首页|基于物理指纹图谱优选加味六君子汤浸膏粉助干剂

基于物理指纹图谱优选加味六君子汤浸膏粉助干剂

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目的 考察不同助干剂对加味六君子汤(MLJZD)浸膏粉吸湿性的影响,并筛选出最佳助干剂.方法 将MLJZD干浸膏与β-环糊精、微晶纤维素、乳糖、阿拉伯胶、麦芽糊精、玉米淀粉、甘露醇、糊精、可溶性淀粉、预胶化淀粉10种助干剂分别以药辅质量比1∶0.3、1∶0.5的比例混合均匀,真空干燥后制备成浸膏粉;以含水率、松密度、振实密度、间隙率、卡尔指数、豪斯纳比、休止角和吸湿率8个物理指标建立物理指纹图谱并进行相似度评价;绘制矩阵热点图分析各物理指标对MLJZD浸膏粉吸湿性的影响;测定MLJZD浸膏粉在室温放置2、4、8、10 h和1、2、3、7 d时的吸湿率,绘制吸湿率-时间曲线图,并筛选出助干效果最好的辅料.结果 物理指纹图谱相似度评价结果显示,制备的MLJZD浸膏粉粉体性质稳定,相似度均在0.90以上;矩阵热点图分析结果显示,MLJZD浸膏粉的吸湿率与松密度、振实密度等具有显著相关性(P<0.05);吸湿率-时间曲线图分析结果显示,以药辅质量比1∶0.5制得的MLJZD浸膏粉比以1∶0.3制得的吸湿率小;2种比例下均以乳糖的助干效果最佳,而后是可溶性淀粉、甘露醇.结论 乳糖作为助干剂(药辅质量比为1∶0.5)可以明显改善MLJZD浸膏粉的吸湿效果,可为后续MLJZD固体制剂的辅料选择提供参考.
Screening of the best drying aid for the extract powder of modified Liujunzi decoction based on physical fingerprint
OBJECTIVE To investigate the effects of different drying aids on the hygroscopic property of extract powder of modified Liujunzi decoction (MLJZD),and screen the best drying aid. METHODS MLJZD extract was mixed with β-cyclodextrin,microcrystalline cellulose,lactose,arabic gum,maltodextrin,corn starch,mannitol,dextrin,soluble starch and pre-gelatinized starch at the mass ratio of 1∶0.3 and 1∶0.5,respectively. The extract powder was prepared after vacuum drying. Physical fingerprints were established with 8 physical indexes,including moisture content,bulk density,vibrating-solid density,gap rate,Carr index,Hausner ratio,angle of rest and hygroscopicity,and then similarity evaluation was performed. The matrix hotspot map was drawn to analyze the influence of physical indexes on hygroscopicity. The moisture absorption rate of MLJZD extract powder was measured at room temperature for 2,4,8,10 h and 1,2,3,7 d. The moisture absorption rate-time curve was drawn,and the best auxiliary materials were selected by comparison. RESULTS The similarity evaluation results of physical fingerprint showed that the prepared MLJZD extract powder were stable and the similarities were above 0.90. The matrix hotspot analysis showed that there was significant correlation between bulk density and vibratory density and the moisture absorption rate of the MLJZD extract powder (P<0.05). The moisture absorption rate-time curve analysis showed that the moisture absorption rate of MLJZD extract powder prepared with the mass ratio of 1∶0.5 was lower than prepared with the mass ratio of 1∶0.3. Under both ratios,lactose showed the best drying aid effect,followed by soluble starch and mannitol. CONCLUSIONS Lactose,as the drying aid (under the mass ratio of 1∶0.5),can obviously improve the hygroabsorbance effect of the extract powder of MLJZD,which provides a reference for the selection of auxiliary materials for MLJZD solid preparations.

modified Liujunzi decoctionextract powderdrying aidhygroscopicityphysical fingerprint

朱亚苹、刘玉鑫、邵孟其、吴磊

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南京中医药大学附属医院药学部,南京 210029

南京中医药大学第一临床医学院,南京 210029

南京中医药大学附属医院中药制剂实验室,南京 210029

加味六君子汤 浸膏粉 助干剂 吸湿性 物理指纹图谱

2024

中国药房
中国医院协会,中国药房杂志社

中国药房

CSTPCD北大核心
影响因子:0.956
ISSN:1001-0408
年,卷(期):2024.35(23)