Study On Cinepazide Maleate Sodium Chloride Injection

Cardiovascular disease is a serious threat to the Chinese people's health prob-lems, common diseases and effective and safe treatment drugs is an important weapon for clinician. Cinepazide Maleate for the new generation has a weak calcium antago-nism of endogenous adenosine booster, with expansion and promote cell metabolism dual role, for the treatment of cerebrovascular disease, cardiovascular disease, periph-eral vascular disease, clinical use has no side-effects, safe and effective.At home and abroad only Cinepazide Maleate injection listing, is rich in clinical medicine, avoid small capacity injection of a lot of inconvenience and quality risks, according to the SFDA related technical evaluation principles and registration, this article was Cinepazide Maleate sodium chloride injection technology, quality, stability studies. Prescription for a solvent selection, selection of the stabilizer, according to select, pH value selection, selection of sterilization conditions, ultimately determine the amount of the following process:prescription drug injecting water dissolved after, joining 0.05% activated carbon, pH adjustment to 3.5-5.5, constant volume after fill-ing,115°c heat sterilization after the 30min. Quality of major conducting material, content assay, ultimately determine using high performance liquid chromatography control products for substances and detection product content, with 18 alkyl Silanes bonded silica as filler; to acetonitrile-0.05mol/mL of sodium dihydrogen phosphate buffer (adjust the pH to 4.5+0.1) (30:70) for the mobile phase; detection of wave-length as 230nm conditions for testing. Stability of major by the low temperature test, elevated temperature testing. Searchlight, freezing and thawing test and other factors, accelerated testing and long-term stability test, test results indicate that the product object is a powerful; other conditions more stable; storage conditions to shading, and confined to save, valid for 2 years.In short, fixed prescription process of Cinepazide Maleate sodium chloride in-jection product stability controlled, safe and effective.