中药生产过程质量生物评控方法研究——以板蓝根颗粒为例  

Investigation on production process quality control of traditional Chinese medicine——Banlangen granule as an example

作　　者：谭曼容[1,2] 鄢丹[1] 邱玲玲[1] 陈龙虎[1] 闫琰[1] 金城[1] 李寒冰[3] 肖小河[1] 

机构地区：[1]解放军第302医院中药研究所,北京100039 [2]江西中医学院,江西南昌330004 [3]河南中医学院,河南郑州450008

出　　处：《中国中药杂志》2012年第8期1122-1126,共5页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(30873385);北京市自然科学基金项目(7112128)

摘　　要：针对中药材-中间体-成品一体化质量管理体系中存在的方法学"短板效应",借鉴过程控制理念,从中药生产实际出发,建立符合中药特点的生产过程质量控制新策略、新方法。以疗效确切、临床应用广泛的板蓝根颗粒为示例,采用性状鉴别、指标成分含量测定、化学指纹图谱和生物测定技术分别对板蓝根药材-中间体(水提醇沉)-成品进行质量评控,以化学信息转移率和生物效价转移率为指标,考察上述不同评控方法的效力性与传递性,最终建立基于化学组分分析-生物测定关联分析的板蓝根颗粒生产过程质量控制方法,有效地解决目前板蓝根颗粒生产厂家繁多、质量参差不齐的现状,以确保与提升其临床疗效,亦为中药生产过程质量控制的方法学构建提供了研究基础。For the quality management system of herbal medicines,intermediate and finished products it exists the ＂short board＂ effect of methodologies.Based on the concept of process control,new strategies and new methods of the production process quality control had been established with the consideration of the actual production of traditional Chinese medicine an the characteristics of Chinese medicine.Taking Banlangen granule as a practice example,which was effective and widespread application,character identification,determination of index components,chemical fingerprint and biometrics technology were sequentially used respectively to assess the quality of Banlangen herbal medicines,intermediate（water extraction and alcohol precipitation） and finished product.With the transfer rate of chemical information and biological potency as indicators,the effectiveness and transmission of the above different assessments and control methods had been researched.And ultimately,the process quality control methods of Banlangen granule,which were based on chemical composition analysis-biometric analysis,had been set up.It can not only validly solute the current status that there were many manufacturers varying quality of Banlangen granule,but also ensure and enhance its clinical efficacy.Furthermore it provided a foundation for the construction of the quality control of traditional Chinese medicine production process.

关 键 词：过程控制 组分分析 生物测定 板蓝根颗粒 

分 类 号：TQ461[化学工程—制药化工]