Calcitriol soft capsule preparation production method
A technology of calcitriol and soft capsules, which is used in capsule delivery, bone diseases, pharmaceutical formulations, etc., can solve the problems of long-term stable existence, light, heat and air sensitivity, and low bioavailability, so as to improve comprehensive performance. and market competitiveness, short half-life, eliminating the effect of absorbing excipients
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[0026] Example 1. Preparation method of calcitriol soft capsule
[0027] Contents:
[0028]
[0029] Preparation Process:
[0030] (1) Put the above-mentioned prescription amount of materials in the batching tank, stir and mix for 30 minutes; grind into a homogeneous mixture to make it evenly mixed, and form a uniform and stable content, vacuum for use;
[0031] (2) Put 20 parts by weight of glycerin and 40 parts by weight of purified water into the gelatinization tank, heat and stir to raise the temperature to 70-80°C, then put in 40 parts by weight of gelatin, and continue to stir for 20-30 minutes;
[0032] (3) Vacuum to remove air bubbles, filter while hot, and then cool the material to 60-65°C and keep warm;
[0033] (4) Put the content obtained in the above step (1) and the glue obtained in step (2) into the rotary moulding soft capsule machine for pill pressing, and the rotating speed of the rotary moulding soft capsule machine is 2.5-3r / min;
[0034] (5) The soft capsules after pe...
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[0037] Example 2. Stability experiment of the calcitriol soft capsule of the present invention:
[0038] Test of influencing factors: Take calcitriol soft capsules and conduct investigations under the conditions of 60℃, 25℃, relative humidity 92.5%, and illuminance 4500Ix. The results of the sample are easy to absorb water and become soft under high humidity conditions, but under light conditions It is easy to harden, and its disintegration time limit and content have no obvious changes. Accelerated test: Take 3 batches of samples under the packaging conditions of the market and place them for 12 months under the conditions of temperature (40±2)qC and relative humidity (75±10)%, respectively in the first, second, third, and sixth part of the test , Sampling at 9 and 12 months for stability inspection. Results showed that the appearance, disintegration time limit and content of the samples did not change significantly. Long-term test: Take 3 batches of samples under the listed pac...
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