经典名方三化汤颗粒制备工艺研究

Research on the Preparation Process of Classic prescription Sanhua Decoction Granules

关键词:  经典名方  三化汤  颗粒剂  制备工艺  量值传递

Key words:  Classic prescription  Sanhua Decoction  Granule preparation  Preparation process  Value transfer.

摘要:

目的 参照基准样品的关键质量属性，优化三化汤颗粒制备工艺，以评价制剂与基准样品的质量一致性，确定合理的临床剂量。方法 超高效液相色谱法（ultra-high-performance liquid chromatography, UPLC）建立三化汤颗粒指标成分含量测定方法，正交试验优选三化汤颗粒提取工艺，以指标成分含量、干膏率及指纹图谱相似度为评价指标，初步对比基准样品与最优工艺质量一致性。通过物理指纹图谱筛选辅料，以药辅比、辅糖比、乙醇浓度为评价指标，AHP-CRITIC法结合Box-Behnken优化设计三化汤颗粒成型工艺，按确定的工艺制备三化汤颗粒，考察挥发性成分在颗粒制备过程中的量值传递规律，确定挥发油加入量。结果 优化得 SHD 颗粒提取工艺：浸泡0.5 h，提取2次，第一次加12倍水提取2 h，第二次加10倍水提取1 h。优选得三化汤颗粒成型工艺：药辅比为1:1.25，辅糖比为2:1.1，75%浓度的乙醇作为润湿剂。药粉、辅料、0.3 g 包合物过筛混匀，14 目筛制粒，60 ℃干燥，整粒，得三化汤颗粒。结论 该制备工艺稳定可行，可为经典名方三化汤制剂研发提供可靠依据。

Abstract:

OBJECTIVE To optimize the preparation process of Sanhua Decoction granules by referencing the critical quality attributes of the benchmark sample, evaluate the quality consistency between the preparation and the benchmark sample, and determine a reasonable clinical dosage.METHODS An ultra-high-performance liquid chromatography (UPLC) method was established to determine the content of indicator components in Sanhua Decoction granules. An orthogonal experiment was conducted to optimize the extraction process of Sanhua Decoction granules, using the content of indicator components, dry extract yield, and similarity of fingerprint profiles as evaluation criteria to preliminarily compare the quality consistency between the benchmark sample and the optimal process. Physical fingerprint profiles were used to screen excipients, with the ratios of drug to excipient, excipient sugar ratio, and ethanol concentration as evaluation indicators. The AHP-CRITIC method combined with Box-Behnken optimization was used to design the granulation process for Sanhua Decoction granules. The granules were prepared according to the determined process, and the transfer law of volatile components during the granule preparation process was investigated to determine the amount of volatile oil to be added. RESULTS Optimization of SHD granule extraction process: Soak for 0.5 hours and extract twice. For the first extraction, add 12 times the water and extract for 2 hours; for the second extraction, add 10 times the water and extract for 1 hour. The optimized granulation process for Sanhua Decoction granules involves a drug-to-excipient ratio of 1:1.25, an excipient-to-sugar ratio of 2:1.1, and 75% ethanol as a wetting agent. The herbal powder, excipients, and 0.3 g of the complex are mixed and sieved, granulated using a 14-mesh screen, dried at 60°C, and then formed into granules, resulting in Sanhua Decoction granules. CONCLUSION The preparation process is stable and feasible, providing a reliable basis for the development of the classic formula Sanhua Decoction.