Antipruritic Effects of Compound Fushen Cream and Its Safety Evaluation

PENG Fangchen; ZHENG Bin; WANG Jing; ZHANG Hui; CHEN Lifang; HAO Jie; LEI Kun; KANG Jing

doi:10.14009/j.issn.1672-2124.2022.02.003

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Antipruritic Effects of Compound Fushen Cream and Its Safety Evaluation

更新时间：2022-10-08

- Antipruritic Effects of Compound Fushen Cream and Its Safety Evaluation
- Vol. 22, Issue 2, Pages: 137-141(2022)
- 作者机构：
  
  1. 山西省人民医院药学部临床药学科
  2. 山西省人民医院皮肤科
  3. 山西省人民医院内分泌科
  4. 山西省人民医院中医科
- 作者简介：
- 基金信息：
- DOI：10.14009/j.issn.1672-2124.2022.02.003
  CLC： R285.5
- Published：2022，
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PENG Fangchen, ZHENG Bin, WANG Jing, et al. Antipruritic Effects of Compound Fushen Cream and Its Safety Evaluation. [J]. 22(2):137-141(2022)
DOI：

PENG Fangchen, ZHENG Bin, WANG Jing, et al. Antipruritic Effects of Compound Fushen Cream and Its Safety Evaluation. [J]. 22(2):137-141(2022) DOI： 10.14009/j.issn.1672-2124.2022.02.003.

摘要

目的：通过动物实验，评价复方肤参霜的抗炎止痒作用及安全性。方法：(1)取昆明种小鼠50只，随机分为阳性对照组、空白对照组，低、中和高剂量复方肤参霜组，采用二甲苯致小鼠耳廓肿胀，考察复方肤参霜的抗炎作用。(2)取右后足剃毛豚鼠50只，随机分为阳性对照组、空白对照组，低、中和高剂量复方肤参霜组，采用磷酸组胺致豚鼠舔该侧后足，计算致痒阈。(3)取背部去毛的昆明种小鼠40只，随机分为基质组和复方肤参霜组，在小鼠背部脱毛区分别涂抹空白基质和复方肤参霜(每只0.25 g)

连续观察7 d小鼠的中毒反应及死亡情况，评价皮肤给药的急性毒性作用。(4)取背部去毛的新西兰兔16只，随机分为单次给药组和多次给药组，再分为完整皮肤组和破损皮肤组。各组在左侧去毛区分别涂抹复方肤参霜(0.5、1.0 g)

在右侧去毛区分别涂抹空白基质(1.0 g)和空白(不涂抹)给药后观察皮肤情况，评价皮肤给药的安全性。结果：(1)与空白对照组比较，低、中和高剂量复方肤参霜组小鼠耳廓肿胀度降低，差异均有统计学意义(P<0.05)。(2)与空白对照组比较，阳性对照组和低、中、高剂量复方肤参霜组豚鼠磷酸组胺所致的致痒阈均提高，差异均有统计学意义(P<0.05)。(3)皮肤给药的急性毒性试验中，各组小鼠均存活、主要脏器未见异常，基质组与复方肤参霜组小鼠体重比较，差异无统计学意义(P>0.05)。(4)单次/多次皮肤刺激试验中，完整/破损皮肤组新西兰兔在涂药后均存活，其饮食、行为活动、眼和黏膜均正常，皮肤无明显红斑、水肿现象，且多次皮肤刺激试验破损皮肤组新西兰兔的破损部位已结痂。结论：复方肤参霜在本实验动物模型中具有较明显的抗炎止痒疗效和良好的安全性。

Abstract

OBJECTIVE: To evaluate the antipruritic effects and safety of compound Fushen cream through animal experiments.METHODS:（1） Fifty KM mice were randomly divided into positive control group and blank control group

low

medium and high dose compound Fushen cream groups

xylene was used to cause swelling in the auricle of mice to investigate the anti-inflammatory effect of compound Fushen cream.（2） Fifty guinea pigs with right hind foot shaved were randomly divided into positive control group and blank control group

low

medium and high dose compound Fushen cream groups

histamine phosphate was used to cause guinea pigs to lick the right hind foot

and the itch-causing threshold was calculated.（3） Forty KM mice with dorsal unhaired were randomly divided into substrate group and compound Fushen cream group

the blank substrate and compound Fushen cream（0.25 g each） were applied to the unhaired area

the toxic reactions and death of mice were continuously observed for 7 d to evaluate the acute toxic effects of cutaneous administration.（4） Sixteen New Zealand rabbits with dorsal unhaired were randomly divided into single administration group and multiple administration group

and then divided into intact skin group and damaged skin group.Each group was given compound Fushen cream（0.5 g

1.0 g） on the left side of unhaired area

and blank substrate（1.0 g） and blank（no application） on the right side of unhaired area

so as to observe the skin condition and to evaluate the safety of cutaneous administration.RESULTS:（1） Compared with the blank control group

the auricular swelling of mice in the low

medium and high dose compound Fushen cream groups was reduced

with statistically significant differences（P<0.05）.（2） Compared with the blank control group

the positive control group and the low

medium and high dose compound Fushen cream groups were able to increase the itch-causing threshold induced by histamine phosphate

with statistically significant differences（P<0.05）.（3） In the acute toxicity test of cutaneous administration

all the mice in each group survived and no abnormalities were observed in major organs

and there was no statistically significant difference in body weight of mice between the substrate group and the compound Fushen cream group（P>0.05）.（4） In the single/multiple skin irritation test

all New Zealand rabbits in the intact/damaged skin groups survived after administration

and their diet

behavioral activities

eyes and mucous membranes were normal

with no obvious erythema or edema on skin

and the damaged areas in the damaged skin group had crusted over in the multiple skin irritation test.CONCLUSIONS: The compound Fushen cream has obvious anti-inflammatory and anti-itching efficacy and good safety in this experimental animal model.

关键词

中药复方肤参霜抗炎止痒药效学安全性

Keywords

Traditional Chinese medicineCompound Fushen creamAnti-inflammatory and anti-itchingPharmacodynamicsSafety

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