Acetylcysteine particles and preparation method thereof

Abstract

The invention discloses acetylcysteine particles and a preparation method thereof, and relates to the field of pharmaceutical preparations. According to the acetylcysteine granules and the preparation method thereof, the acetylcysteine granules comprise an effective amount of acetylcysteine and blank granules, the blank granules contain water-soluble polyhydroxy compounds, the pharmaceutical composition can be further prepared into a pharmaceutical preparation, and the pharmaceutical preparation is granules. According to the acetylcysteine granule and the preparation method thereof, a process of singly granulating a part of auxiliary materials to obtain blank granules, and then mixing the dried blank granules with acetylcysteine and other auxiliary materials is adopted, so that the stability of the active ingredient acetylcysteine is improved, and the effectiveness and safety of the medicine are ensured; compared with acetylcysteine, blank particles have large particle size and proportion difference, the mixing uniformity is difficult to control, and the content uniformity of the preparation is further improved through combined control of components, the particle size and a preparation process.

Description

Technical Field

[0001] The invention relates to the technical field of pharmaceutical preparations, in particular to acetylcysteine ​​particles and a preparation method thereof. Background Art

[0002] Acetylcysteine ​​is a mucolytic agent with a strong mucolytic effect. The sulfhydryl group contained in its molecule can break the disulfide bonds in the glycoprotein polypeptide chain in the sputum, thereby reducing the viscosity of the sputum and making the sputum liquid and easier to cough up. It is suitable for respiratory diseases characterized by excessive viscous secretions, such as COPD, bronchiectasis, etc.

[0003] Currently, acetylcysteine ​​available on the market in China includes effervescent tablets and granules. The granules are easy to carry and convenient to take. The solution is favored by doctors and patients because the drug is dispersed in the medium in molecular form, with a large dispersion, fast absorption, easy to take, and can quickly exert therapeutic effects.

[0004] At present, stabilizers and flow aids need to be added in the preparation process of acetylcysteine ​​on the market. Stabilizers are used to improve the physical properties and chemical stability of the product, improve the quality and service life of the product, and flow aids are used to reduce the friction between particles and improve the fluidity of the powder. During production, the amount of stabilizer and flow aid added needs to be strictly controlled, resulting in a complex overall preparation process. In addition, when acetylcysteine ​​particles are processed, the mixing uniformity of the drug composition is poor, resulting in poor long-term stability, which is not conducive to large-scale industrial production. Therefore, we propose a kind of acetylcysteine ​​particles and a preparation method thereof. Summary of the invention

[0005] In view of the deficiencies in the prior art, the present invention provides an acetylcysteine ​​granule and a preparation method thereof, which solves the problem that a stabilizer and a glidant are added during the preparation of acetylcysteine, the amount of the stabilizer and the glidant added needs to be strictly controlled, resulting in a complicated overall preparation process, and the acetylcysteine ​​granule has poor mixing uniformity during processing of the pharmaceutical composition, resulting in poor long-term stability, which is not conducive to large-scale industrial production.

[0006] To achieve the above objectives, the present invention is implemented through the following technical scheme: an acetylcysteine ​​granule and a preparation method thereof, comprising an effective amount of acetylcysteine, blank granules and sucrose, characterized in that the acetylcysteine ​​with a particle size in the range of 20-80 mesh accounts for 80% to 100%, the blank granules with a particle size in the range of 20 mesh to 100 mesh accounts for 60% to 100%, and the blank granules with a particle size in the range of 20 mesh to 100 mesh accounts for 60% to 100%.

[0007] According to weight, the pharmaceutical composition contains 100 to 200 parts of acetylcysteine, 700 to 1400 parts of blank particles, and 700 to 1400 parts of sucrose. The blank particles contain a water-soluble polyol, wherein the water-soluble polyol is selected from lactose, sucrose, sorbitol and glucose; In parts by weight, the blank particles contain 692 to 1384 parts of water-soluble polyhydroxy compounds.

[0008] Preferably, the pharmaceutical composition is further prepared to obtain acetylcysteine ​​particles.

[0009] Preferably, the following ingredients are included in parts by weight: 100-200 parts of acetylcysteine; 692-1384 parts of sucrose I; 700-1400 parts of sucrose II.

[0010] Preferably, the sucrose I is sucrose powder obtained by pre-treating sucrose through an 80-mesh sieve after sucrose is crushed, and the sucrose II is sucrose crystals.

[0011] Preferably, the sucrose crystals with a particle size in the range of 20-100 mesh account for 80% to 100% of the sucrose II.

[0012] Preferably, the pharmaceutical composition is obtained by mixing acetylcysteine ​​and blank particles by an incremental method.

[0013] Preferably, the method comprises the following steps: S1: Weigh the excipients according to the prescription amount, mix with sucrose I, granulate, and dry to obtain blank granules; S2: the blank granules, sucrose II and acetylcysteine ​​obtained in S1 are uniformly mixed by a stepwise addition method and then acetylcysteine ​​granules are processed by a granulation processing equipment; The granulation processing equipment used in step S2 includes a granulator; A discharge seat and a collecting seat are arranged on the outer wall of the granulator, the discharge seat is connected with the granulator, a discharge port is arranged directly below the discharge seat, and the discharge port is located directly above the collecting seat; A pressing roller is rotatably connected in the collecting seat, the pressing roller is connected to a driving mechanism in the granulator, and extrusion units are arranged on both sides of the pressing roller; The extrusion unit includes a moving seat, a connecting seat and a mounting seat, the moving seat is slidably connected to the inner wall of the collecting seat, the connecting seat is fixedly connected to the moving seat, the mounting seat is fixedly connected between the connecting seats, a forming screen is installed in the mounting seat, and the forming screen is directly below the pressing roller.

[0014] A fixing seat is fixedly connected to the inner wall of the collecting seat, a sliding rod is slidably connected to the inner wall of the fixing seat, a spring is sleeved on the outer peripheral wall of the sliding rod, and two ends of the spring are fixedly connected to the moving seat and the fixing seat respectively.

[0015] The present invention discloses an acetylcysteine ​​granule and a preparation method thereof, which have the following beneficial effects: The acetylcysteine ​​granules and preparation method thereof adopt a process of separately granulating some auxiliary materials to obtain blank granules, and then mixing the dried blank granules with acetylcysteine ​​and other auxiliary materials, because the active ingredient acetylcysteine ​​is unstable to moisture and heat, thereby improving the stability of the active ingredient acetylcysteine ​​and ensuring the effectiveness and safety of the drug.

[0016] The acetylcysteine ​​granules and the preparation method thereof have large differences in particle size and proportion between blank particles and acetylcysteine, making it difficult to control the mixing uniformity. The present invention further improves the content uniformity of the preparation by jointly controlling the ingredients, particle size and preparation process.

[0017] The acetylcysteine ​​granules and the preparation method thereof have simple and feasible preparation processes, and the quality of the prepared preparation is stable and controllable, which is conducive to industrial large-scale production, and the product production can be completed without adding stabilizers and flow aids during the production process. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 It is a schematic diagram of the structure of the present invention; Figure 2 This is a schematic diagram of the internal structure of the collecting seat of the present invention; Figure 3 It is a schematic diagram of the structure of the extrusion unit of the present invention.

[0019] In the figure: 1. granulator; 2. discharge seat; 201. discharge port; 3. collecting seat; 301. pressure roller; 4. extrusion unit; 401. moving seat; 402. connecting seat; 403. mounting seat; 404. spring; 405. sliding rod; 406. fixed seat; 5. forming screen. DETAILED DESCRIPTION

[0020] In the description of the present invention, it is also necessary to explain that, unless otherwise clearly specified and limited, the terms "set", "install", "connect", and "connect" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0021] The following will be combined with the drawings in the embodiments of the invention to clearly and completely describe the technical solutions in the embodiments of the invention. Obviously, the described embodiments are only part of the embodiments of the invention, not all of the embodiments. Based on the embodiments of the invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the invention.

[0022] The embodiment of the present application provides an acetylcysteine ​​granule and a preparation method thereof, which solves the problem that a stabilizer and a glidant need to be added during the preparation of acetylcysteine, and the amount of the stabilizer and the glidant added needs to be strictly controlled, resulting in a complex overall preparation process. In addition, when the acetylcysteine ​​granules are processed, the mixing uniformity of the pharmaceutical composition is poor, resulting in poor long-term stability and being unfavorable for large-scale industrial production. Since the active ingredient acetylcysteine ​​is unstable to moisture and heat, a process is implemented in which some excipients are separately granulated to obtain blank granules, and the dried blank granules are then mixed with acetylcysteine ​​and other excipients, thereby improving the stability of the active ingredient acetylcysteine ​​and ensuring the effectiveness and safety of the drug.

[0023] The blank particles have a large difference in particle size and proportion compared with acetylcysteine, and it is difficult to control the mixing uniformity. The present invention further improves the content uniformity of the preparation by jointly controlling the ingredients, particle size and preparation process.

[0024] The preparation process of the invention is simple and feasible, the quality of the prepared preparation is stable and controllable, it is conducive to industrial large-scale production, and the product production can be completed without adding stabilizers and flow aids during the production process.

[0025] In order to better understand the above technical solution, the above technical solution will be described in detail below in conjunction with the accompanying drawings and specific implementation methods.

[0026] The embodiment of the invention discloses acetylcysteine ​​particles and a preparation method thereof.

[0027] According to the attached Figure 1-3 As shown, it includes an effective amount of acetylcysteine ​​and blank particles, wherein the acetylcysteine ​​is characterized in that the acetylcysteine ​​with a particle size in the range of 20-80 mesh accounts for 80% to 100%, and the blank particles are characterized in that the blank particles with a particle size in the range of 20-100 mesh account for 60% to 100%, and the sucrose with a particle size of 20 mesh to 100 mesh accounts for 60% to 100%. The pharmaceutical composition contains 100 to 200 parts of acetylcysteine, 700 to 1400 parts of blank particles, and 700 to 1400 parts of sucrose.

[0028] Studies have shown that the mixing uniformity of the pharmaceutical composition can be improved by controlling the composition and particle size of the material.

[0029] In the present invention, the blank particles contain water-soluble polyhydroxy compounds, wherein the water-soluble polyhydroxy compounds are one or more of lactose, sucrose, sorbitol or glucose. In parts by weight, the blank particles contain 692 to 1384 parts of the water-soluble polyhydroxy compounds.

[0030] It is particularly disclosed that in the present invention, the pharmaceutical composition may further add other auxiliary ingredients according to the preparation requirements, and the auxiliary ingredients include but are not limited to at least one of flavoring agents, flavors, colorants, etc. Among them, the flavoring agent may be a flavoring ingredient known in the industry, such as saccharin sodium, aspartame, stevioside, etc. The flavor is a flavor known in the industry, such as various fruit flavors, etc. The colorant is a common colorant, which may be a natural pigment or a synthetic pigment.

[0031] Furthermore, in the present invention, the pharmaceutical composition can be further prepared into a pharmaceutical preparation. The pharmaceutical preparation is a granule, and the pharmaceutical composition is prepared into acetylcysteine ​​granules, and the granules contain the following ingredients in parts by weight: 100-200 parts of acetylcysteine; 692-1384 parts of sucrose I; 700-1400 parts of sucrose II.

[0032] The shapes of the raw materials and auxiliary materials in the present invention are different, such as blank particles, acetylcysteine, and sucrose crystals are respectively nearly spherical, needle-shaped, and square, and the mixing uniformity is poor.

[0033] A preparation process of uniformly mixing acetylcysteine, blank particles and sucrose crystals is adopted to improve mixing uniformity.

[0034] Sucrose I is sucrose powder obtained by pre-treating sucrose through an 80-mesh sieve after sucrose is crushed; Sucrose II is sucrose crystals, and the sucrose crystals are characterized in that the proportion of particle sizes in the range of 20 mesh to 100 mesh is 80% to 100%.

[0035] The pharmaceutical composition is obtained by mixing acetylcysteine ​​and blank particles by a stepwise addition method, and then acetylcysteine ​​particles are processed by a granulation processing device; The granulation processing equipment of acetylcysteine ​​granules comprises a granulator 1; a discharging seat 2 and a collecting seat 3 are arranged on the outer wall of the granulator 1, the discharging seat 2 is connected with the granulator 1, a discharging port 201 is arranged directly below the discharging seat 2, and the discharging port 201 is directly above the collecting seat 3. Purified water is weighed by the granulator 1, sucralose, a compound colorant β-carotene 1% powder, and an orange powder flavor are added, stirred, and evenly dispersed, and the mixture enters the collecting seat 3 through the discharging port 201.

[0036] A pressing roller 301 is rotatably connected to the collecting seat 3, and the pressing roller 301 is connected to a driving mechanism in the granulator 1. Extrusion units 4 are arranged on both sides of the pressing roller 301. The extrusion unit 4 includes a movable seat 401, a connecting seat 402 and a mounting seat 403. The movable seat 401 is slidably connected to the inner wall of the collecting seat 3, the connecting seat 402 is fixedly connected to the movable seat 401, and the mounting seat 403 is fixedly connected between the connecting seats 402. A forming screen 5 is installed in the mounting seat 403. The forming screen 5 is located directly below the pressing roller 301. The pressing roller 301 rotates so that the pressing roller 301 extrude the mixture, so that the mixture is granulated through the forming screen 5.

[0037] A fixed seat 406 is fixedly connected to the inner wall of the collecting seat 3, a sliding rod 405 is slidably connected to the inner wall of the fixing seat 406, a spring 404 is sleeved on the outer peripheral wall of the sliding rod 405, and two ends of the spring 404 are fixedly connected to the moving seat 401 and the fixing seat 406 respectively; By pulling the sliding rod 405 to move, the moving seat 401 and the connecting seat 402 are driven to move accordingly. Under the movement of the moving seat 401, the mounting seat 403 is driven to move accordingly, and the forming screen 5 is driven to move downward. By removing the forming screen 5 from the mounting seat 403 and changing the size of the forming screen 5, the quality of the blank particles can be controlled. As the sliding rod 405 moves, the moving seat 401 compresses the spring 404. As the spring 404 rebounds, the moving seat 401, the connecting seat 402 and the mounting seat 403 move in the opposite direction, so that the forming screen 5 moves upward, and the forming screen 5 fits with the pressing roller 301, which is convenient for granulation.

[0038] Taking acetylcysteine ​​granules as an example, the preparation process includes: S1: Weigh the excipients according to the prescription amount, mix with sucrose powder, granulate and dry to obtain blank granules; S2: Mix the blank granules, acetylcysteine ​​and sucrose crystals evenly by the incremental method and divide them into packages to obtain acetylcysteine ​​granules.

[0039] Furthermore, the preparation process of acetylcysteine ​​granules comprises the following steps: S1: Weigh the excipients according to the prescription amount, mix sucralose, carotene, sweet orange flavor and sucrose powder, wet granulate, dry and granulate to obtain blank granules; S2: Mix the blank granules, acetylcysteine ​​and sucrose crystals evenly by the incremental method and divide them into packages to obtain acetylcysteine ​​granules.

[0040] The granules further prepared contain the following ingredients in parts by weight: 100-200 parts of acetylcysteine; 692-1384 parts of sucrose powder; 700-1400 parts of sucrose crystals; 0-5 parts of sucralose; 0-1.5 parts of carotene; and 0-10 parts of sweet orange essence.

[0041] Furthermore, the combined control of ingredients, particle size and formulation process can help to further improve the content uniformity and stability of the formulation.

[0042] It should be particularly emphasized that since the active ingredient acetylcysteine ​​is unstable to moisture and heat, a process is used in which some excipients are granulated separately to obtain blank granules, and the dried blank granules are then mixed with acetylcysteine ​​and other excipients. This improves the stability of the active ingredient acetylcysteine ​​and ensures the effectiveness and safety of the drug.

[0043] It is particularly disclosed that the blank particles have a large difference in particle size and proportion compared with acetylcysteine, making it difficult to control the mixing uniformity. The present invention further improves the content uniformity of the preparation by jointly controlling the ingredients, particle size and preparation process.

[0044] Furthermore, the preparation process of the present invention is simple and feasible, and the quality of the prepared preparation is stable and controllable, which is conducive to large-scale industrial production. Example

[0045] A method for preparing acetylcysteine ​​granules, wherein the acetylcysteine ​​granules are composed of the following raw materials and auxiliary materials: 0.2 g of acetylcysteine, 1.3835 g of sucrose I, 1.4 g of sucrose II, 1.5 g of carotene, 2.5 g of sucralose, and 0.01 g of orange essence, and the specific operation steps are as follows: S1: Weighing: Weigh the crushed sucrose part, compound colorant β-carotene 1% powder, sucralose, and orange powder flavor.

[0046] S2: Pretreatment: Take the crushed part of sucrose and process it with a universal grinder, collect the crushed sucrose, and weigh the crushed sucrose according to the prescription amount.

[0047] S3: Preparation of blank granules: ① Preparation of wetting agent: Weigh purified water, add sucralose, compound colorant β-carotene 1% powder, and orange powder flavor, stir and disperse evenly. Weigh purified water and set aside. ② Granulation: Add the crushed sucrose to the low-level wet granulator, start stirring and chopping, and add the prepared wetting agent to the low-level wet granulator for granulation. ③ Drying: Use a boiling granulation dryer to dry the granulated material. During the process, control the temperature of the blank granules not to exceed 60°C, and finally control the moisture content of the blank granules to ≤0.5%. ④ Granulation: After drying, use a swing granulator for granulation.

[0048] S4: Weighing: According to the weight of the blank granules, convert the sampled amounts of acetylcysteine ​​and added sucrose according to the prescription ratio. Sampled amount of acetylcysteine ​​= batch prescription amount of acetylcysteine ​​× weight of blank granules ÷ batch prescription amount of blank granules. Sampled amount of added sucrose = batch prescription amount of added sucrose × weight of blank granules ÷ batch prescription amount of blank granules. After converting the sampled amount of added sucrose, weigh the added sucrose separately according to the converted 1 / 7 amount of added sucrose, the converted 4 / 7 amount of added sucrose, and the converted 2 / 7 amount of added sucrose. Weigh the blank granules separately according to 2 / 7 blank granules, 2 / 7 blank granules, and 3 / 7 blank granules.

[0049] S5: Co-granulation: Take the weighed converted acetylcysteine ​​and 2 / 7 blank granules and use a granulator to granulate them together for later use. After the process is completed, take another 2 / 7 blank granules and use a granulator to granulate them together for later use.

[0050] S6: Total mixing: Add 1 / 7 of the converted external sucrose into the hopper of the square cone mixer and mix at 30Hz for 2 minutes. Add the co-granulated material acetylcysteine ​​and 2 / 7 of the blank granules and mix at 30Hz for 5 minutes. Continue to add 4 / 7 of the converted external sucrose and mix at 30Hz for 10 minutes. After mixing, add 2 / 7 of the co-granulated blank granules, 3 / 7 of the blank granules and 2 / 7 of the converted external sucrose into the hopper, control the speed at 30Hz and continue mixing for 40 minutes.

[0051] S7: Packaging: The amount is converted according to the content of the intermediate product of acetylcysteine ​​granules, and the amount is packaged according to the converted amount. The difference in the amount of 0.2g specification is controlled within ±7%. Adjust the equipment parameters for granule packaging. The vertical sealing temperature is 180±10℃, the horizontal sealing temperature is 160±10℃, and the speed is 30-50 bags / min to ensure that the packaging appearance and sealing meet the requirements.

[0052] S8: Outsourcing: Pack the sub-packaged samples in individual boxes to ensure good appearance, accurate quantity and clear information. Example

[0053] A method for preparing acetylcysteine ​​granules, wherein the acetylcysteine ​​granules are composed of the following raw materials and auxiliary materials: 0.2 g of acetylcysteine, 1.3835 g of sucrose I, 1.4 g of sucrose II, 1.5 g of carotene, 2.5 g of sucralose, and 0.01 g of orange essence, and the specific operation steps are as follows: S1: Weighing: Weigh the crushed sucrose part, compound colorant β-carotene 1% powder, sucralose, and orange powder flavor.

[0054] S2: Pretreatment: Take the crushed part of sucrose and process it with a universal grinder, collect the crushed sucrose, and weigh the crushed sucrose according to the prescription amount.

[0055] S3: Blank particle preparation: ① Preparation of wetting agent: Weigh purified water, add sucralose, compound colorant β-carotene 1% powder, and orange powder essence, stir and disperse evenly. Weigh purified water and set aside.

[0056] ② Granulation: Add the crushed sucrose into a low-level wet granulator, start stirring and chopping, and add the prepared wetting agent into the low-level wet granulator for granulation.

[0057] ③ Drying: The granulated material is dried using a boiling granulation dryer. During the process, the temperature of the blank particles is controlled not to exceed 60°C, and the moisture content of the blank particles is finally controlled to be ≤0.5%.

[0058] ④ Granulation: After drying, use a swing granulator for granulation.

[0059] S4: Weighing: Based on the weight of the blank granules, convert the sample amount of acetylcysteine ​​and added sucrose according to the prescription ratio.

[0060] The sample amount of acetylcysteine ​​= the batch prescription amount of acetylcysteine ​​× the weight of blank granules ÷ the batch prescription amount of blank granules. The sample amount of added sucrose = the batch prescription amount of added sucrose × the weight of blank granules ÷ the batch prescription amount of blank granules. After converting the sample amount of added sucrose, weigh the added sucrose separately according to the converted 1 / 7 amount of added sucrose, the converted 4 / 7 amount of added sucrose, and the converted 2 / 7 amount of added sucrose. Weigh the blank granules separately according to 2 / 7 blank granules, 2 / 7 blank granules, and 3 / 7 blank granules.

[0061] S5: Co-granulation: Take the weighed converted acetylcysteine ​​and 2 / 7 blank granules and use a granulator to granulate them together for later use. After the process is completed, take another 2 / 7 blank granules and use a granulator to granulate them together for later use.

[0062] S6: Total mixing: Add 1 / 7 of the converted external sucrose into the hopper of the square cone mixer and mix at 30Hz for 2 minutes. Add the co-granulated material acetylcysteine ​​and 2 / 7 of the blank granules and mix at 30Hz for 5 minutes. Continue to add 4 / 7 of the converted external sucrose and mix at 30Hz for 10 minutes. After mixing, add 2 / 7 of the co-granulated blank granules, 3 / 7 of the blank granules and 2 / 7 of the converted external sucrose into the hopper, control the speed at 30Hz and continue mixing for 40 minutes.

[0063] S7: Packaging: The amount is converted according to the content of the intermediate product of acetylcysteine ​​granules, and the amount is packaged according to the converted amount. The difference in the amount of 0.2g specification is controlled within ±7%. Adjust the equipment parameters for granule packaging. The vertical sealing temperature is 180±10℃, the horizontal sealing temperature is 160±10℃, and the speed is 30-50 bags / min to ensure that the packaging appearance and sealing meet the requirements.

[0064] S8: Outsourcing: Pack the sub-packaged samples in individual boxes to ensure good appearance, accurate quantity and clear information.

[0065] Table 1 Preparation quality test results (0.2g) Table 2 Preparation quality test results (0.1g) The test results of the three batches of samples (batches 1-3) produced in the above Example 1 and the three batches of samples (batches 4-6) produced in Example 2 all met the standard limit requirements, and there was no obvious difference between the batches, indicating that the quality of the product can be effectively guaranteed under the prescription and process conditions and can meet the requirements of commercial production.

[0066] Finally, it should be noted that the above are only preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, it is still possible for those skilled in the art to modify the technical solutions described in the aforementioned embodiments, or to make equivalent substitutions for some of the technical features therein. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. An acetylcysteine ​​granule, comprising an effective amount of acetylcysteine, blank granules and sucrose, characterized in that: The proportion of acetylcysteine ​​in the acetylcysteine ​​with a particle size of 20-80 meshes is 80% to 100%, the proportion of blank particles in the blank particles with a particle size of 20-100 meshes is 60% to 100%, and the proportion of blank particles in the sucrose with a particle size of 20-100 meshes is 60% to 100%; In terms of weight, the pharmaceutical composition contains 100 to 200 parts of acetylcysteine, 700 to 1400 parts of blank particles, and 700 to 1400 parts of sucrose; The blank particles contain a water-soluble polyol, wherein the water-soluble polyol is selected from lactose, sucrose, sorbitol and glucose; In parts by weight, the blank particles contain 692 to 1384 parts of water-soluble polyhydroxy compounds.

2. The acetylcysteine ​​granules according to claim 1, characterized in that: The pharmaceutical composition is further prepared to obtain acetylcysteine ​​granules.

3. A kind of acetylcysteine ​​granules according to claim 2, characterized in that, According to weight parts, it contains the following ingredients: 100-200 parts of acetylcysteine; 692-1384 parts of sucrose I; 700-1400 parts of sucrose II.

4. The acetylcysteine ​​granules according to claim 3, characterized in that: The sucrose I is sucrose powder obtained by pre-treating sucrose after crushing sucrose and passing it through an 80-mesh sieve, and the sucrose II is sucrose crystals.

5. The acetylcysteine ​​granules according to claim 4, characterized in that: In the sucrose II, the sucrose crystals with a particle size within the range of 20-100 meshes account for 80% to 100%.

6. The acetylcysteine ​​granules according to claim 1, characterized in that: The pharmaceutical composition is obtained by mixing acetylcysteine ​​and blank particles by using a stepwise addition method.

7. A method for preparing acetylcysteine ​​granules, based on the acetylcysteine ​​granules according to any one of claims 1 to 4, characterized in that: The following steps are involved: S1: Weigh the excipients according to the prescription amount, mix with sucrose I, granulate, and dry to obtain blank granules; S2: the blank granules, sucrose II and acetylcysteine ​​obtained in S1 are uniformly mixed by a stepwise addition method, and then acetylcysteine ​​granules are processed by a granulation processing equipment; The granulation processing equipment used in step S2 includes a granulator (1); A discharge seat (2) and a collecting seat (3) are provided on the outer wall of the granulator (1); the discharge seat (2) is connected to the granulator (1); a discharge port (201) is provided directly below the discharge seat (2); and the discharge port (201) is located directly above the collecting seat (3); A pressing roller (301) is rotatably connected to the collecting seat (3), the pressing roller (301) is connected to a driving mechanism in the granulator (1), and extrusion units (4) are arranged on both sides of the pressing roller (301); The extrusion unit (4) comprises a movable seat (401), a connecting seat (402) and a mounting seat (403); the movable seat (401) is slidably connected to the inner wall of the collecting seat (3); the connecting seat (402) is fixedly connected to the movable seat (401); the mounting seat (403) is fixedly connected between the connecting seats (402); a forming screen (5) is installed in the mounting seat (403); and the forming screen (5) is located directly below the pressing roller (301); A fixed seat (406) is fixedly connected to the inner wall of the collecting seat (3), a sliding rod (405) is slidably connected to the inner wall of the fixing seat (406), a spring (404) is sleeved on the outer peripheral wall of the sliding rod (405), and two ends of the spring (404) are respectively fixedly connected to the movable seat (401) and the fixed seat (406).

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