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Nanometer preparation of silybin and preparation method thereof

A technology of silibinin and nano-preparation, which is applied in the field of silibinin lipid nano-preparation medicine and its preparation, can solve the problems of poor stability, unstable preparation, poor stability, etc., and achieve the convenience of industrial production and loading The effect of high drug dose and increased distribution

Active Publication Date: 2007-12-26
句容市科诺健康科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantage of the high-pressure homogenization method is that the emulsification process is carried out directly under high pressure, and the emulsification process is insufficient. Although the particle size is small, the stability is poor; Poor; the disadvantage of the solvent emulsification method is that there are many residual organic solvents in the preparation. Although it can be removed by drying, it also increases the chance of destroying the nanoparticles and causes the instability of the preparation; the film emulsification method is used to prepare LN. The emulsification process is very sufficient, the stability is good, and the drug loading capacity of insoluble drugs can be significantly increased. The method is simple and can avoid the loss and deterioration of drugs during the preparation process. The main disadvantage is that the particle size is large; It is an effective method to reduce the particle size of nanoparticles and increase their stability, and because the high-pressure homogenizer is used for operation, the method has good reproducibility and is suitable for industrial production, but this method is not suitable for the direct preparation of nanoparticles

Method used

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  • Nanometer preparation of silybin and preparation method thereof
  • Nanometer preparation of silybin and preparation method thereof
  • Nanometer preparation of silybin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] 1. Weigh 2g of soybean lecithin, 0.5g of glycerin, and 1g of mannitol into a beaker, add 80ml of distilled water, use a high-speed shear to disperse the lecithin evenly in the water phase, and place it in a water bath at 60°C for later use.

[0033] 2. Weigh 0.1g of silibinin and 0.2g of soybean lecithin, add 30ml of absolute ethanol, ultrasonically dissolve it, then add 0.5g of natural vitamin E, shake to dissolve, remove ethanol by rotary evaporation, add 2.5g of soybean oil and Shake well and place in a 60°C water bath for later use.

[0034] 3. Add the water phase containing the emulsifier prepared in step 1 into the oil phase prepared in step 2 in a water bath at 60±5°C, mix evenly and emulsify with a high-speed shear for 8 to 10 minutes to obtain milk thistle The crude product of the ben nanoformulation.

[0035] 4. The crude product was subjected to high-pressure homogenization for 5 times at a pressure of 1000 bar to obtain a silybin nano-preparation drug emuls...

Embodiment 2

[0038] 1. Weigh 8g of soybean lecithin, 1.5g of glycerin, and 5g of mannitol into a beaker, add 80ml of distilled water, use a high-speed shear to disperse the lecithin evenly in the water phase, and place it in a water bath at 60°C for later use.

[0039] 2. Weigh 0.1 g of silibinin and 1.0 g of soybean lecithin. Add 30ml of absolute ethanol, ultrasonically dissolve it, then add 15g of natural vitamin E, shake to dissolve, remove the ethanol by rotary evaporation, add 24g of soybean oil and shake well, and place in a 60°C water bath for later use.

[0040] 3. Add the water phase containing the emulsifier prepared in step 1 into the oil phase prepared in step 2 in a water bath at 60±5°C, mix evenly and emulsify with a high-speed shear for 8 to 10 minutes to obtain milk thistle The crude product of the ben nanoformulation.

[0041] 4. The crude product was subjected to high-pressure homogenization for 5 times, and the pressure was 1000 bar to obtain a nano-preparation drug emu...

Embodiment 3

[0044] 1. Weigh 4g of soybean lecithin, 1.5g of glycerin, and 2g of mannitol into a beaker, add 80ml of distilled water, use a high-speed shear to disperse the lecithin evenly in the water phase, and place it in a water bath at 60°C for later use.

[0045] 2. Weigh 0.1 g of silibinin and 0.5 g of soybean lecithin. Add 30ml of absolute ethanol, ultrasonically dissolve it, then add 5g of natural vitamin E, shake to dissolve, remove the ethanol by rotary evaporation, add 10g of soybean oil and shake well, and place in a 60°C water bath for later use.

[0046] 3. Add the water phase containing the emulsifier prepared in step 1 into the oil phase prepared in step 2 in a water bath at 60±5°C, mix evenly and emulsify with a high-speed shear for 8 to 10 minutes to obtain milk thistle The crude product of the ben nanoformulation.

[0047] 4. The crude product was subjected to high-pressure homogenization for 5 times at a pressure of 1000 bar to obtain a silybin nano-preparation drug e...

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Abstract

The invention provides a silybin nano medicinal preparation, which comprises liposome nano particles of silybin, the liposome material is the mixture of soya bean lecithin, vitamin E and soyabean oil by the mass ratio of 1:2.5:12.5-1:15:24, the mass ratio of silybin and lipsome material is 1:32-1:400, the grain diameter of the liposome nano particles is less than 500 nanometer. The invention also discloses the preparing process of the preparation.

Description

Technical field: [0001] The invention relates to a preparation method of a nano-preparation drug, in particular to a silibinin lipid nano-preparation drug and a preparation method thereof. Background technique: [0002] Silybin (SLB) is a flavonoid compound extracted and isolated from the fruit of the Compositae plant Silybum marianus. Because of its obvious protective and stabilizing effect on liver cells, it is effective for various liver diseases. With varying degrees of therapeutic effects, it has become an ideal drug for repairing liver damage, and is widely used clinically to treat liver diseases such as acute and chronic hepatitis, liver fibrosis, and early liver cirrhosis [see: Flora K, Hahn M, Rahn H, et al. Milk thisle (silybum marianum) for the therapy of live disease. Am J Gastroenterol, 1998, 93(13): 139.]. Because SLB is insoluble in water, the bioavailability of common oral preparations is low. Recently, the research on new dosage forms and new preparations o...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/357A61K9/14A61K9/19A61P1/16
Inventor 徐希明余江南朱源童珊珊
Owner 句容市科诺健康科技有限公司