Study on the quality stability of Pre-decocted Cynanchi Paniculati Radix et Rhizoma, a Chinese medicinal herb for post-decoction
中药汤剂先煎后下类药材预煎成品“徐长卿”质量稳定性研究

摘要

目的 评价徐长卿预煎液在不同储存条件下的质量稳定性。方法 采用高效液相色谱技术（HPLC）测定指标成分丹皮酚的含量，同时结合pH计测定每日取样样品的pH值。结果 在阴凉与常温条件下储存8天，样品中丹皮酚含量的相对标准偏差（RSD）分别为2.35%、2.78%，均小于3%，表明稳定性良好。冷藏条件下，样品前5天丹皮酚的RSD为2.79%，稳定性尚可；自第6天起，丹皮酚含量呈下降趋势，RSD值超过3%，稳定性变差，但也在可控范围内。结论 徐长卿预煎液在阴凉或常温下储存具有良好的稳定性，这一点通过质量控制技术研究得到了验证，从而确保了其在实际应用中的可行性。本研究为“后下”类中药预煎制剂的储存与质量控制提供了参考和科学依据。

Abstract

Objective To evaluate the quality stability of the pre-decocted product of Cynanchi Paniculati Radix et Rhizoma under different storage conditions.
Methods The content of paeonol, the index component, was determined by High-Performance Liquid Chromatography (HPLC), and the pH value of the samples was measured daily.
Results When stored for 8 days under cool and ambient temperature conditions, the relative standard deviations (RSDs) of paeonol content were 2.35% and 2.78%, respectively (both < 3%), indicating good stability. Under refrigerated conditions, the RSD was 2.79% for the first 5 days, showing acceptable stability. However, from the 6th day onward, the paeonol content began to decrease with the RSD exceeding 3%, signifying deteriorated stability, but it remained within a controllable range.
Conclusion   The pre-decocted product of Cynanchi Paniculati Radix et Rhizoma exhibits good stability when stored at cool or ambient temperatures, which is verified by quality control technology research, thus ensuring its feasibility in practical application. This study provides a reference and scientific basis for the storage and quality control of pre-decocted product preparations of Chinese medicines that require “post-decoction”.