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Stable nystatin medicine composition and preparation method thereof

A technology of nystatin and composition, applied in the field of nystatin pharmaceutical composition and preparation thereof, can solve the problems of no therapeutic effect of systemic fungal infection, unsatisfactory curative effect, low blood drug concentration, etc., and achieve optimal suspension stability, Improved convenience and compliance, easy viscosity effect

Inactive Publication Date: 2016-06-08
南京泽恒医药技术开发有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to the methods currently used in China, the chemical drug nystatin is not absorbed in the body, and the blood concentration is extremely low after the usual oral dose, and has no therapeutic effect on systemic fungal infections, so it is not suitable for injection.
Clinically, it is limited to local application and the curative effect is not ideal

Method used

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  • Stable nystatin medicine composition and preparation method thereof
  • Stable nystatin medicine composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Embodiment 1 Nystatin Oral Suspension

[0039] Drug-stabilizer complex:

[0040] Nystatin 8.8g

[0041] 2g

[0042] Sodium bicarbonate 5g

[0043] Sodium dihydrogen phosphate 10g

[0044] Purified water 50g

[0045] Glycerin 60ml

[0046] Sucrose 50g

[0047] Suspension additives:

[0048] Sucrose 200g

[0049] Methylparaben 1g

[0050] Blueberry essence 1ml

[0051] Appropriate amount of water

[0052] Makes 500ml

[0053] The raw material of nystatin is micronized so that its particle size ranges from 8 to 12 μm; , sodium bicarbonate, and sodium dihydrogen phosphate were dispersed in about 100ml of water, added glycerin, and stirred at 15,000rpm for 3 minutes to prepare a combined stabilizer; put the above combined stabilizer in a high-pressure homogenizer, and add the prescribed amount The micronized raw material of nystatin is circulated three times at 100-200 bar, and five times at 300-500 bar, so that the drug is completely coated by the combined s...

Embodiment 2

[0054] Embodiment 2 Nystatin oral dry suspension

[0055] Drug-stabilizer complex:

[0056] Nystatin 8.8g

[0057] 2.0g

[0058] Polysorbate - 8060ml

[0059] Sodium bicarbonate 4.0g

[0060] Sodium dihydrogen phosphate 6.5g

[0061] Methylparaben 0.5g

[0062] Sodium saccharin 0.05g

[0063] Sucrose 30.0g

[0064] 40g of water

[0065] Dry suspension additives:

[0066] Mannitol 180g

[0067] Lactose 200g

[0068] Appropriate amount of ethanol water

[0069] Made into 500g

[0070] The nystatin raw material is micronized so that the particle size ranges from 15 to 20 μm; the sucrose is pulverized and passed through a 100-mesh sieve. Will , sodium bicarbonate, and sodium dihydrogen phosphate were dispersed in about 20ml of water, polysorbate-80 was added, and stirred at 10,000rpm for 5min to prepare a combined stabilizer. Put the above combined stabilizer in a high-pressure homogenizer, add the prescribed amount of micronized nystatin raw material at the same...

Embodiment 3

[0071] Embodiment 3 Nystatin Granules

[0072] Drug-stabilizer complex:

[0073] Nystatin 9.0g

[0074] 2.5g

[0075] Sodium bicarbonate 3.0g

[0076] Glycerin 50ml

[0077] Citric acid 8.0g

[0078] Purified water 30.0g

[0079] Granules and other additives:

[0080] Lactose 250.0g

[0081] Mannitol 100.0g

[0082] Sucrose 100.0g

[0083] Methylparaben 0.5g

[0084] Propylparaben 0.1g

[0085] Sodium saccharin 0.05g

[0086] Made into 500g

[0087] The nystatin raw material is micronized so that the particle size ranges from 10 to 15 μm. Will , sodium bicarbonate, sodium citrate, and citric acid were dispersed in about 15ml of water, added glycerin, and stirred at 10,000~20,000rpm for 3 minutes to prepare a combined stabilizer. Put the above combined stabilizer in a high-pressure homogenizer, add the prescribed amount of micronized nystatin raw material at the same time, cycle 2 times at 200 bar, and cycle 4 times at 400 bar, so that the drug is completely w...

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Abstract

A stable nystatin medicine composition comprises medicine and stabilizer compound and other additives, wherein medicine and stabilizer compound is prepared from nystatin and composite stabilizer. The stable nystatin medicine composition is characterized in that a preparation can be directly prepared by preparing medicine and stabilizer compound from high-pressure-homogenized nystatin and composition stabilizer and adding other additives, and the stable nystatin medicine composition can also be prepared by conducting freeze drying or decompression drying and then adding other additives. The composition can be used for preparing oral dry suspensions, oral suspensions, granules, pills, tablets and oral gels.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a stable nystatin pharmaceutical composition and a preparation method thereof. Background technique [0002] Oral candidiasis is an acute, subacute or chronic fungal disease of the oral mucosa caused by Candida infection. It is more common in newborns, children with malnutrition, diarrhea, long-term use of broad-spectrum antibiotics or hormones, and can also occur in frail adults. It is also one of the common nosocomial infectious diseases in NICU. Candida albicans is also commonly found in the oral cavity of healthy children but is not pathogenic. With the widespread clinical use of corticosteroids, broad-spectrum antibiotics and other immunosuppressants, coupled with the emergence of acquired immunodeficiency syndrome and the development of organ transplantation, oral candidiasis is becoming more and more common clinically, and its treatment has been become a hot issu...

Claims

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Application Information

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IPC IPC(8): A61K47/02A61K47/38A61K31/7048A61P1/02A61P31/02A61P31/10
CPCA61K47/02A61K9/0053A61K9/10A61K9/1611A61K9/1652A61K31/7048A61K47/38
Inventor 刘宇婧岳德仁何淑旺谢晓燕
Owner 南京泽恒医药技术开发有限公司
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