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Cefepime hydrochloride/arginine pharmaceutical composition suspension injection

A technology of cefepime hydrochloride and injection, which is applied in the field of medicine, can solve the problems of short validity period, poor stability and easy deterioration of cefepime hydrochloride, and achieve the effects of low cost, improved drug therapeutic index, and improved stability

Inactive Publication Date: 2010-07-14
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] After long-term serious research, the present inventors have unexpectedly found that cefepime hydrochloride is spray-dried using emulsification technology to make cefepime hydrochloride suspension particles, and then mixed with arginine for packaging, which solves the problem of the stability of cefepime hydrochloride. Poor performance, easy to deteriorate when exposed to light and heat, and short validity period, thus completing the present invention

Method used

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  • Cefepime hydrochloride/arginine pharmaceutical composition suspension injection
  • Cefepime hydrochloride/arginine pharmaceutical composition suspension injection
  • Cefepime hydrochloride/arginine pharmaceutical composition suspension injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Example 1 Preparation of Cefepime Hydrochloride / Arginine Pharmaceutical Composition Suspension Injection

[0044] Prescription (100 bottles): Cefepime Hydrochloride 50g

[0045] Sodium deoxycholate 136g

[0046] Poloxamer 188 34g

[0047] Sodium Metabisulfite 2.5g

[0048] Sorbitol 225g

[0049] Arginine 34g

[0050] Preparation Process

[0051] (1) Add 136g of sodium deoxycholate, 34g of poloxamer 188, and 2.5g of sodium metabisulfite into 5000ml of water for injection, then add 50g of cefepime hydrochloride and mix evenly, heat and stir in a water bath at 70°C to a suspended state;

[0052] (2) The above liquid was sheared and stirred with a tissue masher for 20 minutes under the condition of heat preservation at 70-90 ° C, and the rotation speed was 12000 r / min to obtain the first emulsion, and then circulated and emulsified by a high-pressure homogenizer for 5 times to obtain an emulsion;

[0053] (3) Add 225g sorbitol to the emulsion, filter wit...

Embodiment 2

[0055] The preparation of embodiment 2 cefepime hydrochloride / arginine pharmaceutical composition suspension injection

[0056] Prescription (100 bottles): Cefepime Hydrochloride 100g

[0057] Sodium deoxycholate 464g

[0058] Poloxamer 188 116g

[0059] Sodium bisulfite 80g

[0060] Sorbitol 770g

[0061] Arginine 75g

[0062] Preparation Process

[0063] (1) Add 464g of sodium deoxycholate, 116g of poloxamer 188, and 80g of sodium bisulfite to 20,000ml of water for injection, then add 100g of cefepime hydrochloride and mix evenly, heat and stir in a water bath at 90°C to a suspended state;

[0064] (2) The above liquid was sheared and stirred with a tissue masher for 10 minutes under the condition of heat preservation at 70-90 ° C, and the rotation speed was 15000 r / min to obtain the first emulsion, and then circulated and emulsified by a high-pressure homogenizer for 5 times to obtain an emulsion;

[0...

Embodiment 3

[0067] Preparation of Example 3 Cefepime Hydrochloride / Arginine Pharmaceutical Composition Suspension Injection

[0068] Prescription (100 bottles): Cefepime Hydrochloride 200g

[0069] Sodium deoxycholate 736g

[0070] Poloxamer 188 184g

[0071] Sodium metabisulfite 120g

[0072] Sorbitol 1200g

[0073] Arginine 124g

[0074] Preparation Process

[0075] (1) Add 736g of sodium deoxycholate, 184g of poloxamer 188, and 120g of sodium metabisulfite into 36,000ml of water for injection, then add 200g of cefepime hydrochloride and mix evenly, heat and stir in a water bath at 80°C to a suspended state;

[0076] (2) The above liquid was sheared and stirred with a tissue masher for 20 minutes under the condition of heat preservation at 70-90 ° C, and the rotation speed was 15000 r / min to obtain the first emulsion, and then circulated and emulsified by a high-pressure homogenizer for 5 times to obtain an emulsion...

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Abstract

The invention discloses a cefepime hydrochloride / arginine pharmaceutical composition suspension injection and a preparation method thereof. The suspension injection is characterized in that the injection is prepared by mixing cefepime hydrochloride suspension particles with arginine, wherein the weigh ratio of cefepime hydrochloride suspension particles (calculated by cefepime hydrochloride) to arginine is 1:0.62-0.75. Specifically, the cefepime hydrochloride suspension particles are prepared from the following components in parts by weight: 1 part of cefepime hydrochloride, 3.4-5.8 parts of surfactant, 0.05-0.8 part of antioxidant and 4.5-7.7 parts of support agent. More specifically, surfactant is composed of sodium deoxycholate and poloxamer 188 in a weight ratio of 4:1. The method of the invention adopts emulsification technology to prepare the cefepime hydrochloride suspension particles, and then the particles are mixed with arginine, and the mixture is subpackaged to obtain the cefepime hydrochloride / arginine pharmaceutical composition suspension injection, thus solving the problems that cefepime hydrochloride has poor stability and short expiration date and is easy to modify under the actions of light or heat, and obtaining satisfactory technical effects.

Description

technical field [0001] The invention relates to a cefepime hydrochloride / arginine pharmaceutical composition suspension injection, which belongs to the technical field of medicine. Background technique [0002] Cefepime hydrochloride, its chemical name is: 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamide]-2-carboxy-8-oxo -5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidine chloride, 72-(Z)-(O-methyl oxime), hydrochloride monohydrate, molecular formula: C 19 h 24 N 6 o 5 S 2 ·2HCl·H 2 O, molecular weight: 571.49 structural formula is: [0003] [0004] It is a broad-spectrum fourth-generation cephalosporin, which achieves bactericidal effect by inhibiting the biosynthesis of bacterial cell walls. In vitro tests show that this product has effects on Gram-positive bacteria and negative bacteria, especially the activity of Streptococcus and Streptococcus pneumoniae is greatly enhanced. At present, it is mainly used clinically for various infections...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K9/10A61P31/04
Inventor 王明
Owner HAINAN LINGKANG PHARMA CO LTD
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