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Dopamine prodrug composition and preparation method thereof

A technology of composition and dopamine, which is applied in the field of medicine, can solve the problems that the quality of finished products cannot meet the quality standards, the components of the composition and the preparation method are complicated, and the stability problems such as product discoloration are covered up, and the amount of excipients is cheap, easy to obtain, and stable. Excellent performance and low cost

Active Publication Date: 2013-01-23
SHANGHAI SINE PHARMA LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, due to the extremely unstable properties of benserazide hydrochloride, it will change color when exposed to light, heat, and humidity, and the drug content will also decrease. The quality of the finished product fails to meet the quality standards during the storage process
[0005] CN101623278A discloses a method for preparing a pharmaceutical composition of levodopa and benserazide hydrochloride by mixing benserazide hydrochloride with levodopa and a pharmaceutically acceptable carrier after being dispersed in a specific carrier. This invention claims that the composition can be stabilized Good performance, but the composition and preparation method are relatively complicated
[0006] Madopar developed and marketed by Roche, the original manufacturer of Dopaserazide (Dopastazide Tablets) is currently the leading product in the market, but because the product is a colored tablet similar to red, it may have a certain effect on the stability of the product such as discoloration

Method used

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  • Dopamine prodrug composition and preparation method thereof
  • Dopamine prodrug composition and preparation method thereof
  • Dopamine prodrug composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0083]

[0084] Preparation:

[0085] The hypromellose was configured as a 5% aqueous solution, and anhydrous citric acid was added and stirred until dissolved. Put levodopa, benserazide hydrochloride, and starch into a PMA-25 high-speed stirring granulator (GEA Company, Germany) after crushing and sieving, start mixing, add slurry soft materials, and pass through a YK-60 oscillating granulator (Shanghai) Tianxiang Jiantai Pharmaceutical Machinery Co., Ltd.) sieves the wet granules, then the wet granules are dried on the FL-5 type fluidized granulator (Shanghai Huafa Pharmaceutical Machinery Complete Set Development Company), granulated, and magnesium stearate is added. After mixing by a V-type high-efficiency mixer (Shanghai Tianhe Pharmaceutical Machinery Co., Ltd.), GKF-120 capsule filling machine (Bosch Packaging Technology (Hangzhou) Co., Ltd.) fills the capsules.

Embodiment 2

[0087]

[0088] Preparation:

[0089] The hypromellose was configured as a 4% aqueous solution, and anhydrous citric acid was added and stirred until dissolved. Put levodopa, benserazide hydrochloride, and starch into a PMA-25 high-speed stirring granulator (GEA Company, Germany) after crushing and sieving, start mixing, add slurry soft materials, and pass through a YK-60 oscillating granulator (Shanghai) Tianxiang Jiantai Pharmaceutical Machinery Co., Ltd.) sieves the wet granules, then the wet granules are dried on the FL-5 type fluidized granulator (Shanghai Huafa Pharmaceutical Machinery Complete Set Development Company), granulated, and magnesium stearate is added. After mixing by a V-type high-efficiency mixer (Shanghai Tianhe Pharmaceutical Machinery Co., Ltd.), GKF-120 capsule filling machine (Bosch Packaging Technology (Hangzhou) Co., Ltd.) fills the capsules.

Embodiment 3

[0091]

[0092]

[0093] Preparation:

[0094] The hypromellose was configured as a 3% aqueous solution, and anhydrous citric acid was added and stirred until dissolved. Put levodopa, benserazide hydrochloride, and starch into a PMA-25 high-speed stirring granulator (GEA Company, Germany) after crushing and sieving, start mixing, add slurry soft materials, and pass through a YK-60 oscillating granulator (Shanghai) Tianxiang Jiantai Pharmaceutical Machinery Co., Ltd.) sieves wet granules, and then dries the wet granules in a DHG-9246A electric heating constant temperature blast drying oven (Shanghai Jinghong Experimental Equipment Co., Ltd.), granulates, and adds stearic acid Magnesium, after mixing by a V-type high-efficiency mixer (Shanghai Tianhe Pharmaceutical Machinery Co., Ltd.), GKF-120 capsule filling machine (Bosch Packaging Technology (Hangzhou) Co., Ltd.) to fill the capsules.

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Abstract

The invention relates to a dopamine prodrug composition and a preparation method of the dopamine prodrug composition. The invention provides a pharmaceutical composition of dopamine prodrug, and the composition comprises the dopamine prodrug, benserazide hydrochloride, an adhesive, a stabilizer and a pharmaceutically acceptable carrier. The pharmaceutical composition containing the dopamine prodrug provided by the invention has excellent stability and does not occur color change, and is capable of effectively guaranteeing that the product quality meets a quality standard requirement within a storage period. The pharmaceutical composition containing the dopamine prodrug provided by the invention has a simple prescription, and auxiliary materials are cheap and available with a small amount; the preparation process provided by the invention is simple and easy to control, used devices are the most conventional workshop production devices, the cost is low, and the preparation process is suitable for industrial production.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a pharmaceutical composition containing a dopamine prodrug for treating Parkinson's disease and symptomatic Parkinson's syndrome and a preparation method thereof. Background technique [0002] Parkinson's disease is a degenerative disease of the central nervous system that seriously endangers the health of middle-aged and elderly people. The cause of its onset is the lack of dopamine in the basal ganglia of patients. At present, the drugs for the treatment of Parkinson's disease are roughly divided into five categories: dopamine prodrugs, dopamine receptor agonists, levodopa potentiators, cholinergic receptor blockers, and dopamine release-stimulating drugs. Dopamine prodrugs (levodopa-like drugs, such as levodopa, etid-levodopa) have been the most basic drugs for the treatment of Parkinson's disease since the 1960s. Dopamine cannot enter the central nervous system through the ...

Claims

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Application Information

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IPC IPC(8): A61K31/198A61K47/38A61K47/32A61P25/16A61K31/165
Inventor 孙宁云张军东廉云飞顾缪凯乔华
Owner SHANGHAI SINE PHARMA LAB
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