Solid self-emulsifying agent and preparation method thereof

A self-emulsifying and emulsifying agent technology, which is applied in the direction of pharmaceutical formulations, active ingredients of heterocyclic compounds, medical preparations of non-active ingredients, etc., to achieve the effect of improving solubility and absorption surface area, promoting absorption speed and degree, and simple synthesis route

Inactive Publication Date: 2017-05-31
GUANGZHOU ZHONGDA NANSHA TECH INNOVATION IND PARK +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] At present, the application of mesoporous silica in insoluble drug delivery systems is limited to the loading of a single drug molecule. How to further develop the superior properties of mesoporous silica and apply it to multi-component co-delivery systems is the development Issues that must be resolved in the process of developing a novel poorly soluble drug delivery system

Method used

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  • Solid self-emulsifying agent and preparation method thereof
  • Solid self-emulsifying agent and preparation method thereof
  • Solid self-emulsifying agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Example 1 Fenofibrate solid self-emulsifying formulation based on mesoporous silica SBA-15

[0051] The construction method of the fenofibrate solid self-emulsifying preparation of the present embodiment comprises the following steps:

[0052] 1. Construction of fenofibrate liquid self-emulsifying system

[0053] Accurately weigh 2.5502g of the oil phase (ethyl oleate), 2.5499g of the emulsifier (Cremophor RH40), and 3.4000g of the co-emulsifier (Transcutol HP) and vortex and mix evenly to obtain a uniform and clear oily solution; accurately weigh 1.5001g of Add fenofibrate to the above-prepared oily solution (blank self-emulsifying solution), vortex and mix evenly, and equilibrate in a water bath at 37°C until the drug is completely dissolved to obtain the fenofibrate liquid self-emulsifying system.

[0054] 2. Preparation of mesoporous silica SBA-15

[0055] Accurately weigh 8.0 g of template agent P123, add 365 mL of hydrochloric acid solution (2 mol / L), and stir a...

Embodiment 2

[0061] Example 2 Construction of fenofibrate solid self-emulsifying preparation based on mesoporous silica SBA-15

[0062] The construction method of the fenofibrate solid self-emulsifying preparation of the present embodiment comprises the following steps:

[0063] 1. Construction of fenofibrate liquid self-emulsifying system

[0064] Accurately weigh 2.5502g of the oil phase (ethyl oleate), 2.5501g of the emulsifier (Cremophor RH40), and 3.4000g of the co-emulsifier (Transcutol HP) and vortex and mix evenly to obtain a uniform and clear oily solution. Accurately weigh 1.5000g of fenofibrate, add the blank self-emulsifying solution (i.e. oily solution) prepared above, vortex and mix evenly, equilibrate in a water bath at 37°C until the drug is completely dissolved, and obtain fenofibrate liquid self-emulsifying solution. emulsifying system.

[0065] 2. Preparation of mesoporous silica SBA-15

[0066] Mesoporous silica SBA-15 was prepared according to the method of Example ...

Embodiment 3

[0069] Example 3 Construction of celecoxib solid self-emulsifying formulation based on mesoporous silica SBA-15

[0070] The construction method of the celecoxib solid self-emulsifying preparation of the present embodiment comprises the following steps:

[0071] 1. Construction of celecoxib liquid self-emulsifying system

[0072]Accurately weigh 2.0005g of the oil phase (ethyl oleate), 2.0003g of the emulsifier (Cremophor RH40), and 4.0001g of the co-emulsifier (Transcutol HP) and vortex and mix evenly to obtain a uniform and clear oily solution. Accurately weigh 2.0000 g of celecoxib, add the blank self-emulsifying solution (i.e. oily solution) prepared above, vortex and mix evenly, equilibrate in a water bath at 37°C until the drug is completely dissolved, and then the celecoxib liquid self-emulsifying solution is obtained. emulsifying system.

[0073] 2. Preparation of mesoporous silica SBA-15

[0074] Mesoporous silica SBA-15 was prepared according to the method of Exam...

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Abstract

The invention discloses a solid self-emulsifying agent and a preparation method thereof. The solid self-emulsifying agent is prepared from mesoporous silica SBA-15 and a liquid self-emulsifying transfer system, wherein the liquid self-emulsifying transfer system is prepared from an indissolvable drug, an oil phase, an emulsifying agent and a co-emulsifier according to the mass ratio of 1-2 to 1-4 to 1-4 to 3-6, and the mass ratio of the liquid self-emulsifying transfer system to the mesoporous silica SBA-15 is 1-4 to 1. The solid self-emulsifying agent completes curing of an oily concentrated solution by solubilizing the indissolvable drug in the oily concentrated solution and utilizing the unique pore-passage structure of the mesoporous silica, effective combination of a self-emulsifying technology and a solid preparation is achieved, the solid self-emulsifying agent is high in supporting rate, good in stability, prolonged in storage time and easy to take, can remarkably improve the bioavailability of the drug, and the preparation method of the solid self-emulsifying agent is simple and feasible and has good development and application prospect.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and more specifically, the invention relates to a solid self-emulsifying preparation based on mesoporous silica SBA-15 and a preparation method thereof. Background technique [0002] Oral administration, as the most common and simplest route of administration, is the most acceptable way of administration for most patients with chronic diseases. After the drug enters the gastrointestinal tract orally, it first needs to go through the dissolution process to release the drug molecules, so that it can be absorbed by the body through the epithelial mucosa layer of the gastrointestinal tract, realize the distribution, metabolism and excretion process, and then exert the drug effect. Therefore, solubility is an important criterion for a new chemical entity from discovery to development into an active drug. According to the difference in solubility and permeability, the biopharmaceut...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K47/04A61K31/216A61K31/635A61K31/55
CPCA61K9/143A61K31/635A61K31/55A61K31/216
Inventor 吴传斌林师麒权桂兰潘昕陈航平
Owner GUANGZHOU ZHONGDA NANSHA TECH INNOVATION IND PARK
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