目的：研究建立符合滴丸剂生产工艺性能和滴丸质量控制要求的 PEG 6 000 质量控制方法。方法：本研究选取常用辅料聚乙二醇 6 000（polyethylene glycol 6 000,PEG 6 000）,以复方丹参滴丸为例,首先开发了适用于滴丸剂生产工况条件下的黏度检测方法,并与《中华人民共和国药典》规定的分子量、黏度、凝 点、酸度4 类质量属性指标结合,采用多元统计分析方法,以生产出合格滴丸、符合生产要求的 15 个批次样本作为训练集,建立多元统计控制模型。结果：选取不同供应商的符合、不符合工艺要求的 12 个批次样本作为验证集,模型准确性达到 100%,能够准确区分出 PEG 6 000 是否符合滴丸生产要求。结论：本研究建立的方法能够为药品制造企业提高辅料质量控制以及供应商提升质量管理提供参考。
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