Physical/Chemical Properties and Resorption Behavior of a Newly Developed Ca/P/S-Based Bone Substitute Material

摘要

Properly regulating the resorption rate of a resorbable bone implant has long been a great challenge. This study investigates a series of physical/chemical properties, biocompatibility and the behavior of implant resorption and new bone formation of a newly developed Ca/P/S-based bone substitute material (Ezechbone® Granule CBS-400). Experimental results show that CBS-400 is comprised majorly of HA and CSD, with a Ca/P/S atomic ratio of 54.6/39.2/6.2. After immersion in Hank’s solution for 7 days, the overall morphology, shape and integrity of CBS-400 granules remain similar to that of non-immersed samples without showing apparent collapse or disintegration. With immersion time, the pH value continues to increase to 6.55 after 7 days, and 7.08 after 14 days. Cytotoxicity, intracutaneous reactivity and skin sensitization tests demonstrate the good biocompatibility features of CBS-400. Rabbit implantation/histological observations indicate that the implanted granules are intimately bonded to the surrounding new bone at all times. The implant is not merely a degradable bone substitute, but its resorption and the formation of new cancellous bone proceed at the substantially same pace. After implantation for 12 weeks, about 85% of the implant has been resorbed. The newly-formed cancellous bone ratio quickly increases to >40% at 4 weeks, followed by a bone remodeling process toward normal cancellous bone, wherein the new cancellous bone ratio gradually tapers down to about 30% after 12 weeks.