四类眼用制剂流变学性质的研究
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- 英文论文题名：Comparative Study of Rheological Properties of Four types of Ophthalmic Preparations
- 论文作者：吴晓鸾 ; 马建芳 ; 范宵宇 ; 王林波
- 英文论文作者：Wu Xiaoluan ; Ma Jianfang ; Fan Xiaoyu ; Wang Linbo ; Shanghai Institute for Food and Drug Control
- 年：2016
- 作者机构：上海市食品药品检验所;
- 论文关键词：眼用制剂 ; 眼用凝胶剂 ; 流变学性质 ; 质量控制
- 英文论文关键词：ophthalmic preparations ; ophthalmic gels ; rheological parameters ; quality control
- 会议召开时间：2016-09-27
- 会议录名称：中国药学会第十三届青年药学科研成果交流会论文集
- 语种：中文
- 分类号：R943
- 学会代码：YYWS
- 会议名称：中国药学会第十三届青年药学科研成果交流会
- 会议地点：中国江西南昌
- 主办单位：中国药学会
- 学会名称：中国药学会
- 页数：10
- 文件大小：452k
- 原文格式：O
- 会议级别：全国
摘要
目的:通过对四类眼用制剂流变学性质的研究,比较眼用凝胶剂与其它类型眼用制剂的区别,为眼用凝胶剂质量标准增设流变学指标和参数提供依据。方法:采用配备锥板式测定模具的马尔文流变仪对四类眼用制剂进行非稳态与稳态流变学参数的测定,分析结果的异同,总结区分眼用凝胶剂与其它类型眼用制剂的流变学指标和参数。结果:(1)眼用凝胶剂在线性粘弹区范围内,弹性模量应大于粘性模量;(2)眼用凝胶剂应为具有一定屈服应力和较大触变性的剪切变稀型非牛顿流体;(3)在25℃,剪切速率为50s~(-1)时,眼用凝胶剂动力黏度应大于0.5pa·s范围内。结论:本文确立了区分眼用凝胶剂与其它类型眼用制剂的流变学指标和参数,测定方法简单,可操作性强,对于眼用凝胶剂的处方设计,生产工艺,质量控制都具有重要意义。
Objectives:To provide the basis for the rheological parameters for the additional quality standard of ophthalmic gels,the ophthalmic gels and other types of ophthalmic preparations were compared through the study of the rheological properties for four types of ophthalmic preparations.Methods:The cone-plate rheometer was used to determine the dynamic and steadily rheological parameters of four types of ophthalmic preparations.The similarities and differences of the results were compared and analyzed to summarize the rheological parameters which can be applied to distinguish the ophthalmic gels and the other types of ophthalmic preparations.Results:(1)The elastic modulus should be greater than the viscous modulus for the ophthalmic gels in the range of the linear viscoelastic region.(2) The ophthalmic gels should be shear thinning non Newtonian fluid with a small yield stress and larger thixotropy.(3) The dynamic viscosity should be in the range of 0.8-3 Pa·s at 25 ℃ with the 50 s~(-1)shear rate.Conclusions:The main rheological parameters and indexes which can distinguish the ophthalmic gels and the other types of ophthalmic preparations were established in this article.The determination methods are simple and feasible.They can be widely used to judge the quality of ophthalmic gels.The main rheological parameters and indexes have important significance to the prescription design,production technology and quality control of ophthalmic gels.
Objectives:To provide the basis for the rheological parameters for the additional quality standard of ophthalmic gels,the ophthalmic gels and other types of ophthalmic preparations were compared through the study of the rheological properties for four types of ophthalmic preparations.Methods:The cone-plate rheometer was used to determine the dynamic and steadily rheological parameters of four types of ophthalmic preparations.The similarities and differences of the results were compared and analyzed to summarize the rheological parameters which can be applied to distinguish the ophthalmic gels and the other types of ophthalmic preparations.Results:(1)The elastic modulus should be greater than the viscous modulus for the ophthalmic gels in the range of the linear viscoelastic region.(2) The ophthalmic gels should be shear thinning non Newtonian fluid with a small yield stress and larger thixotropy.(3) The dynamic viscosity should be in the range of 0.8-3 Pa·s at 25 ℃ with the 50 s~(-1)shear rate.Conclusions:The main rheological parameters and indexes which can distinguish the ophthalmic gels and the other types of ophthalmic preparations were established in this article.The determination methods are simple and feasible.They can be widely used to judge the quality of ophthalmic gels.The main rheological parameters and indexes have important significance to the prescription design,production technology and quality control of ophthalmic gels.
引文
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[3]Malvem Kinexus流变仪配套工作站软件中的帮助文件
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[7]LIU Y L,ZHANG X L,WANG Y P,et al.Evaluation on rheological properties of Dange ophthalmic in-situ gel and its common gel.Chinese Traditional and Herbal Drugs(中草药),2014,45(10):1388-1392
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[9]WANG L B,LIU W,CHEN Z K,et al.Research on method for measurement of the dynamic viscosity of vitamin A palmitate gel.Chin J Pharm Anal(药物分析),2009,29(11):2040-2043
[2]Ch.P(2015)Vol皿(中国药典2015年版四部)[S].2015:8
[3]Malvem Kinexus流变仪配套工作站软件中的帮助文件
[4]WU X L,MA J F,NIE L,et al.Rheological Property and Dynamic Viscosity Determination Method of Fusidic Acid Eye Drop.Chin J Pharmaceutical Affairs.(中国药事),2016,30(4):401-405
[5]CHEN Y P,WANG L B,SHAO H,et al.Determination Method of Dynamic Viscosity of Methylcellulose.Chin Pharm J(中国药学杂志),2013,48(5):385-388
[6]CHEN Y P,WANG L B,SHAO H,et al.Study on determination method of dynamic viscosity of hydroxypropylcellulose.Chin J Pharm Anal(药物分析杂志),2011,31(12):2252-2255
[7]LIU Y L,ZHANG X L,WANG Y P,et al.Evaluation on rheological properties of Dange ophthalmic in-situ gel and its common gel.Chinese Traditional and Herbal Drugs(中草药),2014,45(10):1388-1392
[8]WANG L B,JIN W,LE J,et al.Research of method to measure the dynamic viscosity of adapalene gel.Chin J Pharm Anal(药物分析),2008,28(12):2040-2043
[9]WANG L B,LIU W,CHEN Z K,et al.Research on method for measurement of the dynamic viscosity of vitamin A palmitate gel.Chin J Pharm Anal(药物分析),2009,29(11):2040-2043