A terbinafine hydrochloride tablet and a method for preparing the same

Abstract

The application relates to the technical field of veterinary drugs, in particular to a terbinafine hydrochloride tablet and a preparation method thereof. The terbinafine hydrochloride tablet comprises the following components in parts by weight: 10-20 parts of terbinafine hydrochloride, 60-80 parts of a filling agent, 10-20 parts of a binding agent, 0.05-0.2 parts of a lubricant and 0.2-0.4 parts of component A, wherein the component A comprises yellow iron oxide. The terbinafine hydrochloride tablet provided by the application has the advantages of simple preparation process, good stability and good application prospect. Further, the application further provides a preparation method of the terbinafine hydrochloride tablet. The terbinafine hydrochloride tablet is efficiently and stably prepared through several steps of pretreatment, wet granulation, whole-granulation and tablet pressing, and the process is simple and applicable.

Description

A terbinafine hydrochloride tablet and its preparation method Technical Field

[0001] This application relates to the field of veterinary drug technology, specifically to a terbinafine hydrochloride tablet and its preparation method. Background Technology

[0002] Terbinafine hydrochloride is an allylamine drug with broad-spectrum antifungal activity. It can specifically interfere with the early biosynthesis of fungal sterols and selectively inhibit fungal squalene epoxidase, thereby blocking the squalene epoxidation reaction during fungal cell membrane formation, thus achieving the effect of killing or inhibiting fungi. It has a definite curative effect and mild toxic side effects, and has broad development prospects.

[0003] However, the existing technology for preparing terbinafine hydrochloride tablets is not yet mature, and there is a certain probability that animals will experience adverse reactions such as anorexia or difficulty eating after taking terbinafine hydrochloride tablets, which affects the widespread use of this product.

[0004] Therefore, there is an urgent need in the field for a terbinafine hydrochloride tablet and its preparation method, hence this application is filed. Summary of the Invention

[0005] The purpose of this application is to provide a terbinafine hydrochloride tablet and a method for preparing the same, in order to solve at least one of the technical problems described in the background art.

[0006] Specifically, in a first aspect of this application, a terbinafine hydrochloride tablet is provided, comprising, by weight, the following components:

[0007] Terbinafine hydrochloride 10-20 parts,

[0008] 60-80 parts of filler

[0009] 10-20 parts adhesive

[0010] Lubricant 0.05-0.2 parts,

[0011] Component A: 0.2-0.4 parts

[0012] Component A includes yellow iron oxide.

[0013] Preferably, the terbinafine hydrochloride tablets, by weight, comprise the following components:

[0014] Terbinafine hydrochloride 16.7 parts,

[0015] 66.234 parts of filler,

[0016] 16.7 parts adhesive,

[0017] 0.1 parts lubricant,

[0018] Component A: 0.266 parts.

[0019] Preferably, the filler is selected from one or more of starch, pregelatinized starch, and microcrystalline cellulose.

[0020] Preferably, the adhesive is selected from one or more of dextrin, sodium carboxymethyl cellulose, and hydroxypropyl methylcellulose.

[0021] Preferably, the lubricant is selected from one or more of magnesium stearate, talc, and micronized silica gel.

[0022] Preferably, the terbinafine hydrochloride tablets further include 0.5-1.5 parts of a flow aid selected from colloidal silica.

[0023] Preferably, the diameter of the terbinafine hydrochloride powder is no higher than 30 μm.

[0024] Preferably, the diameter of the component A powder is not higher than 100 μm.

[0025] Preferably, the terbinafine hydrochloride tablets further include 2-8 parts of component B, wherein component B includes sodium carboxymethyl starch and mannitol.

[0026] Preferably, the ratio of sodium carboxymethyl starch to mannitol is 1:1 to 1:3.

[0027] Preferably, the ratio of component A to component B is 1:10 to 1:30.

[0028] A second aspect of this application provides a method for preparing terbinafine hydrochloride tablets as described in the first aspect of this application, wherein the filler is starch, the binder is dextrin, and the lubricant is magnesium stearate, and the terbinafine hydrochloride tablets include the following steps:

[0029] For pretreatment, take a portion of the starch, add yellow ferric oxide and purified water, and stir while adding water to make a starch slurry for later use;

[0030] For wet granulation, turn on the vacuum feeder and sequentially feed the weighed starch, dextrin, and terbinafine hydrochloride into the high-speed wet granulator. Add starch slurry and start the high-speed wet granulator to granulate.

[0031] Granulation: Granulate the terbinafine hydrochloride granules and set them aside for later use.

[0032] To compress the tablets, feed the terbinafine hydrochloride granules into a mixer, add magnesium stearate, turn on the mixer, mix, and then compress into tablets.

[0033] Preferably, in the pretreatment step, the ratio of starch to purified water is 1:8.

[0034] Preferably, in the pretreatment step, the temperature when the starch is mixed with purified water is 90-95℃.

[0035] Preferably, in the wet granulation step, the high-speed wet granulator is adjusted to 3000-5000 rpm, and after working for 5-10 minutes, it is drawn into a fluidized bed for drying at 60-100℃ for 30-90 minutes.

[0036] Preferably, during the tableting step, magnesium stearate is added and mixed for 30 minutes.

[0037] Preferably, the gliding agent is added during the tableting step.

[0038] Preferably, component B is added during wet granulation.

[0039] In summary, this application has the following beneficial effects:

[0040] 1. The terbinafine hydrochloride tablets provided in this application have a simple preparation process, good stability, and good application prospects.

[0041] 2. The terbinafine hydrochloride tablets provided in this application, by adding an appropriate amount of component B, can effectively reduce adverse reactions such as anorexia or difficulty in eating in animals after taking the drug, making them safer to use.

[0042] 3. The method for preparing terbinafine hydrochloride tablets provided in this application involves several steps, including pretreatment, wet granulation, granulation, and tableting, which efficiently and stably prepares terbinafine hydrochloride tablets. The process is simple and has strong applicability. Detailed Implementation

[0043] The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The singular forms “a,” “the,” and “the” used in this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used herein refers to and includes any or all possible combinations of one or more of the associated listed items.

[0044] The present application will be described in detail below through examples.

[0045] Existing terbinafine hydrochloride tablets suffer from immature tableting technology and a high rate of adverse reactions, hindering their widespread application. Therefore, this invention aims to provide a terbinafine hydrochloride tablet that solves one of the aforementioned technical problems. By weight, the tablet comprises: 10-20 parts terbinafine hydrochloride, 60-80 parts filler, 10-20 parts binder, 0.05-0.2 parts lubricant, and 0.2-0.4 parts component A, wherein component A includes ferric oxide. The terbinafine hydrochloride tablets obtained using the above technical solution have a simple preparation process, good stability, and promising application prospects.

[0046] To better understand the above technical solutions, a detailed description of the specific implementation methods will be provided below. It should be noted that components not specifically emphasized in this application are all commercially available.

[0047] Example 1

[0048] Weigh out 10 kg of terbinafine hydrochloride, 60 kg of starch, 10 kg of dextrin, 0.05 kg of magnesium stearate, and 0.2 kg of ferric oxide by weight, and prepare terbinafine hydrochloride tablets according to the following steps: The terbinafine hydrochloride tablets are all passed through a 460-mesh sieve (i.e., their diameter is no higher than 30 μm), and the ferric oxide is passed through a 170-mesh sieve (i.e., their diameter is no higher than 100 μm).

[0049] For pretreatment, take 2.5 kg of starch, add 0.2 kg of yellow ferric oxide and 20 L of purified water at 90℃, and stir while adding water to make starch slurry for later use;

[0050] For wet granulation, turn on the vacuum feeder and sequentially feed the weighed starch, dextrin, and terbinafine hydrochloride into the high-speed wet granulator. Add starch slurry, turn on the high-speed wet granulator, and granulate at 3000 rpm for 5 minutes. Then feed the granulator into a fluidized bed for drying at 60°C for 30 minutes.

[0051] Granulation: Add terbinafine hydrochloride granules to a granulator and granulate them through a 20-mesh sieve. Set aside after granulation.

[0052] For tableting, terbinafine hydrochloride granules are drawn into a mixer and magnesium stearate is added. The mixer is turned on and mixed for 30 minutes before tableting. The tablets are pressed using an 11mm flat-slant punch, and the hardness is controlled at 100N.

[0053] Example 2

[0054] Weigh out 20 kg of terbinafine hydrochloride, 80 kg of starch, 20 kg of dextrin, 0.2 kg of magnesium stearate, and 0.4 kg of ferric oxide by weight, and prepare terbinafine hydrochloride tablets according to the following steps: The terbinafine hydrochloride tablets are all passed through a 460-mesh sieve (i.e., their diameter is no higher than 30 μm), and the ferric oxide is passed through a 170-mesh sieve (i.e., their diameter is no higher than 100 μm).

[0055] For pretreatment, take 2.5 kg of starch, add 0.4 kg of yellow ferric oxide and 20 L of purified water at 95 °C, and stir while adding water to make starch slurry for later use;

[0056] For wet granulation, turn on the vacuum feeder and sequentially feed the weighed starch, dextrin, and terbinafine hydrochloride into the high-speed wet granulator. Add starch slurry, turn on the high-speed wet granulator, and granulate at 5000 rpm for 10 minutes. Then feed the granulator into a fluidized bed for drying at 100°C for 90 minutes.

[0057] Granulation: Add terbinafine hydrochloride granules to a granulator and granulate them through a 20-mesh sieve. Set aside after granulation.

[0058] For tableting, terbinafine hydrochloride granules are drawn into a mixer and magnesium stearate is added. The mixer is turned on and mixed for 30 minutes before tableting. The tablets are pressed using an 11mm flat-slant punch, and the hardness is controlled at 100N.

[0059] Example 3

[0060] Weigh out 16.7 kg of terbinafine hydrochloride, 66.234 kg of starch, 16.7 kg of dextrin, 0.1 kg of magnesium stearate, and 0.266 kg of ferric oxide by weight, and prepare terbinafine hydrochloride tablets according to the following steps: The terbinafine hydrochloride tablets are all passed through a 460-mesh sieve (i.e., their diameter is no higher than 30 μm), and the ferric oxide is passed through a 170-mesh sieve (i.e., their diameter is no higher than 100 μm).

[0061] For pretreatment, take 2.5 kg of starch, add 0.266 kg of yellow iron oxide and 20 L of purified water at 93℃, and stir while adding water to make starch slurry for later use;

[0062] For wet granulation, turn on the vacuum feeder and sequentially feed the weighed starch, dextrin, and terbinafine hydrochloride into the high-speed wet granulator. Add starch slurry, turn on the high-speed wet granulator, and granulate at 4000 rpm for 8 minutes. Then feed the granulator into a fluidized bed for drying at 80°C for 60 minutes.

[0063] Granulation: Add terbinafine hydrochloride granules to a granulator and granulate them through a 20-mesh sieve. Set aside after granulation.

[0064] For tableting, terbinafine hydrochloride granules are drawn into a mixer and magnesium stearate is added. The mixer is turned on and mixed for 30 minutes before tableting. The tablets are pressed using an 11mm flat-slant punch, and the hardness is controlled at 100N.

[0065] Example 4

[0066] Weigh out 10 kg of terbinafine hydrochloride, 60 kg of starch, 10 kg of dextrin, 0.05 kg of magnesium stearate, 0.2 kg of ferric oxide, 1 kg of sodium carboxymethyl starch, and 1 kg of mannitol according to the following steps, and prepare terbinafine hydrochloride tablets according to the following steps: wherein the terbinafine hydrochloride is passed through a 460-mesh sieve, i.e., its diameter is not higher than 30 μm, and the ferric oxide is passed through a 170-mesh sieve, i.e., its diameter is not higher than 100 μm.

[0067] For pretreatment, take 2.5 kg of starch, add 0.2 kg of yellow ferric oxide and 20 L of purified water at 90℃, and stir while adding water to make starch slurry for later use;

[0068] For wet granulation, turn on the vacuum feeder and sequentially feed the weighed starch, dextrin, terbinafine hydrochloride, sodium carboxymethyl starch, and mannitol into the high-speed wet granulator. Add starch slurry, turn on the high-speed wet granulator, and granulate at 3000 rpm. After working for 5 minutes, feed the granulator into a fluidized bed for drying at 60°C for 30 minutes.

[0069] Granulation: Add terbinafine hydrochloride granules to a granulator and granulate them through a 20-mesh sieve. Set aside after granulation.

[0070] For tableting, terbinafine hydrochloride granules are drawn into a mixer and magnesium stearate is added. The mixer is turned on and mixed for 30 minutes before tableting. The tablets are pressed using an 11mm flat-slant punch, and the hardness is controlled at 100N.

[0071] Example 5

[0072] Weigh out 20 kg of terbinafine hydrochloride, 80 kg of starch, 20 kg of dextrin, 0.2 kg of magnesium stearate, 0.4 kg of ferric oxide, 3 kg of sodium carboxymethyl starch, and 5 kg of mannitol according to the following steps, and prepare terbinafine hydrochloride tablets according to the following steps: wherein the terbinafine hydrochloride is passed through a 460-mesh sieve, i.e., its diameter is not higher than 30 μm, and the ferric oxide is passed through a 170-mesh sieve, i.e., its diameter is not higher than 100 μm.

[0073] For pretreatment, take 2.5 kg of starch, add 0.4 kg of yellow ferric oxide and 20 L of purified water at 95 °C, and stir while adding water to make starch slurry for later use;

[0074] For wet granulation, turn on the vacuum feeder and sequentially feed the weighed starch, dextrin, terbinafine hydrochloride, sodium carboxymethyl starch, and mannitol into the high-speed wet granulator. Add starch slurry, turn on the high-speed wet granulator, and granulate at 5000 rpm for 10 minutes. Then feed the granulator into a fluidized bed for drying at 100°C for 90 minutes.

[0075] Granulation: Add terbinafine hydrochloride granules to a granulator and granulate them through a 20-mesh sieve. Set aside after granulation.

[0076] For tableting, terbinafine hydrochloride granules are drawn into a mixer and magnesium stearate is added. The mixer is turned on and mixed for 30 minutes before tableting. The tablets are pressed using an 11mm flat-slant punch, and the hardness is controlled at 100N.

[0077] Example 6

[0078] Weigh out 16.7 kg of terbinafine hydrochloride, 66.234 kg of starch, 16.7 kg of dextrin, 0.1 kg of magnesium stearate, 0.266 kg of ferric oxide, 1 kg of sodium carboxymethyl starch, and 3 kg of mannitol according to the following steps, and prepare terbinafine hydrochloride tablets according to the following steps: wherein the terbinafine hydrochloride is passed through a 460-mesh sieve, i.e., its diameter is not higher than 30 μm, and the ferric oxide is passed through a 170-mesh sieve, i.e., its diameter is not higher than 100 μm.

[0079] For pretreatment, take 2.5 kg of starch, add 0.266 kg of yellow iron oxide and 20 L of purified water at 93℃, and stir while adding water to make starch slurry for later use;

[0080] For wet granulation, turn on the vacuum feeder and sequentially feed the weighed starch, dextrin, terbinafine hydrochloride, sodium carboxymethyl starch, and mannitol into the high-speed wet granulator. Add starch slurry, turn on the high-speed wet granulator, and granulate at 4000 rpm for 8 minutes. Then feed the granulator into a fluidized bed for drying at 80°C for 60 minutes.

[0081] Granulation: Add terbinafine hydrochloride granules to a granulator and granulate them through a 20-mesh sieve. Set aside after granulation.

[0082] For tableting, terbinafine hydrochloride granules are drawn into a mixer and magnesium stearate is added. The mixer is turned on and mixed for 30 minutes before tableting. The tablets are pressed using an 11mm flat-slant punch, and the hardness is controlled at 100N.

[0083] Comparative Example 1

[0084] The technical solutions of Comparative Example 1 and Example 3 are basically the same, except that the terbinafine hydrochloride is the part between a 460-mesh sieve and a 100-mesh sieve, that is, the particle size is between 30-150 μm.

[0085] Comparative Example 2

[0086] The technical solutions of Comparative Example 2 and Example 6 are basically the same, except that the sodium carboxymethyl starch is 0.5 kg and the mannitol is 0.5 kg.

[0087] Comparative Example 3

[0088] The technical solutions of Comparative Example 3 and Example 6 are basically the same, except that the amount of yellow iron oxide is 0.2 kg, sodium carboxymethyl starch is 2 kg, and mannitol is 6 kg.

[0089] Comparative Example 4

[0090] The patented technology solution with publication number CN112156078A is adopted, specifically as follows:

[0091] (1) Weigh the raw materials and excipients according to the following weight parts: 281.3 parts of terbinafine hydrochloride, 50 parts of microcrystalline cellulose, 45 parts of sodium carboxymethyl starch, 9.94 parts of hydroxypropyl methylcellulose E50, 4 parts of magnesium stearate, and 2 parts of silicon dioxide; (2) Preparation of binder: Take purified water, stir until it forms a vortex, slowly add hydroxypropyl methylcellulose E50 while stirring, stir for 2 hours to disperse it evenly, and set aside; (3) Premixing and granulation: Place the terbinafine hydrochloride, sodium carboxymethyl starch, and microcrystalline cellulose in a high-efficiency mixing granulator and mix for 15 minutes. (3) Add binder within 250 seconds, stir at high speed for 120 seconds, and granulate through a 10-mesh nylon screen using a gyratory pelletizer; (4) Drying: Place the prepared wet granules in a spray dryer and dry at 45°C until the moisture content is ≤2.0%; (5) Granulation: Granulate the dried granules through a 14-mesh nylon screen using a gyratory pelletizer; (6) Mixing: Place the granules, magnesium stearate, and silicon dioxide in a three-dimensional motion mixer in sequence for mixing for 15 minutes; (7) Tableting: Use an 11mm flat and slanted punch to press the tablets, controlling the hardness to 100N.

[0092] Example 7 Feeding Experiment

[0093] This embodiment describes the experimental method for the food intake experiment in this application. Adult beagle dogs with a weight range of 10.50±1 kg were selected and administered approximately 30 mg of terbinafine per kg of body weight. The administration was once daily, followed by oral administration of 10 ml of pure water. Food intake was resumed 4 hours after administration. Five dogs were included in each group, while the blank control group was administered 30 mg of physiological saline per kg of body weight. The experimental results are shown in Table 1.

[0094] Table 1. Food intake data of experimental dogs in Examples 1-6 and Comparative Examples 1-4.

[0095]

[0096] Based on the experimental results in Table 1, those skilled in the art can understand that:

[0097] First, in groups 4-6 of Examples, the experimental dogs consumed significantly more food than other groups during the experiment, indicating that the addition of component B can alleviate the adverse reactions of anorexia or difficulty in eating in the experimental dogs to a certain extent; moreover, the experimental dogs were able to return to normal food intake within 3 days after the experiment, and the recovery speed was also faster.

[0098] Second, observing the experimental data of Comparative Example 2 and Example 6, when the content of component B is low, the prepared terbinafine hydrochloride tablets still have obvious adverse reactions that cause experimental dogs to lose their appetite or have difficulty eating.

[0099] Third, observing the experimental data of Comparative Example 3 and Example 6, when the relative ratio of component A to component B is too low, the prepared terbinafine hydrochloride tablets will also have obvious adverse reactions that cause the experimental dogs to lose their appetite or have difficulty eating.

[0100] Therefore, this embodiment shows that adding an appropriate amount of component B to terbinafine hydrochloride tablets can alleviate the adverse reactions of anorexia or difficulty eating in experimental dogs to a certain extent.

[0101] Example 8: Tablet Quality Test

[0102] Content determination test:

[0103] Content determination: determined according to high performance liquid chromatography (Chinese Pharmacopoeia 2020 edition, Part IV, General Chapter 0512).

[0104] Test solution: Take 20 tablets of this product, grind them into a fine powder, accurately weigh an appropriate amount of the fine powder, add solvent to dissolve and quantitatively dilute to a solution containing approximately 0.1 mg of terbinafine per 1 ml, filter, and take the filtrate as the test solution.

[0105] Reference solution: Weigh an appropriate amount of terbinafine hydrochloride reference standard accurately, dissolve it in solvent and dilute quantitatively to prepare a solution containing approximately 0.1 mg of terbinafine per 1 ml.

[0106] Assay: Accurately measure the test solution and reference solution, inject them separately into the liquid chromatograph, and record the chromatograms. Calculate the terbinafine content in the test solution based on peak area using the external standard method.

[0107] Dissolution test:

[0108] Take samples and determine dissolution and release according to the method (Chinese Pharmacopoeia 2020 Edition, Part IV, General Chapter 0931, Method II). Use 900 ml of pH 1.2 dissolution medium as the dissolution medium, rotate at 50 rpm, and operate according to the method. After 30 minutes, take 15 ml of each sample, discard 10 ml, and use this as the test sample. Separately, accurately weigh approximately 20 mg of terbinafine hydrochloride reference standard, place it in a 100 ml volumetric flask, dissolve it in solvent (methanol:water = 1:1) and quantitatively dilute to the mark, and shake well. Accurately measure 5 ml of this solution, place it in a 25 ml volumetric flask, add pH 1.2 medium and quantitatively dilute to the mark, and shake well. Take the test sample solution and the reference standard solution, and measure the absorbance at a wavelength of 283 nm using ultraviolet-visible spectrophotometry (Chinese Pharmacopoeia 2020 Edition, Part IV, General Chapter 0401), and calculate the cumulative dissolution amount per tablet.

[0109] The test results are shown in Table 2.

[0110] Table 2 Tablet quality tests of Examples 1-6 and Comparative Examples 1-4

[0111] Group Content (%) Dissolution Rate (%) Example 1 99.5 75.2 Example 2 100.0 74.6 Example 3 100.2 77.2 Example 4 99.7 74.3 Example 5 99.9 76.0 Example 6 99.5 75.7 Comparative Example 1 100.1 65.9 Comparative Example 2 99.8 73.2 Comparative Example 3 99.6 75.5 Comparative Example 4 99.8 70.1 surface

[0112] Based on the experimental results in Table 2, those skilled in the art can understand that:

[0113] First, the terbinafine hydrochloride tablets prepared in Examples 1-6 all met the qualified standards;

[0114] Second, compared with the existing technology, the terbinafine hydrochloride tablets prepared in Examples 1-6 all have better dissolution at 30 minutes and the drug takes effect faster.

[0115] Third, by observing the experimental data of Comparative Example 1 and Example 3, it was found that when the particle size of the terbinafine hydrochloride component is too large, it will affect the dissolution rate of the product, and thus affect the rapid onset of action of the product.

[0116] In summary, the terbinafine hydrochloride tablets and their preparation method provided in this application have a simple preparation process, good stability, and good application prospects. Furthermore, by adding an appropriate amount of component B, the terbinafine hydrochloride tablets can effectively reduce adverse reactions such as anorexia or difficulty eating in animals after taking the drug, making them safer to use and easier to promote.

[0117] For those skilled in the art, the technical features in the above embodiments can be freely combined, and the resulting technical solutions also belong to the embodiments disclosed in this application.

[0118] Furthermore, without departing from the principles of this application, several improvements and modifications may be made to this application, and these improvements and modifications also fall within the protection scope of the claims of this application.

Claims

1. A terbinafine hydrochloride tablet, characterized in that, The product comprises, by weight, 10-20 parts of terbinafine hydrochloride with a diameter not exceeding 30 μm, 60-80 parts of starch, 10-20 parts of dextrin, 0.05-0.2 parts of lubricant, 0.2-0.4 parts of component A, and 2-8 parts of component B, wherein component A is yellow iron oxide, and component B is composed of sodium carboxymethyl starch and mannitol; the ratio of component A to component B is 1:10-1:

30.

2. The terbinafine hydrochloride tablets according to claim 1, characterized in that, The terbinafine hydrochloride tablets, by weight, comprise the following components: 16.7 parts terbinafine hydrochloride, 66.234 parts starch, 16.7 parts dextrin, 0.1 parts lubricant, and 0.266 parts component A.

3. The terbinafine hydrochloride tablets according to claim 1 or 2, characterized in that, The lubricant is selected from one or more of magnesium stearate, talc, and micronized silica gel.

4. The terbinafine hydrochloride tablets according to claim 1 or 2, characterized in that, The diameter of the terbinafine hydrochloride powder is no higher than 30 μm.

5. The terbinafine hydrochloride tablets according to claim 4, characterized in that, The diameter of component A powder is no higher than 100 μm.

6. The terbinafine hydrochloride tablets according to claim 1, characterized in that, The ratio of sodium carboxymethyl starch to mannitol is 1:1 to 1:

3.

7. A method for preparing terbinafine hydrochloride tablets as described in any one of claims 1-6, comprising the steps of: pretreatment, taking a portion of starch and adding ferric oxide and purified water, stirring while adding water to form a starch slurry for later use; wet granulation, opening the vacuum feeder, sequentially feeding the weighed starch, dextrin, and terbinafine hydrochloride into a high-speed wet granulator, adding the starch slurry, and starting the high-speed wet granulator for granulation; granulation, granulating the terbinafine hydrochloride granules for later use; tableting, feeding the terbinafine hydrochloride granules into a mixer and adding magnesium stearate, turning on the mixer, mixing, and then tableting.

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