Sargassum pallidum polysaccharide effervescent tablet as well as preparation method and quality evaluation thereof

Abstract

The invention relates to the technical field of pharmaceutical preparations, and particularly discloses sargassum pallidum polysaccharide effervescent tablets as well as a preparation method and quality evaluation thereof. According to the effervescent tablet, sargassum pallidum polysaccharide is used as an active ingredient, anhydrous citric acid and sodium bicarbonate are used as an acid-base disintegrating agent, and dextrin, stevioside and polyethylene glycol 6000 are used as a filling agent, a flavoring agent and a lubricating agent respectively in cooperation with the sargassum pallidum polysaccharide. The preparation method comprises the following steps: respectively sieving the main drug and the acid-base disintegrating agent, granulating step by step according to a ratio, respectively drying to obtain acid granules and alkali granules, and finally mixing the acid granules and the alkali granules with the residual auxiliary materials, tabletting and forming. By optimizing and screening and controlling the tableting hardness range, the disintegration time limit of the obtained effervescent tablets meets the pharmacopoeia standard, the weight difference is qualified, and the effervescent tablets have good taste. According to the preparation method, the problems that traditional effervescent tablets are unstable in disintegration and poor in auxiliary material compatibility are effectively solved through scientific compatibility and process control, and the product has biological activity and taking compliance and meets the large-scale production requirement.

Description

Technical Field

[0001] The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to an artemisia seaweed polysaccharide effervescent tablet and a preparation method and quality evaluation thereof. Background Art

[0002] Sargassum pallidum, as an important marine brown algae resource, is rich in bioactive ingredients such as polysaccharides, polyphenols, and algin. Among them, Sargassum pallidum polysaccharides have attracted much attention in the fields of medicine and functional foods in recent years due to their significant pharmacological activities such as anti-oxidation, immunomodulation, anti-tumor and anti-inflammatory. Studies have confirmed that Sargassum pallidum polysaccharides can play a health-care role by scavenging free radicals, regulating immune cell functions, and have the potential to be developed into a new functional preparation. However, there are currently no products or research reports on Sargassum pallidum polysaccharide dosage forms.

[0003] As an innovative solid preparation, effervescent tablets are widely used in the fields of medicine and health care products due to their rapid disintegration, good taste and high bioavailability. The core preparation principle is to release carbon dioxide through the reaction of acid-base disintegrants (such as citric acid and sodium bicarbonate) in an aqueous environment, which promotes the rapid dispersion of tablets. However, the development of effervescent tablets faces multiple technical challenges: first, the ratio of acid and base components needs to be precisely controlled to ensure that the reaction efficiency and disintegration time meet the requirements of the pharmacopoeia; second, the physicochemical properties of the main drug ingredients (such as hygroscopicity and particle size) are prone to affect the stability and disintegration performance of the preparation; third, the selection of excipients needs to take into account fluidity, flavor correction effect and process feasibility to avoid problems such as sticking and cracking during tableting. In the prior art, there has been no systematic report on the study of sea wormwood polysaccharide effervescent tablets, and the prescription design of traditional effervescent tablets often has problems such as unstable disintegration time, insufficient taste coordination or lack of scientific optimization of process parameters (such as particle size and tablet hardness).

[0004] For example, some existing effervescent tablets have delayed disintegration or insufficient gas production due to an imbalance in the acid-base ratio, which affects the user experience; improper selection of fillers may cause poor material fluidity and increase production difficulty; and lax control of the particle size of the main drug can easily cause turbidity of the solution after disintegration or uneven release of active ingredients. In addition, the hygroscopic properties of polysaccharide ingredients put forward higher requirements for the storage stability of effervescent tablets, which need to be overcome through formulation and process optimization.

[0005] Based on the above background, the present invention aims to provide an artemisia seaweed polysaccharide effervescent tablet and a preparation method thereof, by systematically screening the acid-base disintegrant ratio, the types of flavoring agents and fillers, the amount of lubricant and key process parameters (such as sieve mesh number, tablet hardness), to solve the problems of unqualified disintegration time, poor taste, low production feasibility in the prior art, and finally obtain an effervescent tablet preparation that meets the pharmacopoeia standards, has excellent stability and is suitable for industrial production. Summary of the invention

[0006] The technical problem to be solved by the present invention is to provide a sea wormwood polysaccharide effervescent tablet and a preparation method and quality evaluation thereof in view of the deficiencies in the prior art.

[0007] In order to achieve the purpose of the present invention, the following technical means are specifically adopted:

[0008] A sea wormwood polysaccharide effervescent tablet, characterized in that it is composed of the following components by weight percentage:

[0009] Artemisia seaweed polysaccharide (main drug) 8-12%,

[0010] Anhydrous citric acid (disintegrant) 12-18%,

[0011] Sodium bicarbonate (disintegrant) 10-16%,

[0012] Polyethylene glycol 6000 (lubricant) 2-6%,

[0013] Stevioside (flavoring agent) 3-4%,

[0014] Dextrin (filler) balance;

[0015] The mass ratio of anhydrous citric acid to sodium bicarbonate is 1.2:1 to 1.4:1, and the total proportion of the two is 28-32%.

[0016] The sea wormwood polysaccharide effervescent tablet is characterized in that the sieve mesh number of the sea wormwood polysaccharide is 80 meshes, and its quality indicators meet the following requirements: polysaccharide content ≥50% (in terms of glucose), loss on drying ≤1%, residue on ignition ≤0.5%, heavy metal ≤10ppm, pesticide residue ≤2ppm, total bacteria count <1000CFU / g, mold and yeast <100CFU / g, and no detection of Salmonella and Escherichia coli.

[0017] The sea wormwood polysaccharide effervescent tablet is characterized in that the mass ratio of the anhydrous citric acid to the sodium bicarbonate is 1.3:1.

[0018] The sea wormwood polysaccharide effervescent tablet is characterized in that the tablet weight is 80-120 mg, the diameter is 5-7 mm, and the tablet hardness is 20-60N.

[0019] The preparation method of the Artemisia seagrass polysaccharide effervescent tablet is characterized by comprising the following steps:

[0020] (1) Passing sargassum polysaccharide, anhydrous citric acid and sodium bicarbonate through a 80-mesh sieve respectively;

[0021] (2) Mix 50% of the prescribed amount of Artemisia seagrass polysaccharide with anhydrous citric acid, add 95% ethanol to make a soft material, sieve through a 20-mesh sieve to granulate, dry at 55° C. until the water content is less than 1.5%, and granulate to obtain acid granules;

[0022] (3) mixing the remaining 50% of the seaweed polysaccharide with sodium bicarbonate, adding 95% ethanol to make a soft material, granulating through a 20-mesh sieve, drying at 55° C. until the moisture content is less than 1.5%, and granulating to obtain alkaline granules;

[0023] (4) Evenly mix dextrin, polyethylene glycol 6000, steviol glycoside, acid particles and alkali particles, and press into tablets.

[0024] The sea wormwood polysaccharide effervescent tablet is used in the preparation of health products or medicines with antioxidant or immunomodulatory functions. The sea wormwood polysaccharide described in the present invention is powdery, brown, has a polysaccharide content (in terms of glucose) of ≥50%, a drying loss of ≤1%, an ignition residue of ≤0.2%, heavy metals of ≤10ppm, pesticide residues of ≤2ppm, a total bacterial count of <1000CFU / g, molds and yeasts of <100CFU / g, no salmonella detected, and no Escherichia coli detected.

[0025] Beneficial Effects

[0026] Beneficial effects of the present invention:

[0027] 1. Optimize the formula to ensure product performance: The optimal prescription and process parameters were determined through systematic screening of key factors such as the ratio of acid-base disintegrants, the amount of flavoring agents added, the type of filler, the amount of lubricant added, the mesh size of sea wormwood polysaccharide sieve, and the tablet hardness range. The disintegration time of the prepared sea wormwood polysaccharide effervescent tablets meets the requirements of the 2020 edition of the "Chinese Pharmacopoeia". It disintegrates rapidly and can quickly release the active ingredients to ensure product quality and effectiveness. At the same time, the optimized formula also performs well in terms of taste and material fluidity. The taste score reaches a high level, and the material repose angle after total mixing is reasonable, which ensures the smooth progress of the production process and a good product experience.

[0028] 2. Provide a dosage form option for the development and application of sea wormwood polysaccharide. The present invention successfully prepares sea wormwood polysaccharide effervescent tablets through scientific and rigorous experiments, providing a convenient and highly advantageous option for the application of sea wormwood polysaccharide, opening up a new way for its wide application in the fields of medicine, health care products, etc., expanding the application scenarios of sea wormwood polysaccharide, and meeting the market demand for a convenient use form of sea wormwood polysaccharide. DETAILED DESCRIPTION

[0029] The technical solution of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all of the embodiments. The following description of at least one exemplary embodiment is actually only illustrative and is by no means intended to limit the present invention and its application or use. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0030] Description of the sea wormwood polysaccharide used in the present invention: the manufacturer is Shaanxi Mixianer Biotechnology Co., Ltd., the product batch number is: 2024.08.21, the polysaccharide content (calculated as glucose) is 50.1%, the drying loss is 0.54%, the ignition residue is 0.12%, the heavy metal is ≤10ppm, the pesticide residue is ≤2ppm, the total bacteria count is <1000CFU / g, the mold and yeast are <100CFU / g, Salmonella shall not be detected, and Escherichia coli shall not be detected.

[0031] Example 1

[0032] 1. The preliminary prescription is as follows:

[0033] Element effect Prescription ratio (%) Artemisia seaweed polysaccharide Main drug 10 dextrin Fillers 50 Polyethylene glycol 6000 Lubricants 6 Stevioside Flavoring agents 4 Anhydrous citric acid Acidic disintegrants 15.71 Sodium bicarbonate Alkaline disintegrants 14.29

[0034] 2. The preliminary preparation method is as follows:

[0035] Pass the polysaccharide of sea wormwood, anhydrous citric acid and sodium bicarbonate through an 80-mesh sieve respectively, and weigh the required prescription dosage respectively. Mix 50% of the prescription amount of polysaccharide of sea wormwood with citric acid, add an appropriate amount of 95% ethanol soft material, pass through a 20-mesh sieve, dry at 55°C under normal pressure until the granule moisture content is less than 1.5%, pass through a 20-mesh sieve to obtain acid granules; another 50% of polysaccharide of sea wormwood with sodium bicarbonate, add 95% ethanol soft material, pass through a 20-mesh sieve, dry at 55°C under normal pressure until the granule moisture content is less than 1.5%, pass through a 20-mesh sieve to obtain alkaline granules. Evenly mix dextrin, polyethylene glycol 6000, stevioside with the acid granules and alkaline granules, and press into tablets to obtain.

[0036] 3. The calculation and measurement methods of some evaluation indicators are as follows:

[0037] 3.1 Disintegration time

[0038] According to the 2020 edition of the "Chinese Pharmacopoeia" 0921 disintegration time limit test method: take 1 tablet and place it in a 250ml beaker (containing 200ml of water at a temperature of 20℃±5℃), and many bubbles will be released. When the gas around the tablet or fragment stops escaping, the tablet should be dissolved or dispersed in the water, and no aggregated particles will remain. Unless otherwise specified, check 6 tablets in the same way, and each tablet should disintegrate within 5 minutes. If 1 tablet cannot be completely disintegrated, another 6 tablets should be taken for retesting, and all should meet the requirements.

[0039] 3.2 Taste Rating

[0040] The effervescent tablet was placed in warm water to disintegrate completely. The ratio of the mass of the effervescent tablet to the amount of water used for disintegration was 1g:50ml. Three healthy volunteers aged 20-30 were selected to taste the effervescent solution and give an overall score of the taste, with a full score of 100, and the average score was taken.

[0041] Example 2

[0042] 1. Screening of acid-base disintegrant ratio

[0043] The total proportion of the acidic disintegrant (anhydrous citric acid) and the alkaline disintegrant (sodium bicarbonate) in the prescription was kept constant at 30%, and the disintegration time of the samples was investigated when the acid-base disintegrant ratio was 0.7:1, 0.9:1, 1.1:1 and 1.3:1. The experiment was carried out according to the above-mentioned preliminary preparation method, and the sea wormwood polysaccharide, anhydrous citric acid and sodium bicarbonate were sieved through 80 mesh sieves respectively, and the required prescription dosage was weighed respectively. 50% of the prescription amount of sea wormwood polysaccharide was mixed with citric acid, an appropriate amount of 95% ethanol-made soft material was added, sieved through 20 mesh sieves, dried at 55℃ at normal pressure until the granule moisture content was <1.5%, and granulated through 20 mesh sieves to obtain acid granules; the other 50% of the sea wormwood polysaccharide was mixed with sodium bicarbonate, 95% ethanol-made soft material was added, sieved through 20 mesh sieves, dried at 55℃ at normal pressure until the granule moisture content was <1.5%, and granulated through 20 mesh sieves to obtain alkaline granules. Mix dextrin, polyethylene glycol 6000, stevioside, acid particles and base particles evenly, the target tablet weight is 100 mg, the round tablet has a diameter of 6 mm, and the same tablet hardness range of 20-40N is controlled for different groups of samples, and the tablets are compressed to obtain the tablets. Compare the disintegration time of different groups of samples.

[0044] Acid-base disintegrant ratio Disintegration time 0.7：1 >5min 0.9：1 >5min 1.1：1 Two tablets failed to disintegrate completely within 5 minutes 1.3：1 <5min

[0045] Based on the above research results, the acid-base disintegrant ratio was determined to be 1.3:1.

[0046] 2. Screening of the amount of flavoring agent added

[0047] The effects of 3%, 4% and 5% flavoring agents on the disintegration time and taste of the product were compared, and the amount of filler was adjusted synchronously to keep the total amount of the prescription at 100%. The acid-base disintegrant ratio was 1.3:1. The experiment was carried out according to the above-mentioned preliminary preparation method. The sea wormwood polysaccharide, anhydrous citric acid and sodium bicarbonate were sieved through 80 mesh sieves, and the required prescription dosage was weighed respectively. 50% of the prescription amount of sea wormwood polysaccharide was mixed with citric acid, an appropriate amount of 95% ethanol was added to make a soft material, passed through a 20 mesh sieve, dried at 55℃ at normal pressure until the granule moisture content was less than 1.5%, and granulated through a 20 mesh sieve to obtain acid granules; the other 50% of the sea wormwood polysaccharide was mixed with sodium bicarbonate, 95% ethanol was added to make a soft material, passed through a 20 mesh sieve, dried at 55℃ at normal pressure until the granule moisture content was less than 1.5%, and granulated through a 20 mesh sieve to obtain alkaline granules. Mix dextrin, polyethylene glycol 6000, stevioside, acid particles and base particles evenly, the target tablet weight is 100 mg, the round tablet has a diameter of 6 mm, and different groups of samples have the same tablet hardness range of 20-40N, and tablets are obtained. Compare the disintegration time and taste of different groups of samples.

[0048] Flavoring agent added Disintegration time Taste 3％ <5min 85 4％ <5min 89.33 5％ >5min 88.67

[0049] According to the above investigation results, the amount of flavoring agent added has an impact on the disintegration time of the product, and the qualified range of flavoring agent addition is determined to be 3-4%. The flavoring agent addition amount is temporarily selected as 4% for subsequent research.

[0050] 3. Screening of filler types

[0051] Compare the effects of fillers mannitol, dextrin and lactose monohydrate on the fluidity (angle of repose) of the mixed material and the disintegration time of the final product. The optimal conditions investigated in the above experiment were used for this study. The ratio of acid-base disintegrant was 1.3:1, and the amount of flavoring agent added was 4%. The experiment was carried out according to the above preliminary preparation method. The polysaccharide of sea wormwood, anhydrous citric acid and sodium bicarbonate were sieved through 80 mesh sieves respectively, and the required prescription dosage was weighed respectively. 50% of the prescription amount of sea wormwood polysaccharide was mixed with citric acid, and an appropriate amount of 95% ethanol was added to make a soft material, and the mixture was sieved through a 20 mesh sieve. The mixture was dried at 55℃ and pressure until the moisture content of the particles was less than 1.5%, and the particles were sieved through a 20 mesh sieve to obtain acid particles; the other 50% of the sea wormwood polysaccharide was mixed with sodium bicarbonate, and a soft material of 95% ethanol was added to make a soft material, and the mixture was sieved through a 20 mesh sieve. The mixture was dried at 55℃ and pressure until the moisture content of the particles was less than 1.5%, and the particles were sieved through a 20 mesh sieve to obtain alkaline particles. The filler, polyethylene glycol 6000, stevioside, acid particles and base particles were mixed evenly, the target tablet weight was 100 mg, the round tablet had a diameter of 6 mm, and different groups of samples were controlled to have the same tablet hardness range of 20-40N, and tablets were obtained. The material fluidity after total mixing and the disintegration time of the compressed finished product of different groups of samples were compared.

[0052] Filler Type Disintegration time Angle of repose of materials after mixing Mannitol >5min 29.57° dextrin <5min 26.17° Lactose Monohydrate >5min 34.33°

[0053] According to the above research results, fillers have an impact on product disintegration time and material fluidity, and it is determined that the filler of this product is dextrin.

[0054] 4. Screening of lubricant addition amount

[0055] The addition amount of lubricant polyethylene glycol 6000 was 2%, 4% and 6%, respectively. The fluidity of the samples with different addition amounts after total mixing and the disintegration time of the finished product were compared, and the amount of filler was adjusted synchronously so that the total amount of the prescription was always kept at 100%. The optimal conditions investigated in the above experiment were used for this study. The ratio of acid-base disintegrant was 1.3:1, the amount of flavoring agent added was 4%, and the filler was dextrin. The experiment was carried out according to the above preliminary preparation method. The polysaccharide of Artemisia seagrass, anhydrous citric acid and sodium bicarbonate were sieved through 80 meshes respectively, and the required prescription amount was weighed respectively. Mix 50% of the prescribed amount of sea wormwood polysaccharide with citric acid, add an appropriate amount of 95% ethanol-made soft material, pass through a 20-mesh sieve, dry at 55°C at normal pressure until the granule moisture content is less than 1.5%, pass through a 20-mesh sieve to obtain acid granules; another 50% of sea wormwood polysaccharide is mixed with sodium bicarbonate, add 95% ethanol-made soft material, pass through a 20-mesh sieve, dry at 55°C at normal pressure until the granule moisture content is less than 1.5%, pass through a 20-mesh sieve to obtain alkaline granules. Mix fillers, polyethylene glycol 6000, stevioside, acid granules and alkaline granules evenly, the target tablet weight is 100 mg, the round tablet has a diameter of 6 mm, and different groups of samples control the same tablet hardness range of 20-40N, and tablet compression is performed. Compare the material fluidity after total mixing of different groups of samples and the disintegration time of the compressed finished products.

[0056] Lubricant addition amount Disintegration time Angle of repose of materials after mixing 2％ <5min 37.4° 4％ <5min 36.23° 6％ <5min 32.97°

[0057] According to the above research results, the addition amount of lubricant is in the range of 2-6%, the disintegration time of the prepared samples meets the standards of the Chinese Pharmacopoeia, and the fluidity of the materials after total mixing is good. It is determined that the addition amount of lubricant polyethylene glycol 6000 in this product is in the range of 2-6%. The addition amount of lubricant polyethylene glycol 6000 is temporarily selected as 6% for subsequent research.

[0058] 5. Screening of sieve mesh number of Artemisia seaweed polysaccharide

[0059] The sieve mesh of Artemisia seagrass polysaccharide was 40 mesh, 60 mesh and 80 mesh respectively, and the difference in disintegration time of samples prepared by Artemisia seagrass polysaccharide with different sieve mesh was investigated. The optimal conditions investigated in the above experiment were used for this study, the acid-base disintegrant ratio was 1.3:1, the flavoring agent was added in an amount of 4%, the filler was dextrin, and the lubricant polyethylene glycol 6000 was added in an amount of 6%. The experiment was carried out according to the above preliminary preparation method, Artemisia seagrass polysaccharide was sieved with different meshes, anhydrous citric acid and sodium bicarbonate were sieved with 80 mesh, and the required prescription dosage was weighed respectively. Mix 50% of the prescribed amount of sea wormwood polysaccharide with citric acid, add an appropriate amount of 95% ethanol-made soft material, pass through a 20-mesh sieve, dry at 55°C under normal pressure until the granule moisture content is less than 1.5%, pass through a 20-mesh sieve to obtain acid granules; another 50% of sea wormwood polysaccharide is mixed with sodium bicarbonate, add 95% ethanol-made soft material, pass through a 20-mesh sieve, dry at 55°C under normal pressure until the granule moisture content is less than 1.5%, pass through a 20-mesh sieve to obtain alkaline granules. Mix fillers, polyethylene glycol 6000, stevioside with acid granules and alkaline granules evenly, the target tablet weight is 100 mg, the round tablet has a diameter of 6 mm, and different groups of samples control the same tablet hardness range of 20-40N, and tablet compression is performed. Compare the disintegration time of different groups of samples.

[0060] Sieve mesh number of Artemisia seaweed polysaccharide Disintegration time 40 mesh >5min 60 mesh >5min 80 mesh <5min

[0061] According to the above research results, the sieve mesh number of Artemisia seaweed polysaccharide has an impact on the disintegration time of the product, and the sieve mesh number of Artemisia seaweed polysaccharide is determined to be 80 meshes.

[0062] 6. Screening of tablet hardness range

[0063] The disintegration time of the products with tablet hardness ranges of 20-40N, 40-60N and 60-80N was compared. The optimal conditions investigated in the above experiment were used for this study, with the acid-base disintegrant ratio of 1.3:1, the flavoring agent added in an amount of 4%, the filler being dextrin, the lubricant polyethylene glycol 6000 added in an amount of 6%, and the sea wormwood polysaccharide being sieved through an 80-mesh sieve. The experiment was carried out according to the above preliminary preparation method, and the anhydrous citric acid and sodium bicarbonate were sieved through an 80-mesh sieve respectively, and the required prescription dosage was weighed respectively. 50% of the prescription amount of sea wormwood polysaccharide is mixed with citric acid, an appropriate amount of 95% ethanol-made soft material is added, the mixture is passed through a 20-mesh sieve, dried at 55°C at normal pressure until the moisture content of the particles is less than 1.5%, and the particles are sieved through a 20-mesh sieve to obtain acid particles; the other 50% of sea wormwood polysaccharide is mixed with sodium bicarbonate, 95% ethanol-made soft material is added, the mixture is passed through a 20-mesh sieve, dried at 55°C at normal pressure until the moisture content of the particles is less than 1.5%, and the particles are sieved through a 20-mesh sieve to obtain alkaline particles. Fillers, polyethylene glycol 6000, and stevioside are mixed evenly with acid particles and alkaline particles, the target tablet weight is 100 mg, the tablet is round, and the diameter is 6 mm. The tablet hardness ranges of different groups of samples are 20-40N, 40-60N, and 60-80N, respectively, and the disintegration time of different groups of samples is compared.

[0064] Tablet hardness range Disintegration time 20-40N <5min 40-60N <5min 60-80N This hardness range cannot be pressed smoothly

[0065] According to the above results, for a round tablet weighing 100 mg and a diameter of 6 mm, the appropriate tablet hardness range is 20-60 N.

[0066] Example 3 Quality Evaluation

[0067] The best formulation and process investigated above were used to prepare samples for quality evaluation.

[0068] 1. Traits

[0069] This product is light brown round tablets with uneven dark spots on the surface; it tastes sweet.

[0070] 2. Weight Difference

[0071] The determination is carried out according to the requirements of the 2020 edition of the Chinese Pharmacopoeia. Take 20 tablets of the test sample, accurately weigh the total weight, and after obtaining the average tablet weight, accurately weigh each tablet separately. Compare the weight of each tablet with the average tablet weight. According to the provisions in the table, no more than 2 tablets shall exceed the weight difference limit, and no one tablet shall exceed the limit by 1 times.

[0072] Average tablet weight or stated tablet weight Weight Difference Limit 0.30g or less ±7.5％ 0.30g and above ±5％

[0073] 20 tablets were randomly sampled and the weighing results were as follows (all in g): 0.1091, 0.1081, 0.1021, 0.1025, 0.1066, 0.1111, 0.1073, 0.1112, 0.1093, 0.1093, 0.1092, 0.1044, 0.1125, 0.1099, 0.1125, 0.1099, 0.1127, 0.1059, 0.1044, 0.1043. After evaluation, the weight difference meets the requirements of the Chinese Pharmacopoeia.

[0074] 3. Disintegration time limit

[0075] According to the 2020 edition of the "Chinese Pharmacopoeia" 0921 disintegration time limit test method: take 1 tablet and place it in a 250ml beaker (containing 200ml of water at a temperature of 20℃±5℃), and many bubbles will be released. When the gas around the tablet or fragment stops escaping, the tablet should be dissolved or dispersed in the water, and no aggregated particles will remain. Unless otherwise specified, check 6 tablets in the same way, and each tablet should disintegrate within 5 minutes. If 1 tablet cannot be completely disintegrated, another 6 tablets should be taken for retesting, and all should meet the requirements.

[0076] Six tablets were randomly sampled and tested, and the disintegration time was less than 5 minutes, which meets the requirements of the Chinese Pharmacopoeia.

[0077] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A sea wormwood polysaccharide effervescent tablet, characterized in that: By weight percentage, it is composed of the following components: Artemisia seaweed polysaccharide (main drug) 8-12%, Anhydrous citric acid (disintegrant) 12-18%, Sodium bicarbonate (disintegrant) 10-16%, Polyethylene glycol 6000 (lubricant) 2-6%, Stevioside (flavoring agent) 3-4%, Dextrin (filler) balance; The mass ratio of anhydrous citric acid to sodium bicarbonate is 1.2:1 to 1.4:1, and the total proportion of the two is 28-32%.

2. The Artemisia seagrass polysaccharide effervescent tablet according to claim 1, characterized in that: The sieving mesh number of the sea wormwood polysaccharide is 80 meshes, and its quality indicators meet the following requirements: polysaccharide content ≥50% (in terms of glucose), loss on drying ≤1%, residue on ignition ≤0.5%, heavy metal ≤10ppm, pesticide residue ≤2ppm, total bacteria count <1000CFU / g, mold and yeast <100CFU / g, and no detection of Salmonella and Escherichia coli.

3. The Artemisia seagrass polysaccharide effervescent tablet according to claim 1, characterized in that: The mass ratio of the anhydrous citric acid to the sodium bicarbonate is 1.3:

1.

4. The Artemisia seagrass polysaccharide effervescent tablet according to claim 1, characterized in that: The effervescent tablet has a tablet weight of 80-120 mg, a diameter of 5-7 mm, and a tableting hardness of 20-60N.

5. A method for preparing the Artemisia seagrass polysaccharide effervescent tablet according to any one of claims 1 to 4, characterized in that: The following steps are involved: (1) Passing sargassum polysaccharide, anhydrous citric acid and sodium bicarbonate through a 80-mesh sieve respectively; (2) Mix 50% of the prescribed amount of Artemisia seagrass polysaccharide with anhydrous citric acid, add 95% ethanol to make a soft material, sieve through a 20-mesh sieve to granulate, dry at 55° C. until the water content is less than 1.5%, and granulate to obtain acid granules; (3) mixing the remaining 50% of the seaweed polysaccharide with sodium bicarbonate, adding 95% ethanol to make a soft material, granulating through a 20-mesh sieve, drying at 55° C. until the moisture content is less than 1.5%, and granulating to obtain alkaline granules; (4) Evenly mix dextrin, polyethylene glycol 6000, steviol glycoside, acid particles and alkali particles, and press into tablets.

6. Use of the Artemisia seagrass polysaccharide effervescent tablet according to any one of claims 1 to 5 in the preparation of health products or medicines with antioxidant or immunomodulatory functions.