Exploration For The Range Of Molecular Weight Of Sodium Hyaluronate And Sterilizing Parameters For Sodium Hyaluronate Eye Drops

0.1%sodium hyaluronate (SH) eye drops and0.3%SH eye drops have been used in the treatment of corneal epithelial injury and dry eye. They can heal corneal epithelial injury caused by endogenous disease such as Sjogren’s syndrome, Stevens-Johnson syndrome, dry eye etc. as well as caused by exogenous diseases likesurgery, drug-induced, injuries, wear of lens etc. SH exhibits excellent water entrapping capability as to prolong break up time of tear film and help to maintain tear film stability. SH is the one of most widely used glycosaminoglycans as active component in artificial tear. SH eye drops in sales grow year after year with the increasing incidence of dry eye.Requirement of microbial limits was upgraded to sterility for eye drops as per ChP2010being effective as of Oct.1st,2010. Sterile products must be manufactured by the process conformable to new GMP by end-2013. SH is a kind of glycosaminoglycans composed of glucuronic acid and N-acetylglucosamine. Its molecular weights distributes in a wide range from hundreds of thousands to several millions. Dynamic viscosity of SH solution is positively related to its molecular weight of SH, which rises as the molecular weight of SH increases. SH is sensitive to heat, sugar chain in its structure will be broken off by heating, so that the viscosity of SH solution is reduced. We should determine the suitable range of molecular weights of SH and sterizing parameters according to the characteristics of SH and the requirement of SH eye drops, to ensure to manufacture SH eye drops with constant viscosity and stable quality. In this study, sodium hyaluronate eye drops were produced using sodium hyaluronate with different molecular weight, and were autoclaved under different sterilizing parameters. We test the items of description, pH, dynamic viscosity and molecular weight of eye drops. The main results and conclusions are listed as follows.1. The molecular weight of sodium hyaluronate and autoclaved parameters have little effect on description and pH of eye drops.2. Sodium hyaluronate with molecular weight ranged from0.8×106to1.6×106of is applicable for the production of0.1%Sodium Hyaluronate Eye Drops,1.2×106or so is the optimum molecular weight.3.121℃x15min is the optimum sterilizing parameters for0.1%Sodium Hyaluronate eye drops.4. The HA with molecular weight ranged from1.1×106to1.6×106of sodium hyaluronate is applicable for production of0.3%Sodium Hyaluronate Eye Drops,1.2x106or so is the optimum molecular weight.5.121℃×15min is the optimum sterilizing parameters for0.3%Sodium Hyaluronate eye drops.