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CC BY 4.0 · Pharmaceutical Fronts 2024; 06(03): e305-e314
DOI: 10.1055/s-0044-1789234
Original Article

Study on Preparation Technology and Quality Standard of Acne Granules

Bo Dai‡   #
1   Department of Pharmacy, Air Force Medical Center, PLA, Air Force Medical University, Beijing, People's Republic of China
,
Fang Wang‡   #
1   Department of Pharmacy, Air Force Medical Center, PLA, Air Force Medical University, Beijing, People's Republic of China
,
Yan Geng
1   Department of Pharmacy, Air Force Medical Center, PLA, Air Force Medical University, Beijing, People's Republic of China
,
Chen Chen
1   Department of Pharmacy, Air Force Medical Center, PLA, Air Force Medical University, Beijing, People's Republic of China
,
Min Zhou
1   Department of Pharmacy, Air Force Medical Center, PLA, Air Force Medical University, Beijing, People's Republic of China
,
Lingyu Hang
1   Department of Pharmacy, Air Force Medical Center, PLA, Air Force Medical University, Beijing, People's Republic of China
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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.




Publication History

Received: 18 February 2024

Accepted: 30 July 2024

Article published online:
03 September 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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