Amoxicillin sodium potassium clavulanate composition microballoon injection

A technology for amoxicillin sodium clavulanate potassium and amoxicillin sodium is applied in the field of pharmaceutical preparations, can solve the problems of poor stability, undisclosed amoxicillin sodium clavulanate potassium, poor clarity and the like, and achieves improved stability. , reduce drug toxicity, prolong the effect of drug efficacy

Inactive Publication Date: 2010-11-24
HAINAN MEILAN SMITH KLINE PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Chinese patent CN101647779A discloses a new amoxicillin sodium clavulanate potassium compound powder for injection and its preparation technology. Although the ratio of amoxicillin sodium / clavulanate potassium has been changed and the preparation process has been improved, it has no effect on the activity The ingredients have not taken any protective measures, the stability is poor, and the clarity after reconstitution is poor
[0008] The prior art does not disclose microsphere preparations of amoxicillin sodium and clavulanate potassium, and the art still needs an excellent pharmaceutical composition of amoxicillin sodium and clavulanate potassium, which has excellent sustained-release properties and stability, and the present invention Amoxicillin sodium and clavulanate potassium microspheres were prepared by using microsphere technology, and amoxicillin sodium and clavulanate potassium microsphere injections with excellent sustained-release characteristics and stability were provided

Method used

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  • Amoxicillin sodium potassium clavulanate composition microballoon injection
  • Amoxicillin sodium potassium clavulanate composition microballoon injection
  • Amoxicillin sodium potassium clavulanate composition microballoon injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Embodiment 1 Preparation of Amoxicillin Sodium Clavulanate Potassium Pharmaceutical Composition Microsphere Injection

[0069] Prescription: (100 bottles)

[0070] Amoxicillin Sodium 50g

[0071] Potassium clavulanate 10g

[0072] Gelatin 40g

[0073] Gum Arabic 40g

[0074] Disodium hydrogen phosphate 30g

[0075] Trehalose 20g

[0076] Glycerin 10g

[0077] making process:

[0078] (1) Dissolve 40g of gelatin and 40g of gum arabic in 500ml of water for injection, add 50g of amoxicillin sodium, 10g of potassium clavulanate, 10g of glycerin, 20g of trehalose and 30g of disodium hydrogen phosphate;

[0079] (2) Put the above solution into the spray dryer, adjust the spray conditions (the inlet temperature is 85°C, the outlet temperature is about 40°C, the nozzle size is 0.5mm, the spray flow rate is 5ml / min, and the compressed air velocity is 8L / min) to spray dry , to obtain white microspheres with uniform shape;

[0080](3) The obtained microspheres were finall...

Embodiment 2

[0095] Example 2 Preparation of Amoxicillin Sodium Clavulanate Potassium Pharmaceutical Composition Microsphere Injection

[0096] Prescription: (100 bottles)

[0097] Amoxicillin Sodium 50g

[0098] Potassium clavulanate 10g

[0099] Gelatin 45g

[0100] Gum Arabic 45g

[0101] Disodium hydrogen phosphate 40g

[0102] Trehalose 30g

[0103] Glycerin 15g

[0104] making process:

[0105] (1) Dissolve 45g of gelatin and 45g of gum arabic in 600ml of water for injection, add 50g of amoxicillin sodium, 10g of potassium clavulanate, 15g of glycerin, 30g of trehalose and 40g of disodium hydrogen phosphate;

[0106] (2) Put the above solution into the spray dryer, adjust the spray conditions (inlet temperature is 80°C, outlet temperature is about 30°C, nozzle size is 1mm, spray liquid flow rate is 10ml / min, compressed airflow speed is 15L / min) spray drying, Obtain white microspheres with uniform shape;

[0107] (3) Finally, heat and solidify the obtained microspheres at a t...

Embodiment 3

[0120] Example 3 Preparation of Amoxicillin Sodium Clavulanate Potassium Pharmaceutical Composition Microsphere Injection

[0121] Prescription: (100 bottles)

[0122] Amoxicillin Sodium 50g

[0123] Potassium clavulanate 10g

[0124] Gelatin 60g

[0125] Gum Arabic 60g

[0126] Disodium hydrogen phosphate 60g

[0127] Trehalose 40g

[0128] Glycerin 30g

[0129] making process:

[0130] (1) Dissolve 60g gelatin and 60g gum arabic in 3000ml water for injection, add 50g sodium amoxicillin, 10g potassium clavulanate, 30g glycerin, 40g trehalose and 60g disodium hydrogen phosphate;

[0131] (2) Put the above solution into the spray dryer, adjust the spray conditions (inlet temperature is 90°C, outlet temperature is about 40°C, nozzle size is 0.8mm, spray flow rate is 7ml / min, compressed air velocity is 12L / min) spray drying , to obtain white microspheres with uniform shape;

[0132] (3) Finally, heat and solidify the obtained microspheres at a temperature of 120° C. for ...

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Abstract

The invention discloses an amoxicillin sodium potassium clavulanate composition microballoon injection, which is characterized by comprising the following components in parts by weight: 5 parts of amoxicillin sodium, 1 part of potassium clavulanate, 4-6 parts of gelatin, 4-6 parts of Arabic gum, 3-6 parts of disodium hydrogen phosphate, 2-4 parts of trehalose and 1-3 parts of glycerol. Compared with the prior art, the amoxicillin sodium potassium clavulanate composition microballoon injection prepared by the invention has good stability, high entrapment rate, good process repeatability, even particle distribution, good injectable property and good slow release character, and is suitable for industrialization production.

Description

technical field [0001] The invention relates to a microsphere injection of a pharmaceutical composition, in particular to a microsphere injection of amoxicillin sodium clavulanate potassium pharmaceutical composition, and belongs to the field of pharmaceutical preparations. Background technique [0002] Amoxicillin is a broad-spectrum penicillin antibiotic, and clavulanate potassium itself has only weak antibacterial activity, but has a strong broad-spectrum β-lactamase inhibitory effect. The combination of the two can protect amoxicillin from β-lactamase hydrolysis. The antibacterial spectrum of this product is the same as that of amoxicillin, and it has been expanded. It has a good effect on enzyme-producing Staphylococcus aureus, Staphylococcus epidermidis, coagulase-negative staphylococcus and enterococci, and has good effects on certain β-lactamase-producing Enterobacteriaceae, Haemophilus influenzae, and Moraxella catarrhalis , Bacteroides fragilis, etc. also have goo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/43A61K31/424A61K9/16A61P31/04
Inventor 胡建荣
Owner HAINAN MEILAN SMITH KLINE PHARMA
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