New packaging of Artesun® triple injection promoted by Guilin Pharma
The packaging form of double injection has been used since the clinical application of Artesun® for injection (60mg) manufactured by Guilin Pharma Co., Ltd. in the 90s of last century, that is, a small box packaging of 1 vial of Artesun® for injection (60mg) with 1 vial of sodium bicarbonate injection (1ml:50mg). In clinical application, 1 vial of Artesun® for injection is dissolved in 1 vial of specific solvent attached - sodium bicarbonate injection, and then diluted in 5ml of 0.9% sodium chloride injection or 5% glucose injection for use.
With the wide use of Artesun® for injection (60mg) in malaria-epidemic areas, more and more medical institutions and patients feel that double injection of Artesun® for injection (60mg) cannot meet the requirement of diluent preparation for clinical use, as prepared diluent is not rapidly available in malaria-epidemic poverty-stricken areas where there is a lack of drugs. According to the feedbacks from abroad, in order to provide convenience for use of Artesun® for injection in the treatment of malaria, especially avoid the risk of contamination and cross-contamination during preparation in malaria-epidemic areas, with the trend of human oriented design, 1 vial of additional diluent-sodium chloride injection on the basis of double injection is considered to make a triple injection packaging. The study and sample production of this packaging (1 vial of Artesun® for injection, 1 vial of sodium bicarbonate injection and 1 vial of sodium chloride injection in one small box) were planned in the year of 2010.
Sodium chloride injection samples of large specification were manufactured after the completion of the transformation in small capacity workshop production line in September 2011, and the quality study of the product was also implemented. In July 2012, we submitted the application for the change from double injection to triple injection to World Health Organization (WHO) after the acquirement of relevant results from quality study on sodium chloride injection, and this application passed PQ certification by WHO in February 2013 and now the product has actually been on the market.