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目的:研究百部新碱口腔崩解片的最佳处方和制备工艺,并评价其质量。方法:采用干法直接压片制备百部新碱口腔崩解片,以体外崩解时间为评价指标,通过单因素实验和正交试验优化处方。利用紫外分光光度法测定百部新碱口腔崩解片的溶出度;利用高效液相法测定崩解片中百部新碱的含量。结果:百部新碱口腔崩解片在30 s内崩解,药物30 min内溶出约95%,含量稳定。结论:该制备工艺简单可行,可制备出优良的百部新碱口腔崩解片。
OBJECTIVE: To study the best prescription and preparation technology of one hundred new caustic orally disintegrating tablets and evaluate its quality. Methods: One hundred and eighty new alkali - orally disintegrating tablets were prepared by direct compression with dry method. The disintegration time in vitro was used as evaluation index, and the prescription was optimized by single factor experiment and orthogonal experiment. The dissolution of baicalin alkali-based orally disintegrating tablets was determined by UV spectrophotometry. The content of baicalin alkali in disintegrating tablets was determined by HPLC. Results: One hundred new alkali disintegrating tablets in 30 s disintegration within 30 min drug dissolution of about 95%, the content was stable. Conclusion: The preparation process is simple and feasible, can be prepared excellent oral newborn tablets orally disintegrating tablets.