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Radioactive glass microsphere injection as well as preparation method and application thereof

A technology of glass microspheres and radioactivity, which is applied in the field of medicine, can solve the problems of burdening safety risks, difficulty in uniform distribution of drugs, and large amount of excipients, etc., to achieve the effects of reducing burden and safety risks, good application prospects, and reducing toxic and side effects

Pending Publication Date: 2022-06-24
CHENGDU NEW RADIOMEDICINE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this method of using a high-viscosity dispersion medium can achieve the purpose of relatively uniformly dispersing glass microspheres, this preparation also has several shortcomings: 1. The viscosity of this type of injection generally exceeds 100mPa·S, and the viscosity is not only The mixing process before injection is difficult, and the injection liquid is easy to wrap bubbles and difficult to remove during the mixing process; 2. The injection process is also difficult to inject due to the large mass transfer resistance and the drug injected into the tissue is not easy to distribute evenly; 3. The used The large amount of excipients will increase the burden on metabolism and may bring safety risks; 4. The mixed glass microspheres will settle to different degrees with the storage time; 5. It is difficult to adjust the dosage of radioactive microspheres through the administration volume make accurate calculations

Method used

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  • Radioactive glass microsphere injection as well as preparation method and application thereof
  • Radioactive glass microsphere injection as well as preparation method and application thereof
  • Radioactive glass microsphere injection as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] A preparation of yttrium [ 90 Y] a method for injecting glass microspheres, the method comprising the steps of:

[0049] Dissolve 20 mg of sodium alginate in 10 ml of sterile water for injection, pass through a 0.22 μm sterile filter membrane, add 10 ml of 0.45 g / L sterile calcium chloride solution, and mix to obtain a viscosity of 16.6 mPa·S (about 20 ℃) ​​calcium alginate hydrogel, as A1 agent; the yttrium [ 90 50 mg of Y] glass microspheres were dispersed in 1 ml of sterile water for injection, packaged, and sterilized by moist heat at 121°C for 15 minutes for later use. The radioactive glass microspheres did not start to settle within 2 hours of the injection.

Embodiment 2

[0051] A preparation of yttrium [ 90 Y] a method for injecting glass microspheres, the method comprising the steps of:

[0052] Dissolve 20 mg of sodium alginate in 10 ml of sterile water for injection, pass through a 0.22 μm sterilizing filter membrane, and encapsulate it for later use as agent A2; the yttrium [ 90 Y] 100 mg of glass microspheres were dispersed in 1 ml of sterile water for injection containing 5 mg of calcium chloride, packaged, sterilized by moist heat at 121°C for 15 min for later use, and used as agent B2; A2 agent obtained above was added to agent B2, Mix well. The radioactive glass microspheres did not start to settle within 2 hours of the injection.

Embodiment 3

[0054] A preparation of holmium [ 166 Ho] glass microsphere injection method, the method comprises the following steps:

[0055] Dissolve 20 mg of sodium alginate in 10 ml of sterile water for injection, pass through a 0.22 μm sterilizing filter membrane, and encapsulate it for later use as agent A2; 166 300 mg of Ho] glass microspheres were dispersed in 1 ml of sterile water for injection containing 5 mg of calcium chloride, packaged, sterilized by moist heat at 121 °C for 15 min for later use, and used as agent B2; the obtained agent A2 was added to agent B2, Mix well. The radioactive glass microspheres did not start to settle within 2 hours of the injection.

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Abstract

The invention belongs to the technical field of medicine, and discloses a radioactive glass microsphere injection and a preparation method and application thereof, and every 1 ml of the radioactive glass microsphere injection comprises 0.1-100 mg of radioactive glass microspheres and 1-0.95 ml of hydrogel. The injection is used for preparing a medicine for treating tumors and can be directly injected into the tumors in an interventional mode, the radioactive dose of the radioactive glass microspheres is directly determined through the administration volume, and hydrogel in the tumors and calcium ions can form gel in the tumors; therefore, the radioactive glass microspheres are uniformly dispersed and limited in the tumor, high-dose local radiotherapy is provided through the radioactive glass microspheres to achieve treatment of the solid tumor, and the radioactive glass microspheres have wide application prospects in solid tumor treatment.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a radioactive glass microsphere injection and a preparation method and application thereof. Background technique [0002] At present, the radioactive microsphere products used clinically mainly include yttrium [ 90 Y] resin microspheres SIR-Spheres® (Sirtex Medical Limited, Australia) and yttrium [ 90 Y] glass microspheres TheraSphere® (BTG, UK) and holmium [ 166 Ho] resin microspheres (QuriemSphere®), these three microsphere products are all radioactive microsphere products dispersed in sterile water for injection or 0.9% sodium chloride injection solution, because sedimentation in the dispersion solution is quick and easy to occur The blocked needle makes it impossible to administer these products by direct injection through a syringe. In order to achieve the convenience of administration and the purpose of radiation shielding, its administration requires the aid of figure...

Claims

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Application Information

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IPC IPC(8): A61K51/12A61K51/02A61K47/36A61P35/00A61K103/32A61K103/10A61K103/00A61K101/00
CPCA61K51/1213A61K51/02A61K9/0024A61K47/36A61P35/00A61K51/00A61K51/12
Inventor 赵小生马文亮张驰翔张钧白冰路静刘强强吴文轩赵世强柳芳葛强蔡继鸣
Owner CHENGDU NEW RADIOMEDICINE TECH CO LTD
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