WO2024109930A1 - 一种雾化吸入袋及其在雾化吸入给药中的应用 - Google Patents

一种雾化吸入袋及其在雾化吸入给药中的应用 Download PDF

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WO2024109930A1
WO2024109930A1 PCT/CN2023/133971 CN2023133971W WO2024109930A1 WO 2024109930 A1 WO2024109930 A1 WO 2024109930A1 CN 2023133971 W CN2023133971 W CN 2023133971W WO 2024109930 A1 WO2024109930 A1 WO 2024109930A1
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bag
atomizing
inhalation
inhalation bag
atomizing inhalation
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PCT/CN2023/133971
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English (en)
French (fr)
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赵晓龙
苏荣尧
陈丽杰
李虎伯
司伟雪
朱涛
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康希诺生物股份公司
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/02—Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body

Definitions

  • the present invention relates to the field of biomedical technology, and in particular to an atomizing inhalation bag and its application in atomizing inhalation drug administration, in particular to atomizing inhalation drug administration for preventing and/or treating respiratory diseases.
  • one treatment method for respiratory diseases is aerosol inhalation, which uses a nebulizer to disperse the drug solution into fine droplets, which are inhaled through the patient's nose or mouth.
  • the aerosolized drug directly acts on the target organ, which can increase the local concentration of the drug and achieve a therapeutic effect. Aerosol inhalation has a very good therapeutic effect on bronchiolitis, asthmatic bronchitis, bronchial asthma, acute and chronic bronchitis, acute laryngitis, acute pneumonia, etc.
  • Nebulized inhalation vaccines are vaccines that are administered through nebulized inhalation.
  • the so-called nebulized inhalation immunization refers to the use of a nebulizer to atomize the vaccine into tiny particles. These tiny particles enter the respiratory tract and lungs through inhalation, stimulating mucosal immunity.
  • the equipment and devices that realize this kind of atomized inhalation treatment and immunization are very important for the implementation and quality of treatment and immunization, and have received great attention from researchers and researchers.
  • the existing atomized drug delivery devices in the prior art mainly use a method of administering drugs by atomization and inhalation at the same time, which requires guidance to the subjects before administration. Children and even many adults often greatly affect the inhalation and absorption of drug mist due to improper control of the frequency of inhalation administration and their own breathing, which is very unfavorable for immunization.
  • the part of the device for inhalation by the subject should be disinfected or discarded after use.
  • nebulizer cup is generally used in the prior art.
  • the cost of the nebulizer cup is high, and the volume is large and not suitable for transportation; therefore, further development and use of nebulizer bags are considered, but in actual applications, it is found that when using nebulizer inhalation bags for nebulization inhalation, the nebulized drug mist is easily liquefied on the bag wall to form droplets due to electrostatic effects and cannot be normally inhaled by the human body.
  • the resistivity of the nebulizer bag will have a greater impact on the nebulization delivery rate; in addition, the bag body of different thicknesses has a greater impact on the morphology of the nebulizer bag and the changes in the bag body shape before and after nebulization.
  • the resistivity of the bag body will affect the molding, touch and effective amount of the nebulized drug mist. Therefore, it is urgent to explore the various performances of the nebulizer bag to form a suitable nebulizer bag.
  • the present invention provides an atomization inhalation bag and its application, wherein the atomization inhalation bag can be used to collect and carry the drug mist generated by the nebulizer for inhalation by a subject to achieve therapeutic or immunization effects.
  • an atomizing inhalation bag comprising a bag body and a bag cover.
  • the thickness of a single layer is 0.01-0.5 mm, preferably 0.01-0.2 mm, preferably 0.05 mm-0.15 mm, preferably 0.05-0.1 mm;
  • the surface resistivity of the inner layer of the atomizing bag body is: 10 1 -10 20 ⁇ , preferably 10 5 -10 10 ⁇ ; more preferably, 10 5 -10 9 ⁇ ; more preferably, 10 6 -10 9 ⁇ ;
  • the shape of the bag body can be any suitable shape, such as a cylindrical shape, a truncated cone shape that is wide at the top and narrow at the bottom and tapers, etc.
  • a handle may be provided on the side wall of the bag body to facilitate taking the atomizing inhalation bag.
  • an antistatic agent is added into the bag body.
  • the antistatic agent is a combination of one or more of anionic antistatic agents, zwitterionic antistatic agents, nonionic antistatic agents, and polymer antistatic agents.
  • the anionic antistatic agent is a combination of one or more of alkyl sulfonates, alkyl phosphates, maleic anhydride and other monomer copolymer salts, polyacrylic acid salts, and polystyrene sulfonates.
  • the zwitterionic antistatic agent is amphoteric alkyl imidazoline salts and alkyl amino acids;
  • the nonionic antistatic agent is a combination of fatty acid polyol esters and polyethylene oxide additives;
  • the polymer antistatic agent is a combination of polyoxyethylene fatty ethers, polyoxyethylene alkylphenyl ethers, polyethylene glycol fatty acid esters, and polyacrylic acid derivatives.
  • the nonionic antistatic agent is preferably a combination of one or more fatty alcohol polyoxyethylene ether, alkylphenol polyoxyethylene ether, and glycerol monofatty acid ester;
  • the zwitterionic antistatic agent is preferably one or a combination of alkyl dicarboxymethyl ammonium ethyl lactone and dodecyl dimethyl betaine;
  • the polymer antistatic agent is preferably a combination of one or more ethylene oxide propylene oxide adducts of ethylenediamine, poly 4-vinylpyridine type polysoap, octyl styrene and styrene sulfonic acid copolymer polysoap.
  • the content of antistatic agent added to the bag is 0.01-20%; preferably, it is 0.03%-10% or 0.05-5% or 0.03%-10% or 0.02%-5% or 0.01%-15% or 0.1%-5% or 1%-10% or 2%-10% or 5%-15%.
  • the material of the bag body is plastic, selected from: one or more of polyethylene (PE), biaxially oriented polypropylene, polypropylene (PP), polyvinyl chloride (PVC), polystyrene (PS), polyester, ethylene-vinyl acetate, polyvinylidene chloride, nylon, polyvinylidene chloride, polycarbonate (PC), polyamide, polylactic acid (PLA), polyethylene cellophane, moisture-proof cellophane, moisture-proof cellophane (vinyl chloride); preferably, the polyethylene is selected from low-density polyethylene, medium-density polyethylene, and high-density polyethylene; preferably, it is low-density polyethylene; preferably, the polyvinyl chloride is selected from soft polyvinyl chloride and hard polyvinyl chloride; preferably, it is PP/K4535 and/or PP/S25.
  • PE polyethylene
  • PP polypropylene
  • PVC polyvinyl chloride
  • the inner layer material and the outer layer material of the atomizing inhalation bag are different.
  • the bag body is made of one or more of cellulose/polyethylene, stretched polypropylene/polyethylene, nylon/polyethylene, polyester/unstretched polypropylene, polyester/aluminum foil/inner layer (any one of polyethylene, polypropylene, polyvinyl chloride, and hydrochloric acid rubber).
  • the alcoholysis degree of the polyvinyl alcohol is 40-100%, preferably 60%-100%.
  • the molecular weight of the polymer is 1000-200000, preferably 9000-150000.
  • the bag cover is provided with a mist inlet and a nozzle; preferably, the inner diameter of the nozzle is 5-50mm; more preferably, the inner diameter of the nozzle is 15-25mm.
  • the suction nozzle protrudes from the bag cover and is connected to the space inside the bag. It can be in any shape suitable for the subject to inhale the mist, such as tubular or conical.
  • the suction port end of the suction nozzle can be in a circular, elliptical or other shape suitable for the subject to suck.
  • the suction port of the suction nozzle can also be provided with a closure to facilitate closing the suction nozzle before the nebulizer inhalation bag is used.
  • the mist inlet can be opened at any suitable position of the bag cover, such as the edge, the center, especially the edge of the bag cover; a closure member can also be provided at the mist inlet to facilitate closing the mist inlet before the atomization inhalation bag is used.
  • the volume of the atomizing inhalation bag is 100-1000 ml, preferably 300-800 ml, and preferably 200 ml-500 ml.
  • the volume of the atomizing inhalation bag can be 300-800 ml (e.g., 300, 350, 400, 450, 500, 550, 600, 700, 800 ml), in particular 500 ml.
  • the invention provides a method for preparing an atomizing inhalation bag, comprising the following steps: mixing raw materials and auxiliary materials and adding them into a stirrer, mixing them uniformly to obtain a mixture, stirring them uniformly, and heating them with an extruder to obtain a tube-packed plastic film, that is, the atomizing inhalation bag.
  • the method further comprises a molding step, such as molding by extrusion, blow molding, etc.
  • the application is the use of the above-mentioned atomization inhalation bag in the preparation of a device for atomization inhalation administration of drugs for the prevention and/or treatment of respiratory diseases.
  • the drug is a vaccine.
  • the drug is a vaccine, such as pneumococcal vaccine, influenza vaccine, coronavirus vaccine, varicella vaccine, Newcastle virus vaccine, measles vaccine, tuberculosis vaccine, dust mite allergy vaccine, etc.
  • an atomization inhalation drug delivery device which comprises the atomization inhalation bag described in the first aspect of the present invention, and a nebulizer.
  • the nebulizer can be an ultrasonic nebulizer, a compression nebulizer, a vibrating mesh nebulizer or other suitable nebulizers, especially a vibrating mesh nebulizer.
  • a method for drug administration by aerosol inhalation comprises the step of administering the drug to a subject through the aerosol inhalation bag described in the first aspect.
  • the method is an aerosol inhalation immunization method, wherein the drug is a vaccine, such as pneumococcal vaccine, influenza vaccine, coronavirus vaccine, varicella vaccine, Newcastle virus vaccine, measles vaccine, tuberculosis vaccine, dust mite allergy vaccine, etc.; in some embodiments of the present invention, the vaccine is a coronavirus vaccine, in particular a SARS-CoV-2 vaccine.
  • a vaccine such as pneumococcal vaccine, influenza vaccine, coronavirus vaccine, varicella vaccine, Newcastle virus vaccine, measles vaccine, tuberculosis vaccine, dust mite allergy vaccine, etc.
  • the vaccine is a coronavirus vaccine, in particular a SARS-CoV-2 vaccine.
  • the method comprises the following steps:
  • step (2) collecting the drug mist generated in step (1) through the atomization inhalation bag;
  • step (3) is performed within 30 seconds (s) (e.g., 20s, 15s, 10s, 5s) after completing the mist collection, and in particular, step (3) is performed within 10s after completing the mist collection.
  • s e.g., 20s, 15s, 10s, 5s
  • the nebulizer in step (1) can be a suitable nebulizer such as a vibrating mesh nebulizer, a metered pressure aerosol dosing device, a soft mist dosing device, etc., in particular a vibrating mesh nebulizer.
  • a suitable nebulizer such as a vibrating mesh nebulizer, a metered pressure aerosol dosing device, a soft mist dosing device, etc., in particular a vibrating mesh nebulizer.
  • the mist will enter the bag through the atomizer port, and the subject can inhale the mist through the atomizer nozzle to achieve vaccination.
  • the lid can be screwed on to ensure that the residual mist in the bag will not overflow into the air, protecting the environment from being contaminated by biological products.
  • the atomization inhalation bag is disposable to avoid cross infection.
  • the atomizing inhalation bag provided by the present invention can be used for atomizing inhalation administration of drugs for the prevention and/or treatment of respiratory diseases.
  • Atomizing therapy mainly refers to aerosol inhalation therapy.
  • aerosol refers to tiny solid or liquid particles suspended in the air. Therefore, atomizing inhalation therapy is to use an atomizing device to disperse the drug into tiny droplets or particles, so that it is suspended in the gas and enters the respiratory tract and lungs.
  • the atomizing inhalation bag of the present invention comprehensively considers various mechanisms causing the deposition of fog particles, including but not limited to impact deposition, gravity deposition, dispersion deposition, electrostatic attraction deposition and interception deposition, etc., to provide an atomizing inhalation bag with stable and excellent atomization performance.
  • the atomization inhalation bag of the present invention is suitable for large-scale inoculation, solves the problem that the atomization cup is inconvenient to transport, can prevent cross infection and reduce costs at the same time, and has high inhalation inoculation efficiency.
  • subject refers to a human being who receives the administration method (especially the aerosol inhalation immunization method) of the present invention.
  • Example 1 Effect of different bag resistivity on atomization effect
  • Nebulized model drug CanSino recombinant novel coronavirus vaccine (adenovirus type 5 vector) liquid preparation;
  • Nebulization volume 0.1ml.
  • the vacuum pump flow rate was calibrated to 15L/min by TSI gas flow meter; 0.1ml of recombinant novel coronavirus vaccine (adenovirus type 5 vector) was added to the nebulizer cup and atomized into the atomizer bag.
  • the atomizer bag was made of PE with a single layer thickness of 0.1mm. The atomizer bag was treated with antistatic agents.
  • the resistivity is shown in Table 1 below; after the nebulization is completed, the bag is allowed to stand for 10 seconds, and the vacuum pump and the nebulization bag are connected to extract the gas in the nebulization bag; 20 ml of eluent is added to the nebulization bag to fully moisten the inner wall of the nebulization bag; the type 5 adenovirus vector in the eluent is quantified using the qPCR method.
  • Control group add 0.1 ml of recombinant novel coronavirus vaccine (adenovirus type 5 vector) to 20 ml of eluate and mix well; use qPCR method to quantify the adenovirus type 5 vector in the eluate;
  • Residual amount calculation method atomization bag eluate vaccine concentration / control group vaccine concentration ⁇ 100%
  • the PE material used has a resistivity greater than 10 9 ⁇ , and the mist condenses rapidly on the bag wall, leaving a large amount of mist in the bag.
  • the resistivity is 10 5 -10 9
  • the amount of mist remaining in the atomization bag is relatively low 10 seconds after the atomization is completed, and the residual rate is less than 50%.
  • Example 2 Effect of different bag thickness on atomization effect
  • Nebulized model drug CanSino recombinant novel coronavirus vaccine (adenovirus type 5 vector) liquid preparation;
  • Nebulization volume 0.1ml.
  • the vacuum pump flow rate was calibrated to 15 L/min by TSI gas flow meter; 0.1 ml of CanSino recombinant novel coronavirus vaccine (adenovirus type 5 vector) liquid preparation was added to the nebulizer cup and atomized into the atomizer bag.
  • the atomizer bag was made of PE with a resistivity of 10 9 . Leave it in the air for 10 seconds, connect the vacuum pump and the nebulizer bag, and extract the gas in the nebulizer bag; add 20 ml of eluent to the nebulizer bag to fully wash the inner wall of the nebulizer bag; use the qPCR method to quantify the type 5 adenovirus vector in the eluent.
  • Control group add 0.1 ml of recombinant novel coronavirus vaccine (adenovirus type 5 vector) to 20 ml of eluate and mix well; use qPCR method to quantify the adenovirus type 5 vector in the eluate;
  • Residual amount calculation method atomization bag eluate vaccine concentration / control group vaccine concentration ⁇ 100%
  • the vaccine residue results in the atomizer bags with a bag thickness of 0.05 mm to 0.15 mm were low, and the residue rate was less than 50%.
  • the bag thickness was less than 0.05 mm, the atomizer bag had poor formability, and a large amount of mist was deposited during the 10-second standing time.
  • the bag thickness was greater than 0.15 mm, a large number of droplets gathered at the pleats, and the residue rate increased.
  • Nebulized model drug CanSino recombinant novel coronavirus vaccine (adenovirus type 5 vector) liquid preparation;
  • Nebulization volume 0.1ml.
  • the vacuum pump flow rate was calibrated to 15 L/min using the TSI gas flowmeter; 0.1 ml of CanSino recombinant novel coronavirus vaccine (adenovirus type 5 vector) liquid preparation was added to the nebulizer medicine cup and atomized into the atomizer bag.
  • the atomizer bag was made of PE, and the resistivity and bag thickness were shown in Table 3.
  • the bag was allowed to stand for 10 seconds, and the vacuum pump and the atomizer bag were connected to extract the gas in the atomizer bag; 20 ml of eluent was added to the atomizer bag to fully moisten the inner wall of the atomizer bag; the adenovirus type 5 vector in the eluent was quantified using the qPCR method.
  • Control group add 0.1 ml of recombinant novel coronavirus vaccine (adenovirus type 5 vector) to 20 ml of eluate and mix well; use qPCR method to quantify the adenovirus type 5 vector in the eluate;
  • Residual amount calculation method atomization bag eluate vaccine concentration / control group vaccine concentration ⁇ 100%
  • the vaccine residue in the atomizing bag with a bag resistivity of 10 5 -10 9 ⁇ and a bag thickness of 0.05mm-0.15mm is low and the results are stable.
  • the more preferred range is the atomizing bag with a resistivity of 10 6 -10 9 ⁇ and a bag thickness of 0.05mm to 0.1mm.
  • Example 4 Effect of different bag materials on atomization effect
  • the atomization effect is best when the resistivity is 10 6 -10 9 ⁇ and the bag thickness is 0.05-0.1 mm. Based on this, the influence of different bag materials on the atomization effect is further verified.
  • Nebulized model drug CanSino recombinant novel coronavirus vaccine (adenovirus type 5 vector) liquid preparation;
  • Nebulization volume 0.1ml.
  • the vacuum pump flow rate was calibrated to 15 L/min using a TSI gas flowmeter; 0.1 ml of CanSino recombinant novel coronavirus vaccine (adenovirus type 5 vector) liquid preparation was added to the nebulizer medicine cup, the bag thickness was 0.1 mm, the bag resistivity was 10 9 , and the bag material was shown in Table 4 below.
  • the bag was allowed to stand for 10 s, and the vacuum pump and nebulization bag were connected to extract the gas in the nebulization bag; 20 ml of eluent was added to the nebulization bag to fully moisten the inner wall of the nebulization bag; the adenovirus type 5 vector in the eluent was quantified using the qPCR method.
  • Control group add 0.1 ml of recombinant novel coronavirus vaccine (adenovirus type 5 vector) to 20 ml of eluate and mix well; use qPCR method to quantify the adenovirus type 5 vector in the eluate;
  • Residual amount calculation method atomization bag eluate vaccine concentration / control group vaccine concentration ⁇ 100%
  • Nebulized model drug CanSino recombinant novel coronavirus vaccine (adenovirus type 5 vector) liquid preparation;
  • Nebulization volume 0.1ml.
  • the flow rate of the inhalation preparation particle size detector (Helos inhaler, sympatec GmbH) was calibrated to 15 L/min by the TSI gas flowmeter; 0.1 ml of CanSino recombinant novel coronavirus vaccine (adenovirus type 5 vector) liquid preparation was added to the nebulizer medicine cup, the bag thickness was 0.05 mm, the bag resistivity was 10 8 , and the bag material was shown in Table 4 below. After nebulization, the bag was left to stand for 10 seconds, and after 10 seconds, the nebulizer bag was placed in the inhalation preparation particle size detector to detect the aerosol particle size in the nebulizer:

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Abstract

本发明公开了一种雾化吸入袋及其在雾化吸入给药中的应用，特别是在呼吸***疾病的预防和/或治疗药物的雾化吸入给药中的应用。该雾化吸入袋在一定时间内可有效维持药物气溶胶的稳定性，粒径状态较稳定，袋内药物残留较少，保证有效的可吸入量，给药操作简单便捷，可明显提高接种效率，可用于大规模接种。

Description

一种雾化吸入袋及其在雾化吸入给药中的应用 技术领域
本发明涉及生物医药技术领域，具体涉及一种雾化吸入袋及其在雾化吸入给药中的应用，特别是在呼吸***疾病的预防和/或治疗药物的雾化吸入给药中的应用。
背景技术
目前呼吸道疾病的一种治疗方式是雾化吸入给药，其通过利用雾化器将药液分散成细小的雾滴，经过患者鼻或口吸入，雾化的药物则直接作用于靶器官，可以提高药物的局部浓度，达到治疗效果。雾化吸入对于毛细支气管炎、哮喘性支气管炎、支气管哮喘、急、慢性支气管炎、急性喉炎、急性肺炎等均有非常好的治疗效果。
雾化吸入式疫苗是通过雾化吸入免疫的疫苗，所谓雾化吸入免疫，是指通过雾化器将疫苗雾化成微小颗粒，通过呼吸吸入的方式，这些微小颗粒进入呼吸道和肺部，激发黏膜免疫。
实现这种雾化吸入治疗和免疫的设备、装置对于治疗和免疫的实施和质量非常重要，受到研发人员的极大关注。现有技术中已有的雾化给药装置主要采用边雾化边吸入的方式给药，需要在给药前对受试者进行指导，儿童甚至很多成人常常由于对吸入给药和自身呼吸的频率控制不当而大大影响药物雾气的吸入和吸收，这对于免疫接种是很不利的。另外，对于免疫接种，为防止交叉感染，供受试者吸入的装置部分应在使用后进行消毒处理或丢弃处理。鉴于大规模接种的必要性，提供一种能够防止交叉感染同时又降低成本、且吸入接种效率高的雾化给药装置是一项亟需解决的问题。目前现有技术中通常使用雾化杯， 但雾化杯成本较高，且体积较大不适宜运输；因此考虑进一步开发使用雾化袋，但在实际应用中发现，在使用雾化吸入袋进行雾化吸入时，雾化后的药雾由于静电作用容易在袋壁液化形成液滴而无法正常被人体吸入，因此雾化袋的电阻率对雾化递送率会产生较大影响；此外不同厚度的袋体对雾化袋的形态、雾化给药前后袋体形态变化影响较大，袋体厚度较薄，袋体成形性较差而表面折皱较多；袋体的厚度过大，袋体压缩和展开均受到影响；会直接影响雾化袋内Q3≤5.25的粒径占比，进而影响雾化递送效率。此外袋体电阻率会影响袋体的成型，触感以及并对雾化后的药雾的有效量带来威胁。因此，亟需对雾化袋的多方面性能进行探究，形成适宜应用的雾化袋。
发明内容
为克服现有技术的不足，本发明提供一种雾化吸入袋及其应用，该雾化吸入袋可用于收集和承载雾化器所产生的药物雾气，并供受试者吸入，实现治疗或免疫等效果。
在本发明第一方面，提供一种雾化吸入袋，包含袋体和袋盖。
具体地，单层厚度为0.01-0.5mm，优选地为0.01-0.2mm，优选地为0.05mm-0.15mm，优选为0.05-0.1mm；
具体地，所述雾化袋身内层表面电阻率：101-1020Ω，优选地105-1010Ω；更优选地，为105-109Ω；更优选地，为106-109Ω；
具体地，袋体的形状可以为任何合适的形状，例如圆柱形、上宽下窄呈渐缩状的圆台形等。
具体地，袋体侧壁上还可设有把手，方便雾化吸入袋的拿取。
具体地，所述袋体中添加有抗静电剂。
具体地，其中所述抗静电剂为阴离子型抗静电剂、两性离子型抗静电剂、非离子型抗静电剂、高分子型抗静电剂中的一种或多种的组合。
具体地，所述阴离子型抗静电剂为烷基磺酸盐类、磷酸烷基酯类、马来酸酐与其他单体共聚物盐类、聚丙烯酸盐、聚苯乙烯磺酸盐一种或多种的组 合；所述两性离子型抗静电剂为两性烷基咪唑啉盐、烷基氨基酸；所述非离子型抗静电剂为脂肪酸多元醇酯、聚氧化乙烯附加物一种或多种的组合；所述高分子型抗静电剂为聚氧化乙烯脂肪醚、聚氧化乙烯烷基苯醚、聚乙二醇脂肪酸酯、聚丙烯酸衍生物一种或多种的组合。
具体地，所述非离子型抗静电剂优选为脂肪醇聚氧乙烯醚、烷基酚聚氧乙烯醚、甘油单脂肪酸酯一种或多种的组合；所述两性离子型抗静电剂优选为烷基二羧甲基铵乙内酯、十二烷基二甲基甜菜碱一种或其组合；所述高分子型抗静电剂优选为乙二胺的环氧乙烷环氧丙烷加成物、聚4-乙烯吡啶型聚皂、辛烷基苯乙烯和苯乙烯磺酸共聚型聚皂一种或多种的组合。
具体地，以质量百分比计，所述袋体中添加抗静电剂的含量为0.01-20％；优选地，为0.03％-10％或0.05-5％或0.03％-10％或0.02％-5％或0.01％-15％或0.1％-5％或1％-10％或2％-10％或5％-15％。
具体地，所述袋体的材质为塑料，选自：聚乙烯(PE)、双向拉伸聚丙烯、聚丙烯(PP)、聚氯乙烯(PVC)、聚苯乙烯(PS)、聚酯、乙烯-醋酸乙烯、聚偏氯乙烯、尼龙、聚偏二氯乙烯、聚碳酸酯(PC)、聚酰胺、聚乳酸(PLA)、聚乙烯赛璐玢、防潮赛璐玢、防潮赛璐玢(氯乙烯)中的一种或多种；优选地，所述聚乙烯选自低密度聚乙烯、中密度聚乙烯、高密度聚乙烯；优选地为低密度聚乙烯；优选地，聚氯乙烯选自软质聚氯乙烯、硬质聚氯乙烯；优选地，为PP/K4535和/或PP/S25。
具体地，所述雾化吸入袋的内层材质与外层材质不同。
具体地，所述袋体的材质为纤维素/聚乙烯、拉伸聚丙烯/聚乙烯、耐纶/聚乙烯、聚酯/未拉伸聚丙烯、聚酯/铝箔/内层(聚乙烯、聚丙烯、聚氯乙烯、盐酸橡胶的任一种)中的一种或多种。
具体地，其中所述的聚乙烯醇的醇解度为40-100％，优选地，60％-100％。
具体地，其中所述的聚合物的分子量为1000-200000，优选地，9000-150000。
具体地，所述袋盖上开设有雾气入口及吸嘴；优选地，吸嘴内径为 5-50mm；更优选地，吸嘴内径为15-25mm。
具体地，吸嘴突出设置于袋盖上并与袋体内空间连通，其可以为任何适宜受试者吸入雾气的形状，例如管状、锥状，吸嘴的吸入口端可以为圆形、椭圆形等适宜受试者吸吮的形状；吸嘴的吸入口还可设有封闭件，便于在雾化吸入袋使用前封闭吸嘴。
具体地，雾气入口可开设在袋盖的任何合适的位置，例如边缘处、中心处，特别是袋盖边缘处；雾气入口处还可设有封闭件，便于在雾化吸入袋使用前封闭雾气入口。
具体地，所述雾化吸入袋的容积为100-1000ml，优选为300-800ml，优选为200ml-500ml。
具体地，该雾化吸入袋的容积可以为300-800ml(例如300、350、400、450、500、550、600、700、800ml)，特别是500ml。
本发明提供一种雾化吸入袋的制备方法，包括以下步骤：将原料和辅料混合后加入搅拌机中，混合均匀得到混合物，搅拌均匀，挤压机将其加热，得到管装塑料薄膜，即得所述的雾化吸入袋。
具体地，该方法还包括成型步骤，例如通过挤出、吹塑等方法成型。
在本发明第三方面，提供第一方面所述的雾化吸入袋在制备雾化吸入给药的装置中的应用。
具体地，该应用为上述雾化吸入袋在制备用于呼吸***疾病的预防和/或治疗药物的雾化吸入给药的装置中的应用。
具体地，所述药物为疫苗。具体地，该药物为疫苗，例如肺炎球菌疫苗、流感疫苗、冠状病毒疫苗、水痘疫苗、新城病毒疫苗、麻疹疫苗、结核疫苗、尘螨过敏疫苗等。
在本发明第四方面，提供一种雾化吸入给药装置，其包含本发明第一方面所述的雾化吸入袋，以及雾化器。
具体地，该雾化器可以为超声波雾化器、压缩雾化器、振动网筛雾化器等合适的雾化器，特别是振动网筛雾化器。
在本发明第五方面，提供一种雾化吸入给药方法，其包括通过第一方面所述的雾化吸入袋向受试者施用药物的步骤。
具体地，该方法为雾化吸入免疫方法，其中药物为疫苗，例如肺炎球菌疫苗、流感疫苗、冠状病毒疫苗、水痘疫苗、新城病毒疫苗、麻疹疫苗、结核疫苗、尘螨过敏疫苗等；在本发明的一些实施例中，该疫苗为冠状病毒疫苗，特别是SARS-CoV-2疫苗。
具体地，该方法包括如下步骤：
(1)通过雾化器将药物雾化；
(2)通过所述雾化吸入袋收集步骤(1)所产生的药物雾气；
(3)受试者通过雾化吸入袋的吸嘴吸入药物雾气。
具体地，完成雾气收集后30秒(s)内(例如20s，15s，10s，5s)进行步骤(3)，特别是，在完成雾气收集后10s内进行步骤(3)。
具体地，步骤(1)中的雾化器可以为振动网筛雾化器、定量压力气雾剂给药器，软雾给药器等合适的雾化器，特别是振动网筛雾化器。
使用前先用手将雾化袋拉撑开。雾化药液时产生雾气通过雾化口进入袋中，受试者可通过雾化口吸嘴吸入雾气实现接种。接种完毕后，可拧上盖子，可确保袋中雾气残留不会外溢至空气中，保护环境不被生物制品污染。
具体地，该雾化吸入袋为一次性使用，避免交叉感染。
本发明提供的雾化吸入袋可用于呼吸***疾病的预防和/或治疗药物的雾化吸入给药。雾化治疗主要指气溶胶吸入疗法。所谓气溶胶是指悬浮于空气中微小的固体或液体微粒。因此雾化吸入疗法是用雾化的装置将药物分散成微小的雾滴或微粒，使其悬浮于气体中，并进入呼吸道及肺内。
本发明所述的雾化吸入袋，综合考虑引起雾粒沉积的多种机制，包括但不限于撞击沉积、重力沉积、弥散沉积、静电吸引沉积和拦截沉积等，提供雾化性能稳定且优异的雾化吸入袋。
本发明所述的雾化吸入袋，适用于大规模接种，解决了雾化杯不方便运输，能够防止交叉感染同时又降低成本、且吸入接种效率高。
附图说明
图1.不同电阻率袋体雾化后袋内制剂残留量
图2.不同厚度雾化袋雾化后药液残留量
图3.不同厚度及电阻率雾化袋雾化后药液残留量
图4.不同材质雾化袋雾化后药液残留量
具体实施方式
除非另有定义，本发明中所使用的所有科学和技术术语具有与本发明涉及技术领域的技术人员通常理解的相同的含义。
在本发明中，“受试者”是指接受本发明所述给药方法(特别是雾化吸入免疫方法)的人类。
本文所引用的各种出版物、专利和公开的专利说明书，其公开内容通过引用整体并入本文。
下面将结合本发明实施例，对本发明的技术方案进行清楚、完整地描述，显然，所描述的实施例仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
实施例1不同袋体电阻率雾化效果影响
雾化模型药物：康希诺重组新型冠状病毒疫苗(5型腺病毒载体)液体制剂；
雾化量：0.1ml。
吸入条件：15L/min
雾化操作：
实验组：通过TSI气体流量计将真空泵流速标定为15L/min；在雾化器药杯中加入0.1ml重组新型冠状病毒疫苗(5型腺病毒载体)，将其雾化至雾化袋中，雾化袋材质为PE，袋体单层厚度0.1mm，雾化袋经过抗静电处 理，电阻率如下表1所示；分别在雾化完成后静置10s，连接真空泵和雾化袋，将雾化袋中的气体抽出；在雾化袋中加入20ml洗脱液，充分润洗雾化袋内壁；使用qPCR法对洗脱液中5型腺病毒载体定量。
对照组：取0.1ml重组新型冠状病毒疫苗(5型腺病毒载体)加入20ml洗脱液中，混匀；使用qPCR法对洗脱液中5型腺病毒载体定量；
残留量计算方法：雾化袋洗脱液疫苗浓度/对照组疫苗浓度×100％
具体实验分组及结果见表1及图1
表1.不同电阻率雾化袋雾化后药液残留量
实验结果和分析
雾化0.1ml重组新型冠状病毒疫苗，使用的PE材质，电阻率为大于109Ω时，雾气急剧凝结至袋壁，大量雾气残留于袋子。而电阻率为105-109时，在雾化完成10S后，雾化袋内残留量相对最低，残留率均低于50％。
实施例2不同袋体厚度雾化效果影响
雾化模型药物：康希诺重组新型冠状病毒疫苗(5型腺病毒载体)液体制剂；
雾化量：0.1ml。
吸入条件：15L/min
雾化操作：
实验组：通过TSI气体流量计将真空泵流速标定为15L/min；在雾化器药杯中加入康希诺重组新型冠状病毒疫苗(5型腺病毒载体)液体制剂0.1ml，将其雾化至雾化袋中，雾化袋材质为PE，电阻率为109分别在雾化完成后静 置10s，连接真空泵和雾化袋，将雾化袋中的气体抽出；在雾化袋中加入20ml洗脱液，充分润洗雾化袋内壁；使用qPCR法对洗脱液中5型腺病毒载体定量。
对照组：取0.1ml重组新型冠状病毒疫苗(5型腺病毒载体)加入20ml洗脱液中，混匀；使用qPCR法对洗脱液中5型腺病毒载体定量；
残留量计算方法：雾化袋洗脱液疫苗浓度/对照组疫苗浓度×100％
具体实验分组及结果见表2及图2
表2.不同厚度雾化袋雾化后药液残留量
实验结果和分析
雾化0.1ml重组新型冠状病毒疫苗至电阻率为109Ω的雾化袋中，袋体厚度为0.05mm至0.15mm的雾化袋中疫苗残留结果较低，残留率均低于50％。袋体厚度小于0.05mm时雾化袋的成形性较差，在10秒的静置时间内有大量的雾气沉积。袋体后厚度大于0.15mm时，在压褶处，聚集大量液滴，残留率提高。
实施例3不同袋体对雾化效果影响
基于实施例1和2的实验数据，进一步研究电阻率以及袋体厚度共同作用对雾化效果的影响，具体如下：
雾化模型药物：康希诺重组新型冠状病毒疫苗(5型腺病毒载体)液体 制剂；
雾化量：0.1ml。
吸入条件：15L/min
雾化操作：
实验组：通过TSI气体流量计将真空泵流速标定为15L/min；在雾化器药杯中加入康希诺重组新型冠状病毒疫苗(5型腺病毒载体)液体制剂0.1ml，将其雾化至雾化袋中，雾化袋材质为PE，电阻率和袋体厚度如下表3所示，分别在雾化完成后静置10s，连接真空泵和雾化袋，将雾化袋中的气体抽出；在雾化袋中加入20ml洗脱液，充分润洗雾化袋内壁；使用qPCR法对洗脱液中5型腺病毒载体定量。
对照组：取0.1ml重组新型冠状病毒疫苗(5型腺病毒载体)加入20ml洗脱液中，混匀；使用使用qPCR法对洗脱液中5型腺病毒载体定量；
残留量计算方法：雾化袋洗脱液疫苗浓度/对照组疫苗浓度×100％
具体实验分组及结果见表3及图3
表3.不同厚度及电阻率雾化袋雾化后药液残留量

实验结果和分析
通过实验验证，雾化0.1ml重组新型冠状病毒疫苗，当袋体电阻率为105-109Ω，厚度为0.05mm-0.15mm的雾化袋中疫苗残留均较低且结果稳定。其中更优选的范围为电阻率为106-109Ω，袋体厚度为0.05mm至0.1mm的雾化袋。
实施例4不同袋体材质对雾化效果影响
根据实施例1-3的结果，电阻率为106-109Ω，袋体厚度为0.05-0.1mm时，雾化效果最佳，基于此进一步验证不同袋体材质对雾化效果的影响。
雾化模型药物：康希诺重组新型冠状病毒疫苗(5型腺病毒载体)液体制剂；
雾化量：0.1ml。
吸入条件：15L/min
雾化操作：
实验组：通过TSI气体流量计将真空泵流速标定为15L/min；在雾化器药杯中加入康希诺重组新型冠状病毒疫苗(5型腺病毒载体)液体制剂0.1ml，袋体厚度为0.1mm，袋体电阻率为109，袋体材质如下表4所示，分别在雾化完成后静置10s，连接真空泵和雾化袋，将雾化袋中的气体抽出；在雾化袋中加入20ml洗脱液，充分润洗雾化袋内壁；使用qPCR法对洗脱液中5型腺病毒载体定量。
对照组：取0.1ml重组新型冠状病毒疫苗(5型腺病毒载体)加入20ml洗脱液中，混匀；使用使用qPCR法对洗脱液中5型腺病毒载体定量；
残留量计算方法：雾化袋洗脱液疫苗浓度/对照组疫苗浓度×100％
具体实验分组及结果见表4及图4
表4.不同材质雾化袋雾化后药液残留量

实验结果和分析
不同袋体材质对雾化效果均无影响，与雾化杯无显著差异。
实施例5不同袋体材质对气溶胶粒径影响
根据实施例1-3的结果，电阻率为大于106-109，袋体厚度为0.05-0.1mm时，雾化效果最佳，基于此进一步验证不同袋体材质对雾化效果的影响。
雾化模型药物：康希诺重组新型冠状病毒疫苗(5型腺病毒载体)液体制剂；
雾化量：0.1ml。
吸入条件：15L/min
雾化操作：
实验组：通过TSI气体流量计将吸入制剂粒度检测仪(Helos inhaler，sympatec GmbH)流速标定为15L/min；在雾化器药杯中加入康希诺重组新型冠状病毒疫苗(5型腺病毒载体)液体制剂0.1ml，袋体厚度为0.05mm，袋体电阻率为108，袋体材质如下表4所示，分别在雾化后静置10s，10s后雾化袋至吸入制剂粒度检测仪，检测雾化器中气溶胶粒径情况：
具体实验分组及结果见表5
表5.不同材质雾化袋雾化后气溶胶粒径分布
实验结果和分析
疫苗雾化至不同材料的雾化袋，在静置10s后的粒径分布与雾化杯无显著差异。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换等，均应包含在本发明的保护范围之内。
本发明中描述的前述实施例和方法可以基于本领域技术人员的能力、经验和偏好而有所不同。
本发明中仅按一定顺序列出方法的步骤并不构成对方法步骤顺序的任何限制。

Claims (20)

  1. 一种雾化吸入袋，其特征在于，包含袋体和袋盖，所述雾化袋体单层厚度为0.01-0.5mm，优选地为0.01-0.2mm，优选地为0.05mm-0.15mm，优选为0.05-0.1mm。
  2. 根据权利要求1所述的雾化吸入袋，其特征在于，所述雾化袋身内层表面电阻率：101-1020Ω，优选地105-1010Ω；更优选地，为105-109Ω；更优选地，为106-109Ω。
  3. 根据权利要求1或2中任一项所述的雾化吸入袋，其特征在于，所述雾化吸入袋的材质为塑料，镀金属塑料或纸；优选为塑料，所述塑料选自：聚乙烯(PE)、双向拉伸聚丙烯、聚丙烯(PP)、聚氯乙烯(PVC)、聚苯乙烯(PS)、聚酯、乙烯-醋酸乙烯、聚偏氯乙烯、尼龙、聚偏二氯乙烯、聚碳酸酯(PC)、聚酰胺、聚乳酸(PLA)、聚乙烯赛璐玢、防潮赛璐玢、防潮赛璐玢(氯乙烯)中的一种或多种；优选地，所述聚乙烯选自低密度聚乙烯、中密度聚乙烯、高密度聚乙烯；优选地为低密度聚乙烯；优选地，聚氯乙烯选自软质聚氯乙烯、硬质聚氯乙烯；优选地，为PP/K4535和/或PP/S25。
  4. 根据权利要求1-3中任一项所述的雾化吸入袋，其特征在于，优选地，所述雾化吸入袋中添加有抗静电剂。
  5. 根据权利要求1-4任一项所述的雾化吸入袋，其特征在于，以质量百分比计，所述雾化吸入袋中添加抗静电剂的含量为0.01-20％；优选地，为0.03％-10％或0.05-5％或0.03％-10％或0.02％-5％或0.01％-15％或0.1％-5％或1％-10％或2％-10％或5％-15％。
  6. 根据权利要求4-5任一项所述的雾化吸入袋，其特征在于，其中所述抗静电剂为阴离子型抗静电剂、两性离子型抗静电剂、非离子型抗静电剂、高分子型抗静电剂中的一种或多种的组合。
  7. 根据权利要求6所述的雾化吸入袋，其特征在于，所述阴离子型抗静电剂为烷基磺酸盐类、磷酸烷基酯类、马来酸酐与其他单体共聚物盐类、聚 丙烯酸盐、聚苯乙烯磺酸盐一种或多种的组合；所述两性离子型抗静电剂为两性烷基咪唑啉盐、烷基氨基酸；所述非离子型抗静电剂为脂肪酸多元醇酯、聚氧化乙烯附加物一种或多种的组合；所述高分子型抗静电剂为聚氧化乙烯脂肪醚、聚氧化乙烯烷基苯醚、聚乙二醇脂肪酸酯、聚丙烯酸衍生物一种或多种的组合。
  8. 根据权利要求6任一项所述的雾化吸入袋，其特征在于，所述非离子型抗静电剂优选为脂肪醇聚氧乙烯醚、烷基酚聚氧乙烯醚、甘油单脂肪酸酯一种或多种的组合；所述两性离子型抗静电剂优选为烷基二羧甲基铵乙内酯、十二烷基二甲基甜菜碱一种或其组合；所述高分子型抗静电剂优选为乙二胺的环氧乙烷环氧丙烷加成物、聚4-乙烯吡啶型聚皂、辛烷基苯乙烯和苯乙烯磺酸共聚型聚皂一种或多种的组合。
  9. 根据权利要求1-8任一项所述的雾化吸入袋，其特征在于，所述雾化吸入袋的内层材质与外层材质不同。
  10. 根据权利要求1-9任一项所述的雾化吸入袋，其特征在于，所述雾化袋身静电衰减小于0.1秒，优选地为小于0.01、0.02、0.03、0.04、0.05秒。
  11. 根据权利要求1-10任一项所述的雾化吸入袋，其特征在于，所述袋盖上开设有雾气入口及吸嘴；优选地，吸嘴内径为5-50mm；更优选地，吸嘴内径为15-25mm。
  12. 根据权利要求1-11任一项所述的雾化吸入袋，其特征在于，所述雾化吸入袋的容积为100-1000ml，优选为300-800ml，优选为200ml-500ml。
  13. 根据权利要求1-12任一项，其特征在于，所述雾化吸入袋还添加有交联剂，其中按聚合物重量为100重量％计，所述交联剂的用量不超过2重量％。
  14. 根据权利要求1-13任一项所述的雾化吸入袋，其特征在于，所述雾化吸入袋还含有其他医用材料可接受的功能性辅料；优选地，包括相容剂、抗菌剂和/或防雾剂。
  15. 一种雾化吸入袋，其特征在于，所述雾化袋身内层表面电阻率： 101-1020Ω，优选地105-1010Ω；更优选地，为105-109Ω；更优选地，为106-109Ω。
  16. 一种如权利要求1-15任一所述雾化吸入袋的制备方法，其特征在于，包括以下步骤：将聚合物和辅料混合后加入搅拌机中，混合均匀得到混合物，搅拌均匀，挤压机将其加热，得到管装塑料薄膜，即得。
  17. 权利要求1-15任一项所述的雾化吸入袋在制备雾化吸入给药的装置中的应用。
  18. 根据权利要求17所述的应用，其特征在于，所述应用为所述雾化吸入袋在制备用于呼吸***疾病的预防和/或治疗药物的雾化吸入给药的装置中的应用。
  19. 根据权利要求18所述的应用，其特征在于，所述药物为疫苗。
  20. 一种雾化吸入给药装置，其特征在于，其包含权利要求1-15任一项所述的雾化吸入袋，以及雾化器。
PCT/CN2023/133971 2022-11-24 2023-11-24 一种雾化吸入袋及其在雾化吸入给药中的应用 WO2024109930A1 (zh)

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CN116173358A (zh) * 2021-11-29 2023-05-30 康希诺生物股份公司 一种雾化杯及其在雾化吸入给药中的应用
CN219814705U (zh) * 2022-08-04 2023-10-13 康希诺生物股份公司 一种具有双层结构的雾化吸入给药用自立袋

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1213975A (zh) * 1996-03-22 1999-04-14 阿斯特拉公司 吸入装置的构件
CN104640589A (zh) * 2012-04-20 2015-05-20 Fsc实验室有限公司 吸入装置和***以及包括该装置和***的方法
CN114522152A (zh) * 2015-03-11 2022-05-24 艾利斯达医药品公司 气道中的防静电材料用于热气溶胶凝结方法的用途
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