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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 severe preparation process conditions, poor stability of protein drugs, and low bioavailability, so as to reduce toxicity Effects of side effects, enhanced bioavailability, and enhanced therapeutic index

Active Publication Date: 2011-06-29
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

[0078] Example 1 Examine the concentration of biological surface active agents to the packet and particle size inspection of nanoparticles:

[0079] Examine the amount of sodium gall acid S The effect of CT-SLNS preparation.Precision is called salmon decreased calcium ( S CT) 3.75mg is dissolved in 0.01mol / ml HCL aqueous solution of 0.5ml, adds an appropriate amount of sodium bile acid after dissolving, 30min, and then adds to dissolved 1 mg of 1mg of glycolic acid, 10mg of Palm acid glycolin, and 20mg of soybean phospholipids.In the 1ml dichloromethane solution.Probe ultrasound 15S and 40W of power, forming colostrum.Add colostrum to a 0.1%Polosam 188 solution of 4ml, the probe ultrasonic 15S and the power of 80W, forming nanomal milk.Dilute the nano -milk with the same concentration of Polosham 188, and then steam it to dichloromethane completely.

[0080] The amount of sodium gallopate is examined in accordance with the above preparation methods to 0, 10, 20, 30, 50, 100, 150m...

Embodiment 2

[0081] Example 2 Examine the types of organic solvents on the type of nanopartal particle size and stability:

[0082] Examine different organic solvents pairs S CT-SLNS has the effects of particle size and stability. It is precisely known as salmon reduced calcium calcium or 7.5mg to dissolve in 0.5ml 0.01mol / ml HCL aqueous solution.In the 1ml organic solvent of 20mg of phospholipid, the probe ultrasonic 15S and the power of 40W, forming colostrum.Add colostrum to a 0.1%Polosam 188 solution of 4ml, the probe ultrasonic 15S and the power of 80W, forming nanomal milk.Dilute nanocal milk with the same concentration of Polosam 188 solution and steam to the organic solvents completely, that is, the SCT-SLNS dispersing solution is obtained to check the changes in particle size and stability. Among them, the stability is 'good',The evaluation of ',' difference ',' / ', of which' good 'means that after 24 hours of placement, the particle size is not changed, and the solution is a clear ...

Embodiment 3

[0087] Example 3 The effect of examining different lipid materials on the packaging rate, particle size and stability:

[0088] Precision is called salmon oligomatin 7.5mg dissolved in 0.5ml 0.01mol / ml HCL aqueous solution, adds 25 mg of sodium sodium after dissolving, 30 minutes of vortex, and then adds to dissolved (according to SLN1, 2, 4-4 in Table 2The 10th prescription requires different ratios to add mixed lipid materials) 1ml dichloromethane solution for lipid materials.Probe ultrasound 15S and 40W of power, forming colostrum.Add colostrum to the Polosam 188 solution of 4ml0.1%, the probe ultrasonic 15S and the power of 80W, forming nanomal milk.Dilute the nano -milk with the same concentration of Polosham 188, and then steam it to dichloromethane completely.The effects of each prescription on the package rate, particle size and stability (stability after 24 hours) are shown in Table 2:

[0089] Table 2: Different lipid materials Mixed -packed and particle size inspection...

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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 involves a new type of medication system for protein, especially the solid lipid nanoprocryment system for new type of protein drugs, which belongs to the field of biopharmaceutical preparations. Background technique [0002] Protein drugs are widely used in the treatment of various major diseases, but due to some special properties of itself, it has a lot of restrictions in its application and cannot fully play a role.To this end, many scientific researchers have begun to study and develop stability in recent years, long half -life, good biocompatibility, and easy to absorb protein drugs. [0003] Solid Lipid Nanoparticle (SLN) is a targeted controlled gum supplier system that has been active in recent years after emulsion and lipids.It wraps drugs in a solid natural or synthetic lipids in a lipid -like solid gum gauge dosing system with a particle size of about 50 to 1000 nm. It usually presents solid state at room temperature.The advantag...

Claims

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Application Information

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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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