A preparation method and application of Jiawei Kaixin San capsules

Abstract

This application discloses a preparation method and application of Jiawei Kaixin San capsules, relating to the field of traditional Chinese medicine preparation technology, including the following steps: 1. Material selection: Select 12-15 parts by weight of ginseng, 12-15 parts by weight of Polygala tenuifolia, 26-29 parts by weight of Poria cocos, 12-15 parts by weight of Acorus tatarinowii, 12-15 parts by weight of Platycladus orientalis seed, and 12-15 parts by weight of Ziziphus jujuba seed; 2. Processing; 3. Sterilization; 4. Drying; 5. Processing: Mix the dried materials and pulverize them at low temperature, controlling the temperature at 2-8℃. After sieving, add 0.5-2% by weight of silica, and after thorough mixing, fill into capsules to obtain the finished Jiawei Kaixin San capsules. This application uses polyacrylic acid and silica composite to enhance the surface negative charge structure of the silica composite material. Polyacrylic acid promotes the disintegration of the silica composite material during expansion, thereby enabling the preparation to be rapid, stable, and effective, achieving accurate dosage while avoiding irritation to the mouth and throat during medication.

Description

Technical Field

[0001] This application relates to the field of traditional Chinese medicine preparation technology, and in particular to a preparation method and application of Jiawei Kaixin San capsules. Background Technology

[0002] Kaixin San, originating from Sun Simiao's *Essential Prescriptions Worth a Thousand Pieces of Gold* from the Tang Dynasty, is a representative formula for invigorating qi, nourishing the heart, calming the mind, and stabilizing the will. It is primarily used to treat symptoms such as insufficient heart qi, restlessness, forgetfulness, insomnia, and palpitations. Modern clinical studies indicate that while Kaixin San treats Alzheimer's disease and depression, it is accompanied by side effects such as abdominal distension and constipation. Numerous studies on Kaixin San have been conducted by physicians throughout history, resulting in various modifications. Jiawei Kaixin San, from Wang Ang's *Collection of Medical Prescriptions* from the Qing Dynasty, adds two herbs, cypress seed and jujube seed, to the basic formula to enhance its laxative and calming effects, aiming to eliminate the constipation side effect of Kaixin San.

[0003] In existing techniques, Kaixin San and its modified formulas are generally prepared into powders and pills for oral administration. Because the formula contains Polygala tenuifolia and Acorus tatarinowii, the preparation of powders and pills can irritate the mouth and throat during administration, leading to discomfort. Clinical feedback indicates that raw Polygala tenuifolia, Poria cocos, ginseng, and Acorus tatarinowii have caused constipation as a side effect. Furthermore, the powders are not water-soluble, making them difficult to finish. Additionally, the poor stability of powders and pills affects the efficacy of modified Kaixin San and requires further improvement. Summary of the Invention

[0004] In view of this, the first objective of this application is to provide a method for preparing Jiawei Kaixin San capsules, so as to achieve the purpose of avoiding irritation to the mouth and throat during medication, and ensuring accurate dosage and stable formulation. The specific method is as follows:

[0005] A method for preparing Jiawei Kaixin San capsules includes the following steps:

[0006] Step 1, Material Selection: Select 12-15 parts ginseng, 12-15 parts polygala, 26-29 parts poria, 12-15 parts acorus, 12-15 parts arborvitae seed, and 12-15 parts jujube seed by weight.

[0007] Step 2, Processing: Clean, wash and soften the ginseng, polygala, and acorus tatarinowii in sequence, slice them and set them aside. Clean and prepare the poria cocos, arborvitae seed, and jujube seed and set them aside as well.

[0008] Step 3, Sterilization: Ginseng, Polygala tenuifolia, and Poria cocos are sterilized by high-pressure steam at 115℃ for 15 minutes, and Acorus tatarinowii, Platycladus orientalis seed, and Ziziphus jujuba seed are sterilized by high-pressure steam at 105℃ for 8 minutes to obtain sterilized materials;

[0009] Step 4, Drying: Place the ginseng, polygala, and poria cocos in the sterilized material at 100℃ and dry until the moisture content is <8%. Place the acorus tatarinowii, cypress seed, and jujube seed in the sterilized material at 50℃ and dry until the moisture content is <8%. Obtain the dried material.

[0010] Step 5, Processing: Mix the dried materials and pulverize them at a low temperature, controlling the temperature to be 2-8℃. After sieving, add 0.5-2% silicon dioxide by mass percentage, mix thoroughly, and then fill into capsules to obtain the finished product, Jiawei Kaixin San capsules.

[0011] Preferably, in step 3, the pressure of the high-pressure steam sterilization is 2-10 atmospheres.

[0012] Preferably, in step 5, the silica is a silica composite material, which is obtained by modifying silica with polyacrylic acid composite.

[0013] Preferably, the preparation method of the silica composite material includes step ① preparing fumed silica, polyacrylic acid and butyl acrylate in appropriate weight parts; step ② mixing and stirring the fumed silica and butyl acrylate, and then performing melt or radiation graft polymerization to obtain a silica-grafted polybutyl acrylate semi-composite material; step ③ covering the surface of the silica-grafted polybutyl acrylate semi-composite material with polyacrylic acid to obtain a SiO2@PAA-PBA composite material.

[0014] Preferably, the mass ratio of fumed silica, polyacrylic acid and butyl acrylate is 1:0.05-0.15:0.01-0.1.

[0015] Preferably, in step ③, polyacrylic acid is coated onto the surface of the silica-grafted polybutyl acrylate semi-composite material by melt blending, surface deposition, or chemical grafting.

[0016] Preferably, the melt blending is achieved by mixing and melting a silica-grafted polybutyl acrylate semi-composite material with polyacrylic acid, followed by cooling and solidification.

[0017] Preferably, the surface deposition is achieved by dispersing a silica-grafted polybutyl acrylate semi-composite material in a polyacrylic acid solution, followed by high-temperature evaporation to allow the polyacrylic acid to cover the surface of the silica-grafted polybutyl acrylate semi-composite material.

[0018] Preferably, it also includes step 6, which is to package the finished Jiawei Kaixin San capsules and store them in a warehouse.

[0019] The second objective of this invention is to provide an application of Jiawei Kaixin San capsules, including the Jiawei Kaixin San capsules prepared by the preparation method described above, and their application in the treatment of Alzheimer's disease and amnesia.

[0020] As can be seen from the above scheme, this application provides a method for preparing Jiawei Kaixin San capsules and its application. The method for preparing Jiawei Kaixin San capsules has the following beneficial effects:

[0021] 1. By adding cypress seed and jujube seed, the effects of moisturizing the intestines, relieving constipation, and calming the nerves are enhanced, and the constipation caused by Kaixin San is effectively relieved.

[0022] 2. The silica composite material promotes the disintegration of the finished Jiawei Kaixin San capsules in the body, thereby exerting a full therapeutic effect;

[0023] 3. By using silica composite material to accumulate negative charges on the surface of silica, it can be uniformly mixed with dry materials in a dry state. When the outer capsule of the prepared Jiawei Kaixin San capsule breaks and comes into contact with the body water, the fatty acid carboxyl groups rich in cypress seed and jujube seed adsorb each other and form vesicle structures, thereby achieving the effect of rapid disintegration of the Jiawei Kaixin San capsule.

[0024] 4. By using polyacrylic acid and silica composite, the surface negative charge structure of silica composite material is significantly improved. At the same time, the water absorption property of polyacrylic acid promotes the disintegration of the added flavor Kaixin San capsule during the expansion process of silica composite material, so as to make the preparation fast and stable and achieve the effect of accurate dosage while avoiding irritation to the mouth and throat during the medication process.

[0025] 5. By combining the negatively charged surface structures of polyacrylic acid and silica, and promoting the synergistic effect between polyacrylic acid and silica, tests showed that under the combined action of polyacrylic acid and silica, it promotes the rapid disintegration of the Jiawei Kaixin San capsules after ingestion as the capsules melt and break, thereby achieving timely and effective therapeutic effects, and further achieving accurate dosage and stable formulation.

[0026] 6. By combining edible-grade polyacrylic acid with silicon dioxide, the efficacy of the Jiawei Kaixin San capsules can be enhanced while avoiding harm to the human body. Attached Figure Description

[0027] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of this application. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0028] Figure 1 This is a flowchart of the preparation method of Jiawei Kaixin San capsules disclosed in this application. Detailed Implementation

[0029] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0030] It should be mentioned that the graft polymerization by melt or radiation in the embodiments of this application is a conventional method and will not be described in detail here.

[0031] The preparation method of the Jiawei Kaixin San capsules of this application will be described in detail below.

[0032] A method for preparing Jiawei Kaixin San capsules includes the following steps:

[0033] Step 1, Material Selection: Select 12-15 parts ginseng, 12-15 parts polygala, 26-29 parts poria, 12-15 parts acorus, 12-15 parts arborvitae seed, and 12-15 parts jujube seed by weight.

[0034] Step 2, Processing: Clean, wash and soften the ginseng, polygala, and acorus tatarinowii in sequence, slice them and set them aside. Clean and prepare the poria cocos, arborvitae seed, and jujube seed and set them aside as well.

[0035] Step 3, Sterilization: Ginseng, Polygala tenuifolia, and Poria cocos are sterilized by high-pressure steam at 115℃ for 15 minutes, and Acorus tatarinowii, Platycladus orientalis seed, and Ziziphus jujuba seed are sterilized by high-pressure steam at 105℃ for 8 minutes. The pressure of high-pressure steam sterilization is controlled at 2-10 atmospheres to obtain sterilized materials.

[0036] Step 4, Drying: Place the ginseng, polygala, and poria cocos in the sterilized material at 100℃ and dry until the moisture content is <8%. Place the acorus tatarinowii, cypress seed, and jujube seed in the sterilized material at 50℃ and dry until the moisture content is <8%. Obtain the dried material.

[0037] Step 5, Processing: Mix the dried materials and pulverize them at a low temperature, controlling the temperature to be 2-8℃. After sieving, add 0.5-2% silicon dioxide by mass percentage, mix thoroughly, and then fill into capsules to obtain the finished product, Jiawei Kaixin San capsules.

[0038] Step 6, Storage: Package the finished Jiawei Kaixin San capsules and store them in the warehouse.

[0039] It should be mentioned that in step 5 of this application, the low-temperature pulverization is performed multiple times, each time for 10-20 minutes, until complete pulverization is achieved after repeated pulverization. Then, the mixture is sieved to achieve a sieve pass rate of over 90% on a No. 6 sieve. Finally, it is mixed with silica in a mixer at 500 rpm for 30 minutes. The silica is a silica composite material, specifically obtained by modifying silica with polyacrylic acid composite.

[0040] The preparation method of the silica composite material includes the following steps: Step ① Prepare fumed silica, polyacrylic acid and butyl acrylate in a mass ratio of 1:0.05-0.15:0.01-0.1; Step ② Mix and stir the fumed silica and butyl acrylate, and then perform melt or radiation-based graft polymerization to obtain a silica-grafted polybutyl acrylate semi-composite material; Step ③ Apply polyacrylic acid to the surface of the silica-grafted polybutyl acrylate semi-composite material by melt blending, surface deposition or chemical grafting to obtain the SiO2@PAA-PBA composite material.

[0041] Melt blending, surface deposition, and chemical grafting are all conventional techniques and will not be elaborated upon here. Based on the preparation of the silica composite material in the embodiments of this application, melt blending involves mixing and melting a silica-grafted polybutyl acrylate semi-composite material with polyacrylic acid, followed by cooling and solidification. Surface deposition involves dispersing the silica-grafted polybutyl acrylate semi-composite material in a polyacrylic acid solution, followed by high-temperature evaporation to coat the surface of the silica-grafted polybutyl acrylate semi-composite material with polyacrylic acid.

[0042] An application of Jiawei Kaixin San capsules includes preparing Jiawei Kaixin San capsules using the preparation method described above, and applying them to the treatment of Alzheimer's disease and amnesia symptoms.

[0043] Example 1

[0044] A method for preparing Jiawei Kaixin San capsules includes the following steps:

[0045] Step 1, Material Selection: Select 12 parts ginseng, 12 parts polygala, 26 parts poria, 12 parts acorus, 12 parts arborvitae seed, and 12 parts jujube seed by weight.

[0046] Step 2, Processing: Clean, wash and soften the ginseng, polygala, and acorus tatarinowii in sequence, slice them and set them aside. Clean and prepare the poria cocos, arborvitae seed, and jujube seed and set them aside as well.

[0047] Step 3, Sterilization: Ginseng, Polygala tenuifolia, and Poria cocos are sterilized by high-pressure steam at 115℃ for 15 minutes, and Acorus tatarinowii, Platycladus orientalis seed, and Ziziphus jujuba seed are sterilized by high-pressure steam at 105℃ for 8 minutes. The pressure of high-pressure steam sterilization is controlled at 2 atmospheres to obtain sterilized materials.

[0048] Step 4, Drying: Place the ginseng, polygala, and poria cocos in the sterilized material at 100℃ and dry until the moisture content is <8%. Place the acorus tatarinowii, cypress seed, and jujube seed in the sterilized material at 50℃ and dry until the moisture content is <8%. Obtain the dried material.

[0049] Step 5, Processing: Mix the dried materials and pulverize them at a low temperature of 2°C. After sieving, add 0.5% silica by mass and mix thoroughly before filling into capsules to obtain the finished product, Jiawei Kaixin San capsules.

[0050] Step 6, Storage: Package the finished Jiawei Kaixin San capsules and store them in the warehouse.

[0051] It should be mentioned that in step 5 of this application, the silica is a silica composite material. Furthermore, the silica composite material is obtained by modifying silica with polyacrylic acid.

[0052] The preparation method of the silica composite material includes the following steps: Step ① Prepare fumed silica, polyacrylic acid, and butyl acrylate in a mass ratio of 1:0.05:0.01; Step ② Mix and stir the fumed silica and butyl acrylate, and then perform melt graft polymerization to obtain a silica-grafted polybutyl acrylate semi-composite material; Step ③ Apply polyacrylic acid to the surface of the silica-grafted polybutyl acrylate semi-composite material through melt blending to obtain the SiO2@PAA-PBA composite material. Furthermore, the silica-grafted polybutyl acrylate semi-composite material is mixed and melted with polyacrylic acid during melt blending, and then cooled and solidified to obtain the final product.

[0053] An application of Jiawei Kaixin San capsules includes preparing Jiawei Kaixin San capsules using the preparation method described above, and applying them to the treatment of Alzheimer's disease and amnesia symptoms.

[0054] Example 2

[0055] A method for preparing Jiawei Kaixin San capsules includes the following steps:

[0056] Step 1, Material Selection: Select 13.8 parts ginseng, 13.8 parts polygala, 27.6 parts poria, 13.8 parts acorus, 13.8 parts arborvitae seed and 13.8 parts jujube seed by weight;

[0057] Step 2, Processing: Clean, wash and soften the ginseng, polygala, and acorus tatarinowii in sequence, slice them and set them aside. Clean and prepare the poria cocos, arborvitae seed, and jujube seed and set them aside as well.

[0058] Step 3, Sterilization: Ginseng, Polygala tenuifolia, and Poria cocos are sterilized by high-pressure steam at 115℃ for 15 minutes, and Acorus tatarinowii, Platycladus orientalis seed, and Ziziphus jujuba seed are sterilized by high-pressure steam at 105℃ for 8 minutes. The pressure of high-pressure steam sterilization is controlled at 5 atmospheres to obtain sterilized materials.

[0059] Step 4, Drying: Place the ginseng, polygala, and poria cocos in the sterilized material at 100℃ and dry until the moisture content is <8%. Place the acorus tatarinowii, cypress seed, and jujube seed in the sterilized material at 50℃ and dry until the moisture content is <8%. Obtain the dried material.

[0060] Step 5, Processing: Mix the dried materials and pulverize them at a low temperature of 5°C. After sieving, add 1% silica by mass and mix thoroughly. Then, fill the mixture into capsules to obtain the finished product, Jiawei Kaixin San capsules.

[0061] Step 6, Storage: Package the finished Jiawei Kaixin San capsules and store them in the warehouse.

[0062] It should be mentioned that in step 5 of this application, the silica is a silica composite material. Furthermore, the silica composite material is obtained by modifying silica with polyacrylic acid.

[0063] The preparation method of the silica composite material includes the following steps: Step ① Prepare fumed silica, polyacrylic acid, and butyl acrylate in a mass ratio of 1:0.1:0.05; Step ② Mix and stir the fumed silica and butyl acrylate, and then perform melt graft polymerization to obtain a silica-grafted polybutyl acrylate semi-composite material; Step ③ Apply polyacrylic acid to the surface of the silica-grafted polybutyl acrylate semi-composite material through melt blending to obtain the SiO2@PAA-PBA composite material. Furthermore, the silica-grafted polybutyl acrylate semi-composite material is mixed and melted with polyacrylic acid during melt blending, and then cooled and solidified to obtain the final product.

[0064] An application of Jiawei Kaixin San capsules includes preparing Jiawei Kaixin San capsules using the preparation method described above, and applying them to the treatment of Alzheimer's disease and amnesia symptoms.

[0065] Example 3

[0066] A method for preparing Jiawei Kaixin San capsules includes the following steps:

[0067] Step 1, Material Selection: Select 15 parts ginseng, 15 parts polygala, 29 parts poria, 15 parts acorus, 15 parts arborvitae seed, and 15 parts jujube seed by weight.

[0068] Step 2, Processing: Clean, wash and soften the ginseng, polygala, and acorus tatarinowii in sequence, slice them and set them aside. Clean and prepare the poria cocos, arborvitae seed, and jujube seed and set them aside as well.

[0069] Step 3, Sterilization: Ginseng, Polygala tenuifolia, and Poria cocos are sterilized by high-pressure steam at 115℃ for 15 minutes, and Acorus tatarinowii, Platycladus orientalis seed, and Ziziphus jujuba seed are sterilized by high-pressure steam at 105℃ for 8 minutes. The pressure of high-pressure steam sterilization is controlled at 10 atmospheres to obtain sterilized materials.

[0070] Step 4, Drying: Place the ginseng, polygala, and poria cocos in the sterilized material at 100℃ and dry until the moisture content is <8%. Place the acorus tatarinowii, cypress seed, and jujube seed in the sterilized material at 50℃ and dry until the moisture content is <8%. Obtain the dried material.

[0071] Step 5, Processing: Mix the dried materials and pulverize them at a low temperature of 8°C. After sieving, add 2% silica by mass and mix thoroughly before filling into capsules to obtain the finished product, Jiawei Kaixin San capsules.

[0072] Step 6, Storage: Package the finished Jiawei Kaixin San capsules and store them in the warehouse.

[0073] It should be mentioned that in step 5 of this application, the silica is a silica composite material. Furthermore, the silica composite material is obtained by modifying silica with polyacrylic acid.

[0074] The preparation method of the silica composite material includes the following steps: Step ① Prepare fumed silica, polyacrylic acid, and butyl acrylate in a mass ratio of 1:0.15:0.1; Step ② Mix and stir the fumed silica and butyl acrylate, and then perform radiation-based graft polymerization to obtain a silica-grafted polybutyl acrylate semi-composite material; Step ③ Deposit polyacrylic acid onto the surface of the silica-grafted polybutyl acrylate semi-composite material to obtain the SiO2@PAA-PBA composite material. During surface deposition, the silica-grafted polybutyl acrylate semi-composite material is dispersed in a polyacrylic acid solution, and after high-temperature evaporation, the polyacrylic acid covers the surface of the silica-grafted polybutyl acrylate semi-composite material.

[0075] An application of Jiawei Kaixin San capsules includes preparing Jiawei Kaixin San capsules using the preparation method described above, and applying them to the treatment of Alzheimer's disease and amnesia symptoms.

[0076] Comparative Example 1

[0077] The difference between Comparative Example 1 and Example 2 is that the silicon dioxide used in Comparative Example 1 is fumed silicon dioxide.

[0078] Comparative Example 2

[0079] The difference between Comparative Example 2 and Example 2 is that no cypress seed kernel was added in Comparative Example 2.

[0080] Comparative Example 3

[0081] The difference between Comparative Example 3 and Example 2 is that no jujube seed was added in Comparative Example 3.

[0082] Performance testing:

[0083] The test was conducted using artificial gastric fluid.

[0084] The Jiawei Kaixin San capsules prepared by the corresponding preparation methods in Examples 1 to 3 and Comparative Examples 1 to 3 of this application were added to artificial gastric fluid at controlled concentrations of 50 mg, 100 mg, and 150 mg to determine whether the corresponding Jiawei Kaixin San capsules completely disintegrated within 60 minutes; and to determine the degree of disintegration and disintegration time of the corresponding Jiawei Kaixin San capsules at 15 minutes. The performance tests are shown in Table 1 below.

[0085]

[0086] As shown in Table 1 above, the addition of Platycladus orientalis seed and Ziziphus jujuba seed in this embodiment of the application will enhance the effects of bowel movement and calming the nerves, thereby eliminating the side effects of constipation caused by Kaixin San. Simultaneously, it has a synergistic effect with the added silica composite material, thereby promoting drug disintegration. Meanwhile, based on Comparative Example 1 and Example 2, it can be seen that the silica composite material obtained by modifying silica with polyacrylic acid in this embodiment of the application has a synergistic effect with the water absorption and swelling effect of polyacrylic acid. It will also synergize with the hydrophilic effect of chitosan, utilizing its negative surface charge to adsorb the fatty acid carboxyl groups abundant in Platycladus orientalis seed and form vesicle structures. This vesicle structure further promotes drug disintegration, thereby shortening the disintegration time and increasing the degree of disintegration per unit time. This solves the problem that the long disintegration time of existing materials makes it difficult for the standard dosage to exert its therapeutic effect efficiently. Furthermore, by encapsulating each component in capsule form, and then rapidly combining the capsule breakage and drug disintegration after the components enter the body, the drug significantly improves its efficacy while addressing issues such as poor taste, throat irritation, and poor patient compliance caused by large dosages.

[0087] In summary, this application provides a method for preparing and applying Jiawei Kaixin San capsules. This method enhances the laxative and calming effects of adding cypress seed and jujube seed, effectively relieving constipation. Simultaneously, to ensure rapid disintegration of the Jiawei Kaixin San capsules during application and maximize their therapeutic effect, a silica composite material is used to promote the disintegration of the finished capsules in vivo, thereby maximizing their therapeutic effect. The silica composite material has a negatively charged surface, allowing for uniform mixing with dry materials in a dry state. When the outer capsule of the prepared Jiawei Kaixin San capsule breaks open and comes into contact with body moisture, the fatty acid carboxyl groups abundant in the cypress seed and jujube seed mutually adsorb and form vesicle structures, thus achieving rapid disintegration of the Jiawei Kaixin San capsules. This invention utilizes a composite of polyacrylic acid and silica to significantly enhance the negatively charged surface structure of the silica composite material. Simultaneously, the water-absorbing properties of polyacrylic acid promote the disintegration of the Jiawei Kaixin San capsules during the expansion process, thereby accelerating the formulation's rapid and stable efficacy. This achieves accurate dosage while avoiding irritation to the mouth and throat during administration. To ensure the silica composite material significantly promotes the disintegration of the Jiawei Kaixin San capsules, this application combines the negatively charged surface structures of polyacrylic acid and silica with a synergistic effect between them. Tests revealed that the combined action of polyacrylic acid and silica promotes the rapid disintegration of the Jiawei Kaixin San capsules after ingestion, resulting in timely and effective therapeutic effects, accurate dosage, and stable formulation. Furthermore, to ensure food safety, edible-grade polyacrylic acid is combined with silica, thereby enhancing the efficacy of the Jiawei Kaixin San capsules while avoiding harm to the human body.

[0088] The terms “first,” “second,” “third,” “fourth,” etc., used in this application (if applicable) are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms “comprising” and “having,” and any variations thereof, are intended to cover non-exclusive inclusion; for example, a process, method, or apparatus that includes a series of steps or units is not necessarily limited to those explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, or apparatus.

[0089] It should be noted that the use of terms such as "first" and "second" in this application is for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of those features. Furthermore, the technical solutions of the various embodiments can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. If the combination of technical solutions is contradictory or impossible to implement, such a combination of technical solutions should be considered non-existent and not within the scope of protection claimed in this application.

[0090] This document uses specific examples to illustrate the principles and implementation methods of this application. The descriptions of the above embodiments are only for the purpose of helping to understand the methods and core ideas of this application. At the same time, for those skilled in the art, there will be changes in the specific implementation methods and application scope based on the ideas of this application. Therefore, the content of this specification should not be construed as a limitation of this application.

Claims

1. A method for preparing a modified Kaixin San capsule, characterized in that, Includes the following steps: Step 1, Material Selection: Select 12-15 parts ginseng, 12-15 parts polygala, 26-29 parts poria, 12-15 parts acorus, 12-15 parts arborvitae seed, and 12-15 parts jujube seed by weight. Step 2, Processing: Clean, wash and soften the ginseng, polygala, and acorus tatarinowii in sequence, slice them and set them aside. Clean and prepare the poria cocos, arborvitae seed, and jujube seed and set them aside as well. Step 3, Sterilization: Ginseng, Polygala tenuifolia, and Poria cocos are sterilized by high-pressure steam at 115℃ for 15 minutes, and Acorus tatarinowii, Platycladus orientalis seed, and Ziziphus jujuba seed are sterilized by high-pressure steam at 105℃ for 8 minutes to obtain sterilized materials; Step 4, Drying: Place the ginseng, polygala, and poria cocos in the sterilized material at 100℃ and dry until the moisture content is <8%. Place the acorus tatarinowii, cypress seed, and jujube seed in the sterilized material at 50℃ and dry until the moisture content is <8%. Obtain the dried material. Step 5, Processing: Mix the dried materials and pulverize them at a low temperature, controlling the temperature to be 2-8℃. After sieving, add 0.5-2% silicon dioxide by mass percentage, mix thoroughly, and then fill into capsules to obtain the finished product, Jiawei Kaixin San capsules. In step 5, the silica is a silica composite material, which is obtained by modifying silica with polyacrylic acid. The preparation method of the silica composite material includes step ① preparing fumed silica, polyacrylic acid and butyl acrylate in a mass ratio of 1:0.05-0.15:0.01-0.1; step ② mixing and stirring the fumed silica and butyl acrylate, and then performing melt or radiation graft polymerization to obtain a silica-grafted polybutyl acrylate semi-composite material; step ③ covering the surface of the silica-grafted polybutyl acrylate semi-composite material with polyacrylic acid to obtain the SiO2@PAA-PBA composite material.

2. The preparation method of the Jiawei Kaixin San capsule according to claim 1, characterized in that: In step 3, the pressure of the high-pressure steam sterilization is 2-10 atmospheres.

3. The preparation method of the Jiawei Kaixin San capsule according to claim 1, characterized in that: In step ③, polyacrylic acid is coated onto the surface of the silica-grafted polybutyl acrylate semi-composite material by melt blending, surface deposition, or chemical grafting.

4. The preparation method of the Jiawei Kaixin San capsule according to claim 3, characterized in that: The melt blending is achieved by mixing and melting a silica-grafted polybutyl acrylate semi-composite material with polyacrylic acid, followed by cooling and solidification.

5. The preparation method of the Jiawei Kaixin San capsule according to claim 3, characterized in that: The surface deposition is achieved by dispersing a silica-grafted polybutyl acrylate semi-composite material in a polyacrylic acid solution, followed by high-temperature evaporation to allow the polyacrylic acid to cover the surface of the silica-grafted polybutyl acrylate semi-composite material.

6. The preparation method of the Jiawei Kaixin San capsule according to claim 1, characterized in that: It also includes step 6, which involves packaging the finished Jiawei Kaixin San capsules and storing them in a warehouse.

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