API Pramipexole HCl, High purity cas 104632-26-0 Pramipexole hydrochloride

Details:

Introduction

Product Name: Pramipexole Dihydrochloride Monohydrate

Chinese Pinyin Name: YanSuanPuLaKeSuo

English Generic Name: Pramipexole Dihydrochloride Monohydrate

Chemical Name: (6S)-6-N-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine dihydrochloride monohydrate

CAS: 191217-81-9

Product Code: 0410001

Structural Formula:

Molecular Formula:C₁₀H₁₉Cl₂N₃S .H₂O

Molecular Weight: 302.27

3 Physicochemical Property: The drug is white or off-white crystalline powder, easily soluble in water, soluble in methyl alcohol, slightly soluble in ethyl alcohol, hardly soluble in dichloromethane, without any hygroscopicity.
2) Quality standard, clinical application, Packaging specification and storage.

1 Quality Standard

Quality Standard for Declaration

Application

Parkinson’s disease is a common chronic progressive neurodegenerative disease among middle-aged and elderly people, that dopaminergic neurodegeneration in the substantia nigra compacta results in obvious reduction of dopaminergic neurotransmitters on the striatonigral degeneration pathway. Although levodopa substitution therapy can improve I clinical symptoms at the initial stage of Parkinson’s disease effectively, its long-term use results in the recession of curative effect and some complications, such as motor fluctuation, dyskinesia, mental symptom, etc. The dopamine receptor agonist can overcome the above insufficiencies of levodopa, delay starting time of levodopa treatment and enhance curative effect. In clinic, the drug is mainly applied to treat some signs and symptoms of idiopathic Parkinson’s disease, separately-used (no levodopa) or jointly-used (with levodopa). For example, with wearing-off, change or fluctuation (end of dose phenomenon or “on-off” fluctuation) of levodopa’s curative effect at the later stage, the drug shall be applied.

3 Packaging specification and storage

Packaging Specification: Pramipexole dihydrochloride monohydrate raw medicine uses multi-layer packaging. Internal packaging uses sealable double-layer medicinal polyethylene plastic bag. External packaging uses sealable aluminum foil bag. Packaging specification is 100g～300g/bag.

Storage: sealed and stored in a shade and dry place.

Category: chemicals

Validity: 24 months (tentative)

Descriptions:

Pramipexole dihydrochloride monohydrate is new-generation non-ergot dopamine receptor agonist, which can avoid nervous lesion caused by long-term use of levodopa, delay levodopa treatment time, and reduce the dosage of levodopa. Moreover, the drug can be applied to D2/D3 receptors selectively, thus controlling sports-related symptoms like tremor, easing psychic symptoms and treating Parkinson’s disease.

According to in-vitro study, Pramipexole has relatively-high specificity for D2 receptor and complete intrinsic activity, and higher affinity for D3 receptor than that for D2 and D4 receptors.

The interaction of Pramipexole and D3 receptor and its correlation with Parkinson’s disease are indefinite. Definite mechanism for Pramipexole’s treating Parkinson’s disease is unclear. According to current opinion, it is related to dopamine receptor of activated corpus striatum. According to animal electricity physiological test, Pramipexole can influence the discharge frequency of corpus striatum neuron through activating corpus striatum and nigral dopamine receptor.

Specifications