Tablets containing egg yolk phospholipids, process for their preparation and use

Abstract

The present application provides a tablet containing egg yolk phospholipid and a preparation method thereof. The preparation raw material of the tablet containing egg yolk phospholipid comprises egg yolk phospholipid, filler and lubricant in a mass ratio of (300-600):(399-699):1. The egg yolk phospholipid is prepared by the following steps: preparing the egg yolk phospholipid by supercritical CO2 extraction and secondary separation of egg yolk powder. The egg yolk phospholipid prepared by the supercritical CO2 extraction and secondary separation method makes the egg yolk phospholipid more suitable for tabletting, without using other excipients as diluents or preventing the egg yolk phospholipid from sticking together, leading to a long disintegration time. And the egg yolk phospholipid contains more than 30% of phospholipid, greatly reducing the dosage compared with similar products.

Description

Technical Field

[0001] This invention relates to the field of food processing technology, and more particularly to the preparation and application of egg yolk phospholipids suitable for tableting. Background Technology

[0002] Lecithin is known as the "third nutrient" alongside protein and vitamins. Its recognized physiological functions include regulating lipid metabolism, lowering serum cholesterol, preventing cardiovascular and cerebrovascular diseases, promoting nerve conduction to improve brain memory, and enhancing the body's immunity. Egg yolk lecithin can alleviate blood clotting and clarify blood lipids, and it can replace saturated fatty acids in arterial cell membranes with unsaturated fatty acids, thus preventing arteriosclerosis and repairing damaged cell membranes. This helps prevent arteriosclerosis, myocardial infarction, and cerebral hemorrhage.

[0003] Choline in PC can increase choline levels in the blood and brain. Choline is a precursor to the neurotransmitter acetylcholine, which can improve memory and learning abilities. Choline in PC is also an essential nutrient for maintaining normal liver function. A choline deficiency of 1-2 weeks can lead to abnormal liver function; PC supplementation can restore normal function and improve alcoholic liver disease. The alveoli contain lung surfactant composed of phospholipids and proteins, with PC making up 70%. PC is a physiologically active substance that ensures lung gas exchange; a deficiency can cause alveolar collapse, resulting in loss of expansion and contraction. Sufficient PC is an effective substance for improving lung function and enhancing tolerance to hypoxia. The US FDA mandates the addition of egg yolk lecithin to infant formula. Infancy is the most critical period for brain development, and lecithin can promote the development and growth of brain nerves.

[0004] Because of its emulsifying properties, phospholipids are prone to disintegration or have a long disintegration time when prepared into tablets. Therefore, most phospholipid dosage forms are currently soft capsules.

[0005] CN 106974894A discloses an egg yolk lecithin tablet and its preparation method. This method involves first granulating and drying egg yolk lecithin and a filler, then separately granulating and drying a disintegrant. The dried granules from both parts are then mixed, compressed into tablets, and coated to obtain egg yolk lecithin tablets with moderate hardness and good disintegration. However, the egg yolk lecithin content in this method is low; the proportion of egg yolk lecithin in the formulation does not exceed 22%, and the lecithin content in the finished product does not exceed 2.55%. This results in a low lecithin content and a large dosage. Currently, due to the difficulty in tablet forming, high-content lecithin tablets are mainly produced with low content.

[0006] Therefore, there are still problems such as low lecithin content in egg yolk tablets, difficulty in tablet formation, long disintegration time, reduced excipient usage, and dosage.

[0007] In view of this, the present invention is hereby proposed. Summary of the Invention

[0008] One of the objectives of this invention is to provide a tablet containing egg yolk phospholipids. This invention provides a tablet containing egg yolk phospholipids to solve the problems of low content, large dosage, long disintegration time, and poor taste in current egg yolk phospholipid tablets.

[0009] The second objective of this invention is to provide a method for preparing the aforementioned egg yolk phospholipid-containing tablets.

[0010] A third objective of this invention is the application of the aforementioned egg yolk phospholipid-containing tablet in the preparation of brain-boosting chewable tablets. The tablets are also suitable for chewing by adolescents and can be used as a daily health supplement for brain development in teenagers.

[0011] In order to achieve the above-mentioned objectives of the present invention, the following technical solution is adopted:

[0012] In a first aspect, the present invention provides a tablet containing egg yolk phospholipids, wherein the raw materials for preparing the tablet containing egg yolk phospholipids include egg yolk phospholipids, fillers, and lubricants in a mass ratio of (300-600):(399-699):1.

[0013] Among them, "300~600" can be, for example, 300, 350, 400, 450, 500, 550, 600, etc.; and "399~699" can be, for example, 399, 400, 450, 500, 550, 600, 650, 699, etc.

[0014] The tablets containing egg yolk phospholipids described in this invention have a non-loose core, moderate hardness, and good disintegration, meeting the requirements for tablets in the pharmacopoeia. Moreover, the egg yolk phospholipid tablets have a sweet taste, making them suitable for chewing by teenagers and other groups.

[0015] Preferably, the egg yolk phospholipids comprise the following components by weight percentage:

[0016] Phospholipids 30-40%, protein 50-60%, triglycerides 5-10%.

[0017] Based on the total mass content of the egg yolk phospholipids being 100%, the phospholipid content is 30-40%, for example, it can be 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, etc.

[0018] Based on the total mass content of egg yolk phospholipids being 100%, the protein content is 50-60%, for example, it can be 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, etc.

[0019] Based on the total mass content of the egg yolk phospholipids being 100%, the triglyceride content is 5% to 10%, for example, it can be 5%, 6%, 7%, 8%, 9%, 10%, etc.

[0020] The egg yolk phospholipids prepared by the present invention through supercritical CO2 extraction and secondary separation contain more than 50% protein, making them easier to compress into tablets without the need for other excipients as diluents or to prevent the phospholipids from sticking together and causing prolonged disintegration time. Furthermore, containing more than 30% phospholipids, this significantly reduces the dosage compared to similar products.

[0021] Preferably, the egg yolk phospholipids are prepared by the following steps:

[0022] The egg yolk phospholipids were prepared by supercritical CO2 extraction and secondary separation of egg yolk powder.

[0023] Preferably, the pressure of the supercritical CO2 extraction is 30-40 MPa, for example, 30 MPa, 32 MPa, 34 MPa, 36 MPa, 38 MPa, 40 MPa, etc., and the temperature is 40-50℃, for example, 40℃, 42℃, 44℃, 46℃, 48℃, 50℃, etc.

[0024] Preferably, in the secondary separation: the pressure of the primary separation vessel is 8-12 MPa, for example, 8 MPa, 9 MPa, 10 MPa, 11 MPa, 12 MPa, etc., and the temperature is 40-50℃; the pressure of the secondary separation vessel is 4-7 MPa, for example, 4 MPa, 4.5 MPa, 5 MPa, 5.5 MPa, 6 MPa, 6.5 MPa, 7 MPa, etc., and the temperature is 30-45℃, for example, 30℃, 32℃, 34℃, 36℃, 38℃, 40℃, 42℃, 45℃, etc.

[0025] Preferably, the extraction time is 2 to 5 hours, for example, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, etc.

[0026] Preferably, the filler is selected from any one or a combination of at least two of sodium carboxymethyl starch, maltodextrin, microcrystalline cellulose, or sorbitol.

[0027] Preferably, the filler is composed of maltodextrin and sorbitol.

[0028] Preferably, the mass ratio of maltodextrin to sorbitol is (0.9-1.1):(3.9-5.9).

[0029] Among them, "0.9~1.1" can be, for example, 0.9, 0.95, 1.0, 1.05, 1.1, etc.;

[0030] Among them, "3.9~5.9" can be, for example, 3.9, 4.0, 4.5, 5.0, 5.5, 5.9, etc.

[0031] Preferably, the lubricant is selected from magnesium stearate and / or silicon dioxide.

[0032] Preferably, the raw materials for preparing the egg yolk phospholipid-containing tablets also include a binder.

[0033] Preferably, the adhesive is hydroxypropyl cellulose.

[0034] Preferably, the amount of adhesive added is 0.25% to 0.75%, for example, it can be 0.25%, 0.35%, 0.45%, 0.55%, 0.65%, 0.75%, etc.

[0035] Secondly, the present invention provides a method for preparing tablets containing egg yolk phospholipids as described in the first aspect, wherein the preparation method employs wet granulation and tableting, and the wet granulation and tableting specifically includes the following steps:

[0036] Egg yolk phospholipids and fillers are mixed to obtain the first mixture;

[0037] The adhesive solution and the first mixture are mixed to obtain the second mixture;

[0038] The second mixture is subjected to wet granulation to obtain mixture particles;

[0039] After drying the particles of the mixture, it is then mixed with a lubricant to obtain a third mixture;

[0040] The third mixture is compressed into tablets to prepare the tablets containing egg yolk phospholipids.

[0041] Preferably, the mixing speed of the egg yolk phospholipid and the filler is 10-20 r / min, for example, 10 r / min, 12 r / min, 14 r / min, 16 r / min, 18 r / min, 20 r / min, etc., and the mixing time is 3-10 min, for example, 3 min, 4 min, 5 min, 6 min, 7 min, 8 min, 9 min, 10 min, etc.

[0042] Preferably, the total mass of the adhesive solution is 100%, and the content of the adhesive is 1-10%, for example, it can be 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, etc.

[0043] Preferably, the total mass of the second mixture is 100%, and the content of the adhesive solution is 5% to 15%, for example, it can be 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, etc.

[0044] Preferably, in the wet granulation process, the stirring speed is 400-500 r / min, for example, 400 r / min, 420 r / min, 440 r / min, 460 r / min, 480 r / min, 500 r / min, etc.; the chopping speed is 2000-3000 r / min, for example, 2000 r / min, 2200 r / min, 2400 r / min, 2600 r / min, 2800 r / min, 3000 r / min, etc.; and the time is 1-5 min, for example, 1 min, 1.5 min, 2 min, 2.5 min, 3 min, 3.5 min, 4 min, 4.5 min, 5 min, etc.

[0045] Preferably, the moisture content of the dried mixture particles is <5%, for example, it can be 4.9%, 4.5%, 4%, 3.5%, 3%, 2.5%, 2%, 1.5%, 1%, 0.5%, 0.1%, etc.

[0046] Preferably, the rotation speed for mixing the dried mixture particles and the lubricant is 10-20 r / min, for example, 10 r / min, 12 r / min, 14 r / min, 16 r / min, 18 r / min, 20 r / min, etc., and the mixing time is 10-15 min, for example, 10 min, 11 min, 12 min, 13 min, 14 min, 15 min, etc.

[0047] Preferably, in the wet granulation and tableting process, the tableting pressure is 13-35 kN, for example, it can be 13 kN, 15 kN, 20 kN, 25 kN, 30 kN, 35 kN, etc.

[0048] Thirdly, the present invention provides the application of the egg yolk phospholipid-containing tablet as described in the first aspect in the preparation of brain-boosting chewable tablets.

[0049] Compared with the prior art, the present invention has the following beneficial effects:

[0050] (1) The egg yolk phospholipids prepared by the present invention through supercritical CO2 extraction and two-stage separation contain more than 50% protein, making the egg yolk phospholipids easier to compress into tablets without the need for other excipients as diluents or to prevent the egg yolk phospholipids from sticking together, which would lead to a long disintegration time. In addition, it contains more than 30% phospholipids, which greatly reduces the dosage compared with similar products.

[0051] (2) The method of the present invention mixes supercritical egg yolk phospholipids with excipients, so that the egg yolk phospholipids are uniformly dispersed in the filler, without the need to use disintegrants, thus reducing the types and amounts of excipients used.

[0052] (3) The tablet core of the egg yolk phospholipid tablets of the present invention is not loose and has moderate hardness. At the same time, it has good disintegration and meets the requirements of the pharmacopoeia for tablets. Moreover, the egg yolk phospholipid tablets have a sweet taste and are suitable for chewing by teenagers and other people. Detailed Implementation

[0053] Unless otherwise defined herein, the scientific and technical terms used in conjunction with this invention shall have the meanings commonly understood by one of ordinary skill in the art. The meaning and scope of terms shall be clear; however, in any case of potential ambiguity, the definitions provided herein shall prevail over any dictionary or foreign definitions. In this application, unless otherwise stated, the use of "or" means "and / or". Furthermore, the use of the term "comprising" and other forms is non-limiting.

[0054] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0055] The present invention will be further illustrated below by way of examples. Unless otherwise specified, the materials in the examples are prepared according to existing methods or purchased directly from the market.

[0056] Preparation Example 1

[0057] This preparation example provides an egg yolk phospholipid, which is prepared by the following method:

[0058] Egg yolk powder particles were placed in a supercritical CO2 extraction vessel and subjected to supercritical CO2 extraction and two-stage separation.

[0059] The extraction vessel was operated at a pressure of 35 MPa and a temperature of 45°C; the primary separation vessel was operated at a pressure of 10 MPa and a temperature of 45°C; the secondary separation vessel was operated at a pressure of 6 MPa and a temperature of 32°C; and the egg yolk phospholipids were obtained after an extraction time of 4 hours.

[0060] Preparation Example 2

[0061] This preparation example provides an egg yolk phospholipid, which is prepared by the following method:

[0062] Egg yolk powder particles were placed in a supercritical CO2 extraction vessel and subjected to supercritical CO2 extraction and two-stage separation.

[0063] The extraction vessel was operated at a pressure of 30 MPa and a temperature of 50°C; the primary separation vessel at a pressure of 8 MPa and a temperature of 50°C; and the secondary separation vessel at a pressure of 4 MPa and a temperature of 40°C. After an extraction time of 5 hours, the egg yolk phospholipids were obtained.

[0064] Preparation Example 3

[0065] This preparation example provides an egg yolk phospholipid, which is prepared by the following method:

[0066] Egg yolk powder particles were placed in a supercritical CO2 extraction vessel and subjected to supercritical CO2 extraction and two-stage separation.

[0067] The extraction vessel was operated at a pressure of 40 MPa and a temperature of 40°C; the primary separation vessel was operated at a pressure of 12 MPa and a temperature of 40°C; the secondary separation vessel was operated at a pressure of 7 MPa and a temperature of 30°C; and the egg yolk phospholipids were obtained after an extraction time of 2 hours.

[0068] Preparation Example 4

[0069] This preparation example provides an egg yolk phospholipid, which is prepared by the following method:

[0070] Egg yolk powder particles were placed in a supercritical CO2 extraction vessel and subjected to supercritical CO2 extraction and two-stage separation.

[0071] The extraction vessel was operated at a pressure of 25 MPa and a temperature of 50°C; the primary separation vessel at a pressure of 8 MPa and a temperature of 50°C; and the secondary separation vessel at a pressure of 5 MPa and a temperature of 40°C. After an extraction time of 4 hours, the egg yolk phospholipids were obtained.

[0072] Preparation Example 5

[0073] This preparation example provides an egg yolk phospholipid, which is prepared by the following method:

[0074] Egg yolk powder particles were placed in a supercritical CO2 extraction vessel and subjected to supercritical CO2 extraction and two-stage separation.

[0075] The extraction vessel was operated at a pressure of 45 MPa and a temperature of 40°C; the primary separation vessel was operated at a pressure of 10 MPa and a temperature of 40°C; the secondary separation vessel was operated at a pressure of 7 MPa and a temperature of 35°C; and the egg yolk phospholipids were obtained after an extraction time of 4 hours.

[0076] Test Example 1

[0077] The content of active ingredients in egg yolk phospholipids has been determined.

[0078] Test samples: Egg yolk phospholipids prepared in Examples 1-5;

[0079] Test methods: Phospholipid determination refers to GB5009.272 National Food Safety Standard for the Determination of Phosphatidylcholine, Phosphatidylethanolamine and Phosphatidylinositol in Food; Protein determination refers to GB 5009.5-2016; Triglyceride determination uses acetone extraction method.

[0080] The specific test results are shown in Table 1:

[0081] Table 1

[0082] sample Phospholipid content (%) Protein content (%) Triglyceride content (%) Preparation Example 1 35 55 8 Preparation Example 2 36 54 8 Preparation Example 3 32 58 6 Preparation Example 4 25 55 15 Preparation Example 5 26 65 2

[0083] As shown in Table 1, under the preferred supercritical CO2 extraction and secondary separation process parameters of this invention, the prepared egg yolk phospholipids include the following components by mass percentage: phospholipids 30-40%, protein 50-60%, and triglycerides 5-10%. Under this ratio, the egg yolk phospholipids are easier to compress into tablets, and the high phospholipid content greatly reduces the dosage compared to similar products.

[0084] Example 1

[0085] This embodiment provides a tablet containing egg yolk phospholipids, the raw materials for preparing the egg yolk phospholipid-containing tablet include the following components:

[0086] Preparation Example 1: 60g egg yolk phospholipids, 20g maltodextrin, 118g sorbitol, and 2g magnesium stearate.

[0087] The tablets containing egg yolk phospholipids are prepared by the following method:

[0088] S1. Weighing: Weigh the raw and auxiliary materials according to the above prescription and set aside;

[0089] S2. Grinding and sieving: Grind the egg yolk lecithin through an 80-mesh sieve and sorbitol through a 40-mesh sieve;

[0090] S3. First, mix the sieved egg yolk lecithin with maltodextrin at 15 r / min for 1 min, then add sorbitol and mix at 15 r / min for 2 min, then add magnesium stearate and mix at 15 r / min for 10 min. Compress the mixture into tablets at a pressure of 20 kN, with a tablet weight of 0.5 g / tablet. During the tableting process, it was found that the powder flowability was poor.

[0091] Example 2

[0092] This embodiment provides a tablet containing egg yolk phospholipids, the raw materials for preparing the egg yolk phospholipid-containing tablet include the following components:

[0093] Preparation Example 1: 60g egg yolk phospholipids, 36g maltodextrin, 102g sorbitol, and 2g magnesium stearate.

[0094] The tablets containing egg yolk phospholipids are prepared by the following method:

[0095] S1. Weighing: Weigh the raw and auxiliary materials according to the above prescription and set aside;

[0096] S2. Grinding and sieving: Grind the egg yolk lecithin through an 80-mesh sieve and sorbitol through a 40-mesh sieve;

[0097] S3. First, mix the sieved egg yolk lecithin with maltodextrin at 15 r / min for 1 min, then add sorbitol and mix at 15 r / min for 2 min, then add magnesium stearate and mix at 15 r / min for 10 min. Compress the mixture into tablets at a pressure of 20 kN, with a tablet weight of 0.5 g / tablet. During the tableting process, it was found that the powder flowability was poor.

[0098] Example 3

[0099] This embodiment provides a tablet containing egg yolk phospholipids, the raw materials for preparing the egg yolk phospholipid-containing tablet include the following components:

[0100] Preparation Example 1: 60g egg yolk phospholipids, 34g maltodextrin, 102g sorbitol, 2g silicon dioxide, and 2g magnesium stearate.

[0101] The tablets containing egg yolk phospholipids are prepared by the following method:

[0102] S1. Weighing: Weigh the raw and auxiliary materials according to the above prescription and set aside;

[0103] S2. Grinding and sieving: Grind the egg yolk lecithin through an 80-mesh sieve and sorbitol through a 40-mesh sieve;

[0104] S3. First, mix the sieved egg yolk lecithin with maltodextrin at 15 r / min for 1 min, then add sorbitol and mix at 15 r / min for 2 min, then add silicon dioxide and magnesium stearate and mix at 15 r / min for 10 min. Compress the mixture into tablets at a pressure of 20 kN, with a tablet weight of 0.5 g / tablet. During the tableting process, it was found that the powder flowability was poor.

[0105] Example 4

[0106] This embodiment provides a tablet containing egg yolk phospholipids, the raw materials for preparing the egg yolk phospholipid-containing tablet include the following components:

[0107] Preparation Example 1: 60g egg yolk phospholipids, 12g sodium carboxymethyl starch, 102g sorbitol, 24g maltodextrin, 2g silicon dioxide, and 2g magnesium stearate.

[0108] The tablets containing egg yolk phospholipids are prepared by the following method:

[0109] S1. Weighing: Weigh the raw and auxiliary materials according to the above prescription and set aside;

[0110] S2. Grinding and sieving: Grind the egg yolk lecithin through an 80-mesh sieve and sorbitol through a 40-mesh sieve;

[0111] S3. First, mix the sieved egg yolk phospholipids with sodium carboxymethyl starch at 15 r / min for 1 min. Then, add sorbitol and mix at 15 r / min for 2 min. Add maltodextrin and mix at 15 r / min for 2 min. Add silica and magnesium stearate and mix at 15 r / min for 10 min. Compress the mixture at a pressure of 20 kN to form tablets with a weight of 0.5 g / tablet. During the tableting process, it was found that the powder flowability was poor.

[0112] Example 5

[0113] This embodiment provides a tablet containing egg yolk phospholipids, the raw materials for preparing the egg yolk phospholipid-containing tablet include the following components:

[0114] Preparation Example 1: 60g egg yolk phospholipids, 20g maltodextrin, 118g sorbitol, 5% hydroxypropyl methylcellulose, and 2g magnesium stearate.

[0115] The tablets containing egg yolk phospholipids are prepared by the following method:

[0116] S1. Weighing: Weigh the raw and auxiliary materials according to the above prescription and set aside;

[0117] S2. Grinding and sieving: Grind the egg yolk lecithin through an 80-mesh sieve and sorbitol through a 40-mesh sieve;

[0118] S3. First, mix the sieved egg yolk lecithin with maltodextrin at 20 r / min for 1 min, then add sorbitol and mix at 20 r / min for 2 min. Then add 5% hydroxypropyl methylcellulose for granulation. The amount of binder solution for granulation is 24 g. In wet granulation, the stirring speed is 500 r / min, the chopping speed is high speed 3000 r / min, and the time is 60 s. After granulation, dry to a moisture content of <5%, then add magnesium stearate and mix at 15 r / min for 10 min. Compress the mixture at a pressure of 20 kN to form tablets with a tablet weight of 0.5 g / tablet. The powder has good flowability and the tablet weight deviation is small.

[0119] Example 6

[0120] This embodiment provides a tablet containing egg yolk phospholipids, the raw materials for preparing the egg yolk phospholipid-containing tablet include the following components:

[0121] Preparation Example 1: 100g egg yolk phospholipids, 20g maltodextrin, 78g sorbitol, 5% hydroxypropyl methylcellulose, and 2g magnesium stearate.

[0122] The tablets containing egg yolk phospholipids are prepared by the following method:

[0123] S1. Weighing: Weigh the raw and auxiliary materials according to the above prescription and set aside;

[0124] S2. Grinding and sieving: Grind the egg yolk lecithin through an 80-mesh sieve and sorbitol through a 40-mesh sieve;

[0125] S3. First, mix the sieved egg yolk lecithin with maltodextrin at 10 r / min for 2 min. Then, add sorbitol and mix at 10 r / min for 3 min. Next, add 5% hydroxypropyl methylcellulose for granulation. The binder solution for granulation is 28 g. In wet granulation, the stirring speed is 400 r / min, the chopping speed is 2000 r / min, and the time is 90 s. After granulation, dry to a moisture content of <5%. Then, add magnesium stearate and mix at 15 r / min for 10 min. Compress the mixture at a pressure of 25 kN to form tablets with a tablet weight of 0.5 g / tablet. The powder has good flowability and the tablet weight deviation is small.

[0126] Example 7

[0127] This embodiment provides a tablet containing egg yolk phospholipids, the raw materials for preparing the egg yolk phospholipid-containing tablet include the following components:

[0128] Preparation Example 1: 120g egg yolk phospholipids, 20g maltodextrin, 58g sorbitol, 5% hydroxypropyl methylcellulose, and 2g magnesium stearate.

[0129] The tablets containing egg yolk phospholipids are prepared by the following method:

[0130] S1. Weighing: Weigh the raw and auxiliary materials according to the above prescription and set aside;

[0131] S2. Grinding and sieving: Grind the egg yolk lecithin through an 80-mesh sieve and sorbitol through a 40-mesh sieve;

[0132] S3. First, mix the sieved egg yolk lecithin with maltodextrin at 15 r / min for 1 min, then add sorbitol and mix at 15 r / min for 2 min. Then add 5% hydroxypropyl methylcellulose for granulation. The amount of binding solution for granulation is 20 g. In wet granulation, the stirring speed is 400 r / min, the chopping speed is 2000 r / min, and the time is 90 s. After granulation, dry to a moisture content of <5%, then add magnesium stearate and mix at 15 r / min for 10 min. Compress the mixture at a pressure of 30 kN to form tablets with a tablet weight of 0.5 g / tablet. The powder has good flowability and the tablet weight deviation is small.

[0133] Example 8

[0134] This embodiment provides a tablet containing egg yolk phospholipids, the raw materials for preparing the egg yolk phospholipid-containing tablet include the following components:

[0135] Preparation Example 1: 60g egg yolk phospholipids, 20g maltodextrin, 118g microcrystalline cellulose, 5% hydroxypropyl methylcellulose, and 2g magnesium stearate.

[0136] The tablets containing egg yolk phospholipids are prepared by the following method:

[0137] S1. Weighing: Weigh the raw and auxiliary materials according to the above prescription and set aside;

[0138] S2. Grinding and sieving: Grind the egg yolk lecithin through an 80-mesh sieve;

[0139] S3. First, mix the sieved egg yolk lecithin with maltodextrin at 15 r / min for 1 min, then add microcrystalline cellulose and mix at 15 r / min for 2 min. Then add 5% hydroxypropyl methylcellulose for granulation. The amount of binder solution for granulation is 24 g. In wet granulation, the stirring speed is 500 r / min, the chopping speed is 3000 r / min, and the time is 120 s. After granulation, dry to a moisture content of <5%, then add magnesium stearate and mix at 15 r / min for 10 min. Compress the mixture at a pressure of 20 kN to form tablets with a tablet weight of 0.5 g / tablet. The powder has good flowability and the tablet weight deviation is small.

[0140] Example 9

[0141] This embodiment provides a tablet containing egg yolk phospholipids, the raw materials for preparing the egg yolk phospholipid-containing tablet include the following components:

[0142] Preparation Example 1: 60g egg yolk phospholipids, 20g maltodextrin, 118g modified starch, 5% hydroxypropyl methylcellulose, and 2g magnesium stearate.

[0143] The tablets containing egg yolk phospholipids are prepared by the following method:

[0144] S1. Weighing: Weigh the raw and auxiliary materials according to the above prescription and set aside;

[0145] S2. Grinding and sieving: Grind the egg yolk lecithin through an 80-mesh sieve;

[0146] S3. First, mix the sieved egg yolk lecithin with maltodextrin at 15 r / min for 1 min, then add modified starch and mix at 15 r / min for 2 min, then add 5% hydroxypropyl methylcellulose for granulation. The amount of binder solution for granulation is 21 g. In wet granulation, the stirring speed is 400 r / min, the chopping speed is 2000 r / min, and the time is 60 s. After granulation, dry to a moisture content of <5%, then add magnesium stearate and mix at 15 r / min for 10 min. Compress the mixture at a pressure of 20 kN to form tablets with a tablet weight of 0.5 g / tablet. The powder has good flowability and the tablet weight deviation is small.

[0147] Comparative Example 1

[0148] This comparative example provides a tablet containing egg yolk phospholipids, the raw materials for preparing the egg yolk phospholipid-containing tablet comprising the following components:

[0149] Preparation Example 4: 60g egg yolk phospholipids, 20g maltodextrin, 118g sorbitol, 5% hydroxypropyl methylcellulose, and 2g magnesium stearate.

[0150] The tablets containing egg yolk phospholipids are prepared by the following method:

[0151] S1. Weighing: Weigh the raw and auxiliary materials according to the above prescription and set aside;

[0152] S2. Grinding and sieving: Grind the egg yolk lecithin through an 80-mesh sieve and sorbitol through a 40-mesh sieve;

[0153] S3. First, mix the sieved egg yolk lecithin with maltodextrin at 15 r / min for 1 min, then add sorbitol and mix at 15 r / min for 2 min. Then add 5% hydroxypropyl methylcellulose for granulation. The amount of binder solution for granulation is 25 g. In wet granulation, the stirring speed is 500 r / min, the chopping speed is 3000 r / min, and the time is 120 s. After granulation, dry to a moisture content of <5%, then add magnesium stearate and mix at 15 r / min for 10 min. Compress the mixture at a pressure of 25 kN to form tablets with a tablet weight of 0.5 g / tablet. The powder has good flowability but is difficult to compress.

[0154] Comparative Example 2

[0155] This comparative example provides a tablet containing egg yolk phospholipids, the raw materials for preparing the egg yolk phospholipid-containing tablet comprising the following components:

[0156] Preparation Example 1: 40g egg yolk phospholipids, 104g corn starch, 14.2g sodium carboxymethyl starch, 31.8g hydroxypropyl methylcellulose, and 8g talc.

[0157] The tablets containing egg yolk phospholipids are prepared by the following method:

[0158] S1. Weighing: Weigh the raw and auxiliary materials according to the above prescription and set aside;

[0159] S2. Grinding and sieving: Grind the egg yolk lecithin through an 80-mesh sieve;

[0160] S3. First, mix the sieved egg yolk lecithin with corn starch at high speed and dry until the moisture content does not exceed 2%. Add 62g of purified water to sodium carboxymethyl starch, mix and stir evenly, then add hydroxypropyl methylcellulose for granulation, drying until the moisture content is <2%. Add 8g of talc to the above granules and mix thoroughly. Tableting is not possible.

[0161] Comparative Example 3

[0162] This comparative example provides a tablet containing egg yolk phospholipids, the raw materials for preparing the egg yolk phospholipid-containing tablet comprising the following components:

[0163] Preparation Example 1: 60g egg yolk phospholipids, 84g corn starch, 62g purified water, 14.2g sodium carboxymethyl starch, 31.8g hydroxypropyl methylcellulose, and 8g talc.

[0164] S1. Weighing: Weigh the raw and auxiliary materials according to the above prescription and set aside;

[0165] S2. Grinding and sieving: Grind the egg yolk lecithin through an 80-mesh sieve;

[0166] S3. Take egg yolk lecithin and corn starch and stir at high speed until the moisture content is <2%. Take purified water and add sodium carboxymethyl starch to make a slurry and stir evenly. Add 31.8g of hydroxypropyl methylcellulose and stir at high speed to feed the material. Dry the material until the moisture content is <2%. Add the above granules to 8g of talc powder and mix at high speed. The tablets cannot be formed.

[0167] Test Example 2

[0168] Tablet performance testing

[0169] Test samples: tablets of egg yolk phospholipids provided in Examples 1-9 and tablets provided in Comparative Examples 1-3;

[0170] Test methods: The disintegration time test and tablet friability test were conducted according to the Chinese Pharmacopoeia, Volume IV. Hardness was measured using a hardness tester.

[0171] The specific test results are shown in Table 2:

[0172] Table 2

[0173]

[0174]

[0175] As can be seen from Table 2, the tablets obtained by dry granulation in Examples 1-3 have the required hardness and friability, but not the required disintegration. Although sodium carboxymethyl cellulose was added as a disintegrant in Example 4, the disintegration was improved, but the flowability of the powder was poor, so the dry granulation process was not feasible.

[0176] Examples 8 and 9 used egg yolk lecithin, maltodextrin, microcrystalline cellulose (or modified starch) for granulation, and added 5% hydroxypropyl methylcellulose for granulation. It was found that the tablets had good formability, good powder flowability, small tablet weight deviation, and their hardness and brittleness met the requirements. However, the disintegration time did not meet the requirements.

[0177] Comparative Example 2 used the method of patent CN 106974894A for tablet compression, and it was found that the tablets could not be formed. Therefore, this invention uses supercritical egg yolk phospholipids, maltodextrin, and sorbitol for granulation, and adds 5% hydroxypropyl methylcellulose for granulation. It was found that the tablets had good formability, good powder flowability, small tablet weight deviation, and their hardness, disintegration, and friability all met the requirements. Moreover, the proportion of egg yolk phospholipids in the formula can be as high as 60%.

[0178] Supercritical fluid extraction of egg yolk lecithin preserves the protein, making it ideal for tableting. However, directly granulating egg yolk lecithin with excipients results in tablets with unsatisfactory disintegration or hardness. The solution is to granulate 200g of egg yolk lecithin with 520g of corn starch using high-speed stirring, ensuring the moisture content does not exceed 2%. These granules are then mixed with other excipients and compressed into tablets. Therefore, this invention, using supercritical fluid extraction to prepare protein-containing egg yolk lecithin, eliminates the need for two-step granulation, achieving tableting in a single step.

[0179] As shown in Comparative Example 1, when the supercritical extraction limit pressure decreases, carbon dioxide can only extract some triglyceride components, resulting in egg yolk phospholipids containing more triglycerides. When egg yolk phospholipids containing more than 10% triglycerides are used in the tablet preparation process, the increased amount of triglycerides leads to increased lubricity between powders, which is not conducive to tablet formation.

[0180] As shown in Preparation Example 2, when the supercritical pressure increases, carbon dioxide can extract almost all of the triglycerides in egg yolk phospholipids, but some phospholipids will also be extracted, resulting in a decrease in the phospholipid content of egg yolk phospholipids, making them unsuitable for further tablet development.

[0181] Test Example 3

[0182] Test samples: Tablets of egg yolk phospholipids provided in Examples 5-7;

[0183] Test methods: Disintegration time was referenced from Chinese Pharmacopoeia, Part IV; egg yolk phospholipid content was referenced from GB5009.272 National Food Safety Standard for the Determination of Phosphatidylcholine, Phosphatidylethanolamine, and Phosphatidylinositol in Food.

[0184] The specific test results are shown in Table 3:

[0185] Table 3

[0186]

[0187] As shown in Table 3, tablets made with phospholipid content of 30%, 50%, and 60% in this invention exhibit good tablet formability, good powder flowability, and small tablet weight deviation. Their hardness, disintegration, and friability all meet the requirements, and they have a moderate sweetness, making them suitable as chewable tablets for teenagers and a natural source of brain-boosting nutrients. Furthermore, the egg yolk phospholipid content in these tablets is as high as 19.83%.

[0188] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A tablet containing egg yolk phospholipids, characterized in that, The raw materials for preparing the tablets containing egg yolk phospholipids include egg yolk phospholipids, fillers, and lubricants in a mass ratio of (300~600):(399~699):10; The egg yolk phospholipids comprise the following components by mass percentage: phospholipids 30-40%, protein 50-60%, and triglycerides 5-10%. The egg yolk phospholipids are prepared by the following steps: egg yolk powder is extracted by supercritical CO2 and then separated in a two-stage process to obtain the egg yolk phospholipids; wherein the pressure of the supercritical CO2 extraction is 30-40 MPa and the temperature is 40-50℃. The filler is composed of maltodextrin and sorbitol; the mass ratio of maltodextrin to sorbitol is (0.9~1.1):(3.9~5.9); the lubricant is magnesium stearate; the raw materials for preparing the tablets containing egg yolk phospholipids also include a binder; the binder is hydroxypropyl cellulose; the amount of binder added is 0.25~0.75%; The tablets containing egg yolk phospholipids are prepared by wet granulation and tableting, which specifically includes the following steps: Egg yolk phospholipids and fillers are mixed to obtain the first mixture; The adhesive solution and the first mixture are mixed to obtain the second mixture; The second mixture is subjected to wet granulation to obtain mixture particles; After drying the particles of the mixture, it is then mixed with a lubricant to obtain a third mixture; The third mixture is compressed into tablets to prepare the tablets containing egg yolk phospholipids.

2. The tablet containing egg yolk phospholipids according to claim 1, characterized in that, In the two-stage separation: the pressure of the primary separation vessel is 8~12 MPa and the temperature is 40~50℃; the pressure of the secondary separation vessel is 4~7 MPa and the temperature is 30~45℃.

3. The tablet containing egg yolk phospholipids according to claim 1, characterized in that, The extraction time is 2-5 hours.

4. A method for preparing a tablet containing egg yolk phospholipids according to any one of claims 1 to 3, characterized in that, The preparation method employs wet granulation and tableting, which specifically includes the following steps: Egg yolk phospholipids and fillers are mixed to obtain the first mixture; The adhesive solution and the first mixture are mixed to obtain the second mixture; The second mixture is subjected to wet granulation to obtain mixture particles; After drying the particles of the mixture, it is then mixed with a lubricant to obtain a third mixture; The third mixture is compressed into tablets to prepare the tablets containing egg yolk phospholipids.

5. The method for preparing tablets containing egg yolk phospholipids according to claim 4, characterized in that, The mixing speed of the egg yolk phospholipids and fillers is 10~20 r / min, and the mixing time is 3~10 min.

6. The method for preparing tablets containing egg yolk phospholipids according to claim 4, characterized in that, The total mass of the adhesive solution is 100%, and the content of the adhesive is 1-10%.

7. The method for preparing tablets containing egg yolk phospholipids according to claim 4, characterized in that, With the total mass of the second mixture being 100%, the content of the adhesive solution is 5-15%.

8. The method for preparing tablets containing egg yolk phospholipids according to claim 4, characterized in that, In the wet granulation process, the stirring speed is 400~500 r / min, the chopping speed is 2000~3000 r / min, and the time is 1~5 min.

9. The method for preparing tablets containing egg yolk phospholipids according to claim 4, characterized in that, The moisture content of the dried mixture particles is <5%.

10. The method for preparing tablets containing egg yolk phospholipids according to claim 4, characterized in that, The dry mixture particles and lubricant are mixed at a speed of 10-20 r / min for a time of 10-15 min.

11. The method for preparing tablets containing egg yolk phospholipids according to claim 4, characterized in that, In the wet granulation and tableting process, the tableting pressure is 13~35 kN.

12. The use of a tablet containing egg yolk phospholipids according to any one of claims 1 to 3 in the preparation of brain-boosting chewable tablets.

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