Study on the Preparation Technique and Quality of Xuelian Freeze-dry Sterile Injection powder / 中国药房

ABSTRACT

OBJECTIVE:To prepare xuelian freeze-dry sterile injection powder and to establish a quality control for this drug.METHODS:The best formulation and preparation technique of the powder for injection was optimized by screening the variety and quantity of vehicle;the contents,which were determined by UV,together with the finger print were taken as the main index to study the quality.The stability was observed through long test.RESULTS:Take the40%mannitol as excipient;The mean recovery results was99.4%(RSD=0.90%);The freeze-dry sterile injection powder could be reflection the finger print character of extract fluid better than injection.The preparation was stable after12months storage at room tempera-ture.CONCLUSION:The formulation is reasonable,the preparation technique is feasible and the quality is controllable.