Preparation Process Optimization and Quality Control of the Classical Prescription Yiguanjian Granules (一贯煎颗粒)
Author：YANG Shengnan1, WU Yongsheng1,2, ZHENG Shunliang1,2, WEI Huaifu2
Unit：1.Tianjin University of Traditional Chinese Medicine, Tianjin 301600, China; 2.Jiuzhitang Co., Ltd., Beijing 101300, China
Quote：引用：杨胜南，务勇圣，郑顺亮，韦怀福.经典名方一贯煎颗粒的制备工艺优化及质量控制[J].中医药导报,2026,32(2):74-79.
DOI：10.13862/j.cn43-1446/r.2026.02.012
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Abstract：
Objective: To optimize the preparation
process and establish the quality standard for Yiguanjian granules. Methods:
Using the granule yield, qualification rate, moisture content, angle of repose,
and solubility as evaluation indices, the optimal conditions for one-step
granulation were determined by single-factor experiments investigating
parameters such as the relative density of the extract, spraying speed, and
inlet air temperature. Thin-layer chromatography (TLC) was used for the qualitative
identification of Maidong (Ophiopogonis Radix) and Gouqi (Lycii Fructus). The
content of rehmannioside D was determined by high-performance liquid
chromatography (HPLC). Results: One-step granulation was identified as the
optimal process. The optimized parameters were as follows: relative density of
the extract, 1.10-1.15; mass ratio of dry extract to excipients, 1:0.7-1:1;
inlet air temperature, 70-80 ℃; atomization
pressure, 0.15 MPa; peristaltic pump feed speed, 40 r/min; and fan frequency,
25-45 Hz. TLC spots were clear, indicating good specificity of the method.
Verification results from three batches showed that the granule yield,
qualification rate, moisture content, and solubility all complied with
pharmacopoeial requirements. HPLC results showed that the transfer rate of
rehmannioside D from the herbal pieces to the granules exceeded 75%, with a
mean content of 0.147% and an RSD of 3.0%. Conclusion: The preparation process
for Yiguanjian granules is stable, meeting the modern granulation objective of
"reducing dose while enhancing efficacy". The established quality
standard can effectively control product quality and it is suitable for
large-scale production.
Key words：Yiguanjian granules; classical prescription; one-step granulation; process optimization; quality control
摘要：
目的：研究一贯煎颗粒制备工艺和质量标准。方法：以颗粒得率、合格率、水分、休止角及溶化性为评价指标，通过单因素试验考察浸膏相对密度、喷液速度、进风温度等参数确定一步制粒最佳工艺条件。采用薄层色谱（TLC）法对麦冬、枸杞进行定性鉴别。采用高效液相色谱（HPLC）法测定地黄苷D含量。结果：一步制粒为最适工艺，其参数调节为：浸膏相对密度为1.10~1.15，干膏与辅料质量比为1∶0.7~1∶1，进风口温度设为70~80 ℃，雾化压力为0.15 Mpa，蠕动泵供液转速为40 r/min，风机频率25~45 Hz。TLC斑点清晰，方法专属性强；3批验证结果显示颗粒收率、合格率、水分、溶化性均符合药典要求。HPLC法测定结果显示，地黄苷D从饮片到颗粒过程中的转移率均在75%以上，含量均值为0.147%，RSD值为3.0%。结论：一贯煎颗粒制备工艺稳定，符合“减量增效”的现代制粒要求，质量标准可有效控制产品质量，适用于一贯煎颗粒的规模化生产。
关键词：一贯煎颗粒；经典名方；一步制粒；工艺优化；质量控制
Release time：2026-03-05
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