Study on manufacturing process performance index of Qingkailing injection

Abstract

In this paper, the process performance indexes (PPIs) P(p) and P(pk) were introduced and applied to evaluate the process capability and quality consistence of Chinese medicine products. The historical quality analysis data of Qingkailing injection were collected and taken as the research object. The confidence intervals of P(p) and P(pk) were estimated based on the Bootstrap sampling methods. Results showed that the value and width of the confidence interval P(p) of were smaller that of P(pk) suggesting that the P(pk) index was more sensitive than P(p) in process capability analysis. Within the production period concerned, the P(pk) values estimated from different quality indexes of Qingkailing injection, such as baicalin, cholic acid, geniposide and total nitrogen, were 1.122, 2.055, 1.564 and 0.891, respectively. It could be found that the cholic acid had the highest process capability, followed by the geniposide and baicalin. The total nitrogen had the lowest process capability, indicating that it is necessary to reinforce the quality management of total nitrogen related manufacturing processes. The case studies demonstrate the effectiveness and feasibility of PPIs, which are convenient to be used in production practice of Chinese medicine.