Study On The Quality Of Crude Mitiglinide Calcium

Mitiglinide calcium is used to treat II-type diabetes mellitus (DM).It's a new drug with up-to-date machines action, agility administration, quicker and better curative effect, and good pharmacokinetics character. Mitiglinide calcium has a beautiful name"abdominal salivary gland outside the body", it's the first election to treat light and earlier period DM with highly safety and good tolerance. Mitiglinide calcium is first to go on the market in Japan with better curative effect and little adverse effect than Repaglinide and Nateglinide which have already on the market.We determined the route of synthesis of Mitiglinide calcium through inquest literatures of internal and abroad, and according to the synthetic route, we determine the practicable analytical method of quality control. After the study of quality of crude drug of mag. craft, it has been showed that, the analytical method that we set up can control the quality of Mitiglinide calcium.This article is about the internal study on quality control of Mitiglinide calcium we synthesized. We studied on the trait, solubility, specific optical rotation, absorption coefficient , identification, residual solvent, moisture content, general foreign matter examine, related substance and assay, as well as authenticated the methods of detection of residual solvent, related substance and assay. It is shown that, the quality of product correspond to the requirement of crude drug., This study proved reliable foundation on formulating quality criteria of the final product of Mitiglinide calcium.