Medicine bottle and production process method thereof
By using a double-layered pharmaceutical bottle design, the synergistic effect of the inner sterilization layer and the outer protective layer solves the problems of incomplete and poor antibacterial effect of pharmaceutical packaging bottles, achieving dynamic sterilization and long-term aseptic preservation of pharmaceuticals, and improving medication safety.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-12-29
- Publication Date
- 2026-03-27
AI Technical Summary
Existing drug packaging bottles have limitations in antibacterial function due to their single mechanism of action, poor sustainability, volatile antibacterial components that affect drug stability, and the risk of microbial contamination.
The medicine bottle adopts a double-layer structure. The inner layer is an inner sterilization layer containing inorganic slow-release antibacterial agents and organic contact antibacterial agents, and the outer layer is an outer protective layer. It is prepared by co-extrusion blow molding process. The inner sterilization layer and the outer protective layer work together to achieve dynamic sterilization and long-lasting antibacterial effect.
It effectively kills microorganisms that enter the bottle, prolongs the sterile shelf life of medicines, and improves medication safety, especially for people with low immunity. It has a simple structure and controllable cost.
Smart Images
Figure CN121733901A_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the field of medicine packaging containers, in particular to a medicine bottle and a production process thereof. BACKGROUND
[0002] With the rapid development of the pharmaceutical industry, the safety and functionality requirements of medicine packaging containers are increasingly improved. Traditional medicine packaging bottles are mainly made of high-density polyethylene (HDPE), polypropylene (PP) and other plastic materials, which have good chemical stability, moisture resistance and cost advantages, but have obvious shortcomings in antibacterial function.
[0003] Firstly, most of the existing antibacterial packaging materials use a single antibacterial mechanism, which lacks comprehensive killing effect on various microorganisms (bacteria, molds, yeasts, etc.) that may be encountered during medicine storage; secondly, the existing antibacterial agents often have poor antibacterial effect persistence, and it is difficult to maintain stable antibacterial performance during the entire storage period of the medicine; finally, the existing technology uses a single antibacterial layer, and the antibacterial layer is in long-term contact with the external environment, and the antibacterial components continuously volatilize to the external environment, affecting the antibacterial effect, and further affecting the stability of the medicine, and even posing a potential risk to the health of patients.
[0004] Therefore, it is urgent to develop a medicine packaging bottle with high efficiency, durability and broad-spectrum antibacterial function, which can effectively solve the problem of microbial contamination during medicine storage and ensure the quality of medicine and the safety of medication. SUMMARY
[0005] In order to solve the technical problems of the existing oral solid medicine packaging bottle lacking antibacterial function, external microorganisms entering the bottle causing pollution when repeatedly opening and taking medicine, and to achieve the technical effects of dynamic sterilization of air entering the bottle, ensuring the cleanliness of the medicine microenvironment in the bottle and improving the safety of medication, a medicine packaging bottle with antibacterial function is provided.
[0006] The technical solution adopted by the present application to solve its technical problems is to provide a medicine bottle, which comprises a bottle body and a bottle cap, the bottle body comprises an inner sterilization layer and an outer protective layer, the inner sterilization layer is made of polypropylene, a slow-release antibacterial composition and an inner layer functional additive, and the outer protective layer is made of polyethylene terephthalate and a functional additive.
[0007] The above-mentioned medicine bottle, the slow-release antibacterial composition comprises inorganic slow-release antibacterial agent and organic contact type antibacterial agent.
[0008] Preferably, the inorganic slow-release antibacterial agent is silver-loaded zirconium phosphate or silver-loaded zeolite, and the mass percentage of the inorganic slow-release antibacterial agent in the inner bactericidal layer is 0.5%-5.0%; the organic contact-type antibacterial agent is a high-temperature-resistant double-chain quaternary ammonium salt or guanidine antibacterial agent, and the mass percentage of the organic contact-type antibacterial agent in the inner bactericidal layer is 0.2%-3.0%.
[0009] Further, the mass ratio of the organic contact-type antibacterial agent to the inorganic slow-release antibacterial agent is 1:1-10:1.
[0010] Preferably, the inner bactericidal layer comprises, by weight percentage, polypropylene 70%-95%, slow-release antibacterial composition 5%-30%, and inner layer functional additive 0%-5%; the inner layer functional additive comprises a dispersant and an antioxidant; the outer protective layer comprises, by weight percentage, polyethylene terephthalate 94%-99.8% and outer layer functional additive 0.2%-6%; the outer layer functional additive comprises a nucleating agent, a thermal stabilizer, a lubricant, an impact modifier, and a colorant.
[0011] The above-mentioned production process of the medicine bottle comprises the following steps:
[0012] S1: preparing a premix, drying polypropylene in a blast oven at 80-90°C for 3-4 hours, controlling the water content to be ≤0.05%, drying the inorganic slow-release antibacterial agent, the organic contact-type antibacterial agent, and the inner layer functional additive at 105±5°C for 1-2 hours, weighing according to the inner layer composition range of claim 6, the inner layer functional additive comprising a dispersant 0.05%-0.3% and an antioxidant 0.1%-0.25%; putting all the weighed solid components into a high-speed heated mixer, and mixing at 90-115°C for 5-10 minutes to obtain the premix;
[0013] S2: preparing an antibacterial functional master batch, feeding the premix into a co-rotating parallel twin-screw extruder, controlling the temperature of each zone to be in the range of 160-185°C, controlling the screw speed to be 250-350 rpm and the vacuum degassing to be-0.05 to-0.07 MPa, achieving uniform dispersion of each component, and after water cooling, granulation, screening, and drying, obtaining the high-concentration inner layer antibacterial functional master batch;
[0014] S3: Preparation of the inner sterilization layer material and the outer protective layer material, according to the concentration of the antibacterial composition in the antibacterial functional master batch obtained in S2, and the final antibacterial agent content range in the inner sterilization layer defined in claims 3 and 6, the mixing ratio of the antibacterial functional master batch and the polypropylene resin is calculated, and the two are mixed in a mixer at room temperature for 15-30 minutes to obtain the inner sterilization layer forming mixed material; according to the outer protective layer composition range described in claim 6, the polyethylene terephthalate resin is premixed with the corresponding functional additives or directly used with the required market modified PET material, the outer layer functional additives include nucleating agent 0.15%-0.35%, heat stabilizer 0.15%-0.25%, lubricant 0.05%-0.15%, impact modifier 0.8%-2.5%, colorant 0.5%-4.0%;
[0015] S4: Double-layer bottle body co-extrusion blow molding, the inner sterilization layer material prepared in S3 is put into the hopper of A extruder, the processing temperature is 170-190 DEG C, the processing temperature is 240-270 DEG C, the outer protective layer material is put into the hopper of B extruder, the plasticized melt of the two extruders is transported to the double-layer die, the concentric structure of the outer protective layer and the inner sterilization layer is formed in the die, the melt is co-extruded into a multi-layer parison in the die head, the die opening is adjusted in real time to ensure that the final bottle body meets the requirement that the thickness of the inner sterilization layer accounts for 30%-60% of the total wall thickness of the bottle body, after the parison reaches the predetermined length, the mold is closed, 0.6-1.2 MPa of high-pressure clean air is injected, the mold temperature is 10-25 DEG C, the parison is blown and formed tightly against the cold mold cavity, after 8-15 seconds of pressure holding and cooling, the mold is opened to obtain an integrally formed double-layer bottle body.
[0016] S5: Post-processing, the formed bottle body is automatically trimmed to remove the bottle mouth flash, and clean air is blown.
[0017] Preferably, the dispersant of the inner layer functional additive in step S1 is polyethylene wax or polypropylene wax; the antioxidant is a composite antioxidant B215 or B900; the nucleating agent of the outer layer functional additive in step S3 is an organic phosphate, the heat stabilizer is a compound of hindered phenol and phosphite, the lubricant is calcium stearate or lignite wax derivative, the impact modifier is ethylene-acrylate-glycidyl methacrylate terpolymer, and the colorant is PET-based pre-dispersed color master batch.
[0018] The beneficial effects of the present application are:
[0019] By adopting the double-layer structure design of "inner sterilization layer + outer protective layer", the air entering the bottle can be dynamically sterilized. When the medicine bottle is opened and external air enters, the microorganisms in the air are killed or inhibited when contacting the bottle inner wall with sterilization function and flowing through the air with sterilization particles. The outer protective layer effectively slows down the invalid loss of antibacterial components and protects the inner layer function. The compounding of inorganic and organic antibacterial agents produces a synergistic effect, combining the advantages of instant strong and persistent slow release, ensuring that the micro environment of the medicine in the bottle is clean, prolonging the sterile storage period of the medicine after opening, improving the safety of drug use, especially for people with low immunity. The structure is simple and the cost is controllable, which overcomes the shortcomings of the prior art that the desiccant cannot kill microorganisms and the cost of aluminum plastic blister packaging is high. BRIEF DESCRIPTION OF DRAWINGS
[0020] Figure 1 is the overall structure schematic diagram of the medicine bottle of the present application;
[0021] Figure 2 is the partial cross-sectional structure schematic diagram of the medicine bottle of the present application;
[0022] Figure 3 is the test data of short-term antibacterial property of the medicine bottle of the present application;
[0023] Figure 4 is the test data of long-term antibacterial property of the medicine bottle of the present application.
[0024] LEGEND:
[0025] 1-bottle body, 101-inner sterilization layer, 102-outer protective layer, 2-bottle cap. DETAILED DESCRIPTION
[0026] The technical solutions of the present application will be described clearly and completely by combining the embodiments with the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present application, not all the embodiments. Based on the embodiments of the present application, all other embodiments obtained by those skilled in the art without creative labor belong to the scope of protection of the present application.
[0027] Example 1, a production process method of a medicine bottle, comprising the following steps:
[0028] S1: preparing a premix, drying food-grade polypropylene in a blast oven at 85℃ for 3.5 hours. Ag + content 3.8%, average particle size 1.5μm of silver-loaded zirconium phosphate, double decyl dimethyl ammonium chloride, polyethylene wax, composite antioxidant B215 are dried at 105℃ for 1.5 hours.
[0029] After drying, the dried components were weighed and mixed: PP 78.5 parts, silver-loaded zirconium phosphate 15.0 parts, didecyldimethylammonium chloride 5.0 parts, polyethylene wax 1.0 part, and antioxidant B215 0.5 part. All solid components were put into a high-speed heated mixer and mixed at 1000 rpm for 8 minutes at 100°C to obtain a premix.
[0030] S2: Preparation of antibacterial functional masterbatch, the premix was fed into a co-rotating parallel twin-screw extruder, and the temperature of each zone of the extruder was set to: Zone 1 165°C, Zone 2 172°C, Zone 3 178°C, Zone 4 180°C, Zone 5 and die head 175°C. The screw speed was set to 300 rpm, and the vacuum degassing system was turned on after the melting section, with a vacuum degree of -0.06 MPa. The melt after melting, dispersing, and devolatilization was extruded into a strip through a multi-hole die, entered a 25°C circulating water tank for cooling, and then was cut and sieved, and vacuum dried at 75°C for 5 hours to obtain a high-concentration inner antibacterial functional masterbatch.
[0031] S3: Preparation of inner bactericidal layer material and outer protective layer material, according to the calculation of silver-loaded zirconium phosphate 1.5% and double-chain quaternary ammonium salt 0.8%, the antibacterial functional masterbatch and pure PP resin were mixed in a mass ratio of 1:7.25 in a drum mixer at room temperature for 20 minutes to obtain a mixed material for forming an inner bactericidal layer. The outer protective layer forming material was bottle-grade PET chip, and 100 parts of outer protective layer modified material was prepared according to the following formula: PET resin 97.0 parts, organic phosphate nucleating agent TMB-5 0.25 parts, antioxidant Irganox 1010 0.08 parts, antioxidant Irgafos 168 0.12 parts, calcium stearate 0.10 parts, ethylene-acrylate-glycidyl methacrylate terpolymer 1.5 parts, and amber light-shielding PET color masterbatch 0.95 parts. The components were premixed and reserved, or the modified PET material premixed according to the formula was directly used.
[0032] S4: Double-layer bottle body co-extrusion blow molding, double-layer bottle body co-extrusion blow molding: using a double-layer co-extrusion blow molding unit, the inner sterilization layer forming material is put into the A extruder, and the temperature of each section is set to 180℃ / 185℃ / 188℃ / 188℃ / 185℃. The outer protective layer forming material is put into the B extruder, and the temperature of each section is set to 245℃ / 260℃ / 268℃ / 268℃ / 263℃, and the die temperature is set to 265℃. The two extruders work synchronously, the plasticized melt is transported to the double-layer die, and the melt is extruded in the die in a concentric circle mode to form a tubular parison with an outer protective layer / inner sterilization layer structure. The opening degree of the die is adjusted by the parison wall thickness control system, so that the thickness of the inner layer is about 45% of the total wall thickness. After the parison reaches the predetermined length, the blow mold is closed, and 0.8 MPa of high-pressure clean air is injected into the bottle mouth to blow and tightly adhere the parison to the inner wall of the mold cavity at 20℃. The mold is opened after 12 seconds of pressure maintaining and cooling to obtain an integrally formed double-layer bottle body.
[0033] S5: Post-processing and assembly: the double-layer bottle body is automatically trimmed, the flash at the bottle mouth is removed, and clean compressed air is blown. Then, the medicine is filled in a clean environment of 100,000 levels, and the bottle cap with a sealing gasket is screwed, to obtain the medicine bottle of the application.
[0034] Example 2: The same inner sterilization layer formula as in Example 1 is used, containing 1.5% silver-loaded zirconium phosphate and 0.8% quaternary ammonium salt, but a single-layer bottle body without an outer protective layer is formed.
[0035] Example 3: A double-layer structure of inner sterilization layer and outer protective layer is used, but the inner sterilization layer only contains 2.3% silver-loaded zirconium phosphate and does not contain organic quaternary ammonium salt.
[0036] Example 4: A double-layer structure of inner sterilization layer and outer protective layer is used, but the inner sterilization layer only contains 2.3% double-chain quaternary ammonium salt and does not contain inorganic silver-loaded agent.
[0037] Example 5: A commercially available ordinary single-layer HDPE medicine packaging bottle.
[0038] The plastic bottles of the above examples are tested for short-term antibacterial performance, and the antibacterial performance test is carried out according to (GB / T 31402-2015): the 24-hour antibacterial rate of the bottle body inner surface to Escherichia coli (ATCC 8739) and Staphylococcus aureus (ATCC 6538).
[0039] Examples In-bottle E. coli antibacterial rate In-bottle S. aureus antibacterial rate Example 1 >99.99% >99.99% Example 2 99.70% 99.65% Example 3 99.95% 99.90% Example 4 99.92% 99.95% Example 5 0% (no antibacterial properties) 0% (no antibacterial properties)
[0040] Conclusion: The above specific data show that the Example 1 of the application achieves the best antibacterial effect in the 24-hour contact antibacterial test.
[0041] The long-term antibacterial test of the above-mentioned plastic bottle is carried out. The blank simulated medicine tablets are put in each experimental bottle, and are exposed to the laboratory environment for 30 seconds once a day. 1 mL of E. coli with a bacterial content of 10-5 CFU / mL is injected into the bottle on the 1st day, the 30th day and the 60th day respectively. After being closed and placed for 24 hours, the antibacterial rate of the surface of the simulated medicine tablets in the bottle is detected.
[0042] Example Day 1 antibacterial rate Day 30 antibacterial rate Day 30 antibacterial rate Example 1 >99.99% >99.99% 99.98% Example 2 99.70% 85.20% 60.50% Example 3 99.95% 99.80% 95.30% Example 4 99.92% 92.10% <10% Example 5 0% 0% 0%
[0043] Conclusion: Specific data clearly show that the antibacterial rate of the medicine bottle of the present application to E. coli can still be maintained above 99.98% after a simulated use period of 60 days.
[0044] Finally, it should be pointed out that the above-mentioned is only the preferred embodiment of the present application, and is not used to limit the present application. Although the present application has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions recorded in the foregoing embodiments, or equivalently replace some technical features, as long as they are within the spirit and principles of the present application. Any modification, equivalent replacement, improvement, etc. should be included in the protection scope of the present application.
Claims
1. A medicine bottle, comprising a bottle body (1) and a bottle cap (2), characterized in that, The bottle body (1) includes an inner sterilization layer (101) and an outer protective layer (102). The inner sterilization layer (101) is made of polypropylene, a slow-release antibacterial composition and an inner functional additive. The outer protective layer (102) is made of polyethylene terephthalate and a functional additive.
2. A medicine bottle according to claim 1, characterized in that: The sustained-release antibacterial composition comprises an inorganic sustained-release antibacterial agent and an organic contact antibacterial agent.
3. A medicine bottle according to claim 2, characterized in that: The inorganic slow-release antibacterial agent is silver-loaded zirconium phosphate or silver-loaded zeolite, and its mass percentage in the inner bactericidal layer (101) is 0.5%-5.0%; The organic contact antibacterial agent is a high-temperature resistant double-chain quaternary ammonium salt or guanidine antibacterial agent, and its mass percentage in the inner bactericidal layer (101) is 0.2%-3.0%.
4. A medicine bottle according to claim 3, characterized in that: The mass ratio of the organic contact antibacterial agent to the inorganic slow-release antibacterial agent is 1:1 to 10:
1.
5. A medicine bottle according to claim 1, characterized in that: The thickness of the inner sterilization layer (101) accounts for 30%-60% of the total wall thickness of the bottle body (1).
6. A medicine bottle according to claim 1, characterized in that: The inner bactericidal layer (101) comprises, by weight percentage: 70%-95% polypropylene, 5%-30% slow-release antibacterial composition, and 0%-5% inner layer functional additives; the inner layer functional additives include self-dispersing agents and antioxidants. The outer protective layer (102) comprises, by weight percentage: 94%-99.8% polyethylene terephthalate and 0.2%-6% outer functional additives; the outer functional additives include nucleating agents, heat stabilizers, lubricants, impact modifiers, and colorants.
7. A manufacturing process for a pharmaceutical bottle according to any one of claims 1-6, characterized in that: Includes the following steps: S1: Prepare the premix by drying polypropylene in a forced-air oven at 80-90℃ for 3-4 hours, with the moisture content controlled to ≤0.05%. Dry the inorganic slow-release antibacterial agent, organic contact antibacterial agent, and inner layer functional additives at 105±5℃ for 1-2 hours. Weigh the inner layer components according to the composition range described in claim 6, where the inner layer functional additives include 0.05%-0.3% dispersant and 0.1%-0.25% antioxidant. Add all weighed solid components to a high-speed heating mixer and mix at 90-115℃ for 5-10 minutes to obtain the premix. S2: To prepare antibacterial functional masterbatch, the premixed material is fed into a co-rotating parallel twin-screw extruder. The temperature of each zone is controlled within the range of 160-185℃. The screw speed is controlled at 250-350 rpm and vacuum degassing is performed at -0.05 to -0.07 MPa to achieve uniform dispersion of each component. After water cooling, pelletizing, sieving, and drying, a high-concentration inner layer antibacterial functional masterbatch is obtained. S3: Preparation of the inner bactericidal layer material and the outer protective layer material: Based on the concentration of the antibacterial composition in the antibacterial functional masterbatch obtained in S2, and the final antibacterial agent content range in the inner bactericidal layer as defined in claims 3 and 6, calculate the mixing ratio of the antibacterial functional masterbatch and polypropylene resin, and mix the two in a mixer at room temperature for 15-30 minutes to obtain the mixture for molding the inner bactericidal layer; according to the composition range of the outer protective layer as described in claim 6, premix the polyethylene terephthalate resin with the corresponding functional additives or directly use commercially available modified PET material that meets the requirements, the outer layer functional additives include nucleating agent 0.15%-0.35%, heat stabilizer 0.15%-0.25%, lubricant 0.05%-0.15%, impact modifier 0.8%-2.5%, and colorant 0.5%-4.0%; S4: Co-extrusion blow molding of double-layer bottle body. The inner sterilization layer material prepared in S3 is fed into the hopper of extruder A, with a processing temperature of 170-190℃ and a processing temperature of 240-270℃. The outer protective layer material is fed into the hopper of extruder B. The two extruders convey the plasticized melt to the double-layer die head, forming a tubular preform with a concentric structure of outer protective layer and inner sterilization layer in the die head. After melting, it is compound extruded into a multi-layer preform in the die head. The die opening is adjusted in real time to ensure that the final bottle body meets the requirement that the thickness of the inner sterilization layer accounts for 30%-60% of the total wall thickness of the bottle body. After the preform reaches the predetermined length, the die is closed, and high-pressure clean air of 0.6-1.2 MPa is injected. The die temperature is 10-25℃. The preform is inflated and pressed tightly against the cold mold cavity for molding. After 8-15 seconds of pressure holding and cooling, the die is opened to obtain an integrally formed double-layer bottle body. S5: Post-processing, automatically trimming the molded bottle body, removing burrs from the bottle neck, and purging with clean air.
8. The manufacturing process of a medicine bottle according to claim 7, characterized in that: The dispersant of the inner layer functional additive in step S1 is polyethylene wax or polypropylene wax; the antioxidant is composite antioxidant B215 or B900; the nucleating agent of the outer layer functional additive in step S3 is an organophosphate, the heat stabilizer is a compound of hindered phenols and phosphites, the lubricant is calcium stearate or lignite wax derivative, the impact modifier is ethylene-acrylate-glycidyl methacrylate terpolymer, and the colorant is PET-based predispersed masterbatch.