Combined cover for infusion container and preparation method of combined cover

Abstract

The invention relates to the technical field of sealing covers, and particularly discloses a combined cover for an infusion container, which comprises an outer cover and an inner cover, the outer cover comprises polypropylene A, polypropylene B, polyethylene A, an elastomer B, a degradable material and an antibacterial material; the inner cover comprises polypropylene A, polypropylene B, polyethylene A, polyethylene B, an elastomer A, an elastomer B and an antibacterial material. According to the combined cover for the infusion container and the preparation method of the combined cover, the formula is excellent in stability, good in fluidity and easy to process; the injection molding product is high in safety, good in temperature adaptability and good in feedback after being applied to production of the vertical infusion bag, and the problems of insoluble particles, high puncture falling scraps, microorganism control and medical waste treatment of the product are obviously improved.

Description

Technical Field

[0001] The present invention relates to the technical field of sealing covers, and in particular to a combined cover for an infusion container and a preparation method thereof. Background Art

[0002] At present, polypropylene and polyethylene are widely used in the pharmaceutical packaging industry due to their high safety, stable properties, and easy molding and processing, becoming one of the fastest growing, fastest developing, and most active varieties of synthetic resins. In the field of infusion packaging materials, most packaging materials need to undergo stability tests and clinical applications under various harsh conditions, among which the combination cap for infusion containers is a typical example; however, the products in the existing market generally have high insoluble particles, a lot of puncture debris, and microbial contamination, which seriously affect product quality and user experience; at the same time, the post-processing of medical waste is also a difficult problem that needs to be solved urgently. Summary of the invention

[0003] The purpose of the present invention is to provide a combined cover for an infusion container and a preparation method thereof, which has excellent formula stability, good fluidity and is easy to process; the injection molded product has high safety and good temperature adaptability, and has good feedback after being applied to the production of upright infusion bags, and significantly improves the problems of insoluble particles, high puncture debris, microbial control and medical waste treatment of the product.

[0004] The present invention is achieved through the following technical scheme: the combined cover for the infusion container of the present invention comprises an outer cover and an inner cover; the components of the outer cover include polypropylene A, polypropylene B, polyethylene A, elastomer B, degradable materials, and antibacterial materials; the components of the inner cover include polypropylene A, polypropylene B, polyethylene A, polyethylene B, elastomer A, elastomer B, and antibacterial materials.

[0005] Furthermore, the polypropylene A is a binary copolymer polypropylene, the polypropylene B is a ternary copolymer polypropylene, the polyethylene A is a linear low-density polyethylene (LLDPE), and the polyethylene B is an ultra-low-density polyethylene (ULDPE). (2) The inner cover is in direct contact with the drug, so it has higher requirements for safety and functionality. ULDPE itself has excellent biocompatibility and is safe and reliable; adding ULDPE can increase the compatibility of POE, SEBS and PP systems, and PP has good compatibility with POP and PB. Such matching addition can increase the stability and toughness of the inner cover formula. The inner cover formula is safe and stable, with a low processing temperature, which can effectively reduce the precipitation of small molecules during the processing process, thereby reducing the probability of the inner cover producing insoluble particles; this formula has a high content of elastomers and plasticizers, good toughness, and excellent low-temperature performance, which enlarges the temperature range of the combined cover during clinical use and reduces the chip shedding rate during the puncture process (by about 50%).

[0006] Furthermore, the elastomer A is a polyolefin-based thermoplastic elastomer, and the elastomer B is a styrene-based thermoplastic elastomer.

[0007] Furthermore, the olefin-based thermoplastic elastomer is one or more of polyethylene-octene copolymer elastomer (POE), polypropylene-octene copolymer plastomer (POP), and polybutylene elastomer (PB); and the styrene-based thermoplastic elastomer is a hydrogenated styrene-butadiene-styrene triblock copolymer elastomer (SEBS).

[0008] Furthermore, the degradable material is one or both of polylactic acid (PLA) and polypropylene succinate (PBAT). The outer cover has the highest mass proportion in the combined cover, so adding the degradable component PBAT improves the degradation efficiency, effectively reduces the difficulty of post-treatment of medical waste, and increases environmental protection. The natural antibacterial material chitosan is added to both the inner and outer covers, which can reduce the probability of introducing Staphylococcus aureus and Escherichia coli, especially in the rubber plug combination link, providing a layer of antibacterial protection for subsequent pharmaceutical factories to use the combined cover, ensuring a higher degree of sterility in drug production.

[0009] Furthermore, the antibacterial material is one or both of lignans and chitosan.

[0010] Furthermore, in terms of weight percentage, the outer cover contains 20-90 parts of polypropylene A, 10-50 parts of polypropylene B, 0-10 parts of polyethylene A, 5-30 parts of elastomer B, 5-15 parts of degradable material, and 1-3 parts of antibacterial material; the inner cover contains 10-90 parts of polypropylene A, 10-50 parts of polypropylene B, 0-10 parts of polyethylene A, 0-10 parts of polyethylene B, 5-20 parts of elastomer A, 5-30 parts of elastomer B, and 0.5-3 parts of antibacterial material.

[0011] The present invention also provides a method for preparing the combined cover for the infusion container, comprising the following steps:

[0012] (1) mixing polyethylene A, elastomer B, biodegradable material, and antibacterial material in the outer cover component and feeding the mixture into an extruder to extrude the mixture to obtain an outer cover masterbatch;

[0013] The polyethylene A, polyethylene B, elastomer A, elastomer B and antibacterial material in the inner cover component are mixed and fed into an extruder to obtain an inner cover masterbatch after extrusion;

[0014] (2) Polypropylene A, polypropylene B, and outer cover masterbatch are mixed and fed into an injection molding machine, and after feeding, melting, filling, holding pressure, cooling, and demolding, a finished outer cover is obtained;

[0015] Polypropylene A, polypropylene B and inner cover masterbatch are mixed and fed into an injection molding machine, and after feeding, melting, filling, holding pressure, cooling and demoulding, the inner cover finished product is obtained;

[0016] Through process optimization, the number of polypropylene heating times is reduced: polypropylene is used as the main material of the combined cap, and the production process needs to go through two high-temperature heating processes of extrusion and injection, which is easy to cause aging decomposition and small molecule precipitation; the common method in the industry is to add antioxidants, but the molecular weight of antioxidants is small and it is also easy to cause precipitation and reaction. Therefore, the present invention reduces the number of polypropylene heating times by half, no longer avoids adding antioxidants, reduces the probability of polypropylene decomposition and small molecule precipitation, and thus achieves the effect of controlling insoluble particles.

[0017] (3) The finished outer cover, the finished inner cover, and the rubber plug are squeezed and connected by external force to obtain a combined cover for an infusion container.

[0018] Furthermore, in step (1), the mixing rate is preferably 500-1000 r / min, the mixing time is 10 min, the melting temperature of the extruder is 130-160° C., and the pelletizing water cooling temperature is preferably 30-60° C.; in step (2), the mixing rate is preferably 300-500 r / min, the mixing time is 10 min, and the injection molding temperature of the injection molding machine is 170-210° C.

[0019] The technical solution of the present invention has at least the following advantages and beneficial effects: the combined cover for infusion container of the present invention and the preparation method thereof, the combined cover has better safety, stability and clinical applicability, including (1) high safety of raw materials and better compatibility with drugs; (2) good formula stability, more environmentally friendly processing, reducing the number of heating times of polypropylene, reducing small molecule precipitation and aging, thereby minimizing insoluble particles; (3) the product has strong clinical adaptability, the inner cover has a more reasonable mechanical property range, especially in the low temperature section, can be effectively used under the condition of -10℃-40℃, and the proportion of puncture debris is reduced by about 50%; (4) the product has its own antibacterial property, better protection for drugs, and stronger stability; (5) the outer cover has a self-decomposition function, which is convenient for post-processing of medical waste. At the same time, the raw material fluidity of the product is reasonable, the processing temperature is low, it has good injection molding performance, and the production conditions are both environmentally friendly and efficient. The present invention also provides a production method of the above-mentioned combined cover. DETAILED DESCRIPTION

[0020] Example

[0021] In the embodiments, the model of polypropylene A is RP260, produced by Lanzhou Petrochemical Co., Ltd.; the model of polypropylene B is F5606, produced by Yanshan Petrochemical Co., Ltd.; the model of polyethylene A is LD26D, produced by Lanzhou Petrochemical Co., Ltd.; the model of polyethylene B is 4701, produced by Dow Chemical; elastomer A is one or more of POE, POP and PB, produced by ExxonMobil, LG Chemical and Borealis; elastomer B is a hydrogenated grade styrene-butadiene-styrene triblock copolymer elastomer (SEBS), models such as G1645, G1651, G1657, produced by Kraton Corporation of the United States.

[0022] Examples 1-3

[0023] (1) preparing an inner cap masterbatch, feeding LLDPE, ULDPE, POE, POPO, PB, SEBS, chitosan, and PBAT into an extruder, extruding at 130° C., and underwater pelletizing at 360° C. to obtain an inner cap masterbatch; wherein the components and their contents are shown in Table 1 below; the inner cap masterbatches obtained in Examples 1-3 are respectively denoted as masterbatch A, masterbatch B, and masterbatch C;

[0024] (2) Preparing an inner cover: the inner cover masterbatch obtained in step (1) is mixed with RP260 and F5606 and then fed into an injection molding machine. The product is obtained by injection molding at 180° C. The injection molding is carried out at high speed and high pressure to obtain a finished inner cover. The components and their contents are shown in Table 2 below. The finished inner covers obtained in Examples 1-3 are respectively referred to as inner cover A, inner cover B, and inner cover C.

[0025] Example 4

[0026] (1) preparing a masterbatch for the outer cover, feeding LLDPE, SEBS, chitosan and PBAT into an extruder, extruding at 130° C., and underwater pelletizing at 360° C. to obtain a masterbatch for the outer cover, which is referred to as masterbatch D; wherein the components and their contents are shown in Table 1 below;

[0027] (2) Preparing an outer cover: the outer cover masterbatch obtained in step (1), RP260 and F5606 are mixed and fed into an injection molding machine, and the product is obtained by injection molding at 180° C. The injection molding is carried out under high speed and high pressure conditions to obtain a finished outer cover; wherein the components and their contents are shown in Table 2 below.

[0028] Table 1 Content of each component in masterbatch AD in Examples 1-4

[0029]

[0030] Table 2 Content of each component in the inner (outer) cover AD in Examples 1-4

[0031]

[0032] Experimental example

[0033] The inner caps A, B and C prepared in Examples 1-3 were respectively connected and assembled with the finished outer caps and rubber plugs prepared in Example 4 to obtain combined caps A, B and C, respectively. The combined caps A, B and C were respectively connected with the infusion bottles for drug filling, welding and sterilization, and then the performance tests were conducted. The test standards were referred to "YBB00242004-2015". The detailed data are shown in Table 3.

[0034] Table 3 Test results of combination cover A, combination cover B, combination cover C

[0035]

[0036] According to the test comparison data, the physical and chemical properties of the combination cap have been significantly improved after raw material optimization, formula adjustment and process simplification, especially in terms of puncture debris, insoluble particles, antibacterial efficiency and late self-decomposition, which greatly improves the safety and clinical adaptability of the product. Due to the reduction of product production steps and the lower temperature, the production process is more efficient; at the same time, the degradation guidance effect is significant, which improves the environmental friendliness of the product.

[0037] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A combined cover for an infusion container, characterized in that: It comprises an outer cover and an inner cover; the components of the outer cover comprise polypropylene A, polypropylene B, polyethylene A, elastomer B, degradable materials, and antibacterial materials; the components of the inner cover comprise polypropylene A, polypropylene B, polyethylene A, polyethylene B, elastomer A, elastomer B, and antibacterial materials.

2. The combined cover for an infusion container according to claim 1, characterized in that: The polypropylene A is a binary copolymer polypropylene, the polypropylene B is a ternary copolymer polypropylene, the polyethylene A is a linear low-density polyethylene, and the polyethylene B is an ultra-low-density polyethylene.

3. The combined cover for an infusion container according to claim 1, characterized in that: The elastomer A is a polyolefin-based thermoplastic elastomer, and the elastomer B is a styrene-based thermoplastic elastomer.

4. The combined cover for an infusion container according to claim 3, characterized in that: The olefin thermoplastic elastomer is one or more of polyethylene-octene copolymer elastomer, polypropylene-octene copolymer plastomer, and polybutylene elastomer; the styrene-based thermoplastic elastomer is a hydrogenated styrene-butadiene-styrene triblock copolymer elastomer.

5. The combined cap for an infusion container according to claim 1, characterized in that: The degradable material is one or both of polylactic acid and poly(propylene succinate).

6. The combined cap for an infusion container according to claim 1, characterized in that: The antibacterial material is one or both of lignans and chitosan.

7. The combined cap for an infusion container according to claim 1, characterized in that: In terms of mass percentage, the outer cover comprises 20-90 parts of polypropylene A, 10-50 parts of polypropylene B, 0-10 parts of polyethylene A, 5-30 parts of elastomer B, 5-15 parts of degradable material, and 1-3 parts of antibacterial material; The inner cover contains 10-90 parts of polypropylene A, 10-50 parts of polypropylene B, 0-10 parts of polyethylene A, 0-10 parts of polyethylene B, 5-20 parts of elastomer A, 5-30 parts of elastomer B, and 0.5-3 parts of antibacterial material.

8. A method for preparing a combined cover for an infusion container according to any one of claims 1 to 7, characterized in that: The steps include: (1) mixing polyethylene A, elastomer B, biodegradable material, and antibacterial material in the outer cover component and feeding the mixture into an extruder to extrude the mixture to obtain an outer cover masterbatch; The polyethylene A, polyethylene B, elastomer A, elastomer B and antibacterial material in the inner cover component are mixed and fed into an extruder to obtain an inner cover masterbatch after extrusion; (2) Polypropylene A, polypropylene B, and outer cover masterbatch are mixed and fed into an injection molding machine, and after feeding, melting, filling, holding pressure, cooling, and demolding, a finished outer cover is obtained; Polypropylene A, polypropylene B and inner cover masterbatch are mixed and fed into an injection molding machine, and after feeding, melting, filling, holding pressure, cooling and demoulding, the inner cover finished product is obtained; (3) The finished outer cover, the finished inner cover, and the rubber plug are squeezed and connected by external force to obtain a combined cover for an infusion container.

9. The method for preparing a combined cap for an infusion container according to claim 8, characterized in that: The melting temperature of the extruder in step (1) is 130-160° C., and the injection temperature of the injection molding machine in step (2) is 170-210° C.

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