Preparation method and application of modified Kaixin powder capsule

By preparing Jiawei Kaixinsan Capsules, the synergistic effect of silica composite material and polyacrylic acid is used to solve the problems of dosage form stability and stimulation of taking, rapid disintegration and accurate dosage are achieved, the effect of moistening the intestines and laxatives is enhanced, and the efficacy of treating Alzheimer's disease and amnesia is improved.

CN120267628AActive Publication Date: 2025-07-08HANGZHOU ZHENDIAN PHARM RES CO LTD
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Patent Information

Application Number
CN202510521929.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-04-24
Publication Date
2025-07-08
Estimated Expiration
2045-04-24

AI Technical Summary

Technical Problem

The existing dosage forms of Jiawei Kaixin San are prone to irritating the mouth and throat during the use, and have poor stability, resulting in constipation and difficulty in taking medicine.

Method used

Jiawei Kaixinsan capsules are prepared by high-pressure steam sterilization, drying and low-temperature crushing after adding silica composite materials. The negative charge of silica composite materials and the water absorption properties of polyacrylic acid are used to promote the rapid disintegration of the capsules in the body and achieve uniform mixing through the vesicle structure.

Benefits of technology

It achieves avoiding oral and throat irritation during the use, ensures accurate dosage, enhances the effect of intestinal moistening and laxative, and improves the stability and therapeutic effect of the preparation.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention discloses a preparation method and application of modified Kaixin powder capsules, and relates to the technical field of traditional Chinese medicine preparations, the preparation method comprises the following steps: 1, material selection: selecting 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 rhizoma acori graminei, 12-15 parts by weight of platycladi seeds and 12-15 parts by weight of spina date seeds; 2, processing; 3, sterilizing; 4, drying; and 5, processing: mixing the dried materials, performing low-temperature crushing, controlling the low temperature to be 2-8 DEG C, performing sieving, adding 0.5-2% by mass of silicon dioxide, performing uniform mixing, and performing sub-filling and capsule filling so as to obtain finished products of the flavored pistachio powder capsules. The polyacrylic acid and the silicon dioxide are compounded, the surface negative electricity structure of the silicon dioxide composite material is improved, the polyacrylic acid is used for promoting the silicon dioxide composite material to achieve the purpose of promoting disintegration during expansion, so that the preparation takes effect quickly and stably, and the effect that the oral cavity and the throat are prevented from being stimulated in the medicine taking process, and meanwhile the medicine taking amount is accurate is achieved.
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Description

Technical Field

[0001] The present application relates to the technical field of traditional Chinese medicine preparations, and in particular to a preparation method and application of flavored Kaixinsan capsules. Background Art

[0002] Kaixinsan comes from Sun Simiao's "Prescriptions for Emergencies" in the Tang Dynasty. It is a representative prescription for nourishing qi and nourishing the heart, calming the mind and settling the spirit. It is mainly used to treat symptoms such as insufficient heart qi, restlessness, forgetfulness and insomnia, and palpitations. Modern clinical studies have shown that Kaixinsan can treat Alzheimer's disease and depression, but it also has side effects such as abdominal distension and constipation. Doctors of all dynasties have conducted a lot of research on Kaixinsan, and each has its own unique modifications. Jiawei Kaixinsan comes from Wang Ang's "Medical Prescriptions" in the Qing Dynasty. It adds two herbs, cypress seeds and spiny jujube seeds, to the basic formula of Kaixinsan to enhance the effects of moistening the intestines and relieving constipation and calming the mind, in order to eliminate the side effect of Kaixinsan's constipation.

[0003] In the prior art, Kaixin Powder and its modified prescriptions are generally made into powders and pills for administration. Since the prescription contains two herbs, Polygala and Acorus calamus, the preparation of the powders and pills will irritate the mouth and throat during administration, causing discomfort. According to clinical feedback, Polygala (raw), Poria, Ginseng, and Acorus calamus have the side effect of causing constipation. In addition, the powder is not soluble in water during medication, which makes it difficult to take the whole medicine. At the same time, in view of the poor stability of the powders and pills, the efficacy of the modified Kaixin Powder is affected, which needs to be improved. Summary of the invention

[0004] In view of this, the first purpose of the present application is to provide a method for preparing a flavored Kaixinsan capsule, so as to achieve the purpose of preventing the oral cavity and throat from being irritated during the medication process, and ensuring accurate dosage and stable preparation. The specific scheme is as follows: A method for preparing flavored Kaixinsan capsules comprises the following steps: Step 1, material selection: select 12-15 parts of ginseng, 12-15 parts of polygala, 26-29 parts of tuckahoe, 12-15 parts of calamus, 12-15 parts of cypress seed and 12-15 parts of spiny jujube seed according to weight; Step 2, processing: clean, wash, soften, and slice ginseng, polygala and calamus in turn, and set aside; clean and set aside Poria, cypress seed and spiny jujube seed; Step 3, sterilization: sterilize ginseng, Polygala tenuifolia, and Poria cocos at 115° C. for 15 min, and sterilize Acorus calamus, Platycladus orientalis, and Semen Ziziphi spinosus at 105° C. for 8 min to obtain sterilized materials; Step 4, Drying: Place ginseng, polygala, and poria cocos in the sterilized material at a temperature of 100 °C and dry until the moisture content is <8%. Place acorus tatarinowii, semen platycladi, and semen ziziphi spinosae in the sterilized material at a temperature of 50 °C and dry until the moisture content is <8% to obtain the dried material; Step 5, Processing: Mix the dried materials and pulverize them at a low temperature. Control the low temperature at 2-8 °C. After sieving, add silicon dioxide at a mass percentage of 0.5-2%. After total mixing and uniform mixing, fill and encapsulate the capsules to obtain the finished Jiawei Kaixin San capsules.

[0005] Preferably: In Step 3, the pressure of the high-pressure steam sterilization is 2-10 atmospheres.

[0006] Preferably: In Step 5, the silicon dioxide is a silicon dioxide composite material, and the silicon dioxide composite material is obtained by compound modification of silicon dioxide with polyacrylic acid.

[0007] Preferably: The preparation method of the silicon dioxide composite material includes Step ① Prepare corresponding parts by weight of fumed silica, polypropylene, and butyl acrylate; Step ② Mix and stir fumed silica and butyl acrylate, and use melt or radiation graft polymerization to obtain a silicon dioxide grafted polybutyl acrylate semi-composite material; Step ③ Cover the surface of the silicon dioxide grafted polybutyl acrylate semi-composite material with polypropylene to obtain the SiO2@PP-PBA composite material.

[0008] Preferably: The mass ratio of the fumed silica, polypropylene, and butyl acrylate is 1:0.05-0.15:0.01-0.1.

[0009] Preferably: In Step ③, polypropylene is covered on the surface of the silicon dioxide grafted polybutyl acrylate semi-composite material by melt blending, surface deposition, or chemical grafting.

[0010] Preferably: The melt blending is obtained by mixing and melting the silicon dioxide grafted polybutyl acrylate semi-composite material and polypropylene, and then cooling and solidifying.

[0011] Preferably: The surface deposition is achieved by dispersing the silicon dioxide grafted polybutyl acrylate semi-composite material in a polypropylene solution, and after high-temperature evaporation, polypropylene covers the surface of the silicon dioxide grafted polybutyl acrylate semi-composite material.

[0012] Preferably: It further includes Step 6, and Step 6 is to package the finished Jiawei Kaixin San capsules and store them in the warehouse.

[0013] The second object of the present invention is to provide an application of the Jiawei Kaixin San capsules, including the Jiawei Kaixin San capsules prepared by the preparation method of the Jiawei Kaixin San capsules as described above, and applying them to the treatment of Alzheimer's disease and forgetfulness symptoms.

[0014] As can be seen from the above solution, the present application provides a preparation method and application of Jiawei Kaixin Powder capsules. The preparation method of the Jiawei Kaixin Powder capsules has the following beneficial effects: 1. By adding semen platycladi and semen ziziphi spinosae, the effects of moistening the intestines and relieving constipation and calming the mind are enhanced, and the phenomenon of constipation in Kaixin Powder is effectively alleviated; 2. The silica composite material is used to promote the disintegration of the finished Jiawei Kaixin Powder capsules in vivo, and then to exert a full therapeutic effect; 3. The silica composite material is used to cause negative charge accumulation on the surface of silica, so as to be uniformly mixed with dry materials in a dry state. When the outer capsule of the prepared Jiawei Kaixin Powder capsules is broken and contacts with the body moisture, the fatty acid carboxyl groups rich in semen platycladi and semen ziziphi spinosae are adsorbed to each other to form a vesicle structure, so as to achieve the effect of quickly disintegrating the Jiawei Kaixin Powder capsules; 4. By using polyacrylic acid and silica in combination, while significantly enhancing the surface negative charge structure of the silica composite material, the water absorption performance of polyacrylic acid is used to promote the expansion of the silica composite material, so as to achieve the purpose of promoting the disintegration of the Jiawei Kaixin Powder capsules, so that the preparation can achieve rapid and stable efficacy, and achieve the effect of accurate dosage while avoiding irritation to the oral cavity and throat during the medication process; 5. By combining the surface negative charge structures of polyacrylic acid and silica and promoting the synergistic effect between polyacrylic acid and silica, it is found through testing that under the combined action of polyacrylic acid and silica, it can promote the expansion and cracking, so as to promote the rapid disintegration of the Jiawei Kaixin Powder capsules after taking, so as to achieve timely and effective curative effects, and then achieve the effects of accurate dosage and stable preparation; 6. Combining edible polyacrylic acid and silica can improve the use effect of the Jiawei Kaixin Powder capsules while avoiding harm to the human body. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only the embodiments of the present application. For those of ordinary skill in the art, other drawings can be obtained according to the provided drawings without creative efforts.

[0016] Figure 1 It is a flowchart of the preparation method of the Jiawei Kaixin Powder capsules disclosed in the present application. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0017] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present application without creative efforts shall fall within the protection scope of the present application.

[0018] It should be noted that the graft polymerization by melting or radiation in the embodiments of the present application is a conventional means in the art and will not be elaborated here.

[0019] The preparation method of the Jiawei Kaixin San capsules of the present application will be specifically described below.

[0020] A preparation method of Jiawei Kaixin San capsules comprises the following steps: Step 1, material selection: Select 12 - 15 parts by weight of ginseng, 12 - 15 parts by weight of polygala root, 26 - 29 parts by weight of poria cocos, 12 - 15 parts by weight of acorus tatarinowii, 12 - 15 parts by weight of semen platycladi, and 12 - 15 parts by weight of semen ziziphi spinosae. Step 2, treatment: Successively clean, wash and soften, and slice ginseng, polygala root, and acorus tatarinowii for standby, and clean and reserve poria cocos, semen platycladi, and semen ziziphi spinosae. Step 3, sterilization: Sterilize ginseng, polygala root, and poria cocos at 115°C under high-pressure steam for 15 minutes, and sterilize acorus tatarinowii, semen platycladi, and semen ziziphi spinosae at 105°C under high-pressure steam for 8 minutes, controlling the pressure of high-pressure steam sterilization to be 2 - 10 atmospheres to obtain sterilized materials. Step 4, drying: Place ginseng, polygala root, and poria cocos in the sterilized materials at 100°C and dry until the moisture content is <8%, and place acorus tatarinowii, semen platycladi, and semen ziziphi spinosae in the sterilized materials at 50°C and dry until the moisture content is <8% to obtain dried materials. Step 5, processing: Mix the dried materials and pulverize them at a low temperature, controlling the low temperature to be 2 - 8°C. After sieving, add silicon dioxide at a mass percentage of 0.5 - 2%, and after total mixing and uniform mixing, pack and fill the capsules to obtain the finished Jiawei Kaixin San capsules.

[0021] Step 6, storage: Pack the finished Jiawei Kaixin San capsules and store them in the warehouse.

[0022] It should be noted that in step 5 of the present application, low-temperature pulverization is carried out multiple times, and each pulverization is for 10 - 20 minutes until it is completely pulverized after multiple repeated pulverizations. Then, after sieving treatment, the passing rate through a No. 6 sieve reaches more than 90%. Finally, it is mixed with silicon dioxide in a mixer at a rotation speed of 500 r / min for 30 minutes. The silicon dioxide is a silicon dioxide composite material. And the silicon dioxide composite material is obtained by compound modification of silicon dioxide with polyacrylic acid.

[0023] The preparation method of the silica composite material includes the following steps: ① preparing fumed silica, polypropylene and butyl acrylate according to a mass ratio of 1:0.05-0.15:0.01-0.1 for standby; ② mixing and stirring the fumed silica and butyl acrylate, and performing graft polymerization by melting or radiation to obtain a silica-grafted polybutyl acrylate semi-composite material; and ③ covering the surface of the silica-grafted polybutyl acrylate semi-composite material with polypropylene by melt blending, surface deposition or chemical grafting to obtain a SiO2@PP-PBA composite material.

[0024] Melt blending, surface deposition and chemical grafting are all conventional techniques and will not be described in detail here. Based on the preparation of the silica composite material in the embodiment of the present application, when melt blending is adopted, the silica grafted polybutyl acrylate semi-composite material is mixed and melted with polypropylene, and then cooled and solidified to obtain it. When surface deposition is adopted, the silica grafted polybutyl acrylate semi-composite material is dispersed in the polypropylene solution, and after high-temperature evaporation, the polypropylene is covered on the surface of the silica grafted polybutyl acrylate semi-composite material.

[0025] An application of a modified Kaixinsan capsule comprises the modified Kaixinsan capsule prepared by the method for preparing the modified Kaixinsan capsule as described above, and is applied to the treatment of Alzheimer's disease and amnesia symptoms.

[0026] Embodiment 1 A method for preparing flavored Kaixinsan capsules comprises the following steps: Step 1, material selection: select 12 parts of ginseng, 12 parts of polygala, 26 parts of tuckahoe, 12 parts of calamus, 12 parts of cypress seed and 12 parts of spiny jujube seed according to weight; Step 2, processing: clean, wash, soften, and slice ginseng, polygala and calamus in turn, and set aside; clean and set aside Poria, cypress seed and spiny jujube seed; Step 3, sterilization: sterilize ginseng, Polygala tenuifolia, and Poria cocos at 115° C. for 15 min, and sterilize Acorus calamus, Platycladus orientalis, and Semen Ziziphi spinosus at 105° C. for 8 min, and control the pressure of the high-pressure steam sterilization to 2 atmospheres to obtain sterilized materials; Step 4, drying: placing the ginseng, polygala, and poria in the sterilized material at a temperature of 100° C. and drying them until the moisture content is less than 8%, and placing the calamus, cypress seed, and spiny jujube seed in the sterilized material at a temperature of 50° C. and drying them until the moisture content is less than 8%, to obtain a dried material; Step 5, processing: the dry materials are mixed and crushed at low temperature, and the low temperature is controlled to be 2°C. After screening, 0.5% by mass of silicon dioxide is added, and after the total mixing is uniform, the mixture is divided into capsules to obtain the finished product of the flavored Kaixinsan capsules.

[0027] Step 6, Storage: Package the finished Jiawei Kaixin San capsules and store them in the warehouse.

[0028] It should be noted that in Step 5 of this application, the silica is a silica composite material. And the silica composite material is obtained by compound-modifying silica with polyacrylic acid.

[0029] Among them, the preparation method of the silica composite material includes Step ① Prepare fumed silica, polypropylene and butyl acrylate for use according to a mass ratio of 1:0.05:0.01; Step ② Mix and stir fumed silica and butyl acrylate, and use melt graft polymerization to obtain a silica grafted polybutyl acrylate semi-composite material; Step ③ Cover the surface of the silica grafted polybutyl acrylate semi-composite material with polypropylene by melt blending to obtain the SiO2@PP-PBA composite material. And it is obtained by mixing and melting the silica grafted polybutyl acrylate semi-composite material and polypropylene during melt blending, and then cooling and solidifying.

[0030] An application of Jiawei Kaixin San capsules, including Jiawei Kaixin San capsules prepared by the preparation method of Jiawei Kaixin San capsules as described above, and applied to the treatment of Alzheimer's disease and forgetfulness symptoms.

[0031] Example 2 A preparation method of Jiawei Kaixin San capsules, including the following steps: Step 1, Material Selection: Select 13.8 parts of ginseng, 13.8 parts of polygala, 27.6 parts of poria cocos, 13.8 parts of acorus tatarinowii, 13.8 parts of semen platycladi and 13.8 parts of semen ziziphi spinosae by weight; Step 2, Treatment: Clean, wash and soften, and slice ginseng, polygala and acorus tatarinowii in sequence and set aside, and clean and back up poria cocos, semen platycladi and semen ziziphi spinosae; Step 3, Sterilization: Sterilize ginseng, polygala and poria cocos at 115°C for 15 minutes under high-pressure steam, and sterilize acorus tatarinowii, semen platycladi and semen ziziphi spinosae at 105°C for 8 minutes under high-pressure steam, and control the pressure of high-pressure steam sterilization to be 5 atmospheres to obtain sterilized materials; Step 4, Drying: Place ginseng, polygala and poria cocos in the sterilized materials at 100°C and dry until the moisture content < 8%, and place acorus tatarinowii, semen platycladi and semen ziziphi spinosae in the sterilized materials at 50°C and dry until the moisture content < 8% to obtain dried materials; Step 5, Processing: Mix the dried materials and crush them at a low temperature, control the low temperature to be 5°C, sieve them, add 1% of silica by mass percentage, and after total mixing and uniform mixing, fill and package them into capsules to obtain the finished Jiawei Kaixin San capsules.

[0032] Step 6, Storage: Package the finished Jiawei Kaixin San capsules and store them in the warehouse.

[0033] It should be noted that in Step 5 of this application, the silica is a silica composite material. And the silica composite material is obtained by compound modification of silica with polyacrylic acid.

[0034] Among them, the preparation method of the silica composite material includes Step ① Prepare fumed silica, polypropylene, and butyl acrylate for use according to a mass ratio of 1:0.1:0.05; Step ② Mix and stir fumed silica and butyl acrylate, and use melt graft polymerization to obtain a silica-grafted polybutyl acrylate semi-composite material; Step ③ Cover the silica-grafted polybutyl acrylate semi-composite material with polypropylene by melt blending to obtain a SiO2@PP-PBA composite material. And it is obtained by mixing and melting the silica-grafted polybutyl acrylate semi-composite material and polypropylene during melt blending, followed by cooling and solidification.

[0035] An application of Jiawei Kaixin San capsules, including Jiawei Kaixin San capsules prepared by the preparation method of Jiawei Kaixin San capsules as described above, and applied to the treatment of Alzheimer's disease and forgetfulness symptoms.

[0036] Example Three A preparation method of Jiawei Kaixin San capsules, including the following steps: Step 1, Material Selection: Select 15 parts of ginseng, 15 parts of polygala root, 29 parts of poria cocos, 15 parts of acorus tatarinowii, 15 parts of semen platycladi, and 15 parts of semen ziziphi spinosae by weight; Step 2, Processing: Clean, wash and soften, and slice ginseng, polygala root, and acorus tatarinowii in sequence and set aside, and clean and backup poria cocos, semen platycladi, and semen ziziphi spinosae; Step 3, Sterilization: Sterilize ginseng, polygala root, and poria cocos at 115°C under high-pressure steam for 15 minutes, and sterilize acorus tatarinowii, semen platycladi, and semen ziziphi spinosae at 105°C under high-pressure steam for 8 minutes, and control the pressure of high-pressure steam sterilization to be 10 atmospheres to obtain sterilized materials; Step 4, Drying: Place ginseng, polygala root, and poria cocos in the sterilized materials at a temperature of 100°C and dry until the moisture content < 8%, and place acorus tatarinowii, semen platycladi, and semen ziziphi spinosae in the sterilized materials at a temperature of 50°C and dry until the moisture content < 8% to obtain dried materials; Step 5, Processing: Mix the dried materials and pulverize them at low temperature, control the low temperature to be 8°C, sieve them, add 2% silica by mass percentage, and after total mixing and uniform mixing, divide and fill capsules to obtain the finished Jiawei Kaixin San capsules.

[0037] Step 6, Storage: Package the finished Jiawei Kaixin San capsules and store them in the warehouse.

[0038] It should be noted that in step 5 of the present application, the silica is a silica composite material. And the silica composite material is obtained by compound modification of silica with polyacrylic acid.

[0039] Among them, the preparation method of the silica composite material includes step ① preparing fumed silica, polypropylene and butyl acrylate for use according to a mass ratio of 1:0.15:0.1; step ② mixing and stirring the fumed silica and butyl acrylate, and carrying out radiation graft polymerization to obtain a silica-grafted polybutyl acrylate semi-composite material; step ③ covering the silica-grafted polybutyl acrylate semi-composite material with polypropylene by surface deposition to obtain a SiO2@PP-PBA composite material. And during surface deposition, the silica-grafted polybutyl acrylate semi-composite material is dispersed in a polypropylene solution, and after high-temperature evaporation, the polypropylene covers the surface of the silica-grafted polybutyl acrylate semi-composite material.

[0040] An application of Jiawei Kaixin Powder capsules, including Jiawei Kaixin Powder capsules prepared by the preparation method of Jiawei Kaixin Powder capsules as described above, and applied to the treatment of Alzheimer's disease and forgetfulness symptoms.

[0041] Comparative Example 1 The difference between Comparative Example 1 and Example 2 is that the silica used in Comparative Example 1 is fumed silica.

[0042] Comparative Example 2 The difference between Comparative Example 2 and Example 2 is that semen platycladi is not added in Comparative Example 2.

[0043] Comparative Example 3 The difference between Comparative Example 3 and Example 2 is that semen ziziphi spinosae is not added in Comparative Example 3.

[0044] Performance test: The test is carried out using artificial gastric juice.

[0045] The Jiawei Kaixin Powder capsules prepared by the corresponding preparation methods in Examples 1 to 3 and Comparative Examples 1 to 3 of the present application are respectively put into artificial gastric juice when the controlled specifications are 50 mg, 100 mg and 150 mg to determine whether the corresponding Jiawei Kaixin Powder capsules are all disintegrated within 60 min; and to determine the disintegration degree and disintegration time limit of the corresponding Jiawei Kaixin Powder capsules at 15 min. The performance test is shown in Table 1 below:

[0046] As can be seen from Table 1 above, in the embodiments of the present application, by adding semen platycladi and semen ziziphi spinosae, it will play a role in enhancing laxative and calming the nerves, in order to eliminate the side effects of constipation caused by Kaixin Powder, and at the same time, it has a synergistic effect with the added silica composite material to promote drug disintegration. At the same time, based on Comparative Example 1 and Example 2, it can be seen that the silica composite material obtained by polyacrylic acid composite modification of silica in the embodiments of the present application has a synergistic water absorption and swelling effect with polyacrylic acid, and will also synergistically with the hydrophilic effect of chitosan, and use its surface negative charge to adsorb the fatty acid carboxyl groups rich in semen platycladi and semen ziziphi spinosae to form a vesicle structure, so as to further promote drug disintegration through the vesicle structure, in order to achieve the purpose of shortening the disintegration time limit and increasing the disintegration degree per unit time, and solve the problem that the standard drug dose taken is difficult to exert its efficacy efficiently due to the long disintegration time limit of the existing materials. And by encapsulating each component in the form of a capsule, and when each component enters the body, quickly combine the breakage of the capsule and the disintegration of the drug, so as to solve the problem of poor patient compliance caused by poor taste, sore throat, and large drug dosage, while significantly improving the efficacy of the drug.

[0047] In summary, the present application provides a preparation method and application of Jiawei Kaixin Powder capsules. The preparation method of the Jiawei Kaixin Powder capsules enhances the effects of moistening the intestines and relieving constipation and calming the nerves by adding semen platycladi and semen ziziphi spinosae, and effectively alleviates the phenomenon of constipation of Kaixin Powder. At the same time, in order to achieve rapid disintegration of the Jiawei Kaixin Powder capsules during application, so as to fully exert the curative effect, a silica composite material is used to promote the disintegration of the finished Jiawei Kaixin Powder capsules in the body, and then give full play to the therapeutic effect. Among them, the silica composite material has a surface negative charge accumulation, which is uniformly mixed with the dry material in the dry state. When the outer capsule of the prepared Jiawei Kaixin Powder capsules is broken and comes into contact with the body moisture, the fatty acid carboxyl groups rich in semen platycladi and semen ziziphi spinosae are adsorbed to each other and form a vesicle structure, so as to achieve the effect of rapidly disintegrating the Jiawei Kaixin Powder capsules. By using polyacrylic acid and silica in combination, while significantly enhancing the surface negative charge structure of the silica composite material, the water absorption performance of polyacrylic acid is used to promote the silica composite material during expansion, so as to achieve the purpose of promoting the disintegration of the Jiawei Kaixin Powder capsules, so that the preparation can achieve rapid and stable efficacy, and achieve the effect of avoiding irritation to the oral cavity and throat during taking medicine while ensuring accurate dosage. In order to enable the silica composite material to have a significant effect of promoting the disintegration of the Jiawei Kaixin Powder capsules, the present application combines the surface negative charge structure of polyacrylic acid and silica, and promotes the synergistic effect between polyacrylic acid and silica. It is found by testing that under the combined action of polyacrylic acid and silica, it promotes the expansion and cracking, so as to promote the rapid disintegration of the Jiawei Kaixin Powder capsules after taking, with the melting and rupture of the capsules, so as to achieve timely and effective curative effect, and then achieve the effects of accurate dosage and stable preparation. At the same time, in order to ensure food safety, edible polyacrylic acid and silica are combined, so as to improve the use effect of the Jiawei Kaixin Powder capsules while avoiding damage to the human body.

[0048] The "first", "second", "third", "fourth", etc. (if any) involved in the present application are used to distinguish similar objects and do not necessarily have to be used to describe a specific order or sequence. It should be understood that such data can be interchanged under appropriate circumstances so that the embodiments described herein can be implemented in an order other than those illustrated or described herein. In addition, the terms "comprising" and "having" and any variations thereof are intended to cover non-exclusive inclusion. For example, a process, method or device comprising a series of steps or units does not necessarily have to be limited to those steps or units clearly listed, but may include other steps or units not clearly listed or inherent to these processes, methods or devices.

[0049] It should be noted that the descriptions involving "first", "second", etc. in this application are only for descriptive purposes, and should not be construed as indicating or implying their relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include at least one such feature. Additionally, the technical solutions between various embodiments may be combined with each other, but it must be based on the ability of those of ordinary skill in the art to implement. When the combination of technical solutions results in contradictions or cannot be implemented, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection required by this application.

[0050] Specific examples are used in this article to elaborate on the principles and implementation manners of this application. The description of the above embodiments is only for helping to understand the method and its core idea of this application; at the same time, for those of ordinary skill in the art, according to the idea of this application, there will be changes in the specific implementation manners and application scopes. In summary, the content of this specification should not be construed as a limitation to this application.

Claims

1. A preparation method of Jiawei Kaixin San capsules, characterized in that, It includes the following steps: Step 1, material selection: Select 12 - 15 parts by weight of ginseng, 12 - 15 parts of polygala tenuifolia, 26 - 29 parts of poria cocos, 12 - 15 parts of acorus tatarinowii, 12 - 15 parts of semen platycladi, and 12 - 15 parts of semen ziziphi spinosae; Step 2, processing: Clean, wash and soften, and slice ginseng, polygala tenuifolia, and acorus tatarinowii in sequence and set aside, and clean and backup poria cocos, semen platycladi, and semen ziziphi spinosae; Step 3, sterilization: Sterilize ginseng, polygala tenuifolia, and poria cocos at 115 °C under high - pressure steam for 15 min, and sterilize acorus tatarinowii, semen platycladi, and semen ziziphi spinosae at 105 °C under high - pressure steam for 8 min to obtain sterilized materials; Step 4, drying: Place ginseng, polygala tenuifolia, and poria cocos in the sterilized materials at 100 °C and dry until the moisture content < 8%, and place acorus tatarinowii, semen platycladi, and semen ziziphi spinosae in the sterilized materials at 50 °C and dry until the moisture content < 8% to obtain dried materials; Step 5, processing: Mix the dried materials and crush them at low temperature, control the low - temperature at 2 - 8 °C, sieve them, add silicon dioxide at a mass percentage of 0.5 - 2%, and after total mixing and uniform mixing, pack and fill capsules to obtain the finished product of Jiawei Kaixin Powder capsules; 2. The preparation method of a Jiawei Kaixin Powder 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 a Jiawei Kaixin San capsule according to claim 1, characterized in that: In step 5, the silicon dioxide is a silicon dioxide composite material, and the silicon dioxide composite material is obtained by compound - modifying silicon dioxide with polyacrylic acid.

4. The preparation method of a Jiawei Kaixin Powder capsule according to claim 3, characterized in that: The preparation method of the silicon dioxide composite material includes step ① Prepare corresponding parts by weight of fumed silica, polypropylene, and butyl acrylate; step ② Mix and stir fumed silica and butyl acrylate, and use melt or radiation graft polymerization to obtain a silicon dioxide - grafted polybutyl acrylate semi - composite material; step ③ Cover the surface of the silicon dioxide - grafted polybutyl acrylate semi - composite material with polypropylene to obtain SiO2@PP - PBA composite material.

5. The preparation method of a Jiawei Kaixin Powder capsule according to claim 4, characterized in that: The mass ratio of the fumed silica, polypropylene, and butyl acrylate is 1:0.05 - 0.15:0.01 - 0.

1.

6. The preparation method of a Jiawei Kaixin Powder capsule according to claim 4, characterized in that: In step ③, cover the surface of the silicon dioxide - grafted polybutyl acrylate semi - composite material with polypropylene by melt blending, surface deposition, or chemical grafting.

7. The preparation method of a Jiawei Kaixin San capsule according to claim 6, characterized in that: The melt blending is obtained by mixing and melting the silicon dioxide - grafted polybutyl acrylate semi - composite material and polypropylene, and then cooling and solidifying.

8. The preparation method of a Jiawei Kaixin Powder capsule according to claim 6, characterized in that: The surface deposition is achieved by dispersing the silicon dioxide - grafted polybutyl acrylate semi - composite material in a polypropylene solution, and after high - temperature evaporation, polypropylene covers the surface of the silicon dioxide - grafted polybutyl acrylate semi - composite material.

9. The preparation method of the Jiawei Kaixin Powder capsule according to claim 1, characterized in that: It also includes step 6, and step 6 is to package the finished product of Jiawei Kaixin Powder capsules and store them in the warehouse.

10. Use of Jiawei Kaixin Powder capsules, characterized in that: It includes Jiawei Kaixin Powder capsules prepared by using the preparation method of the Jiawei Kaixin Powder capsules described in any one of claims 1 - 8, and is applied to the treatment of senile dementia and forgetfulness symptoms.

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