摘要
目的建立止痒润肤乳膏质量标准,并评价该制剂的皮肤用药安全性。方法采用薄层色谱法对止痒润肤乳膏中的当归、苦参、大风子仁进行定性鉴别;采用高效液相色谱法对止痒润肤乳膏中苦杏仁苷进行定量检测;通过家兔皮肤刺激性实验对止痒润肤乳膏的皮肤安全性进行评价。结果薄层色谱斑点显色清晰,且阴性对照无干扰。3批次止痒润肤乳膏中苦杏仁苷平均含量为0.302 mg/g。皮肤刺激性实验中,观察期内家兔皮肤均无刺激性,皮肤病理学检查结果无异常。结论建立的质量标准结果准确,可用于止痒润肤乳膏的质量控制。止痒润肤乳膏无皮肤刺激性,外用治疗安全。
Objective To establish the quality standard of Zhiyang Runfu Cream and evaluate its skin safety.Methods The qualitative identification of Angelicae Sinensis Radix,Sophorae Flavescentis Radix,and Hydnocarpi Anthelminthici Semen in Zhiyang Runfu Cream was carried out by thin-layer chromatography.The amygdalin in Zhiyang Runfu Cream was quantitatively detected by high performance liquid chromatography.The skin safety of Zhiyang Runfu Cream was evaluated by skin irritation test in rabbits.Results The thin-layer chromatography spots were clearly visible,and there was no interference from the negative control.The average content of amygdalin in three batches of Zhiyang Runfu Cream was 0.302 mg/g.In the skin irritation test,no skin irritation was observed in the rabbits skin during the observation period,and no abnormal results were found in the histopathological examination of the skin.Conclusion The established quality standard is accurate and can be used for the quality control of Zhiyang Runfu Cream.Zhiyang Runfu Cream has no skin irritation,and is safe for topical treatment.
作者
鹿爱娟
唐林
李海英
彭理
杨磊
LU Aijuan;TANG Lin;LI Haiying;PENG Li;YANG Lei(Hospital-made Preparations Center,the First Hospital of Hunan University of Chinese Medicine,Hunan Province,Changsha 410000,China)
出处
《中国医药导报》
2026年第1期71-75,共5页
China Medical Herald
基金
湖南省自然科学基金青年项目(2024JJ6362)
中央财政转移支付地方项目(湘中医药函〔2024〕5号)
湖南省卫生健康高层次人才项目(湘卫函〔2024〕43号)。
关键词
止痒润肤乳膏
质量标准
薄层色谱法
高效液相色谱法
皮肤刺激性
Zhiyang Runfu Cream
Quality standard
Thin-layer chromatography
High performance liquid chromatography
Skin irritation
