Metfromin Hydrochlori De And Glipizide Tablet In The Quality Of Research

Diabetes is a common, multiple endocrine disease caused by the rise of blood glucose concentration due to the insulin is absolutely or relatively insufficient inside human body. Diabetes may cause several symptoms like polydipsia, polyuria, polyphagia, weight loss, dizziness, fatigue, etc. and some serious chronic or acute complications that will threaten the health of patients. One survey discovered that the increase velocity of diabetes prevalence rate in China has been appalling. Epidemiology survey of diabetes during the National Survey on Nutrient Conditions 2002 showed: the diabetes prevalence rate was 4.5% in urban areas and 1.8% in rural areas; it was calculated that there might be over 20 million diabetics all over the country. At a distance of 6 years, epidemiology survey 2008 found that the prevalence rate of diabetes in people over 20 years old already reached to 9.7%, the diabetics might be 92 million; and the prophase prevalence rate was 15.5%, the pre-diabetes patients might be more than 148 million. This means that the number of"reserves"of diabetics is huge.Metfromin Hydrochloride and Glipizide tablet is an oral anti-hyperglycemia compound medicine which R&D by Bristol-Myers Squibb Company for the treatment of type-2 diabetes. It was manufactured by Bristol-Myers Squibb and approved to come into US market first in Oct 2002. The dosage form in US market is oral tablet, specifications (glipizide/Metformin Hydroc) are: 2.5mg/250mg, 2.5mg/500mg, and 5mg/500mg, the brand name is Metaglip. So far the Metaglip still not appears in China market. The Metformin Hydrochloride and Glipizide tablet developed by our company is a new compound medicine for type-2 diabetes treatment, including 2 anti- hyperglycemia drugs—Glipizide and Metformin Hydrochloride, so this innovative drug has a good market prospects.In order to make the quality of Metformin Hydrochloride and Glipizide tablets be controllable, the author has taken a detailed quality research on the samples in this thesis and sets Drug Quality Standards for Manufacturing based on the recommended index of description, Differential Tests, inspection (content balance, Dissolution rate, microbial limit, related substances) and content according to the criterions for Drug Quality Standards in Chinese Pharmacopeia 2005. The result of 3 batches (20060401, 20060402,20060403) pilot plant tests shows that the Quality Standards in this thesis can control the quality of Metformin Hydrochloride and Glipizide tablets effectively. The Quality Standards in this thesis have officially been approved by SFDA in March 2009; at the same time this project was granted the New Drug Certificate and Manufacturing Approve Number issued by SFDA.