| Compound ossotide (COT) injection with chaerateritics of healing bone fracture, antiinflamation and abirritation, low side effects and patient tolerance, has been used to treat rheumatism, rheumatoid arthritis, hyperostosis and bone fracture. In this thesis, the bone extract and the total scorpion extract were prepared, the priscription and preparation processe of COT injection were studied, and the quality standard was established.The bone extract (BE) was prepared with process as followings. Bone was extracted with two volume water under high presure for two times, and deposited fat under low temperature for 36h. The suppernant was condensates under vaccume at 70℃following depodition with final concentration of 70% enthanol for 36h. The resulting suppernant was again condensation and deposited with acid and alkali, respectively. After absorbtion with active carbon, the suppernant was filtrated though 10000 Da membrane, and got BE. Total scorpion extract (TSE) was prepared similar to preparation of bone extract. Scorpion was smashed into powder and screened with sieve plate. The powder was extracted with six and three volume boiling water for 2h, respectively. After decompressing concentration and 70% ethanol deposition over night at 4℃, the suppernant was precipitated with acid and alkali, respectively, finally filtrated and got TSE. Labrotary and module scale preparation showed that the processes were stable and controllable.The priscription of COT injection composed of BE and TSE supplemented with 2% mannitol. COT injection was prepared by lyophilization process. the mixture (pH6.8-7.2) was freezed for 22h, and elevate temperature to final 34℃under 15-35 Pa. Three batches of labatory process validation exhibited that high temperature and light slightly affect the stability. Three batches of module process showed that 95% of the finished products was eligible, and would be used with 0.9% NaCl injection and 5% glucose injection. Accecelaration and long term tests suggested that values of the checked items of COT were no obvusiouly changes, indicating that the quality of COT samples was stable, and valid in two years.The prepared COT with stability and quality control allows the primising economical and social benefits. |
