ADDITION SALT OF 2,6-DIMETHYLPYRIMIDONE DERIVATIVES USEFUL FOR TREATING A TISSUE OR ORGANIC FIBROSIS DISORDER
Patent Information
- Application Number
- ARP20170102111
- Authority / Receiving Office
- AR · AR
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2016-07-27
- Filing Date
- 2017-07-26
- Publication Date
- 2026-08-28
- Estimated Expiration
- 2037-07-26
Abstract
Description
SALTS OF 2,6-DIMETHYLPYRIMIDONE DERIVATIVES AND THEIR USES CROSS REFERENCE TO RELATED APPLICATION This application claims the benefit of Chinese patent application serial number 201610598745.1, filed on July 27, 2016, which is incorporated herein by reference in its entirety. FIELD OF INVENTION The present invention pertains to the field of pharmaceuticals, relates to salts of 2,6-dimethylpyrimidone derivatives and their uses, specifically to salts of 3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / 7)-one (compound I) and its uses, and also relates to pharmaceutical compositions containing the salts. The salts or pharmaceutical compositions are used to treat and prevent tissue or organ fibrosis disorders. The salts of the compound of the invention may be a crystalline form, a partial crystal form, a polymorph, or an amorphous form. BACKGROUND OF THE INVENTION Fibrosis is a process of excessive fibrous connective tissue formation in an organ or tissue for repair or as a reaction. Mild fibrosis of organs or tissues is called fibrosis; severe fibrosis can cause tissue damage leading to organ scarring. Tissue fibrosis is not limited to tissues of the lungs, liver, heart, kidneys, and similar organs, but also affects all organs and systems of the human body. Approximately one-third of people worldwide die from tissue fibrosis and organ failure caused by it. Nitrogenous heterocyclic derivatives having antifibrotic effects were disclosed in patent application WO2014012360 and CN103570630, where the compound 3-(4-(dihexylamine)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / - / )-one (compound I) can prevent or treat tissue fibrosis lesions in a human or animal. Drug polymorphism is a common phenomenon in drug discovery and is an important factor affecting drug quality. Several crystalline forms of the same drug have significantly different properties (such as solubility, melting point, dissolution, and bioavailability) and therefore have different effects on stability, bioavailability, and efficacy. Consequently, the problem of drug polymorphism should generally be considered in drug discovery. Amorphism is a form of substance polymorphism; it is an amorphous state. Several physicochemical properties and clinical efficacy characteristics of an amorphous drug are often different from those of a typical crystalline drug. Consequently, a thorough analysis of an amorphous substance is also important in the search for polymorphism in solid drugs. SUMMARY OF THE INVENTION The amino compound 3-(4-(dihexylamine)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3-)-one (the compound represented by formula I) is a pale yellow oil. In order to improve the stability and bioavailability of the compound, the present invention studies the salts of compound (I) and their crystalline forms and then provides a pharmaceutically acceptable acid-addition salt of compound (I) and its compositions. The salts and pharmaceutical composition have improved biological activity, lower toxicity, and much better stability, and thus have improved pharmacability. For example, the salts and pharmaceutical compositions have good pharmacokinetic properties and / or fewer side effects such as vomiting in dogs. In particular, the present invention relates to acid addition salts of compound (I) and its pharmaceutical compositions and uses of the salts of the compound and the pharmaceutical compositions in the production of a medicament for preventing or treating a tissue fibrosis disorder. The acid addition salt disclosed herein may be a crystalline form, a partially crystalline form, a polymorphism, or an amorphism; in another aspect, the acid addition salt disclosed herein may be a solvate, such as a hydrate. In one aspect, the present invention provides a salt by addition of acids from compound (I), In some embodiments, the salt is provided by the addition of acids (I). In the present case, it is a salt of an inorganic acid or a salt of an organic acid. In some other embodiments, the inorganic acid salt provided herein is hydrochloride, sulfate, hydrosulfide, nitrate, hydrobromide, hydroiodide, carbonate, bicarbonate, sulfite, bisulfite, pyrosulfate, hydrophosphate, dihydrophosphate, perchlorate, persulfate, hemisulfate, bisulfate, thiocyanate, phosphate, pyrophosphate, metaphosphate or one of their combinations. In some other forms of production, the organic acid salt proposed herein is formate, acetate, propionate, butyrate, benzoate, malonate, succinate, pyruvate, mesylate, ethanesulfonate, propanesulfonate, citrate, 4-nitrobenzoate, bencensulfonate, tosylate, malate, propiolate, 2-butynoate, 2-hidroxyethanesulfonate, vinylacetate, tartrate, L-tartrate, fumarate, hidroxyethylenesulfonate, maleate, lactate, lactobionate, pamoate, salicylate, galactarate, gluceptate, mandelate, 1,2ethanedisulfonate, naphthalenesulfonate, oxalate, trifluoroacetate, trifluoromethanesulfonate, adipate, suberate, sebacate, butylene-1,4-dioate, hexene-1,6-dioate, hydroxyacetate, alginate, ascorbate, erythorbate, aspartate, ¿-aspartate, glutamate, L-glutamate, 2-phenoxybenzoate, 2-(4-hydroxybenzo¡l)benzoate, acetoacetate, 2-hydroxyethanesulfonate, borate, chlorobenzoate, camphor, itaconate, camphorsulfonate, levocamphorsulfonate, methylbenzoate, dinitrobenzoate, sulfamate, galacturonate, cyclopentylpropanoate,dodecyl sulfate, acrylate, cypionate, glycerophosphate, methoxybenzoate, digluconate, gluconate, heptylate, hexanoate, 2-hydroxyethanesulfonate, pivalate, glucuronate, laurate, phthalate, phenylacetate, lauryl sulfate, 2-acetoxybenzoate, nicotinate, cinnamate, oleate, palmitate, pectate, bencendicarboxylate, glutarate, hydroxymaleate, hydroxybenzoate, 3-hydroxy-2-naphthoate, 3-phenylpropionate, isobutyrate, pivalate, picrate, estearate, 2,2-dichloroacetate, amino acid salt, alginate, 4-acetamidobenzensulfonate, decanoate, cholate, caprylate, pelargonate, cyclamate, phthalate, cystine salt hydrochloride, sorbate, pamoate, glycinate hydrochloride, naphthalene disulfonate, xylene sulfonate, cystine salt dihydrochloride, undecanoate, poly(vinylsulfonate), sulfosalicylate, phenylbutyrate, 4hidroxybutyrate, poly(vinylsulphate), naphthalene-1-sultanate, naphthalene-2-sulfonate, valerate or one of its combinations., In some embodiments, the acid addition salt provided herein is hydrochloride crystal I of compound (I), characterized by an X-ray powder diffraction pattern comprising peaks expressed as 20 at 3.68 ± 0.2°, 10.88 ± 0.2°, 17.30 ± 0.2°, 22.20 ± 0.2°, 26.67 ± 0.2°. In some embodiments, the acid-addition salt provided herein is crystal I of hydrochloride of compound (I), which is characterized by a X-ray powder diffraction pattern comprising peaks expressed as 20 at 3.68 ± 0.2°, 10.88 ± 0.2°, 11.53 ± 0.2°, 12.43 ± 0.2°, 17.30 ± 0.2°, 17.65 ± 0.2°, 19.43 ± 0.2°, 21.83 ± 0.2°, 22.20 ± 0.2°, 22.90 ± 0.2°, 25.51 ± 0.2°, 26.67 ± 0.2°. In some embodiments, the acid-addition salt provided herein is hydrochloride crystal I of compound (I), characterized by an X-ray powder diffraction pattern comprising peaks expressed as 20 at 3.68 ± 0.2°, 7.25 ± 0.2°, 10.88 ± 0.2°, 11.53 ± 0.2°, 12.43 ± 0.2°, 12.74 ± 0.2°, 13.63 ± 0.2°, 14.47 ± 0.2°, 14.77 ± 0.2°, 15.23 ± 0.2°, 16.82 ± 0.2°, 17.30 ± 0.2°, 17.65 ± 0.2°, 18.16 ± 0.2°, 19.43 ± 0.2°, 20.19 ± 0.2°, 21.41 ± 0.2°, 21.83 ± 0.2°, 22.20 ± 0.2°, 22.90 ± 0.2°, 23.28 ± 0.2°, 23.79 ± 0.2°, 24.13 ± 0.2°, 24.64 ± 0.2°, 24.99 ± 0.2°, 25.51 ± 0.2°, 25.97 ± 0.2°, 26.67 ± 0.2°, 27.30 ± 0.2°, 27.73 ± 0.2°, 28.86 ± 0.2°, 29.33 ± 0.2°, 29.88 ± 0.2°, 31.02 ± 0.2°, 31.81 ± 0.2°, 32.39 ± 0.2°, 32.83 ± 0.2°, 34.05 ± 0.2°, 34.48 ± 0.2°, 35.69 ± 0.2°, 36.56 ± 0.2°, 37.07 ± 0.2°, 37.83 ± 0.2°. In some embodiments, the acid addition salt provided herein is crystal I of the hydrochloride of compound (I), which is characterized by an X-ray powder diffraction pattern substantially as shown in Figure 1. In some embodiments, the acid-addition salt provided herein is crystal I of the hydrochloride of compound (I), which is characterized by a Fourier transform infrared spectrogram comprising absorption peaks at 606, 656, 721, 756, 819, 878, 911, 964, 981, 1028, 1078, 1101, 1117, 1153, 1166, 1198, 1215, 1265, 1290, 1343, 1366, 1397, 1435, 1455, 1464, 1512, 1538, 1592, 1616, 1633, 1665, 1694, 1738, 1822, 1957, 2342, 2355, 2555, 2724, 2754, 2857, 2930, 2956, 3024, 3046, 3183, 3256, 3324, 3374, 3419, 3432, 3453, 3459, 3479, 3493 and 3500 cm'1; the absorption peak has a margin of error of ± 2 cm'1. In some embodiments, the acid addition salt provided herein is crystal I of hydrochloride of compound (I), which is characterized by a Fourier transform infrared spectrogram substantially as shown in Figure 2. In some embodiments, the acid addition salt provided herein is hydrochloride crystal II of compound (I), characterized by an X-ray powder diffraction pattern comprising peaks expressed as 20 at 6.12 ± 0.2°, 8.83 ± 0.2°, 15.56 ± 0.2°, 19.69 ± 0.2°, 25.24 ± 0.2°, 26.35 ± 0.2°. In some embodiments, the acid addition salt provided herein is hydrochloride crystal II of compound (I), characterized by an X-ray powder diffraction pattern comprising peaks expressed as 2Θ at 6.12 ± 0.2°, 8.83 ± 0.2°, 12.27 ± 0.2°, 13.97 ± 0.2°, 15.56 ± 0.2°, 16.51 ± 0.2°, 17.24 ± 0.2°, 18.48 ± 0.2°, 19.69 ± 0.2°, 22.68 ± 0.2°, 25.24 ± 0.2°, 26.35 ± 0.2°. In some embodiments, the acid-addition salt provided herein is hydrochloride crystal II of compound (I), characterized by an X-ray powder diffraction pattern comprising peaks expressed as 2Θ at 6.12 ± 0.2°, 8.83 ± 0.2°, 12.27 ± 0.2°, 13.54 ± 0.2°, 13.80 ± 0.2°, 13.97 ± 0.2°, 15.56 ± 0.2°, 16.51 ± 0.2°, 17.24 ± 0.2°, 18.48 ± 0.2°, 19.69 ± 0.2°, 21.81 ± 0.2°, 22.68 ± 0.2°, 23.80 ± 0.2°, 24.70 ± 0.2°, 25.24 ± 0.2°, 25.72 ± 0.2°, 26.35 ± 0.2°, 26.66 ± 0.2°, 27.17 ± 0.2°, 27.50 ± 0.2°, 28.12 ± 0.2°, 29.03 ± 0.2°, 30.43 ± 0.2°, 31.03 ± 0.2°, 31.56 ± 0.2°, 37.58 ± 0.2°. In some embodiments, the acid addition salt provided herein is hydrochloride crystal II of compound (I), which is characterized by an X-ray powder diffraction pattern substantially as shown in Figure 3. In some embodiments, the acid-addition salt provided herein is hydrochloride crystal II of compound (I), characterized by a Fourier transform infrared spectrogram comprising absorption peaks at 667, 727, 757, 882, 969, 1026, 1039, 1081, 1109, 1159, 1199, 1291, 1365, 1396, 1439, 1457, 1478, 1509, 1545, 1593, 1611, 1666, 1729, 2524, 2550, 2581, 2684, 2871, 2934, 2955, 3010, 3257 and 3377 cm'1, the The absorption peak has a margin of error of ± 2 cm'1. In some embodiments, the acid addition salt provided herein is crystal II of the hydrochloride of compound (I), which is characterized by a Fourier transform infrared spectrogram substantially as shown in Figure 4. In some embodiments, the acid addition salt provided herein is hydrochloride crystal III of compound (I), characterized by an X-ray powder diffraction pattern comprising peaks expressed as 2Θ at 3.46 ± 0.2°, 10.25 ± 0.2°, 13.62 ± 0.2°, 17.26 ± 0.2°. In some embodiments, the acid addition salt provided herein is hydrochloride crystal III of compound (I), characterized by an X-ray powder diffraction pattern comprising peaks expressed as 2Θ at 3.46 ± 0.2°, 10.25 ± 0.2°, 13.62 ± 0.2°, 17.26 ± 0.2°, 20.56 ± 0.2°, 24.10 ± 0.2°, 26.44 ± 0.2°, 26.66 ± 0.2°, 27.35 ± 0.2°. In some embodiments, the acid-addition salt provided herein is hydrochloride crystal III of compound (I), characterized by an X-ray powder diffraction pattern comprising peaks expressed as 2Θ at 3.46 ±0.2°, 6.80 ±0.2°, 10.25 ±0.2°, 11.51 ±0.2°, 11.93 ±0.2°, 12.77 ±0.2°, 13.62 ±0.2°, 14.77 ±0.2°, 17.26 ±0.2°, 18.95 ±0.2°, 19.83 ±0.2°, 20.56 ±0.2°, 21.64 ±0.2°, 22.57 ± 0.2°, 23.09 ± 0.2°, 24.10 ± 0.-2°, 26.44 ± 0.2°, 26.66 ± 0.2°, 27.35 ± 0.2°, 28.41 ± 0.2°, 29.09 ± 0.2°, 30.50 ± 0.2°, 31.67 ± 0.2°, 34.16 ± 0.2°, 37.13 ± 0.2°, 39.38 ± 0.2°. In some embodiments, the acid addition salt provided herein is hydrochloride crystal III of compound (I), which is characterized by a powder X-ray diffraction pattern substantially as shown in Figure 12. In some embodiments, the acid addition salt provided herein is sulfate crystal I of compound (I), characterized by an X-ray powder diffraction pattern comprising peaks expressed as 2Θ at 3.35 ± 0.2°, 6.61 ± 0.2°, 16.50 ± 0.2°, 21.43 ± 0.2°. In some embodiments, the acid addition salt provided herein is sulfate crystal I of compound (I), characterized by an X-ray powder diffraction pattern comprising peaks expressed as 20 at 3.35 ± 0.2°, 6.61 ± 0.2°, 13.20 ± 0.2°, 16.50 ± 0.2°, 19.03 ± 0.2°, 21.43 ± 0.2°, 23.19 ± 0.2°. In some embodiments, the acid-addition salt provided herein is sulfate crystal I of compound (I), which is characterized by having an X-ray powder diffraction pattern comprising peaks expressed as 20 at 3.35 ± 0.2°, 6.61 ± 0.2°, 7.89 ± 0.2°, 9.90 ± 0.2°, 10.45 ± 0.2°, 12.74 ± 0.2°, 13.20 ± 0.2°, 14.86 ± 0.2°, 15.22 ± 0.2°, 16.50 ± 0.2°, 16.87 ± 0.2°, 17.30 ± 0.2°, 18.40 ± 0.2°, 19.03 ± 0.2°, 19.43 ± 0.2°, 19.65 ± 0.2°, 20.56 ± 0.2°, 20.87 ± 0.2°, 21.43 ± 0.2°, 21.74 ± 0.2°, 23.19 ± 0.2°, 23.45 ± 0.2°, 23.80 ± 0.2°, 24.60 ± 0.2°, 25.29 ± 0.2°, 25.90 ± 0.2°, 26.07 ± 0.2°, 26.40 ± 0.2°, 27.26 ± 0.2°, 28.22 ± 0.2°, 28.47 ± 0.2°, 30.82 ± 0.2°, 31.75 ± 0.2°, 33.80 ± 0.2°, 34.55 ± 0.2°, 36.77 ± 0.2°, 37.30 ± 0.2°, 39.02 ± 0.2°. In some embodiments, the acid addition salt provided herein is sulfate crystal I of compound (I), which is characterized by an X-ray powder diffraction pattern substantially as shown in Figure 5. In some embodiments, the acid-addition salt provided herein is the sulfate amorphism of compound (I), which is characterized by a powder X-ray diffraction pattern substantially as shown in Figure 6. In some embodiments, the acid addition salt provided herein is tosylate crystal I of compound (I), which is characterized by an X-ray powder diffraction pattern comprising peaks expressed as 2Θ at 6.55 ± 0.2°, 13.74 ± 0.2°, 20.08 ± 0.2°, 21.32 ± 0.2°, 22.17 ± 0.2°, 22.99 ± 0.2°. In some embodiments, the acid addition salt provided herein is tosylate crystal I of compound (I), which is characterized by an X-ray powder diffraction pattern comprising peaks expressed as 2Θ at 6.55 ± 0.2°, 13.74 ± 0.2°, 13.96 ± 0.2°, 17.18 ± 0.2°, 17.44 ± 0.2°, 19.83 ± 0.2°, 20.08 ± 0.2°, 20.31 ± 0.2°, 21.32 ± 0.2°, 22.17 ± 0.2°, 22.99 ± 0.2°, 26.83 ± 0.2°. In some embodiments, the acid-addition salt provided herein is tosylate crystal I of compound (I), characterized by an X-ray powder diffraction pattern comprising peaks expressed as 2Θ at 6.55 ± 0.2°, 8.18 ± 0.2°, 8.68 ± 0.2°, 9.37 ± 0.2°, 9.60 ± 0.2°, 9.97 ± 0.2°, 10.80 ± 0.2°, 11.05 ± 0.2°, 12.80 ± 0.2°, 13.18 ± 0.2°, 13.74 ± 0.2°, 13.96 ± 0.2°, 15.48 ± 0.2°, 16.41 ± 0.2°, 17.18 ± 0.2°, 17.44 ± 0.2°, 17.87 ± 0.2°, 18.18 ± 0.2°, 18.97 ± 0.2°, 19.83 ± 0.2°, 20.08 ± 0.2°, 20.31 ± 0.2°, 20.95 ± 0.2°, 21.32 ± 0.2°, 22.17 ± 0.2°, 22.47 ± 0.2°, 22.99 ± 0.2°, 23.79 ± 0.2°, 24.02 ± 0.2°, 24.86 ± 0.2°, 25.44 ± 0.2°, 26.27 ± 0.2°, 26.83 ± 0.2°, 27.32 ± 0.2°, 27.65 ± 0.2°, 28.10 ± 0.2°, 29.06 ± 0.2°, 30.39 ± 0.2°, 30.87 ± 0.2°, 31.57 ± 0.2°, 32.04 ± 0.2°, 33.18 ± 0.2°, 36.87 ± 0.2°. In some embodiments, the acid addition salt provided herein is tosylate crystal I of compound (I), which is characterized by an X-ray powder diffraction pattern comprising peaks substantially as shown in Figure 7. In some embodiments, the acid addition salt provided herein is tosylate crystal I of compound (I), which is characterized by a differential scanning calorimetry thermogram comprising an endothermic peak at 231.51 °C ± 3 °C. In some embodiments, the acid addition salt provided herein is tosylate crystal I of compound (I), which is characterized by a differential scanning calorimetry thermogram substantially as shown in Figure 8. In some embodiments, the acid-addition salt provided herein is a tosylate amorphism of compound (I), which is characterized by a powder X-ray diffraction pattern substantially as shown in Figure 9. In some embodiments, the acid addition salt provided herein is maleate crystal I of compound (I), characterized by an X-ray powder diffraction pattern comprising peaks expressed as 20 to 4.10 ± 0.2°, 16.33 ± 0.2°, 20.45 ± 0.2°. In some embodiments, the acid addition salt provided herein is maleate crystal I of compound (I), which is characterized by an X-ray powder diffraction pattern comprising peaks expressed as 2Θ at 4.10 ± 0.2°, 8.16 ± 0.2°, 16.33 ± 0.2°, 17.72 ± 0.2°, 20.45 ± 0.2°, 21.58 ± 0.2°, 24.63 ± 0.2°. In some embodiments, the acid-addition salt provided herein is maleate crystal I of compound (I), characterized by an X-ray powder diffraction pattern comprising peaks expressed as 20 at 4.10 ± 0.2°, 8.01 ± 0.2°, 8.16 ± 0.2°, 12.23 ± 0.2°, 13.94 ± 0.2°, 14.31 ± 0.2°, 15.32 ± 0.2°, 16.33 ± 0.2°, 16.82 ± 0.2°, 17.72 ± 0.2°, 18.38 ± 0.2°, 18.39 ± 0.2°, 19.14 ± 0.2°, 19.77 ± 0.2°, 20.45 ± 0.2°, 20.95 ± 0.2°, 21.58 ± 0.2°, 22.34 ± 0.2°, 23.87 ± 0.2°, 24.63 ± 0.2°, 25.56 ± 0.2°, 26.43 ± 0.2°, 27.51 ± 0.2°, 28.24 ± 0.2°, 28.78 ± 0.2°, 29.62 ± 0.2°, 30.13 ± 0.2°, 30.93 ± 0.2°, 33.01 ± 0.2°, 35.58 ± 0.2°, 37.37 ± 0.2°. In some embodiments, the acid addition salt provided herein is maleate crystal I of compound (I), which is characterized by an X-ray powder diffraction pattern substantially as shown in Figure 10. In some embodiments, the acid addition salt provided herein is maleate crystal I of compound (I), which is characterized by a differential scanning calorimetry thermogram comprising an endothermic peak at 116.28 °C ± 3 °C. In some embodiments, the acid addition salt provided herein is maleate crystal I of compound (I), which is characterized by a differential scanning calorimetry thermogram substantially as shown in Figure 11. In one aspect, the present invention also provides a pharmaceutical composition comprising any acid addition salt of compound (I) or one of its combinations; optionally, the pharmaceutical composition also comprises a pharmaceutically acceptable carrier, excipient, diluent, adjuvant, or one of its combinations. In some embodiments, the acid addition salt in the pharmaceutical composition provided herein may be in any crystalline form, specifically any crystalline form, amorphous form, or one of its combinations. In some embodiments, the pharmaceutical composition provided herein comprises any acid addition salt of compound (I) or any crystalline form provided herein, or amorphous form, or any combination thereof. In another aspect, the present invention also provides for the use of the acid-addition salt of compound (I) or one of its combinations or the pharmaceutical composition in the production of a medicament, wherein the medicament is used to prevent, treat or reduce a tissue or organ fibrosis disorder in a human or animal; furthermore, the use comprises the administration of a therapeutically effective amount of the acid-addition salt provided herein or the pharmaceutical composition to a patient or animal. In some embodiments, the tissue or organ fibrosis disorder provided herein is renal interstitial fibrosis, glomerulosclerosis, hepatic fibrosis, pulmonary fibrosis, peritoneal fibrosis, myocardial fibrosis, dermatofibrosis, post-surgical adhesions, benign prostatic hypertrophy, skeletal muscle fibrosis, dermatosclerosis, multiple sclerosis, pancreatic fibrosis, hepatic cirrhosis, myosarcoma, neurofibroma, pulmonary interstitial fibrosis, diabetic nephropathy, Alzheimer's disease, or vascular fibrosis. In some other embodiments, the pulmonary fibrosis provided herein includes idiopathic pulmonary fibrosis (IPF). In some other forms of implementation, the post-surgical adhesions provided herein are scar healing. The present invention also relates to the use of the salt by addition of acids of compound (I) or one of the combinations thereof or the pharmaceutical composition in the production of a medicament, wherein the medicament is used to prevent, treat or reduce diabetic nephropathy or Alzheimer's disease in a patient. In another aspect, the present invention relates to a method of preventing, treating, or reducing a tissue or organ fibrosis disorder in a patient, comprising administering a therapeutically effective amount of the salt by addition of acids provided herein or one of its combinations or pharmaceutical composition to a patient. In some embodiments, the tissue or organ fibrosis disorder provided herein is renal interstitial fibrosis, glomerulosclerosis, hepatic fibrosis, pulmonary fibrosis, peritoneal fibrosis, myocardial fibrosis, dermatofibrosis, post-surgical adhesions, benign prostatic hyperplasia, skeletal muscle fibrosis, dermatosclerosis, multiple sclerosis, pancreatic fibrosis, hepatic cirrhosis, myosarcoma, neurofibroma, pulmonary interstitial fibrosis, diabetic nephropathy, Alzheimer's disease, or vascular fibrosis. In some other embodiments, the pulmonary fibrosis provided herein includes idiopathic pulmonary fibrosis (IPF). In some other forms of implementation, the post-surgical adhesions provided herein are scar healing. The present invention in another aspect relates to the salt by addition of acids of compound (I) or one of its combinations or the pharmaceutical composition for use in preventing, treating or reducing a tissue or organ fibrosis disorder. In some embodiments, the tissue or organ fibrosis disorder provided herein is renal interstitial fibrosis, glomerulosclerosis, hepatic fibrosis, pulmonary fibrosis, peritoneal fibrosis, myocardial fibrosis, dermatofibrosis, post-surgical adhesions, benign prostatic hypertrophy, skeletal muscle fibrosis, dermatosclerosis, multiple sclerosis, pancreatic fibrosis, hepatic cirrhosis, myosarcoma, neurofibroma, pulmonary interstitial fibrosis, diabetic nephropathy, Alzheimer's disease, or vascular fibrosis. In some other embodiments, the pulmonary fibrosis provided herein includes idiopathic pulmonary fibrosis (IPF). In some other forms of implementation, the post-surgical adhesions provided herein are scar healing. In another aspect, the present invention also relates to a method of preparing the salt by adding acids of compound (I) provided herein and its crystalline form. The crystalline forms of the salt by addition of acids provided herein can be prepared by some common methods, wherein some of the crystalline forms provided herein can also be obtained by crystal transformation. The amorphous material provided herein can be obtained by spray drying. The yield of the amorphous material obtained by spray drying is affected by some factors such as the air absorption temperature or The air outlet temperature of the instrument or the system pressure during the spraying process, etc., and the air absorption temperature or air outlet temperature of the instrument or the system pressure during the spraying process refer to the instrument model, the solvent used, and other factors. The solvent used in the method for preparing the salt provided herein is not particularly restricted; any solvent is included in the invention provided it can dissolve the raw materials to some degree and does not affect their properties. Additionally, many similar modifications to the art, substitutions of the same or equivalent solvent, combinations of solvents, and combinations of solvents in different proportions described herein are all intended to be included. The optimal solvents used at any stage of the reaction are provided herein. The experiment for preparing the salt provided herein will be detailed in the examples. Meanwhile, the present invention provides an activity test (such as a pharmacokinetic test), a solubility test, a stability test, and a hygroscopic test, etc., of the salt. It can be inferred from the results that the salts provided herein have improved biological activity (such as better pharmacokinetic properties), good solubility, high stability, and are suitable for pharmaceutical use. When the description of hygroscopicity characteristics and definition of hygroscopicity weight gain (Chinese Pharmacopoeia 2015 edition appendix 9103, principles of guide to drug hygroscopicity, experimental conditions: 25 °C + 1 °C, 80% ± 2% relative humidity) are described as in the following table: The description of hygroscopic characteristics and definition of hygroscopic weight gain absorbs enough water and forms liquid not less than 15% less than 15% but not less than 2% less than 2% but not less than 0.2% less than 0.2% weight gain hygroscopicity hygroscopicity characteristics deliquescence high hygroscopicity hygroscopicity low hygroscopicity none or almost no hygroscopicity The salt provided herein will not be easily affected by high humidity to deliquescence, a property that is convenient during long-term storage. The salt and pharmaceutical composition provided herein are less toxic. The inventors have found that the hydrochloride salt or its pharmaceutical composition is less toxic to dogs, such as in cases of vomiting or similar reactions. DEFINITIONS AND GENERAL TERMINOLOGY Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by a person skilled in the art to which this invention pertains. All patents and publications mentioned herein are incorporated by reference in their entirety. Although any method and material similar or equivalent to those described herein may be used in the practice or testing of the present invention, the preferred methods, devices, and materials will now be described. “Pharmaceutically acceptable acid addition salt” refers to a salt formed from compound (I) of the invention and pharmaceutically acceptable non-toxic acid, including, but not limited to, various organic acid salts and inorganic acid salts described herein. “Acid-addition salt of compound (1)” refers to a salt formed from compound (I) (free base) and one of several organic acid salts and inorganic acid salts, including, but not limited to, hydrochloride, hydrobromide, sulfate, maleate, benzenesulfonate, tosylate, naphthalenesulfonate, oxalate, mesylate, etc., described herein. When the “acid-addition salt of compound (1)” includes an amorphous form or a crystalline form, it includes a solvate (e.g., hydrate) and also includes polymorphism of the salt. For example, the hydrochloride of compound (I) includes an amorphous form, several crystalline forms, several solvates, several hydrates, and also polymorphism of the salt. “Crystalline” or “crystalline form” refers to a solid that has a highly regular chemical structure, including, but not limited to, crystals of one or more components, and / or polymorphic forms of the compound, such as solvates, hydrates, clathrates, cocrystals, salts, salt solvates, and salt hydrates. The crystalline forms of a substance can be obtained by a number of methods known in the art. These methods include, but are not limited to, melt crystallization, melt cooling, solvent crystallization, crystallization in confined spaces such as, for example, in nanopores or capillaries, and crystallization on surfaces or templates. such as, for example, in polymers, crystallization in the presence of additives, such as, for example, cocrystalline countermolecules, desolvation, dehydration, rapid evaporation, rapid cooling, slow cooling, vapor diffusion, sublimation, reaction crystallization, addition of antisolvent, milling and solvent drip milling. “Amorphism” or “amorphous form” refers to a substance composed of particles (such as molecules, atoms, ions) arranged in a non-periodic three-dimensional space, characterized by a diffuse X-ray powder pattern without sharp peaks. Amorphism is a special physical form of solid substance; the ordered structural features in a portion of the amorphous substance imply that there are countless links between the amorphous and crystalline substances. Amorphous substances can be obtained by many methods known in the art. These methods include, but are not limited to, rapid freezing, antisolvent flocculence, ball milling, spray drying, freeze-drying, wet granulation, and solids dispersion techniques, among others. The term “solvent” means a substance, normally a liquid, that is capable of dissolving, completely or partially, another substance, normally a solid. “Solvent,” as used herein, includes, but is not limited to, water, acetic acid, acetone, acetonitrile, benzene, chloroform, carbon tetrachloride, dichloromethane, dimethyl sulfoxide, 1,4-dioxane, ethanol, ethyl acetate, butanol, tert-butanol, dimethylacetamide, dimethylformamide, formamide, formic acid, heptane, hexane, isopropanol, methanol, methyl ethyl ketone, mesitylene, nitromethane, polyethylene glycol, propanol, pyridine, tetrahydrofuran, toluene, xylene, mixtures thereof, and the like. The term “antisolvent” refers to a fluid that promotes the precipitation of the solvent from the product (or a precursor to the product). The antisolvent may be a cold gas or a fluid that promotes precipitation through a chemical reaction, or a fluid that reduces the product's solubility in the solvent; it may be the same liquid as the solvent but at a different temperature, or it may be a different liquid from the solvent. The term “solvate”, as used herein, means having on a surface, in a network, or on a surface and in a network, a solvent such as water, acetic acid, acetone, acetonitrile, benzene, chloroform, carbon tetrachloride, Dichloromethane, dimethyl sulfoxide, 1,4-dioxane, ethanol, ethyl acetate, butanol, tert-butanol, β-,β-dimethylacetamide, α-,β-dimethylformamide, formamide, formic acid, heptane, hexane, isopropanol, methanol, methyl ethyl ketone, 1-methyl-2-pyrrolidone, mesitylene, nitromethane, polyethylene glycol, propanol, pyridine, tetrahydrofuran, toluene, xylene, mixtures thereof, and the like. A specific example of a solvate is a hydrate, where the solvent on the surface, in the lattice, or on both the surface and the lattice is water. Hydrates may or may not have solvents other than water on the surface, in the lattice, or on both the surface and the lattice of a substance. The crystalline form or amorphous nature can be identified by multiple technological means, such as X-ray powder diffraction (XRPD), infrared (IR) spectroscopy, melting point method, differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), nuclear magnetic resonance method, Raman spectroscopy, X-ray diffraction of single crystals, solution calorimetry, scanning electron microscopy (SEM), quantitative analysis, solubility, dissolution rate, etc. Information such as changes in crystal form, crystallinity, crystal structure state, etc., can be obtained by X-ray powder diffraction (XRPD), a common method for identifying crystal form. The peak position of the XRPD pattern depends primarily on the crystal structure, which is relatively insensitive to experimental details, and the relative peak height depends on many factors related to sample preparation and instrument geometry. Thus, in some embodiments, the crystal form revealed herein is characterized by an X-ray powder diffraction pattern with peaks at certain positions, substantially the same as the XRPD pattern shown in the accompanying figures of the present invention.Meanwhile, the 2Θ measurement in the XRPD pattern could have some experimental errors; for example, the 20° measurements in the XRPD pattern could be slightly different due to different instruments and samples. Consequently, the 20° value is not absolute. Depending on the instrument settings for the experiment, the margin of error for the 20° characteristic peaks is ±0.2°. Differential scanning calorimetry (DSC) is a technology used to measure the energy difference between a sample and an inert reference compound (usually α-Al₂O₃) as a function of temperature, achieved through constant heating or cooling under program control. The peak height The endothermic nature of the DSC thermogram depends on many factors related to sample preparation and instrument geometry, and the peak position is relatively insensitive to experimental details. Thus, in some embodiments, the crystalline form disclosed herein is characterized by a DSC thermogram with peaks in certain positions, which is substantially the same as the DSC thermogram shown in the accompanying figures of the present invention. However, a DSC thermogram may have certain experimental errors; for example, the peak position and peak value in the DSC thermogram may differ slightly due to different instruments and samples. Consequently, the peak position and peak value in the DSC thermogram are not absolute. According to the instrument setup for the experiment disclosed herein, the margin of error for the endothermic peaks is ±3 °C. Differential scanning calorimetry (DSC) is used for the detection and analysis of either a crystalline transformation or a mixed grain phenomenon in crystalline form. Solids with the same chemical composition usually form polymorphs, or variants, which have different crystalline structures under different thermodynamic conditions. This phenomenon is called polymorphism or polyphase. When temperature and pressure conditions change, a change occurs between these variants, known as a crystal transition. The properties of the crystalline forms change significantly, including mechanical, electrical, and magnetic properties, due to the crystal transition. The crystal transition process can be observed in differential scanning calorimetry (DSC) thermograms when the transition temperature falls within a measurable range. The DSC thermogram is characterized by an exothermic peak reflecting the transformation and two or more endothermic peaks, which are characteristic of different crystalline forms before and after the transformation. Thermogravimetric analysis (TGA) is a technology for determining the quantitative change of a substance as a function of temperature under program control. It is appropriate for detecting solvent loss in crystals, or sublimation and dissociation of the sample. The condition of the crystalline water and crystalline solvent contained in the crystal can be inferred through analysis of the detection results. The qualitative change described in the TGA curve depends on many factors related to sample preparation and the instrument; and the quantitative change detected by TGA could be slightly variable. The results differ due to different instruments and samples. The amorphous form of the invention is characterized by a TGA detection weight loss ranging from 1.75% to 4.10%. Based on the instrument's condition for the experiment disclosed herein, the margin of error for the quality change is ±0.1%.Raman spectroscopy is a spectrophotometric technique used to study the vibrational and rotational modes of molecules, as well as other low-frequency modes, within a system. Different structures of the same molecule exhibit different Raman activities. Consequently, Raman spectroscopy can be used to determine and identify crystalline or amorphous forms. The peak positions in Raman spectroscopy primarily reflect the structure of substances, which is relatively insensitive to experimental details, and the intensity of the peaks depends on factors such as sample preparation and instrument settings. Thus, the crystalline or amorphous forms revealed herein are characterized by a Raman spectrogram with characteristic peaks at specific positions, substantially similar to the Raman spectrogram shown in the accompanying figures of the present invention.Meanwhile, a Raman spectrogram may have certain experimental errors; the peak position and peak value in the Raman spectrogram may be slightly different due to different instruments and samples. Consequently, the peak position and peak value in the Raman spectrogram are not absolute. According to the instrument settings for the experiment described herein, the margin of error for the absorption peaks is ± 2 cm⁻¹. The bond length and bond angle of certain chemical bonds in different spatial structures of the same molecule differ, leading to different vibrational-rotational transition energy levels and variations in the main characteristics of the corresponding infrared spectroscopy, such as absorption frequency band, peak shape, peak position, peak intensity, etc. Thus, infrared spectroscopy can be used in the investigation of pharmacological polymorphism. The crystalline form or amorphism revealed herein is characterized by a Fourier-infrared (FT-IR) spectrogram that has characteristic peaks at a certain position, which is substantially the same as the Fourier-infrared spectrogram provided in the appended figures of the present invention.Meanwhile, a Raman spectrogram may have certain experimental errors; the peak position and peak value in the Raman spectrogram may be slightly different due to different instruments and different samples. Consequently, the peak position and peak value in the Raman spectrogram are not absolute. According to the instrument settings for the experiment described herein, the margin of error for the absorption peaks is ± 2 cm⁻¹. As used herein, the value of 20 in X-ray powder diffraction (XRPD) patterns is in degrees (°). The expression “substantially as shown in the figure” refers to an X-ray powder diffraction pattern (XRPD) or a differential scanning calorimetry (DSC) thermogram or a Raman spectrogram or an infrared spectrogram having at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, at least 95% or at least 99% of the peaks shown in the figure. When referring to a spectrum and / or data present in a figure, the term “peak” refers to a feature that would not be attributed to background noise that an expert in the technique would recognize. The various crystalline forms of the acid addition salt of 3-(4-(dihexylamine)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / - / )-one mentioned herein exist in substantially pure crystalline forms. The amorphism of the acid addition salt of 3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3H)-one mentioned herein is prepared by spray drying. The expression “substantially pure” refers to a crystalline form that is substantially free of one or more other crystalline forms, that is, the form Crystalline has a purity of at least approximately 80%, at least approximately 85%, at least approximately 90%, at least approximately 93%, at least approximately 95%, at least approximately 98%, at least approximately 99%, at least approximately 99.5%, at least approximately 99.6%, at least approximately 99.7%, at least approximately 99.8% or at least approximately 99.9%; or the crystalline form comprises other crystalline forms and the percentage of the other crystalline forms in total volume or total weight is less than 20%, less than 10%, less than 5%, less than 3%, less than 1%, less than 0.5%, less than 0.1% or less than 0.01%. The expression “substantially free” refers to the percentage of one or more other crystalline forms in total volume or total weight being less than 20%, less than 10%, less than 5%, less than 4%, less than 3%, less than 2%, less than 1%, less than 0.5%, less than 0.1% or less than 0.01%. The expression “relative intensity” (or “relative height”) in XRPD pattern refers to the intensity of a peak with respect to the intensity of the strongest peak in the X-ray powder diffraction (XRPD) pattern, which is considered to be 100%. As used in the context of the present invention, regardless of whether the word “approximately” is used, meaning within 10%, appropriately within 5%, and particularly within 1% of a given value or range. Alternatively, the term “approximately” means within an acceptable standard error of the mean for those skilled in the art. If a number having a value N is disclosed, it specifically means any number having a value within N ± 1%, N ± 2%, N ± 3%, N ± 5%, N ± 7%, N ± 8%, or N ± 10%, where N refers to plus or minus. As used herein, “room temperature” refers to a temperature of approximately 10 °C to approximately 40 °C. In some embodiments, “room temperature” is approximately 20 °C to approximately 30 °C; in other embodiments, “room temperature” is 20 °C, 22.5 °C, 25 °C, 27.5 °C, etc. COMPOSITION, FORMULATION, ADMINISTRATION AND USES OF SALTS BY ADDITION OF ACIDS OF THE COMPOUND OF THE INVENTION The pharmaceutical composition of the invention includes acid addition salts of compound (I) and a pharmaceutically acceptable carrier, adjuvant, or excipient. The amount of the acid addition salt of the compound in the pharmaceutical composition of the invention can effectively and detectably treat or reduce a tissue or organ fibrosis disorder. As previously described, the pharmaceutically acceptable compositions disclosed herein also comprise a pharmaceutically acceptable carrier, adjuvant, or vehicle which, as used herein, includes any and all solvents, diluents or other liquid vehicles, dispersion or suspension aids, surfactants, isotonic agents, thickening or emulsifying agents, preservatives, solid binders, lubricants, and the like, as appropriate for the particular desired dosage form. As described in the following references: In Remington: Troy et al., Remington: The Science and Practice of Pharmacy, 21st ed., 2005, Lippincott Williams & Wilkins, Philadelphia, and Swarbrick et al., Encyclopedia of Pharmaceutical Technology, eds. 1988-1999, Maree Dekker, New York, both incorporated herein by The reference in its entirety discloses various carriers used in the formulation of pharmaceutically acceptable compositions and known techniques for their preparation. Except for any conventional carrier incompatible with the compounds disclosed herein, such that it may produce any undesired biological effect or otherwise interact detrimentally with any other component of the pharmaceutically acceptable composition, its use is contemplated within the scope of this invention. Some non-limiting examples of materials that may serve as pharmaceutically acceptable carriers include ion exchangers; aluminum; aluminum stearate; lecithin; serum proteins such as human serum albumin; buffering substances such as phosphates; glycine; sorbic acid; potassium sorbate; mixtures of partial glycerides of saturated vegetable fatty acids; water; salts or electrolytes such as protamine sulfate, disodium hydrogen phosphate, potassium hydrogen phosphate, sodium chloride, and zinc salts; colloidal silica; magnesium trisilicate; polyvinylpyrrolidone; polyacrylates; waxes; polyethylene-polyoxypropylene block polymers; lanolin; sugars such as lactose, glucose, and sucrose; starches such as corn starch and potato starch; cellulose and its derivatives such as sodium carboxymethylcellulose, ethylcellulose, and cellulose acetate; tragacanth powder; malt; gelatin; talc;Excipients such as cocoa butter and suppository waxes; oils such as peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn oil, and soybean oil; glycols such as propylene glycol and polyethylene glycol; esters such as ethyl oleate and ethyl laurate; agar; buffering agents such as magnesium hydroxide and aluminum hydroxide; alginic acid; pyrogen-free water; isotonic saline solution; Ringer's solution; ethyl alcohol; and phosphate buffer solutions, as well as other compatible non-toxic lubricants such as sodium lauryl sulfate and magnesium stearate, as well as coloring agents, release agents, coating agents, sweetening agents, flavorings and perfumes, preservatives, and antioxidants. The compositions disclosed herein may be capsules, tablets, pills, powders, granules and suspension or solution in water; and may be administered by the following method: orally, parenterally, inhalation spray, topically, rectally, nasally, buccally, vaginally or by implanted reservoir. Oral administration can be in the following forms: tablets, pellets, capsules, powders, particles or suspensions 19 Dispenses, syrups, and elixirs. Alternatively, it can be administered externally in the form of ointments, gels, drug-containing rubber cement, etc. The compositions of the invention can be administered parenterally as a sterile injectable solution or suspension and can also be administered parenterally or intraperitoneally. Solutions or suspensions of these active compounds as a pharmacologically acceptable free base or salt can be prepared in water appropriately mixed with a surfactant such as hydroxypropylcellulose or polyvinylpyrrolidone. Dispersions can also be prepared in liquid glycerol, polyethylene glycols, and mixtures thereof in oils. Under ordinary storage and use conditions, these preparations contain a preservative to prevent the growth of microorganisms. Suitable dosage forms for injection include sterile aqueous solutions or dispersions and sterile powders for the extemporaneous preparation of sterile injectable solutions or dispersions. In all cases, the dosage form must be sterile and fluid, provided there is sufficient syringe capacity. It must be stable under manufacturing and storage conditions and protected from contamination by microorganisms such as bacteria and fungi. The carrier may be a solvent or dispersion medium containing, for example, water, ethanol (e.g., glycerol, propylene glycol, and liquid polyethylene glycol), appropriate mixtures thereof, and vegetable oil. The compound, salt, or pharmaceutical composition disclosed herein may be administered locally rather than systemically. For example, by injection of the compound directly into an organ, often in a depot or sustained-release formulation. Alternatively, a pharmaceutical composition containing a compound of the invention may be administered in a targeted drug delivery system, for example, in a liposome coated with an organ-specific antibody. The liposomes will be selectively targeted and absorbed by the organ. Furthermore, pharmaceutical compositions containing a compound of the invention may be provided in the form of a rapid-release formulation, an extended-release formulation, or an intermediate-release formulation. For administration by inhalation, the compound or its salt of the invention may be in the form of an aerosol, mist, or powder. Pharmaceutical compositions of the compound or its salts of the invention may be conveniently supplied in the form of an aerosol spray presentation. of pressurized containers or a nebulizer, using a suitable propellant, for example, dichlorodifluoromethane, trichlorofluoromethane, dichlorotetrafluoroethane, carbon dioxide, or another suitable gas. In the case of a pressurized aerosol, the dose unit can be determined by providing a valve to deliver the measured amount. Capsules and cartridges, such as, for example, gelatin for use in an inhaler or insufflator, can be formulated to contain a mixed powder of the compound and a suitable powder base such as lactose or starch. The compound or its salts of the invention can also be formulated in rectal compositions such as enemas, rectal gels, rectal foams, rectal sprays, suppositories, gelatin suppositories, or retention enemas, containing conventional suppository bases such as cocoa butter or other glycerides, as well as synthetic polymers such as polyvinylpyrrolidone, PEG, and the like. In suppository forms of the compositions, a low-melting-point wax such as, but not limited to, a mixture of fatty acid glycerides, optionally in combination with cocoa butter, is melted first. In addition, the compound or its salts can also be combined with other drugs to treat fibrosis. These other drugs include, but are not limited to, ivacaftor, roflumilast, pirfenidone, nintedanib, miglustat, losartan, interferon, araphastreptodornase, veldone, atalurene, cortical hormone, amethopterin, tacrolimus, etc. Pharmaceutical compositions can be formulated conventionally using one or more physiologically acceptable carriers comprising excipients and auxiliaries that facilitate the processing of the active compounds into pharmaceutically usable preparations. The appropriate formulation depends on the selected route of administration. Any of the well-known techniques, carriers, and excipients may be used as appropriate and within the art. Pharmaceutical compositions comprising a compound of the invention can be prepared conventionally, such as, by way of example only, by conventional processes of mixing, dissolving, granulating, preparing tablets, levigating, emulsifying, encapsulating, encapsulating, or compressing.Pharmaceutical compositions containing a compound of the invention can be administered in therapeutically effective amounts as pharmaceutical compositions by any conventional form and route known in the art, including, but not limited to: intravenous, oral, rectal, aerosol, parenteral, ophthalmic, pulmonary, transdermal, vaginal, otic, nasal and. topical administration. Pharmaceutical compositions shall include at least one pharmaceutically acceptable carrier, diluent, or excipient and the compound or its salts described herein as the active ingredient in the form of a free acid or free base or in a pharmaceutically acceptable salt form. In addition, pharmaceutical compositions may include other medical or pharmaceutical agents, carriers, adjuvants such as preservatives, stabilizers, wetting agents, or emulsifiers, solution promoters, salts for regulating osmotic pressure, and / or buffers. Furthermore, pharmaceutical compositions may also contain other therapeutically valuable substances. Methods for preparing compositions comprising the compounds described herein include formulating the compounds with one or more pharmaceutically acceptable inert excipients or carriers to form a solid, semisolid, or liquid. Solid compositions include, but are not limited to, powders, tablets, dispersible granules, capsules, caplets, and suppositories. Liquid compositions include solutions in which a compound is dissolved, emulsions comprising a compound, or a solution containing liposomes, micelles, or nanoparticles comprising a compound as disclosed herein. Semisolid compositions include, but are not limited to, gels, suspensions, and creams. The compositions may be in liquid solutions or suspensions, solid forms suitable for dissolution or suspension in a liquid prior to use, or as emulsions.These compositions may also contain smaller amounts of non-toxic auxiliary substances, such as wetting or emulsifying agents, pH buffering agents, etc. The compound or its salts disclosed herein are preferably formulated in a unit-dose form for ease of administration and uniformity of dosage. The term “unit-dose form” refers to a physically discrete unit of the agent appropriate for the patient being treated. It is understood, however, that the total daily use of the compound or its salts or pharmaceutical compositions disclosed herein will be determined by the treating physician within the scope of their medical judgment.The specific effective dose level for any particular patient or organism will depend on a variety of factors, including the disorder being treated and the severity of the disorder; the activity of the specific compound or its salts used; the specific composition used; the patient's age, body weight, general health, sex, and diet; the time of administration, route of administration, and excretion rate of the specific compound used; the duration of treatment; drugs used in combination with or concurrently with the specific compound used; and similar factors well known in medical practice. The effective dose of the active ingredient used may vary depending on the compounds or their salts used, the route of administration, and the severity of the disease being treated. However, satisfactory results can be obtained when the compounds of the present invention are administered at a daily dose of approximately 0.25–1000 mg / kg of animal weight; preferably, they are administered in 2–4 divided doses per day or in sustained-release form. For most large mammals, the total daily dose is approximately 1–100 mg / kg, preferably approximately 2–80 mg / kg. Dosage forms suitable for oral administration contain approximately 0.25–500 mg of the active compounds intimately mixed with a pharmaceutically acceptable solid or liquid carrier. The dose may be adjusted to provide the optimal therapeutic response.Furthermore, depending on the urgent requirements of the treatment status, several divided doses may be administered daily or the dose may be reduced proportionally. The compound or its salts, pharmaceutical compositions, can be used effectively in the prevention, control, treatment, or reduction of tissue or organ fibrosis disorders in a patient, specifically to effectively treat renal interstitial fibrosis, glomerulosclerosis, hepatic fibrosis, pulmonary fibrosis, idiopathic pulmonary fibrosis, peritoneal fibrosis, myocardial fibrosis, dermatofibrosis, post-surgical adhesions, benign prostatic hyperplasia, skeletal muscle fibrosis, dermatosclerosis, multiple sclerosis, pancreatic fibrosis, hepatic cirrhosis, myosarcoma, neurofibroma, pulmonary interstitial fibrosis, diabetic nephropathy, Alzheimer's disease, or vascular fibrosis BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 shows the X-ray powder diffraction pattern of crystal I hydrochloride of the compound of formula (I); Figure 2 shows the Fourier transform infrared spectrogram of crystal I of the hydrochloride compound of formula (I); Figure 3 shows the X-ray powder diffraction pattern of crystal II hydrochloride of the compound of formula (I); Figure 4 shows the Fourier transform infrared spectrogram of crystal II of the hydrochloride compound of formula (I); Figure 5 shows the X-ray powder diffraction pattern of sulfate crystal I of the compound of formula (I); Figure 6 shows the powder X-ray diffraction pattern of sulfate amorphism of the compound of formula (I); Figure 7 shows the X-ray powder diffraction pattern of tosylate crystal I of the compound of formula (I); Figure 8 shows the differential scanning calorimetry thermogram of crystal I tosylate of the compound of formula (I); Figure 9 shows the X-ray powder diffraction pattern of tosylate amorphism of the compound of formula (I); Figure 10 shows the X-ray powder diffraction pattern of crystal I maleate of the compound of formula (I); Figure 11 shows the differential scanning calorimetry thermogram of crystal I of the maleate compound of formula (I); and Figure 12 shows the X-ray powder diffraction pattern of crystal III hydrochloride of the compound of formula (I). EXAMPLES The invention is also illustrated by the following examples, which are not intended to limit the scope of the invention. The analytical method of powder X-ray diffraction described herein is as follows: X-ray powder diffraction patterns were recorded using empirical diffraction with Cu-Ka radiation (45 kV, 40 mA). A thin layer was prepared from a powder sample on a single-crystal silicon sample holder, placed on a rotating sample stage, and analyzed in the 3° to 40° range with a step size of 0.0158°. Data were collected using Data Collector software, processed using HighScore Plus software, and read using Data Viewer software. The differential scanning calorimetry (DSC) analytical method disclosed herein is as follows: Differential scanning calorimetry thermograms were recorded on a TA Q2000 module with a thermoanalysis controller. The data were processed and analyzed using TA Instruments Thermal Solutions software. Approximately 15 mg of sample were accurately weighed into a special aluminum crucible with a lid and heated using a linear heating device at 10 °C / minute and analyzed from room temperature to approximately 300 °C. The DSC cabinet was purged with dry nitrogen during use. The analytical method for Fourier transform infrared (FT-IR) spectroscopy is as follows: the Fourier transform infrared spectrogram was recorded on a Germanic Bruker TENSOR27 infrared spectrometer. The data were collected and analyzed using OPUS software. A KBr disk was prepared, the scan time was 16 times, the wavenumber range was from 4000 to 600 crri1, and the resolution was 2 cm'1. The solubility revealed herein was measured using an Agilent 1200 high-performance liquid chromatography (HPLC) VWD detector. The chromatography column model was a Waters Xbridge-C18 (4.6 x 150 mm, 5 pm). The detection wavelength was 266 nm, the flow rate was 1.0 mL / min, the column temperature was 35 °C, the mobile phase A was 0.01 M acetonitrile-ammonium acetate (VV, 10:90), the analytical method was acetonitrile-mobile phase A = 70:30 (V.V), and the throughput period was 10 min. EXAMPLES Compound (I), namely 3-(4-(dihexylamine)-3-fluorophenyl)-2,6-dimethylpyrimidin4(3H)-one, was prepared according to the synthesis method disclosed in example 24 of patent application WO 2014012360. Example 1: 3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3H)-one, hydrochloride crystal I 1. Preparation of 3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / - / )-one, hydrochloride crystal I Method one: 3-(4-(Dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / - / )-one (5.01 g) was dissolved in methyl tert-butyl ether (200.0 mL). Ethyl acetate hydrochloride solution (5.0 mL, 15.55 mmol) prepared by the same company was added to the solution dropwise. After the addition, the mixture was stirred at room temperature overnight and filtered by suction. The filter cake was vacuum-dried at 50 °C for 6.5 hours and ground with ethyl acetate (30.0 mL) and ethanol (10.0 mL) for 24 hours. The mixture was filtered, and the filter cake was vacuum-dried overnight at 50 °C to give a white solid product (3.75 g, 68.6%). Method two: 3-(4-(Dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / 7)-one (0.4 g) was dissolved in ethyl acetate (8.0 mL), ethyl acetate hydrochloride solution (0.4 25 mL (1.24 mL) prepared by itself was added to the solution dropwise, and then ethyl acetate (8.0 mL) was added. The mixture was stirred at room temperature for 5 hours and filtered by suction. The filter cake was vacuum dried at room temperature to give a white solid product (0.372 g, 85.27%). Method three: 3-(4-(Dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3H)-one (5.24 g) was dissolved in isopropanol (40.0 mL). To the solution, seed crystals of hydrochloride (200 mg; for the synthesis method, see Method One or Method Two) were added, followed by isopropanol hydrochloride solution (1.9 g, 15.6 mmol). The mixture was stirred at room temperature overnight to precipitate the crystals and filtered by suction. The filter cake was washed with isopropanol (5.0 mL x 2) and dried under vacuum overnight to give a white solid product (5.29 g, 92.9%). 2. Identification of 3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3A7)-one hydrochloride crystal I (1) The XRPD pattern was analyzed and identified using empirical X-ray powder diffraction (XRPD) with Cu-Kα radiation, which has the following characteristic peaks expressed in degrees 2Θ at 3.68°, 7.25°, 10.88°, 11.53°, 12.43°, 12.74°, 13.63°, 14.47°, 14.77°, 15.23°, 16.82°, 17.30°, 17.65°, 18.16°, 19.43°, 20.19°, 21.41°, 21.83°, 22.20°, 22.90°, 23.28°, 23.79°, 24.13°, 24.64°, 24.99°, 25.51°, 25.97°, 26.67°, 27.30°, 27.73°, 28.86°, 29.33°, 29.88°, 31.02°, 31.81°, 32.39°, 32.83°, 34.05°, 34.48°, 35.69°, 36.56°, 37.07° and 37.83°. The margin of error in 20 of the characteristic peaks is ± 0.2°. (2) The infrared spectroscopy was analyzed and identified using a TENSOR 27 infrared spectrometer, which has the following absorption peaks at 606, 656, 721, 756, 819, 878, 911, 964, 981, 1028, 1078, 1101, 1117, 1153, 1166, 1198, 1215, 1265, 1290, 1343, 1366, 1397, 1435, 1455, 1464, 1512, 1538, 1592, 1616, 1633, 1665, 1694, 1738, 1822, 1957, 2342, 2355, 2555, 2724, 2754, 2857, 2930, 2956, 3024, 3046, 3183, 3256, 3324, 3374, 3419, 3432, 3453, 3459, 3479, 3493 and 3500 cm'1. The margin of error in 2Θ of the characteristic peaks is ± 0.2°. Example 2: 3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3H)-one, hydrochloride crystal II. 1. Preparation of 3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylprimidin-4(3 / - / )-one hydrochloride crystal II 3-(4-(Dihexylamine)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3H)-one hydrochloride crystal I (10 g) was added to acetic acid (40 mL). The mixture was heated to 80 °C until the solid was completely dissolved. The mixture was held at 80 °C for 2.0 hours and then slowly cooled to room temperature and stirred to precipitate the crystal. The mixture was suction filtered, the filter cake was washed with a small amount of acetic acid (2.0 mL), and then vacuum dried at room temperature to give a white solid product (4.2 g, 42%). 2. Identification of 3-(4-(dihexylamine)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3H)-one, hydrochloride crystal II (1) The XRPD pattern was analyzed and identified using empirical X-ray powder diffraction (XRPD) with Cu-Kα radiation, which has the following characteristic peaks expressed in degrees: 6.12°, 8.83°, 12.27°, 13.54°, 13.80°, 13.97°, 15.56°, 16.51°, 17.24°, 18.48°, 19.69°, 21.81°, 22.68°, 23.80°, 24.70°, 25.24°, 25.72°, 26.35°, 26.66°, 27.17°, 27.50°, 28.12°, 29.03°, 30.43°, 31.03°, 31.56° and 37.58°. The margin of error in 26 of the characteristic peaks is ± 0.2°. (2) The infrared spectroscopy was analyzed and identified using a TENSOR 27 infrared spectrometer, which has the following absorption peaks at 667, 727, 757, 882, 969, 1026, 1039, 1081, 1109, 1159, 1199, 1291, 1365, 1396, 1439, 1457, 1478, 1509, 1545, 1593, 1611, 1666, 1729, 2524, 2550, 2581, 2684, 2871, 2934, 2955, 3010, 3257 and 3377 crri1. The margin of error in 2Θ of the characteristic peaks is ± 0.2°. Example 3: 3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3H)-one, hydrochloride crystal III 1. Preparation of 3-(4-(dihexalamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / - / )-one, hydrochloride crystal III 3-(4-(Dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / - / )-one (5.24 g) was added to the mixed solvent of β-methylpyrrolidone and water (V:V=4:1, 2.0 mL). The solution was cooled to -15 °C and diluted with isopropanol hydrochloride solution (90 pL, wt. 30%) and the mixed solvent of β-methylpyrrolidone and water (V:V=4:1, 0.5 mL). The mixture was suction filtered, the filter cake was washed with methyl tert-butyl ether (1.0 mL × 3) and dried under vacuum at room temperature to give a white solid product (142 mg, 67.4%). 2. Identification of 3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylprimidin-4(3H)-one, hydrochloride crystal III The XRPD pattern was analyzed and identified using empirical X-ray powder diffraction (XRPD) with Cu-Kα radiation, which has the following characteristic peaks expressed in 2Θ degrees: 3.46°, 6.80°, 10.25°, 11.51°, 11.93°, 12.77°, 13.62°, 14.77°, 17.26°, 18.95°, 19.83°, 20.56°, 21.64°, 22.57°, 23.09°, 24.10°, 26.44°, 27 26.66°, 27.35°, 28.41°, 29.09°, 30.50°, 31.67°, 34.16°, 37.13° and 39.38°. The margin of error in 29 of the characteristic peaks is ± 0.2°. Example 4: 3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / 7)-one, sulfate crystal I 1. Preparation of 3-(4-(dihexylamine)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / 7)-one, sulfate crystal I 3-(4-(Dihexylamino)-3-fluorophenyl)-2,6-dimethylprimidin-4(3 / 7)-one (0.602 g) was dissolved in ethyl acetate (8.0 mL) and concentrated sulfuric acid (0.5 mL) was added to the solution. The mixture was stirred at room temperature overnight and filtered by suction. The filter cake was washed with ethyl acetate to give a white solid product (0.64 g, 85.45%). 2. Identification of 3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3H)-one sulfate crystal I The XRPD pattern was analyzed and identified using empirical X-ray powder diffraction (XRPD) with Cu-Kα radiation, which has the following characteristic peaks expressed in 2Θ degrees: 3.35°, 6.61°, 7.89°, 9.90°, 10.45°, 12.74°, 13.20°, 14.86°, 15.22°, 16.50°, 16.87°, 17.30°, 18.40°, 19.03°, 19.43°, 19.65°, 20.56°, 20.87°, 21.43°, 21.74°, 23.19°, 23.45°, 23.80°, 24.60° 25.29°, 25.90°, 26.07°, 26.40°, 27.26°, 28.22°, 28.47°, 30.82°, 31.75°, 33.80°, 34.55°, 36.77°, 37.30° and 39.02°. The margin of error in 29 of the characteristic peaks is ± 0.2°. Example 5: 3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3H)-one, sulfate amorphism 1. Preparation of 3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3H)-one1 sulfate amorphism 3-(4-(Dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / 7)-one (0.42 g) was dissolved in ethyl acetate (3.0 mL), and concentrated sulfuric acid (0.1 mL) was added to the solution. The mixture was stirred at room temperature overnight and filtered by suction. The filter cake was washed with ethyl acetate and dried under vacuum at room temperature to give a white solid product (0.428 g, 81.92%). 2. Identification of 3-(4-(dihexylamine)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / - / )-one, sulfate amorphism The XRPD pattern was analyzed and identified using empirical X-ray powder diffraction (XRPD) substantially as shown in Figure 6. Example 6: 3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3H)-one, tosylate crystal I 1. Preparation of 3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / 7)-one, tosylate crystal I 3-(4-(Dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / - / )-one (0.201 g) was dissolved in butanone (5.0 mL), and ptoluenesulfonic acid monohydrate (0.238 g) was added to the solution. The mixture was stirred at room temperature overnight and filtered by suction. The filter cake was washed with n-heptane to give a white solid product (0.23 g, 61.6%). 2. Identification of 3-(4-(dihexylamine)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3F / )-one, tosylate crystal I (1) The XRPD pattern was analyzed and identified using empirical X-ray powder diffraction (XRPD) with Cu-Kα radiation, which has the following characteristic peaks expressed in degrees 2Θ at 6.55°, 8.18°, 8.68°, 9.37°, 9.60°, 9.97°, 10.80°, 11.05°, 12.80°, 13.18°, 13.74°, 13.96°, 15.48°, 16.41°, 17.18°, 17.44°, 17.87°, 18.18°, 18.97°, 19.83°, 20.08°, 20.31°, 20.95°, 21.32°, 22.17°, 22.47°, 22.99°, 23.79°, 24.02°, 24.86°, 25.44°, 26.27°, 26.83°, 27.32°, 27.65°, 28.10°, 29.06°, 30.39°, 30.87°, 31.57°, 32.04°, 33.18° and 36.87°. The margin of error in 2Θ of the characteristic peaks is ±0.2°. The DSC thermogram was analyzed and identified using TA Q2000 differential scanning calorimetry (DSC) with a scan rate of 10 °C / minute, comprising an endothermic peak at 231.51 °C. The margin of error of the endothermic peaks is ±3°C. Example 7: 3-(4-(d¡hex¡lamino)-3-fluorophenyl)-2,6-dimethyl¡rimidin-4(3H)-one, tosylate amorphism 1. Preparation of 3-(4-(d¡hexalam¡no)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / - / )-one, tosylate amorphism 3-(4-(Dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / - / )-one, tosylate crystal I (3.0 g) was dissolved in anhydrous methanol (30 mL), the mixture was heated until dissolved. The solution was sprayed with a spray dryer to give a white powder product. 2. Identification of 3-(4-(d¡hexalam¡no)-3-fluorophen¡l)-2,6-dimethylpyrim¡din-4(3H)-one, tosylate amorphism The XRPD pattern was analyzed and identified using empirical X-ray powder diffraction (XRPD) substantially as shown in Figure 9. Example 8: 3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3H)-one, maleate crystal I 1. Preparation of 3-(4-(d¡hexylamino)-3-fluorophen¡l)-2,6-dimethylpyrmid¡n-4(3H)-one, maleate crystal I 3-(4-(Dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / - / )-one (407 mg) was dissolved in ethyl acetate (1.5 mL), and maleic acid (129 mg) was added to the solution. The mixture was stirred at room temperature overnight and concentrated under vacuum. The residue was ground with n-heptane (6.0 mL) for 2.5 hours and filtered by suction. The filter cake was washed with n-heptane and dried under vacuum at room temperature to give a white solid product (0.45 g, 85.79%). 2. Identification of 3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / - / )-one, maleate crystal I (1) The XRPD pattern was analyzed and identified using empirical X-ray powder diffraction (XRPD) with Cu-Kα radiation, which has the following characteristic peaks expressed in degrees 2Θ at 4.10°, 8.01°, 8.16°, 12.23°, 13.94°, 14.31°, 15.32°, 16.33°, 16.82°, 17.72°, 18.38°, 18.39°, 19.14°, 19.77°, 20.45°, 20.95°, 21.58°, 22.34°, 23.87°, 24.63°, 25.56°, 26.43°, 27.51°, 28.24°, 28.78°, 29.62°, 30.13°, 30.93°, 33.01°, 35.58° and 37.37°. The margin of error in 2Θ of the characteristic peaks is ± 0.2°. (2) The DSC thermogram was analyzed and identified using TA Q2000 differential scanning calorimetry (DSC) with a scan rate of 10 °C / minute, comprising an endothermic peak at 116.28 °C. The margin of error of the endothermic peaks is ±3 °C. Example 9: Pharmacokinetic experiments of the salts of the invention The compound (I) disclosed herein, namely (3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin-4(3 / - / )-one), crystalline forms of the various salts were filled into capsules, which were administered orally. Male Beagle dogs (6–10 kg) were randomly assigned to three groups. One group received compound (I), while the other group received various salts at a dose of 5 mg / kg. Blood samples were collected at 0.25, 0.5, 1.0, 2.0, 4.0, 6.0, 8.0, 12, and 24 hours post-administration. The standard curve was plotted based on sample concentrations within an appropriate range. Concentrations of the test compounds in plasma samples were determined using an Agilent 6430 LC-MS / MS in MRM mode, and quantitative analysis was performed. Pharmacokinetic parameters were calculated from the drug concentration-time curve using a non-compartmental method with WinNonLin 6.3 software. The results are shown in Table 1. Table 1: Pharmacokinetic experiment data for the salts of the invention Test sample T max AUC|ast (h*ng / ml) AUCinf (h'ng / ml) T1 / 2 (h) MRTinf (h) (h) Cmax (ng / ml) Compound 1.17 244 1730 2320 13.8 23.3 (I) Example 1 2.33 364 4470 6310 34.5 41.9 Example 2 8.83 485 2940 2820 9.54 9.43 Example 6 2 329 2720 3010 17.5 17.5 Example 8 2 588 5859.22 38337.53 110.28 155.21 Conclusion: It can be seen from Table 1 that the salts of compound (I) have a higher exposure compared to the free 3-(4-(dihexylamino)-3-fluorophenyl)-2,6-dimethylpyrimidin4(3H)-one (i.e., compound (I)), where example 1 (hydrochloride crystal I), example 2 (hydrochloride crystal II), example 6 (tosylate crystal I), and example 8 (maleate crystal I) have a higher relative exposure. Example 10: Stability experiments of the salts of the invention High-temperature assay: An appropriate amount of sample was placed in a weighing bottle as a thin layer < 5 mm thick and heated to 60 °C for 10 days. Samples were taken on the fifth and tenth days, their appearance was observed, and their purity was determined by HPLC. The results are shown in Table 2. Table 2: High temperature test of the salts of the invention Sample Example 1 Example 2 Example 6 Example 8 test powder powder powder Od solid white white white white powder powder powder solid white to yellow Appearance 5d white white pale white ή A rl powder powder powder solid white to yellow 1 U 0 white white pale white 0d 99.81 99.85 99.83 99.53 Purity / % 5d 99.80 99.86 99.81 99.49 10d 99.79 99.83 99.81 99.05 High humidity test: An appropriate amount of sample was placed in a weighing bottle as a thin layer of approximately 5 mm, under a temperature of 25 °C and RH 90% ± 5% for 10 days. Samples were taken on the fifth and tenth days, their appearance was observed, and purity was determined by HPLC. The results are shown in Table 3. Table 3: High humidity test of the salts of the invention Test Sample Example 1 Example 2 Example 6 Example 8 Od white powder white powder white powder white solid Appearance 5 d white powder white powder white powder white solid 10 d white powder white powder white powder white solid Od 99.81 99.85 99.83 99.53 Purity / % 5 d 99.79 99.86 99.80 99.51 10 d 99.80 99.82 99.83 99.49 Conclusion: It can be seen from Tables 2 and 3 that the appearance and purity of the salts of the invention do not change significantly at high temperature (60 °C) and high humidity (25 °C, RH 90% ± 5%) and the salts of the invention have good stability and are suitable for drug formulation. Example 11: Hygroscopicity experiments of the salts of the invention The hygroscopicity of an appropriate amount of sample was detected using a dynamic moisture absorption instrument. The results showed that the salts provided herein are not easily affected by high humidity to the point of deliquescence. The above contents are merely basic descriptions under the idea of the present invention; any equivalent modifications based on the technical schemes of the invention are all within the claimed scope of the invention. References throughout this descriptive report to “a form of realization,” “some forms of realization,” “another example,” “an example,” “a specific example,” or “some examples” mean that a particular feature, structure, material, or characteristic described in connection with the form of realization or example is included in at least one form of realization or example in the present description. Thus, aspects of phrases such as “in some forms of realization,” “in a form of realization,” “in another example,” “in an example,” “in a specific example,” or “in 32 The phrases "some examples" in various places throughout the descriptive report do not necessarily refer to the same embodiment or example as in the present description. Furthermore, the features, structures, materials, or particular characteristics may be combined in any appropriate way in one or more embodiments or examples. Although explanatory embodiments were shown and described, those skilled in the art will appreciate that the above embodiments cannot be used to limit the present description, and changes, alternatives, and modifications can be made to the embodiments without departing from the spirit, principles, and scope of the present description.
Claims
1. A pharmaceutically acceptable acid addition salt of compound (I), FORMULA 1 (I), characterized in that the salt is hydrochloride crystal I, characterized by an X-ray powder diffraction pattern comprising peaks expressed as 2θ at 3.68 ± 0.2º, 10.88 ± 0.2º, 17.30 ± 0.2º, 22.20 ± 0.2º, 26.67 ± 0.2º; or the salt is crystal II of hydrochloride, which is characterized by an X-ray powder diffraction pattern comprising peaks expressed as 2θ at 6.12 ± 0.2º, 8.83 ± 0.2º, 15.56 ± 0.2º, 19.69 ± 0.2º, 25.24 ± 0.2º, 26.35 ± 0.2º; or the salt is tosylate crystal I, characterized by an X-ray powder diffraction pattern comprising peaks expressed as 2θ at 6.55 ± 0.2°, 13.74 ± 0.2°, 20.08 ± 0.2°, 21.32 ± 0.2°, 22.17 ± 0.2°, 22.99 ± 0.2°; or the salt is maleate crystal I, characterized by an X-ray powder diffraction pattern comprising peaks expressed as 2θ at 4.10 ± 0.2°, 16.33 ± 0.2°, 20.45 ± 0.2°. Six claims follow.