Antibiotic injection of insoluble particulate Quality Investigation.docVIP

 PAGE \* MERGEFORMAT 10 Antibiotic injection of insoluble particulate Quality Investigation [Abstract] Objective To study the domestic production of the antibiotic injection of sterile powder and small volume injection of the quality of particulate matter. Methods GWJ 4 intelligent particle detector at lt;”China Pharmacopoeiagt;gt; PR method were determined. Results 293 Only one batch of the batch sample test results insoluble particles do not meet the 2005 edition lt;”China Pharmacopoeiagt;gt; requirements. Conclusion Domestic sterile antibiotic powder for injection and small volume injection of insoluble particulate test results are satisfactory. [Keywords:] antibiotics; Injection sterile powder; small-volume injection; insoluble particles Abstract: Objective To examine particulate matter in domestic sterile powder for injection and small volume injection of antibiotics. Methods particulate matter were examined by the method of Light Obscuration (ChP 2005) with GWJ 4 Intelligent Particle Detector.Results Only one sample do not meet the requirements in 293 batches of samples. Conclusion The examination results of particulate matter in domestic sterile powder for injection and small volume injection of antibiotics are satisfactory. Keywords:: antibiotics; sterile powder for injection; small volume injection; particulate matter Antibiotics to combat bacterial infections of the main drug, the commonly used 5% glucose injection or 0.9% NaCl solution, dilution was made after intravenous infusion, is widely used in clinical practice. In recent years, intravenous infusion on the sources of insoluble particles harm the human body and its many reports [1 ~ 3], “lt;British Pharmacopoeia gt;gt;,lt;lt; USPgt;” and ““ China Pharmacopoeiagt;gt; all of the injections were made of insoluble particulate regulations and control. article 2005 Edition lt;”China Pharmacopoeiagt;gt; resist [4] methods and criteria of the determination of pharmaceutical manufacturers