Venlafaxine hydrochloride sustained release tablet and preparation method thereof

Abstract

The invention provides a venlafaxine hydrochloride sustained release tablet and a preparation method thereof. The venlafaxine hydrochloride sustained-release tablet is prepared from active ingredients and other pharmaceutic adjuvants through a side spraying process, particles with good uniformity and fluidity can be prepared, and dissolution of the sustained-release tablet is improved. The dissolution rates of the venlafaxine hydrochloride sustained-release tablet prepared by the preparation method disclosed by the invention meet the national pharmacopoeia standard in 2 hours, 4 hours, 6 hours, 8 hours and 12 hours; the venlafaxine hydrochloride sustained release tablet prepared by the invention has the advantages of simple preparation, better intermediate forming, cost saving and no environmental pollution.

Description

Technical Field

[0001] The invention relates to the technical field of oral solid preparations, in particular to a method for preparing venlafaxine hydrochloride sustained-release tablets. Background Art

[0002] The present invention relates to a method for preparing a venlafaxine hydrochloride sustained-release tablet, wherein the active ingredient is venlafaxine hydrochloride, the English name of which is Venlafaxine Hydrochloride, and the chemical name of which is (±)-1-[2-(N,N-dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol hydrochloride, and the content of C 17 H 27 NO2·HCl should be 98.5% to 101.0%, easily soluble in water, soluble in ethanol, almost insoluble in ether; easily soluble in dilute hydrochloric acid, its molecular formula is C 17 H 27 NO2·HCl, molecular weight is 313.87, chemical structure is:

[0003]

[0004] Venlafaxine is a phenylethylamine derivative. Venlafaxine and its active metabolite O-desmethylvenfaxine (ODV) can effectively antagonize the reuptake of 5-hydroxytryptamine (5-HT) and norepinephrine (NA), and also have a certain effect on the reuptake of dopamine (DA), and have an antidepressant effect. Venlafaxine was first developed by Wyeth and was approved by the FDA on December 28, 1993. It entered the Chinese market in 1999 under the trade name of Effexor. It is mainly used for various depressions and generalized anxiety disorders, and is the first-line drug recommended by the "Guidelines for the Prevention and Treatment of Depression Disorders in China".

[0005] The osmotic pump technology used by venlafaxine hydrochloride is currently a widely used method. It is generally composed of a tablet core, a semipermeable membrane, an osmotic pressure active substance, a drug release hole, and a film coating, and relies on osmotic pressure to release the drug. Patents such as CN201010246252.4, CN201110311201.x, and CN201210317323.6 use sodium chloride as a tablet core osmotic pressure regulator to solve the technology of stable release of venlafaxine hydrochloride, and CN201911326756.4 uses mannitol as a tablet core osmotic pressure regulator to solve the technology of stable release of venlafaxine hydrochloride. However, the existing venlafaxine hydrochloride preparation technology still has the following disadvantages:

[0006] 1. The dissolution rate at different time points within a batch of products varies greatly;

[0007] 2. The process fluency is not good, the particle flowability is poor, sticking occurs during tableting, and gun blocking occurs during controlled-release coating. Therefore, it is very important to prepare a venlafaxine hydrochloride sustained-release tablet that can release stably and has good process fluency, and give full play to the advantages of controlled-release preparations. Summary of the invention

[0008] In order to overcome the shortcomings and deficiencies of the existing wet granulation and the large dissolution difference within the batch, the present invention provides a new method for preparing venlafaxine hydrochloride sustained-release tablets. The present invention adopts a side spraying process to configure the active ingredient, binder, and mannitol into a drug-containing solution, thereby improving the forming and uniformity of the particles; after experimental comparison, the present invention adopts the side spraying process to prepare particles with good uniformity and fluidity, and improves the dissolution of the sustained-release tablets.

[0009] To achieve the above object, the present invention provides the following technical solutions:

[0010] The present invention uses only three common excipients, namely, hydroxypropylmethylcellulose, microcrystalline cellulose and mannitol, to prepare particles with good uniformity and good fluidity, and effectively ensures the in vivo bioavailability of the active ingredient. The sustained-release tablet prepared by the present invention has an excellent dissolution effect;

[0011] To achieve the above object, the present invention provides the following technical solutions:

[0012] A venlafaxine hydrochloride sustained-release tablet, characterized in that an active ingredient is mixed with mannitol and a binder to form a drug-containing solution, and the tablet is prepared by side spray granulation, tablet compression, controlled-release coating, punching, aging, and film coating processes, wherein each tablet is composed of the following weight ratio: wherein each tablet core is composed of the following weight ratio: 75 mg of active ingredient, 3.6-7.2 mg of binder, 80-90 mg of excipient, and 1.8-3.6 mg of lubricant; the active ingredient is venlafaxine; the controlled-release coating is composed of a semipermeable membrane molding material and a pore-forming agent, and each tablet of the controlled-release coating contains 13-14.5 mg of semipermeable membrane molding material and 0.8-2.3 mg of pore-forming agent;

[0013] The composition ratio of the drug core is:

[0014]

[0015] The controlled release coating composition ratio is:

[0016] Cellulose acetate 85%-95%

[0017] Polyethylene glycol 5%-15%

[0018] The dosage of the adhesive and the controlled release coating was further screened, and the preferred composition ratio of the drug core was:

[0019]

[0020] The controlled release coating composition ratio is:

[0021] Cellulose acetate 85%

[0022] Polyethylene glycol 15%

[0023] The preparation method of the above-mentioned venlafaxine hydrochloride sustained-release tablets comprises the following steps:

[0024] Step 1: Mannitol is passed through a 40-mesh sieve;

[0025] Step 2: adding the mannitol, active ingredients and binder treated in step 1 into purified water under stirring until they are completely dissolved;

[0026] Step 3: The drug-containing solution prepared in step 2 is combined with the excipient by a side spraying process to form uniform particles, and the particles are dried and mixed with silicon dioxide and magnesium stearate for 5 minutes to obtain intermediate particles;

[0027] Step 4: Tablet pressing, control the tablet thickness to 4.5 mm;

[0028] Step 5: Controlled release coating: cellulose acetate and polyethylene glycol are prepared into a clear controlled release coating solution in a predetermined ratio, preferably acetone: water = 90-97: 3-10, with a solid content of 6%, and controlled release coating is performed;

[0029] Step 6: laser punching the controlled release coated tablet obtained in step 5;

[0030] Step 7: aging the punched controlled-release coated tablet obtained in step 6 at a set temperature;

[0031] Step 8: Prepare the film coating solution according to the prescription, preferably with a concentration of 10%, and film-coat the aged controlled-release coated tablets obtained in step 7.

[0032] The present invention focuses on screening the key factors that affect the good uniformity and fluidity of the particles, the dosage of the binder hydroxypropyl methylcellulose, povidone K30 and its binder, and the best choice is hydroxypropyl methylcellulose, which as a binder in this project embodies the characteristics of rapid disintegration and fast dissolution rate, and its dosage is 3.0% to 4.0% of hydroxypropyl methylcellulose.

[0033] Through research, the process of the present invention has been found to be better than top spraying, bottom spraying and other processes, and can obtain venlafaxine hydrochloride sustained-release tablets with better fluidity and compressibility.

[0034] A large number of experimental studies have been conducted on the configuration of the coating solution of the present invention, and the optimal solid content of 6% has been selected.

[0035] There is no sticking phenomenon during the tableting process of the venlafaxine hydrochloride sustained-release tablets prepared by this prescription process, the coating liquid is completely clarified within 1 hour, and there is no abnormality in the coating process.

[0036] The present invention further discloses that the venlafaxine hydrochloride sustained-release tablet has the following advantages compared with the prior art:

[0037] 1. The venlafaxine hydrochloride sustained-release tablets prepared by the present invention have good fluidity and compressibility, and there is no sticking phenomenon during the tableting process;

[0038] 2. The method for preparing the controlled-release coating solution for venlafaxine hydrochloride sustained-release tablets provided by the present invention can solve the problem of gun blocking during the coating process, greatly shorten the coating time, and the obtained controlled-release coated tablets are more evenly coated. DETAILED DESCRIPTION

[0039] The present invention is described below through specific embodiments. Unless otherwise specified, the technical means used in the present invention are methods known to those skilled in the art. In addition, the embodiments should be understood as illustrative rather than limiting the scope of the present invention, and the essence and scope of the present invention are limited only by the claims. For those skilled in the art, various changes or modifications to the material components and dosages in these embodiments, without departing from the essence and scope of the present invention, also belong to the protection scope of the present invention. The raw materials and reagents used in the present invention are all commercially available. In order to facilitate the understanding of the present invention by those skilled in the art to which the present invention belongs, the present invention provides the following specific embodiments to further illustrate the sustained-release tablet and its preparation method:

[0040] Example 1

[0041] Prescription (3000 tablets)

[0042]

[0043] Preparation method:

[0044] 1. Mannitol is passed through a 40-mesh sieve;

[0045] 2. Add the treated mannitol, venlafaxine hydrochloride and hydroxypropyl methylcellulose into the purified water under stirring until they are completely dissolved;

[0046] 3. Add microcrystalline cellulose to a boiling dryer equipped with a side spray pot, set the air inlet temperature to about 55°C, the fan frequency to 10-20HZ, the atomization pressure to 0.2Mpa, adjust the chassis speed to 500-700rpm, and the peristaltic pump speed to 8-15rpm, and perform side spray granulation. During the granulation process, control the tablet bed temperature to about 25°C, so that the drug-containing liquid is combined with the microcrystalline cellulose to form uniform granules; set the drying temperature to 70°C for drying, and after drying, use a swing granulator equipped with a 20-mesh stainless steel screen to granulate, add silicon dioxide and magnesium stearate to the granulated granules, and mix the granules to obtain the final granules;

[0047] 4. Tablet pressing, control the tablet thickness to 4.5mm;

[0048] 5. Controlled release coating: cellulose acetate and polyethylene glycol are prepared into a clear controlled release coating solution in a ratio of 85:15 for controlled release coating. During the coating process, the inlet air temperature is controlled at 28-32°C and the inlet air volume is 600m 3 / h, atomization pressure 0.16Mpa, peristaltic pump speed about 15rpm, tablet bed temperature 18-22℃;

[0049] 6. The obtained controlled release coated tablet is laser punched with a hole diameter of 0.6 mm;

[0050] 7. Aging the punched controlled-release coated tablets at a set temperature of 50°C for 20 hours;

[0051] 8. Prepare a 10% film coating solution according to the prescription, and film coat the aged controlled-release coated tablets. During the coating process, the tablet bed temperature should be controlled to be greater than 42°C.

[0052] Example 2

[0053] Prescription (3000 tablets)

[0054] Name of raw materials Unit(g) Venlafaxine Hydrochloride 254.6 Microcrystalline Cellulose 234.1 Hydroxypropyl methylcellulose 18.9 Mannitol 27 Silicon dioxide 2.7 Magnesium Stearate 2.7 Purified water Moderate Cellulose acetate 39 Polyethylene glycol 6.9 acetone Moderate Film coating powder 38.1 total 624

[0055] Preparation method:

[0056] 1. Mannitol is passed through a 40-mesh sieve;

[0057] 2. Add the treated mannitol, venlafaxine hydrochloride and hydroxypropyl methylcellulose into the purified water under stirring until they are completely dissolved;

[0058] 3. Add microcrystalline cellulose to a boiling dryer equipped with a top spray pot, set the air inlet temperature to about 55°C, the fan frequency to 15-20HZ, the atomization pressure to 0.2Mpa, and the peristaltic pump speed to 10-20rpm for granulation. During the granulation process, the tablet bed temperature is controlled at about 25°C to allow the drug-containing liquid to combine with the microcrystalline cellulose to form uniform granules; set the drying temperature to 70°C for drying, and after drying, use a swing granulator equipped with a 20-mesh stainless steel screen to granulate, add silicon dioxide and magnesium stearate to the granules obtained, and mix the granules to obtain the final granules;

[0059] 4. Tablet pressing, control the tablet thickness to 4.5mm;

[0060] 5. Controlled release coating: cellulose acetate and polyethylene glycol are prepared into a clear controlled release coating solution in a ratio of 85:15 for controlled release coating. During the coating process, the inlet air temperature is controlled at 28-32°C and the inlet air volume is 600m 3 / h, atomization pressure 0.16Mpa, peristaltic pump speed about 15rpm, tablet bed temperature 18-22℃;

[0061] 6. The obtained controlled release coated tablet is laser punched with a hole diameter of 0.6 mm;

[0062] 7. Aging the punched controlled-release coated tablets at a set temperature of 50°C for 20 hours;

[0063] 8. Prepare a 10% film coating solution according to the prescription, and film coat the aged controlled-release coated tablets. During the coating process, the tablet bed temperature should be controlled to be greater than 42°C.

[0064] Example 3

[0065] Prescription (3000 tablets)

[0066]

[0067]

[0068] Preparation method:

[0069] 1. Mannitol is passed through a 40-mesh sieve;

[0070] 2. Add the treated mannitol, venlafaxine hydrochloride and hydroxypropyl methylcellulose into the purified water under stirring until they are completely dissolved;

[0071] 3. Add microcrystalline cellulose to a boiling dryer equipped with a bottom spray pot, set the air inlet temperature to about 55°C, the fan frequency to 10-25HZ, the atomization pressure to 0.2Mpa, and the peristaltic pump speed to 15-25rpm for granulation. During the granulation process, the tablet bed temperature is controlled at about 25°C to allow the drug-containing liquid to combine with the microcrystalline cellulose to form uniform granules; set the drying temperature to 70°C for drying, and after drying, use a swing granulator equipped with a 20-mesh stainless steel screen to granulate, add silicon dioxide and magnesium stearate to the granules obtained after granulation, and mix the granules to obtain the final granules;

[0072] 4. Tablet pressing, control the tablet thickness to 4.5mm;

[0073] 5. Controlled release coating: cellulose acetate and polyethylene glycol are prepared into a clear controlled release coating solution in a ratio of 85:15 for controlled release coating. During the coating process, the inlet air temperature is controlled at 28-32°C and the inlet air volume is 600m 3 / h, atomization pressure 0.16Mpa, peristaltic pump speed about 15rpm, tablet bed temperature 18-22℃;

[0074] 6. The obtained controlled release coated tablet is laser punched with a hole diameter of 0.6 mm;

[0075] 7. Aging the punched controlled-release coated tablets at a set temperature of 50°C for 20 hours;

[0076] 8. Prepare a 10% film coating solution according to the prescription, and film coat the aged controlled-release coated tablets. During the coating process, the tablet bed temperature should be controlled to be greater than 42°C.

[0077] Example 4

[0078] Prescription (3000 tablets)

[0079]

[0080]

[0081] Preparation method:

[0082] 1. Mannitol is passed through a 40-mesh sieve;

[0083] 2. Add povidone K30 into the purified water under stirring until it is completely dissolved to prepare a 15% concentration of povidone aqueous solution;

[0084] 3. Add microcrystalline cellulose, mannitol and venlafaxine hydrochloride to a wet granulator with a replaceable pot, set the stirring speed to 150 rpm and the cutting speed to 1500 rpm, and premix for 5 minutes; set the stirring speed to 150 rpm and the cutting speed to 1200 rpm, add the polyvidone aqueous solution under stirring to make uniform granules; set the drying temperature to 70°C for drying, and after drying, use a swing granulator equipped with a 20-mesh stainless steel screen to granulate, add silicon dioxide and magnesium stearate to the granulated particles, and mix the granules to obtain the final granules;

[0085] 4. Tablet pressing, control the tablet thickness to 4.5mm;

[0086] 5. Controlled release coating: cellulose acetate and polyethylene glycol are prepared into a clear controlled release coating solution in a ratio of 85:15 for controlled release coating. During the coating process, the inlet air temperature is controlled at 28-32°C and the inlet air volume is 600m 3 / h, atomization pressure 0.16Mpa, peristaltic pump speed about 15rpm, tablet bed temperature 18-22℃;

[0087] 6. The obtained controlled release coated tablet is laser punched with a hole diameter of 0.6 mm;

[0088] 7. Aging the punched controlled-release coated tablets at a set temperature of 50°C for 20 hours;

[0089] 8. Prepare a 10% film coating solution according to the prescription, and film coat the aged controlled-release coated tablets. During the coating process, the tablet bed temperature should be controlled to be greater than 42°C.

[0090] Example 5

[0091] Prescription (3000 tablets)

[0092]

[0093]

[0094] Preparation method:

[0095] 1. Mannitol is passed through a 40-mesh sieve;

[0096] 2. Weigh an appropriate amount of purified water as a wetting agent;

[0097] 3. Add microcrystalline cellulose, mannitol, venlafaxine hydrochloride and povidone K30 to a replaceable pot wet granulator, set the stirring speed to 150 rpm and the cutting speed to 1500 rpm, and premix for 5 minutes; set the stirring speed to 150 rpm and the cutting speed to 1200 rpm, add the povidone aqueous solution under stirring to make uniform granules; set the drying temperature to 70°C for drying, and after drying, use a swing granulator equipped with a 20-mesh stainless steel screen to granulate, add silicon dioxide and magnesium stearate to the granules obtained, and mix the granules to obtain the final granules;

[0098] 4. Tablet pressing, control the tablet thickness to 4.5mm;

[0099] 5. Controlled release coating: cellulose acetate and polyethylene glycol are prepared into a clear controlled release coating solution in a ratio of 85:15 for controlled release coating. During the coating process, the inlet air temperature is controlled at 28-32°C and the inlet air volume is 600m 3 / h, atomization pressure 0.16Mpa, peristaltic pump speed about 15rpm, tablet bed temperature 18-22℃;

[0100] 6. The obtained controlled release coated tablet is laser punched with a hole diameter of 0.6 mm;

[0101] 7. Aging the punched controlled-release coated tablets at a set temperature of 50°C for 20 hours;

[0102] 8. Prepare a 10% film coating solution according to the prescription, and film coat the aged controlled-release coated tablets. During the coating process, the tablet bed temperature should be controlled to be greater than 42°C.

[0103] Example 6

[0104] Prescription (3000 tablets)

[0105]

[0106]

[0107] Preparation method:

[0108] 1. Mannitol is passed through a 40-mesh sieve;

[0109] 2. Add the treated mannitol, venlafaxine hydrochloride and povidone K30 into the purified water under stirring until they are completely dissolved;

[0110] 3. Add microcrystalline cellulose to a boiling dryer equipped with a side spray pot, set the air inlet temperature to about 55°C, the fan frequency to 10-20HZ, the atomization pressure to 0.2Mpa, adjust the chassis speed to 500-700rpm, and the peristaltic pump speed to 8-15rpm, and perform side spray granulation. During the granulation process, control the tablet bed temperature to about 25°C, so that the drug-containing liquid is combined with the microcrystalline cellulose to form uniform granules; set the drying temperature to 70°C for drying, and after drying, use a swing granulator equipped with a 20-mesh stainless steel screen to granulate, add silicon dioxide and magnesium stearate to the granulated granules, and mix the granules to obtain the final granules;

[0111] 4. Tablet pressing, control the tablet thickness to 4.5mm;

[0112] 5. Controlled release coating: cellulose acetate and polyethylene glycol are prepared into a clear controlled release coating solution in a ratio of 85:15 for controlled release coating. During the coating process, the inlet air temperature is controlled at 28-32°C and the inlet air volume is 600m 3 / h, atomization pressure 0.16Mpa, peristaltic pump speed about 15rpm, tablet bed temperature 18-22℃;

[0113] 6. The obtained controlled release coated tablet is laser punched with a hole diameter of 0.6 mm;

[0114] 7. Aging the punched controlled-release coated tablets at a set temperature of 50°C for 20 hours;

[0115] 8. Prepare a 10% film coating solution according to the prescription, and film coat the aged controlled-release coated tablets. During the coating process, the tablet bed temperature should be controlled to be greater than 42°C.

[0116] Comparative Example

[0117] Comparative Example 1: Study on Venlafaxine Hydrochloride Microporous Osmotic Pump Controlled Release Tablets, Liu Hui, Proceedings of the 2008 National Hospital Pharmacy Academic Conference

[0118]

[0119] Preparation method:

[0120] 1. Preparation of drug tablet core: Weigh the prescribed amount of venlafaxine hydrochloride, sodium chloride, povidone and microcrystalline cellulose in a wet granulator and mix for 5 minutes, add an appropriate amount of 30% alcohol to make a soft material, dry at 60°C for 2 hours, add the prescribed amount of magnesium stearate to 20 mesh granules, mix for 5 minutes and tablet, and obtain the tablet core;

[0121] 2. Controlled release coating solution preparation: Mix the prescribed amount of cellulose acetate, diethyl phthalate and polyethylene glycol evenly, add to an appropriate amount of acetone / water (95:5) solution, and mix evenly until clear;

[0122] 3. Use the coating solution prepared in step 2 for coating, with a weight gain of 2%, age at 40°C for 24h, and use laser drilling to punch holes with a hole diameter of 0.9mm;

[0123] 4: Film-coating the controlled-release coated tablets obtained in step 3.

[0124] Comparative Example 2: Refer to CN201911326756.4

[0125] Prescription composition (3000 tablets)

[0126]

[0127] Preparation method:

[0128] 1. Preparation of drug tablet core: Add povidone to 30% ethanol solution to prepare solution, stir until clear, weigh the prescribed amount of venlafaxine hydrochloride, mannitol and microcrystalline cellulose in a wet granulator and mix for 5 minutes, add the prepared binder, dry at 60℃ for 2 hours, add the prescribed amount of magnesium stearate to 20 mesh granules, mix for 5 minutes and tablet, and obtain the tablet core;

[0129] 2. Controlled release coating solution preparation: Mix the prescribed amount of cellulose acetate, diethyl phthalate and polyethylene glycol evenly, add to an appropriate amount of acetone / water (94:6) solution with a solid content of 5%, and mix evenly until clear.

[0130] 3. Use the coating solution prepared in step 2 to coat the sample, with a weight gain of 9.3%. Dry the coated sample to obtain a coated tablet with a moisture content of 3%, and use laser drilling to punch holes with a hole diameter of 0.6 mm.

[0131] 4: Film-coating the controlled-release coated tablets obtained in step 3.

[0132] The test results of the venlafaxine hydrochloride sustained-release tablets prepared in Comparative Examples 1-2 and Examples 1-6 are as follows:

[0133]

[0134] From the analysis of the results in the above table, it can be seen that the venlafaxine hydrochloride sustained-release tablets of Example 1 obtained by the venlafaxine hydrochloride sustained-release tablets and the preparation method thereof of the present invention have better particle flowability and compressibility, particle mixing uniformity, and tablet content uniformity, which are all superior to samples prepared by other processes.

[0135] No abnormality occurred during the sample preparation process of Example 1, and the process controllability was good; the dissolution at 2h, 4h, 6h, 8h, and 12h met the national pharmacopoeia standard Chinese Pharmacopoeia (2 hours less than 25%, 4 hours 25-50%, 6 hours 40-65%, 8 hours: 55-80%, 12 hours: more than 75%): the batch difference was small, and the dissolution RSD relative proportion was small.

[0136]

[0137] The results in the above table show that: the venlafaxine hydrochloride sustained-release tablets of Example 1 obtained by the venlafaxine hydrochloride sustained-release tablets of the present invention and the preparation method thereof, the cumulative release of the related substances at 0 days and accelerated 30 days is basically unchanged, and the related substances have no obvious increase, which is in line with the national pharmacopoeia standards;

[0138] Based on the above results, it can be seen that the venlafaxine hydrochloride sustained-release tablets and the preparation method thereof (Example 1) of the present invention have smooth process and good process controllability, and the quality of the prepared samples meets the requirements of the pharmacopoeia and is stable.

[0139] The above embodiments are only used to help understand the method and core idea of ​​the present invention. For those skilled in the art, the present invention can be improved and modified without departing from the principle of the present invention, and these improvements and modifications also fall within the scope of protection of the claims of the present invention.

Claims

1. A venlafaxine hydrochloride sustained-release tablet, which is composed of an active ingredient, a binder, an excipient, a lubricant, a semipermeable membrane material, a pore-forming agent, and a film coating powder, and is prepared by side spray granulation, tablet compression, controlled release coating, perforation, aging, and film coating processes; wherein each tablet core is composed of the following weight ratios: The active ingredient is 75 mg, the binder is 3.6-7.2 mg, the excipient is 80-90 mg, and the lubricant is 1.8-3.6 mg; the active ingredient is venlafaxine; the controlled release coating is composed of a semipermeable membrane forming material and a pore-forming agent, and each piece of the controlled release coating contains 13-14.5 mg of the semipermeable membrane forming material and 0.8-2.5 mg of the pore-forming agent.

2. The venlafaxine hydrochloride sustained-release tablet according to claim 1, characterized in that The adhesive is selected from hydroxypropyl methylcellulose; the excipient is a composition of mannitol and microcrystalline cellulose; the lubricant is a composition of silicon dioxide and magnesium stearate; the semipermeable membrane forming material is cellulose acetate; the pore-forming agent is polyethylene glycol; and the film coating powder is composed of titanium dioxide, hydroxypropyl methylcellulose, lactose, and triethylglycerol.

3. The venlafaxine hydrochloride sustained-release tablet according to claim 2, characterized in that: The composition ratio of the drug core is: The controlled release coating composition ratio is: Cellulose acetate 85%-95% Polyethylene glycol 5%-15%.

4. The venlafaxine hydrochloride sustained-release tablet according to claim 3, characterized in that: The composition ratio of the drug core is: The controlled release coating composition ratio is: Cellulose acetate 85% Polyethylene glycol 15%.

5. A method for preparing any one of claims 1 to 4 of the venlafaxine hydrochloride sustained-release tablets, comprising the following steps: Step 1: Mannitol is passed through a 40-mesh sieve; Step 2: adding the mannitol, active ingredients and binder treated in step 1 into purified water under stirring until they are completely dissolved; Step 3: The drug-containing solution prepared in step 2 is combined with microcrystalline cellulose through a side spraying process to prepare uniform particles, and the particles are dried and mixed with silicon dioxide and magnesium stearate for 5 minutes to obtain intermediate particles; Step 4: Tablet pressing, control the tablet thickness to 4.5 mm; Step 5: Controlled release coating: cellulose acetate and polyethylene glycol are prepared into a clear controlled release coating solution according to a predetermined ratio, preferably acetone: water = 90-97: 3-10, with a solid content of 6%, and controlled release coating is performed; Step 6: laser punching the controlled release coated tablet obtained in step 5; Step 7: aging the punched controlled-release coated tablet obtained in step 6 at a set temperature; Step 8: Prepare the film coating solution according to the prescription, preferably with a concentration of 10%, and film-coat the aged controlled-release coated tablets obtained in step 7.

Images