加味双柏凝胶贴膏质量研究及安全性考察
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R284.1

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广东省中医药局科研立项资助项目(20201169,20211208,20211212);广州市海珠区科技计划项目(海科工商信计2018-95)


Study on the Quality and Safety of Modified Shuangbai Gel Paster
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    摘要:

    目的:建立加味双柏凝胶贴膏中黄柏、冰片、大黄的薄层色谱法(TLC),对其质量稳定性进行考 察,并初步评价加味双柏凝胶贴膏敷贴的用药安全性。方法:通过TLC 对加味双柏凝胶贴膏处方中的黄柏、 冰片、大黄进行鉴别,采用加速试验、长期试验和影响因素试验考察其稳定性,试验以新西兰兔为模型进行多 次皮肤刺激试验,以Hartley 豚鼠为模型进行主动皮肤过敏试验和豚鼠Buehler 试验,观察凝胶贴膏的皮肤刺激 作用和致敏作用。结果:TLC 中色谱斑点清晰、特征明显且阴性对照无干扰。3 批产品在长期试验和加速试验 中均具有较好的稳定性,加味双柏凝胶贴膏对新西兰兔皮肤无刺激性,对豚鼠皮肤无过敏性。结论:建立的 TLC 可作为加味双柏凝胶贴膏的质量控制方法,加味双柏凝胶贴膏是一种较安全的新型外用制剂且制剂质量稳 定可控。

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    Abstract: Objective: To establish a thin layer chromatography (TLC) identification method for Phellodendri Chinensis Cortex,Borneolum Syntheticum and Rhei Radix et Rhizoma in Modified Shuangbai Gel Paster, investigate their quality stability, and preliminarily evaluate the drug safety of Modified Shuangbai Gel Plaster. Methods:Phellodendri Chinensis Cortex,Borneolum Syntheticum and Rhei Radix et Rhizoma in the prescription of Modified Shuangbai Gel Paster were identified by TLC, and its stability was investigated by accelerated test,long-term test and influence factor test. The skin irritation test was conducted many times with New Zealand rabbits as the model,and the active skin allergy test and Buehler test were conducted with Hartley guinea pigs as the model to observe the skin irritation and sensitization of gel plaster. Results: The chromatographic spots in TLC were clear and characteristic, and the negative control had no interference. The three batches of products have good stability in the long- term test and accelerated test. The Modified Shuangbai Gel Paster has no irritation to the skin of New Zealand rabbits and no allergy to the skin of guinea pigs. Conclusion:The established TLC can be used as the quality control method for Modified Shuangbai Gel Paster, and Modified Shuangbai Gel Paster is a relatively safe new external preparation with stable and controllable quality.

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周艳,吴雪茹,张力文,陈土荣,赵毛香,黄晓冰,钟碧莲.加味双柏凝胶贴膏质量研究及安全性考察[J].新中医,2023,55(5):22-27

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  • 在线发布日期: 2023-03-15
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