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A kind of bioabsorbable bone wax and its preparation method

A bone wax, biological technology, applied in the direction of drug delivery, tissue regeneration, pharmaceutical formulation, etc., can solve the problems of irritation, human harm, toxicity and so on

Active Publication Date: 2020-10-23
济南上知医疗科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The cross-linking agents commonly used in the market are irritating or even toxic, and are potentially harmful to the human body.

Method used

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  • A kind of bioabsorbable bone wax and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Example 1 Preparation of bioabsorbable bone wax.

[0034] (1) Add xanthan gum with a molecular weight of 2 million to normal saline for 25 s -1 Under high-speed shearing, it is prepared into a solution with a concentration of 1.5%, and the viscosity is about 80Pa·s (0.1 s -1 shear rate);

[0035] (2) Mix β-tricalcium phosphate and hydroxyapatite at a mass ratio of 75:25, add the mixed powder to the solution in step (1), and mix at high speed to form a uniform suspension;

[0036] (3) 2-DG and tramadol hydrochloride with a mass ratio of 1:1 and BMP, bFGF, NGF, IGF, PDGF are prepared into a solution with physiological saline, and the drug solution is added to the suspension in step (2), wherein , the final concentrations of growth factors were 20ng / g, 10ng / g, 15ng / g, 10ng / g, and 5ng / g, and after high-speed shear mixing at 0-4°C, gray-white gelatinous bone was obtained. wax.

Embodiment 2

[0037] Example 2 Biocompatibility of bone wax.

[0038] Pre-osteoblast MC3T3-E1 was treated with 3 × 10 6 / mL cells were inoculated into culture flasks for primary culture. After the cells confluent into a monolayer, they were digested with 2.5 g / L trypsin. The conditioned medium was used at 37 °C with a volume fraction of 5% CO 2 and cultured under saturated humidity conditions. Digest the cells with 2.5 g / L trypsin, centrifuge at 1000 rpm for 5 min, collect the cells, add fresh α-MEM medium with a concentration of 10% fetal bovine serum, and adjust the cell concentration to 5×10 6 / mL. The cell suspension was added to two 12-well plates, 0.5 mL was added to each well, one without bone wax was set as the control group; the bone wax was put into the other 12-well plate, and the weight of each well was the same. At 37 °C, 5% CO by volume 2 After 3 hours, 1 mL of culture medium was added to each well to continue the culture, and the medium was changed every 24 hours.

[003...

Embodiment 3

[0040] Example 3 Procoagulant effect of bone wax.

[0041] Determination of prothrombin (PT) time: Add 1.8 mL of freshly collected whole blood into a test tube containing 0.2 mL of 3.8% sodium citrate solution, mix well, and centrifuge at 3000 rpm for 10 min to separate the plasma. Take three 8 mm test tubes, add thromboplastin and 0.025 mol / L CaCl to each tube 2 Add 0.1 mL of each solution, then add 0.1 mL of whole blood / PBS or whole blood / bone wax extract mixture, mix well, and start timing immediately. Measure the prothrombin time and calculate the average value of 3 tubes. The error is required to be less than 0.5 s. Determination of prothrombin time of normal blood and bone wax-added extract. Blood clotting time shortening rate = (blood clotting time of control group-blood clotting time of bone wax group) / blood clotting time of control group×100%. Generally, it is considered effective if the coagulation time is shortened by more than 30% compared with the blank contro...

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Abstract

The invention provides bio-absorbable bone wax with a healing promotion function. The bone wax is prepared from components (g / kg) as follows: 500-800 g / kg of absorbable biological ceramic, 5*10<-9>-2.5*10<-7> g / kg of bone healing promoting medicines, 5-20 g / kg of antibacterial and anti-inflammatory medicines, 10-20 g / kg of xanthan gum and 9 g / kg of sodium chloride, wherein the absorbable biological ceramic is selected from beta-tricalcium phosphate and hydroxyapatite and the bone healing promoting medicines are growth factors. The invention further provides a preparation method of the bone wax. The method comprises the steps as follows: the absorbable biological ceramic, the bone healing promoting medicines and the antibacterial and anti-inflammatory medicines are added after a solution is prepared from the xanthan gum, and then, the mixture is sheared and uniformly mixed. The bone wax has good biocompatibility, can be degraded and absorbed in the human body, causes no inflammatory reactions, can promote blood coagulation and has bacteriostasis and pain relieving effects.

Description

technical field [0001] The invention relates to a bone wax with a function of promoting healing and bioabsorbability used in orthopedics or surgery and a preparation method thereof, belonging to the technical field of biomedical materials. Background technique [0002] During the surgical operation, bone bleeding often occurs, so it is necessary to control the bone bleeding or take bone hemostasis measures. People have researched and developed bone wax as a mechanical barrier applied to the bone, which can effectively control the phenomenon of bone bleeding. Most of the bone wax currently used in surgery is prepared from beeswax by mixing it with water-insoluble hydrocarbons and vegetable oils. The disadvantage of this type of bone wax is that the wax has poor adhesion and high brittleness at room temperature. In addition, the most common paraffin-based bone waxes are not absorbed by the body, and such waxes, when used in surgery, remain at the site of application for a lo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L24/02A61L24/00A61L24/08A61L24/10
CPCA61L24/0015A61L24/0042A61L24/02A61L24/08A61L24/108A61L2300/204A61L2300/232A61L2300/252A61L2300/402A61L2300/404A61L2300/412A61L2300/414A61L2300/418A61L2400/04A61L2430/02C08L5/00C08L89/00
Inventor 郭晓波张红霞李乐平
Owner 济南上知医疗科技有限公司
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