Amlodipine atorvastatin calcium tablet and preparation method and use thereof
By improving the component formulation and micronization of the active pharmaceutical ingredient, amlodipine atorvastatin calcium tablets were prepared using a direct powder compression process. This solved the problems of low dissolution and poor stability, achieving high dissolution and stability, and improving bioavailability and efficacy.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- ANHUI HONGYE PHARMA
- Filing Date
- 2026-03-18
- Publication Date
- 2026-05-29
AI Technical Summary
The existing amlodipine-atorvastatin calcium tablets have low dissolution and poor stability, which affects bioavailability and efficacy.
Amlodipine and atorvastatin calcium tablets were prepared using a direct powder compression process. By improving the formulation of the components and micronizing the active pharmaceutical ingredient, a mixture of amlodipine besylate, atorvastatin calcium, fillers, matrix materials, binders, lubricants and surfactants was formed in a specific ratio. A three-dimensional network structure was formed through physical cross-linking, thereby controlling the dissolution rate and dissolution degree of the drug.
It improved the dissolution and stability of amlodipine atorvastatin calcium tablets, enhanced bioavailability, reduced the frequency of dosing, and improved medication adherence.
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Abstract
Description
Technical Field
[0001] This invention relates to the field of pharmaceutical formulation technology, specifically to an amlodipine atorvastatin calcium tablet, its preparation method, and its uses. Background Technology
[0002] Amlodipine is a long-acting dihydropyridine calcium channel blocker, clinically used to treat hypertension and angina pectoris related to coronary heart disease. Amlodipine is weakly basic, poorly water-soluble, and unstable, requiring the formation of a salt with an acid radical to increase its solubility and stability. Amlodipine besylate is a salt formed by the combination of amlodipine and benzenesulfonic acid; the core component is still amlodipine, but it has better solubility and can reduce the impact of gastric acid on its efficacy.
[0003] Atorvastatin calcium is a statin lipid-regulating drug that primarily acts on the liver. It reduces cholesterol synthesis, increases LDL receptor synthesis, thereby lowering blood cholesterol and LDL cholesterol levels, moderately reducing serum triglyceride levels, and increasing high-density lipoprotein levels.
[0004] Caduet (Amlodipine and Atorvastatin Calcium Tablets), marketed as Caduet, is a combination drug developed by Pfizer, primarily used to treat hypertension complicated by hypercholesterolemia and related cardiovascular diseases. Caduet contains two active ingredients: amlodipine besylate and atorvastatin calcium. The combination of these two ingredients synergistically controls blood pressure and blood lipids, reducing the frequency of medication use. As the world's first combination drug targeting both conditions, Caduet simplifies the dosing regimen through its single-tablet design. Clinical studies have shown that it can reduce the risk of coronary heart disease and improve treatment adherence.
[0005] Because amlodipine besylate is only slightly soluble in water, and atorvastatin calcium is a lipid-soluble drug, the tablet dissolution rate is low, thus affecting bioavailability and efficacy. Furthermore, amlodipine besylate is sensitive to temperature and humidity, resulting in poor stability. The content of related substances may increase during the manufacturing or storage process, posing safety risks for clinical application. Summary of the Invention
[0006] The technical problem to be solved by the present invention is to provide an amlodipine-atorvastatin calcium tablet and its preparation method. The resulting amlodipine-atorvastatin calcium tablet has good stability and high dissolution, thereby improving bioavailability and enabling amlodipine and atorvastatin to exert a better synergistic effect.
[0007] The technical problem to be solved by this invention is achieved by the following technical solution:
[0008] One objective of this invention is to provide an amlodipine-atorvastatin calcium tablet comprising amlodipine besylate, atorvastatin calcium, filler, matrix material, binder, and lubricant.
[0009] Further, the mass ratio of amlodipine besylate, calcium atorvastatin, filler, skeleton material, adhesive and lubricant is (5~10): (5~10): (50~80): (20~40): (10~20): (1~5).
[0010] Furthermore, the filler includes, but is not limited to, one or more of microcrystalline cellulose, pregelatinized starch, starch, lactose, dextrin, and sucrose. The main function of the filler is to increase the weight or volume of the tablet to ensure that the drug can be compressed into tablets and to ensure accurate dosage of each tablet.
[0011] Furthermore, the backbone material is cyclodextrin-mannitol, formed by physical cross-linking of β-cyclodextrin and mannitol in a mass ratio of 10:(1~5). Even further, the preparation method of the cyclodextrin-mannitol includes the following steps: adding mannitol to water, stirring until completely dissolved, then adding β-cyclodextrin, heating to 70~80℃ and stirring for 5~8 h, cooling to room temperature, and freeze-drying to obtain cyclodextrin-mannitol. The physical cross-linking of β-cyclodextrin and mannitol to form a three-dimensional network structure aims to regulate the dissolution rate and dissolution rate of the drug.
[0012] Furthermore, the backbone material is cyclodextrin-mannitol-lactose, formed by physical cross-linking of β-cyclodextrin, mannitol, and lactose in a mass ratio of 10:(1~5):(1~5). Even further, the preparation method of the cyclodextrin-mannitol-lactose includes the following steps: adding mannitol and lactose to water, stirring until completely dissolved, then adding β-cyclodextrin, heating to 70~80℃ and stirring for 5~8 h, cooling to room temperature, and freeze-drying to obtain cyclodextrin-mannitol-lactose. The physical cross-linking of β-cyclodextrin with mannitol and lactose forms a three-dimensional network structure, the purpose of which is to regulate the dissolution rate and dissolution rate of the drug.
[0013] Furthermore, the adhesive includes, but is not limited to, one or more of methylcellulose, ethylcellulose, hydroxypropylcellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose, povidone, gelatin, and polyethylene glycol. The adhesive's function is to agglomerate non-sticky or insufficiently sticky powdered materials into granules, facilitating tableting. The amount of adhesive used needs to be controlled. Excessive amounts will result in overly tight internal binding of the tablets, hindering moisture penetration and thus delaying disintegration; insufficient amounts will result in insufficient internal binding, inadequate hardness, and easy breakage.
[0014] Furthermore, the adhesive is modified hydroxypropyl methylcellulose, which is prepared by dissolving hydroxypropyl methylcellulose in water, then adding cholesterol, refluxing and stirring for 8-12 hours, and vacuum drying to obtain modified hydroxypropyl methylcellulose. Even further, the mass ratio of hydroxypropyl methylcellulose to cholesterol is (85-90):(10-15). Cholesterol modifies hydroxypropyl methylcellulose through hydrogen bonding, which is simpler and safer than chemical modification.
[0015] Furthermore, the lubricant includes, but is not limited to, one or more of magnesium stearate, sodium stearate fumarate, talc, and micronized silica gel. The main function of the lubricant is to improve particle flowability, making the tablet filling more uniform; and to reduce the friction between the particles and the die, preventing sticking; while also facilitating the smooth ejection of the tablet from the die, maintaining a smooth surface.
[0016] Furthermore, the amlodipine-atorvastatin calcium tablets also include a surfactant. Specifically, the mass ratio of amlodipine besylate, atorvastatin calcium, filler, matrix material, binder, lubricant, and surfactant is (5~10): (5~10): (50~80): (20~40): (10~20): (1~5): (1~5). Even further, the surfactant includes, but is not limited to, one or more of polysorbate, Span, and poloxamer. The addition of surfactants can improve the solubility of amlodipine besylate and atorvastatin calcium in water.
[0017] The second objective of this invention is to provide a method for preparing the amlodipine atorvastatin calcium tablets, wherein amlodipine besylate, atorvastatin calcium, filler, matrix material, binder, lubricant and surfactant are sieved, mixed evenly, and compressed into tablets to obtain amlodipine atorvastatin calcium tablets.
[0018] Furthermore, the amlodipine besylate and atorvastatin calcium are micronized before use, with a particle size not exceeding 15 μm. Micronization can increase the specific surface area of the drug, improve its water solubility, and enhance its absorption and bioavailability after oral administration.
[0019] A third objective of this invention is to provide the amlodipine atorvastatin calcium tablets for use as a drug for the prevention and / or treatment of hypertension, hyperlipidemia, angina pectoris, etc.
[0020] The beneficial effects of this invention are:
[0021] 1. This invention uses a powder direct compression process to prepare amlodipine and atorvastatin calcium tablets, avoiding the influence of moisture and high temperature on the drug in wet granulation, and solving the problem of poor stability of amlodipine besylate;
[0022] 2. This invention improves the dissolution rate of amlodipine besylate and atorvastatin calcium by modifying the component formulation and micronizing the active pharmaceutical ingredient, and regulates the dissolution rate of amlodipine besylate and atorvastatin calcium to keep their blood drug concentrations stable within the effective therapeutic range, thereby improving bioavailability, reducing the frequency of dosing, enhancing efficacy, and improving medication adherence. Detailed Implementation
[0023] To make the technical means, creative features, objectives and effects of this invention easier to understand, the invention will be further described below with reference to specific embodiments.
[0024] The following examples and comparative examples illustrate the sources of raw materials:
[0025] β-Cyclodextrin, amlodipine besylate, atorvastatin calcium, microcrystalline cellulose, pregelatinized starch, corn starch, anhydrous lactose, sucrose, ethyl cellulose (viscosity 180~220 mPa.s), hydroxypropyl methylcellulose (type II, viscosity 400 mPa.s), sodium carboxymethyl cellulose (viscosity 800~1000 mPa.s), polyethylene glycol 4000, magnesium stearate, sodium stearate fumarate, and polysorbate 80 were all purchased from Shanghai Aladdin Biochemical Technology Co., Ltd.; povidone K30 was purchased from Huzhou Shenhua Polymer Materials Co., Ltd.; micronized silica gel was purchased from Shanxi Jinyang Pharmaceutical Excipients Co., Ltd.; and Span 60 was purchased from Hebei Hongtao Bioengineering Co., Ltd.
[0026] In the following examples and comparative examples, the tablets were pressed individually for 1 second under a pressure of 40 kN.
[0027] Example 1
[0028] Preparation of cyclodextrin-mannitol:
[0029] Add 10 g mannitol to 500 mL of water, stir until completely dissolved, then add 100 g β-cyclodextrin, heat to 70℃ and stir for 8 h, cool to room temperature, freeze dry, and pulverize to obtain cyclodextrin-mannitol.
[0030] Preparation of amlodipine-atorvastatin calcium tablets:
[0031] By weight, 5 parts of amlodipine besylate and 10 parts of atorvastatin calcium were micronized using an air jet mill to a D50 particle size of 5-10 μm. Then, they were mixed evenly with 50 parts of microcrystalline cellulose, 30 parts of anhydrous lactose, 25 parts of cyclodextrin-mannitol, 10 parts of ethyl cellulose, 5 parts of sodium carboxymethyl cellulose, 1 part of magnesium stearate, and 2 parts of Span 60 that had passed through a 100-mesh sieve. The mixture was then compressed into tablets to obtain amlodipine atorvastatin calcium tablets (0.25 g).
[0032] Example 2
[0033] Preparation of cyclodextrin-mannitol:
[0034] Add 50 g of mannitol to 500 mL of water, stir until completely dissolved, then add 100 g of β-cyclodextrin, heat to 75℃ and stir for 6 h, cool to room temperature, freeze dry, and pulverize to obtain cyclodextrin-mannitol.
[0035] Preparation of amlodipine-atorvastatin calcium tablets:
[0036] By weight, 10 parts of amlodipine besylate and 5 parts of atorvastatin calcium were micronized using an air jet mill to a D50 particle size of 5-10 μm. Then, they were mixed evenly with 60 parts of pregelatinized starch, 20 parts of cyclodextrin-mannitol, 10 parts of hydroxypropyl methylcellulose, 10 parts of povidone K30, 1 part of sodium stearate fumarate, 1 part of micronized silica gel and 3 parts of polysorbate 80, and compressed into tablets to obtain amlodipine atorvastatin calcium tablets (0.25 g).
[0037] Example 3
[0038] Preparation of cyclodextrin-mannitol:
[0039] Add 25 g mannitol to 500 mL of water, stir until completely dissolved, then add 100 g β-cyclodextrin, heat to 80℃ and stir for 5 h, cool to room temperature, freeze dry, and pulverize to obtain cyclodextrin-mannitol.
[0040] Preparation of amlodipine-atorvastatin calcium tablets:
[0041] By weight, 5 parts of amlodipine besylate and 5 parts of atorvastatin calcium were micronized using an air jet mill to a D50 particle size of 5-10 μm. Then, they were mixed evenly with 50 parts of corn starch, 10 parts of sucrose, 30 parts of cyclodextrin-mannitol, 10 parts of sodium carboxymethyl cellulose, 5 parts of polyethylene glycol 4000, 1 part of magnesium stearate, 0.5 parts of micronized silica gel, 2 parts of polysorbate 80 and 1 part of Span 60, and compressed into tablets to obtain amlodipine atorvastatin calcium tablets (0.25 g).
[0042] Comparative Example 1
[0043] Amlodipine atorvastatin calcium tablets were prepared according to the method in Example 3, except that cyclodextrin-mannitol was replaced with a mixture of β-cyclodextrin and mannitol.
[0044] Preparation of amlodipine and atorvastatin calcium tablets: By weight, 5 parts amlodipine besylate and 5 parts atorvastatin calcium were micronized using an air jet mill to a D50 particle size of 5-10 μm. Then, they were mixed evenly with 50 parts corn starch, 10 parts sucrose, 24 parts β-cyclodextrin, 6 parts mannitol, 10 parts sodium carboxymethyl cellulose, 5 parts polyethylene glycol 4000, 1 part magnesium stearate, 0.5 parts micronized silica gel, 2 parts polysorbate 80 and 1 part Span 60 that had passed through a 120-mesh sieve. The mixture was then compressed into tablets to obtain amlodipine and atorvastatin calcium tablets (0.25 g).
[0045] Comparative Example 2
[0046] Amlodipine atorvastatin calcium tablets were prepared according to the method in Example 3, except that cyclodextrin-mannitol was replaced with β-cyclodextrin.
[0047] Preparation of amlodipine-atorvastatin calcium tablets:
[0048] By weight, 5 parts of amlodipine besylate and 5 parts of atorvastatin calcium were micronized using an air jet mill to a D50 particle size of 5-10 μm. Then, they were mixed evenly with 50 parts of corn starch, 10 parts of sucrose, 30 parts of β-cyclodextrin, 10 parts of sodium carboxymethyl cellulose, 5 parts of polyethylene glycol 4000, 1 part of magnesium stearate, 0.5 parts of micronized silica gel, 2 parts of polysorbate 80 and 1 part of Span 60, and compressed into tablets to obtain amlodipine atorvastatin calcium tablets (0.25 g).
[0049] According to the second method of General Chapter 0931 of Part IV of the 2025 edition of the Chinese Pharmacopoeia, the amlodipine and atorvastatin calcium tablets prepared in Examples 1-3 and Comparative Examples 1-2 were subjected to dissolution tests in pH 6.8 phosphate buffer (900 mL, 37±0.5℃, 75 rpm). The cumulative dissolution rate at different time points (2 h, 4 h, 6 h, 8 h, 10 h, 12 h) was calculated, and the results are shown in Table 1.
[0050] Table 1. Cumulative dissolution of amlodipine and atorvastatin calcium tablets at different time points.
[0051]
[0052] As can be seen from Table 1, compared with Comparative Examples 1-2, the amlodipine atorvastatin calcium tablets prepared in Examples 1-3 have a faster dissolution rate and higher dissolution rate.
[0053] Example 4
[0054] Amlodipine atorvastatin calcium tablets were prepared according to the method in Example 3, except that cyclodextrin-mannitol was replaced with cyclodextrin-mannitol-lactose.
[0055] Preparation of cyclodextrin-mannitol-lactose:
[0056] Add 25 g mannitol and 10 g anhydrous lactose to 500 mL of water, stir until completely dissolved, then add 100 g β-cyclodextrin, heat to 80℃ and stir for 5 h, cool to room temperature, freeze dry, and pulverize to obtain cyclodextrin-mannitol-lactose.
[0057] Preparation of amlodipine-atorvastatin calcium tablets:
[0058] By weight, 5 parts of amlodipine besylate and 5 parts of atorvastatin calcium were micronized using an air jet mill to a D50 particle size of 5-10 μm. Then, they were mixed evenly with 50 parts of corn starch, 10 parts of sucrose, 30 parts of cyclodextrin-mannitol-lactose, 10 parts of sodium carboxymethyl cellulose, 5 parts of polyethylene glycol 4000, 1 part of magnesium stearate, 0.5 parts of micronized silica gel, 2 parts of polysorbate 80 and 1 part of Span 60, and compressed into tablets to obtain amlodipine atorvastatin calcium tablets (0.25 g).
[0059] Example 5
[0060] Amlodipine atorvastatin calcium tablets were prepared according to the method in Example 3, except that cyclodextrin-mannitol was replaced with cyclodextrin-mannitol-lactose.
[0061] Preparation of cyclodextrin-mannitol-lactose:
[0062] Add 25 g mannitol and 30 g anhydrous lactose to 500 mL of water, stir until completely dissolved, then add 100 g β-cyclodextrin, heat to 80℃ and stir for 5 h, cool to room temperature, freeze dry, and pulverize to obtain cyclodextrin-mannitol-lactose.
[0063] Preparation of amlodipine-atorvastatin calcium tablets:
[0064] By weight, 5 parts of amlodipine besylate and 5 parts of atorvastatin calcium were micronized using an air jet mill to a D50 particle size of 5-10 μm. Then, they were mixed evenly with 50 parts of corn starch, 10 parts of sucrose, 30 parts of cyclodextrin-mannitol-lactose, 10 parts of sodium carboxymethyl cellulose, 5 parts of polyethylene glycol 4000, 1 part of magnesium stearate, 0.5 parts of micronized silica gel, 2 parts of polysorbate 80 and 1 part of Span 60, and compressed into tablets to obtain amlodipine atorvastatin calcium tablets (0.25 g).
[0065] Example 6
[0066] Amlodipine atorvastatin calcium tablets were prepared according to the method in Example 3, except that cyclodextrin-mannitol was replaced with cyclodextrin-mannitol-lactose.
[0067] Preparation of cyclodextrin-mannitol-lactose:
[0068] Add 25 g mannitol and 50 g anhydrous lactose to 500 mL of water, stir until completely dissolved, then add 100 g β-cyclodextrin, heat to 80℃ and stir for 5 h, cool to room temperature, freeze dry, and pulverize to obtain cyclodextrin-mannitol-lactose.
[0069] Preparation of amlodipine-atorvastatin calcium tablets:
[0070] By weight, 5 parts of amlodipine besylate and 5 parts of atorvastatin calcium were micronized using an air jet mill to a D50 particle size of 5-10 μm. Then, they were mixed evenly with 50 parts of corn starch, 10 parts of sucrose, 30 parts of cyclodextrin-mannitol-lactose, 10 parts of sodium carboxymethyl cellulose, 5 parts of polyethylene glycol 4000, 1 part of magnesium stearate, 0.5 parts of micronized silica gel, 2 parts of polysorbate 80 and 1 part of Span 60, and compressed into tablets to obtain amlodipine atorvastatin calcium tablets (0.25 g).
[0071] According to the second method of General Chapter 0931 of Part IV of the 2025 edition of the Chinese Pharmacopoeia, the amlodipine and atorvastatin calcium tablets prepared in Examples 4-6 were subjected to dissolution tests in pH 6.8 phosphate buffer (900 mL, 37±0.5℃, 75 rpm). The cumulative dissolution rate at different time points (2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h) was calculated, and the results are shown in Table 2.
[0072] Table 2. Cumulative dissolution of amlodipine and atorvastatin calcium tablets at different time points.
[0073]
[0074] As can be seen from Table 2, compared with Example 3, the amlodipine atorvastatin calcium tablets prepared in Examples 4-6 have a certain sustained-release effect and can prolong the drug's action time.
[0075] Example 7
[0076] Amlodipine atorvastatin calcium tablets were prepared according to the method in Example 2, except that hydroxypropyl methylcellulose was replaced with modified hydroxypropyl methylcellulose.
[0077] Preparation of modified hydroxypropyl methylcellulose:
[0078] Dissolve 85 g of hydroxypropyl methylcellulose in 1 L of water, then add 15 g of cholesterol, reflux and stir for 12 h, and vacuum dry to obtain modified hydroxypropyl methylcellulose.
[0079] Preparation of cyclodextrin-mannitol:
[0080] Add 50 g of mannitol to 500 mL of water, stir until completely dissolved, then add 100 g of β-cyclodextrin, heat to 75℃ and stir for 6 h, cool to room temperature, freeze dry, and pulverize to obtain cyclodextrin-mannitol.
[0081] Preparation of amlodipine-atorvastatin calcium tablets:
[0082] By weight, 10 parts of amlodipine besylate and 5 parts of atorvastatin calcium were micronized using an air jet mill to a D50 particle size of 5-10 μm. Then, they were mixed evenly with 60 parts of pregelatinized starch, 20 parts of cyclodextrin-mannitol, 10 parts of modified hydroxypropyl methylcellulose, 10 parts of povidone K30, 1 part of sodium stearate fumarate, 1 part of micronized silica gel and 3 parts of polysorbate 80, and compressed into tablets to obtain amlodipine atorvastatin calcium tablets (0.25 g).
[0083] Example 8
[0084] Amlodipine atorvastatin calcium tablets were prepared according to the method in Example 2, except that hydroxypropyl methylcellulose was replaced with modified hydroxypropyl methylcellulose.
[0085] Preparation of modified hydroxypropyl methylcellulose:
[0086] Dissolve 90 g of hydroxypropyl methylcellulose in 1 L of water, then add 10 g of cholesterol, reflux and stir for 8 h, and vacuum dry to obtain modified hydroxypropyl methylcellulose.
[0087] Preparation of cyclodextrin-mannitol:
[0088] Add 50 g of mannitol to 500 mL of water, stir until completely dissolved, then add 100 g of β-cyclodextrin, heat to 75℃ and stir for 6 h, cool to room temperature, freeze dry, and pulverize to obtain cyclodextrin-mannitol.
[0089] Preparation of amlodipine-atorvastatin calcium tablets:
[0090] By weight, 10 parts of amlodipine besylate and 5 parts of atorvastatin calcium were micronized using an air jet mill to a D50 particle size of 5-10 μm. Then, they were mixed evenly with 60 parts of pregelatinized starch, 20 parts of cyclodextrin-mannitol, 10 parts of modified hydroxypropyl methylcellulose, 10 parts of povidone K30, 1 part of sodium stearate fumarate, 1 part of micronized silica gel and 3 parts of polysorbate 80, and compressed into tablets to obtain amlodipine atorvastatin calcium tablets (0.25 g).
[0091] According to the second method of General Chapter 0931 of Part IV of the 2025 edition of the Chinese Pharmacopoeia, the amlodipine and atorvastatin calcium tablets prepared in Examples 2 and 7-8 were subjected to dissolution tests in pH 6.8 phosphate buffer (900 mL, 37±0.5℃, 75 rpm). The cumulative dissolution rate at different time points (2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h) was calculated, and the results are shown in Table 3.
[0092] Table 3. Cumulative dissolution of amlodipine and atorvastatin calcium tablets at different time points.
[0093]
[0094] As can be seen from Table 3, compared with Example 2, the amlodipine atorvastatin calcium tablets prepared in Examples 7 and 8 have a certain sustained-release effect and can prolong the drug's action time.
[0095] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed. The scope of protection of this invention is defined by the appended claims and their equivalents.
Claims
1. An amlodipine-atorvastatin calcium tablet, characterized in that: This includes amlodipine besylate, calcium atorvastatin, fillers, skeleton materials, adhesives, and lubricants.
2. The amlodipine-atorvastatin calcium tablets according to claim 1, characterized in that: The mass ratio of amlodipine besylate, calcium atorvastatin, filler, skeleton material, adhesive and lubricant is (5~10): (5~10): (50~80): (20~40): (10~20): (1~5).
3. The amlodipine-atorvastatin calcium tablets according to claim 1, characterized in that: The filler is selected from one or more of microcrystalline cellulose, pregelatinized starch, starch, lactose, dextrin, and sucrose.
4. The amlodipine-atorvastatin calcium tablets according to claim 1, characterized in that: The backbone material is cyclodextrin-mannitol, which is formed by physical cross-linking of β-cyclodextrin and mannitol in a mass ratio of 10:(1~5).
5. The amlodipine-atorvastatin calcium tablets according to claim 4, characterized in that: The preparation method of the cyclodextrin-mannitol includes the following steps: adding mannitol to water, stirring until completely dissolved, adding β-cyclodextrin, heating to 70~80℃ and stirring for 5~8 h, cooling to room temperature, and freeze-drying to obtain cyclodextrin-mannitol.
6. The amlodipine-atorvastatin calcium tablets according to claim 1, characterized in that: The adhesive is selected from one or more of methylcellulose, ethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, sodium carboxymethylcellulose, povidone, gelatin, and polyethylene glycol.
7. The amlodipine-atorvastatin calcium tablets according to claim 1, characterized in that: The lubricant is selected from one or more of magnesium stearate, sodium stearate fumarate, talc, and micronized silica gel.
8. The amlodipine-atorvastatin calcium tablets according to claim 1, characterized in that: The amlodipine atorvastatin calcium tablets also include surfactants; Preferably, the surfactant is selected from one or more of polysorbate, Span, and poloxamer.
9. The method for preparing amlodipine-atorvastatin calcium tablets according to any one of claims 1 to 8, characterized in that: Amlodipine besylate, atorvastatin calcium, filler, matrix material, binder, lubricant and surfactant are sieved, mixed evenly and compressed into tablets to obtain amlodipine atorvastatin calcium tablets.
10. The use of the amlodipine atorvastatin calcium tablets according to any one of claims 1 to 8 as a drug for the prevention and / or treatment of hypertension, hyperlipidemia, and angina pectoris.