Preparation method and device of hawthorn pills for digestive system diseases

Abstract

The invention relates to the technical field of medicine preparation, in particular to a hawthorn pill preparation method and device for digestive system diseases, and relates to a pretreatment mode of dividing hawthorn fruits based on the transverse diameter, the longitudinal diameter and the hardness of the hawthorn fruits. Performing solvent extraction separation on the pretreated hawthorn fruits, and collecting organic acid concentration and flavone concentration to determine whether the pepsin activation rate is qualified or not; in response to the disqualification of the pepsin activation rate, adjusting the pretreatment mode of the hawthorn fruits; concentrating the distilled water eluent under reduced pressure to prepare a coating solution, and spraying the coating solution on the surface of the hawthorn pill core to obtain a molded hawthorn pill; collecting the weight and the dissolution time of a plurality of hawthorn pills, judging the layer thickness degree of the coating based on the weight and the dissolution time, and adjusting the adhesive dosage of the distilled water eluent or adjusting the ethyl acetate concentration of the ethyl acetate eluent based on the judgment result of the layer thickness degree; the accuracy of the preparation method of the hawthorn pill for treating digestive system diseases is obviously improved.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical analysis and preparation, and in particular to a method and apparatus for preparing hawthorn pills for digestive system diseases. Background Technology

[0002] With the accelerated pace of modern life and changes in dietary structure, the incidence of digestive system diseases continues to rise. Conditions such as functional dyspepsia, food stagnation, abdominal distension, and loss of appetite have become common and frequently occurring diseases affecting a large population. Although these diseases are not acute or severe, they seriously impact patients' quality of life. Hawthorn pills, with their core ingredient hawthorn, have the effects of promoting digestion, strengthening the stomach, regulating qi, and dispersing blood stasis, and are particularly effective in digesting greasy and meaty foods. However, with the deepening of clinical applications and the development of modern pharmaceutical technology, traditional hawthorn pills and their conventional preparation methods have gradually revealed many limitations, such as low preparation efficiency, component stability and absorption issues, and difficulty in quality control. To overcome these shortcomings, this invention aims to provide a hawthorn pill for digestive system diseases and its preparation method, providing a hawthorn pill preparation with stable and controllable quality.

[0003] Chinese Patent Publication No. CN117783374A discloses an invention relating to the field of pharmaceutical analysis technology, specifically a HPLC detection method for hawthorn pills, a fingerprint chromatogram of hawthorn pills, and its applications. The detection method includes a fingerprint chromatogram of hawthorn pills and a quantitative method for key indicator components. Different extraction methods, extraction times, extraction solvents, and extraction volumes were systematically investigated to identify the optimal extraction conditions. Chemometric tools were used to systematically analyze the measurement data. The method yields reliable and highly accurate results, reflecting the overall quality of commercially available hawthorn pills. This method effectively monitors the quality of hawthorn pills, providing a scientific evaluation strategy for controlling the consistency and effectiveness of this preparation.

[0004] Therefore, existing technologies have failed to extract the effective substances and edible ineffective substances from hawthorn separately to prepare hawthorn pills with higher purity. At the same time, the edible ineffective substances are used as a protective outer layer of hawthorn pills to reduce the loss of hawthorn pills during the process of improving the digestive system from the mouth to the stomach, and to reduce irritation to the mouth and esophagus. Summary of the Invention

[0005] Therefore, the present invention provides a method and apparatus for preparing hawthorn pills for digestive system diseases, which overcomes the failure of the prior art to extract the effective substances and edible ineffective substances from hawthorn separately, thus preparing hawthorn pills with higher purity. At the same time, the edible ineffective substances are used as a protective outer layer of the hawthorn pills to reduce the loss of hawthorn pills from the mouth to the stomach in the process of improving the digestive system, and to reduce the problem of irritation to the mouth and esophagus.

[0006] To achieve the above objectives, on the one hand, the present invention provides a method for preparing hawthorn pills for digestive system diseases, the preparation process comprising: Fruit characterization values ​​were generated based on the transverse diameter, longitudinal diameter, and firmness of hawthorn fruits to classify the pretreatment methods of hawthorn fruits. Solvent extraction was performed on the pretreated hawthorn fruits to separate them, and the concentrations of organic acids and flavonoids in the ethyl acetate eluent were collected to generate elution characterization values ​​to determine whether the pepsin activation rate was qualified. If the pepsin activation rate is qualified, hawthorn pills are prepared. If the pepsin activation rate is unqualified, the pretreatment method of hawthorn fruit is adjusted based on the comparison between the elution characterization value and the preset elution characterization value and the preset difference. The distilled water eluent was concentrated under reduced pressure and a binder was added and stirred evenly to prepare a coating solution. A filler was added to the concentrated ethyl acetate eluent to prepare a hawthorn pill core. The coating solution was sprayed onto the surface of the hawthorn pill core to form a coating and obtain a shaped hawthorn pill. The weight of several hawthorn pills and their dissolution time in simulated gastric juice at a preset temperature are collected. Based on the weight and dissolution time, a texture characterization value is generated to determine the coating thickness. Based on the determination of the coating thickness, the amount of binder in the distilled water eluent or the concentration of ethyl acetate in the ethyl acetate eluent is adjusted.

[0007] Furthermore, the process of generating fruit characterization values ​​based on the transverse diameter, longitudinal diameter, and firmness of hawthorn fruits includes, The ratio of the longitudinal diameter to the transverse diameter is calculated as the fruit index; The ratio of the hardness to the standard hardness is determined as the hardness factor; The weighted sum of the fruit index and the firmness factor is determined to be the fruit characterization value.

[0008] Furthermore, if the fruit characterization value is less than the preset fruit characterization value, then the pretreatment method of the hawthorn fruit is determined to be the first crushing method. If the fruit characterization value is greater than or equal to the preset fruit characterization value, then the pretreatment method of the hawthorn fruit is determined to be the second crushing method.

[0009] Furthermore, the process of collecting the concentrations of organic acids and flavonoids in the ethyl acetate eluent to generate elution characterization values ​​includes, The ratio of the concentration of the organic acid to the concentration of the elution standard organic acid is determined as the elution organic acid factor; The ratio of the flavonoid concentration to the elution standard flavonoid concentration is determined as the elution flavonoid factor; The weighted sum of the eluted organic acid factor and the eluted flavonoid factor was determined to be the elution characterization value.

[0010] Furthermore, the pepsin activation rate was determined to be acceptable based on the elution characterization values, wherein... If the elution characterization value is greater than or equal to the preset elution characterization value, the pepsin activation rate is deemed qualified. If the elution characterization value is less than the preset elution characterization value, the pepsin activation rate is deemed unqualified.

[0011] Furthermore, the pretreatment method for hawthorn fruit was determined based on the difference between the elution characterization value and the preset elution characterization value. In response to the difference being greater than or equal to a preset difference, if the pretreatment method of the hawthorn fruit is the first crushing method, it is determined that the pretreatment method should be adjusted to perform the first crushing method first and then the second crushing method; if the pretreatment method of the hawthorn fruit is the second crushing method, it is determined that the pretreatment method should be adjusted to perform the second crushing method twice. In response to the difference being less than the preset difference, if the pretreatment method of the hawthorn fruit is the first crushing method, then it is determined that the pretreatment method should be adjusted to the second crushing method; if the pretreatment method of the hawthorn fruit is the second crushing method, then it is determined that the pretreatment method should be adjusted to perform the first crushing method first and then the second crushing method.

[0012] Furthermore, the process of generating texture characterization values ​​based on the weight and the dissolution time includes, The ratio of the average weight of several hawthorn pills to the standard weight is determined as the weight factor; The ratio of the mean dissolution time of several hawthorn pills to the standard dissolution time is determined as the dissolution factor; The weighted sum of the weight factor and the solubility factor is determined to be the texture characterization value.

[0013] Furthermore, the thickness of the coating layer is determined based on texture characterization values, wherein, If the texture characterization value is less than the first preset texture characterization value, the coating thickness is determined to be too thin. If the texture characterization value is greater than the first preset texture characterization value and less than or equal to the second preset texture characterization value, then the coating thickness is determined to be normal. If the texture characterization value is greater than the second preset texture characterization value, the coating thickness is determined to be too thick.

[0014] Furthermore, the process of adjusting the amount of binder in the distilled water eluent or adjusting the ethyl acetate concentration in the ethyl acetate eluent based on the determination of layer thickness includes, If the coating thickness is determined to be too thin, the amount of binder in the distilled water eluent is adjusted based on the difference between the texture characterization value and the first preset texture characterization value. If the coating thickness is determined to be too thick, the ethyl acetate concentration of the ethyl acetate eluent is adjusted based on the difference between the second preset texture characterization value and the texture characterization value.

[0015] On the other hand, the present invention also provides an apparatus for preparing hawthorn pills for digestive system diseases, comprising: A pretreatment facility used to pretreat hawthorn fruits; The extraction and separation unit is used to perform solvent extraction and separation on the pretreated hawthorn fruits; The preparation mechanism, in response to the qualified pepsin activation rate, concentrates the distilled water eluent under reduced pressure and adds a binder and stirs evenly to prepare a coating solution, and adds a filler to the concentrated ethyl acetate eluent to prepare hawthorn pill cores. The spraying mechanism is used to evenly spray the coating liquid onto the outer surface of the hawthorn pill core to form hawthorn pills; An analytical unit, which is connected to the hawthorn dividing unit and the solvent analysis unit respectively, is used to determine whether the pepsin activation rate is qualified based on the concentration of organic acid and flavonoid in the ethyl acetate eluent, and to adjust the pretreatment method of hawthorn fruit under the condition that the pepsin activation rate is not qualified, and to determine the coating thickness based on the weight and dissolution time of hawthorn pills. An adjustment mechanism, which is connected to the extraction and separation mechanism, the preparation mechanism, and the analysis mechanism respectively, is used to adjust the amount of binder in the distilled water eluent or the ethyl acetate concentration in the ethyl acetate eluent based on the determination result of the coating thickness.

[0016] Compared with the prior art, the beneficial effects of the preparation method of hawthorn pills for digestive system diseases of the present invention are that the fruit characterization values ​​are generated based on the transverse diameter, longitudinal diameter and hardness of hawthorn fruit to classify the pretreatment methods of hawthorn fruit. The transverse diameter and longitudinal diameter reflect the size of hawthorn fruit, and the hardness reflects the maturity and firmness of hawthorn fruit. Based on these values, hawthorn fruit in different states can be distinguished. Furthermore, different crushing methods are adopted according to the state of hawthorn fruit to quickly crush the hawthorn fruit, which can improve the efficiency of subsequent solvent extraction and separation processes, and further improve the accuracy of the preparation method of hawthorn pills for digestive system diseases.

[0017] Furthermore, this invention also involves solvent extraction and separation of pretreated hawthorn fruits, collecting the concentrations of organic acids and flavonoids in the ethyl acetate eluent to generate elution characterization values ​​to determine whether the pepsin activation rate is qualified. If the pepsin activation rate is qualified, hawthorn pills are prepared. If the pepsin activation rate is unqualified, the pretreatment method of the hawthorn fruits is adjusted based on the comparison between the elution characterization value and the preset elution characterization value. The organic acids in hawthorn can promote gastric acid secretion, and flavonoids can assist in regulating digestive-related physiological processes. When their concentrations reach preset values, they can synergistically influence pepsin activation, which is crucial. The pepsin activation rate is directly related to the core digestive efficacy of hawthorn pills. When the pepsin activation rate is unqualified, the crushing method of the hawthorn fruits is adjusted. Specifically, based on the different content differences between the extracted effective substances and the preset values, different enhancement adjustments are made to the crushing process, which can quickly ensure that the extraction effect of the effective components of hawthorn reaches the standard, further improving the accuracy of the preparation method of hawthorn pills for digestive system diseases.

[0018] Furthermore, this invention can also concentrate the distilled water eluent under reduced pressure and add a binder to prepare a coating solution. A filler is added to the concentrated ethyl acetate eluent to form a hawthorn pill core. The coating solution is then sprayed onto the surface of the hawthorn pill core to form a coating, resulting in a shaped hawthorn pill. Hawthorn pill preparation is carried out when the concentrations of organic acids and flavonoids in the ethyl acetate eluent are both within acceptable limits. This ensures the stability and consistency of product quality from the source. Using a binder to prepare the coating solution from the concentrated distilled water eluent provides a protective barrier for the hawthorn pill, reducing irritation to the mouth and esophagus. In addition, the coating has moisture-proof, light-proof, and oxidation-proof functions, protecting the effective components in the pill core and extending the product's shelf life. Adding a filler to the concentrated ethyl acetate eluent to prepare the hawthorn pill core allows the core to have suitable hardness, weight, and shape, facilitating uniform coating and overall product quality control, further improving the accuracy of the preparation method for hawthorn pills used for digestive system diseases.

[0019] Furthermore, this invention also collects the weight of several hawthorn pills and their dissolution time in simulated gastric juice at a preset temperature. Based on the weight and dissolution time, a texture characterization value is generated to determine the coating thickness. Based on the thickness determination result, the amount of binder in the distilled water eluent or the ethyl acetate concentration in the ethyl acetate eluent is adjusted based on the texture characterization value. The coating thickness directly affects the dissolution time and drug release rate of the hawthorn pills. Accurately controlling the coating quality makes the hawthorn pills more stable and reliable in effect. For hawthorn pills with coating thickness outside the normal range, the amount of binder in the distilled water eluent and the ethyl acetate concentration in the ethyl acetate eluent are adjusted in a targeted manner, which helps to ensure the quality of the hawthorn pills and further improves the accuracy of the preparation method of hawthorn pills for digestive system diseases. Attached Figure Description

[0020] Figure 1 This is a schematic flowchart illustrating a method for preparing hawthorn pills for digestive system diseases according to an embodiment of the present invention. Figure 2 This is a logic decision diagram for classifying the pretreatment methods of hawthorn fruits according to an embodiment of the present invention; Figure 3 This is a logic diagram for determining whether the pepsin activation rate is qualified in an embodiment of the present invention. Figure 4 This is a logic diagram for determining the coating thickness according to an embodiment of the present invention; Figure 5 This is a schematic diagram of the spraying mechanism according to an embodiment of the present invention; Among them, 1 is an image acquisition unit; 2 is a spraying unit; 21 is a moving nozzle; 22 is a rotating nozzle; 23 is a slide rail; 3 is a rotating unit; 4 is a cooling unit; 5 is a base; and 6 is a hawthorn pill. Detailed Implementation

[0021] To make the objectives and advantages of the present invention clearer, the present invention will be further described below with reference to embodiments; it should be understood that the specific embodiments described herein are merely for explaining the present invention and are not intended to limit the present invention.

[0022] Preferred embodiments of the present invention will now be described with reference to the accompanying drawings. Those skilled in the art should understand that these embodiments are merely illustrative of the technical principles of the present invention and are not intended to limit the scope of protection of the present invention.

[0023] It should be noted that in the description of this invention, the terms "upper", "lower", "left", "right", "inner", "outer", etc., which indicate directions or positional relationships, are based on the directions or positional relationships shown in the accompanying drawings. This is only for the convenience of description and is not intended to indicate or imply that the device or element must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation of this invention.

[0024] Furthermore, it should be noted that, in the description of this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0025] Please see Figure 1 The diagram shown is a flowchart illustrating the preparation method of hawthorn pills for digestive system diseases according to an embodiment of the present invention. The present invention provides a method for preparing hawthorn pills for digestive system diseases, comprising: Step S1: Generate fruit characterization values ​​based on the transverse diameter, longitudinal diameter, and hardness of hawthorn fruits to classify the pretreatment methods of hawthorn fruits. Step S2: Solvent extraction and separation are performed on the pretreated hawthorn fruit, and the concentrations of organic acids and flavonoids in the ethyl acetate eluent are collected to generate elution characterization values ​​to determine whether the pepsin activation rate is qualified. Step S3: If the pepsin activation rate is qualified, hawthorn pills are prepared; if the pepsin activation rate is unqualified, the pretreatment method of hawthorn fruit is adjusted based on the comparison between the elution characterization value and the preset elution characterization value. Step S4: Concentrate the distilled water eluent under reduced pressure and add a binder, stirring evenly to prepare a coating solution. Add a filler to the concentrated ethyl acetate eluent and prepare a hawthorn pill core. Spray the coating solution onto the surface of the hawthorn pill core to form a coating and obtain a shaped hawthorn pill. Step S5: Collect the weight of several hawthorn pills and the dissolution time in simulated gastric juice at a preset temperature. Generate a texture characterization value based on the weight and dissolution time to determine the coating thickness. Adjust the amount of binder in the distilled water eluent or adjust the ethyl acetate concentration in the ethyl acetate eluent based on the thickness determination result.

[0026] Specifically, the process of generating fruit characterization values ​​based on the transverse diameter, longitudinal diameter, and firmness of hawthorn fruits includes, The ratio of longitudinal diameter to transverse diameter is calculated as the fruit index; The ratio of hardness to standard hardness is determined as the hardness factor; The weighted sum of the fruit index and the firmness factor is determined to be the fruit characterization value.

[0027] Understandably, the standard hardness is the hardness of hawthorn fruit when it is confirmed that the fruit is ripe and ready for harvesting. This hardness can be measured using a hardness tester, while the longitudinal and transverse diameters can be measured using vernier calipers.

[0028] Specifically, the sum of the weighting coefficients of the fruit index and the firmness factor is 1. Since the transverse and longitudinal diameters of hawthorn fruit can be used to determine the size of hawthorn fruit, and the size and firmness of hawthorn fruit have the same effect on determining the ripeness of hawthorn fruit, the weighting coefficient of the fruit index is generally taken as 0.5, and the weighting coefficient of the firmness factor is also taken as 0.5. When calculating the fruit characterization value, only the numerical value is used for calculation.

[0029] In one specific embodiment, the longitudinal diameter was measured to be 1.2 cm and the transverse diameter was measured to be 1.5 cm, so the fruit index was 0.8. The hardness was measured to be 10 kg / cm², and the standard hardness was 12 kg / cm², so the hardness factor was 0.83. Therefore, the fruit characterization value was 0.82.

[0030] Specifically, fruit characterization values ​​are generated based on the transverse diameter, longitudinal diameter, and hardness of hawthorn fruits to classify the pretreatment methods of hawthorn fruits. The transverse and longitudinal diameters reflect the size of the hawthorn fruits, while the hardness reflects the maturity and firmness of the hawthorn fruits. Based on these values, hawthorn fruits in different states can be distinguished, and different crushing methods can be adopted according to the state of the hawthorn fruits to quickly crush them, which can improve the efficiency of subsequent solvent extraction and separation processes, and further improve the accuracy of the preparation method of hawthorn pills for digestive system diseases.

[0031] Please see Figure 2 As shown, this is a logic decision diagram for classifying the pretreatment methods of hawthorn fruits according to an embodiment of the present invention. The pretreatment methods for classifying hawthorn fruits are based on fruit characterization values. If the fruit characterization value is less than the preset fruit characterization value, the pretreatment method of the hawthorn fruit is determined to be the first crushing method. If the fruit characterization value is greater than or equal to the preset fruit characterization value, then the pretreatment method of the hawthorn fruit is determined to be the second crushing method.

[0032] Specifically, the pressure of the second crushing method is greater than that of the first crushing method.

[0033] In one specific embodiment, a preset fruit characterization value is set to 0.82. If the fruit characterization value is 0.78, which is less than the preset fruit characterization value, then the pretreatment method of the hawthorn fruit is determined to be the first crushing method. If the fruit characterization value is 0.93, which is greater than the preset fruit characterization value, then the pretreatment method for hawthorn fruit is determined to be the second crushing method.

[0034] Understandably, the smaller the difference between the longitudinal and transverse diameters of a hawthorn fruit, the smaller the difference between the measured hardness and the standard hardness, indicating a better maturity of the hawthorn fruit. Therefore, the general range of the fruit's characteristic value is 0.75 to 0.95.

[0035] Specifically, the process of collecting the concentrations of organic acids and flavonoids in the ethyl acetate eluent to generate elution characterization values ​​includes: The ratio of the organic acid concentration to the concentration of the elution standard organic acid is defined as the elution organic acid factor. The ratio of flavonoid concentration to elution standard flavonoid concentration is determined as the elution flavonoid factor; The weighted sum of the elution organic acid factor and the elution flavonoid factor was determined as the elution characterization value.

[0036] Specifically, the standard organic acid concentration for elution refers to the baseline value of organic acid in the ethyl acetate eluent that is within the optimal concentration range required for pepsin to achieve a qualified activation rate. The standard flavonoid concentration for elution is the baseline concentration that flavonoid components in the ethyl acetate eluent need to reach, ensuring that flavonoids and organic acids work synergistically to jointly guarantee a qualified pepsin activation rate. Both the organic acid concentration and the flavonoid concentration can be measured using a high-performance liquid chromatograph.

[0037] Specifically, the sum of the weighting coefficients of the elution organic acid factor and the elution flavonoid factor is 1. Since the concentration of organic acid in the ethyl acetate eluent is higher than that of flavonoids, and organic acid has a greater effect on activating pepsin, the weighting coefficient of the elution organic acid factor is generally taken as 0.6, and the weighting coefficient of the elution flavonoid factor is 0.4. Only the numerical values ​​are used for calculation when elution characterization values ​​are calculated.

[0038] In one specific embodiment, the organic acid concentration was measured to be 9 mg / mL, the elution standard organic acid concentration was 10 mg / mL, so the elution organic acid factor was 0.9; the flavonoid concentration was measured to be 0.7 mg / mL, the elution standard flavonoid concentration was 0.9 mg / mL, so the elution flavonoid factor was 0.78; therefore, the elution characterization value was 0.85.

[0039] Please see Figure 3 As shown, this is a logic diagram for determining whether the pepsin activation rate is qualified according to an embodiment of the present invention. The qualification of the pepsin activation rate is determined based on the elution characterization values. If the elution characterization value is greater than or equal to the preset elution characterization value, the pepsin activation rate is deemed qualified. If the elution characterization value is less than the preset elution characterization value, the pepsin activation rate is deemed unqualified.

[0040] In one specific embodiment, a preset elution characterization value is set to 0.9. If the elution characterization value is 0.92, which is greater than the preset elution characterization value, the pepsin activation rate is determined to be qualified. If the elution characterization value is 0.86, which is less than the preset elution characterization value, then the pepsin activation rate is deemed unqualified.

[0041] It is understandable that the closer the measured organic acid concentration is to the elution standard organic acid concentration, the closer the measured flavonoid concentration is to the elution standard flavonoid concentration, and the closer the pepsin activation rate is to the successful activation rate. Therefore, the general range of elution characterization values ​​is 0.8 to 0.95.

[0042] Specifically, the pretreatment method for hawthorn fruit is determined based on the difference between the elution characterization value and the preset elution characterization value. In response to a difference greater than or equal to a preset difference, if the pretreatment method of hawthorn fruit is the first crushing method, it is determined that the pretreatment method should be adjusted to perform the first crushing method first and then the second crushing method; if the pretreatment method of hawthorn fruit is the second crushing method, it is determined that the pretreatment method should be adjusted to perform the second crushing method twice. If the difference is less than a preset difference, and the pretreatment method of the hawthorn fruit is the first crushing method, then it is determined to adjust the pretreatment method to the second crushing method. If the pretreatment method of the hawthorn fruit is the second crushing method, then it is determined to adjust the pretreatment method to perform the first crushing method first and then the second crushing method.

[0043] In a specific embodiment, a preset difference value of 0.2 is set. In response to a difference value of 0.3 being greater than the preset difference value, if the pretreatment method of hawthorn fruit is the first crushing method, it is determined that the pretreatment method is adjusted to perform the first crushing method first and then the second crushing method. If the pretreatment method of hawthorn fruit is the second crushing method, it is determined that the pretreatment method is adjusted to perform the second crushing method twice. In response to a difference of 0.1 that is less than a preset difference, if the pretreatment method for hawthorn fruit is the first crushing method, then it is determined that the pretreatment method should be adjusted to the second crushing method. If the pretreatment method for hawthorn fruit is the second crushing method, then it is determined that the pretreatment method should be adjusted to perform the first crushing method first and then the second crushing method.

[0044] It is understandable that organic acids and flavonoids are the main active ingredients in hawthorn fruit. The error in the ripeness of hawthorn fruit caused by the error of these two factors has a great impact on the determination of the pretreatment method of hawthorn fruit. Therefore, the preset range of the difference is generally 0.15 to 0.25.

[0045] Specifically, this invention further involves solvent extraction and separation of pretreated hawthorn fruits. The concentrations of organic acids and flavonoids in the ethyl acetate eluent are collected to generate elution characterization values ​​to determine if the pepsin activation rate is acceptable. If the pepsin activation rate is acceptable, hawthorn pills are prepared. If the pepsin activation rate is unacceptable, the pretreatment method of the hawthorn fruits is adjusted based on the comparison between the elution characterization value and the preset elution characterization value. The organic acids in hawthorn can promote gastric acid secretion, and flavonoids can assist in regulating digestive physiological processes. When their concentrations reach preset values, they can synergistically influence pepsin activation. The pepsin activation rate is directly related to the core digestive efficacy of hawthorn pills. When the pepsin activation rate is unacceptable, the crushing method of the hawthorn fruits is adjusted. Specifically, based on the different content differences between the extracted effective substances and the preset values, different enhancements are made to the crushing process, which can quickly ensure that the extraction effect of the effective components of hawthorn meets the standards, further improving the accuracy of the preparation method of hawthorn pills for digestive system diseases.

[0046] Specifically, this invention can also concentrate distilled water eluent under reduced pressure and add a binder to prepare a coating solution. A filler is added to the concentrated ethyl acetate eluent to form a hawthorn pill core. The coating solution is then sprayed onto the surface of the hawthorn pill core to form a coating, resulting in a shaped hawthorn pill. Hawthorn pill preparation is carried out when the concentrations of organic acids and flavonoids in the ethyl acetate eluent are both within acceptable limits. This ensures the stability and consistency of product quality from the source. Using a binder to prepare the coating solution from the concentrated distilled water eluent provides a protective barrier for the hawthorn pill, reducing irritation to the mouth and esophagus. Furthermore, the coating also has moisture-proof, light-proof, and oxidation-proof functions, protecting the effective components in the pill core and extending the product's shelf life. Adding a filler to the concentrated ethyl acetate eluent to prepare the hawthorn pill core allows the core to have suitable hardness, weight, and shape, facilitating uniform coating and overall product quality control, further improving the accuracy of the preparation method for hawthorn pills used for digestive system diseases.

[0047] Specifically, for those skilled in the art, the process of concentrating the distilled water eluent under reduced pressure to prepare the coating also requires the addition of talc to improve the taste of the hawthorn pills. The binder can be hydroxypropyl methylcellulose, gum arabic, starch paste, etc., and the filler can be microcrystalline cellulose, pregelatinized starch, calcium sulfate, etc., which are existing technologies and will not be elaborated here.

[0048] Specifically, the process of generating texture characterization values ​​based on weight and dissolution time includes, The ratio of the average weight of several hawthorn pills to the standard weight is determined as the weight factor; The ratio of the mean dissolution time of several hawthorn pills to the standard dissolution time is determined as the dissolution factor; The weighted sum of the weight factor and the solubility factor is determined to be the texture characterization value.

[0049] Specifically, the standard weight refers to the average weight of several qualified hawthorn pills, and the standard dissolution time refers to the time benchmark for several qualified hawthorn pills to dissolve to the required level within a preset temperature, reflecting the standard rate of release of the effective ingredients of hawthorn pills.

[0050] Specifically, the sum of the weight coefficients of the weight factor and the solubility factor is 1. Since the weight of the hawthorn pill has a smaller impact on the dissolution time of the hawthorn pill in the simulated gastric juice, the weight coefficient of the weight factor is generally taken as 0.4 and the weight coefficient of the solubility factor is taken as 0.6. Only the numerical value is used for the calculation of the texture characterization value.

[0051] In one specific embodiment, the average weight of several hawthorn pills was calculated to be 8.7g, and the standard weight was 9g, so the weight factor was 0.97. The average dissolution time of several hawthorn pills was calculated to be 28min, and the standard dissolution time was 30min, so the dissolution factor was 0.93. Therefore, the texture characterization value was 0.95.

[0052] Please see Figure 4 As shown, this is a logic diagram for determining the coating thickness according to an embodiment of the present invention. The coating thickness is determined based on texture characterization values. If the texture characterization value is less than the first preset texture characterization value, the coating thickness is determined to be too thin. If the texture characterization value is greater than the first preset texture characterization value and less than or equal to the second preset texture characterization value, then the coating thickness is determined to be normal. If the texture characterization value is greater than the second preset texture characterization value, the coating thickness is determined to be too thick.

[0053] In one specific embodiment, a first preset texture characterization value is set to 0.9 and a second preset texture characterization value is set to 1.1. If the texture characterization value is 0.86, which is less than the first preset texture characterization value, the coating thickness is determined to be too thin. If the texture characterization value is 1.07, which is greater than the first preset texture characterization value and less than the second preset texture characterization value, then the coating thickness is determined to be normal. If the texture characterization value is 1.15, which is greater than the second preset texture characterization value, then the coating thickness is determined to be too thick.

[0054] It is understandable that when the average weight of several hawthorn pills is much smaller than the standard weight and the average dissolution time is much smaller than the standard dissolution time, it indicates that the coating is too thin. Conversely, when the average weight of several hawthorn pills is much larger than the standard weight and the average dissolution time is much larger than the standard dissolution time, it indicates that the coating is too thick. Therefore, the range of the first preset texture characterization value is generally 0.85 to 1.05, and the range of the second preset texture characterization value is 1.08 to 1.28.

[0055] Specifically, the process of adjusting the amount of binder in the distilled water eluent or adjusting the ethyl acetate concentration in the ethyl acetate eluent based on the determination of layer thickness includes, If the coating thickness is determined to be too thin, the amount of binder in the distilled water eluent is adjusted based on the difference between the first preset texture characterization value and the texture characterization value. If the coating thickness is determined to be too thick, the ethyl acetate concentration of the ethyl acetate eluent is adjusted based on the difference between the texture characterization value and the second preset texture characterization value.

[0056] In one specific embodiment, the solid content of the distilled water eluent is 100g, the initial amount of adhesive is 100 x 1.0% = 1g, the first preset texture characterization value is set to 0.9, the texture characterization value is 0.8, and the difference ratio is (0.9 - 0.8) / 0.9 = 0.11. Therefore, the amount of adhesive is the initial amount of adhesive x (1 + difference ratio), that is, 1 x (1 + 0.11) = 1.11g; In one specific embodiment, the initial ethyl acetate concentration is 60%, the second preset texture characterization value is set to 1.1, the texture characterization value is set to 1.2, and the difference between the texture characterization values ​​is 1.2-1.1=0.1. Therefore, the ethyl acetate concentration is the initial ethyl acetate concentration + (texture characterization value difference / 10) x 100%, that is, 60%+1%=61%.

[0057] Specifically, this invention also collects the weight of several hawthorn pills and their dissolution time in simulated gastric juice at a preset temperature. Based on the weight and dissolution time, a texture characterization value is generated to determine the coating thickness. Based on the thickness determination result, the amount of binder in the distilled water eluent or the ethyl acetate concentration in the ethyl acetate eluent is adjusted based on the texture characterization value. The coating thickness directly affects the dissolution time and drug release rate of the hawthorn pills. Accurately controlling the coating quality makes the hawthorn pills more stable and reliable in effect. For hawthorn pills with coating thickness outside the normal range, the amount of binder in the distilled water eluent and the ethyl acetate concentration in the ethyl acetate eluent are adjusted in a targeted manner, which helps to ensure the quality of the hawthorn pills and further improves the accuracy of the preparation method of hawthorn pills for digestive system diseases.

[0058] Specifically, the present invention also provides an apparatus for preparing hawthorn pills for digestive system diseases, comprising: A pretreatment facility used to pretreat hawthorn fruits; The extraction and separation unit is used to perform solvent extraction and separation on the pretreated hawthorn fruits; The preparation mechanism, in response to the qualified pepsin activation rate, concentrates the distilled water eluent under reduced pressure and adds a binder and stirs evenly to prepare a coating solution, and adds a filler to the concentrated ethyl acetate eluent to prepare hawthorn pill cores. The spraying mechanism is used to evenly spray the coating liquid onto the outer surface of the hawthorn pill core to form hawthorn pills; The analysis unit is connected to the hawthorn grading unit and the solvent analysis unit respectively. It is used to determine whether the pepsin activation rate is qualified based on the concentration of organic acid and flavonoid in the ethyl acetate eluent, and to adjust the pretreatment method of hawthorn fruit when the pepsin activation rate is not qualified, and to determine the coating thickness based on the weight and dissolution time of hawthorn pills. The adjustment mechanism, which is connected to the extraction and separation mechanism, the preparation mechanism, and the analysis mechanism respectively, is used to adjust the amount of binder in the distilled water eluent or the ethyl acetate concentration in the ethyl acetate eluent based on the determination of the coating thickness.

[0059] The spraying mechanism includes an image acquisition unit, a spraying unit, a rotating unit, and a cooling unit. Based on the cooling image of the hawthorn pills acquired by the image acquisition unit, it is determined whether to adjust the air outlet speed and cooling temperature of the cooling unit. The spraying unit includes a moving nozzle and a rotating nozzle. The moving nozzle can slide on a limit rod, and the rotating nozzle can adjust the spraying angle according to the position of the moving nozzle on the limit rod.

[0060] Please see Figure 5As shown, this is a schematic diagram of the spraying mechanism according to an embodiment of the present invention. The spraying mechanism includes an image acquisition unit 1, a spraying unit 2, a rotating unit 3, a cooling unit 4, and a base 5. The hawthorn pill 6 is connected to the rotating unit 3 via a connecting rod and can rotate with the rotating unit 3. The spraying unit 2 includes a movable spray pipe 21, a rotating nozzle 22, and a slide rail 23. One end of the movable spray pipe 21 is connected to the slide rail 23 and can move up and down along the slide rail 23, and the other end is connected to the rotating nozzle 22. The rotating nozzle 22 adjusts its spray angle at different positions as the movable spray pipe 21 moves up and down along the slide rail 23. The nozzle is always aligned with the hawthorn pill 6; the cooling unit 4 is connected to the image acquisition unit 1, and dries the coating liquid sprayed by the spraying unit by blowing cold air onto the hawthorn pill 6. The air outlet speed and cooling temperature are adjusted according to the signal corresponding to the image analysis result transmitted by the image acquisition unit 1; the image acquisition unit 1 acquires the image of the coating liquid after the hawthorn pill 6 passes through the cooling unit 4, and sends a signal to reduce the air outlet speed when the coating liquid wrinkles, and sends a signal to reduce the cooling temperature when the coating liquid condenses and slides down; the image acquisition unit 1, the spraying unit 2, the rotating unit 3 and the cooling unit 4 are all mounted on the base 5.

[0061] It is understandable that for those skilled in the art, the rotating nozzle 22 adjusting its own spray angle at different positions as the moving nozzle 21 moves up and down on the slide rail 23 to keep the nozzle always aligned with the hawthorn pill 6 is existing technology and will not be described in detail here.

[0062] The technical solution of the present invention has been described above with reference to the preferred embodiments shown in the accompanying drawings. However, it will be readily understood by those skilled in the art that the scope of protection of the present invention is obviously not limited to these specific embodiments. Without departing from the principles of the present invention, those skilled in the art can make equivalent changes or substitutions to the relevant technical features, and the technical solutions after these changes or substitutions will all fall within the scope of protection of the present invention.

Claims

1. A method for preparing hawthorn pills for digestive system diseases, characterized in that, include: Fruit characterization values ​​were generated based on the transverse diameter, longitudinal diameter, and firmness of hawthorn fruits to classify the pretreatment methods of hawthorn fruits. Solvent extraction was performed on the pretreated hawthorn fruits to separate them, and the concentrations of organic acids and flavonoids in the ethyl acetate eluent were collected to generate elution characterization values ​​to determine whether the pepsin activation rate was qualified. If the pepsin activation rate is qualified, hawthorn pills are prepared. If the pepsin activation rate is unqualified, the pretreatment method of hawthorn fruit is adjusted based on the comparison between the elution characterization value and the preset elution characterization value and the preset difference. The distilled water eluent was concentrated under reduced pressure and a binder was added and stirred evenly to prepare a coating solution. A filler was added to the concentrated ethyl acetate eluent to prepare a hawthorn pill core. The coating solution was sprayed onto the surface of the hawthorn pill core to form a coating and obtain a shaped hawthorn pill. The weight of several hawthorn pills and their dissolution time in simulated gastric juice at a preset temperature are collected. Based on the weight and dissolution time, a texture characterization value is generated to determine the coating thickness. Based on the determination of the coating thickness, the amount of binder in the distilled water eluent or the concentration of ethyl acetate in the ethyl acetate eluent is adjusted.

2. The method for preparing hawthorn pills for digestive system diseases according to claim 1, characterized in that, The process of generating fruit characterization values ​​based on the transverse diameter, longitudinal diameter, and firmness of hawthorn fruits includes, The ratio of the longitudinal diameter to the transverse diameter is calculated as the fruit index; The ratio of the hardness to the standard hardness is determined as the hardness factor; The weighted sum of the fruit index and the firmness factor is determined to be the fruit characterization value.

3. The method for preparing hawthorn pills for digestive system diseases according to claim 2, characterized in that, Pretreatment methods for hawthorn fruits were categorized based on their characteristic values. If the fruit characterization value is less than the preset fruit characterization value, then the pretreatment method of the hawthorn fruit is determined to be the first crushing method. If the fruit characterization value is greater than or equal to the preset fruit characterization value, then the pretreatment method of the hawthorn fruit is determined to be the second crushing method.

4. The method for preparing hawthorn pills for digestive system diseases according to claim 3, characterized in that, The process of collecting the concentrations of organic acids and flavonoids in the ethyl acetate eluent to generate elution characterization values ​​includes the following steps: The ratio of the concentration of the organic acid to the concentration of the elution standard organic acid is determined as the elution organic acid factor; The ratio of the flavonoid concentration to the elution standard flavonoid concentration is determined as the elution flavonoid factor; The weighted sum of the eluted organic acid factor and the eluted flavonoid factor was determined to be the elution characterization value.

5. The method for preparing hawthorn pills for digestive system diseases according to claim 4, characterized in that, The pepsin activation rate was determined to be acceptable based on the elution characterization values. If the elution characterization value is greater than or equal to the preset elution characterization value, the pepsin activation rate is deemed qualified. If the elution characterization value is less than the preset elution characterization value, the pepsin activation rate is deemed unqualified.

6. The method for preparing hawthorn pills for digestive system diseases according to claim 5, characterized in that, The pretreatment method for hawthorn fruit was determined based on the difference between the elution characterization value and the preset elution characterization value. In response to the difference being greater than or equal to a preset difference, if the pretreatment method of the hawthorn fruit is the first crushing method, it is determined that the pretreatment method should be adjusted to perform the first crushing method first and then the second crushing method; if the pretreatment method of the hawthorn fruit is the second crushing method, it is determined that the pretreatment method should be adjusted to perform the second crushing method twice. In response to the difference being less than the preset difference, if the pretreatment method of the hawthorn fruit is the first crushing method, then it is determined that the pretreatment method should be adjusted to the second crushing method; if the pretreatment method of the hawthorn fruit is the second crushing method, then it is determined that the pretreatment method should be adjusted to perform the first crushing method first and then the second crushing method.

7. The method for preparing hawthorn pills for digestive system diseases according to claim 6, characterized in that, The process of generating texture characterization values ​​based on the weight and the dissolution time includes, The ratio of the average weight of several hawthorn pills to the standard weight is determined as the weight factor; The ratio of the mean dissolution time of several hawthorn pills to the standard dissolution time is determined as the dissolution factor; The weighted sum of the weight factor and the solubility factor is determined to be the texture characterization value.

8. The method for preparing hawthorn pills for digestive system diseases according to claim 7, characterized in that, The thickness of the coating layer is determined based on texture characterization values, among which, If the texture characterization value is less than the first preset texture characterization value, the coating thickness is determined to be too thin. If the texture characterization value is greater than the first preset texture characterization value and less than or equal to the second preset texture characterization value, then the coating thickness is determined to be normal. If the texture characterization value is greater than the second preset texture characterization value, the coating thickness is determined to be too thick.

9. The method for preparing hawthorn pills for digestive system diseases according to claim 8, characterized in that, The process of adjusting the amount of binder in the distilled water eluent or adjusting the ethyl acetate concentration in the ethyl acetate eluent based on the determination of layer thickness includes, If the coating thickness is determined to be too thin, the amount of binder in the distilled water eluent is adjusted based on the difference between the texture characterization value and the first preset texture characterization value. If the coating thickness is determined to be too thick, the ethyl acetate concentration of the ethyl acetate eluent is adjusted based on the difference between the second preset texture characterization value and the texture characterization value.

10. An apparatus for preparing hawthorn pills for digestive system diseases, comprising the method for preparing hawthorn pills for digestive system diseases as described in any one of claims 1-9, characterized in that, include, A pretreatment facility used to pretreat hawthorn fruits; The extraction and separation unit is used to perform solvent extraction and separation on the pretreated hawthorn fruits; The preparation mechanism, in response to the qualified pepsin activation rate, concentrates the distilled water eluent under reduced pressure and adds a binder and stirs evenly to prepare a coating solution, and adds a filler to the concentrated ethyl acetate eluent to prepare hawthorn pill cores. The spraying mechanism is used to evenly spray the coating liquid onto the outer surface of the hawthorn pill core to form hawthorn pills; An analytical unit, which is connected to the hawthorn dividing unit and the solvent analysis unit respectively, is used to determine whether the pepsin activation rate is qualified based on the concentration of organic acid and flavonoid in the ethyl acetate eluent, and to adjust the pretreatment method of hawthorn fruit under the condition that the pepsin activation rate is not qualified, and to determine the coating thickness based on the weight and dissolution time of hawthorn pills. An adjustment mechanism, which is connected to the extraction and separation mechanism, the preparation mechanism, and the analysis mechanism respectively, is used to adjust the amount of binder in the distilled water eluent or the ethyl acetate concentration in the ethyl acetate eluent based on the determination result of the coating thickness.

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