Novel solid lipid nanoparticle medicament delivery system for protein-loaded medicaments

A solid lipid nano and solid lipid technology, which is applied in drug delivery, liposome delivery, pharmaceutical formulations, etc., can solve the problems of poor stability of protein drugs, severe preparation process conditions, and low bioavailability, so as to improve biological Utilization, reduction of toxic and side effects, and improvement of therapeutic index

Active Publication Date: 2013-04-10
SICHUAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Therefore, looking at the research of the whole protein solid lipid nanoparticle drug delivery system, although its prescription design and preparation technology are constantly improving, and can solve the defects of the existing technology from a certain aspect, it ignores other aspects. problems or the introduction of other new problems, so that the current protein solid lipid nano drug delivery system still exists such as severe preparation process conditions, poor stability of protein drugs, low encapsulation efficiency and serious leakage, poor safety and after administration by non-injection routes Many problems such as low bioavailability need to be solved urgently

Method used

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  • Novel solid lipid nanoparticle medicament delivery system for protein-loaded medicaments
  • Novel solid lipid nanoparticle medicament delivery system for protein-loaded medicaments
  • Novel solid lipid nanoparticle medicament delivery system for protein-loaded medicaments

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] Example 1 Investigate the impact of biosurfactant concentration on nanoparticle encapsulation efficiency and particle size:

[0073] Investigate the dosage of sodium cholate S Effect of CT-SLNs preparation. Accurately weigh salmon calcitonin ( SCT) 3.75mg was dissolved in 0.5ml of 0.01mol / ml Hcl aqueous solution, after the dissolution was complete, an appropriate amount of sodium cholate was added, vortexed for 30min, and then added to the dissolved 1mg stearic acid, 10mg tripalmitin and 20mg soybean lecithin 1ml of dichloromethane solution. Probe ultrasound 15s, power 40W, the formation of colostrum. Colostrum was added to 4 mL of 0.1% poloxamer 188 solution, and the probe was sonicated for 15 s with a power of 80 W to form a nanoemulsion. Dilute the nanoemulsion with the same concentration of poloxamer 188, and spin evaporate until the dichloromethane is completely evaporated.

[0074] According to the above preparation method, when the dosage of sodium cho...

Embodiment 2

[0075] Example 2 Investigate the type of organic solvent on the size and stability of nanoparticles:

[0076] Examining different organic solvent pairs S CT-SLNs particle size and stability, accurately weighed salmon calcitonin 7.5mg dissolved in 0.5ml 0.01mol / ml HCl aqueous solution, after the dissolution is complete, add an appropriate amount of sodium cholate, and then add dissolved 1mg stearic acid, 20mg of phospholipids in 1ml of organic solvent, the probe ultrasonic 15s, power 40W, to form colostrum. Colostrum was added to 4 mL of 0.1% poloxamer 188 solution, and the probe was sonicated for 15 s with a power of 80 W to form a nanoemulsion. The nanoemulsion was diluted with the same concentration of poloxamer 188 solution, and the SCT-SLNs dispersion was obtained after rotary evaporation until the organic solvent was completely evaporated. 'Medium', 'poor', ' / ' evaluation, wherein 'good' means that after 24 hours of standing, the particle size does not change, and...

Embodiment 3

[0080] Example 3 Investigate the effect of mixing different lipid materials on encapsulation efficiency, particle size and stability:

[0081] Precisely weigh 7.5 mg of salmon calcitonin and dissolve it in 0.5 ml of 0.01 mol / ml HCl aqueous solution. After the dissolution is complete, add 25 mg of sodium cholate, vortex for 30 min, and then add to the solution (according to SLN1, 2, 4 in Table 2). Prescription No. 10 requires adding mixed lipid materials) in 1ml dichloromethane solution of lipid materials in different proportions. Probe ultrasound 15s, power 40W, the formation of colostrum. The colostrum was added to 4mL of 0.1% poloxamer 188 solution, and the probe was ultrasonicated for 15s with a power of 80W to form a nanoemulsion. Dilute the nanoemulsion with the same concentration of poloxamer 188, and spin evaporate until the dichloromethane is completely evaporated. The effects of each formulation on encapsulation efficiency, particle size and stability (stabili...

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Abstract

The invention provides novel solid lipid nanoparticles for protein medicaments and a preparation method thereof. Each solid lipid nanoparticle consists of two parts, namely a core and a shell, wherein the core is that a biosurfactant forms a micelle or an aggregate to wrap active ingredients, or / and the biosurfactant and the active ingredients form a synergic aggregate; and the shell is that a solid lipid material is adopted for encapsulating the core. A novel solid lipid nanoparticle medicament delivery system has extremely high safety, can effectively protect the biological activity of polypeptides and polypeptide medicaments and remarkably improve the stability of preparations of the polypeptides and the polypeptide medicaments at the same time, can be applied in multiple ways such as injection, non-injection and the like, and achieves better bioavailability.

Description

technical field [0001] The invention relates to a novel drug delivery system for protein-loaded drugs, in particular to a novel solid lipid nanoparticle drug delivery system for protein-loaded drugs, and belongs to the field of biological drug preparations. Background technique [0002] Protein drugs are widely used in the treatment of various major diseases, but due to their special properties, they are subject to many restrictions in application and cannot fully play their role. For this reason, in recent years, many scientific researchers have begun to study and develop new drug delivery systems for protein drugs that are stable, long in half-life, good in biocompatibility and easy to absorb. [0003] Solid lipid nanoparticle (SLN) is a targeted controlled-release micellar drug delivery system that has been studied very actively in recent years after emulsions and liposomes. It encapsulates the drug in the lipid core with solid natural or synthetic lipids to form a solid...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/127A61K9/14A61K9/12A61K9/19A61K9/72A61K47/28
Inventor 黄园陈春会樊婷婷张志荣
Owner SICHUAN UNIV
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