Ruxolitinib Phosphate Tablets and Preparation Method Thereof

Abstract

This application relates to the field of pharmaceutical tablet preparation, and particularly to a ruxolitinib phosphate tablet and a preparation method thereof. The ruxolitinib phosphate tablet, by mass, comprises the following raw materials: 5-10 parts of ruxolitinib phosphate, 65-75 parts of polyhydroxy compound, 5-15 parts of colloid auxiliary, 2-3.5 parts of disintegrant, 1-4 parts of glidant, 2-5 parts of binder, and 4-10 parts of functional auxiliary. The ruxolitinib phosphate tablet prepared by this application not only has good ruxolitinib phosphate carrier efficiency, improves the drug loading of the tablet, but also greatly improves the tablet stability of the ruxolitinib phosphate tablet itself, can be stably stored in high humidity and high temperature environments, and avoids the phenomena of tablet moisture absorption and powdering, ruxolitinib phosphate moisture absorption and hydrolysis, and high temperature cracking of the existing tablets due to the above special environments, and has a very excellent application prospect.

Description

Technical Field

[0001] This application relates to the field of preparation of pharmaceutical tablets, and particularly relates to a ruxolitinib phosphate tablet and a preparation method thereof. Background Art

[0002] The chemical name of ruxolitinib phosphate is (r)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate, which is a selective JAK1 and JAK2 inhibitor and is used to treat various myeloproliferative diseases. Ruxolitinib phosphate tablets are mostly used for the treatment of intermediate or high-risk myelofibrosis (MF), including primary myelofibrosis, myelofibrosis after polycythemia vera (PV), and myelofibrosis after essential thrombocythemia (ET). As the first therapeutic drug for myelofibrosis and the only currently approved targeted drug for the pathogenesis.

[0003] Currently, in terms of the clinical situation in China, there is an urgent need for ruxolitinib phosphate tablets. However, the technical information of domestic ruxolitinib phosphate tablets is lacking at present, and the main source still mainly depends on foreign imports, with relatively high prices, which increases the family burden of patients. On the other hand, the existing formulation schemes of ruxolitinib phosphate tablets mostly contain components such as lactose and microcrystalline cellulose. These components all have a certain hygroscopicity, and due to the problem of the compactness of the tablets themselves, if stored in a high-humidity or high-temperature environment, obvious phenomena such as tablet hygroscopic caking, ruxolitinib phosphate hygroscopic hydrolysis, and high-temperature cracking are likely to occur. For the expensive ruxolitinib phosphate tablets, this further increases the potential treatment costs for patients or clinics.

[0004] Therefore, to solve the above problems, this application provides a ruxolitinib phosphate tablet and a preparation method thereof. The ruxolitinib phosphate tablet prepared in this application not only has good ruxolitinib carrier efficiency, maintains a good drug loading capacity of the tablets, but also greatly improves the tablet stability of the ruxolitinib phosphate tablets themselves, can be stably stored in high-humidity and high-temperature environments, and avoids the phenomena of tablet hygroscopic caking, ruxolitinib phosphate hygroscopic hydrolysis, and high-temperature cracking caused by the above special environments in the existing tablets, and has a very excellent application prospect. Summary of the Invention

[0005] To solve the above problems, in the first aspect of this application, a ruxolitinib phosphate tablet is provided. Calculated by mass parts, the raw materials are: 5-10 parts of ruxolitinib phosphate, 65-75 parts of polyhydroxy compound, 5-15 parts of colloidal auxiliary, 2-3.5 parts of disintegrant, 1-4 parts of glidant, 2-5 parts of binder, and 4-10 parts of functional auxiliary.

[0006] As a preferred embodiment, the mass ratio of the polyhydroxy compound, the colloid aid, and the binder is (6.8 - 7.4):(0.6 - 1.2):(0.3 - 0.5).

[0007] As a preferred embodiment, the mass ratio of the polyhydroxy compound, the colloid aid, and the binder is (7 - 7.2):(0.8 - 1.1):(0.3 - 0.4).

[0008] As a preferred embodiment, the polyhydroxy compound is a composition of sulfobutyl ether-β-cyclodextrin, sorbitol, and mannitol.

[0009] As a preferred embodiment, the mass ratio of the sulfobutyl ether-β-cyclodextrin, sorbitol, and mannitol is (1 - 2):(2 - 3):(4 - 5.5).

[0010] As a preferred embodiment, the mass ratio of the sulfobutyl ether-β-cyclodextrin, sorbitol, and mannitol is (1.5 - 1.6):(2 - 2.5):(4.5 - 5).

[0011] As a preferred embodiment, the colloid aid is a composition of gum arabic, gelatin, and polyoxyalkylene block copolymer.

[0012] As a preferred embodiment, the mass ratio of the gum arabic, gelatin, and polyoxyalkylene block copolymer is (2 - 2.5):(3.5 - 4.5):(1 - 1.5).

[0013] As a preferred embodiment, the mass ratio of the gum arabic, gelatin, and polyoxyalkylene block copolymer is 2.2:4.3:1.

[0014] As a preferred embodiment, the weight-average molecular weight of the gum arabic is 230,000 - 250,000.

[0015] As a preferred embodiment, the weight-average molecular weight of the gelatin is 60,000 - 80,000.

[0016] As a preferred embodiment, the polyoxyalkylene block copolymer is a polyoxyethylene-polyoxypropylene block copolymer.

[0017] In this application, by using the above-mentioned compound of the colloidal auxiliary agent and the polyhydroxy compound, the tablet stability of the ruxolitinib phosphate tablets themselves can be greatly improved, and it has excellent moisture absorption resistance and high-temperature stability. The added colloidal auxiliary agent in this application can form an ordered and dense three-dimensional network entanglement structure with the added polyhydroxy compound through strong intermolecular forces inside and different flow and migration speeds within the system, strengthening the internal molecular density, thereby greatly reducing the free speed of water molecules in the internal system, increasing the free resistance, and greatly restricting the aggregation of water molecules in the internal system. On the other hand, the addition of colloidal auxiliary agents with different molecular weights can form a multi-layer stacked surface film structure through the continuous phase action of the colloid during the formation of tablet particles. The existence of this structure can effectively cover the surface of the prepared tablets, thereby greatly reducing the formation speed of the surface hydration layer in a high-temperature active environment and a high-humidity environment, blocking the penetration of active molecules and water molecules into the tablet system, and restricting the collision efficiency of internal molecules through the film layer, and thus obtaining excellent high-temperature and high-humidity stability.

[0018] As a preferred embodiment, the disintegrant is at least one of sodium carboxymethyl starch, hydroxypropyl cellulose, croscarmellose sodium, and sodium lauryl sulfate.

[0019] As a preferred embodiment, the disintegrant is a composition of croscarmellose sodium and sodium lauryl sulfate.

[0020] As a preferred embodiment, the mass ratio of sodium carboxymethyl starch to sodium lauryl sulfate is (2 - 3):(0.3 - 0.6).

[0021] As a preferred embodiment, the mass ratio of sodium carboxymethyl starch to sodium lauryl sulfate is (2 - 2.5):(0.4 - 0.5).

[0022] As a preferred embodiment, the glidant is at least one of colloidal silica, magnesium stearate, calcium stearate, microcrystalline cellulose, talc powder, and colloidal silica powder.

[0023] As a preferred embodiment, the glidant is a composition of magnesium stearate and talc powder.

[0024] As a preferred embodiment, the average particle size of the talc powder is 0.1 - 0.5 μm.

[0025] As a preferred embodiment, the mass ratio of magnesium stearate to talc powder is (3 - 4):(0.5 - 1).

[0026] As a preferred embodiment, the binder is at least one of polyvinylpyrrolidone, gelatinized starch, polyvinyl alcohol, and hydroxypropyl methylcellulose.

[0027] As a preferred solution, the binder is a composition of polyvinylpyrrolidone and polyvinyl alcohol.

[0028] As a preferred solution, the mass ratio of polyvinylpyrrolidone to polyvinyl alcohol is (4 - 6):(1 - 1.5).

[0029] As a preferred solution, the functional auxiliary agent at least includes starch material and surfactant.

[0030] As a preferred solution, the mass ratio of starch material to surfactant is (6 - 8):(1 - 2).

[0031] As a preferred solution, the surfactant is at least one of sodium dodecyl sulfate, sodium dodecylbenzenesulfonate, alkyl glycoside, betaine, fatty acid glyceride, and lecithin.

[0032] As a preferred solution, the surfactant is a composition of sodium dodecylbenzenesulfonate and fatty acid glyceride.

[0033] As a preferred solution, the mass ratio of sodium dodecylbenzenesulfonate to fatty acid glyceride is (3 - 3.5):(1 - 1.4).

[0034] As a preferred solution, the starch material is a composition of amylopectin and amylose.

[0035] As a preferred solution, the mass ratio of amylopectin to amylose is (2 - 2.4):(0.8 - 1).

[0036] In this application, the combined action of the added starch material and surfactant can effectively improve the self - stability of ruxolitinib phosphate tablets, and maintain a good ruxolitinib phosphate content on the premise of adding more filling raw materials. The added amylopectin in this application can enhance the group bridging effect of its multiple branches on the internal polyhydroxy system of the tablet through the action of the composite surfactant. Thus, under the guidance of the long - helical amylose molecules, the internal molecular chain system's inhibitory effect on the active molecules is strengthened. Furthermore, it synergistically forms a phenomenon of entrapping the active molecules inside and outside with the colloidal film layer acting on the outside, increasing the steric hindrance, and thus maintaining excellent stability during long - term storage.

[0037] The second aspect of the present application provides a preparation method of the above-mentioned ruxolitinib phosphate tablets, which specifically includes the following steps: S1: Mix ruxolitinib phosphate with pure water, and then mix the obtained liquid with a polyhydroxy compound evenly. After that, dry to remove the pure water, melt-extrude the mixture, and crush the mixture through a 200-400 mesh sieve after cooling; S2: Mix the mixture with the remaining raw materials, granulate in a dry granulator, and vacuum-dry the obtained solid particles at 80-90 °C; S3: After drying is completed, press the obtained solid particles with a tableting machine. After tableting is completed, the tablets are obtained.

[0038] The beneficial effects of the present application are:

[0039] 1. The ruxolitinib phosphate tablets provided in the present application not only have good carrier efficiency of ruxolitinib phosphate, maintain a good drug loading of the tablets, but also greatly improve the tablet stability of the ruxolitinib phosphate tablets themselves. They can be stably stored in high-humidity and high-temperature environments, avoiding the phenomena of tablet moisture absorption and powdering, ruxolitinib phosphate moisture absorption and hydrolysis, and high-temperature cracking of existing tablets due to the above special environments, and have very excellent application prospects.

[0040] 2. The ruxolitinib phosphate tablets provided in the present application can greatly improve the tablet stability of the ruxolitinib phosphate tablets themselves by using a compound of a colloidal auxiliary agent and a polyhydroxy compound, and have excellent moisture absorption resistance and high-temperature stability; the colloidal auxiliary agent can form an ordered and dense three-dimensional network entanglement structure with the added polyhydroxy compound through strong intermolecular forces inside and different flow and migration speeds in different systems, strengthening the internal molecular intimacy, thereby greatly reducing the free speed of water molecules in the internal system, increasing the free resistance, and greatly restricting the aggregation of water molecules in the internal system; on the other hand, the addition of colloidal auxiliary agents with different molecular weights can form a multi-layer stacked surface film structure through the continuous phase action of the colloid during the formation of tablet particles. The existence of this structure can effectively cover the surface of the prepared tablets, thereby greatly reducing the formation speed of the surface hydration layer in high-temperature active environments and high-humidity environments, and blocking the penetration of active molecules and water molecules into the tablet system.

[0041] 3. In the ruxolitinib phosphate tablets provided in this application, the combined action of the added starch material and surfactant can effectively improve the self-stability of the ruxolitinib phosphate tablets, and maintain a good ruxolitinib phosphate content on the premise of adding more filling raw materials; the added amylopectin can enhance the bridging effect of its multiple branches on the polyhydroxy system inside the tablet through the action of the composite surfactant, so that under the guidance of the long helical amylose molecules, the internal molecular chain system's inhibitory effect on the active molecules is strengthened, and then cooperate to form a phenomenon of entrapping the active molecules inside and outside by the colloidal film layer with an external wrapping effect, increasing the steric hindrance, thereby maintaining excellent stability during long-term storage. Detailed implementation mode

[0042] The technical solutions in the above-mentioned invention content of this application will be further described and demonstrated in the following specific implementation modes. And the following examples are only actual examples for explaining and interpreting the content of the technical solutions in the specification, and should not limit the scope of the claims to be protected by this application. All technical products based on the technical solutions described in the invention content of this application should be covered within the scope to be protected by this application.

[0043] In the following examples, unless otherwise specified, the raw materials are commercially available products that can be obtained, or can be prepared by methods well-known to those skilled in the art.

[0044] Example 1

[0045] Example 1 provides a kind of ruxolitinib phosphate tablet. By mass, the raw materials are: 8.5 parts of ruxolitinib phosphate, 71.8 parts of polyhydroxy compound, 10.5 parts of colloid aid, 2.8 parts of disintegrant, 2.2 parts of glidant, 3.6 parts of binder, and 7.5 parts of functional aid.

[0046] The polyhydroxy compound is a composition of sulfobutyl ether-β-cyclodextrin, sorbitol and mannitol, and the mass ratio of the three is 1.55:2.2:4.65.

[0047] The colloid aid is a composition of arabic gum, gelatin and polyoxyalkylene block copolymer, and the mass ratio of the three is 2.2:4.3:1.

[0048] The polyoxyalkylene block copolymer is a polyoxyethylene-polyoxypropylene block copolymer, and is purchased from the product of poloxamer 188 model sold by Shanxi Jinyang Pharmaceutical Excipients Co., Ltd.

[0049] The weight-average molecular weight of arabic gum is 240,000, and is purchased from the corresponding molecular weight product sold by Jiangsu Caiwei Biotechnology Co., Ltd.

[0050] The weight-average molecular weight of gelatin is 72,000, and it is purchased from the corresponding molecular weight product sold by Hebei Pengyu Biotechnology Co., Ltd.

[0051] The disintegrant is a composition of croscarmellose sodium and sodium lauryl sulfate, and the mass ratio of the two is 2.4:0.4. Croscarmellose sodium is purchased from the food-grade product sold by Shandong Xinxiong Biotechnology Co., Ltd.

[0052] The glidant is a composition of magnesium stearate and talc powder, and the mass ratio of the two is 3.2:0.8; the average particle size of talc powder is 0.25 μm.

[0053] The binder is a composition of polyvinylpyrrolidone and polyvinyl alcohol, and the mass ratio of the two is 5:1.2.

[0054] Polyvinylpyrrolidone is purchased from the medical-grade polyvinylpyrrolidone K90 product sold by Hebei Tuohai Biotechnology Co., Ltd.

[0055] Polyvinyl alcohol is purchased from the medical-grade CP2020 type product sold by Xi'an Tianzheng Pharmaceutical Excipients Co., Ltd.

[0056] The functional auxiliary agent is a composition of starch material and surfactant, and the mass ratio of the two is 7:1.5.

[0057] The surfactant is a composition of sodium dodecylbenzenesulfonate and fatty acid glyceride, and the mass ratio of the two is 3.2:1.1.

[0058] The starch material is a composition of amylopectin and amylose, and the mass ratio of the two is 2.2:0.9.

[0059] Amylopectin is purchased from Wuhan Huaxiang Kejie Biotechnology Co., Ltd., and the amylopectin content is ≥70%.

[0060] Amylose is purchased from Wuhan Huaxiang Kejie Biotechnology Co., Ltd., and the amylose content is ≥70%.

[0061] In the second aspect of this example, a preparation method of the above-mentioned ruxolitinib phosphate tablets is provided, which specifically includes the following steps: S1: Mix ruxolitinib phosphate with 5 times the mass of pure water, and mix the obtained liquid with a polyhydroxy compound evenly, then dry to remove the pure water, hot melt extrude the mixture, and after cooling, crush the mixture and pass through a 300-mesh sieve; S2: Mix the mixture with the remaining raw materials, place it in a dry granulator to granulate, and vacuum dry the obtained solid particles at 90 °C; S3: After drying, press the obtained solid particles with a tablet press, and after pressing, the tablets are obtained.

[0062] Example 2

[0063] Example 2 provides a ruxolitinib phosphate tablet in the first aspect. In terms of parts by mass, the raw materials are: 8.5 parts of ruxolitinib phosphate, 68.2 parts of polyhydroxy compound, 12 parts of colloid adjuvant, 3 parts of disintegrant, 2.2 parts of glidant, 3.1 parts of binder, and 8.8 parts of functional adjuvant.

[0064] The polyhydroxy compound is a composition of sulfobutyl ether-β-cyclodextrin, sorbitol, and mannitol, and the mass ratio of the three is 1.4:2.5:5.

[0065] The colloid adjuvant is a composition of gum arabic, gelatin, and polyoxyalkylene block copolymer, and the mass ratio of the three is 2.4:3.8:1.2.

[0066] The polyoxyalkylene block copolymer is a polyoxyethylene-polyoxypropylene block copolymer, and it is purchased as the product of poloxamer 188 model sold by Shanxi Jinyang Pharmaceutical Excipients Co., Ltd.

[0067] The gum arabic has a weight-average molecular weight of 240,000 and is purchased as the corresponding molecular weight product sold by Jiangsu Caiwei Biotechnology Co., Ltd.

[0068] The gelatin has a weight-average molecular weight of 72,000 and is purchased as the corresponding molecular weight product sold by Hebei Pengyu Biotechnology Co., Ltd.

[0069] The disintegrant is a composition of croscarmellose sodium and sodium lauryl sulfate, and the mass ratio of the two is 2.4:0.4. The croscarmellose sodium is purchased as the food-grade product sold by Shandong Xinxiong Biotechnology Co., Ltd.

[0070] The glidant is a composition of magnesium stearate and talc powder, and the mass ratio of the two is 3.2:0.8; the average particle size of the talc powder is 0.25 μm.

[0071] The binder is a composition of polyvinylpyrrolidone and polyvinyl alcohol, and the mass ratio of the two is 5:1.2.

[0072] The polyvinylpyrrolidone is purchased as the medical-grade polyvinylpyrrolidone K90 product sold by Hebei Tuohai Biotechnology Co., Ltd.

[0073] The polyvinyl alcohol is purchased as the medical-grade CP2020 type product sold by Xi'an Tianzheng Pharmaceutical Excipients Co., Ltd.

[0074] The functional adjuvant is a composition of starch material and surfactant, and the mass ratio of the two is 7:1.5.

[0075] The surfactant is a composition of sodium dodecylbenzenesulfonate and fatty acid glyceride, and the mass ratio of the two is 3.2:1.1.

[0076] The starch material is a composition of amylopectin and amylose, and the mass ratio of the two is 2.2:0.9.

[0077] The amylopectin was purchased from Wuhan Huaxiang Kejie Biotechnology Co., Ltd., and the amylopectin content was ≥ 70%.

[0078] The amylose was purchased from Wuhan Huaxiang Kejie Biotechnology Co., Ltd., and the amylose content was ≥ 70%.

[0079] In the second aspect of this example, a preparation method of the above-mentioned ruxolitinib phosphate tablets is provided, which specifically includes the following steps: S1: Mix ruxolitinib phosphate with 5 times the mass of pure water, and mix the resulting liquid with a polyhydroxy compound evenly. Then, dry to remove the pure water, melt-extrude the mixture, and after cooling, crush the mixture through a 300-mesh sieve; S2: Mix the mixture with the remaining raw materials, place it in a dry granulator to granulate, and vacuum-dry the obtained solid particles at 90 °C; S3: After drying is completed, press the obtained solid particles with a tableting machine, and after tableting is completed, it is obtained.

[0080] Comparative Example 1

[0081] The specific implementation manner of this comparative example is basically the same as that of Example 1, except that: for the ruxolitinib phosphate tablets, by mass, the raw materials are: 8.5 parts of ruxolitinib phosphate, 80.5 parts of polyhydroxy compound, 2.5 parts of colloid auxiliary, 3 parts of disintegrant, 2.2 parts of glidant, 3.1 parts of binder, and 8.8 parts of functional auxiliary.

[0082] Comparative Example 2

[0083] The specific implementation manner of this comparative example is basically the same as that of Example 1, except that: for the ruxolitinib phosphate tablets, by mass, the raw materials are: 8.5 parts of ruxolitinib phosphate, 55.5 parts of polyhydroxy compound, 25.5 parts of colloid auxiliary, 3 parts of disintegrant, 2.2 parts of glidant, 3.1 parts of binder, and 8.8 parts of functional auxiliary.

[0084] Comparative Example 3

[0085] The specific implementation manner of this comparative example is basically the same as that of Example 1, except that: the polyhydroxy compound is a composition of sulfobutyl ether-β-cyclodextrin, sorbitol and mannitol, and the mass ratio of the three is 0.5:1:7.5.

[0086] Comparative Example 4

[0087] The specific implementation manner of this comparative example is basically the same as that of Example 1, except that: the colloid auxiliary is a composition of arabic gum, gelatin and polyoxyolefin block copolymer, and the mass ratio of the three is 1.2:5.8:0.5.

[0088] Comparative Example 5

[0089] The specific implementation of this comparative example is basically the same as that of Example 1, except that: the mass ratio of amylopectin to amylose is 5:0.8.

[0090] Comparative Example 6

[0091] The specific implementation of this comparative example is basically the same as that of Example 1, except that: the mass ratio of amylopectin to amylose is 0.6:3.5.

[0092] Performance Evaluation

[0093] Total impurity content: The total impurity content of the ruxolitinib phosphate tablets prepared in the examples and comparative examples was tested. The tablet specification was 20 mg / tablet, and the test value was the average of 10 tests and recorded in Table 1.

[0094] Dissolution rate: The ruxolitinib phosphate tablets (20 mg / tablet) prepared in the examples and comparative examples were stored in a constant temperature and humidity chamber at 25 - 30 °C and 50% relative humidity for 3 months, and the dissolution rate after normal storage was detected. The time was 30 min, and the test value was the average of 10 tests and recorded in Table 1.

[0095] High temperature and high humidity stability: The ruxolitinib phosphate tablets (20 mg / tablet) prepared in the examples and comparative examples were stored in a constant temperature and humidity chamber at 50 - 55 °C and 75% relative humidity for 3 months. After three months, they were taken out to observe whether there were phenomena such as tablet moisture absorption and cracking, powdering, and fragmentation. If so, it was recorded as unqualified, otherwise as qualified. 100 samples were tested in each group, and the qualified rate of the test samples was recorded in Table 1. The qualified rate % = number of qualified samples / 100 × 100%.

[0096] Table 1 Performance test result table

[0097]

[0098] From the data results of the examples, comparative examples of this application and Table 1, it can be known that Examples 1 and 2 of this application have obvious advantages over Comparative Examples 1 - 6 in terms of total tablet impurities, moisture and temperature resistance, and self - stability, etc. This is mainly because of the combined action of the polyhydroxy compounds, colloid additives and functional additives specified in this application. While in Comparative Examples 1 - 6, due to the fact that the technical solutions specified in this application were not adopted, obvious disadvantages occurred in the above - mentioned performance tests, which further proves the necessity of the technical solutions specified in this application for the technical effects and solving technical problems of this application.

Claims

1. A ruxolitinib phosphate tablet, characterized in that: Ruxolitinib phosphate tablets, by mass, the raw materials are: 5-10 parts of ruxolitinib phosphate, 65-75 parts of polyhydroxy compound, 5-15 parts of colloid auxiliary, 2-3.5 parts of disintegrant, 1-4 parts of glidant, 2-5 parts of binder, 4-10 parts of functional auxiliary; The mass ratio of the polyhydroxy compound, colloid auxiliary and binder is (6.8-7.4):(0.6-1.2):(0.3-0.5); The polyhydroxy compound is a composition of sulfobutyl ether-β-cyclodextrin, sorbitol and mannitol; the mass ratio of the sulfobutyl ether-β-cyclodextrin, sorbitol and mannitol is (1-2):(2-3):(4-5.5); The colloid auxiliary is a composition of gum arabic, gelatin and polyoxyalkylene block copolymer; The weight-average molecular weight of the gum arabic is 230000-250000; The weight-average molecular weight of the gelatin is 60000-80000; The disintegrant is at least one of sodium carboxymethyl starch, hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, sodium lauryl sulfate; The glidant is at least one of colloidal silica, magnesium stearate, calcium stearate, microcrystalline cellulose, talc powder, silica micropowder; The binder is at least one of polyvinylpyrrolidone, gelatinized starch, polyvinyl alcohol, hydroxypropyl methylcellulose; The functional auxiliary at least includes starch material and surfactant; The mass ratio of the starch material and surfactant is (6-8):(1-2); The mass ratio of the gum arabic, gelatin and polyoxyalkylene block copolymer is (2-2.5):(3.5-4.5):(1-1.5); The surfactant is a composition of sodium dodecylbenzenesulfonate and fatty acid glyceride; the mass ratio of the sodium dodecylbenzenesulfonate and fatty acid glyceride is (3-3.5):(1-1.4); The starch material is a composition of amylopectin and amylose; The mass ratio of the amylopectin and amylose is (2-2.4):(0.8-1).

2. The ruxolitinib phosphate tablets according to claim 1, characterized in that: The disintegrant is a composition of cross-linked sodium carboxymethyl cellulose and sodium lauryl sulfate.

3. The ruxolitinib phosphate tablets according to claim 2, wherein: The mass ratio of the sodium carboxymethyl cellulose and sodium lauryl sulfate is (2-3):(0.3-0.6).

4. The ruxolitinib phosphate tablets according to claim 3, characterized in that: The glidant is a composition of magnesium stearate and talc powder; the mass ratio of the magnesium stearate and talc powder is (3-4):(0.5-1).

5. The ruxolitinib phosphate tablets according to claim 4, wherein: The binder is a composition of polyvinylpyrrolidone and polyvinyl alcohol; the mass ratio of the polyvinylpyrrolidone and polyvinyl alcohol is (4-6):(1-1.5).

6. A preparation method of the ruxolitinib phosphate tablets according to any one of claims 1 to 5, characterized in that: Specifically, it includes the following steps: S1: Mix ruxolitinib phosphate with pure water, and mix the obtained liquid with the polyhydroxy compound evenly, then dry to remove the pure water, melt-extrude the mixture, and after cooling, crush the mixture and pass through a 200-400 mesh sieve; S2: Mix the mixture with the remaining raw materials, place it in a dry granulator to granulate, and vacuum-dry the obtained solid particles at 80-90 °C; S3: After drying is completed, press the obtained solid particles with a tableting machine, and after tableting is completed, it is obtained.

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