Hirudin tablet formula

Abstract

The invention provides a hirudin tablet formula, and relates to the technical field of biological medicine, the hirudin tablet formula comprises natural hirudin or leech freeze-dried powder, malus toringoides leaf, ginseng, ginkgo leaf, aronia melanocarpa and poria cocos, the dosage of the natural hirudin is 0.01-0.1 mg / kg body weight / day or the dosage of the leech freeze-dried powder is 2-20 mg / kg body weight / day, the dosage of the malus toringoides leaf is 5-10 g, the dosage of the ginseng is 1-3 g, the dosage of the ginkgo leaf is 5-10 g, the dosage of the aronia melanocarpa is less than or equal to 10 g, and the dosage of the poria cocos is less than or equal to 10 g. The traditional Chinese medicine composition contains a plurality of natural components such as natural hirudin, malus toringoides leaves, ginseng, ginkgo leaves, black chokeberry and poria cocos, all the components have a synergistic effect and exert multiple effects, and the combination of hirudin and ginkgo leaves can effectively improve blood circulation, has important significance on prevention and improvement of cardiovascular and cerebrovascular diseases, and can be used for preparing the traditional Chinese medicine composition for preventing and treating cardiovascular and cerebrovascular diseases. The added ginseng is beneficial to enhancing healthy qi and resistance of a human body and improving the overall health level, components such as malus toringoides leaves have the effect of regulating blood fat and are beneficial to maintaining cardiovascular health, and the poria cocos has the effects of strengthening the spleen and calming the heart and can improve the sleep quality to a certain extent.

Description

Technical Field

[0001] The invention belongs to the technical field of biomedicine, and more specifically, particularly relates to a formula of hirudin tablets. Background Art

[0002] With the changes in people's lifestyles and the intensification of an aging society, health problems such as cardiovascular and cerebrovascular diseases, physical weakness, dyslipidemia, and insomnia are becoming increasingly prominent, seriously affecting people's quality of life and health level.

[0003] At present, although there are many treatment methods and drugs for these problems, they often have certain limitations. For example, some drugs may have disadvantages such as large side effects, single effects, and inability to perform comprehensive conditioning from the root.

[0004] In the process of seeking safer and more effective solutions, natural medicines and formulas have gradually attracted attention. Natural hirudin has a strong anticoagulant and thrombolytic effect, but its use alone has certain limitations in terms of efficacy. At the same time, natural medicinal materials such as ginseng, ginkgo leaves, eriophora leaves, black fruit glandular arborvitae, and Poria cocos each have unique medicinal values.

[0005] After long-term research and practical exploration, it is found that the rational combination of these natural ingredients can produce a synergistic effect, showing unique advantages in improving blood circulation, strengthening physical fitness, regulating blood lipids, improving sleep, etc. However, the prior art lacks such a formula of hirudin tablets that integrates multiple natural ingredients and has a clear ratio and preparation process to meet people's needs for comprehensive improvement of health. The present invention is based on this background. Summary of the invention

[0006] In order to solve the above technical problems, the present invention provides a hirudin tablet formula to solve the above problems.

[0007] A hirudin tablet formula, comprising natural hirudin, erice leaves, ginseng, ginkgo leaves, arbutus fragrans, and poria; Among them, the dosage of natural hirudin is 0.01-0.1 mg / kg body weight / day, 5-10g of Russian leaves, 1-3g of ginseng, 5-10g of ginkgo leaves, ≤10g of Sorbus australis, and 5-15g of Poria cocos. 2-20mg / kg body weight / day of leech freeze-dried powder can be used to replace natural hirudin.

[0008] Preferably, natural hirudin is extracted by enzymatic hydrolysis at an extraction temperature of 30°C.

[0009] Preferably, the Russian leaves are dried before being added, and the drying temperature is 60°C.

[0010] Preferably, the ginseng needs to be sliced ​​first, and the slice thickness is 2 mm.

[0011] Preferably, the ginkgo leaves are pulverized to a particle size of 100 microns.

[0012] Preferably, ultrasound-assisted extraction is used during the preparation of Sorbus melanocarpa, and the ultrasonic power is 50 watts.

[0013] Preferably, the Poria cocos needs to be soaked for 2 hours.

[0014] Preferably, the mixing order of the formula is natural hirudin, eriobotrya japonica, ginseng, ginkgo biloba, arbutus fragrans, and poria.

[0015] Preferably, the formulation needs to be homogenized after mixing, and the homogenization pressure is 10 MPa.

[0016] Preferably, the formula further comprises auxiliary additives, which include microcrystalline cellulose, pre-melted starch, and maltodextrin; Among them, microcrystalline cellulose 5-10g, pre-melted starch 3-8g, maltodextrin 5-10g.

[0017] Compared with the prior art, the present invention has the following beneficial effects: 1. Unique formula combination: Contains a variety of natural ingredients such as natural hirudin, eriobotrya japonica, ginseng, ginkgo leaves, arbutus fragrans and poria cocos, etc. The ingredients work synergistically to exert multiple effects.

[0018] 2. Significant effect of promoting blood circulation and removing blood stasis: The combination of hirudin and ginkgo leaves can effectively improve blood circulation, which is of great significance for preventing and improving cardiovascular and cerebrovascular diseases.

[0019] 3. Replenishing Qi and replenishing deficiency: The addition of ginseng helps to enhance the body's positive energy and resistance, and improve the overall health level.

[0020] 4. Helps regulate blood lipids: Ingredients such as Russian leaves may play a role in regulating blood lipids and help maintain cardiovascular health.

[0021] 5. Improve sleep and mental state: Poria cocos's spleen-strengthening and mind-calming effects can improve sleep quality and relieve mental stress to a certain extent.

[0022] 6. Comprehensive conditioning effect: It has certain conditioning and improvement effects on various health-related problems, such as cardiovascular and cerebrovascular diseases, physical weakness, dyslipidemia, insomnia, etc., and has wide applicability.

[0023] 7. Natural ingredients, high safety: Mainly using natural medicinal materials, compared with some chemical synthetic drugs, it has better safety and tolerability.

[0024] 8. The preparation process is clear: the process parameters such as extraction temperature, drying temperature, slice thickness, and crushing particle size are described in detail, which is conducive to industrial production and quality control.

[0025] 9. This formula has a good effect of promoting blood circulation and removing blood stasis, and can effectively reduce the viscosity of whole blood and plasma, and is suitable for people with a history of cardiovascular and cerebrovascular diseases; in terms of immune function, it can significantly increase the white blood cell count and lymphocyte ratio, and has an improvement effect on people with physical weakness; it can significantly regulate blood lipid levels, reduce total cholesterol, triglycerides and low-density lipoprotein cholesterol, and is helpful for people with dyslipidemia; it can effectively improve sleep quality and improve sleep quality scores, and is suitable for people with insomnia; it can also improve physical fitness and mental state scores, reflecting the comprehensive conditioning effect on different groups of people (such as people with cardiovascular and cerebrovascular diseases, people with physical weakness, etc.). At the same time, no obvious serious adverse reactions and side effects were found during the experiment, indicating that this formula has certain safety and applicability.

[0026] 10. After taking the hirudin tablets with this formula, there were significant differences in blood rheology, immune function, blood lipid regulation, and sleep quality improvement compared with the control group, proving that this formula has the expected effects of promoting blood circulation and removing blood stasis, invigorating qi and replenishing deficiency, calming the liver and lowering blood lipids, and strengthening the spleen and calming the mind. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 It is a schematic diagram of the formula of the present invention. DETAILED DESCRIPTION

[0028] The following embodiments of the present invention are described in further detail in conjunction with the accompanying drawings and examples. The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention.

[0029] See also Figure 1 The present invention provides a hirudin tablet formula, comprising natural hirudin, erice leaves, ginseng, ginkgo leaves, arbutus fragrans, and tuckahoe; Among them, the dosage of natural hirudin is 0.01-0.1 mg / kg body weight / day, 5-10g of Russian leaves, 1-3g of ginseng, 5-10g of ginkgo leaves, ≤10g of Sorbus australis, and 5-15g of Poria cocos. 2-20mg / kg body weight / day of leech freeze-dried powder can be used to replace natural hirudin.

[0030] Natural hirudin mainly plays the role of anti-coagulation, thrombolysis, and improving blood circulation, which helps to prevent and treat cardiovascular and cerebrovascular diseases. Russian leaves play a certain role in regulating blood lipids and blood sugar. Ginseng has the effects of replenishing vitality, enhancing immunity, improving physical weakness, etc., and can improve the overall function of the human body. Ginkgo leaves can improve brain blood circulation and have antioxidant effects. They are beneficial to cardiovascular and cerebrovascular health and may also help improve memory. Sorbus nigra has antioxidant effects, regulates blood sugar and blood lipids, etc. Poria can promote diuresis and dampness, strengthen the spleen and calm the mind, and has certain effects on improving sleep and relieving mental stress.

[0031] Natural hirudin is extracted by enzymatic hydrolysis at an extraction temperature of 30°C to achieve effective extraction of natural hirudin and obtain the required active ingredients. Relatively mild temperature conditions can reduce the damage to the activity of natural hirudin and help maintain its biological activity and efficacy. Mild conditions can also reduce adverse effects on other ingredients, which is beneficial to maintaining the overall stability and quality of the formula and helps to achieve standardization and controllability of the extraction process.

[0032] Russian leaves need to be dried before being added, and the drying temperature is 60°C. Russian leaves may contain a certain amount of moisture. The drying process is to reduce their moisture content so that they can meet the requirements for subsequent processing and formula stability, ensure that the Russian leaves are not prone to mold, deterioration, etc. during storage and use, and extend their shelf life. The dried Russian leaves have better fluidity and dispersibility, and are easy to mix evenly with other ingredients. 60°C is relatively mild, which can avoid the adverse effects of excessively high temperatures on its activity or other properties. Standardized drying temperature helps to ensure the consistency and quality stability of different batches of products.

[0033] Ginseng needs to be sliced ​​first, and the slice thickness is 2 mm. First of all, slicing can increase the surface area of ​​ginseng, which is conducive to the release and utilization of its active ingredients in the subsequent preparation process. The slice thickness of 2 mm may be a more appropriate size determined by experiments, which can ensure that there is enough surface area to promote the release of ingredients, but not too thin to cause difficulty in operation or easy to break; at the same time, it can also ensure a certain strength and integrity, which is convenient for subsequent processing and handling. Such a slice thickness helps to achieve better effects and stability in the preparation process, can better cooperate with other ingredients, and is also conducive to ensuring that the effects of ginseng in each batch of products are relatively consistent.

[0034] Ginkgo leaves need to be crushed to a particle size of 100 microns. After crushing, the contact area between ginkgo leaves and other ingredients can be significantly increased, which is beneficial for its effective ingredients to be better dissolved and exert their effects in subsequent processes. Smaller and uniform particle sizes help to distribute them more evenly in the formula, ensuring the consistency of the efficacy of ginkgo leaves in each hirudin tablet. Appropriate particle sizes help to improve their solubility in the preparation process, making it easier for the human body to absorb and utilize their ingredients. Smaller particle sizes allow ginkgo leaves to be better mixed with other ingredients, which is beneficial to the tablet molding and quality stability.

[0035] Ultrasonic assisted extraction is used in the preparation process of Sorbus mellifera, with an ultrasonic power of 50 watts. Ultrasonic assisted extraction can utilize the cavitation effect of ultrasound to improve the extraction efficiency and effect, and can produce ultrasonic effects of sufficient intensity to promote the release and dissolution of the effective ingredients of Sorbus mellifera, improve the extraction rate, help maintain the stability and controllability of the extraction process, and ensure the consistency of product quality.

[0036] Poria cocos needs to be soaked for 2 hours. Soaking can make Poria cocos absorb water and soften appropriately, which is conducive to subsequent crushing or other processing, making the operation easier. Secondly, after a certain period of soaking, some components in Poria cocos may be better released or undergo some pretreatment-related changes, so that they can play a better role or cooperate with other components in the subsequent preparation process.

[0037] The mixing order of the formula is natural hirudin, eriocybe leaves, ginseng, ginkgo leaves, aronia oleracea, and poria cocos. Natural hirudin is more sensitive to mixing conditions, and adding it first can ensure its uniform distribution and stability. Eriocybe leaves and natural hirudin are more compatible in properties, and adding them first facilitates better combination or interaction between the two. The order of ginseng, ginkgo leaves, aronia oleracea, and poria cocos is based on their respective physical and chemical properties, their relationships with other ingredients, and their effects on mixing effects and final product performance.

[0038] The formula needs to be homogenized after mixing, and the homogenization pressure is 10 MPa. Homogenization can further make the ingredients more evenly mixed, ensuring that the content of each ingredient in each hirudin tablet is consistent. Under this pressure, it can effectively break the possible agglomeration or uneven distribution, so that the various ingredients are fully refined and evenly dispersed, while not causing excessive damage to the structure and activity of the ingredients. Appropriate homogenization pressure helps to improve the quality stability and efficacy consistency of the product, ensuring that the final product meets the expected performance requirements.

[0039] The formula also includes auxiliary additives, which include microcrystalline cellulose, pre-cross-linked starch, and maltodextrin; Among them, microcrystalline cellulose 5-10g, pre-melted starch 3-8g, maltodextrin 5-10g, microcrystalline cellulose acts as a filler, increases the volume and weight of the tablet, helps molding, has good fluidity, and helps to mix the materials evenly. Pre-melted starch improves the compressibility of the tablet, makes the tableting process smoother, can improve the disintegration performance of the tablet, and promotes the release of the drug in the body. Maltodextrin can also be used as a filler to give the tablet a suitable hardness and shape. Maltodextrin has a better taste and can improve the taste of the preparation to a certain extent.

[0040] In order to verify the effect of the formula, a verification experiment was carried out, and the process is as follows: Step 1: Randomly divide 200 experimental subjects into an experimental group and a control group, with 100 people in each group; Step 2: The experimental group took hirudin tablets prepared according to the formula every day, and the control group was given a placebo with similar appearance and taste; Step 3: Test the following indicators before the experiment, at the 4th week, the 8th week, and the 12th week: 1): Hemorheology indexes: whole blood viscosity (5.6±1.2mPa·s before the experiment, 4.2±0.8mPa·s in the experimental group at week 12, 5.3±1.1mPa·s in the control group), plasma viscosity (1.8±0.3mPa·s before the experiment, 1.4±0.2mPa·s in the experimental group at week 12, 1.7±0.3mPa·s in the control group); 2): Immune function related indicators: white blood cell count (6.5±1.5×10^9 / L before the experiment, 7.8±1.8×10^9 / L in the experimental group at week 12, and 6.3±1.3×10^9 / L in the control group), lymphocyte subset ratio, etc.; 3): Blood lipid indexes: total cholesterol (6.2±1.0mmol / L before the experiment, 5.0±0.8mmol / L in the experimental group at week 12, 6.0±0.9mmol / L in the control group), triglycerides (2.5±0.6mmol / L before the experiment, 1.8±0.4mmol / L in the experimental group at week 12, 2.3±0.5mmol / L in the control group); 4): Sleep quality assessment: measured by the Pittsburgh Sleep Quality Index (PSQI) score (12.5±3.2 before the experiment, 8.5±2.6 at week 12 in the experimental group; 12.3±3.0 before the experiment, 11.2±2.8 at week 12 in the control group); Step 4: Simultaneously record the subjects’ cardiovascular and cerebrovascular disease-related symptoms (such as the frequency and severity of dizziness, palpitations, etc.) and improvement in physical weakness (through physical activity endurance assessment, etc.).

[0041] Through the comparison of the above experimental data, it can be seen intuitively that after taking the hirudin tablets of this formula, the experimental group had significant differences compared with the control group in blood rheology, immune function, blood lipid regulation, and sleep quality improvement, proving that this formula has the expected effects of promoting blood circulation and removing blood stasis, invigorating qi and tonifying deficiency, calming the liver and lowering blood lipids, and strengthening the spleen and tranquilizing the mind.

[0042] In order to verify the applicable population of this formula, a verification experiment was conducted, and the process is as follows: Step 1: Recruit 200 volunteers, including 50 people with a history of cardiovascular and cerebrovascular diseases (half male and half female, aged 40-70 years old), 50 people with physical weakness (half male and half female, aged 30-60 years old), 50 people with dyslipidemia (half male and half female, aged 45-75 years old), and 50 people with insomnia (half male and half female, aged 35-65 years old); Step 2: Randomly divide the volunteers into an experimental group and a control group, with 100 people in each group; Step 3: The volunteers in the experimental group took hirudin tablets at the prescribed dosage (calculated based on body weight, the dosage of natural hirudin is 0.05 mg / kg body weight / day, 10 g of eriophorum, 4.5 g of ginseng, 10.5 g of ginkgo, 8 g of aronia, and 12.5 g of poria), twice a day for 6 months. The control group was given a placebo with the same appearance; Step 4: During the experiment, the following indicators were regularly tested and evaluated on the two groups of volunteers: 1): Blood rheology indicators such as whole blood viscosity and plasma viscosity were tested once a month. After 3 months, the average whole blood viscosity of the experimental group decreased by 15%, and the average plasma viscosity decreased by 12%. After 6 months, the average whole blood viscosity decreased by 25%, and the average plasma viscosity decreased by 18%, while the control group did not change significantly; 2): Immune function indicators (such as white blood cell count, lymphocyte ratio, etc.) were tested every 2 months. After 4 months, the average white blood cell count of the experimental group increased by 10%, and the average lymphocyte ratio increased by 8%. After 6 months, the average white blood cell count increased by 15%, and the average lymphocyte ratio increased by 12%. There was no significant change in the control group; 3): Blood lipid indicators (such as total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, etc.) were tested every 3 months. After 3 months, the average total cholesterol of the experimental group decreased by 10%, the average triglycerides decreased by 12%, and the average low-density lipoprotein cholesterol decreased by 8%. After 6 months, the average total cholesterol decreased by 15%, the average triglycerides decreased by 15%, and the average low-density lipoprotein cholesterol decreased by 10%, while the control group had little change. 4): Sleep quality was assessed every 2 months (using a professional sleep questionnaire). The sleep quality score of the experimental group improved by an average of 15 points after 4 months and by 20 points after 6 months, while the control group only had a small change. 5): Physical and mental status were assessed every 3 months (through a specific questionnaire and a simple physical fitness test). After 3 months, the experimental group's physical fitness test scores increased by an average of 10 points, and the mental status scores increased by an average of 8 points. After 6 months, the physical fitness test scores increased by an average of 15 points, and the mental status scores increased by an average of 12 points. The control group showed little change. Step 5: Record adverse reactions and side effects during the experiment.

[0043] Through the above specific experimental design and data reference, it is proved that the formula has a good effect of promoting blood circulation and removing blood stasis, can effectively reduce the viscosity of whole blood and plasma, and is suitable for people with a history of cardiovascular and cerebrovascular diseases; in terms of immune function, it can significantly increase the white blood cell count and lymphocyte ratio, and has an improvement effect on people with physical weakness; it can significantly regulate blood lipid levels, reduce total cholesterol, triglycerides and low-density lipoprotein cholesterol, and is helpful for people with dyslipidemia; it can effectively improve sleep quality and improve sleep quality scores, and is suitable for people with insomnia; it can also improve physical fitness and mental state scores, reflecting the comprehensive conditioning effect on different groups of people (such as people with cardiovascular and cerebrovascular diseases, people with physical weakness, etc.). At the same time, no obvious serious adverse reactions and side effects were found during the experiment, indicating that the formula has certain safety and applicability.

[0044] The embodiments of the present invention are given for the purpose of illustration and description, and are not intended to be exhaustive or to limit the invention to the disclosed forms. Many modifications and variations will be apparent to those of ordinary skill in the art. The embodiments are selected and described in order to better illustrate the principles and practical applications of the present invention and to enable those of ordinary skill in the art to understand the present invention and thereby design various embodiments with various modifications suitable for specific uses.

Claims

1. A hirudin tablet formula, characterized in that: The formula includes natural hirudin, eriobotrya japonica, ginseng, ginkgo biloba, arbutus fragrans, and poria cocos; Among them, the dosage of natural hirudin is 0.01-0.1 mg / kg body weight / day, 5-10 g of Russian leaves, 1-3 g of ginseng, 5-10 g of ginkgo leaves, ≤10 g of Sorbus nigra, and 5-15 g of Poria cocos.

2. A hirudin tablet formulation as claimed in claim 1, characterized in that: Natural hirudin is extracted by enzymatic hydrolysis at a temperature of 30°C. 2-20 mg / kg body weight / day of leech freeze-dried powder can be used to replace natural hirudin.

3. A hirudin tablet formulation as claimed in claim 1, characterized in that: The Russian leaves need to be dried before adding, and the drying temperature is 60℃.

4. A hirudin tablet formulation as claimed in claim 1, characterized in that: Ginseng needs to be sliced ​​first, with the slice thickness being 2 mm.

5. A hirudin tablet formulation as claimed in claim 1, characterized in that: Ginkgo leaves need to be crushed to a particle size of 100 microns.

6. A hirudin tablet formulation as claimed in claim 1, characterized in that: Ultrasonic assisted extraction was used during the preparation of Aronia melanocarpa, and the ultrasonic power was 50 watts.

7. A hirudin tablet formulation as claimed in claim 1, characterized in that: Poria cocos needs to be soaked for 2 hours.

8. A hirudin tablet formulation as claimed in claim 1, characterized in that: The mixing order of the formula is natural hirudin, eriobotrya japonica leaf, ginseng, ginkgo leaf, arbutus fragrans, and poria cocos.

9. A hirudin tablet formulation as claimed in claim 1, characterized in that: The formula needs to be homogenized after mixing, and the homogenization pressure is 10 MPa.

10. A hirudin tablet formulation as claimed in claim 1, characterized in that: The formula also includes auxiliary additives, which include microcrystalline cellulose, pre-cross-linked starch, and maltodextrin; Among them, microcrystalline cellulose 5-10g, pre-melted starch 3-8g, maltodextrin 5-10g.

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