The Process Certification And Quality Research Of Methylprednisolone Sodium Succinate Injection’s Quantity Production

Methylprednisolone sodium succinate injection is a kind of glucocorticoids, with a strong pharmacological action on anti-inflammatory, immunosuppression, allergy and shock resistance. At present, it has an outstanding performance in the treatment of some critical disease, widely be used in the domestic clinical application. The current process stability has the vital role on the safety of clinical medication. Therefore, the related research for the current production process is the key to ensure the quality of the drug. Through the broth aseptic filling test, this paper verified the reliability of the current technology.It can produce the qualified product. Medium filling test from the integrity of the process to verify the reliability of the whole aseptic production,as far as possible with including environment, equipment conditions, the actual production condition of the same simulation of the actual production,using medium nutrient broth medium (TSB) with microorganism or soybean tryptone liquid medium (TSA) to replace the product, the selection of reasonable "worst conditions", including the equipment, the whole process system is challenged.It is the key to have related research on the product which produced by current process technology.To the methylprednisolone sodium succinate freeze-dried as the research project, this paper studied the method of two key projects:content determination and bacterial endotoxin, according to the existing process, prescription characteristics, and the test method of national drug standards of YBH00472010. It also studied the method of related substance, to change the mobil phase chlorinated normal butane-water saturated water saturation chlorinated normal butane tetrahydrofuran-methanol-glacial acetic acid (475:475-70:35:30) instead of chlorinated normal butane-water saturated water saturation chlorinated normal butane-tetrahydrofuran-methanol-glacial acetic acid (130:130:14:7:6) to separate the peak of related substance and main peak. Due to methylprednisolone sodium succinate injection is prodrug, succinic acid ions are all free after entering the body.So we also studid the content method of sodium succinate with the HPLC method analysis. The results indicated that we can calculate the amount of sodium succinate from available the amount of free methylprednisolone.