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Cross-linked polyglutamic acid gel microsphere suspension for injection and preparation method of suspension

A technology of polyglutamic acid gel microspheres and polyglutamic acid gel, which is used in pharmaceutical formulations, medical science, prostheses, etc., can solve the problems of large injection resistance, high solution viscosity, and syringe bursting. , to achieve the effect of small bolus resistance, small particle size and reduced bolus resistance

Active Publication Date: 2017-11-24
SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the large molecular weight of cross-linked polyglutamic acid, the viscosity of the solution is high, resulting in high injection resistance for filling injections, which can easily lead to difficult injections and even dangerous accidents such as syringe bursts.

Method used

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  • Cross-linked polyglutamic acid gel microsphere suspension for injection and preparation method of suspension
  • Cross-linked polyglutamic acid gel microsphere suspension for injection and preparation method of suspension
  • Cross-linked polyglutamic acid gel microsphere suspension for injection and preparation method of suspension

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Weigh 5 g of polyglutamic acid, add 100 mL of distilled water to dissolve to obtain polyglutamic acid aqueous solution. Take 10mL of Span 80 and 30ml of Tween 80 respectively, put them into 160mL of liquid paraffin, stir and mix well. Add polyglutamic acid aqueous solution into liquid paraffin containing mixed emulsifier, and make polyglutamic acid microspheres through membrane emulsification. Observation by oil microscope, the polyglutamic acid gel microspheres are spherical. When more than 90% of the microspheres have a particle size of <5 μm, add 0.25 mL polyethylene glycol glycidyl ether, heat at 45 °C and stir at 50 rpm for 12 hours to cross-link. The liquid layer was removed by centrifugation, washed successively with petroleum ether, acetone and ethanol, and finally the cross-linked polyglutamic acid microspheres were suspended in 0.9% saline to obtain a suspension of cross-linked polyglutamic acid gel microspheres, which could be Injects smoothly through a 30G ...

Embodiment 2

[0024] Weigh 25 g polyglutamic acid, add 100mL distilled water to dissolve to obtain polyglutamic acid aqueous solution. Take 30mL of Span 80 and 10mL of Tween 80 respectively to make emulsifier. Take 1000mL of liquid paraffin and 60mL of petroleum ether with a boiling range of 60°C to 90°C, then add the prepared emulsifier, stir and mix well. The polyglutamic acid aqueous solution is added to the oil phase containing emulsifier, and the polyglutamic acid microspheres are prepared by emulsifying through a homogenizer. Observation by oil microscope, the polyglutamic acid gel microspheres are spherical, when more than 90% of the microspheres have a particle size <5 μm, add 10 mL of ethylene glycol glycidyl ether, heat at 75 °C and stir at 500 rpm for 4 h to cross-link. The liquid layer was removed by centrifugation, washed with chloroform and ethanol in turn, and finally the cross-linked polyglutamic acid microspheres were suspended in physiological saline containing 0.5% proca...

Embodiment 3

[0026] Weigh 12g polyglutamic acid, add 100mL distilled water to dissolve to obtain polyglutamic acid aqueous solution. Take 30mL of Span 80 and 30mL of Tween 80 respectively to make emulsifier. Take 1000mL of liquid paraffin, add 40mL of petroleum ether with a boiling range of 60°C to 90°C, then add the prepared emulsifier, stir and mix well. The polyglutamic acid aqueous solution is added to the oil phase containing emulsifier, and the polyglutamic acid microspheres are prepared by emulsifying through a homogenizer. Observation by oil microscope, the polyglutamic acid gel microspheres are spherical, when more than 90% of the microspheres have a particle size of <5 μm, add 2.4mL ethylene glycol glycidyl ether, heat at 55°C and stir at 100rmp for 10h to cross-link. The liquid layer was removed by centrifugation, washed with chloroform and ethanol in turn, and finally the cross-linked polyglutamic acid microspheres were suspended in physiological saline containing 0.5% procain...

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Abstract

The invention relates to a preparation method of high polymer cross-linked gel microspheres and in particular relates to a cross-linked polyglutamic acid gel microsphere suspension for injection and a preparation method of the suspension. The preparation method of the cross-linked polyglutamic acid gel microsphere suspension for injection comprises the following steps: adding an aqueous solution of polyglutamic acid into an oil phase containing an emulsifier, and forming polyglutamic acid gel microspheres through emulsification; adding a cross-linking agent, heating, stirring and cross-linking, centrifuging to take the lower liquid layer after cross-linking, deterging by using a detergent, and suspending the deterged polyglutamic acid gel microspheres in normal saline or buffered saline for swelling, thereby obtaining the cross-linked polyglutamic acid gel microsphere suspension for injection. The method is simple in operation and easy for industrialized production. According to application of the cross-linked polyglutamic acid gel microspheres for injection prepared by the method in cosmetic injection, the push resistance during injection can be reduced, and risk of injection misoperation is reduced.

Description

technical field [0001] The invention relates to a preparation method of polymer cross-linked hydrogel microspheres, in particular to a suspension of cross-linked polyglutamic acid gel microspheres for injection and a preparation method thereof. Background technique [0002] At present, common cosmetic polymer hydrogel products for injection include hyaluronic acid, collagen and other substances. Collagen and other substances are extracted from animals, which has risks such as virus infection. At present, hyaluronic acid products prepared by microbial fermentation are mainly used to avoid cross-infection of animal sources. [0003] Polyglutamic acid is another water-soluble polymer compound produced by microbial fermentation. It is a polymer of L-glutamic acid, which can be degraded into glutamic acid in the body and is non-toxic to the human body. Polyglutamic acid has the same water absorption as hyaluronic acid, and the water absorption of polyglutamic acid is more than ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/18A61L27/58A61L27/52
CPCA61L27/18A61L27/52A61L27/58A61L2400/06A61L2430/34C08L77/04
Inventor 陈磊陈勉刘飞孙康张晓元郝荣华张金华张秀华张林军朱希强凌沛学
Owner SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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