Biological medicine high-efficiency polypeptide rinsing gel and preparation process thereof

Abstract

The application discloses a kind of biological medicine efficient polypeptide flushing gel and preparation process, it is related to polypeptide flushing gel preparation technical field, first, at 20 ℃ with 550rpm stirring speed injection water is stirred, and slowly adding sodium carboxymethyl cellulose, after all is added, put into kudzu root polysaccharide, the stirring speed is promoted to 1200rpm and continues to mix 45 minutes, then reduce the speed to 300rpm, add sodium chloride and stir until dissolved, make up injection water, and adjust pH to 7.0-7.5, prepare water phase carrier, immediately cool to 2-8 ℃ for standby, then, in the independent 5 ℃ low temperature environment, freeze-dried polypeptide powder is slowly added into pre-cooled phosphate buffer according to the proportion of 1mg / mL, stirring and dissolving, prepare polypeptide mother liquor, then, polypeptide mother liquor is stirred with the above-mentioned standby water phase carrier, after mixing evenly, the final solution is filled and sealed, and finally using high-temperature steam sterilization method is handled.

Description

Technical Field

[0001] This invention relates to the field of polypeptide rinsing adhesive preparation technology, specifically to a high-efficiency polypeptide rinsing adhesive for biomedicine and its preparation process. Background Technology

[0002] In surgical procedures, saline solution is typically used to rinse and treat various wounds. However, saline solution only cleans the wound and does not promote healing or prevent adhesions. Therefore, a series of functional rinsing solutions have emerged on the market. One type is a rinsing solution made primarily from plant fibers, such as sodium carboxymethyl cellulose. This solution can form a physical barrier on the wound while cleaning it, preventing adhesions and promoting wound healing. Furthermore, the pure natural plant fibers have good biocompatibility, no adverse reactions, and are non-toxic, non-irritating, and non-antigenic to the human body. They can be completely decomposed and metabolized in the body, protecting the normal biological activity of tissues, soothing irritation, and promoting the repair of epithelial, mucosal, and tissue wounds.

[0003] Currently, the production and preparation of rinsing adhesives generally involves processes such as raw material stirring, filtration, vacuum degassing, and aseptic filling. In the raw material stirring stage, the mixing of multiple raw materials is usually achieved through high-speed stirring and shearing. However, for rinsing adhesives containing bioactive peptides, the high shear force generated by high-speed stirring can cause peptide molecular chains to break or their conformation to change, resulting in irreversible inactivation. Therefore, when producing peptide-containing adhesives, mild process conditions must be adopted, i.e., significantly reducing the stirring speed and avoiding violent shearing. However, polysaccharide raw materials hydrate rapidly upon contact with water, forming a high-viscosity gel layer on the surface. Under low-speed stirring conditions, the shear force of the fluid is greatly reduced, making it difficult to overcome the adsorption force between the viscous material and the surface of the stirring rod. This situation leads to a prolonged stirring time for the colloidal product, and the effective raw material adhering to the stirring blades is difficult to participate in the mixing, causing the actual formula ratio to deviate from the design value and affecting the final product performance. Summary of the Invention

[0004] The purpose of this invention is to provide a highly efficient polypeptide rinsing solution for biomedicine and its preparation process, so as to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention provides a process for preparing a highly efficient peptide rinsing adhesive for biomedicine, comprising the following steps:

[0006] S1: Preparation of aqueous carrier: In a stirred tank, add water for injection through the feed port, start stirring, control the temperature at 20℃, and slowly and evenly feed sodium carboxymethyl cellulose powder through the feed port while stirring at a medium speed of 550 rpm.

[0007] After all the ingredients are added, add kudzu polysaccharide, increase the stirring speed to 1200 rpm, and continue stirring for 45 minutes until the solution is completely mixed. Then reduce the stirring speed to 300 rpm, add sodium chloride, and stir until completely dissolved. Add water for injection to the total volume, stir evenly, and finally adjust the pH of the solution to 7.0-7.5 with a pH adjuster to obtain an aqueous carrier. Cool the prepared aqueous carrier to 2-8℃ using a cooling system for later use.

[0008] S2: Preparation of peptide solution: Pour pre-cooled phosphate buffer into an independent stirring container. At a low temperature of 5°C, slowly add lyophilized peptide powder to the phosphate buffer at a ratio of 1 mg / mL and stir until the powder is completely dissolved to form peptide mother liquor.

[0009] S3: Mixing. Confirm that the temperature of the aqueous carrier in the mixing tank has stabilized at 2-8℃. Turn on the drive motor and stir at low speed for 60 rpm to form a stable vortex. While stirring, add the peptide mother liquor at 2-8℃ to the mixing tank at a rate of 3 mL / min. The mixing tank is equipped with a drive rod and a stirring rod fitted in its scraping groove. During the stirring process, the drive rod drives the stirring rod to rotate, and at the same time, the stirring rod slides horizontally back and forth in the scraping groove to scrape off the adhering material. The raw materials are dispersed by vibration and rotary cutting. After the peptide mother liquor is added, continue to stir at low speed for 8 minutes at the same temperature to ensure that the system is mixed evenly.

[0010] S4: Post-processing. After stirring is complete, take out the mixed solution, fill it, seal it and sterilize it with high-temperature steam.

[0011] Optionally, the mixing tank is also provided with a fixing rod, a drive plate, a support frame, a turntable, and protrusions;

[0012] When the drive rod rotates, the stirring rod is driven to reciprocate horizontally along the drive rod axis while revolving around the revolution, through the meshing transmission between the fixed rod and the drive plate, so as to mechanically scrape off the adhesive layer.

[0013] At the same time, the protrusions on the turntable intermittently squeeze the connecting blocks on the support frame, driving the vibrating rod to vibrate back and forth, and the material is dispersed by the rotating cutting head at its end.

[0014] Optionally, the post-processing in step S4 specifically includes:

[0015] After the mixed solution is pre-filtered and degassed, it is sterilized by passing it through a 0.22μm sterilization-grade filter. Then, it is filled into pre-sterilized packaging containers in a Class A clean environment and vacuum-sealed.

[0016] Optionally, a drive motor is fixedly installed on the top of the mixing tank, and a drive rod is vertically arranged inside the mixing tank. The bottom output shaft of the drive motor passes through the top of the mixing tank and is fixedly connected to the top of the drive rod. Scraping grooves are evenly spaced through the outer wall of the drive rod, and the mixing rod is slidably connected to the inner wall of the scraping groove. A sliding scraping component is provided inside the drive rod.

[0017] The sliding scraping component includes:

[0018] A fixed rod is vertically installed inside the drive rod. The outer wall of the fixed rod is provided with toothed grooves at equal intervals. A drive cavity is provided inside each of the several stirring rods. A drive plate is provided inside the drive cavity. A number of gear teeth are fixedly connected to the inner wall of the drive plate corresponding to the fixed rod.

[0019] The upper and lower surfaces of the stirring rod are respectively traversed by sliding grooves. The outer wall of the fixed rod slides against the inner wall of the sliding groove. The gear teeth mesh with the grooves. The top of the fixed rod is rotatably connected to the top inner wall of the drive rod. The bottom of the fixed rod passes through the bottom of the drive rod and is fixedly connected to the bottom inner wall of the mixing tank. Support plates are fixedly connected to both ends of the drive plate. Support grooves are formed on the inner walls of both ends of the stirring rod corresponding to the support plates. The outer wall of the support plate slides against the inner wall of the support groove. Mounting seats are symmetrically fixedly connected to the inner walls of both ends of the stirring rod. A spring is rotatably connected to the inner wall of the mounting seat. A connecting ring is fixedly connected to the other end of the spring. Pressing grooves are formed on the upper and lower surfaces of both ends of the drive plate. Pressing rods are slidably connected to the inner walls of the pressing grooves. The inner wall of the connecting ring is rotatably connected to the outer wall of the pressing rod.

[0020] Optionally, the drive rod is provided with vibration-shearing and dispersing components at equal intervals inside;

[0021] The vibratory cutting and even distribution component includes:

[0022] A symmetrical support frame is arranged inside the drive rod. Several vibrating rods are rotatably connected to the two support frames on opposite sides. A rotary cutting head is fixedly connected to the other end of the vibrating rod. Turntables are fixedly connected at equal intervals to the outer wall of the fixed rod. Protrusions are fixedly connected at equal intervals to the outer wall of the turntable. Connecting blocks are fixedly connected to the upper and lower end faces of the support frame to the corresponding protrusions.

[0023] Two springs are fixedly connected to the opposite sides of the two connecting blocks, and the other end of the springs is fixedly connected to the inner wall of the drive rod. The outer walls of the drive rod are provided with through holes at equal intervals corresponding to the scraping grooves. The outer wall of the vibrating rod slides against the inner wall of the through hole. A ball is fixedly connected to the outer wall of the vibrating rod. The inner wall of the through hole is provided with a spiral groove corresponding to the ball. The outer wall of the ball slides against the inner wall of the spiral groove.

[0024] Optionally, the stirring rod is provided with an internal sealing component;

[0025] The adaptive sealing component includes two sets of sealing triangular blocks symmetrically arranged inside the stirring rod. The upper and lower inner walls of the slide groove are respectively symmetrically provided with grooves. The upper and lower outer walls of the sealing triangular blocks slide against the inner walls of the grooves. Two adjacent sealing triangular blocks are staggered and fitted together. A spring is fixedly connected to one side of the sealing triangular block, and the other end of the spring is fixedly connected to the inner wall of the groove. Supplementary blocks are fixedly connected to the inner walls of both ends of the stirring rod.

[0026] This invention also provides a high-efficiency peptide rinsing adhesive for biomedicine prepared by performing the above-described process, comprising an aqueous carrier and a peptide solution;

[0027] The aqueous carrier comprises water for injection, sodium carboxymethyl cellulose, sodium chloride, and kudzu polysaccharide. It is prepared by adding 0.1%–1.0% sodium carboxymethyl cellulose, 0.7%–1.1% sodium chloride, and 0.5%–2% kudzu polysaccharide by weight, and then adding water for injection to a final concentration of 100%.

[0028] The polypeptide solution comprises lyophilized polypeptide powder and phosphate buffer, wherein the concentration of the lyophilized polypeptide powder in the phosphate buffer is 1 mg / mL.

[0029] Optionally, the aqueous carrier is prepared by weight ratio of 0.5% sodium carboxymethyl cellulose, 0.9% sodium chloride, 1.3% kudzu polysaccharide, and water for injection to 100%.

[0030] Compared with the prior art, the beneficial effects of the present invention are:

[0031] 1. In the preparation of peptide washing solution, by pre-cooling the aqueous carrier to 2-8℃ and maintaining this low temperature range throughout the process, combined with an extremely low stirring speed of 40-80 rpm, the heat generated by the viscous carrier formed by sodium carboxymethyl cellulose and kudzu polysaccharide during stirring friction is effectively suppressed, avoiding damage to the thermodynamics and kinetics of peptide molecules. A separate, low-temperature buffer solution is used to pre-dissolve the lyophilized peptides to form a high-concentration mother liquor, which is then added precisely and slowly below the liquid surface using a syringe pump. This minimizes the risk of peptide denaturation caused by exposure to the gas-liquid interface and local high shear during the mixing stage, thereby ensuring the bioactivity and stability of the peptides in the final solution.

[0032] 2. To address the problem that the highly viscous aqueous carrier composed of sodium carboxymethyl cellulose and kudzu polysaccharide is prone to adhesion during stirring, leading to local deviations in the formulation concentration, this invention utilizes the linkage between the drive rod and the fixed rod. This allows the stirring rod to reciprocate axially while revolving around its axis, thereby continuously scraping the contact surface during stirring. This prevents the viscous carrier formed by sodium carboxymethyl cellulose and kudzu polysaccharide from forming an adhesion layer on the surface of the stirring rod. This effectively eliminates the uneven distribution of polysaccharide components such as sodium carboxymethyl cellulose and kudzu polysaccharide caused by adhesion, ensuring the accuracy and uniformity of the formulation ratio of the aqueous carrier and peptide solution, and improving the overall quality and batch consistency of the peptide rinsing solution.

[0033] 3. To avoid the problem of high-viscosity carriers scraped off due to hard extrusion forming dense clumps that are difficult to quickly redisperse in the main liquid when stirring the raw materials of the rinsing adhesive, this invention uses the intermittent extrusion of the protrusions and connecting blocks of the vibratory cutting and dispersing component to drive the vibratory rod to reciprocate and spin-cut the scraped high-viscosity carriers; the spin-cutting head at the end of the vibratory rod rotates and cuts into the interior of the clumps during the vibration process, realizing the mechanical loosening and shearing depolymerization of the polysaccharide-peptide mixed aggregates, completely breaking the dense structure formed by adhesion and extrusion, ensuring that the scraped high-viscosity carriers can be quickly redispersed and uniformly integrated into the main flow field, thereby achieving efficient and homogeneous mixing of peptides in viscous adhesives under low temperature and low shear conditions. Attached Figure Description

[0034] Figure 1 This is a flowchart illustrating the preparation process of the present invention;

[0035] Figure 2 This is a schematic diagram of the overall structure of the present invention;

[0036] Figure 3 This is a schematic diagram of the internal structure of the mixing tank of the present invention;

[0037] Figure 4 This is a schematic diagram of a portion of the internal structure of the drive rod of the present invention;

[0038] Figure 5This is a structural schematic diagram of the connection position between the fixing rod and the drive plate of the present invention;

[0039] Figure 6 For the present invention Figure 5 Enlarged structural diagram at point A;

[0040] Figure 7 This is a structural schematic diagram showing the installation positions of the support frame and the turntable in this invention;

[0041] Figure 8 This is a structural diagram showing the installation positions of the sealing triangular block and the supplementary block of the present invention.

[0042] In the diagram: 1. Mixing tank; 2. Feeding port; 3. Discharge port; 4. Drive motor; 5. Drive rod; 6. Mixing rod; 10. Scraping groove; 11. Through hole; 12. Spiral groove; 7. Sliding scraping component; 701. Fixed rod; 702. Slide groove; 703. Drive cavity; 704. Drive plate; 705. Gear tooth; 706. Support plate; 707. Support groove; 708. Mounting base; 709. Spring 710. Pressure groove; 711. Pressure rod; 712. Connecting ring; 8. Vibratory cutting and even distribution component; 801. Support frame; 802. Connecting block; 803. Spring 2; 804. Turntable; 805. Protrusion; 806. Vibrating rod; 807. Rotary cutting head; 808. Ball bearing; 9. Adaptive sealing component; 901. Groove; 902. Sealing triangular block; 903. Spring 3; 904. Supplementary block. Detailed Implementation

[0043] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0044] For examples, please refer to Figure 1 — Figure 8 This invention provides a process for preparing a highly efficient peptide rinsing adhesive for biomedicine, comprising the following steps:

[0045] S1: Preparation of aqueous carrier: In the mixing tank 1, add 97.3 water for injection in proportion to weight through the feeding port 2, start stirring, control the temperature at 20℃, and slowly and evenly feed 0.5% sodium carboxymethyl cellulose powder in proportion to weight through the feeding port 2 while stirring at medium speed of 550 rpm.

[0046] After all ingredients are added, add 1.3% kudzu polysaccharide by weight, increase the stirring speed to 1200 rpm, and continue stirring for 45 minutes until the solution is completely mixed. Then reduce the stirring speed to 300 rpm, add 0.9% sodium chloride by weight, and stir until completely dissolved. Add water for injection to the total volume, stir evenly, and finally adjust the pH of the solution to 7.0-7.5 using a pH adjuster to obtain an aqueous carrier. Cool the prepared aqueous carrier to 2-8℃ using a cooling system for later use.

[0047] S2: Preparation of peptide solution: Pour pre-cooled phosphate buffer into an independent stirring container. Under low temperature (5°C), slowly add lyophilized peptide powder to the phosphate buffer at a ratio of 1 mg / mL and stir until the powder is completely dissolved to form peptide mother liquor.

[0048] S3: Mixing. Confirm that the temperature of the aqueous carrier in the mixing tank 1 has stabilized at 2-8℃. Turn on the drive motor 4 and stir at low speed for 60 rpm to form a stable vortex. While stirring, add the peptide mother liquor at 2-8℃ to the mixing tank 1 at a rate of 3 mL / min. The mixing tank 1 is equipped with a drive rod 5 and a stirring rod 6 fitted in its scraping groove 10. During the stirring process, the drive rod 5 drives the stirring rod 6 to rotate. At the same time, the stirring rod 6 slides horizontally back and forth in the scraping groove 10 to scrape off the adhering material and disperse the accumulated raw materials through vibration and rotary cutting actions. After the peptide mother liquor is added, continue to stir at low speed for 8 minutes at the same temperature to ensure that the system is mixed evenly.

[0049] The top of the mixing tank 1 is fixedly installed with a drive motor 4, and a drive rod 5 is vertically arranged inside the mixing tank 1. The bottom output shaft of the drive motor 4 passes through the top of the mixing tank 1 and is fixedly connected to the top of the drive rod 5. The outer wall of the drive rod 5 is provided with scraping grooves 10 at equal intervals, and the inner wall of the scraping grooves 10 is slidably connected to the mixing rod 6. The drive rod 5 is provided with a sliding scraping component 7 inside.

[0050] The sliding scraping component 7 includes a fixed rod 701 vertically disposed inside the drive rod 5. The outer wall of the fixed rod 701 is provided with toothed grooves at equal intervals. The interior of each of the several stirring rods 6 is provided with a drive cavity 703, and a drive plate 704 is disposed inside the drive cavity 703. The inner wall of the drive plate 704 is fixedly connected with several gear teeth 705 corresponding to the fixed rod 701, so that the drive rod 5 can drive the stirring rods 6 to perform circumferential rotation and translation around the fixed rod 701.

[0051] In this embodiment, during the mixing process of preparing the polypeptide rinsing adhesive, the drive motor 4 drives the drive rod 5 located in the stirring tank 1 to rotate, thereby driving several stirring rods 6 that are slidably connected to the drive rod 5 to move and stir in a circular motion.

[0052] Then, during the stirring process, due to the significant reduction in fluid shear force under low-speed stirring conditions, it becomes difficult to overcome the adsorption force between the highly viscous aqueous carrier composed of sodium carboxymethyl cellulose and kudzu polysaccharide and the surface of the stirring rod 6. This situation leads to a prolonged product stirring time, and the effective raw materials adhering to the stirring rod 6 are difficult to participate in the mixing. Therefore, by using the sliding grooves 702 that are respectively opened through the upper and lower surfaces of the stirring rod 6, the outer wall of the fixed rod 701 slides against the inner wall of the sliding groove 702, the top of the fixed rod 701 is rotatably connected to the top inner wall of the drive rod 5, and the bottom of the fixed rod 701 passes through the bottom of the drive rod 5 and is fixedly connected to the bottom inner wall of the mixing tank 1. The two ends of the drive plate 704 are respectively fixedly connected to the support plates 706, and the inner walls of the two ends of the stirring rod 6 are provided with corresponding support plates 706. The support groove 707, and the outer wall of the support plate 706 slides against the inner wall of the support groove 707, so that when the drive rod 5 rotates, the stirring rod 6 can drive the internal drive plate 704 to rotate around the fixed rod 701. Taking advantage of the fact that the fixed rod 701 cannot rotate, the stirring rod 6 can be driven to perform a circumferential rotational translational motion by using the cooperation of the tooth groove and the gear tooth 705. This allows the viscous layer formed by sodium carboxymethyl cellulose and kudzu polysaccharide adhering to the surface of the stirring rod 6 to be peeled off in time and pushed back into the main material liquid through the scraping groove 10. This effectively eliminates the uneven distribution of polysaccharide components such as sodium carboxymethyl cellulose and kudzu polysaccharide caused by adhesion, ensuring the accuracy and uniformity of the formulation ratio of the aqueous carrier and the peptide solution, thereby improving the overall quality and batch consistency of the peptide rinsing solution.

[0053] Furthermore, since the general stirring process is unidirectional rotation, in order to match the rotation direction, mounting bases 708 are symmetrically fixedly connected to the inner walls of both ends of the stirring rod 6, and spring 709 is rotatably connected to the inner wall of the mounting base 708. A connecting ring 712 is fixedly connected to the other end of the spring 709. The upper and lower surfaces of both ends of the drive plate 704 are provided with pressing grooves 710, and pressing rods 711 are slidably connected to the inner wall of the pressing grooves 710. The inner wall of the connecting ring 712 is rotatably connected to the outer wall of the pressing rod 711. Thus, the bias of the spring 709 can squeeze the pressing rod 711 located in the pressing groove 710, causing the drive plate 704 to be biased to one side. The groove of the fixed rod 701 contacts only the gear teeth 705 on one side of the inner wall of the drive plate 704. When the stirring rod 6 slides to the end, the groove of the fixed rod 701 will rotate with the gear teeth 705 on the arc-shaped inner wall of the drive plate 704, thereby pulling the drive plate 704 to the other side. The drive plate 704 will push the pressing rod 711 through the pressing groove 710 until the pressing rod 711 moves a certain distance, causing the spring 709 to move from an angle biased to one side to a direction biased to the other side. This allows the inner wall of the other side of the drive plate 704 to contact the outer wall of the fixed rod 701, thereby automatically switching the sliding direction and realizing cyclic sliding during the stirring process.

[0054] By precooling the aqueous carrier to 2–8°C and maintaining this low temperature range throughout the process, combined with an extremely low stirring speed of 40–80 rpm, the heat generated during stirring friction of the viscous carrier formed by sodium carboxymethyl cellulose and kudzu polysaccharide is effectively suppressed, avoiding damage to the thermodynamics and kinetics of the peptide molecules. An independent, low-temperature buffer solution is used to pre-dissolve the lyophilized peptides to form a high-concentration mother liquor, which is then added precisely and slowly below the liquid surface using a syringe pump. This minimizes the risk of denaturation of the peptides during the mixing stage due to exposure to the gas-liquid interface and local high shear, thereby ensuring the bioactivity and stability of the peptides in the final gel.

[0055] Furthermore, the drive rod 5 is equipped with vibration-shearing and dispersing components 8 at equal intervals inside.

[0056] The vibratory cutting and dispersing component 8 includes a support frame 801 symmetrically arranged inside the drive rod 5. Several vibrating rods 806 are rotatably connected to the side of the two support frames 801 that are far apart. The other end of the vibrating rod 806 is fixedly connected to a rotary cutting head 807. A turntable 804 is fixedly connected at equal intervals to the outer wall of the fixed rod 701. A protrusion 805 is fixedly connected at equal intervals to the outer wall of the turntable 804. Connecting blocks 802 are fixedly connected to the upper and lower end faces of the support frame 801 respectively to the protrusions 805.

[0057] In this embodiment, to avoid the problem that the highly viscous carrier scraped off due to hard extrusion forms dense clumps that are difficult to quickly redisperse in the main liquid, a support frame 801 is used. Several vibrating rods 806 are rotatably connected to the opposite sides of the two support frames 801, and a rotary cutting head 807 is fixedly connected to the other end of each vibrating rod 806. A turntable 804 is fixedly connected at equal intervals to the outer wall of the fixed rod 701, and protrusions 805 are fixedly connected at equal intervals to the outer wall of the turntable 804. Connecting blocks 802 are fixedly connected to the upper and lower end faces of the support frame 801 corresponding to the protrusions 805, respectively. Springs 803 are fixedly connected to the opposite sides of the two connecting blocks 802, and the other end of each spring 803... The part is fixedly connected to the inner wall of the drive rod 5. The outer walls of the drive rod 5 are provided with through holes 11 at equal intervals corresponding to the scraping groove 10. The outer wall of the vibrating rod 806 slides against the inner wall of the through hole 11. Thus, during the rotation of the drive rod 5, the two support frames 801 will be driven to move in a circle around the fixed rod 701. This causes several protrusions 805 to intermittently squeeze the connecting blocks 802 on the upper and lower ends of the support frame 801 through the inclined surface, and reset by the rebound force of the spring 803. This enables multiple vibrating rods 806 distributed around the scraping groove 10 to reciprocate and vibrate the scraped material, and to vibrate and disperse the polysaccharide-peptide mixed aggregates that have been compressed and detached due to the squeezing.

[0058] Furthermore, a ball bearing 808 is fixedly connected to the outer wall of the vibrating rod 806. A spiral groove 12 is opened on the inner wall of the through hole 11 corresponding to the ball bearing 808. The outer wall of the ball bearing 808 slides in contact with the inner wall of the spiral groove 12. Thus, during the back-and-forth sliding of the vibrating rod 806, the cooperation between the ball bearing 808 and the spiral groove 12 causes the vibrating rod 806 to drive the end cutting head 807 to rotate. This allows for cutting and dispersing when the material is deeply embedded, achieving a dual depolymerization effect of loosening and shearing. This completely breaks the dense structure formed by extrusion, ensuring that the scraped high-viscosity carrier can be quickly redispersed and uniformly integrated into the main flow field. This achieves efficient and homogeneous mixing of peptides in viscous liquid while maintaining low temperature and low shear conditions.

[0059] Furthermore, the stirring rod 6 is equipped with a suitable sealing component 9 inside.

[0060] The sealing component 9 includes two sets of sealing triangular blocks 902 symmetrically arranged inside the stirring rod 6. The upper and lower inner walls of the slide groove 702 are respectively provided with grooves 901 symmetrically. The upper and lower outer walls of the sealing triangular blocks 902 slide against the inner walls of the grooves 901. The two adjacent sealing triangular blocks 902 are staggered and fitted together.

[0061] In this embodiment, to avoid the viscous carrier formed by sodium carboxymethyl cellulose and kudzu polysaccharide during stirring, which could easily seep into the sliding interface of the stirring rod 6 and cause equipment contamination, jamming, and mixing contamination risks, grooves 901 are symmetrically provided on the upper and lower inner walls of the slide groove 702. The upper and lower outer walls of the sealing triangular blocks 902 slide against the inner walls of the grooves 901. Adjacent sealing triangular blocks 902 are staggered. A spring 903 is fixedly connected to one side of the sealing triangular block 902, and the other end of the spring 903 is fixedly connected to the inner wall of the groove 901. Thus, through the cooperation of the spring 903 and the sealing triangular block 902, the stirring rod 6 outside the drive rod 5 can be stirred. The upper and lower surfaces are sealed by multiple mutually pressing and fitting sealing triangular blocks 902. This allows the fixing rod 701 inside the drive rod 5 to be compressed and contracted into the groove 901 by the inclined surface of the sealing triangular blocks 902. This ensures the stable operation of the stirring rod 6 during reciprocating sliding, effectively preventing high-viscosity carriers from penetrating into the interior of the stirring rod 6, preventing mechanical failures and cross-contamination caused by polysaccharide residues, thus ensuring stable operation of the stirring process and maintaining the cleanliness and formula integrity of the polypeptide rinsing solution during preparation. At the same time, the fixedly set supplementary block 904 fills the gaps of the two sealing triangular blocks 902 at the outermost edge of the groove 702.

[0062] S4: Post-processing. After stirring, the mixed solution is pre-filtered and degassed, then sterilized by passing it through a 0.22μm sterilization filter. Subsequently, it is filled into pre-sterilized packaging containers in a Class A clean environment and vacuum-sealed.

[0063] The present invention also provides a high-efficiency peptide rinsing adhesive for biomedicine prepared by performing the above-described process for preparing a high-efficiency peptide rinsing adhesive for biomedicine, comprising an aqueous carrier and a peptide solution.

[0064] The aqueous carrier comprises water for injection, sodium carboxymethyl cellulose, sodium chloride, and kudzu polysaccharide. 0.1%–1.0% sodium carboxymethyl cellulose, 0.7%–1.1% sodium chloride, and 0.5%–2% kudzu polysaccharide are added by weight and then diluted to 100% with water for injection.

[0065] The peptide solution comprises lyophilized peptide powder and phosphate buffer, wherein the concentration of the lyophilized peptide powder in the phosphate buffer is 1 mg / mL.

[0066] Furthermore, the aqueous carrier is prepared by mixing 0.5% sodium carboxymethyl cellulose, 0.9% sodium chloride, and 1.3% kudzu polysaccharide by weight, and adding water for injection to bring the concentration to 100%.

[0067] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A process for preparing a highly efficient polypeptide rinsing adhesive for biomedicine, characterized in that, Includes the following steps: S1: Preparation of aqueous carrier: In the mixing tank (1), add water for injection through the feeding port (2), start stirring, control the temperature at 20°C, and slowly and evenly feed sodium carboxymethyl cellulose powder from the feeding port (2) while stirring at a medium speed of 550 rpm. After all the ingredients are added, add kudzu polysaccharide, increase the stirring speed to 1200 rpm, and continue stirring for 45 minutes until the solution is completely mixed. Then reduce the stirring speed to 300 rpm, add sodium chloride, and stir until completely dissolved. Add water for injection to the total volume, stir evenly, and finally adjust the pH of the solution to 7.0-7.5 with a pH adjuster to obtain an aqueous carrier. Cool the prepared aqueous carrier to 2-8℃ using a cooling system for later use. S2: Preparation of peptide solution: Pour pre-cooled phosphate buffer into an independent stirring container. At a low temperature of 5°C, slowly add lyophilized peptide powder to the phosphate buffer at a ratio of 1 mg / mL and stir until the powder is completely dissolved to form peptide mother liquor. S3: Mixing. Confirm that the temperature of the aqueous carrier in the mixing tank (1) has stabilized at 2-8℃. Turn on the drive motor (4) to stir at low speed for 60 rpm to form a stable vortex. While stirring, add the polypeptide mother liquor at 2-8℃ to the mixing tank (1) at a rate of 3 mL / min. The mixing tank (1) is equipped with a drive rod (5) and a stirring rod (6) fitted in its scraping groove (10). During the stirring process, the drive rod (5) drives the stirring rod (6) to rotate. At the same time, the stirring rod (6) slides horizontally back and forth in the scraping groove (10) to scrape off the adhering material. The raw materials are dispersed by vibration and rotary cutting. After the polypeptide mother liquor is added, continue to stir at low speed for 8 minutes at the same temperature to ensure that the system is mixed evenly. S4: Post-processing. After stirring is complete, take out the mixed solution, fill it, seal it and sterilize it with high-temperature steam.

2. The preparation process of a high-efficiency polypeptide rinsing adhesive for biomedicine according to claim 1, characterized in that, The mixing tank (1) is also equipped with a fixing rod (701), a drive plate (704), a support frame (801), a turntable (804), and a protrusion (805). When the drive rod (5) rotates, the stirring rod (6) is driven to slide horizontally back and forth along the axis of the drive rod (5) while revolving around the revolution, through the meshing transmission between the fixed rod (701) and the drive plate (704), so as to mechanically scrape off the adhesive layer; At the same time, the protrusions (805) on the turntable (804) intermittently squeeze the connecting block (802) on the support frame (801), driving the vibrating rod (806) to vibrate back and forth, and the material is dispersed by rotating and cutting the rotary cutting head (807) at its end.

3. The preparation process of a high-efficiency polypeptide rinsing adhesive for biomedicine according to claim 1, characterized in that, The post-processing in step S4 specifically includes: After the mixed solution is pre-filtered and degassed, it is sterilized by passing it through a 0.22μm sterilization-grade filter. Then, it is filled into pre-sterilized packaging containers in a Class A clean environment and vacuum-sealed.

4. The preparation process of a high-efficiency polypeptide rinsing adhesive for biomedicine according to any one of claims 1-3, characterized in that: A drive motor (4) is fixedly installed on the top of the mixing tank (1). A drive rod (5) is vertically arranged inside the mixing tank (1). The bottom output shaft of the drive motor (4) passes through the top of the mixing tank (1) and is fixedly connected to the top of the drive rod (5). Scraping grooves (10) are equidistantly opened on the outer wall of the drive rod (5). A stirring rod (6) is slidably connected to the inner wall of the scraping groove (10). A sliding scraping component (7) is arranged inside the drive rod (5). The sliding scraping component (7) includes: A fixed rod (701) is vertically installed inside the drive rod (5). The outer wall of the fixed rod (701) is provided with toothed grooves at equal intervals. A drive cavity (703) is provided inside each of the stirring rods (6). A drive plate (704) is provided inside the drive cavity (703). A number of gear teeth (705) are fixedly connected to the inner wall of the drive plate (704) corresponding to the fixed rod (701). The upper and lower surfaces of the stirring rod (6) are respectively traversed by grooves (702). The outer wall of the fixed rod (701) slides against the inner wall of the groove (702). The gear teeth (705) mesh with the grooves. The top of the fixed rod (701) is rotatably connected to the top inner wall of the drive rod (5). The bottom of the fixed rod (701) passes through the bottom of the drive rod (5) and is fixedly connected to the bottom inner wall of the mixing tank (1). Support plates (706) are fixedly connected to both ends of the drive plate (704). Support grooves are provided on the inner walls of both ends of the stirring rod (6) corresponding to the support plates (706). 707), and the outer wall of the support plate (706) slides against the inner wall of the support groove (707). The inner walls of the two ends of the stirring rod (6) are symmetrically fixedly connected to the mounting base (708), and the inner wall of the mounting base (708) is rotatably connected to the spring (709). The other end of the spring (709) is fixedly connected to the connecting ring (712). The upper and lower surfaces of the two ends of the drive plate (704) are provided with the pressure groove (710), and the inner wall of the pressure groove (710) is slidably connected to the pressure rod (711). The inner wall of the connecting ring (712) is rotatably connected to the outer wall of the pressure rod (711).

5. The preparation process of a high-efficiency polypeptide rinsing adhesive for biomedicine according to claim 4, characterized in that, The drive rod (5) is provided with vibration cutting and dispersion components (8) at equal intervals inside; The vibratory cutting and dispersing component (8) includes: A support frame (801) is symmetrically arranged inside the drive rod (5). Several vibrating rods (806) are rotatably connected to the two support frames (801) on opposite sides. A rotary cutting head (807) is fixedly connected to the other end of the vibrating rod (806). A turntable (804) is fixedly connected at equal intervals to the outer wall of the fixed rod (701). A protrusion (805) is fixedly connected at equal intervals to the outer wall of the turntable (804). A connecting block (802) is fixedly connected to the upper and lower end faces of the support frame (801) corresponding to the protrusion (805). Two springs (803) are fixedly connected to the opposite side of the two connecting blocks (802), and the other end of the springs (803) is fixedly connected to the inner wall of the drive rod (5). The outer walls of the two sides of the drive rod (5) are provided with through holes (11) at equal intervals corresponding to the scraping grooves (10). The outer wall of the vibrating rod (806) slides against the inner wall of the through hole (11). A ball (808) is fixedly connected to the outer wall of the vibrating rod (806). A spiral groove (12) is provided on the inner wall of the through hole (11) corresponding to the ball (808). The outer wall of the ball (808) slides against the inner wall of the spiral groove (12).

6. The preparation process of a high-efficiency polypeptide rinsing adhesive for biomedicine according to claim 5, characterized in that, The stirring rod (6) is provided with an adaptive sealing component (9). The adaptive sealing component (9) includes two sets of sealing triangular blocks (902) symmetrically arranged inside the stirring rod (6). The upper and lower inner walls of the slide groove (702) are respectively symmetrically provided with grooves (901). The upper and lower outer walls of the sealing triangular blocks (902) slide against the inner wall of the groove (901). Two adjacent sealing triangular blocks (902) are staggered and fitted together. A spring three (903) is fixedly connected to one side of the sealing triangular block (902), and the other end of the spring three (903) is fixedly connected to the inner wall of the groove (901). The inner walls of both ends of the stirring rod (6) are correspondingly fixedly connected with supplementary blocks (904).

7. A high-efficiency polypeptide rinsing adhesive for biomedicine prepared by performing the preparation process of a high-efficiency polypeptide rinsing adhesive according to any one of claims 1-3, characterized in that, Includes aqueous carrier and peptide solution; The aqueous carrier comprises water for injection, sodium carboxymethyl cellulose, sodium chloride, and kudzu polysaccharide. It is prepared by adding 0.1%–1.0% sodium carboxymethyl cellulose, 0.7%–1.1% sodium chloride, and 0.5%–2% kudzu polysaccharide by weight, and then adding water for injection to a final concentration of 100%. The polypeptide solution comprises lyophilized polypeptide powder and phosphate buffer, wherein the concentration of the lyophilized polypeptide powder in the phosphate buffer is 1 mg / mL.

8. The biomedical high-efficiency polypeptide rinsing adhesive according to claim 7, characterized in that, The aqueous carrier is prepared by mixing 0.5% sodium carboxymethyl cellulose, 0.9% sodium chloride, and 1.3% kudzu polysaccharide by weight, and adding water for injection to bring the concentration to 100%.

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