RESUMO
The self-microemulsion formulation of potassium dehydroandrographolidi succinas (PDS) has been optimized and the performance in vitro has been evaluated preliminary. Kinds of prescription accessories were screened by solubility based on the emulsifying result and efficiency, particle size of emulsions. The optimal formulation composition and compatibility proportion were determined by orthogonal design and pseudo-ternary phase diagrams. The appearance, particle size, Zeta potential and stability of this formulation were also investigated. The optimized prescription of PDS was 10% MCT, 40% Tween-20 and 50% glycerol. It can spontaneously form a transparent pale blue opalescent emulsion with emulsification time 31.27 s, particle size 37.1 nm, Zata potential -17.4 mV and good stability.
RESUMO
Objective To explore self-emulsifying particle size characterization methods and compare the regularity of various methods. Methods By setting the clarity level of turbidity standard solution, with two less soluble drugs-diterpene lactone compounds Chuanhuning and dihydropyridine drug nifedipine as model drugs, 10-12 clarity level prescriptions were selected from six different ternary phase diagram. Laser particle size scanner was used to determine the particle size, and UV-visible spectrophotometry to determine its absorbance. Three methods of particle size characterization rules were compared by drawing charts. Results There was a positive correlationship among droplet particle size, absorbance and clarity grade of emulsion formed by prescription in the same phase diagram. But, there was no regularity among droplet particle size, absorbance and clarity grade of emulsion formed by prescription in different phase diagram. Conclusion The droplet particle size of emulsion formed by prescription containing the same drugs and excipients in different proportions can be compared by clarity with visual method or absorbance with UV-visible spectrophotometer.