Preparation and quality control of Bushen Yinao Dispersible Tablets / 中草药

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 12.7, 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.