Rasagiline preparation and preparation method thereof
A technology of rasagiline pharmacy and preparation, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc. It can solve the problems of unsatisfactory stability of rasagiline preparations and achieve Low cost, improved dissolution rate and stability, and guaranteed content uniformity
Active Publication Date: 2013-09-25
SHANGHAI ZHONGXI PHARMA
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Problems solved by technology
[0011] The technical problem to be solved by the present invention is to provide a rasagiline preparation with excellent stability and lower content of related substances and its preparation method in order to overcome the unsatisfactory defect of existing rasagiline preparations.
Method used
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Examples
Experimental program
Comparison scheme
Effect test
Embodiment 1 and 2
[0051] Embodiment 1 and 2 rasagiline mesylate tablet (1mg / tablet) (unit: gram)
[0052]
[0053]
[0054] Example 1 The concentration of buffered water solution is 3.1%, and the pH value is about 3.1.
[0055] Example 2 The concentration of buffered water solution is 3.1%, and the pH value is about 3.1.
Embodiment 3
[0058] Example 3 The concentration of buffered water solution is 1.9%, and the pH value is about 1.9.
Embodiment 4
[0059] Example 4 The concentration of buffered water solution is 3.9%, and the pH value is about 2.9.
[0060] Embodiment 5 and 6 rasagiline mesylate tablet (1mg / tablet) (unit: gram)
[0061]
[0062]
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The invention provides a rasagiline preparation and a preparation method thereof. The rasagiline preparation provided by the invention comprises rasagiline pharmaceutically acceptable salt and pharmaceutically acceptable auxiliary materials comprising a stabilizer and a filling agent. With the method provided by the invention, dissolution rate and stability of the rasagiline preparation are improved, preparation content uniformity is ensured, treatments of crushing and sieving are avoided, and loss and pollution are reduced. The method also has the advantages of simple operation, low cost, and no requirement on special equipment. The method is suitable to be applied on industrial productions.
Description
technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a rasagiline preparation and a preparation method thereof. Background technique [0002] Parkinson's disease (PD), also known as Parkinson's disease, is the second most common neurodegenerative disease after Alzheimer's disease. Its two characteristic pathological signs-the selective death of a large number of dopaminergic neurons in the substantia nigra compacta and the existence of Lewy bodies in the remaining neurons-are the root of the clinical symptoms. Although the etiology of Parkinson's disease is unclear, its important physiological basis is the imbalance between central neurotransmitters caused by the decrease of dopamine and the relative increase of acetylcholine. The etiology of Parkinson's disease may involve aging, genetic and environmental factors, etc. [0003] The chemical name of rasagiline: (1R)-2,3-dihydro-N-2-propynyl-1H-inden-1-amine,...
Claims
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IPC IPC(8): A61K31/135A61K47/12A61K47/02A61P25/16
Inventor 郑斯骥刘潇怡袁少卿
Owner SHANGHAI ZHONGXI PHARMA
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