Preparation method and application of starch-protein-palmitic acid compound

Abstract

The invention relates to a preparation process of a starch-protein-palmitic acid compound and application of the starch-protein-palmitic acid compound in embedding paclitaxel. The preparation process comprises the following steps: (1) respectively dissolving proteins (beta-lactoglobulin, zein, A-type gelatin, soybean protein isolate and glutelin), starch (corn starch, rice starch, cassava starch, mung bean starch and high amylose) and palmitic acid; (2) putting the mixture into water at the temperature of 80 to 100 DEG C, heating the mixture for 20 to 60 minutes, and cooling the mixture; and (3) washing, centrifuging, grinding and storing. According to the preparation method, the starch-protein-palmitic acid complex index and binding stability can be remarkably improved, the process is simple, the property is stable, the complex index is high, and the preparation method can be used for large-scale factory production. The embedding rate and the loading rate can be remarkably improved by embedding the taxodium purpureum by using the nano-material, the water dispersibility, the photo-thermal stability and the slow release performance of the nano-material are remarkably improved, and the nano-material is suitable for the medical field and functional product development.

Description

Technical Field

[0001] The present invention relates to the field of food and medicine, and in particular to the preparation of a starch-protein-palmitic acid complex and its application in encapsulating paclitaxel. Background Art

[0002] Starch is a high-molecular carbohydrate, a polysaccharide composed of a single type of sugar unit. Based on the difference in molecular structure, starch can be divided into two categories: amylose and amylopectin. The former has a helical structure with fewer branches, while the latter has more branches, with multiple glucose residues connected end to end by α-1,4-glycosidic bonds, and connected by α-1,6-glycosidic bonds at the branches. When a suitable ligand is present in the system, amylose can be induced to form a tight helical conformation. This produces a helical structure with a hydrophobic cavity, which provides high affinity and binding sites for non-polar ligands, thus facilitating the formation of complexes with other molecules. As a polysaccharide, starch is safe and non-toxic, and has advantages such as good biocompatibility and degradability, and has attracted much attention as a carrier material.

[0003] Proteins are macromolecular organic compounds composed of amino acids linked by peptide bonds and are widely present in living organisms. They possess both hydrophilic and hydrophobic regions, and are therefore often considered to bridge the starch-lipid-protein ternary complex, facilitating the assembly of amylose-lipid complexes. Furthermore, proteins' multifunctional groups, structural flexibility, interfacial activity, and cross-linking capabilities enable them to effectively connect starch, protein, and fatty acids to form stable ternary polymer complexes.

[0004] Free fatty acids are the main components of lipids. Most of them contain 14-24 carbon atoms and therefore have aliphatic chains with carboxylic acid groups. Free fatty acids are further divided into saturated, unsaturated, and polyunsaturated fatty acids. The amphiphilic nature, hydrophobic interactions, hydrogen bonding and electrostatic interactions, interfacial activity, and structural diversity of lipids enable them to effectively connect starch and protein to form stable ternary polymer complexes. Interactions between starch, protein, and fatty acid molecules can form binary complexes such as starch-fatty acid and starch-protein. Lipid molecules utilize their hydrophobic properties to physically embed within the helical structure of starch molecules, forming starch-fatty acid complexes. Proteins and their hydrolysis products can attach to the surface of starch granules or within their helical cavities through hydrogen bonding, electrostatic, and hydrophobic interactions, forming a complex gel network structure and starch-protein complexes.

[0005] The interactions between starch, protein, and fatty acid molecules can form binary complexes, such as starch-fatty acid and starch-protein. Lipid molecules, leveraging their hydrophobic properties, physically embed themselves within the helical structure of starch molecules, forming starch-fatty acid complexes. Proteins and their hydrolysates can adhere to the surface of starch granules or within their helical cavities through hydrogen bonding, electrostatics, and hydrophobic interactions, forming a complex gel network structure and, ultimately, a starch-protein complex.

[0006] The starch-lipid-protein ternary complex consists of a lipid hydrophobic group linked to amylose, while the negatively charged carboxyl functional group is linked to the equally negatively charged protein. Therefore, free fatty acids may serve as a bridge between amylose and protein in the ternary complex. The interaction between lipids, proteins, and starch can lead to changes in its physical and chemical properties, such as increased thermal stability, increased resistance to digestion, altered gelatinization properties, increased viscosity, and enhanced texture. Existing research has primarily focused on the factors influencing the starch-fatty acid binary complex, but has lacked understanding of starch-protein-fatty acid processing methods and the effects of thermal processing on the formation of the starch-protein-fatty acid ternary complex.

[0007] Studies have shown that the product of the interaction between starch, protein and fatty acids can also be used as a new type of material to encapsulate and control drug release. Amylose is a linear chain molecule formed by connecting α-D-pyranose with α-1,4 glycosidic bonds. It contains an inner hydrophobic helical cavity structure. The helical cavity has the ability to capture guest molecules. Usually, the presence of guest molecules requires inducing helix formation in the amylose chain. Proteins have the function of transporting fatty acids and fat-soluble vitamins, and the carboxyl functional group of free fatty acids is an essential structure for the formation of this complex ternary system.

[0008] Paclitaxel, a natural diterpenoid extracted from the bark of the Pacific yew tree, is a classic anticancer drug that belongs to the class of microtubule stabilizers. It exerts potent antitumor effects through a unique microtubule-stabilizing mechanism, but its application is limited by solubility, toxicity, and drug resistance. Current research focuses on novel delivery technologies, often using encapsulation techniques to improve solubility, achieve targeted release, and reduce toxic side effects. Summary of the Invention

[0009] The purpose of the present invention is to provide a novel preparation process of starch-protein-palmitic acid complex assisted by thermal processing, and to use the same to achieve the embedding of paclitaxel, thereby improving production efficiency and stability and reducing food safety risks.

[0010] The objectives of the present invention are achieved through the following technical means.

[0011] A method for preparing a starch-protein-fatty acid ternary complex comprises the following steps.

[0012] Step 1: Dissolve starch, fatty acids, and protein separately, mix thoroughly, and heat continuously at 50-60°C. Then, heat in a water bath at 80-100°C. The resulting composite sample is cooled to room temperature, washed with ethanol, centrifuged, and frozen at -18°C. Freeze-dry in a freezer for 24 hours, crushed, and passed through a 100-mesh sieve.

[0013] In step 1, the ratio of starch, fatty acid and protein is 20:1:2.

[0014] In step 1, the starch and protein are dissolved by heating distilled water to 50-60° C. in advance and dissolving the starch and protein separately.

[0015] In step 1, the fatty acid is dissolved in ethanol.

[0016] Preferably, the mixture is placed in water at 50-60°C and heated for 1-20 minutes, and then directly placed in a water bath at 80-100°C and heated for 20-60 minutes for full reaction, with continuous stirring during the process.

[0017] Preferably, the starch used is corn starch, rice starch, tapioca starch, mung bean starch, or high-amylose corn starch.

[0018] Preferably, the protein used is β-lactoglobulin, zein, type A gelatin, soy protein isolate, or gluten.

[0019] Preferably, the fatty acid used is palmitic acid.

[0020] The steps for encapsulating paclitaxel with starch-fat-protein are as follows:

[0021] 0.5 g of the terpolymer was added to 100 mL of deionized water containing 280 μL of Tween 80. The solution was heated to 70-90° C. for 20-40 min to effect gelatinization and ensure complete hydration of the terpolymer.

[0022] 10 mg of paclitaxel was added to 5 mL of anhydrous ethanol and dissolved by thorough stirring at 20-50°C. The mixture was then added to the ternary complex dispersion.

[0023] The mixture was homogenized at 20,000 rpm for 5-10 minutes until the alcohol evaporated, and then immediately frozen. After freezing, vacuum drying was performed to obtain paclitaxel-trivalent starch nanoparticles. Protect from light at all times.

[0024] Compared with the prior art, the present invention has the following advantages:

[0025] The present invention provides a simple, fast and good performance method for preparing composite starch-protein-palmitic acid, and the required components are easily available and low in cost.

[0026] The present invention prepares starch, lipid and protein into a starch-protein-palmitic acid ternary complex, which can be stored for a long time after drying. This starch-protein-palmitic acid complex with unique functional properties can be used as a food ingredient in the preparation of various foods, thereby extending the shelf life.

[0027] The starch-protein-palmitic acid ternary complex obtained by the invention has a high composite index and strong stability, is easy to realize industrial production, and has high economic benefits.

[0028] The ternary complex prepared by the present invention can achieve efficient embedding of paclitaxel, significantly improve its water dispersibility, photothermal stability and sustained-release performance, and is suitable for industrial production and functional product development.

[0029] Compared with the prior art, the present invention has the following advantages:

[0030] The present invention provides a simple, fast and good performance method for preparing composite starch-protein-palmitic acid, and the required components are easily available and low in cost.

[0031] The present invention prepares starch, lipid and protein into a starch-protein-palmitic acid ternary complex, which can be stored for a long time after drying. This starch-protein-palmitic acid complex with unique functional properties can be used as a food ingredient in the preparation of various foods, thereby extending the shelf life.

[0032] The starch-protein-palmitic acid ternary complex obtained by the invention has a high composite index and strong stability, is easy to realize industrial production, and has high economic benefits.

[0033] The ternary complex prepared by the present invention can achieve efficient encapsulation of paclitaxel, significantly improve its water dispersibility, photothermal stability and sustained-release performance, and is suitable for the medical field and functional product development. Attached photos

[0034] Figure 1 Microscope images of ternary complexes formed by different proteins and high-amylose corn starch-palmitic acid.

[0035] Figure 2 Figure 2 shows the stability of ternary complexes formed by different proteins with high-amylose corn starch-palmitic acid. DETAILED DESCRIPTION

[0036] To make the purpose, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without making any creative efforts shall fall within the scope of protection of the present invention.

[0037] Example 1: A method for preparing a rice starch-palmitic acid-soy protein isolate ternary complex: First, 3g of rice starch and 0.3g of soy protein isolate were weighed and thoroughly dissolved in 90mL of 55°C distilled water. The mixture was shaken and then mixed. 0.15g of palmitic acid was dissolved in 10mL of ethanol. Once fully dissolved, the mixture was added to the rice starch-soy protein isolate solution and stirred thoroughly. The mixture was then heated at 55°C for 10 minutes and then at 90°C for 40 minutes. After cooling to room temperature, the mixture was washed with 50% ethanol, freeze-dried, and passed through a 100-mesh sieve. The composite index and freeze-thaw stability of the ternary complex were measured. The ternary complex of this example encapsulates paclitaxel through the following steps. 0.5 g of the rice starch-palmitic acid-soy protein isolate ternary complex was added to 100 mL of deionized water containing 280 μL of Tween 80. The solution was heated to 80°C for 30 min to gelatinize and ensure complete hydration of the rice starch-palmitic acid-soy protein isolate ternary complex. Next, 10 mg of paclitaxel was added to 5 mL of anhydrous ethanol and dissolved with thorough stirring at 40°C. It was then added to the ternary complex dispersion. The mixture was homogenized at 20,000 rpm for 5 minutes until the alcohol evaporated and then immediately frozen. After freezing, the mixture was vacuum-dried to obtain paclitaxel-rice starch-palmitic acid-soy protein isolate ternary complex nanoparticles. The mixture was protected from light at all times. The encapsulation efficiency and loading rate were measured.

[0038] Example 2: A method for preparing a mung bean starch-palmitic acid-soybean protein isolate ternary complex: First, weigh 3g of mung bean starch and 0.3g of soy protein isolate and thoroughly dissolve them in 90mL of 55°C distilled water. Shake well and mix. Then weigh 0.15g of palmitic acid and dissolve it in 10mL of ethanol. Once fully dissolved, add it to the mung bean starch-soy protein isolate solution and stir thoroughly. Heat it at 55°C for 10 minutes, then at 90°C for 40 minutes. After allowing it to cool to room temperature, wash it with 50% ethanol, freeze-dry it, and pass it through a 100-mesh sieve. The composite index and freeze-thaw stability of the ternary complex were measured. The encapsulation of Paclitaxel by the ternary complex of this example is carried out by the following steps. 0.5 g of mung bean starch-palmitic acid-soy protein isolate ternary complex was added to 100 mL of deionized water containing 280 μL of Tween 80. The solution was heated to 80°C for 30 min to gelatinize and ensure that the mung bean starch-palmitic acid-soy protein isolate ternary complex was fully hydrated. Next, 10 mg of paclitaxel was added to 5 mL of anhydrous ethanol and stirred thoroughly at 40°C to dissolve. It was then added to the ternary complex dispersion. The mixture was homogenized at 20,000 rpm for 5 min until the alcohol evaporated and then immediately frozen. After freezing, vacuum drying was performed to obtain paclitaxel-mung bean starch-palmitic acid-soy protein isolate ternary complex nanoparticles. Light was protected at all times. The encapsulation efficiency and loading rate were measured.

[0039] Example 3: A method for preparing a high-amylose corn starch-palmitic acid-soy protein isolate ternary complex: First, weigh 3g of high-amylose corn starch and 0.3g of soy protein isolate and thoroughly dissolve them in 90mL of 55°C distilled water. Shake well and mix. Then weigh 0.15g of palmitic acid and dissolve it in 10mL of ethanol. Once fully dissolved, add it to the high-amylose corn starch-soy protein isolate solution and stir thoroughly. Heat it at 55°C for 10 minutes, then at 90°C for 40 minutes. After allowing it to cool to room temperature, wash it with 50% ethanol, freeze-dry it, and pass it through a 100-mesh sieve. The composite index and freeze-thaw stability of the ternary complex were measured. The encapsulation of Paclitaxel by the ternary complex of this example is carried out by the following steps. 0.5 g of high-amylose corn starch-palmitic acid-soy protein isolate ternary complex was added to 100 mL of deionized water containing 280 μL of Tween 80. The solution was heated to 80°C for 30 min to gelatinize and ensure that the high-amylose corn starch-palmitic acid-soy protein isolate ternary complex was fully hydrated. Next, 10 mg of paclitaxel was added to 5 mL of anhydrous ethanol and stirred thoroughly at 40°C to dissolve. It was then added to the ternary complex dispersion. The mixture was homogenized at 20,000 rpm for 5 min until the alcohol evaporated and then immediately frozen. After freezing, vacuum drying was performed to obtain paclitaxel-high-amylose corn starch-palmitic acid-soy protein isolate ternary complex nanoparticles. Light was protected at all times. The encapsulation efficiency and loading rate were measured.

[0040] Example 4: A method for preparing a ternary complex of cassava starch, palmitic acid and soy protein isolate: First, 3g of tapioca starch and 0.3g of soy protein isolate were weighed and thoroughly dissolved in 90mL of 55°C distilled water. The mixture was shaken and then mixed. 0.15g of palmitic acid was dissolved in 10mL of ethanol. Once fully dissolved, the mixture was added to the tapioca starch-soy protein isolate solution and stirred thoroughly. The mixture was then heated at 55°C for 10 minutes and then at 90°C for 40 minutes. After cooling to room temperature, the mixture was washed with 50% ethanol, freeze-dried, and passed through a 100-mesh sieve. The composite index and freeze-thaw stability of the ternary complex were measured. The encapsulation of Paclitaxel by the ternary complex of this example is carried out by the following steps. 0.5 g of the ternary complex of cassava starch-palmitic acid-soy protein isolate was added to 100 mL of deionized water containing 280 μL of Tween 80. The solution was heated to 80°C for 30 min to gelatinize and ensure that the ternary complex of cassava starch-palmitic acid-soy protein isolate was fully hydrated. Next, 10 mg of paclitaxel was added to 5 mL of anhydrous ethanol and dissolved by thorough stirring at 40°C. It was then added to the ternary complex dispersion. The mixture was homogenized at 20,000 rpm for 5 min until the alcohol evaporated and then immediately frozen. After freezing, vacuum drying was performed to obtain quaternary complex nanoparticles of paclitaxel-cassava starch-palmitic acid-soy protein isolate. Light was protected at all times. The encapsulation efficiency and loading rate were measured.

[0041] Example 5: A method for preparing a corn starch-palmitic acid-soy protein isolate ternary complex: First, weigh 3g of corn starch and 0.3g of soy protein isolate and thoroughly dissolve them in 90mL of 55°C distilled water. Shake well and mix. Then weigh 0.15g of palmitic acid and dissolve it in 10mL of ethanol. Once fully dissolved, add it to the corn starch-soy protein isolate solution and stir thoroughly. Heat it at 55°C for 10 minutes, then at 90°C for 40 minutes. After allowing it to cool to room temperature, wash it with 50% ethanol, freeze-dry it, and pass it through a 100-mesh sieve. The composite index and freeze-thaw stability of the ternary complex were measured. The encapsulation of Paclitaxel by the ternary complex of this example is carried out by the following steps. 0.5 g of corn starch-palmitic acid-soy protein isolate ternary complex was added to 100 mL of deionized water containing 280 μL of Tween 80. The solution was heated to 80°C for 30 min to gelatinize and ensure that the corn starch-palmitic acid-soy protein isolate ternary complex was fully hydrated. Next, 10 mg of paclitaxel was added to 5 mL of anhydrous ethanol and dissolved with thorough stirring at 40°C. It was then added to the ternary complex dispersion. The mixture was homogenized at 20,000 rpm for 5 min until the alcohol evaporated and then immediately frozen. After freezing, vacuum drying was performed to obtain paclitaxel-corn starch-palmitic acid-soy protein isolate ternary complex nanoparticles. Light was protected at all times. The encapsulation efficiency and loading rate were measured.

[0042] Comparative Example 1: A method for preparing a palmitic acid-soy protein isolate binary complex: First, 0.3 g of soy protein isolate was weighed and thoroughly dissolved in 90 mL of 55°C distilled water. The mixture was shaken and then mixed. 0.15 g of palmitic acid was dissolved in 10 mL of ethanol. Once fully dissolved, the mixture was added to the soy protein isolate solution and stirred thoroughly. The mixture was then heated at 55°C for 10 minutes and then at 90°C for 40 minutes. After allowing the mixture to cool to room temperature, it was washed with 50% ethanol, freeze-dried, and passed through a 100-mesh sieve. The composite index and freeze-thaw stability of the binary complex were measured. The binary complex of this example is embedded with paclitaxel by the following steps. 0.5 g of palmitic acid-soy protein isolate binary complex was added to 100 mL of deionized water containing 280 μL of Tween80. The solution was heated to 80°C for 30 min to gelatinize and ensure that the palmitic acid-soy protein isolate binary complex was fully hydrated. Next, 10 mg of paclitaxel was added to 5 mL of anhydrous ethanol and dissolved by thorough stirring at 40°C. It was then added to the binary complex dispersion. The mixture was homogenized at 20,000 rpm for 5 min until the alcohol evaporated and then immediately frozen. After freezing, vacuum drying was performed to obtain paclitaxel-palmitic acid-soy protein isolate ternary complex nanoparticles. Light was avoided at all times. The encapsulation efficiency and loading rate were measured.

[0043] Example 6: A method for preparing a high-amylose corn starch-palmitic acid-gluten ternary complex: First, 3g of high-amylose corn starch and 0.3g of gluten were weighed and thoroughly dissolved in 90mL of 55°C distilled water. The mixture was shaken and then mixed. 0.15g of palmitic acid was dissolved in 10mL of ethanol. Once fully dissolved, the mixture was added to the corn starch-β-lactoglobulin solution and stirred thoroughly. The mixture was then heated at 55°C for 10 minutes and then at 90°C for 40 minutes. After cooling to room temperature, the mixture was washed with 50% ethanol, freeze-dried, and passed through a 100-mesh sieve. The composite index and freeze-thaw stability of the ternary complex were measured. The encapsulation of Paclitaxel by the ternary complex of this example is carried out by the following steps. 0.5 g of high-amylose corn starch-palmitic acid-gluten ternary complex was added to 100 mL of deionized water containing 280 μL of Tween 80. The solution was heated to 80°C for 30 min to gelatinize and ensure complete hydration of the high-amylose corn starch-palmitic acid-gluten ternary complex. Next, 10 mg of paclitaxel was added to 5 mL of anhydrous ethanol and stirred thoroughly at 40°C to dissolve. It was then added to the ternary complex dispersion. The mixture was homogenized at 20,000 rpm for 5 min until the alcohol evaporated and then immediately frozen. After freezing, vacuum drying was performed to obtain paclitaxel-high-amylose corn starch-palmitic acid-gluten ternary complex nanoparticles. Light was protected at all times. The encapsulation efficiency and loading rate were measured.

[0044] Example 7: A method for preparing a high-amylose corn starch-palmitic acid-β-lactoglobulin ternary complex: First, 3g of high-amylose corn starch and 0.3g of β-lactoglobulin were weighed and thoroughly dissolved in 90mL of 55°C distilled water. The mixture was shaken and then mixed. 0.15g of palmitic acid was dissolved in 10mL of ethanol. Once fully dissolved, the mixture was added to the corn starch-β-lactoglobulin solution and stirred thoroughly. The mixture was then heated at 55°C for 10 minutes and then at 90°C for 40 minutes. After cooling to room temperature, the mixture was washed with 50% ethanol, freeze-dried, and passed through a 100-mesh sieve. The composite index and freeze-thaw stability of the ternary complex were measured. The encapsulation of Paclitaxel by the ternary complex of this example is carried out by the following steps. 0.5 g of the high-amylose corn starch-palmitate-β-lactoglobulin ternary complex was added to 100 mL of deionized water containing 280 μL of Tween 80. The solution was heated to 80°C for 30 min to gelatinize and ensure complete hydration of the high-amylose corn starch-palmitate-β-lactoglobulin ternary complex. Next, 10 mg of paclitaxel was added to 5 mL of anhydrous ethanol and dissolved with thorough stirring at 40°C. It was then added to the ternary complex dispersion. The mixture was homogenized at 20,000 rpm for 5 min until the alcohol evaporated and then immediately frozen. After freezing, the mixture was vacuum-dried to obtain paclitaxel-high-amylose corn starch-palmitate-β-lactoglobulin ternary complex nanoparticles. The mixture was protected from light at all times. The encapsulation efficiency and loading rate were measured.

[0045] Example 8: A method for preparing a high-amylose corn starch-palmitic acid-type A-gelatin ternary complex: First, 3g of high-amylose corn starch and 0.3g of type A gelatin were weighed and thoroughly dissolved in 90mL of 55°C distilled water. The mixture was shaken and then mixed. 0.15g of palmitic acid was dissolved in 10mL of ethanol. Once fully dissolved, the mixture was added to the corn starch-β-lactoglobulin solution and stirred thoroughly. The mixture was then heated at 55°C for 10 minutes and then at 90°C for 40 minutes. After cooling to room temperature, the mixture was washed with 50% ethanol, freeze-dried, and passed through a 100-mesh sieve. The composite index and freeze-thaw stability of the ternary complex were measured. The encapsulation of Paclitaxel by the ternary complex of this example is carried out by the following steps. 0.5 g of high-amylose corn starch-palmitic acid-type A-gelatin ternary complex was added to 100 mL of deionized water containing 280 μL of Tween 80. The solution was heated to 80°C for 30 min to gelatinize and ensure complete hydration of the high-amylose corn starch-palmitic acid-type A-gelatin ternary complex. Next, 10 mg of paclitaxel was added to 5 mL of anhydrous ethanol and dissolved with thorough stirring at 40°C. It was then added to the ternary complex dispersion. The mixture was homogenized at 20,000 rpm for 5 min until the alcohol evaporated and then immediately frozen. After freezing, the mixture was vacuum-dried to obtain paclitaxel-high-amylose corn starch-palmitic acid-type A-gelatin quaternary complex nanoparticles. The mixture was protected from light at all times. The encapsulation efficiency and loading rate were measured.

[0046] Example 9: A method for preparing a high-amylose corn starch-palmitic acid-zein ternary complex: First, 3g of high-amylose corn starch and 0.3g of zein were weighed and thoroughly dissolved in 90mL of 55°C distilled water. The mixture was shaken and then mixed. 0.15g of palmitic acid was dissolved in 10mL of ethanol. Once fully dissolved, the mixture was added to the corn starch-β-lactoglobulin solution and stirred thoroughly. The mixture was then heated at 55°C for 40 minutes and then at 90°C for 60 minutes. After cooling to room temperature, the mixture was washed with 50% ethanol, freeze-dried, and passed through a 100-mesh sieve. The composite index and freeze-thaw stability of the ternary complex were measured. The encapsulation of Paclitaxel by the ternary complex of this example is carried out by the following steps. 0.5 g of high-amylose corn starch-palmitic acid-zein ternary complex was added to 100 mL of deionized water containing 280 μL of Tween 80. The solution was heated to 80°C for 30 min to gelatinize and ensure that the high-amylose corn starch-palmitic acid-zein ternary complex was fully hydrated. Next, 10 mg of paclitaxel was added to 5 mL of anhydrous ethanol and dissolved with thorough stirring at 40°C. It was then added to the ternary complex dispersion. The mixture was homogenized at 20,000 rpm for 5 min until the alcohol evaporated and then immediately frozen. After freezing, vacuum drying was performed to obtain paclitaxel-high-amylose corn starch-palmitic acid-zein ternary complex nanoparticles. Protect from light at all times. The encapsulation efficiency and loading rate were measured.

[0047] Comparative Example 2: A method for preparing a palmitic acid-high amylose corn starch binary complex: First, weigh 3g of high-amylose corn starch and dissolve it thoroughly in 90mL of 55°C distilled water. Then, weigh 0.15g of palmitic acid and dissolve it in 10mL of ethanol. Shake well and mix thoroughly. Heat at 55°C for 10 minutes, then at 90°C for 40 minutes. After cooling to room temperature, wash with 50% ethanol, freeze-dry, and pass through a 100-mesh sieve. The composite index and freeze-thaw stability of the ternary complex were measured. The encapsulation of Paclitaxel by the ternary complex of this example is carried out by the following steps. 0.5 g of high-amylose corn starch-palmitic acid binary complex was added to 100 mL of deionized water containing 280 μL of Tween 80. The solution was heated to 80°C for 30 min to gelatinize and ensure complete hydration of the high-amylose corn starch-palmitic acid binary complex. Next, 10 mg of paclitaxel was added to 5 mL of anhydrous ethanol and dissolved with thorough stirring at 40°C. It was then added to the ternary complex dispersion. The mixture was homogenized at 20,000 rpm for 5 min until the alcohol evaporated and then immediately frozen. After freezing, vacuum drying was performed to obtain paclitaxel-high-amylose corn starch-palmitic acid ternary complex nanoparticles. Protect from light at all times. The encapsulation efficiency and loading rate were measured.

[0048] The steps for determining the ternary complex described in Examples 1-9 and Comparative Examples 1-2 are as follows:

[0049] Composite Index: Add 100 mg of sample (dry basis: DW) to a mixture consisting of 1 mL of ethanol and 9 mL of distilled water. Heat the mixture in a boiling water bath for 20 min, then cool to room temperature and dilute to 1000 mL. Then, take 2.5 mL of the diluted mixture, add 1 mL of I2-KI aqueous solution, and measure the absorbance of the colorimetric solution at 620 nm using an ultraviolet spectrometer. Use a mixture of distilled water and I2-KI as a control. Allow the colorimetric solution to stand for 20 min to complete the color reaction. Calculate the CI according to formula (1).

[0050] Freeze-thaw stability: Accurately weigh 0.6 g of sample into a centrifuge tube of known weight. Add an appropriate amount of distilled water to make a 3% starch paste. Gelatinize in a boiling water bath at 100°C for 20 minutes, then cool to room temperature. Freeze in a -18°C refrigerator for 22 hours, thaw for 4 hours, and centrifuge at 10,000 rpm for 10 minutes. Discard the supernatant. Wherein, Vc is the dehydration rate, %; M1 is the weight of the centrifuge tube, g; M2 is the total weight of the centrifuge tube and the gelatinized sample, g; M3 is the total weight of the centrifuge tube and the sample after discarding the supernatant, g.

[0051] Encapsulation efficiency and loading rate: 2 mg of sample was completely dissolved in 100 mL of anhydrous ethanol by stirring, followed by centrifugation at 9000 g for 10 min. The photometric value at 425 nm was measured using an Agilent 8453 UV spectrophotometer. The free curcumin concentration was calculated based on the curcumin standard curve. Table 1 Composite index and freeze-thaw stability of ternary complexes Table 2 Encapsulation efficiency and loading rate of ternary complex sample Encapsulation efficiency Load factor Example 1 <![CDATA[0.567±0.02 e ]]> <![CDATA[0.033±0.04 e ]]> Example 2 <![CDATA[0.873±0.03 b ]]> <![CDATA[0.125±0.01 b ]]> Example 3 <![CDATA[0.892±0.04 a ]]> <![CDATA[0.156±0.01 a ]]> Example 4 <![CDATA[0.656±0.04 d ]]> <![CDATA[0.057±0.04 d ]]> Example 5 <![CDATA[0.817±0.02 c ]]> <![CDATA[0.083±0.04 c ]]> Comparative Example 1 <![CDATA[0.503±0.04 f ]]> <![CDATA[0.022±0.01 f ]]> Example 6 <![CDATA[0.863±0.03 d ]]> <![CDATA[0.077±0.02 d ]]> Example 7 <![CDATA[0.937±0.04 a ]]> <![CDATA[0.198±0.02 a ]]> Example 8 <![CDATA[0.906±0.02 c ]]> <![CDATA[0.166±0.02 c ]]> Example 9 <![CDATA[0.917±0.01 b ]]> <![CDATA[0.173±0.03 b ]]> Comparative Example 2 <![CDATA[0.834±0.02 e ]]> <![CDATA[0.066±0.02 e ]]>

[0052] Based on the above results, we can conclude that the high-amylose corn starch-palmitic acid-β-lactoglobulin obtained by this process has a good composite index and freeze-thaw stability. The desorption rate is used to represent the freeze-thaw stability of the sample; the lower the desorption rate, the higher the freeze-thaw stability. As shown in Table 1, the starch-fatty acid-protein composite index and freeze-thaw stability are highest when heated in a 90°C water bath for 40 minutes and the protein is β-lactoglobulin. This indicates that heat treatment can effectively promote the formation of starch-fatty acid-protein complexes and significantly improve the stability of the ternary complex, making it highly applicable in future production. The encapsulation efficiency of paclitaxel in high-amylose corn starch-palmitic acid-β-lactoglobulin can reach up to 94%, significantly improving its water dispersibility, photothermal stability, and sustained-release properties, making it suitable for medical applications and functional product development.

[0053] The basic principles, main features, and advantages of the present invention are shown and described above. Those skilled in the art should understand that the present invention is not limited to the foregoing embodiments. The foregoing embodiments and descriptions are merely illustrative of the principles of the present invention. Various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention. Such changes and modifications are intended to fall within the scope of the present invention. The scope of protection claimed in the present invention is defined by the appended claims and their equivalents.

Claims

1. A preparation of a starch-protein-palmitic acid ternary complex, comprising the following steps: Step S1: Starch, fatty acid, and protein are dissolved in deionized water or ethanol, respectively, stirred thoroughly, and then placed in a water bath at 50-60°C for continuous heating, and then placed in a water bath at 80-100°C for heating. The resulting ternary complex sample is cooled to room temperature, washed with ethanol, centrifuged, placed in a -18°C refrigerator, freeze-dried in a freeze dryer for 24 hours, crushed, and passed through a 100-mesh sieve.

2. The process for preparing the starch-protein-fatty acid complex according to claim 1, wherein: The ratio of starch, fatty acid and protein in step S1 is required to be 20:1:

2.

3. The process for preparing the starch-protein-fatty acid complex according to claim 1, wherein: It is required that in step S1, starch and protein are dissolved in distilled water heated to 50-60° C. respectively, and fatty acids are dissolved in ethanol and shaken until completely dissolved.

4. The process for preparing the starch-protein-fatty acid complex according to claim 1, wherein: The starch used is required to be corn starch, rice starch, tapioca starch, mung bean starch, or high-amylose corn starch; the protein used is required to be β-lactoglobulin, zein, type A gelatin, soy protein isolate, or gluten; and the fatty acid used is required to be palmitic acid.

5. The process for preparing the starch-protein-fatty acid complex according to claim 1, wherein: It is required to be placed in 50-60℃ water and heated for 1-20 minutes, and then directly placed in a 80-100℃ water bath and heated for 20-60 minutes to fully react. Stir continuously during this process, and it is required to ensure that the sample solution temperature reaches the corresponding temperature when placed in a 50-60℃ and 90℃ water bath before timing.

6. An application of a starch-protein-palmitic acid ternary complex, characterized in that: The starch-protein-palmitic acid ternary complex was used to encapsulate paclitaxel, thereby improving its stability.

7. The use of a starch-protein-palmitic acid ternary complex according to claim 6, characterized in that: The method of using starch-protein-palmitic acid ternary complex to embed Paclitaxel comprises the following steps: adding 0.5g of the ternary polymer to deionized water containing Tween 80 to gelatinize the water, then adding Paclitaxel to the ternary complex dispersion, homogenizing and freeze-drying.

8. The method according to claim 7, wherein 0.5 g of the terpolymer is added to 100 mL of deionized water containing 200-300 μL of Tween 80; the solution is heated to 70-90° C. for 20-40 minutes to gelatinize and ensure that the terpolymer is fully hydrated.

9. The method according to claim 7, wherein 10 mg of paclitaxel is added to 5 mL of anhydrous ethanol and thoroughly stirred at 20-50° C. to dissolve, and then added to the ternary complex dispersion; the mixture is homogenized at 20,000 rpm for 5-10 minutes until the alcohol evaporates, and then immediately frozen and vacuum-dried to obtain paclitaxel-ternary starch nanoparticles.

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