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Compound betamethasone suspension injection and preparation method thereof

A technology of betamethasone dipropionate and injection, which is applied in liquid delivery, pharmaceutical formula, emulsion delivery, etc., and can solve problems such as dynamic instability of betamethasone dipropionate suspended particles

Active Publication Date: 2012-07-04
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] 1. Add flocculant to solve the problem of dynamic instability of betamethasone dipropionate suspended particles

Method used

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  • Compound betamethasone suspension injection and preparation method thereof
  • Compound betamethasone suspension injection and preparation method thereof
  • Compound betamethasone suspension injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0109] (1) Formula

[0110] Betamethasone Dipropionate 64.6g Sodium Chloride 15g

[0111] Betamethasone Sodium Phosphate 26.6g Mannitol 100g

[0112] Methylparaben 5g Macrogol 4000 50g

[0113] Benzyl Alcohol 50g Sodium Edetate Calcium 4g

[0114] Tween-80 5g Disodium Hydrogen Phosphate 125g

[0115] Sodium Carboxymethyl Cellulose 100g Phosphoric Acid 10g

[0116] Add water for injection to make up to 10000ml

[0117] (2) Preparation method

[0118] 1) Prepare sterile betamethasone dipropionate suspension

[0119] ①Preparation of sodium carboxymethyl cellulose solution

[0120] Take the prescribed amount of sodium carboxymethyl cellulose, swell in a class 10,000 clean room with heated water for injection and stir, cool to room temperature, and pass through a 10um filter membrane to obtain solution (I).

[0121] ② Preparation of sterile matrix solution

[0122]Take the prescribed amount of benzyl alcohol, Tween-80, and methylparaben, stir and dissolve in a water bath a...

Embodiment 2

[0133] (1) Formula

[0134] Betamethasone Dipropionate 64.6g Carmellose Sodium 100g

[0135] Betamethasone Sodium Phosphate 26.6g Sodium Chloride 15g

[0136] Methylparaben 10g Mannitol 100g

[0137] Benzyl Alcohol 70g Macrogol 4000 50g

[0138] Tween-80 5g Sodium Edetate Calcium 4g

[0139] Disodium hydrogen phosphate 125g Phosphoric acid 10g

[0140] Add water for injection to make up to 10000ml

[0141] (2) Preparation method

[0142] 1) Prepare sterile betamethasone dipropionate suspension

[0143] ①Preparation of sodium carboxymethyl cellulose solution

[0144] Take the prescribed amount of sodium carboxymethyl cellulose, swell in a class 10,000 clean room with heated water for injection and stir, cool to room temperature, and pass through a 10um filter membrane to obtain solution (I).

[0145] ② Preparation of sterile matrix solution

[0146] Take the prescribed amount of benzyl alcohol, Tween-80, and methylparaben, stir and dissolve in a water bath at 40°C in a...

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Abstract

The invention finds applications of nipagin and phenylcarbinol for serving as flocculating agents in a compound betamethasone suspension injection, and screens an appropriate flocculating agent using amount. By adding the flocculating agents, the particle size, uniformity and precipitating speed of suspension fine particles can be controlled effectively, and the suspension fine particles can be vibrated and dispersed uniformly without being agglomerated after the injection is kept for a long time. The invention further provides a sterile process for producing the suspension injection by adapting to an industrial way. Due to the adoption of the process, the problems of degradation of a main medicament and agglomeration of fine particles existing in a terminal high-temperature sterilizing method are solved, and a sterile product with stable quality is finally obtained.

Description

technical field [0001] The invention relates to the use of paraben and benzyl alcohol as flocculants in the preparation of suspension injections. The present invention also relates to a suspension type injection containing betamethasone dipropionate and betamethasone sodium phosphate, especially an injection that adds an adjuvant that can increase the stability of suspended particles; the present invention also relates to a It can adapt to the aseptic process of producing the above-mentioned suspension injection in an industrialized manner. Background technique [0002] Compound betamethasone suspension injection contains two active ingredients with different solubility: highly soluble betamethasone sodium phosphate and slightly soluble betamethasone dipropionate. The former is highly water-soluble and acts quickly in the body. However, betamethasone dipropionate has low water solubility and is in the state of suspended particles in the injection solution, which can be slo...

Claims

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Application Information

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IPC IPC(8): A61K31/661A61K31/573A61K47/14A61K47/10A61K9/10
Inventor 徐飞刘钧胜李娟袁媛
Owner CHONGQING HUAPONT PHARMA
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