丹参总酚酸滴丸的制备及质量评价

目的制备丹参总酚酸滴丸,并对其进行质量评价。方法以外观、成型性为评价指标,单因素试验考察冷却剂种类、基质配比、药物与基质配比、滴距、滴速、料温对制备工艺的影响。然后,HPLC法测定丹酚酸B、迷迭香酸含有量,TLC法定性鉴别,药典法检测重量差异限度、溶散时限。结果最佳条件为冷却剂二甲基硅油,基质配比3∶1,药物与基质配比1∶5,滴距6cm,滴速60滴/min,料温65℃,所得滴丸圆整均一,无拖尾和粘连。丹酚酸B、迷迭香酸分别在19.01~190.12μg/mL(R^2=0.999 6)、1.49~14.90μg/mL(R^2=0.999 8)范围内线性关系良好,平均加样回收率分别为97.92%、96.58%,RSD分别为2.45%、1.64%;TLC斑点清晰,重复性好;重量差异限度、溶散时限符合药典要求。结论该方法合理、可行、稳定,可用于制备丹参总酚酸滴丸。

Preparation and quality evaluation for dropping pills of total salvianolic acids

AIM To prepare the dropping pills of total salvianolic acids and to make quality evaluation.METHODS With appearance and formability as evaluation indices, the effects of coolant type, matrix ratio, drug-matrix ratio, dropping distance, dropping speed and material temperature on preparation process were investigated by single factor test. Subsequently, HPLC was adopted in the content determination of salvianolic acid B and rosmarinic acid, TLC was used for qualitative identification, and pharmacopeia method was applied to detecting weight difference degree and dissolving time.RESULTS The optimal conditions were determined to be dimethicone as coolant, 3∶1 for matrix ratio, 1∶5 for drug-matrix ratio, 6 cm for dropping distance, 60 drops/min for dropping speed, 65 ℃ for material temperature, the obtained round and uniform dropping pills displayed no tailing and adhesion. Salvianolic acid B and rosmarinic acid showed good linear relationships within the ranges of 19.01-190.12 μg/mL(R^2=0.999 6) and 1.49-14.90 μg/mL(R^2=0.999 8), whose average recoveries were 97.92% and 96.58% with the RSDs of 2.45% and 1.64%. The clear TLC spots were reproducible. Both weight difference degree and dissolving time accorded with the pharmacopoeia requirements.CONCLUSION This reasonable, feasible and stable method can be used for the preparation of total salvianolic acids dropping pills.