Lutein or its derivative particles for tablet preparation, preparation method and application thereof

Abstract

The present invention relates to the field of food and drug processing technology, and in particular to a lutein or its derivative particles for tablet preparations, and a preparation method and application thereof. The lutein or its derivative particles of the present invention are prepared from raw materials comprising the following components in parts by weight: 60-80 parts of lutein and / or lutein derivatives, 3-6 parts of antioxidants, and 20-30 parts of auxiliary materials; wherein the auxiliary materials include corn starch, maltodextrin, oligomeric isomaltosaccharides, microcrystalline cellulose, and magnesium stearate. The granular preparation can better protect lutein or its derivatives, has high stability, and thus significantly improves the storage stability of lutein or its derivatives in products prepared using the granular preparations as raw materials; moreover, compared with embedded preparations, the granular preparations have a significantly higher loading capacity. In addition, the granular preparation preparation process is simple and easy, the conditions are mild, and no high-temperature treatment is required, and it has good prospects for industrial application.

Description

Technical Field

[0001] The present invention relates to the technical field of food and medicine processing, and in particular to lutein or its derivative particles for tablet preparations, and a preparation method and application thereof. Background Art

[0002] Both lutein and lutein esters have the effects of protecting the eyes, improving vision, and enhancing immunity. In terms of eye protection, lutein and lutein esters can reduce the damage of blue light to the eyes, while also relieving eye fatigue, effectively preventing severe myopia, and alleviating cataracts; in addition, lutein and lutein esters can supplement the nutrients needed by the eyes and reduce the occurrence of lesions such as macular degeneration. Therefore, consuming lutein esters (limited to 12 mg / d) has a good protective effect on the eyes. However, lutein esters are very easy to oxidize when in contact with air or oxygen at room temperature and have poor stability. The existing technology mostly uses formulation technology to encapsulate lutein or lutein esters to improve its stability. Specifically, by separately preparing an oil phase containing lutein and lutein esters and an aqueous phase containing a water-soluble wall material, the oil phase and the aqueous phase are emulsified to obtain an emulsion, which is then spray-dried to obtain an encapsulated preparation containing a water-soluble wall material and a lutein ester core material. For example, prior art CN102389108A discloses lutein ester microcapsule powder and its preparation method. The raw materials for the preparation include lutein ester crystals, an oil-phase antioxidant, an oil-phase emulsifier, a vegetable oil, a wall material, an aqueous emulsifier, an aqueous antioxidant, and a filler. The preparation method includes the steps of separately preparing an oil-phase solution and an aqueous solution, emulsifying the two, and spray-drying them. However, the preparation of this lutein ester microcapsule powder requires the use of multiple emulsifiers, which limits its application in the food and pharmaceutical fields. The preparation process also requires spray drying, which consumes a lot of energy, and high-temperature heating is not conducive to the protection of lutein. In addition, the lutein ester loading of the above-mentioned embedded preparation is low. Summary of the Invention

[0003] The present invention provides lutein or its derivative particles for tablet preparation, and a preparation method and application thereof.

[0004] The present invention aims to develop a lutein or its derivative preparation with high loading and high stability, and has made a large number of attempts to the preparation of lutein, lutein derivatives (especially lutein esters) and their preparation methods. The present invention finds that even if the components such as the wall material, emulsifier, and filler are optimized using the embedding preparation technology commonly used in the prior art, it is difficult to obtain a high-load embedding preparation, and the preparation process requires high-temperature spray drying, which is more likely to cause the loss of lutein or its derivatives. During the research and development process, the present invention unexpectedly found that instead of using traditional embedding technology, lutein or its derivatives are prepared as granular preparations, and the excipients of a specific composition are used to encapsulate them and cooperate with the use of antioxidants. This can not only greatly reduce the proportion of excipients, effectively increase the content of lutein or its derivatives in the granular preparation, but also the obtained particles have higher storage stability and can be used as raw materials for the preparation of products containing lutein or its derivatives, which has a positive promoting effect on ensuring the content of lutein or its derivatives in the product and its storage stability.

[0005] It is worth noting that the purpose of preparing lutein or its derivatives as granular preparations in the present invention is to improve the stability of lutein or its derivatives (similar to the effect of microencapsulation), thereby making it more suitable as a raw material for preparing tablets and other products containing lutein or its derivatives.

[0006] Specifically, the present invention provides the following technical solutions:

[0007] The present invention provides a lutein or a derivative thereof particle, which is prepared from raw materials comprising the following components in parts by weight: 60-80 parts of lutein and / or a lutein derivative, 3-6 parts of an antioxidant, and 20-30 parts of an auxiliary material;

[0008] Wherein, the excipients include corn starch, maltodextrin, isomaltooligosaccharide, microcrystalline cellulose and magnesium stearate;

[0009] The lutein and lutein derivatives in the raw materials are not subjected to embedding treatment.

[0010] Prior art reports describe the use of encapsulated (e.g., microencapsulated) lutein or its derivatives in tablet formulations containing lutein or its derivatives. However, the lutein and / or lutein derivatives used in the lutein or its derivative granules of the present invention are unencapsulated raw materials. Mixing unencapsulated lutein and / or its derivatives with the aforementioned antioxidants and excipients to form a granular formulation not only significantly improves the stability of the lutein and / or its derivatives but also produces granular formulations with a high content of lutein and / or its derivatives. This approach eliminates the need for complex emulsifiers and does not rely on oil-water emulsification or spray drying techniques.

[0011] The excipients in the granular preparation of the present invention serve to encapsulate and protect the lutein or its derivatives, playing an important role in maintaining the stability of the lutein or its derivatives in the granular preparation. The present invention has discovered that using corn starch, maltodextrin, isomaltooligosaccharide, microcrystalline cellulose, and magnesium stearate as excipients can significantly improve the stability of the lutein or its derivatives in the granular preparation and the resulting product, thereby significantly increasing the retention rate of the lutein or its derivatives in the product after storage.

[0012] Among the aforementioned excipients, the mass ratio of corn starch, isomaltooligosaccharide, and microcrystalline cellulose is (0.5-2.5):(0.5-2):1. Controlling the mass ratio of corn starch, isomaltooligosaccharide, and microcrystalline cellulose within the aforementioned range can further improve the stability of lutein or its derivatives in the granular preparation and the resulting product.

[0013] Preferably, the excipients include the following components in parts by weight: 5-10 parts corn starch, 3-8 parts maltodextrin, 2-8 parts isomaltooligosaccharide, 4-10 parts microcrystalline cellulose, and 0.1-0.5 parts magnesium stearate. The excipients in this ratio can effectively encapsulate lutein or its derivatives during the wet granulation process, which is more conducive to ensuring the stability of the lutein or its derivatives in the granular preparation and the resulting product. Furthermore, the excipients can effectively ensure the properties of the granules produced by the wet granulation process (regular particles and uniform shape).

[0014] The corn starch described above is gelatinized.

[0015] Preferably, the gelatinization treatment comprises: mixing corn starch with water to obtain starch milk, heating the starch milk at 120-180°C for 50-70 minutes, and cooling to 60-90°C.

[0016] The concentration of the starch milk is preferably 5-15%.

[0017] The starch paste obtained after the cooling is the gelatinized corn starch.

[0018] The antioxidants mentioned above include phospholipids and one or more selected from ascorbic acid, ascorbate salts, fatty acid ascorbic acid esters, and vitamin E.

[0019] Antioxidants can help lutein or its derivatives resist oxidation. The present invention has found that adding phospholipids as antioxidants to the granule preparation prepared from the above excipient system is more conducive to reducing the oxidation of lutein or its derivatives and improving their stability.

[0020] In the present invention, the lutein derivative is one or more selected from lutein ester, 3-hydroxylutein, 3,3-dihydroxy-β-ionic lutein and 4-hydroxylutein.

[0021] In some embodiments of the present invention, the lutein derivative is a lutein ester. The lutein ester contains 75%-99% lutein dipalmitate and less than 4.2% zeaxanthin. Lutein ester samples can be assayed according to the T / CCCMHPIE 1.67-2021 standard for lutein esters in plant extracts.

[0022] Preferably, the antioxidant comprises phospholipid and ascorbic acid in a mass ratio of (0.5-2):1.

[0023] Preferably, the raw materials for preparing the granules further include water, or water and ethanol aqueous solution. The amount of water or ethanol aqueous solution used can be calculated according to the conventional amount required for preparing soft materials by gelatinization and wet granulation of corn starch.

[0024] The present invention provides a method for preparing the above-mentioned lutein or derivative particles, which comprises: preparing the lutein or derivative particles by wet granulation.

[0025] Prior art typically uses spray drying to prepare lutein or its derivatives-encapsulated formulations. When preparing lutein or its derivatives tablets, dry granulation followed by tablet compression is often employed. The present inventors have discovered that, for the granular raw material composition of the present invention, wet granulation is more conducive to compression molding. Furthermore, wet granulation does not involve high-temperature treatment, which is more conducive to reducing the loss of lutein or its derivatives during processing.

[0026] Preferably, the method comprises: mixing raw materials other than corn starch to obtain a mixed powder, mixing the gelatinized corn starch and the mixed powder with water or an ethanol aqueous solution to obtain a soft material, wet granulating the mixture to obtain wet granules, and drying the wet granules.

[0027] The granules prepared by wet granulation using the above method have regular particles and high preparation stability.

[0028] The raw materials other than corn starch include lutein or its derivatives, antioxidants, maltodextrin, isomaltooligosaccharide, microcrystalline cellulose and magnesium stearate.

[0029] The preparation method of the mixed powder comprises: grinding lutein or its derivatives, antioxidants, maltodextrin, isomaltooligosaccharide, microcrystalline cellulose and magnesium stearate, passing through a 40-mesh sieve and mixing to obtain the mixed powder.

[0030] The above-mentioned ethanol aqueous solution is preferably a 70-80% ethanol aqueous solution.

[0031] The amount of water or ethanol aqueous solution added is such that the mass ratio of the gelatinized corn starch and the mixed powder is (3-7):100.

[0032] The wet granules are preferably prepared by passing through a 20-mesh screen.

[0033] The drying condition is preferably 40-60°C. Preferably, the drying is performed until the moisture content is less than 5%. Drying methods such as airflow drying can be used.

[0034] The present invention provides the use of the above-mentioned lutein or derivative particles in the preparation of food or medicine.

[0035] Preferably, the food or medicine is a tablet. The granular preparation provided by the present invention is particularly suitable for use as a raw material for preparing tablets, and can well ensure the storage stability of lutein or its derivatives in tablet products, and the retention rate of lutein or its derivatives after storage is significantly improved.

[0036] In the prior art (e.g., CN114504104A, CN115251217A), lutein or its derivatives used to prepare tablets are usually provided in the form of encapsulated preparations (e.g., microcapsules). This is because directly compressing lutein or its derivatives into tablets has poor storage stability and makes it difficult to maintain its content during the shelf life.

[0037] When preparing tablets, the lutein or its derivative particles can be combined with tablet excipients to produce tablets through tableting (such as rotary tableting).

[0038] In some embodiments of the present invention, the food is a compressed candy. Practice has shown that the granular preparation of the present invention is particularly suitable as a raw material for preparing compressed candies. The compressed candies produced have excellent storage stability and a high retention rate of lutein or its derivatives during the shelf life.

[0039] The beneficial effects of the present invention are as follows: the lutein or its derivative particles provided by the present invention can effectively protect lutein or its derivatives, have high stability, and thus significantly improve the storage stability of lutein or its derivatives in products prepared using them as raw materials; moreover, compared with encapsulated preparations, the granular preparations have a significantly higher loading capacity, and can obtain granular preparations with high lutein or its derivative content (the content of lutein or its derivatives can reach 40% or more), which are convenient to use and can be used to prepare products such as food and medicine. In addition, the granular preparations do not require emulsification, encapsulation, or spray drying processes, and the preparation process is simple and easy to perform, with mild conditions and no need for high-temperature treatment, which is more conducive to reducing the loss of lutein or its derivatives during processing and reducing energy consumption. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] In order to more clearly illustrate the technical solutions in the present invention or the prior art, a brief introduction is given below to the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0041] Figure 1 The results are a comparison of the stability test results of the lutein ester granular compressed candy of Example 1 and the lutein ester compressed candy of the control group in the experimental examples of the present invention. DETAILED DESCRIPTION

[0042] To make the objectives, technical solutions, and advantages of the present invention more clear, the technical solutions of the present invention are described clearly and completely below. Obviously, the embodiments described are only some of the embodiments of the present invention, not all of them. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0043] The lutein esters used as raw materials in the following examples can be obtained by extracting lutein esters through conventional lutein ester extraction methods in the art, or purchased through commercial channels. The lutein esters are raw materials that have not been processed by any embedding technology.

[0044] Example 1

[0045] This embodiment provides a lutein ester granule, which is prepared from raw materials comprising the following components: 70 parts of lutein ester, 3 parts of phospholipids, 2 parts of vitamin C, 5 parts of corn starch, 3 parts of maltodextrin, 8 parts of isomaltooligosaccharide, 6 parts of microcrystalline cellulose, and 0.2 parts of magnesium stearate.

[0046] This embodiment also provides a method for preparing the lutein ester particles, comprising the following steps:

[0047] Corn starch is dispersed in distilled water to prepare a 5% starch emulsion, which is heated in an oil bath at 160°C for 60 minutes and then cooled to 80°C to obtain a starch paste; lutein ester, phospholipids, vitamin C, maltodextrin, oligoisomaltose, microcrystalline cellulose, and magnesium stearate are sieved through a 40-mesh sieve and then uniformly mixed to obtain a mixed powder; the starch paste is added to the mixed powder and 5% distilled water is added to prepare a soft material, which is then sieved through a 20-mesh sieve to obtain wet granules, which are then air-dried to obtain dry granules; the dry granules are packaged in bags to obtain finished lutein ester granules.

[0048] According to the test, the content of the effective component lutein ester in the lutein ester granules prepared above is 60.5%.

[0049] Example 2

[0050] This embodiment provides a lutein ester granule, which is prepared from raw materials comprising the following components: 72 parts of lutein ester, 3 parts of phospholipids, 2 parts of vitamin C, 7.5 parts of corn starch, 5 parts of maltodextrin, 5 parts of isomaltooligosaccharide, 6 parts of microcrystalline cellulose, and 0.2 parts of magnesium stearate.

[0051] This embodiment also provides a method for preparing the lutein ester particles, comprising the following steps:

[0052] Corn starch is dispersed in distilled water to prepare a 15% starch emulsion, which is steamed at 180°C for 60 minutes using high-pressure steam from a jet liquefier, and then cooled to 90°C to obtain a starch paste; lutein ester, phospholipids, vitamin C, maltodextrin, oligoisomaltose, microcrystalline cellulose, and magnesium stearate are sieved through a 40-mesh sieve and then uniformly mixed to obtain a mixed powder; the starch paste is added to the mixed powder and 5% distilled water is added to prepare a soft material, which is then sieved through a 20-mesh sieve for granulation to obtain wet granules, which are then air-dried to obtain dry granules; and the dry granules are packaged in bags to obtain finished lutein ester granules.

[0053] According to the test, the content of the effective component lutein ester in the lutein ester granules prepared above is 62.1%.

[0054] Example 3

[0055] This embodiment provides a lutein ester granule, which is prepared from raw materials comprising the following components: 76 parts of lutein ester, 3 parts of phospholipids, 3 parts of vitamin C, 10 parts of corn starch, 5 parts of maltodextrin, 2 parts of isomaltooligosaccharide, 4 parts of microcrystalline cellulose, and 0.1 part of magnesium stearate.

[0056] This embodiment also provides a method for preparing the lutein ester particles, comprising the following steps:

[0057] Corn starch is dispersed in distilled water to prepare a 5% starch emulsion, which is heated in an oil bath at 120°C for 60 minutes and then cooled to 60°C to obtain a starch paste; lutein ester, phospholipids, vitamin C, maltodextrin, oligoisomaltose, microcrystalline cellulose, and magnesium stearate are sieved through a 40-mesh sieve and then uniformly mixed to obtain a mixed powder; the starch paste is added to the mixed powder and 5% distilled water is added to prepare a soft material, which is then sieved through a 20-mesh sieve to obtain wet granules, which are then air-dried to obtain dry granules; the dry granules are packaged in bags to obtain finished lutein ester granules.

[0058] According to the test, the content of the effective component lutein ester in the lutein ester granules prepared above is 61.3%.

[0059] Example 4

[0060] This embodiment provides a lutein ester granule, which is prepared from raw materials comprising the following components: 70 parts of lutein ester, 2 parts of phospholipids, 3 parts of vitamin C, 5 parts of corn starch, 3 parts of maltodextrin, 5 parts of isomaltooligosaccharide, 10 parts of microcrystalline cellulose, and 0.3 parts of magnesium stearate.

[0061] This embodiment also provides a method for preparing the lutein ester particles, comprising the following steps:

[0062] Corn starch is dispersed in distilled water to prepare a 10% starch milk, which is steamed at 160°C for 60 minutes using high-pressure steam from a jet liquefier, and then cooled to 70°C to obtain a starch paste; lutein ester, phospholipids, vitamin C, maltodextrin, oligoisomaltose, microcrystalline cellulose, and magnesium stearate are sieved through a 40-mesh sieve and then uniformly mixed to obtain a mixed powder; the starch paste is added to the mixed powder and 5% distilled water is added to prepare a soft material, which is then sieved through a 20-mesh sieve for granulation to obtain wet granules, which are then air-dried to obtain dry granules; and the dry granules are packaged in bags to obtain finished lutein ester granules.

[0063] According to the test, the content of the effective component lutein ester in the lutein ester granules prepared above is 61.1%.

[0064] Example 5

[0065] This embodiment provides a lutein ester granule, which is prepared from raw materials comprising the following components: 71 parts of lutein ester, 3 parts of phospholipids, 2 parts of vitamin C, 5 parts of corn starch, 8 parts of maltodextrin, 6 parts of isomaltooligosaccharide, 6 parts of microcrystalline cellulose, and 0.2 parts of magnesium stearate.

[0066] This embodiment also provides a method for preparing the lutein ester particles, comprising the following steps:

[0067] Corn starch is dispersed in distilled water to prepare a 5% starch emulsion, which is heated in an oil bath at 150°C for 60 minutes and then cooled to 90°C to obtain a starch paste; lutein ester, phospholipids, vitamin C, maltodextrin, oligoisomaltose, microcrystalline cellulose, and magnesium stearate are sieved through a 40-mesh sieve and then uniformly mixed to obtain a mixed powder; the starch paste is added to the mixed powder and 5% distilled water is added to prepare a soft material, which is then sieved through a 20-mesh sieve to obtain wet granules, which are then air-dried to obtain dry granules; the dry granules are packaged in bags to obtain finished lutein ester granules.

[0068] According to the test, the content of the effective component lutein ester in the lutein ester granules prepared above is 61.6%.

[0069] Comparative Example 1

[0070] This comparative example provides a lutein ester granule, the raw material composition of which is different from that of Example 1 except that corn starch is replaced with an equal amount of tapioca starch.

[0071] The only difference between the preparation method of the lutein ester granules and the method of Example 1 is that the corn starch is replaced by tapioca starch.

[0072] The results showed that during the wet granulation process of the above-mentioned granular preparation, the viscosity of the materials after mixing was relatively high, which easily blocked the screen and resulted in irregular granules.

[0073] According to the test, the content of the effective component lutein ester in the lutein ester granules prepared above is 63.1%.

[0074] Comparative Example 2

[0075] This comparative example provides a lutein ester granule, the raw material composition of which is different from that of Example 1, except that the corn starch is replaced by an equal amount of potato starch.

[0076] The only difference between the preparation method of the lutein ester granules and the method of Example 1 is that the corn starch is replaced by potato starch.

[0077] The results showed that during the wet granulation process of the above-mentioned granular preparation, the starch gelatinization effect was poor, the material granulation effect was poor, and there were more powdery particles.

[0078] According to the test, the content of the effective component lutein ester in the lutein ester granules prepared above is 62.2%.

[0079] Comparative Example 3

[0080] This comparative example provides a lutein ester granule. The raw material composition thereof is different from that of Example 1 only in that phospholipids are removed and the amount of vitamin C is increased to 5 parts.

[0081] The difference between the preparation method of the lutein ester particles and the method of Example 1 is only the difference in the raw materials.

[0082] According to the test, the content of the effective component lutein ester in the lutein ester granules prepared above is 60.0%.

[0083] Comparative Example 4

[0084] This comparative example provides a lutein ester granule. The raw material composition of the lutein ester granule is different from that of Example 1 in that maltodextrin and isomaltooligosaccharide are removed, and the amount of corn starch is increased to 15 parts.

[0085] The difference between the preparation method of the lutein ester particles and the method of Example 1 is only the difference in the raw materials.

[0086] According to the test, the content of the effective component lutein ester in the lutein ester granules prepared above is 61.3%.

[0087] Comparative Example 5

[0088] This comparative example provides a lutein ester granule. The raw material composition thereof is different from that of Example 1 only in that isomaltooligosaccharide and microcrystalline cellulose are removed, and the amount of maltodextrin is increased to 17 parts.

[0089] The difference between the preparation method of the lutein ester particles and the method of Example 1 is only the difference in the raw materials.

[0090] According to the test, the content of the effective component lutein ester in the lutein ester granules prepared above is 61.4%.

[0091] Comparative Example 6

[0092] This comparative example provides a lutein ester granule. The raw material composition thereof is different from that of Example 1 only in that maltodextrin and isomaltooligosaccharide are removed, and the amount of microcrystalline cellulose is increased to 17 parts.

[0093] The difference between the preparation method of the lutein ester particles and the method of Example 1 is only the difference in the raw materials.

[0094] According to the test, the content of the effective component lutein ester in the lutein ester granules prepared above is 61.1%.

[0095] Comparative Example 7

[0096] This comparative example provides a lutein ester granule. The raw material composition of the lutein ester granule is different from that of Example 1 in that corn starch is removed and the amount of maltodextrin is increased to 8 parts.

[0097] The difference between the preparation method of the lutein ester particles and the method of Example 1 is only the difference in the raw materials.

[0098] According to the test, the content of the effective component lutein ester in the lutein ester granules prepared above is 61.7%.

[0099] Experimental Example Storage Stability Test of Products Prepared from Lutein Ester Granules

[0100] The lutein ester granules of the above-mentioned examples and comparative examples were respectively mixed with the same tablet excipients (sorbitol accounting for 98.5%, magnesium stearate accounting for 1%, and 0.5% lutein ester granules) and rotary tabletted to prepare tablet candies.

[0101] The resulting compressed candies were subjected to stability testing at 40°C and 75% humidity (constant temperature and humidity, using the accelerated stability evaluation method specified in the Chinese Pharmacopoeia). A UV spectrophotometer was used to measure the total lutein ester content before and after storage, and the retention rate was calculated. The retention rate is the ratio of the lutein ester content in the product at different testing times to its initial content. The results are shown in Table 1. A compressed candy (lutein ester compressed candy) prepared by rotary tableting using lutein esters directly (not prepared as granules) with the same tablet excipients as described above was used as a control.

[0102] Take the lutein ester granules of Example 1 as an example to prepare the compressed candy. Figure 1 As shown in the figure, with the increase of storage time, the retention rates of lutein ester compressed candy and lutein ester granule compressed candy both decreased, but the retention rate of lutein ester compressed candy decreased significantly more. After 6 months of storage stability test, the retention rate of lutein ester compressed candy was only 21.4%, while the retention rate of lutein ester granule compressed candy could still reach 71.5%, indicating that the granule preparation technology of the present invention has a good protective effect on lutein ester.

[0103] Table 1 Storage stability of lutein ester / lutein ester granular tablet candy

[0104]

[0105]

[0106] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A lutein or lutein derivative particle, characterized in that: It is prepared from raw materials comprising the following components in parts by weight: 60-80 parts of lutein and / or lutein derivatives, 3-6 parts of antioxidants, and 20-30 parts of auxiliary materials; The auxiliary materials include the following components in parts by weight: 5-10 parts of corn starch, 3-8 parts of maltodextrin, 2-8 parts of isomaltooligosaccharide, 4-10 parts of microcrystalline cellulose, and 0.1-0.5 parts of magnesium stearate; the corn starch is gelatinized; The antioxidant comprises phospholipids and ascorbic acid in a mass ratio of (0.5-2):1; The lutein and lutein derivatives in the raw materials have not been subjected to embedding treatment; The lutein or its derivative particles are prepared by wet granulation; The wet granulation comprises: mixing raw materials except corn starch to obtain mixed powder, mixing the gelatinized corn starch and the mixed powder with water or ethanol aqueous solution to obtain a soft material, wet granulating the mixture to obtain wet granules, and drying the wet granules.

2. The lutein or its derivative particles according to claim 1, characterized in that The gelatinization treatment comprises: mixing corn starch with water to obtain starch milk, heating the starch milk at 120-180° C. for 50-70 minutes, and cooling to 60-90° C.

3. The lutein or its derivative particles according to any one of claims 1 to 2, characterized in that The lutein derivative is one or more selected from lutein ester, 3-hydroxylutein, 3,3-dihydroxy-β-ionic lutein, and 4-hydroxylutein.

4. The method for preparing lutein or its derivative particles according to any one of claims 1 to 3, characterized in that: The method comprises: preparing lutein or its derivative particles by wet granulation.

5. The method for preparing lutein or its derivative particles according to claim 4, characterized in that: The method comprises: mixing raw materials except corn starch to obtain mixed powder, mixing the gelatinized corn starch, the mixed powder and water or ethanol aqueous solution to obtain a soft material, wet granulating to obtain wet granules, and drying the wet granules.

6. Use of the lutein or derivative particles according to any one of claims 1 to 3 in the preparation of food or medicine.

7. The use according to claim 6, characterized in that The food or medicine is a tablet.

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