Study On Quality Evaluation Method

Jipusu Injection is a kind of II category biologic agent which contain lots of active compound and is made from fermentation of staphylococcus aureus in affluent nutrient medium. It is mainly used in adjunctive therapy after radiotheraphy and chemotheraphy of malignant tumor patient.The biologic agent has important protection on hypoleucocytosis induced by radiotheraphy and chemotheraphy. And it has used to cure bone fracture delayed union or disunion.In the study quality criteria of Jipusu Injection would be improved according to temporarily Regulation in《China Biological product Regulations》whose version is 2000 edition, so that the quality critera may reflect efficacy, safety and controllability of drug. Major component staphylococcal enterotoxin C2 in Jipusu Injection would been separated and purified.After lots of experiments we vill establish detection method and carry out technology verification for it.1. Purification of major component staphylococcal enterotoxin C2 in Jipusu Injection: The stock solution of Jipusu injection is been ultrafiltrated by 5K ultrafiltration membrane in order to enrich staphylococcal enterotoxin C2. After ultrafiltration process, the concentrated solution sample is applied on ion exchange chromatography and separate taphylococcal enterotoxin C2.2. Study of detection method of major component staphylococcal enterotoxin C2 in Jipusu Injection:enzyme linked immunosorbent assay(ELISA) is used to quantity detection for staphylococcal enterotoxin C2 and carried out technology verification in the study. Verification result is that the concentration of staphylococcal enterotoxin C2 and absorption value are well linear correlation. In the range of 20ng/mL, correlation coefficient of standard curve is all above 0.99;sample average recovery is 97.14%, RSD 4.53%; reproducibility test RSD 5.91%; detection limit 1.44ng·mL-1. Using normal rabit surum as controls in Specificity test,results show that the reaction is negative between SEC2 to normal rabit serum. And cross-reaction is absence between staphylococcal enterotoxin C2 kit to the other enterotoxins. In interference factor investigation test, normal rabit serum or high potency goat anti-SEC2 enzyme conjugate is used to avoid IgG-protein A interferencing determination. 3. Stability investigation:Three batch samples were stored for fifteen months in ordinary temperature first and carried out the accelerated test for six months in 40℃then. At last, the content of the staphylococcal enterotoxin C2 in Jinpusu Injection didn’t change on the whole. And the pure enterotoxin C2 also didn’t change at the same test.