Colchicine framework controlled release tablets or capsules
A technology of colchicine and controlled-release tablets, which is applied in bone diseases, medical preparations of non-active ingredients, organic active ingredients, etc., can solve the problem of repeated administration and cumulative release that cannot reach the Pharmacopoeia Requirements and other issues to achieve the effect of improving the safety of medication, reducing the number of medications, and ensuring the therapeutic effect
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[0125] 4. Preparation of Pilot Products
[0126] According to the optimized prescription, three batches of colchicine matrix tablets (batch numbers: 071001, 071002, and 071003) were prepared in our company, with 10,000 tablets in each batch. The results are shown in Table 10.
[0127] Table 10 Pilot test results
[0128]
[0129]The test results show that the product quality is stable and the process is feasible.
Embodiment 1
[0131]
[0132] The preparation method: a. mixing colchicine, hydrophilic polymer and other pharmaceutical excipients according to the method of equal increase to prepare a mixture;
[0133] b. Mix the mixture with ethanol solution to make a soft material, the amount of the added ethanol solution is to make the soft material knead into agglomerates and disperse when waved; then granulate through a 22 mesh sieve to obtain wet granules, and Dry the wet granules at 40°C for 5 hours to obtain dry granules; then use a 20-mesh sieve to sieve the granules to obtain drug granules;
[0134] c. Add the granules obtained in step b to magnesium stearate and mix evenly; the die of the tablet press is shallow concave (Φ=0.8mm); carry out tablet compression and press molding; tablet core hardness 50-70N, tablet weight 150mg ±2%.
Embodiment 2
[0136]
[0137] The preparation method: a. mixing colchicine, hydrophilic polymer and other pharmaceutical excipients according to the method of equal increase to prepare a mixture;
[0138] b. Mix the mixture with ethanol solution to make a soft material, the amount of the added ethanol solution is to make the soft material knead into agglomerates and disperse when waved; then granulate through a 22 mesh sieve to obtain wet granules, and Dry the wet granules at 40°C for 5 hours to obtain dry granules; then use a 20-mesh sieve to sieve the granules to obtain drug granules;
[0139] c. Add magnesium stearate to the granules obtained in step b and mix evenly, and pack into capsules.
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