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A kind of betamethasone dipropionate nano freeze-dried powder injection and preparation method thereof

A technology of betamethasone dipropionate and nano freeze-dried powder is applied in freeze-dried delivery, powder delivery, pharmaceutical formulation and other directions, and can solve the problems of unguaranteed uniformity, poor micronization effect, and reduced ratio of active pharmaceutical ingredients, etc. Achieve the effect of improving bioavailability, full force and reducing impact

Active Publication Date: 2022-04-26
SOUTHEAST UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The patent application number 2007101642994 discloses a compound betamethasone suspension injection, which is a compound preparation composed of low-solubility betamethasone dipropionate and high-solubility betamethasone sodium phosphate, but its A large number of excipients such as methyl p-hydroxybenzoate and propyl p-hydroxybenzoate are added to the components as protective agents to greatly reduce the proportion of active pharmaceutical ingredients
The patent application number 2010101754347 discloses a preparation method of betamethasone dipropionate microparticles, dissolving betamethasone dipropionate in a solvent, then adding it to the anti-solvent under stirring, and continuing to stir and crystallize, However, its particle size distribution is mainly 5-10 μm, the micronization effect is poor, and its uniformity cannot be guaranteed

Method used

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  • A kind of betamethasone dipropionate nano freeze-dried powder injection and preparation method thereof
  • A kind of betamethasone dipropionate nano freeze-dried powder injection and preparation method thereof
  • A kind of betamethasone dipropionate nano freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] The raw materials are selected as follows

[0028] betamethasone dipropionate 10mg Poloxamer 188 60mg Sodium carboxymethyl cellulose 35mg Povidone K17 50mg Good solvent ethanol 300mg Water for Injection 1g

[0029] see figure 1 The process flow is that the ethanol is first passed through the ethanol through the weighing tank and then added to the mixing tank, stirred and mixed with betamethasone dipropionate and poloxamer 188, and then completely dissolved through the slurry tank and high-efficiency dissolver, and finally passed through the solution tank It is pumped out to the middle tank, and after being filtered by an ultrafilter and a 0.22μm membrane, it enters the microchannel under the action of a peristaltic pump; then the water for injection, sodium carboxymethyl cellulose and povidone K17 are stirred and mixed in the mixing tank , added to the slurry tank and continued to stir until completely dissolved, then p...

Embodiment 2

[0032] The raw materials are selected as follows

[0033]

[0034]

[0035] see figure 1 The technological process of this method is that the ethanol is first passed through the ethanol through the weighing tank and then added to the mixing tank, stirred and mixed with betamethasone dipropionate and polysorbate 80, and then completely dissolved through the slurry tank and high-efficiency dissolving machine, and finally passed through the solution tank It is pumped out to the middle tank, and after being filtered by an ultrafilter and a 0.22μm membrane, it enters the microchannel under the action of a peristaltic pump; then the water for injection, sodium alginate and povidone K17 are stirred and mixed in the mixing tank, and added to the Continue to stir in the slurry tank until it is completely dissolved, pump it into the middle tank through a rotary pump, and then enter the microchannel under the action of a peristaltic pump after being treated with an ultrafilter and ...

Embodiment 3

[0037] The raw materials are selected as follows

[0038] betamethasone dipropionate 10mg Polysorbate 80 70mg sodium alginate 40mg carboxymethyl cellulose 60mg Good solvent tert-butanol 300mg Water for Injection 0.6g

[0039] see figure 1 The technological process is that tert-butanol is put into the mixing tank after ethanol is passed through the weighing tank, stirred and mixed with betamethasone dipropionate and polysorbate 80, and then completely dissolved through the slurry tank and high-efficiency dissolving machine, and then passed through The solution pool is pumped out to the middle pool, and after being filtered by an ultrafilter and a 0.22 μm membrane, it enters the microchannel under the action of a peristaltic pump; then the water for injection, sodium alginate and carboxymethyl cellulose are stirred and mixed in the mixing pool , added to the slurry tank and continued to stir until completely dissolved, then pump...

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Abstract

The invention discloses a betamethasone dipropionate nanometer freeze-dried powder injection and a preparation method thereof. The freeze-dried powder injection comprises 6% to 12% of betamethasone dipropionate and 20% to 54% of betamethasone dipropionate by weight. agent, 11%~37% suspending agent and 21%~50% lyoprotectant. The preparation method is to use a good solvent containing betamethasone dipropionate and a support agent as a good solvent phase, use an aqueous solution containing a suspending agent and a lyoprotectant as an anti-solvent phase, and separate the good solvent phase and the anti-solvent phase through peristaltic The pump is pumped out, and after the fluid in the microchannel collides, it is collected and stirred in the container, and then the product is obtained through microfiltration, filling, pre-freezing, and freeze-drying. The particle size of the active medicine prepared by the invention is small, loose in texture, can be quickly dissolved after adding water and restore the original characteristics of the medicine liquid; the curative effect of the medicine is improved, the range of dosage forms is expanded, and it is convenient for storage and transportation, fully meeting the requirements of storage. and treatment needs.

Description

technical field [0001] The invention belongs to a freeze-dried powder injection, in particular to a nanometer freeze-dried powder injection of betamethasone dipropionate and a preparation method thereof. Background technique [0002] Betamethasone dipropionate (betamethasone dipropionate), also known as betamethasone dipropionate, chemical name 11β,17α,21-trihydroxy-16β-methyl-9α-fluoro-pregna-1,4-di ene-3,20-dione-17,21-dipropionate, a prodrug of the glucocorticoid drug betamethasone. Compared with the original drug, two propionate groups are added to its structure, so it has greater fat solubility, good skin penetration performance, and long maintenance time. The compound preparation Deprosone composed of it and betamethasone sodium phosphate has anti-inflammatory, anti-rheumatic and anti-allergic effects, and is mainly used in the treatment of allergic and autoimmune inflammatory diseases, such as neurodermatitis and vitiligo , Urticaria, rheumatoid arthritis, lupus ery...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/573A61K47/10A61K47/26A61K47/32A61K47/38A61K47/40A61P37/02A61P37/08A61J3/02
CPCA61K31/573A61K9/19A61K9/0019A61K47/10A61K47/32A61K47/40A61K47/38A61K47/26A61P37/02A61P37/08A61J3/02
Inventor 孙伯旺刘文张雨晨沈征葛纪龙
Owner SOUTHEAST UNIV
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