Research On Preparation And Quality Of TY-302 Granules

As a very common disease in clinical, Osteoporosis has been recognized as the second largest after cardiovascular disease killer, has become a health problem social now. Clinically, drug prevention and treatment of osteoporosis can be roughly divided into two categories: inhibitors of bone resorption and bone formation accelerator. TY-302 as a new effective and safe treatment of osteoporosis, has a unique dual mode of action, on the one hand, it can stimulate the replication of osteoblasts ago, to promote mature osteoblast collagen and non-collagen protein synthetic, belonging bone formation promoting agent, on the other hand, it is possible to inhibit the differentiation of osteoclasts, reduce its activity, is a bone resorption inhibitor. Therefore, the development of pharmaceutical preparations TY-302 as the active ingredient for alleviating osteoporosis lack of clinical drug has a very important significance.This paper describes the TY-302 granules small test Formulation and Preparation; three batches of samples for the pilot production of TY-302 key parameters were investigated and confirmed, including dry-mixing time study(by dry mixing different time sampling, measurement content uniformity); adhesive formulation parameters, including stirring time(viscosity index), dispersion temperature and the amount of binder(in yield and size distribution index); wet mixing time study(appearance of granules, moldability and wet the whole time as an indicator); wet whole mesh visits(to mobility and friability particles as an indicator); fluidized bed drying inlet temperature visits(to efficacy and moisture as an indicator) and filling speed and investigation finalize the appropriate production parameters, could direct the industrialization of large-scale production.According to the contents under the 2010 edition of Pharmacopoeia granules term, the development of related substances, dissolution, content quality standards, respectively, was carried out method validation. Determination of related substances in the test sample, content and dissolution results showed that: other detections dissolution, content and other related substances meet the requirement. With homemade products and related substances original research products, content, dissolution and sedimentation volume were compared, no significant difference. The stability of three batches of samples were tested factors experiment, accelerated test and long-term test, stability test inspection process, the appearance of TY-302 granules, content and dissolution were no obvious change, with the placement of related substances prolonged increase, but all in the quality control standard range. Preliminary in vivo pharmacokinetics of the pre-trial is underway.This article contains four aspects: First, the production of key parameters confirmation; Second, the quality standards; three, stability;Four, pre-text preliminary pharmacokinetics.