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A kind of suspension containing dexamethasone and preparation method thereof

A technology of dexamethasone and suspension, which is applied in the field of medicine and can solve problems such as particle agglomeration, long sterilization time, and crystal form change of dexamethasone

Active Publication Date: 2019-08-20
成都明慈医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The object of the present invention is to provide a suspension containing dexamethasone and its preparation method, to solve the problems of dexamethasone crystal form change, particle agglomeration and long sterilization time in the prior art when sterilization

Method used

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  • A kind of suspension containing dexamethasone and preparation method thereof
  • A kind of suspension containing dexamethasone and preparation method thereof
  • A kind of suspension containing dexamethasone and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Example 1 Preparation of the suspension of tobramycin and dexamethasone of the present invention

[0043] Name of raw materials 1000ml prescription Tobramycin3.0g Dexamethasone1.0g Hypromellose4.0g Edetate disodium0.2g Sodium sulfate10.0g Sodium chloride5.0g Benzalkonium bromide0.1g Polysorbate-800.5g Add water for injection to 1000ml

[0044] Preparation process equipment: The equipment used is composed of two autoclave sterilization tanks (tank 1, tank 2), the two tanks are connected by a stainless steel pipeline, and the connecting pipeline is composed of a filter sterilization device, and high-pressure steam is used before production Carry out 121℃ autoclave sterilization of the whole tank and related pipelines and filter sterilization device to make the whole tank and pipelines sterile.

[0045] Preparation Process:

[0046] a. Take 90% of the prescription amount of hypromellose, 10% of the prescription amount of sodium chloride, add water to make a 2% w / v hy...

Embodiment 2

[0053] Example 2 Preparation of the suspension of tobramycin and dexamethasone of the present invention

[0054] Name of raw materials 1000ml prescription Tobramycin3.0g Dexamethasone1.0g Hypromellose3.0g Edetate disodium0.1g Sodium sulfate8.0g Sodium chloride6.0g Benzalkonium bromide0.1g Polysorbate-800.4g Add water for injection to 1000ml

[0055] Preparation process equipment: The equipment used is composed of two autoclave sterilization tanks (tank 1, tank 2), the two tanks are connected by a stainless steel pipeline, and the connecting pipeline is composed of a filter sterilization device, and high-pressure steam is used before production Carry out 121 ℃ autoclave sterilization of the entire tank and related pipelines and filter sterilization device to make the entire tank and pipeline sterile.

[0056] Preparation Process:

[0057] a. Take 10% of the prescription amount of hypromellose, 5% of the prescription amount of sodium chloride, add water to make a 2% w / v hy...

Embodiment 3

[0064] Example 3 Preparation of the suspension of tobramycin and dexamethasone of the present invention

[0065] Name of raw materials 1000ml prescription Tobramycin3.0g Dexamethasone1.0g Hypromellose5.0g Edetate disodium0.3g Sodium sulfate12.0g Sodium chloride4.0g Benzalkonium bromide0.1g Polysorbate-800.6g Add water for injection to 1000ml

[0066] Preparation process equipment: The equipment used is composed of two autoclave sterilization tanks (tank 1, tank 2), the two tanks are connected by a stainless steel pipeline, and the connecting pipeline is composed of a filter sterilization device, and high-pressure steam is used before production Carry out 121 ℃ autoclave sterilization of the entire tank and related pipelines and filter sterilization device to make the entire tank and pipeline sterile.

[0067] Preparation Process:

[0068] a. Take 50% of the prescription amount of hypromellose, 50% of the prescription amount of sodium chloride, add water to make a 2% w / v ...

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Abstract

The invention discloses suspension containing dexamethasone. The suspension is prepared from water and the following raw materials and assistant materials in parts by weight: 1-3 parts of dexamethasone, 1-5 parts of hydroxypropyl methylcellulose and 0.1-0.8 part of a wetting agent. The inventor finds by accident in the production process that if hydroxypropyl methylcellulose is taken as a suspending agent in the preparation formula of the suspension, solid can be separated in the hot-press sterilization process to agglomerate and wrap dexamethasone, so that the crystal form of dexamethasone in a hydrothermal solution is not changed, and particle agglomeration can be avoided. Quality evaluation results show that the crystal form of dexamethasone is not greatly changed after the suspension disclosed by the invention is sterilized, the average particle size of the suspension is smaller than 10 [mu]m, the suspension is uniform in particle size and free of agglomeration, and dexamethasone suspension which is stable in property can be provided.

Description

Technical field [0001] The invention relates to a suspension containing dexamethasone and a preparation method thereof, and belongs to the field of medicine. Background technique [0002] Dexamethasone is one of the most widely used clinical glucocorticoids. It has excellent anti-inflammatory effects. It is often used in combination with other antibiotics (such as tobramycin, ciprofloxacin, etc.), and has significant antibacterial and anti-inflammatory effects. However, when preparing a suspension containing dexamethasone, its sterilization stability has always been a problem that plagues technicians. [0003] Since dexamethasone does not dissolve in water, it cannot be sterilized by filtration. At present, only dry or moist heat sterilization can be used. Patent CN1164392A discloses that the crystal form of dexamethasone is easily changed in a hot and humid liquid. The crystals will quickly grow into needles or clusters or form huge crystals, and the problem of crystal form chang...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/10A61K31/573A61K47/38A61P29/00A61P31/04A61K31/702A61K31/496
Inventor 谢永平袁平孟亮蔡鑫海王霞玲
Owner 成都明慈医药科技有限公司
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