Study on Preparation Technology and Quality Standard of Acne Granules

Abstract

The study aimed to optimize the preparation process of acne granules and establish their quality standards. In this work, the extraction process of Chinese herbal extract was optimized by the amount of water added, the number of decoction, the extraction time, and the soaking time with extraction yield as an evaluation index. The indexes of the acne granules such as molding rate, dissolvability, angle of repose, moisture content, and ease of preparation were evaluated. Thin-layer chromatography (TLC) was used to identify Salviae, Scutellaria baicalensis, and Indigowoad Leaf. High-performance liquid chromatography (HPLC) was used to determine the baicalin content in the granules. Based on orthogonal and single-factor experiments, the optimized extraction process of the prescription of nine medicinal materials was as follows: soaked in cold water for 2 hours, boiled three times, decocted with eight times the amount of water for 1.5 hours for the first time, and six times the amount of water for 1 hour for the second and third times. The combined extracts were concentrated to a relative density of 1.30 to 1.40 (20–30°C), and mixed evenly according to the mass ratio of extract to excipient 1:5, and dextrin: powdered sugar = 1:3. The mixture was granulated, dried, prepared into granules, and the acne granules were formed at a molding rate of 95.52% and a critical relative humidity of 82%. The spots in TLC were clear and easy to identify. The HPLC result showed that the content of baicalin was not less than 1.0 mg/g. The study provides a valuable reference for the production and preparation of the granules through optimization of the wet process and the excipient dosage. Furthermore, the established TLC method for the identification and the HPLC method for baicalin quantification laid the foundation for the quality control of the preparation in future studies.

Keywords

acne granules - orthogonal experiment - extraction technology - wet granulation - quality standard

^# These authors contributed equally to this work.

Publikationsverlauf

Eingereicht: 18. Februar 2024

Angenommen: 30. Juli 2024

Artikel online veröffentlicht:
03. September 2024

• References

• 1 Xu H, Li H. Acne, the skin microbiome, and antibiotic treatment. Am J Clin Dermatol 2019; 20 (03) 335-344
• 2 Habeshian KA, Cohen BA. Current issues in the treatment of acne vulgaris. Pediatrics 2020; 145 (Suppl. 02) S225-S230
• 3 Berry K, Lim J, Zaenglein AL. Acne vulgaris: treatment made easy for the primary care physician. Pediatr Ann 2020; 49 (03) e109-e115
• 4 Parvizi MM, Fatehi N, Jaladat AM, Gholampour Z, Shahriarirad R, Erfani A. Epidemiological factors in patients with dermatologic conditions referring to the clinic of traditional Persian Medicine: a cross-sectional study. Int J Clin Pract 2021; 75 (11) e14788
• 5 Zheng Y, Yin S, Xia Y. et al. Efficacy and safety of 2% supramolecular salicylic acid compared with 5% benzoyl peroxide/0.1% adapalene in the acne treatment: a randomized, split-face, open-label, single-center study. Cutan Ocul Toxicol 2019; 38 (01) 48-54
• 6 Kou L, Yu N, Ren J, Yang B, Tao Y. Observation for clinical effect of acupuncture combined with conventional therapy in the treatment of acne vulgaris. Medicine (Baltimore) 2020; 99 (18) e19764
• 7 Wei J, Li YL, Li JR. et al. Research on the prescription and clinical application of classic prescription Loquat Qingfei Decoction [in Chinese]. Lishizhen Medicine and Materia Medica Research 2022; 33 (10) 2480-2483
• 8 National Pharmacopoeia Commission. Pharmacopoeia of the People's Republic of China. 2020 Ed. Beijing: China Medical Science and Technology Press; 2020
• 9 Yang J, Jing CF, Li SC. et al. Preparation optimiztion of compound Codonopsis Radix granules and simultaneous determination of its four components [in Chinese]. J Chin Pharm Sci 2023; 32 (08) 665-676
• 10 Chen GY, Rao Z. Qu, et al. Optimization of juice granule prescription and its hygroscopicity. Chin Patent Med 2021; 43: 2157-2160
• 11 Sun MJ, Dai XW, Zou Q. Optimization of prescription and determination of hygroscopicity. Chin Patent Med 2021; 43: 177-181
• 12 Pang LN, Ma BR, Zhang M. et al. Optimization of extraction process of Fuyou Granule and its prescription formulation [in Chinese]. Acta Chinese Medicine and Pharmacology 2021; 49 (05) 19-25
• 13 Chu J, Ming Y, Cui Q. et al. Efficient extraction and antioxidant activity of polyphenols from Antrodia cinnamomea. BMC Biotechnol 2022; 22 (01) 9
• 14 Yang F, Du W, Tang Z, Wei Y, Dong J. Protective effects of Qing-Re-Huo-Xue formula on bleomycin-induced pulmonary fibrosis through the p53/IGFBP3 pathway. Chin Med 2023; 18 (01) 33
• 15 Wang W, Xian M, Shi X. et al. Efficacy and safety of Sanfeng Tongqiao Diwan in the treatment of upper airway cough syndrome: a randomized, double-blind, placebo-controlled clinical study. J Thorac Dis 2023; 15 (04) 1716-1725
• 16 Yu WY, Gao CX, Zhang HH, Wu YG, Yu CH. Herbal active ingredients: potential for the prevention and treatment of acute lung injury. BioMed Res Int 2021; 2021: 5543185
• 17 Da X, Nishiyama Y, Tie D, Hein KZ, Yamamoto O, Morita E. Antifungal activity and mechanism of action of Ou-gon (Scutellaria root extract) components against pathogenic fungi. Sci Rep 2019; 9 (01) 1683
• 18 Liu T, Luo J, Bi G, Du Z, Kong J, Chen Y. Antibacterial synergy between linezolid and baicalein against methicillin-resistant Staphylococcus aureus biofilm in vivo . Microb Pathog 2020; 147: 104411
• 19 Zhang S, Hu B, Xu J. et al. Baicalin suppress growth and virulence-related factors of methicillin-resistant Staphylococcus aureus in vitro and vivo . Microb Pathog 2020; 139 (08) 103899
• 20 Wu Z, Fan Q, Miao Y, Tian E, Ishfaq M, Li J. Baicalin inhibits inflammation caused by coinfection of Mycoplasma gallisepticum and Escherichia coli involving IL-17 signaling pathway. Poult Sci 2020; 99 (11) 5472-5480
• 21 Lee H, Lee DH, Oh JH, Chung JH. Skullcapflavone II suppresses TNF-α/IFN-γ-induced TARC, MDC, and CTSS production in HaCaT cells. Int J Mol Sci 2021; 22 (12) 6428
• 22 Marito S, Keshari S, Traisaeng S. et al. Electricity-producing Staphylococcus epidermidis counteracts Cutibacterium acnes. Sci Rep 2021; 11 (01) 12001