CN104436198B - A kind of high viscosity injection of vehicle for being resistant to irradiation sterilization and preparation method thereof - Google Patents
A kind of high viscosity injection of vehicle for being resistant to irradiation sterilization and preparation method thereof Download PDFInfo
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- CN104436198B CN104436198B CN201410643147.2A CN201410643147A CN104436198B CN 104436198 B CN104436198 B CN 104436198B CN 201410643147 A CN201410643147 A CN 201410643147A CN 104436198 B CN104436198 B CN 104436198B
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Abstract
A kind of high viscosity injection of vehicle material and preparation method thereof, the injection of vehicle material includes injection stage glycerine 87~96%, gelatin 0.5~3%, water 2~12%, sodium chloride 0.22~1.5% by weight.Its preparation method comprises the following steps：Gelatin is crushed, sodium chloride solution is added in gelatin to carry out pre-swollen to the gelatin, the gelatin for absorbing the sodium chloride solution is dissolved in into mixing in the injection stage glycerine for be heated to certain temperature forms decentralized medium；Further sol system is irradiated using ultraviolet under 50 60 DEG C of heating-up temperatures, material character is stable after low-temperature treatment, forms colloidal sol excipient of the viscosity in 2000~3000Pas.The excipient materials of the present invention are applicable to the larger implantation material and microballoon of density.The injection of vehicle stability is good, is adapted to irradiation sterilization.Because the presence of glycerine and sodium chloride can also suppress bacterial proliferation, pre- aseptic generation.
Description
Technical field
The present invention relates to medical field, and in particular to a kind of high viscosity colloidal sol shape injection of vehicle of tolerance irradiation sterilization and
Its preparation method.
Background technology
The material such as the larger medicine of proportion or functional therapeutic microballoon need to use it is special have it is more full-bodied special
Injection of vehicle material, the excipient materials of existing high score subclass such as common sodium hyaluronate, chitosan, poloxamer, first
Base cellulose etc. generally can not be resistant to irradiation sterilization, after being irradiated by Co 60 viscosity from more than 1000Pas, drastically drop to 0~
10Pas, close to zero.Therefore in the urgent need to a kind of high viscosity excipient materials for being resistant to irradiation sterilization.
The content of the invention
We are by constantly research, using sodium chloride solution, and gelatin compound glycerin again is swelled such as 10% sodium chloride solution
To obtain the excipient materials of uniform injectable, the uniformity excipient material for meeting the stabilization that injection is required so can be not only obtained
Material, is changed the architectural feature of glutin molecule using sodium chloride, dramatically increases the viscosity and stability of this material, further exist
12~48h irradiations are carried out sol system under 50~60 DEG C of heating conditions using ultraviolet to realize in excipient gelatin molecule
Crosslinking, cools to -40~-20 DEG C, carries out material character stabilization after 48~96h low-temperature treatment, recovers to room temperature to obtain viscosity
Scope 2000~3000Pas high viscosity injection of vehicle material, more than 20KGy dose delivery sterilizing after, viscosity
Decline and be no more than 30%, can meet the injection figuration of the larger medicine of proportion or functional material (8.9 ＞ density ps ＞ 1.0) needs
Will.
The invention provides a kind of high viscosity colloidal sol shape injection of vehicle material for being resistant to irradiation sterilization.
Present invention also offers the preparation method of above-mentioned injection of vehicle material.
By the present invention preparation method prepare injection of vehicle material have it is homogeneous, stably, viscosity scope it is extremely wide
Model, the performance that irradiation sterilization can be resistant to.
In order to achieve the above object, the technical proposal of the invention is realized in this way：
It is a kind of be resistant to irradiation sterilization high viscosity injection of vehicle material, by weight, it include injection stage glycerine 87~
96%, gelatin 0.5~3%, water 2~12%, sodium chloride 0.22~1.5%, wherein gelatin, sodium chloride are constituted in G ＆ W
It is dispersed in solvent, the sol of excellent flowability is formed, its viscosity scope is up to 2000~3000Pas, and property is stable, can
Using the figuration of the injection of vehicle as the larger material of proportion (8.9 ＞ density ps ＞ 1.0), such as various mineral matter artificial bone materials
Agent.
The preparation method of above-mentioned injection of vehicle material, comprises the following steps：
Gelatin is crushed to below 30 mesh, configure sodium chloride solution, added in the gelatin sodium chloride solution with
Pre-swollen and pattern handling are carried out, the gelatin for absorbing the sodium chloride solution is dissolved in the note for being heated to certain temperature
Penetrate to mix in grade glycerine and form decentralized medium；Further sol system is carried out using ultraviolet under 50~60 DEG C of heating conditions
The crosslinking in excipient between gelatin molecule is realized in 12~48h irradiations, cools to -40~-20 DEG C, carries out 48-96h low-temperature treatment
Material character is stable afterwards, recovers to room temperature formation viscosity in 2000~3000Pas colloidal sol shape excipient, the colloidal sol shape is assigned
Shape agent is packed, and after the Co 60 irradiation through 20~50KGy of dosage, its viscosity value changes ＜ 30% can meet clinical practice
Need.
Further characteristic of the invention is that the sodium chloride solution is the sodium chloride solution of 10% mass fraction.
Further characteristic of the invention is that the injection stage glycerine is heated to 70~100 DEG C.
Further characteristic of the invention is that the preswollen processing time is 1~6 hour.
Further characteristic of the invention is that the heating-up temperature of the sol system of the UV treatment is 50~60 DEG C.
Further characteristic of the invention is that the time of the UV treatment is 12~48h.
Further characteristic of the invention is that the temperature of the cooling is -40~-20 DEG C.
Further characteristic of the invention is that the time of the low-temperature treatment is 48~96h.
Compared with prior art, excipient materials of the present invention are under above-mentioned condition scope, with a wide range of adjustable
Viscosity, the addition of water causes gelatin dispersion process more quick uniform, and without blob of viscose, the addition of a small amount of sodium chloride is dramatically increased
The viscosity and stability of colloid, the need for meeting through pin hole injection application；In the glycerin gelatine system that sodium chloride is present, colloid
Viscoelastic modulus is high, and highly stable, will not form jelly.It is glutinous by action of ultraviolet radiation and the low-temperature treatment injection of vehicle material
Degree is up to 2000~3000Pas, stability and protruded, and is adapted to most convenient irradiation sterilization mode, in 20~50KGy of dosage irradiation
After sterilizing, viscosity value changes ＜ 30%, and preserve stable for a long time, the larger material of proportion (8.9 ＞ density ps ＞ can be used as
1.0) injection of vehicle.Further, it is pre- aseptic because the presence of glycerine and sodium chloride can also suppress bacterial proliferation
Occur.
Embodiment
Embodiment 1
1) 30g gelatin is crushed to below 30 mesh.
2) the sodium chloride solution 100g of 10% mass fraction is configured.
3) above-mentioned size-reduced gelatin is added into above-mentioned 10% sodium chloride solution and carries out pre-swollen 2 hours.
4) gelatin for absorbing the sodium chloride solution is dissolved in the injection stage glycerine 900g for be heated to 85 DEG C and mixes shape
Into decentralized medium.
5) sol system formed under 50 DEG C of heating-up temperatures using ultraviolet to step 4 carries out 24h irradiations.
6) -20 DEG C, 72h low-temperature treatments are cooled to.
7) sol system is recovered to room temperature, forms colloidal sol excipient of the viscosity in 2728Pas.
8) the colloidal sol excipient is packed, after the Co 60 irradiation through dosage 50KGy, the viscosity of the colloidal sol excipient
It is worth for 2564Pas, the need for clinical treatment application can be met well.
Embodiment 2
1) 20g gelatin is crushed to below 30 mesh.
2) the sodium chloride solution 50g of 10% mass fraction is configured.
3) above-mentioned size-reduced gelatin is added into above-mentioned 10% sodium chloride solution and carries out pre-swollen 2 hours.
4) gelatin for absorbing the sodium chloride solution is dissolved in the injection stage glycerine 1000g for be heated to 100 DEG C and mixed
Form decentralized medium.
5) sol system formed under 50 DEG C of heating-up temperatures using ultraviolet to step 4 carries out 24h irradiations
6) -40 DEG C, 72h low-temperature treatments are cooled to
7) sol system is recovered to room temperature, forms colloidal sol excipient of the viscosity in 2316Pas.
8) the colloidal sol excipient is packed, after the Co 60 irradiation through dosage 25KGy, the viscosity of the colloidal sol excipient
It is worth for 2208Pas, the need for clinical treatment application can be met well.
Finally it should be noted that：Embodiment of above and embodiment are merely illustrative of the technical solution of the present invention, rather than right
It is limited；Although the present invention is described in detail with reference to aforementioned embodiments and embodiment, the ordinary skill of this area
Personnel should be understood：It can still modify to the technical scheme described in aforementioned embodiments or embodiment, or right
Which part technical characteristic carries out equivalent substitution；And these modifications or replacement, do not make the essence disengaging of appropriate technical solution
The spirit and scope of embodiment of the present invention or embodiment technical scheme.
Claims (5)
1. it is a kind of be resistant to irradiation sterilization high viscosity injection of vehicle material, by weight, it include injection stage glycerine 87~
96%, gelatin 0.5~3%, water 2~12%, sodium chloride 0.22~1.5%, wherein gelatin, sodium chloride are constituted in G ＆ W
It is dispersed in solvent, the sol of excellent flowability is formed, its viscosity scope is up to 2000~3000Pa s, and property is steady
It is fixed, can as the larger material of proportion injection of vehicle, the larger material of proportion refers to 8.9 ＞ density ps ＞ 1.0 material
Material.
2. a kind of preparation method of injection of vehicle material as claimed in claim 1, it is characterised in that comprise the following steps：
1) gelatin is crushed to below 30 mesh；
2) sodium chloride solution is configured；
3) sodium chloride solution is added in the gelatin to carry out pre-swollen to the gelatin, changes gelatin structure；
4) gelatin for absorbing the sodium chloride solution is dissolved in mixing in the injection stage glycerine for be heated to certain temperature and formed
Decentralized medium；
5) ultraviolet is utilized under 50~60 DEG C of heating-up temperatures to step 4）It is real that the sol system of formation carries out 12~48h irradiations
Crosslinking in existing excipient between gelatin molecule；
6) -40~-20 DEG C are cooled to, carrying out 48~96h low-temperature treatment makes material character stable homogeneous；
7) sol system is recovered to room temperature, forms colloidal sol shape excipient of the viscosity in 2000~3000Pa s；
8) the colloidal sol shape excipient is packed；
9) 60Coradiation for packing 20~50KGy of progress dosage of the colloidal sol shape excipient is sterilized, the colloidal sol shape
The viscosity change ＜ 30% of injection of vehicle.
3. preparation method as claimed in claim 2, it is characterised in that the sodium chloride solution is the chlorination of 10% mass fraction
Sodium solution.
4. preparation method as claimed in claim 2, it is characterised in that the injection stage glycerine is heated to 70~100 DEG C.
5. preparation method as claimed in claim 2, it is characterised in that the preswollen processing time is 1~6 hour.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410643147.2A CN104436198B (en) | 2014-11-14 | 2014-11-14 | A kind of high viscosity injection of vehicle for being resistant to irradiation sterilization and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410643147.2A CN104436198B (en) | 2014-11-14 | 2014-11-14 | A kind of high viscosity injection of vehicle for being resistant to irradiation sterilization and preparation method thereof |
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| CN104436198A CN104436198A (en) | 2015-03-25 |
| CN104436198B true CN104436198B (en) | 2017-08-15 |
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| CN113521395A (en) * | 2021-07-16 | 2021-10-22 | 北京鑫康辰医学科技发展有限公司 | Glycerol gelatin-shaped DBM nose-humping material |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1999038543A2 (en) * | 1998-01-28 | 1999-08-05 | Regeneration Technologies, Inc. | Bone paste subjected to irradiative and thermal treatment |
| CN102895703A (en) * | 2012-11-08 | 2013-01-30 | 北京鑫康辰医学科技发展有限公司 | Decalcified bone matrix material and preparation method thereof |
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2014
- 2014-11-14 CN CN201410643147.2A patent/CN104436198B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1999038543A2 (en) * | 1998-01-28 | 1999-08-05 | Regeneration Technologies, Inc. | Bone paste subjected to irradiative and thermal treatment |
| CN102895703A (en) * | 2012-11-08 | 2013-01-30 | 北京鑫康辰医学科技发展有限公司 | Decalcified bone matrix material and preparation method thereof |
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