Study on in vitro Dissolution of Three Solid Preparations of Tianshu

ZHANG Ai-li1; ZHANG Qing-fen2

doi:10.13422/j.cnki.syfjx.2010.18.055

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Study on in vitro Dissolution of Three Solid Preparations of Tianshu

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- Study on in vitro Dissolution of Three Solid Preparations of Tianshu
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 16, Issue 18, Pages: 10-13(2010)
- 作者机构：
  
  1. 江苏联合职业技术学院连云港中医药分院
  2. 江苏康缘药业股份有限公司
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.2010.18.055
  CLC： R283.6
- Published：2010
- 稿件说明：
移动端阅览
[1]张爱丽,张庆芬.3种不同天舒固体剂型溶出度研究[J].中国实验方剂学杂志,2010,16(18):10-13.

ZHANG Ai-li1, ZHANG Qing-fen2. Study on in vitro Dissolution of Three Solid Preparations of Tianshu[J]. Chinese journal of experimental traditional medical formulae, 2010, 16(18): 10-13.
[1]张爱丽,张庆芬.3种不同天舒固体剂型溶出度研究[J].中国实验方剂学杂志,2010,16(18):10-13. DOI： 10.13422/j.cnki.syfjx.2010.18.055.

ZHANG Ai-li1, ZHANG Qing-fen2. Study on in vitro Dissolution of Three Solid Preparations of Tianshu[J]. Chinese journal of experimental traditional medical formulae, 2010, 16(18): 10-13. DOI： 10.13422/j.cnki.syfjx.2010.18.055.

摘要

目的:比较天舒制剂3种不同固体剂型的体外溶出度。方法:采用小杯法和HPLC法

以阿魏酸为指标

考察不同时间的累积溶出度

并以威布尔分布模型提取溶出参数

采用相似因子法对溶出度进行评价。结果:3种天舒固体制剂溶出度符合《中国药典》相关规定

天舒滴丸（A）、胶囊（B）、片剂（C）的Td值分别为6.15

11.30

18.66

C的相似因子f2<50

溶出度与A不等效。结论:3种天舒制剂的溶出度有显著差异

A的溶出度显著优于B和C

为改进生产工艺

评价和控制产品质量提供依据。

Abstract

Objective:To compare the dissolution of Tianshu dropping pill（A）

capsule（B） and tablet（C） in vitro.Method:Small vessel and HPLC method were applied to determine the accumulated dissolution rate of ferulic acid at the different time

data were analyzed by Weibull distribution

and the dissolution rate was evaluated by similar factor method.Result: The dissolution results of 3 kinds of Tianshu were all up to the standards of Chinese Pharmacopeia;the Td of Tianshu（A

B and C） preparations were as follows: 6.15

11.30 and 18.66 minute;the similarity factors（f2） of preparation B and C were less than 50

and the dissolutions of preparation B and C were significantly different from preparation A.Conclusion: Among them

the dissolution profile of preparation A was superior to other preparations.This provides the basis of improving the preparation process

evaluating and controlling the quality.

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