3D printing preparation as well as preparation method and application thereof

A 3D printing and preparation technology, applied in the field of medicine, can solve the problems of insufficient pediatric preparations, uneven dispersion, dosage errors, etc., and achieve the effect of ensuring the safety of clinical medication, good stability, and excellent release

Inactive Publication Date: 2021-11-05
ACADEMY OF MILITARY MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The "2019-2025 China Pediatric Medicine Market Panorama Survey and Development Prospect Forecast Report" shows that among the more than 3,500 kinds of chemical pharmaceutical preparations in my country, there are less than 60 kinds of special medicines for children, and 90% of medicines have no dosage forms suitable for children's medicines, and pediatric preparations are seriously insufficient
The FDA-approved oral suspension (trade name: Katerzia) is used to treat hypertension in children over six years old, but it needs to be transported in a cold chain, and has defects such as poor stability, uneven dispersion, prone to dosage errors, and high cost

Method used

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  • 3D printing preparation as well as preparation method and application thereof
  • 3D printing preparation as well as preparation method and application thereof
  • 3D printing preparation as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0142] Example 1 Preparation of amlodipine besylate 3D printing preparation

[0143]

[0144]

[0145] The preparation method of amlodipine besylate 3D printing preparation comprises the following steps:

[0146] 1. Preparation of powder mixture

[0147] Mannitol is passed through a 100-mesh sieve, maltitol is crushed and passed through a 100-mesh sieve, amlodipine besylate, mannitol, maltitol, sucralose, sodium carboxymethylcellulose, sodium carboxymethyl starch, tartrazine, Add the lemon essence into the wet mixer, set the stirring rate to 300rpm, and the shear rate to 650rpm, and stir for 10min to make the powder mix uniformly to obtain a powder mixture.

[0148] 2. Liquid mixture preparation

[0149] Add methylparaben into purified water, heat at 80°C for 30min, completely dissolve methylparaben and evenly disperse in purified water, after cooling, add citric acid and glycerin, stir until uniformly mixed, and obtain a liquid mixture.

[0150] 3. Preparation of s...

Embodiment 2

[0167] Example 2 Preparation of amlodipine besylate 3D printing preparation

[0168]

[0169]

[0170] The preparation method of amlodipine besylate 3D printing preparation comprises the following steps:

[0171] 1. Preparation of powder mixture

[0172] Mannitol passed through a 100-mesh sieve, maltitol crushed and passed through a 100-mesh sieve, amlodipine besylate, mannitol, maltitol, sucralose, sodium carboxymethylcellulose, tartrazine and lemon essence were added to the wet mix In the machine, set the stirring rate to 500rpm, the shear rate to 500rpm, and stir for 15min to make the powder mix uniformly and obtain a powder mixture.

[0173] 2. Preparation of liquid mixture

[0174] Add methylparaben to purified water, heat at 70°C for 30min, completely dissolve methylparaben and evenly disperse in purified water, add citric acid and glycerin after cooling, stir and mix evenly to obtain a liquid mixture.

[0175] 3. Preparation of semi-solid materials

[0176] ...

Embodiment 3

[0192] Example 3 Preparation of amlodipine besylate 3D printing preparation

[0193]

[0194]

[0195] The preparation method of amlodipine besylate 3D printing preparation comprises the following steps:

[0196] 1. Preparation of powder mixture

[0197] Mannitol passed through a 100-mesh sieve, maltitol crushed and passed through a 100-mesh sieve, amlodipine besylate, mannitol, maltitol, sucralose, sodium carboxymethylcellulose, crospovidone, tartrazine, lemon The essence was added into a wet mixer, the stirring rate was 400 rpm, the shear rate was 550 rpm, and the stirring rate was 550 rpm for 10 minutes, so that the powder was mixed evenly to obtain a powder mixture.

[0198] 2. Preparation of liquid mixture

[0199] Referring to Example 1.

[0200] 3. Preparation of semi-solid materials

[0201] Referring to Example 2.

[0202] 4. Preparation before printing

[0203] Fill the prepared semi-solid material into the syringe device configured by the 3D printer, p...

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PUM

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Abstract

The invention relates to a 3D printing preparation as well as a preparation method and application thereof. The invention provides the 3D printing preparation; and the preparation is composed of an active pharmaceutical ingredient and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier is selected from any one or a combination of a diluent, an adhesive, a disintegrating agent, a corrective, a lubricant, a pH regulator, a preservative, a humectant and a flavoring agent. In addition, the invention further provides an intermediate product semi-solid material of the 3D printing preparation and a preparation method of the intermediate product semi-solid material. The dosage of the preparation provided by the invention can be flexibly adjusted according to needs of patients, and the shape is rich, so that the medication compliance of children patients is improved, and the problem of shortage of children preparations is solved. The drug-loaded semi-solid material provided by the invention is safe and reliable in product and convenient to use, errors of preparing are prevented, and the safety of medication is guaranteed.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a 3D printing preparation, a preparation method and an application thereof. Background technique [0002] Children's preparations have the characteristics of many specifications for clinical use, small batches, and high costs. The "2019-2025 China Pediatric Medicine Market Panorama Survey and Development Prospect Forecast Report" shows that among the more than 3,500 kinds of chemical pharmaceutical preparations in my country, there are less than 60 kinds of special medicines for children, and 90% of medicines have no dosage forms suitable for children's medicines, and pediatric preparations are seriously insufficient . Clinical children's medication is mostly solved by dividing doses of adult preparations or making suspensions by pharmacists, which leads to damage to the structure of the preparations, cross-contamination during deployment, poor stability, poor distribution uniformity, int...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/20A61K47/38A61K31/4422A61P9/12A61P9/10A61K31/138A61K31/18A61K45/00A61P9/00A61P25/00A61P1/00A61P11/00A61P31/00A61P13/00B33Y10/00B33Y70/10B33Y80/00
CPCA61K9/2059A61K9/2054A61K31/4422A61P9/12A61P9/10A61K31/138A61K31/18A61K45/00A61P9/00A61P25/00A61P1/00A61P11/00A61P31/00A61P13/00B33Y10/00B33Y70/10B33Y80/00
Inventor 郑爱萍韩晓璐王增明李聪慧高静张慧高翔刘楠
Owner ACADEMY OF MILITARY MEDICAL SCI
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