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CN-122005898-A - Absorbable bone wax, preparation method and application

CN122005898ACN 122005898 ACN122005898 ACN 122005898ACN-122005898-A

Abstract

The invention discloses absorbable bone wax, a preparation method and application thereof, and relates to the technical field of medicines; the absorbable bone wax comprises, by weight, 8-25 parts of calcium stearate, 15-35 parts of vitamin E or a derivative thereof, 12-45 parts of polyethylene glycol or a derivative thereof, and 12-50 parts of calcium sulfate; according to the invention, the calcium stearate is used for endowing the bone wax with excellent blocking and hemostasis performance, the hardness of the bone wax is regulated by the vitamin E and the derivatives thereof, and the relationship between the blocking and hemostasis performance and loosening time of the bone wax is effectively balanced under the synergistic effect of the calcium sulfate and the polyethylene glycol or the derivatives thereof, so that the bone wax is ensured to have good hemostasis effect, can be absorbed relatively quickly, and has the characteristics of good operation performance, no wet and slippery feeling and no sticking to gloves.

Inventors

  • WANG BIQING
  • SHI CHUNXIA
  • ZHANG KE
  • XIONG CHENGDONG

Assignees

  • 成都瑞诺美捷医疗器械有限公司

Dates

Publication Date
20260512
Application Date
20260211

Claims (10)

  1. 1. The absorbable bone wax is characterized by comprising, by weight, 8-25 parts of calcium stearate, 15-35 parts of vitamin E or a derivative thereof, 12-45 parts of polyethylene glycol or a derivative thereof and 12-50 parts of calcium sulfate.
  2. 2. The absorbable bone wax of claim 1, wherein the vitamin E derivative is vitamin E acetate.
  3. 3. The absorbable bone wax of claim 1, wherein the polyethylene glycol derivative is at least one of polyethylene glycol monomethyl ether and polyethylene glycol dimethyl ether.
  4. 4. An absorbable bone wax according to claim 1, wherein the polyethylene glycol or derivative thereof has a molecular weight of 300Da to 30000Da.
  5. 5. The bone resorbable wax of claim 4 wherein the polyethylene glycol or derivative thereof has a molecular weight of 1500Da to 10000Da.
  6. 6. An absorbable bone wax as defined in claim 1 wherein the calcium sulfate is selected from at least one of anhydrous calcium sulfate, calcium sulfate hemihydrate, calcium sulfate dihydrate or other aqueous calcium sulfate.
  7. 7. The absorbable bone wax of claim 1, further comprising at least one of a bone-compatible substance selected from the group consisting of hydroxyapatite, β -tricalcium phosphate, BCP biphasic ceramic, bioactive glass, an anti-inflammatory drug, poloxamer 188, poloxamer 407.
  8. 8. The absorbable bone wax of claim 7, wherein the bone compatible substance, poloxamer 188, poloxamer 407 is added to the absorbable bone wax in an amount of no more than 10% by mass.
  9. 9. A method of preparing an absorbable bone wax, as set forth in claim 1, comprising the steps of: All the components are added into a reactor with stirring according to the formula, and after being melted and blended uniformly above the melting point temperature of the fusible material, the absorbable bone wax is obtained after cooling to room temperature.
  10. 10. Use of an absorbable bone wax as defined in claim 1 for the preparation of hemostatic material for filling bone defects.

Description

Absorbable bone wax, preparation method and application Technical Field The invention relates to the technical field of medicines, in particular to absorbable bone wax, a preparation method and application. Background The bone hemostatic material widely used in clinic at present is generally a waxy substance commonly known as bone wax. In the use process, the bone wax is smeared and extruded at the bone wound surface to physically seal the blood vessel of the wound surface and control the local bone bleeding, so the sealing and hemostasis functions of the bone wax are the most important performance indexes. The bone wax used in the existing surgery is mainly non-absorbable and is prepared by mixing beeswax, paraffin or vaseline, vegetable oil and the like, and the non-absorbable bone wax has good hemostatic performance on bleeding bone wound surface and is difficult to bleed, but has the defect of non-absorbable, and can cause heterogeneous chronic inflammation and influence the healing of bones, so that the absorbable bone wax appears clinically. The prior art, immediately after the beginning of the clinical application of absorbable bone waxes, uses water-soluble alkylene oxide copolymers or homopolymers, such as poloxamers or polyethylene glycols, as bone hemostatic materials, such as Ostene, which are already on the market. The water-soluble polymer can be completely dissolved in water quickly (within about tens of minutes), has obvious wet slippery feel when in operation and is easy to slip when meeting water or blood, so that the plugging hemostatic performance is inferior to that of not absorbing bone wax. For example, patent documents with publication numbers CN210992034U, CN101444635a, CN106039390a, CN108744019B, CN102727930B, CN111068101a, US10549009B2, etc., all disclose water-soluble bone waxes containing water-soluble polymers such as polyethylene glycol and ethylene oxide-propylene oxide copolymer, carboxymethyl cellulose or carboxymethyl starch, chitosan, gelatin, glycan, etc. In view of the deficiencies of water-soluble bone waxes, patents disclose water-insoluble or partially water-soluble absorbable bone waxes. For example, patent publication No. CN108939138A, US4440789A provides water-insoluble absorbable bone wax, but the water-insoluble bone wax is often absorbed slowly and has acidic degradation products, and patent publication No. CN101052360B discloses a partially water-soluble absorbable bone wax, but because the water-insoluble calcium stearate is absorbed slowly, more poloxamer is needed to accelerate the loosening absorption of the bone wax, so that the wet feeling of the bone wax is increased, the blocking hemostasis is not facilitated, and patent publication No. CN111729125B discloses a partially water-soluble bone hemostasis material, and both the added poloxamer and sodium carboxymethyl cellulose are water-soluble polymers, so that the blocking hemostasis effect of the bone wax is affected. Therefore, the absorbable bone wax product in the prior art is difficult to compare favorably with the non-absorbable bone wax in terms of plugging hemostatic performance, so that the development of the absorbable bone wax with plugging hemostatic performance which is equivalent to, even better than, and easy to absorb is a difficult problem to be solved in the field. Disclosure of Invention The invention aims to solve the technical problems that the existing absorbable bone wax cannot be easily absorbed and has good blocking and hemostasis performances, and aims to provide the absorbable bone wax, the preparation method and the application thereof, wherein calcium stearate is used for endowing the bone wax with good blocking and hemostasis performances, vitamin E and derivatives thereof are used for adjusting the hardness of the bone wax, and under the synergistic effect of the calcium sulfate and polyethylene glycol or derivatives thereof, the relationship between the blocking and hemostasis performances and loosening time of the bone wax is effectively balanced, so that the bone wax is guaranteed to have good hemostasis effects, can be absorbed relatively quickly, and has the characteristics of good operation performance, no wet and slippery feeling and nonsticky gloves. The invention is realized by the following technical scheme: The first aim of the invention is to provide an absorbable bone wax which comprises, by weight, 8-25 parts of calcium stearate, 15-35 parts of vitamin E or a derivative thereof, 12-45 parts of polyethylene glycol or a derivative thereof, and 12-50 parts of calcium sulfate. In the absorbable bone wax, calcium stearate is a hard waxy solid and is insoluble in water, and the absorbable bone wax can endow the bone wax with texture and excellent plugging hemostatic performance, but is relatively slow to absorb in vivo, so that the bone wax with less calcium stearate is more suitable on the premise of meeting the plugging hemostatic performance. In the absorbable bo