葛花滴丸的制备工艺及葛根素的含量测定

Research on Preparation Process of Dropping Pills from Pueraria lobata(Willd.)Ohwi Bud and Content Determination of Puerarin

[目的]优选葛花滴丸制备工艺条件并测定滴丸中葛根素的含量。[方法]以滴丸圆整率、重量差异和溶散时限为考察指标,采用L9(34)正交试验考察PEG6000与S-40比、基质与药物比、冷凝剂管口温度和滴速等因素对滴丸成型的影响,并采用高效液相色谱法测定滴丸中葛根素的含量。[结果]优选出的最佳工艺条件为:PEG6000与S-40为3∶1(g/g),基质与药物为4∶1(g/g),冷凝剂管口温度为35～40℃,滴速为50 d/min;3批样品中葛根素的平均含量为52.26±1.33 mg/g。[结论]葛花滴丸制备工艺合理,重现性好,外观质量好,溶散时限和重量差异合符《中国药典》要求;高效液相色谱法先进、准确、可靠,可作为葛花滴丸的质量控制方法。

[ Objective ] To optimize the preparation process of dropping pills from Pueraria lobata （Willd.）Ohwi bud and determine the content of puerarin. [ Method ] Taking the percent rate of roundness, weight difference and dissolve time as the indexes, the PEG6000-S-40 ratio, matrix-drug ratio, refrigerant temperature and dropping rate were optimized by orthogonal test with table L9（3^4） in the course of preparing dropping pills from P. lobata （ Willd. ） bud. And the content of puerarin in dropping pills was determined by HPLC. [ Result ] The optimal conditions for preparing dropping pills from P. lobata bud were as follows： 3：1 （g/g）, matrix-drug ratio 4：1 （g/g）, refrigerant temperature 35 -40 ℃, 50 dropping pills per minute. And the average content of puerarin in 3 batches of dropping pills were （52.26 ＋ 1.33） mg/g. [ Conclusion] The preparation process of dropping pills from P. Iobata bud is reasonable and repetitive. The dropping pills have good quality of appearance and meet the requirements of China Pharmacopoeia. And the HPLC method is advanced, accurate and reliable, which can be used to control the quality of dropping pills from P. lobata bud.