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Betamethasone dipropionate nano freeze-dried powder injection and preparation method thereof

A technology of betamethasone dipropionate and nano-freeze-dried powder, which is applied in freeze-dried transportation, powder transportation, pharmaceutical formulations, etc., and can solve problems such as unguaranteed uniformity, reduced proportion of active pharmaceutical ingredients, and poor micronization effect. To achieve the effect of improving bioavailability, reducing impact and fully bearing force

Active Publication Date: 2021-07-02
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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  • Betamethasone dipropionate nano freeze-dried powder injection and preparation method thereof
  • Betamethasone dipropionate nano freeze-dried powder injection and preparation method thereof
  • 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 nano freeze-dried powder injection and a preparation method thereof. The freeze-dried powder injection comprises the following components in percentage by weight: 6%-12% of betamethasone dipropionate, 20%-54% of a supporting agent, 11%-37% of a suspending aid and 21%-50% of a freeze-drying protective agent. The preparation method comprises the following steps: taking a good solvent containing betamethasone dipropionate and a supporting agent as a good solvent phase, taking an aqueous solution containing a suspending aid and a freeze-drying protective agent as an anti-solvent phase, respectively pumping out the good solvent phase and the anti-solvent phase through a peristaltic pump, colliding with fluid in the micro-channel, collecting in a container, stirring, and performing microfiltration, filling, pre-freezing and freeze-drying to obtain the product. The product prepared by the invention is small in active drug particle size and loose in texture, and can be quickly dissolved after being added with water to recover the original characteristics of the liquid medicine; the product improves the curative effect of the medicine, expands the range of dosage forms, is convenient to store and transport, and fully meets the requirements of storage and treatment.

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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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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