CN106039390A - Bone wax composition and preparation method thereof - Google Patents

Abstract

The invention discloses a bone wax composition and a preparation method thereof. The raw materials of the bone wax composition are composed of the following components in weight percentage: PEG-PPG-PEG block copolymer 14000 16-40%, PEG-PPG random copolymer 12000 30-68% and 16-50% of water-insoluble chitosan with a molecular weight of 5000. The bone wax composition of the present invention is absorbable, non-toxic to cells, completely biodegradable, has a coagulation-promoting effect on blood, and can remain in the body for a long enough time to help hemostasis at the bone interface, and the time is more than 72 hours.

Description

A kind of bone wax composition and preparation method thereof

technical field

The invention belongs to the technical field of medical supplies, and in particular relates to a bone wax composition and a preparation method thereof.

Background technique

Hemostasis has always been one of the important issues in emergency medicine. From ancient times to the present, whether it is internal medicine to stop bleeding or external use (burning method, fire needle method, herbal medicine, external application of plaster, etc.), it is the crystallization of the wisdom of ancient doctors. "Elbow Reserve Emergency Prescriptions" written by Ge Liaohong in the Eastern Jin Dynasty of our country adopts different treatment methods for various causes of bleeding, such as cauterization to stop bleeding. Burn the spun iron to burn the pulse." The method of eliminating fatigue and hemostasis is a treatment method of traditional Chinese medicine that uses drugs to promote blood circulation and eliminate addiction to treat bleeding syndrome. It is a treatment method with the most characteristics of traditional Chinese medicine. , supplemented by addiction. Hemostasis is to stop the flow of blood, prevent blood from overflowing from the meridians, and make the blood flow along the meridians normally; to remove addiction is to activate the blood, get rid of the addiction, and keep the blood that is blocked by the addiction from leaving the meridians or staying in the channels. Internal blood addiction dissipates and dissipates. The two governance laws seem to be contradictory, but they are often closely related and unified into a law in practical application. The principle of hemostasis in modern medicine is that platelets aggregate to the edge of the wound, produce fibrin, form a thrombus, block the wound and stop bleeding.

The cancellous bone structure is loose and the blood supply is rich. The wound bleeding is mostly oozing, and it is difficult to stop the bleeding by vasoconstriction. Bone wax is commonly used clinically for hemostasis of cancellous bone wounds. The main components of bone wax are beeswax, sesame oil, etc., which have poor biocompatibility and are difficult to be degraded and absorbed by the body. Residues in the local area will greatly hinder bone healing, because the hemostatic mechanism is only a mechanical physical barrier, which can hinder blood components. The aggregation of (fibrin and platelets) is not conducive to the formation of primitive bone disease, thus causing bone nonunion. In addition, bone wax remains in the body as a foreign body for a long time, forming foreign body granuloma, causing local pain, exudate and other symptoms, which not only reduces the anti-infection ability of the tissue, but also increases the risk of postoperative infection.

In addition, the trauma of orthopedic surgery is often relatively large, and there is no definite hemostatic method for cancellous bone surface bleeding and venous sinus bleeding during surgery. risk of blood-borne infections. Scholars at home and abroad have carried out research work on bone wax substitute products from synthetic polymer materials, biological agents, etc. Such as collagen fibers, gelatin sponge, oxidized cellulose, polylactic acid and polysaccharides, etc. Animal experiments and clinical applications show that although these substances have good biocompatibility and degradability, most of them are in the form of powder or jelly, which have poor compatibility with wounds, are difficult to operate during surgery, and are easily washed away by blood flow. Walk. The raw materials of such polymer materials are expensive, the physical properties are not easy to modify, and there are many unresolved practical problems in terms of material safety. Further in-depth research and improvement are needed.

Contents of the invention

The purpose of the present invention is to overcome the defects of the prior art and provide a bone wax composition.

Another object of the present invention is to provide a preparation method of the above-mentioned bone wax composition.

Concrete technical scheme of the present invention is as follows:

A kind of bone wax composition, its raw material is made up of the component of following percentage by weight:

PEG–PPG–PEG block copolymer 14000 16～40％

PEG–PPG random copolymer 12000 30～68％

16-50% of water-insoluble chitosan with a molecular weight of 5000.

In a preferred embodiment of the present invention, its raw material is made up of the component of following weight ratio: PEG-PPG-PEGblock copolymer 14000:PEG-PPG random copolymer 12000: molecular weight is the water-insoluble chitosan=2:8 of 5000 :2.

A preparation method of the above-mentioned bone wax composition, comprising the steps of:

(1) Take each raw material component in proportion;

(2) Put PEG–PPG–PEG block copolymer 14000 and PEG–PPG random copolymer 12000 in a reaction vessel, heat to 90°C in a water bath while stirring with magnetic force, and mix well;

(3) in the material of step (2) gained, slowly add the non-water-soluble chitosan that molecular weight is 5000, and continue magnetic stirring to even;

(4) Pour the material obtained in step (3) into a mold while it is hot, and cool and solidify naturally at room temperature to obtain the bone wax composition.

The beneficial effects of the present invention are:

1. The bone wax composition of the present invention is absorbable, non-toxic to cells, completely biodegradable, has a coagulation-promoting effect on blood, and can remain in the body for a long enough time to help stop bleeding at the bone interface for more than 72 hours.

2. The preparation process of the present invention is simple, the raw materials are easily obtained, the cost is low, and it is suitable for industrial production.

Description of drawings

Figure 1 is an infrared spectrum analysis chart of the bone wax composition prepared in Example 1 of the present invention.

Fig. 2 is a TEG analysis diagram of the bone wax composition prepared in Example 1 of the present invention.

Fig. 3 is a cell activity analysis graph of the bone wax composition prepared in Example 1 of the present invention.

detailed description

The technical solutions of the present invention will be further illustrated and described below through specific embodiments in conjunction with the accompanying drawings.

Example 1

(1) Take each raw material component by weight as follows: PEG-PPG-PEG block copolymer 14000: PEG-PPGrandom copolymer 12000: molecular weight is 5000 water-insoluble chitosan=2:8:2;

(2) Put PEG–PPG–PEG block copolymer 14000 and PEG–PPG random copolymer 12000 in a reaction vessel, heat to 90°C in a water bath while stirring with magnetic force, and mix well;

(3) in the material of step (2) gained, slowly add the non-water-soluble chitosan that molecular weight is 5000, and continue magnetic stirring to even;

(4) Pour the material obtained in step (3) into a mold while it is hot, and cool and solidify naturally at room temperature to obtain the bone wax composition.

The bone wax composition prepared in this example was analyzed by infrared spectroscopy, and the specific results are shown in Figure 1, wherein B-co/CS is the bone wax composition prepared in this example, and B-co is PEG–PPG–PEG block Copolymer 14000, CS is chitosan.

The bone wax composition prepared in this example was subjected to thromboelastometry (TEG) analysis. TEG analysis is an index that reflects the dynamic changes of blood coagulation (including the formation speed of fibrin, the dissolution state and the solidity and elasticity of the coagulation) as a function of time. TEG analysis measures four commonly used basic parameters of blood clot formation and dissolution, including: (1) R, R time is the time from the start of blood sample detection until the first fibrin clot is formed for a period of latency, and the amplitude on the TEG scan is 2mm; (2) K, coagulation time K is the speed at which the clot strength reaches a certain level (the time required for the amplitude of 2-20mm on the TEG scan), reflecting the speed of blood clot weaving; (3) α angle, evaluating the fibrin block The speed of formation and clot reinforcement, that is, the angle between the tangent line and the horizontal line from the formation of the blood clot to the maximum arc of the scan graph on the TEG scan graph; (4) MA, the maximum amplitude of the TEG scan graph, indicating the maximum strength of the blood clot , can reflect platelet function. As shown in Figure 2, it can be seen that the R time of the bone wax composition prepared in this example is 3.3mim, which is much lower than the normal level of 5-10min, indicating that the bone wax has a coagulation-promoting effect on blood.

The bone wax composition prepared in this example was subjected to cell activity analysis. Cell activity is an important indicator for judging whether cells cultured in vitro can grow normally under certain conditions, such as drug treatment, radioactivity or ultraviolet radiation, changes in culture conditions, etc. One of the important methods of antitumor drug and clinical tumor drug susceptibility test. This analysis was detected by the cck8 method. The three groups of determinations took 1, 3, 5, and 7 days as the observation period respectively. As shown in FIG. 3 , as time goes by, the value becomes larger and larger, indicating that the bone wax composition prepared in this example has no toxicity to cells.

Those of ordinary skill in the art will know that when the technical solution of the present invention changes within the following ranges, the same or similar technical effects as those of the above-mentioned embodiments can still be obtained:

A kind of bone wax composition, its raw material is made up of the component of following percentage by weight:

PEG–PPG–PEG block copolymer 14000 16～40％

PEG–PPG random copolymer 12000 30～68％

16-50% of water-insoluble chitosan with a molecular weight of 5000.

The above is only a preferred embodiment of the present invention, so the scope of the present invention cannot be limited accordingly, that is, equivalent changes and modifications made according to the patent scope of the present invention and the content of the specification should still be covered by the present invention In the range.

Claims (3)

1. A bone wax composition, characterized in that: its raw material is made up of the following components by weight percentage: PEG–PPG–PEG block copolymer 14000 16～40％ PEG–PPG random copolymer 12000 30～68％ 16-50% of water-insoluble chitosan with a molecular weight of 5000. 2. A kind of bone wax composition as claimed in claim 1, is characterized in that: its raw material is made up of the component of following weight ratio: PEG-PPG-PEG block copolymer 14000: PEG-PPG random copolymer 12000: molecular weight is 5000 The non-water-soluble chitosan=2:8:2. 3. a preparation method of the described bone wax composition of claim 1 or 2, is characterized in that: comprises the steps: (1) Take each raw material component in proportion; (2) Put PEG–PPG–PEG block copolymer 14000 and PEG–PPG random copolymer 12000 in a reaction vessel, heat to 90°C in a water bath while stirring with magnetic force, and mix well; (3) in the material of step (2) gained, slowly add the non-water-soluble chitosan that molecular weight is 5000, and continue magnetic stirring to even; (4) Pour the material obtained in step (3) into a mold while it is hot, and cool and solidify naturally at room temperature to obtain the bone wax composition.