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Self-emulsifying pharmaceutical emulsion for injection as well as preparation method and application thereof

A technology for self-emulsification and injection, which is applied in the direction of drug delivery, pharmaceutical formulations, and medical preparations containing active ingredients. Good sustained release effect, wide range of effects

Active Publication Date: 2019-03-29
CHENGDU MAXVAX BIOTECHNOLOGY LLC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The invention adopts emulsification technology and uses the oil-water interface film to load the drug, which solves the problem of increasing the drug loading due to the incompatibility of Dexibuprofen in water. Compared with other preparations, the adverse reactions and side effects are reduced, and the biological The availability is improved, and the cost of the preparation is reduced, which is convenient for patients to use. However, the invention is an injection emulsion of Dexibuprofen, and the scope of use is limited. The long-term release of the drug in the preparation cannot be controlled, and the effect of long-term treatment cannot be achieved.

Method used

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  • Self-emulsifying pharmaceutical emulsion for injection as well as preparation method and application thereof
  • Self-emulsifying pharmaceutical emulsion for injection as well as preparation method and application thereof
  • Self-emulsifying pharmaceutical emulsion for injection as well as preparation method and application thereof

Examples

Experimental program
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Effect test

preparation example Construction

[0078] Preparation method of self-emulsifying drug emulsion

[0079] The self-emulsifying drug delivery system of the present invention includes the following components by weight percentage: 30-50% oil phase, 5-10% emulsifier and 40-60% aqueous drug solution.

[0080] High pressure homogenization is not required in the production process. Mix the oil phase and emulsifier in a suitable weight ratio in the liquid mixing tank. The general mixing method is to stir at room temperature at a speed of 150-300 revolutions per minute until it is clear and transparent. Generally, stirring is required for 1 hour. Subsequently, the drug-containing water phase (aqueous drug solution) is added, and the weight ratio of the water phase to the emulsifier-containing oil phase (emulsion premix) is generally 1:1. Keep stirring during the addition of the water phase. After the addition, continue to stir for 1 hour. The resulting product is milky white and is an oil-in-water-water emulsion. The av...

Embodiment 1

[0087] The self-emulsifying ampicillin nanoemulsion prepared in Example 1 can be observed under an inverted microscope at 1000 times magnification, and many emulsion particles with uniform particle size can be seen such as figure 1 Shown. There are many small particles in the middle of these emulsion particles. The small particles are the water phase containing the drug and the large particles are the oil and surfactant components in the emulsion preformulation.

[0088] Analysis with Ma Erwen's Nanoziser nanoparticle analysis instrument shows that the average diameter of the nanoparticles is 210nm and the diameter of 90% (volume) of the particles is between 120-420nm, such as figure 2 Shown.

[0089] Put 10 ml of the emulsion into a test tube and place it at 37°C for 14 days, and observe the delamination phenomenon every day. There was no change in the first 7 days. From the 8th day, a transparent oil phase appeared on the upper layer of the emulsion and increased day by day, a...

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Abstract

The invention relates to a self-emulsifying pharmaceutical emulsion for injection as well as a preparation method and application thereof. The self-emulsifying pharmaceutical emulsion comprises the following components by weight percentage: 30-50% of an oil phase, 5-10% of an emulsifier and 40-60% of a drug aqueous solution. According to the invention, a low-dose surfactant with high emulsibilityis used, the self-emulsifying pharmaceutical emulsion has very little irritation to body tissues and can be used for injection; the preparation method is optimized by adjusting the content of each component, so that the preparation is widely used and suitable for water-soluble drugs and fat-soluble drugs, such as chemical drugs, biological products and vaccines. Preparation granules of the self-emulsifying pharmaceutical emulsion is a nano-emulsion which is very stable and can achieve the effect of sustained release of the drugs in vivo.

Description

Technical field [0001] The invention belongs to the technical field of biology and chemical pharmacy, and relates to a self-emulsifying pharmaceutical emulsion for injection and a preparation method and application thereof. Background technique [0002] The traditional self-emulsifying drug delivery system (SEDDS) refers to a drug delivery system that is a mixture of oil phase, surfactant (emulsifier), and co-surfactant (co-emulsifier). It is mainly used for oral delivery of solid or liquid drugs that are difficult to dissolve in water. The self-emulsifying preparation is absorbed in the gastric juice and intestinal juice following the gastrointestinal motility and gastrointestinal fluid mixing, and spontaneously emulsifying into a microemulsion. The spontaneous emulsifying preparation solves the problem of poorly soluble drugs, improves the absorption of drugs, and increases the bioavailability and effects of drugs. The current self-emulsifying drugs on the market include cycl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/113A61K45/00
CPCA61K9/0019A61K9/1075A61K9/113A61K45/00
Inventor 陈德祥董丽春
Owner CHENGDU MAXVAX BIOTECHNOLOGY LLC