Iron dextran dispersible tablet and preparation method thereof

Abstract

The invention provides an iron-dextran dispersible tablet and a preparation method thereof, and relates to the technical field of medicines.The preparation method comprises the steps that iron-dextran and nanoscale vitamin C are mixed and ground, and a main medicine compound is obtained; dissolving poloxamer 407 in an ethanol-glycerol mixed solvent, stirring until the poloxamer 407 is completely dissolved, adding the main drug compound, and carrying out ultrasonic dispersion to form a uniform suspension; the preparation method comprises the following steps: dissolving carboxymethyl chitosan-beta-cyclodextrin in ethanol, stirring until the solution is clear, sequentially adding polyvinylpolypyrrolidone and a sodium bicarbonate-citric acid effervescent pair, carrying out ultrasonic dispersion, filtering a membrane, and adjusting the viscosity to obtain a mixed solution; respectively taking the suspension and the mixed solution as medicine ink and disintegrating agent ink, printing a medicine layer and a disintegrating agent layer by utilizing an ink-jet printing technology to obtain a tablet, and sequentially performing freeze drying and surface nanofiber treatment on the tablet to obtain the iron-dextran dispersible tablet. The problem that the iron dextran dispersible tablet cannot be quickly disintegrated in the prior art is solved.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical technology, and particularly to an iron dextran dispersible tablet and a preparation method thereof. Background Art

[0002] Iron dextran dispersible tablets are tablets prepared by mixing iron dextran with other excipients, and have the characteristics of convenient administration, good taste, rapid absorption, etc.

[0003] Currently, the preparation of iron dextran dispersible tablets mainly includes the wet granulation method and the direct compression method. The wet granulation method is to mix iron dextran with excipients, add an appropriate amount of liquid binder to form wet granules, and then prepare the dispersible tablets through steps such as drying, sieving, and tabletting. The direct compression method is to mix iron dextran with other excipients (such as disintegrants, lubricants, fillers, etc.) and then directly perform tabletting.

[0004] However, neither the direct compression method nor the wet granulation method can achieve the rapid disintegration of the dispersible tablets, which affects the timely release of the drug efficacy. Summary of the Invention

[0005] Based on this, the purpose of the present invention is to provide an iron dextran dispersible tablet and a preparation method thereof, aiming to solve the problem that the iron dextran dispersible tablets in the prior art cannot be rapidly disintegrated.

[0006] One object of the present invention is to provide a preparation method of an iron dextran dispersible tablet, and the preparation method includes: Mix iron dextran with nanoscale vitamin C of a preset particle size in a set ratio, add to a planetary ball mill for grinding for a preset time, and then sieve to obtain a main drug complex; Dissolve poloxamer 407 in an ethanol-glycerol mixed solvent, magnetically stir until completely dissolved, and then add the main drug complex for ultrasonic dispersion to form a uniform suspension; Dissolve carboxymethyl chitosan-β-cyclodextrin in ethanol and stir until clear, sequentially add crospovidone and a sodium bicarbonate-citric acid effervescent pair for ultrasonic dispersion, then filter through a membrane and adjust the viscosity to obtain a mixed solution; Respectively use the suspension and the mixed solution as drug ink and disintegrant ink, and use inkjet printing technology to print a drug layer and a disintegrant layer to obtain tablets, and sequentially perform freeze-drying and surface nanofiber treatment on the tablets to obtain iron dextran dispersible tablets.

[0007] Further, in the above preparation method of the iron dextran dispersible tablet, the step of using inkjet printing technology to print a drug layer and a disintegrant layer to obtain tablets includes: Jet the drug ink on the substrate to form a drug-loaded layer; The disintegrant ink and the drug ink are alternately jetted onto the drug-loaded layer to form a periodically alternating laminated disintegrant layer and drug layer on the drug-loaded layer; The disintegrant ink is jetted onto the last drug layer to form a high disintegrant content layer to obtain tablets.

[0008] Furthermore, for the above preparation method of iron dextran dispersible tablets, the step of using inkjet printing technology to print the drug layer and the disintegrant layer to obtain tablets further includes: The drug ink is jetted onto the substrate to form a drug-loaded layer; The drug ink and the disintegrant ink are respectively jetted onto the drug-loaded layer to form a mixed layer with alternating drug layers and disintegrant layers, and multiple stacked mixed layers are printed to obtain tablets.

[0009] Furthermore, for the above preparation method of iron dextran dispersible tablets, the printing process of the mixed layer is as follows: The disintegrant ink is jetted onto the selected central area of the drug-loaded layer to form a disintegrant layer, and then the drug ink is jetted evenly spaced around the central area to form a drug layer, and the disintegrant ink is jetted between the spaced drug layers to form a disintegrant layer to obtain a mixed layer.

[0010] Furthermore, for the above preparation method of iron dextran dispersible tablets, the particle size of nano-vitamin C is 50 nm to 100 nm, and iron dextran and nano-vitamin C are mixed in a mass ratio of 1:0.15.

[0011] Furthermore, for the above preparation method of iron dextran dispersible tablets, the main drug complex, ethanol, glycerol, and poloxamer 407 are mixed in the following mass percentages: Main drug complex: 20% - 25%; Ethanol: 60% - 65%; Glycerol: 14% - 20%; Poloxamer 407: 0.8% - 1%; The balance is water.

[0012] Furthermore, for the above preparation method of iron dextran dispersible tablets, carboxymethyl chitosan-β-cyclodextrin, crospovidone, sodium bicarbonate-citric acid effervescent pair, and ethanol are mixed in the following mass percentages: Carboxymethyl chitosan-β-cyclodextrin: 5% - 10%; Crospovidone: 8% - 15%; Sodium bicarbonate-citric acid effervescent pair: 6% - 15%; Ethanol: 60% - 80%.

[0013] Further, in the above method for preparing iron dextran dispersible tablets, the step of subjecting the tablets to freeze-drying and surface nanofiber treatment in sequence to obtain iron dextran dispersible tablets includes: Placing the tablets at a preset temperature for pre-freezing for a preset time, and transferring them to a vacuum freeze-dryer for freeze-drying for a preset time at a set pressure and temperature; Spraying a nanofiber solution on the surface of the freeze-dried tablets to form a network layer with a preset thickness on the surface of the tablets.

[0014] Further, in the above method for preparing iron dextran dispersible tablets, the nanofiber solution includes nanocellulose and chitosan.

[0015] Another object of the present invention is to provide an iron dextran dispersible tablet prepared by the above method for preparing iron dextran dispersible tablets.

[0016] By setting a main drug complex formed by mixing iron dextran and vitamin C and a highly dispersible suspension system formed by poloxamer 407, the present invention can increase the contact area with the dissolution medium, accelerate the release of iron ions, reduce the surface tension, promote the infiltration of water into the interior of the tablets, utilize carboxymethyl chitosan-β-cyclodextrin, crospovidone, and sodium bicarbonate-citric acid effervescent pairs to form an independent disintegrant layer with disintegration function, precisely stack the drug layer and the disintegrant layer through printing technology, the disintegrant layer generates a directional disintegration driving force, quickly destroys the interlayer interface of the tablets, and the β-cyclodextrin in carboxymethyl chitosan-β-cyclodextrin can include iron dextran, reduce the strong interaction between the main drug and the excipients, reduce the structural resistance during disintegration, accelerate the fragmentation of the tablet structure, and at the same time utilize freeze-drying and surface nanofiber treatment technologies to balance the adhesion strength and disintegration performance, greatly improving the disintegration speed of iron dextran dispersible tablets. It solves the problem that the iron dextran dispersible tablets in the prior art cannot disintegrate quickly. Detailed implementation manners

[0017] To facilitate the understanding of the present invention, the present invention will be described more comprehensively below. The present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, these embodiments are provided to make the disclosure of the present invention more thorough and comprehensive.

[0018] It should be noted that when an element is referred to as being "fixed to" another element, it can be directly on the other element or there can also be an intermediate element. When an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be an intermediate element at the same time. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are only for the purpose of illustration.

[0019] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field to which this invention belongs. The terms used in the description of this invention herein are for the purpose of describing specific embodiments only and are not intended to limit the invention. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0020] In view of the problem that the iron dextran dispersible tablets in the prior art cannot disintegrate quickly, an embodiment of the present invention provides a preparation method for iron dextran dispersible tablets, which includes the following steps: Step 1: Mix iron dextran with nano-sized vitamin C of a preset particle size in a set ratio, add it to a planetary ball mill, grind for a preset time, and then pass through a sieve to obtain a main drug complex.

[0021] Among them, the particle size of nano-sized vitamin C is 50nm - 100nm. Iron dextran and nano-sized vitamin C are mixed in a mass ratio of 1:0.15. As an antioxidant and disintegration promoter, vitamin C can prevent the oxidation of iron ions in iron dextran, maintain the drug stability, and the nano-sized particle size can provide a large specific surface area, increase the contact area with the dissolution medium, and accelerate the release of iron ions. After mixing iron dextran and vitamin C, use a planetary ball mill to ball mill iron dextran and vitamin C and then pass through a sieve to obtain a main drug complex. Exemplarily, the ball milling speed can be 300rpm, the grinding medium can be zirconia beads, and the ball-to-material ratio can be 10:1.

[0022] Step 2: Dissolve poloxamer 407 in an ethanol-glycerol mixed solvent, stir magnetically until completely dissolved, and then add the main drug complex for ultrasonic dispersion to form a uniform suspension; Among them, a binary solvent system of ethanol-glycerol is used as the dispersion medium to disperse the main drug complex, reduce the surface tension, promote spreading, and maintain the stability of the suspension. Introducing the amphiphilic polymer poloxamer 407 can improve the solubility of the main drug complex in the ethanol-glycerol system, and maintain the dispersibility through the hydrophilic end, avoid agglomeration, promote the infiltration of water into the tablet interior, and accelerate disintegration. Specifically, the main drug complex, ethanol, glycerol, and poloxamer 407 are mixed in the following mass percentages: Main drug complex: 20% - 25%; Ethanol: 60 - 65%; Glycerol: 14% - 20%; Poloxamer 407: 0.8 - 1%; The balance is water.

[0023] Step 3: Dissolve carboxymethyl chitosan-β-cyclodextrin in ethanol and stir until clear. Then, sequentially add crospovidone and sodium bicarbonate-citric acid effervescent pair, perform ultrasonic dispersion, filter through a membrane, and adjust the viscosity to obtain a mixed solution. Among them, carboxymethyl chitosan-β-cyclodextrin is a composite material with carboxymethyl chitosan (CMCS) as the substrate grafted with β-cyclodextrin (β-CD). Carboxymethyl chitosan can rapidly swell under acidic conditions, destroying the tablet structure. The hydrophobic cavity of β-cyclodextrin can encapsulate iron dextran to form an inclusion complex, improving the drug dispersibility and dissolution rate. Crospovidone acts as a superdisintegrant, generating a disintegration driving force and synergistically acting with the bubbles produced by the sodium bicarbonate-citric acid effervescent pair to form a dual disintegration mechanism. The sodium bicarbonate-citric acid effervescent pair is beneficial for forming porous channels inside the tablet, increasing the contact area between the drug and the dissolution medium. After ultrasonic dispersion, the membrane is filtered to remove impurities, and the viscosity is measured and adjusted to suit the conditions of inkjet printing. Specifically, carboxymethyl chitosan-β-cyclodextrin, crospovidone, sodium bicarbonate-citric acid effervescent pair, and ethanol are mixed in the following mass percentages: Carboxymethyl chitosan-β-cyclodextrin: 5% - 10%; Crospovidone: 8% - 15%; Sodium bicarbonate-citric acid effervescent pair: 6% - 15%, and the ratio of sodium bicarbonate to citric acid is 1:1; Ethanol: 60% - 80%.

[0024] Step 4: Respectively use the suspension and the mixed solution as the drug ink and the disintegrant ink, and use inkjet printing technology to print the drug layer and the disintegrant layer to obtain tablets. Then, freeze-dry and perform surface nanofiber treatment on the tablets in sequence to obtain iron dextran dispersible tablets.

[0025] Among them, after obtaining the drug ink and the disintegrant ink, inkjet printing technology can be used to print the drug layer and the disintegrant layer to obtain tablets. Exemplarily, the inkjet printing system supports multi-channel independent ink supply, and is equipped with at least 2 nozzles, one for jetting the drug ink and one for jetting the disintegrant ink. It is equipped with a motion platform with high-precision X-Y-Z three-axis movement and a drying system to achieve high-precision printing and real-time drying of each layer of printing liquid until the solvent completely evaporates. It should be noted that inkjet printing is a technology known to those skilled in the art, and the configuration of the inkjet printing system is also understandable to those skilled in the art, so it will not be elaborated here.

[0026] Specifically, the printing methods include: Jet the drug ink on the substrate to form a drug-loaded layer; Alternately jet the disintegrant ink and the drug ink on the drug-loaded layer to form a periodically alternating stacked disintegrant layer and drug layer on the drug-loaded layer; Spray disintegrant ink on the drug layer of the last layer to form a high-disintegrant-content layer to obtain a tablet; or Spray drug ink on a substrate to form a drug-loaded layer; Spray drug ink and disintegrant ink on the drug-loaded layer respectively to form a mixed layer with alternating drug layers and disintegrant layers, and print multi-layer stacked mixed-layer tablets; The printing process of the mixed layer is as follows: Spray disintegrant ink on a selected central area of the drug-loaded layer to form a disintegrant layer, then spray drug ink evenly spaced around the central area to form a drug layer, and spray disintegrant ink between the spaced drug layers to form a disintegrant layer to obtain a mixed layer.

[0027] Among them, in specific implementation, there are two different printing methods. One is that on a drug-loaded substrate (such as a starch tablet core), first print a drug-loaded layer with a preset thickness, then print periodically alternating stacked disintegrant layers and drug layers on the drug-loaded layer, and finally spray disintegrant ink on the drug layer of the last layer to form a high-disintegrant-content layer to obtain a tablet. Among them, the thickness of the high-disintegrant-content layer is higher than that of the disintegrant layer. Exemplarily, the layer thickness of the drug-loaded layer can be set to 80 μm, multiple layers can be set, the layer thickness of the disintegrant layer and the drug layer can be set to 50 μm, and the layer thickness of the high-disintegrant-content layer can be set to 70 μm; the other is to print tablets in the form of a mixed layer. After printing the drug-loaded layer, print disintegrant ink on a selected central area of the drug-loaded layer to form a central disintegrant layer, then form drug layers evenly spaced around the central area, and spray disintegrant ink between the spaced drug layers to form a disintegrant layer to obtain a mixed layer. Print multi-layer stacked mixed layers to obtain tablets. The printing method of the mixed layer can form a "burst point" in the center of the tablet, promoting the rapid outward divergence of the tablet to achieve rapid disintegration.

[0028] After printing the tablets, place the tablets at a preset temperature for pre-freezing for a preset time, and transfer them to a vacuum freeze dryer for freeze-drying for a preset time at a set pressure and temperature; Spray a nanofiber solution on the surface of the freeze-dried tablets to form a network layer with a preset thickness on the surface of the tablets.

[0029] Among them, the pre-freezing temperature can be set to -40 °C. During the pre-freezing process, ice crystals can form pores, and after freeze-drying, through-going pores are formed, improving the water penetration rate. The printed tablets are immersed in a mixed solution of nanocellulose and chitosan (mass ratio of 1:0.5, concentration of 0.3%), and a nanofiber network is formed on the surface by electrostatic spraying, accelerating water absorption, while improving the friability of the tablets and balancing the adhesion strength and disintegration performance.

[0030] An embodiment of the present invention also provides an iron dextran dispersible tablet, which is prepared by the above-mentioned preparation method of the iron dextran dispersible tablet.

[0031] To facilitate the understanding of the present invention, the present invention will be described more comprehensively below with reference to related embodiments. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, these embodiments are provided to make the disclosure of the present invention more thorough and comprehensive.

[0032] Example 1 An embodiment of the present invention provides a preparation method of an iron dextran dispersible tablet, including: Mix iron dextran with nanoscale vitamin C with a particle size of 70 nm at a ratio of 1:0.15, add it to a planetary ball mill for grinding, and then pass through a sieve to obtain a main drug complex; Dissolve poloxamer 407 in an ethanol-glycerol mixed solvent, stir magnetically until completely dissolved, and then add the main drug complex for ultrasonic dispersion to form a uniform suspension; Among them, the main drug complex, ethanol, glycerol, and poloxamer 407 are mixed according to the following mass percentages: Main drug complex: 25%; Ethanol: 60%; Glycerol: 12%; Poloxamer 407: 1%; The balance is water; Dissolve carboxymethyl chitosan-β-cyclodextrin in ethanol and stir until clear, then sequentially add crospovidone and sodium bicarbonate-citric acid effervescent pair for ultrasonic dispersion, filter through a membrane, and adjust the viscosity to obtain a mixed solution; Among them, carboxymethyl chitosan-β-cyclodextrin, crospovidone, sodium bicarbonate-citric acid effervescent pair, and ethanol are mixed according to the following mass percentages: Carboxymethyl chitosan-β-cyclodextrin: 5%; Crospovidone: 15%; Sodium bicarbonate-citric acid effervescent pair: 10%; Ethanol: 70%; Respectively use the suspension and the mixed solution as the drug ink and the disintegrant ink, spray the drug ink on the substrate to form a drug-loaded layer; Spray the disintegrant ink on the selected central area on the drug-loaded layer to form a disintegrant layer, then evenly and spacedly spray the drug ink around the central area to form a drug layer, and spray the disintegrant ink between the spaced drug layers to form a disintegrant layer to obtain a mixed layer, and print multiple stacked mixed layers to obtain tablets; Freeze-dry and surface nanofiber-treat the tablets in sequence to obtain the iron dextran dispersible tablets.

[0033] Example 2 Embodiment 2 of the present invention also provides a method for preparing iron dextran dispersible tablets. The difference between the method for preparing iron dextran dispersible tablets in this embodiment and the method for preparing iron dextran dispersible tablets in Embodiment 1 lies in that: The disintegrant ink and the drug ink are alternately sprayed on the drug-loading layer to form a periodically alternating and laminated disintegrant layer and drug layer on the drug-loading layer; The disintegrant ink is sprayed on the last drug layer to form a high disintegrant content layer to obtain tablets.

[0034] Embodiment 3 Embodiment 3 of the present invention also provides a method for preparing iron dextran dispersible tablets. The difference between the method for preparing iron dextran dispersible tablets in this embodiment and the method for preparing iron dextran dispersible tablets in Embodiment 1 lies in that: Carboxymethyl chitosan-β-cyclodextrin, cross-linked polyvinylpyrrolidone, sodium bicarbonate-citric acid effervescent pair, and ethanol are mixed in the following mass percentages: Carboxymethyl chitosan-β-cyclodextrin: 10%; Cross-linked polyvinylpyrrolidone: 15%; Sodium bicarbonate-citric acid effervescent pair: 10%; Ethanol: 65%.

[0035] Embodiment 4 Embodiment 4 of the present invention also provides a method for preparing iron dextran dispersible tablets. The difference between the method for preparing iron dextran dispersible tablets in this embodiment and the method for preparing iron dextran dispersible tablets in Embodiment 1 lies in that: Carboxymethyl chitosan-β-cyclodextrin, cross-linked polyvinylpyrrolidone, sodium bicarbonate-citric acid effervescent pair, and ethanol are mixed in the following mass percentages: Carboxymethyl chitosan-β-cyclodextrin: 8%; Cross-linked polyvinylpyrrolidone: 15%; Sodium bicarbonate-citric acid effervescent pair: 10%; Ethanol: 67%.

[0036] Embodiment 5 Embodiment 5 of the present invention also provides a method for preparing iron dextran dispersible tablets. The difference between the method for preparing iron dextran dispersible tablets in this embodiment and the method for preparing iron dextran dispersible tablets in Embodiment 1 lies in that: Carboxymethyl chitosan-β-cyclodextrin, cross-linked polyvinylpyrrolidone, sodium bicarbonate-citric acid effervescent pair, and ethanol are mixed in the following mass percentages: Carboxymethyl chitosan-β-cyclodextrin: 8%; Cross-linked polyvinylpyrrolidone: 8%; Sodium bicarbonate - citric acid effervescent pair: 10%; Ethanol: 74%.

[0037] Example Six Example Six of the present invention also provides a method for preparing iron dextran dispersible tablets. The difference between the method for preparing iron dextran dispersible tablets in this example and the method for preparing iron dextran dispersible tablets in Example One lies in that: Carboxymethyl chitosan - β - cyclodextrin, cross - linked povidone, sodium bicarbonate - citric acid effervescent pair, and ethanol are mixed according to the following mass percentages: Carboxymethyl chitosan - β - cyclodextrin: 8%; Cross - linked povidone: 12%; Sodium bicarbonate - citric acid effervescent pair: 10%; Ethanol: 70%.

[0038] Example Seven Example Seven of the present invention also provides a method for preparing iron dextran dispersible tablets. The difference between the method for preparing iron dextran dispersible tablets in this example and the method for preparing iron dextran dispersible tablets in Example One lies in that: Carboxymethyl chitosan - β - cyclodextrin, cross - linked povidone, sodium bicarbonate - citric acid effervescent pair, and ethanol are mixed according to the following mass percentages: Carboxymethyl chitosan - β - cyclodextrin: 8%; Cross - linked povidone: 12%; Sodium bicarbonate - citric acid effervescent pair: 6%; Ethanol: 74%.

[0039] Example Eight Example Eight of the present invention also provides a method for preparing iron dextran dispersible tablets. The difference between the method for preparing iron dextran dispersible tablets in this example and the method for preparing iron dextran dispersible tablets in Example One lies in that: Carboxymethyl chitosan - β - cyclodextrin, cross - linked povidone, sodium bicarbonate - citric acid effervescent pair, and ethanol are mixed according to the following mass percentages: Carboxymethyl chitosan - β - cyclodextrin: 8%; Cross - linked povidone: 12%; Sodium bicarbonate - citric acid effervescent pair: 15%; Ethanol: 65%.

[0040] Please refer to Table 1 below, which shows the above-mentioned Embodiments 1 to 8 of the present invention and their corresponding parameters. The corresponding iron dextran dispersible tablets were prepared by using the preparation methods and parameters corresponding to the above-mentioned Embodiments 1 to 8 of the present invention, and the disintegration times of the iron dextran dispersible tablets prepared in each embodiment were tested respectively.

[0041] It should be noted that in order to ensure the reliability of the verification results, when preparing the iron dextran dispersible tablets corresponding to the above-mentioned Embodiments 1 to 8 of the present invention, except for the above-mentioned different parameters, others should be the same. For example, the thickness of the drug layer and the disintegrant layer, as well as the parameters of stirring and freezing, should be kept consistent.

[0042] Table 1

[0043] Combining Embodiment 1 and Embodiment 2, it can be clearly seen that in the alternating layer-by-layer printing method, the drug layer and the disintegrant layer are periodically staggered. The disintegrant needs to penetrate layer by layer, and the path is long. In the mixed layer printing method, on the drug-loaded layer, a "burst point" of the disintegrant is formed in the central area, and the surrounding drug layer and the disintegrant layer are distributed at intervals. Multiple disintegration sites act simultaneously to accelerate the fragmentation of the tablets. Combining Embodiment 1, Embodiment 3 and Embodiment 4, it can be clearly seen that too high content of carboxymethyl chitosan-β-cyclodextrin will enhance the viscosity of the tablets and hinder the penetration of water. Too low content of carboxymethyl chitosan-β-cyclodextrin will reduce the performance of encapsulating iron dextran and increase the disintegration resistance. Combining Embodiment 4 to Embodiment 6, it can be clearly seen that cross-linked polyvinylpyrrolidone is the core component of disintegration. Too low content will lead to a significant reduction in the water absorption and swelling ability. Combining Embodiment 4, Embodiment 5 to Embodiment 8, it can be clearly seen that gas generation is the core driving force for disintegration. When the content of sodium bicarbonate-citric acid effervescent pair is low, the power is insufficient. When the content of sodium bicarbonate-citric acid effervescent pair is high, gas generation is intense, accelerating disintegration. And a balance and synergistic effect are required between the sodium bicarbonate-citric acid effervescent pair and cross-linked polyvinylpyrrolidone.

[0044] In summary, in the embodiment of the present invention, by setting a main drug complex formed by mixing iron dextran and vitamin C, and a highly dispersed suspension system formed by poloxamer 407, the contact area with the dissolution medium can be increased, the release of iron ions can be accelerated, the surface tension can be reduced, and the penetration of water into the tablet interior can be promoted. The carboxymethyl chitosan-β-cyclodextrin, cross-linked polyvinylpyrrolidone, and sodium bicarbonate-citric acid effervescent pair are used to form an independent disintegrant layer with disintegration function. Through printing technology, the drug layer and the disintegrant layer are precisely stacked. The disintegrant layer generates a directional disintegration driving force to quickly destroy the interfacial layer between tablets. The β-cyclodextrin in carboxymethyl chitosan-β-cyclodextrin can encapsulate iron dextran, reduce the strong interaction between the main drug and excipients, reduce the structural resistance during disintegration, and accelerate the fragmentation of the tablet structure. At the same time, the freeze-drying and surface nanofiber treatment technologies are used to balance the adhesion strength and disintegration performance, greatly improving the disintegration speed of iron dextran dispersible tablets. The problem that the iron dextran dispersible tablets in the prior art cannot disintegrate quickly is solved.

[0045] The above embodiments merely represent several implementation manners of the present invention. The description thereof is relatively specific and detailed, but it should not be construed as a limitation to the scope of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the appended claims.

Claims

1. A preparation method of iron dextran dispersible tablets, characterized in that, The preparation method includes the following steps: Mix iron dextran with nanoscale vitamin C of a preset particle size in a set ratio, add them to a planetary ball mill, grind for a preset time, and then pass through a sieve to obtain the main drug complex; Dissolve poloxamer 407 in an ethanol-glycerol mixed solvent, stir magnetically until completely dissolved, and then add the main drug complex and perform ultrasonic dispersion to form a uniform suspension; Dissolve carboxymethyl chitosan-β-cyclodextrin in ethanol and stir until clear. Then, sequentially add cross-linked povidone and a sodium bicarbonate-citric acid effervescent pair, perform ultrasonic dispersion, filter through a membrane, and adjust the viscosity to obtain a mixed solution; Respectively use the suspension and the mixed solution as the drug ink and the disintegrant ink, and use an inkjet printing technique to print a drug layer and a disintegrant layer to obtain tablets. Then, freeze-dry and perform surface nanofiber treatment on the tablets in sequence to obtain iron dextran dispersible tablets; 2. The preparation method of iron dextran dispersible tablets according to claim 1, wherein The step of using an inkjet printing technique to print a drug layer and a disintegrant layer to obtain tablets includes: Jet the drug ink onto a substrate to form a drug-loaded layer; Alternately jet the disintegrant ink and the drug ink on the drug-loaded layer to form a periodically alternating stacked disintegrant layer and drug layer on the drug-loaded layer; Jet the disintegrant ink on the last drug layer to form a high-disintegrant-content layer to obtain tablets; 3. The preparation method of iron dextran dispersible tablets according to claim 1, characterized in that, The step of using an inkjet printing technique to print a drug layer and a disintegrant layer to obtain tablets further includes: Jet the drug ink onto a substrate to form a drug-loaded layer; Respectively jet the drug ink and the disintegrant ink on the drug-loaded layer to form a mixed layer with alternating drug layers and disintegrant layers, and print multiple stacked mixed layers to obtain tablets; 4. The method for preparing iron dextran dispersible tablets according to claim 3, characterized in that, The printing process of the mixed layer is as follows: Jet the disintegrant ink on a selected central area of the drug-loaded layer to form a disintegrant layer, then evenly and spacedly jet the drug ink around the central area to form a drug layer, and jet the disintegrant ink between the spaced drug layers to form a disintegrant layer to obtain a mixed layer; 5. The preparation method of iron dextran dispersible tablets according to claim 1, characterized in that, The particle size of the nanoscale vitamin C is 50 nm to 100 nm, and iron dextran and nanoscale vitamin C are mixed in a mass ratio of 1:0.15; 6. The preparation method of iron dextran dispersible tablets according to claim 1, characterized in that, The main drug complex, ethanol, glycerol, and poloxamer 407 are mixed in the following mass percentages: Main drug complex: 20% - 25%; Ethanol: 60% - 65%; Glycerol: 14% - 20%; Poloxamer 407: 0.8% - 1%; The balance is water; 7. The preparation method of iron dextran dispersible tablets according to claim 1, characterized in that, Carboxymethyl chitosan-β-cyclodextrin, cross-linked povidone, sodium bicarbonate-citric acid effervescent pair, and ethanol are mixed in the following mass percentages: Carboxymethyl chitosan-β-cyclodextrin: 5% - 10%; Cross-linked povidone: 8% - 15%; Sodium bicarbonate-citric acid effervescent pair: 6% - 15%; Ethanol: 60% - 80%; 8. The preparation method of iron dextran dispersible tablets according to claim 1, characterized in that, The step of performing freeze-drying and surface nanofiber treatment on the tablets in sequence to obtain iron dextran dispersible tablets includes: Place the tablets at a preset temperature for pre-freezing for a preset time, transfer them to a vacuum freeze dryer, and perform freeze-drying for a preset time at a set pressure and temperature; Spray a nanofiber solution on the surface of the freeze-dried tablets to form a network layer of a preset thickness on the surface of the tablets; 9. The preparation method of iron dextran dispersible tablets according to claim 8, characterized in that, The nanofiber solution includes nanocellulose and chitosan; 10. An iron dextran dispersible tablet, characterized in that, Prepared by the method for preparing iron dextran dispersible tablets according to any one of claims 1 to 9.

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