Preparation method for preparing composite drug-loaded biological material

Abstract

The invention discloses a preparation method of a composite drug-loaded biological material, and particularly relates to the technical field of biological material preparation, and the preparation method comprises the following steps: step 1, preparing 1-2g of vancomycin, 1-2g of mineralized collagen and 10-15g of bone cement; 2, preparing a beaker, sterilizing the beaker, mixing and shaping the mineralized collagen and vancomycin in the beaker in a sterile environment, then adding the bone cement, and uniformly mixing and stirring; and 3, preparing a mold, sterilizing the mold, pouring the mixture into the mold with the length, width and height of 12mm in a sterile environment, waiting for solidification, and taking out the mixture for later use after solidification. The prepared composite drug-loaded biological material can increase the porosity of the surface of bone cement and increase the release metering and efficiency of antibiotics, so that the actual use effect of the composite drug-loaded biological material is relatively good.

Description

Technical Field

[0001] The present invention relates to the technical field of biocompatible material preparation, and more particularly, to a method for preparing a composite drug-loaded biocompatible material. Background Art

[0002] In clinical practice, the incidence of bone defects caused by trauma, limb deformity, tumors, and infectious diseases is increasing day by day. Large-area bone defects cause great inconvenience to patients, seriously affect the postoperative recovery of patients, and endanger the physical and mental health of patients. Bone defects are extremely prone to bacterial infection, and postoperative infection of fractures has become one of the most common forms of bone infection. Staphylococcus aureus is the most common pathogenic bacterium, and the incidence of postoperative infection after internal fixation of fractures can reach 0.4% - 16.1%, with an average incidence of about 5%. If bone defects with infection are not treated in a timely manner or are treated improperly, it will cause serious limb deformity and dysfunction. Prevention and treatment of postoperative infection of fractures are urgent.

[0003] Currently, the treatment of bone defect infection mainly adopts repeated thorough debridement, negative pressure drainage, and antibiotic treatment. However, its treatment cycle is long, the cost is high, the recurrence rate is high, and it may cause antibiotic resistance and organ toxicity damage. The treatment is difficult and extremely tricky to handle. At present, polymethylmethacrylate (PMMA) bone cement plus antibiotics is a simple and effective technique for repairing segmental bone defects. By loading antibiotics, a scaffold material with antibacterial properties is prepared and filled into the infected bone defect site. However, some patients do not achieve ideal treatment effects when using PMMA bone cement plus antibiotics to treat bone defects with infection, and sometimes the infection even worsens. The possible reasons are problems such as poor biocompatibility of the system, low antibiotic release rate, short effective antibiotic release time, and non-biodegradable characteristics of the bone cement. Among them, the surface size and porosity of the bone cement are considered to be the key factors affecting the release of antibiotics from PMMA.

[0004] In view of the problems of low antibiotic release rate and short effective antibiotic release time of existing PMMA loaded with antibiotics, a method for preparing a composite drug-loaded biocompatible material is proposed. Summary of the Invention

[0005] In order to overcome the above-mentioned defects of the prior art, an embodiment of the present invention provides a method for preparing a composite drug-loaded biocompatible material. The composite drug-loaded biocompatible material prepared by the present invention can increase the porosity of the bone cement surface, increase the release dosage and efficiency of antibiotics, and make the actual use effect of the present invention better, so as to solve the problems raised in the above background art.

[0006] To achieve the above object, the present invention provides the following technical solution: A method for preparing a composite drug-loaded biocompatible material, comprising the following steps:

[0007] Step 1: Prepare 1 - 2 g of vancomycin, 1 - 2 g of mineralized collagen, and 10 - 15 g of bone cement;

[0008] Step 2: Prepare a beaker, sterilize the beaker, mix and shape the mineralized collagen and vancomycin in the beaker under a sterile environment, then add the bone cement and mix and stir evenly;

[0009] Step 3: Prepare a mold, sterilize the mold, pour the mixture into a mold with a length, width, and height of 12 mm under a sterile environment, wait for it to solidify, and take it out for standby after solidification.

[0010] In a preferred embodiment, the environmental temperature for the operation of mixing and stirring in Step 2 is controlled at 22 - 24°C.

[0011] In a preferred embodiment, the environmental temperature for the operation of pouring the mixture into the mold and waiting for it to solidify in Step 3 is controlled at 22 - 24°C.

[0012] Technical effects and advantages of the present invention:

[0013] The present invention first prepares 1 - 2 g of vancomycin, 1 - 2 g of mineralized collagen, and 10 - 15 g of bone cement, then prepares a beaker, sterilizes the beaker, mixes and shapes the mineralized collagen and vancomycin in the beaker under a sterile environment, then adds the bone cement and mixes and stirs evenly. The environmental temperature for the operation of mixing and stirring is controlled at 22 - 24°C. Prepare a mold, sterilize the mold, pour the mixture into a mold with a length, width, and height of 12 mm under a sterile environment, wait for it to solidify, and the environmental temperature for the operation of pouring the mixture into the mold and waiting for it to solidify is controlled at 22 - 24°C. Take it out for standby after solidification. The composite drug - loaded biomaterial prepared by the present invention can increase the porosity of the bone cement surface, increase the release dosage and efficiency of the antibiotic, and make the actual use effect of the present invention better. Specific embodiments

[0014] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0015] Example 1

[0016] The present invention provides a preparation method for a composite drug - loaded biomaterial, including the following steps:

[0017] Step 1: Prepare 1 g of vancomycin, 2 g of mineralized collagen, and 13 g of bone cement;

[0018] Step 2: Prepare a beaker, sterilize the beaker, mix and shape mineralized collagen and vancomycin in the beaker under a sterile environment, then add bone cement and mix well.

[0019] Step 3: Prepare a mold, sterilize the mold, pour the mixture into a mold with a length, width and height of 12 mm under a sterile environment, wait for it to solidify, and take it out for standby after solidification.

[0020] The environmental temperature for the mixing operation in Step 2 is controlled at 23 °C.

[0021] The environmental temperature for the operation of pouring the mixture into the mold and waiting for it to solidify in Step 3 is controlled at 23 °C.

[0022] The composite drug-loaded biomaterial prepared in this example has better release efficiency and release time compared with the prior art. 26.3% of the drug can be released on the first day, and the drug release reaches 45.6% on the 14th day and tends to be stable. Therefore, the composite drug-loaded biomaterial prepared in this example can increase the porosity of the bone cement surface, and increase the release dosage and efficiency of the antibiotic.

[0023] Example 2

[0024] The present invention provides a preparation method for a composite drug-loaded biomaterial, comprising the following steps:

[0025] Step 1: Prepare 1 g of vancomycin, 1 g of mineralized collagen, and 13 g of bone cement.

[0026] Step 2: Prepare a beaker, sterilize the beaker, mix and shape mineralized collagen and vancomycin in the beaker under a sterile environment, then add bone cement and mix well.

[0027] Step 3: Prepare a mold, sterilize the mold, pour the mixture into a mold with a length, width and height of 12 mm under a sterile environment, wait for it to solidify, and take it out for standby after solidification.

[0028] The environmental temperature for the mixing operation in Step 2 is controlled at 23 °C.

[0029] The environmental temperature for the operation of pouring the mixture into the mold and waiting for it to solidify in Step 3 is controlled at 23 °C.

[0030] The composite drug-loaded biomaterial prepared in this example has better release efficiency and release time compared with the prior art. 16% of the drug is released on the first day, and the drug release reaches 46.5% on the 38th day. Therefore, the composite drug-loaded biomaterial prepared in this example can increase the porosity of the bone cement surface, and increase the release dosage and efficiency of the antibiotic.

[0031] Comparative Example 1

[0032] The present invention provides a method for preparing a composite drug-loaded biomaterial, comprising the following steps:

[0033] Step 1: Prepare 1 g of vancomycin and 13 g of bone cement;

[0034] Step 2: Prepare a beaker, sterilize the beaker, mix and shape vancomycin in the beaker under a sterile environment, then add bone cement and mix and stir evenly;

[0035] Step 3: Prepare a mold, sterilize the mold, pour the mixture into a mold with a length, width and height of 12 mm under a sterile environment, wait for solidification, and take it out for standby after solidification.

[0036] The environmental temperature of the mixing and stirring operation in Step 2 is controlled at 23°C.

[0037] The environmental temperature of the operation of pouring the mixture into the mold and waiting for solidification in Step 3 is controlled at 23°C.

[0038] The drug release efficiency of this comparative example is poorer than that of Example 1 and Example 2. The drug releases 8.5% on the first day and only reaches 19.1% on the 38th day.

[0039] The present invention first prepares 1-2 g of vancomycin, 1-2 g of mineralized collagen, and 10-15 g of bone cement, then prepares a beaker, sterilizes the beaker, mixes and shapes the mineralized collagen and vancomycin in the beaker under a sterile environment, then adds bone cement and mixes and stirs evenly. The environmental temperature of the mixing and stirring operation is controlled at 22-24°C. Prepare a mold, sterilize the mold, pour the mixture into a mold with a length, width and height of 12 mm under a sterile environment, wait for solidification. The environmental temperature of the operation of pouring the mixture into the mold and waiting for solidification is controlled at 22-24°C. Take it out for standby after solidification. The composite drug-loaded biomaterial prepared by the present invention can increase the porosity of the bone cement surface, increase the release dosage and efficiency of the antibiotic, and make the actual use effect of the present invention better.

[0040] Finally: The above are only the preferred embodiments of the present invention and are not used to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A preparation method of a composite drug-loaded biomaterial, characterized in that, It includes the following steps: Step 1: Prepare 1-2 g of vancomycin, 1-2 g of mineralized collagen, and 10-15 g of bone cement; Step 2: Prepare a beaker, sterilize the beaker, mix and shape the mineralized collagen and vancomycin in the beaker under a sterile environment, and then add the bone cement and mix and stir evenly; Step 3: Prepare a mold, sterilize the mold, pour the mixture into a mold with a length, width, and height of 12 mm under a sterile environment, wait for it to solidify, and take it out for standby after solidification.

2. The preparation method of a composite drug-loaded biomaterial according to claim 1, characterized in that: The environmental temperature for the operation of mixing and stirring in Step 2 is controlled at 22-24 °C.

3. The preparation method of a composite drug-loaded biomaterial according to claim 1, characterized in that: The environmental temperature for the operation of pouring the mixture into the mold and waiting for it to solidify in Step 3 is controlled at 22-24 °C.