Preparation of compound Shenzao chewable tablets and determination of spinosin content / 国际药学研究杂志

ABSTRACT

Objective: To optimize the formulation and preparation process of compound Shenzao chewable tablets, and establish a method for the determination of the active ingredient spinosin. Methods: Using the wet granulation process, the types, dosages and adding manners of diluents, wetting agents, sweeteners and lubricants were optimized, and three batches of the compound Shenzao chewable tablets were prepared. An HPLC method for the determination of spinosin in the tablets was established and the HPLC conditions were as follows ZORBAX SB-C 18 column(4.6 mm×250 mm, 5 μm)was adopted. The mobile phase was the acetonitrile-water solution in a gradient elution. The flow rate was 1.0 ml/min, the column temperature was 25℃ and the detection wavelength was 335 nm. Results: In the wet granulation process, the dry Lepidium meyenii (Maca)powder and 20% mannitol were used as diluents, the 80% ethanol as wetting agent, and the 0.50% aspartame as sweetener. In the tabletting process, the 1.0% magnesium stearate was used as lubricant. The prepared tablets showed smooth surface, moderate sweetness, and a stable and controllable quality. The HPLC method for the determination of spinosin showed a good linearity within the concentration range of 5~100 μg/ml (r=0.9995)and the average recovery was 98.55%. Conclusion: The optimized formulation and preparation process are stable and feasible for the preparation of the compound Shenzao chewable tablets. The determination of spinosin by the HPLC method is accurate and reliable, which might be used for the quality control of the preparation.