Orally administered solid dosage form drug

1 . An orally administered solid dosage form for treating cancers, tumors or cell proliferative disorders, the orally administered solid dosage form comprising a compound having structural formula I or II as follow:

2 . The solid dosage form of claim 1 , wherein the solid dosage form is a tablet.

3 . The solid dosage form of claim 2 , wherein the tablet comprises at least one alkaline agent selected from the group consisting of Na 2 CO 3 , NaHCO 3 , NaOH, and KH 2 PO 4 , so that the tablet is dissolved or dispersed in water to form an aqueous solution or an aqueous dispersion having a pH value greater than 6.8.

4 . The solid dosage form of claim 2 , wherein the tablet comprises the compound having structural formula I or II and pharmaceutical excipients.

5 . The solid dosage form of claim 1 , wherein the solid dosage form is an enteric-coated tablet.

6 . The solid dosage form of claim 5 , wherein the enteric-coated tablet comprises an enteric coating and a tablet core, and the tablet core comprises the compound having structural formula I or II and pharmaceutical excipients.

7 . The solid dosage form of claim 1 , wherein the solid dosage form is an enteric capsule.

8 . The solid dosage form of claim 7 , wherein the enteric capsule comprises an enteric-coated capsule shell and a mixture filled in the enteric-coated capsule shell, wherein the mixture comprises the compound having structural formula I or II and pharmaceutical excipients.

9 . The solid dosage form of claim 8 , wherein the mixture is in a form of granules.

10 . The solid dosage form of claim 8 , wherein the enteric capsule comprises a soft enteric-coated capsule shell, and

wherein the mixture is a solution, and a concentration of the compound having structural formula I or II in the solution is 1-270 mg/ml.

11 . The solid dosage form of claim 10 , wherein the solution comprises a solvent mixture of ethanol and propylene glycol.

12 . The solid dosage form of claim 11 , wherein the solvent mixture comprises at least 50% of ethanol by volume.

13 . The solid dosage form of claim 12 , wherein the solvent mixture is composed of 75% of ethanol and 25% of propylene glycol by volume.

14 . The solid dosage form of claim 10 , wherein no water is added to the solution, and a content of the water is controlled within 0.5% by mass.

15 . The solid dosage form of claim 1 , wherein the tumors, the cancers, or the proliferative disorders are selected from the group consisting of

lung cancer, non-small cell lung cancer, liver cancer, pancreatic cancer, stomach cancer, bone cancer, esophagus cancer, breast cancer, prostate cancer, testicular cancer, colon cancer, ovarian cancer, bladder cancer, cervical cancer, melanoma, squamous-cell cancer, basal cell carcinoma, adenocarcinoma, squamous-cell carcinoma, sebaceous carcinoma, papillary carcinoma, papillary adenocarcinoma, cystadenocarcinoma, cystic carcinoma, medullary carcinoma, bronchial carcinoma, bone cell carcinoma, epithelial carcinoma, cholangiocarcinoma, choriocarcinoma, embryonic carcinoma, seminoma, Wilms' carcinoma, glioblastoma, astrocytoma, medulloblastoma, craniopharyngioma, ependymoma, pineal tumor, hemoblastoma, neurogenic tumor of the larynx, meningiomas, neuroblastoma of optic nerve, neuroblastomas, retinoblastomas, neurofibromas, fibroma sarcomatosum, fibroblastomas, fibroma, fibroadenomas, fibrochondromas, fibrocystic tumors, fibrous myxoma, osterfibroma, myxofibrosarcoma, fibropapillary, myxofibrosarcoma, bursal tumor, myxonchondroma, myxonchondrosarcoma, myxedema, myxoblastoma, liposarcoma, lipoma, lipoadenoma, lipoblastoma, lipochondroma, lipofibroma, lipoangioma, myxolipoma, chondrosarcoma, chondroma, chondromyoma, chordoma, chorioadenoma, chorioepithelioma, chorioblastoma, osteosarcoma, osteoblastoma, osteochondrofibroma, osteochondrosarcoma, osteochondroma, osteocystoma, cementoma, osteofibroma, fibrosarcoma, angiosarcoma, hemangioma, angiolipoma, angiochondroma, hemangioblastoma, angiokeratoma, angioglioma, hemangioendothelioma, angiofibroma, angiomyoma, angiolipoma, angiolymphoma, angiolipiomyoma, angiomyolipomas, angiomyoneuroma, angiomyxoma, angioreticuloendothelioma, lymphangiosarcoma, lymphogranuloma, lymphangioma, lymphoma, lymphomyxoma, lymphosarcoma, lymphangial fibrom, lymphocytoma, lymphoepithelioma, lymphoblastoma, endothelioma, endothelioblastoma, synovialoma, synovial sarcoma, mesothelioma, desmoplastic tumor, Ewing's tumor, leiomyoma, leiomyosarcoma, leioblastoma, leiomyofibroma, rhabdomyoma, rhabdomyosarcoma, rhabdomyomatous myxoma, acute lymphoblastic leukemia, acute myeloid leukemia, chronic disease cells, polycythemia, lymphoma, endometrial cancer, glioma, colorectal cancer, thyroid cancer, urothelial cancer or multiple myeloma.

16 . A preparation method of the solid dosage form of claim 1 , the method comprising:

mixing pharmaceutical excipients, an ethanol solution of the compound having the structural formula I or II of claim 1 , and water to form a mixture;

granulating the mixture to form granulates;

directly tableting the granulates to obtain a tablet; and

coating the tablet to obtain an enteric-coated tablet.

17 . A compound having structural formula I or II:

18 . A method of treating a subject having cancers, tumors or cell proliferative disorders, the method comprising orally administering to the subject in need thereof an effective dosage of the solid dosage form of claim 1 .

19 . The method of claim 18 , wherein a minimum administrable dosage unit of the solid dosage form comprises 0.2 mg, 0.5 mg, or 1.0 mg of the compound having structural formula I or II.

20 . A method of preparing the compound of claim 17 , the method comprising reacting compounds III and IV with a compound V:

wherein X is a halogen atom, and

M is H, an alkali metal or an alkaline earth metal.

21 . The solid dosage form of claim 6 , wherein the pharmaceutical excipients comprise at least one of Na 2 CO 3 , NaHCO 3 , NaOH, and KH 2 PO 4 .

22 . The solid dosage form of claim 8 , wherein the pharmaceutical excipients comprise at least one of Na 2 CO 3 , NaHCO 3 , NaOH, and KH 2 PO 4 .