A kind of thyroid tablet and preparation method thereof
A thyroid tablet and thyroid technology, which is applied to pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problems of thyroid powder raw materials and thyroid tablet test results that do not meet the regulations, and achieve particle size. Uniformity, improving the effect of content uniformity
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Embodiment 1
[0080] The inventor has analyzed the existing production technology. Thyroid body is hard and tough after dehydration, degreasing and drying, and it is difficult to crush. However, after pulverization, the thyroid powder is loose, fibrous and elastic. At present, when the universal pulverizer equipped in the workshop of our company is crushed, it will pass through the sieve hole after being squeezed, and the particle size of more than 60 mesh cannot be achieved after repeated pulverization.
[0081] We carried out sieve analysis on the thyroid powder raw materials produced by the original process, and the results showed that the proportion of coarse powder with a particle size greater than 40 mesh is about 10-15%, and the proportion of fine powder between 40 mesh and 60 mesh is 15%-20% , The proportion of fine powder less than 60 mesh is 65-70%. However, the particle size of thyroid powder raw materials and excipients used in thyroid tablets is less than 80 mesh, and the lar...
Embodiment 2
[0087] Improvement of degreasing process:
[0088] Liothyronine (C 15 h 12 I 3 NO 4 , T3), levothyroxine (C 15 h 11 I 4 NO 4 , T4) are all tyrosine iodides, the chemical structure of T4 is not stable, and it is easy to degrade under the conditions of heating and light. It is known that it is easy to remove the iodine on the 5' position and degrade into T3 or The structural formulas of rT3, T3 and T4 are shown in the following formulas.
[0089]
[0090] Thyroxine (T 4 ): R 1 = I, R 2 = I, R 3 =I
[0091] Triiodothyronine (T 3 ): R 1 = I, R 2 = I, R 3 =I
[0092] Liothyronine (C 15 h 12 I 3 NO 4 , T3), levothyroxine (C 15 h 11 I 4 NO 4 , T4) Molecular structural formula
[0093] In the original process, acetone heat reflux dehydration and ether heat reflux degreasing processes were adopted. The heat reflux temperature was 60°C. Because the dehydration of organic solvents led to rapid denaturation of surface proteins and hardening of the surface, in ...
Embodiment 3
[0099] The improved thyroid powder production process is as follows:
[0100] 1. Grinding: After the thyroid gland has been sorted out to remove connective tissue and fat, use a meat grinder (mesh board) in the general production area ), twist the glands into a slurry and repeat the twisting one more time.
[0101] 2. Dehydration: Put the thyroid body serum into freeze-drying trays, about 2-5kg per tray, and the thickness of the trays should not exceed 2cm, and freeze-dry in a freeze dryer.
[0102] 2.1 Pre-freezing stage: Turn on the freeze-dryer and quickly lower the product temperature to the temperature required by the product (below -40°C).
[0103] Maintain this temperature for 2-6 hours.
[0104] 2.2 Primary sublimation stage: Turn on the vacuum pump, and the vacuum degree will reach below 30Pa in 30 minutes. Heating according to the requirements of the product, during the heating process, the system temperature rises from -40°C to -5°C and keeps warm for 10-18 hour...
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