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Orally disintegrating tablet containing trihexyphenidyl hydrochloride and folic acid and its preparation method

A technology of trihexyphenidyl hydrochloride and trihexyphenidyl acid, applied in the field of medicine

Active Publication Date: 2022-05-20
北京斯利安药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Based on this, it is necessary to provide an orally disintegrating tablet containing trihexyphenidyl hydrochloride and folic acid and a preparation method thereof for traditional orally disintegrating tablets that are difficult to have fast disintegration speed, convenient administration and good compliance

Method used

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  • Orally disintegrating tablet containing trihexyphenidyl hydrochloride and folic acid and its preparation method
  • Orally disintegrating tablet containing trihexyphenidyl hydrochloride and folic acid and its preparation method
  • Orally disintegrating tablet containing trihexyphenidyl hydrochloride and folic acid and its preparation method

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preparation example Construction

[0034] The embodiment of the present invention provides a preparation method of an orally disintegrating tablet containing trihexyphenidyl hydrochloride and folic acid, comprising the following steps:

[0035] (a) Preparation of trihexyphenidyl hydrochloride granules: granulate trihexyphenidyl hydrochloride, microcrystalline cellulose, the first solid auxiliary material and water, the first solid auxiliary material is a mixture of sugar and alcohol, and the trihexyphenidyl hydrochloride The mass fraction of the solid component is 2% to 5%, and the mass fraction of the microcrystalline cellulose in the solid component is 2% to 4%;

[0036] (b) Preparation of folic acid granules: Folic acid, microcrystalline cellulose, second solid auxiliary material and polyethylene glycol are granulated, the second solid auxiliary material is a mixture of sugar and alcohol, and the folic acid accounts for the folic acid granule component The mass fraction is 0.4%-5%, the microcrystalline cellu...

Embodiment 1

[0064] The group assignments are shown in Table 1.

[0065] Table 1

[0066]

[0067] Process:

[0068] (1) Pulverization: Mechanical pulverization of trihexyphenidyl hydrochloride to measure the particle size; airflow pulverization of folic acid to measure the particle size; mechanical pulverization of sucrose, passing through an 80-mesh sieve, and set aside.

[0069] (2) Preparation of trihexyphenidyl hydrochloride granules: add trihexyphenidyl hydrochloride, sucrose, mannitol and microcrystalline cellulose to a wet granulator and mix, add a wetting agent and purified water to make a soft material, granulate with 20 mesh, 50-60 °C Fluidized bed drying, 20 mesh granulation;

[0070] (3) Preparation of folic acid granules: Folic acid, sucrose, mannitol and microcrystalline cellulose are first mixed in a wet granulator, then mixed with polyethylene glycol 4000 in a three-dimensional mixer, then dry granulated, granulated at 20 mesh;

[0071] (4) Total mixing: add trihexyp...

Embodiment 2

[0074] The group assignments are shown in Table 2.

[0075] Table 2

[0076]

[0077] (1) Pulverization: Mechanical pulverization of trihexyphenidyl hydrochloride to measure the particle size; airflow pulverization of folic acid to measure the particle size; mechanical pulverization of sucrose, passing through an 80-mesh sieve, and set aside.

[0078] (2) Preparation of trihexyphenidyl hydrochloride granules: Add trihexyphenidyl hydrochloride, sucrose, sorbitol and microcrystalline cellulose to a wet granulator and mix, add a wetting agent and purified water to make soft materials, granulate with 20 mesh, 50-60°C Fluidized bed drying, 20 mesh granulation;

[0079] (3) Preparation of folic acid granules: Folic acid, sucrose, sorbitol and microcrystalline cellulose are first mixed in a wet granulator, then mixed with polyethylene glycol 4000 in a three-dimensional mixer, then dry granulated, granulated at 20 mesh;

[0080] (4) Total mixing: add trihexyphenidyl hydrochloride...

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Abstract

The invention discloses a preparation method of an orally disintegrating tablet containing trihexyphenidyl hydrochloride and folic acid, comprising the following steps: (a) preparation of trihexyphenidyl hydrochloride granules: preparing trihexyphenidyl hydrochloride, microcrystalline cellulose, and a first solid auxiliary material Granulating with water, the first solid auxiliary material is a mixture of sugar and alcohol, trihexyphenidyl hydrochloride accounts for 2% to 5% of the solid component, and microcrystalline cellulose accounts for 2% to 4%; (b) folic acid Granule preparation: granulate folic acid, microcrystalline cellulose, second solid auxiliary material and polyethylene glycol, the second solid auxiliary material is a mixture of sugar and alcohol, and the mass fraction of folic acid in the folic acid granule component is 0.4% to 5%. , microcrystalline cellulose accounts for 2% to 4%, and polyethylene glycol accounts for 0.4% to 1%; (c) blending: the trihexyphenidyl hydrochloride granules prepared in step (a), and the granules obtained in step (b) Folic acid granules and polyethylene glycol are mixed; (d) the mixture obtained in step (c) is compressed into tablets.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an orally disintegrating tablet containing trihexyphenidyl hydrochloride and folic acid and a preparation method thereof. Background technique [0002] Parkinson's disease is a common degenerative disease of the nervous system in the middle-aged and elderly. It is mainly characterized by the progressive degeneration of dopaminergic neurons in the substantia nigra and the pathological changes of Lewy body formation. Physiological changes of mass imbalance, motor symptoms of tremor, muscle rigidity, slow movement, postural balance disorder and non-motor symptoms of hyposmia, constipation, abnormal sleep behavior and depression are clinically significant features. The prevalence of the disease increases with age, with an insidious onset and slow progression. The overall prevalence rate of people over 65 years old in my country is 1700 / 100,000, which brings a heavy burden to famili...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/519A61K9/20A61K47/10A61K47/26A61K47/38A61P25/16A61K9/16
CPCA61K31/4453A61K31/519A61K9/2077A61K9/0056A61K47/10A61K47/26A61K47/38A61P25/16A61K9/1652A61K9/1623A61K2300/00
Inventor 赵欢解艳蔡正军张颖然杨卓理
Owner 北京斯利安药业有限公司
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