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Sodium ferulic acid nano micelle preparation and preparation method thereof

A technology of sodium ferulate and nanomicelles, which is applied in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. Strong irritation and other problems, to avoid easy aggregation into agglomerates, improve bioavailability, and be suitable for industrial production.

Inactive Publication Date: 2009-04-29
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the sodium ferulate freeze-dried powder injections on the domestic market are all prepared by traditional techniques, such as conventional solvent crystallization or freeze-drying methods. The prepared products have poor quality stability, strong liquid irritation, and poor solubility. Poor, high unqualified rate of clarity, pH value drop, content drop, color deepening, easy to deteriorate and other problems, resulting in unstable curative effect or seriously affecting the curative effect
The main reason for the above problems may be that some impurities such as protein, tannin, etc. are not completely removed during the preparation of sodium ferulate, and the instability of sodium ferulate itself
Those skilled in the art searched for several ways to solve this problem, but all failed

Method used

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  • Sodium ferulic acid nano micelle preparation and preparation method thereof
  • Sodium ferulic acid nano micelle preparation and preparation method thereof
  • Sodium ferulic acid nano micelle preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Preparation composition:

[0032] Component Content

[0033] Sodium Ferulate 100g

[0034] Macrogol 2000 Distearoyl Phosphatidylethanolamine 200g

[0035] Mannitol 100g

[0036] Phosphate buffer 10g

[0037] Preparation:

[0038] (1) Dissolve 100g sodium ferulate and 200g polyethylene glycol 2000 distearoylphosphatidylethanolamine in 300ml n-hexane, mix and disperse evenly, remove n-hexane under reduced pressure to obtain a polymer lipid film of sodium ferulate ;

[0039] (2) Dissolve 100g of mannitol in 1000ml of water, add it to the polymer lipid film obtained in step (1), then add 10g of phosphate buffer solution, adjust the pH to 6.9, heat it in a water bath to 70°C for hydration for 1 hour, and obtain Polyethylene glycol 2000 distearoylphosphatidylethanolamine entrapped nano-micelle solution of sodium ferulate;

[0040] (3) Freeze-drying the obtained micellar solution to obtain a freeze-dried preparation of sodium ferulate.

Embodiment 2

[0042] Preparation composition:

[0043] Component Content

[0044] Sodium Ferulate 300g

[0045] Macrogol 4000 Dipalmitoyl Phosphatidylethanolamine 1200g

[0046] Glucose 1000g

[0047] Citrate buffer 50g

[0048] Preparation:

[0049] (1) Sodium ferulate 300g and macrogol 4000 dipalmitoylphosphatidylethanolamine 1200g are dissolved in 3000ml dehydrated alcohol, mix and disperse evenly, remove dehydrated alcohol under reduced pressure, obtain the polymer lipid of sodium ferulate membrane;

[0050] (2) Dissolve 1000g of glucose in 6700ml of water, add it to the obtained polymer lipid film, then add 50g of citrate buffer solution to adjust the pH value to 6.8, heat it in a water bath to 50°C for hydration for 3 hours, and obtain sodium ferulate Polyethylene glycol 4000 dipalmitoylphosphatidylethanolamine encapsulated nanomicelle solution;

[0051] (3) Freeze-drying the obtained micellar solution to obtain a freeze-dried preparation of sodium ferulate.

Embodiment 3

[0053] Preparation composition:

[0054] Component Content

[0055] Sodium Ferulate 150g

[0056] PEG 2000 Dioleoyl Phosphatidylethanolamine 600g

[0057] Lactose 700g

[0058] Citrate buffer 18g

[0059] According to the same method as in Example 1, the sodium ferulate nanomicelle lyophilized preparation was prepared.

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Abstract

The invention relates to a sodium ferulate nanomicelle preparation that can be used for intravenous injection, and a preparation method thereof. The sodium ferulate nanomicelle preparation has a plurality of advantages, and the preparation method well controls the quality of products, has good stability and greatly improves the biological availability; the obtained nanomicelle freeze-dried preparation has small particle diameter and is characterized by targeting. The preparation method also has the advantages of being suitable for industrialized production and low production cost.

Description

technical field [0001] The invention relates to a sodium ferulate nano-micelle preparation and a preparation method thereof, in particular, the sodium ferulate nano-micelle preparation is intravenously injectable. Background technique [0002] Sodium ferulate (English name: sodium ferulate, alias: chuanqiongsu, angelica) is the sodium salt of the effective monomer component ferulic acid (ferulic acid, ferulic acid) extracted from the traditional Chinese medicine angelica and chuanxiong. Its chemical name is It is 3-methoxy-4-hydroxycinnamate dihydrate, the molecular formula is: C 10 h 9 o 4 Na.2H 2 O, can antagonize non-peptide endothelin receptors, antagonize endothelin-induced vasoconstriction, pressurization and vascular smooth muscle cell proliferation, reduce vascular endothelial injury; increase NO synthesis, relax vascular smooth muscle; inhibit platelet aggregation, anticoagulation 1. Improve blood rheology characteristics; inhibit the synthesis of cholesterol, r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127A61K31/192A61K47/34A61P9/10A61P9/12A61P3/10A61P9/00A61K47/10A61K47/12A61K47/24A61K47/26
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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