Thyroid tablets produced by direct whole-powder tabletting and preparation process thereof

A thyroid tablet and a preparation process technology, applied in the field of thyroid powder, can solve the problems of complex preparation process, inactivation, drug degradation, etc., and achieve the effects of rough particle surface, preventing re-aggregation, and increasing bulk density

Active Publication Date: 2019-03-15
CHINA PHARM UNIV
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  • 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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  • Thyroid tablets produced by direct whole-powder tabletting and preparation process thereof
  • Thyroid tablets produced by direct whole-powder tabletting and preparation process thereof
  • Thyroid tablets produced by direct whole-powder tabletting and preparation process thereof

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 thyroid tablets produced by direct whole-powder tabletting and a preparation process of the thyroid tabletsproduced by the direct whole-powder tabletting, in particular to synergetic application of calcium hydrogen phosphate-assisted optimization of powder properties of thyroid raw materials and freeze-drying assisted grinding technology. More than 98% of the particle sizes of thyroid mixed ground materials prepared by the invention are smaller than 250 microns, and the thyroid mixed ground materials are difficultly reaggregated, and uniformly mixed with other auxiliary materials; RSD of the T3 and T4 contents in thyroid powder is not greater than 4%; the angle of repose of the mixed powder is smaller than 35 degrees, so that requirements of powder direct tabletting are met; the content uniformity (A+2.2S) of T3 and T4 in the thyroid tablets is not greater than 20, each tablet is disintegratedwithin 15min, and the disintegration time limit difference is small (RSD is not greater than 5%). The thyroid tablets produced by the direct whole-powder tabletting and the preparation process of thethyroid tablets produced by the direct whole-powder tabletting disclosed by the invention effectively solve the problems that the thyroid raw materials are not easily ground, and not uniformly mixed with the auxiliary materials and the like, optimize the grinding effect of the thyroid raw materials, improve the powder properties of the thyroid raw materials, and greatly enhance the content uniformity of T3 and T4 in the thyroid tablets.

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 Applications(China)
IPC IPC(8): A61K9/36A61K9/19A61K47/02A61P5/14
CPCA61K47/02A61K9/1611A61K9/19A61K9/2054A61K9/2095A61K9/2866A61K35/55
Inventor 周卫丁宇李娜
Owner CHINA PHARM UNIV
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