Quality Evaluationa on Stability of ZhiBing In-Situ Gel Nasal-Cavity

DONG Fu-rong1; LIU Li2; CHEN Zhi-liang1; LIU Qiang2

doi:10.13422/j.cnki.syfjx.2011.04.016

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Quality Evaluationa on Stability of ZhiBing In-Situ Gel Nasal-Cavity

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- Quality Evaluationa on Stability of ZhiBing In-Situ Gel Nasal-Cavity
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 17, Issue 4, Pages: 19-22(2011)
- 作者机构：
  
  1. 南方医科大学附属南方医院药学部
  2. 南方医科大学中医药学院
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.2011.04.016
  CLC： R283
- Published：2011
- 稿件说明：
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[1]董芙蓉,刘莉,陈志良,刘强.芷冰鼻腔原位凝胶剂的质量评价[J].中国实验方剂学杂志,2011,17(04):19-22.

DONG Fu-rong1, LIU Li2, CHEN Zhi-liang1, et al. Quality Evaluationa on Stability of ZhiBing In-Situ Gel Nasal-Cavity[J]. Chinese journal of experimental traditional medical formulae, 2011, 17(4): 19-22.
[1]董芙蓉,刘莉,陈志良,刘强.芷冰鼻腔原位凝胶剂的质量评价[J].中国实验方剂学杂志,2011,17(04):19-22. DOI： 10.13422/j.cnki.syfjx.2011.04.016.

DONG Fu-rong1, LIU Li2, CHEN Zhi-liang1, et al. Quality Evaluationa on Stability of ZhiBing In-Situ Gel Nasal-Cavity[J]. Chinese journal of experimental traditional medical formulae, 2011, 17(4): 19-22. DOI： 10.13422/j.cnki.syfjx.2011.04.016.

摘要

目的:评定芷冰鼻腔原位凝胶的质量

考察其初步稳定性。方法:采用HPLC测定方中欧前胡素和异欧前胡素的含量;采用黏度计测定凝胶黏度

采用位移法测定其黏附力;采用Valia-chien小池扩散法

考察凝胶的体外鼻黏膜渗透情况;采用体外溶出法

考察凝胶剂体外释药行为

采用pH计测定相变pH;采用离心、耐热耐寒、暴露试验和室温留样观察法对其稳定性进行初步研究。结果:凝胶剂有效成分含量稳定

黏度和黏附力、渗透系数、体外释放度、相变pH均符合2005年版《中国药典》中相关规定。初步稳定性试验表明凝胶剂耐热耐寒

性质稳定

可以长期存放。结论:芷冰鼻腔原位凝胶剂质量稳定

批间的差异较小。

Abstract

Objective:To evaluate the quality and study the stability of Zhibing in-situ gel nasal-cavity.Method:High performance liquid chromatography（HPLC） was used to determine the content of imperatorin and isoimperatorin.Viscometer was used to determine the viscocity of gel.Displacement method was used to determine the adhesive force of gel.Valia-chien diffusion method was used to study the membrane permeation characteristics in vitro.In vitro dissolution method was used to study the in vitro release characteristics;pH meter was used to deter-mine the phase-transition pH.Centrifuge method

heat proof and cold-resistant method

exposure method and room temperature retained sample observation method were used to study the stability of gel.Result:The content of active component was stable.The viscocity and adhesive force

the permeability coefficient

the in vitro release and the phase-transition pH were all in line with the rules of The Pharmacopoeia of the PRC（edition 2005）.Conclusion: The quality of Zhibing in-situ gel nasal-cavity is stable;there is little difference among groups.

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