Ezetimibe tablet and preparation method thereof

Abstract

The application belongs to the technical field of pharmaceutical preparations, and particularly relates to a ezetimibe tablet and a preparation method thereof. The formula of the ezetimibe tablet is as follows: ezetimibe, starch, dextrin, microcrystalline cellulose, neotame and magnesium stearate. The application solves the problems of easy decomposition of ezetimibe under light and low dissolution rate in the prior art by improving the formula of the ezetimibe tablet and the preparation process, and provides the ezetimibe tablet with high stability and high dissolution rate.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical preparation technology, specifically relating to an ezetimibe tablet and its preparation method. Background Technology

[0002] The information disclosed in this background section is intended only to enhance understanding of the overall background of the invention and is not necessarily to be construed as an admission or in any way implying that such information constitutes prior art known to those skilled in the art.

[0003] Primary hypercholesterolemia (PHH) is a lipid metabolism disorder caused by genetic or environmental factors, primarily characterized by elevated plasma total cholesterol (TC) or low-density lipoprotein cholesterol (LDL-C). PHH has a serious impact on patients' health and quality of life, with the following harms: 1. Increased risk of cardiovascular disease: High cholesterol is one of the main risk factors for atherosclerosis, increasing the incidence and mortality of cardiovascular diseases such as heart disease and stroke. 2. Inducing fatty liver: Long-term high cholesterol can damage liver function, affecting the metabolic and excretory functions of hepatocytes through blood circulation, as well as the production and excretion of bile acids, leading to fatty liver and even serious diseases such as cirrhosis and liver cancer. 3. Affecting reproductive capacity: High cholesterol is related to the metabolism of sex hormones; long-term high cholesterol can affect the synthesis and metabolism of sex hormones, affecting sperm reproduction and maturation, ultimately impacting male fertility. 4. Damaging the kidneys: High cholesterol can cause the deposition of glomerulonephrine and other aggregates in the kidneys, leading to diseases such as nephritis and nephrotic syndrome. 5. Increased risk of malignant tumors: High cholesterol is associated with the development of malignant tumors such as colorectal cancer, breast cancer, and prostate cancer. Severe high cholesterol can increase the risk of developing these malignant tumors.

[0004] Ezetimibe, developed by a pharmaceutical company, is a lipid-lowering drug that received FDA approval in the United States several years ago. Clinically, it is mainly used to treat primary hypercholesterolemia and homozygous familial hypercholesterolemia. Its advantages are mainly reflected in the following aspects: 1. Inhibition of cholesterol absorption: Ezetimibe is a cholesterol absorption inhibitor that can attach to the edge of the small intestinal villi, inhibiting cholesterol absorption and thus reducing the transport of cholesterol from the small intestine to the liver, thereby reducing the amount of cholesterol stored in the liver. 2. Lowering blood lipid levels: By inhibiting cholesterol absorption, ezetimibe can lower the levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B in plasma, controlling blood lipids within the target range. 3. Prevention of complications: If primary hypercholesterolemia is not treated promptly and properly, it may lead to serious consequences such as coronary atherosclerotic heart disease, cerebrovascular disease, peripheral vascular disease, myocardial infarction, and cerebral infarction. Ezetimibe can reduce the risk of vascular blockage and play a role in preventing complications of hypercholesterolemia. 4. High safety profile: Ezetimibe has demonstrated a high safety profile in clinical applications with relatively few side effects.

[0005] However, ezetimibe also has drawbacks, such as low oral bioavailability, which affects its efficacy; it is easily decomposed by light, and ezetimibe will undergo chemical changes such as decomposition or oxidation under light, which will reduce the efficacy of the drug or produce harmful substances.

[0006] Chinese patent CN109718215A discloses an ezetimibe sheet composed of the following ingredients by weight percentage: 10% ezetimibe, 55-60% lactose, 15-20% microcrystalline cellulose, 4-8% croscarmellose sodium, 3-5% povidone K30, 2-3% sodium dodecyl sulfate, 0.5-1% magnesium stearate, and 0.5-1% micronized silica, which improves the dissolution of ezetimibe.

[0007] Chinese patent CN105213342A discloses an ezetimibe tablet composed of the following components: ezetimibe: 100-200g, lactose: 600-1200g, microcrystalline cellulose PH101: 50-100g, croscarmellose sodium: 50-100g, sodium dodecyl sulfate: 1-2g, polyvinylpyrrolidone K30: 2-4g, magnesium stearate: 0.5-1g, and wetting agent: 40-80g. This reduces the fluctuation in the dissolution rate of the ezetimibe tablet.

[0008] While existing technologies have addressed the issue of low ezetimibe dissolution to some extent, the problem of ezetimibe's easy decomposition upon exposure to light remains unresolved. Summary of the Invention

[0009] Overcoming the shortcomings of existing technologies, this invention improves the formulation and preparation process of ezetimibe tablets, solving the problems of easy decomposition of ezetimibe upon exposure to light and low dissolution in existing technologies, and provides an ezetimibe tablet with high stability and high dissolution.

[0010] The technical solution of the present invention is as follows: The first objective of this invention is to provide a formulation for ezetimibe tablets, comprising: ezetimibe, starch, dextrin, microcrystalline cellulose, neotame, and magnesium stearate.

[0011] In several embodiments, the formulation of the ezetimibe sheet is as follows: 10 parts by weight of Ezekiel 120-280 parts by weight of starch 30-60 parts by weight of dextrin 3-7 parts by weight of microcrystalline cellulose Neotame 0.1~1 part by weight Magnesium stearate 0.2~2 parts by weight.

[0012] In one embodiment, the formulation of the ezetimibe sheet is as follows: 10 parts by weight of Ezekiel 180 parts by weight of starch 45 parts by weight of dextrin 5 parts by weight of microcrystalline cellulose Neotame 0.3 parts by weight 1 part by weight of magnesium stearate.

[0013] In one embodiment, the formulation of the ezetimibe sheet is as follows: 10 parts by weight of Ezekiel 150 parts by weight of starch 35 parts by weight of dextrin 4 parts by weight of microcrystalline cellulose Neotame 0.2 parts by weight 0.6 parts by weight of magnesium stearate.

[0014] In one embodiment, the formulation of the ezetimibe sheet is as follows: 10 parts by weight of Ezekiel 230 parts by weight of starch 55 parts by weight of dextrin 6 parts by weight of microcrystalline cellulose Neotame 0.6 parts by weight 1.5 parts by weight of magnesium stearate.

[0015] A second objective of this invention is a method for preparing the above-mentioned ezetimibe sheet, the method comprising the following steps: (1) Mix ezetimibe, microcrystalline cellulose and neotame to make mixture A; (2) Mix the mixture A obtained in step (1) with an appropriate amount of purified water, granulate, dry, and granulate to obtain drug granules A; (3) Crush starch and dextrin, pass through an 80-mesh sieve, add an appropriate amount of water, mix, granulate, dry, and granulate to obtain drug granules B; (4) Mix drug A and drug B, add magnesium stearate, mix, compress into tablets, and obtain ezetimibe tablets.

[0016] Further, step (1) is: pulverize ezetimibe, microcrystalline cellulose and neotame together, pass through an 80-mesh sieve to make mixture A.

[0017] Furthermore, the temperature of the purified water in step (2) is 30℃~40℃.

[0018] Furthermore, the ezetimibe tablets are in the specification of 10mg.

[0019] In several embodiments, the ezetimibe tablets may also contain at least one of fenofibrate, gemfibrozil, cholestyramine, cimetidine, glipizide, lovastatin, pravastatin, atorvastatin, rosuvastatin, and fluvastatin for combination therapy.

[0020] Compared with the prior art, the beneficial effects of the present invention are as follows: This invention overcomes the defects of ezetimibe being easily decomposed and oxidized by light by improving the formulation of ezetimibe tablets, especially by adding a certain proportion of microcrystalline cellulose and neotame, and by improving the preparation method and adjusting the mixing order of excipients. It also solves the problems of unstable ezetimibe content and low dissolution in ezetimibe tablets, and provides an ezetimibe tablet with high dissolution and high stability. Attached Figure Description

[0021] Figure 1 Dissolution curves of ezetimibe tablets in Examples 1-5 and Comparative Examples 1-6.

[0022] Figure 2 Content changes of ezetimibe tablets in Examples 1-5 and Comparative Examples 1-6 under light irradiation test. Detailed Implementation

[0023] To make the objectives and technical solutions of this invention clearer, the following embodiments are provided for further explanation. However, the scope of protection of this invention is not limited to these embodiments; the embodiments are merely for illustrative purposes. Those skilled in the art should understand that any changes or equivalent substitutions that do not depart from the inventive concept are included within the scope of protection of this invention. It should be noted that the following detailed descriptions are illustrative and intended to provide further explanation of this application. Unless otherwise specified, all technical and scientific terms used in this application have the same meaning as commonly understood by those skilled in the art to which this application pertains.

[0024] Example 1: Izzy Wheat Sheet formula: 10 parts by weight of Ezekiel 180 parts by weight of starch 45 parts by weight of dextrin 5 parts by weight of microcrystalline cellulose Neotame 0.3 parts by weight 1 part by weight of magnesium stearate Preparation method: (1) Ezetamib, microcrystalline cellulose and neotame are pulverized together and passed through an 80-mesh sieve to make mixture A; (2) Mix the mixture A obtained in step (1) with an appropriate amount of purified water at 30℃~40℃, granulate, dry, and granulate to obtain drug granules A; (3) Crush starch and dextrin, pass through an 80-mesh sieve, add an appropriate amount of water, mix, granulate, dry, and granulate to obtain drug granules B; (4) Mix drug A and drug B, add magnesium stearate, mix, compress into tablets, and obtain ezetimibe tablets.

[0025] Example 2: Izzy Wheat Sheet formula: 10 parts by weight of Ezekiel 150 parts by weight of starch 35 parts by weight of dextrin 4 parts by weight of microcrystalline cellulose Neotame 0.2 parts by weight 0.6 parts by weight of magnesium stearate Preparation method: (1) Ezetamib, microcrystalline cellulose and neotame are pulverized together and passed through an 80-mesh sieve to make mixture A; (2) Mix the mixture A obtained in step (1) with an appropriate amount of purified water at 30℃~40℃, granulate, dry, and granulate to obtain drug granules A; (3) Crush starch and dextrin, pass through an 80-mesh sieve, add an appropriate amount of water, mix, granulate, dry, and granulate to obtain drug granules B; (4) Mix drug A and drug B, add magnesium stearate, mix, compress into tablets, and obtain ezetimibe tablets.

[0026] Example 3: Izzy Wheat Sheet formula: 10 parts by weight of Ezekiel 230 parts by weight of starch 55 parts by weight of dextrin 6 parts by weight of microcrystalline cellulose Neotame 0.6 parts by weight 1.5 parts by weight of magnesium stearate Preparation method: (1) Ezetamib, microcrystalline cellulose and neotame are pulverized together and passed through an 80-mesh sieve to make mixture A; (2) Mix the mixture A obtained in step (1) with an appropriate amount of purified water at 30℃~40℃, granulate, dry, and granulate to obtain drug granules A; (3) Crush starch and dextrin, pass through an 80-mesh sieve, add an appropriate amount of water, mix, granulate, dry, and granulate to obtain drug granules B; (4) Mix drug A and drug B, add magnesium stearate, mix, compress into tablets, and obtain ezetimibe tablets.

[0027] Example 4: Izzy Wheat Sheet formula: 10 parts by weight of Ezekiel 120 parts by weight of starch 30 parts by weight of dextrin 3 parts by weight of microcrystalline cellulose Neotame 0.1 parts by weight 0.2 parts by weight of magnesium stearate Preparation method: (1) Ezetamib, microcrystalline cellulose and neotame are pulverized together and passed through an 80-mesh sieve to make mixture A; (2) Mix the mixture A obtained in step (1) with an appropriate amount of purified water at 30℃~40℃, granulate, dry, and granulate to obtain drug granules A; (3) Crush starch and dextrin, pass through an 80-mesh sieve, add an appropriate amount of water, mix, granulate, dry, and granulate to obtain drug granules B; (4) Mix drug A and drug B, add magnesium stearate, mix, compress into tablets, and obtain ezetimibe tablets.

[0028] Example 5: Izzy Wheat Sheet formula: 10 parts by weight of Ezekiel 280 parts by weight of starch 60 parts by weight of dextrin 7 parts by weight of microcrystalline cellulose 1 serving of neotame 2 parts by weight of magnesium stearate Preparation method: (1) Ezetamib, microcrystalline cellulose and neotame are pulverized together and passed through an 80-mesh sieve to make mixture A; (2) Mix the mixture A obtained in step (1) with an appropriate amount of purified water at 30℃~40℃, granulate, dry, and granulate to obtain drug granules A; (3) Crush starch and dextrin, pass through an 80-mesh sieve, add an appropriate amount of water, mix, granulate, dry, and granulate to obtain drug granules B; (4) Mix drug A and drug B, add magnesium stearate, mix, compress into tablets, and obtain ezetimibe tablets.

[0029] Example 6: Izzy Wheat Sheet formula: 10 parts by weight of Ezekiel 10 parts by weight of glipizide 180 parts by weight of starch 45 parts by weight of dextrin 5 parts by weight of microcrystalline cellulose Neotame 0.3 parts by weight 1 part by weight of magnesium stearate Preparation method: (1) Ezetimibe, glipizide, microcrystalline cellulose and neotame are pulverized together and passed through an 80-mesh sieve to make mixture A; (2) Mix the mixture A obtained in step (1) with an appropriate amount of purified water at 30℃~40℃, granulate, dry, and granulate to obtain drug granules A; (3) Crush starch and dextrin, pass through an 80-mesh sieve, add an appropriate amount of water, mix, granulate, dry, and granulate to obtain drug granules B; (4) Mix drug A and drug B, add magnesium stearate, mix, compress into tablets, and obtain ezetimibe tablets.

[0030] Example 7: Izzy Wheat Sheet formula: 10 parts by weight of Ezekiel Lovastatin 10 parts by weight 180 parts by weight of starch 45 parts by weight of dextrin 5 parts by weight of microcrystalline cellulose Neotame 0.3 parts by weight 1 part by weight of magnesium stearate Preparation method: (1) Ezetimibe, lovastatin, microcrystalline cellulose and neotame are pulverized together and passed through an 80-mesh sieve to make mixture A; (2) Mix the mixture A obtained in step (1) with an appropriate amount of purified water at 30℃~40℃, granulate, dry, and granulate to obtain drug granules A; (3) Crush starch and dextrin, pass through an 80-mesh sieve, add an appropriate amount of water, mix, granulate, dry, and granulate to obtain drug granules B; (4) Mix drug A and drug B, add magnesium stearate, mix, compress into tablets, and obtain ezetimibe tablets.

[0031] Example 8: Izzy Wheat Sheet formula: 10 parts by weight of Ezekiel Pravastatin 10 parts by weight 180 parts by weight of starch 45 parts by weight of dextrin 5 parts by weight of microcrystalline cellulose Neotame 0.3 parts by weight 1 part by weight of magnesium stearate Preparation method: (1) Ezetimibe, pravastatin, microcrystalline cellulose and neotame are pulverized together and passed through an 80-mesh sieve to make mixture A; (2) Mix the mixture A obtained in step (1) with an appropriate amount of purified water at 30℃~40℃, granulate, dry, and granulate to obtain drug granules A; (3) Crush starch and dextrin, pass through an 80-mesh sieve, add an appropriate amount of water, mix, granulate, dry, and granulate to obtain drug granules B; (4) Mix drug A and drug B, add magnesium stearate, mix, compress into tablets, and obtain ezetimibe tablets.

[0032] Example 9: Izzy Wheat Sheet formula: 10 parts by weight of Ezekiel Atorvastatin 10 weight doses 180 parts by weight of starch 45 parts by weight of dextrin 5 parts by weight of microcrystalline cellulose Neotame 0.3 parts by weight 1 part by weight of magnesium stearate Preparation method: (1) Ezetimibe, atorvastatin, microcrystalline cellulose and neotame are pulverized together and passed through an 80-mesh sieve to make mixture A; (2) Mix the mixture A obtained in step (1) with an appropriate amount of purified water at 30℃~40℃, granulate, dry, and granulate to obtain drug granules A; (3) Crush starch and dextrin, pass through an 80-mesh sieve, add an appropriate amount of water, mix, granulate, dry, and granulate to obtain drug granules B; (4) Mix drug A and drug B, add magnesium stearate, mix, compress into tablets, and obtain ezetimibe tablets.

[0033] Example 10: Izzy Wheat Sheet formula: 10 parts by weight of Ezekiel 10 parts by weight of rosuvastatin 180 parts by weight of starch 45 parts by weight of dextrin 5 parts by weight of microcrystalline cellulose Neotame 0.3 parts by weight 1 part by weight of magnesium stearate Preparation method: (1) Ezetimibe, rosuvastatin, microcrystalline cellulose and neotame are pulverized together and passed through an 80-mesh sieve to make mixture A; (2) Mix the mixture A obtained in step (1) with an appropriate amount of purified water at 30℃~40℃, granulate, dry, and granulate to obtain drug granules A; (3) Crush starch and dextrin, pass through an 80-mesh sieve, add an appropriate amount of water, mix, granulate, dry, and granulate to obtain drug granules B; (4) Mix drug A and drug B, add magnesium stearate, mix, compress into tablets, and obtain ezetimibe tablets.

[0034] Example 11: Ezreal wheat cloth sheet formula: 10 parts by weight of Ezekiel 10 parts by weight of fluvastatin 180 parts by weight of starch 45 parts by weight of dextrin 5 parts by weight of microcrystalline cellulose Neotame 0.3 parts by weight 1 part by weight of magnesium stearate Preparation method: (1) Ezetimibe, fluvastatin, rosuvastatin, microcrystalline cellulose and neotame are pulverized together and passed through an 80-mesh sieve to make mixture A; (2) Mix the mixture A obtained in step (1) with an appropriate amount of purified water at 30℃~40℃, granulate, dry, and granulate to obtain drug granules A; (3) Crush starch and dextrin, pass through an 80-mesh sieve, add an appropriate amount of water, mix, granulate, dry, and granulate to obtain drug granules B; (4) Mix drug A and drug B, add magnesium stearate, mix, compress into tablets, and obtain ezetimibe tablets.

[0035] Example 12: Izzy Wheat Sheet formula: 10 parts by weight of Ezekiel 200 parts by weight of fenofibrate 120 parts by weight of starch 30 parts by weight of dextrin 3 parts by weight of microcrystalline cellulose Neotame 0.1 parts by weight 0.2 parts by weight of magnesium stearate Preparation method: (1) Ezetamib, microcrystalline cellulose and neotame are pulverized together and passed through an 80-mesh sieve to make mixture A; (2) Mix the mixture A obtained in step (1) with an appropriate amount of purified water at 30℃~40℃, granulate, dry, and granulate to obtain drug granules A; (3) Crush starch and dextrin, pass through an 80-mesh sieve, add an appropriate amount of water, mix, granulate, dry, and granulate to obtain drug granules B; (4) Mix drug A and drug B, add magnesium stearate, mix, compress into tablets, and obtain ezetimibe tablets.

[0036] Comparative Example 1: Ezraquinone tablets formula: 10 parts by weight of Ezekiel 180 parts by weight of starch 45 parts by weight of dextrin 5 parts by weight of microcrystalline cellulose 1 part by weight of magnesium stearate Preparation method: (1) Pulverize ezetimibe and microcrystalline cellulose together and pass them through an 80-mesh sieve to make mixture A; (2) Mix the mixture A obtained in step (1) with an appropriate amount of purified water at 30℃~40℃, granulate, dry, and granulate to obtain drug granules A; (3) Crush starch and dextrin, pass through an 80-mesh sieve, add an appropriate amount of water, mix, granulate, dry, and granulate to obtain drug granules B; (4) Mix drug A and drug B, add magnesium stearate, mix, compress into tablets, and obtain ezetimibe tablets.

[0037] Comparative Example 2: Ezreal Meal formula: 10 parts by weight of Ezekiel 180 parts by weight of starch 45 parts by weight of dextrin Neotame 0.3 parts by weight 1 part by weight of magnesium stearate Preparation method: (1) Grind ezetimibe and neotame together, pass through an 80-mesh sieve, and make mixture A; (2) Mix the mixture A obtained in step (1) with an appropriate amount of purified water at 30℃~40℃, granulate, dry, and granulate to obtain drug granules A; (3) Crush starch and dextrin, pass through an 80-mesh sieve, add an appropriate amount of water, mix, granulate, dry, and granulate to obtain drug granules B; (4) Mix drug A and drug B, add magnesium stearate, mix, compress into tablets, and obtain ezetimibe tablets.

[0038] Comparative Example 3: Ezraquinone tablets formula: 10 parts by weight of Ezekiel 180 parts by weight of starch 45 parts by weight of dextrin 5 parts by weight of microcrystalline cellulose 0.3 parts by weight of sucralose 1 part by weight of magnesium stearate Preparation method: (1) Ezetimibe, microcrystalline cellulose and sucralose are pulverized together and passed through an 80-mesh sieve to make mixture A; (2) Mix the mixture A obtained in step (1) with an appropriate amount of purified water at 30℃~40℃, granulate, dry, and granulate to obtain drug granules A; (3) Crush starch and dextrin, pass through an 80-mesh sieve, add an appropriate amount of water, mix, granulate, dry, and granulate to obtain drug granules B; (4) Mix drug A and drug B, add magnesium stearate, mix, compress into tablets, and obtain ezetimibe tablets.

[0039] Comparative Example 4: Ezraquinone tablets formula: 10 parts by weight of Ezekiel 180 parts by weight of starch 45 parts by weight of dextrin 2 parts by weight of microcrystalline cellulose 2 servings of neotame 1 part by weight of magnesium stearate Preparation method: (1) Ezetamib, microcrystalline cellulose and neotame are pulverized together and passed through an 80-mesh sieve to make mixture A; (2) Mix the mixture A obtained in step (1) with an appropriate amount of purified water at 30℃~40℃, granulate, dry, and granulate to obtain drug granules A; (3) Crush starch and dextrin, pass through an 80-mesh sieve, add an appropriate amount of water, mix, granulate, dry, and granulate to obtain drug granules B; (4) Mix drug A and drug B, add magnesium stearate, mix, compress into tablets, and obtain ezetimibe tablets.

[0040] Comparative Example 5: Ez-folded wheat flakes formula: 10 parts by weight of Ezekiel 180 parts by weight of starch 45 parts by weight of dextrin 5 parts by weight of microcrystalline cellulose Neotame 0.3 parts by weight 1 part by weight of magnesium stearate Preparation method: (1) Mix ezetimibe, microcrystalline cellulose, neotame, starch and dextrin, pass through an 80-mesh sieve, mix with an appropriate amount of purified water, granulate, dry and granulate to obtain drug granules; (2) Mix the granules with magnesium stearate and compress them into tablets to obtain ezetimibe tablets.

[0041] Comparative Example 6: Ezetimibe tablets (Approval No. H20130837) Examples and comparative examples based on the dissolution rate of ozonated tebufenozide tablets Examples 1-12 (ezetimibe tablets) and Comparative Examples 1-6 (ezetimibe tablets) were tested according to the method under item 0931 of Part IV of the 2020 edition of the Chinese Pharmacopoeia. The method was paddle method, temperature 37°C, rotation speed 50 rpm, and dissolution medium was 500 ml of 0.1 M hydrochloric acid solution containing 0.45% sodium dodecyl sulfate. The detection was performed using a UV detector at a wavelength of 233 nm.

[0042] Figure 1 The dissolution curves of Ezetimibe tablets in Examples 1-5 and Comparative Examples 1-6 show that the dissolution fluctuations of Ezetimibe tablets in Examples 1-5 of the present invention are small and the dissolution rate is high. The dissolution curves of Ezetimibe tablets in Examples 6-12 of the present invention are similar, and no dissolution fluctuations are observed. The dissolution rate at 30 min is greater than 95%.

[0043] Examples and comparative examples: stability of folded tebufen sheets Light test Ezetimibe tablets from Examples 1-12 and Comparative Examples 1-6 were used as test samples and placed in a light box equipped with fluorescent lamps at an illuminance of 4500 lx ± 500 lx for 60 days. Samples were taken on days 0, 10, 20, 30, and 60, and the ezetimibe content was determined according to the method described above. The ezetimibe content was determined according to the method under the content determination section of the quality standard "Imported Drug Registration Standard JX20030223".

[0044] Figure 2The graphs show the content changes of ezetimibe tablets in Examples 1-5 and Comparative Examples 1-6 under light exposure. The results show that the ezetimibe content of the present invention is stable; during the light exposure test, the ezetimibe content remained essentially unchanged, with virtually no decomposition or oxidation. It should be noted that the test results of the ezetimibe tablets in Examples 6-12 are basically similar to those in Examples 1-5, with the ezetimibe content remaining stable in all cases.

Claims

1. A type of folded wheat cloth sheet, characterized in that, The components of the ezetimibe sheet are: 10 parts by weight of Ezekiel 120-280 parts by weight of starch 30-60 parts by weight of dextrin 3-7 parts by weight of microcrystalline cellulose Neotame 0.1~1 part by weight Magnesium stearate 0.2~2 parts by weight; The preparation method of the ezetimibe sheet includes the following steps: (1) Mix ezetimibe, microcrystalline cellulose and neotame to make mixture A; (2) Mix the mixture A obtained in step (1) with an appropriate amount of purified water, granulate, dry, and granulate to obtain drug granules A; (3) Crush starch and dextrin, pass through an 80-mesh sieve, add an appropriate amount of water, mix, granulate, dry, and granulate to obtain drug granules B; (4) Mix drug A and drug B, add magnesium stearate, mix, compress into tablets, and obtain ezetimibe tablets.

2. The ezetavib sheet according to claim 1, characterized in that, The components of the ezetimibe sheet are: 10 parts by weight of Ezekiel 180 parts by weight of starch 45 parts by weight of dextrin 5 parts by weight of microcrystalline cellulose Neotame 0.3 parts by weight 1 part by weight of magnesium stearate.

3. The ezorhab sheet according to claim 1, characterized in that, The components of the ezetimibe sheet are: 10 parts by weight of Ezekiel 150 parts by weight of starch 35 parts by weight of dextrin 4 parts by weight of microcrystalline cellulose Neotame 0.2 parts by weight 0.6 parts by weight of magnesium stearate.

4. The ezetavib sheet according to claim 1, characterized in that, The components of the ezetimibe sheet are: 10 parts by weight of Ezekiel 230 parts by weight of starch 55 parts by weight of dextrin 6 parts by weight of microcrystalline cellulose Neotame 0.6 parts by weight 1.5 parts by weight of magnesium stearate.

5. The ezetavib sheet according to claim 1, characterized in that, Step (1) is as follows: Ezetamib, microcrystalline cellulose and neotame are pulverized together and passed through an 80-mesh sieve to make mixture A.

6. The ezetavib sheet according to claim 1, characterized in that, The temperature of the purified water in step (2) is 30℃~40℃.

7. The ezetavib sheet according to claim 1, characterized in that, The ezetimibe tablets are in the specification of 10mg.

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