Preparation and Quality Control of Sustained Release Tablets of Salbutamol Sulfate / 中国药房

ABSTRACT

OBJECTIVE: To prepare the sustained release tablets of salbutamol sulfate,and to establish the method of quality control.METHODS: The sustained release tablets were prepared by using salbutamol sulfate, lactose, sodium carboxymethyl starch, HPMC, EC, and MCC and coated with enteric soluble acrylic resin.HPLC was employed to determine the content of salbutamol sulfate, while at the same time dissolution grade in vitro was determined, and stability was investigated.RESULTS: The detectable concentration of salbutamol sulfate showed a good linear correlation with peak area in the range of 1.25～20.00?g/ml.The average recovery of salbutamol sulfate was 98.60% (RSD=0.66%).The prepared tablets showed a timing release 5 hours after administration.No evident changes in dissolution were found in all tests of stability.CONCLUSION: The formulation of the preparation is reasonable; the preparation technique is simple and feasible, and the quality is stable and controllable.