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Preparation method of hard-core soft-membrane type nano slow-release drug delivery system for injection

A nano-sustained release and drug delivery system technology, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients. and quality control issues, to achieve the effect of simple structure design and preparation process, high safety, easy sterilization and scale-up production

Active Publication Date: 2022-01-11
高州市人民医院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, from the design and development of the product to the actual application in the marketed preparations, it is still necessary to solve whether the production process of the designed synthetic material is simple and easy to scale up, whether the impurities and quality are controllable, the difficulty of sterilization, and the physical and chemical properties of the product. Stability, safety in the human body and other issues, this is the contradiction between the functional research and development of preparation excipients and practical application. The structure and preparation of preparation excipients with many functions are often complicated, and it is difficult to scale up production and quality control. One of the reasons why there are so many new nanomaterials in cutting-edge research, but few can be applied clinically

Method used

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  • Preparation method of hard-core soft-membrane type nano slow-release drug delivery system for injection
  • Preparation method of hard-core soft-membrane type nano slow-release drug delivery system for injection
  • Preparation method of hard-core soft-membrane type nano slow-release drug delivery system for injection

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Experimental program
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Effect test

Embodiment 1

[0031] put H 3 PO 4 The aqueous solution was added to the Ca(OH) under stirring condition 2 Suspension, maintain the pH value of the system in the range of 9-12. The reacted precipitate was frozen at -25°C, placed at 0°C for vacuum drying, and the obtained powder was calcined at 900°C to make HAP powder.

[0032] Mix L-aspartic acid, phosphoric acid and deionized water in a round bottom flask. The mixture was heated to 170° C. under reduced pressure on a rotary evaporator for 1 hour. When the reaction was complete, the temperature was lowered to 100 °C, and an appropriate amount of N,N-dimethylformamide was added to dissolve the residue. It was slowly dropped into 500 mL deionized water at room temperature. The product was collected by filtration, washed with deionized water and dichloromethane.

[0033] Dissolve 1.0g of the prepared PSI in N,N-dimethylformamide to make a PSI solution for later use, take 8.0g of HAP hydroxyapatite and put it in a beaker, add an appropria...

Embodiment 2

[0035] Dissolve 5mL of Tween-80 in 25mL of toluene, add 60mL of 1mol / mL Na 2 CO 3 solution, and use a sonicator to sonicate (sonication conditions are 60° C., 35 kW, 20 minutes). The resulting solution was transferred to a burette and slowly added dropwise to 0.2mol / L of CaCl with constant stirring 2 In solution at room temperature, a precipitate was obtained. The precipitate was filtered, washed several times with deionized water and absolute ethanol, and dried at 80 °C for 12 h to obtain CaCO 3 powder. 1 g of synthesized CaCO 3 The powder was added to deionized water (200 mL) and stirred to form a suspension. 200 mL of Na at a rate of 2 mL / min at 60 °C 2 HPO 4(0.03mol / L) was dropped into the solution. The pH of the above solution was adjusted to 11 using 20% ​​NaOH (g / mL) aqueous solution, and stirring was continued at 60 °C for 1 h. The product was collected by filtration, washed 5 times with deionized water and absolute ethanol, and dried at 80 °C for 24 h. HAP w...

Embodiment 3

[0040] Add 0.3mol / L H3PO4 aqueous solution to 0.5mol / L Ca(OH) under high-speed stirring 2 Add dropwise to the suspension to maintain the pH of the system in the range of 9-12. The reacted precipitate was frozen at -25°C, and then vacuum-dried at 0°C to obtain HAP powder.

[0041] L-Aspartic acid (10.0 g), phosphoric acid (85%, 6 mL) and deionized water (1 mL) were mixed in a 250 mL round bottom flask. The mixture was heated to 180° C. under reduced pressure on a rotary evaporator for 1.5 hours. When the reaction was complete, the temperature was lowered to 100° C., and 60 mL of N,N-dimethylformamide was added to dissolve the residue. It was slowly dropped into 500 mL of mechanically stirred deionized water accompanied by ultrasonic conditions at room temperature (stirring rate of 800 rpm, ultrasonic conditions of 55° C., 1600 W). The product was collected by filtration, washed with deionized water and dichloromethane, and dried.

[0042] Weigh 25 mg of PSI and completely d...

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Abstract

The invention discloses a preparation method of a hard-core soft-membrane type nano slow-release drug delivery system for injection. The preparation method comprises the following steps of: S1, preparing hydroxyapatite; S2, preparing a soft-membrane material PEG-PSI; S3, mixing a drug to be delivered with the prepared hydroxyapatite in a solution, then adding the PEG-PSI dissolved in dimethyl sulfoxide for injection, uniformly mixing, and then centrifuging a preparation at a high speed; and S4, washing, then re-suspending in pure water, and carrying out freeze drying to obtain a final product. According to the preparation method disclosed by the invention, polyethylene glycol modified polysuccinimide with different molecular weights is used as an organic coating material, the hydroxyapatite is used as a drug carrying core, the drug is adsorbed, and a nano preparation form with a hard-core soft-membrane structure is formed through a coating effect of the polysuccinimide on the hydroxyapatite, so that the drug carrying capacity of a nano preparation is increased, the burst release of the nano preparation is avoided, the aggregation of nano particles is reduced, and the physical and chemical stability is improved.

Description

technical field [0001] The invention relates to the field, in particular to a preparation method of a hard-core soft membrane nano-sustained-release drug delivery system for injection. Background technique [0002] Cancer is one of the major diseases that threaten human life. The "World Cancer Report" released by the International Cancer Research Center (IARC) of the World Health Organization in 2014 predicts that global cancer cases will show a rapid growth trend, from 14 million in 2012 to 19 million in 2025 and 19 million in 2035. The annual population will reach 24 million. The rise of gene medicines such as RNA has brought hope to many difficult-to-cure cancers. With the maturity of genetic testing technology, the design and synthesis of such drugs become easier. However, because RNA drugs are easily found and degraded by ribozymes in the body and have low cell permeability, it is difficult to reach the cells to exert their drug effects. Therefore, the carrier techno...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K47/02A61K47/34A61K31/7088A61P35/00C08G81/00
CPCA61K9/0019A61K9/5115A61K9/5146A61K31/7088A61P35/00C08G81/00
Inventor 于凤波黄春明崔燎王强孟焕范兴君
Owner 高州市人民医院
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