Microcrystalline cellulose used as tablet auxiliary material as well as preparation method and application of microcrystalline cellulose
By optimizing the preparation process of microcrystalline cellulose, including ultrasonic treatment and acid hydrolysis, the tablet hardness and frigidity problems in the prior art are solved, and microcrystalline fibers with high hardness, low frigidity and short disintegration time are achieved. , which significantly improves the stability and application performance of the tablets.
Patent Information
- Application Number
- CN202411257159.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-09-09
- Publication Date
- 2024-12-10
- Estimated Expiration
- 2044-09-09
AI Technical Summary
The existing microcrystalline cellulose preparation methods have poor hardness and high frigidity, and prolonged disintegration time, making it difficult to meet the stability requirements of the tablets during transportation and use.
Short fibers are obtained by dispersing the dissolved slurry in water, sieving and drying, and ultrasonic treatment and acid hydrolysis are carried out to optimize the ultrasonic frequency, power and time of the fibers, and combined with the treatment of specific temperature and acid solution concentration, a relatively high fiber is prepared. Microcrystalline cellulose with hardness and low fragility.
The prepared microcrystalline cellulose has a particle size of less than 40 μm and a crystallinity of more than 75%. The ibuprofen tablets used for preparation exhibit fragility of less than 0.6% and hardness of more than 60N, disintegrating The time is less than 1300s and the dissolution is higher than 50%, which significantly improves the performance of the tablet.
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Abstract
Description
Technical Field
[0001] The invention relates to the technical field of microcrystalline cellulose preparation, and in particular to microcrystalline cellulose used as a tablet auxiliary material and a preparation method and application thereof. Background Art
[0002] The information disclosed in the background of the invention is only intended to enhance the understanding of the overall background of the invention and should not be necessarily regarded as an acknowledgment or any form of suggestion that the information constitutes the prior art already known to a person skilled in the art.
[0003] Microcrystalline cellulose is a cellulose derivative obtained by hydrolysis of cellulose. As a natural polymer material, it is widely used as an excipient in the preparation of pharmaceutical tablets in medicine. It mainly acts as a filler, and can also play the role of lubrication, flow aid, disintegration and bonding. It can reduce the friction between drug particles, improve the fluidity of drug particles, and facilitate tablet formation.
[0004] For tablets, they not only need to have a suitable disintegration time, but also need to have high hardness and low friability to prevent damage during transportation and use, and ensure the quality and stability of the drug. However, current methods often remain at the stage of optimizing the tablet molding process, lacking research on the regulation of the performance of the excipients themselves. The inventors found that when the microcrystalline cellulose obtained by the existing microcrystalline cellulose preparation process is used as a tablet excipient, the obtained tablets have poor hardness and high friability, even greater than 1%; and the increase in tablet hardness generally leads to a longer disintegration time.
[0005] Therefore, how to provide a method for preparing microcrystalline cellulose so that the prepared microcrystalline cellulose can make the tablets have higher hardness and lower friability and shorter disintegration time when used as a tablet excipient is an urgent problem to be solved. Summary of the invention
[0006] In view of this, the present invention provides a microcrystalline cellulose used as a tablet excipient, a preparation method and an application thereof. When the microcrystalline cellulose provided by the present invention is used as an excipient to prepare tablets, the tablets can have higher hardness and lower friability, and at the same time, the disintegration time is shorter.
[0007] In a first aspect, the present invention provides a method for preparing microcrystalline cellulose used as a tablet excipient, comprising the following steps:
[0008] The dissolving pulp is dispersed in water, and then debonded, sieved and dried to obtain short fibers;
[0009] The short fibers are dispersed in water for ultrasonic treatment, the ultrasonic frequency is 20 to 30 kHz, the ultrasonic power is 350 to 650 W, and the ultrasonic treatment time is 3 to 10 minutes;
[0010] The short fibers after ultrasonic treatment are subjected to acid hydrolysis, and then filtered, and the filter residue is washed and dried to obtain the product.
[0011] Preferably, the α-cellulose content of the dissolving pulp is above 95%; and the mesh size of the short fibers is 50 to 100 meshes.
[0012] Preferably, in the step of dispersing the short fibers in water and subjecting them to ultrasonic treatment, the mass fraction of the short fibers is 0.5 to 2 wt %.
[0013] Preferably, the temperature of the ultrasonic treatment is 0-5°C.
[0014] Preferably, the acid hydrolysis step is specifically as follows: placing the short fibers in an inorganic acid solution, and stirring and hydrolyzing at 80 to 90° C. for 50 to 70 minutes.
[0015] Furthermore, the inorganic acid is selected from hydrochloric acid, sulfuric acid or nitric acid, and the concentration of the inorganic acid solution is 3-5wt%.
[0016] Furthermore, the dosage ratio of the short fiber to the inorganic acid solution is 1 g: (20-40) mL; and the stirring speed is 100-500 rpm.
[0017] Preferably, in the steps of washing the filter residue and drying, the filter residue is washed with hot water at 95 to 100° C., and the drying method is freeze-drying.
[0018] In a second aspect, the present invention provides microcrystalline cellulose used as a tablet excipient, which is obtained by the above-mentioned preparation method.
[0019] In a third aspect, the present invention provides the use of the microcrystalline cellulose used as a tablet excipient in the preparation of ibuprofen tablets, wherein the ibuprofen tablets mainly include, by mass percentage: 32-38% of the microcrystalline cellulose used as a tablet excipient, 15-25% of ibuprofen, 1-3% of magnesium stearate, 2-4% of talc, 1-3% of stevioside, 2-4% of corn starch, and the balance is lactose;
[0020] The preparation method of the ibuprofen tablet is as follows: fully grinding and mixing the components according to a proportion, and tableting by a direct tableting method to obtain the ibuprofen tablet.
[0021] Compared with the prior art, the present invention has achieved the following beneficial effects:
[0022] The present invention first improves the uniformity of short fibers by screening, and then pre-treats the short fibers with ultrasound of a specific power, which can improve the water retention value and specific surface area of the fibers, improve the accessibility of chemical reagents to the short fibers during acid hydrolysis, and significantly affect the final microcrystalline cellulose particle size and crystallinity; the fibers are then acid-hydrolyzed to prepare microcrystalline cellulose, and the obtained microcrystalline cellulose has a smaller particle size, a median diameter D50 of less than 40 μm, and a higher crystallinity of more than 75%. When the microcrystalline cellulose obtained by the preparation method of the present invention is directly compressed to prepare ibuprofen tablets, the ibuprofen tablets exhibit low friability (less than 0.6%) and high hardness (more than 60N), while the disintegration time is less than 1300s and the dissolution rate is more than 50%, and has good application prospects. DETAILED DESCRIPTION
[0023] It should be noted that the following detailed descriptions are exemplary and are intended to provide further explanation of the present invention. Unless otherwise specified, all technical and scientific terms used herein have the same meanings as those commonly understood by those skilled in the art to which the present invention belongs.
[0024] The present invention provides a method for preparing microcrystalline cellulose used as a tablet excipient, comprising the following steps:
[0025] The dissolving pulp is dispersed in water, and then debonded, sieved and dried to obtain short fibers;
[0026] The short fibers are dispersed in water for ultrasonic treatment, the ultrasonic frequency is 20 to 30 kHz, the ultrasonic power is 350 to 650 W, and the ultrasonic treatment time is 3 to 10 minutes;
[0027] The short fibers after ultrasonic treatment are subjected to acid hydrolysis, and then filtered, and the filter residue is washed and dried to obtain the product.
[0028] The present invention uses dissolving pulp as a raw material for preparing microcrystalline cellulose, which has high fiber whiteness, uniform molecular weight, low ash content and good reaction performance, and is suitable for preparing microcrystalline cellulose. The present invention does not impose any special restrictions on the specific source of the dissolving pulp, and the commonly used dissolving pulp in the art can be used. The α-cellulose content of the dissolving pulp of the present invention is preferably above 95%, which is more conducive to the preparation of microcrystalline cellulose.
[0029] The present invention does not impose any special restrictions on the process of deflaking, screening and drying, and the commonly used deflaking, screening and drying methods in the art can be used. The above steps can obtain short fibers with uniform particle size, which is beneficial to the subsequent reaction and the performance of the final microcrystalline cellulose. In the present invention, the mesh number of the short fibers is preferably 50 to 100 meshes.
[0030] In the present invention, in the step of dispersing the short fibers in water for ultrasonic treatment, the mass fraction of the short fibers is 0.5-2 wt %. The appropriate concentration can fully disperse the short fibers and is conducive to absorbing the energy released by ultrasonic waves.
[0031] In the present invention, the temperature of the ultrasonic treatment is 0-5° C. Controlling the temperature within this range can avoid the adverse effects of the fiber itself caused by excessively high temperature caused by the ultrasonic wave.
[0032] The present invention preferably uses an ultrasonic probe to provide ultrasound, which can produce a greater cavitation effect. The ultrasonic power of the present invention is further preferably 350-550W, more preferably 430-470W; the ultrasonic treatment time is further preferably 4-6min. The ultrasonic power will have a greater impact on the performance of the final microcrystalline cellulose. If the ultrasonic power is too low, the performance improvement effect on the final microcrystalline cellulose is not obvious; if the ultrasonic power is too high, it will cause certain damage to the structure of the microcrystalline cellulose, thereby affecting the subsequent use performance. Therefore, the appropriate ultrasonic treatment power can make the microcrystalline cellulose have suitable properties such as morphology, particle size and crystallinity, thereby improving the hardness and solubility of the tablet when it is used as a filling excipient, reducing friability and shortening disintegration time.
[0033] The ultrasonic process of the present invention is carried out before acid hydrolysis, which can effectively avoid the corrosion of ultrasonic equipment on the one hand, and on the other hand, the short fibers treated with ultrasound have better reaction accessibility and can improve the reaction degree of the acid hydrolysis process.
[0034] In the present invention, the acid hydrolysis step is specifically: placing the short fibers in an inorganic acid solution, stirring and hydrolyzing at 80-90° C. for 50-70 minutes. The inorganic acid is selected from hydrochloric acid, sulfuric acid or nitric acid, and hydrochloric acid is preferred in the present invention. The concentration of the inorganic acid solution is 3-5wt%, more preferably 4wt%.
[0035] In the present invention, the ratio of the short fibers to the inorganic acid solution is 1 g: (20-40) mL; the stirring speed is 100-500 rpm, more preferably 100-300 rpm.
[0036] In the steps of washing the filter residue and drying the filter residue of the present invention, the filter residue is washed with hot water at 95-100°C, and the drying method is freeze drying. The present invention does not impose any special restrictions on the method of washing the filter residue with hot water and the specific steps of freeze drying, and the steps commonly used in the art can be used.
[0037] The present invention also provides microcrystalline cellulose used as a tablet auxiliary material, which is obtained by the above preparation method, has a polymerization degree of 160-180, a median diameter (D50) of 35-40 μm, and a crystallinity of 75.5-77%.
[0038] The present invention also provides the use of the microcrystalline cellulose used as a tablet excipient in the preparation of ibuprofen tablets, wherein the ibuprofen tablets mainly include, by mass percentage: 32-38% of the microcrystalline cellulose used as a tablet excipient, 15-25% of ibuprofen, 1-3% of magnesium stearate, 2-4% of talc, 1-3% of stevioside, 2-4% of corn starch, and the balance is lactose;
[0039] The preparation method of the ibuprofen tablet is as follows: fully grinding and mixing the components according to a proportion, and tableting by a direct tableting method to obtain the ibuprofen tablet.
[0040] In the present invention, the tabletting pressure is 8-12 MPa, more preferably 10 MPa.
[0041] The prepared ibuprofen tablets have a hardness higher than 60N, a disintegration time lower than 1300s, a friability lower than 0.6%, and a solubility higher than 50%.
[0042] The technical solution of the present invention is further described below in conjunction with specific embodiments.
[0043] Example 1
[0044] This embodiment provides a method for preparing microcrystalline cellulose.
[0045] (1) Weigh 500 g of an absolutely dry softwood dissolving pulp board, tear it into pieces and disperse it in water, soak it for 24 hours to disperse it, and sieve the fibers with a Bauer sieve to obtain 50-100 mesh short fibers.
[0046] (2) The short fibers obtained in step (1) were dried and transferred to a sealed bag to balance the moisture. The short fibers were basically characterized. The average fiber length was 0.690 mm, the average fiber width was 31.3 μm, the crystallinity was 72.63%, the water retention value was 0.9109 g / g, and the specific surface area was 4.1911 m 2 / g.
[0047] (3) Weigh 3.0 g (absolutely dry) of the short fibers obtained in step (2), place them in a 500 mL jacketed beaker, add a certain amount of deionized water to make the mass fraction of the short fibers 1 wt%, place them in an ultrasonic cell disruptor for reaction, connect an external intelligent energy-saving thermostatic bath, fix the ultrasonic frequency at 25 kHz, the treatment temperature at 0 ° C, the reaction time at 5 min, and the ultrasonic power at 360 W. After the ultrasonic treatment, balance the moisture content, characterize and analyze. After ultrasonic pretreatment, the water retention value of the short fibers is 1.1743 g / g, and the specific surface area is 6.1532 m 2 / g.
[0048] (4) Weigh 2.0 g (absolutely dry) of the short fibers obtained in step (3) and place them in a reaction container. Add hydrochloric acid and deionized water to the reaction container, wherein the amount of hydrochloric acid is 4 wt% and the solid-liquid ratio is 1 g:30 mL. The reaction is carried out in a heat-collecting constant temperature heating magnetic stirrer at a reaction temperature of 85° C. and a reaction time of 60 min.
[0049] (5) The reaction mixture obtained in step (4) is rapidly cooled, filtered using a G4 sand core funnel, and the solid hydrolyzate is fully washed with hot water until it is neutral. The solid hydrolyzate is freeze-dried for 48 hours to obtain microcrystalline cellulose.
[0050] Results: The degree of polymerization of the obtained microcrystalline cellulose was 181, D50 was 39.0 μm, and the crystallinity was 75.97%.
[0051] Example 2
[0052] This embodiment provides a method for preparing microcrystalline cellulose.
[0053] (1) Weigh 500 g of an absolutely dry softwood dissolving pulp board, tear it into pieces and disperse it in water, soak it for 24 hours to disperse it, and sieve the fibers with a Bauer sieve to obtain 50-100 mesh short fibers.
[0054] (2) The short fibers obtained in step (1) were dried and transferred to a sealed bag to balance the moisture. The short fibers were basically characterized. The average fiber length was 0.690 mm, the average fiber width was 31.3 μm, the crystallinity was 72.63%, the water retention value was 0.9109 g / g, and the specific surface area was 4.1911 m 2 / g.
[0055] (3) Weigh 3.0 g (absolutely dry) of the short fibers obtained in step (2), place them in a 500 mL jacketed beaker, add a certain amount of deionized water to make the mass fraction of the short fibers 1 wt%, place them in an ultrasonic cell disruptor for reaction, connect an external intelligent energy-saving thermostatic bath, fix the ultrasonic frequency at 25 kHz, the treatment temperature at 0 ° C, the reaction time at 5 min, and the ultrasonic power at 450 W. After the ultrasound is completed, balance the moisture content and characterize and analyze. After ultrasonic pretreatment, the water retention value of the short fibers is 1.2549 g / g, and the specific surface area is 6.9369 m 2 / g.
[0056] (4) Weigh 2.0 g (absolutely dry) of the short fibers obtained in step (3) and place them in a reaction container. Add hydrochloric acid and deionized water to the reaction container, wherein the amount of hydrochloric acid is 4 wt% and the solid-liquid ratio is 1 g:30 mL. The reaction is carried out in a heat-collecting constant temperature heating magnetic stirrer at a reaction temperature of 85° C. and a reaction time of 60 min.
[0057] (5) The reaction mixture obtained in step (4) is rapidly cooled, filtered using a G4 sand core funnel, and the solid hydrolyzate is fully washed with hot water until it is neutral. The solid hydrolyzate is freeze-dried for 48 hours to obtain microcrystalline cellulose.
[0058] Example 3
[0059] This embodiment provides a method for preparing microcrystalline cellulose.
[0060] (1) Weigh 500 g of an absolutely dry softwood dissolving pulp board, tear it into pieces and disperse it in water, soak it for 24 hours to disperse it, and sieve the fibers with a Bauer sieve to obtain 50-100 mesh short fibers.
[0061] (2) The short fibers obtained in step (1) were dried and transferred to a sealed bag to balance the moisture. The short fibers were basically characterized. The average fiber length was 0.690 mm, the average fiber width was 31.3 μm, the crystallinity was 72.63%, the water retention value was 0.9109 g / g, and the specific surface area was 4.1911 m 2 / g.
[0062] (3) Weigh 3.0 g (absolutely dry) of the short fibers obtained in step (2), place them in a 500 mL jacketed beaker, add a certain amount of deionized water to make the mass fraction of the short fibers 1 wt%, place them in an ultrasonic cell disruptor for reaction, connect an external intelligent energy-saving thermostatic bath, fix the ultrasonic frequency at 25 kHz, the treatment temperature at 0 ° C, the reaction time at 5 min, and the ultrasonic power at 540 W. After the ultrasound is completed, balance the moisture content and characterize and analyze. After ultrasonic pretreatment, the water retention value of the short fibers is 1.3686 g / g, and the specific surface area is 7.9751 m 2 / g.
[0063] (4) Weigh 2.0 g (absolutely dry) of the short fibers obtained in step (3) and place them in a reaction container. Add hydrochloric acid and deionized water to the reaction container, wherein the amount of hydrochloric acid is 4 wt% and the solid-liquid ratio is 1 g:30 mL. The reaction is carried out in a heat-collecting constant temperature heating magnetic stirrer at a reaction temperature of 85° C. and a reaction time of 60 min.
[0064] (5) The reaction mixture obtained in step (4) is rapidly cooled, filtered using a G4 sand core funnel, and the solid hydrolyzate is fully washed with hot water until it is neutral. The solid hydrolyzate is freeze-dried for 48 hours to obtain microcrystalline cellulose.
[0065] Example 4
[0066] This embodiment provides a method for preparing microcrystalline cellulose.
[0067] (1) Weigh 500 g of an absolutely dry softwood dissolving pulp board, tear it into pieces and disperse it in water, soak it for 24 hours to disperse it, and sieve the fibers with a Bauer sieve to obtain 50-100 mesh short fibers.
[0068] (2) The short fibers obtained in step (1) were dried and transferred to a sealed bag to balance the moisture. The short fibers were basically characterized. The average fiber length was 0.690 mm, the average fiber width was 31.3 μm, the crystallinity was 72.63%, the water retention value was 0.9109 g / g, and the specific surface area was 4.1911 m 2 / g.
[0069] (3) Weigh 3.0 g (absolutely dry) of the short fibers obtained in step (2), place them in a 500 mL jacketed beaker, add a certain amount of deionized water to make the mass fraction of the short fibers 1 wt%, place them in an ultrasonic cell disruptor for reaction, connect an external intelligent energy-saving thermostatic bath, fix the ultrasonic frequency at 25 kHz, the treatment temperature at 0 ° C, the reaction time at 5 min, and the ultrasonic power at 630 W. After the ultrasound is completed, balance the moisture content and characterize and analyze. After ultrasonic pretreatment, the water retention value of the short fibers is 1.3742 g / g, and the specific surface area is 8.6879 m 2 / g.
[0070] (4) Weigh 2.0 g (absolutely dry) of the short fibers obtained in step (3) and place them in a reaction container. Add hydrochloric acid and deionized water to the reaction container, wherein the amount of hydrochloric acid is 4 wt% and the solid-liquid ratio is 1 g:30 mL. The reaction is carried out in a heat-collecting constant temperature heating magnetic stirrer at a reaction temperature of 85° C. and a reaction time of 60 min.
[0071] (5) The reaction mixture obtained in step (4) is rapidly cooled, filtered using a G4 sand core funnel, and the solid hydrolyzate is fully washed with hot water until it is neutral. The solid hydrolyzate is freeze-dried for 48 hours to obtain microcrystalline cellulose.
[0072] Comparative Example 1
[0073] Compared with Example 1, this comparative example does not undergo ultrasonic treatment. The specific steps are as follows:
[0074] (1) Weigh 500 g of an absolutely dry softwood dissolving pulp board, tear it into pieces and disperse it in water, soak it for 24 hours to disperse it, and sieve the fibers with a Bauer sieve to obtain 50-100 mesh short fibers.
[0075] (2) The short fibers obtained in step (1) were dried and transferred to a sealed bag to balance the moisture. The short fibers were basically characterized. The average fiber length was 0.690 mm, the average fiber width was 31.3 μm, the crystallinity was 72.63%, the water retention value was 0.9109 g / g, and the specific surface area was 4.1911 m 2 / g.
[0076] (3) Weigh 2.0 g (absolutely dry) of the short fibers obtained in step (2) and place them in a reaction container. Add hydrochloric acid and deionized water to the reaction container, wherein the amount of hydrochloric acid is 4 wt% and the solid-liquid ratio is 1 g:30 mL. The reaction is carried out in a heat-collecting constant temperature heating magnetic stirrer at a reaction temperature of 85° C. and a reaction time of 60 min.
[0077] (5) The reaction mixture obtained in step (4) is rapidly cooled, filtered using a G4 sand core funnel, and the solid hydrolyzate is fully washed with hot water until it is neutral. The solid hydrolyzate is freeze-dried for 48 hours to obtain microcrystalline cellulose.
[0078] Comparative Example 2
[0079] Compared with Example 1, the ultrasonic power of this comparative example is 180W.
[0080] Comparative Example 3
[0081] Compared with Example 1, the ultrasonic power of this comparative example is 270W.
[0082] Application Examples
[0083] The microcrystalline cellulose of Examples 1 to 4 and Comparative Examples 1 to 3 was used as a pharmaceutical excipient, and ibuprofen tablets were prepared according to the following formula: by mass fraction, microcrystalline cellulose 35%, lactose 35%, ibuprofen 20%, magnesium stearate 2%, talc 3%, stevioside 2%, corn starch 3%; the preparation method was: all the components were fully ground and mixed, and tablets were compressed by direct tableting method, the tableting pressure was 10 MPa, and the tablet mass was controlled to be 200 mg.
[0084] The properties of the microcrystalline cellulose of Examples 1 to 4, Comparative Examples 1 to 3 and the prepared ibuprofen tablets were measured, as shown in Table 1.
[0085] Table 1 Performance data of microcrystalline cellulose and ibuprofen tablets
[0086]
[0087] As can be seen from Table 1, when no ultrasonic treatment is performed, the crystallinity of microcrystalline cellulose is 73.25%, the particle size D50 is 42.9 μm, the tablet hardness obtained is less than 50N, the disintegration time is long, up to 1473s, the friability is also high, and the dissolution rate is only 48.75%. When the ultrasonic treatment power is low (less than 300W), the influence on microcrystalline cellulose and tablet performance is small. When the ultrasonic treatment power reaches more than 360W, the particle size D50 of microcrystalline cellulose is less than 40 μm, the crystallinity reaches more than 75.5%, and the tablet hardness remains above 60N, the friability is less than 0.6%, and the disintegration time is within 1260s. When the ultrasonic treatment power is 450W, the prepared microcrystalline cellulose has the highest crystallinity, and the tablet friability is the lowest (less than 0.5%), the hardness is the highest (higher than 70N), and has a shorter disintegration time. As the ultrasonic power continued to increase, the particle size and degree of polymerization of microcrystalline cellulose continued to decrease, but the crystallinity also decreased, the hardness of the resulting tablets also decreased, and the friability increased.
[0088] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.
Claims
1. A method for preparing microcrystalline cellulose used as a tablet excipient, characterized in that: The steps include: The dissolving pulp is dispersed in water, and then debonded, sieved and dried to obtain short fibers; The short fibers are dispersed in water for ultrasonic treatment, the ultrasonic frequency is 20 to 30 kHz, the ultrasonic power is 350 to 650 W, and the ultrasonic treatment time is 3 to 10 minutes; The short fibers after ultrasonic treatment are subjected to acid hydrolysis, and then filtered, and the filter residue is washed and dried to obtain the product.
2. The preparation method according to claim 1, characterized in that The α-cellulose content of the dissolving pulp is above 95%; the mesh number of the short fibers is 50 to 100 meshes.
3. The preparation method according to claim 1, characterized in that: In the step of dispersing the short fibers in water and subjecting them to ultrasonic treatment, the mass fraction of the short fibers is 0.5-2 wt %.
4. The preparation method according to claim 1, characterized in that: The temperature of the ultrasonic treatment is 0-5°C.
5. The preparation method according to claim 1, characterized in that: The acid hydrolysis step is specifically as follows: placing the short fibers in an inorganic acid solution, and stirring and hydrolyzing at 80 to 90° C. for 50 to 70 minutes.
6. The preparation method according to claim 5, characterized in that: The inorganic acid is selected from hydrochloric acid, sulfuric acid or nitric acid, and the concentration of the inorganic acid solution is 3-5 wt %.
7. The preparation method according to claim 5, characterized in that: The dosage ratio of the short fiber to the inorganic acid solution is 1 g: (20-40) mL; the stirring speed is 100-500 rpm.
8. The preparation method according to claim 1, characterized in that: In the steps of washing the filter residue and drying, the filter residue is washed with hot water at 95-100° C., and the drying method is freeze drying.
9. A microcrystalline cellulose for use as a tablet excipient, characterized in that: Obtained by the preparation method according to any one of claims 1 to 8.
10. The use of microcrystalline cellulose as a tablet excipient in the preparation of ibuprofen tablets as claimed in claim 9, characterized in that: The ibuprofen tablet mainly comprises, by mass percentage, 32-38% of the microcrystalline cellulose used as tablet excipients, 15-25% of ibuprofen, 1-3% of magnesium stearate, 2-4% of talc, 1-3% of stevioside, 2-4% of corn starch, and the balance of lactose; The preparation method of the ibuprofen tablet is as follows: fully grinding and mixing the components according to a proportion, and tableting by a direct tableting method to obtain the ibuprofen tablet.
Citation Information
Patent Citations
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CN103232547A
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CN109666078A
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CN117285656A
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CN117304346A
