Xinmaikang tablet and preparation method thereof

Abstract

The invention provides Xinmaikang tablets and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. The Xinmaikang tablet comprises medicinal components and auxiliary materials, the medicine components comprise turtle shells, rhizoma sparganii, curcuma zedoary, immature bitter oranges, prepared arisaema cum bile and dendrobe, and the auxiliary materials comprise a disintegrating agent, a filling agent and a lubricating agent. On the basis of the patent CN109700972A, auxiliary materials are selected, so that the prepared Xinmaikang tablet has better stability and brittleness, and the disintegration efficiency and the dissolution rate of the tablet both meet the requirements.

Description

Technical Field

[0001] The present invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a Xinmaikang tablet and a preparation method thereof. Background Art

[0002] Atherosclerosis is an inflammatory condition of the arteries that causes thickening and hardening of the arterial walls, loss of elasticity, and narrowing of the lumen. Atherosclerosis is a vascular disease that develops with aging, typically beginning in adolescence and worsening in middle or older age. Atherosclerosis is highly prevalent and affects arteries throughout the body, primarily the aorta, coronary arteries, cerebral arteries, renal arteries, and large and medium-sized muscular elastic arteries, ultimately leading to stenosis and even complete blockage of their lumen, resulting in ischemia and hypoxia in vital organs, dysfunction, and even death.

[0003] Atherosclerosis (AS) is a common form of arteriosclerosis obliterans and a leading cause of cardiovascular and cerebrovascular diseases, including coronary heart disease. It primarily affects large and medium-sized arteries in the body, such as the coronary arteries, cerebral arteries, carotid arteries, and femoral arteries. AS is characterized by the deposition of cholesterol and other lipids in the intima and subintima of arterial walls and their branches, accompanied by smooth muscle cell proliferation, forming atherosclerotic plaques, ultimately leading to narrowing of arterial diameter and thickening and hardening of the arterial wall. In recent years, modern medicine has made breakthrough advances in the basic theory and prevention and treatment of AS. Comprehensive interventions to address the development and progression of AS can effectively reduce the incidence of cardiovascular and cerebrovascular events. Major treatment options include medication, surgery, and interventional therapy. However, the incidence of atherosclerosis remains high. While existing treatments can slow the disease's progression, they are not yet a cure, and Western medicine carries significant side effects. Traditional Chinese medicine offers a comprehensive and diverse range of methods for preventing and treating atherosclerosis, offering unique advantages and promising prospects for its future application in the prevention and treatment of AS.

[0004] The "softening and dispersing nodules" method, developed by Dr. Ye Xiaohan, Chief TCM Physician of Dongguan City Traditional Chinese Medicine Hospital, draws on years of clinical experience in cardiovascular medicine and combines it with current medical understanding of arteriosclerosis. It is a method for treating atherosclerosis by focusing on the accumulation of symptoms. It posits that lipid metabolism disorders, leading to lipid accumulation within vascular endothelial cells, lead to internal accumulation of qi, blood, phlegm, and stasis. This accumulation, which persists and causes atherosclerosis, is the basis for the proposed method's prevention and treatment.

[0005] Chinese Patent CN109700972A discloses a Chinese herbal medicine composition, its preparation method, and application. The composition comprises the following components: Carapace of Turtle, Trigonosciadium japonicum, Curcuma zedoaria, Citrus aurantium immaturus, processed Gallbladder Starch, and Dendrobium officinale. The preparation method comprises the following steps: taking a portion of Trigonosciadium japonicum and a portion of Curcuma zedoaria, grinding them into fine powder, and sieving to obtain a first powder; mixing the Trigonosciadium japonicum, Citrus aurantium immaturus, processed Gallbladder Starch, and Dendrobium officinale with the remaining Trigonosciadium japonicum and Curcuma zedoaria, adding water and reflux for extraction; filtering the extract, concentrating the filtrate into a paste, and then grinding it into a fine powder to obtain a second powder; mixing the first and second powders, and adding excipients to form a desired dosage form. The composition is used in the treatment of arteriosclerosis, cerebral infarction, coronary heart disease, hyperlipidemia, and fatty liver. The Chinese medicine composition described in this invention has good therapeutic effects on arteriosclerosis, cerebral infarction, coronary heart disease, hyperlipidemia and fatty liver, and has low side effects. The turtle shell is the main ingredient in the composition, which has the effects of nourishing yin and clearing heat, suppressing yang and extinguishing wind, and softening and dispersing nodules. Trillium and Curcuma have the functions of breaking blood and promoting qi circulation, eliminating accumulation and relieving pain. The two herbs combined with turtle shell have the effect of softening and dispersing nodules. Citrus aurantium can break up qi and eliminate accumulation, resolve phlegm and eliminate abdominal distension, while Radix Glechomae can clear heat and resolve phlegm. The two herbs can eliminate phlegm and help dissipate nodules. Dendrobium can promote fluid production and benefit the stomach, nourish yin and clear heat, replenish qi and tonify the kidney, improve eyesight and strengthen the waist. The qi-breaking effect of the first five herbs can be controlled, so that the qi-breaking effect is not damaged by the qi-replenishing effect, and the other five herbs can be prevented from damaging gastrointestinal function. The six herbs are used together to soften and dissipate nodules, and replenish qi and unblock the meridians.

[0006] However, the stability and brittleness of the traditional Chinese medicine tablet compositions prepared in the prior art cannot better meet the needs, so it is necessary to develop a Xinmaikang tablet with better stability and brittleness and a preparation method thereof. Summary of the Invention

[0007] Based on the deficiencies in the prior art, the present invention selects excipients based on patent CN109700972A to make the prepared Xinmaikang tablets have better stability and brittleness, and the disintegration efficiency and dissolution rate of the tablets meet the requirements.

[0008] In order to achieve the above purpose, the following technical solutions are adopted:

[0009] The invention provides a Xinmaikang tablet, which comprises medicinal ingredients and auxiliary materials; the medicinal ingredients are composed of turtle shell, triangularis root, zedoaria, immature bitter orange, processed dandelion and dendrobium, and the auxiliary materials include a disintegrant, a filler and a lubricant.

[0010] in,

[0011] The disintegrant is selected from one or more of sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, cross-linked polyvinyl pyrrolidone and cross-linked sodium carboxymethyl cellulose;

[0012] Preferably, the disintegrant is a mixture of cross-linked sodium carboxymethyl cellulose and sodium carboxymethyl starch;

[0013] More preferably, the disintegrant is cross-linked sodium carboxymethyl cellulose and sodium carboxymethyl starch in a mass ratio of 2-5:1;

[0014] More preferably, the disintegrant is cross-linked sodium carboxymethyl cellulose and sodium carboxymethyl starch in a mass ratio of 3:1.

[0015] The filler is selected from one or more of dextrin, lactose and compressible starch;

[0016] Preferably, the filler is a mixture of dextrin, lactose and compressible starch;

[0017] More preferably, the filler is dextrin, lactose and compressible starch in a mass ratio of 3-5:1-2:2-4;

[0018] Further preferably, the filler is dextrin, lactose and compressible starch in a mass ratio of 4:1:3.

[0019] The lubricant is magnesium stearate.

[0020] The present invention also provides a method for preparing the Xinmaikang tablets, comprising the following steps:

[0021] 1. Pretreatment of medicinal materials:

[0022] Take the prescribed amount of turtle shell, immature bitter orange, scutellaria baicalensis, dendrobium, three-edged sword and zedoaria, clean and dry them, and set aside;

[0023] 2. Preparation of medicinal extracts:

[0024] (2.1) Take the dried Dendrobium and half of the Curcuma zedoaria and add them to a wall-breaking machine, add water and beat to obtain a slurry, set aside;

[0025] (2.2) heating water, steaming the dried turtle shell, immature bitter orange, herba dandelae and half of the amount of Tripterygium wilfordii, adding the steamed medicinal materials to the slurry in step (2) and adding water for reflux extraction, filtering the extract, and then concentrating it to a water content of 15-20%, thereby obtaining a medicinal material extract;

[0026] 3. Preparation of Tablets

[0027] (3.1) Grind the remaining half of the Curcuma zedoaria and the other half of the Tripterygium wilfordii to a particle size of 80-100 mesh to obtain a powder;

[0028] (3.2) Adding medicinal material extract and filler to the powder in step S1 and mixing to prepare a soft material;

[0029] (3.3) Drying the soft material in step S2, and then adding a disintegrant and a lubricant to granulate the soft material to obtain granules;

[0030] (3.4) The granules prepared in step S3 are compressed into tablets to obtain the Xinmaikang tablets.

[0031] The amount of water added in the above step (2.1) is 2-3 times the weight of the medicinal material; preferably 2 times;

[0032] The amount of water added in the above step (2.2) is 3-5 times the weight of the medicinal material; preferably 4 times.

[0033] The medicinal material extract used as the adhesive in the present invention can not only retain the effective ingredients in the medicinal material, making the final product more stable in physical properties, but also enhance the medicinal effect.

[0034] As some preferred embodiments, the mass ratio of the disintegrant, medicinal material extract, filler and lubricant is 1-3:2-5:1-3:1;

[0035] More preferably, the mass ratio of the disintegrant, medicinal material extract, filler and lubricant is 2:5:2:1.

[0036] During the implementation of the present invention, it was found that using medicinal material extract as a binder and controlling the mass ratio of disintegrant, medicinal material extract, filler and lubricant to be 1-3:2-5:1-3:1 can not only enable the tablets to be better formed, have better stability and brittleness, but also enable the tablets to have better disintegration efficiency and solubility, so that the prepared pharmaceutical tablets have a better pass rate.

[0037] As some preferred embodiments, the mass ratio of the turtle shell, Trigonosciadium japonicum, Curcuma zedoaria, Citrus aurantium, processed Gastrodia elata and Dendrobium officinale is 5-15:2-10:2-10:3-12:0.5-6:2-15.

[0038] As a preferred embodiment, the mass ratio of the turtle shell, Trigonosciadium japonicum, Curcuma zedoaria, Citrus aurantium, processed Gastrodia elata and Dendrobium officinale is 10:5:5:6:3:10.

[0039] Compared with the prior art, the present invention has the following beneficial effects:

[0040] (1) The present invention studies the dosage form of a Chinese medicine composition based on the existing patent CN109700972A, and unexpectedly finds that the performance of pharmaceutical tablets can be significantly improved by controlling the composition and mass ratio of excipients. During the implementation process, it was found that using medicinal material extract as a binder and controlling the mass ratio of disintegrant, medicinal material extract, filler and lubricant to be 1-3:2-5:1-3:1 can not only make the tablets better shaped, but also have better stability and brittleness, and the prepared pharmaceutical tablets have a better pass rate.

[0041] (2) The present invention uses a mixture of cross-linked sodium carboxymethyl cellulose and sodium carboxymethyl starch as a disintegrant, a mixture of dextrin, lactose and compressible starch as a filler, and a medicinal material extract as a binder. Through the reasonable combination of the various components, the disintegration efficiency and dissolution rate of the drug tablets meet the requirements, thereby improving the bioavailability of the Chinese medicinal materials. DETAILED DESCRIPTION

[0042] The following will be combined with the tables in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0043] Hereinafter, examples of the present invention and comparative examples will be shown to explain the composition of the present invention in more detail, but the present invention is not limited thereto.

[0044] The present invention does not limit the sources of the raw materials used. Unless otherwise specified, the raw materials used in the present invention are common commercial products in the technical field.

[0045] Example 1 A Xinmaikang tablet and its preparation method

[0046] The Xinmaikang tablets include medicinal ingredients and excipients; the medicinal ingredients are composed of 10 parts of turtle shell, 5 parts of Trigonum multiflorum, 5 parts of Curcuma zedoaria, 6 parts of Citrus aurantium, 3 parts of processed Gastrodia elata and 10 parts of Dendrobium officinale, and the excipients are disintegrants, fillers and lubricants.

[0047] The disintegrant is cross-linked sodium carboxymethyl cellulose and sodium carboxymethyl starch in a mass ratio of 2:1;

[0048] The filler is dextrin, lactose and compressible starch in a mass ratio of 3:1:2;

[0049] The lubricant is magnesium stearate;

[0050] The preparation method comprises the following steps:

[0051] 1. Pretreatment of medicinal materials:

[0052] Take the prescribed amount of turtle shell, immature bitter orange, scutellaria baicalensis, dendrobium, three-edged sword and zedoaria, clean and dry them, and set aside;

[0053] 2. Preparation of medicinal extracts:

[0054] (2.1) Take the dried Dendrobium and half of the Curcuma zedoaria and add them to a wall-breaking machine with 2 times the amount of water to make a pulp, and set aside;

[0055] (2.2) heating water, steaming the dried turtle shell, immature bitter orange, prepared dandelion and half of the amount of Tripterygium wilfordii, adding the steamed medicinal materials to the slurry in step (2) and adding 5 times the amount of water for reflux extraction, filtering the extract, and then concentrating it to a water content of 15-20%, thereby obtaining a medicinal material extract;

[0056] 3. Preparation of Tablets

[0057] (3.1) Grind the remaining half of the Curcuma zedoaria and the other half of the Tripterygium wilfordii to a particle size of 80-100 mesh to obtain a powder;

[0058] (3.2) Adding medicinal material extract and filler to the powder in step S1 and mixing to prepare a soft material;

[0059] (3.3) Drying the soft material in step S2, and then adding a disintegrant and a lubricant to granulate the soft material to obtain granules;

[0060] (3.4) The granules prepared in step S3 are compressed into tablets to obtain the Xinmaikang tablets.

[0061] The mass ratio of the disintegrant, the medicinal extract, the filler and the lubricant is 1:2:1:1.

[0062] Example 2 A Xinmaikang tablet and its preparation method

[0063] The Xinmaikang tablets include ingredients and excipients; the medicinal ingredients are composed of 10 parts of turtle shell, 5 parts of Trigonosciadium japonicum, 5 parts of Curcuma zedoaria, 6 parts of Citrus aurantium, 3 parts of processed Gastrodia elata and 10 parts of Dendrobium officinale, and the excipients are disintegrants, fillers and lubricants.

[0064] The disintegrants are cross-linked sodium carboxymethyl cellulose and sodium carboxymethyl starch in a mass ratio of 5:1;

[0065] The filler is dextrin, lactose and compressible starch in a mass ratio of 5:2:4;

[0066] The lubricant is magnesium stearate;

[0067] The preparation method comprises the following steps:

[0068] 1. Pretreatment of medicinal materials:

[0069] Take the prescribed amount of turtle shell, immature bitter orange, scutellaria baicalensis, dendrobium, three-edged sword and zedoaria, clean and dry them, and set aside;

[0070] 2. Preparation of medicinal extracts:

[0071] (2.1) Take the dried Dendrobium and half of the amount of Curcuma zedoaria and add them to a wall-breaking machine with 3 times the amount of water to make a pulp, and set aside;

[0072] (2.2) heating water, steaming the dried turtle shell, immature bitter orange, prepared dandelion and half of the amount of Tripterygium wilfordii, adding the steamed medicinal materials to the slurry in step (2) and adding 3 times the amount of water for reflux extraction, filtering the extract, and then concentrating it to a water content of 15-20%, thereby obtaining a medicinal material extract;

[0073] 3. Preparation of Tablets

[0074] (3.1) Grind the remaining half of the Curcuma zedoaria and the other half of the Tripterygium wilfordii to a particle size of 80-100 mesh to obtain a powder;

[0075] (3.2) Adding medicinal material extract and filler to the powder in step S1 and mixing to prepare a soft material;

[0076] (3.3) Drying the soft material in step S2, and then adding a disintegrant and a lubricant to granulate the soft material to obtain granules;

[0077] (3.4) The granules prepared in step S3 are compressed into tablets to obtain the Xinmaikang tablets.

[0078] The mass ratio of the disintegrant, medicinal material extract, filler and lubricant is 3:5:3:1.

[0079] Example 3 A Xinmaikang tablet and its preparation method

[0080] The Xinmaikang tablets include ingredients and excipients; the medicinal ingredients are composed of 10 parts of turtle shell, 5 parts of Trigonosciadium japonicum, 5 parts of Curcuma zedoaria, 6 parts of Citrus aurantium, 3 parts of processed Gastrodia elata and 10 parts of Dendrobium officinale, and the excipients are disintegrants, fillers and lubricants.

[0081] The disintegrants are cross-linked sodium carboxymethyl cellulose and sodium carboxymethyl starch in a mass ratio of 3:1;

[0082] The filler is dextrin, lactose and compressible starch in a mass ratio of 4:1:3;

[0083] The lubricant is magnesium stearate;

[0084] The preparation method comprises the following steps:

[0085] 1. Pretreatment of medicinal materials:

[0086] Take the prescribed amount of turtle shell, immature bitter orange, scutellaria baicalensis, dendrobium, three-edged sword and zedoaria, clean and dry them, and set aside;

[0087] 2. Preparation of medicinal extracts:

[0088] (2.1) Take the dried Dendrobium and half of the Curcuma zedoaria and add them to a wall-breaking machine with 2 times the amount of water to make a pulp, and set aside;

[0089] (2.2) heating water, steaming the dried turtle shell, immature bitter orange, prepared dandelion and half of the amount of Tripterygium wilfordii, adding the steamed medicinal materials to the slurry in step (2) and adding 4 times the amount of water for reflux extraction, filtering the extract, and then concentrating it to a water content of 15-20%, thereby obtaining a medicinal material extract;

[0090] 3. Preparation of Tablets

[0091] (3.1) Grind the remaining half of the Curcuma zedoaria and the other half of the Tripterygium wilfordii to a particle size of 80-100 mesh to obtain a powder;

[0092] (3.2) Adding medicinal material extract and filler to the powder in step S1 and mixing to prepare a soft material;

[0093] (3.3) Drying the soft material in step S2, and then adding a disintegrant and a lubricant to granulate the soft material to obtain granules;

[0094] (3.4) The granules prepared in step S3 are compressed into tablets to obtain the Xinmaikang tablets.

[0095] The mass ratio of the disintegrant, medicinal material extract, filler and lubricant is 2:5:2:1.

[0096] Comparative Example 1

[0097] The difference from Example 3 is that the mass ratio of disintegrant, medicinal material extract, filler and lubricant is 4:1:4:1, the total mass of disintegrant, medicinal material extract, filler and lubricant is the same as that of Example 3, and the rest are the same as that of Example 3.

[0098] Comparative Example 2

[0099] The difference from Example 3 is that the mass ratio of disintegrant, medicinal material extract, filler and lubricant is 1:7:1:1, the total mass of disintegrant, medicinal material extract, filler and lubricant is the same as that of Example 3, and the rest are the same as that of Example 3.

[0100] Comparative Example 3

[0101] The difference from Example 3 is that the disintegrant is only cross-linked sodium carboxymethyl cellulose and the filler is only dextrin; the rest is the same as Example 3.

[0102] Comparative Example 4

[0103] The difference from Example 3 is that the disintegrant is cross-linked sodium carboxymethyl cellulose and sodium carboxymethyl starch in a mass ratio of 1:3; and the filler is microcrystalline cellulose.

[0104] Effect experiment:

[0105] 1. The appearance, hardness, friability and disintegration time of the prepared tablets were tested. Random samples were taken three times and the average value was taken. The results are shown in Table 1 below.

[0106] Table 1

[0107]

[0108]

[0109] According to the test results in Table 1 above, the Xinmaikang tablets prepared in Examples 1-3 of the present invention have a smooth surface, suitable hardness, a friability of 0.12-0.15%, and no cracking phenomenon, which is significantly better than the Xinmaikang tablets prepared in Comparative Examples 1-4.

[0110] From Comparative Examples 1-2, it can be seen that changing the mass ratio of disintegrant, medicinal extract, filler and lubricant affects the interaction between the active ingredients of the drug and the excipient components, thereby significantly affecting the friability of the tablets; in addition, changing the mass ratio of disintegrant, medicinal extract, filler and lubricant affects the uniformity of the mixing between the components, thereby significantly affecting the disintegration time of the tablets.

[0111] It can be seen from Comparative Examples 3-4 that changing the type and ratio of disintegrants will also affect the friability of tablets. The reason may be that different types or ratios of disintegrants or fillers will affect the interaction between the active ingredients and the excipient components, thereby significantly affecting the disintegration and friability of the tablets.

[0112] That is, only the Xinmaikang tablets obtained by the method of the present invention have better appearance, disintegration time and brittleness.

[0113] 2. Stability testing

[0114] A glass desiccator containing a supersaturated sodium chloride solution at the bottom was placed in a constant temperature oven at 40°C for 5 hours. The relative humidity in the desiccator was then 75%. Xinmaikang tablets prepared in Examples 1-3 and Comparative Examples 1-4 were placed in a constant weight flat weighing bottle (10 tablets per case). After accurate weighing, the tablets were placed in a desiccator and stored at 40°C. After 12 hours, the tablets were weighed. The moisture absorption percentage of the Xinmaikang tablets was calculated by measuring the weight before and after moisture absorption. The results are shown in Table 2 below.

[0115] Table 2

[0116] Moisture absorption percentage % Example 1 2.54 Example 2 2.46 Example 3 2.13 Comparative Example 1 3.97 Comparative Example 2 4.08 Comparative Example 3 3.15 Comparative Example 4 3.20

[0117] According to the test results in Table 2 above, it can be seen that the Xinmaikang tablets prepared in Examples 1-3 of the present invention have better stability. When stored for 12 hours at a relative humidity of 75% and 40°C, the tablets show no obvious changes, and the moisture absorption percentage is 2.13-2.54%, which is better than the Xinmaikang tablets prepared in Comparative Examples 1-4.

[0118] Changing the mass ratio of disintegrant, medicinal material extract, filler and lubricant in Comparative Example 1-2 will affect the interaction between the active ingredients of the drug and the excipient components, resulting in poor moisture resistance of the prepared Xinmaikang tablets and a significant increase in the percentage of moisture absorption.

[0119] Changing the type and ratio of the disintegrant in Comparative Examples 3-4 also affects the hygroscopicity of the tablets, resulting in poor moisture resistance of the prepared Xinmaikang tablets and increased moisture absorption percentage.

[0120] Obviously, the described embodiments are only individual embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other implementations obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

Claims

1. A Xinmaikang tablet, characterized in that: The Xinmaikang tablets include pharmaceutical ingredients and excipients; the pharmaceutical ingredients are composed of turtle shell, Trigonosciadium japonicum, Curcuma zedoaria, Citrus aurantium, processed Gastrodia elata and Dendrobium candidum, and the excipients include disintegrants, fillers and lubricants; The disintegrant is selected from one or more of sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, cross-linked polyvinyl pyrrolidone and cross-linked sodium carboxymethyl cellulose; The filler is selected from one or more of dextrin, lactose and compressible starch.

2. The Xinmaikang tablet according to claim 1, characterized in that: The disintegrant is cross-linked sodium carboxymethyl cellulose and sodium carboxymethyl starch in a mass ratio of 2-5:

1.

3. The Xinmaikang tablet according to claim 2, characterized in that: The disintegrant is cross-linked sodium carboxymethyl cellulose and sodium carboxymethyl starch in a mass ratio of 3:

1.

4. The Xinmaikang tablet according to claim 1, characterized in that: The filler is dextrin, lactose and compressible starch in a mass ratio of 3-5:1-2:2-4.

5. The Xinmaikang tablet according to claim 4, characterized in that: The filler is dextrin, lactose and compressible starch in a mass ratio of 4:1:

3.

6. The Xinmaikang tablet according to claim 1, characterized in that: The mass ratio of the turtle shell, triangular prawn, zedoary turmeric, immature bitter orange, processed scutellaria baicalensis and dendrobium is 5-15:2-10:2-10:3-12:0.5-6:2-15.

7. The method for preparing the Xinmaikang tablet according to any one of claims 1 to 6, characterized in that: The steps include:

1. Pretreatment of medicinal materials: Take the prescribed amount of turtle shell, immature bitter orange, scutellaria baicalensis, dendrobium, three-edged sword and zedoaria, clean and dry them, and set aside; 2. Preparation of medicinal extracts: (2.1) Take the dried Dendrobium and half of the Curcuma zedoaria and add them to a wall-breaking machine, add water and beat to obtain a slurry, set aside; (2.2) heating water, steaming the dried turtle shell, immature bitter orange, herba dandelae and half of the amount of Tripterygium wilfordii, adding the steamed medicinal materials to the slurry in step (2) and adding water for reflux extraction, filtering the extract, and then concentrating it to a water content of 15-20%, thereby obtaining a medicinal material extract; 3. Preparation of Tablets (3.1) Grind the remaining half of the Curcuma zedoaria and the other half of the Tripterygium wilfordii to a particle size of 80-100 mesh to obtain a powder; (3.2) Adding medicinal material extract and filler to the powder in step S1 and mixing to prepare a soft material; (3.3) Drying the soft material in step S2, and then adding a disintegrant and a lubricant to granulate the soft material to obtain granules; (3.4) The granules prepared in step S3 are compressed into tablets to obtain the Xinmaikang tablets.

8. The preparation method according to claim 7, characterized in that: The amount of water added in step (2.1) is 2-3 times the weight of the medicinal material; the amount of water added in step (2.2) is 3-5 times the weight of the medicinal material.

9. The preparation method according to claim 7, characterized in that: The mass ratio of the disintegrant, medicinal material extract, filler and lubricant is 1-3:2-5:1-3:

1.

10. The preparation method according to claim 7, characterized in that: The mass ratio of the disintegrant, medicinal material extract, filler and lubricant is 2:5:2:1.

Images