[关键词]
[摘要]
目的 研制葛根总黄酮滴丸,并考察其溶出度。方法 以滴丸的外观、丸质量变异系数、溶散时限为评价指标,采用正交试验设计优选滴丸的制备工艺;HPLC法测定滴丸中葛根素;转篮法比较葛根素在滴丸与片剂中的溶出度。结果 最优制备工艺:药物与基质比例为1:3,滴速为20滴/min,药液温度为80 ℃,管口温度为50 ℃,滴距为6 cm,制冷温度为10 ℃;制得滴丸中葛根素为5.542 mg/g;滴丸在20 min内累积溶出率达到98.81%,片剂20 min内的累积溶出率仅有10.70%。结论 葛根总黄酮滴丸制备方法稳定、可行,定量测定方法简便、易行,滴丸可提高葛根素的溶出速度。
[Key word]
[Abstract]
Objective To prepare Puerariae Radix Flavones Dropping Pills and to investigate the dissolution. Methods Exterior quality, weight variation, and resolving time were used as comprehendsive evaluation indicators to select dropping conditions by orthogonal design. HPLC was used to determine the content of puerarin and rotating basket method was used to determine the dissolution rate in vitro of the dropping pills and tablets. Results The optimal preparation conditions for the pills were as follows: proportion of drug and matrix was 1:3, drop rate was 20 d/min, the temperature of drug fluids was 80 ℃, the condensate tube outlet temperature was 50 ℃, dimethylsilicone was the refrigerant at the temperature of 10 ℃ and 6 cm distance above liquid level. The content of peurarin in the dropping pills was 5.542 mg/g. The accumulated dissolution rate of puerarin in the dropping pills reached 98.81% in 20 min, while the accumulated dissolution rate of puerarin in tablets was only 10.70% in 20 min. Conclusion The preparation process and HPLC determination method are simple, stable, and feasible. The dissolution rate of puerarin can be improved in the Dropping pills.
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[基金项目]
国家自然科学基金资助项目(51102052)