Nicotinic acid derivative of fenofibrate and preparation method of nicotinic acid derivative
A technology of fenofibrate and niacin, applied in the field of medicine, can solve problems such as unsatisfactory effect
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Embodiment 1
[0017] The preparation method of the compound shown in embodiment 1 formula I,
[0018] The preparation method comprises the following four steps:
[0019] The first step: fenofibrate acid reacts with alkali sodium hydroxide to generate fenofibrate sodium salt,
[0020] The second step: nicotinic acid and vinyl acetate react under the catalysis of mercury acetate and concentrated sulfuric acid to form nicotinic acid vinyl ester,
[0021] The third step: nicotinic acid vinyl ester reacts with hydrogen bromide acetic acid solution to generate nicotinic acid-α-bromo-ethyl ester,
[0022] Part Four: The reaction of fenofibrate sodium salt and nicotinic acid-α-bromo-ethyl ester produces the product fenofibrate nicotinate I.
[0023]
Embodiment 2
[0024] Embodiment 2: the preparation of dry suspension
[0025] formula
Dosage (% mass)
Micronized Fenofibrate Nicotinate
64.5
Neutral particles
21
Polysorbate 80
3.3
11.2
[0026] Preparation:
[0027] 1. Add micronized fenofibrate nicotinate, Polysorbate 80, and hypromellose into purified water and stir evenly to make an aqueous suspension;
[0028] 2. Spray the aqueous suspension on the neutral fine particles in a fluidized bed, and dry at 50°C to obtain small drug-containing particles.
[0029] 3. Mix other excipients in proportion, pack to obtain dry suspension.
Embodiment 3
[0030] Embodiment 3: the preparation method of capsule
[0031] formula
Dosage (% mass)
Micronized Fenofibrate Nicotinate
67.1
Neutral particles
17.2
sodium lauryl sulfate
3.3
11.5
35% dimethicone emulsion
0.2
0.5
[0032] Preparation:
[0033] 1. Take micronized fenofibrate nicotinate, sodium lauryl sulfate, and hypromellose and add them into purified water and stir evenly to make an aqueous suspension;
[0034] 2. Spray the aqueous suspension and 35% dimethicone emulsion on the neutral micro-particles in a fluidized bed, and dry at 50 degrees to obtain granules;
[0035] 3. Add an appropriate amount of talcum powder and put it into a No. 1 gelatin capsule to obtain a capsule.
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