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Alendronate sodium solid lipid nanoparticle and preparation method thereof

A technology of solid lipid nanometer and alendronate sodium, which is applied in the directions of liposome delivery, pharmaceutical formulations, and medical preparations of inactive ingredients, etc., can solve the problem of lack of oral bioavailability information, etc. degree, less residue, and the effect of increasing water solubility and stability

Inactive Publication Date: 2017-06-13
NANCHANG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, the patents on alendronate sodium mainly include alendronate sodium pharmaceutical composition, alendronate sodium powder, alendronate sodium effervescent granule, alendronate sodium powder injection, alendronate sodium sodium alendronate solid dispersion, alendronate sodium nano-preparation, alendronate sodium cyclodextrin inclusion complex, alendronate sodium enteric-coated preparation, alendronate sodium compound preparation, etc. These preparations are effective in reducing mucosal irritation It has significant advantages in reducing adverse reactions, but most of them do not have information on their oral bioavailability

Method used

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  • Alendronate sodium solid lipid nanoparticle and preparation method thereof
  • Alendronate sodium solid lipid nanoparticle and preparation method thereof
  • Alendronate sodium solid lipid nanoparticle and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0040] Example 1: Preparation of solid lipid nanoparticles of alendronate sodium; prescription: 3 mg of sodium alendronate, 30 mg of glyceryl behenate, 20 mg of soybean lecithin, 50 mg of poloxamer 188, 0.4 ml of absolute ethanol , 10ml of distilled water.

[0041] Preparation of Alendronate Sodium Solid Lipid Nanoparticles: Step 1: Accurately weigh each component of the prescription amount, dissolve Alendronate Sodium in a small amount of organic solvent (absolute ethanol), and then mix it with behenic acid Glyceride and soybean lecithin are mixed, heated to 85°C to melt the lipid to obtain an oil phase; step 2, add Poloxamer 188 to 10ml of distilled water, and heat to the same temperature as the oil phase to form a water phase; step 3. Pour the water phase into the oil phase, high-speed shear at 7000rpm for 3min, and ultrasonically break at 300w for 3min to obtain alendronate sodium solid lipid nanoparticles.

Embodiment 2

[0042] Example 2 Preparation of solid lipid nanoparticles of alendronate sodium; the prescription is as follows: 5 mg of sodium alendronate; 50 mg of glyceryl behenate; 20 mg of soybean lecithin; 50 mg of poloxamer 188; 0.4 ml of absolute ethanol ; Distilled water 10ml.

[0043] Preparation of Alendronate Sodium Solid Lipid Nanoparticles: Step 1: Accurately weigh each component of the prescription amount, dissolve Alendronate Sodium in a small amount of organic solvent (absolute ethanol), and then mix it with behenic acid Glyceride and soybean lecithin are mixed, heated to 85°C to melt the lipid to obtain an oil phase; step 2, add Poloxamer 188 to 10ml of distilled water, and heat to the same temperature as the oil phase to form a water phase; step 3. Pour the water phase into the oil phase, high-speed shear at 7000rpm for 3min, and ultrasonically break at 300w for 3min to obtain alendronate sodium solid lipid nanoparticles.

Embodiment 3

[0044] Example 3 Preparation of Alendronate Sodium Solid Lipid Nanoparticles; the prescription is as follows: Alendronate Sodium 1mg

[0045] Glyceryl behenate 50mg; soybean lecithin 25mg; poloxamer 188 30mg; absolute ethanol 0.4ml; distilled water 10ml.

[0046] Preparation of Alendronate Sodium Solid Lipid Nanoparticles: Step 1: Accurately weigh each component of the prescription amount, dissolve Alendronate Sodium in a small amount of organic solvent (absolute ethanol), and then mix it with behenic acid Glyceride and soybean lecithin are mixed, heated to 85°C to melt the lipid to obtain an oil phase; step 2, add Poloxamer 188 to 10ml of distilled water, and heat to the same temperature as the oil phase to form a water phase; step 3. Pour the water phase into the oil phase, high-speed shear at 11000rpm for 3min, and ultrasonic crush at 300w for 3min to obtain alendronate sodium solid lipid nanoparticles.

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Abstract

The invention discloses an alendronate sodium solid lipid nanoparticle and a preparation method thereof. The alendronate sodium solid lipid nanoparticle comprises the following components in weight percentage: 0.01-0.05% of alendronate sodium, 0.29-0.5% of solid lipid, 0.19-0.5% of a fat soluble emulsifier, 0.49-0.98% of a water soluble emulsifier and balance of distilled water. The preparation method disclosed by the invention adopts a shear-ultrasonic method, and alendronate sodium is wrapped into a solid lipid nanoparticle, so that the alendronate sodium solid lipid nanoparticle is obtained. The preparation method comprises the following steps: precisely weighing all the components in prescription dosage, firstly dissolving alendronate sodium into a small amount of organic solvent, then mixing with the solid lipid and the fat soluble emulsifier, heating and fusing, so that an oil phase is obtained; adding the water soluble emulsifier into the distilled water, and heating to the temperature the same with the oil phase, so that an aqueous phase is formed; and pouring the aqueous phase into the oil phase, and carrying out high-speed shearing and ultrasonication, so that the alendronate sodium solid lipid nanoparticle is obtained. Urine excretion dynamic effects show that the bioavailability of a rat oral solid lipid nanoparticle is 3-4 times that of an alendronate sodium solution.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a sodium alendronate solid lipid nanoparticle and a preparation method thereof. Background technique [0002] Osteoporosis (osteoporosis) is a systemic bone disease, characterized by decreased bone mass and destruction of bone microstructure, manifested as increased bone fragility, so fracture is a common complication, especially in the hip, vertebral body and the distal radius most frequently. Currently, it ranks 7th among common diseases and frequently-occurring diseases in the world. Osteoporosis is a multifactorial chronic disease. Before the fracture occurs, there are usually no special clinical manifestations. After women enter menopause, bone loss is obvious. If there is no proper prevention and treatment, osteoporosis will inevitably lead to fractures of radius, spine and hip. With the increase of the elderly population in my country, t...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K9/51A61K47/14A61K47/12A61K47/26A61K47/34A61K47/24A61K31/663A61P19/10
CPCA61K9/127A61K9/5123A61K9/5146A61K9/5192A61K31/663A61K47/12A61K47/14A61K47/24A61K47/26A61K47/34
Inventor 谢宝刚王毓王海鹏杨婧余梦杰
Owner NANCHANG UNIV
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