|
Compound bone peptide injection to promote fracture healing, anti-inflammatory analgesic , toxicity , patient tolerance , and efficacy , are now widely used in the treatment of rheumatism , rheumatoid arthritis , osteoarthritis, fractures . The thesis of the the bone extract Scorpion extracts preparation process , Formulation , establish quality standards with compound bone peptide injection . Using orthogonal design, to determine the process of bone extracts . Pressure treatment with 2-fold of water 2 times , each 1H . The filtrate was allowed to stand at a low temperature for 36 h, and was heated to remove the fat, 70OC , and concentrated in vacuo . Precipitated with final concentration of 70% (V / V) of ethanol was allowed to stand 36h, the supernatant at 60OC concentrated in vacuo . Acid and alkali precipitation to remove contaminating proteins , activated carbon adsorption , 10000Da membrane filtration . Scorpion extract process . Crushed scorpion full worms sifted 6 times and 3 times successively with water immersion , impermeable boiling 2h centrifugal supernatant . After concentration under reduced pressure , washed with 70% ethanol overnight at 4 ℃ centrifuged supernatant . Supernatant alkali the precipitation , 10000Da film , ultrafiltration . Small and pilot , the bone extract Scorpion extracts preparation process , quality controlled . Complex bone peptide injection prescription and freeze-drying process . 2.0% mannitol as excipients , pH 6.8 to 7.2 , lyophilized 22h maintain 15-35Pa slow warming , the endpoint temperature 34 ° C insulation 2h . Three batches of three batches of small test process validation results show that heat, light a slight impact on the stability of the product ; continuous zoom , finished product rate of more than 95% , with 0.9% sodium chloride injection , 5% dextrose injection use liquid compatibility . Accelerated testing and long-term tests show that the basic indicators of the sample there was no significant change in the quality of packaging samples stable valid tentatively scheduled for two years . Compound bone peptide injection paper developed a stable process , quality control, and has good prospects for economic and social benefits .
|