摘要
目的优化复方参枣咀嚼片的制剂处方和成型工艺,并建立其主要有效成分斯皮诺素的含量测定方法。方法采用湿法制粒工艺,对制剂处方中稀释剂、润湿剂、甜味剂、润滑剂等辅料种类、用量和加入方式进行优化,并进行3批样品试制。建立斯皮诺素的HPLC含量测定方法:Agilent ZORBAX SB-C18色谱柱(4.6 mm×250 mm,5μm),以乙腈-水为流动相梯度洗脱,流速1.0 ml/min,柱温25℃,检测波长335 nm。结果内加玛咖干粉和20%甘露醇作为稀释剂,80%乙醇作为润湿剂、0.50%阿司帕坦(阿斯巴甜)作为甜味剂,进行湿法制粒,以1.0%硬脂酸镁作为润滑剂进行压片。所得咀嚼片表面光洁、甜度适中且质量稳定可控。建立的斯皮诺素HPLC含量测定方法在5~100μg/ml范围内线性关系良好(r=0.9995),加样回收率为98.55%。结论优化的复方参枣咀嚼片的制剂处方和成型工艺稳定可行。斯皮诺素的HPLC含量测定方法准确可靠,可用于该制剂的质量控制。
Objective To optimize the formulation and preparation process of compound Shenzao chewable tablets,and estab lish a method for the determination of the active ingredient spinosin.Methods Using the wet granulation process,the types,dosages and adding manners of diluents,wetting agents,sweeteners and lubricants were optimized,and three batches of the compound Shen zao chewable tablets were prepared.An HPLC method for the determination of spinosin in the tablets was established and the HPLC conditions were as follows:ZORBAX SB-C18 column(4.6 mm×250 mm,5μm)was adopted.The mobile phase was the acetonitrilewater solution in a gradient elution.The flow rate was 1.0 ml/min,the column temperature was 25℃ and the detection wavelength was 335 nm.Results In the wet granulation process,the dry Lepidium meyenii(Maca)powder and 20%mannitol were used as diluents,the 80%ethanol as wetting agent,and the 0.50%aspartame as sweetener.In the tabletting process,the 1.0%magnesium stearate was used as lubricant.The prepared tablets showed smooth surface,moderate sweetness,and a stable and controllable quality.The HPLC method for the determination of spinosin showed a good linearity within the concentration range of 5~100μg/ml(r=0.9995)and the av erage recovery was 98.55%.Conclusion The optimized formulation and preparation process are stable and feasible for the prepara tion of the compound Shenzao chewable tablets.The determination of spinosin by the HPLC method is accurate and reliable,which might be used for the quality control of the preparation.
作者
李心蕊
苏靖
敬应春
邱明丰
LI Xin-rui;SU Jing;JING Ying-chun;QIU Ming-feng(School of Pharmacy,Shanghai Jiao Tong University,Shanghai 200240,China;Shanghai Medicilon Inc.,Shanghai 201299,China)
出处
《国际药学研究杂志》
CAS
北大核心
2020年第2期156-162,共7页
Journal of International Pharmaceutical Research
关键词
复方参枣咀嚼片
成型工艺
斯皮诺素
HPLC
compound Shenzao chewable tablets
preparation technology
spinosin
HPLC
