款冬花经粉碎分散处理后对小儿肺咳颗粒水分散稳定性的影响
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篇名: 款冬花经粉碎分散处理后对小儿肺咳颗粒水分散稳定性的影响
TITLE:
摘要: 目的:改善款冬花粉末的水分散稳定性,提高其成方制剂小儿肺咳颗粒的用药依从性。方法:以吸光度变化率(β)、Zeta电位为指标,考察在款冬花药材粉碎过程中加入4种不同分散稳定助剂(六偏磷酸钠、糊精、聚乙二醇4000、卵磷脂)及其用量后混悬液的水分散稳定性,并对样品进行红外光谱表征;以未加分散稳定助剂的原处方颗粒为对照,比较加入分散稳定助剂后新处方颗粒的水分散稳定性。结果:4种不同分散稳定助剂中以六偏磷酸钠所制样品的β最小、Zeta电位绝对值最大;加入2.5%六偏磷酸钠的款冬花粉末与原款冬花粉末比较,β减少16.8%,Zeta电位绝对值增大29.4%,红外光谱未见新峰出现;与对照颗粒比较,新处方颗粒混悬液β更小、Zeta电位绝对值更大(P<0.01),后者粒径约为30 μm,未见大颗粒聚集现象,沉降放置20 s内β小于5.0%。结论:在小儿肺咳颗粒制备过程中,使用加入六偏磷酸钠进行分散处理的款冬花粉末,可较好地改善颗粒的水分散稳定性,从而提高制剂的用药依从性。
ABSTRACT: OBJECTIVE: To improve the dispersion stability in water of Tussilago farfara powder, and to improve compliance of Xiao’er feike granules. METHODS: The effects of 4 kinds of dispersion stabilizer (sodium hexametaphosphate, dextrin, PEG4000 and lecithin) on dispersion stability of suspension in water were investigated during the grinding of T. farfara using rate of absorbance change (β) and Zeta potential as index; IR spectrum of samples were characterized. Using original formulation without dispersion stabilizer as control, the dispersion stability of new formulation granules in water were analyzed comparatively after adding dispersion stabilizer. RESULTS: Among 4 kinds of dispersion stabilizer, β of sample prepared by sodium hexametaphosphate was the lowest, while Zeta potential of it was the highest; compared with original T. farfara, β of T. farfara grinded with 2.5% sodium hexametaphosphate decreased by 16.8%, and Zeta potential absolute value increased by 29.4%; no new peak was found in IR spectrum. Compared with control granules, granules suspension prepared by new formulation had lower β and higher Zeta potential absolute value (P<0.01); particle size was 30 μm and no large particle aggregation was found; β was less than 5.0% within 20 s sedimentation. CONCLUSIONS: During the preparation of Xiao’er feike granules, the application of sodium hexametaphosphate in the grinding of T. farfara powder can improve the dispersion stability of granules in water and the compliance of the preparation.
期刊: 2016年第27卷第16期
作者: 张红,季金苟,吴越,程原原,徐溢,穆小静
AUTHORS: ZHANG Hong,JI Jingou,WU Yue,CHENG Yuanyuan,XU Yi,MU Xiaojing
关键字: 小儿肺咳颗粒;款冬花;粉碎;水分散稳定性;六偏磷酸钠;吸光度变化率;Zeta电位
KEYWORDS: Xiao’er feike granules; Tussilago farfara; Grinding dispersion; Dispersion stability in water; Sodium hexametaphosphate; Rate of absorbance change; Zeta potential
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