The Study Of Quality Standard Of Ligustrazine Ferulate Preparation

Ligustrazine is a kind of the alkaloid monomer which is extracted from the rhizome of the umbelliferae Ligusticum wallichii. Chemistry structure is 2, 3, 5, 6- Tetramethylpyrazine. At present it can be artificial synthetised already. Pharmacological studies suggest Ligustrazine has various effects such as expanding blood vessel, restraining platelet aggregation, preventing thrombopoiesis, improving cerebral ischemia and so on. It is mainly used for the clinical treatment of ischemic cerebrovascular disease and gets the fairly good curative effect. Ferulic acid is one of pedantic derivative of cassia and exists in various traditional Chinese medicine such as Ligusticum wallichii, Chinese angelica and rhizoma. At present the chemical synthesis sodium salt is clinical applied, which has the anti-platelet aggregation, the anti- thrombosis, myocardial preservation, the anti- lipid peroxidation and other physical activity. It is widely used in clinic for the treatment of heart, brain, kidney disease.As Ligustrazine and ferulic acid are consistent in certain function directions, Combination of both producing synergism in vascular smooth muscle spasm, anti-platelet aggregation and lowering blood viscosity role. Furthermore, toxicity can be reduced. The combined application is valuable.Ligustrazine ferulate is a new synthetised compound guided by above-mentioned thought, verified whose structure conform to theory structure through the physico-chemical constant and various spectroscopy.The raw material and the tablet quality specification of Ligustrazine ferulate has drawn up for the first time.Through the research of the raw material character, Physical and chemical properties, Identification, the inspection and the content determination, the raw material quality specification of Ligustrazine ferulate is established.Preparation Technology of Ligustrazine ferulate orally disintegrating tablet is established.The orally disintegrating tablet quality standards of quality has been established through the study of the disintegrating tablets, physical and chemical properties, indentification, inspection and content determination.This subject research provides the basical experimental material for the new drug development. And its development and application should have tremendous economic and social benefits. At the same time, it will play an important role in the prevention and treatment of cardiovascular and cerebrovascular diseases.