基于投料规范值评价中药制剂质量风险

Quality risk evaluation of traditional Chinese medicine preparations based on the value of the feeding standard

通过建立投料规范值数学公式,构建中药制剂质量风险分类管理模式。采用高效液相色谱法测定3种含前胡制剂(4厂家8批次)中白花前胡甲素、白花前胡乙素的质量分数,计算投料规范值,评价制剂质量风险。根据投料规范值将制剂质量风险分为4类,可有效评估制剂质量风险。该方法可评估中药投料规范性,及时发现制剂质量风险,为风险分类管理提供决策依据。

The mathematical formula for calculating the value of the feeding standard was developed,and the mode of quality risk management in traditional Chinese medicine preparations was constructed.The contents of peucedane A and peucedane B in three preparations containing Peucedani Radix(eight batches from four manufacturers)were determined using high-performance liquid chromatography;the feeding standard values were calculated;and the quality risks of the preparations were evaluated.The quality risks of preparations were divided into four categories based on the value of the feeding standard,allowing for an effective evaluation of the risks of preparations.The established method can be used to evaluate the standardization of preparation feeding and detect quality risks in real time,providing a decision-making basis for risk classification management.