Sanhua decoction granules and preparation method thereof

Abstract

This invention discloses a Sanhua Decoction granule and its preparation method, belonging to the field of traditional Chinese medicine preparation technology. The preparation method includes: separately processing Magnolia officinalis, Citrus aurantium, Rheum palmatum, and Notopterygium incisum slices; first, soaking the Magnolia officinalis slices in 16 times its weight of water overnight, then adding the other three slices and 16 times their total weight of water for soaking and decoction, combining the two decoctions; concentrating under reduced pressure to a clear extract with a relative density of 1.10–1.15 at 60℃; mixing the clear extract with dextrin, followed by fluidized bed granulation, granulation and mixing, and packaging with aluminum-plastic film to obtain the finished product. This invention optimizes the processing and extraction processes based on the characteristics of each medicinal material, reducing the decomposition of effective components and improving the transfer rate; precisely controlling the concentration density to improve the granule formation rate; fluidized bed granulation ensures uniform granules and stable quality, and the process is suitable for industrial production with good batch-to-batch consistency.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, and in particular to a Sanhua Decoction granule and its preparation method. Background Technology

[0002] Sanhua Decoction is a classic formula from Liu Wansu's *Suwen Bingji Qiyi Baoming Ji* (Collection of Medical Principles for Preserving Life and Pathogenesis) during the Jin-Yuan period. It consists of four herbs: Magnolia officinalis, Rheum palmatum, Citrus aurantium, and Notopterygium incisum. It has the effects of opening the bowels, regulating qi, and clearing turbidity. Clinically, it is often used to treat stroke, constipation, and other conditions caused by obstructed bowel qi. Traditional decoctions suffer from problems such as cumbersome preparation, inconvenient portability, and inconsistent quality, making them difficult to meet the needs of modern clinical medication.

[0003] Currently, some research has been conducted on Sanhua Decoction preparations, but most of them remain at the laboratory small-scale test stage, lacking process parameters that can be directly used for industrial production. Furthermore, the existing preparation processes have the following shortcomings: 1. The extraction process was not optimized for the physicochemical properties of the four medicinal materials. The phenolic components of Magnolia officinalis are easily lost, and the anthraquinone components of Rheum palmatum are easily decomposed due to prolonged high temperature. 2. The lack of precise density control during the concentration process leads to difficulties in subsequent granulation and a low granule formation rate; 3. The lack of systematic pilot-scale verification means that process parameters cannot be directly matched with industrial equipment, making it difficult to guarantee batch-to-batch consistency. Summary of the Invention

[0004] This invention provides a Sanhuatang granule and its preparation method, which can solve the problems of large loss of effective ingredients, low granule formation rate, and poor batch-to-batch consistency caused by lack of industrial-scale adaptation parameters in the existing Sanhuatang preparation process.

[0005] The objective of this invention can be achieved through the following technical solutions: In a first aspect, the present invention provides a method for preparing Sanhuatang granules, comprising the following steps: S1. Prepare Magnolia officinalis slices, Citrus aurantium slices, Rheum palmatum slices, and Notopterygium incisum slices separately for later use; S2. First, soak the Magnolia officinalis slices in 16 times the amount of drinking water overnight. Then, add the Citrus aurantium slices, Rheum palmatum slices, Notopterygium incisum slices, and 16 times the total mass of the three slices of drinking water, soak for 1 hour, and decoct for 2 hours. Filter to obtain a first decoction and a first dregs. Add drinking water to the first dregs and decoct. Filter to obtain a second decoction. Combine the first and second decoctions to obtain a decoction. S3. Concentrate the decoction under reduced pressure to a clear extract with a relative density of 1.10 to 1.15 at 60℃; S4. Mix the clear paste with dextrin, and then sequentially perform fluidized bed granulation, granulation and mixing, and aluminum-plastic composite film packaging to obtain the finished product.

[0006] Further, in step S1, the specific preparation method of the Magnolia officinalis slices is as follows: take Magnolia officinalis medicinal material, scrape off the rough skin, moisten until softened, cut into slices 5-10 mm thick, dry at 60-80℃ for 3-5 hours, and pass through a 10-mesh sieve.

[0007] Further, in step S1, the specific preparation method of the Citrus aurantium slices is as follows: take Citrus aurantium medicinal material, clean it, moisten it until softened, cut it into 1-2 mm thin slices, dry it at 60-80℃ for 4-6 hours, and pass it through a 10-mesh sieve.

[0008] Further, in step S1, the specific preparation method of the rhubarb slices is as follows: take rhubarb medicinal material, clean it, moisten it until softened, cut it into slices of 2-4 mm thickness, air dry it, and pass it through a 10-mesh sieve.

[0009] Further, in step S1, the specific preparation method of the Qianghuo medicinal slices is as follows: take Qianghuo medicinal material, clean it, moisten it until softened, cut it into slices with a thickness of 2-4 mm, dry it at 50℃ for 3-5 hours, and pass it through a 10-mesh sieve.

[0010] Furthermore, in step S2, the mass ratio of the Magnolia officinalis slices, Citrus aurantium slices, Rheum palmatum slices, and Notopterygium incisum slices is 1:1:1:1.

[0011] Furthermore, in step S2, the overnight soaking time is 12 hours.

[0012] Furthermore, in step S2, during the process of adding drinking water to the dregs for decoction, the amount of drinking water added is 12 times the mass of the dregs, and the decoction time is 1 hour.

[0013] Furthermore, in step S3, the reduced pressure concentration uses a single-effect concentrator, controlling the concentration temperature at 60-70°C and the vacuum degree at -0.07 to -0.09 MPa.

[0014] Further, in step S4, the weight ratio of the dextrin to the total amount of Magnolia officinalis slices, Citrus aurantium slices, Rheum palmatum slices, and Notopterygium incisum slices is (0.2-0.3):1.

[0015] Furthermore, in step S4, the key parameters for fluidized bed granulation are: inlet air temperature 65–100℃, and atomization pressure 0.8–1.2 kg / cm³. 2 The fan frequency is 10-45Hz.

[0016] Further, in step S4, the specific steps for granulation and mixing are as follows: after granulation, granulation is carried out using a vibrating screen, passing through a 10-mesh screen and an 80-mesh screen to collect particles between 10 and 80 mesh; then the particles are placed in an automatic lifting hopper mixer for uniform mixing and ready for use.

[0017] Secondly, the present invention provides a Sanhuatang granule, which is prepared by the method for preparing Sanhuatang granules described in any of the above contents.

[0018] The beneficial effects of this invention are: 1. In the preparation method of Sanhua Decoction granules provided by this invention, S1 involves separately processing Magnolia officinalis, Citrus aurantium, Rheum palmatum, and Notopterygium incisum into slices, setting the cutting specifications and drying temperature according to the characteristics of each herb, effectively preserving the effective components of each herb and facilitating subsequent extraction; S2 involves first soaking Magnolia officinalis alone overnight, and then soaking and decocting it together with the other three herbs, which not only promotes the full dissolution of Magnolia officinalis phenolic components, but also avoids the decomposition of Rheum palmatum anthraquinone components due to prolonged high-temperature co-decoction, while using a second decoction to further extract residual herbs from the dregs. The active ingredients are significantly improved, increasing the transfer rate of active ingredients. S3 uses vacuum concentration and controls the density of the extract within a suitable range at a lower temperature, which not only prevents the destruction of heat-sensitive components but also provides a moderately viscous extract for subsequent granulation, ensuring the granule formation rate. S4 uses fluidized bed granulation combined with granulation and mixing with aluminum-plastic composite membrane for packaging, achieving simultaneous spraying and drying. The granules are uniform in size, have controllable moisture content, and have small batch-to-batch filling differences, ultimately producing Sanhuatang granules with good solubility and stable quality, suitable for industrial production.

[0019] 2. The process parameters of this invention have been verified by a pilot test of 18,000 bags, and can be directly matched with industrial equipment, solving the problem of difficulty in scaling up small-scale processes.

[0020] 3. This invention optimizes the processing and extraction processes for different medicinal materials based on their physicochemical properties, reducing the loss rate of effective components such as phenols in Magnolia officinalis and anthraquinones in Rheum palmatum. Attached Figure Description

[0021] Figure 1 This is a process flow diagram for preparing the Sanhuatang granules of the present invention. Detailed Implementation

[0022] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below.

[0023] In a first aspect, the present invention provides a method for preparing Sanhuatang granules, comprising the following steps: S1. Prepare Magnolia officinalis slices, Citrus aurantium slices, Rheum palmatum slices, and Notopterygium incisum slices separately for later use; The above steps involve cleaning, slicing, and drying four medicinal materials: Magnolia officinalis, Citrus aurantium, Rheum palmatum, and Notopterygium incisum. Different slicing specifications and drying temperatures are set according to the physicochemical properties of each medicinal material. This effectively preserves heat-sensitive components such as magnolol and rheum anthraquinones, while ensuring the uniformity of particle size of the processed slices and the subsequent extraction efficiency, thus laying a material foundation for high transfer rates.

[0024] S2. First, soak the Magnolia officinalis slices in 16 times the amount of drinking water overnight. Then, add the Citrus aurantium slices, Rheum palmatum slices, Notopterygium incisum slices, and 16 times the total mass of the three slices of drinking water, soak for 1 hour, and decoct for 2 hours. Filter to obtain a first decoction and a first dregs. Add drinking water to the first dregs and decoct. Filter to obtain a second decoction. Combine the first and second decoctions to obtain a decoction. The above steps first involve soaking Magnolia officinalis slices alone in 16 times the amount of drinking water overnight to allow the internal tissues of Magnolia officinalis to fully swell and promote the dissolution of magnolol and honokiol; then adding Citrus aurantium, Rheum palmatum, Notopterygium incisum slices and 16 times the total mass of the three in drinking water for decoction. Through the two-stage decoction process, the anthraquinone components of Rheum palmatum are prevented from decomposing due to prolonged heating with Magnolia officinalis, and the residual effective components in the dregs are fully extracted. S3. Concentrate the decoction under reduced pressure to a clear extract with a relative density of 1.10 to 1.15 at 60℃; Low-temperature vacuum concentration and strict control of relative density can reduce the thermal decomposition of heat-sensitive active ingredients and ensure the retention rate of ingredients; at the same time, it makes the viscosity of the paste moderate, improves the subsequent granulation performance, increases the granule formation rate and uniformity, and reduces problems such as sticking to the wall and excessive fine powder.

[0025] S4. Mix the clear paste with dextrin, and then sequentially perform fluidized bed granulation, granulation and mixing, and aluminum-plastic composite film packaging to obtain the finished product.

[0026] Fluidized bed granulation ensures good granule formation, uniform particle size, and controllable moisture content, reducing the risk of moisture absorption and clumping; whole granulation and mixing guarantee batch-to-batch quality uniformity; aluminum-plastic composite film packaging provides good sealing and high stability, resulting in a final product with excellent solubility, convenient carrying and consumption, and suitability for large-scale industrial production.

[0027] In some embodiments, the specific preparation method of the Magnolia officinalis slices in step S1 is as follows: Take Magnolia officinalis medicinal material, scrape off the rough bark, moisten until softened, cut into slices 5-10 mm thick, dry at 60-80℃ for 3-5 hours, and pass through a 10-mesh sieve. This can retain phenolic components and facilitate extraction; if the slices are too thick or the drying temperature is too high or the drying time is too long, it will lead to component loss, while if the slices are too thin or the drying is insufficient, they will be brittle or have excessive moisture content.

[0028] In some embodiments, the specific preparation method of the Citrus aurantium slices in step S1 is as follows: Take Citrus aurantium, clean it, moisten it until softened, cut it into 1-2 mm thin slices, dry it at 60-80℃ for 4-6 hours, and pass it through a 10-mesh sieve. This can promote the dissolution of active ingredients; if the slices are too thin, they are prone to powdering; if they are too thick, the extraction is insufficient; improper drying temperature or time may cause component damage or moisture residue.

[0029] In some embodiments, the specific preparation method of the rhubarb slices in step S1 is as follows: take rhubarb medicinal material, clean it, moisten it until softened, cut it into slices 2-4 mm thick, air dry it, and pass it through a 10-mesh sieve. This can avoid high temperature damage to anthraquinone components; if the slices are too thin, the components are easily oxidized and lost, and if they are too thick, the extraction rate will decrease.

[0030] In some embodiments, the specific preparation method of the Notopterygium root slices in step S1 is as follows: Take Notopterygium root, clean it, moisten it until softened, cut it into slices 2-4 mm thick, dry it at 50°C for 3-5 hours, and pass it through a 10-mesh sieve. Low temperature preserves volatile oil components; too high a temperature will cause the volatile oil to be lost, and too low a temperature or insufficient time will result in incomplete drying and easy mold growth.

[0031] In some embodiments, in step S2, the mass ratio of the Magnolia officinalis slices, Citrus aurantium slices, Rheum palmatum slices, and Notopterygium incisum slices is 1:1:1:1. This conforms to the classic formula ratio and balances the efficacy; an imbalanced ratio will change the nature of the prescription and affect the therapeutic effect and extraction transfer rate.

[0032] In some embodiments, in step S2, the overnight soaking time is 12 hours. This allows for sufficient saturation of the Magnolia officinalis tissue and promotes the dissolution of phenols; too short a time results in insufficient swelling, while too long a time can lead to component hydrolysis or microbial growth.

[0033] In some embodiments, in step S2, during the process of adding drinking water to the dregs for decoction, the amount of drinking water added is 12 times the mass of the dregs, and the decoction time is 1 hour. This allows for the full extraction of residual active ingredients; too little water or too short a time will result in incomplete extraction, while too much or too long a time will increase energy consumption and may cause heat-sensitive components to decompose.

[0034] In some embodiments, in step S3, the reduced pressure concentration uses a single-effect concentrator, controlling the concentration temperature at 60–70°C and the vacuum degree at -0.07–-0.09 MPa. Low temperature protects heat-sensitive components; excessively high temperature or low vacuum can lead to component degradation and paste coking, while excessively low temperature or high vacuum results in low concentration efficiency.

[0035] In some embodiments, in step S4, the weight ratio of dextrin to the total amount of Magnolia officinalis slices, Citrus aurantium slices, Rheum palmatum slices, and Notopterygium incisum slices is (0.2-0.3):1. This ensures granule formation and disintegration; too little dextrin results in loose granules and low formation rate, while too much affects efficacy and increases dosage.

[0036] In some embodiments, the key parameters for fluidized bed granulation in step S4 are: inlet air temperature 65–100°C and atomization pressure 0.8–1.2 kg / cm³. 2The fan frequency is 10-45Hz. Spraying and drying are completed simultaneously, resulting in uniform particles. If the inlet air temperature is too high, it will damage the components; if it is too low, the drying will be incomplete. If the atomization pressure is too high, there will be too much fine powder; if it is too low, the atomization will be poor. If the fan frequency is too high, the material loss will be large; if it is too low, the fluidization will be poor.

[0037] In some embodiments, the specific steps of granulation and mixing in step S4 are as follows: after granulation, granulation is performed using a vibrating screen, passing the granules through a 10-mesh screen and an 80-mesh screen to collect particles between 10 and 80 mesh; then the particles are placed in an automatic lifting hopper mixer for uniform mixing and ready for use. This ensures uniform particle size and content; if the particle size is too coarse, dissolution is slow, and if it is too fine, it is prone to moisture absorption and has large variations in filling volume.

[0038] Secondly, the present invention provides a Sanhuatang granule, which is prepared by the method for preparing Sanhuatang granules described in any of the above contents.

[0039] The specific embodiments of the present invention will be described in detail below, but it should be understood that the scope of protection of the present invention is not limited to the specific embodiments.

[0040] Example 1 S1. Preparation of medicinal slices: Magnolia officinalis (Houpu) was prepared according to the following steps: the outer bark was scraped off, the slices were moistened until softened, cut into 8mm thick slices, dried at 70℃ for 4 hours, and passed through a 10-mesh sieve to obtain Magnolia officinalis slices; Citrus aurantium (Zhishi) was cleaned, moistened until softened, cut into 2mm thin slices, dried at 70℃ for 5 hours, and passed through a 10-mesh sieve to obtain Citrus aurantium slices; Rheum palmatum (Dahuang) was cleaned, moistened until softened, cut into 3mm thick slices, air-dried, and passed through a 10-mesh sieve to obtain Rheum palmatum slices; Notopterygium incisum (Qianghuo) was cleaned, moistened until softened, cut into 3mm thick slices, dried at 50℃ for 4 hours, and passed through a 10-mesh sieve to obtain Notopterygium incisum slices. All samples met the standards of Part I of the 2025 edition of the Chinese Pharmacopoeia. S2. Extraction: Take 92.9 kg of Magnolia officinalis slices and soak them in 16 times the amount of drinking water for 12 hours; add 92.9 kg each of Rheum palmatum, Citrus aurantium, and Notopterygium incisum slices, and then add drinking water that is 16 times the total mass of the three slices. Soak for 1 hour and then decoct for 2 hours. Filter to obtain a primary decoction and a primary dregs. Add 12 times the amount of drinking water to the primary dregs and decoct for 1 hour. Filter to obtain a secondary decoction. Combine the primary and secondary decoctions to obtain a decoction. S3. Concentration: The decoction is concentrated under reduced pressure, with the temperature controlled at 65℃ and the vacuum degree at -0.08MPa, until a clear extract with a relative density of 1.12 (60℃) is obtained. S4. Granulation, granulation, mixing, and packaging: Mix the clear extract with 90 kg of dextrin, and granulate using a fluidized bed granulation process. The inlet air temperature is 80℃ and the atomization pressure is 1.0 kg / cm³. 2The fan operates at a frequency of 30 Hz to produce wet granules. After drying, the wet granules are passed through 10-mesh and 80-mesh sieves, and the intermediate granules are collected and mixed evenly. The granules are then packaged in aluminum-plastic composite film, with each bag containing 11g, resulting in approximately 18,000 bags of finished product.

[0041] Upon inspection, the granules prepared in this embodiment had a granulation rate of 93.2%, a moisture content of 4.2%, and the filling weight variation met the requirements. The content of effective ingredients was uniform, and the batch-to-batch consistency was good.

[0042] Comparative Example 1 S1. Preparation of medicinal slices: The raw materials and steps are the same as those in step S1 of Example 1; S2. Extraction: Take 92.9 kg each of Magnolia officinalis, Rheum palmatum, Citrus aurantium, and Notopterygium incisum slices, mix them, add 16 times the total mass of Magnolia officinalis, Rheum palmatum, Citrus aurantium, and Notopterygium incisum slices of drinking water, soak for 1 hour, decoct for 2 hours, filter to obtain a primary decoction and a primary dregs; add 12 times the amount of drinking water to the primary dregs and decoct for 1 hour, filter to obtain a secondary decoction, combine the primary and secondary decoctions to obtain a decoction; S3. Concentration: The decoction is concentrated under reduced pressure, with the temperature controlled at 65℃ and the vacuum degree at -0.08MPa, until it is concentrated to a clear extract with a relative density of 1.12 at 60℃. S4. Granulation, granulation, and packaging: The extract is mixed with 90 kg of dextrin and granulated using a fluidized bed granulation process. The inlet air temperature is 80℃ and the atomization pressure is 1.0 kg / cm³. 2 The fan frequency is 30Hz to produce wet granules; after drying, the wet granules are passed through 10-mesh and 80-mesh sieves, the intermediate granules are collected and mixed evenly; and packaged in aluminum-plastic composite film, 11g per bag.

[0043] Tests showed that the product had a granulation rate of 81.5%, a moisture content of 6.8%, a low leaching rate of active ingredients, and poor granule uniformity.

[0044] Comparative Example 2 S1. Preparation of medicinal slices: The raw materials and steps are the same as those in step S1 of Example 1; S2. Extraction: Take 92.9 kg of Magnolia officinalis slices and soak them in 16 times the amount of drinking water for 12 hours; add 92.9 kg each of Rheum palmatum, Citrus aurantium, and Notopterygium incisum slices, and then add 10 times the amount of drinking water as the total mass of the three slices. Soak for 1 hour and then decoct for 1.5 hours. Filter to obtain a primary decoction and a primary dregs; add 8 times the amount of drinking water to the primary dregs and decoct for 0.5 hours. Filter to obtain a secondary decoction. Combine the primary and secondary decoctions to obtain a decoction. S3. Concentration: The decoction is concentrated under reduced pressure, with the temperature controlled at 65℃ and the vacuum degree at -0.08MPa, until it is concentrated to a clear extract with a relative density of 1.12 at 60℃. S4. Granulation, granulation and mixing, packaging: The clear paste is mixed with 90 kg of dextrin and granulated using a fluidized bed granulation process with an inlet air temperature of 80℃, an atomization pressure of 1.0 kg / cm², and a fan frequency of 30 Hz to obtain wet granules. Granulation: After the wet granules are dried, they are passed through 10-mesh and 80-mesh sieves, the intermediate granules are collected and mixed evenly; Aluminum-plastic composite film is repackaged, 11g per bag.

[0045] Tests showed that the granule formation rate of this product was 78.3%, the content of active ingredients was low, and there were large differences in content between batches.

[0046] Comparative Example 3 S1. Preparation of medicinal slices: The raw materials and steps are the same as those in step S1 of Example 1; S2. Extraction: Take 92.9 kg of Magnolia officinalis slices and soak them in 16 times the amount of drinking water for 12 hours; add 92.9 kg each of Rheum palmatum, Citrus aurantium, and Notopterygium incisum slices, and then add drinking water that is 16 times the total mass of the three slices. Soak for 1 hour and then decoct for 2 hours. Filter to obtain a primary decoction and a primary dregs. Add 12 times the amount of drinking water to the primary dregs and decoct for 1 hour. Filter to obtain a secondary decoction. Combine the primary and secondary decoctions to obtain a decoction. S3. Concentration: The decoction is concentrated under reduced pressure, with the temperature controlled at 80℃ and the vacuum degree at -0.05MPa, until it is concentrated to a clear extract with a relative density of 1.08 at 60℃. S4. Granulation, granulation and mixing, packaging: Mix the clear paste with 90kg of dextrin, granulate using a fluidized bed with an inlet air temperature of 80℃, atomization pressure of 1.0kg / cm², and fan frequency of 30Hz to obtain wet granules; after drying the wet granules, pass them through 10-mesh and 80-mesh sieves, collect the intermediate granules, and mix them evenly; package them in aluminum-plastic composite film, 11g per bag.

[0047] Tests showed that the product had a granule formation rate of 75.7%, a moisture content of 8.2%, and was prone to absorbing moisture and clumping, with poor flowability.

[0048] Comparative Example 4 S1. Preparation of medicinal slices: The raw materials and steps are the same as those in step S1 of Example 1; S2. Extraction: Take 92.9 kg of Magnolia officinalis slices and soak them in 16 times the amount of drinking water for 12 hours; add 92.9 kg each of Rheum palmatum, Citrus aurantium, and Notopterygium incisum slices, and then add drinking water that is 16 times the total mass of the three slices. Soak for 1 hour and then decoct for 2 hours. Filter to obtain a primary decoction and a primary dregs. Add 12 times the amount of drinking water to the primary dregs and decoct for 1 hour. Filter to obtain a secondary decoction. Combine the primary and secondary decoctions to obtain a decoction. S3. Concentration: The decoction is concentrated under reduced pressure, with the temperature controlled at 65℃ and the vacuum degree at -0.08MPa, until it is concentrated to a clear extract with a relative density of 1.12 at 60℃. S4. Granulation, granulation and mixing, packaging: Mix the clear paste with 90kg of dextrin and granulate using a shaking wet granulation method to obtain wet granules; after drying the wet granules, pass them through 10-mesh and 80-mesh sieves, collect the intermediate granules, and mix them evenly; package them in aluminum-plastic composite film, 11g per bag.

[0049] Upon inspection, the product had a granulation rate of 72.1%, uneven particle size, excessive fine powder, and excessive content variation.

[0050] Comparative Example 5 S1. Preparation of medicinal slices: The raw materials and steps are the same as those in step S1 of Example 1; S2. Extraction: Take 92.9 kg of Magnolia officinalis slices and soak them in 16 times the amount of drinking water for 12 hours; add 92.9 kg each of Rheum palmatum, Citrus aurantium, and Notopterygium incisum slices, and then add drinking water that is 16 times the total mass of the three slices. Soak for 1 hour and then decoct for 2 hours. Filter to obtain a primary decoction and a primary dregs. Add 12 times the amount of drinking water to the primary dregs and decoct for 1 hour. Filter to obtain a secondary decoction. Combine the primary and secondary decoctions to obtain a decoction. S3. Concentration: The decoction is concentrated under reduced pressure, with the temperature controlled at 65℃ and the vacuum degree at -0.08MPa, until it is concentrated to a clear extract with a relative density of 1.12 at 60℃. S4. Granulation, granulation and mixing, packaging: Mix the clear paste with 90kg of dextrin, granulate using a fluidized bed with an inlet air temperature of 110℃, atomization pressure of 1.5kg / cm², and fan frequency of 50Hz to obtain wet granules; after drying the wet granules, pass them through 10-mesh and 80-mesh sieves, collect the intermediate granules, and mix them evenly; package them in aluminum-plastic composite film, 11g per bag.

[0051] Upon inspection, the product showed a granule formation rate of 70.4%, with some granules being charred and discolored, uneven content of active ingredients, and a low finished product qualification rate.

[0052] The average transfer rates of magnolol, honokiol, rhein, and emodin in the Sanhuatang granules obtained in Example 1 and Comparative Examples 1-5 were tested. The total contents of magnolol (honokiol and honokiol) and rhein anthraquinones (emodin, rhein, and aloe-emodin) were determined by high performance liquid chromatography (HPLC). The chromatographic conditions were in accordance with the Chinese Pharmacopoeia. The transfer rate (%) was calculated as (total measured amount of index components in the granules / theoretical total amount of index components in the feed) × 100%. The test results are shown in Table 1.

[0053] Table 1

[0054] Table 1 shows that the Sanhuatang granules prepared in Example 1 of this invention have significantly better average transfer rates of the four components—honokiol, magnolol, rhein, and emodin—than those of Comparative Examples 1-5.

[0055] Comparative Example 1 used a single soaking extraction with a mixture of four medicinal slices, without pre-soaking Magnolia officinalis. This resulted in a significant decrease in the transfer rates of phenolic compounds from Magnolia officinalis and anthraquinone compounds from rhubarb, indicating that soaking Magnolia officinalis alone overnight facilitates the full dissolution of phenolic compounds while avoiding the loss of rhubarb components due to prolonged co-decoction. Comparative Example 2 reduced the amount of water and the duration of the second decoction, further decreasing the transfer rate, indicating insufficient extraction. Comparative Example 3 increased the concentration temperature and decreased the density of the extract, also significantly reducing the transfer rate, suggesting that high-temperature concentration can damage heat-sensitive components. Comparative Example 4 used a swing wet granulation method, which, although not directly affecting the extraction process, resulted in poor particle formation and low uniformity, indirectly affecting the content determination results. Comparative Example 5's fluidized bed granulation parameters (inlet air temperature, atomization pressure, fan frequency) exceeded the optimal range, leading to scorched particles or uneven composition, and the lowest transfer rate.

[0056] The above-disclosed embodiments are merely a few specific examples of the present invention. However, the embodiments of the present invention are not limited thereto, and any variations that can be conceived by those skilled in the art should fall within the protection scope of the present invention.

Claims

1. A method for preparing Sanhuatang granules, characterized in that, Includes the following steps: S1. Prepare Magnolia officinalis slices, Citrus aurantium slices, Rheum palmatum slices, and Notopterygium incisum slices separately for later use; S2. First, soak the Magnolia officinalis slices in 16 times the amount of drinking water overnight. Then, add the Citrus aurantium slices, Rheum palmatum slices, Notopterygium incisum slices, and 16 times the total mass of the three slices of drinking water, soak for 1 hour, and decoct for 2 hours. Filter to obtain a first decoction and a first dregs. Add drinking water to the first dregs and decoct. Filter to obtain a second decoction. Combine the first and second decoctions to obtain a decoction. S3. Concentrate the decoction under reduced pressure to a clear extract with a relative density of 1.10 to 1.15 at 60℃; S4. Mix the clear paste with dextrin, and then sequentially perform fluidized bed granulation, granulation and mixing, and aluminum-plastic composite film packaging to obtain the finished product.

2. The method for preparing Sanhuatang granules as described in claim 1, characterized in that, In step S1, the specific preparation method of the Magnolia officinalis slices is as follows: take Magnolia officinalis medicinal material, scrape off the rough skin, moisten until softened, cut into slices with a thickness of 5-10 mm, dry at 60-80℃ for 3-5 hours, and pass through a 10-mesh sieve; In step S1, the specific preparation method of the Citrus aurantium slices is as follows: take Citrus aurantium medicinal material, clean it, moisten it until softened, cut it into 1-2 mm thin slices, dry it at 60-80℃ for 4-6 hours, and pass it through a 10-mesh sieve; In step S1, the specific preparation method of the rhubarb slices is as follows: take rhubarb medicinal material, clean it, moisten it until it softens, cut it into slices with a thickness of 2-4 mm, air dry it, and pass it through a 10-mesh sieve. In step S1, the specific preparation method of the Qianghuo medicinal slices is as follows: take Qianghuo medicinal material, clean it, moisten it until softened, cut it into slices with a thickness of 2-4 mm, dry it at 50℃ for 3-5 hours, and pass it through a 10-mesh sieve.

3. The method for preparing Sanhuatang granules as described in claim 1, characterized in that, In step S2, the mass ratio of the Magnolia officinalis slices, Citrus aurantium slices, Rheum palmatum slices, and Notopterygium incisum slices is 1:1:1:

1.

4. The method for preparing Sanhuatang granules as described in claim 1, characterized in that, In step S2, the overnight soaking time is 12 hours.

5. The method for preparing Sanhuatang granules as described in claim 1, characterized in that, In step S2, during the process of adding drinking water to the dregs and decocting, the amount of drinking water added is 12 times the mass of the dregs, and the decoction time is 1 hour.

6. The method for preparing Sanhuatang granules as described in claim 1, characterized in that, In step S3, the reduced pressure concentration uses a single-effect concentrator, and the concentration temperature is controlled at 60-70℃, and the vacuum degree is -0.07 to -0.09MPa.

7. The method for preparing Sanhuatang granules as described in claim 1, characterized in that, In step S4, the weight ratio of the dextrin to the total amount of Magnolia officinalis slices, Citrus aurantium slices, Rheum palmatum slices, and Notopterygium incisum slices is (0.2-0.3):

1.

8. The method for preparing Sanhuatang granules as described in claim 1, characterized in that, In step S4, the key parameters for fluidized bed granulation are: inlet air temperature 65–100℃ and atomization pressure 0.8–1.2 kg / cm³. 2 The fan frequency is 10-45Hz.

9. The method for preparing Sanhuatang granules as described in claim 1, characterized in that, In step S4, the specific steps for granulation and mixing are as follows: After granulation, granulation is carried out using a vibrating screen, passing the granules through a 10-mesh screen and an 80-mesh screen to collect particles between 10 and 80 mesh; then the particles are placed in an automatic lifting hopper mixer for uniform mixing and ready for use.

10. A type of Sanhua Tang granules, characterized in that, It is prepared by the method of any one of claims 1-9 for preparing Sanhuatang granules.

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