Spirulina tablet as well as preparation method and application thereof

Abstract

The invention discloses spirulina tablets as well as a preparation method and application thereof, and belongs to the technical field of health food processing. The spirulina tablet comprises spirulina, polyethylene glycol, a first auxiliary material and a second auxiliary material, the first auxiliary material comprises at least one of gel silicon powder, silicon dioxide, a microcrystalline cellulose colloidal silicon dioxide co-treatment substance and superfine silica powder; the second auxiliary material comprises at least one of sugar alcohol, maltodextrin and microcrystalline cellulose; the preparation method of the spirulina tablets comprises the following steps: performing primary granulation; performing secondary granulation; and uniformly mixing the granules of the second granulation with polyethylene glycol, and tabletting. The polyethylene glycol, the porous first auxiliary material with the adsorption effect and the second auxiliary material beneficial to disintegration are adopted as the auxiliary materials together, the step-by-step granulation process is matched, the forming performance and disintegration performance of the spirulina tablets can be effectively improved, and the spirulina tablets which are high in functional component content, few in auxiliary material, high in hardness and short in disintegration time are prepared.

Description

Technical Field

[0001] The present application relates to the technical field of health food processing, and in particular to a spirulina tablet and a preparation method and application thereof. Background Art

[0002] Immunity is the body's own defense mechanism. It is the body's ability to identify and eliminate foreign matter (viruses, bacteria, etc.), to deal with aging, damaged, dead, and degenerated cells, and to identify and deal with mutant cells and virus-infected cells in the body. Modern immunology believes that immunity is the body's physiological response to identify and eliminate "foreign substances."

[0003] Immunity plays a very important role in the human body. The level of immunity directly affects a person's physical health. 99% of human diseases are related to the body's immunity. High immunity means strong resistance and it is not easy to get sick; low immunity will often get sick, fatigue and infection. Studies have shown that human immunity is a dynamic development process from weak to strong and then from strong to weak. The human body's immunity is basically sound at the age of 12, relatively stable at the age of 13-45, and gradually decreases after the age of 46. In real life, due to high work pressure, frequent overtime or playing with mobile phones, irregular diet and lack of exercise, the human body's immunity is reduced and it is easy to get sick. Good immunity can be "eaten". Balanced nutrition is the most basic requirement for healthy people. Eating scientifically and reasonably will help improve one's immunity, otherwise it will be counterproductive.

[0004] Spirulina has been recommended by many organizations as a "superfood". Its representative nutrients include protein (including phycocyanin and allophycocyanin), vitamins, metal elements, γ-linolenic acid, carotenoids, chlorophyll, etc. It is a natural health food. The protein content is as high as 60%-70%, and the essential amino acids it contains are complete and reasonably composed. Its fat content is 5%-6% of dry weight, of which 70%-80% are unsaturated fatty acids, especially linolenic acid, which is 500 times that of human milk. The cellulose content of spirulina is about 2%-4%, and the cell wall is mainly composed of collagen and hemicellulose, with a high absorption rate. It is also rich in vitamins and minerals, including vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin E, vitamin K, zinc, iron, potassium, calcium, magnesium, phosphorus, selenium, iodine, etc. The ratio of biological zinc to iron is basically consistent with the physiological needs of the human body and is easier to be absorbed by the human body. Phycocyanin can enhance the body's immune function, specifically through its splitting effect. Cyanobacterial protein can stimulate the body's immune T cells and B lymphocytes, improve the activation and proliferation ability of these two cells, thereby differentiating more T cells and plasma cells, synthesizing more antibodies, and improving the body's immune ability.

[0005] Spirulina powder has an unpleasant taste and stickiness, and poor compliance, so spirulina is usually made into spirulina tablets for use. Due to the characteristics of spirulina raw materials, it is difficult to form and process. In traditional methods, more auxiliary materials are usually added to prepare spirulina tablets with better formability and adjust their disintegration time.

[0006] For example, there is a method that discloses a spirulina composition, a spirulina disintegrating tablet and a preparation method thereof, which improves the problem of long disintegration time of spirulina tablets by adding sugar alcohol, acid source, polyethylene glycol 6000 and disintegrant. Sugar alcohol is easily soluble in water, the acid source allows spirulina to dissociate protein under acidic conditions, thereby reducing its viscosity after wetting, and the polyethylene glycol 6000 surfactant can increase the solubility and osmotic wettability of spirulina, allowing water to enter the core of the tablet. The four excipients synergistically shorten the disintegration time. However, in this method, too many excipients are added, and the proportion of effective ingredients is low. If you want to take in enough effective ingredients, you need to take in too many excipients, which is not reasonable from a nutritional point of view.

[0007] In addition, there are methods to reduce the amount of auxiliary materials, but specific raw materials, strict processes or complex equipment are needed to achieve good processing of spirulina tablets, and it is still difficult to prepare spirulina products with high content of effective ingredients, less auxiliary materials, high hardness and short disintegration time.

[0008] For example, some methods solve the problem of spirulina tablets breaking by adding highly substituted hydroxypropyl cellulose, and achieve qualified disintegration time by screening efficient disintegrants. Some methods utilize the hydrophilicity of oligoxylose, isomaltulose, and polyethylene glycol 6000, and solve the problem of long tablet disintegration time by wet granulation process, but ethanol is used in the granulation process, and the workshop needs to use explosion-proof equipment, which is costly and has safety hazards. The granulation process easily leads to a sharp and large attenuation of the β-carotene content in spirulina, and the process is complicated, resulting in a large loss of effective efficacy ingredients, resulting in unstable effective ingredient content between batches and high costs. Some methods require freezers, ultrafine grinding and microwave vacuum drying equipment, which have a large investment cost in actual production, and the operation steps are cumbersome, which is not conducive to the feasibility of actual large-scale production. Some methods introduce a small amount of liquid excipients during the preparation process, and the actual operation process requires equal amounts of incremental mixing, which is difficult to mix, and the amount of disintegrant added is large.

[0009] In summary, there are basically no spirulina products on the market with high content of active ingredients, few excipients, high hardness and short disintegration time. High content of active ingredients means less excipients added, so the tablets pressed out are not easy to form, have low hardness and long disintegration time. Even if more excipients are added, the problem of long disintegration time cannot be solved. Summary of the invention

[0010] Based on this, it is necessary to provide a spirulina tablet and a preparation method and application thereof. By adopting polyethylene glycol, a porous first excipient with adsorption effect, and a second excipient that helps disintegration as excipients, and cooperating with a step-by-step granulation process, a spirulina product with high content of effective ingredients, less excipients, high hardness and short disintegration time is provided. At the same time, the process is simple, and no complicated equipment or strict process conditions are required, which can reduce the process cost.

[0011] In one aspect of the present application, a method for preparing a spirulina tablet is provided, wherein the spirulina tablet comprises spirulina, polyethylene glycol, a first auxiliary material and a second auxiliary material;

[0012] The first auxiliary material comprises at least one of gel silicon powder, silicon dioxide, microcrystalline cellulose colloidal silicon dioxide co-processed product and micro powder silica gel;

[0013] The second auxiliary material includes at least one of sugar alcohol, maltodextrin and microcrystalline cellulose;

[0014] The preparation method of the spirulina tablets comprises the following steps:

[0015] S1, first granulation: mixing the spirulina with the first auxiliary material, granulating, and preparing first granulated particles;

[0016] S2, second granulation: mixing the first granulated particles with the second auxiliary materials, granulating, and preparing second granulated particles;

[0017] S3: Evenly mix the second granulated particles and the polyethylene glycol, and press into tablets to prepare the spirulina tablets.

[0018] In some embodiments, the spirulina tablets include, by weight: 75-85 parts of spirulina, 0.1-0.5 parts of polyethylene glycol, 3.8-10 parts of the first auxiliary material, and 7.5-15.5 parts of the second auxiliary material.

[0019] In some embodiments, the spirulina tablets include, by weight: 75-85 parts of spirulina, 0.3-0.5 parts of polyethylene glycol, 4-10 parts of the first auxiliary material, and 8.7-15.5 parts of the second auxiliary material.

[0020] In some embodiments, the sugar alcohol includes at least one of sorbitol, erythritol, and mannitol.

[0021] In some embodiments, in step S1, the mixing conditions include: mixing time 40-100s, chopping speed 2-6r / s, stirring speed 20-60r / s; optionally, mixing time 60s, chopping speed 4r / s, stirring speed 40r / s.

[0022] In some embodiments, in step S1, the granulation is dry granulation; the parameters of the granulation include a sieve aperture of 0.1-1.0 mm, a pressing wheel pressure of 5-7 MPa, a granulation speed of 500-600 rpm, and a finished product particle size of 0.1-0.5 mm.

[0023] In some embodiments, in step S2, the granulation is wet granulation.

[0024] In some embodiments, in step S2, the step of mixing the first granulated particles with the second auxiliary material specifically includes: spraying the second auxiliary material into the first granulated particles.

[0025] In some embodiments, in step S2, the granulation parameters include: air inlet speed: 100-500m 3 / h, bed temperature <37℃, spray speed 20-40 m 3 / h, sieve aperture 1-3mm.

[0026] In some embodiments, the mass ratio of the spirulina to the first auxiliary material is 1:(0.05-0.1); the mass ratio of the first granulated particles to the second auxiliary material is 1:(0.1-0.2).

[0027] Another aspect of the present application provides Spirulina tablets prepared by the aforementioned preparation method.

[0028] The third aspect of the present application provides the use of the aforementioned Spirulina tablets in the preparation of medicines or health products capable of improving the body's immune ability.

[0029] The beneficial effects of this application are:

[0030] 1. The present application adopts polyethylene glycol, a porous first excipient with adsorption function, and a second excipient that helps disintegration as excipients, and cooperates with a step-by-step granulation process to solve the problem of difficulty in tableting caused by the light weight and easy flying of spirulina raw materials, and effectively improves the forming performance and disintegration performance of spirulina tablets.

[0031] 2. The first granulation of the present application is aimed at improving the state of Spirulina, preliminarily preparing small particles, and inputting a porous first auxiliary material with adsorption effect; the second granulation introduces materials that help disintegration (second auxiliary material and polyethylene glycol), so that the materials adhere to the first particles and partially penetrate into the pores of the first auxiliary material, which can greatly accelerate the disintegration rate, and the whole process is operated at low temperature, which will not cause the attenuation of the effective ingredients.

[0032] 3. The process of this application is simple, does not require complicated equipment or strict process conditions, and the production cost is low, which can meet the needs of mass production.

[0033] 4. In general, magnesium stearate needs to be added as a lubricant during tablet granulation to improve the disintegration performance of the tablet. The raw materials and processes specified in this application can accelerate the disintegration time without adding magnesium stearate, and prepare a spirulina tablet that can disintegrate quickly. DETAILED DESCRIPTION

[0034] In order to facilitate the understanding of the present application, the present application will be described more comprehensively below in conjunction with specific embodiments. Preferred embodiments of the present application are provided hereinafter. However, the present application can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the understanding of the disclosure of the present application more thorough and comprehensive.

[0035] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this application belongs. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0036] In this article, the technical features described in an open manner include closed technical solutions composed of the listed features, and also include open technical solutions containing the listed features.

[0037] In this article, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features.

[0038] In the description herein, "at least one" means more than one, including one or more than two, for example, one, two, three, etc., unless otherwise clearly defined.

[0039] Herein, when it comes to numerical ranges, unless otherwise specified, the numerical ranges are deemed to be continuous and include the minimum and maximum values ​​of the range, as well as every value between such minimum and maximum values. Further, when a range refers to an integer, every integer between the minimum and maximum values ​​of the range is included. In addition, when multiple ranges are provided to describe features or characteristics, the ranges can be merged. In other words, unless otherwise specified, all ranges disclosed herein should be understood to include any and all subranges included therein.

[0040] In this article, when referring to the unit of a data range, if there is a unit only after the right endpoint, it means that the units of the left and right endpoints are the same. For example, 500-600rpm means that the units of the left endpoint "500" and the right endpoint "600" are both rpm (revolutions per minute).

[0041] The temperature parameters herein, unless otherwise specified, allow for both constant temperature treatment and treatment within a certain temperature range. The constant temperature treatment allows for temperature fluctuations within the precision range of instrument control.

[0042] In one aspect of the present application, a method for preparing a spirulina tablet is provided, wherein the spirulina tablet comprises spirulina, polyethylene glycol, a first auxiliary material and a second auxiliary material;

[0043] The first auxiliary material comprises at least one of gel silicon powder, silicon dioxide, microcrystalline cellulose colloidal silicon dioxide co-processed product and micro powder silica gel;

[0044] The second auxiliary material includes at least one of sugar alcohol, maltodextrin and microcrystalline cellulose;

[0045] The preparation method of the spirulina tablets comprises the following steps:

[0046] S1, first granulation: mixing the spirulina with the first auxiliary material, granulating, and preparing first granulated particles;

[0047] S2, second granulation: mixing the first granulation with the second auxiliary material, granulating, and preparing second granulated particles;

[0048] S3: Evenly mix the second granulated particles and the polyethylene glycol, and press into tablets to prepare the spirulina tablets.

[0049] Due to the characteristics of spirulina raw materials, it is difficult to process it into a shape. Traditional methods usually require the addition of more excipients, specific raw materials, strict processes or complex equipment to prepare spirulina tablets with good shapeability and adjust their disintegration time. However, using common excipients (diluents, fillers, disintegrants, etc.), even if more excipients are added and more stearic acid or stearate is added as a lubricant, it is still impossible to prepare spirulina tablets with good shapeability and disintegration performance.

[0050] The inventors found that on the basis of polyethylene glycol, the forming performance and disintegration performance of the spirulina tablet can be effectively improved by using a porous first auxiliary material with adsorption and a second auxiliary material that helps disintegration through a step-by-step granulation process. The porosity and adsorption of the first auxiliary material are necessary, and it can be well attached to the surface of spirulina, and can also achieve good attachment of the second auxiliary material that helps disintegration, thereby improving the forming performance while improving the disintegration performance.

[0051] It should be noted that the first granulation is aimed at improving the state of Spirulina, preliminarily preparing small particles, and inputting a porous first auxiliary material with adsorption effect; the second granulation introduces materials that help disintegration (second auxiliary material and polyethylene glycol), so that the materials adhere to the first particles and partially penetrate into the pores of the first auxiliary material, which can greatly accelerate the disintegration rate.

[0052] The first auxiliary material can be gel silica powder, silicon dioxide, microcrystalline cellulose colloidal silicon dioxide co-processed product or micro-powder silica gel, or a combination of the above raw materials, such as gel silica powder and silicon dioxide, silicon dioxide, microcrystalline cellulose colloidal silicon dioxide co-processed product and micro-powder silica gel; the second auxiliary material can be sugar alcohol, maltodextrin or microcrystalline cellulose, or a combination of the above raw materials, such as sugar alcohol and maltodextrin, sugar alcohol, maltodextrin and microcrystalline cellulose. There is no specific limitation.

[0053] It is understandable that there is no special requirement for the particle size of the first auxiliary material, which can be micron or nanometer, for example, it can be 1nm-1000μm, 10nm-200μm, 10nm-500nm, 1-500μm, etc.; there is no special requirement for the specific gravity of the first auxiliary material, for example, it can be >2; preferably, the specific gravity of the first auxiliary material is >2.2; there is no special requirement for the particle size of the second auxiliary material, for example, it can be <5μm; preferably, the particle size of the second auxiliary material is <2μm.

[0054] In some embodiments, the spirulina tablets include, by weight: 75-85 parts of spirulina, 0.1-0.5 parts of polyethylene glycol, 3.8-10 parts of the first auxiliary material, and 7.5-15.5 parts of the second auxiliary material.

[0055] In some embodiments, the spirulina tablets include, by weight: 75-85 parts of spirulina, 0.3-0.5 parts of polyethylene glycol, 4-10 parts of the first auxiliary material, and 8.7-15.5 parts of the second auxiliary material.

[0056] It should be noted that the amount of spirulina is 75-85 parts, specifically 75 parts, 76 parts, 77 parts, 78 parts, 79 parts, 80 parts, 81 parts, 82 parts, 83 parts, 84 parts or 85 parts; the amount of polyethylene glycol is 0.1-0.5 parts, specifically 0, 1 parts, 0.2 parts, 0.3 parts, 0.4 parts or 0.5 parts; the amount of the first auxiliary material is 3.8-10 parts, specifically The dosage of the second auxiliary material is 7.5-15.5 parts, specifically 7.5 parts, 8 parts, 8.7 parts, 9 parts, 9.5 parts, 10 parts, 10.5 parts, 11 parts, 11.5 parts, 12 parts, 12.5 parts, 13 parts, 13.5 parts, 14 parts, 14.5 parts, 15 parts or 15.5 parts, etc. It is not specifically limited. When the dosage of each raw material is within the above range, a spirulina tablet with high content of effective ingredients, less auxiliary materials, high hardness and short disintegration time can be prepared.

[0057] It should be noted that sugar alcohol refers to a type of polyol generated by hydrogenation of the reducing carbonyl group of sugar (including four-carbon sugar, five-carbon sugar, six-carbon sugar or its polymer). Commonly used sugar alcohols include erythritol, sorbitol, xylitol, maltitol and mannitol. Sugar alcohols are not hygroscopic under conditions of extremely high relative humidity. The hygroscopicity can be reduced by incorporating them into excipients with strong hygroscopicity, and they have the advantages of strong anti-adhesiveness and compressibility. In the present application, sugar alcohols can use only a single sugar alcohol or a combination of multiple sugar alcohols, and there is no specific requirement for the specific type of sugar alcohol; more preferably, the sugar alcohol includes at least one of sorbitol, erythritol and mannitol.

[0058] Microcrystalline cellulose is a crystalline cellulose with a low degree of polymerization obtained by partial hydrolysis of cellulose. It has good compressibility and strong binding force, and the tablets pressed into it have a large hardness. There is no special requirement for the specifications of microcrystalline cellulose in this application, and any common specifications of microcrystalline cellulose can be used, such as microcrystalline cellulose PH101, microcrystalline cellulose PH102, etc.

[0059] Polyethylene glycol, also known as α-hydrogen-ω-hydroxyl (oxy-1,2-ethylenediyl) polymer, polyethylene oxide (PEO-LS), is a general term for ethylene glycol polymers with an average molecular weight of about 200 to at least 6000. In this application, there is no specific requirement for the average molecular weight of polyethylene glycol, for example, it can be 200-6000, and the specific models can be polyethylene glycol 300 (PEG300), polyethylene glycol 600 (PEG600), polyethylene glycol 1000 (PEG1000), polyethylene glycol 1500 (PEG1500), polyethylene glycol 2000 (PEG2000), polyethylene glycol 4000 (PEG4000), polyethylene glycol 6000 (PEG6000), etc.

[0060] It is understandable that, in the step of uniformly mixing the spirulina and the first auxiliary material, any common mixing equipment may be used for mixing, such as a three-dimensional mixer, a high-speed mixer, etc.; preferably, a high-speed mixer is used for mixing.

[0061] Optionally, the mixing conditions in step S1 include: mixing time 40-100s, for example, 40s, 50s, 60s, 70s, 80s, 90s, 100s, etc., preferably, the mixing time is 60s; chopping speed 2-6r / s, for example, 2r / s, 3r / s, 4r / s, 5r / s, 6r / s, etc., preferably, the chopping speed is 4r / s; stirring speed 20-60r / s, for example, 20r / s, 30r / s, 40r / s, 50r / s, 60r / s, etc., preferably, the stirring speed is 40r / s. The above mixing conditions can achieve a good mixing effect.

[0062] Optionally, in step S1, the granulation is dry granulation. It is understandable that the dry granulation is performed using a dry granulator.

[0063] Optionally, the granulation parameters include: mesh aperture 0.1-1.0mm, pressure wheel pressure 5-7MPa, granulation speed 500-600rpm, finished product particle size 0.1-0.5mm. For example, the mesh aperture can be 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1.0mm, etc.; the pressure wheel pressure can be 5MPa, 5.5MPa, 6MPa, 6.5MPa, 7MPa, etc.; the granulation speed can be 500rpm, 520rpm, 540rpm, 560rpm, 580rpm, 600rpm, etc.; the finished product particle size can be 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, etc. The above granulation parameters can ensure good granulation quality.

[0064] In some embodiments, in step S2, the step of mixing the first granulated particles with the second auxiliary material specifically includes: spraying the second auxiliary material into the first granulated particles.

[0065] Optionally, in step S2, the granulation is wet granulation. It is understandable that the wet granulation is performed using a wet granulator, and there is no specific requirement for the type of wet granulator, for example, it can be a high-efficiency wet granulator.

[0066] Optionally, in step S2, the granulation parameters include: air inlet speed: 100-500m 3 / h, bed temperature <37℃, spray speed 20-40 m 3 / h, the mesh size is 1-3mm. For example, the air velocity can be 100m 3 / h、200m 3 / h、300m 3 / h、400m 3 / h、500m 3 / h, etc.; the bed temperature can be 30℃, 31℃, 32℃, 33℃, 34℃, 35℃, 36℃, 36.5℃, etc.; the sieve aperture can be 1mm, 1.5mm, 2mm, 2.5mm, 3mm, etc.

[0067] Another aspect of the present application provides Spirulina tablets prepared by the aforementioned preparation method.

[0068] It should be noted that the spirulina tablets of the present application have good hardness and a relatively short disintegration time. Optionally, the disintegration time of the spirulina tablets is less than 10 minutes; the hardness of the spirulina tablets is greater than 15 kg.

[0069] The third aspect of the present application provides the use of the aforementioned Spirulina tablets in the preparation of medicines or health products capable of improving the body's immune ability.

[0070] It is understandable that the spirulina tablets of the present application have a high content of effective ingredients, less auxiliary materials, high hardness, and a short disintegration time. They have better compliance and use effect, can be used in common uses of spirulina, and have the effect of improving the body's immunity.

[0071] It is worth noting that the raw materials used in the examples of the present application are all common commercially available products, and their sources are not specifically limited.

[0072] The following is an exemplary description of some raw materials:

[0073] Silica: gel type, purchased from WR Grace & Co.;

[0074] Microcrystalline cellulose colloidal silicon dioxide co-processed product: Model SMCC90, purchased from JRS Company, Germany;

[0075] Gel silica powder: purchased from Anhui Shanhe Pharmaceutical Excipients Co., Ltd.;

[0076] Micro powder silica gel: GEL1, purchased from Silicycle.

[0077] The following are specific embodiments.

[0078] Example 1

[0079] Preparation of Spirulina Tablets

[0080] The recipe is as follows:

[0081] Spirulina 80 parts;

[0082] 15.5 parts of sorbitol;

[0083] Polyethylene glycol (PEG6000) 0.5 parts;

[0084] 4 parts of gel silica powder;

[0085] Preparation process

[0086] S1: First granulation:

[0087] Granulation: Add spirulina and gel silica powder into a high-speed mixer and mix for 60 seconds, with a chopping speed of 4r / s and a stirring speed of 40r / s. After mixing, add them into a dry granulator; Granulation parameters: sieve aperture 0.1mm, pressure wheel pressure 7MPa, granulation speed 600rpm, finished product particle size 0.1-0.3mm;

[0088] S2: Second granulation:

[0089] The first granulated granules are transferred into a high-efficiency wet-sizing machine and sprayed with sorbitol powder; Granulation parameters: Inlet wind speed: 100m 3 / h, bed temperature 35℃, spray speed 20m 3 / h;

[0090] S3: The second granulated particles were mixed with polyethylene glycol, and then tableted (0.5 g / tablet) after mixing.

[0091] The average tablet hardness is 18.3kg, the disintegration time is 7min, the tablet surface is smooth, the color is uniform, and the tablet weight is stable.

[0092] Example 2

[0093] Preparation of Spirulina Tablets

[0094] The recipe is as follows:

[0095] Spirulina 85 parts;

[0096] Polyethylene glycol (PEG4000) 0.3 parts;

[0097] 6 parts of microcrystalline cellulose colloidal silicon dioxide co-processed product;

[0098] Maltodextrin 8.7 parts;

[0099] Preparation process:

[0100] S1: First granulation:

[0101] Granulation: Add the co-processed product of spirulina and microcrystalline cellulose colloidal silicon dioxide into a high-speed mixer and mix for 60 seconds, with a chopping speed of 4r / s and a stirring speed of 40r / s. After mixing, add it into a dry granulator; granulation parameters: mesh aperture 0.2mm, pressure wheel pressure 5MPa, granulation speed 600rpm, finished product particle size 0.2-0.4mm;

[0102] S2: Second granulation:

[0103] The first granulated granules are transferred into a high-efficiency wet-sizing machine and sprayed with maltodextrin powder; Granulation parameters: Inlet wind speed: 200m 3 / h, bed temperature 35℃, spray speed 20m 3 / h;

[0104] S3: The second granulated particles were mixed with polyethylene glycol, and then tableted (0.5 g / tablet) after mixing.

[0105] The average tablet hardness is 19kg, the disintegration time is 8min, the tablet surface is smooth, the color is uniform, and the tablet weight is stable.

[0106] Example 3

[0107] Preparation of Spirulina Tablets

[0108] The recipe is as follows:

[0109] Spirulina 75 parts;

[0110] Polyethylene glycol (PEG6000) 0.5 parts;

[0111] 10 parts of silicon dioxide;

[0112] Microcrystalline cellulose (PH101) 14.5 parts;

[0113] Preparation process:

[0114] S1: First granulation:

[0115] Granulation: Add spirulina and silicon dioxide to a high-speed mixer and mix for 60 seconds, chop at 4r / s, stir at 40r / s, mix well and add to a dry granulator; granulation parameters: mesh aperture 0.5mm, roller pressure 6MPa, granulation speed 550rpm, finished product particle size 0.2-0.5mm; mix the second granulation particles with polyethylene glycol, mix well and press into tablets. The average tablet hardness is 19kg, the disintegration time is 8min, the tablet surface is smooth, the color is uniform, and the tablet weight is stable.

[0116] S2: Second granulation:

[0117] The first granulated granules were transferred into a high-efficiency wet-sizing machine and sprayed with microcrystalline cellulose powder; granulation parameters: air inlet speed: 300 m3 / h, bed temperature 30℃, spray speed 40 m 3 / h;

[0118] S3: The second granulated particles were mixed with polyethylene glycol, and then tableted (0.5 g / tablet) after mixing.

[0119] The average tablet hardness is 17.5kg, the disintegration time is 7min, the tablet surface is smooth, the color is uniform, and the tablet weight is stable.

[0120] Example 4

[0121] Spirulina 80 parts;

[0122] 15.5 parts of erythritol;

[0123] Polyethylene glycol (PEG6000) 0.5 parts;

[0124] 4 parts of micro powder silica gel;

[0125] Preparation process:

[0126] S1: First granulation:

[0127] Granulation: Add spirulina and micro-powdered silica gel into a high-speed mixer and mix for 60 seconds, with a chopping speed of 4r / s and a stirring speed of 40r / s. After mixing, add the mixture into a dry granulator. Granulation parameters: sieve aperture 0.3mm, roller pressure 7MPa, granulation speed 500rpm, finished product particle size 0.1-0.3mm.

[0128] S2: Second granulation:

[0129] The first granulated granules are transferred into a high-efficiency wet-sizing machine and sprayed with erythritol powder; granulation parameters: air inlet speed: 400m 3 / h, bed temperature 30℃, spray speed 30m 3 / h;

[0130] S3: Mix the second granulated particles with polyethylene glycol, mix well and then compress into tablets (specification 0.5 g / tablet).

[0131] The average tablet hardness is 17.9 kg, the disintegration time is 6 min, the tablet surface is smooth, the color is uniform, and the tablet weight is stable.

[0132] Example 5

[0133] Spirulina 80 parts;

[0134] 4 parts of microcrystalline cellulose colloidal silicon dioxide copolymer;

[0135] Polyethylene glycol (PEG4000) 0.5 parts;

[0136] Microcrystalline cellulose (PH102) 15.5 parts;

[0137] Preparation process:

[0138] S1: First granulation:

[0139] Granulation: Spirulina and microcrystalline cellulose colloidal silicon dioxide copolymer were added to a high-speed mixer and mixed for 60 seconds, with a chopping speed of 4r / s and a stirring speed of 40r / s. After mixing, they were added to a dry granulator. Granulation parameters: sieve aperture 0.8mm, pressure wheel pressure 7MPa, granulation speed 580rpm, finished product particle size 0.3-0.5mm.

[0140] S2: Second granulation:

[0141] The first granulated granules are transferred into a high-efficiency wet-sizing machine and sprayed with microcrystalline cellulose powder; granulation parameters: air inlet speed: 500m 3 / h, bed temperature 30℃, spray speed 40m 3 / h;

[0142] S3: Mix the second granulated particles with polyethylene glycol, mix well and then compress into tablets (specification 0.5 g / tablet).

[0143] The average tablet hardness is 19.3kg, the disintegration time is 8min, the tablet surface is smooth, the color is uniform, and the tablet weight is stable.

[0144] Comparative Example 1

[0145] The formula of Comparative Example 1 is the same as that of Example 1, except that the preparation process is dry mixing and direct pressing, as follows:

[0146] Put the formulated amount of polyethylene glycol and 1 part of spirulina in a ziplock bag and mix manually for 2 minutes. After mixing, add 4 parts of gel silicon powder and 4 parts of spirulina and continue to mix manually for 2 minutes to obtain a premixed powder. Put 37.5 parts of spirulina, premixed powder, 4 parts of gel silicon powder and 37.5 parts of spirulina in this order into a three-dimensional mixer and mix for 20 minutes to obtain a total mixed powder.

[0147] The total mixed powder was placed in a tablet press and tableted (specification 0.5g / tablet). The average tablet hardness was 5.4kg, the disintegration time was 167min, the tablet surface had white spots, was rough, easy to fall off, the hardness was not enough, and the tablet weight was unstable.

[0148] Comparative Example 2

[0149] The preparation process of Comparative Example 2 is the same as that of Example 2, except for the formula, which is as follows:

[0150] Spirulina 86 parts;

[0151] Polyethylene glycol (PEG4000) 1 part;

[0152] 2 parts of microcrystalline cellulose colloidal silicon dioxide co-processed product;

[0153] 11 parts of maltodextrin.

[0154] The average tablet hardness is 12.6kg, the disintegration time is 39min, the tablet surface is smooth, the color is uniform, and the tablet weight is stable.

[0155] Comparative Example 3

[0156] The preparation process of Comparative Example 3 is the same as that of Example 3, except for the formula, which is as follows:

[0157] Spirulina 50 servings;

[0158] Polyethylene glycol (PEG6000) 0.5 parts;

[0159] 25 parts of silicon dioxide;

[0160] Microcrystalline cellulose (PH101) 24.5 parts.

[0161] The average tablet hardness is 8.1kg, the disintegration time is 20min, the tablet surface is smooth, the color is uniform, the tablet weight is stable, the taste is astringent, and the tableting is not smooth.

[0162] Comparative Example 4

[0163] 40 servings of Spirulina;

[0164] Polyethylene glycol (PEG6000) 5 parts;

[0165] 3 parts of silicon dioxide;

[0166] Microcrystalline cellulose (PH102) 16 parts;

[0167] 24 parts of sorbitol;

[0168] 1 part of L-ascorbic acid;

[0169] 10 parts of sodium carboxymethyl starch;

[0170] 1 part of magnesium stearate;

[0171] Preparation process: dry mixing and direct pressing.

[0172] The formulated amounts of polyethylene glycol, silicon dioxide, L-ascorbic acid and 5 parts of spirulina are placed in a ziplock bag and mixed for 2 minutes. After mixing, sodium carboxymethyl starch, the remaining 35 parts of spirulina, microcrystalline cellulose and sorbitol are placed in a three-dimensional mixer and mixed for 20 minutes. Then, magnesium stearate is added and mixing is continued for 4 minutes to obtain a total mixed powder.

[0173] The total mixed powder is placed in a tablet press for tableting.

[0174] The average tablet hardness is 15.6 kg, the disintegration time is 67 min, the tablet surface is smooth and the color is uniform.

[0175] Comparative Example 5

[0176] Spirulina 80 parts;

[0177] Polyethylene glycol (PEG6000) 0.5 parts;

[0178] 3 parts of silicon dioxide;

[0179] Microcrystalline cellulose (PH102) 6.5 parts;

[0180] 5 parts of sodium starch glycolate;

[0181] 5 parts of croscarmellose sodium;

[0182] Preparation process: dry mixing and direct pressing.

[0183] Place the formulated amount of polyethylene glycol and silicon dioxide in a ziplock bag and mix for 2 minutes. Then add microcrystalline cellulose, sodium starch glycolate and cross-linked sodium carboxymethyl cellulose and mix for 2 minutes to obtain a premixed powder. Then put half of the spirulina, the premixed powder and the other half of the spirulina into a three-dimensional mixer in this order and mix for 20 minutes. Then add magnesium stearate and continue mixing for 4 minutes to obtain a total mixed powder.

[0184] The total mixed powder is placed in a tablet press for tableting.

[0185] The average hardness of the tablets is 10.2 kg, the disintegration time is 88 min, and there are small white spots on the tablet surface, which is shiny.

[0186] Comparative Example 6:

[0187] Spirulina 75 parts;

[0188] Polyethylene glycol (PEG6000) 1 part;

[0189] 3 parts of silicon dioxide;

[0190] 8 parts of maltodextrin;

[0191] Microcrystalline cellulose (PH102) 8 parts;

[0192] 5 parts of L-sodium ascorbate;

[0193] Preparation process: wet granulation.

[0194] Place the formulated amount of spirulina, polyethylene glycol, maltodextrin and sodium L-ascorbate in a wet granulator and mix for 2 minutes. After mixing, spray a 95% ethanol solution of a wetting agent into the granulator for wet granulation. Granulate the wet granules with a 24-mesh swing granulator and then dry them in a fluidized bed with an inlet air temperature of less than 37°C. When the drying is completed with a moisture content of 1.3%, pass the dry granules through a 24-mesh sieve to dry the whole granules.

[0195] The dry granules were mixed with microcrystalline cellulose and then tableted.

[0196] The average hardness of the tablets is 16.9 kg, the disintegration time is 104 min, the tablet surface is smooth, with small white spots, and is more uniform than Comparative Example 5.

[0197] Comparative Example 7

[0198] The preparation process of Comparative Example 7 is the same as that of Example 3, except that silicon dioxide is replaced by calcium silicate. The specific formula is as follows:

[0199] Spirulina 75 parts;

[0200] Polyethylene glycol (PEG6000) 0.5 parts;

[0201] 10 parts of calcium silicate;

[0202] Microcrystalline cellulose (PH101) 14.5 parts;

[0203] Preparation process:

[0204] S1: First granulation:

[0205] Granulation: Spirulina and calcium silicate were added to a high-speed mixer and mixed for 60 s, with a chopping speed of 4 r / s and a stirring speed of 40 r / s. After mixing, they were added to a dry granulator. Granulation parameters: sieve aperture 0.5 mm, pressure wheel pressure 6 MPa, granulation speed 550 rpm, and finished product particle size 0.2-0.5 mm.

[0206] S2: Second granulation:

[0207] The first granulated granules were transferred into a high-efficiency wet-sizing machine and sprayed with microcrystalline cellulose powder; granulation parameters: air inlet speed: 300 m 3 / h, bed temperature 30℃, spray speed 40 m 3 / h;

[0208] S3: The second granulated particles were mixed with polyethylene glycol, and then tableted (0.5 g / tablet) after mixing.

[0209] The average tablet hardness is 17.1kg, the disintegration time is 65min, the tablet surface is smooth, the color is uniform, and the tablet weight is stable

[0210] Comparative Example 8

[0211] The preparation process of Comparative Example 8 is the same as that of Example 3, except that microcrystalline cellulose is replaced by lactose. The specific formula is as follows:

[0212] Spirulina 75 parts;

[0213] Polyethylene glycol (PEG6000) 0.5 parts;

[0214] 10 parts of silicon dioxide;

[0215] Lactose 14.5 parts;

[0216] Preparation process:

[0217] S1: First granulation:

[0218] Granulation: Add spirulina and silicon dioxide into a high-speed mixer and mix for 60 seconds, with a chopping speed of 4r / s and a stirring speed of 40r / s. After mixing, add them into a dry granulator; Granulation parameters: mesh aperture 0.5mm, pressure wheel pressure 6MPa, granulation speed 550rpm, finished product particle size 0.2-0.5mm;

[0219] S2: Second granulation:

[0220] The first granulated granules are transferred into the high-efficiency wet-sizing machine and sprayed with lactose powder; Granulation parameters: Inlet wind speed: 300 m 3 / h, bed temperature 30℃, spray speed 40 m 3 / h;

[0221] S3: The second granulated particles were mixed with polyethylene glycol, and then tableted (0.5 g / tablet) after mixing.

[0222] The average tablet hardness is 17.3kg, the disintegration time is 76min, the tablet surface is smooth, the color is uniform, and the tablet weight is stable

[0223] Comparative Example 9

[0224] The formula of Comparative Example 9 is the same as that of Example 3, except that the preparation process is as follows:

[0225] S1: First granulation:

[0226] Granulation: Transfer the spirulina into a high-efficiency wet-sizing machine and spray microcrystalline cellulose powder; Granulation parameters: Inlet wind speed: 300 m 3 / h, bed temperature 30℃, spray speed 40 m 3 / h;

[0227] S2: Second granulation:

[0228] The first granulated particles and silicon dioxide were added to a high-speed mixer and mixed for 60 seconds at a stirring speed of 40 r / s. After mixing, they were added to a dry granulator. Granulation parameters: sieve aperture 0.5 mm, roller pressure 6 MPa, granulation speed 550 rpm, finished product particle size 0.2-0.5 mm.

[0229] S3: The second granulated particles were mixed with polyethylene glycol, and then tableted (0.5 g / tablet) after mixing.

[0230] The average tablet hardness is 7.2kg, the disintegration time is 54min, the tablet surface is smooth, the color is uniform, and the tablet weight is stable

[0231] The results of Examples 1-5 and Comparative Examples 1-9 are summarized in Table 1, where the hardness is tested using a hardness tester, the disintegration time limit test condition is 37° C., and the β-carotene attenuation rate is the attenuation after being placed for 3 months under the conditions of temperature 37° C.±2° C. and humidity 75%±5%, i.e., 100%-(β-carotene content after placement / β-carotene content before placement)×100%:

[0232] Table 1 Summary of the performance of Examples 1-5 and Comparative Examples 1-9

[0233]

[0234] As can be seen from Table 1, Examples 1-5 of the present application use polyethylene glycol and the specified first and second excipients to prepare Spirulina tablets with high content of effective ingredients, less excipients, high hardness and short disintegration time through a two-step granulation method. The hardness is greater than 15 kg, the disintegration time is less than 10 min, the tablet weight is stable and the difference is small, and the attenuation degree of β-carotene content is small.

[0235] By comparing Example 1 and Comparative Example 1, it can be seen that the two-step granulation method can improve the comprehensive performance of the tablets compared with dry mixing and direct compression.

[0236] By comparing Example 2-3 and Comparative Example 2-3, it can be seen that the dosage of each component also has a considerable influence on the tableting quality and disintegration time. The defined dosage relationship is conducive to the preparation of spirulina tablets with high hardness, short disintegration time, stable tablet weight, small difference and small attenuation of β-carotene content.

[0237] As can be seen from Comparative Example 4, when the amount of auxiliary materials added is greatly increased and multiple auxiliary materials are added, the disintegration time of the Spirulina tablets prepared by the dry mixing direct compression method is also relatively long, and it is impossible to simultaneously obtain high hardness and short disintegration time, and the use requirements cannot be met.

[0238] Comparative Example 5 replaces part of the first and second excipients with disintegrants sodium starch glycolate and croscarmellose sodium. The hardness of the spirulina tablets prepared by the dry mixing direct compression method is low, the disintegration time is too long, and the β-carotene content decays greatly. Comparative Example 6 changes the composition of the excipients and adopts wet granulation. The prepared spirulina tablets have a long disintegration time and a great degree of decay of the β-carotene content. It can be seen that the specific selection of excipients and the granulation process will affect the comprehensive performance of the tablets.

[0239] By comparing Example 3 with Comparative Examples 7-8, it can be seen that the use of the first auxiliary material without pore size or the use of the unrestricted second auxiliary material will lead to obvious deterioration of the hardness and disintegration performance of the Spirulina tablets.

[0240] By comparing Example 3 and Comparative Example 9, it can be seen that the specific order of the two-step granulation also has a significant effect on the hardness and disintegration performance of the Spirulina tablets. First, granulation with the first auxiliary material and then granulation with the second auxiliary material is beneficial to improve the interaction between the first auxiliary material and the second auxiliary material, and adjust the molding performance and disintegration performance of the Spirulina tablets.

[0241] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0242] The above-mentioned embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the attached claims.

Claims

1. A method for preparing spirulina tablets, characterized in that: The spirulina tablet comprises spirulina, polyethylene glycol, a first auxiliary material and a second auxiliary material; The first auxiliary material comprises at least one of gel silicon powder, silicon dioxide, microcrystalline cellulose colloidal silicon dioxide co-processed product and micro powder silica gel; The second auxiliary material includes at least one of sugar alcohol, maltodextrin and microcrystalline cellulose; The preparation method of the spirulina tablets comprises the following steps: S1, first granulation: mixing the spirulina with the first auxiliary material, granulating, and preparing first granulated particles; S2, second granulation: mixing the first granulated particles with the second auxiliary materials, granulating, and preparing second granulated particles; S3: mixing the second granulated particles with the polyethylene glycol, and tableting to prepare the spirulina tablets.

2. The preparation method according to claim 1, characterized in that The spirulina tablets include, by weight: 75-85 parts of spirulina, 0.1-0.5 parts of polyethylene glycol, 3.8-10 parts of a first auxiliary material, and 7.5-15.5 parts of a second auxiliary material.

3. The preparation method according to claim 2, characterized in that: Calculated by weight, the spirulina tablets include: 75-85 parts of spirulina, 0.3-0.5 parts of polyethylene glycol, 4-10 parts of the first auxiliary material and 8.7-15.5 parts of the second auxiliary material.

4. The preparation method according to any one of claims 1 to 3, characterized in that: The sugar alcohol includes at least one of sorbitol, erythritol and mannitol.

5. The preparation method according to any one of claims 1 to 3, characterized in that: In step S1, the mixing conditions include: mixing time 40-100s, chopping speed 2-6r / s, stirring speed 20-60r / s.

6. The preparation method according to any one of claims 1 to 3, characterized in that: In step S1, the granulation is dry granulation; and / or in step S2, the granulation is wet granulation.

7. The preparation method according to any one of claims 1 to 3, characterized in that: In step S1, the granulation parameters include: screen aperture 0.1-1.0 mm, pressure of pressing wheel 5-7 MPa, granulation speed 500-600 rpm, and finished product particle size 0.1-0.5 mm.

8. The preparation method according to any one of claims 1 to 3, characterized in that: In step S2, the step of mixing the first granulated particles with the second auxiliary material specifically includes: spraying the second auxiliary material into the first granulated particles; and / or the parameters of the granulation include: air inlet speed: 100-500m 3 / h, bed temperature <37℃, spray speed 20-40 m 3 / h, sieve aperture 1-3mm.

9. The Spirulina tablets prepared by the preparation method according to any one of claims 1 to 8.

10. Use of the spirulina tablets according to claim 9 in preparing medicines or health products for improving the body's immune ability.

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