1.Historical Evolution and Key Information Research on Pediatric Famous Classical Formula Yigongsan
Jiangmin SU ; Jun ZHANG ; Cong GUO ; Anyi ZHAO ; Liang JIANG ; Heng ZHANG ; Jipeng DI ; Sha CHEN ; Li LIU ; Yan LIU ; An LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(7):205-214
Yigongsan is derived from Xiaoer Yaozheng Zhijue written by QIAN Yi in the Northern Song dynasty, which is the No. 3 formula in the Catalogue of Ancient Famous Classical Formulas(The Second Batch of Pediatrics) released by the National Administration of Traditional Chinese Medicine(TCM) in September 2022, and it can be developed as a class 3.1 new TCM drug. By referring to ancient medical books and modern literature, this study conducted herbal textual research on Yigongsan from five aspects, including historical evolution, origin and processing, dosage conversion, usage and preparation methods, and functional application, then formed the key information table of this formula, in order to provide reference for the development of reference samples and preparations of Yigongsan. Based on the results of the study, it is recommended that Panax ginseng should be removed the basal part of stem(rhizoma), Poria cocos should be removed the peel, Citrus reticulata should be cut into shreds and Glycyrrhiza uralensis should be used. According to 4.13 g/Qian(钱), 1 g/slice for ginger, 3 g for each jujube and 300 mL/Zhan(盏), the doses of Ginseng Radix, Poria, Atractylodis Macrocephalae Rhizoma, Glycyrrhizae Radix et Rhizoma, Citri Reticulatae Pericarpium, Zingiberis Rhizoma Recens, Jujubae Fructus were 1.652, 1.652, 1.652, 1.652, 1.652, 5, 6 g, and the total amount was 19.26 g. The decocting method was to crush the medicinal materials into fine powder with 50-80 mesh, add 300 mL of water and decoct to 210 mL for each dose, then remove the dregs and take it warmly. This formula was recorded in ancient books as the main treatment for the cold-deficiency of spleen and stomach, and Qi stagnation in children with vomiting and diarrhea and lack of appetite. It has been flexibly applied by later generations of physicians, and is often used to treat anorexia, inflammation of the digestive tract, diarrhea and other diseases in children.
2.Quality Uniformity Analysis of 7 Commercially Available Yangyin Qingfei Preparations
Jiangmin SU ; Yongzhen LAO ; Sha CHEN ; Jun ZHANG ; Cong GUO ; Anyi ZHAO ; Jipeng DI ; An LIU ; Yan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(18):164-170
ObjectiveTo establish the fingerprint of seven commercially available Yangyin Qingfei preparations, to quantitatively analyze the index components, to evaluate their quality uniformity with multivariate statistical analysis, and to explore the quality differences among different dosage forms. MethodA total of 33 batches of commercially available 7 kinds of Yangyin Qingfei preparations were analyzed by high performance liquid chromatography(HPLC), the fingerprints were established and the common peaks were identified. Paeoniflorin, verbascoside, harpagoside, glycyrrhizic acid and paeonol were selected as the indicators of quality attributes to quantitatively analyze 33 batches of preparations. Based on the administration methods of Yangyin Qingfei preparations, the daily intake was calculated and the radar charts were poltted, and cluster analysis and principal component analysis were used to explore the quality differences of 7 kinds of Yangyin Qingfei preparations and the quality uniformity among different batches of the same dosage form. ResultThe similarity of fingerprints of 7 dosage forms was 0.248-0.956, suggesting that there were significant differences among different dosage forms of Yangyin Qingfei preparations, and a total of 15 common peaks were calibrated, of which peak 7, peak 8, peak 11, peak 13 and peak 15 were paeoniflorin, verbascoside, harpagoside, glycyrrhizic acid and paeonol, respectively. The radar plots showed that the average total daily intake of large honeyed pills and water honeyed pills was the highest, and the uniformity of pill components was better. The quality of 33 batches of samples was divided into poor quality and high quality by cluster analysis. Principal component analysis showed that the uniformity and dosage form of different dosage forms were significantly different, the oral liquid had the best quality homogeneity with the minimum dispersion. And the content of paeonol in different dosage forms was significantly different, which was the key component of quality control of Yangyin Qingfei preparations. ConclusionYangyin Qingfei large honeyed pills and water honeyed pills show high content and good uniformity, which are relatively preferred dosage forms. Different preparation processes have a great influence on the content of paeonol, and its quality control should be emphasized during production. This study provides a scientific method for the comparison of product quality of different dosage forms of traditional Chinese medicine prescriptions, which is helpful for the development of preferred dosage forms of different prescriptions, and provides a reference for efficient use of medication in the clinical practice.