复方骨质增生贴剂的毒理学与药效学研究

Toxicology and Pharmacodynamics Study of Guzhizengsheng Complex Plaster

目的考察复方骨质增生贴剂对动物皮肤的急性毒性、刺激性及其药效学。方法①取大鼠60只进行皮肤急性毒性实验,随机分为A1、A2、B1、B2和对照组1、对照组2,每组10只。均对称脱去脊柱两侧共40cm2毛,A2、B2和对照组2制作破损皮肤模型。A1、A2组脱毛区给予复方骨质增生贴剂,B1、B2组脱毛区给予复方骨质增生贴剂基质,两对照组不给予任何药物。观察大鼠短期内接触受试物所产生的全身及局部毒性反应。②取家兔6只进行皮肤刺激性实验,随机分成两组,脱去家兔脊柱两侧毛各约50cm2,脊柱右侧脱毛区涂复方骨质增生贴剂基质1g,左侧脱毛区涂复方骨质增生贴剂融化物1g,每天换药1次,连续7d。观察用药局部有无红斑、水肿等异常情况,进行刺激反应评分。③将痛阈约为6s的小鼠40只随机平均分为4组,实验组Ⅰ和实验组Ⅱ分别给予复方骨质增生贴剂1.5和3.0g,实验组Ⅲ给予骨质增生一贴灵3.0g,空白组涂基质3.0g,连续给药3d。于第3天给药后30,60,90,120min测定小鼠的痛阈。结果①A2组大鼠死亡3只,B2组死亡1只,对死亡大鼠进行尸检,无肉眼可见病变。其他组大鼠无死亡,未死亡大鼠均无异常表现。②复方骨质增生贴剂对正常皮肤和破损皮肤刺激反应平均值分别为1.40,2.00;其基质对正常和破损皮肤的刺激反应平均值分别为0.30,0.30。经刺激强?

Objective To study the acute skin toxicity, the skin irritation and analgesic effect of guzhizengsheng complex plaster. Methods ① Sixty rats were randomized into six groups evenly:A 1, A 2, B 1, B 2, control one and control two (n= 10), each one with 40 cm 2 molted on both sides of backbone to take the acute skin toxicity test. A 2, B 2 and control two were used as the skin-impaired models. A 1 and A 2 were given guzhizengsheng complex plaster, B 1 and B 2 were given the plaster basis. The systematic toxicity and topical toxicity were observed. ② Six rabbits were randomized into two groups, each one with 50 cm 2 molted on both sides of backbone to take the acute skin irritation test. The left areas were given 1 g guzhizengsheng complex plaster daily, sequentially for 7 d, and the right areas given the plaster basis in the same way. And the irritation was observed and graded. ③ Forty mice with a pain threshold of 6 s were randomized into four groups: Ⅰ, Ⅱ, Ⅲand Ⅳ. Group Ⅰand group Ⅱ were separately given 1. 5 g and 3. 0 g guzhizengsheng complex plaster daily, for 3 d. Group Ⅲ were given 3. 0 g guzhizengshengyitieling, and group Ⅳ given 3. 0 g plaster basis. On the forth day, their pain thresholds were tested at 30, 60, 90, 120 min. Results ① There were three rats died in A 2 group, and one in B 2 group. And there were no abnormality found in the live rats. ② The scores on normal skin and on impaired skin were 1.40, and 2.00 by guzhizengsheng complex plaster; and 0.30 and 0.30 by the plaster basis. The irritation is slight to normal skin and moderate to impaired skin by degree analysis, and the plaster basis had no irritation to normal skin and impaired skin.③ By comparison to group Ⅳ, the pain thresholds in group Ⅰ, Ⅱ, and Ⅲ were significantly increased (P<0. 01). Conclusion The guzhizengsheng complex plaster and the plaster basis have slight toxicity and irritation on the normal skin, and light toxicity and moderate irritation on impaired skin.Guzhizengsheng complex plaster can increase the pain threshold and has the value to develop.