ABSTRACT
Objective: To optimize the preparation technology of Bushen Yinao Dispersible Tablets (BYDT) and establish a method for the quality control of BYDT. Methods: The prescription of BYDT was optimized by single factor test with the disintegrating time as index. The contents of psoralen and isopsoralen were determined by HPLC. The dissolution of BYDT was determined and compared with other two preparations. Results: PVPP was optimized as the disintegrants, MCC was optimized as the stuffing bulking agents, the proportion of PVPP and MCC was 1:2.7, and 80% ethanol was optimized as adhesives. The concentration of psoralen and isopsoralen showed a good linear relationship at the range of 4.2-52.5 and 4.6-57.5 μg/mL (r=0.9998), respectively. The average recoveries of psoralen and isopsoralen were 98.89% with RSD of 0.53%; and 100.65% with RSD of 0.93%, respectively. The total content and dissolution of psoralen and isopsoralen had no significant differences among different batches. BYDT had the higher dissolution speed and could reach the highest dissolution rate in vitro compared with the other preparations. Conclusion: This prescription of BYDT is reasonable and effective. The method is simple and accurate and could be used for the quality control of BYDT.
ABSTRACT
OBJECTIVE:To prepare a rapid-disintegrated lozenge METHODS:The formula and technology were decided by taking the disintegrating time and dissolubility as standard RESULTS:The lozenge could completely disintegrate in 20s and the accumnlated dissolubility of the model drug was 99% after 5 minutes in phosphate buffer(pH=6 80) CONCLUSION:Using now available equipment,suitable excipients and workmanship can prepare a rapid-disintegrated lozenge