复方沙棘片的制备和质量标准研究

摘要

To optimize the preparation and prescription of tablets and study the quality standards of sea buck-thorn tablets. Used mesh size, drying time and drying temperature as factors to determine the best preparation process,and used the different kinds of fillers, adhesives, lubricants as factors to optimize the prescription.The total flavonoids and proanthocyanidins were identified by TLC and determined by UV-visible spectrophotome-try. Use a mixture of starch and dextrin (2 ∶ 1) as the filler,60 % ethanol as binder and 0.5 % magnesium stearate as lubricant.Granulate by 16 mesh sieve with 50℃as drying temperature and 60 min as drying time.The identification method was exclusive.The TLC sports were fairly clear.The determination of flavonoids and proan-thocyanidins kept the good linear relation in the concentration ranges of 0.01 mg/mL~0.05 mg/mL (r=0.999 0), 0.01 mg/mL~0.05 mg/mL (r=0.999 5). The average recoveries of flavonoids and proanthocyanidins were 100.36 %and 98.53%respectively. The compound sea buckthorn tablets have good appearance, hardness and disintegrate fast. The qualitative and quantitative analysis method is simple and accurate.It can effectively con-trol the quality of the tablet.%优化复方沙棘片的制备工艺和处方，研究制定复方沙棘片的质量标准。以颗粒性状、片剂的外观、硬度和崩解时限为指标，确定最优制备工艺和处方；采用薄层色谱鉴别法对复方沙棘片中总黄酮和原花青素进行定性鉴别；采用紫外-可见分光光度法对有效成分总黄酮和原花青素进行定量测定。结果表明，复方沙棘片的最优处方和制备工艺为：以淀粉和糊精（2∶1）的混合物为稀释剂，60%乙醇为黏合剂，0.5%硬脂酸镁为润滑剂，用16目筛湿法制粒，50℃下干燥60 min，整粒后压片。薄层色谱鉴别法专属性强，黄酮、原花青素的斑点清晰，紫外-可见分光光度法测定沙棘总黄酮和葡萄籽原花青素的线性范围分别为：0.01 mg/mL~0.05 mg/mL（r=0.9990），0.01 mg/mL~0.05 mg/mL（r=0.9995），平均加样回收率分别为100.36%（RSD=0.97%，n=5）、98.53%（RSD=2.66%，n=5）。所制的复方沙棘片外观好、硬度适中、崩解速度快，所建立的定性、定量分析方法简便易行，准确度高，能够有效控制片剂的质量。