Environment simulating sustained-release storage system and preparation method thereof

A slow-release and storage technology, which is used in pharmaceutical formulations, medical preparations with non-active ingredients, and emulsion delivery to achieve sustained and smooth drug release, solve the problem of sudden release, and improve temperature-sensitive and phase-sensitive properties.

Inactive Publication Date: 2011-01-12
ZHEJIANG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The biodegradable polymer-solid lipid slow-release storage system is a simple phase-sensitive slow-release storage, which requires a large amount of organic solvents. Although they are biocompatible, the body does not need them; in addition, the slow-release When the reservoir is injected into the body, it starts to release faster, so its drug release behavior needs to be changed

Method used

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  • Environment simulating sustained-release storage system and preparation method thereof
  • Environment simulating sustained-release storage system and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Weigh 25g of poloxamer 407, add 100ml of water for injection to make a solution with a certain concentration, and let it stand in a refrigerator at 4°C overnight to fully dissolve it. Observe its appearance at 4°C; then place it in an environment of 37°C for 10 minutes to observe its appearance.

[0042] Results: The poloxamer 407 solution prepared at low temperature was transparent and had a certain consistency. As the temperature increases, the viscosity increases until it becomes a transparent solid (gel), which does not flow when the container is tilted. When the gel was brought to low temperature again, it regained its fluidity.

[0043] Weigh 150g of poloxamer 407, add 500ml of water for injection, and configure a solution with a certain concentration as the water phase. Dissolve 30 g of PLGA (molecular weight: 50,000, LA:GA=70:30) and 1 g of risperidone in 100 ml of triethyl citrate, then add 3 g of stearic acid and shake to form the oil phase. The water phase...

Embodiment 2-11

[0045] Repeat the steps of Example 1 with different types of thermosensitive hydrophilic materials, biodegradable polymers, solid lipids, and organic solvents, as shown in Table 1:

[0046] Table 1 Description of reservoir morphology composed of different types of thermosensitive hydrophilic materials, polymers, solid lipids, and organic solvents

[0047] Reality

Embodiment 12

[0049] Get 50ml benzyl alcohol (BA) and 50ml glyceryl triacetate (GT) and mix evenly, accurately take methotrexate 2g and 10g glyceryl monostearate and mix and dissolve in the above-mentioned mixed solvent, then take 10gPLGA (molecular weight 20,000 , LA:GA=50:50) was added to the above mixed solution, and shaken at 37°C until it was completely dissolved to form a transparent and uniform solution, which was used as the oil phase.

[0050] Dissolve 100 g of poloxamer 407 in 500 ml of water for injection as the water phase.

[0051] Under the condition of ice bath, the oil phase was added dropwise into the water phase, and stirred at a high speed of 16000r / min for 3min to form an O / W emulsion. That is, the environment-promoted sustained-release storage system is prepared.

[0052] Observe the state of the emulsion at 4°C and 37°C, and observe the morphology of the emulsion under an optical microscope.

[0053] Results: The prepared O / W emulsion was in liquid state at 4°C. As t...

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Abstract

The invention discloses an environment priming type sustained-release storage system which is prepared by materials with the following weight percentages: 0.1 to 50 percent of temperature sensitive hydrophilic material, 0.1 to 20 percent of biodegradable polymer, 10 to 35 percent of organic solvent, 0.01 to 15 percent of medicament, 0 to 5 percent of solid lipid, 0 to 10 percent of emulsifier; and the rest is water for injection; wherein, the medicament refers to one or a plurality of fat-soluble medicaments. The invention also discloses a preparation method of the environment priming type sustained-release storage system. After the sustained-release storage system enters a body, the sustained-release storage system can simultaneously respond the change of temperature and body fluid environment, form a sustained-release skeleton in an injection part, slowly release the medicament for a plurality of days or even a plurality of weeks, and is characterized by convenient administration, safety and environmental protection as well as effective control on the medicament release.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an environment-promoting sustained-release storage system capable of subcutaneous injection and intramuscular injection and a preparation method thereof. technical background [0002] In recent years, more and more people pay attention to the environment-promoted slow-release drug storage. This kind of slow-release storage is often in liquid state outside the body. After being injected into the body, it can sense the changes in the body environment and transform into a semi-solid state. Or in a solid state, thereby forming an in-situ drug reservoir and slowly releasing the drug. It can effectively avoid the problem of surgical trauma of traditional implants and the problem of residual toxic organic solvents of microspheres. Temperature-sensitive and phase-sensitive slow-release depots are the two main classes of environmentally-triggered slow-release depots...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K9/127A61K9/00A61K47/30
Inventor 梁文权董思宇吴定伟金一
Owner ZHEJIANG UNIV
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