口服固体制剂最佳混合时间及混合均匀性的统计学研究

Statistics Research on Optimum mixing Time and Mixing Uniformity of Oral Solid Preparation

在口服固体制剂的整个工艺过程中,总混工序是促使产品均匀的最关键的工序,总混结束后,混粉的质量均一性直接影响了每一份成品之间的一致性。如果混粉未混合均匀,会因为后面的分剂量的工序把这一质量方面的缺陷放大数倍,更甚者会导致产品无治疗效果,或者剂量过剩,从而对服药者带来危险。本篇通过统计学的方法研究总混工序的最佳时间和均匀性,提供一种科学的分析思路。

In the whole craft process of oral solid preparations, total mixing process is the key step of promoting product evenly, after the total mixing, the quality homogeneity of mixed powder directly affects the consistency between each finished product. If the mixed powders do not get mixing uniformity, the dose process will enlarge the quality defects in several times, worsely, it will lead to the invalid treatment for products, or excess dosage and then cause danger to medications. In this paper, it takes the statistics method to study the optimum time and uniformity of total mixing process and provides a scientific analysis method.