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Suspension powder injection of cefamandole nafate and new application thereof

A technology of cefamandole sodium and cefamandole sodium, which is applied in the directions of powder delivery, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problem of poor stability and stable problems such as poor performance, to achieve the effects of low cost, improved bioavailability, increased safety and stability

Inactive Publication Date: 2010-02-03
HAINAN YONGTIAN PHARMA INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The inventor has been studying hard for a long time, and found unexpectedly that the application of emulsified suspension technology to make powder injection by freeze-drying not only solved the problem of poor stability of cefamandole sodium, but also used it for the treatment of acute suppurative cholangitis, Also have significant curative effect, thus completed the present invention
[0011] The object of the present invention is to provide a kind of stable cefamandole sodium powder injection, specifically, through the combination of certain content surfactant, lyophilized support agent and active ingredient, adopt emulsification suspension technology to make the present invention Cefamandole sodium freeze-dried suspension powder injection not only solves the problem of its poor stability, but also obtains satisfactory therapeutic effect

Method used

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  • Suspension powder injection of cefamandole nafate and new application thereof
  • Suspension powder injection of cefamandole nafate and new application thereof
  • Suspension powder injection of cefamandole nafate and new application thereof

Examples

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Effect test

Embodiment 1

[0034] The preparation of embodiment 1 cefamandole sodium suspension powder injection

[0035] Prescription (100 bottles):

[0036] Cefamandole Sodium 50g

[0037] Cholesterol 83.3g

[0038] Poloxamer 188 41.7g

[0039]Mannitol 75g

[0040] Sorbitol 75g

[0041] Preparation Process

[0042] (1) Add 83.3g of cholesterol and 41.7g of poloxamer 188 into 1000ml of water for injection, then add 50g of cefamandole sodium and mix evenly, heat and stir in a water bath at 80°C until it melts;

[0043] (2) Heat the above liquid at 70-90°C and use a tissue masher to shear and stir for 15 minutes at a speed of 12000r / min to obtain a primary emulsion, and then circulate and emulsify it through a high-pressure homogenizer for 5 times to obtain an emulsion;

[0044] (3) Add 75g of mannitol and 75g of sorbitol into the emulsion, filter and subpackage after dissolving, and freeze-dry to obtain cefamandole sodium suspension powder injection.

Embodiment 2

[0053] The preparation of embodiment 2 cefamandole sodium suspension powder injection

[0054] Prescription (100 bottles):

[0055] Cefamandole Sodium 100g

[0056] Cholesterol 333.3g

[0057] Poloxamer 188 166.7g

[0058] Glucose 175g

[0059] Glycine 525g

[0060] Preparation Process

[0061] (1) Add 333.3g of cholesterol and 166.7g of poloxamer 188 into 6500ml of water for injection, then add 100g of cefamandole sodium and mix evenly, heat and stir in a water bath at 70°C until it melts;

[0062] (2) Keeping the above liquid at 70-90°C for 20 minutes with a tissue masher to shear and stir at a speed of 10,000 r / min to obtain a primary emulsion, and then circulate and emulsify it through a high-pressure homogenizer for 4 times to obtain an emulsion;

[0063] (3) Add 175g of glucose and 525g of glycine to the emulsion, filter and subpackage after dissolving, and freeze-dry to obtain cefamandole sodium suspension powder injection.

Embodiment 3

[0072] The preparation of embodiment 3 cefamandole sodium suspension powder injection

[0073] Prescription (100 bottles):

[0074] Cefamandole Sodium 200g

[0075] Cholesterol 600g

[0076] Poloxamer 188 300g

[0077] Trehalose 100g

[0078] Lactose 500g

[0079] Preparation Process

[0080] (1) Add 600g of cholesterol and 300g of poloxamer 188 into 7000ml of water for injection, then add 200g of cefamandole sodium and mix evenly, heat and stir in a water bath at 90°C until molten;

[0081] (2) Keeping the above liquid at 70-90°C for 20 minutes with a tissue masher to shear and stir at a speed of 15000r / min to obtain a primary emulsion, and then circulate and emulsify it through a high-pressure homogenizer for 5 times to obtain an emulsion;

[0082] (3) Add 100g trehalose and 500g lactose to the emulsion, dissolve, filter, subpackage, and freeze-dry to obtain cefamandole sodium suspension powder injection.

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Abstract

The invention relates to suspension powder injection of cefamandole nafate and a preparation method thereof and further relates to new application of the injection in treating acute suppurative cholangitis. The frozen-dried suspension powder injection comprises the following components in parts by weight: 1 part of cefamandole nafate, 1.5-12 parts of surfactant and 2-15 parts of frozen-dried supporting agents.

Description

technical field [0001] The invention relates to a suspension powder injection form of cefamandole sodium, in particular to the suspension powder injection of cefamandole sodium and its new application. Background technique [0002] Acute suppurative cholangitis is caused by bile stasis due to biliary stricture or occlusion, coupled with bacterial infection and acute suppurative symptoms. Patients may present with chills and high fever, jaundice and right upper quadrant pain, accompanied by nausea and vomiting. As the disease progresses, the toxins produced by bacteria continue to enter the blood circulation through the hepatic sinusoids and sepsis and toxic shock occur. Oxygen produces a large number of oxygen free radicals, promotes the production of various inflammatory mediators, induces pancreatitis, and leads to multiple organ failure such as liver, kidney, heart, lung, and blood vessels. In an acute attack, biliary drainage and antibiotics are required. However, with ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/546A61K47/24A61K47/34A61K47/32A61K47/20A61K47/28A61K47/42A61K47/44A61K47/14A61K47/26A61K47/36A61K47/18A61P31/04A61P1/16A61K47/10
Inventor 王明
Owner HAINAN YONGTIAN PHARMA INST
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