Sanhuang tablet slurry mixing and coating improvement process

Abstract

The invention provides an improved process for slurry mixing and coating of Sanhuang tablets, and belongs to the technical field of medicine preparation. The invention relates to a Sanhuang tablet mixed slurry coating improvement process, which comprises: providing a Sanhuang tablet plain tablet, coating the plain tablet, sequentially coating the surface of the plain tablet with a foundation make-up layer, an isolation layer, a mixed slurry layer, a sugar-coating layer, a colored sugar-coating layer and a polishing layer, and airing the tablet to obtain the finished product. The invention provides a Sanhuang tablet slurry mixing and coating improvement process which can improve color and luster, avoid piebald and improve drug stability at the same time.

Description

Technical Field

[0001] The invention belongs to the technical field of drug preparation, and particularly relates to an improved process for mixing slurry and coating of Sanhuang tablets. Background Art

[0002] Sanhuang Tablets are derived from the classic prescription "Sanhuang Xiexin Decoction" by the medical saint Zhang Zhongjing. It is composed of rhubarb, scutellaria extract and berberine hydrochloride, and is included in the "Chinese Pharmacopoeia" of all editions. It clears away heat and detoxifies, and relieves fire and relieves constipation. It is used for red and swollen eyes, mouth and nose sores, sore throat, swollen gums, irritability and thirst, yellow urine, and constipation caused by excessive heat in the triple energizer; it is also used for acute gastroenteritis and dysentery.

[0003] In order to improve the taste of the drug, control the release of the drug, and reduce indoor dust, Sanhuang tablets are usually coated. However, the coating process is not perfect enough, and defects such as uneven color and color spots often occur during production, which needs to be improved. Summary of the invention

[0004] The technical problem to be solved by the present invention is to provide an improved process for Sanhuang tablets slurry coating in view of the deficiencies of the prior art, so as to improve the color, avoid spots and improve the drug stability.

[0005] In order to solve the above technical problems, the technical solution adopted by the present invention is: an improved process for Sanhuang tablets slurry coating, comprising: providing Sanhuang tablets, coating the tablets, wherein the coating comprises sequentially coating a powder base layer, an isolation layer, a slurry layer, a sugar coating layer, a colored sugar coating layer and a polishing layer on the surface of the tablets, and drying the tablets to obtain a finished product.

[0006] Optionally, the coating excipients are: gelatin for capsules, sucrose, talcum powder, insect white wax, tartrazine and dimethicone.

[0007] Optionally, the process parameters of the base layer include: adding diluted syrup to the plain tablet, mixing until the surface is completely wetted, quickly sprinkling talcum powder, and drying at 40-50° C. for 35-45 minutes; The mass ratio of sucrose to water in the syrup is (2-3):1, and the mass ratio of the diluted syrup, talcum powder and plain tablets is (3.1-7.6):(10-11.5):100.

[0008] Optionally, the process parameters of the isolation layer include: adding gum syrup to the plain sheet coated with the powder base layer, mixing until the surface is completely wetted, quickly sprinkling talcum powder, drying at 40-50° C. for 28-32 minutes, and repeating the operation 3-5 times; The mass ratio of gelatin, syrup and water for capsules in the gum syrup is 1:(35-37):(3-4), and the mass ratio of the gum syrup, talcum powder and plain tablets is (6.0-6.5):(15.0-17.0):100.

[0009] Optionally, the process parameters of the slurry layer include: spraying the slurry into the plain sheet coated with the isolation layer, drying at 40-50° C. for 12-18 minutes, and repeating the above operation 10-15 times until the slurry is used up; The mixed slurry is composed of syrup, lemon yellow solution and talcum powder, the mass fraction of lemon yellow in the lemon yellow solution is 9-10%, the mass ratio of the syrup, lemon yellow solution and talcum powder is (140-150):1:(70-75), and the mass ratio of the mixed slurry to the plain tablet is (54-62):100.

[0010] Optionally, the process parameters of the sugar coating layer include: adding syrup to the plain tablets coated with the mixed slurry layer, drying at 40-50°C for 9-12 minutes, cooling to 25°C, and repeating the above operation 5-7 times, the amount of syrup added is reduced gradually, and the ratio of the mass of the syrup used for the first time to the mass of the plain tablets is (1.0-1.4):100; the mass ratio of the syrup to the plain tablets is (6.5-7.5):100.

[0011] Optionally, a tartrazine solution is added to the syrup used for the sugar coating layer, the mass fraction of tartrazine in the tartrazine solution is 10-13%, and the mass dosage of the tartrazine solution is 1.0-1.5% of the syrup.

[0012] Optionally, the process parameters of the colored sugar coating layer include: adding colored syrup and syrup to the plain tablet coated with the sugar coating layer, drying at 40-50° C. for 5-10 minutes, and repeating the above operation 3-5 times; the amount of the colored syrup added is gradually increased, and the amount of the syrup added is gradually decreased, and the sum of the amounts of the colored syrup and the syrup used each time is equal, and only the colored syrup is added in the last coating, and the amount of the colored syrup used is equal to the sum of the amounts of the colored syrup and the syrup used in the previous coating, and the mass ratio of the colored syrup used in the first coating to the mass ratio of the plain tablet is (0.13-0.18):100, and the mass ratio of the syrup used in the first coating to the mass ratio of the plain tablet is (0.3-0.6):100; The colored syrup consists of a lemon yellow solution and syrup, the mass fraction of lemon yellow in the lemon yellow solution is 20-25%, the mass dosage of the lemon yellow solution is 6-10% of the syrup, and the mass ratio of the colored syrup, syrup and plain tablets is (1.6-1.9):(1.2-1.5):100.

[0013] Optionally, the process parameters of the polishing layer include: adding a first portion of insect wax powder to the plain tablets coated with the colored sugar coating layer, and after 8 to 12 minutes, adding a second portion of a mixture of insect wax powder and dimethicone, the mass of the first portion of insect wax powder is 1.5 to 2.0 times that of the second portion of insect wax powder, turning on the exhaust for 1 to 2 minutes, and continuing to polish for 25 to 35 minutes before serving; wherein the mass ratio of insect wax powder, dimethicone to plain tablets is (0.15 to 0.20): (0.008 to 0.02): 100.

[0014] In actual production, the coating quality of Sanhuang Tablets is affected by many factors. It is challenging to obtain a stable and reliable process. The main reason is that there are many variables involved in the coating process, including the formulation of each layer of coating solution, the control of operating conditions, etc. For example, the material properties and concentration of the coating solution will affect the characteristics of the coating layer, such as hardness, uniformity and solubility; in addition, operating conditions, such as drying temperature, dosage and addition order, are also crucial to the coating quality. Therefore, to achieve a stable and reliable coating process, it is necessary to comprehensively consider these factors and conduct detailed process optimization and control.

[0015] Although Sanhuang Tablets, as a traditional Chinese medicine preparation, has significant effects in clearing away heat and detoxifying, purging fire and relieving constipation, the existing literature is relatively scarce in the field of coating technology. Through searching, it was found that there are not many professional documents on Sanhuang Tablets coating technology, which limits the applicant's ability to obtain in-depth technical inspiration and innovative ideas from existing research. For example, although there are studies comparing the process and finished product quality of different coating methods, and exploring the application of powder coating technology in masking bitterness, these studies are relatively few and mostly focus on specific process improvements rather than comprehensive technical analysis and guidance. Therefore, when exploring the coating technology of Sanhuang Tablets, the present invention faces the dual challenges of lack of information and lack of focus in the direction of technical improvement.

[0016] Compared with the prior art, the present invention has the following beneficial effects: Compared with the existing Sanhuang Tablet slurry mixing process, the present invention has made a series of key improvements on the coating auxiliary materials and the coating process, which are manifested in the following aspects: (1) The traditional coating process of Sanhuang Tablets is to coat the isolation layer first, and then coat the slurry layer. At the same time, the isolation layer is often coated with corn syrup, and the slurry layer is made of monosaccharide syrup and talcum powder; while the coating process of the present invention is to coat the powder base layer first, then the isolation layer, and then the slurry layer, and the auxiliary material composition and ratio used in the powder base layer, isolation layer and slurry layer are different from those of the traditional process. The present invention improves the fusion and stability of the coating of Sanhuang Tablets by adding a powder base layer, and can also obtain a good coating effect when the mechanical properties of the plain tablets are less consistent. The powder base layer uses a suitable concentration of monosaccharide syrup and talcum powder, the raw materials are easy to obtain, and the process control is easy; by improving the auxiliary material composition of the isolation layer and the slurry layer, and cooperating with the powder base layer, the Sanhuang Tablets are further provided with moisture-proof protection, covering up bad odors, and improving the appearance.

[0017] (2) The present invention simultaneously improves the composition of the auxiliary materials used in the sugar coating layer, the colored sugar coating layer and the polishing layer, so that the whole coating process of Sanhuang Tablets has good smoothness, high coordination degree, and greatly improved coating uniformity, and finally forms a coating layer with a more uniform and beautiful appearance, more stable drug ingredients, and easier to take and absorb, thereby overcoming the uneven spots on the surface, improving production efficiency by more than 10%, and improving the working environment.

[0018] (3) The mixed slurry layer, sugar coating layer and colored sugar coating layer of the present invention are organically coordinated to adjust the color of the coating layer by layer, so that the color uniformity and aesthetics of the coating appearance are greatly improved, and the occurrence of spots is effectively avoided, which not only improves the qualified rate of finished products, but also reduces costs and increases efficiency.

[0019] (4) The auxiliary materials used in the present invention are safe and have no interaction with the active ingredients. The precise matching and control of the proportions of the ingredients and process parameters such as drying provide a good foundation for the smooth progress of the coating process.

[0020] The present invention overcomes the defects of uneven coating, different colors, easy appearance of spots, long production cycle and the like of Sanhuang tablets through the above-mentioned technical improvements, so that the coating quality of Sanhuang tablets is higher, the product color is consistent, there is basically no spot, and the production cycle is effectively shortened. DETAILED DESCRIPTION

[0021] In order to better understand the present invention, the content of the present invention is further clearly set forth in conjunction with the embodiments below, but the protection content of the present invention is not limited to the following embodiments. In the following description, a large number of specific details are provided in order to provide a more thorough understanding of the present invention. However, it is obvious to those skilled in the art that the present invention can be implemented without one or more of these details.

[0022] Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in the field without making any creative work shall fall within the scope of protection of the present invention.

[0023] The numerical ranges and parameters shown in the present invention are approximate values, but the numerical values ​​shown in the specific embodiments are recorded as accurately as possible. However, all numerical values ​​essentially contain specific errors that are inevitably generated by the standard deviation seen in each experimental measurement value. In addition, the terms "about" and "about" refer to within the allowable standard error when considered by those skilled in the art.

[0024] Unless otherwise specified, all raw materials are from commercially available products and do not contain other unspecified components except inevitable impurities unless otherwise specified.

[0025] The invention provides an improved process for slurry coating of Sanhuang tablets, comprising: providing Sanhuang tablets plain tablets, coating the plain tablets, the coating process comprising sequentially coating a powder base layer, an isolation layer, a slurry layer, a sugar coating layer, a colored sugar coating layer and a polishing layer on the surface of the plain tablets, drying the tablets to obtain finished products.

[0026] In the present invention, the coating auxiliary materials are gelatin for capsules, sucrose, talcum powder, insect white wax, tartrazine and dimethicone, and the above auxiliary materials all meet the requirements of relevant regulations.

[0027] The process parameters of the coating powder base layer, isolation layer, slurry mixing layer, sugar coating layer, colored sugar coating layer and glazing layer are described in detail below.

[0028] (1) Foundation layer In some specific embodiments of the present invention, the process parameters of the base layer include: adding the diluted syrup to the plain tablet, mixing until the surface is completely wetted, quickly sprinkling talcum powder, drying at 40-50° C. for 35-45 minutes, Among them, the drying process parameters of the base layer can be selected as follows: drying at 40°C for 45 minutes, drying at 43°C for 42 minutes, drying at 45°C for 40 minutes, or drying at 50°C for 35 minutes; The mass ratio of sucrose to water in the syrup is (2-3):1, and can be 2:1, 2.3:1, 2.7:1 or 3:1; The mass ratio of the diluted syrup, talcum powder and plain tablets is (3.1-7.6):(10-11.5):100, which can be 3.1:10:100, or 4.0:10.5:100, or 5.0:10.8:100, or 6.0:11.2:100, or 7.6:11.5:100.

[0029] The syrup is prepared in advance, and purified water is used. The preparation method includes: adding sucrose and purified water into a sugar dissolving tank, starting stirring, opening the steam valve and heating to boiling, continuing to heat until completely dissolved, turning down the steam, continuing to heat and boil for 10 minutes, then closing the steam valve and stirring, filtering with a sieve into a bucket; then hanging a material identification card to indicate the material name, weight, etc., and placing it at room temperature for use.

[0030] The present invention preferably coats the surface of the plain tablet with a layer of the base coat, and the syrup used for the base coat is preferably diluted 1.10 to 1.13 times. The auxiliary materials used are safe and non-toxic, and no organic solvent is used to avoid gastrointestinal irritation. It can not only eliminate corners and facilitate coating, but also improve tablet stability, which is conducive to the smooth progress of subsequent coating.

[0031] (2) Isolation layer In some specific embodiments of the present invention, the process parameters of the isolation layer include: adding gum syrup to the plain sheet coated with the powder base layer, mixing until the surface is completely wetted, quickly sprinkling talcum powder, drying at 40-50° C. for 28-32 minutes, and repeating the operation 3-5 times; The process parameters for drying the isolation layer are as follows: drying at 40°C for 32 minutes, drying at 42°C for 30 minutes, drying at 45°C for 30 minutes, and drying at 50°C for 28 minutes. The mass ratio of gelatin, syrup and water for capsules in the gelatin syrup is 1: (35-37): (3-4), and the options are 1: 35: 3, 1: 36: 3.5, 1: 37: 4; The mass ratio of gum syrup, talcum powder and plain tablets is (6.0~6.5):(15.0~17.0):100, which can be selected as 6.0:15.0:100, or 6.2:16.0:100, or 6.3:16.5:100, or 6.5:17.0:100.

[0032] The syrup and the gum syrup are prepared in advance, and the preparation method of the syrup has been described above and will not be repeated. The preparation method of the gum syrup includes: weighing gelatin for capsules and putting it into a container in advance, and soaking it in purified water; placing the container in a water bath and heating it until the gelatin is dissolved; measuring the syrup and putting it into another container, placing it on an induction cooker and heating it to 60±2°C, mixing it with the above-mentioned dissolved gelatin solution, stirring it evenly, and placing it in a 60-70°C hot water bath for use.

[0033] The isolation layer of the present invention is preferably coated with 4 to 6 layers, more preferably 5 layers. The auxiliary materials used are safe and non-toxic, avoid gastrointestinal irritation, do not use any organic solvents, and have simple process control. The isolation layer is coated after the base layer, which can not only isolate moisture but also adhere more evenly, making the coating appearance quality more uniform, which is conducive to the uniform presentation of subsequent coating color.

[0034] (3) Mixed slurry layer In some specific embodiments of the present invention, the process parameters of the slurry layer include: spraying the slurry into the plain sheet coated with the isolation layer, drying at 40-50° C. for 12-18 minutes, and repeating the above operation 10-15 times until the slurry is used up; The process parameters for drying the mixed slurry layer can be selected as 18 minutes at 40°C, 16 minutes at 43°C, 15 minutes at 47°C, and 12 minutes at 50°C. The mixed slurry is composed of syrup, lemon yellow solution and talcum powder, the mass fraction of lemon yellow in the lemon yellow solution is 9-10%, and the mass ratio of syrup, lemon yellow solution and talcum powder is (140-150):1:(70-75), which can be 140:1:70, or 142:1:72, or 147:1:73, or 150:1:75; The mass ratio of the mixed slurry to the plain tablets is (54-62):100, which can be 54:100, or 58:100, or 60:100, or 62:100.

[0035] The mixed slurry layer of the present invention is preferably coated with 11 to 16 layers, more preferably 13 to 15 layers, and the preparation method of the syrup used is the same as the above, which will not be repeated. In this way, by coating a specific number of mixed slurry layers after the isolation layer, and optimizing the materials, ratio and amount of the mixed slurry layer, the uniformity of the coating of the Sanhuang tablets is improved, the coating is made more strict and smooth, the color is initially improved, and a good foundation is provided for the high-quality presentation of the subsequent coating.

[0036] (4) Sugar coating layer In some specific embodiments of the present invention, the process parameters of the sugar coating layer include: adding syrup to the plain tablets coated with the mixed slurry layer, drying at 40-50°C for 9-12 minutes, slowly cooling to 25°C, and repeating the above operation 5-7 times, with the amount of syrup added decreasing gradually, and the mass ratio of the amount of syrup used in the first time to the plain tablets (1.0-1.4): 100; The mass ratio of syrup to plain tablets is (6.5~7.5):100, which can be selected as 6.5:100, or 6.8:100, or 7.2:100, or 7.5:100.

[0037] In some specific embodiments of the present invention, a tartrazine solution is added to the syrup used for the sugar coating layer, and the mass fraction of tartrazine in the tartrazine solution is 10-13%; The dosage of the tartrazine solution is 1.0-1.5% of the syrup, which can be 1.0%, 1.2%, 1.35%, or 1.5%.

[0038] The sugar coating layer of the present invention preferably covers 6 to 9 layers, more preferably 7 to 8 layers, wherein the syrup used is the same as the preparation process of the previous syrup, which will not be repeated. In this way, by controlling the amount of syrup, the successive changes and the drying parameters, the coating of the Sanhuang tablets is made smoother, firmer, more delicate and firmer. The present invention can also preferably add a suitable amount of lemon yellow solution in this step, which is closely matched with the mixed slurry layer to further improve the color presentation effect, optimize the appearance uniformity, and avoid color spots.

[0039] (5) Colored sugar coating layer In some specific embodiments of the present invention, the process parameters of the colored sugar coating layer include: adding colored syrup and syrup to the plain tablet coated with the sugar coating layer, drying at 40-50° C. for 5-10 minutes, and repeating the above operation 3-5 times; the amount of colored syrup added increases gradually, the amount of syrup added decreases gradually, the amount of colored syrup increased gradually is equal to the amount of syrup decreased gradually, the sum of the amount of colored syrup and syrup used each time is equal, only colored syrup is added in the last coating, and the amount of colored syrup used is equal to the sum of the amount of colored syrup and syrup used in the previous coating, the mass ratio of the colored syrup used in the first time to the mass of the plain tablet is (0.13-0.18):100, and the mass ratio of the syrup used in the first time to the mass of the plain tablet is (0.3-0.6):100; The colored syrup is composed of a lemon yellow solution and syrup, wherein the mass fraction of the lemon yellow in the lemon yellow solution is 20-25%. The mass dosage of lemon yellow solution is 6-10% of the syrup, and 6%, 7.5%, 8.5%, or 10% can be selected. The mass ratio of colored syrup, syrup and plain tablets is (1.6-1.9):(1.2-1.5):100, which can be 1.6:1.2:100, or 1.7:1.3:100, or 1.8:1.4:100, or 1.9:1.5:100.

[0040] Preparation method of colored syrup: weigh lemon yellow and put it into a container, add purified water, and stir to dissolve; measure the syrup and put it into another container, heat it on an induction cooker until it boils, stop heating, pour it into the lemon yellow solution, stir evenly, and the colored syrup is obtained.

[0041] The colored sugar coating layer of the present invention is preferably coated with 4 to 6 layers, more preferably 5 layers. The preparation method of the syrup used in the colored sugar coating layer is the same as the above. The colored sugar coating layer uses a lemon yellow solution with a specific concentration and a reasonable amount to further improve the coloring uniformity and aesthetics and avoid the generation of color spots.

[0042] (6) Lighting layer In some specific embodiments of the present invention, the process parameters of the polishing layer include: adding a first portion of insect wax powder to the plain tablet coated with the colored sugar coating layer, and after 8 to 12 minutes, adding a second portion of a mixture of insect wax powder and dimethicone, the mass of the first portion of insect wax powder is 1.5 to 2.0 times that of the second portion of insect wax powder, turning on the exhaust for 1 to 2 minutes, and continuing to polish for 25 to 35 minutes before serving.

[0043] In this process, the mass ratio of insect wax powder, dimethicone and plain tablets is (0.15-0.20):(0.008-0.02):100, which can be 0.15:0.008:100, or 0.16:0.010:100, or 0.18:0.015:100, or 0.20:0.020:100.

[0044] The polishing layer of the present invention is preferably coated with one layer, so as to further improve the appearance color and moisture-proof performance of Sanhuang Tablets and enhance the storage stability of the product.

[0045] The following is a specific implementation case, taking 300kg of plain tablets as an example.

[0046] Example 1: An improved process for coating slurry of Sanhuang tablets, the specific process is as follows: Preparation of excipients for S1 coating: S2 pulping (1) Syrup Add 138kg of sucrose and 62kg of purified water into the sugar dissolving tank, start stirring, open the steam valve and heat to boiling, continue heating until completely dissolved, turn down the steam, continue heating and boiling for 10 minutes, then close the steam valve and stirring, filter through an 80-mesh sieve into a bucket, let it reach room temperature, and set aside.

[0047] (2) Gum syrup Weigh 0.77 kg of gelatin for capsules and put it into a basin in advance, then add 2.8 kg of purified water to soak it; place the basin in a water bath and heat it until the gelatin is dissolved; measure 28 kg of syrup and put it into a bucket, place it on an induction cooker and heat it to 60±2°C, mix it with the above-mentioned dissolved gelatin solution, stir evenly, and place it in a 65±5°C hot water bath for later use.

[0048] (3) Colored syrup Weigh 92g of lemon yellow into a basin, add 308g of purified water, and stir to dissolve; measure 5.0kg of syrup and put it into a stainless steel pot, heat it on an induction cooker until it boils, stop heating, pour it into the lemon yellow solution, and stir evenly.

[0049] S3 coating process Base layer → Isolation layer → Mixing layer → Sugar coating layer → Colored sugar coating layer → Polishing layer S301 foundation layer Measure 8.3 kg of syrup and pour it into a small bucket. Add 0.9 kg of purified water and heat it to 60±2℃ on an induction cooker for later use.

[0050] Three pots were used for coating at the same time. 100 kg of plain tablets were added to each pot. The main machine was turned on and the main machine speed was set to 8 rpm. About 3.01 kg of the diluted syrup was added to each pot. After the surface of the tablets was completely wetted, 10.8 kg of talcum powder was quickly sprinkled in. The tablets were dried at 45 ± 5 °C for 40 minutes.

[0051] S302 isolation layer First layer: Add 2.01 kg of gum syrup to each pot, and when the surface of the tablets is completely wetted, quickly sprinkle 5.4 kg of talcum powder and dry at 45±5℃ for 30 minutes.

[0052] Second to fifth layers: Repeat the first layer operation.

[0053] S303 slurry layer Prepare an insulation bucket for each pot and prepare the mixed slurry separately: pour 37kg of syrup into a stainless steel insulation bucket, add 0.253kg of lemon yellow solution (23g of lemon yellow plus 230g of purified water, stir evenly) while stirring, then slowly add 18kg of talcum powder, stir evenly and connect the infusion pipeline, adjust the position and angle of the nozzle, start the "spraying pump" circulation, set the insulation temperature to 55±2℃, and set aside.

[0054] Spray 4.3 kg of mixed slurry into each pot each time and dry at 45±5℃ for 15 minutes until the mixed slurry is used up (13 times in total).

[0055] S304 sugar coating Measure 20.0 kg of syrup and pour it into a bucket. Add 0.257 kg of lemon yellow solution (27 g of lemon yellow plus 230 g of purified water, stir evenly) while stirring. Stir to make the color uniform and set aside.

[0056] First layer: Add 1.30 kg of the above syrup to each pot, dry for 10 minutes, and slowly reduce the drying temperature from 50°C to 25°C.

[0057] Second layer: Repeat the first operation and add syrup at 1.17kg / pot.

[0058] Third layer: Repeat the first operation and add syrup at 1.04kg / pot.

[0059] Fourth layer: Repeat the first operation and add syrup at 0.91kg / pot.

[0060] Fifth layer: Repeat the first operation and add syrup at 0.78kg / pot.

[0061] Sixth layer: Repeat the first operation and add syrup at 0.65kg / pot.

[0062] Seventh layer: Repeat the first operation and add syrup at 0.52kg / pot.

[0063] Eighth layer: Repeat the first operation and add syrup at 0.39kg / pot.

[0064] S305 colored sugar coating First layer: Measure 154g of colored syrup, add 462g of syrup, mix well, add to the pot, and dry for about 8 minutes. Repeat the same process for the other two pots.

[0065] Second layer: Measure 231g of colored syrup, add 385g of syrup, mix well, add to the pot, and dry for about 8 minutes. Repeat the same process for the other two pots.

[0066] Third layer: Measure 308g of colored syrup, add 308g of syrup, mix well, add to the pot, and dry for about 8 minutes. Repeat the same process for the other two pots.

[0067] Fourth layer: Measure 385g of colored syrup, add 231g of syrup, mix well, add to the pot, and dry for about 8 minutes. Repeat the same process for the other two pots.

[0068] Fifth layer: Measure 616g of colored syrup and add it to the pot. After the slices are completely spread out, adjust the pot speed to 3rpm and rotate for about 15 minutes. Repeat the same process for the other two pots.

[0069] S306 Polishing Layer Adjust the pan speed to 6rpm, sprinkle 115g of insect wax powder into each pan, and after 10 minutes, sprinkle a mixture of insect wax powder and dimethicone, including 65g of insect wax powder and 10g of dimethicone, open the exhaust for 1 minute, continue polishing for 30 minutes and then remove from the pan. Put the sugar-coated tablets into the stainless steel basket on the drying cart and flatten them, and push them into the drying room.

[0070] S4 drying sheet Turn on the dehumidifier in the drying room, place the drying cart in the drying room, and dry the slices for no less than 10 hours.

[0071] Example 2: An improved process for slurry coating of Sanhuang tablets, which is different from Example 1 in that: S301 foundation layer Measure 10.7 kg of syrup into a small bucket, add 1.3 kg of purified water, and heat to 60 ± 2 ° C on an induction cooker.

[0072] Add about 100 kg of plain tablets to each pot, turn on the main machine, set the main machine speed to 9 rpm, add about 4.0 kg of the diluted syrup mentioned above to each pot, after the surface of the tablets is completely wetted, quickly sprinkle 11.2 kg of talcum powder, and dry at 45±5℃ for 40 minutes.

[0073] S302 isolation layer First layer: Add 2.017 kg of gum syrup to each pot, and when the surface of the tablets is completely wetted, quickly sprinkle 5.6 kg of talcum powder and dry at 45±5℃ for 30 minutes.

[0074] Second to fifth layers: Repeat the first layer operation.

[0075] S303 slurry layer Spray 4.5 kg of mixed slurry into each pot each time and dry at 45±5℃ for 17 minutes until the mixed slurry is used up (12 times in total).

[0076] S304 sugar coating Measure 20.2 kg of syrup and pour it into a bucket. Add 0.24 kg of lemon yellow solution (26 g of lemon yellow plus 200 g of purified water, stir evenly) while stirring. Stir to make the color uniform and set aside.

[0077] First layer: Add 1.2kg of the above syrup to each pot and dry for 12 minutes. The drying temperature slowly decreases from 45±5℃ to 25℃.

[0078] Second layer: Repeat the first operation and add syrup at 1.1kg / pot.

[0079] Third layer: Repeat the first operation and add syrup at 1.0kg / pot.

[0080] Fourth layer: Repeat the first operation and add syrup at 0.9kg / pot.

[0081] Fifth layer: Repeat the first operation and add syrup at 0.8kg / pot.

[0082] Sixth layer: Repeat the first operation and add syrup at 0.7kg / pot.

[0083] Seventh layer: Repeat the first operation and add syrup at 0.6kg / pot.

[0084] Eighth layer: Repeat the first operation and add syrup at 0.5kg / pot.

[0085] S305 colored sugar coating The preparation method of colored syrup is as follows: weigh 100g of lemon yellow and put it into a basin, add 300g of purified water, and stir to dissolve; measure 5.0kg of syrup and put it into a stainless steel pot, heat it to boiling on an induction cooker, stop heating, pour it into the lemon yellow solution, and stir evenly.

[0086] The method for making syrup is the same as above and will not be repeated here.

[0087] First layer: Measure 160g of colored syrup, add 480g of syrup, mix well, add to the pot, and dry for about 9 minutes. Repeat the same process for the other two pots.

[0088] Second layer: Measure 240g of colored syrup, add 400g of syrup, mix well, add to the pot, and dry for about 9 minutes. Repeat the same process for the other two pots.

[0089] Third layer: Measure 320g of colored syrup, add 320g of syrup, mix well, add to the pot, and dry for about 9 minutes. Repeat the same process for the other two pots.

[0090] Fourth layer: Measure 400g of colored syrup, add 240g of syrup, mix well, add to the pot, and dry for about 9 minutes. Repeat the same process for the other two pots.

[0091] Fifth layer: Measure 640g of colored syrup and add it to the pot. After the slices are completely spread out, adjust the pot speed to 4rpm and rotate for about 16 minutes. Repeat the same process for the other two pots.

[0092] S306 Polishing Layer Adjust the pan speed to 7rpm, sprinkle 120g of insect wax powder into each pan, and after 10 minutes, sprinkle a mixture of insect wax powder and dimethicone, including 70g of insect wax powder and 12g of dimethicone, open the exhaust for 2 minutes, continue polishing for 30 minutes and then remove from the pan. Put the sugar-coated tablets into the stainless steel basket on the drying cart and flatten them, and push them into the drying room.

[0093] Example 3: An improved process for slurry coating of Sanhuang tablets, which is different from Example 1 in that: S304 sugar coating Measure 20.0 kg of syrup and pour it into a bucket. Add 0.257 kg of lemon yellow solution (27 g of lemon yellow plus 230 g of purified water, stir evenly) while stirring. Stir to make the color uniform and set aside.

[0094] First layer: Add 1.10 kg of the above syrup to each pot, dry for 10 minutes, and slowly reduce the drying temperature from 50°C to 25°C.

[0095] Second layer: Repeat the first operation and add syrup at 1.02kg / pot.

[0096] Third layer: Repeat the first operation and add syrup at 0.94kg / pot.

[0097] Fourth layer: Repeat the first operation and add syrup at 0.86kg / pot.

[0098] Fifth layer: Repeat the first operation and add syrup at 0.78kg / pot.

[0099] Sixth layer: Repeat the first operation and add syrup at 0.70kg / pot.

[0100] Seventh layer: Repeat the first operation and add syrup at 0.62kg / pot.

[0101] Eighth layer: Repeat the first operation and add syrup at 0.54kg / pot.

[0102] S305 colored sugar coating First layer: Measure 140g of colored syrup, add 510g of syrup, mix well, add to the pot, and dry for about 8 minutes. Repeat the same process for the other two pots.

[0103] Second layer: Measure 230g of colored syrup, add 420g of syrup, mix well, add to the pot, and dry for about 8 minutes. Repeat the same process for the other two pots.

[0104] Third layer: Measure 320g of colored syrup, add 330g of syrup, mix well, add to the pot, and dry for about 8 minutes. Repeat the same process for the other two pots.

[0105] Fourth layer: Measure 410g of colored syrup, add 240g of syrup, mix well, add to the pot, and dry for about 8 minutes. Repeat the same process for the other two pots.

[0106] Fifth layer: Measure 650g of colored syrup and add it to the pot. After the slices are completely spread out, adjust the pot speed to 3rpm and rotate for about 15 minutes. Repeat the same process for the other two pots.

[0107] The following is a comparative test example.

[0108] Comparative Example 1: A slurry coating process for Sanhuang tablets, which is different from Example 1 in that the powder base layer is omitted in the S3 coating step, and the other processes and parameters are the same as Example 1.

[0109] Comparative Example 2: A slurry coating process for Sanhuang tablets, which is different from Example 1 in that the slurry layer is omitted in the S3 coating step, and the other processes and parameters are the same as Example 1.

[0110] Comparative Example 3: A slurry coating process for Sanhuang tablets, which is different from Example 1 in that its S3 coating process includes, in sequence: isolation layer → powder base layer → slurry layer → sugar coating layer → colored sugar coating layer → polishing layer, and each process and parameter are the same as Example 1.

[0111] Comparative Example 4: A slurry coating process for Sanhuang tablets, which is different from Example 1 in that in the preparation of the slurry layer in the S3 coating step, the slurry preparation method is as follows: pour 37 kg of syrup into a stainless steel insulation barrel, then slowly add 18 kg of talcum powder, stir evenly and connect the infusion pipeline, adjust the position and angle of the nozzle, start the "spray pump" circulation, set the insulation temperature to 55±2°C, and set it aside.

[0112] Comparative Example 5: A slurry coating process for Sanhuang tablets, which is different from Example 1 in that: in the preparation of the slurry layer in the S3 coating step, an insulation barrel is prepared for each pot, and the slurry is prepared separately: 45 kg of syrup is poured into a stainless steel insulation barrel, 0.253 kg of lemon yellow solution (23 g of lemon yellow plus 230 g of purified water, stirred evenly) is added under stirring, and then 15 kg of talcum powder is slowly added. After stirring evenly, the infusion pipeline is connected, the position and angle of the nozzle are adjusted, the spray pump circulation is started, and the insulation temperature is set to 55±2°C for standby use.

[0113] Comparative Example 6: A slurry coating process for Sanhuang tablets, which is different from Example 1 in that in the preparation of the sugar coating layer in the S3 coating step, after the syrup is prepared, 0.84 kg of the above-mentioned syrup is added to each pot each time, dried for 10 minutes, and the drying temperature is slowly reduced from 50°C to 25°C, and repeated 8 times.

[0114] The following is a case study of process effect evaluation.

[0115] 1. The Sanhuang tablets prepared in Examples 1-3 and Comparative Examples 1-6 were tested with reference to the Chinese Pharmacopoeia and related standards. 300 tablets were sampled from one pot. The test results are shown in the following table: The above results show that the color consistency of the Sanhuang tablets prepared by the process of the present invention is good and there is no color spot; while the color inconsistency of the Sanhuang tablets obtained by changing different process conditions increases to varying degrees, and the color spot rate increases significantly, which is not conducive to obtaining a Sanhuang tablet coated finished product with uniform color and no color spot. In addition, the properties of the Sanhuang tablets obtained in Examples 1-3 of the present invention and Comparative Examples 1-6 all meet the requirements, and the disintegration time also meets the requirement of the disintegration time limit "should be completely disintegrated within 60 minutes".

[0116] 2. The Sanhuang tablets prepared in Example 1, Example 2, Example 3 and Comparative Examples 1-6 were placed at a temperature of 40°C ± 2°C and a relative humidity of 75% ± 5% for six months for accelerated testing to examine whether the quality of the drug has changed significantly. When at least one active ingredient in the drug is lower than the standard, the quality of the drug is considered to have changed significantly.

[0117] As can be seen from the above results, the contents of the effective ingredients of the Sanhuang Tablets prepared in Examples 1, 2 and 3 of the present invention all meet the requirements of the pharmacopoeia standards during the six-month accelerated inspection period, and the quality has not changed significantly. After the accelerated inspection, the content of rhubarb in Comparative Example 2 is not up to standard, and although the contents of the three components in Comparative Example 1 and Comparative Examples 3-6 are up to standard, the decrease in the content of the corresponding components during the accelerated inspection period is more obvious than that of the present invention. It can be seen that under the same storage conditions, the coating process or process conditions of the present invention are more conducive to maintaining the stability of the effective ingredients in the medicine, and the coating quality is more excellent.

[0118] 3. The three batches of Sanhuang Tablets prepared in Example 1 were placed in a constant temperature and humidity culture room at a temperature of 25°C ± 2°C and a relative humidity of 60% ± 5% for continuous stability investigation. The samples were placed for 24 months, and taken out at the 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month, respectively, and tested according to the prescribed investigation items, and the results were averaged. The test results are shown in the following table.

[0119] The above data show that the properties, disintegration time, microbial limits and contents (rhubarb, berberine hydrochloride and scutellaria baicalensis extract) of the Sanhuang tablets of the present invention all meet the requirements of relevant standards, and all meet the standards in the 24-month stability study, indicating that the Sanhuang tablets prepared after improved coating of the present invention can meet the standard requirements.

[0120] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit it. Other modifications or equivalent substitutions made to the technical solution of the present invention by ordinary technicians in the field should be included in the scope of the claims of the present invention as long as they do not depart from the spirit and scope of the technical solution of the present invention.

Claims

1. An improved process for slurry coating of Sanhuang tablets, characterized in that: include: A Sanhuang Tablet plain tablet is provided, and the plain tablet is coated. The coating comprises sequentially coating a powder base layer, an isolation layer, a slurry layer, a sugar coating layer, a colored sugar coating layer and a polishing layer on the surface of the plain tablet, and drying the tablet to obtain a finished product.

2. The improved slurry coating process of Sanhuang Tablets according to claim 1, characterized in that: The coating auxiliary materials include gelatin for capsules, sucrose, talcum powder, insect white wax, tartrazine and dimethicone.

3. The improved slurry coating process of Sanhuang Tablets according to claim 2, characterized in that: The process parameters of the base layer include: adding diluted syrup to the plain tablet, mixing until the surface is completely wetted, quickly sprinkling talcum powder, and drying; The mass ratio of sucrose to water in the syrup is (2-3):1, and the mass ratio of the diluted syrup, talcum powder and plain tablets is (3.1-7.6):(10-11.5):

100.

4. The improved slurry coating process for Sanhuang Tablets according to claim 3, characterized in that: The process parameters of the isolation layer include: adding gum syrup to the plain sheet coated with the powder base layer, mixing until the surface is completely wetted, quickly sprinkling talcum powder, drying, and repeating the operation 3 to 5 times; The mass ratio of gelatin, syrup and water for capsules in the gum syrup is 1:(35-37):(3-4), and the mass ratio of the gum syrup, talcum powder and plain tablets is (6.0-6.5):(15.0-17.0):

100.

5. The improved slurry coating process of Sanhuang Tablets as claimed in claim 4, characterized in that: The process parameters of the slurry layer include: spraying the slurry into the plain sheet coated with the isolation layer, drying, and repeating the above operation 10 to 15 times until the slurry is used up; The mixed slurry is composed of syrup, lemon yellow solution and talcum powder, the mass fraction of lemon yellow in the lemon yellow solution is 9-10%, the mass ratio of the syrup, lemon yellow solution and talcum powder is (140-150):1:(70-75), and the mass ratio of the mixed slurry to the plain tablet is (54-62):

100.

6. The improved slurry coating process for Sanhuang Tablets according to claim 5, characterized in that: The process parameters of the sugar coating layer include: adding syrup to the plain tablets coated with the mixed slurry layer, drying, cooling to 25°C, and repeating the above operation 5 to 7 times, with the amount of syrup added decreasing gradually, and the mass ratio of the syrup used in the first time to the mass of the plain tablets (1.0 to 1.4): 100; The mass ratio of the syrup to the plain tablets is (6.5-7.5):

100.

7. The improved slurry coating process for Sanhuang Tablets according to claim 6, characterized in that: A lemon yellow solution is added to the syrup used for the sugar coating layer, the mass fraction of lemon yellow in the lemon yellow solution is 10-13%, and the mass dosage of the lemon yellow solution is 1.0-1.5% of the syrup.

8. The improved slurry coating process for Sanhuang Tablets according to claim 7, characterized in that: The process parameters of the colored sugar coating layer include: adding colored syrup and syrup to the plain tablets coated with the sugar coating layer, drying, and repeating the above operation 3 to 5 times; the amount of the colored syrup added is gradually increased, and the amount of the syrup added is gradually reduced, and the sum of the amounts of the colored syrup and the syrup used each time is equal, only the colored syrup is added during the last coating, and the amount of the colored syrup used is equal to the sum of the amounts of the colored syrup and the syrup used in the previous coating, the mass ratio of the colored syrup used for the first time to the mass of the plain tablet is (0.13 to 0.18):100, and the mass ratio of the syrup used for the first time to the mass of the plain tablet is (0.3 to 0.6):

100.

9. The improved slurry coating process for Sanhuang Tablets according to claim 8, characterized in that: The colored syrup consists of a lemon yellow solution and syrup, the mass fraction of lemon yellow in the lemon yellow solution is 20-25%, the mass dosage of the lemon yellow solution is 6-10% of the syrup, and the mass ratio of the colored syrup, syrup and plain tablets is (1.6-1.9):(1.2-1.5):

100.

10. The improved slurry coating process for Sanhuang Tablets according to claim 9, characterized in that: The process parameters of the polishing layer include: adding a first portion of insect wax powder to a plain tablet coated with a colored sugar coating layer, and after 8 to 12 minutes, adding a second portion of a mixture of insect wax powder and dimethicone, wherein the mass of the first portion of insect wax powder is 1.5 to 2.0 times that of the second portion of insect wax powder, turning on the exhaust for 1 to 2 minutes, and continuing to polish for 25 to 35 minutes before serving; wherein the mass ratio of the insect wax powder, dimethicone to the plain tablet is (0.15 to 0.20): (0.008 to 0.02): 100.

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