CN113088028A - Polypropylene material for stem cell medical infusion bag and preparation process thereof - Google Patents
Polypropylene material for stem cell medical infusion bag and preparation process thereof Download PDFInfo
- Publication number
- CN113088028A CN113088028A CN202110348052.8A CN202110348052A CN113088028A CN 113088028 A CN113088028 A CN 113088028A CN 202110348052 A CN202110348052 A CN 202110348052A CN 113088028 A CN113088028 A CN 113088028A
- Authority
- CN
- China
- Prior art keywords
- stem cell
- infusion bag
- medical infusion
- polypropylene material
- polypropylene
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L53/00—Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers
-
- 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
- C08L23/10—Homopolymers or copolymers of propene
- C08L23/12—Polypropene
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2201/00—Properties
- C08L2201/08—Stabilised against heat, light or radiation or oxydation
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2201/00—Properties
- C08L2201/10—Transparent films; Clear coatings; Transparent materials
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2203/00—Applications
- C08L2203/02—Applications for biomedical use
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Chemistry (AREA)
- Polymers & Plastics (AREA)
- Organic Chemistry (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
The invention belongs to the technical field of medical packaging, and particularly relates to a stem cell medical infusion bag polypropylene material and a preparation process thereof. The stem cell medical infusion bag polypropylene material provided by the invention is a high-molecular non-PVC material, and is PP modified by SEBS. The polypropylene resin material does not contain a plasticizer, is the lowest density in general plastics, is non-toxic and has good transparency; the material has good mechanical properties, good rigidity and wear resistance and higher hardness; the heat resistance is better, the sterilization is suitable for high temperature sterilization at 121 ℃, and the modified product can endure low temperature of-70 ℃; the water absorption is avoided, the chemical stability is good, and the finally prepared stem cell medicinal infusion bag has high safety.
Description
Technical Field
The invention belongs to the technical field of medical packaging, and particularly relates to a stem cell medical infusion bag polypropylene material and a preparation process thereof.
Background
The stem cell biological medicine is a novel innovative medicine. Clinical research on mesenchymal stem cells has been carried out in many countries, more than 60 clinical trials have been approved in the united states, and with the increasing maturity of mesenchymal stem cells and related technologies thereof, many clinical trials have been approved in China, and the research and development stage of the mesenchymal stem cell core technology has entered. The development of stem cell research work has been vigorously strengthened in China, and research technologies have been led to the clinic by a plurality of authoritative research institutions including national Oncosi cell genetic engineering Limited companies and national cell product engineering research centers and various local umbilical cord blood banks. Research to date indicates that umbilical cord-derived mesenchymal stem cells not only can become an ideal substitute for bone marrow mesenchymal stem cells, but also have greater application potential. The umbilical cord mesenchymal stem cells express the specific molecular markers of various embryonic stem cells, and have the characteristics of large differentiation potential, strong proliferation capacity, low immunogenicity, convenient material taking, no limitation of moral ethical problems, easiness for industrial preparation and the like, so that the umbilical cord mesenchymal stem cells are possibly the pluripotent stem cells with the most clinical application prospect.
The research on stem cell medicines is rapidly progressed, and the research direction of how to ensure the safety and the effectiveness of stem cells in the packaging, transportation and use processes is also the research direction of medicine packaging material enterprises. The stem cell preparation is packaged by adopting a blood collection bag or a glass bottle temporarily at present, but the common blood collection bag is made of PVC material, contains a large amount of plasticizer and is not suitable for packaging stem cell medicines, and a glass container is fragile and cannot resist low temperature, so that the cross contamination risk is caused, and the use is inconvenient.
Disclosure of Invention
The technical problem to be solved by the invention is as follows: overcomes the defects of the prior art, provides a polypropylene material for a stem cell medical infusion bag, is a high molecular non-PVC material, and is improved and modified PP. The polypropylene resin material does not contain a plasticizer, is the lowest density in general plastics, is non-toxic and has good transparency; the material has good mechanical properties, good rigidity and wear resistance and higher hardness; the heat resistance is better, the sterilization is suitable for high temperature sterilization at 121 ℃, and the modified product can endure low temperature of-70 ℃; no water absorption and good chemical stability.
The polypropylene material of the stem cell medical infusion bag is prepared from PP and SEBS.
The PP is one or more of homo-polypropylene or co-polypropylene. Preferably, the PP is a block (impact) copolymer polypropylene.
PP-B block (impact) copolymer Polypropylene: the ethylene content is high (7-15%). The regularity of the homopolymerized PP-H is not reduced. Does not reduce the melting point and the crystallinity, and is beneficial to the high-temperature sterilization of medical products. High impact strength, certain rigidity and capability of ensuring the tearing strength and the stiffness of the medicine packaging bag. Since PP in the homopolymer form is very brittle at temperatures above 0 ℃ and below, PP materials for many commercial applications are random copolymers with 1-4% ethylene added or block copolymers with higher ethylene content. The PP material of the copolymer type has a lower heat distortion temperature (100 ℃), low transparency, low gloss, low rigidity, but a stronger impact strength. The strength of PP increases with increasing ethylene content. The Vicat softening temperature of PP is 150 ℃. Due to the high degree of crystallinity, the surface stiffness and scratch resistance properties of this material are good.
The polypropylene of the invention: the pellet has been subjected to USP < 88 > for in vivo biological tests [ systemic toxicity (0.9% sodium chloride injection, polyethylene glycol 400, ethanol: 0.9% sodium chloride injection ═ 1:20, vegetable oil), intradermal irritation (0.9% sodium chloride injection, polyethylene glycol 400, ethanol: 0.9% sodium chloride injection ═ 1:20, vegetable oil), implantation test ], with test results of: has no potential system toxicity, no irritation, and no tissue contact stimulation, and meets USP & lt 88 & gt requirement.
In order to further verify the safety of polypropylene, the granules are subjected to biocompatibility evaluation tests by the institute of food and drug assay of China, and the biocompatibility evaluation tests comprise an in vitro cytotoxicity test, an acute toxicity test (intravenous maximum sample dosage), an acute toxicity test (intraperitoneal maximum sample dosage measurement), a subchronic toxicity test (rat intravenous 30 days), a chronic toxicity test (rat intraperitoneal injection for 26 weeks), an eye irritation test, a blood vessel irritation test, a muscle irritation test, an intradermal reaction test, a systemic active hypersensitivity test, a delayed hypersensitivity test (maximum dosage method), a genetic toxicity test-Ames test, a genetic toxicity test-chromosome aberration test, a genetic toxicity test-micronucleus test, a muscle implantation test, a fertility and early embryo development toxicity test (I), an embryo-embryo development toxicity test (II), The perinatal period toxicity test (III section) and the pyrogen test sequentially show that the cytotoxicity is grade 1, symptoms and signs which cause the weight reduction, death or systemic toxicity of animals do not appear under the acute toxicity test condition, the sub-chronic systemic toxicity reaction (30 days), the chronic systemic toxicity reaction (26 weeks), the eye irritation reaction, the vascular irritation reaction, the muscle irritation reaction, the intradermal irritation reaction, the systemic active anaphylaxis reaction, the delayed hypersensitivity reaction and the genetic toxicity do not appear, the muscle implantation test result is negative, and the reproductive toxicity and the pyrogenicity do not appear.
The SEBS is a linear triblock copolymer which takes polystyrene as a terminal segment and takes an ethylene-butylene copolymer obtained by hydrogenation of polybutadiene as a middle elastic block. SEBS does not contain unsaturated double bonds, so the SEBS has good stability and aging resistance. SEBS has better ultraviolet stability, oxygen resistance and thermal stability. SEBS has better compatibility with paraffin, so that the SEBS can be used as a more flexible surface coating of paper products. SEBS is not temperature sensitive with no significant shear flow on heating, so it can serve as a template for IPN. (the rationale behind IPN: two immiscible polymers, interpenetration of the entangled segments is achieved, thus "locking" the two immiscible polymers together by covalent bonding) SEBS oil blend organic solutions can replace natural latex for the manufacture of surgical gloves and the like, where the SEBS does not contain unsaturated double bonds and has a high degree of purity, with the following two advantages: (1) the oxygen resistance and the ozone resistance are good; (2) the natural rubber contains proteins which can cause dangerous allergic reactions in some patients, while the blend does not.
The SEBS thermoplastic elastomer materials used in the present invention have passed the united states pharmacopeia in vitro < 87 >, in vivo < 88 > bioreaction test, and passed a set of toxicology tests conducted by an independent laboratory approved by the FDA in the united states, the test results indicating that these products pass a new international ISO standard which is more stringent than the conventional USP class VI, and pass the ISO 10993 standard. Kraton G1645 is approved by the FDA for use in direct contact applications with food products, without any restrictions on the conditions or type of food product, and complies with the European food contact directive 2002/72/EC.
The mass ratio of the PP to the SEBS is preferably 100: 10-130.
The preparation process of the stem cell medical infusion bag polypropylene material specifically comprises the following steps:
screening and analyzing raw materials → drying and mixing raw materials → extrusion modification → water-cooling and hot-cutting granulation → material quality detection → finished product packaging.
In the drying and mixing process of the raw materials, the raw materials are mixed and stirred by a low-speed mixer according to the formula proportion, and simultaneously the temperature is increased to 65-85 ℃, and the drying time is 30-60 minutes, preferably 45 minutes.
The two mixed raw materials are processed and modified by a double-screw plastic processing extruder. In terms of processing temperature, the PP processing temperature is generally between 160 and 230 ℃, and the SEBS is generally between 190 and 260 ℃; the required shear rate is lower in PP processing, and higher in SEBS processing; during extrusion processing, PP generally adopts moderate shearing rate, and extrusion molding generally adopts a screw with low compression ratio, while SEBS processing preferably adopts a screw with high injection molding rate and high compression ratio. Therefore, the length-diameter ratio of the double-screw extruder is more than 38 times, the compression ratio is 2.8:1, the feeding section is 80 ℃, the rest is 190 ℃ and 230 ℃, and the maximum temperature is 260 ℃.
In order to ensure that the granule has no powder, wire drawing, uneven particle size and uneven particle length, the granule is granulated by water cooling and hot cutting.
After the product is granulated, indexes such as melt index, density, melting point, Vicat temperature, tensile strength, elongation at break, normal hexane, residues on ignition, heavy metal ions and the like are detected according to relevant standards of national formulary and enterprises. And finally, packaging and warehousing after the detection is qualified.
Compared with the prior art, the invention has the following beneficial effects:
the stem cell medical infusion bag polypropylene material provided by the invention is a high-molecular non-PVC material, and is PP modified by SEBS. The polypropylene resin material does not contain a plasticizer, is the lowest density in general plastics, is non-toxic and has good transparency; the material has good mechanical properties, good rigidity and wear resistance and higher hardness; the heat resistance is better, the sterilization is suitable for high temperature sterilization at 121 ℃, and the modified product can endure low temperature of-70 ℃; the water absorption is avoided, the chemical stability is good, and the finally prepared stem cell medicinal infusion bag has high safety.
Detailed Description
The present invention will be further described with reference to the following examples.
All in the examples are in parts by weight.
Example 1
100 parts of PP-B block (impact-resistant) copolymer polypropylene and 30 parts of SEBS are used as raw materials, and the polypropylene PP and the SEBS are mixed and stirred by a low-speed mixer according to a formula proportion before processing, and are heated to 70 ℃ and dried for 45 minutes. Then placing the mixture into a double-screw extruder for extrusion modification, wherein the length-diameter ratio of the double-screw extruder is 40:1, and the compression ratio is 2.8:1, the feeding section is 80 ℃, the other sections are 190 ℃ and 230 ℃, and the maximum temperature is 260 ℃. And then granulating by water cooling and hot cutting, and detecting indexes such as melt index, density, melting point, Vicat temperature, tensile strength, elongation at break, normal hexane, residues on ignition, heavy metal ions and the like according to relevant standards of national formulary and enterprises after the product is granulated. And packaging and warehousing after the detection is qualified.
Example 2
100 parts of PP-B block (impact-resistant) copolymer polypropylene and 70 parts of SEBS are used as raw materials, and the polypropylene PP and the SEBS are mixed and stirred by a low-speed mixer according to a formula proportion before processing, and are heated to 70 ℃ and dried for 45 minutes. Then placing the mixture into a double-screw extruder for extrusion modification, wherein the length-diameter ratio of the double-screw extruder is 40:1, and the compression ratio is 2.8:1, the feeding section is 80 ℃, the other sections are 190 ℃ and 230 ℃, and the maximum temperature is 260 ℃. And then granulating by water cooling and hot cutting, and detecting indexes such as melt index, density, melting point, Vicat temperature, tensile strength, elongation at break, normal hexane, residues on ignition, heavy metal ions and the like according to relevant standards of national formulary and enterprises after the product is granulated. And packaging and warehousing after the detection is qualified.
Example 3
The polypropylene-B composite material is prepared with PP-B block copolymer 100 weight portions and SEBS 100 weight portions as material, and through mixing polypropylene PP and SEBS in certain proportion in a low speed mixer, heating to 70 deg.c and stoving for 45 min. Then placing the mixture into a double-screw extruder for extrusion modification, wherein the length-diameter ratio of the double-screw extruder is 40:1, and the compression ratio is 2.8:1, the feeding section is 80 ℃, the other sections are 190 ℃ and 230 ℃, and the maximum temperature is 260 ℃. And then granulating by water cooling and hot cutting, and detecting indexes such as melt index, density, melting point, Vicat temperature, tensile strength, elongation at break, normal hexane, residues on ignition, heavy metal ions and the like according to relevant standards of national formulary and enterprises after the product is granulated. And packaging and warehousing after the detection is qualified.
The polypropylene materials prepared in the examples 1-3 are prepared into stem cell medical infusion bags under the same conditions, the stem cell medical infusion bags are of three-layer structures including an inner layer, a middle layer and an outer layer, and the inner layer, the middle layer and the outer layer are all made of polypropylene materials. The multilayer coextrusion blow molding process is adopted for production, and the specific process is as follows: raw materials → film blowing → slitting → film rolling → conveying → welding and filling interface → welding four sides into bags → nitrogen sealing inspection → visual inspection → wet heat sterilization at 121 ℃, automatic double-layer packaging → boxing and warehousing. The molding and manufacturing process requires operation in a clean environment of 'C + A' to ensure the cleanness and no pollution of products.
Then, the performance of the infusion bag product is detected according to the national drug package standard, and the performance of the infusion bag product is as follows: high thickness uniformity, good elasticity, good drop resistance, high temperature resistance, high light transmittance (more than or equal to 99 percent), convenient clarity inspection, residue burning (less than or equal to 0.01 percent), dissolution test, biological test and the like, and meets the requirements on water vapor (less than or equal to 2.0 g/(m) in the specification224h)), oxygen (less than or equal to 700 cm)3/(m224h 0.1MPa)) and nitrogen (less than or equal to 200 cm)3/(m224h 0.1MPa) and the like, and is suitable for filling various electrolyte infusion, nutrient infusion, therapeutic infusion and the like.
Of course, the foregoing is only a preferred embodiment of the invention and should not be taken as limiting the scope of the embodiments of the invention. The present invention is not limited to the above examples, and equivalent changes and modifications made by those skilled in the art within the spirit and scope of the present invention should be construed as being included in the scope of the present invention.
Claims (8)
1. The polypropylene material for the stem cell medical infusion bag is characterized in that: prepared from PP and SEBS.
2. The stem cell medical infusion bag polypropylene material according to claim 1, wherein: the PP is one or more of homo-polypropylene or co-polypropylene.
3. The stem cell medical infusion bag polypropylene material according to claim 1 or 2, wherein: the PP is block copolymerization polypropylene.
4. The stem cell medical infusion bag polypropylene material according to claim 1, wherein: the SEBS is a linear triblock copolymer which takes polystyrene as a terminal segment and takes an ethylene-butylene copolymer obtained by hydrogenation of polybutadiene as a middle elastic block.
5. The stem cell medical infusion bag polypropylene material according to claim 1, wherein: the mass ratio of the PP to the SEBS is 100: 10-130.
6. A process for preparing the polypropylene material for stem cell medical infusion bags according to any one of claims 1 to 5, which is characterized in that: the method comprises the following steps:
screening and analyzing raw materials → drying and mixing raw materials → extrusion modification → water-cooling and hot-cutting granulation → material quality detection → finished product packaging.
7. The preparation process of the stem cell medical infusion bag polypropylene material according to claim 6, which is characterized in that: in the drying and mixing process of the raw materials, the drying temperature is 65-85 ℃ and the drying time is 30-60 minutes.
8. The preparation process of the stem cell medical infusion bag polypropylene material according to claim 6, which is characterized in that: in the extrusion modification procedure, a double-screw extruder is adopted, the length-diameter ratio is more than 38, and the compression ratio is 2.8:1, the temperature of the feeding section is 80 ℃.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110348052.8A CN113088028A (en) | 2021-03-31 | 2021-03-31 | Polypropylene material for stem cell medical infusion bag and preparation process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110348052.8A CN113088028A (en) | 2021-03-31 | 2021-03-31 | Polypropylene material for stem cell medical infusion bag and preparation process thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN113088028A true CN113088028A (en) | 2021-07-09 |
Family
ID=76671610
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110348052.8A Pending CN113088028A (en) | 2021-03-31 | 2021-03-31 | Polypropylene material for stem cell medical infusion bag and preparation process thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN113088028A (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH11290422A (en) * | 1998-04-09 | 1999-10-26 | Kawasumi Lab Inc | Transfusion container |
| CN101780855A (en) * | 2010-02-09 | 2010-07-21 | 南京泰邦生物医用材料有限公司 | Five-layer coextrusion transfusion medicine packing film and manufacturing method thereof |
| CN101851370A (en) * | 2010-05-19 | 2010-10-06 | 安徽双鹤药业有限责任公司 | Material special for medicinal transfusion bag |
-
2021
- 2021-03-31 CN CN202110348052.8A patent/CN113088028A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH11290422A (en) * | 1998-04-09 | 1999-10-26 | Kawasumi Lab Inc | Transfusion container |
| CN101780855A (en) * | 2010-02-09 | 2010-07-21 | 南京泰邦生物医用材料有限公司 | Five-layer coextrusion transfusion medicine packing film and manufacturing method thereof |
| CN101851370A (en) * | 2010-05-19 | 2010-10-06 | 安徽双鹤药业有限责任公司 | Material special for medicinal transfusion bag |
Non-Patent Citations (1)
| Title |
|---|
| 曹志敏: "聚丙烯共混输液袋中SEBS分散度的测定", 《安徽工程大学学报》 * |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| EP0679170B1 (en) | Polymeric compositions for medical packaging and devices | |
| US4588777A (en) | Synthetic resin composition | |
| CN100389948C (en) | Multilayer co-extrusion transfusion film and manufacturing method thereof | |
| CN101052682A (en) | Toughened polyamide for food packaging and health care applications | |
| Sam et al. | Current application and challenges on packaging industry based on natural polymer blending | |
| CN101210102A (en) | Composite material for packaging full-biological degradation medicament | |
| CN109367173A (en) | A kind of plastic bag high biological based fully degradable PP TYPE of low cost and preparation method thereof | |
| KR20090006140A (en) | Retortable composition | |
| CN101845173A (en) | Manufacturing process and production equipment for medical infusion bags | |
| KR20170133381A (en) | Algae-blended composition without plasticizer | |
| CN111055565A (en) | Low-temperature-resistant outer-bag multilayer co-extrusion film for cooking sterilization and preparation method thereof | |
| CN112898740A (en) | Talcum powder filled biodegradable blown film material and preparation method thereof | |
| CN105175849A (en) | Plastic packaging material for injection powder and preparation process thereof | |
| CN109971070A (en) | A kind of polypropylene medicine bottle formula and preparation method thereof that can be used for high-temperature sterilization | |
| CN113088028A (en) | Polypropylene material for stem cell medical infusion bag and preparation process thereof | |
| CN101451011A (en) | Polyolefin thermoplastic elastomer blending resin and preparation method thereof | |
| EP3042927A1 (en) | Method for producing sterilized medical molded body | |
| CN108384093B (en) | Medicinal freeze-dried sterile polyethylene film and preparation method thereof | |
| CN114643768B (en) | Food-grade air-resistance light-transmitting multilayer film | |
| CN104403281A (en) | Medical fiber-based polymer material and preparation method thereof | |
| CN101514250A (en) | Polyolefin thermoplastic elastomer blood storage material and preparation method thereof | |
| CN110128774A (en) | A kind of thermoplastic elastomer composite material, preparation method and application | |
| JPH11313872A (en) | Surgical/medical pipe and vessel for use at transfer of medical solution | |
| CN103965594A (en) | Preparation method for polycaprolactone/montmorillonite composite degradable material | |
| CN107556636A (en) | A kind of degradable plastic packaging material and its preparation technology |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination |