Intelligent continuous production method of Xiaochaihu granules

Abstract

This invention relates to an intelligent continuous production method for Xiaochaihu granules, comprising the following steps: sieving and pulverizing the filler, and conveying it to a preparation silo for airflow premixing; adding the extract to an extract tank and stirring until uniformly mixed; conveying the premixed filler and extract to a mixer, mixing uniformly, adding a wetting agent, and mixing to obtain a soft material; simultaneously premixing the filler for the next batch; conveying the soft material to a granulator for granulation, and feeding the granules into a fluidized bed hot air section for drying; conveying the filler for the next batch to the mixer; after the soft material is conveyed, sequentially conveying the extract and wetting agent to prepare the soft material for the next batch; after the granules are transferred to the fluidized bed cold air section, granulating the soft material for the next batch and feeding it into the fluidized bed hot air section; sieving to obtain the final product. This continuous production method improves production efficiency while also enhancing product quality and stability, and significantly saves materials and energy.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine production technology, and relates to a method for producing traditional Chinese medicine granules, specifically a smart continuous production method for Xiaochaihu granules. Background Technology

[0002] Xiao Chai Hu Granules are a traditional Chinese medicine developed based on the famous formula Xiao Chai Hu Tang from the medical classic *Shang Han Lun* (Treatise on Cold Damage) by Zhang Zhongjing, combined with modern Chinese medicine extraction and preparation technology. The original formula, Xiao Chai Hu Tang, is traditionally summarized in Chinese medicine as follows: "Xiao Chai Hu Tang harmonizes and resolves, with Pinellia, Ginseng, and Licorice as adjuncts; further enhanced with Scutellaria, Ginger, and Jujube, this formula is the foundation for Shao Yang syndrome." In the 1990s, Guangzhou Baiyunshan Guanghua Pharmaceutical Co., Ltd. improved Xiao Chai Hu Tang into Xiao Chai Hu Granules, composed of Bupleurum, Licorice, Ginger, Scutellaria, Ginger-processed Pinellia, Codonopsis, and Jujube. Benefiting from its scientifically sound formula, it can relieve exterior syndromes, clear heat, soothe the liver and stomach, and is used for exogenous diseases, specifically Shao Yang syndrome, characterized by alternating chills and fever, fullness and discomfort in the chest and ribs, loss of appetite, irritability, nausea, bitter taste in the mouth, and dry throat.

[0003] Traditional Xiaochaihu granule production primarily employs an intermittent production process, with batch-based material feeding: First, various Chinese medicinal herbs are weighed according to the prescription, and after water extraction and percolation, they are concentrated into Xiaochaihu granule extract. Then, according to the batch production order, the Xiaochaihu granule extract and excipients are requisitioned, and their appearance and quality are checked. The excipients used in preparing Xiaochaihu granules include fillers and wetting agents; fillers include sucrose, dextrin, mannitol, etc.

[0004] Intermittent manufacturing methods offer advantages such as simple preparation processes and ease of implementation. However, intermittent production introduces excessive manual operations, significantly reducing overall manufacturing efficiency and quality, and resulting in substantial batch-to-batch variations. For a mature product like Xiaochaihu granules, with annual sales exceeding 100 million bags, hundreds or even thousands of batches need to be produced annually. Even minor batch-to-batch differences can impact actual product quality, and production efficiency needs improvement. Summary of the Invention

[0005] Based on this, the purpose of the present invention is to provide an intelligent continuous production method for Xiaochaihu granules, which can effectively improve production efficiency while also improving product quality and stability between different batches.

[0006] This invention provides a continuous production method for Xiaochaihu granules, comprising the following steps:

[0007] (1) The filler used to prepare Xiaochaihu granules is sieved, crushed, and transported to the preparation silo for air premixing;

[0008] (2) Add the extract obtained from the preparation of Xiaochaihu granules from traditional Chinese medicine raw materials to the extract tank and stir to mix evenly;

[0009] (3) The premixed filler is conveyed to the mixer; the uniformly mixed extract is drawn from the extract tank through a closed pipeline, and after the weight is checked by the metering tank, it is conveyed to the mixer and mixed evenly with the filler; a wetting agent is conveyed into the mixer and mixing is continued to obtain a soft material; at the same time, the filler for the next machine is premixed by airflow in the preparation silo;

[0010] (4) The soft material is fed into a granulator for granulation, and the obtained particles are fed into the hot air section of the fluidized bed of the fluidized bed drying equipment for drying; at the same time, the premixed filler for the next batch is fed into the mixer; after the soft material is fed, the extract and wetting agent are fed into the mixer in sequence to prepare the soft material for the next batch.

[0011] (5) When the granules reach the drying temperature, they are transferred to the cold air section of the fluidized bed. The soft material of the next machine is fed into the hot air section of the fluidized bed through the granulator. When the granules of the next machine are discharged from the cold air section, the granules of the next machine enter the hot air section for drying.

[0012] (6) The dry particles discharged from the fluidized bed dryer are fed into the screening equipment and screened to obtain Xiaochaihu granules.

[0013] In some embodiments, the moisture content of the extract is controlled to be 37%–43%, and the viscosity is controlled to be 1000 mPa·s–3000 mPa·s; preferably, the moisture content of the extract is controlled to be 38%–41%, and the viscosity is controlled to be 1200 mPa·s–2850 mPa·s; more preferably, the moisture content of the extract is controlled to be 39%–41%, and the viscosity is controlled to be 1400 mPa·s–2100 mPa·s.

[0014] In some embodiments, the ratio of the filler, extract and wetting agent is (180-200):(26-32):(0.4-1), preferably (185-195):(27-30):(0.4-0.8), and more preferably (185-195):(27-29):(0.4-0.7).

[0015] In some embodiments, the stirring and mixing conditions in step (2) are: stirring frequency 25 Hz to 35 Hz, time 25 min to 35 min; preferably, stirring frequency 28 Hz to 32 Hz, time 25 min to 35 min.

[0016] In some embodiments, the screened recycled material is added to the preparation silo and premixed with the filler using airflow.

[0017] In some embodiments, the ratio of the filler, recycled material, extract and wetting agent is (180-200):(50-70):(26-32):(0.8-2), preferably (185-195):(60-70):(27-30):(0.8-1.6).

[0018] In some embodiments, after a wetting agent is supplied to the mixer, mixing continues for 2 to 6 minutes to obtain a soft material.

[0019] In some embodiments, the feed amount from the pellet mill is above the pellet mill roller and 1cm to 3cm above the roller.

[0020] In some embodiments, the granulation rate in the granulator is 19 kg / min to 46 kg / min, and the overall granulation time is 5 min to 12 min; preferably, the granulation rate in the granulator is 25 kg / min to 40 kg / min, and the overall granulation time is 7 min to 12 min.

[0021] In some embodiments, the thickness of the particle feed into the fluidized bed dryer is <4 cm; and / or,

[0022] The inlet air temperature of the fluidized bed dryer is 80℃~90℃, the fan frequency of the hot air section is 30Hz~45Hz, and the fan frequency of the cold air section is 25Hz~45Hz; preferably, the inlet air temperature of the fluidized bed dryer is 85℃~90℃, the fan frequency of the hot air section is 35Hz~40Hz, and the fan frequency of the cold air section is 30Hz~40Hz.

[0023] In some embodiments, the mixer is a trough mixer.

[0024] In some embodiments, the pellet mill is a gyratory pellet mill.

[0025] In some embodiments, the filler is selected from at least one of sucrose, dextrin, and mannitol.

[0026] In some embodiments, the wetting agent is selected from at least one of water and 40% to 60% ethanol.

[0027] This invention provides a continuous production method for Xiaochaihu granules by improving the existing process. A new process was designed, key influencing factors for achieving continuous production were investigated, and the pretreatment steps for fillers and extracts were optimized. The filler is pre-mixed with airflow, and the extract is simultaneously stirred and pre-mixed to obtain a homogeneous extract with suitable moisture content and viscosity, which is then directly fed through a pipeline. This effectively reduces the mixing time and the time required to form the soft mass in the mixer, achieving soft mass preparation within 2-6 minutes. This provides a complete and organically coordinated method for continuous production. Furthermore, appropriate granulation parameters (granulation rate and time) and drying conditions are controlled to effectively adapt the production rhythm of each step—material mixing, soft mass preparation, granulation, drying, and sieving—ensuring efficient and rational integration. Ultimately, continuous manufacturing of Xiaochaihu granules is achieved, while effectively improving production efficiency and ensuring product yield; the one-time granulation rate can reach over 80%.

[0028] Furthermore, by pretreating the extract and controlling the ratio of extract to wetting agent, uniform and stable granules of Bupleurum chinense can be continuously prepared. The granules have a stable and narrow bulk density, low fine powder content, and uniform content.

[0029] The continuous production method of this invention can increase production efficiency by approximately 130%, increasing the production of Xiaochaihu granules from 3 tons per shift (8 hours) in traditional production to over 7 tons per shift. Furthermore, it reduces material sticking and screen sealing, achieves a high one-time granulation rate, reduces screen and material losses, and minimizes the number of machine cycles and equipment operation time required for batch completion, thus significantly saving materials and energy. Attached Figure Description

[0030] Figure 1 This is a flowchart of the continuous production method of the present invention.

[0031] Figure 2 This is a comparison diagram of the continuous production method of the present invention and the conventional production method. Detailed Implementation

[0032] To facilitate understanding of the present invention, a more complete description will be provided below. The present invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a thorough and complete understanding of the disclosure of the present invention.

[0033] Unless otherwise specified, experimental methods in the following examples are generally performed under standard conditions or as recommended by the manufacturer. All commonly used chemical reagents used in the examples are commercially available products.

[0034] Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used in this specification is for the purpose of describing particular embodiments only and is not intended to limit the invention. The term "and / or" as used in this invention includes any and all combinations of one or more of the associated listed items.

[0035] Furthermore, as used herein, the term "or" is an inclusive "or" sign and is equivalent to the term "and / or" unless the context clearly specifies otherwise. The term "based on" is not exclusive and allows for basing on other factors not described unless the context clearly specifies otherwise. Additionally, throughout the specification, the meanings of "an," "a," and "the" include plural indicators. The meaning of "in" includes both "in" and "on."

[0036] Xiao Chai Hu Granules are a traditional Chinese medicine developed based on the famous formula Xiao Chai Hu Tang from the medical classic *Shang Han Lun* (Treatise on Cold Damage) by Zhang Zhongjing, combined with modern Chinese medicine extraction and preparation technology. The original formula, Xiao Chai Hu Tang, is traditionally summarized in Chinese medicine as follows: "Xiao Chai Hu Tang harmonizes and resolves, with Pinellia, Ginseng, and Licorice as adjuncts; further enhanced with Scutellaria, Ginger, and Jujube, this formula is the foundation for Shao Yang syndrome." In the 1990s, Guangzhou Baiyunshan Guanghua Pharmaceutical Co., Ltd. improved Xiao Chai Hu Tang into Xiao Chai Hu Granules, composed of Bupleurum, Licorice, Ginger, Scutellaria, Ginger-processed Pinellia, Codonopsis, and Jujube. Benefiting from its scientifically sound formula, it can relieve exterior syndromes, clear heat, soothe the liver and stomach, and is used for exogenous diseases, specifically Shao Yang syndrome, characterized by alternating chills and fever, fullness and discomfort in the chest and ribs, loss of appetite, irritability, nausea, bitter taste in the mouth, and dry throat.

[0037] The herbal extract of Xiao Chai Hu granules of this invention is prepared from the following raw materials in parts by weight: Bupleurum 150±5 parts, Pinellia ternata 56±5 parts, Scutellaria baicalensis 56±5 parts, Codonopsis pilosula ±5 parts, Glycyrrhiza uralensis 56±5 parts, fresh ginger 56±5 parts, and jujube 56±5 parts.

[0038] The Xiaochaihu granules of the present invention are prepared from the traditional Chinese medicine extract and excipients, wherein the excipients include fillers and wetting agents.

[0039] In some preferred embodiments, the Xiaochaihu granules of the present invention are prepared from the following raw materials: the Chinese herbal extract, filler and wetting agent: the mass ratio of the filler, the Chinese herbal extract and the wetting agent is (180-200): (26-32): (0.4-1).

[0040] In some preferred embodiments, the filler is selected from at least one of sucrose, dextrin, and mannitol; more preferably, the filler is sucrose.

[0041] In some preferred embodiments, the wetting agent is selected from at least one of water and 40% to 60% ethanol.

[0042] Some embodiments of the present invention relate to a continuous production method of Xiaochaihu granules, comprising the following steps:

[0043] (1) The filler used to prepare Xiaochaihu granules is sieved, pulverized, and conveyed to the preparation silo for air-air premixing:

[0044] (2) Add the extract obtained from the preparation of Xiaochaihu granules from traditional Chinese medicine raw materials to the extract tank and stir to mix evenly;

[0045] (3) The premixed filler is conveyed to the mixer; the uniformly mixed extract is drawn from the extract tank through a closed pipeline, and after the weight is verified by the metering tank, it is conveyed to the mixer and mixed evenly with the filler; a wetting agent is conveyed into the mixer, and mixing continues to obtain a soft material; at the same time, the filler for the next machine is premixed by airflow in the preparation silo:

[0046] (4) The soft material is fed into a granulator for granulation, and the resulting granules are fed into the hot air section of a fluidized bed dryer for drying; at the same time, the premixed filler for the next batch is fed into a mixer; after the soft material is fed, an extract and a wetting agent are sequentially fed into the mixer to prepare the soft material for the next batch:

[0047] (5) When the granules reach the drying temperature, they are transferred to the cold air section of the fluidized bed. The soft material of the next machine is fed into the hot air section of the fluidized bed through the granulator. When the granules of the next machine are discharged from the cold air section, the granules of the next machine enter the hot air section for drying.

[0048] (6) The dry particles discharged from the fluidized bed dryer are fed into the screening equipment and screened to obtain Xiaochaihu granules.

[0049] Traditional Xiaochaihu granule production primarily employs an intermittent process, with batch-based material feeding, resulting in low production efficiency and significant quality variations between batches, leading to poor repeatability. To improve the production efficiency and quality stability of Xiaochaihu granules, it is necessary to develop a continuous production method.

[0050] This invention reveals that directly connecting the various steps of an intermittent production process cannot achieve continuous production of Xiaochaihu granules, resulting in low first-pass yield and poor repeatability between different batches. To address this, the inventors conducted extensive research and discovered that the production rhythms of each step in the intermittent production process are mismatched. In particular, the preparation of the extract and filler into a soft material requires a long time, which cannot be efficiently and rationally connected with subsequent granulation and drying steps. This leads to low production efficiency, low first-pass yield, few qualified granules obtained through screening, and a large amount of recycled material.

[0051] Therefore, this invention, through extensive research, has developed a continuous production method for Xiaochaihu granules. By optimizing the pretreatment steps of fillers and extracts, the fillers are first pre-mixed with airflow, and the extract is simultaneously stirred and pre-mixed to obtain a uniform extract with suitable moisture content and viscosity. This extract is then directly fed through a pipeline, effectively reducing the mixing time and the time required to form the soft material in the mixer. The soft material is prepared within 2 to 6 minutes, providing a foundation for continuous production. Furthermore, by controlling appropriate granulation parameters (particle rate and time) and drying conditions, the production rhythm of each step—soft material preparation, granulation, drying, and sieving—is effectively matched and efficiently connected, ultimately achieving continuous manufacturing of Xiaochaihu granules. This method effectively improves production efficiency while ensuring product yield, with a one-time granule forming rate exceeding 80%.

[0052] In some embodiments, the moisture content of the extract is controlled to be 37% to 43%, and the viscosity is controlled to be 1000 mPa·s to 3000 mPa·s.

[0053] In some preferred embodiments, the amount of wetting agent is selected according to the moisture content and viscosity of the extract, as shown in Table 1 below:

[0054] Table 1

[0055]

[0056] In some embodiments, the screened recycled material is added to the preparation silo and premixed with the filler using airflow.

[0057] When using recycled material and filler for airflow premixing, the ratio of filler, recycled material, extract and wetting agent is (180-200):(50-70):(26-32):(0.8-2).

[0058] In some preferred embodiments, the amounts of the recycled material, extract, and wetting agent are as shown in Table 2 below:

[0059] Table 2

[0060]

[0061]

[0062] Furthermore, in traditional Chinese medicine extract production, the concentrated extract is transferred from the concentration tank to the extract container. During this transfer, the concentration tank is closed and the vacuum stops circulating, but the liquid temperature remains high, continuing the concentration process. Additionally, sedimentation and other changes occur during storage, resulting in inconsistent viscosity between different containers of extract produced in a batch. Traditional intermittent production methods directly pour the extract into a trough mixer after premixing the materials, with the mixing time and wetting agent dosage for each batch of granules depending on worker experience. This leads to variations in process parameters, material conditions, and granule quality for each batch. The continuous production method of this invention uses online monitoring of the extract's moisture and viscosity after premixing to control them within a suitable range. The wetting agent formula is automatically adjusted based on the extract parameters, and the extract is then accurately and evenly delivered to the trough mixer via a metering tank. This allows for the continuous production of uniform and stable Xiaochaihu granules with stable and narrow bulk density, low fine powder content, and uniform particle size.

[0063] This invention's production method is continuous, starting from the feeding of the extract and continuing until the product is packaged. Corresponding excipients are pre-mixed by airflow and then weighed in a preparation silo according to the appropriate proportions and quantities before being continuously fed into the granulator. Simultaneously, the extract, after being pre-mixed evenly, is also continuously fed into the granulator via the weighing module for continuous granulation. Through system-controlled material conveying, multiple granulators work together to achieve continuous production; while one granulator is feeding, another is simultaneously discharging. The material from the outlet enters a fluidized bed dryer for continuous drying. After drying, the Xiaochaihu granules are sieved and then packaged. The entire continuous manufacturing process requires only a few manual inspection stations to achieve high-efficiency production.

[0064] The production method of this invention involves continuous feeding and transformation of input materials during the production process, accompanied by continuous output of output materials. This continuous manufacturing process offers numerous advantages, including uninterrupted production steps, high production efficiency, low equipment downtime, small footprint, real-time product quality monitoring, and easy adjustment of production batches. These features contribute to improving and enhancing the efficiency and quality of pharmaceutical production.

[0065] The present invention will be further described in detail below with reference to specific embodiments.

[0066] Figure 1 This is a flowchart of the continuous production method of the present invention; Figure 2 This is a comparison diagram of the continuous production method (continuous production) of the present invention and the conventional production method (conventional production).

[0067] Example 1

[0068] This embodiment provides a continuous manufacturing solution for the entire process from extracting Xiaochaihu granules to packaging the finished product. By adding an extract mixing process, placing a pre-airflow mixing device and process in the raw material mixing process, and automatically matching appropriate process parameters after online detection of data such as extract viscosity, and then controlling the amount of wetting agent and the soft material preparation process, Xiaochaihu granules with consistent quality and uniform content are prepared, so that the production rhythm of each process is adapted, and finally the continuous manufacturing of Xiaochaihu granules is realized.

[0069] 1. Continuous manufacturing process

[0070] 1.1 Preparation of Extract

[0071] Traditional Chinese medicine prescription: Bupleurum 150kg, Pinellia ternata 56kg, Scutellaria baicalensis 56kg, Codonopsis pilosula 56kg, Glycyrrhiza uralensis 56kg, Zingiber officinale 56kg, Jujube 56kg.

[0072] The medicinal materials were weighed and processed according to the prescription, and concentrated into Xiao Chai Hu granule extract after water extraction and percolation. 594.3 kg of Xiao Chai Hu granule extract was prepared, with a water content of 41.5% and a viscosity of 1542 mPa·s (extract acceptance range: extract water content 37.0%~42.5%, extract viscosity 1000~3000 mPa·s, extract batch size 550~660 kg / 400,000 bags).

[0073] 1.2 Material preparation process

[0074] The filler sucrose is sieved through a 12-35 mesh screen and equipped with 40-mesh moving and fixed blades; the conveyor screw operates at 16Hz, with full-bin conveying; the grinding time is 2 minutes and 35 seconds per 40kg. The content of the ground sugar powder >40 mesh should not exceed 3.0%; >80 mesh should be 15-25%. The ground sugar powder is conveyed to the preparation silo via a material conveying system, with a preparation time of approximately 12 minutes per machine. Before producing Xiaochaihu granules, the extract is added to the extract tank, and the stirring premixing is started. The total mixing time is 30 minutes, with each forward and reverse rotation of the motor lasting 20 seconds, and the stirring frequency is 30Hz.

[0075] 1.3 Granulation process

[0076] ① Batching: An airflow mixing device has been added to the raw material mixing process. The airflow process replaces mechanical mixing, reduces the exposed area of ​​materials, and improves mixing efficiency and material uniformity.

[0077] A trough mixer and a swing granulator (typically 218-290 kg / machine) are used, with two trough mixers preparing materials alternately. By setting parameters in the batching system, 190 kg / machine of sucrose, 70 kg / machine of recycled material, and approximately 28 kg / machine of extract are used. The recycled material and sucrose are conveyed from the material storage area to the preparation silo for premixing for 2 minutes, and then conveyed from the preparation silo to the trough mixer to begin premixing of the other machine's materials in the preparation silo.

[0078] ② Online pipeline conveying of extract mixing process: The extract is mixed by using a fully enclosed pipeline for continuous online feeding, which improves the uniformity of the extract and the efficiency of production compared to the traditional method of feeding one bucket at a time. The extract is quantitatively extracted from the storage tank through the fully enclosed pipeline, and after being verified by the metering tank, it is transported to the trough mixer and stirred for another 2 minutes.

[0079] ③ Addition of wetting agent and stirring time: The continuous manufacturing process automatically matches the appropriate amount of wetting agent (Tables 1 and 2) and stirring time by online detection of data such as the viscosity and moisture content of the extract. Wetting agent: 0.7 kg / machine of 50% ethanol and 0.4 kg / machine of water are added sequentially after the filler sucrose is added to the extract, for a total of 21 machines; Stirring time: 2-6 minutes after adding the wetting agent, the soft material is basically uniformly mixed with no obvious color difference, and the premixing of the material in the preparation bin for the other machine begins.

[0080] ④ Granulation: The soft material is transferred to a gyratory granulator. The material feed to the gyratory granulator should cover the rollers and remain approximately 1-3 cm above them. The gyratory granulation rate is controlled at 40 kg / min, and the total granulation time is controlled at 7 minutes. The soft material is then conveyed to the fluidized bed via a conveyor, while material for the next batch is simultaneously transported from the preparation silo to another gyratory granulator. Once the granules reach the drying temperature, they are transferred to the cold air section of the fluidized bed for cooling. The next batch of soft material begins to be fed through the gyratory granulator into the hot air section of the fluidized bed. After all the soft material has passed through, the granulation process begins in another trough mixer. The granulation speed is 940-1200 kg granules / hour.

[0081] 1.4 Drying process

[0082] A horizontal fluidized bed dryer is used. ① The inlet air temperature is set to 90℃, and the fan frequency is 40Hz, maintaining the material temperature below 65℃ during the drying process. ② After the entire machine is fed, continue drying for 2 minutes until the material temperature reaches 66℃. ③ Transfer the granules to the cold air section for cooling, with the fan frequency at 38Hz, until the material temperature inside the bed drops to 50℃ and the auxiliary machine outlet air reaches 54℃. ④ Once the granules begin to discharge, the oscillating granulator begins adding extract to produce the next batch of soft material.

[0083] 1.5 Screening process

[0084] Dry granules are sieved through 12-mesh and 24-mesh sieves to remove coarse particles and fine powder. A star-shaped valve at 14Hz controls the speed of the dry granules entering the sieving equipment. Particles are sampled and inspected at the beginning, middle, and end of the sieving process. Based on the inspection results, granulation parameters are fine-tuned to ensure consistent granule quality, achieving the effect of eliminating the need for final mixing and inspection. Coarse particles are pulverized in a grinding tank and returned to the preparation silo and recovery tank along with the fine powder. Qualified granules are transported to a granule storage tank for temporary storage via a material conveying system. The sieving rate is 700–930 kg / hour of qualified granules, with an average sieving efficiency of 1450 kg / hour.

[0085] 1.6 Packaging process:

[0086] Packaging: The operating room temperature is controlled at 25℃ and the relative humidity is below 65%. Automatic weighing module and automatic packaging machine are used for packaging. The filling difference is controlled within ±4%. The front and rear horizontal sealing temperature is set at 140~180℃. The actual temperature should be within ±5℃ of the set temperature. The seal should be tight, flat, and free from leakage, perforation, wrinkles, etc. (Particle packaging speed is about 1000kg / hour).

[0087] Outer Packaging: ① Boxing: Pack the inner packaging products (10 small bags or 6 bags) and one instruction manual into the small box according to the specified quantity. The quantity should be accurate and there should be no shortage. Print the product batch number, production date, and expiration date in the designated location on the small box. The printouts should be accurate and clear. ② Shrink Film Packaging: Pack 5 small boxes with BOPP packaging film and heat-seal to shrink and fix them into shape. The BOPP packaging film wrapping the small boxes should be flat and free of perforations or damage, and should be able to tightly wrap the small boxes. The shrink opening of the BOPP packaging film must be able to cover both ends of the small boxes. ③ Cartoning: Verify the product name, specifications, and batch number. Ensure the quantity is accurate. Seal the carton tightly and securely. Affix a corner sticker to the outside of the carton, with the product batch number, production date, expiration date, product information, certificate of conformity, and traceability code printed on the corner sticker. The printouts should be accurate and clear.

[0088] 2. Specific Implementation Status

[0089] 2.1 The production conditions of different extract feeds under continuous production are shown in Table 3:

[0090] Table 3

[0091]

[0092]

[0093] 2.2 Inspection and Results of Finished Products from Continuous Production The inspection and results of finished products from continuous production are shown in Table 4:

[0094] Table 4

[0095]

[0096]

[0097] The above results show that, under different extract feeding conditions, the continuous production method of the present invention can be implemented according to the formula, ensuring consistent continuous production efficiency and output quality of Xiaochaihu granules. The granules have stable bulk density, narrow range, uniform content, low fine powder content, and high one-time forming rate, thus combining high production efficiency and quality.

[0098] 3. Production status of traditional processes

[0099] The traditional process involves: sucrose is pulverized and weighed (the amount of recycled material produced and added per machine is not fixed), then transferred to a trough mixer for premixing for 8 minutes. Next, bupleurum chinense granule extract and a wetting agent are added to form a soft mass. This soft mass is then passed through a vibrating granulator into a fluidized bed. After drying, the granules are transferred to a cooling section for further cooling. Once cooled, the granules are sieved using a vibrating screen and then transferred to a packaging unit to begin granulation in the next machine. The granulation, drying, and sieving processes for the soft mass are the same as the continuous manufacturing process described above.

[0100] Table 5 shows the production conditions of different extracts using traditional processes:

[0101] Table 5

[0102]

[0103] It is evident that in traditional production processes, sugar is directly weighed and transferred to a trough mixer after being crushed, and the extract is directly poured into the trough mixer. This requires a longer stirring time to achieve uniform mixing, and the time for preparing soft materials is also longer. This results in an inability to effectively and reasonably connect with subsequent granulation and drying processes, leading to low production efficiency, a wide range of granule bulk density, poor content uniformity, low one-time forming rate, and a large amount of fine powder.

[0104] Example 2

[0105] This embodiment compares the continuous production method of the present invention with the traditional intermittent process production method for producing soft materials and granulation.

[0106] A comparison of the continuous production method of the present invention with a conventional batch process is made for an extract with a moisture content of approximately 40.5%, a viscosity of approximately 1250 mPa·s, and a weight of approximately 600 kg. Other operations of the continuous production method and the conventional batch process are the same as in Example 1.

[0107] 1. Comparison of soft material manufacturing using traditional and continuous production methods

[0108] Traditional production involves directly pouring the extract into a tank mixer after premixing, based on the amount of extract per machine. The mixing time and wetting agent dosage for each batch of granulation depend on worker experience, resulting in variations in process parameters, material conditions, and granule quality for each batch. Continuous manufacturing, on the other hand, uses online viscosity monitoring after premixing the extract, automatically adjusting the wetting agent formula based on the extract parameters, and then accurately and evenly conveying the extract to the tank mixer via a metering tank. This ensures a stable output of products with consistent quality and uniform content.

[0109] The production situation is compared as shown in Tables 6 to 9 below:

[0110] Table 6

[0111]

[0112]

[0113] Table 7

[0114]

[0115] Table 8

[0116]

[0117]

[0118] Table 9

[0119]

[0120]

[0121] It is evident that the traditional method requires constant adjustment of the wetting agent dosage and stirring time, resulting in significant variations in the bulk density, particle size, and fine powder content of the produced granules. In contrast, the continuous production method of this invention only requires fixing the wetting agent dosage and stirring time to produce granules of stable and uniform quality. Furthermore, due to the low one-time forming rate of the traditional method, more batches are needed compared to the continuous production method of this invention.

[0122] 2. Comparison of granulation conditions in multiple batches of Xiaochaihu granules production

[0123] As shown in Table 10:

[0124] Table 10

[0125]

[0126] It is evident that the continuous production method of this invention significantly reduces the number of screen changes, screen change time, number of screen breakages, and screen loss. In contrast, the intermittent production method for preparing soft materials exhibits significant variations per batch, resulting in a high number of screen sealing operations, difficulty in controlling screen installation tightness, and more frequent and more frequent screen breakages.

[0127] Example 3

[0128] This embodiment compares the material mixing and air dust density of four batches in the continuous production method of the present invention with those of the traditional intermittent process production method in Embodiment 2.

[0129] The material mixing and air dust density of the two production methods are shown in Table 10:

[0130]

[0131]

[0132] Materials (sucrose filler and recycled materials) need to be premixed until they are uniform in color and free of white spots and color differences before being added to the extract for granulation. Traditionally, workers transport the materials from the crushing room to the granulation room, where they are premixed using a trough mixer. This process is labor-intensive, generates a lot of drug dust during mixing, and has low mixing efficiency. This invention, in its continuous production process, uses a pre-positioned airflow pulverizer for airflow premixing during material preparation in the preparation silo. The materials are then transported to the trough mixer via a fully sealed pipeline, resulting in high mixing efficiency, no dust generation, and extremely low risk of drug exposure.

[0133] Example 4

[0134] This embodiment compares the impact of two material mixing methods (filler sucrose and recycled material) on continuous production: (1) Filler sucrose and recycled material are directly mixed in a trough mixer, and then mixed with a pre-mixed and homogeneous extract in a trough mixer; (2) Filler sucrose and recycled material are pre-mixed by airflow in a preparation silo, and then mixed with a pre-mixed and homogeneous extract in a trough mixer. The granulation, drying, and sieving processes after the two material mixing methods are completed in the trough mixer are the same as in Example 1.

[0135] Table 11 shows the material mixing time and granulation conditions for an extract with 40.0% moisture content, 1570 mPa·s viscosity, and a weight of 28.2 kg, along with 190 kg of sucrose, 1.3 kg of wetting agent, and 70 kg of recycled material, using the following mixing methods:

[0136] Table 11

[0137]

[0138] As shown in Table 11, when the filler sucrose and recycled material are mixed using a stirring method, the long mixing time leads to a mismatch between the production efficiency of the granulation process and the drying process. Continuous production results in idle fluidized bed drying. Since the fluidized bed drying requires leaving some material at the bottom of each machine to prevent collapse in the next cycle, the long idle time causes the particles inside the bed to be blown apart, resulting in high material loss, low first-pass yield, and the generation of a large amount of fine powder, leading to low production efficiency. In contrast, this invention first premixes the filler sucrose and recycled material in the preparation silo using airflow before mixing them with the pre-mixed and uniformly stirred extract in a trough mixer. This effectively reduces the mixing time required for the materials, allowing for a seamless connection between the production efficiency of soft material preparation, granulation, and drying processes. This significantly improves the first-pass yield of granules, reduces the fine powder content, and increases production efficiency.

[0139] Example 5

[0140] This embodiment studies the effect of extract quality on the preparation of soft materials and granulation.

[0141] The extract weighs 28.0–28.2 kg, sucrose 190 kg, and recycled material 70 kg. Except for the parameters in Table 12, the other operations are the same as in Example 1.

[0142] The granulation process is shown in Table 12:

[0143] Table 12

[0144]

[0145] As shown in Table 12, if the moisture content of the extract is too high (machines C and D), the viscosity will be too low, the formability of the soft material will be poor, and the stirring time will need to be extended. After drying, the particles will be fine and have a lot of fine powder, resulting in a low one-time molding rate. If the moisture content of the extract is too low (machines A and B), the viscosity will be too high, and the stirring time will need to be extended to disperse the particles. This will result in a lot of coarse particles, a low one-time molding rate, and low content uniformity, making it impossible to effectively achieve continuous production.

[0146] Example 6

[0147] This embodiment studies the effect of different ratios of extract and wetting agent on the preparation of soft materials and granulation.

[0148] The extract has a moisture content of 40.5%, a viscosity of 1250 mPa·s, a weight of 28.6 kg, 190 kg of sucrose per machine, and 70 kg of recycled material per machine. Except for the parameters in Table 13, the other operations are the same as in Example 1.

[0149] The granulation process is shown in Table 13:

[0150] Table 13

[0151]

[0152] Table 13 shows that excessive wetting agent dosage (processes 3 and 4) results in slow granulation speed, easy clogging of the granulation mesh by the soft material, prolonged drying time, more coarse particles, a tendency for the granulation bed to collapse, and a low first-pass yield. Insufficient wetting agent dosage (processes 1 and 2) results in loose soft material, rapid drying leading to a high fine powder content, and a low first-pass yield. Therefore, selecting the appropriate wetting agent dosage based on the moisture content and viscosity of the extract has a significant impact on the continuous production of Xiaochaihu granules, as it directly affects the soft material preparation time, thereby further affecting the rational and efficient connection between subsequent processes.

[0153] Example 7

[0154] This embodiment studies the effect of granulation speed on granulation in a swing granulator.

[0155] The extract had a moisture content of 40.5%, a viscosity of 1250 mPa·s, a weight of 28.6 kg, 190 kg of sucrose, 70 kg of recycled material, and a wetting agent dosage of 1.2 kg. The pelleting time was 1 min. Except for the speed of the oscillating granulator and the pelleting time, the other operations were the same as in Example 1.

[0156] The granulation process is shown in Table 14:

[0157] Table 14

[0158]

[0159]

[0160] Table 14 shows that when the gyratory granulator speed is too slow (cycles 9 and 10), the granulation time is long, the particles in the bed are heated for a long time, and the low moisture content leads to loose particles and an increase in fine powder. When the gyratory granulator speed is too fast (cycles 11 and 12), theoretically, gyratory granulation only takes 5 minutes, but due to severe screen blockage and damage, a lot of time is spent replacing the screen, resulting in low overall production efficiency. It is evident that in the continuous production method of this invention, a suitable gyratory granulator speed is very important for effectively realizing the continuous production of Xiaochaihu granules, enabling reasonable and efficient connection between various processes.

[0161] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A continuous production method of Xiaochaihu granules, characterized in that, Includes the following steps: (1) Filler premixing: After the filler is sieved and crushed, it is transported to the preparation silo and premixed by airflow. (2) Add the extract obtained from the Chinese herbal raw materials of Xiaochaihu granules to the extract tank and stir to mix evenly; (3) Preparation of soft material and premixing of filler: The premixed filler is conveyed to the mixer; the uniformly mixed extract is drawn from the extract tank through a closed pipeline and conveyed to the mixer, where it is mixed evenly with the filler, and the moisture content of the extract is controlled to be 37% to 43% and the viscosity to be 1000 mPa·s to 3000 mPa·s; a wetting agent is conveyed into the mixer, and mixing is continued for 2 min to 6 min to obtain soft material; while preparing the soft material, the filler for the next batch is premixed by airflow in the preparation silo; (4) The soft material prepared in step (3) is fed into a granulator for granulation at a granulation rate of 19 kg / min to 46 kg / min and a granulation time of 5 min to 12 min. The prepared granules are then fed into the hot air section of the fluidized bed of the fluidized bed dryer for drying. During granulation and drying, the premixed filler for the next batch is fed into the mixer. After the soft material is fed into the mixer, the extract and wetting agent are fed into the mixer in sequence to prepare the soft material for the next batch. (5) When the granules reach the drying temperature, they are transferred to the cold air section of the fluidized bed. The soft material of the next machine is fed into the hot air section of the fluidized bed through the pellet mill. When the granules of the cold air section are discharged, the granules of the next machine enter the hot air section for drying. (6) The dry particles discharged from the fluidized bed dryer are fed into the screening equipment and screened to obtain small Bupleurum granules; the screened recycled material is added to the preparation silo and premixed with the filler by airflow. The ratio of the filler, recycled material, extract and wetting agent is (180~200):(50~70):(26~32):(0.8~2); Repeat the above steps to continuously obtain Xiaochaihu granules.

2. The continuous production process of claim 1, wherein, The mixing conditions in step (2) are: stirring frequency 25 Hz~35 Hz, time 25 min~35 min.

3. The continuous production method as described in claim 1, characterized in that, The thickness of the feed material into the fluidized bed dryer is less than 4 cm.

4. The continuous production method as described in claim 1 or 3, characterized in that, The inlet air temperature of the fluidized bed dryer is 80℃~90℃, the fan frequency of the hot air section is 30 Hz~45 Hz, and the fan frequency of the cold air section is 25 Hz~45 Hz.

5. The continuous production method as described in claim 1, characterized in that, The mixer is a trough-type mixer.

6. The continuous production method as described in claim 1 or 5, characterized in that, The pellet mill is a swing pellet mill.

7. The continuous production method as described in claim 1 or 5, characterized in that, The filler is selected from at least one of sucrose, dextrin, and mannitol.

8. The continuous production method as described in claim 1 or 5, characterized in that, The wetting agent is selected from at least one of water and 40% to 60% ethanol.

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