Valsartan-silicon dioxide micro-capsule orally disintegrating tablet and preparation method thereof

Abstract

The invention discloses a valsartan-silicon dioxide micro-capsule orally disintegrating tablet and a preparation method thereof, and relates to the technical field of medicines. The invention relates to a preparation method of a valsartan-silicon dioxide micro-capsule orally disintegrating tablet. The preparation method comprises the following steps: S11, preparing an aqueous solution of a cationic surface active agent; s12, valsartan is added and stirred, so that the surface of valsartan is positively charged; s13, continuing to add silicon dioxide and stirring to enable a silicon dioxide monomer to be adsorbed on the surface of valsartan; and S14, continuously adding the cationic polymer and carrying out high-speed shearing, so that the cationic polymer is encapsulated on the surface of the silicon dioxide. The valsartan-silicon dioxide micro-capsule orally disintegrating tablet prepared by the invention has a medicine taste masking effect, and the taste masking effect is excellent; meanwhile, the problems of poor compressibility and flowability of materials caused by hygroscopicity and viscosity of valsartan are solved; a sweetening agent and a flavoring agent are not needed in the formula, so that the formula is simplified, impurities are prevented from being introduced into the essence, and the stability is effectively improved.

Description

Technical Field

[0001] The invention relates to the technical field of medicines, and in particular to a valsartan-silicon dioxide microcapsule orally disintegrating tablet and a preparation method thereof. Background Art

[0002] Orally disintegrating tablets refer to tablets that can quickly disintegrate or dissolve in the mouth without the need for water. The formulation requirements for orally disintegrating tablets include: they can quickly disintegrate or dissolve in the mouth, have a good taste, are easy to swallow, and are non-irritating to the oral mucosa. The drugs in orally disintegrating tablets are mainly absorbed through the intestinal mucosa, and some drugs can be absorbed through the oral mucosa, with the advantages of rapid absorption, rapid onset of action, and high bioavailability.

[0003] Orally disintegrating tablets are a new type of solid rapid-release and fast-acting preparation developed in recent years, and have become a hot topic in tablet research and development after chewable tablets and dispersible tablets. This type of preparation not only provides new ideas for the development of rapid-acting preparations, but also opens up new ways for clinical medication for special patients. It is especially suitable for children, the elderly, patients with mental illness or dysphagia who are unwilling to cooperate, and personnel who need to work in special environments.

[0004] Valsartan is an angiotensin II receptor antagonist. Valsartan can selectively act on the AT1 receptor subtype known to be associated with the action of angiotensin II, selectively block the binding of angiotensin II to the AT1 receptors of tissue cells such as the adrenal glands and vascular smooth muscle, inhibit vasoconstriction and aldosterone secretion, and produce a hypotensive effect. Valsartan has the advantages of rapid oral onset, few side effects, and no effect on heart rate when blood pressure drops. Therefore, valsartan has been widely used in the field of hypertension treatment, bringing good news and hope to patients.

[0005] At present, the valsartan dosage forms available for clinical selection in China include ordinary tablets, dispersible tablets, and capsules. Tablets and capsules are large in size and are not suitable for young and elderly people with weak swallowing ability. Orodisintegrating valsartan tablets have better blood pressure control rates for the treatment of severe hypertension and reduce adverse reactions. In particular, orodisintegrating tablets do not need to be taken with water, which provides convenience for some elderly people, infants and children, or patients with difficulty in swallowing drugs or difficulty in getting water. Orodisintegrating valsartan tablets are easy to take, have a good taste, fast efficacy, high bioavailability, and greatly improve patient compliance.

[0006] Chinese patent CN108938581A discloses a valsartan orally disintegrating tablet and its preparation method. This patent adopts a powder direct compression process, but valsartan will become moist or agglomerate due to moisture absorption, which affects the fluidity of the powder and increases the viscosity between the powder particles. This may cause the machine to not run smoothly and the process to be not smooth during the direct tableting process.

[0007] Chinese patents CN110652499A and CN115707454A disclose a valsartan orodisintegrating tablet and a preparation method thereof. This patent adopts a process of spray-drying and mixing the granules with the spices dissolved in propylene glycol after dry granulation. Although the compressibility and fluidity of the material are improved, the taste masking process is complicated and the taste masking effect is average; because valsartan tastes relatively bitter, patients have a poor experience of taking valsartan orodisintegrating tablets orally.

[0008] Therefore, overcoming the problems of poor compressibility and fluidity of valsartan due to its hygroscopicity and viscosity, optimizing the taste masking process, improving the taste, and enhancing the stability of the preparation are technical problems currently faced by general technicians in this field.

[0009] The information disclosed in this background technology section is only intended to enhance the understanding of the overall background of the invention and should not be 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. Summary of the invention

[0010] In view of the above technical problems, the embodiments of the present invention provide a valsartan-silicon dioxide microcapsule orally disintegrating tablet and a preparation method thereof to solve the problems raised in the above background technology.

[0011] A method for preparing a valsartan-silicon dioxide microcapsule orally disintegrating tablet comprises the following steps: S11: preparing an aqueous solution of a cationic surfactant; S12: adding valsartan and stirring to make the surface of valsartan carry positive charge; Figure 1 As shown in a; S13: continue to add silicon dioxide and stir to allow silicon dioxide monomer to be adsorbed on the surface of valsartan; Figure 1 b where shown; S14: continue to add the cationic polymer and perform high-speed shearing to encapsulate the cationic polymer on the surface of the silica, and after the encapsulation is completed, valsartan-silica microcapsules with a complete microcapsule shell structure are obtained; Figure 1 As shown in c; the speed of high-speed shearing is 1000rpm - 20000 rpm; S15: Fillers, binders, disintegrants and lubricants are uniformly added into valsartan-silicon dioxide microcapsules and pressed into tablets.

[0012] In step S12, the surface of valsartan can be positively charged because valsartan is a hydrophobic drug with hydrophobic groups in its molecular structure. The cationic surfactant contacts valsartan through the hydrophobic groups and the hydrophilic groups contact the aqueous solution, causing the cationic surfactant to aggregate on the surface of valsartan through its cationic groups, making the surface of valsartan positively charged.

[0013] In step S13, silica is adsorbed on the surface of valsartan because silica is negatively charged in the range of pH>2, and silica monomers are adsorbed and polymerized on the surface of valsartan through electrostatic adsorption; the thickness of the silica layer polymerized and wrapped on the surface of valsartan will be different depending on the amount of silica used.

[0014] In step S14, the cationic polymer is encapsulated in the outer layer of silica under the action of high-speed shear force, filling the gaps on the surface of the silica layer to form a complete valsartan-silica microcapsule structure, thereby increasing the stability of the valsartan-silica microcapsule; at the same time, cationic polymers usually contain multiple quaternary ammonium groups, which can form a stable three-dimensional network structure with gaps through different cross-linking methods, and this structure also has a sustained-release effect.

[0015] Preferably, the cationic surfactant is selected from one or more of: amine salt type cationic surfactants, quaternary ammonium salt type cationic surfactants, heterocyclic type cationic surfactants, such as hexadecyltrimethylammonium chloride (CTAC), octadecyltrimethylammonium chloride, cationic guar gum, cationic panthenol, cationic silicone oil, dodecyldimethylamine oxide, etc.

[0016] Preferably, the cationic polymer is selected from: one or more of polyquaternium polymers, polyacrylamine (PAM), polyamine, polyvinylamine (PEI) cationic polymers, such as polyquaternium-7, polyquaternium-6, polyquaternium-5, polyquaternium-39, etc.

[0017] Preferably, the raw material components in the valsartan-silicon dioxide microcapsule orally disintegrating tablets include, by weight: 10-40 parts of valsartan, 1-20 parts of silicon dioxide, 17-81.5 parts of filler, 2-5 parts of binder, 5-25 parts of disintegrant, and 0.5-3 parts of lubricant.

[0018] Preferably, the weight ratio of valsartan to silicon dioxide in the orodisintegrating tablet is 10:1-1:1.

[0019] Preferably, the weight ratio of the cationic surfactant to silicon dioxide in the orally disintegrating tablet is 0.01:1-1:1; the weight ratio of the cationic polymer to silicon dioxide in the orally disintegrating tablet is 0.01:1-1:1.

[0020] Preferably, in steps S11-S12, the weight ratio of water added to silicon dioxide in the aqueous solution is 0.01:1-2.8:1; the standard is that after adding an appropriate amount of silicon dioxide to the aqueous solution for adsorption, the material is solid or semi-solid.

[0021] Preferably, the filler is selected from one or more of microcrystalline cellulose, lactose, starch, mannitol, pregelatinized starch, dextrin, powdered sugar, and inorganic salts.

[0022] Preferably, the disintegrant is selected from one or more of low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, cross-linked sodium carboxymethyl cellulose, cross-linked polyvinylpyrrolidone, dry starch, and effervescent disintegrant.

[0023] Preferably, the binder is selected from one or more of hydroxypropyl methylcellulose, hydroxypropyl cellulose, pregelatinized starch, povidone, copovidone, ethyl cellulose, methyl cellulose, and starch slurry.

[0024] Preferably, the lubricant is selected from one or more of magnesium stearate, calcium stearate, stearic acid, glyceryl monostearate, and glyceryl distearate.

[0025] A valsartan-silicon dioxide microcapsule orally disintegrating tablet is prepared by the preparation method of the valsartan-silicon dioxide microcapsule orally disintegrating tablet as described above.

[0026] A valsartan-silicon dioxide microcapsule orally disintegrating tablet and a preparation method thereof provided in an embodiment of the present invention have the following beneficial effects: (1) By preparing valsartan-silica microcapsules, silica can form a microcapsule shell layer on the surface of valsartan, and the silica shell layer can effectively wrap the valsartan particles to form a physical isolation layer, thereby preventing valsartan from directly contacting moisture in the air, so that the surface of valsartan is no longer exposed, thereby avoiding adhesion and moisture caused by valsartan absorbing moisture; (2) The silica microcapsules form a microcapsule shell layer on the surface of the valsartan particles. This microcapsule shell can effectively isolate valsartan from the taste receptors in the mouth. Since the bitter taste of valsartan mainly comes from its solubility and direct contact with the taste buds, the silica microcapsule shell can provide a physical barrier to prevent its taste from being released in the mouth, thus achieving a taste-masking effect. (3) The prepared valsartan-silicon dioxide microcapsules have an excellent taste-masking effect, a smooth taste, and no gritty feeling; at the same time, since no sweeteners and flavoring agents are required in the formula, the formula is simplified, impurities introduced by flavors are avoided, and stability is effectively improved; (4) By controlling the amount of silica monomer adsorption and polymer encapsulation, the shell thickness of the microcapsule can be adjusted, and then the dissolution curve can be adjusted to meet different drug release requirements; (5) By mixing valsartan-silica microcapsules and excipients and directly compressing them into tablets, the process is simple and has low requirements on equipment and production lines; (6) By mixing valsartan-silica microcapsules with excipients and directly compressing them into tablets, it is possible to ensure that the tablets quickly disintegrate into granules, which further disintegrate to release the drug. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1Various particle structures presented during the preparation of valsartan-silica microcapsules; in, Figure 1 a is a demonstration diagram of the effect of positive charge on the surface of valsartan; Figure 1 b is a demonstration diagram of the effect of silica monomer adsorbed on the surface of valsartan; 1c is an electron microscope image of valsartan-silica microcapsules; Figure 2 The dissolution curve results of Examples 1-4 are shown. DETAILED DESCRIPTION

[0028] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments 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 those skilled in the art without creative work are within the scope of protection of the present invention.

[0029] In view of the above technical problems, the embodiments of the present invention provide a valsartan-silicon dioxide microcapsule orally disintegrating tablet and a preparation method thereof to solve the problems raised in the above background technology.

[0030] 1. Experimental Grouping Example 1 The raw material components of valsartan-silicon dioxide microcapsule orally disintegrating tablets are shown in Table 1 by weight.

[0031] Prepare an aqueous solution of hexadecyltrimethylammonium chloride (CTAC), add valsartan, and stir for 30 minutes.

[0032] Silica was added and stirred for 30 minutes to allow silica monomer to be adsorbed.

[0033] Add polyquaternium-7 and stir for 30 minutes for polymer encapsulation.

[0034] Valsartan-silica microcapsules were formed.

[0035] Add low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, microcrystalline cellulose, lactose and magnesium stearate, mix well and press into tablets to obtain the product.

[0036] Example 2 The raw material components of valsartan-silicon dioxide microcapsule orally disintegrating tablets are shown in Table 2 by weight.

[0037] Octadecyltrimethylammonium chloride was prepared into an aqueous solution, valsartan was added, and the mixture was stirred for 10 minutes.

[0038] Add silica and stir for 10 minutes to adsorb silica monomer.

[0039] Add polyquaternium-7 and stir for 10 minutes for polymer encapsulation.

[0040] Valsartan-silica microcapsules were formed.

[0041] Add low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, microcrystalline cellulose, lactose and magnesium stearate, mix well and press into tablets to obtain the product.

[0042] Example 3 The raw material components of valsartan-silicon dioxide microcapsule orally disintegrating tablets are shown in Table 3 by weight.

[0043] Cetyltrimethylammonium chloride (CTAC) was prepared into an aqueous solution, valsartan was added, and stirred for 10 minutes.

[0044] Add silica and stir for 1 hour to allow silica monomer to be adsorbed.

[0045] Add 5 and stir for 1 h for polymer encapsulation.

[0046] Valsartan-silica microcapsules were formed.

[0047] Add low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, microcrystalline cellulose, lactose and magnesium stearate, mix well and press into tablets to obtain the product.

[0048] Example 4 The raw material components of valsartan-silicon dioxide microcapsule orally disintegrating tablets are shown in Table 4 by weight.

[0049] Cetyltrimethylammonium chloride (CTAC) was prepared into an aqueous solution, valsartan was added, and stirred for 10 minutes.

[0050] Silica was added and stirred for 30 minutes to allow silica monomer to be adsorbed.

[0051] Add polyquaternium-7 and stir for 30 minutes for polymer encapsulation.

[0052] Add low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, microcrystalline cellulose, lactose and magnesium stearate, mix well and press into tablets to obtain the product.

[0053] Example 5 The raw material components of valsartan-silicon dioxide microcapsule orally disintegrating tablets are shown in Table 5 by weight.

[0054] Cetyltrimethylammonium chloride (CTAC) was prepared into an aqueous solution, valsartan was added, and stirred for 10 minutes.

[0055] Add silica and stir for 10 minutes to adsorb silica monomer.

[0056] Add polyquaternium-7 and stir for 10 minutes for polymer encapsulation.

[0057] Valsartan-silica microcapsules were formed.

[0058] Add low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, microcrystalline cellulose, lactose, aspartame, orange flavor, and magnesium stearate, mix well, and press into tablets to obtain the product.

[0059] Example 6 The raw material components of valsartan-silicon dioxide microcapsule orally disintegrating tablets are shown in Table 6 by weight.

[0060] Cetyltrimethylammonium chloride (CTAC) was prepared into an aqueous solution, valsartan was added, and stirred for 10 minutes.

[0061] Add silica and stir for 10 minutes to adsorb silica monomer.

[0062] Add polyquaternium-7 and stir for 10 minutes for polymer encapsulation.

[0063] Valsartan-silica microcapsules were formed.

[0064] Add low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, microcrystalline cellulose, lactose, aspartame, mint flavor, and magnesium stearate, mix well, and press into tablets to obtain the product.

[0065] Comparative Example 1 The raw material components of valsartan-silicon dioxide microcapsule orally disintegrating tablets are shown in Table 7 by weight.

[0066] Valsartan was sieved through a 100-mesh sieve, and other excipients were sieved through a 60-mesh sieve for later use; Weigh the formula amount of valsartan, colloidal silicon dioxide, mannitol, microcrystalline cellulose, calcium silicate, low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, saccharin sodium, apple powder flavor, magnesium stearate, valsartan and colloidal silicon dioxide and mix them evenly; The above mixture was compressed into tablets.

[0067] Comparative Example 2 The raw material components of valsartan-silicon dioxide microcapsule orally disintegrating tablets are shown in Table 8 by weight.

[0068] Valsartan was sieved through a 100-mesh sieve, and other excipients were sieved through a 60-mesh sieve for later use; Weigh the formula amount of valsartan and colloidal silicon dioxide, pass through a 100-mesh sieve and mix evenly to obtain a valsartan and colloidal silicon dioxide complex; Weigh the formula amount of lactose, microcrystalline cellulose, calcium silicate, low-substituted hydroxypropyl cellulose, crospovidone, aspartame, strawberry powder flavor, magnesium stearate and valsartan and colloidal silicon dioxide complex and mix them evenly; The above mixture was compressed into tablets.

[0069] Comparative Example 3 The raw material components of valsartan-silicon dioxide microcapsule orally disintegrating tablets are shown in Table 9 by weight.

[0070] Mix valsartan, part of the flavoring agent, filler, binder and part of the disintegrant in a three-dimensional mixer for 3 minutes until uniformly mixed; The mixture was granulated using a dry granulator; the sieve was 24 mesh; The particles are spray-dried and mixed with a flavoring agent in a multifunctional fluidized bed, wherein the flavoring agent is a flavor dissolved in propylene glycol at a certain concentration; Add the remaining flavoring agent, disintegrant, glidant and lubricant and mix well; Tablets of the required hardness were obtained by tableting using a Φ7 mm flat die.

[0071] Comparative Example 4 The raw material components of valsartan-silicon dioxide microcapsule orally disintegrating tablets are shown in Table 10 by weight.

[0072] Prepare an aqueous solution of hexadecyltrimethylammonium chloride (CTAC), add valsartan, and stir for 30 minutes.

[0073] Silica was added and stirred for 30 minutes to allow silica monomer to be adsorbed.

[0074] Valsartan-silica microcapsules were formed.

[0075] Add low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, microcrystalline cellulose, lactose and magnesium stearate, mix well and press into tablets to obtain the product.

[0076] 2. Group Experiment Performance Evaluation 1. Investigation of properties of total mixed particles The properties of the total mixed particles of the embodiments and comparative examples of the present invention were investigated, and the results are shown in Table 11:

[0077] The particles of Examples 1-6 have very good fluidity and good compressibility. Comparative Example 1 powder is directly compressed, and the material fluidity is very poor and the compressibility is poor. Comparative Example 2 prepares a valsartan and colloidal silica composite, and the material fluidity is poor, the compressibility is poor, and the improvement effect is weak. Comparative Example 3 is dry granulated. Although the total mixed particles have general fluidity and compressibility, the dry granulation material has very poor fluidity and cannot be smoothly discharged. Comparative Example 4 particles have very good fluidity and good compressibility. The valsartan-silica microcapsules are not encapsulated with cationic polymers, which will not affect the properties of the total mixed particles.

[0078] 2. Tablet properties inspection The hardness, friability and disintegration time of the tablets of each embodiment and each comparative example were investigated. The results are shown in Table 12:

[0079] Examples 1-6 have good compressibility, tablet hardness is controlled at 40-60N, hardness is moderate, friability is qualified, and disintegration is rapid. Comparative Examples 1 and 2 have very poor compressibility, the maximum hardness can only be compressed to 20-30N, and the friability is unqualified. Comparative Example 3 has average compressibility, the hardness can be controlled at 40-60N, and the disintegration is slow. Comparative Example 4 has good compressibility, tablet hardness is controlled at 40-60N, hardness is moderate, friability is qualified, and disintegration is rapid.

[0080] 3. Tablet taste test The taste of the tablets of the examples and comparative examples was investigated, and at least 10 subjects were asked to taste the tablets. The results are shown in Table 13:

[0081] Embodiment 1-4 has a fine taste without a sense of gravel and bitterness. Since no flavoring agent and sweetener are added, there is no sweetness and fragrance, and no peculiar smell. Embodiment 5 adds aspartame and orange flavor, and has sweetness and orange fragrance. Embodiment 6 adds aspartame and mint flavor, has sweetness, mint fragrance and refreshing feeling, has both the sweetness just entered the mouth, and the mint fragrance and refreshing feeling can well cover the peculiar smell brought by the sweetness of aspartame. Comparative Example 1-3 has a heavy bitter taste, and aspartame has a heavy sweet taste. The aspartame taste rush causes a certain peculiar smell, and the mouthfeel is poor. Although Comparative Example 4 has no bitterness in the entrance, the aftereffect has a bitter taste, and the taste masking effect is general. The encapsulation of cationic polymer is not carried out, and the surface of valsartan-silicon dioxide microcapsule has pores, and the shell layer is incomplete, which will affect the taste masking effect.

[0082] 4. Dissolution curve investigation The dissolution curves (pH 4.5 / 500 ml / paddle method / 50 rpm) of Examples 1-4 and Comparative Example 4 were investigated. The results are shown in Figure 2 And Table 14:

[0083] In Example 1, the prescription ratio of silica to valsartan is 1:10, the amount of silica monomer adsorption and the amount of polymer encapsulation are small, and the formed valsartan-silica microcapsules are thinner; in Example 2, the prescription ratio of silica to valsartan is 1:2; in Example 3, the prescription ratio of silica to valsartan is 1:4; in Example 4, the prescription ratio of silica to valsartan is 1:1, the amount of silica monomer adsorption and the amount of polymer encapsulation are large, and the formed valsartan-silica microcapsules are thicker; in Comparative Example 4, the valsartan-silica microcapsules are not encapsulated with cationic polymers, and there are pores on the surface of the microcapsules.

[0084] If valsartan-silica microcapsules are not encapsulated with cationic polymers, there will be pores on the surface of the microcapsules and the capsule shell will be incomplete. Compared with valsartan-silica microcapsules encapsulated with cationic polymers, the drug dissolves faster. By controlling the amount of silica monomer adsorption and the amount of polymer encapsulation, the capsule shell thickness of the microcapsule can be adjusted, and then the dissolution curve can be adjusted to meet different drug release requirements. At the same time, the dissolution curve can be adjusted by adjusting the amount of disintegrant, binder and filler in the formula to meet different drug release requirements. The dissolution curve is controllable.

[0085] 5. Formulation process evaluation After preparing valsartan-silicon dioxide microcapsules in embodiment 1-6, auxiliary materials are added for mixed tableting, which is simple to operate, has low requirements on equipment and production line, and the prepared valsartan orodisintegrating tablets are of qualified quality. Comparative Example 1-2 has a complex formula and an unsmooth process, and the prepared valsartan orodisintegrating tablets are of poor quality. Comparative Example 3 has a complex formula and a complex process, and the prepared valsartan orodisintegrating tablets are of average quality. The valsartan-silicon dioxide microcapsule orodisintegrating tablets prepared according to the formula and process of the present invention have obvious advantages.

[0086] The embodiments described above are only descriptions of the preferred implementation modes of the present invention, and are not intended to limit the scope of the present invention. Without departing from the design spirit of the present invention, various modifications and improvements made to the technical solutions of the present invention by ordinary technicians in this field should fall within the protection scope determined by the claims of the present invention.

Claims

1. A method for preparing a valsartan-silicon dioxide microcapsule orally disintegrating tablet, characterized in that: The following steps are involved: S11: preparing an aqueous solution of a cationic surfactant; S12: adding valsartan and stirring to make the surface of valsartan carry positive charge; S13: continue to add silicon dioxide and stir to allow silicon dioxide monomer to be adsorbed on the surface of valsartan; S14: continue to add the cationic polymer and perform high-speed shearing to encapsulate the cationic polymer on the surface of the silica, and after the encapsulation is completed, valsartan-silica microcapsules with a complete microcapsule shell structure are obtained; S15: Fillers, binders, disintegrants and lubricants are uniformly added into valsartan-silicon dioxide microcapsules and pressed into tablets.

2. The method for preparing the valsartan-silicon dioxide microcapsule orally disintegrating tablet according to claim 1, characterized in that: The cationic surfactant is selected from one of an amine salt type cationic surfactant, a quaternary ammonium salt type cationic surfactant, and a heterocyclic type cationic surfactant.

3. The method for preparing the valsartan-silicon dioxide microcapsule orally disintegrating tablet according to claim 1, characterized in that: The raw material components in the valsartan-silicon dioxide microcapsule orally disintegrating tablet include, by weight: 0.01-40 parts of cationic surfactant, 10-40 parts of valsartan, 0.01-40 parts of cationic polymer, 1-20 parts of silicon dioxide, 17-81.5 parts of filler, 2-5 parts of binder, 5-25 parts of disintegrant, and 0.5-3 parts of lubricant.

4. The method for preparing the valsartan-silicon dioxide microcapsule orally disintegrating tablet according to claim 1, characterized in that: The weight ratio of valsartan to silicon dioxide in the orodisintegrating tablet is 10:1-1:

1.

5. The method for preparing the valsartan-silicon dioxide microcapsule orally disintegrating tablet according to claim 1, characterized in that: The weight ratio of the cationic surfactant to silicon dioxide in the orally disintegrating tablet is 0.01:1-1:1; the weight ratio of the cationic polymer to silicon dioxide in the orally disintegrating tablet is 0.01:1-1:

1.

6. The method for preparing the valsartan-silicon dioxide microcapsule orally disintegrating tablet according to claim 1, characterized in that: The filler is selected from one or more of microcrystalline cellulose, lactose, starch, mannitol, pregelatinized starch, dextrin, powdered sugar, and inorganic salts.

7. The method for preparing the valsartan-silicon dioxide microcapsule orally disintegrating tablet according to claim 1, characterized in that: The disintegrant is selected from one or more of low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, cross-linked sodium carboxymethyl cellulose, cross-linked polyvinylpyrrolidone, dry starch, and effervescent disintegrant.

8. The method for preparing the valsartan-silicon dioxide microcapsule orally disintegrating tablet according to claim 1, characterized in that: The binder is selected from one or more of hydroxypropyl methylcellulose, hydroxypropyl cellulose, pregelatinized starch, povidone, copovidone, ethyl cellulose, methyl cellulose and starch slurry.

9. The method for preparing the valsartan-silicon dioxide microcapsule orally disintegrating tablet according to claim 1, characterized in that: The lubricant is selected from one or more of magnesium stearate, calcium stearate, stearic acid, glyceryl monostearate, and glyceryl distearate.

10. A valsartan-silicon dioxide microcapsule orally disintegrating tablet, characterized in that: The valsartan-silicon dioxide microcapsule orally disintegrating tablet is prepared by the preparation method of any one of claims 1 to 9.

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