Valsartan-silica microcapsule orally disintegrating tablets and preparation method thereof

Abstract

The present invention discloses a valsartan-silica microcapsule orally disintegrating tablet and a preparation method thereof, relating to the technical field of medicine. A preparation method of a valsartan-silica 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 a positive charge; S13: continuously adding silica and stirring to make silica monomers adsorb on the surface of valsartan; S14: continuously adding a cationic polymer and performing high-speed shearing to make the cationic polymer encapsulate on the surface of silica. The valsartan-silica microcapsule orally disintegrating tablet prepared by the present invention has a drug taste masking effect, and the taste masking effect is excellent; at the same time, it overcomes the problems of poor compressibility and fluidity of materials caused by the hygroscopicity and viscosity of valsartan; since no sweeteners and flavoring agents are required in the formula, the formula is simplified, the introduction of impurities by flavors is avoided, and the stability is effectively improved.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical technology, and particularly relates to a valsartan-silica microcapsule orally disintegrating tablet and a preparation method thereof. Background Art

[0002] An orally disintegrating tablet refers to a tablet that can rapidly disintegrate or dissolve in the oral cavity without the need for water. The formulation requirements of orally disintegrating tablets include: being able to rapidly disintegrate or dissolve in the oral cavity, having a good taste, being easy to swallow, and having no irritation to the oral mucosa, etc. The drugs in orally disintegrating tablets are mainly absorbed through the intestinal mucosa, and some drugs can be absorbed through the oral mucosa, having the advantages of fast absorption, rapid onset, and high bioavailability.

[0003] An orally disintegrating tablet is a new type of solid fast-release and rapid-acting preparation developed in recent years, and has become a hot spot in the research and development of tablets after chewable tablets and dispersible tablets. This type of preparation not only provides a new idea for the research and development of rapid-acting preparations, but also opens up a new way for the clinical medication of special patients, and is particularly suitable for children, the elderly, patients with mental illness or those who are unwilling to cooperate due to dysphagia, 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 related to the action of angiotensin II, selectively block the binding of angiotensin II to AT1 receptors in tissues and cells such as the adrenal gland and vascular smooth muscle, and inhibit vasoconstriction and aldosterone secretion, thereby producing a blood pressure lowering effect. Valsartan has the advantages of rapid onset after oral administration, small 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 gospel and hope to a large number of patients.

[0005] At present, the valsartan dosage forms available for clinical selection in China are ordinary tablets, dispersible tablets, and capsules. The tablets and capsules are relatively large in volume and are not suitable for young and elderly people with weak swallowing ability. Valsartan orally disintegrating tablets show a better blood pressure control rate for the treatment of severe hypertension and reduce adverse reactions. In particular, orally disintegrating tablets do not require water for administration, providing convenience for some elderly people, infants and children, or patients with swallowing difficulties or inconvenient access to water. Valsartan orally disintegrating tablets are convenient to take, have a good taste, rapid efficacy, and high bioavailability, greatly improving the compliance of patients.

[0006] Chinese Patent CN108938581A discloses a valsartan orally disintegrating tablet and a preparation method thereof. This patent uses a powder direct compression process, but valsartan becomes moist or caked due to moisture absorption, which affects the fluidity of its powder and increases the viscosity between powder particles, which may cause the machine to run smoothly and the process to be unsmooth during the direct compression process.

[0007] Chinese patents CN110652499A and CN115707454A disclose a valsartan orally disintegrating tablet and its preparation method. This patent uses a process of dry granulation followed by spray drying and mixing the granules with a fragrance dissolved in propylene glycol. Although it improves the compressibility and fluidity of the material, the taste masking process is complex and the taste masking effect is average; due to the bitter taste of valsartan, the oral administration experience of patients taking the valsartan orally disintegrating tablet is poor.

[0008] Therefore, overcoming the problems of poor compressibility and fluidity of the material caused by the hygroscopicity and viscosity of valsartan, optimizing the taste masking process, improving the taste, and enhancing the stability of the preparation are the technical problems currently faced by those of ordinary skill in the art.

[0009] The information disclosed in this background art section is only intended to increase the understanding of the overall background of the present invention and should not be regarded as an admission or any form of implication that this information constitutes the prior art already known to those of ordinary skill in the art. Summary of the Invention

[0010] In view of the above technical problems, an embodiment of the present invention provides a valsartan-silica microcapsule orally disintegrating tablet and its preparation method to solve the problems raised in the above background art.

[0011] A preparation method of a valsartan-silica microcapsule orally disintegrating tablet includes the following steps:

[0012] S11: Prepare an aqueous solution of a cationic surfactant;

[0013] S12: Add valsartan and stir to make the surface of valsartan carry a positive charge; Figure 1 as shown in a;

[0014] S13: Continuously add silica and stir to make the silica monomer adsorb on the surface of valsartan; Figure 1 as shown in b;

[0015] S14: Continuously add a cationic polymer and perform high-speed shearing to encapsulate the cationic polymer on the surface of silica. After the encapsulation is completed, a valsartan-silica microcapsule with a complete microcapsule shell structure is obtained; Figure 1 as shown in c; the rotation speed of the high-speed shearing is 1000 rpm - 20000 rpm;

[0016] S15: Uniformly add a filler, a binder, a disintegrant, and a lubricant to the valsartan-silica microcapsule and press into tablets.

[0017] 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.

[0018] 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.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] 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.

[0023] Preferably, the weight ratio of valsartan to silicon dioxide in the orodisintegrating tablet is 10:1-1:1.

[0024] 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.

[0025] Preferably, in steps S11 - S12, the weight ratio of the water addition amount in the aqueous solution to silica is 0.01:1 - 2.8:1; the standard is that after adding an appropriate amount of silica for adsorption in the aqueous solution, the material is in a solid or semi - solid state.

[0026] Preferably, the filler is selected from one or more of microcrystalline cellulose, lactose, starch, mannitol, pre - gelatinized starch, dextrin, powdered sugar, and inorganic salts.

[0027] Preferably, the disintegrant is selected from one or more of low - substituted hydroxypropyl cellulose, sodium carboxymethyl starch, cross - linked sodium carboxymethyl cellulose, cross - linked povidone, dry starch, and effervescent disintegrants.

[0028] Preferably, the binder is selected from one or more of hydroxypropyl methylcellulose, hydroxypropyl cellulose, pre - gelatinized starch, povidone, copovidone, ethyl cellulose, methyl cellulose, and starch paste.

[0029] Preferably, the lubricant is selected from one or more of magnesium stearate, calcium stearate, stearic acid, glycerol monostearate, and glycerol distearate.

[0030] A valsartan - silica microcapsule orally disintegrating tablet is prepared by using the preparation method of the valsartan - silica microcapsule orally disintegrating tablet as described above.

[0031] The valsartan - silica microcapsule orally disintegrating tablet and its preparation method provided by the embodiments of the present invention have the following beneficial effects:

[0032] (1) By preparing valsartan - silica microcapsules, silica can form a microcapsule shell layer on the surface of valsartan. This silica shell layer can effectively wrap the valsartan particles, forming a physical isolation layer to prevent valsartan from directly contacting the moisture in the air, so that the surface of valsartan is no longer exposed, thereby avoiding the adhesion and dampness phenomena that occur after valsartan absorbs moisture.

[0033] (2) The silica microcapsule forms a microcapsule shell layer on the surface of the valsartan particles. This microcapsule shell can effectively isolate valsartan from the taste receptors in the oral cavity. Since the bitterness of valsartan mainly comes from its solubility and direct contact with taste buds, the silica microcapsule shell can provide a physical barrier to prevent its taste from being released in the oral cavity, achieving a taste - masking effect.

[0034] (3) The prepared valsartan - silica microcapsules have a taste - masking effect, and the taste - masking effect is excellent, with a delicate taste and no gritty feeling; at the same time, since no sweeteners and flavoring agents are required in the formula, the formula is simplified, avoiding the introduction of impurities by flavors, and effectively improving stability.

[0035] (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;

[0036] (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;

[0037] (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

[0038] Figure 1 Various particle structures presented during the preparation of valsartan-silica microcapsules;

[0039] 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;

[0040] Figure 2 The dissolution curve results of Examples 1-4 are shown. DETAILED DESCRIPTION

[0041] 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 them. 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.

[0042] 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.

[0043] 1. Experimental Grouping

[0044] Example 1

[0045] The raw material components of valsartan-silicon dioxide microcapsule orally disintegrating tablets are shown in Table 1 by weight.

[0046]

[0047] Prepare an aqueous solution of hexadecyltrimethylammonium chloride (CTAC), add valsartan, and stir for 30 minutes.

[0048] Silica was added and stirred for 30 minutes to allow silica monomer to be adsorbed.

[0049] Add polyquaternium-7 and stir for 30 min for polymer encapsulation.

[0050] Form valsartan-silica microcapsules.

[0051] Add low-substituted hydroxypropyl cellulose, crospovidone, microcrystalline cellulose, lactose, and magnesium stearate, mix evenly, and press into tablets to obtain the product.

[0052] Example 2

[0053] The raw material components of the orally disintegrating tablets of valsartan-silica microcapsules are shown in Table 2 by weight parts;

[0054]

[0055] Prepare an aqueous solution of octadecyltrimethylammonium chloride, add valsartan, and stir for 10 min.

[0056] Add silica and stir for 10 min for silica monomer adsorption.

[0057] Add polyquaternium-7 and stir for 10 min for polymer encapsulation.

[0058] Form valsartan-silica microcapsules.

[0059] Add low-substituted hydroxypropyl cellulose, crospovidone, microcrystalline cellulose, lactose, and magnesium stearate, mix evenly, and press into tablets to obtain the product.

[0060] Example 3

[0061] The raw material components of the orally disintegrating tablets of valsartan-silica microcapsules are shown in Table 3 by weight parts;

[0062]

[0063] Prepare an aqueous solution of cetyltrimethylammonium chloride (CTAC), add valsartan, and stir for 10 min.

[0064] Add silica and stir for 1 h for silica monomer adsorption.

[0065] Add 5 and stir for 1 h for polymer encapsulation.

[0066] Form valsartan-silica microcapsules.

[0067] Add low-substituted hydroxypropyl cellulose, crospovidone, microcrystalline cellulose, lactose, and magnesium stearate, mix evenly, and press into tablets to obtain the product.

[0068] Example 4

[0069] The raw material components of the valsartan-silica microcapsule orally disintegrating tablets are shown in Table 4 by weight parts;

[0070]

[0071] Prepare an aqueous solution of cetyltrimethylammonium chloride (CTAC), add valsartan, and stir for 10 min.

[0072] Add silica and stir for 30 min for silica monomer adsorption.

[0073] Add polyquaternium-7 and stir for 30 min for polymer encapsulation.

[0074] Add low-substituted hydroxypropyl cellulose, crospovidone, microcrystalline cellulose, lactose, and magnesium stearate, and mix evenly. Press into tablets to obtain.

[0075] Example 5

[0076] The raw material components of the valsartan-silica microcapsule orally disintegrating tablets are shown in Table 5 by weight parts;

[0077]

[0078] Prepare an aqueous solution of cetyltrimethylammonium chloride (CTAC), add valsartan, and stir for 10 min.

[0079] Add silica and stir for 10 min for silica monomer adsorption.

[0080] Add polyquaternium-7 and stir for 10 min for polymer encapsulation.

[0081] Form valsartan-silica microcapsules.

[0082] Add low-substituted hydroxypropyl cellulose, crospovidone, microcrystalline cellulose, lactose, aspartame, orange flavor, and magnesium stearate, and mix evenly. Press into tablets to obtain.

[0083] Example 6

[0084] The raw material components of the valsartan-silica microcapsule orally disintegrating tablets are shown in Table 6 by weight parts;

[0085]

[0086] Prepare an aqueous solution of cetyltrimethylammonium chloride (CTAC), add valsartan, and stir for 10 min.

[0087] Add silica and stir for 10 min for silica monomer adsorption.

[0088] Add polyquaternium-7 and stir for 10 minutes for polymer encapsulation.

[0089] Valsartan-silica microcapsules were formed.

[0090] 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.

[0091] Comparative Example 1

[0092] The raw material components of valsartan-silicon dioxide microcapsule orally disintegrating tablets are shown in Table 7 by weight.

[0093]

[0094] Valsartan was sieved through a 100-mesh sieve, and other excipients were sieved through a 60-mesh sieve for later use;

[0095] 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;

[0096] The above mixture was compressed into tablets.

[0097] Comparative Example 2

[0098] The raw material components of valsartan-silicon dioxide microcapsule orally disintegrating tablets are shown in Table 8 by weight.

[0099]

[0100] Valsartan was sieved through a 100-mesh sieve, and other excipients were sieved through a 60-mesh sieve for later use;

[0101] 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;

[0102] 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;

[0103] The above mixture was compressed into tablets.

[0104] Comparative Example 3

[0105] The raw material components of valsartan-silicon dioxide microcapsule orally disintegrating tablets are shown in Table 9 by weight.

[0106]

[0107] Mix valsartan, partial flavoring agents, fillers, binders, and partial disintegrants in a three-dimensional mixer for 3 minutes until evenly mixed;

[0108] Granulate the mixture using a dry granulator; the sieve mesh is 24 meshes;

[0109] Spray-dry and mix the granules with flavoring agents in a multi-functional fluidized bed. The flavoring agents are flavors dissolved in propylene glycol at a certain concentration;

[0110] Add the remaining flavoring agents, disintegrants, glidants, and lubricants, and mix evenly;

[0111] Press tablets using a Φ7mm flat punch die to obtain tablets with the required hardness.

[0112] Comparative Example 4

[0113] The raw material components of the valsartan-silica microcapsule orally disintegrating tablets are shown in Table 10 by weight parts;

[0114]

[0115] Prepare an aqueous solution of cetyltrimethylammonium chloride (CTAC), add valsartan, and stir for 30 minutes.

[0116] Add silica, stir for 30 minutes, and perform silica monomer adsorption.

[0117] Form valsartan-silica microcapsules.

[0118] Add low-substituted hydroxypropyl cellulose, crospovidone, microcrystalline cellulose, lactose, and magnesium stearate, and mix evenly. Press tablets to obtain the product.

[0119] II. Investigation of Group Experiment Performance

[0120] 1. Investigation of the Properties of the Total Mixed Granules

[0121] Investigate the properties of the total mixed granules in the examples and comparative examples of the present invention. The results are shown in Table 11:

[0122]

[0123] The granules of Examples 1-6 have very good fluidity and good compressibility. In Comparative Example 1, direct compression of the powder is used, and the material fluidity is very poor and the compressibility is poor. In Comparative Example 2, a valsartan-colloidal silica complex is prepared, the material fluidity is poor, the compressibility is poor, and the improvement effect is weak. In Comparative Example 3, dry granulation is carried out. Although the fluidity of the total mixed granules is average and the compressibility is average, the fluidity of the dry granulated material is very poor and it cannot be fed smoothly. In Comparative Example 4, the granules have very good fluidity and good compressibility. The valsartan-silica microcapsules are not encapsulated with cationic polymers, which does not affect the properties of the total mixed granules.

[0124] 2. Investigation of tablet properties

[0125] The hardness, friability, and disintegration time limit of the tablets in each example and each comparative example were investigated, and the results are shown in Table 12:

[0126]

[0127] Examples 1-6 have good compressibility, with the tablet hardness controlled at 40-60 N, moderate hardness, qualified friability, and rapid disintegration. Comparative Example 1 and Comparative Example 2 have very poor compressibility, and the maximum hardness can only be pressed to 20-30 N, with unqualified friability. Comparative Example 3 has average compressibility, the hardness can be controlled at 40-60 N, and the disintegration is slow. Comparative Example 4 has good compressibility, with the tablet hardness controlled at 40-60 N, moderate hardness, qualified friability, and rapid disintegration.

[0128] 3. Investigation of tablet taste

[0129] The taste limits of the tablets in the examples and comparative examples were investigated, and at least 10 subjects tasted them. The results are shown in Table 13:

[0130]

[0131] Examples 1-4 have a delicate taste without a gritty feeling and no bitterness. Since no flavoring agent and sweetening agent are added, there is no sweetness, fragrance, or strange smell. Example 5 adds aspartame and orange flavor essence, having a sweet taste and an orange fragrance. Example 6 adds aspartame and mint flavor essence, having a sweet taste, a mint fragrance, and a cool feeling. Both the initial sweet taste, mint fragrance, and cool feeling can well cover the strange smell brought by the sweetness of aspartame. Comparative Examples 1-3 have a strong bitterness, a strong sweetness of aspartame, and the strong taste of aspartame causes a certain sense of strange smell, with a poor taste. Although Comparative Example 4 has no bitterness when entering the mouth, there is bitterness in the aftertaste, and the taste masking effect is average. Without encapsulation with cationic polymer, there are pores on the surface of valsartan-silica microcapsules and the shell layer is incomplete, which will affect the taste masking effect.

[0132] 4. Investigation of dissolution curves

[0133] The dissolution curves (pH 4.5 / 500 ml / paddle method / 50 rpm) of Examples 1-4 and Comparative Example 4 were investigated, and the details are shown in Figure 2 and Table 14:

[0134]

[0135] In Example 1, the prescription ratio of silica to valsartan is 1:10. The adsorption amount of silica monomer and the encapsulation amount of polymer are less, 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 adsorption amount of silica monomer and the encapsulation amount of polymer are larger, and the formed valsartan-silica microcapsules are thicker; in Comparative Example 4, the valsartan-silica microcapsules are not encapsulated with cationic polymer, and there are pores on the surface of the microcapsules.

[0136] If the valsartan-silica microcapsules are not encapsulated with cationic polymer, there are pores on the surface of the microcapsules and the capsule shell is incomplete. Compared with the valsartan-silica microcapsules encapsulated with cationic polymer, the drug dissolution is faster; by controlling the adsorption amount of silica monomer and the encapsulation amount of polymer, the thickness of the microcapsule shell 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 amounts of disintegrant, binder and filler in the formula to meet different drug release requirements. The dissolution curve is controllable.

[0137] 5. Evaluation of formulation process

[0138] After preparing valsartan-silica microcapsules in Examples 1-6, excipients were added and mixed for tabletting. The operation was simple, the requirements for equipment and production line were low, and the prepared valsartan orally disintegrating tablets were of qualified quality. In Comparative Examples 1-2, the formulations were complex, the processes were not smooth, and the prepared valsartan orally disintegrating tablets were of poor quality. In Comparative Example 3, the formulation was complex and the process was complex, and the prepared valsartan orally disintegrating tablets were of average quality. The valsartan-silica microcapsule orally disintegrating tablets prepared according to the formulation process of the present invention have obvious advantages.

[0139] The embodiments described above are only used to describe the preferred embodiments of the present invention, and do not limit the scope of the present invention. Without departing from the design spirit of the present invention, various deformations and improvements made by those of ordinary skill in the art to the technical solutions of the present invention shall fall within the protection scope determined by the claims of the present invention.

Claims

1. A preparation method of valsartan-silica microcapsule orally disintegrating tablets, characterized in that, It includes the following steps: S11: Prepare an aqueous solution of a cationic surfactant; S12: Add valsartan and stir to make the surface of valsartan carry a positive charge; S13: Continuously add silica and stir to adsorb silica monomers on the surface of valsartan; S14: Continuously add a cationic polymer and perform high-speed shearing to encapsulate the cationic polymer on the surface of silica. After encapsulation, a valsartan-silica microcapsule with a complete microcapsule shell structure is obtained; S15: Uniformly add a filler, a binder, a disintegrant, and a lubricant to the valsartan-silica microcapsule and press into tablets; Among them, the cationic surfactant is selected from one of cetyltrimethylammonium chloride and octadecyltrimethylammonium chloride; The cationic polymer is selected from one or more of polyquaternium-7, polyquaternium-6, polyquaternium-5, and polyquaternium-39.

2. The preparation method of the valsartan-silica microcapsule orally disintegrating tablet according to claim 1, characterized in that For each raw material component in the orally disintegrating tablet of valsartan-silica microcapsule, by weight, it includes: 0.01-40 parts of a cationic surfactant, 10-40 parts of valsartan, 0.01-40 parts of a cationic polymer, 1-20 parts of silica, 17-81.5 parts of a filler, 2-5 parts of a binder, 5-25 parts of a disintegrant, and 0.5-3 parts of a lubricant.

3. The preparation method of the valsartan-silica microcapsule orally disintegrating tablet according to claim 1, wherein The weight ratio of valsartan to silica in the orally disintegrating tablet is 10:1-1:

1.

4. The preparation method of the valsartan-silica microcapsule orally disintegrating tablet according to claim 1, characterized in that, The weight ratio of the cationic surfactant to silica in the orally disintegrating tablet is 0.01:1-1:1; the weight ratio of the cationic polymer to silica in the orally disintegrating tablet is 0.01:1-1:

1.

5. The preparation method of the valsartan-silica 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.

6. The preparation method of the valsartan-silica microcapsule orally disintegrating tablet according to claim 1, wherein, The disintegrant is selected from one or more of low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, cross-linked sodium carboxymethyl cellulose, cross-linked povidone, dry starch, and effervescent disintegrants.

7. The preparation method of the valsartan-silica microcapsule orally disintegrating tablet according to claim 1, wherein The binder is selected from one or more of hypromellose, hydroxypropyl cellulose, pregelatinized starch, povidone, copovidone, ethyl cellulose, methyl cellulose, and starch paste.

8. The preparation method of the valsartan-silica microcapsule orally disintegrating tablet according to claim 1, wherein, The lubricant is selected from one or more of magnesium stearate, calcium stearate, stearic acid, glycerol monostearate, and glycerol distearate.

9. An orally disintegrating tablet of valsartan-silica microcapsule, characterized in that, It is prepared by using the preparation method of the orally disintegrating tablet of valsartan-silica microcapsule as described in any one of claims 1-8.

Images