Pharmaceutical composition containing alkalizer and eltrombopag and use thereof
A technology of a composition and an alkalizing agent, applied in the field of biomedicine, can solve problems such as the need for further research
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[0036] The preparation of pharmaceutical composition tablets: including but not limited to powder direct compression method and wet granulation tabletting method: the powder direct compression method is specifically, weighing each component respectively, mixing each component uniformly and directly compressing the tablet to obtain Drug combination tablet for in vitro dissolution test; the wet granulation and tabletting method specifically includes weighing each component separately, mixing some components first, adding purified water or an aqueous solution containing an alkalizing agent, wet granulation, drying, and sizing , and then add the remaining external ingredients such as magnesium stearate, etc., mix and compress into tablets to obtain drug combination tablets for in vitro dissolution tests;
[0037] Preparation of drug capsules: including but not limited to powder method and wet granulation method: the powder method is specifically, weighing a certain amount of eltrom...
Embodiment 1
[0040] In this example, HPLC tests were performed on a series of stock solutions of the test article in different media. In this example, 0.1mol / L HCl, pH 2.0, pH 3.0, pH 4.0, pH 4.5, pH 5.0, pH 6.0, pH 6.8, pH 7.5 and purified water were used for comparison. The equilibrium solubility of Eltrombopag in different media of this embodiment is shown in the table below:
[0041] medium Solubility (μg / ml) 0.1mol / L HCl 0.00 pH 2.0 0.00 pH 3.0 0.00 pH 4.0 0.00 pH 4.5 0.00 pH 5.0 0.00 pH 6.0 0.44 pH 6.8 2.64 pH 7.5 8.78 purified water 1485.23
[0042] It can be seen from the above table that Eltrombopag has the highest solubility in purified water, while other media have lower solubility. The solubility of Eltrombopag in the medium will affect the dissolution effect. If the solubility is too small, it is difficult to distinguish the difference in the dissolution of the pharmaceutical composition. Therefore, i...
Embodiment 2
[0054] In this example, according to the test conditions substantially the same as in Comparative Example 2, the pharmaceutical composition tablet was dissolved in purified water and an aqueous solution containing 2.78mmol / L calcium chloride for HPLC testing. The difference is that in this embodiment, the content of three specific components of the pharmaceutical composition changes: 16.10% by weight of mannitol, 35.50% by weight of microcrystalline cellulose, and 7.50% by weight of newly added sodium carbonate. And, this embodiment is the wet granulation tabletting method: Eltrombopag, mannitol, microcrystalline cellulose, sodium carboxymethyl starch and povidone were first mixed for 10 minutes, and then an aqueous solution of sodium carbonate was added to granulate, Pass the wet granules through a 30-mesh sieve, dry the dry granules in an oven at 50 degrees Celsius for 2 hours, pass through a 30-mesh sieve, add magnesium stearate and mix for 5 minutes, and finally compress to...
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