Formula Optimization and Quality Observation of Artesunate Dry Suspension / 中国药师

ABSTRACT

Objective:To optimize the formula of artesunate dry suspension, and evaluate the quality. Methods:With sedimenta-tion volume ratio, redispersibility and loss on drying as the indices, single factor and orthogonal test were adopted to study the variety and amount of fillers, suspending agents, binders and disintegrating agents to optimize the formula. HPLC was used to determine the content of artesunate in the preparation. Different media and speed were used to investigate the dissolution behavior of artesunate dry suspension. The stability of the preparation was studied under the conditions of temperature (30 ± 2) ℃ and relative humidity (75 ± 5) % for four months. Results:The optimal formula of artesunate dry suspension was as follows: sucrose as the filler, xanthan gum (8%) and CMC-Na (12%) as the suspending agent, MCC (15%) as the disintegrant and 6% PVP K30 (in 50% ethanol solution) as the adhesive. Totally 4 batches of samples were prepared with the optimal formula, and their label contents were all above 95%, the sedimentation volume ratios were all higher than 0. 9 and the dissolution was more than 80% in 20 min. All the indices of samples met the requirements without significant change in 4 months. Conclusion:The preparation process of artesunate dry suspension is simple, reproducible and stable.