Preparation method of clonidine hydrochloride sustained-release tablet

A technology of clonidine hydrochloride and sustained-release tablets, which is applied in the fields of pharmaceutical formulation, drug delivery, cardiovascular system diseases, etc., and achieves the effects of qualified release, dispersion, uniform mixing, and large dispersion

Inactive Publication Date: 2014-11-12
LP PHARM (XIAMEN) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation method can effectively improve the problem of uneven content in the preparation process of clonidine hydrochloride sustained-release tablets, the prepared clonidine hydrochloride sustained-release tablets have uniform content, and the release behavior conforms to the sustained-release characteristics

Method used

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  • Preparation method of clonidine hydrochloride sustained-release tablet
  • Preparation method of clonidine hydrochloride sustained-release tablet
  • Preparation method of clonidine hydrochloride sustained-release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Embodiment 1: the prescription of clonidine hydrochloride sustained-release tablet is as follows:

[0017] Element

Embodiment 2

[0019]Taking the preparation of 10000 clonidine hydrochloride sustained-release tablets as an example, take by weighing 1g clonidine hydrochloride, 450g HPMC2208, 650g lactose, 52g pregelatinized starch, 30g sodium lauryl sulfate, 12g Magnesium stearate and 5g colloidal silicon dioxide, 1g clonidine hydrochloride crude drug is dissolved in 50ml purified water to make the clonidine solution that concentration is 20mg / ml, after medicine dissolves completely, join with the speed uniform spray of 30ml / min There are 650g of lactose and 52g of pregelatinized starch in the granulation pot of granulation for 15 minutes, and the obtained granules are dried and passed through a 60-mesh sieve and granulated with 450g of HPMC2208, 30g of sodium lauryl sulfate, and 12g of magnesium stearate Mix 30 minutes, tabletting with 5g colloidal silicon dioxide with the rotating speed of 10 rev / mins in mixer, obtain clonidine hydrochloride slow-release tablet.

Embodiment 3

[0021] Taking the preparation of 10000 clonidine hydrochloride sustained-release tablets as an example, take by weighing 1g clonidine hydrochloride, 450g HPMC2208, 650g lactose, 52g pregelatinized starch, 30g sodium lauryl sulfate, 12g Magnesium stearate and 5g colloidal silicon dioxide, 1g clonidine hydrochloride crude drug is dissolved in 50ml70% ethanol and make the clonidine solution that concentration is 20mg / ml, after medicine dissolves completely, join with the speed uniform spray of 30ml / min Fill 650g of lactose and 52g of pregelatinized starch in the granulation pot of granulation for 15 minutes, the obtained granules are dried and passed through a 60 mesh sieve and granulated with 450g of HPMC2208, 30g of sodium lauryl sulfate, 12g of stearic acid Magnesium and 5g of colloidal silicon dioxide were mixed with 10 rev / min in a mixer for 30 minutes and compressed into tablets to obtain clonidine hydrochloride sustained-release tablets.

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Abstract

The invention relates to a preparation method of a clonidine hydrochloride sustained-release tablet. The preparation method comprises the steps of dissolving a clonidine hydrochloride raw material into a proper amount of wetting agent by using a solvent dispersion method to prepare a solution containing 10-28.57mg/ml clonidine; adding the solution into a granulation pan filled with a filling agent and a binder at constant speed of 5-40ml/min to granulate; drying the prepared granules, screening by using a 50-100-mesh sieve, mixing the granules, a framework material, a flow aid and a lubricating agent, and tabletting to obtain the clonidine hydrochloride sustained-release tablet. By using the preparation method, the problem of non-uniform content generated in a preparation process of the clonidine hydrochloride sustained-release tablet can be effectively solved, the prepared clonidine hydrochloride sustained-release tablet is uniform in content, and the release behavior is in accord with the sustained-release characteristic. All process parameters in the preparation method can be correspondingly amplified according to the industrial production scale, so that the requirement for large-scale industrial production can be met.

Description

technical field [0001] The invention relates to a preparation method of clonidine hydrochloride sustained-release tablets, in particular to the problem of uneven drug content in the tablets. Background technique [0002] Clonidine hydrochloride is a central α-adrenergic receptor agonist, which can lower blood pressure and slow down the heart rate by reducing the activity of human sympathetic nerves, and at the same time, it can stimulate the prefrontal cortex by regulating the function of norepinephrine. Restore inhibitory control function, so as to achieve the effect of improving attention and learning ability. Clinically, it can be used to treat clinical diseases such as hypertension, migraine, dysmenorrhea, menopausal hot flashes, attention deficit hyperactivity disorder (Attention Deficit Hyperactivity Disorder, ADHD), and has a good curative effect. When clonidine hydrochloride is prepared as a medicine, its specifications are relatively small, generally only 0.05-0.4m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/4168A61P9/12A61P9/06A61P25/06A61P15/00A61P15/12A61P25/00
Inventor 周于波肖晓金苏艺杰蔡林辉葛尚英朱海健叶英
Owner LP PHARM (XIAMEN) CO LTD
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