WO2023130850A1 - Plasma pathogen inactivation treatment method based on riboflavin photochemical method - Google Patents

Plasma pathogen inactivation treatment method based on riboflavin photochemical method Download PDF

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WO2023130850A1
WO2023130850A1 PCT/CN2022/133877 CN2022133877W WO2023130850A1 WO 2023130850 A1 WO2023130850 A1 WO 2023130850A1 CN 2022133877 W CN2022133877 W CN 2022133877W WO 2023130850 A1 WO2023130850 A1 WO 2023130850A1
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bag
riboflavin
plasma
light
pathogen inactivation
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PCT/CN2022/133877
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French (fr)
Chinese (zh)
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潘维超
王艺玮
何琴玲
肖国锋
周军
李郑
胡政芳
潘庆
赵婷
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南京双威生物医学科技有限公司
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Publication of WO2023130850A1 publication Critical patent/WO2023130850A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0029—Radiation
    • A61L2/0047—Ultraviolet radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/22—Blood or products thereof

Definitions

  • the invention relates to the technical field of pathogen inactivation of blood components, in particular to a plasma pathogen inactivation treatment method based on riboflavin photochemical method.
  • S/D method organic solvent/detergent mixture method
  • methylene blue photochemical method methylene blue photochemical method
  • psoralen photochemical method riboflavin photochemical method.
  • studies have confirmed that: the S/D method is ineffective against non-lipid enveloped viruses; the inactivation effect of methylene blue photochemical method on non-lipid enveloped viruses is inconsistent, and may cause long-term side effects clinically; psoralen has potential toxicity.
  • riboflavin photochemical method is: the riboflavin structure of riboflavin can make it bind to the DNA or RNA nucleic acid chain, under the irradiation of ultraviolet light, absorb the energy of photons, and pass through the 1,10 positions on the isoalloxazine
  • the reversible redox reaction of nitrogen atoms transfers electrons, which breaks the guanine residues on the nucleic acid chain, resulting in changes in the structure of the nucleic acid chain of the pathogen, causing the pathogen to lose its replication activity, destroying the nucleic acid or preventing the replication and transcription of the nucleic acid.
  • Non-enveloped viruses, intracellular viruses, bacteria and protozoa can be effectively inactivated, and the virus inactivation spectrum is quite wide.
  • the riboflavin product after light irradiation is the same as its normal metabolite in the human body, and what is produced is only the protein derivative produced by the combination of photochromant and protein with riboflavin, without distortion and mutagenesis.
  • the results of clinical toxicity test prove that riboflavin and its light products have not found any toxic reaction in in vivo and in vitro models.
  • riboflavin photochemically inactivates pathogens in a wide range is safe and non-toxic, and the protein in plasma after treatment is stable, it has been widely studied and applied, especially in the field of biomedicine. Therefore, it is very necessary to design and develop a treatment method and a corresponding treatment system for riboflavin photochemical inactivation of plasma pathogens to meet the market demand for such products.
  • the present invention provides a plasma pathogen inactivation treatment method based on the riboflavin photochemical method.
  • the technical scheme adopted in the present invention is as follows: a plasma pathogen inactivation treatment method based on riboflavin photochemical method, the plasma added with riboflavin medicinal liquid is irradiated under narrow-band ultraviolet light within the wavelength range of 300-308nm, The light energy is calculated as 0.55 ⁇ 0.65J/mL, and the overall thickness of the light bag containing plasma is not greater than 9.5mm during the light.
  • Step S1. Prepare riboflavin medicinal solution
  • Step S2 The plasma is mixed with the riboflavin solution, and transferred to the light bag;
  • Step S3. Irradiating the light bag under narrow-band ultraviolet light
  • Step S4 Transfer the plasma in the light bag to the blood storage bag.
  • step S1 is specifically as follows: sieve the riboflavin raw material drug under the condition of avoiding light, add it into physiological saline, heat it in a water bath until it is completely dissolved, and prepare a riboflavin drug solution with a concentration of 450-550 ⁇ mol/L.
  • step S2 is specifically:
  • Step S2.1 Add the riboflavin medicinal solution to the medicinal solution bag for shading treatment;
  • Step S2.2 Connect the original blood bag, drug solution bag and light bag in sequence
  • Step S2.3 Turn on the switch on the catheter, so that the plasma in the original blood bag enters the drug solution bag under the action of gravity, mixes with the riboflavin drug solution in the drug solution bag, and further enters the light bag.
  • step S2 the leukocyte filtration operation is performed before the blood plasma is mixed with the riboflavin liquid.
  • step S3 is specifically:
  • Step S3.1 Heat sealing to remove the liquid medicine bag and the corresponding catheter, if there is a white blood cell filter component on the catheter, heat sealing and removal;
  • Step S3.2 Place the light bag under narrow and wide ultraviolet light with a wavelength range of 300-308nm for 10-40 minutes, and the power of the ultraviolet lamp is 40W.
  • the riboflavin drug solution is stored in a drug solution bag, and the drug solution bag is made of a calendered film or a three-layer co-extruded film.
  • the drug solution bag stores 30-40 mL of riboflavin drug solution with a concentration of 450-550 ⁇ mol/L, and the light-emitting bag can hold 1-2 units of plasma.
  • a light-shielding bag is arranged outside the medicine solution bag, and the medicine solution bag, the light-emitting bag and the blood storage bag are sequentially connected to form a joint bag.
  • a white blood cell filter assembly is provided on the catheter of the medical solution bag used to connect to the original blood bag.
  • the overall thickness of the light bag is controlled within 9.5mm, which can improve the light performance and ensure the inactivation effect of pathogens, further reduce the light energy demand and reduce the damage to blood components;
  • the bag can also be equipped with a white blood cell filter to remove white blood cells and protein precipitates in the plasma, so that it can be applied to cryoprecipitated plasma.
  • Fig. 1 is a flow chart of the plasma pathogen inactivation treatment method according to the embodiment of the present invention.
  • Fig. 2 is a schematic diagram of a joint bag in an embodiment of the present invention.
  • Fig. 3 is a schematic diagram of another joint bag in the embodiment of the present invention.
  • Liquid medicine bag 1 shading bag 101; light bag 2; blood storage bag 3; leukocyte filter assembly 4, filter 401, bypass 402, stop clamp 3; catheter 5; catheter 2; catheter 3 7; Puncture needle 8; Blind-end catheter 9; No. 1 frangible part 10; No. 2 frangible part 11;
  • FIG. 1 it is a flowchart of a plasma pathogen inactivation treatment method based on riboflavin photochemical method, and the specific steps are as follows.
  • Step S1. Prepare riboflavin medicinal solution.
  • riboflavin raw material drug was sieved under the condition of avoiding light, added into physiological saline, heated in a water bath until completely dissolved, and prepared into a riboflavin drug solution with a concentration of 500 ⁇ mol/L.
  • riboflavin physiological saline solution has the advantages of isotonicity with human body, good uniformity, strong stability, and convenient mixing with blood plasma.
  • Step S2 The plasma is mixed with the riboflavin drug solution, and transferred to the light-emitting bag 2 .
  • Step S2.1 Add the riboflavin drug solution to the drug solution bag 1 for light-shielding treatment.
  • Step S2.2 Connect the original blood bag, the drug solution bag 1 and the light bag 2 in sequence.
  • Step S2.3 Open the switch on the catheter (such as a frangible piece), the plasma in the original blood bag enters the drug solution bag 1 under the action of gravity, mixes with the riboflavin drug solution in the drug solution bag 1, and further Enter the light bag 2.
  • the switch on the catheter such as a frangible piece
  • the liquid medicine bag 1 and the illumination bag 2 use calendered films with good biocompatibility, and the medicine liquid bag 1 can also use a three-layer co-extruded film.
  • the liquid medicine bag 1 has a volume of 35mL and requires good airtightness. It is packaged with a light-shielding bag 101 outside to avoid light exposure.
  • the light-shielding bag 101 can be made of aluminum foil, tin foil or metal-plastic composite material; the volume of the light-shielding bag 2 can accommodate 1 ⁇ 2 units of plasma is appropriate, and good light transmittance and airtightness are required.
  • the thickness of the material of the light bag 2 is 0.38mm. During the light treatment, the overall thickness of the light bag 2 after being spread out (ie, the light thickness) is required to be no more than 9.5mm, so as to facilitate the penetration of ultraviolet rays and improve the inactivation effect.
  • the plasma pathogen inactivation treatment method of the present embodiment adopts a combined bag, specifically as shown in Figure 2, the combined bag is composed of No. 1 catheter 5, medicinal solution bag 1, No. 7 and the blood storage bag 3 are sequentially connected to form.
  • the pre-prepared riboflavin drug solution is stored in the drug solution bag 1, and the end of the first catheter 5 away from the drug solution bag 1 is provided with a puncture needle 8 (or blind-end catheter 9), and the inlet and outlet of the drug solution bag 1 are respectively
  • a No. 1 easy-break piece 10 and a No. 2 easy-break piece 11 are provided, and a No. 1 flow-stop clip 12 and a No. 2 flow-stop clip 13 are respectively arranged on the No. 2 conduit 6 and the No. 3 conduit 7 .
  • step 2 The specific operation of step 2 is as follows: connect the puncture needle 8 (or blind-end catheter 9) to the original blood bag (not shown in Figure 2), open the No. Enter the drug solution bag 1 through the puncture needle 4 (or the blind end 5 after aseptic connection) and the No. 1 catheter 5, and at the same time open the No. 2 frangible part 11 at the outlet of the drug solution bag 1 to mix the plasma of the riboflavin drug solution That is, it enters the light bag 2 by gravity. It can be seen that the addition of riboflavin liquid medicine can be completed automatically by using this kind of joint bag, which saves the link of aseptic connection, which not only saves cost, but also reduces the risk of contamination.
  • the white blood cell filter assembly 4 is arranged on the No. 1 catheter 5 and before the medical solution bag 1, and is composed of a filter 401 and a bypass 402, and a No. 3 stop clamp 403 is arranged on the bypass 402.
  • the leukocyte filter assembly 4 can not only remove leukocytes in plasma, but also be suitable for cryoprecipitating plasma to remove protein precipitation and ensure plasma quality.
  • Step 3 Put the light bag 2 under narrow-band ultraviolet light for irradiation.
  • Step 3.1 Heat sealing to remove the drug solution bag 1 and the second catheter 6, if there is a white blood cell filter assembly 4, also remove it.
  • Step 3.2 Flatten the light bag 2, place it under a narrow and wide ultraviolet light with a wavelength range of 300-308nm and a peak of 308nm, and irradiate for 25 minutes, with the power of the ultraviolet lamp tube at 40W.
  • the peaks of ultraviolet light with the best inactivation effect on plasma pathogens are 254nm, 313nm, and 365nm.
  • the ultraviolet light used to inactivate plasma pathogens is mostly broad-spectrum ultraviolet light, and the light energy used is 6.57J/ml, where the light energy is defined by the irradiation energy and the blood volume.
  • Table 1 shows the inactivation effects of different spectra and light energy on Escherichia coli
  • Table 2 shows the inactivation effects of 308nm narrow-band ultraviolet light on different viruses.
  • Virus 308nm Regular broad-spectrum UV light E. coli 4.9 4.3 Phage 2.1 2.35 Hepatitis C virus (HCV) >2.0 3.15 Encephalomyocarditis virus (EMCV) >5.0 3.15 Hepatitis B virus (HBV) >3.15 2.35 Vesicular stomatitis virus (VSV) >4.9 the
  • narrow-band ultraviolet light with a wavelength of 300-308nm, especially a wavelength of 308nm has a good effect on the inactivation of plasma pathogens, can reduce the demand for light energy, increase the inactivation effect, and reduce the loss of plasma components. less.
  • Step 4 Transfer the plasma in the light exposure bag 2 to the blood storage bag 3 .

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Abstract

Disclosed in the present invention is a plasma pathogen inactivation treatment method based on a riboflavin photochemical method, comprising: placing plasma to which riboflavin is added under narrow-spectrum ultraviolet light within the wavelength range of 300-308 nm for irradiation, wherein the illumination energy is 0.55-0.65 J/mL, and the whole thickness of an illumination bag during illumination is not greater than 9.5 mm. According to the present invention, narrow-spectrum ultraviolet rays having a specific wavelength and a specific illumination energy condition are selected to perform treatment on plasma to which a riboflavin liquid medicine is added, and the whole thickness of the illumination bag during illumination is controlled to be within 9.5 mm, and thus, the present invention has a good pathogen inactivation effect, and has small damage on blood components; riboflavin powder is dissolved by using normal saline, so that the liquid medicine is isotonic to a human body, and the liquid medicine is good in uniformity, high in stability, and convenient to prepare; a combined bag formed by combining a liquid medicine bag, the illumination bag, and a blood storage bag is used, so that sterile connection in an existing method is omitted, the cost is reduced, and the risk of pollution is reduced; and the combined bag is further provided with a leukocyte filter to remove leukocytes and protein precipitates in the plasma, so that the method can be suitable for cryoprecipitation of the plasma.

Description

一种基于核黄素光化学法的血浆病原体灭活处理方法A kind of plasma pathogen inactivation treatment method based on riboflavin photochemical method 技术领域technical field
本发明涉及血液成分病原体灭活技术领域，具体涉及一种基于核黄素光化学法的血浆病原体灭活处理方法。The invention relates to the technical field of pathogen inactivation of blood components, in particular to a plasma pathogen inactivation treatment method based on riboflavin photochemical method.
背景技术Background technique
血液制品的应用存在一定风险，例如筛查方法的“窗口期”问题、免疫静默感染、试剂灵敏度差异造成的漏检、筛查方法本身的局限性以及出现无法检测的新型病毒等。为了提高血液制品的安全性，除加强无偿献血者的征询体检和病原检测外，在不影响血液成分的结构、功能及对人体无不良反应的前提下，对血制品进行病原体灭活处理是杜绝输血传染病的重要手段。There are certain risks in the application of blood products, such as the "window period" of screening methods, immune silent infection, missed detection caused by differences in reagent sensitivity, limitations of screening methods themselves, and the emergence of new viruses that cannot be detected. In order to improve the safety of blood products, in addition to strengthening the physical examination and pathogen detection of voluntary blood donors, on the premise of not affecting the structure and function of blood components and having no adverse reactions to the human body, pathogen inactivation treatment of blood products is the Important means of blood transfusion infectious diseases.
现有的血液成分光化学病原体灭活技术主要包括有机溶剂/去污剂混合物法（S/D法）、亚甲蓝光化学法、补骨脂素光化学法及核黄素光化学法。近年来有研究证实：S/D法对非脂包膜病毒无效；亚甲蓝光化学法对非脂包膜病毒的灭活效果不一致，临床上可能引起远期的副作用；补骨脂素具有潜在的毒性。Existing photochemical pathogen inactivation technologies for blood components mainly include organic solvent/detergent mixture method (S/D method), methylene blue photochemical method, psoralen photochemical method and riboflavin photochemical method. In recent years, studies have confirmed that: the S/D method is ineffective against non-lipid enveloped viruses; the inactivation effect of methylene blue photochemical method on non-lipid enveloped viruses is inconsistent, and may cause long-term side effects clinically; psoralen has potential toxicity.
核黄素光化学法的原理是：核黄素的核醇结构可以使其结合到DNA或RNA核酸链上，在紫外光的照射下，吸收光子的能量，通过异咯嗪上的1,10位氮原子的可逆氧化还原反应转移电子，使核酸链上的鸟嘌呤残基断裂，导致病原体核酸链结构发生改变，使病原体丧失复制活性，破坏核酸或阻止核酸的复制和转录，对包膜病毒、非包膜病毒、细胞内病毒、细菌及原生动物等均能有效灭活，病毒灭活谱相当广泛。而且，光照射后的核黄素产物与其在人体内正常代谢产物相同，产生的只是光色剂和蛋白与核黄素结合产生的蛋白衍生物，无致畸变和致突变作用。临床毒性测验结果证明，核黄素及其光照产物在体内外模型中未发现任何毒性反应。The principle of riboflavin photochemical method is: the riboflavin structure of riboflavin can make it bind to the DNA or RNA nucleic acid chain, under the irradiation of ultraviolet light, absorb the energy of photons, and pass through the 1,10 positions on the isoalloxazine The reversible redox reaction of nitrogen atoms transfers electrons, which breaks the guanine residues on the nucleic acid chain, resulting in changes in the structure of the nucleic acid chain of the pathogen, causing the pathogen to lose its replication activity, destroying the nucleic acid or preventing the replication and transcription of the nucleic acid. Non-enveloped viruses, intracellular viruses, bacteria and protozoa can be effectively inactivated, and the virus inactivation spectrum is quite wide. Moreover, the riboflavin product after light irradiation is the same as its normal metabolite in the human body, and what is produced is only the protein derivative produced by the combination of photochromant and protein with riboflavin, without distortion and mutagenesis. The results of clinical toxicity test prove that riboflavin and its light products have not found any toxic reaction in in vivo and in vitro models.
技术问题technical problem
由于核黄素光化学法灭活病原体范围广泛、安全无毒、处理后血浆中蛋白稳定，现被广泛研究和应用，尤其是应用在生物医学领域。因此设计开发核黄素光化学法灭活血浆病原体的处理方法及对应的处理***，以适应市场对于此类产品的需求，是非常必要的。Because riboflavin photochemically inactivates pathogens in a wide range, is safe and non-toxic, and the protein in plasma after treatment is stable, it has been widely studied and applied, especially in the field of biomedicine. Therefore, it is very necessary to design and develop a treatment method and a corresponding treatment system for riboflavin photochemical inactivation of plasma pathogens to meet the market demand for such products.
技术解决方案technical solution
为了能更好的将核黄素光化学法应用到血液成分病原体灭活中，以实现提高血液制品安全性的目的，本发明提供了一种基于核黄素光化学法的血浆病原体灭活处理方法。In order to better apply the riboflavin photochemical method to the inactivation of pathogens in blood components to achieve the purpose of improving the safety of blood products, the present invention provides a plasma pathogen inactivation treatment method based on the riboflavin photochemical method.
本发明采用的技术方案如下：一种基于核黄素光化学法的血浆病原体灭活处理方法，将添加有核黄素药液的血浆置于波长300~308nm范围内的窄谱紫外光下照射，光照能量按0.55~0.65J/mL计，光照时光照袋含血浆的整体厚度不大于9.5mm。The technical scheme adopted in the present invention is as follows: a plasma pathogen inactivation treatment method based on riboflavin photochemical method, the plasma added with riboflavin medicinal liquid is irradiated under narrow-band ultraviolet light within the wavelength range of 300-308nm, The light energy is calculated as 0.55~0.65J/mL, and the overall thickness of the light bag containing plasma is not greater than 9.5mm during the light.
优选的，具体步骤如下：Preferably, the specific steps are as follows:
步骤S1. 制备核黄素药液；Step S1. Prepare riboflavin medicinal solution;
步骤S2. 将血浆与核黄素药液混合，并转移至光照袋；Step S2. The plasma is mixed with the riboflavin solution, and transferred to the light bag;
步骤S3. 将光照袋置于窄谱紫外光下照射；Step S3. Irradiating the light bag under narrow-band ultraviolet light;
步骤S4. 将光照袋内的血浆转移至贮血袋。Step S4. Transfer the plasma in the light bag to the blood storage bag.
优选的，步骤S1具体为：将核黄素原料药在避光条件下过筛，加入生理盐水中，水浴加热至完全溶解，制备成浓度450~550μmol/L的核黄素药液。Preferably, step S1 is specifically as follows: sieve the riboflavin raw material drug under the condition of avoiding light, add it into physiological saline, heat it in a water bath until it is completely dissolved, and prepare a riboflavin drug solution with a concentration of 450-550 μmol/L.
优选的，步骤S2具体为：Preferably, step S2 is specifically:
步骤S2.1. 将核黄素药液添加至药液袋，作遮光处理；Step S2.1. Add the riboflavin medicinal solution to the medicinal solution bag for shading treatment;
步骤S2.2.依次连接原血袋、药液袋及光照袋；Step S2.2. Connect the original blood bag, drug solution bag and light bag in sequence;
步骤S2.3. 打开导管上的开关，使原血袋内的血浆在重力作用下进入药液袋、与药液袋内的核黄素药液混合，并进一步进入光照袋。Step S2.3. Turn on the switch on the catheter, so that the plasma in the original blood bag enters the drug solution bag under the action of gravity, mixes with the riboflavin drug solution in the drug solution bag, and further enters the light bag.
优选的，步骤S2中，血浆与核黄素药液混合前进行白细胞过滤操作。Preferably, in step S2, the leukocyte filtration operation is performed before the blood plasma is mixed with the riboflavin liquid.
优选的，步骤S3具体为：Preferably, step S3 is specifically:
步骤S3.1. 热合去除药液袋及对应导管，导管上若设有白细胞过滤组件，也一并热合去除；Step S3.1. Heat sealing to remove the liquid medicine bag and the corresponding catheter, if there is a white blood cell filter component on the catheter, heat sealing and removal;
步骤S3.2. 将光照袋置于波长范围为300~308nm的窄宽紫外光下，照射10~40min，紫外灯管功率为40W。Step S3.2. Place the light bag under narrow and wide ultraviolet light with a wavelength range of 300-308nm for 10-40 minutes, and the power of the ultraviolet lamp is 40W.
优选的，核黄素药液储存在药液袋中，药液袋采用压延膜或三层共挤膜制造。Preferably, the riboflavin drug solution is stored in a drug solution bag, and the drug solution bag is made of a calendered film or a three-layer co-extruded film.
优选的，药液袋内储存30~40mL、浓度450~550μmol/L的核黄素药液，光照袋可容纳1~2单位血浆。Preferably, the drug solution bag stores 30-40 mL of riboflavin drug solution with a concentration of 450-550 μmol/L, and the light-emitting bag can hold 1-2 units of plasma.
优选的，药液袋外配遮光袋，且药液袋、光照袋及贮血袋依次连接组成联袋。Preferably, a light-shielding bag is arranged outside the medicine solution bag, and the medicine solution bag, the light-emitting bag and the blood storage bag are sequentially connected to form a joint bag.
优选的，药液袋用于连接原血袋的导管上设置有白细胞过滤组件。Preferably, a white blood cell filter assembly is provided on the catheter of the medical solution bag used to connect to the original blood bag.
有益效果Beneficial effect
本发明具有如下有益效果：The present invention has following beneficial effect:
1.选择特定波长（300~308nm）与特定光照能量条件（0.55~0.65J/mL）的窄谱紫外线对添加有核黄素的血浆进行处理，具有良好的病原体灭活效果，对血液成分的损伤也比较小；1. Select specific wavelength (300~308nm) and specific light energy conditions (0.55~0.65J/mL) of narrow-band ultraviolet rays to treat the plasma added with riboflavin, which has a good pathogen inactivation effect and has a good effect on blood components. The damage is also relatively small;
2. 光照袋的整体厚度控制在9.5mm内，能提高光照性能，保证病原体灭活效果的前提下，进一步降低光照能量需求，减小对血液成分的损伤；2. The overall thickness of the light bag is controlled within 9.5mm, which can improve the light performance and ensure the inactivation effect of pathogens, further reduce the light energy demand and reduce the damage to blood components;
3. 采用生理盐水溶解核黄素粉末，使核黄素药液与人体等渗，而且药液的均一性好，稳定性强，制备也方便；3. Dissolve the riboflavin powder with physiological saline, so that the riboflavin liquid is isotonic with the human body, and the liquid has good uniformity, strong stability and convenient preparation;
4. 应用了药液袋、光照袋及贮血袋相结合的联袋，省去了现有方法中无菌接驳的环节，节约成本，降低污染的风险；4. The joint bag combining the liquid medicine bag, the light bag and the blood storage bag is applied, which saves the link of aseptic connection in the existing method, saves cost and reduces the risk of contamination;
5.同时联袋还可设置白细胞过滤器，以去除血浆中的白细胞与蛋白质沉淀，从而能适用于冷沉淀血浆。5. At the same time, the bag can also be equipped with a white blood cell filter to remove white blood cells and protein precipitates in the plasma, so that it can be applied to cryoprecipitated plasma.
附图说明Description of drawings
图1是本发明实施例血浆病原体灭活处理方法的流程图。Fig. 1 is a flow chart of the plasma pathogen inactivation treatment method according to the embodiment of the present invention.
图2是本发明实施例中联袋示意图。Fig. 2 is a schematic diagram of a joint bag in an embodiment of the present invention.
图3是本发明实施例中另一种联袋的示意图。Fig. 3 is a schematic diagram of another joint bag in the embodiment of the present invention.
药液袋1，遮光袋101；光照袋2；贮血袋3；白细胞过滤组件4，滤器401，旁路402，三号止流夹403；一号导管5；二号导管6；三号导管7；穿刺针8；盲端导管9；一号易折件10；二号易折件11；一号止流夹12；二号止流夹13。Liquid medicine bag 1, shading bag 101; light bag 2; blood storage bag 3; leukocyte filter assembly 4, filter 401, bypass 402, stop clamp 3; catheter 5; catheter 2; catheter 3 7; Puncture needle 8; Blind-end catheter 9; No. 1 frangible part 10; No. 2 frangible part 11;
本发明的实施方式Embodiments of the present invention
下面结合实施例与附图，对本发明作进一步说明。The present invention will be further described below in conjunction with the embodiments and accompanying drawings.
本实施例中，如图1所示，为一种基于核黄素光化学法的血浆病原体灭活处理方法的流程图，具体步骤如下。In this embodiment, as shown in FIG. 1 , it is a flowchart of a plasma pathogen inactivation treatment method based on riboflavin photochemical method, and the specific steps are as follows.
步骤 S1. 制备核黄素药液。 Step S1. Prepare riboflavin medicinal solution.
将核黄素原料药在避光条件下过筛，加入生理盐水中，水浴加热至完全溶解，制备成浓度为500μmol/L的核黄素药液。核黄素生理盐水溶液与粉末核黄素相比，具有与人体等渗，均一性好，稳定性强，方便与血浆混合等优点。The riboflavin raw material drug was sieved under the condition of avoiding light, added into physiological saline, heated in a water bath until completely dissolved, and prepared into a riboflavin drug solution with a concentration of 500 μmol/L. Compared with riboflavin powder, riboflavin physiological saline solution has the advantages of isotonicity with human body, good uniformity, strong stability, and convenient mixing with blood plasma.
步骤 S2. 将血浆与核黄素药液混合，并转移至光照袋2。 Step S2. The plasma is mixed with the riboflavin drug solution, and transferred to the light-emitting bag 2 .
步骤S2.1. 将核黄素药液添加至药液袋1，作遮光处理。Step S2.1. Add the riboflavin drug solution to the drug solution bag 1 for light-shielding treatment.
步骤S2.2.依次连接原血袋、药液袋1及光照袋2。Step S2.2. Connect the original blood bag, the drug solution bag 1 and the light bag 2 in sequence.
步骤S2.3. 打开导管上的开关件（如易折件），原血袋内的血浆在重力作用下进入药液袋1、与药液袋1内的核黄素药液混合，并进一步进入光照袋2。Step S2.3. Open the switch on the catheter (such as a frangible piece), the plasma in the original blood bag enters the drug solution bag 1 under the action of gravity, mixes with the riboflavin drug solution in the drug solution bag 1, and further Enter the light bag 2.
本实施例中药液袋1、光照袋2采用的是具有生物相容性较好的压延膜，药液袋1也可采用三层共挤膜。药液袋1的容积为35mL，要求良好的密闭性，外部有避免光照射的遮光袋101包装，遮光袋101可以由铝箔纸、锡箔纸或者金属塑料复合材料制造；光照袋2容积以可容纳1~2单位血浆为宜，要求具有良好的透光率和密闭性。光照袋2的材质厚度为0.38mm，光照处理时，光照袋2摊开摆放后的整体厚度（即光照厚度）要求不大于9.5mm，以利于紫外线的穿透，提高灭活效果。In this embodiment, the liquid medicine bag 1 and the illumination bag 2 use calendered films with good biocompatibility, and the medicine liquid bag 1 can also use a three-layer co-extruded film. The liquid medicine bag 1 has a volume of 35mL and requires good airtightness. It is packaged with a light-shielding bag 101 outside to avoid light exposure. The light-shielding bag 101 can be made of aluminum foil, tin foil or metal-plastic composite material; the volume of the light-shielding bag 2 can accommodate 1~2 units of plasma is appropriate, and good light transmittance and airtightness are required. The thickness of the material of the light bag 2 is 0.38mm. During the light treatment, the overall thickness of the light bag 2 after being spread out (ie, the light thickness) is required to be no more than 9.5mm, so as to facilitate the penetration of ultraviolet rays and improve the inactivation effect.
本实施例的血浆病原体灭活处理方法采用的是一种联袋，具体如图2所示，联袋由一号导管5、药液袋1、二号导管6、光照袋2、三号导管7及贮血袋3依次连接组成。其中，药液袋1中存储预先制备好的核黄素药液，一号导管5远离药液袋1的一端设穿刺针8（或盲端导管9），药液袋1的进、出口分别设一号易折件10与二号易折件11，二号导管6与三号导管7上还分别设置有一号止流夹12与二号止流夹13。The plasma pathogen inactivation treatment method of the present embodiment adopts a combined bag, specifically as shown in Figure 2, the combined bag is composed of No. 1 catheter 5, medicinal solution bag 1, No. 7 and the blood storage bag 3 are sequentially connected to form. Among them, the pre-prepared riboflavin drug solution is stored in the drug solution bag 1, and the end of the first catheter 5 away from the drug solution bag 1 is provided with a puncture needle 8 (or blind-end catheter 9), and the inlet and outlet of the drug solution bag 1 are respectively A No. 1 easy-break piece 10 and a No. 2 easy-break piece 11 are provided, and a No. 1 flow-stop clip 12 and a No. 2 flow-stop clip 13 are respectively arranged on the No. 2 conduit 6 and the No. 3 conduit 7 .
步骤2的具体操作如下：将穿刺针8（或盲端导管9）与原血袋（图2中未示出）连接，打开药液袋1进口的一号易折件10，待处理的血浆通过穿刺针4（或无菌接驳后的盲端5）、一号导管5进入药液袋1，同时打开药液袋1出口的二号易折件11，混合核黄素药液的血浆即通过重力作用进入光照袋2。可以看出，采用此种联袋，能自动完成核黄素药液的添加，省去了无菌接驳的环节，既节约成本，又降低污染的风险。The specific operation of step 2 is as follows: connect the puncture needle 8 (or blind-end catheter 9) to the original blood bag (not shown in Figure 2), open the No. Enter the drug solution bag 1 through the puncture needle 4 (or the blind end 5 after aseptic connection) and the No. 1 catheter 5, and at the same time open the No. 2 frangible part 11 at the outlet of the drug solution bag 1 to mix the plasma of the riboflavin drug solution That is, it enters the light bag 2 by gravity. It can be seen that the addition of riboflavin liquid medicine can be completed automatically by using this kind of joint bag, which saves the link of aseptic connection, which not only saves cost, but also reduces the risk of contamination.
如图3所示，为本实施例采用的另一种联袋，此种联袋在前种联袋的基础上还加入了白细胞过滤组件4，用于对原血袋内的血浆进行过滤。具体的，白细胞过滤组件4设置在一号导管5上、药液袋1之前，由滤器401与旁路402组成，旁路402上设三号止流夹403。白细胞过滤组件4不光可以去除血浆中的白细胞，还可以适用于冷沉淀血浆，去除蛋白质沉淀，保证血浆质量。As shown in FIG. 3 , it is another type of combined bag used in this embodiment. This type of combined bag is added with a white blood cell filter module 4 on the basis of the previous type of combined bag for filtering the plasma in the original blood bag. Specifically, the white blood cell filter assembly 4 is arranged on the No. 1 catheter 5 and before the medical solution bag 1, and is composed of a filter 401 and a bypass 402, and a No. 3 stop clamp 403 is arranged on the bypass 402. The leukocyte filter assembly 4 can not only remove leukocytes in plasma, but also be suitable for cryoprecipitating plasma to remove protein precipitation and ensure plasma quality.
步骤 3. 将光照袋2置于窄谱紫外光下照射。 Step 3. Put the light bag 2 under narrow-band ultraviolet light for irradiation.
步骤3.1. 热合去除药液袋1及二号导管6，若有白细胞过滤组件4，也一并去除。Step 3.1. Heat sealing to remove the drug solution bag 1 and the second catheter 6, if there is a white blood cell filter assembly 4, also remove it.
步骤3.2. 将光照袋2摊平，放置于波长范围为300~308nm、波峰为308nm的窄宽紫外光下，照射25min，紫外灯管功率为40W。Step 3.2. Flatten the light bag 2, place it under a narrow and wide ultraviolet light with a wavelength range of 300-308nm and a peak of 308nm, and irradiate for 25 minutes, with the power of the ultraviolet lamp tube at 40W.
通常认为，对血浆病原体灭活效果最好的紫外光波峰为254nm、313nm、365nm。目前用于血浆病原体灭活的紫外光多为宽谱紫外光，使用的光照能量为6.57J/ml，其中光照能量由照射能量与血液量进行定义。表1为不同光谱和光照能量对大肠杆菌灭活效果，表2为308nm窄谱紫外光对不同病毒的灭活效果。It is generally believed that the peaks of ultraviolet light with the best inactivation effect on plasma pathogens are 254nm, 313nm, and 365nm. At present, the ultraviolet light used to inactivate plasma pathogens is mostly broad-spectrum ultraviolet light, and the light energy used is 6.57J/ml, where the light energy is defined by the irradiation energy and the blood volume. Table 1 shows the inactivation effects of different spectra and light energy on Escherichia coli, and Table 2 shows the inactivation effects of 308nm narrow-band ultraviolet light on different viruses.
表1. 不同光谱和光照能量对大肠杆菌灭活效果的比较Table 1. Comparison of inactivation effects of different spectra and light energy on E. coli
紫外光ultraviolet light 光照能量（J/ml）Light energy (J/ml) 病毒灭活效果（log）Virus inactivation effect (log)
宽谱紫外光(200-400nm)Broad-spectrum UV (200-400nm) 6.576.57 E.coli（大肠杆菌）：4.0 E. coli(E. coli): 4.0
365nm365nm 6767 E.coli：6.8 E. coli: 6.8
308nm308nm 0.600.60 E.coli：4.98 E. coli: 4.98
300nm300nm 0.550.55 E.coli：4.21 E. coli: 4.21
表2. 308nm紫外光对不同病毒的灭活效果Table 2. Inactivation effect of 308nm ultraviolet light on different viruses
病毒Virus 308nm308nm 常规宽谱紫外光Regular broad-spectrum UV light
E.coliE. coli 4.94.9 4.34.3
噬菌体Phage 2.12.1 2.352.35
丙型肝炎病毒（HCV）Hepatitis C virus (HCV) >2.0>2.0 3.153.15
脑心肌炎病毒（EMCV）Encephalomyocarditis virus (EMCV) >5.0>5.0 3.153.15
乙肝病毒（HBV）Hepatitis B virus (HBV) >3.15>3.15 2.352.35
水疱性口炎病毒（VSV）Vesicular stomatitis virus (VSV) >4.9>4.9  the
经过比较，采用波长为300~308nm、特别是波长为308nm的窄谱紫外光，对于血浆病原体的灭活具有良好的效果，能降低了光照能量需求，增加了灭活效果，且对血浆成分损失较少。After comparison, the use of narrow-band ultraviolet light with a wavelength of 300-308nm, especially a wavelength of 308nm, has a good effect on the inactivation of plasma pathogens, can reduce the demand for light energy, increase the inactivation effect, and reduce the loss of plasma components. less.
步骤 4. 将光照袋2内的血浆转移至贮血袋3。 Step 4. Transfer the plasma in the light exposure bag 2 to the blood storage bag 3 .
利用重力将光照袋2内的血浆转移至贮血袋3，然后热合去除光照袋2及三号导管7，保存或直接用于临床输入。Use gravity to transfer the plasma in the illumination bag 2 to the blood storage bag 3, then heat seal and remove the illumination bag 2 and the No. 3 catheter 7 for preservation or direct use for clinical input.
显然，本发明的上述实施例仅仅是为了说明本发明所作的举例，而并非对本发明的实施方式的限定。其他由本发明的实质精神所引申出的显而易见的变化或变动仍属于本发明的保护范围。Apparently, the above-mentioned embodiments of the present invention are only examples for illustrating the present invention, rather than limiting the implementation of the present invention. Other obvious changes or changes derived from the essence and spirit of the present invention still fall within the protection scope of the present invention.

Claims (10)

  1. 一种基于核黄素光化学法的血浆病原体灭活处理方法，其特征在于，将添加有核黄素的血浆置于波长300~308nm范围内的窄谱紫外光下照射，光照能量按0.55~0.65J/mL计，光照时光照袋（1）含血浆的整体厚度不大于9.5mm。A plasma pathogen inactivation treatment method based on riboflavin photochemical method, characterized in that the plasma added with riboflavin is irradiated with narrow-band ultraviolet light in the wavelength range of 300-308nm, and the light energy is 0.55-0.65 In terms of J/mL, the overall thickness of the light bag (1) containing plasma is not greater than 9.5mm when the light is illuminated.
  2. 根据权利要求1所述的基于核黄素光化学法的血浆病原体灭活处理方法，其特征在于步骤如下：The plasma pathogen inactivation treatment method based on riboflavin photochemical method according to claim 1, is characterized in that the steps are as follows:
    步骤S1. 制备核黄素药液；Step S1. Prepare riboflavin medicinal solution;
    步骤S2.将血浆与核黄素药液混合，并转移至光照袋（2）；Step S2. Mixing the plasma with the riboflavin solution, and transferring to the light bag (2);
    步骤S3. 将光照袋（2）置于窄谱紫外光下照射；Step S3. Irradiating the light bag (2) under narrow-band ultraviolet light;
    步骤S4. 将光照袋（2）内的血浆转移至贮血袋（3）。Step S4. Transfer the plasma in the light bag (2) to the blood storage bag (3).
  3. 根据权利要求2所述的基于核黄素光化学法的血浆病原体灭活处理方法，其特征在于，步骤S1具体为：将核黄素原料药在避光条件下过筛，加入生理盐水中，水浴加热至完全溶解，制备成浓度450~550μmol/L的核黄素药液。The plasma pathogen inactivation treatment method based on riboflavin photochemical method according to claim 2, characterized in that step S1 is specifically: sieve the riboflavin raw material under light-proof conditions, add it to normal saline, and put it in a water bath Heat until completely dissolved, and prepare a riboflavin solution with a concentration of 450-550 μmol/L.
  4. 根据权利要求2所述的基于核黄素光化学法的血浆病原体灭活处理方法，其特征在于，步骤S2具体为：The plasma pathogen inactivation treatment method based on riboflavin photochemical method according to claim 2, characterized in that, step S2 is specifically:
    步骤S2.1. 将核黄素药液添加至药液袋（1），作遮光处理；Step S2.1. Add the riboflavin drug solution to the drug solution bag (1) for shading treatment;
    步骤S2.2.依次连接原血袋、药液袋（1）及光照袋（2）；Step S2.2. Connect the original blood bag, the liquid medicine bag (1) and the light bag (2) in sequence;
    步骤S2.3. 打开导管上的开关，使原血袋内的血浆在重力作用下进入药液袋（1）、与药液袋（1）内的核黄素药液混合，并进一步进入光照袋（2）。Step S2.3. Turn on the switch on the catheter, so that the plasma in the original blood bag enters the drug solution bag (1) under the action of gravity, mixes with the riboflavin drug solution in the drug solution bag (1), and further enters the light source bags (2).
  5. 根据权利要求2所述的基于核黄素光化学法的血浆病原体灭活处理方法，其特征在于，步骤S2中，血浆与核黄素药液混合前进行白细胞过滤操作。The plasma pathogen inactivation treatment method based on riboflavin photochemical method according to claim 2, characterized in that in step S2, leukocyte filtration operation is performed before the plasma and riboflavin liquid are mixed.
  6. 根据权利要求2所述的基于核黄素光化学法的血浆病原体灭活处理方法，其特征在于，步骤S3具体为：The plasma pathogen inactivation treatment method based on riboflavin photochemical method according to claim 2, characterized in that, step S3 is specifically:
    步骤S3.1. 热合去除药液袋及对应导管，导管上若设有白细胞过滤组件（4），也一并热合去除；Step S3.1. Heat sealing to remove the liquid medicine bag and corresponding catheter, if there is a leukocyte filter assembly (4) on the catheter, heat sealing and removal together;
    步骤S3.2. 将光照袋置于波长范围为300~308nm的窄宽紫外光下，照射10~40min，紫外灯管功率为40W。Step S3.2. Place the light bag under narrow and wide ultraviolet light with a wavelength range of 300-308nm for 10-40 minutes, and the power of the ultraviolet lamp is 40W.
  7. 根据权利要求2所述的基于核黄素光化学法的血浆病原体灭活处理方法，其特征在于，核黄素药液储存在药液袋（1）中，药液袋（1）采用压延膜或三层共挤膜制造。The plasma pathogen inactivation treatment method based on riboflavin photochemical method according to claim 2, characterized in that the riboflavin medicinal solution is stored in the medicinal solution bag (1), and the medicinal solution bag (1) adopts a calendered film or Manufactured by three-layer co-extruded film.
  8. 根据权利要求7所述的基于核黄素光化学法的血浆病原体灭活处理方法，其特征在于，药液袋（1）内储存30~40mL、浓度为450~550μmol/L的核黄素药液，光照袋（2）可容纳1~2单位血浆。The plasma pathogen inactivation treatment method based on riboflavin photochemical method according to claim 7, characterized in that the drug solution bag (1) stores 30-40 mL of riboflavin drug solution with a concentration of 450-550 μmol/L , the light bag (2) can hold 1~2 units of plasma.
  9. 根据权利要求7所述的基于核黄素光化学法的血浆病原体灭活处理方法，其特征在于，药液袋（1）外配遮光袋（101），且药液袋（1）、光照袋（2）及贮血袋（3）依次连接组成联袋。The plasma pathogen inactivation treatment method based on riboflavin photochemical method according to claim 7, characterized in that, the drug solution bag (1) is equipped with a shading bag (101), and the drug solution bag (1), the light bag ( 2) and the blood storage bag (3) are sequentially connected to form a joint bag.
  10. 根据权利要求9所述的基于核黄素光化学法的血浆病原体灭活处理方法，其特征在于，药液袋（1）用于连接原血袋的导管上设置有白细胞过滤组件（4）。The plasma pathogen inactivation treatment method based on riboflavin photochemical method according to claim 9, characterized in that, a leukocyte filter assembly (4) is arranged on the catheter of the medical solution bag (1) for connecting the original blood bag.
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