中药生产过程质量生物评控方法研究——以板蓝根颗粒为例

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。

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

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.