Slow release pellet of high-stability type cysteamine hydrochloride and preparation method thereof

A technology of cysteamine hydrochloride and slow-release pellets, which is applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, and pharmaceutical formulas, and can solve the problem of no large-scale development of technology and large-scale The application, difficult to add enough and other problems, to achieve the effect of stable and controllable process, easy mass production, and reduce unit cost

Inactive Publication Date: 2010-02-24
冯利萍
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method has problems such as low coating rate, easy deliquescence, discoloration, poor stability, and low bioavailability
Due to the low content, there are defects such as difficulty in adding sufficient amounts in the premix; thus, the technology has not been greatly developed, so it has not been applied on a large scale
Low content, it is difficult to meet the requirements in the premix; it is necessary to carry out in-depth exploration and research on the preparation method of cysteamine hydrochloride

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] First add 30 kg of cysteamine hydrochloride into the interlayer reaction pot, and heat the interlayer at 95±5°C to melt it. Add 25 kilograms of 0.25-0.6mm granular silicon dioxide in a high-speed granulator, pour liquid cysteamine hydrochloride into it, start stirring, and perform adsorption. Cool naturally, and then sieve to separate the particles. Put 30 kilograms of cysteamine hydrochloride granules in the sugar-coated pan, and use 30 kilograms of 5% acrylic resin solution to carry out coating process. The heating temperature is set at 55-65°C. The material temperature is controlled at 38-42° C., and the coating weight gain is 8%. After the coating is completed, enter the oven at 40° C. for aging for 12 hours. The detection content is 53.63%.

Embodiment 2

[0022] First add 30 kg of cysteamine hydrochloride into the interlayer reaction pot, and heat the interlayer at 95±5°C to melt it. Add 25 kilograms of 0.25-0.6mm granular silicon dioxide in a high-speed granulator, pour liquid cysteamine hydrochloride into it, start stirring, and perform adsorption. Cool naturally, and then sieve to separate the particles.

[0023] Put 55 kilograms of cysteamine hydrochloride granules in the fluidized bed, with 10 kilograms of 2% hydroxypropyl methylcellulose (HPMC) solution, with 50 kilograms of 5% acrylic resin solution, carry out coating process. The heating temperature is set at 55-65°C. The material temperature is controlled at 38-42° C., and the coating weight gain is 8%. After the coating is completed, enter the oven at 40° C. for aging for 12 hours. The detection content is 51.63%.

Embodiment 3

[0025] First add 15 kg of cysteamine hydrochloride into the interlayer reaction pot, heat the interlayer at 95±5°C, add 12 kg of 0.25-0.6mm granular silica in the high-speed granulator, and half the liquid Pour in cystamine hydrochloride, start stirring, and carry out adsorption. Cool naturally, and then sieve to separate the particles.

[0026] Put 27 kilograms of cysteamine hydrochloride granules, 10 kilograms of 2.5% ethyl cellulose solution, and 10 kilograms of 5% acrylic acid resin solution in the coating granulator to carry out coating treatment. The heating temperature is set at 55-65°C. The material temperature is controlled at 38-42° C., and the coating weight gain is 8%. After the coating is completed, enter the oven at 40° C. for aging for 12 hours. The detected content is 53.15%.

[0027] Other examples of the present invention can choose polymer coating material to be: polyacrylic acid resin, shellac, ethyl cellulose, sodium alginate, hydroxypropyl methyl cell...

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Abstract

The invention relates to a slow release pellet of high-stability type cysteamine hydrochloride and a preparation method thereof. The slow release pellet comprises the following components in portionsby weight: 30-70 portions of cysteamine hydrochloride, 20-40 portions of silicon dioxide and 5-25 portions of polymer material as coating wall material. The preparation method comprises the followingsteps: firstly, using silicon dioxide pellets to absorb liquid cysteamine hydrochloride in proportion to form cysteamine hydrochloride particles; then, using the coating wall material to encapsulate the cysteamine hydrochloride particles to form a membrane cavity control structure; and drying the structure to obtain slow release pellets of 50% cysteamine hydrochloride. The slow release pellet hasthe characteristics of stable product quality, high content, reasonable preparation method, easy batch production and simple using method and can be added into the premix.

Description

technical field [0001] The invention relates to a slow-release pellet of cysteamine hydrochloride and a preparation method thereof, belonging to an important coating technology of chemical raw materials and pharmaceutical intermediates. Background technique [0002] Cysteamine Hydrochloride (Cysteamine, CS) HSCH 2 CH 2 NH 2 , also known as β-mercaptoethylamine, white crystalline powder, melting point 99 ~ 100 ℃, slightly smelly, soluble in water and alcohol, showing alkaline reaction. It is easy to deliquescence, and its aqueous solution becomes dark when it contacts with metal ions, and sometimes precipitates. Cysteamine is equivalent to the decarboxylation product of cysteine ​​and is a component of acetyl coenzyme A. Because it contains active sulfhydryl and amino groups, it has a variety of biological functions. It is a biologically active substance in animals and has important physiological functions. Cysteamine is easily oxidized to disulfide in air. Due to the un...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/32A61K9/36A61K9/34A61K31/198A61K47/32A61K47/38A61K47/44A61P43/00A23K1/16
Inventor 冯利萍
Owner 冯利萍
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