KR20200020284A - A powder composition for preparing bone cement providing tunnels for moving bone-forming cells - Google Patents

Abstract

The present invention relates to a powdery composition for manufacturing bone cement comprising calcium sulfate and calcium phosphate, and bone cement manufactured by mixing the composition with a liquid. More particularly, the present invention relates to calcium phosphate/calcium sulfate bone cement containing at least 10 wt% of calcium sulfate or gypsum having a particle size of 100 um or more in order to provide a movement path through which bone tissue-producing cells can move smoothly; and to a manufacturing and packaging method capable of manufacturing the bone cement.

Description

Powder composition for preparing bone cement providing tunnels for moving bone-forming cells

The present specification relates to a powdery composition for producing bone cement comprising calcium sulfate and calcium phosphate, and to bone cement prepared from the composition, and more particularly, to provide a moving passage through which bone tissue producing cells can move smoothly. Calcium phosphate / calcium sulphate bone cement comprising gypsum or calcium sulfate of 100 um or more, and compositions, kits and methods for packaging the same.

Bone cement is used for the fixation of artificial joints such as hip and artificial knee joints, as a filler after bone tumor removal surgery, for the replacement of bone defects after head surgery, and for fracture, plastic surgery, dental treatment, etc. Widely used.

As such a cement for bone bonding, an acrylic cement mainly composed of polymethyl methacrylate (PMMA) is mainly used. This acrylic cement has the advantage of excellent mechanical strength, but there is a disadvantage in that it is not biodegradable to regenerate bone tissue. In addition, acrylic cements have recently been applied to spinal augmentation in osteoporosis patients, but there is a problem in that the spinal nerves may be damaged due to high exothermic reactions and the patients may be in a semi-incompetent state.

In 1983, he developed calcium phosphate cement for the first time by mixing phosphate solution with TTCP, DCP and others by Brown and Chow. The calcium phosphate cement is mainly composed of an aqueous solution containing calcium phosphate powder and a curing accelerator. In clinical applications, when calcium phosphate and aqueous solution are mixed, the calcium phosphate partially ionizes in water and slowly dissolves, and then precipitates with calcium-based compounds such as hydroxy apatite (HA), causing particles to aggregate and harden. Happens. As the curing accelerator, compounds that promote precipitation reactions and compounds that promote ionization of calcium phosphate are used.

This calcium phosphate cement produces hydroxyapatite or brucite (Dicalcium phosphate dihydrate; DCPD) in the body. The hydroxyapatite has a problem that the solubility product is 58.4, which is very slow and affects the regeneration of new bone of the patient. Brucite has a solubility product of 6.59, which is much faster than hydroxyapatite, but this bone cement uses strong acid such as phosphoric acid or sulfuric acid in reaction. Therefore, it causes necrosis of surrounding bone tissue or interferes with proliferation of osteoblasts, thus delaying new bone regeneration. There is. Table 1 is the solubility product of the major calcium-based chemicals used as the bone substitute material.

compound Solubility product (pKsp = -log (Ksp) at 35 ℃) Hydroxyapatite (HA) 58.4 β-Tricalcium phosphate (β-TCP) 28.9 Dicalcium phosphate dihydrate (DCPD) 6.59 Calcium sulfate dihydrate (CSD) 4.62

* pKsp: solubility product; Ksp: Dissolution rate constant.

Calcium sulfate bone cement is widely used. Calcium sulfate, or gypsum, has a solubility product of 4.62, which facilitates biodegradation in the body. However, this substance is so rapidly biodegradable that it is absorbed into the body before bone regeneration is completely completed. Clinically, the problem of fracture or reoperation is left in the bone tissue by leaving a nonunion empty space. Therefore, the biodegradation rate of the bone cement should be approximately equal to the regeneration rate of the new bone, so that the bone cement has bone conductivity and promotes the regeneration of the new bone.

Accordingly, research and commercialization are being made to control the decomposition rate of bone substitutes or bone cements by combining calcium sulfate and calcium phosphate with high decomposition rates. Liu et al. Developed a technique for making calcium sulfate / calcium phosphate complexes by partially converting calcium sulfate particles into calcium phosphate (US Pat. No. 5,462,722 10/31/1995).

Moseley et al. Combine calcium sulfate hemihydrate with monocalcium phosphate monohydrate (MCPM) and beta-tricalcium phosphate (b-TCP) to make gypsum and brucite. Bone cements have been developed (brush 8) (US 8,685,464 B2, 04/01/2014; KR 10-2016-0113594). The present invention is characterized by the fact that MCPM and b-TCP react with each other to produce brucite, but the curing time takes more than 30 minutes and does not cure well.

Cooper has developed a composition containing calcium sulfate powder and beta-tricalcium phosphate powder with a particle size of 0.4-5.0 mm as the main raw materials, and materials for producing calcium and hydroxy ions and therapeutic substances (US 8,496,955 B2, 07/30). / 2013). Large particles of beta-tricalcium phosphate are very slow to decompose, and thus the particles themselves cannot be decomposed to provide a cell migration space, and the reason for using them is to facilitate the attachment of osteoblasts. If it is large, there is a problem that it is not easy to inject with a syringe.

On the other hand, in order for tissue cells to grow, there must be a supporting base, and in order to create three-dimensional tissues, there must be a passage for growth. Therefore, the support used in tissue engineering has a porous structure. Similarly, it is reported that the porous material is used in the bone substitute material and the proper pore size is 100-800 um (Lee Byung-Tak et al., KR 10-1168121; Yang Hee-Suk et al., KR 10-2016-0121726; Sous et al., Biomaterials 19, 2147-53, 1998).

In bone cement, porous cement has been developed to solve this problem because it is not a porous structure and there is no cell migration path (Real, Biomaterials 23, 3673, 2002; Ginebra, JBMR 80A, 351, 2007). However, this method is difficult to apply clinically because it has a lot of problems to apply to the clinical directly because of the weak mechanical properties of cement from the beginning of transplantation due to porosity, and difficult to handle due to late curing time.

Therefore, a situation that requires a study on the composition for producing bone cement that solves the above problems.

US Patent No. 5,462,722 Korean Patent Publication No. 10-2016-0113594 United States Patent No. 8,685,464 United States Patent No. 8,496,955

Accordingly, the present inventors are trying to solve the problem that new bone formation is not smooth due to the difficulty in penetrating into the bone cement cells due to the non-porosity of the bone cement presented above.

One aspect of the present invention is to provide a powder composition for bone cement production to act as a supporter to which osteoblasts can attach and to make the regeneration of bone tissue smoothly by creating a passage of 100 um or more so that cells can move through biodegradation. .

Another aspect of the present invention is to provide a bone cement comprising a reaction product formed by mixing a liquid composition to the powdered composition.

Another aspect of the present invention is to provide a kit for bone cement having the above characteristics.

The object of the present invention is not limited to the above-mentioned object. The object of the present invention will become more apparent from the following description, and will be realized by the means described in the claims and combinations thereof.

One aspect of the present invention is iii) calcium sulfate hemihydrate powder having a particle size of 80 um-450 um; Ii) calcium sulfate hemihydrate powder having a particle size of 60 um or less; And iii) calcium phosphate powder having a particle size of 60 um or less. Provides a powdery composition for bone cement production, which forms a bone graft substitute when mixed with an aqueous solution.

In one aspect of the present invention, the calcium sulfate hemihydrate powder of i) provides a powdery composition for producing bone cement having a particle size of 100 um-400 um.

In one aspect of the present invention, the calcium sulfate hemihydrate powder of i) or ii) comprises any one or more of beta-type calcium sulfate hemihydrate powder and alpha-type calcium sulfate hemihydrate powder, and the calcium phosphate powder of i) Silver is a beta-type calcium triphosphate, provides a powder composition for producing bone cement.

In one aspect of the present invention, the calcium sulfate hemihydrate powder of (i) and the calcium sulfate hemihydrate powder of ii) are included in a weight ratio of 1: 0.5-1.5, to provide a powdery composition for bone cement production.

In one aspect of the present invention, the calcium sulfate hemihydrate powder of i) and calcium phosphate powder i) are included in a weight ratio of 1: 1.5-2.5, to provide a powdery composition for bone cement production.

In one aspect of the invention, the calcium sulfate hemihydrate powder of i), the calcium sulfate hemihydrate powder of i) and the calcium phosphate powder i) are included in a weight ratio of 1: 0.5-1.5: 1.5-2.5. Provided is a powder composition for producing cement.

In one aspect of the invention, with respect to the total weight of the powdered composition for producing bone cement

Calcium sulfate hemihydrate powder of iii) is included in 10% by weight to 40% by weight,

Calcium sulfate hemihydrate powder of ii) is contained in 10 to 30% by weight,

Iii) calcium phosphate powder is provided in 20% by weight to 60% by weight, provides a powdery composition for bone cement production.

Another aspect of the present invention provides a bone cement comprising a reaction product formed by mixing a liquid composition with a powdery composition according to any one of the above.

 In another aspect of the invention, the liquid composition provides bone cement, which is an aqueous solution comprising any one or more of sodium chloride, sodium sulfide and potassium sulfide.

Another aspect of the invention, the first unit containing the powdery composition according to any one of the above; And a second unit including a liquid composition, wherein the first unit and the second unit are separated by a switch, but the powder composition and the second unit included in the first unit when the switch is removed or opened. Provided are kits for bone cement, in which a liquid composition is mixed.

Calcium sulfate / calcium phosphate bone cement according to the present invention is a calcium sulfate / calcium phosphate bone cement that provides a passage for bone tissue producing cells to act as a support to which osteoblasts can attach and biodegradation so that cells can move By creating a passage of 100 um or more, the bone tissue regeneration is effective.

 The effect of this invention is not limited to the effect mentioned above. It is to be understood that the effects of the present invention include all the effects deduced from the description below.

1 is an SEM image of calcium sulfate hemihydrate powder separated using a 100-400 μm sized sample according to Experimental Example 1, FIG. 1A is a 200 times magnification picture, and FIG. 1B is a 500 times magnification picture.
2 is a graph of calcium sulfate and bone cement particle distribution of 100-400 um large particles prepared by Example 1. FIG.
Figure 3 is a SEM photograph of the surface of the bone cement was examined for degradation behavior in 1N hydrochloric acid aqueous solution according to Experimental Example 4, Figure 3a is a 200 times magnification, Figure 3b is a 1000 times magnification.
4 is a bone cement kit according to another aspect of the present invention.

Unless otherwise stated, all numbers, values, and / or expressions used herein to express components, reaction conditions, content of components, and the like, the various values of the measurements that occur in obtaining these values, among other things, are inherently different. Since they are approximations of uncertainty, they should be understood as being modified in all cases by the term "about." In addition, where numerical ranges are disclosed herein, these ranges are continuous and include all values from the minimum to the maximum including the maximum, unless otherwise indicated. Furthermore, where such ranges refer to integers, all integers are included, including the minimum to the maximum including the maximum unless otherwise indicated.

In the present specification, when a range is described for a variable, it will be understood that the variable includes all values within the described range including the listed endpoints of the range. For example, the range "5 to 10" includes any subrange such as 6 to 10, 7 to 10, 6 to 9, 7 to 9, as well as values of 5, 6, 7, 8, 9, and 10. And any value between integers that fall within the scope of the described ranges such as 5.5, 6.5, 7.5, 5.5-8.5, 6.5-9, and the like. Also for example, the range of “10% to 30%” ranges from 10% to 15%, 12% to 10%, 11%, 12%, 13%, etc. as well as all integers including up to 30%. It will be understood to include any subranges such as 18%, 20% to 30%, and any value between reasonable integers within the range of the stated range, such as 10.5%, 15.5%, 25.5% and the like.

Hereinafter, the present invention will be described in detail.

Calcium sulfate has been used for a long time as a bone cement in dentistry or orthopedics, but there are no biological reactions such as foreign body reactions or immune reactions. However, the biodegradation rate is too fast, there is a problem that often occurs when the bone cement that should play a role before the bone regeneration completely disappears. In this regard, studies on delaying the decomposition rate of bone cement by complexing calcium phosphate, which has a relatively low absorption rate, have been conducted since the 1990s, and have recently been widely used in actual clinical practice.

This calcium sulfate / calcium phosphate bone cement has the advantage of slower decomposition rate compared to calcium sulfate cement, but there are few pores over 100um where bone forming cells can grow, which hinders bone tissue growth and causes bone regeneration. Often occurs. Therefore, in the present invention, by using a calcium sulfate of more than 100 um or more in a certain amount has developed a bone cement that can produce large pores. That is, small particles of calcium phosphate and calcium sulfate are mixed with each other, so even if calcium sulfate is decomposed first, calcium phosphate particles remain so that no pores or passages are allowed to grow into tissue cells. On the other hand, in large particles of calcium sulfate of 100 μm or more in diameter, when this melts, pores or passages of 100 μm or more in diameter occur, thereby allowing osteoblasts to grow.

Hereinafter, various aspects of the present invention will be described.

One aspect of the present invention is iii) calcium sulfate hemihydrate powder having a particle size of 80 um-450 um; Ii) calcium sulfate hemihydrate powder having a particle size of 60 um or less; And iii) calcium phosphate powder having a particle size of 60 um or less. Provides a powdery composition for bone cement production, which forms a bone graft substitute when mixed with an aqueous solution.

Calcium sulfate used in the present invention is the chemical name of gypsum, and calcium sulfate hemihydrate, anhydrous, dihydrate, etc., having a solubility product near 4.6 and very similar to each other, as in bone cement. In contact with it all become calcium sulfate dihydrate. Therefore, either calcium sulfate or gypsum can be applied.

In one embodiment, calcium sulfate is prepared by heating gypsum ore, a calcium sulfate dihydrate, in water or in a pressure vessel to remove water, as is generally known. The prepared calcium sulfate is crushed using a grinder, and the particles are placed in a vibrating separator and sifted to sort particles by size. The large particles of calcium sulfate used in the present invention are used to screen particles between 100 and 400 um using a 100 um and a 400 um shaft size. In one embodiment, as a result of SEM analysis, small particles are actually adsorbed on the surface of the particles, and thus, the particles are not 100 μm or more, and the particle distribution analysis shows that about 10% or less of particles exist.

In one embodiment, the small particles of calcium sulfate use calcium sulfate hemihydrate, which is converted into calcium sulfate dihydrate by contact with water and becomes solid, which is the main hardening mechanism of this bone cement. The small particles of calcium sulfate hemihydrate were screened using a size of about 60 um, with an average particle size of about 20-40 um.

In one embodiment, the calcium phosphate uses beta-tricalcium phosphate. It is screened using a size of about 60 um and uses particles having an average particle size of 20-40 um. Particles with an average particle size of 40 um or more have a problem of low sorting efficiency and high cement viscosity in order to obtain a compound having a mean particle size of 20 um or less without complexing with calcium sulfate.

In one aspect of the present invention, the calcium sulfate hemihydrate powder of i) provides a powdery composition for producing bone cement having a particle size of 100 um-400 um.

In one aspect of the present invention, the calcium sulfate hemihydrate powder of i) or ii) comprises any one or more of beta-type calcium sulfate hemihydrate powder and alpha-type calcium sulfate hemihydrate powder, and the calcium phosphate powder of i) Silver is a beta-type calcium triphosphate, provides a powder composition for producing bone cement.

In one aspect of the present invention, the calcium sulfate hemihydrate powder of (i) and the calcium sulfate hemihydrate powder of ii) are included in a weight ratio of 1: 0.5-1.5, to provide a powdery composition for bone cement production.

In one aspect of the present invention, the calcium sulfate hemihydrate powder of i) and calcium phosphate powder i) are included in a weight ratio of 1: 1.5-2.5, to provide a powdery composition for bone cement production.

In one aspect of the invention, the calcium sulfate hemihydrate powder of i), the calcium sulfate hemihydrate powder of i) and the calcium phosphate powder i) are included in a weight ratio of 1: 0.5-1.5: 1.5-2.5. Provided is a powder composition for producing cement.

When the weight ratio is satisfied, the composition acts as a supporter to which osteoblasts can effectively attach to the human body when applied to the human body, and makes the bone regeneration smoothly by creating a passage over 100 um so that the cells can move through biodegradation. A powdery composition for cement production can be provided.

In one aspect of the invention, with respect to the total weight of the powdered composition for producing bone cement

Calcium sulfate hemihydrate powder of iii) is included in 10% by weight to 40% by weight,

Calcium sulfate hemihydrate powder of ii) is contained in 10 to 30% by weight,

Iii) calcium phosphate powder is provided in 20% by weight to 60% by weight, provides a powdery composition for bone cement production.

In one embodiment, the calcium sulfate of iii) used 10-40 wt% of the total powder. When it exceeds 40 wt%, the strength of bone cement may be weakened, and when it is less than 10 wt%, less pores may occur, resulting in less cell migration pathways.

In one embodiment, the calcium sulfate hemihydrate powder of ii) may have a weak strength of bone cement at 10 wt% or less, and a decomposition rate of bone cement at 30 wt% or more.

Another aspect of the present invention provides a bone cement comprising a reaction product formed by mixing a liquid composition with a powdery composition according to any one of the above.

The liquid composition may use an aqueous solution in which salt, sodium sulfate, potassium sulfate, etc. are dissolved in tertiary distilled water. These components may be used at concentrations of up to 4 wt% as materials to promote hardening of the cement. The use of concentrations above 4 wt% has the problem of causing side effects to patients during surgery.

 In another aspect of the invention, the liquid composition provides bone cement, which is an aqueous solution comprising any one or more of sodium chloride, sodium sulfide and potassium sulfide.

Another aspect of the invention, the first unit containing the powdery composition according to any one of the above; And a second unit including a liquid composition, wherein the first unit and the second unit are separated by a switch, but the powder composition and the second unit included in the first unit when the switch is removed or opened. Provided are kits for bone cement, in which a liquid composition is mixed.

It is very difficult to maintain complete sterilization even in an operating room. Therefore, clinicians are always trying to maintain sterilization and to prevent bacterial infection. Therefore, in the present invention, in order to maintain the sterilization state of the cement during mixing, as shown in Figure 4 to install a switchgear (closure) that can be opened and closed in one plastic pack to put the cement liquid on one side and put the powder phase on the other side using a fusion machine The plastic pack was sealed. As shown in FIG. 4, the switch may be replaced with a plastic zipper such as a zipper of a zipper bag. This zipper can be installed twice as needed to improve the reliability of the seal. The pack can be equipped with connectors to connect or connect syringes, tubes, needles, etc. as needed.

When using cement in the operating room, open the switchgear, combine the liquid and powder phases, and mix the packing pack by hand outside the pack. If necessary, re-install the switch on the top of the pack to maintain proper mixing space before mixing. If you are installing a zipper, lock the zipper and rub it by hand to mix. One end of the pack can be cut with scissors and transferred to a syringe or the like for use. Or by installing a connector that connects to the syringe, it can be transferred directly from the pack to the syringe, further reducing the risk of infection.

Hereinafter, the present invention will be described in more detail with reference to specific examples. The following examples are merely examples to help understanding of the present invention, but the scope of the present invention is not limited thereto.

Example 1

Gypsum ore is crushed to 10-20 mm size, and then dried in air at 120 ℃ for 12 hours to prepare beta-type calcium sulfate hemihydrate, and then crushed by using a grinder. Particles are sorted by size. At this time, 60, 100, and 400 um shot sizes are used. The powder of calcium sulfate hemihydrate yields particles of up to 60 um and particles between 100 and 400 um.

To prepare powdered calcium sulfate / calcium phosphate bone cement, 20 g of beta-type calcium triphosphate (average organic particles) with an average particle size of about 26 mm and 10 g of calcium sulfate hemihydrate with a size of less than 60 um and a particle size of 100-400 um 10 g of calcium sulfate hemihydrate was added to a ball mill and mixed by rotating at a rotation speed of 150 rpm for 12 hours. Liquid phase of calcium sulfate / calcium phosphate bone cement is prepared by dissolving 0.6 g of salt in 20 ml of ultrapure water.

Example 2

Gypsum ore is crushed to 10-20 mm size, dried under high pressure for 2 hours in 120 ℃ high pressure reactor to prepare alpha type calcium sulfate hemihydrate, and then crushed by crusher. Particles are sorted by size. At this time, 60, 100, and 400 um shot sizes are used. The powder of alpha-type calcium sulfate hemihydrate (hard gypsum) yields particles up to 60 um and particles between 100 and 400 um.

To prepare powdered calcium sulfate / calcium phosphate bone cement, 20 g of beta-type calcium triphosphate (average particle size of about 26 mm) and 10 g of alpha-type calcium sulfate hemihydrate of less than 60 um and 100-400 um 10 g of alpha-type calcium sulfate hemihydrate of particle size are placed in a ball mill and mixed by rotating at a rotation speed of 150 rpm for 12 hours. The liquid phase of calcium sulfate / calcium phosphate bone cement is prepared by dissolving 0.8 g of sodium sulfide in 20 ml of ultrapure water.

Example 3

The gypsum gemstone is crushed into 10-20 mm size, put into 30 wt% calcium chloride aqueous solution, boiled for 2 hours, thoroughly washed with 100 ^o C ultrapure water, and dried sufficiently in 100 ^o C dry oven, and then alpha calcium sulfate Prepare a hemihydrate (carbide gypsum). Next, the crusher is crushed using a grinder, and the particles are placed in a vibrator and sifted to sort the particles by size. At this time, 60, 100, and 400 um shot sizes are used. The powder of alpha-type calcium sulfate hemihydrate (carbide gypsum) yields particles up to 60 um and particles between 100 and 400 um.

To prepare powdered calcium sulfate / calcium phosphate bone cement, 20 g of beta-type calcium triphosphate (average particle size of about 26 mm) and 10 g of alpha-type calcium sulfate hemihydrate of less than 60 um and 100-400 um 10 g of superhard gypsum of particle size is placed in a ball mill and mixed by rotating at a rotation speed of 150 rpm for 12 hours. The liquid phase of calcium sulfate / calcium phosphate bone cement is prepared by dissolving 0.4 g of potassium sulfide in 20 ml of ultrapure water.

Experimental Example 1

Beta-type calcium sulfate hemihydrate powder of 100-400 um particle size used in the present invention was analyzed using SEM.

FIG. 1A is a 200 times SEM photograph, and FIG. 1B is a 500 times SEM photograph. As shown in the photo, it was confirmed that particles of 100 um or more exist. However, smaller particles were adsorbed or dispersed and separated using 100-400 um mining, but it was confirmed that only 100 um or more of particles were completely absent.

Experimental Example 2

The particle distribution of the calcium sulfate hemihydrate and bone cement prepared in Example 1 was investigated using a particle size analyzer (Microtrac Inc., Bluewave).

Experimental results were as shown in FIG. 2.

The calcium sulfate separated by 60 um mining had a particle size of 29.8 ± 23.5 um and the calcium sulfate separated by 100-400 um mining was 106.4 ± 102.2 um.

Therefore, it could be confirmed that calcium sulfate more than 100 um is present. In addition, the average particle size of bone cement was 29.0 ± 23.0 um.

Experimental Example 3

After mixing the powder phase and liquid phase of the calcium sulfate / calcium phosphate bone cement prepared in Example 1-3, it was put into a 30 ml syringe to evaluate the injection property and the initial curing time was measured using the Gilmore needle method.

The experimental results are shown in Table 2. As shown in Table 2, the injectability is generally better than 90%, and the initial curing time is also within 15 minutes, so it was confirmed that clinical application is possible because there is no big problem in clinical application.

Sample name Injectionability (%) Initial Curing Time (min) Example 1 96 10 Example 2 99 12 Example 3 94 14

Experimental Example 4

Since osteoclasts secrete aqueous hydrochloric acid at pH 5.5 to decompose bone tissue in vivo, the osteoclasts were tested in aqueous hydrochloric acid to investigate the degradation behavior of bone cement.

The bone cement cured product of Example 1 prepared in Experimental Example 3 was crushed to an appropriate size, and then placed in 1 N aqueous hydrochloric acid solution for 2 weeks, and then the surface of the cured product was examined by SEM.

Experimental results were as shown in FIG. 3. As shown in FIG. 3, traces of particle decomposition of 100 μm or more were observed. Therefore, the powdery composition and the bone cement prepared by the composition according to the present invention can provide a path for the growth of osteogenic cells, which are passages of 100 um or more in size, to facilitate the regeneration of bone tissue. Confirmed.

Although the embodiments of the present invention have been described above with reference to the accompanying drawings, those skilled in the art to which the present invention pertains may implement the present invention in other specific forms without changing the technical idea or essential features thereof. You will understand that there is. Therefore, it is to be understood that the embodiments described above are exemplary in all respects and not restrictive.

Claims (10)

Iii) calcium sulfate hemihydrate powder having a particle size of 80 um-450 um;
Ii) calcium sulfate hemihydrate powder having a particle size of 60 um or less; And
Iii) calcium phosphate powder having a particle size of 60 um or less;
A powdery composition for producing bone cement, comprising: forming a bone graft substitute when mixed with an aqueous solution.
The method of claim 1,
Calcium sulfate hemihydrate powder of (iii) has a particle size of 100 um-400 um, powdery composition for bone cement production.
The method of claim 1,
The calcium sulfate hemihydrate powder of i) or ii) comprises at least one of beta type calcium sulfate hemihydrate powder and alpha type calcium sulfate hemihydrate powder,
The calcium phosphate powder of iii) is beta-type calcium triphosphate, a powdery composition for producing bone cement.
The method of claim 1,
The calcium sulfate hemihydrate powder of iii) and the calcium sulfate hemihydrate powder of ii) are included in a weight ratio of 1: 0.5-1.5, wherein the powdery composition for bone cement production.
The method of claim 1,
Iii) calcium sulfate hemihydrate powder and iii) calcium phosphate powder are included in a weight ratio of 1: 1.5-2.5.
The method of claim 1,
The calcium sulfate hemihydrate powder of (iii), the calcium sulfate hemihydrate powder of (ii) and the calcium phosphate powder (iii) are included in a weight ratio of 1: 0.5-1.5: 1.5-2.5.
The method of claim 1,
About the total weight of the powdered composition for bone cement production
Calcium sulfate hemihydrate powder of iii) is included in 10% by weight to 40% by weight,
Calcium sulfate hemihydrate powder of ii) is contained in 10 to 30% by weight,
Iii) the calcium phosphate powder is contained in 20% by weight to 60% by weight, powdery composition for producing bone cement.
A bone cement comprising a reaction product formed by mixing a liquid composition with a powdered composition according to any one of claims 1 to 7.
The method of claim 8,
The liquid composition is bone cement, which is an aqueous solution containing any one or more of sodium chloride, sodium sulfide and potassium sulfide.
A first unit comprising a powdery composition according to any one of claims 1 to 7; And a second unit containing a liquid composition;
The first unit and the second unit is separated by a switch, but when removing or opening the switch, the powder composition contained in the first unit and the liquid composition contained in the second unit, the kit for bone cement.

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