肛肠科外用凝胶剂的制备及其体外透皮性能考察

737·

www.chinagp E-mail:zgqkyx@chinagp ·全科医生技能发展·

流媒体播放肛肠科外用凝胶剂的制备及其体外透皮性能考察mica martinez

马弗罐庞晓晨1,2，成睿珍1,2，赵静1*【摘要】　目的　探讨肛肠科外用凝胶剂的制备方法，并考察其体外透皮给药的性能与特点。方法　2016年9—11月，以卡波姆为基质，以外观性状、离心实验、耐热耐寒实验为观察指标，采用综合评分法考察基质的最佳浓度，制备肛肠科外用凝胶剂。采用改良Franz 扩散池，超高效液相谱（UPLC ）测定芦丁的含量，评价肛肠科外用凝胶剂的体外透皮给药性能与特点。结果　通过外观性状、离心实验、耐热耐寒实验，确定1.5%的卡波姆为最佳浓度。体外透皮实验显示，制剂组的表观渗透系数（Papp ）与稳态流量（Jss ）均高于溶液组，差异有统计学意义（t Papp =0.001，P <0.01；t Jss =0.001，P <0.01）。结论　中药制备成外用凝胶剂后，较原中药熏洗汤剂使用更加方便，刺激性小，且能显著提高透皮渗透性。此结果可进一步应用于该制剂的后续研究中，为其临床应用奠定基础。

【关键词】　凝胶类；芦丁；超高效液相谱；皮肤吸收；中医肛肠科学

【中图分类号】　R 944.15　【文献标识码】　A DOI ：10.3969/j.issn.1007-9572.2017.00.171

庞晓晨，成睿珍，赵静.肛肠科外用凝胶剂的制备及其体外透皮性能考察［J ］.中国全科医学，2018，21（6）：

737-740.［www.chinagp ］PANG X C ，CHENG R Z ，ZHAO J .Preparation of a topical anorectal gel formulation and its in vitro transdermal performance ［J ］.Chinese General Practice ，2018，21（6）：737-740.［www.chinagp ］.

Preparation of a Topical Anorectal Gel Formulation and Its in Vitro Transdermal Performance 　PANG Xiao-chen 1,2, CHENG Rui-zhen 1,2, ZHAO Jing 1*

1.Chinese Medicine Hospital of Tianjin Binhai New Area, Tianjin 300450, China

2.Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China

*Corresponding author ：ZHAO Jing, Competent pharmacists; E-mail:dr_zhaojing@163

vvint【Abstract 】　Objective To study the preparation method of a topical gel formulation for anorectal diseases, and investigate the topical gel formulation 's drug performance and characteristics in topical transdermal drug delivery. Methods The study time was from September to November 2016. Carbomer was used as the matrix. An appearance/quality test, centrifugation and heat/cold resistance test were performed. The optimal concentration of the matrix was determined by a comprehensive scoring method. The rutin content was measured by a modified Franz diffusion cell technique and ultra-high performance liquid chromatography. The drug performance and characteristics of the transdermal delivery of the topical gel formulation were evaluated. Results The optimal concentration of carbomer was determined to be 1.5% by appearance/quality test, centrifugation and heat/cold resistance test. In vitro transdermal delivery test showed that the apparent permeability coefficient (Papp) and steady state flow rate (Jss) of the gel formula were both significantly higher than those of the solution formula (t Papp =0.001, P <0.01; t Jss =0.001, P <0.01). Conclusion The topical gel formulation is more convenient and the gel is less irritating than the original fuming-washing lotion. It is significantly increases the transdermal permeability of active compounds. Our results can

be a reference to guide the subsequent study of the topical gel formulation and lay a foundation for t

he clinical application of the formulation.【Key words 】　Gels; Rutin; UPLC; Skin absorption; Colo-proctology (TCM)基金项目：天津市卫生和计划生育委员会中医中西医结合科

水塔水位控制系统研课题（2015144；2017095）；天津市滨新区中医医院科技项目

（bhzy201607）

缝纫网1.300450天津市滨海新区中医医院

2.300193天津市，天津中医药大学*通信作者：赵静，主管药师；E-mail ：dr_zhaojing@16

3 肛洗二号是一种熏洗汤剂，是天津市滨海新区中医医院

肛肠科使用多年的临床经验方，由黄柏、槐花、苦参、白蔹、五倍子等十余种中药组成，临床常用于湿热瘀阻型混合痔术后的水肿及疼痛，具有清热解毒、消肿止痛的功效［1-2］。尽管此方临床应用广泛，但该剂型存在使用不方便、剂量不准确等缺点，为了克服上述不足，将传统剂型改为外用凝胶剂。外用凝胶剂不但具有使用方便、黏性好、刺激性小等特点，而且提高了药物维持时间，方便局部给药［3］。凝胶剂中的药

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