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Preparation method of betamethasone dipropionate micro-particle

A technology of betamethasone dipropionate and microparticles, which is applied in the directions of medical preparations containing active ingredients, pharmaceutical formulations, organic active ingredients, etc. Good particle size and uniformity

Active Publication Date: 2010-10-06
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The present inventor has studied this pulverizing method and finds that, because betamethasone dipropionate is lighter in texture, it is difficult to pulverize, and the particle size after pulverizing is larger (see Table 1), and the uniformity of size is relatively poor, and the particle size distribution The peak shape of the graph is wider (see attached Figure 11 ), not suitable for preparation of injection

Method used

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  • Preparation method of betamethasone dipropionate micro-particle
  • Preparation method of betamethasone dipropionate micro-particle
  • Preparation method of betamethasone dipropionate micro-particle

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] 1) Prescription: Betamethasone dipropionate 80g, dichloromethane 800g, purified water 2400g

[0034] 2) Preparation method

[0035] Stir and dissolve betamethasone dipropionate in dichloromethane at room temperature, slowly add to purified water at 25°C at 100 rpm, and stir for 2 minutes; filter the microcrystalline suspension, and dry the filter cake under vacuum at 80°C for 6 hours to obtain micro Crystallized betamethasone dipropionate.

Embodiment 2

[0037] 1) Prescription: Betamethasone dipropionate 80g, dichloromethane 2400g, purified water 12000g

[0038] 2) Preparation method

[0039] Stir and dissolve betamethasone dipropionate in dichloromethane at room temperature, slowly add to purified water at 10°C at 800 rpm, and stir for 8 minutes; other operations are the same as in Example 1.

Embodiment 3

[0041] 1) Prescription: Betamethasone dipropionate 80g, acetone 1000g, purified water 8000g

[0042] 2) Preparation method

[0043] Stir and dissolve betamethasone dipropionate in acetone at room temperature, slowly add to purified water at 200 rpm at 30°C, and stir for 3 minutes; other operations are the same as in Example 1.

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Abstract

The invention relates to a preparation method of betamethasone dipropionate micro-particle, which is characterized in that betamethasone dipropionate is dissolved in a solvent, and then the mixture is added into an anti-solvent at the mixing state to be continuously mixed and crystallized. Through the micro crystallization method, the betamethasone dipropionate micro-particle which has small grain size and homogeneity satisfying the preparation requirement is prepared. The micro-particle can be further prepared into semi-solid preparations such as cream and suspension preparations such as injection, spray, aerosol and the like.

Description

Technical field: [0001] The invention relates to a preparation method of betamethasone dipropionate pharmaceutical microparticles, in particular to a microparticle crystallization method. Background technique: [0002] Betamethasone dipropionate is an adrenal corticosteroid drug widely used in the treatment of skin inflammation. [0003] Betamethasone dipropionate is a poorly soluble substance, and is often prepared as a suspension in the form of fine particles. When slightly soluble betamethasone dipropionate microparticles are used to prepare injections, it is a key technology to strictly control the particle size and uniformity of the microparticles: [0004] If the particle size of the particles is too large, the sedimentation of the particles will be accelerated, and the particles will settle at the bottom of the drug container and agglomerate. Moreover, when filling the injection, it is easy to cause uneven content. In addition, too much drug particles in the inject...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/06A61K9/10A61K9/12A61K31/573A61P17/00A61P29/00
Inventor 徐飞刘均胜李娟
Owner CHONGQING HUAPONT PHARMA
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