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| Study on the preparation process and pharmacodynamic effect of a compound traditional Chinese medicine Gel for Acne |
| Hits 270 Download times 30 Received:October 17, 2025 |
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| DOI
10.11656/j.issn.1673-9043.2026.03.05 |
| Key Words
compound traditional Chinese medicine;acne;gel;carbomer 940;process optimization;pharmacodynamic evaluation;safety evaluation |
| Author Name | Affiliation | E-mail | | LI Yangyang | School of Chinese Materia Medica, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Tianjin University of Traditional Chinese Medicine, Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique, Tianjin 301617, China | | | LI Jiawei | School of Chinese Materia Medica, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Tianjin University of Traditional Chinese Medicine, Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique, Tianjin 301617, China | lijiawei1981@163.com | | LIU Zhidong | School of Chinese Materia Medica, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Tianjin University of Traditional Chinese Medicine, Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique, Tianjin 301617, China | |
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| Abstract
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| [Objective] Guided by the traditional Chinese medicine theory of “clearing heat and resolving stasis”， and to address the common issues of drug resistance and skin irritation associated with conventional acne treatments，this study aimed to develop a safe and effective compound traditional Chinese medicine gel for acne and to elucidate its pharmacodynamic effects and safety profile. [Methods] Based on a classical prescription composed of nine herbs，including Scutellaria baicalensis Georgi and Salvia miltiorrhiza Bge.，the gel formulation was optimized through matrix screening and orthogonal experiments. The stability of the preparation process was verified in three consecutive batches. A rabbit ear acne model was established. Different dose groups of the gel were set up，with tretinoin cream as the positive control. Pathological changes in the model tissue were observed，and serum levels of tumor necrosis factor-α（TNF-α），interleukin-6（IL-6），and interleukin-1β（IL-1β） were measured. Safety was evaluated through single and repeated cutaneous irritation tests and a skin sensitization test. [Results] Carbomer-940 was determined to be the optimal gel matrix（comprehensive score：41.2）. The optimized formulation consisted of Carbomer-940（3 g），glycerol（37.5 g），and propylene glycol（75 g）. The average score from the three-batch validation was 48.8，indicating a stable preparation process. Compared with the model group，all dose groups showed significant improvements in epidermal thickening，follicular hyperkeratosis（comedone formation），and inflammatory cell infiltration in the rabbit ear. Serum levels of TNF-α，IL-6，and IL-1β were significantly reduced（P<0.05）. The therapeutic efficacy was comparable to that of tretinoin cream（P>0.05）. The scores for both skin irritation tests were 0，and the incidence of skin sensitization was 0%. [Conclusion] The preparation process for this compound traditional Chinese medicine acne gel is stable. It exerts therapeutic effects by ameliorating acne-related pathological damage and inhibiting the abnormal elevation of inflammatory cytokines. The gel exhibits no skin irritation or sensitization potential，demonstrating a favorable safety profile，and thus offers a new option for acne treatment. |
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