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ABSTRACT OBJECTIVE：To optimize the water extraction and ethanol precipitation technology of Zhuang medicine Baijin
granules. METHODS：HPLC method was adopted to determine the content of bergenin in Baijin granules extract. The extraction
routes of Baijin granules（water decoction，70％ ethanol reflux extraction，water decoction combined with 70％ ethanol reflux
extraction）was screened primarily with the yield of extract and the experiment of reducing uric acid of mice. The orthogonal test
was adopted to optimize water extraction technology of Baijin granules with water multiple，extraction time and extraction times as
factors，taking the extraction yield and the bergenin content as index，then the validation test was carried out. The orthogonal test
was adopted to optimize the alcohol precipitation process of Baijin granules including the relative density of medicinal materials，
alcohol content and the alcohol precipitation time，then the validation test was carried out. By the experiment of reducing uric acid，
the effects of medicinal materials extract of Baijin granules extract were compared before and after ethanol precipitation.
RESLUTS：Established method for content determination of bergenin with linearity range of 0.007 2-0.288 mg/mL，had good
precision，reproducibility，stability and accuracy. The initially chosen extraction process of Baijin granules was water decoction
extraction. The optimal water extraction technology was soaked for 0.5 h，then decocted for 3 times with 14-fold water（mL/g）and
1.0 h each time. The optimal ethanol precipitation process was to concentrate the water extract to a relative density of 1.0 g/mL with
alcohol content of liquid at 60％ and precipitated for 12 h. Validation tests showed that RSDs of extract yield and beragenin content
were all lower than 2％（n＝3）. The experiment of pharmacodynamics showed that water extract（before ethanol precipitation）and
water extract after alcohol precipitation could significantly decrease the level of uric acid in hyperuricemia model mice（P＜0.01）.
There was no statistical significance in the reduction of uric acid between 2 groups（P＞0.05）. CONCLUSIONS：The optimized
water extraction technology can obtain good extract yield and bergenin content，and combined with ethanol precipitation technology
for removing excess impurities would not affect the pharmacodynamics. The water extraction and ethanol precipitation technology is
feasible，and can be used for extracting the medicinal materials of Baijin granules and its edulcoration.
KEYWORDS Zhuang medicine；Baijin granules；Water extraction；Ethanol precipitation；Orthogonal test；Pharmacodynamics；
Bergenin；Hyperuricemia

高尿酸血症（Hyperuricemia）是一种以血尿酸升高 金颗粒的最佳水提工艺，并采用正交设计优选出最佳醇
为特征的代谢疾病，在临床上表现为血尿酸水平高于正 沉工艺，再考察醇沉法除去杂质的过程对其药效作用的
常范围（男性为 420 μmol/L，女性为 350 μmol/L）的异常 影响，最终确定柏金颗粒的最佳水提醇沉工艺，为后续
[1]
机体状态 ，也是导致高血压、高血脂、冠心病等发生的 该颗粒剂的进一步研发提供基础。
重要原因之一 [2-4] ，对人类健康的威胁日益加深。柏金方 1 材料
为广西国际壮医医院的临床经验方，由石上柏 7.5 g、铁 1.1 仪器
包金5 g、小叶金花草5 g、土茯苓5 g、苏木5 g、广金钱草 1260 型高效液相色谱（HPLC）仪（美国 Agilent 公
7.5 g、益母草 7.5 g、白茅根 15 g、葫芦茶 5 g、矮地茶 5 g、 司）；RE-52A 型旋转蒸发仪（上海亚荣生化仪器厂）；
木贼15 g、甘草2.5 g共12味药材组成，经该院多年临床 SHB-Ⅲ型循环水式多用真空泵（郑州长城科工贸有限公
验证适用于高尿酸血症的治疗，疗效显著。本方以壮医 司）；DGF-4AB 型立式电热鼓风干燥箱、98-1-B 型电子
药学理论为指导，通过主药、帮药、带药进行组方，具有 控温电热套（天津市泰斯特仪器有限公司）；KQ-500E型
多靶点、多环节、整体性调节机体的特点 [5-6] 。方中石上 超声波清洗器（昆山市超声仪器有限公司）；JA2003N型
柏、铁包金、小叶金花草等3味为主药，合用可通龙路、调 电子天平（上海佑科仪器仪表有限公司）；CP21 型电子
气道、解热毒；土茯苓、苏木、广金钱草、益母草、白茅根、 天平[奥豪斯仪器（上海）有限公司]；1510型全波长酶标
葫芦茶、矮地茶、木贼等8味为帮药，有加强主药清热除 仪[赛默飞世尔科技（中国）有限公司]；TGL-16A 型医用
湿祛风之功效，通调三道两路；再佐以甘草调和解毒，是 离心机（湖南平凡科技有限公司）。
为带药 [5-7] 。 1.2 药品与试剂
柏金方原为煎煮汤剂，但汤剂存在煎煮过程繁琐、 白茅根、矮地茶、木贼等3味药材饮片均购自广西仙
不便于携带和保存、服用量大等缺点。为了解决这些问 茱中药科技有限公司（批号分别为20180801、20171001、
题并提高患者用药依从性，本课题组拟对柏金方进行改 20181001）；石上柏、铁包金、葫芦茶、小叶金花草、土茯
进和优化，将其研制成颗粒剂。本研究以该方组方药材 苓、广金钱草、甘草、益母草、苏木等9味药材饮片均购自
提取物的浸膏得率和具有明确的抗高尿酸活性的岩白 广西华夏药源药业有限公司（批号分别为 190101、
菜素（矮地茶主要活性成分 ）的含量为指标，在单因素 190101、190101、190101、180601、190101、181101、
[8]
试验的基础上，采取正交设计结合药效学实验优选出柏 190101、190101）。以上药材饮片经中南民族大学药学

·920 · China Pharmacy 2020 Vol. 31 No. 8 中国药房 2020年第31卷第8期