复方丹参黏附微丸对黏膜刺激性研究  

Study on the irritation of compound danshen adhesive pellets to mucosa

作　　者：赵梦迪[1] 黎丹奇 陈笑南[1] 喻刚艳 白洁[1] 李鹏跃[1] 陆洋[1] 杜守颖[1] 

机构地区：[1]北京中医药大学中药学院,北京100102

出　　处：《实用药物与临床》2018年第2期121-128,共8页Practical Pharmacy and Clinical Remedies

基　　金：国家"重大新药创制"科技重大专项(2014ZX093-01306-008);北京市科技新星计划项目(xx2015A048)

摘　　要：目的探讨复方丹参黏附微丸对黏膜的刺激性。方法 (1)体外刺激性:蟾蜍36只,随机分为空白对照组(KB)、空白黏附微丸组(CL)、阳性对照组(SD)、普通复方丹参微丸组(PT)、复方丹参冰片包合黏附微丸组(BNF)、复方丹参冰片不包合黏附微丸组(NBNF),每组6只。将不同药物置于蟾蜍上颚,观察纤毛形态并记录纤毛持续运动时间(PVD),从而评价各制剂对蟾蜍纤毛的毒性;(2)体内刺激性:健康SD大鼠,随机分为空白对照组(KB)、空白黏附微丸组(CL)、普通复方丹参微丸组(PT)、复方丹参冰片包合黏附微丸组(BNF)、复方丹参冰片不包合黏附微丸组(NBNF),每组9只,除空白对照组外,其余各组给药剂量为2.4 g/(kg·d),空白对照组给予等质量的水,每组分为3批,分别给药1、2、4周,处死,对大鼠胃肠道黏膜分别进行肉眼观察、病理切片观察及试剂盒检测。结果 CL组、PT组、BNF组、NBNF组的纤毛持续运动时间(PVD)为(620±22.58)、(602±22.08)、(610±12.25)、(605±20.49)min,比KB组略有缩短,但差异无统计学意义(P>0.05),各制剂组间比较差异亦无统计学意义(P>0.05)。各组制剂体内刺激性胃、肠黏膜病理切片及试剂盒检测结果均表明,空白黏附微丸及不同复方丹参微丸组灌胃给药后,未造成大鼠胃肠道黏膜出血,细胞结构变化及组织损伤。结论空白黏附制剂及3种复方丹参制剂对纤毛没有显著性刺激,连续给药1、2、4周后,未出现明显的胃、肠黏膜刺激性。Objective To investigate the irritation of compound danshen adhesive pellets to the mucosa of gastrointestinal tract. Methods（ 1） In vitro irritation： 36 toads were randomly divided into blank control group（ KB）,positive control group（ SD）,blank adhesive pellet group（ CL）,normal compound danshen pellets group（ PT）,compound danshen adhesive pellet with borneol group（ BNF） and normal compound danshen borneol group（ NBNF）,with6 in each group. The different kinds of medicine were applied to the toad in the upper jaw; the morphology of cilia was observed and the duration of cilia movement was recorded to evaluate the toxicity of cilia.（ 2） In vivo irritation： healthy SD rats were randomly divided into blank control group（ KB）,normal compound danshen adhesive pellets group（ PT）,compound danshen adhesive pellet ＋ borneol group（ BNF）,normal compound danshen borneol group（ NBNF）and blank adhesive pellet group（ CL）,9 rats in each group. Rats in KB group was given 2. 4 g/（ kg·d） of water,while rats in other groups were given the same volume of drugs. Rats in each group were divided into 3 subgroups and killed after 1,2 and 4 weeks after medication. The gastrointestinal mucosa was observed,and the pathological section was observed and detected by kit. Results The PVD of CL group,PT group,BNF group and NBNF group was（ 620 ±22. 58）,（ 602 ± 22. 08）,（ 610 ± 12. 25） and（ 605 ± 20. 49） min,which was slightly lower than that of KB group（ P〈0. 05）; there was no significant difference among the different drug groups（ P〉0. 05）. Results of observation of gastrointestinal mucosa,pathological section and reagent case showed there was no irritation to gastrointestinal mucosa of rats. Conclusion Blank adhesive pellet,normal compound danshen pellets and another two compound danshen adhesive pellets have no significant irritation to cilia and no irritation to the gastrointestinal mucosa after 1,2 and 4 weeks of medication.

关 键 词：复方丹参 黏附制剂 胃肠刺激性 大鼠 蟾蜍 

分 类 号：R285.5[医药卫生—中药学]