摘要
目的:对影响麻竹颗粒制备的关键因素进行优化,确保该制剂药效和质量的稳定。方法:根据麻竹颗粒的组方、理化性质,结合文献报道,选择提取溶剂(乙醇%)、提取时间、提取次数三个参数,以君药升麻的指标性成分升麻素苷为考察指标,使用Box-Behnken响应面法给出各实验组工艺参数,实际制成颗粒剂样品采用高效液相色谱法(HPLC)分析测定升麻素苷含量,并根据结果绘制响应面(RS),进而分析、预测最优工艺参数。结果:根据CCD生成的参数组,共制备20批样品,上述样品中升麻素苷的含量为0.0785-0.4678 mg.g^(-1),Design Expert预测当提取溶剂为55%乙醇,提取时间52.5min,提取循环2次时,所制备的麻竹颗粒中升麻素苷含量最高,为0.4639 mg.g^(-1),结合实际情况,最终选择上述参数分别为提取溶剂55%乙醇,提取时间50min,提取循环2次。结论:本研究全面、准确考察了麻竹颗粒制备的各关键参数,该制剂的试生产产品的质量和疗效。
objective:To optimize the key factors affecting the preparation of Mazhu granule to ensure the stability of its efficacy and quality.Methods:According to the composition and physical and chemical properties of Mazhu granule,and combined with literature reports,three parameters including extraction solvent(ethanol%),extraction time and extraction times were selected,and the Cohosh glycosides,the indicator component of Monosaccharide cohosh,was taken as the investigation index.The process parameters of each experimental group were given by Box-Behnken Response surface.The actual granules were analyzed and determined by HIGH performance liquid chromatography(HPLC),and response surface(RS)was drawn based on the results to analyze and predict the optimal technological parameters.Results:According to the parameter group generated by CCD,a total of 20 batches of samples were prepared,and the content of Cohosh glycosides in the above samples was 0.0785-0.4678 mg.g^(-1).Design Expert predicted that when the extraction solvent was 55%ethanol,the extraction time was 52.5min,and the extraction cycle was 2 times,the content of Cohosh glycosides in the prepared Jatropha granule was the highest,which was 0.4639 mg.g^(-1).Finally,the above parameters are respectively 55%,50min and 2 times.Conclusion:This study comprehensively and accurately investigated the key parameters of Mazhu granule preparation,the quality and efficacy of the preparation.
作者
陈文慧
车轸潮
黄后楷
傅咏梅
CHEN Wen-hui;CHE Zhen-chao;HUANG Hou-kai;FU Yong-mei(Sinopharm Group Guangdong Medi-World Pharmaceutical Co.ltd.,Foshan,Guangdong,528303)
出处
《按摩与康复医学》
2023年第5期87-89,96,共4页
Chinese Manipulation and Rehabilitation Medicine
