TW202014180A - Solid formulation including celecoxib and method for manufacturing the same - Google Patents

Abstract

The present invention relates to a solid formulation including celecoxib and method for manufacturing the same. Based on a total mass of the solid formulation as 100 mass %, the solid formulation is characterized by 1 mass % to 15 mass % of a surfactant and 1 mass % to 5 mass % of a binder without disintegrants therein. Moreover, the method for manufacturing the solid formulation including celecoxib is characterized that the solid formulation is made by wet granulation method.

Description

Solid preparation containing Celecoxib (Celecoxib) and Its manufacturing method

The present invention relates to a solid preparation containing Celecoxib (Celecoxib) and a manufacturing method thereof, in particular to a solid preparation containing Celecoxib which can improve the solubility of Celecoxib without adding a disintegrating agent and a manufacturing method thereof.

Medicaments exist in various shapes, and solid preparations such as tablets and capsules or liquid preparations such as injections and sprays are generally known. Among them, the solid preparation is suitable for oral administration, and has the advantages of excellent stability and is widely used. In order to exert the medicinal effect of the solid preparation, it must be disintegrated in the digestive juice of the stomach or intestine to dissolve the contained medicinal components. However, in solid preparations, it may not be able to disintegrate well in the digestive juice due to the influence of drugs or additives. At this time, the medicinal components in the digestive organs are incompletely dissolved, and the medicinal effects cannot be fully obtained. .

In order to increase the disintegration of solid preparations in digestive juices, one of the methods is to add disintegrating agents. The disintegrant will be affected by moisture and expand its volume, which helps to increase the disintegration of the solid preparation in the body. It is still difficult to add disintegrant As a disintegrating agent, use a super disintegrating agent with better disintegrating properties (for example, croscarmellose sodium, crospovidone, low substituted hydroxypropyl cellulose (low substituted hydroxypropylcellulose) etc.]. However, the use of disintegrants, because of their high volume expansion rate, is generally doubtful about the shape stability. Especially when the amount of the dispersant is large, the tablet may be cracked or broken (for example, refer to Japanese Patent Laid-Open No. 2006-131581).

On the other hand, Celecoxib (Celecoxib(4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazole-1-yl]benzenesulfonamide) is a non-steroidal anti-inflammatory analgesic (non-steroidal anti-analgesic) inflammatory drugs; NSAIDs). Celebrex will selectively inhibit cyclooxygenase-2 (COX-2), which is specific and free of the common gastrointestinal side effects of NSAIDs. However, Celebrex is a poorly soluble drug that is prone to aggregation. In order to improve the dissolution rate of Celebrex from solid preparations, conventional techniques have taken various methods to improve, such as reducing the particle size, blending super disintegrants (for example, refer to Japan Patent No. 3563036).

For example, Japanese Patent Publication No. 3563036 has disclosed a formulation containing a disintegrant and its disintegration test results. However, no matter whether it is a tablet or a solid preparation, there is a problem of disintegration. No matter what kind of formula, the super disintegrant of croscarmellose sodium is a necessary ingredient.

In view of this, there is an urgent need to develop a solid preparation of Xilebao and its manufacturing method, so that the dissolution of Xilebao can be improved by not adding a disintegrating agent.

After intensive research, the inventors of the present invention found that with a specific content of surfactants and binders, even without adding a disintegrant, a method of obtaining a solid preparation with excellent dissolution rate of Celecoxib (Celecoxib) can be obtained, and completed the present invention. . That is, the present invention is to provide the following solid preparation containing Celebrex and its manufacturing method.

Therefore, one aspect of the present invention is to provide a solid preparation containing Celebrex, characterized in that the total mass of the solid preparation is 100% by mass, and the solid preparation contains 1% to 15% by mass of surfactant and 1% by mass % To 5% by mass of binder and no disintegrant.

In one embodiment, the surfactant is an anionic surfactant.

In one embodiment, the anionic surfactant is sodium lauryl sulfate (SLS).

In one embodiment, the binder is a cellulose derivative.

In one embodiment, the cellulose cellulose derivative is hydroxypropyl cellulose.

In one embodiment, the above-mentioned solid preparation containing Celebrex further includes at least one of a group consisting of sugar alcohol and disaccharide.

In one embodiment, the disaccharide is lactose.

In one embodiment, the above solid preparation contains 40% to 60% by mass of Celebrex.

In one embodiment, the above solid preparation is a lozenge.

In one embodiment, the solid preparation is an oral disintegrating tablet.

Another aspect of the present invention is to provide a method for manufacturing a solid preparation containing Celebrex, characterized in that the above-mentioned solid preparation containing Celebrex is manufactured by a wet granulation method.

In one embodiment, the above wet granulation method is a fluidized bed granulation method.

The solid preparation containing Xilebao of the present invention can quickly disintegrate in the body even if it does not contain a disintegrating agent. Therefore, when the above-mentioned solid preparation containing Celebrex is applied to oral medicine, a good therapeutic effect can be achieved.

All references cited herein are deemed to be specific and individually incorporated references by citing each individual document or patent application. If the definition or usage of a term in the cited document is inconsistent or contrary to the definition of the term here, the definition of the term here applies, and the definition of the term in the quotation does not apply.

For the purpose of interpreting the description, the following definitions will apply. Where appropriate, singular nouns include plurals and vice versa. The entire detailed description sets forth additional definitions.

Unless the context is not appropriate, "a (an)" and "the (said)" described herein are defined as "one or more" and include plurals.

The invention discloses a solid preparation containing Celecoxib, characterized in that the total mass of the solid preparation is 100% by mass, the solid preparation contains 1% to 15% by mass of surfactant and 1% to 5% by mass % Of the binder and does not contain disintegrant. The solid preparation containing Celebrex of the present invention can achieve an excellent degree of disintegration in digestive juice by adding a specific content of a surfactant and a binder, even if it does not contain a disintegrating agent. Therefore, when the above-mentioned solid preparation containing Celebrex is applied to oral medicine, a good therapeutic effect can be achieved. Furthermore, the above-mentioned solid preparation containing Celebrex does not contain a disintegrating agent, so it is possible to reduce concerns about the stability of the shape.

Disintegrant refers to an additive added to a solid preparation, which can swell by water absorption, thereby enhancing the degree of disintegration. Specifically, the disintegrant of the present invention may be exemplified as follows: carboxymethyl cellulose (Carmellose), croscarmellose sodium (croscarmellose sodium), carboxymethyl-cellulose calcium (carboxymethyl-cellulose calcium) 1. Low substituted hydroxypropylcellulose (L-HPC), crystalline cellulose, crospovidone and alginic acid. In addition, the low-substituted hydroxypropyl cellulose replaces the hydroxyl groups on the glucose constituting the cellulose with hydroxypropyloxy groups, and the number of moles at which 1 residue of each glucose of hydroxypropyl cellulose is substituted with hydroxypropyloxy groups is 0.11~0.39. This means that the dried product of low-substituted hydroxypropylcellulose contains 5.0 to 16.0% of hydroxypropoxyl (the seventeenth revised edition of the Japanese Pharmacopoeia, also known as the Seventeenth Correction of the Japanese Pharmacopoeia).

About the principle used in the solid preparation containing Xilebao of the present invention The shape of the Celebrex powder is not particularly limited. For example, the Celebrex powder obtained by pulverizing the needle-like crystals may be used, or the Celebrex powder obtained by drying the precipitate obtained by precipitation may be used. The pulverization treatment of the above-mentioned Xilebao crystal can be carried out in a conventional manner using a mixer such as a ball mill, hammer mill, jet mill (jet mill), or the like. Furthermore, the synthesis or precipitation method of the needle crystals of Xilebao can also be performed by a conventional method (for example, Japanese Patent Publication No. 3563036).

With regard to the raw materials used in the solid preparation containing Celebrex of the present invention, the size of Celebrex powder is not particularly limited. From the viewpoint of content uniformity or fluidity in the manufacture of solid preparations, the D ₉₀ of the particle size of Celebrex powder (the cumulative frequency is 90% of the particle size) is preferably in the range of 1 to 200 μm, more preferably in the range of 5 to 100 μm Good, better at 5~50μm, better at 5~30μm. In addition, the particle size of each particle of Xilebao powder can be used by the mesh sieving method (JIS K 0069: 1992), the laser diffraction method (JIS Z 8825: 2013), the small hole passing method (Coulter particle size analysis method) , Coulter Counter method), sedimentation method or microscope method. When the sieve powder is measured by the mesh sieve method, the particle size is the mesh aperture; when measured by the laser diffraction method, the particle size is equivalent to the diameter of the spherical particle; when measured by the microscope method, the particle size is The maximum length of each particle.

There is no particular limitation on the content of Celebrex in the solid preparation containing Celebrex of the present invention. The surfactant and the binder of the present invention are formulated in a specific amount, and even in a solid preparation with a large amount of Xilebao, excellent disintegration can be achieved. Therefore, based on the total mass of the solid preparation being 100% by mass, the solid preparation containing Xilebao of the present invention has a Xilebao content of 30% by mass Good is better, more than 35% by mass is better, more than 40% by mass is better, but more than 45% by mass is even better. In addition, since the necessary excipients can be mixed in a sufficient amount, based on the total mass of the solid preparation is 100% by mass, the content of Celebrex is preferably 70% by mass or less, preferably 65% by mass or less, 60% by mass The following is better.

The raw material suitable for the surfactant of the solid preparation containing Xilebao of the present invention may be a substance that can be used in medicine, and is not particularly limited. The surfactant may be an anionic surfactant such as sodium lauryl sulfate (SLS); polyoxyethylene sorbitan (for example, tween (registered trademark) 20, 40, 60, 80, or 85 nonionic surfactant; and other sorbitol [for example, Span (registered trademark) 20, 40, 60, 80, or 85]. These surfactants may be used alone or in combination of two or more. The surfactant used in the present invention is preferably an anionic surfactant, and preferably SLS.

The adhesive suitable for the solid preparation containing Celebrex of the present invention may be a substance that can be used in medicine, and is not particularly limited. The above-mentioned binders can be, for example, cellulose derivatives, polyvinylpyrrolidone, gelatin, Hantian, sodium alginate, partially saponified polyvinyl alcohol, pullulan, dextrin ), chitonsan gum, gum arabic powder, etc. Cellulose derivatives may be, for example, methylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose (hydroxypropylcellulose), hydroxypropyl methylcellulose (hypromellose), etc. The above-mentioned adhesives may be used alone or in combination of two or more. The binder used in the present invention is preferably a cellulose derivative, but preferably hydroxypropyl cellulose. In addition, hydroxypropyl cellulose replaces the hydroxyl groups on the glucose constituting the cellulose with hydroxypropyloxy groups, and the number of moles of hydroxypropyl cellulose substituted by hydroxypropyloxy groups at each residue of glucose is 53.4~ 80.5%. In other words, the dried product of hydroxypropyl cellulose contains 53.4 to 80.5% of hydroxypropoxyl group (Japanese Pharmacopoeia Seventeenth Revision).

Hydroxypropyl cellulose can be classified according to viscosity. The viscosity of hydroxypropyl cellulose used in the present invention is not particularly limited, but 2 to 400mPa. s is better, and 2~10mPa. s is better. In addition, the viscosity of hydroxypropyl cellulose refers to the viscosity of its 2% by mass aqueous solution at 20°C. This is based on the 17th revised edition of the Japanese Pharmacopoeia "General Test Method Annual Measurement Method Method 2 Rotating Viscometer Method" , Measured with a rotary viscometer.

Based on the total mass of the solid preparation being 100% by mass, the solid preparation containing Xilebao of the present invention may contain 1 to 15% by mass of surfactant and 1 to 5% by mass of binder. Based on the total mass of the solid preparation being 100% by mass, the content of the aforementioned surfactant is preferably 1-12% by mass, preferably 1-10% by mass, more preferably 1-8% by mass, and even more preferably 2-8% by mass . Based on the total mass of the solid preparation being 100% by mass, the content of the aforementioned binder is preferably 2 to 5% by mass, and preferably 2 to 4% by mass.

The solid preparation containing Celebrex of the present invention may contain, in addition to Celebrex, a surfactant, and a binder, additives that can be used in various appropriate combinations and contain necessary contents. The aforementioned addition The agent does not contain a disintegrating agent, and it is not particularly limited as long as it does not impair the effect of the present invention. The aforementioned additives may be, for example, excipients, lubricants, flavoring agents, coloring agents, fragrances, pH adjusting agents, plasticizers, and the like.

The above excipients can be starches such as corn starch, potato starch, wheat starch, rice starch, partially pregelatinized starch, hydroxypropyl starch, etc.; glucose, galactose, mannose, fructose (fructose) and other monosaccharides; lactose (lactose), sucrose (also known as white sugar, refined white sugar, powdered sugar), maltose (maltose), trehalose (trehalose) and other disaccharides; dextran (dextran), Polysaccharides such as dextrin; D-mannitol, xylitol, sorbitol, erythritol and other sugar alcohols; glycerin fatty acid esters (glycerin fatty acid ester), magnesium metasilicate aluminate, synthetic hydrotalcite, anhydrous calcium phosphate, anhydrous calcium phosphate, precipitated calcium carbonate, calcium silicate ), calcium hydrogen phosphate hydrate (calcium hydrogen phosphate hydrate), sodium bicarbonate (sodium bicarbonate) and other inorganic salts. For the excipients contained in the solid preparation containing Celebrex according to the present invention, one or more types selected from the group consisting of sugar alcohols and disaccharides are preferred, disaccharides are preferred, and lactose is preferred. Lactose has other anhydrides and hydrates, but hydrates are preferred.

The content of the excipients contained in the solid preparation containing Celebrex of the present invention is not particularly limited. For example, based on the total mass of the solid preparation being 100% by mass, the content of the aforementioned excipient is preferably 10 to 55% by mass. 20 to 50% by mass is better, and 25 to 45% by mass is better.

The lubricant may be, for example, stearic acid, sodium stearyl fumarate, magnesium stearate, calcium stearate and other stearic acids; sucrose fatty acid Sucrose fatty acid ester, polyethylene glycol, light anhydrous silicic acid, hydrogenated oil, glycerin fatty acid ester, talc ( talc) etc., preferably sodium stearate fumarate, magnesium stearate, calcium stearate, sucrose fatty acid esters. The above-mentioned lubricant may be used alone or in combination of two or more. The lubricant used in the present invention is preferably stearic acid, but magnesium stearate is preferred.

The content of the lubricant used in the present invention is not particularly limited. For example, based on the total mass of the solid preparation being 100% by mass, the content of the aforementioned lubricant is preferably 0.5 to 5% by mass, and preferably 1 to 5% by mass.

The above-mentioned flavoring agents may be, for example, aspartame, stevia, saccharin sodium, glycyrrhizin dipotassium, thaumatin, acesulfame potassium), sucralose, etc. These flavoring agents may be used alone or in combination of two or more.

The colorant may be, for example, Edible Blue No. 1, Edible Blue No. 2, Edible Yellow No. 4, Edible Yellow No. 5, Edible Red No. 2, Edible Red No. 3, Edible Red No. 102, Edible Blue No. 1 Alkyl ( aluminum lake), edible blue No. 2 aluminum reed, edible yellow No. 4 aluminum reed, edible yellow No. 5 aluminum Reed, Edible Red No. 2 Al Reed, Edible Red No. 3 Al Reed, Edible Red No. 102 Al Reed, Cesium Dioxide (Red), Titanium Oxide, Yellow Iron Oxide, Orange Essence (orange essence), Coke Sugar (caramel), talc (talc), green tea powder, etc. The above-mentioned colorants may be used alone or in combination of two or more.

Spices, mint, lemon scent, Orange Courton, Pineapple flavor, 1-menthol, Black tea micron, etc. The above-mentioned fragrances may be used alone or in combination of two or more.

As the pH adjuster, succinic acid, maleic acid, tartaric acid, citric acid, aspartic acid and other acids can be used; sodium hydroxide ), magnesium oxide (magnesium oxide), silicon dioxide (silicon dioxide), sodium bicarbonate (sodium bicarbonate), L-arginine (L-arginine) and other bases. The above-mentioned pH adjusting agent may be used alone or in combination of two or more.

As the plasticizer, triethyl citrate, polyethylene glycol, triacetin can be used. The plasticizer may be used alone or in combination of two or more.

The dosage form of the solid preparation containing Celebrex of the present invention is not particularly limited, for example, lozenges, oral disintegrating tablets, capsules, granules, powders, oral lozenges, etc. may be used. The dosage form of the solid preparation containing Xilebao of the present invention can be specifically directed to a lozenge having disintegration problems or an oral disintegrating lozenge. In addition, if necessary, the above-mentioned solid preparation can be subjected to a film coating process using a commonly used coating base.

The present invention contains a solid preparation of Celebrex, in addition to containing Celebrex In addition to adjusting the content of the surfactant and the binder within a specific range, it can be manufactured by a general solid preparation manufacturing method (refer to Japanese Patent No. 3563036). For example, granules containing Celebrex powder, surfactants, binders and various necessary additives are granulated, and the resulting granules (granules) can be made into solid preparations by a conventional preparation process. For example, in the case of lozenges, the aforementioned granules can be mixed with other necessary additives, for example, by using a rotary tableting machine or the like to perform tableting. In the case of capsules, the mixture of the aforementioned particles and other necessary additives can be filled into capsules. As for the powder, it can be kept as it is, or it can be prepared by appropriately performing the coating process. Oral disintegrants can use generally known methods, such as the granules and additives (excipients, disintegrants, etc.) of the present invention, mixed and shaped in the presence or absence of a solvent, and if necessary, dried be made of. The aforementioned mixing step can be performed using a V-type mixer, a universal mixer, a fluidized bed granulator, an octagonal mixer, and the like.

The granulation method of the above-mentioned Xilebao powder can be used wet granulation method or dry granulation method, but the wet granulation method is preferred to granulate Xilebao powder, so that disintegration can be obtained The preferred solid preparation. The aforementioned wet granulation method may be, for example, extrusion granulation method, which is to extrude the compound containing the drug and additives from a mesh with a fixed aperture, and cut into granules with appropriate sizes for granulation; spraying Dry granulation method, which uses hot air flow to spray solutions or suspensions containing drugs and additives, thereby rapidly drying and granulating; mobile layer granulation method, which is based on hot air flow, spraying mist on floating powder Agitation binder for granulation; and agitation granulation method, which uses high-speed rotating agitating blades while spraying an atomized binder solution for granulation. on All the above methods can be used for granulation, but the fluidized bed granulation method is preferred. The fluidized bed granulation method can be carried out using a commercially available fluidized bed granulation device. The aforementioned fluidized bed granulation device can be, for example, Glatt WSG, FD type (Powerex Corporation) or GRANUREX, FLOW COATER, SPIR-A-FLOW, FLO-5 (machine model, Freund Industrial Co., Ltd.), etc.

The solid preparation containing Celebrex of the present invention achieves a therapeutic or preventive effect by inhibiting COX-2, and can be used as a therapeutic agent for various patients (refer to Japanese Patent No. 3563036). The aforementioned patients may be, for example, inflammatory patients, cancer, dementia and the like. Inflammatory patients may be arthritis patients, such as chronic rheumatoid arthritis, spinal arthritis, gouty arthritis, osteoarthritis, systemic lupus erythematosus, and juvenile arthritis; patients with digestive system, such as gastritis, ulcerative large intestine Inflammation, allergic bowel syndrome, Crohn's disease, etc.; patients with eye diseases, such as retinitis, conjunctivitis, retinopathy, uveitis, photophobia, etc.; patients with respiratory system, such as asthma, bronchitis, allergic rhinitis, etc.; skin Patients, such as skin diseases, psoriasis, eczema, burns, etc.; infectious patients, such as viral infections, bacterial infections, etc. Cancer patients can be, for example, gastric cancer, small intestine cancer, duodenal cancer, colorectal cancer, Barresto esophagus, liver cancer, bladder cancer, pancreatic cancer, ovarian cancer, prostate cancer, uterine cancer, breast cancer, squamous cell carcinoma and basal cell carcinoma Wait.

The dosage of the solid preparation containing Celebrex of the present invention can be adjusted with the elasticity of the content of Celebrex in the solid preparation. In addition, the dosage depends on the medication method, the subject's age, weight, gender, symptoms, sensitivity to the drug, etc., but the dosage can be adjusted in accordance with the improvement of symptoms. For example, for patients who obtain a therapeutic effect by inhibiting COX-2, the present invention contains The amount of Celebrex with the solid preparation of Celebrex can be administered to adults from about 10 mg to about 1000 mg per day. The frequency of administration is about 1 to 3 times a day, and preferably 1 to 2 times.

The following uses several examples, comparative examples, and test examples to illustrate the application of the present invention. However, it is not intended to limit the present invention. Those who have ordinary knowledge in the technical field of the present invention can do so without departing from the spirit and scope of the present invention. Make various changes and retouches.

【Example】

Tablets (tablets A, B, and C are free of disintegrants) were prepared according to the formula in Table 1, and their dissolution properties were comparable to commercially available tablets containing Celecox (Celecox tablets, containing 100 mg Le Bao) for comparison. In addition, commercially available Celecox tablets contain 100 mg of Celebrex tablets with a diameter of 8.0 mm and a thickness of 2.7 mm. The additives include disintegrant (L-HPC), surfactant (SLS), and binder (HPC), including Pharmaceutically acceptable carriers and/or excipients.

Regarding lozenge A, lozenge B and lozenge C, lozenges with a diameter of 8.0 mm and a lozenge thickness of about 2.7 mm can be obtained according to the following processes. In short, first, Xilebao, HPC and SLS were put into water and stirred into granulation liquid. Next, this granulation liquid and a carrier (for example, lactose hydrate) are put into a fluidized bed granulator to obtain granulated and dried granules. After that, the granulation is carried out and mixed with a lubricant (for example, magnesium stearate), and then the rotary spindle machine is used to perform the spindle. Processes such as the preparation of granulation liquid, granulation of the fluidized bed, drying, classification, sizing, mixing of granules, and ingot making are well known to those of ordinary skill in the technical field to which the present invention belongs, and will not be repeated here.

Dissolution test

The prepared lozenge A, lozenge B, lozenge C and Celecox lozenge are put into the first solution (pH 1.2) of the dissolution test solution of the Japanese Pharmacopoeia with the addition of 0.5% (W/V) polysorbate 80. ), the dissolution test was carried out at 50 rpm according to the second method of the dissolution test (paddle method) of the Japanese Pharmacopoeia general test method.

The results of the dissolution test are shown in Table 2. As shown in the results in Table 2, tablets A, B, and C formulated in Table 1 do not contain disintegrants, but the dissociation similarity (f2 ) It is calculated that lozenge A, lozenge B, lozenge C have dissolution similarity compared to Celecox tablets containing disintegrant (f2>42).

Content uniformity test

The content uniformity test of lozenges A was carried out according to the "Content Uniformity Test of the Preparation Uniformity Test Method" described in the Seventeenth Revision of the Japanese Pharmacopoeia. The results show that the judgment value of lozenge A is 0.9%, which meets the judgment criteria (the judgment value is 15.0% or less).

Industry availability

Since the solid preparation containing Celebrex of the present invention has excellent disintegration, it can be used as a therapeutic agent for various diseases to achieve a therapeutic or preventive effect by inhibiting COX-2.

To sum up, although the present invention uses a specially formulated pharmaceutical composition, A specific dosage form or a specific evaluation method is taken as an example to illustrate the solid preparation containing Celebrex of the present invention and its manufacturing method, but anyone with ordinary knowledge in the technical field to which the present invention belongs will know that the present invention is not limited to this, and does not Without departing from the spirit and scope of the present invention, the pharmaceutical composition of the present invention can also be carried out using other dosage forms or other evaluation methods.

From the above-mentioned several examples, the solid preparation containing Xilebao of the present invention and its manufacturing method have the advantage that by adding a specific content of surfactant and binder, the solid preparation can be improved even if it does not contain a disintegrating agent. Xile keeps dissociation, and can achieve good therapeutic effect.

Although the present invention has been disclosed in several embodiments as above, it is not intended to limit the present invention. Anyone with ordinary knowledge in the technical field to which the present invention belongs can be regarded as various without departing from the spirit and scope of the present invention. Changes and retouching, therefore, the scope of protection of the present invention shall be subject to the scope defined in the appended patent application.

Claims (12)

A solid preparation containing Celecoxib (Celecoxib), characterized in that the total mass of the solid preparation is 100% by mass, the solid preparation contains 1% by mass to 15% by mass of surfactant and 1% by mass to 5% by mass One percent of binders do not contain disintegrants. The solid preparation containing Xilebao according to item 1 of the scope of the patent application, wherein the surfactant is an anionic surfactant. The solid preparation containing Celebrex according to item 2 of the patent application scope, wherein the anionic surfactant is sodium lauryl sulfate (SLS). The solid preparation containing Xilebao according to any one of claims 1 to 3, wherein the binder is a cellulose derivative. The solid preparation containing Celebrex according to item 4 of the patent application scope, wherein the cellulose cellulose derivative is hydroxypropyl cellulose. The solid preparation containing Celebrex according to any one of items 1 to 5 of the patent application scope further comprises at least one of a group consisting of sugar alcohols and disaccharides. The solid preparation containing Celebrex according to item 6 of the patent application scope, wherein the disaccharide is lactose. The solid preparation containing Celebrex according to any one of claims 1 to 7 of the patent application range, wherein the solid preparation contains 40% to 60% by mass of Celebrex. According to any one of items 1 to 8 of the patent application range The said solid preparation contains Celebrex, wherein the solid preparation is a lozenge. The solid preparation containing Celebrex according to any one of items 1 to 8 of the patent application range, wherein the solid preparation is an intra-disintegrating tablet. A method for manufacturing a solid preparation containing Celebrex, characterized by using a wet granulation method to manufacture the solid preparation containing Celebrex as described in any one of patent application items 1 to 10. According to the manufacturing method of the solid preparation containing Xilebao described in item 11 of the patent application scope, wherein the wet granulation method is a fluidized bed granulation method.