Injection St (powder For Injection) Pharmacy Part Of The Study

It was confirmed that the main effective component—ST in S material medicine processed the good curative effect to the CD. In the guidance of TCM theory, the subject prepared ST injection successfully from the intermediation extracting of S, systematically researched the fingerprinting of S material medicine, the forming process and quality standard of products. The study for ST injection planed to develop a new, safe, stable and high performance injectionIn fingerprint of S, using the effective component—ST in the S to be the internal standard, by the means of high performance liquid chromatograph, it has been carried out which included the methodological survey and the establishment of technological parameters in fingerprinting. As a result, it was shown that the fingerprint of the tested herbs was resembled to the standard herbs'. And the degree of similarity was more than 0.9. There were 20 common peaks in the fingerprint. And the area of uncommon peaks except solvent peaks was less than 10% of the total peaks area.In the forming technology study of freeze-dry powder injection, guided by the indexes of surface characters and ST content, it has been surveyed which included the selection the technological parameters of the variety, concentration and dosage of bracket excipient, concentration and pH value of confecting liquid, and freeze-dry technology. After pilotscale experimental researches, the qualified ST freeze-dry powder injection was acquired.The quality evaluation system has been established, which included character studies, qualitative distinguish, the general examination items (degree of clarity, pH, water content, insoluble particles, pyrogen), content determination and the stability experiment. By the means of the HPLC, the content of ST that was the main component in the ST injection has been determined in the products. In the end, content limit has been confirmed.