A kind of dasatinib tablet and its preparation process
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A technology for dasatinib and nigra tablets, which is applied in the field of pharmaceutical preparations, can solve the problems of large differences in tablet dissolution uniformity, affecting drug absorption and metabolism, and hidden dangers of drug use by patients, achieving rapid drug dissolution, improving drug use, The effect of eliminating drug adhesion
Active Publication Date: 2018-07-06
SHANDONG NEWTIME PHARMA
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Problems solved by technology
The use of new excipients can not only change the appearance of the pharmaceutical preparation, but also improve the dissolution rate. In the prior art, a fast-dissolution and stable dasatinib tablet has not been provided, and sticking is prone to occur during the drug release process. phenomenon, resulting in a large difference in dissolution uniformity between different tablets, and if the drug with adhesion is taken, the dissolution difference between the tablets is obvious, which affects drug absorption and metabolism, and brings great hidden dangers to patients.
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Embodiment 1
[0025]
[0026] Preparation Process:
[0027] (1) Dasatinib, calcium sulfate, and calcium carbonate were passed through a 100-mesh sieve, weighed the prescription amount, mixed evenly with silicon dioxide, added an appropriate amount of water, granulated, dried at 50°C, and granulated through a 18-mesh sieve;
[0028] (2) Mix the sieved granules with magnesium stearate evenly, and press into tablets.
Embodiment 2
[0030]
[0031] Preparation Process:
[0032] (1) Pass dasatinib and calcium hydrogen phosphate through a 100-mesh sieve, weigh the prescription amount, mix it with silicon dioxide evenly, add an appropriate amount of water, granulate, dry at 60°C, and granulate through a 18-mesh sieve;
[0033] (2) Mix the sieved granules with talcum powder and sodium stearyl fumarate evenly, and press into tablets.
Embodiment 3
[0035]
[0036] Preparation Process:
[0037] (1) Pass dasatinib and calcium sulfate through a 100-mesh sieve, weigh the prescription amount, mix with silicon dioxide evenly, add an appropriate amount of water, granulate, dry at 60°C, and granulate with a 18-mesh sieve;
[0038] (2) Mix the sieved granules with magnesium stearate evenly, and press into tablets.
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Abstract
The invention belongs to the technical field of preparations, and in particular relates to a dasatinib tablet and a preparation process thereof. The tablet of the invention consists of dasatinib, silicon dioxide, a filler and a lubricant. The technical solution of the present invention greatly improves the dissolution uniformity of dasatinib, and disintegrates rapidly, ensuring the rapid dissolution of the drug in the body fluid of the gastrointestinal tract, and no adhesion phenomenon occurs during the drug release process, which improves the safety of the drug. It eliminates the hidden dangers brought by the adhesion and the large difference in drug uniformity to patients. On the other hand, the preparation process of the present invention is simple and suitable for mass production requirements.
Description
technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a dasatinib tablet and a preparation process thereof. Background technique [0002] Dasatinib (Dasatinib / Sprycel), molecular formula C 22 h 26 C l N 7 o 2 S.H 2 O, molecular weight 506.02, used for all disease stages of chronic myelogenous leukemia (chronic phase, accelerated phase, lymphoid cell blast phase and myeloid blast phase) in adult patients. Among the approved drugs, Sprycel is the first oral chemotherapy drug capable of inhibiting multiple configurations of tyrosine protein kinase Abl. At nanomolar concentration, the drug can inhibit Bcr-Abl, SRC kinase family (SRC, LCK, YES, FYN), c-KIT, EPHA2 and PDGFR-B and other kinases. By inhibiting the action of the aforementioned kinases, Sprycel inhibits the proliferation of leukemia cells in the bone marrow of CML and Ph+ALL. It has the advantages of long-lasting curative effect and high safety,...
Claims
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