Preparation method of telmisartan tablet

Abstract

The invention provides a preparation method of telmisartan tablets, which is characterized by comprising the following steps: mixing telmisartan, a pH regulator, a solubilizer and povidone with water to prepare a solution, then freeze-drying the solution, mixing the freeze-dried material with a filler, then mixing with a lubricant, and tabletting to obtain the telmisartan tablets. Through the synergistic effect of the prescription and the preparation method, the material dried by the freeze-drying method can maintain the original chemical composition and physical property, and the prepared telmisartan tablet has the advantages of stable quality, good dissolution behavior, no influence of the raw material telmisartan crystal form, crystal lump and particle size on the process smoothness, high yield, long-term storage, and no toxic or side effect. The method is suitable for large-scale production.

Description

Technical Field

[0001] The invention belongs to the technical field of medicine, and particularly relates to a preparation method of telmisartan tablets. Background Art

[0002] Telmisartan tablets are an oral non-peptide angiotensin II (AT II) receptor antagonist developed by Boehringer Ingelheim International GmbH of Germany. It is approved for the treatment of hypertension and coronary heart disease.

[0003] Telmisartan is highly lipophilic and insoluble in water, which results in complication of the preparation process of telmisartan tablets or low solubility and poor efficacy of telmisartan tablets. In the prior art, telmisartan salt solutions are obtained by adding sodium hydroxide or potassium hydroxide aqueous solution to telmisartan, so that insoluble telmisartan is converted into an alkali metal salt soluble in water, and then telmisartan tablets are prepared by spray drying granulation, wet granulation, or direct mixing processes. However, these preparation methods either have the problem of low yield or have unstable process, and the problems such as large dissolution differences within and between batches are present. Summary of the Invention

[0004] The purpose of the present invention is to overcome the deficiencies of the prior art and provide a method for preparing telmisartan tablets with high yield and stable process.

[0005] In order to solve the above technical problems, the present invention adopts the following technical solutions:

[0006] The invention provides a preparation method of telmisartan tablets. The method comprises the following steps: mixing telmisartan, a pH regulator, a solubilizer and povidone with water to prepare a solution; freeze-drying the solution; mixing the freeze-dried material with a filler and a lubricant; and tableting the mixture to prepare the telmisartan tablets.

[0007] According to some specific embodiments, the pH adjuster is one or more of sodium hydroxide, potassium hydroxide, sodium bicarbonate, sodium carbonate, and calcium hydroxide.

[0008] Furthermore, the pH regulator is sodium hydroxide or potassium hydroxide.

[0009] According to some specific embodiments, the solubilizer is one or more of meglumine, sodium lauryl sulfate, cyclodextrin, polyethylene glycol, Tween, and lecithin.

[0010] Furthermore, the solubilizing agent is meglumine.

[0011] According to some specific embodiments, the filler is one or more of sorbitol, microcrystalline cellulose, lactose, and pregelatinized starch.

[0012] Furthermore, the filler is sorbitol.

[0013] According to some specific embodiments, the lubricant is one or more of magnesium stearate, stearic acid, calcium stearate, and hydrogenated castor oil.

[0014] Furthermore, the lubricant is magnesium stearate.

[0015] According to some specific embodiments, the mass of the pH regulator accounts for 0.5%-5% of the mass of the telmisartan tablet. Further, the mass of the pH regulator accounts for 0.5%-3% of the mass of the telmisartan tablet. Still further, the mass of the pH regulator accounts for 1%-2% of the mass of the telmisartan tablet, for example, 1%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2%, etc.

[0016] According to some specific embodiments, the mass of the solubilizer accounts for 2%-10% of the mass of the telmisartan tablet. Further, the mass of the solubilizer accounts for 2%-8% of the mass of the telmisartan tablet. Further, the mass of the solubilizer accounts for 3%-7% of the mass of the telmisartan tablet, for example, 3%, 3.1%, 3.2%, 3.3%, 3.4%, 3.5%, 3.6%, 3.7%, 3.8%, 3.9%, 4%, 4.1%, 4.2%, 4.3%, 4.4%, 4.5%, 4.6%, 4.7%, 4.8%, 4.9%, 5%, 5.1%, 5.2%, 5.3%, 5.4%, 5.5%, 5.6%, 5.7%, 5.8%, 5.9%, 6%, 6.1%, 6.2%, 6.3%, 6.4%, 6.5%, 6.6%, 6.7%, 6.8%, 6.9% or 7%, etc.

[0017] According to some specific embodiments, the mass of the povidone accounts for 2%-10% of the mass of the telmisartan tablet. Further, the mass of the povidone accounts for 2%-8% of the mass of the telmisartan tablet. Furthermore, the mass of the povidone accounts for 3%-7% of the mass of the telmisartan tablet, for example, 3%, 3.1%, 3.2%, 3.3%, 3.4%, 3.5%, 3.6%, 3.7%, 3.8%, 3.9%, 4%, 4.1%, 4.2%, 4.3%, 4.4%, 4.5%, 4.6%, 4.7%, 4.8%, 4.9%, 5%, 5.1%, 5.2%, 5.3%, 5.4%, 5.5%, 5.6%, 5.7%, 5.8%, 5.9%, 6%, 6.1%, 6.2%, 6.3%, 6.4%, 6.5%, 6.6%, 6.7%, 6.8%, 6.9% or 7%, etc.

[0018] According to some specific embodiments, the mass of the filler accounts for 40%-80% of the mass of the telmisartan tablet. Further, the mass of the filler accounts for 50%-80% of the mass of the telmisartan tablet. Still further, the mass of the filler accounts for 60%-80% of the mass of the telmisartan tablet, for example, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79% or 80%, etc.

[0019] According to some specific embodiments, the mass of the lubricant accounts for 0.5%-2% of the mass of the telmisartan tablet. Further, the mass of the lubricant accounts for 1%-2% of the mass of the telmisartan tablet. Still further, the mass of the lubricant accounts for 1%-2% of the mass of the telmisartan tablet, for example, 1%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2%, etc.

[0020] According to some specific embodiments, the freeze-drying parameters are:

[0021] Pre-freezing temperature and time: The first stage has a set temperature of -30℃~-50℃, a set time of 0.5min-1.5min, and a duration of 100min-140min; the second stage has a set temperature of -1℃~-5℃, a set time of 0.5min-1.5min, and a duration of 100min-140min; the third stage has a set temperature of -30℃~-50℃, a set time of 0.5min-1.5min, and a duration of 160min-200min;

[0022] Condenser cooling: set temperature -30℃~-50℃, duration 4min-6min;

[0023] Pre-vacuum: Pre-vacuum 0.05mbar-0.15mbar, vacuum alarm upper limit 0.9mbar-1.1mbar, alarm vacuum duration 250s-350s;

[0024] Primary drying: first stage set temperature -5°C to -15°C, set time 20 min to 40 min, duration 800 min to 1000 min, set vacuum 0.1 mbar to 0.3 mbar; second stage set temperature -5°C to 5°C, set time 5 min to 15 min, duration 300 min to 400 min, set vacuum 0.1 mbar to 0.3 mbar; third stage set temperature -5°C to -15°C, set time 5 min to 15 min, duration 300 min to 400 min, set vacuum 0.1 mbar to 0.3 mbar;

[0025] Primary drying: first stage set temperature -5°C to -15°C, set time 20 min to 40 min, duration 800 min to 1000 min, set vacuum 0.1 mbar to 0.3 mbar; second stage set temperature -5°C to 5°C, set time 5 min to 15 min, duration 300 min to 400 min, set vacuum 0.1 mbar to 0.3 mbar; third stage set temperature -5°C to -15°C, set time 5 min to 15 min, duration 300 min to 400 min, set vacuum 0.1 mbar to 0.3 mbar;

[0026] Primary drying: first stage set temperature -5°C to -15°C, set time 20 min to 40 min, duration 800 min to 1000 min, set vacuum 0.1 mbar to 0.3 mbar; second stage set temperature -5°C to 5°C, set time 5 min to 15 min, duration 300 min to 400 min, set vacuum 0.1 mbar to 0.3 mbar; third stage set temperature -5°C to -15°C, set time 5 min to 15 min, duration 300 min to 400 min, set vacuum 0.1 mbar to 0.3 mbar;

[0027] Further, the parameters of the freeze-drying are:

[0028] Pre-freezing temperature and time: first stage set temperature -35°C to -45°C, set time 0.7 min to 1.3 min, duration 110 min to 130 min; second stage set temperature -2°C to -4°C, set time 0.7 min to 1.3 min, duration 110 min to 130 min; third stage set temperature -35°C to -45°C, set time 0.7 min to 1.3 min, duration 170 min to 190 min;

[0029] Condenser refrigeration: set temperature -40°C to -50°C, duration 4 min to 6 min;

[0030] Pre-evacuation: pre-evacuation 0.07 mbar to 0.13 mbar, upper vacuum alarm limit 0.9 mbar to 1.1 mbar, alarm vacuum duration 270 s to 330 s;

[0031] Primary drying: the first stage set temperature -7℃ to -13℃, set time 25min to 35min, duration 850min to 950min, set vacuum 0.15mbar to 0.25mbar; the second stage set temperature -3℃ to 3℃, set time 7min to 13min, duration 330min to 380min, set vacuum 0.15mbar to 0.25mbar; the third stage set temperature -7℃ to -13℃, set time 7min to 13min, duration 330min to 380min, set vacuum 0.15mbar to 0.25mbar;

[0032] Primary drying: the first stage set temperature -7℃ to -13℃, set time 25min to 35min, duration 850min to 950min, set vacuum 0.15mbar to 0.25mbar; the second stage set temperature -3℃ to 3℃, set time 7min to 13min, duration 330min to 380min, set vacuum 0.15mbar to 0.25mbar; the third stage set temperature -7℃ to -13℃, set time 7min to 13min, duration 330min to 380min, set vacuum 0.15mbar to 0.25mbar;

[0033] Primary drying: the first stage set temperature -7℃ to -13℃, set time 25min to 35min, duration 850min to 950min, set vacuum 0.15mbar to 0.25mbar; the second stage set temperature -3℃ to 3℃, set time 7min to 13min, duration 330min to 380min, set vacuum 0.15mbar to 0.25mbar; the third stage set temperature -7℃ to -13℃, set time 7min to 13min, duration 330min to 380min, set vacuum 0.15mbar to 0.25mbar;

[0034] According to some specific embodiments, the mixed material after freeze-drying is mixed with the filler in a mixer, the rotation speed is controlled at 4rpm to 6rpm, and the mixing time is 10min to 30min.

[0035] According to some specific embodiments, the mixed material after freeze-drying is mixed with the filler in a mixer, the rotation speed is controlled at 4rpm to 6rpm, and the mixing time is 10min to 30min.

[0036] According to some specific embodiments, when the tablet is prepared, the hardness of the tablet is controlled at 140N to 220N.

[0037] Compared with the prior art, the present application has the following advantages:

[0038] The present application, through the synergistic effect of the prescription and the preparation method, can make the material after freeze-drying maintain the original chemical composition and physical properties, the prepared telmisartan tablet has stable quality and good dissolution behavior, the process smoothness is not affected by the crystal form, crystalline habit and particle size of the raw material telmisartan, the yield is high, it can be stored for a long time, and it is suitable for large-scale production. Specific embodiments

[0039] The present application avoids the problems such as material stratification in the freeze-drying process by synergistic effect of the prescription and preparation method, particularly by mixing and dissolving telmisartan, a pH regulator, a solubilizer and povidone and then freeze-drying, and then by using specific fillers and lubricants to improve the process smoothness and avoid sticking and bumping in the tabletting process, so that the prepared telmisartan tablets have stable quality, good dissolution behavior, high yield, can be stored for a long time and are suitable for large-scale production.

[0040] The present application will be further described in conjunction with the following examples. However, the present application is not limited to the following examples. The implementation conditions used in the examples can be further adjusted according to different requirements of specific use, and the implementation conditions not specified are the conventional conditions in the industry. The technical features involved in each embodiment of the present application can be combined with each other as long as there is no conflict between them.

[0041] The technical solutions and technical effects of the present application will be further described in conjunction with the examples.

[0042] In the following examples, the raw materials and reagents used are obtained by marketing, as long as they meet the pharmaceutical standards. For example, povidone can be povidone K30, povidone K90, povidone K12, etc. that meet the pharmaceutical standards. Cyclodextrin uses β-cyclodextrin. Polyethylene glycol uses PEG-400, 1450, 3350, 4000, etc. Tween can use Tween 20, Tween 40, Tween 60, Tween 80, Tween 85, etc. Lecithin can use egg yolk lecithin, soybean lecithin, etc. Pre-gelatinized starch can use Starch PGS, etc. Unless otherwise specified, the "%" of the present application means mass percentage.

[0043] Example 1

[0044] The prescription of the present example is shown in Table 1.

[0045] Table 1

[0046]

[0047]

[0048] Note 1: Purified water is the solvent used in the process and finally removed.

[0049] The preparation method of the telmisartan tablets of the present example is as follows:

[0050] 1. Preparation: Telmisartan, sodium hydroxide, meglumine, and povidone K30 are added to purified water, stirred, and prepared into a solution.

[0051] 2. Drying: The solution is placed in a freeze dryer for freeze-drying, and the specific parameters are as follows:

[0052] (1) Pre-freeze temperature and time (refrigeration control):

[0053] First stage: Set temperature -40°C, set time 1 min, duration 120 min;

[0054] Second stage: Set temperature -3°C, set time 1 min, duration 120 min;

[0055] Third stage: Set temperature -40°C, set time 1 min, duration 180 min;

[0056] (2) Condenser refrigeration

[0057] Set temperature -45°C, duration 5 min;

[0058] (3) Pre-evacuation:

[0059] Pre-evacuation 0.1 mbar, upper alarm limit for vacuum 1 mbar, alarm vacuum duration 300 s;

[0060] (4) Primary drying:

[0061] First stage: Set temperature -10°C, set time 30 min, duration 900 min, set vacuum 0.2 mbar;

[0062] Second stage: Set temperature 0°C, set time 10 min, duration 360 min, set vacuum 0.2 mbar;

[0063] Third stage: Set temperature -10°C, set time 10 min, duration 360 min, set vacuum 0.2 mbar;

[0064] (5) Secondary drying:

[0065] Set temperature 45°C, set time 10 min, duration 480 min, set vacuum 0.001 mbar;

[0066] (6) Lyophilization end point:

[0067] Pressure rise value 0.003 mbar, duration 2 min.

[0068] 3. Mixing: Sieved telmisartan lyophilisate and sorbitol were added to the mixer hopper, the mixer speed was set to 5 rpm, and mixing was performed for 20 min.

[0069] 4. Lubrication: Magnesium stearate was added, the mixer speed was set to 5 rpm, and mixing was performed for 5 min.

[0070] 5. Tablet compression: Control tablet weight to 230-250 mg and hardness to 140-220 N.

[0071] The preparation method has a smooth process and is not affected by factors such as the raw material crystal form, crystal habit, and particle size. Tests have shown that the dissolution curves of different batches are stable and the yield is about 98%.

[0072] Comparative Example 1

[0073] The prescription for this case is shown in Table 2.

[0074] Table 2

[0075]

[0076] Note 1: Purified water is the solvent used in the process and finally removed.

[0077] The preparation method of the telmisartan tablets of this example is as follows:

[0078] 1. Preparation: Add telmisartan, sodium hydroxide, meglumine and povidone K30 to purified water, stir to prepare a solution.

[0079] 2. Drying: Place the solution in a freeze dryer for freeze drying. The specific parameters are as follows:

[0080] (1) Pre-freezing temperature and time (refrigeration control):

[0081] Stage 1: set temperature to -40℃, set time to 1min, duration to 120min;

[0082] The second stage: set the temperature to -3℃, set the time to 1min, and the duration to 120min;

[0083] The third stage: set the temperature to -40℃, set the time to 1min, and last for 180min;

[0084] (2) Condenser refrigeration

[0085] Set the temperature to -45°C and the duration to 5 minutes;

[0086] (3) Pre-vacuuming:

[0087] Pre-vacuum 0.1mbar, vacuum alarm upper limit 1mbar, alarm vacuum duration 300s;

[0088] (4) Primary drying:

[0089] Stage 1: set temperature -10°C, set time 30 minutes, duration 900 minutes, set vacuum 0.2 mbar;

[0090] Second stage: set temperature 0°C, set time 10 min, duration 360 min, set vacuum 0.2 mbar;

[0091] Third stage: set temperature -10°C, set time 10 min, duration 360 min, set vacuum 0.2 mbar;

[0092] (5) Analysis drying:

[0093] Set temperature 45°C, set time 10 min, duration 480 min, set vacuum 0.001 mbar;

[0094] (6) Lyophilization end point:

[0095] Pressure rise value 0.003 mbar, duration 2 min.

[0096] 3. Mixing: add the sieved telmisartan freeze-dried material and mannitol into the hopper of the mixer, set the mixer speed to 5 rpm, and mix for 20 min.

[0097] 4. Lubrication: add magnesium stearate, set the mixer speed to 5 rpm, and mix for 5 min.

[0098] 5. Tabletting: control the tablet weight to be 230-250 mg, and control the hardness to be 140-220 N.

[0099] The process smoothness of this example is poor, and there is a serious sticking and collision during tabletting.

[0100] Comparative Example 2

[0101] The prescription of this example is shown in Table 3.

[0102] Table 3

[0103]

[0104] Note 1: Purified water is the solvent used in the process and finally removed.

[0105] The preparation method of telmisartan tablets in this example is as follows:

[0106] 1. Preparation: add telmisartan, sodium hydroxide, meglumine, and microcrystalline cellulose into purified water, stir, and prepare a solution.

[0107] 2. Drying: place the solution into a freeze dryer for freeze-drying, and the specific parameters are as follows:

[0108] (1) Pre-freezing temperature and time (refrigeration control):

[0109] First stage: set temperature -40°C, set time 1 min, duration 120 min;

[0110] The second stage: set the temperature to -3℃, set the time to 1min, and the duration to 120min;

[0111] The third stage: set the temperature to -40℃, set the time to 1min, and last for 180min;

[0112] (2) Condenser refrigeration

[0113] Set the temperature to -45°C and the duration to 5 minutes;

[0114] (3) Pre-vacuuming:

[0115] Pre-vacuum 0.1mbar, vacuum alarm upper limit 1mbar, alarm vacuum duration 300s;

[0116] (4) Primary drying:

[0117] Stage 1: set temperature -10°C, set time 30 min, duration 900 min, set vacuum 0.2 mbar;

[0118] Stage 2: Set the temperature to 0°C, the time to 10 minutes, the duration to 360 minutes, and the vacuum to 0.2 mbar;

[0119] Stage 3: set temperature -10°C, set time 10 min, duration 360 min, set vacuum 0.2 mbar;

[0120] (5) Analytical drying:

[0121] Set the temperature to 45°C, the time to 10 min, the duration to 480 min, and the vacuum to 0.001 mbar;

[0122] (6) Freeze-drying endpoint:

[0123] The pressure rise value is 0.003mbar and the duration is 2min.

[0124] 3. Mixing: Add the sieved telmisartan freeze-dried product and mannitol into the mixer hopper, set the mixer speed to 5 rpm, and mix for 20 minutes.

[0125] 4. Lubrication: Add magnesium stearate, set the mixer speed to 5 rpm, and mix for 5 minutes.

[0126] 5. Tablet compression: Control tablet weight to 230-250 mg and hardness to 140-220 N.

[0127] In this case, the materials were stratified during the freeze-drying process and the mixing uniformity was unsatisfactory.

[0128] Comparative Example 3: Spray-drying granulation process

[0129] The prescription of this example is shown in Table 4.

[0130] Table 4

[0131]

[0132] Note 1: Purified water is the solvent used in the process and finally removed.

[0133] The preparation method of the telmisartan tablet of this example is as follows:

[0134] 1. Preparation: Sodium hydroxide, telmisartan, meglumine, povidone K30 are added to purified water in turn, and they are all dissolved into transparent solution.

[0135] 2. Drying: The solution is spray-dried. The parameters are set as follows: inlet air temperature 140-160°C, outlet air temperature 90-110°C, inlet air frequency 32-40Hz, atomizer frequency 37-45Hz, tower pressure 0.15-0.30kPa, air supply frequency 32-40Hz, air supply temperature 40-60°C. The spray-drying process controls the weight loss on drying to be ≤4.0%.

[0136] 3. Mixing: Sorbitol and telmisartan spray-dried material are added to the mixer, and the mixer speed is set to 8rpm, and mixed for 10min.

[0137] 4. Lubrication: Magnesium stearate is added, and the mixer speed is set to 8rpm, and mixed for 5min.

[0138] 5. Tabletting: The tablet weight is controlled to be 230-250mg, and the hardness is controlled to be 135-225N.

[0139] The process of this example is not affected by factors such as crystal form, crystalline habit, particle size, etc., and the dissolution curves of different batches are stable. However, the yield is low, only about 85%.

[0140] Comparative Example 4: Wet granulation process

[0141] The prescription of this example is shown in Table 5.

[0142] Table 5

[0143]

[0144] The preparation method of the telmisartan tablet of this example is as follows:

[0145] 1. Mixing: Telmisartan, sodium hydroxide, meglumine, povidone K30, sorbitol are added to the mixer, and the mixer speed is set to 5rpm, and mixed for 20min.

[0146] 2. Granulation: Add the mixed material into the wet mixing granulator, use a stirring speed of 50 rpm and a shear speed of 2200 rpm, and mix for 15 minutes.

[0147] 3. Drying: Dry the material until the moisture content is less than 3%.

[0148] 4. Granulation: Pass the dried material through a granulator (sieve aperture 1.0 mm, granulation speed 200-300 rpm).

[0149] 3. Lubrication: Add magnesium stearate, set the mixer speed to 5 rpm, and mix for 5 minutes.

[0150] 4. Tablet compression: Control tablet weight to 230-250 mg and hardness to 140-220 N.

[0151] Although the yield in this case can reach about 95%, the process is unstable and is greatly affected by factors such as the raw material crystal form, crystal habit, and particle size. After testing, the dissolution differences within and between batches are large.

[0152] Comparative Example 5: Direct Mixing Process

[0153] The prescription for this case is shown in Table 6.

[0154] Table 6

[0155]

[0156] The preparation method of the telmisartan tablets of this example is as follows:

[0157] 1. Mixing: Add telmisartan, sodium hydroxide, meglumine, povidone K30, and sorbitol to a mixer, set the mixer speed to 5 rpm, and mix for 20 minutes.

[0158] 2 Lubrication: Add magnesium stearate, set the mixer speed to 5 rpm, and mix for 5 minutes.

[0159] 3. Tablet compression: Control tablet weight to 230-250 mg and hardness to 140-220 N.

[0160] Although the yield in this example can reach about 95%, the process is unstable and is greatly affected by factors such as the raw material crystal form, crystal habit, and particle size. The process smoothness is poor. After testing, the dissolution differences within and between batches are also large.

[0161] The telmisartan tablets prepared in Example and Comparative Examples 3-5 were subjected to a dissolution test using the basket method (Chinese Pharmacopoeia Dissolution Test Method 1) at 100 rpm. The test results are shown in Table 7.

[0162] Table 7

[0163]

[0164]

[0165] From Table 7, it can be seen that the dissolution curves of Comparative Example 4 and Comparative Example 5 do not meet the requirements, the tablets of Example 1 and Comparative Example 3 have good dissolution tendency in each medium and high dissolution rate. However, the yield of Comparative Example 3 is low, the yield of Example 1 can reach 98%, and the cost of Example 1 is lower than that of Comparative Example 3.

[0166] The present application can keep the chemical composition and physical properties of the material dried by freeze-drying method by the synergistic effect of the prescription and the preparation method, the prepared telmisartan tablets have stable quality and good dissolution behavior, the process smoothness is not affected by the crystal form, crystalline habit and particle size of the raw material telmisartan, the yield is high, the prepared tablets can be stored for a long time, and the present application is suitable for large-scale production.

[0167] The above detailed description of the present application is intended to enable those skilled in the art to understand and implement the present application, and cannot limit the protection scope of the present application, and any equivalent changes or modifications made according to the spirit and principle of the present application shall be covered within the protection scope of the present application.

Claims

1. A method for preparing telmisartan tablets, characterized in that: Telmisartan, a pH regulator, a solubilizer and povidone are mixed with water to prepare a solution, and then the solution is freeze-dried. The freeze-dried material is mixed with a filler and a lubricant, and then tableted to prepare the telmisartan tablets.

2. The method for preparing telmisartan tablets according to claim 1, wherein: The pH regulator is one or more of sodium hydroxide, potassium hydroxide, sodium bicarbonate, sodium carbonate, and calcium hydroxide; The solubilizing agent is one or more of meglumine, sodium lauryl sulfate, cyclodextrin, polyethylene glycol, Tween, and lecithin; The filler is one or more of sorbitol, microcrystalline cellulose, lactose, and pregelatinized starch; The lubricant is one or more of magnesium stearate, stearic acid, calcium stearate, and hydrogenated castor oil.

3. The method for preparing telmisartan tablets according to claim 1 or 2, wherein: The pH regulator is sodium hydroxide or potassium hydroxide; the solubilizer is meglumine; the filler is sorbitol; and the lubricant is magnesium stearate.

4. The method for preparing telmisartan tablets according to claim 1, wherein: The mass of the pH regulator accounts for 0.5%-5% of the mass of the telmisartan tablets; The mass of the solubilizer accounts for 2%-10% of the mass of the telmisartan tablets; The mass of the povidone accounts for 2%-10% of the mass of the telmisartan tablet; The mass of the filler accounts for 40%-80% of the mass of the telmisartan tablet; The mass of the lubricant accounts for 0.5%-2% of the mass of the telmisartan tablet.

5. The method for preparing telmisartan tablets according to claim 4, wherein: The mass of the pH regulator accounts for 0.5%-3% of the mass of the telmisartan tablets; The mass of the solubilizer accounts for 2%-8% of the mass of the telmisartan tablet; The mass of the povidone accounts for 2%-8% of the mass of the telmisartan tablet; The mass of the filler accounts for 50%-80% of the mass of the telmisartan tablet; The mass of the lubricant accounts for 1%-2% of the mass of the telmisartan tablet.

6. The method for preparing telmisartan tablets according to claim 5, wherein: The mass of the pH regulator accounts for 1%-2% of the mass of the telmisartan tablets; The mass of the solubilizer accounts for 3%-7% of the mass of the telmisartan tablets; The mass of the povidone accounts for 3%-7% of the mass of the telmisartan tablet; The mass of the filler accounts for 60%-80% of the mass of the telmisartan tablet; The mass of the lubricant accounts for 1%-2% of the mass of the telmisartan tablet.

7. The method for preparing telmisartan tablets according to claim 1, wherein: The freeze-drying parameters are: Pre-freezing temperature and time: The first stage has a set temperature of -30℃~-50℃, a set time of 0.5min-1.5min, and a duration of 100min-140min; the second stage has a set temperature of -1℃~-5℃, a set time of 0.5min-1.5min, and a duration of 100min-140min; the third stage has a set temperature of -30℃~-50℃, a set time of 0.5min-1.5min, and a duration of 160min-200min; Condenser cooling: set temperature -30℃~-50℃, duration 4min-6min; Pre-vacuum: Pre-vacuum 0.05mbar-0.15mbar, vacuum alarm upper limit 0.9mbar-1.1mbar, alarm vacuum duration 250s-350s; Primary drying: The first stage has a set temperature of -5°C to -15°C, a set time of 20 min to 40 min, a duration of 800 min to 1000 min, and a set vacuum of 0.1 mbar to 0.3 mbar; the second stage has a set temperature of -5°C to 5°C, a set time of 5 min to 15 min, a duration of 300 min to 400 min, and a set vacuum of 0.1 mbar to 0.3 mbar; the third stage has a set temperature of -5°C to -15°C, a set time of 5 min to 15 min, a duration of 300 min to 400 min, and a set vacuum of 0.1 mbar to 0.3 mbar; Desorption drying: set temperature 40℃-50℃, set time 5min-15min, duration 450min-520min, set vacuum 0.0005mbar-0.005mbar; Freeze-drying endpoint: pressure rise value 0.001mbar-0.005mbar, duration 1min-3min.

8. The method for preparing telmisartan tablets according to claim 1, wherein: The freeze-dried material and the filler are mixed in a mixer, the speed is controlled to be 4 rpm-6 rpm, and the mixing time is 10 min-30 min.

9. The method for preparing telmisartan tablets according to claim 1, wherein: The mixed material and the lubricant are mixed in a mixer, the speed is controlled to be 4 rpm-6 rpm, and the mixing time is 4 min-6 min.

10. The method for preparing telmisartan tablets according to claim 1, wherein: During the tableting process, the hardness of the tablet is controlled to be 140N-220N.

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