国际中医中药杂志
國際中醫中藥雜誌
국제중의중약잡지
INTERNATIONAL JOURNAL OF TRIDITIONAL CHINESE MEDICINE
2013年
12期
1086-1089
,共4页
复方调视膏%青少年近视眼%皮肤急性毒性试验%皮肤刺激性试验%皮肤过敏性试验
複方調視膏%青少年近視眼%皮膚急性毒性試驗%皮膚刺激性試驗%皮膚過敏性試驗
복방조시고%청소년근시안%피부급성독성시험%피부자격성시험%피부과민성시험
Compound Tiaoshi-plaster%Younth's short sight%Acute toxicity test for skin%Provocative test for skin%Anaphylactic test for skin
目的 观察复方调视膏皮肤用药的安全性,为防治青少年近视眼临床安全用药提供科学实验依据.方法 实验1,采用家兔进行皮肤急性毒性试验,分为完整皮肤组和破损皮肤组,同时各组分高、低剂量组和赋形剂对照组(共5组),分别于给药24 h后,去除残留的药物,去除药物后1h、24 h、48 h、72 h至第7天,每天观察上述各组是否引起家兔皮肤急性毒性反应.实验2,采用同体家兔左右侧自身对比进行皮肤刺激性试验,分完整皮肤及破损皮肤组,同时各组分高、中、低剂量组和同体对侧相同剂量赋形剂对照6组,观察各组多次给药后所产生的局部刺激反应,并在连续给药7天后,取给药皮肤组织进行病理组织学检查.实验3,采用豚鼠进行皮肤过敏性试验,分为赋形剂组、调视膏组、及阳性对照3组,分别于第6h、7d、14d进行右侧去毛皮肤致敏试验;于第28天,进行左侧去毛皮肤激发试验.观察各组是否引起豚鼠皮肤或全身过敏反应.结果 实验1,受试各组均未引起皮肤急性毒性反应;实验2,家兔皮肤刺激性试验结果,完整皮肤组肉眼观察无红斑、水肿等现象,破损皮肤组在1～5d内均出现红斑、水肿,分别与相应时间赋形剂对照组比较,差异均无统计学意义,P均＞0.05.家兔破损皮肤组在1～5 d内出现的红斑、水肿现象是由于皮肤损伤引起的炎症反应所致,非用药所致,病理组织学检查均未见异常;实验3,皮肤过敏试验赋形剂和调视膏组未引起豚鼠皮肤过敏反应和全身过敏反应.结论 复方调视膏动物试验,未引起皮肤急性毒反应和皮肤刺激性以及皮肤过敏反应.
目的 觀察複方調視膏皮膚用藥的安全性,為防治青少年近視眼臨床安全用藥提供科學實驗依據.方法 實驗1,採用傢兔進行皮膚急性毒性試驗,分為完整皮膚組和破損皮膚組,同時各組分高、低劑量組和賦形劑對照組(共5組),分彆于給藥24 h後,去除殘留的藥物,去除藥物後1h、24 h、48 h、72 h至第7天,每天觀察上述各組是否引起傢兔皮膚急性毒性反應.實驗2,採用同體傢兔左右側自身對比進行皮膚刺激性試驗,分完整皮膚及破損皮膚組,同時各組分高、中、低劑量組和同體對側相同劑量賦形劑對照6組,觀察各組多次給藥後所產生的跼部刺激反應,併在連續給藥7天後,取給藥皮膚組織進行病理組織學檢查.實驗3,採用豚鼠進行皮膚過敏性試驗,分為賦形劑組、調視膏組、及暘性對照3組,分彆于第6h、7d、14d進行右側去毛皮膚緻敏試驗;于第28天,進行左側去毛皮膚激髮試驗.觀察各組是否引起豚鼠皮膚或全身過敏反應.結果 實驗1,受試各組均未引起皮膚急性毒性反應;實驗2,傢兔皮膚刺激性試驗結果,完整皮膚組肉眼觀察無紅斑、水腫等現象,破損皮膚組在1～5d內均齣現紅斑、水腫,分彆與相應時間賦形劑對照組比較,差異均無統計學意義,P均＞0.05.傢兔破損皮膚組在1～5 d內齣現的紅斑、水腫現象是由于皮膚損傷引起的炎癥反應所緻,非用藥所緻,病理組織學檢查均未見異常;實驗3,皮膚過敏試驗賦形劑和調視膏組未引起豚鼠皮膚過敏反應和全身過敏反應.結論 複方調視膏動物試驗,未引起皮膚急性毒反應和皮膚刺激性以及皮膚過敏反應.
목적 관찰복방조시고피부용약적안전성,위방치청소년근시안림상안전용약제공과학실험의거.방법 실험1,채용가토진행피부급성독성시험,분위완정피부조화파손피부조,동시각조분고、저제량조화부형제대조조(공5조),분별우급약24 h후,거제잔류적약물,거제약물후1h、24 h、48 h、72 h지제7천,매천관찰상술각조시부인기가토피부급성독성반응.실험2,채용동체가토좌우측자신대비진행피부자격성시험,분완정피부급파손피부조,동시각조분고、중、저제량조화동체대측상동제량부형제대조6조,관찰각조다차급약후소산생적국부자격반응,병재련속급약7천후,취급약피부조직진행병리조직학검사.실험3,채용돈서진행피부과민성시험,분위부형제조、조시고조、급양성대조3조,분별우제6h、7d、14d진행우측거모피부치민시험;우제28천,진행좌측거모피부격발시험.관찰각조시부인기돈서피부혹전신과민반응.결과 실험1,수시각조균미인기피부급성독성반응;실험2,가토피부자격성시험결과,완정피부조육안관찰무홍반、수종등현상,파손피부조재1～5d내균출현홍반、수종,분별여상응시간부형제대조조비교,차이균무통계학의의,P균＞0.05.가토파손피부조재1～5 d내출현적홍반、수종현상시유우피부손상인기적염증반응소치,비용약소치,병리조직학검사균미견이상;실험3,피부과민시험부형제화조시고조미인기돈서피부과민반응화전신과민반응.결론 복방조시고동물시험,미인기피부급성독반응화피부자격성이급피부과민반응.
Objective To observe the safety of the compound Tiaoshi-plaster's use to skin,providing the scientific foundation for its use to the treatment for the younth's short sight.Methods Experiment 1,acute toxicity test for skin of rabbits:rabbits were randomly divided into two groups:a integrated skin group and a damaged skin group,in addition,every group further divide into high and low dosage group and vehicle control group,totally 5 groups.All above groups received the plaster or vehicle for 24 hours,then take away the drug,and after lh,24 h,48 h,72 h since the 7th day,observe each group's reaction separately everyday,to see whether there is a acute toxicity reaction or not.Experiment 2,self control group,use onerabbit's left and right sides' skin to observe stimulus toxicity via skin:divide the rabbits into a integrated skin group and a damaged skin group,in addition,every group further divide into high,low dosage group and vehicle control group,totally 6 groups.Observe the reaction after multiple doses,after 7 days' successive doses,take the drug-used tissues to do pathological examination.Experiment 3,cavy's skin irritation test:cavies were divide into vehicle group,plaster group,positive group,totally 3 groups,at the 6h,7th day,14th day,take off right side's skin of every group to do the provocative test respectively.On the 28th day,take off the left side's skin to do the provocative test.To see if the skin or the whole body is allergic to the plaster.Results In experiment 1,toxic response could not be found in any group; In experiment 2,rabbits in the integrated skin group didn't show redness or edema,rabbits in the damaged skin group all had redness and edema,but the differences were not statistically significant,compared with the corresponding time of vehicle group (P＞0.05).Such skin damage was not caused by plaster usage but inflammatory reaction of skin damage.In experiment 3,the vehicle group and the study group didn't show any abnormal anaphylactic reaction.Conclusion The compound Tiaoshiplaster is safe to skin.
