim 2, characterized in that: During the production process of the blending tube (100), demoulding adopts a double-step parting method, and the gate adopts a double-injection glue point design. The double-step parting method includes a fixed mold base plate and a movable mold base plate. The fixed mold base plate is provided with a heating device, and the movable mold base plate is provided with a cooling device.

8. The preparation method according to claim 7, characterized in that: In the two-step parting, the first step of parting is to open the sleeve mold of the blending tube (100), the movable mold base plate drives the blending tube (100) to be ejected from the fixed mold base plate, and the parting surface is located at the mid-vertical line of the sleeve; the second step of parting is to eject the sleeve, the blending tube (100) is cored out of the tube, so that the blending tube (100) is ejected from the movable mold base plate, and the parting surface is located at the bottom of the sleeve flange of the blending tube (100).

9. The preparation method according to claim 7, characterized in that: The double glue injection points are arranged on both side walls of the rear end of the blending tube (100), and the core is arranged at the rear end of the blending tube (100).

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