枳术便秘通丸成型工艺及质量控制研究  

Forming Process and Quality Control of Zhizhu Bianmitong Pills

作　　者：何英蒙 赖慧 米晓琴 蒲清荣 赵春妮 梁刚 赵福兰 HE Yingmeng;LAI Hui;MI Xiaoqin;PU Qingrong;ZHAO Chunni;LIANG Gang;ZHAO Fulan(Department of Pharmacy,The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University,Luzhou,Sichuan,China 646000;Department of Pharmaceutical Preparation,The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University,Luzhou,Sichuan,China 646000;Department of Oncology,The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University,Luzhou,Sichuan,China 646000)

机构地区：[1]西南医科大学附属中医医院药剂科,四川泸州646000 [2]西南医科大学附属中医医院制剂室,四川泸州646000 [3]西南医科大学附属中医医院肿瘤科,四川泸州646000

出　　处：《中国药业》2023年第4期39-43,共5页China Pharmaceuticals

摘　　要：目的优化枳术便秘通丸的成型工艺,并建立其质量标准。方法以丸剂溶散时限和含水量的综合评分为评价指标,糊精浆体积分数、药粉与水质量比、干燥时间为考察因素,采用L_(9)(3^(4))正交试验法优选枳术便秘通丸的成型工艺参数。采用薄层色谱(TLC)法对制剂中麸炒枳实和麸炒白术进行定性鉴别;采用高效液相色谱(HPLC)法测定制剂中大黄素和大黄酚的含量。结果优选的成型工艺参数为,以30%糊精浆为黏合剂,药粉与水质量比为5∶3,混匀后烘干24h。麸炒枳实和麸炒白术的TLC图斑点清晰,分离度好,阴性对照无干扰。大黄素、大黄酚质量浓度分别在0.848~34.01μg/mL和0.864~34.56μg/mL范围内与峰面积线性关系良好(r=0.9999);精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率分别为99.82%和97.08%,RSD分别为1.88%和1.87%(n=9)。结论枳术便秘通丸成型工艺合理,所建标准可用于制剂的质量控制。Objective To optimize the forming process of Zhizhu Bianmitong Pills,and to establish the quality standard.Methods The L_(9)(3^(4))orthogonal test method was used to optimize the forming process parameters of Zhizhu Bianmitong Pills,with the comprehensive score of the dissolution time and water content of the pills as the evaluation index,with the volume fraction of dextrin slurry,the mass ratio of powder to water,and the drying time as the inspection factors.Thin-layer chromatography(TLC)method was used for the qualitative identification of bran-fried Aurantii Fructus and bran-fried Atractylodis Macrocephalae Rhizoma in the preparation.High-performance liquid chromatography(HPLC)was used for the content determination of emodin and chrysophanol in the preparation.Results The optimal molding process parameters were as follows:30% dextrin slurry was used as the binder,the powder and water were mixed in the ratio of 5∶3,and then dried for 24 h.The TLC spots of bran-fried Aurantii Fructus and bran-fried Atractylodis Macrocephalae Rhizoma were clear with good separation,and the negative control had no interference.The linear ranges of emodin and chrysophanol were 0.848-34.01μg/mL and 0.864-34.56μg/mL(r=0.9999).The RSDs of precision,stability and repeatability tests were less than 2.0%.The average recoveries of emodin and chrysophanol were 99.82% and 97.08% with RSDs of 1.88% and 1.87%(n=9),respectively.Conclusion The forming process of Zhizhu Bianmitong Pills is reasonable,and the established standard can be used for the quality control of the preparation.

关 键 词：枳术便秘通丸 成型工艺 质量控制 正交试验 薄层色谱法 高效液相色谱法 

分 类 号：R943[医药卫生—药剂学] R917[医药卫生—药学] R927