热毒宁注射液金银花提取浓缩工段过程性能指数研究  

Study on manufacturing process performance index of extraction and concentration process of Lonicerae Japonicae Flos of Reduning Injection

作　　者：王磊[1] 杨越[1] 李页瑞[1] 陈永杰[2] 陈勇[1] 

机构地区：[1]浙江大学药学院现代中药研究所,浙江杭州310058 [2]江苏康缘药业股份有限公司,江苏连云港222001

出　　处：《中草药》2017年第14期2864-2869,共6页Chinese Traditional and Herbal Drugs

基　　金：国家科技部"国家重大新药创制"项目:现代中药创新集群与数字制药技术平台(2013ZX09402203)

摘　　要：目的以热毒宁注射液的金银花提取浓缩工段为研究对象,使用过程性能指数(PPI)评价金银花提取浓缩中间体质量的可靠性和批间质量一致性。方法收集一定时间内热毒宁注射液金银花提取浓缩工段中间体质量控制指标(新绿原酸、绿原酸、隐绿原酸、咖啡酰奎宁酸质量分数和固含量)的历史数据,使用PPI PPK对其评价,并结合Bootstrap算法计算PPI的置信区间。结果新绿原酸、绿原酸、隐绿原酸、咖啡酰奎宁酸质量分数和固含量的PPK分别为1.115 6、1.111 2、1.117 9、1.110 9和1.560 0,固含量的过程生产能力最高,几种酚酸的能力次之,但均满足工段生产的要求,表明该工段中间体的可靠性和批间质量一致性较好;各个质量控制指标95%置信区间的下限分别为1.068 3、1.049 6、1.066 7、1.052 1、1.495 2,均大于1.000 0,说明分析结果较为可靠。结论该方法可用于热毒宁注射液金银花提取浓缩工段生产能力评价和质量一致性的量化研究,为后续建立质量放行标准和工艺参数放行标准提供判断的依据。Objective To evaluate the probability and quality consistence of Lonicera japonica Flos extraction and concentration intermediate by introducing and applying process performance index（PPI） PPK. Methods With the historical quality analysis date of intermediate of Lonicerae Japonicae Flos extraction and concentration process of Reduning Injection., the confidence intervals of PPKwere estimated based on the Bootstrap sampling methods. Results The PPK of neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, caffeoylquinic acid, solid holdup was 1.115 6, 1.111 2, 1.117 9, 1.110 9, and 1.560 0 respectively. The PPK of solid holdup is the highest, the PPK of several phenolic acids is lower, but all the PPK can meet the production requirements, showed that the probability and quality consistence of this process is good. The lower limit of 95% confidence intervals of quality indexes was 1.068 3, 1.049 6, 1.066 7, 1.052 1, and 1.495 0 respectively, all greater than 1.000 0, indicating the results were credible. Conclusion The method can be used to evaluate the probability and quality consistence of Lonicerae Japonicae Flos extraction and concentration process, and it provides fundamental evidence on establishing quality standards for releasing or process parameters for releasing.

关 键 词：热毒宁注射液 金银花 提取浓缩 中间体 质量评价 过程性能指数 质量一致性 Bootstrap算法 置信区间 新绿原酸 绿原酸 隐绿原酸 咖啡酰奎宁酸 固含量 酚酸 放行标准 

分 类 号：R284.2[医药卫生—中药学]