关键词: 蒙药, 药品标准, 文本分析, 处方相似度, 药物警戒

Abstract: Objective To determine the priorities during the revision of the ministerial Mongolian medicine standards by reviewing related literature from the perspectives of prescription similarity and pharmacovigilance. Methods One hundred and forty-four preparations included in the Drug Standards of the Ministry of Public Health of the People’s Republic of China (Mongolian Medicine Fascicle) were selected as the subjects before text analysis was conducted to retrieve and standardize information about these prescriptions. The Jaccard similarity coefficient between preparations was calculated to identify high-frequency and high-proportion medicinal ingredients, as well as highly similar prescription clusters. Meanwhile, the National Center for ADR Monitoring, the National Medical Products Administration website, and the CNKI database were searched for articles on adverse reactions and toxicity related to the relevant medicinal ingredients and preparations. Results The 144 preparations involved a total of 247 medicinal ingredients with a cumulative frequency of 1 446 occurrences. The top 27 ingredients, including Chebulae Fructus (Hezi), Aucklandiae Radix (Muxiang), and Carthami Flos (Honghua), accounted for 51.5% of the total frequency while the top 26 ingredients accounted for 50.58% of the total prescriptions. Notably, Aconiti Kusnezoffii Radix Cocta (Zhi Caowu) ranked only 21st in frequency, yet its proportion of prescriptions reached 1.70%, indicating a high cumulative risk of toxic constituents. Prescription similarity analysis revealed 15 groups of completely identical series varieties (31 preparations) with a Jaccard coefficient of 1, and 22 groups of highly similar prescription clusters (34 preparations) with a coefficient≥0.5, forming multiple “formula clusters” that revolved around core medicinal ingredients. The search for literature on adverse reactions identified multiple reports about hepatotoxicity, nephrotoxicity, cardiotoxicity, and allergic reactions related to high-frequency ingredients such as Moschus (Shexiang), Aconiti Kusnezoffii Radix Cocta (Zhi Caowu), Gardeniae Fructus (Zhizi), and Carthami Flos (Honghua), and to highly similar preparations like Zhenbao pills and Zhenzhu Tongluo pills. Conclusion The ministerial Mongolian medicine prescriptions are strongly characterized by core ingredient clusters and formula cluster derivation. It is recommended that high-frequency and high-proportion medicinal ingredients involved in over 80% of the preparations be designated as the first-batch priority for revision of the standard, with identical series varieties and highly similar prescription clusters as the second-batch priority and packaged together for revision. Additionally, safety-related items indicated by the literature, such as limit tests for toxic constituents and monitoring of allergic reactions, should be incorporated into the efforts to improve the quality standard so as to establish a comprehensive research model that combines drug quality controllability with safety evaluation.

Key words: Mongolian Medicine, Drug Standards, Text Analysis, Prescription Similarity, Pharmacovigilance