京尼平苷乳膏的制备和稳定性考察

孙敏捷,游伟良,张杰,曹维,施华平*

中国药学杂志 ›› 2013, Vol. 48 ›› Issue (6) : 455-460.

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中国药学杂志 ›› 2013, Vol. 48 ›› Issue (6) : 455-460. DOI: 10.11669/cpj.2013.06.014
资源与鉴定

京尼平苷乳膏的制备和稳定性考察

  • 孙敏捷1,游伟良1,张杰1,曹维3,施华平2*
作者信息 +

Preparation and Stability of geniposide Cream

  • SUN Min-jie1,YOU Wei-liang1,ZHANG Jie1,CAO Wei3, SHI Hua-ping2*
Author information +
文章历史 +

摘要

目的 制备京尼平苷乳膏并考察稳定性。方法 利用正交试验设计法筛选适宜基质,筛选了不同的促渗剂、防腐剂制成o/w型的乳膏,采用Franz 扩散池对纳米乳的体外透皮特性进行了考察,然后对乳膏的流变学和稳定性进行考察。结果 最终处方结果是油相体积分数占33%、乳化剂用量为6%、防腐剂用量为0.3%、京尼平苷占0.5%,乳化温度为80 ℃。此条件制备的乳膏色泽均匀、质地细腻、渗透性良好、便于涂布; 12 h累积渗透量为(212.73±22.76)μg·cm-2。药品在常温(25 ℃)下连续放置6个月,高温(40 ℃)和低温(4 ℃)放置3个月,京尼平苷含量和制剂pH值均符合规定。结论 京尼平苷乳膏渗透性良好,性质稳定可靠,可以作为京尼平苷经皮给药新剂型。

Abstract

Objective To prepare an o/w type geniposide cream and to investigate its stability. METHODS Appropriate base was selected by uniform design; suitable preservative and penetration enhancer were chosen according the characteristics of the cream. Franz diffusion cell was used to evaluate the transdermal characteristics in vitro; the stability and rheology of the cream were evaluated. RESULTS The optimum matrix was composed of oil phase of volume faction 33%,emulsifying agent 6%,and preservative 0.3%. The content of geniposide was 0.5%. The emulsifying temperature was 80 ℃. The cream was uniform in color,homogeneous,exquisite and easy to spread; 12 h cumulative penetration amount was (212.73±22.76)μg·cm-2. The contents and pHs of three batches of samples were in accordance with the quality standard after storage at 40 ℃,25 ℃ and 4 ℃ for 3 months. CONCLUSION Geniposide cream is very stable and has good transdermal characteristics in vitro,which is a new dosage form for transdermal drug delivery.

关键词

京尼平苷 / 乳膏 / 制备工艺 / 稳定性

Key words

geniposide / cream / preparation technology / stability

引用本文

导出引用
孙敏捷,游伟良,张杰,曹维,施华平*. 京尼平苷乳膏的制备和稳定性考察[J]. 中国药学杂志, 2013, 48(6): 455-460 https://doi.org/10.11669/cpj.2013.06.014
SUN Min-jie,YOU Wei-liang,ZHANG Jie,CAO Wei, SHI Hua-ping*. Preparation and Stability of geniposide Cream[J]. Chinese Pharmaceutical Journal, 2013, 48(6): 455-460 https://doi.org/10.11669/cpj.2013.06.014
中图分类号: R944   

参考文献

[1] Ch.P(2010)Vol I(中国药典2010年版. 一部)[S]. 2010:231-232.

[2] FANG S L,LIU Y C,ZHANG Q,et al. Study on the analgesic and anti- inf lammatory effects of geniposide. Lishizhen Med Mater Med Res( 时珍国医国药) ,2008,19(6):1374-1376.

[3] ZHANG Y Q,DU S Y,LU Y,et al. Studies on O/W partition coefficient and absorption kinetics of geniposide in fructus gardeniae extract in rat intestine . China J Chin Mater Med( 中国中药杂志),2009,34(14):1840-1844.

[4] LIU F,XIAO Y Y,PING Q N,et al. Water in oil microemulsions for transdermal delivery of fluorouracil. Acta Pharm Sin ( 药学学报) ,2009,44 (5): 540-547.

[5] ZHANG C F,YANG Z L. Effects of D-limonene and L-limonene ontransdermal absorption of ligustrazine hydrochloride . Acta Pharm Sin (药学学报),2006,41(8): 772-777.

[6] MITTAL A S,UDAIVIR S S ,ALI A,et al. The effect of penetration enhancers on permeation kinetics of nitrendipine in two different skin models. Biol Pharm Bull,2008,31(9):1766-1772.

[7] MELINDA G C,LIU P C,JAMES N,et al. Enhanced transdermal delivery of estradiol in vitro using binary vehicles of isopropyl myristate and short-chain alkanols. Int J Pharm,1995,114(2):237-245.

[8] SUN G Q,PING Q N,LI C. Effect of penetration enhancers on the in vitro permeability of artesunate through excised mouse skin. J Chin Pharm Univ( 中国药科大学学报),1996,27(6): 345-349.

[9] GAO L Q,SHU W J,GAO YO,et al. Ptimization of amorolfine self-emulsifying base cream by D-optimal mixture design and its rheology. Centr South Pharm( 中南药学),2010,8(7):481-486.

基金

江苏省中医药管理局科研项目(LB09015)

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