目的 优选胆黄连bile processed Coptidis Rhizoma的炮制工艺并建立胆黄连饮片的质量标准。方法 以5种生物碱类成分（盐酸小檗碱、巴马汀、黄连碱、表小檗碱、药根碱）及醇浸出物的总评归一值（OD）为评价指标，运用Box-Behnken设计-响应面法试验考察胆汁用量、炒制温度、炒药时间对胆黄连炮制工艺的影响，建立OD值与各自变量的多元二次回归方程的数学模型，通过响应面法确定工艺参数。并通过对10批样品的水分、总灰分、醇浸出物及生物碱成分的分析建立了胆黄连的质量标准。结果 胆黄连最佳炮制工艺是黄连片加入9%胆汁拌匀，闷润至干，置炒制容器内，控制炒制温度为142℃，炒制22 min，取出晾凉。3次验证试验所得OD值分别为0.721 9、0.745 4、0.753 4，接近于预测值，RSD为2.23%，说明该炮制工艺稳定、可行。建议规定胆黄连饮片的水分不得过15.0%，总灰分不得过3.0%，醇浸出物不得少于12.0%，盐酸小檗碱、巴马汀、黄连碱、表小檗碱、药根碱的质量分数分别不得少于6.0%、1.3%、1.6%、1.1%、0.34%。结论 采用响应面法优化的胆黄连炮制工艺简单可行，质量标准可控性强。

Objective To optimize the processing technology of bile processed Coptidis Rhizoma (bpCR) and establish its quality standard. Methods The overall desirability value (OD) of the contents of five alkaloid components (berberine hydrochloride, palmatine, coptisine, epiberberine and jatrorrhizine) and extract were used as evaluation index, and the Box Behnken design-response surface method (BBD-RSM) was applied to investigate the effects of bile dosage, frying temperature and frying time on the processing technology. A mathematical model of multiple quadratic regression equations of OD and respective variables was established, and the process parameters were determined by response surface method. Then, the quality standard of bpCR was established based on the moisture, total ash, extracts and alkaloid components of 10 batches samples. Results The best technological processing conditions was to add 9% of bile to the slices until dry and control the frying temperature of 142℃ and frying time of 22 min. Three validation tests yielded OD of 0.721 9, 0.745 4 and 0.753 4, which were close to the predicted value with RSD of 2.23%, indicating that the processing technology was stable and feasible. The standards were set as follows:the content of moisture and total ash should not exceed 15.0% and 3.0%, respectively, and the content of alcohol soluble extracts should not be less than 12.0%. The content of berberine hydrochloride, palmatine, coptisine, epiberberine and jatrorrhizine should not be less than 6.0%, 1.3%, 1.6%, 1.1% and 0.34%, respectively. Conclusion The processing technology of bpCR optimized by response surface methodology is simple and feasible, and the quality standard is controllable.

R283.6

2022年中央财政转移支付地方项目“基于重点研究室研究领域的中医药多学科研究能力提升项目—中药炮制标准”