Acipimox capsule and preparation method thereof
A technology of acipimox and capsules, which is applied in the field of acipimox capsules, can solve the problems of risks in drug safety and effectiveness, affecting oral absorption and peak blood concentration time, and difficulty in ensuring reasonable storage of drugs, etc., to achieve Good stability and the effect of improving the characteristics of easy bonding
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[0038] Embodiments 1 to 3 are comparative experiments on the effects of preparing acipimus spacers using different preparation methods.
[0039] Preparation of acipimus spacer by grinding method
[0040] Experimental scheme: After uniformly mixing acipimox and solubilizer, add release agent according to the type and amount of release agent recorded in Table 1, and grind thoroughly. The isolation is considered successful when the mixed powder of acipimox and the isolation agent no longer forms a cohesive substance immediately when it meets water. The lubricant can be one or more of magnesium stearate, micronized silica gel, and talcum powder. The isolation effect is shown in Table 1. In the mixture of povidone and silicon dioxide in Table 1,
[0041] Table 1: Comparison of the isolation effects of various isolation agents in Experiment 1
[0042]
[0043] Preparation of acipimus isolate by spray granulation
[0044] Experimental scheme: add the release agent and acipi...
Embodiment 1
[0057] The formula of acipimox capsule of the present embodiment is as follows:
[0058]
[0059] Preparation of acipimox capsules by wet granulation: dissolving the sodium lauryl sulfate in the prescribed amount in 50% ethanol, adding to the raw material of acipimox, and stirring to make wet and soft materials. The amount of 50% ethanol added is subject to the form that can form wet and soft materials. Then add hydrogenated castor oil and silicon dioxide and continue to stir for 5 minutes, pass through a 24-mesh sieve to granulate, dry at 50°C until the water content is ≤5%, and granulate. Mix well with sodium carboxymethyl cellulose and talcum powder. Using a disc-type capsule filling machine, select No. 1 capsule for filling.
[0060] In this embodiment: the release agent is: hydrogenated castor oil and silicon dioxide. The disintegrant is: sodium carboxymethylcellulose; the lubricant is: talc; the solubilizer is: sodium lauryl sulfate.
Embodiment 2
[0062] The formula of acipimox capsule of the present embodiment is as follows:
[0063]
[0064] Preparation of acipimox capsules by dry granulation
[0065] Preparation steps: Detect the moisture content of each material in the formula, keep it below 5.5%, and set aside. After mixing the formulated amount of acipimox and poloxamer evenly, fully mix and grind with silicon dioxide and povidone, when the mixed powder of acipimox and release agent no longer forms a bond immediately when it meets water, After mixing evenly with the formula amount of croscarmellose sodium, a dry granulator is used to prepare 24-80 mesh granules, and the prepared granules are mixed evenly with crospovidone, magnesium stearate, and talcum powder, and Multi-punch filling capsule filling machine, 0 capsules for filling.
[0066] In this embodiment: the release agent is: silicon dioxide and povidone. The disintegrants are: croscarmellose sodium and crospovidone; the lubricants are: magnesium stea...
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