Research on the Preparation Process of Mahuang Xixin Fuzi Decoction Granules

Abstract

Objective The objective of this study was to investigate the preparation process of Mahuang Xixin Fuzi decoction granules based on the clinical pharmacological effects of the classic formulas and to control the quality of the product.

Methods An orthogonal experimental design was used, with extraction yield and transfer rate of key ingredients as evaluation indicators, to optimize the extraction process of Mahuang Xixin Fuzi decoction. The granulation process was optimized based on indicators such as granule formation rate, dissolution rate, and moisture absorption rate.

Results The optimal extraction process for Mahuang Xixin Fuzi decoction was determined as the following: using 10 times the amount of water to soak for 30 minutes, extracting three times, each for 60 minutes, with a concentrated extract relative density of 1.3 g/mL. A mixture of dextrin and starch at a 1:2 ratio was used as a binder for wet granulation. The granule formation rate, dissolution time, and dilution rate of three repeated batches showed relative standard deviation (RSD) values of 1.48, 2.83, and 1.55%.

Conclusion This method is stable and feasible, providing valuable data for the industrial production of Mahuang Xixin Fuzi decoction granules and further research on this formulation.

Keywords

Mahuang Xixin Fuzi decoction - granules - preparation process - Zhang Zhongjing - Treatise on Cold Damage (Shang Han Lun)

CRediT Authorship Contribution Statement

Lingli Cao was the project administration and contributed to conceptualization, data curation, formal analysis, and writing of the original draft. Congying Wang contributed to the investigation, data curation, formal analysis, validation, and methodology. Yinman Feng contributed to project administration, funding acquisition, supervision, and writing—review and editing of the manuscript.

Publikationsverlauf

Eingereicht: 25. August 2024

Angenommen: 29. September 2024

Artikel online veröffentlicht:
30. Dezember 2024

• References

• 1 National Medical Products Administration. Notice from the State Administration of Traditional Chinese Medicine and the State Administration for Market Regulation on Issuing the Catalogue of Ancient Classic Prescriptions (Second Batch): National Medical Science and Technology Letter [2023] No. 159. Available from: https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20230901165919115.html
• 2 Li L, Su K. Professor Chen Xuezhong's experience in treating allergic diseases with ephedra Fuzi asarum decoction. Guangxi Chin Med 2021; 44 (02) 42-44
• 3 Sun TT, Yan JT, Ni YY. et al. Analysis on professor Wang Qingguo's experience in differentiating and treating allergic rhinitis. J Zhejiang Chin Med Univ 2022; 46 (06) 633-636
• 4 Wang RR. Clinical Study on Gao Jianzhong's Experience in Applying MaHuang XiXin FuZi Flavored the Treatment of Allergic Rhinitis. Taiyuan:: Shanxi University of Chinese Medicine;; 2020
• 5 Liu YF, Wang RH, Liu XL. Effect of ephedra fuzi asarum decoction in the treatment of senile patients with bronchial asthma. Practi Clin J Integr Tradit Chin West Med 2023; 23 (14) 17-19 , 53
• 6 Xu H. Observation on the effect of added Mahuang Fuzi Xianxin decoction on cold wheezing syndrome of senile bronchial asthma. Inner Monogolia J Tradit Chin Medi 2021; 40 (01) 23-24
• 7 Chen KJ, Liu XB. Experience of LIU Xiao-Bin in treating congenital myasthenic syndrome with modified Mafu Xixin decoction combined with Gancao Ganjiang decoction. J Guangzhou Univ Tradit Chin Med 2024; 41 (02) 481-486
• 8 Li ZG. Observation on the curative effect of Ma Fu Asarum decoction in treating sick sinus syndrome. J Pract Tradit Chin Med 2012; 28 (10) 827-828
• 9 Zhou YP, Guo MS. Clinical experience of Mahuang Fuzi Xixin decoction in treatment of bradycardia. J Med Theor & Prac 2024; 37 (18) 3238-3240
• 10 Cao HJ. Clinical observation of ephedra Fuzi Xianxin Decoction combined with Guizhi decoction in treating chronic cardio-renal syndrome. J Pract Tradit Chin Med 2024; 40: 692-694
• 11 Liang ZR, Liang RJ. Case studies on application of ephedra, aconite and asarum decoction by chief physician Liang RJ. Asia-Pacific Tradit Med 2023; 19 (09) 156-158
• 12 Chen TS, Chen J. On the determination of weights and measures in Han Dynasty. Hangzhou J 2018; 04: 152-169
• 13 Zhang C, Li RY, Jiang XF. et al. The ancient and modern textual research on the weight of “an aconite” in classical prescriptions. J Emerg Tradit Chin Med 2022; 31 (08) 1147-1151
• 14 Zhang L, Tang RS, Song J. et al. Textual research on principle of dose conversion in ancient famous classical formulas. Chin J Exp Tradit Med Formul 2024; 30 (10) 196-202
• 15 Xu M. Study of the MaHuang FuZi XiXin Tang Formula Presentation. Nanjing:: Nanjing University of Chinese Medicine;; 2020
• 16 Ma XM, Wang YZ, Gao S. et al. Optimization of extraction and purification technology for Mahuang Fuzi Xixin. Liaoning J Tradit Chin Med 2019; 46 (11) 2391-2396
• 17 Ma XM, Li LJ, Xie HC. et al. Study on the dynamic change of six active components extraction from Mahuang Xixin Fuzi decoction. Shandong Sci 2018; 31 (06) 11-17
• 18 Qiu LL, Li C, Fan SS. et al. Effects of different decocting methods on quality of Mahuang Xixin Fuzi decoction. Chin J Chin Mater Med 2018; 43 (02) 316-324
• 19 Kong YY, Jia QW, Shi HW. et al. Optimization of extraction process of Erzhi wan polysaccharides by orthogonal experiment and preparation of granules. Med Pharm J 2024; 28 (07) 1328-1333
• 20 Ye LQ, Wang X, Shen JY. Comparative on the optimization of extraction process of classical prescription Baoyuan decoction. Asia-Pacific Tradit Med 2024; 20 (11) 38-42
• 21 Qin C, Rong R, Yang Y. et al. Optimization of extraction technology for Mahuang FuziXixin decoction by multi-index orthogonal. Chin J Exp Tradit Med Formul 2012; 18 (09) 35-39
• 22 Zhou YP, Zheng ZL, Zhu YY. et al. Response surface method and orthogonal method were used to optimize the extraction process of robustrone. Light Ind Sci Tech 2022; 38 (03) 1-3 , 11
• 23 Yang HN, Zhang JC, Wu SH. et al. Research status analysis of preparation technology, quality evaluation and consistency with traditional decoction of Chinese medicine formula granules. Chin J Exp Tradit Med Formul 2023; 29 (08) 266-274
• 24 Li S, Zhan Y, Yan BX. et al. Study on the preparation technology of Linggui Zhugan decoction granules. Ginseng Research 2023; 35 (05) 26-29
• 25 Li FX. Research on Preparation Technology and Quality Standard of Baihu Decoction Granules. Jinan:: Shandong University of Traditional Chinese Medicine;; 2018
• 26 He DT. Study on Preparation Technology and Quality Standard of the Classic Ganjiang Lingzhu Decoction Granules. Changchun:: Changchun University of Chinese Medicine;; 2021
• 27 Chen JY. Study on Preparation Technology and Quality Standard of Chaiyin Granules. Nanjing:: Nanjing University of Chinese Medicine;; 2021
• 28 Ju N. Study on the Preparation Technology and Quality Standards of Yuyetang. Changchun:: Changchun University of Chinese Medicine;; 2021
• 29 Chinese Pharmacopoeia Commission. Pharmacopoeia of the People's Republic of China (Part I): Edition 2020. Beijing:: China Medical Science Press;; 2020: 240