Determination of in vitro release of musk sustained-release mini-tablets by reciprocating cylinder method
Objective:To determine the in vitro release degree of musk sustained-release mini-tablets by recip-rocating cylinder method.Methods:Gas chromatography was used to establish the in vitro analysis of muscone,which is the main active ingredient of sustained-release mini-tablets.Comparing its equilibrium solubility in different concentrations of Tween-80,hexadecyl trimethyl ammonium bromide(CTAB)and sodium dodecyl sul-fate(SDS),to determine the type of release medium.The effects of residence time,drip time,reciprocation rate,and screen mesh sizes on the release behaviours of muscone were investigated.Results were compared with that of the paddle method.Meanwhile,a preliminary investigation into the mechanism of its release was also car-ried out.Results:The linearity of the constructed analytical method was better,the RSD values of precision,re-peatability and stability were less than 3%,and the spiked sample recovery was qualified.The release medium for the reciprocating cartridge method was 200 mL of 0.05%Tween-80,with a dwell and drip time of 20 s,a reciprocation rate of 15 dip·min-1,and upper and lower screen mesh sizes of 20 and 40 respectively.Compared with the paddle method,Muscone was completely released under different pH conditions in the reciprocating cylin-der method,and the release curve increased smoothly.Conclusion:The study can provide some references for the reciprocating cylinder method in the in vitro evaluation of sustained-release prescriptions of traditional Chinese medicine.