降糖消脂片成型工艺考察及熊果酸的含量测定

任烨; 葛争艳; 金龙; 郭宇洁; 刘建勋

doi:10.13422/j.cnki.syfjx.2015080013

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降糖消脂片成型工艺考察及熊果酸的含量测定

药剂与炮制 | 更新时间：2024-01-04

- 降糖消脂片成型工艺考察及熊果酸的含量测定
- Investigation of Molding Process of Jiangtang Xiaozhi Tablets and Determination of Ursolic Acid in This Tablets
- 中国实验方剂学杂志 2015年21卷第8期页码：13-16
- 作者机构：
- 作者简介：
- 基金信息：
  
  国家"重大新药创制"科技重大专项(2010ZX09102-213);国家自然科学基金青年基金项目(81202950)
- DOI：10.13422/j.cnki.syfjx.2015080013
  中图分类号： R283.6
- 纸质出版日期：2015
- 稿件说明：
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任烨, 葛争艳, 金龙, 等. 降糖消脂片成型工艺考察及熊果酸的含量测定[J]. 中国实验方剂学杂志, 2015,21(8):13-16.

REN Ye, GE Zheng-yan, JIN Long, et al. Investigation of Molding Process of Jiangtang Xiaozhi Tablets and Determination of Ursolic Acid in This Tablets[J]. Chinese journal of experimental traditional medical formulae, 2015, 21(8): 13-16.
任烨, 葛争艳, 金龙, 等. 降糖消脂片成型工艺考察及熊果酸的含量测定[J]. 中国实验方剂学杂志, 2015,21(8):13-16. DOI： 10.13422/j.cnki.syfjx.2015080013.

REN Ye, GE Zheng-yan, JIN Long, et al. Investigation of Molding Process of Jiangtang Xiaozhi Tablets and Determination of Ursolic Acid in This Tablets[J]. Chinese journal of experimental traditional medical formulae, 2015, 21(8): 13-16. DOI： 10.13422/j.cnki.syfjx.2015080013.

摘要

目的: 优选降糖消脂片的成型工艺并建立熊果酸的含量测定方法

为该制剂的工业化生产与质量控制提供参考。方法: 以外观、脆碎度、崩解时限等为指标

采用单因素试验优选降糖消脂片的成型工艺。采用HPLC测定降糖消脂片中熊果酸含量

流动相甲醇-0.05%磷酸水(90:10)

柱温2 ℃

检测波长215 nm。结果: 以15%预胶化淀粉+5%乳糖为填充剂

92%乙醇为润湿剂

内外各加3%交联聚维酮为崩解剂

0.3%硬脂酸镁为润滑剂。熊果酸进样量在0.398~3.980 μg 与峰面积呈良好线性关系

平均回收率96.96%;样品中熊果酸质量分数2.22 mg·g-1。结论: 优选的成型工艺稳定可行

建立的含量测定方法操作简便、准确、灵敏、重复性好。

Abstract

Objective: To provide a reference for industrial production and quality control of Jiangtang Xiaozhi tablets by optimizing its molding process and establishing determination of ursolic acid in this preparation. Method: With appearance

friability

disintegration time and others as indexes

molding process of Jiangtang Xiaozhi tablets was optimized by single-factor tests.HPLC was employed to determine the content of ursolic acid in Jiangtang Xiaozhi tablets with mobile phase of methanol-0.05% phosphoric acid water (90:10)

column temperature of 2 ℃ and detection wavelength at 215 nm. Result: With 15% pregelatinized starch and 5% lactose as filling agent

92% ethanol as wetting agent

adding 3% crosslinking polyvinylpolypyrrolidone internally and externally as disintegrant

0.3% magnesium stearate as lubricant.A good linearity of ursolic acid was in the range of 0.398-3.980 μg

the average recovery was 96.96%

the mass fraction of ursolic acid in samples was 2.22 mg·g-1. Conclusion: This optimized molding process is stable and feasible.This determination is simple

accurate

sensitive with a good reproducibility.

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