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Study on preparation and skin safety evaluation of Qingre Xiaozhong Zhitong Ointment |
Hits 873 Download times 443 Received:June 29, 2021 |
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DOI
10.11656/j.issn.1673-9043.2021.05.22 |
Key Words
Qingre Xiaozhong Zhitong Ointment;skin safety;orthogonal test;preparation process;safety evaluation;big ear white rabbit;guinea pig |
Author Name | Affiliation | WANG Jun | Chengdu Integrated Traditional Chinese Medicine & Western Medicine Hospital, Chengdu 610041, China | LI Ping | Chengdu Integrated Traditional Chinese Medicine & Western Medicine Hospital, Chengdu 610041, China | LIU Jing | College of Food and Bioengineering, Chengdu University, Chengdu 610106, China | ZHUO Hongyi | College of Medicine, Chengdu University, Chengdu 610106, China | LI Wei | College of Medicine, Chengdu University, Chengdu 610106, China | SONG Yu | College of Food and Bioengineering, Chengdu University, Chengdu 610106, China |
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Abstract
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[Objective] To prepare Qingre Xiaozhong Zhitong Ointment and investigate its skin safety.[Methods] The orthogonal experiment was used to optimize the alcohol extraction process of Qingre Xiaozhong Zhitong Ointment with the sum of berberine hydrochloride and the extract rate as the evaluation index. The density of thick ointment, the preparation of matrix, the dosage of thickened ointment and the processing parameters of the preparation were investigated, and the skin irritation and hypersensitivity of the preparationwere tested with the model of big ear white rabbit and guinea pig.[Results] The optimum extraction conditions were as follows:60% ethanol was used as the extraction solvent, adding 6 times and 5 times of the amount of medicinal materials to extract twice, each time for 1.5 h. Forming process:the relative density of thick paste was 1.22×1.27 (80℃), the matrix was prepared by pressure sensitive adhesive and ethyl acetate 10:1 (g/g), and the paste was prepared by the weight of thickened paste and matrix 1:2. The skin safety test shows that Qingre Xiaozhong Zhitong Ointment had no irritating and allergic phenomenon to the skin.[Conclusion] The preparation technology of Qingre Xiaozhong Zhitong Ointment is scientific, reasonable, stable and feasible, and the preparation is safe for external use. |
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