Sugar-coated tablet coating method

Abstract

The invention relates to the technical field of pharmacy, and discloses a coating method of sugar-coated tablets, which comprises the following steps: step 1, preheating tablets: preheating the tablets in coating equipment to 40-50 DEG C; step 2, coating a powder coating layer: controlling the temperature of the material to be 40-50 DEG C, spraying mixed slurry, enabling the mixed slurry to be uniformly attached to the surface of each tablet, blowing hot air after all the tablets are dispersed, coating a next powder coating layer after drying, and repeating for 5-12 times; step 3, coating a sugar-coating layer: controlling the temperature of the materials to be 40-50 DEG C, spraying simple syrup to enable the simple syrup to be uniformly attached to the surface of each tablet, blowing hot air after all the tablets are dispersed, coating a next sugar-coating layer after drying, and repeating for 5-12 times to obtain coated tablets; and step 4, polishing: after spraying is finished, the rotating speed of a main machine of the coating equipment is kept unchanged, and after a coated tablet is in a flowing state in a moving state, Chinese insect wax is uniformly scattered until the surface of the tablet is smooth and bright, so that the sugar-coated tablet is obtained. The method is simple, efficient and good in effect.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical technology, and particularly relates to a method for coating sugar-coated tablets. Background Art

[0002] The sugar coating is a layer of sugar wrapped on drugs or foods, and its functions are as follows: First, the sugar coating has a certain function of light shielding, moisture proofing, and air isolation; second, it can cover up the bad smell of drugs; third, it can improve the appearance and is easy to swallow.

[0003] The traditional coating steps for sugar-coated tablets: isolation layer (3 - 5 layers) for 30 minutes, powder coating layer (15 - 18 layers) for 20 - 30 minutes, sugar coating layer (10 - 15 layers) for 15 - 20 minutes, colored sugar coating layer (8 - 15 layers) for 15 - 20 minutes, and polishing. The operation during the powder coating layer in the traditional coating method is: sprinkle the syrup once and sprinkle the powder once. Rely on the syrup attached to the tablets to adhere to talcum powder, and then repeat the operation 15 - 18 times after drying until the edges and corners of the tablets disappear. However, in this way, the amount of syrup attached to the tablets at one time is too small, resulting in a large number of coating layers, a long time, high energy consumption, and a large amount of dust, causing environmental pollution and material loss. At the same time, the amount of talcum powder scattered is also difficult to control.

[0004] Secondly, sugar is very easy to dissolve in water and heat. After the colored sugar coating layer is completed, the polishing process is directly carried out, which will cause the tablets to fade easily. For example, when patients take the tablets, if their hands are sweaty or wet, and the tablets are placed on the hands, the melted pigment will be stained, and obvious discoloration will occur. The darker the color, the more obvious the discoloration phenomenon. At the same time, at a relatively high temperature, the wax on the outer layer of the tablets is easy to melt, resulting in the melting of sugar, and the tablets absorb moisture, fade, and deteriorate. All of these will reduce the patients' trust in the tablets and even cause resistance to the tablets.

[0005] In response to this, those skilled in the art have also conducted a lot of research. For example, aluminum lake is used instead, but aluminum lake contains aluminum. Although the amount is small and generally recognized as safe, it still has a certain impact on long-term users. Some directly add the sizing agent to the coating solution. Although this method has some advantages, sugar-coated tablets need to be coated with dozens of layers. Adding the sizing agent to the coating solution will increase the coating difficulty, and it will directly affect the disintegration time limit of the tablets. If the disintegration is unqualified, it will directly affect the efficacy of the product, and the product will be unqualified.

[0006] The Chinese invention patent with the publication number CN112641746A discloses a coating method for sugar-coated tablets, including: the first step, coating the isolation layer; the second step, coating the powder coat layer, controlling the temperature at 40 - 50°C, adding 20 - 40 ml / kg of the mixed slurry according to the amount of the core tablets, so that the mixed slurry is evenly attached to the surface of each tablet; adding a small amount of talcum powder to make it evenly attached to the surface of each tablet, and after all the tablets are dispersed, blowing hot air for 2 - 5 minutes, and after sufficient drying, coating the next layer of the powder coat layer, repeating 5 - 15 times until all the edges and corners of the tablets disappear; the third step, coating the sugar coat layer; the fourth step, coating the colored layer; the fifth step, polishing, sprinkling 2 / 3 of a portion of shellac powder into the tablets, and after the surface is shiny, slowly sprinkling the remaining 1 / 3 of the shellac powder, and rotating the coating pan until the surfaces of all the tablets are shiny. This method has high efficiency, low pollution during the production process, and the produced tablets are not easy to fade and are not easy to absorb moisture. However, in this method, the operation of sprinkling talcum powder is still used for coating the powder coat layer, which still has the problems of long time consumption, high energy consumption, large dust, environmental pollution, material loss, and difficult control of the amount of talcum powder sprinkled. Summary of the Invention

[0007] The technical problem to be solved by the present invention is that in the existing coating method for sugar-coated tablets, the operation of sprinkling talcum powder is used for coating the powder coat layer, which has long time consumption, high energy consumption, large dust, causing environmental pollution, material loss, and difficult control. The present invention provides a new coating method for sugar-coated tablets.

[0008] The object of the present invention is to provide a coating method for sugar-coated tablets, including the following steps: Step 1, preheating the core tablets: placing the core tablets in a coating device and preheating them to 40 - 50°C; Step 2, coating the powder coat layer: controlling the material temperature at 40 - 50°C, and after controlling the exhaust air volume of the coating device to be greater than the intake air volume, spraying the mixed slurry at 14 - 24 ml / kg according to the amount of the core tablets, with the spraying angle perpendicular to the intake air angle and avoiding the intake air side, so that the mixed slurry is evenly attached to the surface of each tablet, and after all the tablets are dispersed, blowing hot air, and after drying, coating the next layer of the powder coat layer, repeating 5 - 12 times, wherein the mixed slurry is composed of sucrose, talcum powder and water, and the weight ratio is (1.87 - 2.5):(0.6 - 0.66):(0.8 - 1.2); Step 3, coating the sugar coat layer: controlling the material temperature at 40 - 50°C, and after controlling the exhaust air volume of the coating device to be greater than the intake air volume, spraying the simple syrup at 8 - 14 ml / kg according to the amount of the core tablets, with the spraying angle perpendicular to the intake air angle and avoiding the intake air side, so that the simple syrup is evenly attached to the surface of each tablet, and after all the tablets are dispersed, blowing hot air, and after drying, coating the next layer of the sugar coat layer, repeating 5 - 12 times, wherein the simple syrup is composed of sucrose and water, and the weight ratio is (1.87 - 2.5):(0.8 - 1.2), to obtain the coated tablets; Step 4: Polishing: After the spraying is completed, keep the main engine speed of the coating equipment unchanged. After the movement state of the coated tablets becomes fluid, sprinkle the insect wax evenly until the tablet surface is smooth and bright to obtain the sugar-coated tablets; then take out the sugar-coated tablets and cool them to dehumidify.

[0009] Compared with the prior art, the present invention has the following advantages: the coating process of traditional sugar-coated tablets usually requires an isolation layer to protect the tablet core, and an isolation layer is coated on the outside of the tablet core to protect the tablet core from external factors, such as water, air, coating materials, etc.; secondly, after the isolation layer is coated, the instantaneous adhesion between the tablet and the mixed slurry can be reduced, so that the tablet surface will not be partially peeled off by the mixed slurry with higher viscosity at the moment the mixed slurry is added, resulting in a flat tablet surface. Under the conditions of specific equipment and specific parameters, the coating method of the present invention can directly skip the process of coating the isolation layer and start directly coating the powder coating layer. The principle is to use a slower rotation speed when coating the powder coating layer. Because the viscosity of the mixed slurry is relatively high, a pump with greater power is used in this patent to spray the mixed slurry on the surface of the tablet, which can achieve the purpose of smoothly adding the mixed slurry, so that the tablet will not be damaged to a high degree due to the addition time of the mixed slurry. Even if the tablet surface is slightly affected, the coating liquid (including the mixed slurry of the powder coating layer and the monosaccharide syrup of the sugar coating layer) can be more evenly coated on the tablet surface by subsequently increasing the rotation speed of the coating machine. In the repeated coating process, the tablet will eventually become round and smooth. During the movement, in order to protect the coating environment in the coating equipment, the equipment is set to open the air intake and exhaust conditions, the exhaust air volume is greater than the air volume, so that the coating machine is negative pressure phenomenon, according to the process flow and reasonable process parameters, spray coating medium under negative pressure state, the angle of the nozzle on the spray gun is perpendicular to the air intake angle and avoids the air intake side, after the coating medium is sprayed and the tablets are evenly dispersed into a flow-shaped movement, the hot air is turned on, and the hot air enters the coating machine through the air intake pipe perpendicular to the ground, and is discharged through the exhaust pipe at the bottom of the coating drum after the coated tablets, so that the coating medium sprayed on the surface of the core is quickly and evenly dried to form a firm and smooth surface coating layer. The step of wrapping an isolation layer is not required in the coating step of the present invention, and thus the step of sprinkling talcum powder separately is not required, which is short in time consumption, low in energy consumption, small in dust, does not cause environmental pollution, has small material loss, and is well controlled in the process.

[0010] In a possible implementation, the air inlet temperature of the coating equipment in step 1 is 40-60° C., and the preheating time of the plain tablets is 5-15 min.

[0011] In one possible embodiment, the main engine speed of the coating equipment in step 1 is 2-4 rpm, and the air volume is 1000-3000m 3 / h.

[0012] In a possible implementation, the inlet air temperature in step two is 40 - 60°C, and the outlet air temperature at the end of each layer of powder coating is 35 - 45°C.

[0013] In a possible implementation, the main machine rotation speed of the coating equipment in step two is 2 - 10 rpm, and the spraying speed of the mixed slurry is 400 - 600 rpm.

[0014] In a possible implementation, the number of repetitions of the powder coating layer in step two is 8 - 12 times.

[0015] In a possible implementation, the inlet air temperature in step three is 40 - 60°C, and the outlet air temperature at the end of each layer of sugar coating is 35 - 45°C.

[0016] In a possible implementation, the main machine rotation speed of the coating equipment in step three is 2 - 10 rpm, and the spraying speed of the slurry is 400 - 600 rpm.

[0017] In a possible implementation, the temperature of the simple syrup in step three is 40 - 60°C.

[0018] In a possible implementation, the number of repetitions of the sugar coating layer in step three is 8 - 10 times.

[0019] The beneficial effects of the present invention are as follows: 1. The method of the present invention reduces the production cost in the coating process, saves the production time in the coating process, reduces the operation difficulty in the coating process, and the effect of the coated tablets is not affected. Moreover, this method reduces the production risk by simplifying the coating process.

[0020] 2. In the coating process of traditional sugar-coated tablets, talcum powder is usually sprinkled during the powder coating layer process to eliminate the uneven surface of the tablets caused by the adhesion of the mixed slurry to the tablets. This patent controls the stability of the powder coating layer process through specific equipment and parameters, omits the process of sprinkling talcum powder during the powder coating layer process, reduces the production cost in the coating process, reduces the operation difficulty in the coating process, and avoids the risk of uneven sprinkling of talcum powder by manual hand spraying.

[0021] 3. In the coating process of traditional sugar-coated tablets, after adding the mixed slurry in the powder coating layer process, it usually needs to be dried for 45 - 60 minutes. This patent determines the drying end point by controlling the outlet air temperature under the condition of hot air drying after adding the mixed slurry through specific equipment and parameters. Each layer only needs to be dried for 7 - 10 minutes, greatly reducing the production time.

[0022] 4. The coating process of traditional sugar-coated tablets usually requires coating the colored sugar-coated layer after the powder coating layer and the sugar coating layer are completed. In this patent, the colored sugar-coated layer is omitted, reducing the production cost in the coating process, saving the production time in the coating process, reducing the operation difficulty in the coating process, and significantly reducing the production risk by simplifying the coating process.

[0023] 5. In the polishing process of the coating process of traditional sugar-coated tablets, "fine powder of insect wax, that is, the fine powder ground after refined rice core wax (Sichuan wax) is added with 2% silicone oil and mixed evenly and cooled" is usually added. In this patent, white wax is directly sprinkled for polishing in the polishing stage. After about 15 minutes of polishing, the surface of the coated tablets can produce luster. In this patent, the operation of adding silicone oil is omitted, reducing the production cost in the coating process and reducing the operation difficulty in the coating process.

[0024] 6. The coating method of the present invention is particularly suitable for the preparation of sugar coating of chlorpromazine hydrochloride tablets. Specific Embodiments

[0025] In order to illustrate the technical solutions described in the present invention, the following will be described through specific embodiments.

[0026] The present invention is produced under a specific BGB-350D type high-efficiency coating machine, the manufacturer is Zhejiang Xiaolun Pharmaceutical Machinery Co., Ltd., and the volume of the coating machine drum is 350L. The pump with relatively large power used is the WT600-3J peristaltic pump driver, and the manufacturer is Baoding Lange Constant Flow Pump Co., Ltd. The normal working environment temperature of the BGB-350D type high-efficiency coating machine is 5°C to 40°C.

[0027] The basic concept of the present invention is: putting the tablet core into the coating drum, and the tablet core keeps rolling in the clean and airtight rotating coating drum. During the movement process, in order to protect the coating environment in the coating machine, the equipment is set to have the exhaust air volume greater than the incoming air volume under the condition of opening the inlet air and the exhaust air, so that a negative pressure phenomenon occurs in the coating machine. According to the process flow and reasonable process parameters, the coating medium is sprayed under the negative pressure state. The angle set by the nozzle on the spray gun is perpendicular to the inlet air angle and avoids the inlet air side. After the coating medium is sprayed and the tablets are evenly dispersed and in a flowing motion, the hot air is turned on. The hot air enters the coating machine through the air inlet pipe perpendicular to the ground, passes through the coated tablets and is discharged through the exhaust pipe at the bottom of the coating drum, so that the coating medium sprayed on the surface of the tablet core can be quickly and evenly dried, forming a firm and smooth surface coating layer.

[0028] Since the inlet air temperature and the temperature of the coating medium added during the actual production process are both 50°C, and the concentration and viscosity of the coating medium added are relatively high, the atomization effect cannot be achieved when it is sprayed from the spray gun on the equipment. Therefore, too fast drying will cause the weight of the tablets sprayed with a large amount of coating medium first to increase rapidly and become irregular in shape. To protect the tablets from rapid drying in a short time when the coating medium is added, the inlet air, exhaust air, and heating are not turned on during the process of adding the coating medium.

[0029] The effective volume of the liquid preparation stirring tank DJ-150 used in the present invention is 150L, the inner surface is smooth, there are no dead corners, and it is easy to clean. The stirrer uses pneumatic stirring, which is driven by a pneumatic motor, and the stirring speed is controlled by setting the compressed air pressure, and the pressure size can be adjusted manually.

[0030] After adopting the above equipment, the preparation method of the present invention includes the following steps: Step 1. Preheating of the core tablets: Place the core tablets in the coating equipment and preheat them to 40-50°C; preferably, the inlet air temperature of the coating equipment is 40-60°C, the main machine speed of the coating equipment is 2 rpm, and the inlet air volume is 1000-3000m 3 / h, and the preheating time of the core tablets is 5-15 min. A smaller main machine speed is selected to avoid excessive friction between the tablets and damage the tablets, and a temperature range close to the preheating end temperature is selected to reduce the softening of the medicine during the heating process. When the core tablet temperature rises to 40-50°C, it is regarded as the end of preheating.

[0031] Step 2: Coating with powder coat layer: Control the material temperature at 40 - 50°C, and after controlling the exhaust air volume of the coating equipment to be greater than the inlet air volume, spray the mixed slurry at a rate of 14 - 24 ml / kg based on the amount of plain tablets. The spraying angle is perpendicular to the inlet air angle and avoids the inlet air side, so that the mixed slurry evenly adheres to the surface of each tablet. After all the tablets are dispersed, blow hot air. After drying, coat the next layer of powder coat layer, and repeat 5 - 12 times. The mixed slurry is composed of sucrose, talcum powder and water, and the weight ratio is (1.87 - 2.5):(0.6 - 0.66):(0.8 - 1.2); preferably, repeat 8 - 12 times. The main machine rotation speed of the coating equipment is 2 - 10 rpm, the inlet air temperature is 40 - 60°C, the spraying speed of the mixed slurry is 400 - 600 rpm, and the outlet air temperature at the end of each layer of powder coat layer is 35 - 45°C. After the first layer of powder coat layer coating is completed, the adverse effect of the mixed slurry with high viscosity on the tablet surface is reduced. Therefore, after wrapping the first layer of powder coat layer on the tablet surface, the risk of adverse effects on the tablet appearance caused by increasing the amount of mixed slurry in the subsequent process is greatly reduced. Therefore, increase the amount of mixed slurry to reduce the production time. Taking 12 layers of powder coat layer as an example, if 0.75 - 1 L of mixed slurry is used in the first layer, the amount of mixed slurry used in the subsequent 2 - 8 layers increases by 30 - 50% (i.e., 1.0 - 1.5 L) based on the first layer, and the amount of mixed slurry used in the 9 - 12 layers increases by 50% (i.e., 1.1 - 1.5 L) based on the first layer. Preferably, after several layers of powder coat layer are wrapped, the tablets gradually become firm and wear-resistant, and the main machine rotation speed and spraying speed can be increased in the subsequent layers to facilitate faster coating and save production time.

[0032] Step 3: Coating with sugar coat layer: Control the material temperature at 40 - 50°C, and after controlling the exhaust air volume of the coating equipment to be greater than the inlet air volume, spray simple syrup at a rate of 8 - 14 ml / kg based on the amount of plain tablets. The spraying angle is perpendicular to the inlet air angle and avoids the inlet air side, so that the simple syrup evenly adheres to the surface of each tablet. After all the tablets are dispersed, blow hot air. After drying, coat the next layer of sugar coat layer, and repeat 5 - 12 times. The simple syrup is composed of sucrose and water, and the weight ratio is (1.87 - 2.5):(0.8 - 1.2), to obtain the coated tablets; preferably, the number of repetitions is 8 - 10 times. The main machine rotation speed of the coating equipment is 2 - 10 rpm, the spraying speed is 400 - 600 rpm, the temperature of the simple syrup is 50°C, the inlet air temperature is 40 - 60°C, and the outlet air temperature at the end of each layer of sugar coat layer is 35 - 45°C. In the early stage, multiple layers of powder coat layer have been wrapped on the tablets, and the risk to the tablets themselves caused by continuing to wrap the sugar coat layer is relatively low. Therefore, less simple syrup can be used in the subsequent sugar coat layer wrapping. For example, 0.75 - 1.5 L of simple syrup is used in the 1st - 9th layers during the sugar coat layer wrapping, and 0.5 - 1.2 L of simple syrup is used in the 10th layer while adding Chinese wax for polishing.

[0033] Step 4: Polishing: After the spraying is completed, keep the rotation speed of the main body of the coating equipment unchanged. After the moving state of the coated tablets becomes fluid, evenly sprinkle white wax of Chinese wax scale insects until the tablet surface is smooth and bright, obtaining sugar-coated tablets; then take out the sugar-coated tablets and cool them to remove moisture.

[0034] The specific coating preparation method includes the following steps: preparing simple syrup → preparing mixed syrup → preheating the core tablets → coating the powder coat layer → coating the sugar coat layer → polishing → drying.

[0035] The present invention selects appropriate coating excipients to meet the requirements of sugar coating for chlorpromazine hydrochloride tablets; the present invention uses mixed syrup as the coating solution for the powder coat layer and simple syrup as the coating solution for the sugar coat layer.

[0036] The following takes the sugar coating of chlorpromazine hydrochloride tablets and berberine hydrochloride tablets as examples for specific elaboration. Example

[0037] A coating method for sugar coating of chlorpromazine hydrochloride tablets includes the following steps: (1) Weighing: Weigh the raw and auxiliary materials at 102% of the prescription amount of each batch of chlorpromazine hydrochloride tablets. Taking 500,000 tablets per batch as an example of the prescription amount, that is, 4.465 kg of talc powder, 26.775 kg of sucrose, 10.71 kg of purified water, and 0.105 kg of white wax of Chinese wax scale insects, and set aside for use; (2) Preparation of simple syrup: Add 26.775 kg of sucrose to 10.71 kg of purified water, heat and dissolve to make 37.485 kg of simple syrup, and keep it at 50 °C for later use after insulation.

[0038] (3) Preparation of mixed syrup: Add 4.465 kg of talc powder to 23.585 kg of simple syrup, stir evenly to make 28.05 kg of mixed syrup, and keep it at 50 °C for later use after insulation.

[0039] (4) Coating preheating: Add the core tablets into the coating machine, then set the inlet air volume to 1000 - 3000 m³ / h, the main body rotation speed to 2 rpm, the inlet air temperature to 50 °C. When the core temperature rises to 40 - 50 °C, it is regarded as the end of preheating; (5) Coating stage (the first layer of the powder coat layer): Close the inlet air / exhaust air volume and the inlet air temperature, set the main body rotation speed of the coating machine to 4 rpm, the consumption of mixed syrup to 0.87 L, and the spraying rotation speed to 400 rpm, and start coating. During the coating process, control the outlet air temperature at 40 ± 5 °C. After the spraying is completed, keep the main body rotation speed unchanged. After the moving state of the coated tablets becomes fluid, turn on the inlet air / exhaust air volume and the inlet air temperature. After the coated tablets are completely dried (generally when the outlet air temperature is above 40 °C), continue with the next layer of coating.

[0040] (6) Coating stage (second layer of the powder coat): Close the air intake / air exhaust volume and the air intake temperature. Set the main machine rotation speed of the coating machine to 4 rpm, the dosage of the mixed slurry to 0.87 L, and the spraying rotation speed to 400 rpm. Start coating. During the coating process, control the air outlet temperature at 40 ± 5 °C. After the spraying is completed, keep the main machine rotation speed unchanged. After the movement state of the coated tablets becomes fluid, turn on the air intake / air exhaust volume and the air intake temperature. After the coated tablets are completely dry (generally when the air outlet temperature is above 40 °C), continue with the next layer of coating.

[0041] (7) Coating stage (third layer of the powder coat): Close the air intake / air exhaust volume and the air intake temperature. Set the main machine rotation speed of the coating machine to 4 rpm, the dosage of the mixed slurry to 1.3 L, and the spraying rotation speed to 400 rpm. Start coating. During the coating process, control the air outlet temperature at 40 ± 5 °C. After the spraying is completed, keep the main machine rotation speed unchanged. After the movement state of the coated tablets becomes fluid, turn on the air intake / air exhaust volume and the air intake temperature. After the coated tablets are completely dry (generally when the air outlet temperature is above 40 °C), continue with the next layer of coating.

[0042] (8) Coating stage (fourth layer of the powder coat): Close the air intake / air exhaust volume and the air intake temperature. Set the main machine rotation speed of the coating machine to 5 rpm, the dosage of the mixed slurry to 1.3 L, and the spraying rotation speed to 400 rpm. Start coating. During the coating process, control the air outlet temperature at 40 ± 5 °C. After the spraying is completed, keep the main machine rotation speed unchanged. After the movement state of the coated tablets becomes fluid, turn on the air intake / air exhaust volume and the air intake temperature. After the coated tablets are completely dry (generally when the air outlet temperature is above 40 °C), continue with the next layer of coating.

[0043] (9) Coating stage (fifth to eighth layers of the powder coat): Close the air intake / air exhaust volume and the air intake temperature. Set the main machine rotation speed of the coating machine to 5 rpm, the dosage of the mixed slurry to 1.3 L, and the spraying rotation speed to 500 rpm. Start coating. During the coating process, control the air outlet temperature at 40 ± 5 °C. After the spraying is completed, keep the main machine rotation speed unchanged. After the movement state of the coated tablets becomes fluid, turn on the air intake / air exhaust volume and the air intake temperature. After the coated tablets are completely dry (generally when the air outlet temperature is above 40 °C), continue with the next layer of coating.

[0044] (10) Coating stage (ninth to twelfth layers of the powder coat): Close the air intake / air exhaust volume and the air intake temperature. Set the main machine rotation speed of the coating machine to 5 rpm, the dosage of the mixed slurry to 1.5 L, and the spraying rotation speed to 500 rpm. Start coating. During the coating process, control the air outlet temperature at 40 ± 5 °C. After the spraying is completed, keep the main machine rotation speed unchanged. After the movement state of the coated tablets becomes fluid, turn on the air intake / air exhaust volume and the air intake temperature. After the coated tablets are completely dry (generally when the air outlet temperature is above 40 °C), continue with the next layer of coating.

[0045] (11) Coating stage (layers 1 - 8 of the sugar coating): Close the air intake / air exhaust volume and the air intake temperature. Set the main machine rotation speed of the coating machine to 6 rpm, the dosage of the mixed slurry to 0.87 L, and the spraying rotation speed to 400 rpm. Start coating. During the coating process, control the air outlet temperature at 40 ± 5 °C. After the spraying is completed, keep the main machine rotation speed unchanged. After the movement state of the coated tablets becomes fluid, turn on the air intake / air exhaust volume and the air intake temperature. After the coated tablets are completely dried (generally when the air outlet temperature is above 40 °C), continue with the next layer of coating.

[0046] (12) Coating stage (layers 9 - 10 of the sugar coating): Close the air intake / air exhaust volume and the air intake temperature. Set the main machine rotation speed of the coating machine to 6 rpm, the dosage of the mixed slurry to 0.65 L, and the spraying rotation speed to 400 rpm. Start coating. During the coating process, control the air outlet temperature at 40 ± 5 °C. After the spraying is completed, keep the main machine rotation speed unchanged. After the movement state of the coated tablets becomes fluid, turn on the air intake / air exhaust volume and the air intake temperature. After the coated tablets are completely dried (generally when the air outlet temperature is above 40 °C), continue with the next layer of coating.

[0047] (13) Coating stage (layer 11 of the sugar coating): Close the air intake temperature, turn on the air intake / air exhaust volume. Set the main machine rotation speed of the coating machine to 6 rpm, the dosage of the mixed slurry to 0.43 L, and the spraying rotation speed to 400 rpm. Start coating. During the coating process, control the air outlet temperature at 40 ± 5 °C. After the spraying is completed, keep the main machine rotation speed unchanged. After the movement state of the coated tablets becomes fluid, evenly sprinkle 0.105 kg of Chinese wax. When the tablet surface is smooth and shiny, stop polishing, take out the sugar-coated tablets, and cool the tablets to remove moisture.

[0048] After the appearance inspection of the sugar-coated tablets obtained after the coating is completed, it is found that there is no obvious difference between the sugar-coated tablets of chlorpromazine hydrochloride tablets obtained in this example and the reference preparation of chlorpromazine hydrochloride tablets; after the dissolution curve detection of the sugar-coated tablets obtained after the coating is completed, it is found that the dissolution behavior of the sugar-coated tablets of chlorpromazine hydrochloride tablets obtained in this example is consistent with that of the reference preparation of chlorpromazine hydrochloride tablets.

[0049] The powder coating layer and the sugar coating layer of the tablets in this product have provided light-shielding protection for the drug. This product has no bad smell and does not need to improve the already smooth and round appearance. Example

[0050] A coating method for sugar coating of berberine hydrochloride tablets, comprising the following steps: (1) Weighing: Weigh the raw and auxiliary materials according to the prescription amount of each batch of berberine hydrochloride tablets. Taking 750,000 tablets per batch as an example of the prescription amount, that is, 56.00 kg of sucrose, 18.00 kg of talc powder, 30.00 kg of purified water, and 179 g of Chinese wax. Set aside for use; (2) Preparation of simple syrup: Add 56.00 kg of sucrose to 30.00 kg of purified water, heat and dissolve to make 86.00 kg of simple syrup, and keep it at 50 °C for later use.

[0051] (3) Preparation of mixed slurry: Add 18.00 kg of talc powder to 43.00 kg of simple syrup, stir evenly to make 61.00 kg of mixed slurry, and keep it at 50 °C for later use.

[0052] (4) Coating preheating: Put the plain tablets into the coating machine, then set the inlet air volume to 1000 - 3000 m³ / h, the main machine speed to 2 rpm, and the inlet air temperature to 50 °C. When the core temperature of the tablets rises to 40 - 50 °C, it is regarded as the end of preheating; (5) Coating stage (the first layer of powder coating): Close the inlet air / ventilation air volume and inlet air temperature, set the main machine speed of the coating machine to 4 rpm, the consumption of mixed slurry to 1.7 L, and the spraying speed to 400 rpm, and start coating. During the coating process, control the outlet air temperature at 40 ± 5 °C. After the spraying is finished, keep the main machine speed unchanged. After the movement state of the coated tablets becomes fluid, turn on the inlet air / ventilation air volume and inlet air temperature. After the coated tablets are completely dry (generally when the outlet air temperature is above 40 °C), continue with the next layer of coating.

[0053] (6) Coating stage (the second layer of powder coating): Close the inlet air / ventilation air volume and inlet air temperature, set the main machine speed of the coating machine to 4 rpm, the consumption of mixed slurry to 1.7 L, and the spraying speed to 400 rpm, and start coating. During the coating process, control the outlet air temperature at 40 ± 5 °C. After the spraying is finished, keep the main machine speed unchanged. After the movement state of the coated tablets becomes fluid, turn on the inlet air / ventilation air volume and inlet air temperature. After the coated tablets are completely dry (generally when the outlet air temperature is above 40 °C), continue with the next layer of coating.

[0054] (7) Coating stage (the third layer of powder coating): Close the inlet air / ventilation air volume and inlet air temperature, set the main machine speed of the coating machine to 4 rpm, the consumption of mixed slurry to 2.6 L, and the spraying speed to 400 rpm, and start coating. During the coating process, control the outlet air temperature at 40 ± 5 °C. After the spraying is finished, keep the main machine speed unchanged. After the movement state of the coated tablets becomes fluid, turn on the inlet air / ventilation air volume and inlet air temperature. After the coated tablets are completely dry (generally when the outlet air temperature is above 40 °C), continue with the next layer of coating.

[0055] (8) Coating stage (the 4th layer of the powder coat): Close the air intake / air exhaust volume and the air intake temperature. Set the main machine rotation speed of the coating machine to 5 rpm, the amount of mixed slurry to 2.6 L, and the spraying rotation speed to 400 rpm. Start coating. During the coating process, control the air outlet temperature at 40 ± 5 °C. After the spraying is completed, keep the main machine rotation speed unchanged. After the movement state of the coated tablets becomes fluid, turn on the air intake / air exhaust volume and the air intake temperature. After the coated tablets are completely dry (generally when the air outlet temperature is above 40 °C), continue with the next layer of coating.

[0056] (9) Coating stage (the 5th - 8th layers of the powder coat): Close the air intake / air exhaust volume and the air intake temperature. Set the main machine rotation speed of the coating machine to 5 rpm, the amount of mixed slurry to 2.6 L, and the spraying rotation speed to 500 rpm. Start coating. During the coating process, control the air outlet temperature at 40 ± 5 °C. After the spraying is completed, keep the main machine rotation speed unchanged. After the movement state of the coated tablets becomes fluid, turn on the air intake / air exhaust volume and the air intake temperature. After the coated tablets are completely dry (generally when the air outlet temperature is above 40 °C), continue with the next layer of coating.

[0057] (10) Coating stage (the 9th - 12th layers of the powder coat): Close the air intake / air exhaust volume and the air intake temperature. Set the main machine rotation speed of the coating machine to 5 rpm, the amount of mixed slurry to 2.6 L, and the spraying rotation speed to 500 rpm. Start coating. During the coating process, control the air outlet temperature at 40 ± 5 °C. After the spraying is completed, keep the main machine rotation speed unchanged. After the movement state of the coated tablets becomes fluid, turn on the air intake / air exhaust volume and the air intake temperature. After the coated tablets are completely dry (generally when the air outlet temperature is above 40 °C), continue with the next layer of coating.

[0058] (11) Coating stage (the 1st - 8th layers of the sugar coat): Close the air intake / air exhaust volume and the air intake temperature. Set the main machine rotation speed of the coating machine to 6 rpm, the amount of mixed slurry to 3 L, and the spraying rotation speed to 400 rpm. Start coating. During the coating process, control the air outlet temperature at 40 ± 5 °C. After the spraying is completed, keep the main machine rotation speed unchanged. After the movement state of the coated tablets becomes fluid, turn on the air intake / air exhaust volume and the air intake temperature. After the coated tablets are completely dry (generally when the air outlet temperature is above 40 °C), continue with the next layer of coating.

[0059] (12) Coating stage (the 9th layer of the sugar coat): Close the air intake / air exhaust volume and the air intake temperature. Set the main machine rotation speed of the coating machine to 6 rpm, the amount of mixed slurry to 1.5 L, and the spraying rotation speed to 400 rpm. Start coating. During the coating process, control the air outlet temperature at 40 ± 5 °C. After the spraying is completed, keep the main machine rotation speed unchanged. After the movement state of the coated tablets becomes fluid, turn on the air intake / air exhaust volume and the air intake temperature. After the coated tablets are completely dry (generally when the air outlet temperature is above 40 °C), continue with the next layer of coating.

[0060] (13) Coating stage (the 10th layer of sugar coating): Close the inlet air temperature, turn on the inlet air / ventilation air volume, set the main machine rotation speed of the coating machine to 6 rpm, the dosage of the mixed slurry to 1.2 L, the spraying rotation speed to 400 rpm, and start coating. During the coating process, control the outlet air temperature at 40 ± 5 °C. After the spraying is completed, keep the main machine rotation speed unchanged. After the movement state of the coated tablets becomes fluid, evenly sprinkle 179 g of Chinese wax. When the tablet surface is smooth and bright, stop polishing, take out the sugar-coated tablets, and cool and dehumidify them.

[0061] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements on some of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the various embodiments of the present invention, and should all be included in the protection scope of the present invention.

Claims

1. A coating method for sugar-coated tablets, characterized in that, It includes the following steps: Step 1, preheating the plain tablets: Place the plain tablets in a coating device and preheat them to 40 - 50°C; Step 2, coating the powder coat layer: Control the material temperature at 40 - 50°C, and after controlling the exhaust air volume of the coating device to be greater than the intake air volume, spray the mixed slurry at a rate of 14 - 24 ml / kg based on the amount of plain tablets. The spraying angle is perpendicular to the intake air angle and avoids the intake air side, so that the mixed slurry is evenly attached to the surface of each tablet. After all the tablets are dispersed, blow hot air. After drying, coat the next layer of powder coat layer, and repeat 5 - 12 times. The mixed slurry is composed of sucrose, talcum powder and water, and the weight ratio is (1.87 - 2.5):(0.6 - 0.66):(0.8 - 1.2); Step 3, coating the sugar coat layer: Control the material temperature at 40 - 50°C, and after controlling the exhaust air volume of the coating device to be greater than the intake air volume, spray the simple syrup at a rate of 8 - 14 ml / kg based on the amount of plain tablets. The spraying angle is perpendicular to the intake air angle and avoids the intake air side, so that the simple syrup is evenly attached to the surface of each tablet. After all the tablets are dispersed, blow hot air. After drying, coat the next layer of sugar coat layer, and repeat 5 - 12 times. The simple syrup is composed of sucrose and water, and the weight ratio is (1.87 - 2.5):(0.8 - 1.2), to obtain the coated tablets; Step 4, polishing: After the spraying is completed, keep the main machine speed of the coating device unchanged. After the movement state of the coated tablets becomes flowing, evenly sprinkle white wax until the tablet surface is smooth and bright, to obtain the sugar-coated tablets; then take out the sugar-coated tablets and cool them to remove moisture.

2. The coating method of a sugar-coated tablet according to claim 1, characterized in that In Step 1, the intake air temperature of the coating device is 40 - 60°C, and the preheating time of the plain tablets is 5 - 15 min.

3. A coating method for sugar-coated tablets according to claim 1, characterized in that, In step one, the main machine speed of the coating equipment is 2 - 4 rpm, and the air intake volume is 1000 - 3000 m 3 / h.

4. A method for coating a sugar-coated tablet according to claim 1, characterized in that, In Step 2, the intake air temperature is 40 - 60°C, and the outlet air temperature at the end of each layer of coating the powder coat layer is 35 - 45°C.

5. A coating method for sugar-coated tablets according to claim 1, characterized in that, In Step 2, the main machine speed of the coating device is 2 - 10 rpm, and the spraying speed of the mixed slurry is 400 - 600 rpm.

6. A method for coating a sugar-coated tablet according to claim 1, characterized in that, In Step 2, the number of repetitions of coating the powder coat layer is 8 - 12 times.

7. A method for coating a sugar-coated tablet according to claim 1, characterized in that, In Step 3, the intake air temperature is 40 - 60°C, and the outlet air temperature at the end of each layer of coating the sugar coat layer is 35 - 45°C.

8. A coating method for sugar-coated tablets according to claim 1, characterized in that, In Step 3, the main machine speed of the coating device is 2 - 10 rpm, and the spraying speed is 400 - 600 rpm.

9. A method for coating a sugar-coated tablet according to claim 1, characterized in that, In Step 3, the temperature of the simple syrup is 40 - 60°C.

10. A method for coating a sugar-coated tablet according to claim 1, characterized in that, In Step 3, the number of repetitions of coating the sugar coat layer is 8 - 10 times.