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Unit Operation Optimization for the Manufacturing of Botanical Injections Using a Design Space Approach: A Case Study of Water Precipitation

机译：设计空间法优化植物注射剂生产的单位操作：以水沉淀为例

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Quality by design (QbD) concept is a paradigm for the improvement of botanical injection quality control. In this work, water precipitation process for the manufacturing of Xueshuantong injection, a botanical injection made from Notoginseng Radix et Rhizoma, was optimized using a design space approach as a sample. Saponin recovery and total saponin purity (TSP) in supernatant were identified as the critical quality attributes (CQAs) of water precipitation using a risk assessment for all the processes of Xueshuantong injection. An Ishikawa diagram and experiments of fractional factorial design were applied to determine critical process parameters (CPPs). Dry matter content of concentrated extract (DMCC), amount of water added (AWA), and stirring speed (SS) were identified as CPPs. Box-Behnken designed experiments were carried out to develop models between CPPs and process CQAs. Determination coefficients were higher than 0.86 for all the models. High TSP in supernatant can be obtained when DMCC is low and SS is high. Saponin recoveries decreased as DMCC increased. Incomplete collection of supernatant was the main reason for the loss of saponins. Design space was calculated using a Monte-Carlo simulation method with acceptable probability of 0.90. Recommended normal operation region are located in DMCC of 0.38–0.41 g/g, AWA of 3.7–4.9 g/g, and SS of 280–350 rpm, with a probability more than 0.919 to attain CQA criteria. Verification experiment results showed that operating DMCC, SS, and AWA within design space can attain CQA criteria with high probability.
机译：设计质量（QbD）概念是改善植物注射质量控制的范例。在这项工作中，使用设计空间方法作为样品优化了用于制造血栓通注射液的水沉淀工艺，血栓通注射液是由三七（Radioginseng Radix et Rhizoma）制成的植物注射液。通过对血栓通注射液的所有过程进行风险评估，将上清液中的皂苷回收率和总皂苷纯度（TSP）确定为水沉淀的关键质量属性（CQA）。应用石川图和分数阶乘设计实验来确定关键工艺参数（CPP）。浓缩提取物（DMCC）的干物质含量，加水量（AWA）和搅拌速度（SS）被确定为CPP。通过Box-Behnken设计的实验来开发CPP和过程CQA之间的模型。所有模型的测定系数均高于0.86。当DMCC低而SS高时，可获得上清液中高TSP。随着DMCC的增加，皂苷的回收率下降。上清液收集不完全是皂苷损失的主要原因。使用蒙特卡洛模拟方法计算设计空间，可接受的概率为0.90。推荐的正常运行区域位于DMCC为0.38–0.41 g / g，AWA为3.7–4.9 g / g和SS为280–350 rpm的情况下，达到CQA标准的可能性大于0.919。验证实验结果表明，在设计空间内运行DMCC，SS和AWA可以很可能达到CQA标准。

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