Pharmaceutical composition for treating tumor and preparation method and application thereof
A composition and drug technology, applied in the field of drug preparation, can solve the problems of raw and auxiliary materials fluidity, high particle size requirements, unfavorable personnel protection, dissolution effects, etc., and achieves narrow particle size distribution range, good therapeutic effect, and improved particle properties. Effect
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Embodiment 1
[0048] In this embodiment, the formulation of the pharmaceutical composition is as follows:
[0049]
[0050] The fluidized bed one-step granulation process is adopted. Part of the starch is added internally, and part of it is made into starch slurry and mixed with hypromellose solution as a spray liquid. The steps are as follows:
[0051] (1) 50g starch is dispersed with purified water to make starch slurry, the mass percent concentration of the starch slurry is 13%, and hypromellose and purified water are weighed to form hypromellose Solution (concentration is 10%), starch slurry and hypromellose solution are mixed to obtain spray liquid;
[0052] (2) After mixing the remaining starch with vorinostat and low-substituted hypromellose, place it in a fluidized bed, preheat the material at 40-50°C, and spray the spray liquid obtained in step (1), Granulation and drying are carried out simultaneously, and sieved to make dry granules;
Embodiment 2
[0057] In this embodiment, the formulation of the pharmaceutical composition is as follows:
[0058] Element
Unit dose / mg
percentage / %
Volinota
100
31.25
starch
199.2
62.25
hypromellose
6.4
2.0
Low-substituted hydroxypropyl cellulose
12.8
4.0
1.6
0.5
[0059] The fluidized bed one-step granulation process is adopted. Part of the starch is added internally, and part of it is made into starch slurry and mixed with hypromellose solution as a spray liquid. The steps are as follows:
[0060] (1) 30g starch is dispersed with purified water to make starch slurry, the mass percent concentration of the starch slurry is 10%, and hypromellose and purified water are weighed to form hypromellose Solution (concentration is 10%), starch slurry and hypromellose solution are mixed to obtain spray liquid;
[0061] (2) After mixing the remaining starch with vorinostat and low-substituted hy...
Embodiment 3
[0066] In this embodiment, the formulation of the pharmaceutical composition is as follows:
[0067] Element
Unit dose / mg
percentage / %
Volinota
100
31.25
starch
196
61.2%
hypromellose
9.6
3.0
Low-substituted hydroxypropyl cellulose
12.8
4.0
1.6
0.5
[0068] A pharmaceutical composition prepared by a fluidized bed one-step granulation process, a part of the starch is added as a dry powder, and a part of the starch is made into a starch slurry and mixed with a hypromellose solution as a spray liquid. The steps are as follows:
[0069] (1) 25g starch is dispersed with purified water to make starch slurry, the mass percent concentration of the starch slurry is 6%, and hypromellose and purified water are weighed to form hypromellose Solution (concentration is 8%), starch slurry and hypromellose solution are mixed to obtain spray liquid;
[0070] (2) After mixing the remaining ...
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