戊己胃漂浮片中多指标成分的体外释放及体内滞留时间考察

刘文; 王群; 陈中芬; 杨颂; 施晓伟

doi:10.11653/syfj2013230043

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戊己胃漂浮片中多指标成分的体外释放及体内滞留时间考察

更新时间：2024-01-04

- 戊己胃漂浮片中多指标成分的体外释放及体内滞留时间考察
- Investigation of Release Properties and Residence Time of Multi-Index Constituents from Wuji Gastric Floating Sustained-Release Tablets
- 中国实验方剂学杂志 2013年19卷第23期页码：43-46
- 作者机构：
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  贵州省中药现代化科技产业研究开发专项(黔科合中药[2010]5016号)
- DOI：10.11653/syfj2013230043
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- 纸质出版日期：2013
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刘文, 王群, 陈中芬, 等. 戊己胃漂浮片中多指标成分的体外释放及体内滞留时间考察[J]. 中国实验方剂学杂志, 2013,19(23):43-46.

LIU Wen, WANG Qun, CHEN Zhong-fen, et al. Investigation of Release Properties and Residence Time of Multi-Index Constituents from Wuji Gastric Floating Sustained-Release Tablets[J]. Chinese journal of experimental traditional medical formulae, 2013, 19(23): 43-46.
刘文, 王群, 陈中芬, 等. 戊己胃漂浮片中多指标成分的体外释放及体内滞留时间考察[J]. 中国实验方剂学杂志, 2013,19(23):43-46. DOI： 10.11653/syfj2013230043.

LIU Wen, WANG Qun, CHEN Zhong-fen, et al. Investigation of Release Properties and Residence Time of Multi-Index Constituents from Wuji Gastric Floating Sustained-Release Tablets[J]. Chinese journal of experimental traditional medical formulae, 2013, 19(23): 43-46. DOI： 10.11653/syfj2013230043.

摘要

目的: 考察戊己胃漂浮缓释片中4种成分的体外释放规律及其在家兔胃内的滞留时间。方法: 采用浆法测定戊己胃漂浮缓释片的体外释放度，以含0.8%聚山梨酯-80的0.1 mol·mL-1盐酸溶液为释放介质，运用HPLC测定戊己胃漂浮缓释片中盐酸小檗碱、吴茱萸碱和吴茱萸次碱、芍药苷在12 h内的体外累积释放率，色谱条件为Thermo-ODS2-Hypersil色谱柱（4.6 mm×250 mm，5 μm），流动相乙腈（A）-0.05 mol·L-1磷酸二氢钾（B）梯度洗脱（0~20 min，11%A;22~44 min，28%A;46~70 min，40%A），检测波长225 nm;对数正态分布模型、威布尔分布函数和Higuich方程进行溶出动力学模拟，利用γ-闪烁照相法考察戊己胃漂浮缓释片在家兔胃内的滞留时间。结果: 4种成分的体外释放均符合Higuchi模型，戊己胃漂浮缓释片可在家兔胃内滞留6 h。结论: 饱腹状态下，戊己胃漂浮缓释片在家兔胃内的滞留时间明显长于禁食状态下，提示食物可能对该制剂在胃内的滞留时间具有显著性影响。

Abstract

Objective: To investigate in vitro release properties and gastric residence time in rabbits of four ingredients from Wuji gastric floating sustained-release tablets. Method: In vitro release of Wuji gastric floating sustained-release tablets was determined by slurry method

with 0.1 mol· mL-1 HCl solution containing 0.8% tween-80 as release mediator

cumulative release of paeoniflorin

berberine hydrochloride

evodiamine and rutaecarpin from Wuji gastric floating sustained-release tablets within 12 h were measured by HPLC

chromatographic conditions were as follows:Thermo-ODS2-Hypersil column(4.6 mm×250 mm

5 μm)

mobile phase of acetonitrile(A)-0.05 mol· L-1 potassium dihydrogen phosphate(B) with gradient elution program of (0-20 min

11% A;22-44 min

28% A;46-70 min

40% A)

detection wavelength 225 nm;Dissolution kinetics models were simulated by lognormal distribution model

Weibull function and Higuchi equation

and γ scintigraphy was adopted to detect gastric residence time in rabbits of Wuji gastric floating sustained-release tablets. Result: Cumulative release of four ingredients all fitted Higuchi equation

gastric residence time of this preparation was 6 h in rabbits. Conclusion: Under satiety state

gastric residence time in rabbits of Wuji gastric floating sustained-release tablets was significantly longer than fasting state

it revealed that food may have a significant impact on gastric residence time of this tablets.

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