Octreotide Acetate Synthesis Of Bulk Drugs And Quality Standard Research

Octreotide acetate is a cyclic octapeptide that is an analog of samatostatin with a similar but a significantly strong and long-lasting effect as natural endogenous somatostatin.The half-life of octreotide acetate is 30 times longer than natural somatostatin,reaching 1.5 hours.Since this product displays various physiological activities,it has a wide range of applications.Clinical uses are of importance for the following aspects:esophageal variceal bleeding caused by portal hypertension,stress ulcer and gastrointestinal bleeding,severe pancreatitis,relieve symptoms caused by stomach,intestine,and pancreatic endocrine system tumors,exophthalmic goitre and acromegaly caused by therapeutic failures after surgery,radiotherapy dopamine receptor agonist treatment,gastrointestinal fistula,prevention of postoperative complications of pancreas and carcinoid tumor and carcinoid syndrome.This study was on octreotide acetate raw material production process,quality standards,stability.Preparation technique of octreotide acetate using the current mainstream method for solid-phase synthesis,through the study on the synthetic route,established the final production process.Moreover,through small pilot production and pilot-scale production of each batch it is considered that the synthesis of production process is stable and feasible.The results indicated that the structural characteristics of the raw material is in accord with octreotide acetate.This study on quality standard of octreotide acetate established the methods of the determinations of related substances and content and of the detection of residual solvent,and carried out the related methodological verification tests.In stability research,after exposure to 10 day high temperature,high humidity and high light,accelerated test of 6 months and long-term test of 9 months,the inspection indicators were no significant changes.Conclusion:The octreotide acetate raw material developed in this paper has stable preparation process,strict quality standards,accurate control of the quality of the product,to provide stable chemical synthesis of APIs for the production of the preparation,this study can better meet the needs of the majority of patients medication.