Ginseng and schisandra chinensis orally disintegrating tablet, and preparation method and application thereof

Abstract

This invention discloses a ginseng and schisandra orally disintegrating tablet, its preparation method, and its application. The ginseng and schisandra orally disintegrating tablet, by mass percentage, comprises: 5-10% cross-linked carboxymethyl snow fungus polysaccharide sodium and 90%-95% fresh ginseng and schisandra active freeze-dried powder. The fresh ginseng and schisandra active freeze-dried powder are prepared using fresh ginseng and fresh schisandra in a mass ratio of (1:5)-(5:1). The ginseng and schisandra orally disintegrating tablet of this invention can improve the utilization value of ginseng and schisandra, while being convenient to take or consume, thus meeting the needs of specific populations. Furthermore, the ginseng and schisandra orally disintegrating tablet can be used to relieve palpitations.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine health food processing technology, specifically relating to a ginseng and schisandra orally disintegrating tablet, its preparation method and application. Background Technology

[0002] Palpitation is a common symptom in Traditional Chinese Medicine (TCM), often caused by insufficient heart qi, deficiency of heart yin, or blood stasis in the heart. Modern medicine considers it related to autonomic nervous system dysfunction and arrhythmia. Currently, ginseng (Panax ginseng) and schisandra chinensis are frequently used in TCM compound preparations, such as Ginseng Nourishing Heart Pills or Schisandra Decoction. However, traditional processing methods (such as decoction and drying) easily lead to the oxidative degradation of active ingredients (such as ginsenosides, schisandrin, and active enzymes in ginseng and schisandra), resulting in low efficacy retention (usually <50%). Furthermore, existing freeze-dried products containing only ginseng or schisandra do not involve synergistic mixing with fresh herbs, making it difficult to leverage their complementary effects: ginseng tonifies qi and nourishes yin, while schisandra astringes yin and generates fluids; their combined use can enhance the calming and tranquilizing effect. Currently, the market lacks dedicated freeze-dried tablets for palpitation. To address the aforementioned deficiencies, this invention provides a fresh mixed freeze-drying process to prepare a fresh ginseng and schisandra orally disintegrating tablet, and verifies its significant relieving effect on palpitations. Summary of the Invention

[0003] To develop an orally disintegrating ginseng and Schisandra chinensis tablet, this study aims to enhance the utilization value of ginseng and Schisandra chinensis while providing convenient administration to meet the needs of specific populations. This orally disintegrating ginseng and Schisandra chinensis tablet exhibits a significant effect in relieving palpitations.

[0004] To address the aforementioned technical problems, the present invention provides, in one aspect, a ginseng and schisandra orally disintegrating tablet, comprising, by weight percentage: 5-10% croscarmellose polysaccharide sodium and 90%... The product contains 95% fresh ginseng and Schisandra chinensis active freeze-dried powder, wherein the fresh ginseng and Schisandra chinensis active freeze-dried powder is made from fresh ginseng and fresh Schisandra chinensis in a mass ratio of (1:5) to (5:1). The average disintegration time of the ginseng and Schisandra chinensis orally disintegrating tablets of the present invention is 1 second to 50 seconds.

[0005] Optionally, the weight content of ginsenoside Rg1 in the fresh ginseng and Schisandra chinensis active freeze-dried powder is above 1%.

[0006] Optionally, the cross-linked carboxymethyl snow fungus polysaccharide sodium is prepared by dispersing snow fungus polysaccharide in an organic solvent to form an emulsion, wherein the mass percentage of snow fungus polysaccharide is 35%. 45%; add 15% by weight of the emulsion to the emulsion. 20% sodium-containing alkaline substances and 0.1% snow fungus polysaccharide by mass. 0.15% crosslinking agent was added for pretreatment at a first temperature; then 15% by weight of the emulsion was added to the pretreated system. A 20% carboxymethylating agent was used to carry out the carboxymethylation reaction at a second temperature; the reaction system was then neutralized, filtered, and the resulting filter cake was washed; the mixture was then dried at a third temperature to obtain cross-linked carboxymethyl snow swallow polysaccharide sodium.

[0007] Optionally, the organic solvent includes ethanol, and the washing solution used to wash the filter cake includes ethanol.

[0008] Optionally, the sodium-containing alkaline substance includes sodium hydroxide, the crosslinking agent includes epichlorohydrin, and the carboxymethylating agent includes chloroacetic acid.

[0009] Optionally, the first temperature is 30°C. The pretreatment temperature is 40℃, and the pretreatment time is 15 minutes. 30 min; the second temperature is 50 The carboxymethylation reaction was carried out at 60°C for 2 hours. 3h; the third temperature is 40 55℃.

[0010] On the other hand, the present invention provides a method for preparing ginseng and schisandra orally disintegrating tablets, comprising: taking 90% by weight of... 95% fresh ginseng and Schisandra chinensis active freeze-dried powder are mixed with 5-10% by weight of cross-linked carboxymethyl snow fungus polysaccharide sodium to form a mixture, wherein the fresh ginseng and Schisandra chinensis active freeze-dried powder are made from fresh ginseng and fresh Schisandra chinensis in a mass ratio of (1:5)-(5:1); the mixture is then mixed with water in a weight ratio of 1:(1 5) Mix to obtain a suspension of fresh ginseng and schisandra active freeze-dried powder; subject the fresh ginseng and schisandra active freeze-dried powder suspension to a second freeze-drying process.

[0011] Optionally, the second freeze-drying process includes: cooling the fresh ginseng and Schisandra chinensis active freeze-dried powder suspension to a temperature that is suitable for further processing. 60~ 70℃ and maintain for 1-2 hours; keep the temperature of the fresh human ginseng and Schisandra chinensis active freeze-dried powder suspension at 70℃. 20~ 25°C until the frozen ice in the fresh ginseng and Schisandra chinensis active freeze-dried powder suspension has completely sublimated; then, raise the temperature of the fresh ginseng and Schisandra chinensis active freeze-dried powder suspension after the frozen ice has sublimated to 20°C. 33℃, and maintain until the freeze-drying is complete.

[0012] Optionally, the method for preparing the fresh ginseng and Schisandra chinensis active freeze-dried powder includes: in 25... At 35℃, using water as the extraction solvent, cleaned and crushed fresh ginseng and fresh schisandra berries were extracted, with a mass ratio of fresh ginseng to fresh schisandra berries of (1:5)-(5:1); at 8000 The mixture is separated at 25,000 rpm to obtain a separated liquid; the separated liquid is concentrated to obtain a concentrated liquid; the concentrated liquid is then subjected to a first freeze-drying process to obtain fresh ginseng and Schisandra chinensis active freeze-dried powder, the weight of which is 10% of the total dry weight of fresh ginseng and Schisandra chinensis. 15%, and in the fresh ginseng and Schisandra chinensis active freeze-dried powder, the weight content of ginsenoside Rg1 is more than 1%.

[0013] Optionally, the first freeze-drying method includes: cooling the concentrate to... 55~ 45℃, and maintain for 3 5 hours; maintain the temperature of the concentrate at 20~ 25°C until the frozen ice in the concentrate has completely sublimated; then heat the concentrate, after the frozen ice has sublimated, to 20°C. 33℃, and maintain until the freeze-drying is complete.

[0014] This invention also provides the use of the aforementioned ginseng and schisandra orally disintegrating tablets in the preparation of drugs, foods, or health products for relieving palpitations. The orally disintegrating tablets have a therapeutic effect on palpitations of unknown origin.

[0015] Compared with existing technologies, the technical solution of this invention has the following beneficial effects: The entire preparation process of the ginseng and schisandra orally disintegrating tablets of this invention is controlled at a temperature not exceeding 40℃ to prevent the active enzymes from being destroyed by high temperatures. The active ginseng and schisandra orally disintegrating tablets of this invention contain no other excipients besides the highly effective disintegrant croscarmellose sodium, making the product safer. The ginseng and schisandra orally disintegrating tablets of this invention have a therapeutic effect on palpitations of unknown cause and can be used in the development of pharmaceuticals, food, and health foods. Detailed Implementation

[0016] To enable those skilled in the art to better understand the technical solutions in this application, the present invention will be further described below in conjunction with the embodiments. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of this application.

[0017] This invention provides a ginseng and schisandra orally disintegrating tablet, comprising, by weight percentage: 5-10% croscarmellose sodium and 90%... 95% fresh ginseng and Schisandra chinensis active freeze-dried powder, wherein the fresh ginseng and Schisandra chinensis active freeze-dried powder is made from fresh ginseng and fresh Schisandra chinensis in a mass ratio of (1:5)-(5:1). Orally disintegrating tablets, also called orally disintegrating tablets, are tablets that can rapidly disintegrate or dissolve in the oral cavity. The typical disintegration time is several seconds to more than ten seconds, generally not exceeding one minute. No water or chewing is required in the mouth; it rapidly disintegrates upon contact with saliva to form a suspension or solution, which is then swallowed to take effect. Compared with ordinary tablets, the drug is absorbed through the mucous membrane after rapid disintegration. This dosage form is particularly suitable for some elderly people, children, patients with difficulty swallowing, or people in dehydrated conditions, and has the characteristics of rapid onset of action and high bioavailability.

[0018] The oral disintegrating tablets can improve the compliance of some people, which is significant in that: (1) it reduces swallowing difficulties in some patients and improves compliance; (2) it is suitable for special populations and people with swallowing disorders such as the elderly and children; (3) it can be used in emergency or in situations where water is unavailable; it is suitable for some people who are not used to or have difficulty drinking water; (4) it can reduce the movement of some hospitalized patients and home patients with mobility difficulties and reduce the workload of nursing staff; (5) some drugs have improved bioavailability due to rapid absorption in the oral cavity or reduced enterohepatic metabolism.

[0019] In the fresh ginseng and Schisandra chinensis active freeze-dried powder, the weight content of ginsenoside Rg1 is more than 1%.

[0020] The cross-linked carboxymethyl snow fungus polysaccharide sodium was prepared by dispersing snow fungus polysaccharide in an organic solvent to form an emulsion, wherein the mass percentage of snow fungus polysaccharide was 35%. 45%; add 15% by weight of the emulsion to the emulsion. 20% sodium-containing alkaline substances and 0.1% snow fungus polysaccharide by mass. 0.15% crosslinking agent was added for pretreatment at a first temperature; then 15% by weight of the emulsion was added to the pretreated system. A 20% carboxymethylating agent was used to carry out the carboxymethylation reaction at a second temperature; the reaction system was then neutralized, filtered, and the resulting filter cake was washed; the mixture was then dried at a third temperature to obtain cross-linked carboxymethyl snow swallow polysaccharide sodium.

[0021] The organic solvent includes ethanol, and the washing solution used to wash the filter cake includes ethanol. In some embodiments, both the organic solvent and the washing solution are ethanol with a volume fraction of 95%.

[0022] The sodium-containing alkaline substance includes sodium hydroxide, the crosslinking agent includes epichlorohydrin, and the carboxymethylating agent includes chloroacetic acid. In some embodiments, the sodium-containing alkaline substance is solid sodium hydroxide, the crosslinking agent is epichlorohydrin, and the carboxymethylating agent is chloroacetic acid.

[0023] In some embodiments, the first temperature is 30°C. The pretreatment temperature is 40℃, and the pretreatment time is 15 minutes. 30 min; the second temperature is 50 The carboxymethylation reaction was carried out at 60°C for 2 hours. 3h; the third temperature is 40 55℃. The above reaction temperature and reaction time can make the reaction more complete.

[0024] This invention also provides a method for preparing ginseng and schisandra orally disintegrating tablets, comprising: 90% by weight... 95% fresh ginseng and Schisandra chinensis active freeze-dried powder are mixed with 5-10% by weight of cross-linked carboxymethyl snow fungus polysaccharide sodium to form a mixture, wherein the fresh ginseng and Schisandra chinensis active freeze-dried powder are made from fresh ginseng and fresh Schisandra chinensis in a mass ratio of (1:5)-(5:1); the mixture is then mixed with water in a weight ratio of 1:(1 5) Mix to obtain a suspension of fresh ginseng and schisandra active freeze-dried powder; subject the fresh ginseng and schisandra active freeze-dried powder suspension to a second freeze-drying process.

[0025] The second freeze-drying process includes: cooling the fresh ginseng and Schisandra chinensis active freeze-dried powder suspension to a certain temperature. 60~ 70℃ and maintain for 1-2 hours; keep the temperature of the fresh human ginseng and Schisandra chinensis active freeze-dried powder suspension at 70℃. 20~ 25°C until the frozen ice in the fresh ginseng and Schisandra chinensis active freeze-dried powder suspension has completely sublimated; then, raise the temperature of the fresh ginseng and Schisandra chinensis active freeze-dried powder suspension after the frozen ice has sublimated to 20°C. 33℃, and maintain until the freeze-drying is complete.

[0026] The method for preparing the fresh ginseng and Schisandra chinensis active freeze-dried powder includes: at 25 At 35℃, using water as the extraction solvent, cleaned and crushed fresh ginseng and fresh schisandra berries were extracted, with a mass ratio of fresh ginseng to fresh schisandra berries of (1:5)-(5:1); at 8000 The mixture is separated at 25,000 rpm to obtain a separated liquid; the separated liquid is concentrated to obtain a concentrated liquid; the concentrated liquid is then subjected to a first freeze-drying process to obtain fresh ginseng and Schisandra chinensis active freeze-dried powder, the weight of which is 10% of the total dry weight of fresh ginseng and Schisandra chinensis. 15%, and in the fresh ginseng and Schisandra chinensis active freeze-dried powder, the weight content of ginsenoside Rg1 is more than 1%.

[0027] The first freeze-drying method includes: cooling the concentrate to a certain temperature. 55~ 45℃, and maintain for 3 5 hours; maintain the temperature of the concentrate at 20~ 25°C until the frozen ice in the concentrate has completely sublimated; then heat the concentrate, after the frozen ice has sublimated, to 20°C. 33℃, and maintain until the freeze-drying is complete.

[0028] In this invention, the content of ginsenoside Rg1 in fresh ginseng and Schisandra chinensis active freeze-dried powder was determined by high performance liquid chromatography, wherein the determination parameters are as follows: (1) Instrument: Agilent 1260 high performance liquid chromatograph.

[0029] (2) The test drug ginsenoside Rg1, the reference standard (China National Institute for Biological Products Control), methanol, acetonitrile and phosphoric acid were all chromatographically pure reagents.

[0030] (3) Chromatographic conditions: The chromatographic column was C18 (250 mm × 4.6 mm, 5 μm); the mobile phase was acetonitrile: 1% phosphoric acid solution (20: 80); the flow rate was 1.0 ml / min; the detection wavelength was 203 nm; the column temperature was 30 ℃; and the injection volume was 10 μl. Under these chromatographic conditions, the theoretical plate number of the chromatographic column was set according to the ginsenoside Rg1 > 4000.

[0031] In this invention, the disintegration time of ginseng and schisandra orally disintegrating tablets was determined: Following the method for determining disintegration time in the 2020 edition of the Chinese Pharmacopoeia, six orally disintegrating tablets of ginseng and schisandra were used. Water was used as the medium at a temperature of (37.0±1)℃. One tablet was tested at a time, and the time from the moment the tablet touched the water surface until all the particles passed through the sieve was recorded as the disintegration time. A total of six tests were conducted, and the average disintegration time was calculated. The average disintegration time of active fresh ginseng and orally disintegrating tablets of schisandra was 1 second to 50 seconds.

[0032] The ginseng and schisandra oral disintegrating tablets of this invention have the effect of relieving palpitations, especially for palpitations of unknown cause.

[0033] Example 1: Preparation of Fresh Ginseng and Schisandra chinensis Active Freeze-Dried Powder Take 20 kg of fresh ginseng and 10 kg of fresh Schisandra chinensis, wash them with distilled water, and crush them into 60-80 mesh particles. Extract them using a continuous countercurrent ultrasonic extraction device at 25-35℃, with water as the extraction solvent. After centrifugation (8000-25000 rpm), the extract is concentrated using a reverse osmosis concentrator (Hefei Zhixuan Membrane Separation Technology Co., Ltd.) to obtain a concentrated solution. The concentrated solution is then freeze-dried to obtain fresh ginseng and Schisandra chinensis active freeze-dried powder. The freeze-drying process (freeze-drying conditions: pre-freezing stage: the product is placed in the freezer and cooled to -55℃, and maintained at -55℃ for 5 hours, ending the pre-freezing stage; sublimation stage: the plate temperature is controlled at 15-20℃, maintaining the product temperature at -20 to -25℃ until the frozen ice in the product has sublimated; desorption stage: the product temperature is heated to 20-33℃ and maintained until the freeze-drying is complete) yields fresh ginseng and Schisandra chinensis active freeze-dried powder, weighing 3.2 kg. The content of ginsenoside Rg1 in fresh ginseng and Schisandra chinensis active freeze-dried powder is 2.2%, and the ginsenoside extraction rate is 96.0%.

[0034] Example 2 Preparation of cross-linked carboxymethyl snow fungus polysaccharide sodium 2500 g of snow swallow polysaccharide was added to 5000 mL of 95% ethanol and stirred thoroughly to form an emulsion. 1200 g of NaOH solid was added for alkalization, and simultaneously, 0.12% (by weight) of epichlorohydrin (a crosslinking agent) was added. The mixture was placed in a 10 L Erlenmeyer flask and fitted with a reflux condenser. Pretreatment was carried out at 35 °C for approximately 20 min, followed by carboxylation with 1200 g of chloroacetic acid. The reaction was completed at 55 °C for 2.5 h. After neutralization and hot filtration, the resulting filter cake was washed with 95% ethanol and then vacuum dried at 50 °C to obtain crosslinked carboxymethyl snow swallow polysaccharide sodium.

[0035] The fresh ginseng and Schisandra chinensis active freeze-dried powder and cross-linked carboxymethyl snow swallow polysaccharide sodium prepared in Examples 1-2 were used in the preparation of orally disintegrating tablets in Examples 3-5.

[0036] Example 3: Preparation of Ginseng and Schisandra chinensis Orally Disintegrating Tablets Take 200g of fresh ginseng and Schisandra chinensis active freeze-dried powder, and 10g of cross-linked carboxymethyl snow fungus polysaccharide sodium. Mix the above materials thoroughly in a three-dimensional mixer to obtain a mixture. Add 250g of distilled water to the mixture and prepare a suspension. Add the suspension quantitatively to a pre-made double aluminum blister pack. After rapid freezing in a liquid nitrogen tunnel, freeze-dry (freeze-drying conditions: pre-freezing stage: the product is placed in the chamber and cooled to -70℃, and maintained at -70℃ for 1.5 hours, ending the pre-freezing stage. Sublimation stage: the plate temperature is controlled at 15℃, maintaining the product temperature at -20℃ until the frozen ice in the product has sublimated completely. Desorption stage: the product temperature is heated to 35℃ and maintained until freeze-drying is complete). Package to obtain ginseng and Schisandra chinensis orally disintegrating tablets, each weighing 0.5g.

[0037] Determination of disintegration time of ginseng and schisandra orally disintegrating tablets: Following the method for determining disintegration time in the 2020 edition of the Chinese Pharmacopoeia, six orally disintegrating tablets of Ginseng and Schisandra chinensis were tested using water as the medium at a temperature of (37.0±1)℃. One tablet was tested at a time, and the disintegration time was measured from the moment the tablet touched the water surface until all the particles passed through the sieve. A total of six tests were performed. The average disintegration time was calculated. The average disintegration time of the orally disintegrating tablets of Ginseng and Schisandra chinensis was 7.5 seconds.

[0038] Example 4: Preparation of Ginseng and Schisandra chinensis Orally Disintegrating Tablets Take 500g of fresh ginseng and Schisandra chinensis active freeze-dried powder, and 55g of cross-linked carboxymethyl snow fungus polysaccharide sodium. Mix the above materials thoroughly in a three-dimensional mixer to obtain a mixture. Add 555g of distilled water to the mixture to form a suspension. Add a measured amount of the suspension to a pre-made double aluminum blister pack. After rapid freezing in a liquid nitrogen tunnel, freeze-dry (freeze-drying conditions: pre-freezing stage: the product is placed in the chamber and cooled to -70℃, and maintained at -70℃ for 1.5 hours, ending the pre-freezing stage. Sublimation stage: the plate temperature is controlled at 15℃, maintaining the product temperature at -20℃ until the frozen ice in the product has sublimated completely. Desorption stage: the product temperature is heated to 35℃ and maintained until freeze-drying is complete). Package to obtain ginseng and Schisandra chinensis orally disintegrating tablets, each weighing 0.5g.

[0039] Determination of disintegration time of ginseng and schisandra orally disintegrating tablets: Following the method for determining disintegration time in the 2020 edition of the Chinese Pharmacopoeia, six orally disintegrating tablets of Ginseng and Schisandra chinensis were tested using water as the medium at a temperature of (37.0±1)℃. One tablet was tested at a time, and the disintegration time was measured from the moment the tablet touched the water surface until all the particles passed through the sieve. A total of six tests were performed. The average disintegration time was calculated. The average disintegration time of the orally disintegrating tablets of Ginseng and Schisandra chinensis was 6.5 seconds.

[0040] Example 5: Comparison of novel disintegrant cross-linked carboxymethyl snow fungus polysaccharide sodium with traditional disintegrants Take 20g of fresh ginseng and Schisandra chinensis active freeze-dried powder respectively, and add the following disintegrants respectively: microcrystalline cellulose (MCC), crospovidone (PVPP), low-substituted hydroxypropyl methylcellulose (L-HPC), crospovidone carboxymethyl cellulose sodium (CMC-Na), and crospovidone carboxymethyl snow fungus polysaccharide sodium, and add 20g of distilled water. Mix the above materials thoroughly to obtain a suspension. Quantitatively add the suspension to a pre-made double aluminum blister pack, and after rapid freezing in a liquid nitrogen tunnel, freeze-dry (freeze-drying conditions: pre-freezing stage: the product is placed in the chamber, cooled to -70℃, and maintained at -70℃ for 1 hour, the pre-freezing stage ends. Sublimation stage: the plate temperature is controlled at 15℃, and the product temperature is maintained at -20℃ until the frozen ice in the product has sublimated completely. Desorption stage: the product temperature is heated to 35℃ and maintained until the freeze-drying is completed), package, and obtain ginseng and Schisandra chinensis orally disintegrating tablets with different disintegrants, each tablet weighing 0.5g.

[0041] Determination of disintegration time of ginseng and schisandra orally disintegrating tablets prepared with different disintegrants Following the method for determining disintegration time in the 2020 edition of the Chinese Pharmacopoeia, six tablets of ginseng and schisandra chinensis orally disintegrating tablets were taken and tested in water at a temperature of (37.0±1)℃. One tablet was tested at a time, and the disintegration time was measured from the moment the tablet touched the water surface until all the particles passed through the sieve. A total of six tests were performed. The average disintegration time was calculated. The results are as follows: Table 1. Disintegration time of orally disintegrating tablets of fresh ginseng active extract with different disintegrants The results showed that the cross-linked carboxymethyl snow swallow polysaccharide sodium had excellent disintegration properties.

[0042] Example 6: Therapeutic effect of ginseng and schisandra orally disintegrating tablets on a rat model of palpitation. I. Experimental Materials 1. Test drug 1.1 Test sample: Ginseng and Schisandra chinensis orally disintegrating tablets prepared in Example 3 Dosage and administration: Prepare a suspension with distilled water before use. 1.2 Positive control drug: Wenxin granules (National Drug Approval Number Z10950074), prepared as a suspension with distilled water before use. 1.3 Modeling reagent: Epinephrine hydrochloride injection (1 mg / mL) 1.4 Solvent: 0.9% physiological saline 2. Laboratory animals SD rats, male, weighing 180–220 g, SPF grade, 40 in total. Animal License Number: SCXK (Beijing) 2023-0015 Husbandry conditions: Temperature 22±2℃, 12-hour light-dark cycle, free access to water and food. 3. Instruments and Equipment Multichannel physiological signal acquisition and processing system (PowerLab, ADInstruments) ECG electrode clips Electronic balances, centrifuges, ultrasonic cleaners, etc. II. Experimental Methods 1. Grouping and Dosing Rats were randomly divided into 5 groups (n=8): Blank control group: equal volume of physiological saline administered by gavage. Model control group: equal volume of physiological saline administered by gavage + adrenaline modeling Low-dose group: Orally disintegrating tablets 5 mg / kg (equivalent to the clinically equivalent dose) High-dose group: Orally disintegrating tablets 20 mg / kg Positive drug group: Wenxin granules 15mg / kg Administration: Once daily by gavage for 7 consecutive days. Modeling was performed 30 minutes after the last administration on the 7th day.

[0043] 2. Establishment of a palpitation model On day 7, rats in each group were injected intraperitoneally with epinephrine hydrochloride (0.5 mg / kg), and the same dose was injected again 10 min later to induce rapid arrhythmias and palpitation-like behaviors (such as agitation, rapid breathing, and significantly increased heart rate).

[0044] 3. Observation Indicators Electrocardiogram (ECG) test: Record ECG in lead II and analyze heart rate (HR), QT interval, ST segment changes and the incidence of arrhythmias.

[0045] Behavioral scoring: Palpitation symptoms were scored (0–4 points) based on rats’ agitation, piloerection, respiratory rate, etc.

[0046] Serum biochemical indicators: ELISA method was used to detect the levels of cAMP, cGMP, SOD, and MDA in serum.

[0047] 4. Statistical processing Data are expressed as mean ± standard deviation (x ± pm s). One-way ANOVA was performed using SPSS 26.0 software. P < 0.05 was considered statistically significant.

[0048] III. Experimental Results Table 2. Therapeutic effects of ginseng and schisandra chinensis orally disintegrating tablets on a rat model of palpitation. Note: Compared with the blank control group, **P<0.01; compared with the model control group, *P<0.05, **P<0.01; # indicates P<0.05 compared with the low-dose group.

[0049] High-dose orally disintegrating tablets significantly reduced heart rate and improved palpitation behavior (P<0.01), with effects approaching those of positive control drugs.

[0050] Serum cAMP levels were significantly elevated in the model control group (reflecting sympathetic nerve excitation), but significantly decreased after drug administration.

[0051] The high-dose group showed increased SOD activity and decreased MDA content (P<0.05), suggesting that antioxidant activity is involved in myocardial protection.

[0052] Experiments showed that ginseng and schisandra orally disintegrating tablets could significantly improve the symptoms of an adrenaline-induced palpitation model rat.

[0053] Example 7 Preparation of Ginseng and Schisandra chinensis Orally Disintegrating Tablets 1. Preparation of fresh ginseng and Schisandra chinensis active freeze-dried powder: The preparation method is basically the same as in Example 1, except that the proportion of raw materials is different: 5 kg of fresh ginseng and 25 kg of fresh Schisandra chinensis.

[0054] 2. Preparation of cross-linked carboxymethyl snow swallow polysaccharide sodium: Same as in Example 2.

[0055] 3. Preparation of ginseng schisandra orally disintegrating tablets: The preparation method is the same as in Example 3. The average disintegration time of the prepared ginseng schisandra orally disintegrating tablets is 7.5 seconds.

[0056] Example 8: Preparation of Ginseng and Schisandra chinensis Orally Disintegrating Tablets 1. Preparation of fresh ginseng and Schisandra chinensis active freeze-dried powder: The preparation method is basically the same as in Example 1, except that the proportion of raw materials is different: 25 kg of fresh ginseng and 5 kg of fresh Schisandra chinensis.

[0057] 2. Preparation of cross-linked carboxymethyl snow swallow polysaccharide sodium: Same as in Example 2.

[0058] 3. Preparation of ginseng schisandra orally disintegrating tablets: The preparation method is the same as in Example 3. The average disintegration time of the prepared ginseng schisandra orally disintegrating tablets is 8.5 seconds.

[0059] Example 9: Therapeutic effect of ginseng and schisandra orally disintegrating tablets with different proportions on a rat model of palpitation. I. Experimental Materials Take 5 kg of fresh ginseng and 25 kg of fresh Schisandra chinensis, and prepare fresh ginseng and Schisandra chinensis active freeze-dried powder 1 according to the method of Example 1. Take 25 kg of fresh ginseng and 5 kg of fresh Schisandra chinensis, and prepare fresh ginseng and Schisandra chinensis active freeze-dried powder 2 according to the method of Example 1. Take fresh ginseng and Schisandra chinensis active freeze-dried powder 1 and fresh ginseng and Schisandra chinensis active freeze-dried powder 2 respectively, and prepare ginseng and Schisandra chinensis orally disintegrating tablets 1 and 2 according to the method of Example 3.

[0060] 1. Test drug 1.1 Test products: Ginseng and Schisandra chinensis orally disintegrating tablets 1, Ginseng and Schisandra chinensis orally disintegrating tablets 2 Dosage and administration: Prepare a suspension with distilled water before use. 1.2 Positive control drug: Wenxin Granules (National Drug Approval Number Z10950074), prepared as a suspension with distilled water before use. 1.3 Modeling reagent: Epinephrine hydrochloride injection (1 mg / mL) 1.4 Solvent: 0.9% physiological saline 2. Laboratory animals SD rats, male, weighing 180–220 g, SPF grade, 40 in total. Animal License Number: SCXK (Beijing) 2023-0015 Husbandry conditions: Temperature 22±2℃, 12-hour light-dark cycle, free access to water and food. 3. Instruments and Equipment Multichannel physiological signal acquisition and processing system (PowerLab, ADInstruments) ECG electrode clips Electronic balances, centrifuges, ultrasonic cleaners, etc. II. Experimental Methods 1. Grouping and Dosing Rats were randomly divided into 5 groups (n=8): Blank control group: equal volume of physiological saline administered by gavage. Model control group: equal volume of physiological saline administered by gavage + adrenaline modeling One group of ginseng and schisandra orally disintegrating tablets: 20mg / kg Group 1 of Ginseng and Schisandra chinensis orally disintegrating tablets: 20 mg / kg Positive drug group: Wenxin granules 15mg / kg Administration: Once daily by gavage for 7 consecutive days. Modeling was performed 30 minutes after the last administration on the 7th day.

[0061] 2. Establishment of a palpitation model On day 7, rats in each group were injected intraperitoneally with epinephrine hydrochloride (0.5 mg / kg), and the same dose was injected again 10 min later to induce rapid arrhythmias and palpitation-like behaviors (such as agitation, rapid breathing, and significantly increased heart rate).

[0062] 3. Observation Indicators Electrocardiogram (ECG) test: Record ECG in lead II and analyze heart rate (HR), QT interval, ST segment changes and the incidence of arrhythmias.

[0063] Behavioral scoring: Palpitation symptoms were scored (0–4 points) based on rats’ agitation, piloerection, respiratory rate, etc.

[0064] 4. Statistical processing Data are expressed as mean ± standard deviation (x ± pm s). One-way ANOVA was performed using SPSS 26.0 software. P < 0.05 was considered statistically significant.

[0065] III. Experimental Results Table 3. Therapeutic effects of different proportions of ginseng and schisandra chinensis orally disintegrating tablets on palpitation model rats. Note: Compared with the blank control group, **P<0.01; compared with the model control group, *P<0.05, **P<0.01; # indicates P<0.05 compared with the low-dose group.

[0066] Experiments showed that different proportions of ginseng and schisandra orally disintegrating tablets could significantly improve the symptoms of adrenaline-induced palpitation in rats.

Claims

1. A ginseng and schisandra orally disintegrating tablet, characterized in that, By weight percentage, it includes: 5-10% cross-linked carboxymethyl snow fungus polysaccharide sodium and 90%... 95% fresh ginseng and Schisandra chinensis active freeze-dried powder, wherein the fresh ginseng and Schisandra chinensis active freeze-dried powder is made from fresh ginseng and fresh Schisandra chinensis in a mass ratio of (1:5)-(5:1).

2. The ginseng and schisandra orally disintegrating tablets according to claim 1, characterized in that, The fresh ginseng and Schisandra chinensis active freeze-dried powder contain ginsenoside Rg1 at a weight content of more than 1%.

3. The ginseng and schisandra orally disintegrating tablets according to claim 1, characterized in that, The cross-linked carboxymethyl snow fungus polysaccharide sodium was prepared by the following method: Snow fungus polysaccharides were dispersed in an organic solvent to form an emulsion, wherein the mass percentage of the snow fungus polysaccharides was 35%. 45%; Add 15% by weight of the emulsion to the emulsion. 20% sodium-containing alkaline substances and 0.1% snow fungus polysaccharide by mass. 0.15% crosslinking agent, pretreated at a first temperature; Add 15% (by weight) of the emulsion to the pretreated system. 20% of the carboxymethylating agent was used to carry out the carboxymethylation reaction at a second temperature; The reaction mixture was then neutralized, filtered, and the resulting filter cake was washed. The product was dried at a third temperature to obtain cross-linked carboxymethyl snow swallow polysaccharide sodium.

4. The ginseng and schisandra orally disintegrating tablets as described in claim 3, characterized in that, The organic solvent includes ethanol, and the washing solution used to wash the filter cake includes ethanol.

5. The ginseng and schisandra orally disintegrating tablets as described in claim 3, characterized in that, The sodium-containing alkaline substance includes sodium hydroxide, the crosslinking agent includes epichlorohydrin, and the carboxymethylating agent includes chloroacetic acid.

6. The ginseng and schisandra orally disintegrating tablets as described in claim 3, characterized in that, The first temperature is 30 The pretreatment temperature is 40℃, and the pretreatment time is 15 minutes. 30 min; the second temperature is 50 The carboxymethylation reaction was carried out at 60°C for 2 hours. 3h; the third temperature is 40 55℃.

7. A method for preparing ginseng and schisandra orally disintegrating tablets, characterized in that, include: The quality percentage is 90%. 95% of fresh ginseng and Schisandra chinensis active freeze-dried powder are mixed with 5-10% by mass of cross-linked carboxymethyl snow swallow polysaccharide sodium to form a mixture, wherein the fresh ginseng and Schisandra chinensis active freeze-dried powder are made from fresh ginseng and fresh Schisandra chinensis in a mass ratio of (1:5)-(5:1). The mixture is mixed with water at a weight ratio of 1:(1 5) Mix to obtain a suspension of fresh ginseng and Schisandra chinensis active freeze-dried powder; The fresh ginseng and Schisandra chinensis active freeze-dried powder suspension are subjected to a second freeze-drying process.

8. The method for preparing ginseng and schisandra orally disintegrating tablets according to claim 7, characterized in that, The second freeze-drying process includes: Cool the fresh human ginseng and Schisandra chinensis active freeze-dried powder suspension to... 60~ 70℃, and maintain for 1-2 hours; The temperature of the fresh human ginseng and Schisandra chinensis active freeze-dried powder suspension was maintained at [temperature range]. 20~ 25℃, until the frozen ice in the fresh human ginseng and Schisandra chinensis active freeze-dried powder suspension has completely sublimated; The fresh ginseng and Schisandra chinensis active freeze-dried powder suspension, after complete sublimation of frozen ice, was heated to 25°C. 35℃, and maintain until the freeze-drying is complete.

9. The method for preparing ginseng and schisandra orally disintegrating tablets according to claim 7, characterized in that, The preparation method of the fresh ginseng and Schisandra chinensis active freeze-dried powder includes: In 25 At 35℃, using water as the extraction solvent, the cleaned and crushed fresh ginseng and fresh schisandra were extracted, with the mass ratio of fresh ginseng to fresh schisandra being (1:5)-(5:1). In 8000 Separation was carried out under centrifugal force of 25,000 rpm to obtain the separated liquid; Concentrate the separated liquid to obtain a concentrated liquid; The concentrated liquid is subjected to a first freeze-drying process to obtain fresh ginseng and Schisandra chinensis active freeze-dried powder, wherein the weight of the fresh ginseng and Schisandra chinensis active freeze-dried powder is 10% of the total dry weight of fresh ginseng and fresh Schisandra chinensis. 15%, and in the fresh ginseng and Schisandra chinensis active freeze-dried powder, the weight content of ginsenoside Rg1 is more than 1%.

10. The method for preparing ginseng and schisandra orally disintegrating tablets according to claim 9, characterized in that, The first freeze-drying method includes: Cool the concentrated liquid to 55~ 45℃, and maintain for 3 5 hours; Maintain the temperature of the concentrate at 20~ 25°C, until the frozen ice in the concentrate has completely sublimated; The concentrated liquid after the frozen ice has completely sublimated is heated to 20°C. 33℃, and maintain until the freeze-drying is complete.

11. The use of the ginseng schisandra orally disintegrating tablets according to any one of claims 1-6 or the ginseng schisandra orally disintegrating tablets prepared according to any one of claims 7-10 in the preparation of drugs, foods or health products for relieving palpitations.

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