[Preparation and quality evaluation of tanshinone IIA microemulsion for parenteral injection]

To study the prescription and preparation technology of tanshinone IIA microemulsion for parenteral injection, and to evaluate its quality.

The prescription was selected and optimized through single-factor test, compatibility experiment and the pseudo-ternary phase diagram method. The preparation technology was investigated, and the droplet morphous, particle diameter, zeta potential, stability and haemolyticus were evaluated.

The prescription composition of tanshinone IIA microemulsion was MCT:Solutol HS-15: fabaceous lecithin: absolute alcohol = 9:10:5:6(m/m), oil phase: aqueous phase = 1:10, with the drug-loaded of 1. 0 mg/g. The acquired microemulsion exhibited salmon pink,uniform and transparent, with the average particle diameter of 16. 04 nm, Zeta potential of -11. 57 mV, and the encapsulation efficiency of 98. 53%. The stability result showed that tanshinone IIA content in microemulsion was influenced by high temperature and illumination, indicating tanshinone IIA microemulsion should to be stored at low temperature and protected from light. The preparation was without hemolytic crisis.

The preparation of tanshinone IIA micro- emulsion is simple,corresponding to the main index of parenteral injection and offering the basis for new dosage form development of tanshinone IIA.