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Preparation method of oxacillin film-coated tablets

A film-coated tablet and oxacillin technology, applied in the field of medicine, can solve the problems of poor compressibility of oxacillin sodium, unreachable friability, insufficient hardness of plain tablets, etc., and achieves improved compliance, high yield, The preparation method has the effect of simple process

Active Publication Date: 2012-12-26
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, shallow-arc and deep-arc sugar-coated tablets and film-coated tablets are mostly seen in the market, but there are basically no film-coated tablets with special-shaped and flat tablets. The main reason is that oxacillin sodium has poor compressibility and the hardness of plain tablets is not enough. Friability does not meet the requirements of other tablet coatings

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] The ingredients by weight consist of:

[0035] Tablets

[0036] Oxacillin Sodium 5.7kg

[0037] Talc powder 0.2kg

[0038] Sodium carboxymethyl starch 0.5kg

[0039] Magnesium stearate 0.06kg

[0040] 40% ethanol 400ml

[0041] coating solution

[0042] Gastric coating agent 0.3kg

[0043] Tween-80 5.2g

[0044] Talc powder 8g

[0045] 80% ethanol solution 9.5L

[0046] A total of 10,000 pieces were made

[0047] Preparation Process:

[0048] (1) Granulation: Mix oxacillin sodium and carboxymethyl starch sodium in a mixer for 15 minutes until uniform, use 40% ethanol solution to make soft material, pass through a 20-mesh sieve to granulate, and dry at 60°C. Pass through a 18-mesh sieve and sieve to obtain granules.

[0049] (2) Tablet compression: Add talc powder and magnesium stearate to the granules in step (1), and mix well. The punching die is a 13mm shallow round die, and the tableting pressure is set at 20KN.

[0050] (3) Coating:

[0051] (1) Withi...

Embodiment 2

[0055] The ingredients by weight consist of:

[0056] Tablets

[0057] Oxacillin Sodium 2.9kg

[0058] Talc powder 0.1kg

[0059] Pregelatinized starch 0.2kg

[0060] Magnesium stearate 0.03kg

[0061] 40% ethanol 200ml

[0062] coating solution

[0063] Gastric coating agent 0.15kg

[0064] Tween-80 2.6g

[0065] Talc powder 4g

[0066]80% ethanol solution 4.8L

[0067] A total of 10,000 pieces were made

[0068] Preparation Process:

[0069] (1) Granulation: Mix oxacillin sodium and carboxymethyl starch sodium in a mixer for 18 minutes until uniform, use 40% ethanol solution to make soft material, pass through a 20-mesh sieve to granulate, and dry at 60°C. Pass through a 18-mesh sieve and sieve to obtain granules.

[0070] (2) Tablet compression: Add talcum powder and magnesium stearate to the granules in step (1), and mix well. The punching die is a 10.5mm flat circular die, and the tableting pressure is set at 22KN.

[0071] (3) Coating:

[0072] (...

Embodiment 3

[0076] The ingredients by weight consist of:

[0077] Tablets

[0078] Oxacillin Sodium 2.9kg

[0079] Pregelatinized starch 0.4kg

[0080] Magnesium stearate 0.03kg

[0081] 40% ethanol of 10% PVPk30 200ml

[0082] coating solution

[0083] Gastric coating agent 0.44kg

[0084] Tween-80 2.6g

[0085] Talc powder 4g

[0086] 80% ethanol solution 4.8L

[0087] A total of 10,000 pieces were made

[0088] Preparation Process:

[0089] (1) Granulation: Mix oxacillin sodium and carboxymethyl starch sodium in a mixer for 16 minutes until uniform, use 40% ethanol solution to make soft material, pass 20 mesh to granulate, dry at 60°C, pass 18 mesh sieve to obtain pellets.

[0090] (2) Tablet compression: Add talc powder and magnesium stearate to the granules in step (1), and mix well. The punching die is a 10.5mm flat circular die, and the tableting pressure is set at 25KN.

[0091] (3) Coating:

[0092] (1) Within 30 minutes, the spray speed is 140g / min, the air inlet t...

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Abstract

The invention relates to a preparation method of oxacillin film-coated tablets, belonging to the technical field of medicines. The white pill of the oxacillin film-coated tablets is composed of the following components in percentage by weight: 78-90% of oxacillin sodium, 2-4% of talc, 5-10% of starch filler and 0.5-1.5% of magnesium stearate; the film coating agent is composed of the following components in percentage by weight: 3.5-5% of gastric-soluble coating agent, 0.06-0.09% of Tween-80 and 0.09-0.13% of talc; and the coating agent is prepared into a coating solution the solid content ofwhich is 8-11% with a 80% ethanol aqueous solution for use. In the invention, the difficulty in coating oxacillin sodium tablets and irregular tables are solved, and the oxacillin film-coated tabletscan be prepared.

Description

technical field [0001] The invention relates to a preparation method of oxacillin film-coated tablets, belonging to the technical field of medicine. Background technique [0002] Oxacillin sodium is a semi-synthetic penicillin antibiotic with the same antibacterial spectrum and mode of action as penicillin. This product is resistant to penicillinase and is effective against penicillin-resistant Staphylococcus. Because this product is stable in gastric acid, it can be taken orally. This product is widely distributed in the body and easily enters most tissues and body fluids. It can reach effective concentrations in pleural effusion, pus, joint cavity and suppurative osteomyelitis lesions. It can be used clinically for various infections caused by sensitive bacteria, such as pneumonia. , sepsis, suppurative meningitis and osteomyelitis, tonsillitis, crest inflammation and pyoderma, etc. [0003] Oxacillin sodium has a bitter smell. Currently, there are mainly two types of sug...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/36A61K9/30A61K31/431A61K47/02A61P31/04A61P11/00
Inventor 黄京山李伟沈建王玉广苏立良
Owner REYOUNG PHARMA
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