星点设计-响应面法优化血塞通滴丸成型工艺及冷凝液指纹图谱研究  

Optimization of Molding Technology of Xuesaitong Dripping Pills by Central Composite Design-response Surface Method and Condensate Fingerprint Study

作　　者：屈云萍 蔡向杰 王娇 李菲 姜国志 陈钟 李振江 

机构地区：[1]神威药业集团有限公司,石家庄051430 [2]中药注射剂新药技术开发国家地方联合工程实验室,石家庄051430

出　　处：《中国药房》2016年第34期4829-4832,共4页China Pharmacy

基　　金：国家中医药管理局科技项目中药领域2013年度课题(No.国中医药科技发[2013]30号);河北省科技计划项目(No.14272504D)

摘　　要：目的:优化血塞通滴丸的成型工艺并考察冷凝液液状石蜡的可使用批次数。方法:以三七总皂苷、人参皂苷Rg1、三七皂苷R1的含量、丸重差异、外观成型质量评分等指标的综合评分为考察指标,分别采用单因素和星点设计-响应面法优化滴头口径、滴距、滴制药液温度、冷凝上/下层温度等各因素的水平;以三七总皂苷为对照,收集并比对连续滴制15批(每批50万丸)血塞通滴丸后的冷凝液的指纹图谱,考察冷凝液的可使用批次数。结果:滴丸最优成型工艺为滴头口径3.9/5.1(内/外,mm/mm)、滴距6cm、滴制药液温度80℃、冷凝上层温度40℃、冷凝下层温度10℃。所制3批样品的综合评分与预测值的相对误差分别为-1.37%、-1.71%、-1.51%;与三七总皂苷图谱对应的各成分的保留时间位置上,15批次的冷凝液图谱上均未见相应成分峰。结论:优化得到的血塞通滴丸成型工艺稳定可行;使用液状石蜡冷凝液至少可滴制15批血塞通滴丸。OBJECTIVE：To optimize the forming technology of Xuesaitong drop pills,and to investigate the usable batche number of condensate oleum vaselini.METHODS：Taking the contents of Panax notoginseng saponins,ginsenoside Rg1 and notoginsenoside R1,weight variation,appearance and quality score as index,single factor test and central composite design-response surface method were used to optimize dripper diameter,dripping distance,dripping temperature,the temperature of condensate upper/lower layer.Using P.notoginseng saponins as control,the fingerprints of condensate were collected and compared after preparing 15 batches of Xuesaitong drop pills（500 thousand pills per batch）continuously,and the usable batche number of condensate were investigated.RESULTS：The optimized molding technology of dripping pills was that the dripper diameter 3.9/5.1（inside/outside,mm/mm）,dripping distance 6 cm,dripping system temperature 80 ℃,the upper temperature of condensate 40 ℃,the lower temperature of condensate 10 ℃.Relative deviation of comprehensive score to predicted value were-1.37%,-1.71%,-1.51%for 3 batches,respectively.On retention time position of each component in P.notoginseng saponins fingerprint,corresponding peak was not found in the fingerprint of 15 batches of condensate.CONCLUSIONS：The optimized molding technology of Xuesaitong dripping pills is stable and available.Condensate liquid paraffin can be used to prepare 15 batches of Xuesaitong dripping pills at least.

关 键 词：血塞通滴丸 三七总皂苷 成型工艺 制备 星点设计 响应面法 冷凝液 指纹图谱 

分 类 号：R283[医药卫生—中药学]