A kind of thyroid tablet produced by full powder direct compression and its preparation process

A thyroid tablet and thyroid technology, applied in the field of thyroid powder, can solve problems such as uneven mixing, unstable drug potency, and inactivation

Active Publication Date: 2021-05-04
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The fine structure of thyroid raw materials is obvious floc, which is intertwined in the form of fibers, which is difficult to crush and has poor fluidity
The particle size difference between thyroid raw materials and auxiliary materials is large, and the mixing is uneven, resulting in T 3 , T 4 Uneven content
Generally, it is difficult to crush the thyroid raw material to the particle size required for powder direct compression, and the fluidity of the mixed powder after mixing with auxiliary materials is poor
Therefore, most manufacturers in China usually use wet granulation to prepare thyroid tablets. The preparation process is complicated, and the drug is affected by factors such as humidity and heat for a long time during the preparation process, resulting in drug degradation and inactivation, resulting in lower drug potency. unstable

Method used

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  • A kind of thyroid tablet produced by full powder direct compression and its preparation process
  • A kind of thyroid tablet produced by full powder direct compression and its preparation process
  • A kind of thyroid tablet produced by full powder direct compression and its preparation process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Investigate the effects of different granular substances on the auxiliary crushing of thyroid raw materials, specific examples are: the auxiliary effect of the addition of lactose, calcium hydrogen phosphate dihydrate, sucrose, mannitol, and microcrystalline cellulose on the crushing of thyroid raw materials. Specific steps are as follows:

[0057] Take 10g of thyroid raw material for each portion, add lactose, calcium hydrogen phosphate dihydrate, sucrose, mannitol, and microcrystalline cellulose in a ratio of 1:2, mix evenly, mechanically pulverize for 3 minutes, and mix with the directly mechanically pulverized material of thyroid raw material Compare.

[0058] Taking the particle size of the material and whether it is re-aggregated as the main indicators, the comparison and analysis of the assisted crushing and direct crushing of granular materials are carried out. The inspection method of the particle size of the material is: respectively inspecting the ratio (scr...

Embodiment 2

[0065] Investigate the auxiliary effect of freeze-drying technology on thyroid material auxiliary crushing, and compare with direct crushing.

[0066] Take 10 g of the processed thyroid raw material, grind it mechanically for 3 minutes, and sieve it.

[0067] Another 10 g of processed thyroid raw material was taken for freeze-drying and auxiliary pulverization. The specific steps are as follows:

[0068] (1) Preparation of lyophilized samples of thyroid raw material

[0069] Take 10g of processed thyroid material, add 50mL of water, stir, and fully infiltrate. Spread the wetted samples on a freeze-drying tray with a thickness of about 1 cm, and place them in a freeze-dryer for use.

[0070] (2) freeze-drying

[0071] Place the sample in a freeze dryer and follow the freeze-drying process below to freeze-dry.

[0072] a. Pre-freezing stage: Turn on the freeze dryer, set the pre-freezing temperature to -40°C, and keep the temperature for 2-6 hours until all thyroid raw materia...

Embodiment 3

[0085] According to embodiment 1 and embodiment 2, it is found that calcium hydrogen phosphate assisted crushing technology and freeze-drying technology have respective advantages and disadvantages, and the advantages and disadvantages of the two technologies used alone have a tendency to complement each other and synergy, thus, the two The synergistic use of these technologies further optimizes the pulverization effect of thyroid raw materials.

[0086] The specific implementation plan is: after taking 20g of calcium hydrogen phosphate and 10g of thyroid material and mixing evenly, the calcium hydrogen phosphate particles are uniformly and fully filled in the thyroid material, and after wetting with 50mL of purified water, the operation is performed according to the freeze-drying process in Table 5 .

[0087] Table 5 Freeze-drying process

[0088]

[0089] The mixture was lyophilized and pulverized. The results are shown in Table 6: the synergistic use of the two technol...

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and relates to a thyroid tablet produced by full powder direct compression and a preparation process thereof, in particular to a synergistic application of calcium hydrogen phosphate assisted optimization of thyroid raw material powder properties and freeze-drying assisted pulverization technology. The particle size of the mixed pulverized thyroid material prepared by the present invention is more than 98% below 250 μm, it is not easy to re-aggregate, and it is evenly mixed with other auxiliary materials; T in thyroid powder 3 , T 4 The RSD of content≤4%; the angle of repose of mixed powder is less than 35°, meeting the requirement of powder direct compression; T in thyroid tablets 3 and T 4 The content uniformity of A+2.2S≤20, each tablet disintegrates within 15min, and the disintegration time limit difference is small (RSD≤5%). The present invention effectively solves the problems that thyroid raw materials are not easy to be crushed and unevenly mixed with auxiliary materials, etc., optimizes the pulverization effect of thyroid raw materials, improves the powder properties of thyroid raw materials, and greatly improves the T of thyroid tablets. 3 , T 4 content uniformity.

Description

Technical field: [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a thyroid tablet produced by full powder direct compression and a preparation process thereof, in particular to a synergistic application of calcium hydrogen phosphate assisted optimization of the properties of thyroid raw material powder and freeze-drying assisted pulverization technology. Preparation of thyroid powder ready for direct powder compression. Background technique: [0002] Thyroid hormones have a very important impact on human growth and metabolism. In recent years, the incidence of thyroid-related endocrine system diseases has shown an increasing trend year by year. Hypothyroidism (Hypothyroidism referred to as "hypothyroidism") is a clinically common endocrine system disease, mainly due to the decrease in the synthesis and secretion of thyroid hormones, or the syndrome of decreased metabolism of the body caused by insufficient physiological eff...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K9/19A61K47/02A61P5/14
CPCA61K9/1611A61K9/19A61K9/2054A61K9/2095A61K9/2866A61K35/55A61K47/02
Inventor 周卫丁宇李娜
Owner CHINA PHARM UNIV
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