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Preparation method of vascular anastomosis agent

A blood vessel and mixture technology, which is applied in the field of vascular anastomosis preparation, can solve the problems of no suitable concentration method, high solid content, high viscosity of the vascular anastomosis agent, etc.

Active Publication Date: 2017-01-04
YANTAI YENEPHARMA BIOMEDICAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This causes a continuous phase transition in the solution as it concentrates from low to high concentrations, resulting in the inability of ultrafiltration to remove large amounts of solvent
For example, a vascular anastomotic agent: when its concentration is low, water is used as the continuous phase, and the material is dispersed or swollen in it, and the apparent solution viscosity is very low (10-20cP); as the ultrafiltration removes water, the concentration gradually increases, and the The polymer material transforms into a continuous phase, water is dispersed in its network space structure, and the apparent viscosity increases significantly (10-20k cP), at this time, the ultrafiltration cannot further squeeze out the water dispersed in the material, resulting in the product UF Concentration Failed
It can be seen that due to the high viscosity, high solid content and phase transition temperature of vascular anastomotic agents, there is no suitable concentration method for production, resulting in no marketed products

Method used

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  • Preparation method of vascular anastomosis agent

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preparation example Construction

[0033] The invention discloses a preparation method of a vascular anastomotic agent, and those skilled in the art can learn from the content of this article and appropriately improve the process parameters to realize it. In particular, it should be pointed out that all similar replacements and modifications are obvious to those skilled in the art, and they are all considered to be included in the present invention. The method and application of the present invention have been described through preferred embodiments, and the relevant personnel can obviously make changes or appropriate changes and combinations to the method and application described herein without departing from the content, spirit and scope of the present invention to realize and Apply the technology of the present invention.

[0034] The reagents or instruments used in the preparation method of the vascular anastomotic agent provided by the present invention can be purchased from the market.

Embodiment 1

[0037] Dosing: Take 9.96L of water for injection, add 40g of ethyl cellulose (Natrosol, Ashland_Aqualon) under stirring, the rotation speed of the main stirring paddle is 70-100rpm, the rotation speed of the emulsification flying knife is 2500rpm, emulsify and disperse for 1h, and obtain 0.4% (w / w ) ethyl cellulose aqueous solution.

[0038] Sterilization by filtration: pass 0.4% ethyl cellulose aqueous solution through 0.45 micron and 0.22 micron filter membranes successively to sterilize.

[0039] Concentration by ultrafiltration: Use tangential flow ultrafiltration to remove water from the 0.4% ethylcellulose aqueous solution that has been sterilized by filtration. The molecular weight cut-off of the membrane bag is 5000KD, provided by Millipore. higher than the dissolution temperature), control the water output at 4-25mL / min, adjust the pressure at the inlet end to 2-5bar, and the pressure at the return end to 2-3bar. The water output changes with time as shown in the foll...

Embodiment 2

[0063] Dosing: Take 9.94L of water for injection, add 60g of chitosan (4000KD, Jinke Pharmaceutical) under stirring, the rotation speed of the main stirring paddle is 70-100rpm, the rotation speed of the emulsifying flying knife is 0rpm, and add 1mol / l hydrochloric acid solution to adjust the pH to 3-4, stirred for 1.5h to obtain 0.6% (w / w) chitosan aqueous solution.

[0064] Sterilization by filtration: Sterilize 0.6% chitosan aqueous solution through 0.45 micron and 0.22 micron filter membranes successively.

[0065] Concentration by ultrafiltration: The 0.6% chitosan aqueous solution that has been sterilized by filtration is removed by tangential flow ultrafiltration. The molecular weight cut-off of the membrane bag is 10000KD, provided by Millipore. 10°C, control the water output at 5-26mL / min, adjust the pressure at the liquid inlet to 3 bar, and the pressure at the return end to 2.5 to 3.0 bar. The water output changes with time as shown in the following table:

[0066]...

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Abstract

The invention relates to the field of aseptic production of an injection, and particularly relates to a preparation method of a vascular anastomosis agent. The preparation method comprises the following steps: dissolving a high polymer material in water, implementing filtration sterilization to obtain a dilute solution; and dewatering the dilute solution through a cross-flow ultrafiltration method to obtain the vascular anastomosis agent. The technical maturity of the preparation method is high, a membrane bag is used to concentrate through cross-flow ultrafiltration without adding special equipment, water in the diluted vascular anastomosis agent is extruded by strictly controlling the ultrafiltration temperature, the pressure of a liquid inlet end, the pressure of a backflow end and the water yield, the vascular anastomosis agent is concentrated by 8-10 times, so that the aseptic vascular anastomosis agent is prepared by mass production.

Description

technical field [0001] The invention relates to the field of aseptic production of injections, in particular to a preparation method of a vascular anastomotic agent. Background technique [0002] With the rapid development of society, it is very common clinically to cause vascular injury of extremities due to various traumas. In order to save the affected limbs, many vascular anastomoses are performed. Vascular anastomotic agent, as an intravascular injection used by clinical doctors to carry out vascular anastomosis, is widely used in vascular anastomosis. Vascular anastomotics are prepared from polymer materials through processes such as filtration and sterilization. At present, in order to ensure sterility and qualified endotoxin, injections will adopt the process of combining heat removal by adsorption and sterilization by filtration. For vascular anastomotic agents with high viscosity and high solid content (16-30% (w / w), due to The molecular weight of the material it...

Claims

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Application Information

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IPC IPC(8): A61L17/10
CPCA61L17/10C08L71/02C08L5/08C08L33/02C08L1/284C08L5/04C08L3/02C08L1/02
Inventor 江征王磊陈荣杨士豹
Owner YANTAI YENEPHARMA BIOMEDICAL
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