Deer blood tablet and preparation method thereof
By using a mixture of croscarmellose sodium and microcrystalline cellulose as a disintegrant in vermilion tablets and combining water-soluble carboxymethyl chitosan as a binder, the problem of long disintegration time of vermilion tablets is solved, and the tablets are quickly disintegrated and efficient absorption are achieved.
Patent Information
- Application Number
- CN202411785187.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-06
- Publication Date
- 2025-02-28
AI Technical Summary
The disintegration time of existing deer blood tablets is relatively long, which leads to slow absorption in the body and makes it difficult to take effect quickly.
A mixture of croscarmellose sodium and microcrystalline cellulose is used as the disintegrant, and combined with water-soluble carboxymethyl chitosan as the binder, these raw materials are evenly dispersed through an ethanol aqueous solution to improve the hardness and disintegration rate of the tablet.
It significantly shortens the disintegration time of deer blood tablets, improves the hardness and absorption speed of the tablets, and makes deer blood tablets take effect more quickly in the body.
Abstract
Description
Technical Field
[0001] The present application relates to the technical field of deer blood slices, and in particular to a deer blood slice and a preparation method thereof. Background Art
[0002] Deer blood is the blood of sika deer and red deer, which are animals of the Cervidae family. It is a precious Chinese medicine. Deer blood contains about 80% water and 16-16% organic matter, mainly protein. Protein is rich in 19 kinds of amino acids and various enzymes. In addition, it also contains a variety of lipids, free fatty acids, phospholipids, hormones, vitamins and polysaccharides. Deer blood also contains γ-globulin, cystine, lysine, and phosphocreatine kinase related to heart function. "Compendium of Materia Medica" has already recorded that "deer blood is used to treat impotence, tonify deficiency, stop back pain, epistaxis, falls, rabies, and wine. It can treat pulmonary tuberculosis, vomiting blood, metrorrhagia, leukorrhea, and all kinds of gas pain and danger. It can greatly tonify deficiency, benefit essence and blood, and relieve acne and drug poisoning." In modern times, animal experiments and clinical studies have proved that deer blood does have many therapeutic and health care functions, such as maintaining beauty, treating anemia, regulating immunity, delaying aging, improving memory, resisting fatigue, and improving sexual function.
[0003] For the convenience of consumption, deer blood is often made into lozenges or chewable tablets, but it is difficult to swallow due to the fishy smell of deer blood. When it is made into tablets for swallowing, it cannot be quickly absorbed by the human body because of the long disintegration time of the tablets. Summary of the invention
[0004] In order to reduce the disintegration time of deer blood tablets, the present application provides a deer blood tablet and a preparation method thereof.
[0005] In the first aspect, the present application provides a deer blood slice, which adopts the following technical solution: A deer blood tablet comprises the following raw materials in parts by weight: 150-160 parts of deer blood powder, 70-80 parts of American ginseng powder, 70-80 parts of wolfberry powder, 75-85 parts of a disintegrant, 2.5-4 parts of magnesium stearate and 2.5-3.5 parts of carboxymethyl chitosan; wherein the disintegrant is a mixture of cross-linked sodium carboxymethyl cellulose and microcrystalline cellulose, and the mass ratio of the cross-linked sodium carboxymethyl cellulose to the microcrystalline cellulose is (8-12):70.
[0006] By adopting the above technical scheme, the disintegrant selects a mixture of cross-linked carboxymethyl cellulose sodium and microcrystalline cellulose, and the disintegration rate is higher than when any one of the disintegrants is selected. The disintegrant uses microcrystalline cellulose, which can improve the hardness of the tablet and reduce the disintegration of the tablet, but the brittleness needs to be further improved; compounding with cross-linked carboxymethyl cellulose sodium can make the hardness of the tablet moderate, the disintegration is greatly reduced, and the brittleness is reduced; it shows that the two have a certain synergistic effect. The binder selects carboxymethyl chitosan, which has stronger bonding properties and can improve the hardness of the tablet. At the same time, its brittleness is also reduced. Chitosan has excellent properties such as biocompatibility, blood compatibility, safety, and microbial degradability in structure. It has the functions of improving immunity, activating cells, preventing cancer, lowering blood lipids, lowering blood pressure, anti-aging, and regulating the body environment. And based on its molecular structure, it contains a large number of hydrogen bonds and has high molecular viscosity. Using it as a binder for tablets can make the tablets have a higher hardness and reduce the brittleness of the tablets. However, when chitosan is directly mixed with tablet powder, it has a high viscosity and cannot be evenly dispersed, and tableting is difficult during preparation. Here, water-soluble carboxymethyl chitosan is selected and dissolved in ethanol aqueous solution, so that it can be evenly dispersed in the tablet, and its excellent bonding effect can be exerted, the tablet hardness is improved to a certain extent, and the tableting effect is good.
[0007] Preferably, the deer blood tablets further include 1-5 parts by weight of alkyl glycoside.
[0008] By adopting the above technical solution, the alkyl glycoside has low surface tension, rich and delicate foam, strong hydrophilicity and permeability, and is often used as a food additive. When added to deer blood tablets, it absorbs the body fluid during the disintegration process of the deer blood tablets, which can play a role of foaming and expansion, thereby improving the disintegration degree. In addition, it has a certain bonding effect, and its addition also helps to increase the hardness of the tablets and reduce the brittleness of the tablets.
[0009] Preferably, the alkyl glycoside is one or more of APG0810, APG0814 and APG1214.
[0010] By adopting the above technical solution, the foaming properties of these alkyl polyglycosides are all good. Theoretically, any of them can be selected within this range, but they are not explored one by one in the examples of this application.
[0011] Preferably, the added amount of the alkyl glycoside is 3 parts by weight.
[0012] By adopting the above technical solution, when the addition amount of alkyl glycoside is 3 parts by weight, the comprehensive performance of disintegration, hardness and friability of the tablet is optimal.
[0013] Preferably, the deer blood tablets further include 0.5-1.5 parts by weight of poloxamer.
[0014] By adopting the above technical solution, poloxamer as a surfactant can play a good compatibility role with alkyl glycoside, so that it can foam faster during disintegration, thereby reducing the disintegration rate. Poloxamer has a high viscosity and plays a role of a binder in the tablet, which can increase the hardness of the tablet and reduce the brittleness of the tablet.
[0015] Preferably, the average molecular weight of the poloxamer is 2100-12000.
[0016] By adopting the above technical solution, the higher the molecular weight of poloxamer, the greater the viscosity, resulting in a gradual increase in the hardness of the tablet. However, if the hardness of the tablet is too high, it is not conducive to the disintegration of the tablet. The tablets prepared within this molecular weight range have better comprehensive performance.
[0017] Preferably, the average molecular weight of the poloxamer is 8500.
[0018] By adopting the above technical solution, when the molecular weight of poloxamer is 8500, the synergy between poloxamer and alkyl glycoside is optimal, the disintegration degree of the tablet is the lowest, the friability is also low, and the hardness is moderate.
[0019] In a second aspect, the present application provides a method for preparing deer blood slices, using the following technical solution: A method for preparing deer blood slices comprises the following steps: S1. Mix deer blood powder, American ginseng powder, wolfberry powder and magnesium stearate to obtain a mixture; S2, prepare 55-60 parts by weight of 70-80% ethanol aqueous solution, then add the remaining raw materials except the disintegrant, stir evenly, and after the foam disappears, pour it into the mixture of S1, mix and stir to obtain a soft material, granulate the soft material through a 20-40 mesh sieve to obtain wet granules, and then dry to a water content of less than 6%, and sieve the dried granules through a 20-40 mesh sieve to obtain deer blood dry granules; S3, mixing the deer blood dry granules and the disintegrant, and then transferring them to a rotary tablet press for tableting, and drying the obtained tablets until the moisture content is less than 3%, thereby obtaining deer blood tablets.
[0020] By adopting the above technical scheme, since the powder of the deer blood tablets easily clumps when in contact with water, resulting in poor tableting performance, the use of ethanol aqueous solution can reduce the agglomeration of the powder and improve the tableting performance; and dissolving substances such as binders in the ethanol aqueous solution is conducive to their uniform dispersion in the deer blood tablets, so that the prepared deer blood tablets have uniform performance and good quality.
[0021] In summary, the present application includes at least one of the following beneficial technical effects: 1. The disintegrant is a mixture of cross-linked sodium carboxymethyl cellulose and microcrystalline cellulose, and its disintegration rate is higher than that of any one of the disintegrants. Using microcrystalline cellulose as a disintegrant can increase the hardness of the tablet and reduce the disintegration of the tablet, but the brittleness needs to be further improved; compounding with cross-linked sodium carboxymethyl cellulose can make the tablet hardness moderate, the disintegration is greatly reduced, and the brittleness is reduced; this shows that the two have a certain synergistic effect. Carboxymethyl chitosan is selected as a binder, which can make the tablet have a higher hardness and reduce the brittleness of the tablet. Dissolving it in an ethanol aqueous solution can make it evenly dispersed in the tablet, and can play its excellent bonding role. The hardness of the tablet is improved to a certain extent, and the tableting effect is good.
[0022] 2. Adding alkyl glycoside to deer blood tablets, during the disintegration process of deer blood tablets, it absorbs the body fluid and can play a role of foaming and expansion, thereby improving the disintegration degree. And it has a certain bonding effect. Adding it can also help to improve the hardness of the tablets and reduce the friability of the tablets. Poloxamer, as a surfactant, can play a good compatibility role with alkyl glycoside, so that it foams faster during disintegration, thereby reducing the disintegration degree. Poloxamer has a high viscosity, and it plays the role of a binder in the tablet, which can increase the hardness of the tablet and further reduce the friability of the tablet.
[0023] 2. The deer blood tablets prepared in the present application have a high deer blood content and moderate hardness, an average disintegration degree of 6 minutes or less, a friability of 0.88% or less, and a smooth surface without powdering or cracks, suitable for oral administration. DETAILED DESCRIPTION
[0024] The present application is further described in detail below in conjunction with the specific contents.
[0025] raw material The raw materials of the present application are all purchased from the market, among which the content of deer blood powder is 99%, purchased from Shaanxi Linzhou Biotechnology Co., Ltd.; the particle size of American ginseng powder is 50 mesh, purchased from Anhui Donghe Hanfang Biotechnology Co., Ltd.; the wolfberry powder is wolfberry freeze-dried powder, with a particle size of 50 mesh, purchased from Xi'an Dongchi Biotechnology Co., Ltd.; cross-linked sodium carboxymethyl cellulose is purchased from Shaanxi Zhengyi Pharmaceutical Excipients Co., Ltd.; carboxymethyl chitosan is a superior grade product, with CAS number 83512-85-0 and item number KH-SJ158; and magnesium stearate is food grade. Example
[0026] Example 1 A deer blood tablet, the raw materials and the amounts of the raw materials are shown in Table 1, and the preparation method is as follows: S1. Mix deer blood powder, American ginseng powder, wolfberry powder and magnesium stearate to obtain a mixture; S2, prepare 58.5kg of 75% ethanol aqueous solution, then add carboxymethyl chitosan, stir evenly, after the foam disappears, pour it into the mixture of S1, mix and stir to obtain a soft material, granulate the soft material through a 30-mesh sieve to obtain wet granules, then dry at 45°C to a water content of 4%, and granulate the dried granules through a 30-mesh sieve to obtain deer blood dry granules; S3. Stir and mix the deer blood dry granules and disintegrant, and then transfer them to a rotary tablet press for tableting. The prepared tablets are dried at 45° C. until the moisture content is less than 3%, thereby obtaining deer blood tablets; wherein the rotary tablet press has 9 strokes, a pressure of 40 kN, and a rotation speed of 20 r / min.
[0027] The disintegrant is a mixture of cross-linked sodium carboxymethyl cellulose and microcrystalline cellulose, and the mass ratio of cross-linked sodium carboxymethyl cellulose to microcrystalline cellulose is 10:70; carboxymethyl chitosan is a binder.
[0028] Table 1 Raw materials and amounts of raw materials in Example 1 (kg) Deer Blood Powder 155 American Ginseng Powder 77 Wolfberry powder 75 Disintegrants 80 Magnesium Stearate 3.1 Carboxymethyl chitosan 3.0 Example 2 A deer blood slice, which is different from Example 1 in that 3 kg of alkyl glycoside is further added to the raw materials, the alkyl glycoside is APG0810, the alkyl glycoside is added after carboxymethyl chitosan is added in S1, and the remaining steps are the same as in Example 1.
[0029] Example 3 A deer blood tablet, which is different from Example 1 in that 1 kg of alkyl glycoside is further added to the raw materials, the alkyl glycoside is APG0810, the alkyl glycoside is added when carboxymethyl chitosan is added in S1, and the remaining steps are the same as in Example 1.
[0030] Example 4 A deer blood slice, which is different from Example 1 in that 5 kg of alkyl glycoside is further added to the raw materials, the alkyl glycoside is APG0810, the alkyl glycoside is added when carboxymethyl chitosan is added in S1, and the remaining steps are the same as in Example 1.
[0031] Example 5 A deer blood tablet, which is different from Example 2 in that 1 kg of poloxamer is further added to the raw materials, and the poloxamer is added when carboxymethyl chitosan and alkyl glycoside are added in S1, and the remaining steps are the same as those in Example 2; the average molecular weight of the poloxamer is 2100, and the corresponding model is poloxamer 124.
[0032] Example 6 A deer blood tablet, which is different from Example 5 in that the average molecular weight of its poloxamer is 8500, and the corresponding model is poloxamer 188, and the remaining steps are the same as those of Example 5.
[0033] Example 7 A deer blood tablet, which is different from Example 5 in that the average molecular weight of its poloxamer is 12000, and the corresponding model is poloxamer 338, and the remaining steps are the same as Example 5.
[0034] Example 8 A deer blood tablet, which is different from Example 6 in that the amount of poloxamer added is 0.5 kg, and the remaining steps are the same as Example 6.
[0035] Example 9 A deer blood tablet, which is different from Example 6 in that the amount of poloxamer added is 1.5 kg, and the remaining steps are the same as Example 6.
[0036] Comparative Example Comparative Example 1 A deer blood tablet, which is different from Example 1 in that its disintegrant is cross-linked sodium carboxymethyl cellulose, and the remaining steps are the same as those of Example 1.
[0037] Comparative Example 2 A deer blood tablet, which is different from Example 1 in that its disintegrant is microcrystalline cellulose, and the remaining steps are the same as those of Example 1.
[0038] Comparative Example 3 A deer blood slice, which is different from Example 1 in that its binder is polyvinyl pyrrolidone, the model specification of polyvinyl pyrrolidone is K30, and the remaining steps are the same as those of Example 1.
[0039] Performance testing Detection method / test method Deer blood slices were prepared according to the preparation methods of Examples 1-9 and Comparative Examples 1-3, and then the following tests were performed. The test results are shown in Table 2.
[0040] Disintegration, hardness and friability were measured using the Shanghai Huanghai Drug Testing SY-2D tablet four-in-one tester.
[0041] Table 2 Test results of Examples 1-9 and Comparative Examples 1-3 Disintegration (min) Hardness(N) Friability (%) Example 1 6±3.2 23.13±5.73 0.87 Example 2 3.2±2.7 24.25±4.66 0.64 Example 3 4.1±2.9 23.72±6.70 0.79 Example 4 2.9±2.8 25.33±7.02 0.88 Example 5 1.9±0.8 28.35±2.01 0.22 Example 6 1.5±0.5 32.37±2.04 0.07 Example 7 2.1±1.2 35.14±10.39 0.37 Example 8 2.3±1.1 26.36±3.25 0.29 Example 9 5±1.6 37.18±4.24 0.05 Comparative Example 1 10.4±4.7 20.32±6.27 0.90 Comparative Example 2 9.5±4.9 25.83±5.68 0.93 Comparative Example 3 8.3±3.4 18.88±6.67 1.16 It can be seen from the test data of Examples 1-9 and Comparative Examples 1-3 that the deer blood tablets prepared by the present application have a high deer blood content and moderate hardness, an average disintegration degree of 6 minutes or less, a friability of 0.88% or less, and the surface of the prepared deer blood tablets is smooth, does not fall off, has no cracks, and is suitable for oral administration.
[0042] It can be seen from the test data of Example 1 and Comparative Example 2 that the disintegration rate is higher when the mixture of cross-linked carboxymethyl cellulose sodium and microcrystalline cellulose is selected as the disintegrator than when any one of the disintegrants is selected. The use of microcrystalline cellulose as a disintegrant can increase the hardness of the tablet and reduce the disintegration degree of the tablet, but the brittleness needs to be further improved; compounding with cross-linked carboxymethyl cellulose sodium can make the tablet hardness moderate, the disintegration degree is greatly reduced, and the brittleness is reduced; indicating that the two have a certain synergistic effect.
[0043] It can be seen from the test data of Example 1 and Comparative Example 3 that the binder selects carboxymethyl chitosan, and its bonding performance is stronger, and the hardness of the tablet can be improved, and at the same time, its friability is also reduced. Chitosan has excellent properties such as biocompatibility, blood compatibility, safety, microbial degradability in structure, and has the effects of improving immunity, activating cells, preventing cancer, reducing blood fat, reducing blood pressure, anti-aging, regulating body environment in function. And based on its molecular structure, it contains a large amount of hydrogen bonds, and the molecular viscosity is very high. Using it as the binder of tablets can make tablets have higher hardness, and can reduce the friability of tablets. But select chitosan, because it is insoluble in water, it is directly mixed with tablet powder, and its viscosity is larger, and it can not be evenly dispersed, and it is also difficult to compress tablets when preparing. Here select water-soluble carboxymethyl chitosan, dissolve it in ethanol aqueous solution, can make it dispersed evenly in tablets, can play its excellent bonding effect, tablet hardness is improved to a certain extent, and compressing tablets has a good effect.
[0044] Alkyl glycoside has low surface tension, rich and delicate foam, and has strong hydrophilicity and permeability, and is often used as a food additive. When it is added to deer blood tablets, it absorbs the body fluid during the disintegration process of the deer blood tablets, which can play a role in foaming and expansion, thereby improving the disintegration degree. And it has a certain bonding effect, and adding it also helps to improve the hardness of the tablets and reduce the friability of the tablets, as can be seen from the test results of Examples 1-4. And when the addition amount of alkyl glycoside is 3kg, the comprehensive performance of the disintegration degree, hardness and friability of the tablets is the best. When the addition amount is large, it is speculated that when it is mixed with the deer blood tablets, too many microbubbles are generated, causing the deer blood tablets to contain bubbles, resulting in a higher friability. On this basis, the inventor added poloxamer to the deer blood tablets. Poloxamer, as a surfactant, can play a good compatibility role with alkyl glycosides, so that it foams faster during disintegration, thereby reducing the disintegration degree. The viscosity of poloxamer is relatively high, and it plays the role of a binder in the tablet, which can improve the hardness of the tablet, and the higher its molecular weight, the greater its viscosity, resulting in a gradual increase in the tablet hardness, but the tablet hardness is too high, which is not conducive to the disintegration of the tablet. In conjunction with the test data of Examples 5-7, it can be seen that when the molecular weight of poloxamer is 8500, the synergy between it and the alkyl glycoside is the best, the disintegration of its tablet is the lowest, the friability is also low, and at the same time, its hardness is moderate. On this basis, in conjunction with Examples 8-9, the addition amount of poloxamer is 1kg, which is the optimal addition amount. If too much is added, the tablet hardness is too large, which is not conducive to its disintegration.
[0045] This specific embodiment is merely an explanation of the present invention and is not a limitation of the present invention. After reading this specification, those skilled in the art may make non-creative modifications to the present embodiment as needed. However, as long as they are within the scope of the claims of the present invention, they are protected by the patent law.
Claims
1. A deer blood slice, characterized in that: The invention comprises the following raw materials in parts by weight: 150-160 parts of deer blood powder, 70-80 parts of American ginseng powder, 70-80 parts of wolfberry powder, 75-85 parts of disintegrant, 2.5-4 parts of magnesium stearate and 2.5-3.5 parts of carboxymethyl chitosan; wherein the disintegrant is a mixture of cross-linked sodium carboxymethyl cellulose and microcrystalline cellulose, and the mass ratio of cross-linked sodium carboxymethyl cellulose to microcrystalline cellulose is (8-12):
70.
2. The deer blood slice according to claim 1, characterized in that: The deer blood tablets also include 1-5 parts by weight of alkyl glycoside.
3. The deer blood slice according to claim 2, characterized in that: The alkyl glycoside is one or more of APG0810, APG0814 and APG1214.
4. The deer blood slice according to claim 2, characterized in that: The added amount of the alkyl glycoside is 3 parts by weight.
5. The deer blood slice according to claim 2, characterized in that: The deer blood tablets also include 0.5-1.5 parts by weight of poloxamer.
6. The deer blood slice according to claim 5, characterized in that: The average molecular weight of the poloxamer is 2100-12000.
7. The deer blood slice according to claim 6, characterized in that: The average molecular weight of the poloxamer is 8500.
8. A method for preparing the deer blood slices according to any one of claims 1 to 7, characterized in that: It includes the following steps: S1. Mix deer blood powder, American ginseng powder, wolfberry powder and magnesium stearate to obtain a mixture; S2, prepare 55-60 parts by weight of 70-80% ethanol aqueous solution, then add the remaining raw materials except the disintegrant, stir evenly, and after the foam disappears, pour it into the mixture of S1, mix and stir to obtain a soft material, granulate the soft material through a 20-40 mesh sieve to obtain wet granules, and then dry to a water content of less than 6%, and sieve the dried granules through a 20-40 mesh sieve to obtain deer blood dry granules; S3, mixing the deer blood dry granules and the disintegrant, and then transferring them to a rotary tablet press for tableting, and drying the obtained tablets until the moisture content is less than 3%, thereby obtaining deer blood tablets.