Study on manufacturing process performance index of extraction and concentration process of lonicerae japonicae flos of reduning injection / 中草药

ABSTRACT

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 PPK were 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.