WO2018040847A1 - Système de gel de séparation pour extraire et purifier du plasma riche en plaquettes, et procédé de préparation associé - Google Patents

Système de gel de séparation pour extraire et purifier du plasma riche en plaquettes, et procédé de préparation associé Download PDF

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Publication number
WO2018040847A1
WO2018040847A1 PCT/CN2017/095954 CN2017095954W WO2018040847A1 WO 2018040847 A1 WO2018040847 A1 WO 2018040847A1 CN 2017095954 W CN2017095954 W CN 2017095954W WO 2018040847 A1 WO2018040847 A1 WO 2018040847A1
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WO
WIPO (PCT)
Prior art keywords
separation gel
gel system
platelet
inert
rich plasma
Prior art date
Application number
PCT/CN2017/095954
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English (en)
Chinese (zh)
Inventor
胡祥
Original Assignee
成都瑞琦科技实业股份有限公司
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Publication of WO2018040847A1 publication Critical patent/WO2018040847A1/fr

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L23/04—Homopolymers or copolymers of ethene
    • C08L23/08—Copolymers of ethene
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D17/00—Separation of liquids, not provided for elsewhere, e.g. by thermal diffusion
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L23/04—Homopolymers or copolymers of ethene
    • C08L23/08—Copolymers of ethene
    • C08L23/0807—Copolymers of ethene with unsaturated hydrocarbons only containing more than three carbon atoms
    • C08L23/0815—Copolymers of ethene with aliphatic 1-olefins
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/34—Purifying; Cleaning
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K2201/00—Specific properties of additives
    • C08K2201/011—Nanostructured additives

Definitions

  • the invention relates to the field of clinical medicine and testing, and relates to a separation gel system, in particular to a separation gel system for extracting and purifying platelet rich plasma and a preparation method thereof.
  • the technical problem to be solved by the present invention is that the method for rapidly and safely performing PRP collection in the prior art has low purity and low recovery rate, and provides a platelet-rich plasma extraction and purification for blood collection tubes which solves the above problems.
  • the gum system is separated and the preparation method of the separation gel system is provided.
  • a platelet-rich plasma extraction and purification separation gel system comprising an inert separation gel, nano-scale porous silica and modified silica; the separation gel system has a density ranging from 1.045 to 1.08 g/cm 3 .
  • the invention can better realize the separation of red blood cells, white blood cells or fragments thereof by the combination of the above components and the density, thereby effectively ensuring the purity of the platelet-rich plasma and effectively improving the recovery efficiency.
  • the inert separating gel is a non-o-benzene inert separating gel.
  • the non-o-phenyl-based inert separating gel has biosafety in material selection, biosafety evaluation, and good biocompatibility, thereby providing a safer and more effective biocompatible material for the present invention. Solve the problem of biosafety hazards existing in conventional vacuum blood collection tubes.
  • nanoporous silica is added in an amount of 0.5% to 1.2% of the separation gel system, and the modified silica is added in an amount of 8% to 12% of the separation gel system.
  • the recovery efficiency of the platelet-rich plasma can be greatly improved while ensuring a good purity, and the recovery rate is greatly improved.
  • the non-o-phenyl inert separating gel comprises polybutylene and chlorinated paraffin-52.
  • the polyethylene oxide accounts for 72% to 76% of the inert separating gum, and the chlorinated paraffin-52 accounts for 24% to 28% of the inert separating rubber.
  • the separation gel system has a density in the range of 1.045 to 1.055 g/cm 3 .
  • the purity can be greatly improved in this density range, and the PRP recovery rate can reach 20% or more under this condition.
  • the finished product has a density of 1.065 to 1.08 g/cm 3 .
  • the PRP recovery rate can be greatly improved while ensuring good purity, and the recovery rate can reach 40% or more.
  • the nano-sized porous silica and the modified white carbon have an average particle size of 3,000 mesh - 5000 mesh.
  • a method for preparing a platelet-derived plasma extraction and purification separation gel system comprising:
  • Step 1 preparing the inert separation gel into a viscous system having a viscosity of 300,000 to 600,000;
  • Step 2 adding nano-scale porous silica and modified white carbon black to the viscous system, grinding and stirring to obtain a finished product having a density ranging from 1.045 to 1.08 g/cm 3 .
  • the homogenization of the particles can be effectively realized, and the finished product can be more effective.
  • the nano-sized porous silica and the modified white carbon have an average particle size of 3,000 mesh to 5,000 mesh, and the nano-sized porous silica is added in an amount of 0.5% to 1.2% of the separation gel system, and is modified.
  • the amount of silica added is 8% to 12% of the separation gel system.
  • the grinding time is greater than or equal to 8 h, and the number of operations of the grinding and stirring is greater than or equal to 3 times.
  • the present invention has the following advantages and beneficial effects:
  • the invention solves the current complicated platelet-rich preparation and purification technology, and the components of the invention can ensure the safety and pollution-free condition, better meet the requirements of purity and recovery rate, and achieve better purity. In the case of greatly improving the recovery rate of PRP;
  • the invention can meet the different uses of medical and cosmetic institutions through the setting of two different density systems; the PRP of the lower density system has high purity, and can effectively meet the requirements of dental and orthopedics with high purity requirements and low dosage requirements.
  • the ortho-benzene plasticizer generally used in the industry selects a non-o-benzene system, has biosafety, and has passed biological performance evaluation and is non-toxic.
  • a platelet-derived plasma extraction and purification separation gel system comprising an inert separation gel, nano-scale porous silica and modified silica; wherein the inert separation gel is a non-o-benzene inert separation gel, preferably polyethylene Alkene and chlorinated paraffin-52.
  • the separation gel system has a density in the range of 1.045 to 1.08 g/cm 3 .
  • the amount of nano-sized porous silica added is 0.5% to 1.2% of the separation gel system, and the added amount of modified silica is 8% to 12% of the separation gel system, and the poly(ethylene oxide) accounts for inert separation. 72 to 76% of the gum, chlorinated paraffin-52 accounts for 24 to 28% of the inert separation gel.
  • the nano-sized porous silica adopts a silica of the Degussa model R-974, and the modified silica is a modified white carbon black of the type TS720.
  • the specific preparation method of the platelet-derived plasma extraction and purification separation gel system of the invention is as follows:
  • Step 1 Mixing poly(ethylene oxide) and chlorinated paraffin-52, and stirring in the forward and reverse directions for 12 to 20 hours with a stirrer to prepare a viscous system with a viscosity of 300,000 to 600,000; respectively grinding the nano-scale porous dioxide Silicon and modified silica have a particle size between 3000 mesh and 5000 mesh.
  • Step 2 adding nano-scale porous silica and modified white carbon black to the viscous system, repeat grinding and stirring, grinding time is 8 hours each time, repeating 3 times to make a finished product.
  • the prepared finished product is added to a conventional vacuum blood collection tube, and the amount of each added is 1 to 2 g.
  • a vacuum blood collection tube of 15*100 size is selected, and the amount of each is 2 g.
  • the vacuum blood collection tube with the separation gel system of the invention is prepared by using a conventional vacuum blood collection tube process, that is, a conventional medicinal anticoagulant for vacuum blood collection tube is first added, and then a medicinal butyl rubber stopper is assembled, and finally, radiation sterilization is performed. can.
  • Comparative Example 1-2 differs from Examples 1-6 in that each component is within the range of values and the density is outside the range of values;
  • control 3-4 and the examples 1-6 The difference between the control 3-4 and the examples 1-6 is that the addition of the nano-sized porous silica and the modified white carbon black are respectively absent in each of the constituent components;
  • Comparative Example 5-6 differs from Examples 1-6 in that each component and density are outside the range of values;
  • Comparative Example 7 differs from Examples 1-6 in that each component is outside the range of values, but the density is Within the range value.
  • the finished product was prepared, and then 50 blood samples were selected, and 8 ml of each blood was collected. Each blood sample was separately separated and purified by using the finished product in Table 1 above, and the purity and average recovery rate obtained after separation and purification were examined.
  • Average recovery rate determination method (PRP extraction volume in plasma / quantitative blood collection volume) ⁇ 100%;

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Medicinal Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Thermal Sciences (AREA)
  • Molecular Biology (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Silicon Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

L'invention se réfère à un système de gel de séparation pour extraire et purifier du plasma riche en plaquettes (PRP), et à un procédé de préparation associé. Le système de gel de séparation comprend un gel de séparation inerte, une nanosilice poreuse et du noir de carbone blanc modifié ; ce système de gel de séparation présente une densité comprise dans la plage de 1,045-1,08 g/cm3. Le procédé de préparation du gel de séparation consiste à : préparer le gel de séparation inerte dans un système visqueux présentant une viscosité comprise entre 300000 et 600000 ; ajouter la nanosilice poreuse et le noir de carbone blanc modifié au système visqueux, broyer et agiter afin de produire un produit fini dont la densité est comprise dans la plage de 1,045 ~ 1,08 g/cm3. Ce système de gel de séparation permet de résoudre les problèmes de faible pureté et de faible taux de récupération de la technologie d'extraction de PRP existante, et d'améliorer considérablement le taux de récupération du PRP dans des conditions de pureté supérieure.
PCT/CN2017/095954 2016-08-30 2017-08-04 Système de gel de séparation pour extraire et purifier du plasma riche en plaquettes, et procédé de préparation associé WO2018040847A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201610771296.6A CN106366426B (zh) 2016-08-30 2016-08-30 一种富血小板血浆提取和纯化的分离胶体系及其制备方法
CN201610771296.6 2016-08-30

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Publication Number Publication Date
WO2018040847A1 true WO2018040847A1 (fr) 2018-03-08

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CN (1) CN106366426B (fr)
WO (1) WO2018040847A1 (fr)

Cited By (1)

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Publication number Priority date Publication date Assignee Title
CN114010659A (zh) * 2021-11-23 2022-02-08 新疆维吾尔自治区人民医院 一种富血小板血浆的制备方法

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Publication number Priority date Publication date Assignee Title
CN106366426B (zh) * 2016-08-30 2019-08-20 成都瑞琦科技实业股份有限公司 一种富血小板血浆提取和纯化的分离胶体系及其制备方法
CN110064230A (zh) * 2019-05-31 2019-07-30 朱德新 一种富血小板血浆采集分离容器
CN113717320B (zh) * 2020-05-25 2024-02-02 华熙生物科技股份有限公司 富血小板血浆分离凝胶的制备方法及所得产品和应用
CN111468204A (zh) * 2020-06-08 2020-07-31 珠海朗泰生物科技有限公司 一种可控组分的富血小板血浆制备管及其制备方法
CN116715801B (zh) * 2023-06-30 2024-02-23 珠海朗泰生物科技有限公司 一种低细胞毒性的prp分离胶及其制备方法与应用

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CN103333446A (zh) * 2013-06-21 2013-10-02 武汉曙天科技发展有限公司 一种血清分离胶及其制备方法
CN106366426A (zh) * 2016-08-30 2017-02-01 成都瑞琦科技实业股份有限公司 一种富血小板血浆提取和纯化的分离胶体系及其制备方法

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CN104262651B (zh) * 2014-09-23 2017-05-17 武汉辉斯特科技有限公司 一种自体富血小板血浆触变分离凝胶的制备及应用
CN104558354B (zh) * 2014-12-08 2017-04-26 南雄阳普医疗科技有限公司 一种富血小板血浆分离胶及富血小板血浆制备方法

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Publication number Priority date Publication date Assignee Title
CN114010659A (zh) * 2021-11-23 2022-02-08 新疆维吾尔自治区人民医院 一种富血小板血浆的制备方法
CN114010659B (zh) * 2021-11-23 2023-09-29 新疆维吾尔自治区人民医院 一种富血小板血浆的制备方法

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