基于《中国药典》2025年版的中成药制剂成品抽样量计算模型研究

Study on the Calculation Model of Finished Product Sampling Quantity for Traditional Chinese Patent Medicine Preparations Based on the Chinese Pharmacopoeia (2025 Edition)

摘要

目的：探讨《中国药典》2025年版框架下中成药制剂成品抽样量的形成逻辑，构建适用于监督抽样与检验实践的计算模型。方法：以《中国药典》2025年版中成药制剂品种标准及剂型通则为依据，结合中成药制剂抽样统计资料，对不同剂型检验项目的耗样特征进行归纳分析，解析“合计量”与“二倍量”的形成机制，并建立抽样量计算模型。结果：中成药制剂成品抽样量并非固定经验值，而是由法定检验项目耗样量逐项累加形成，并在此基础上结合平行试验、复核、留样、最小包装换算及操作损耗进行修正。不同剂型的抽样量形成机制存在明显差异：片剂、胶囊剂以单位制剂数累加为主，丸剂以质量单位与制剂单位混合换算为特征，液体制剂则以体积累加并兼顾分装损耗。结论：中成药制剂成品抽样量确定应由经验判断转向基于药典质量标准的项目驱动型计算模式。建立统一的抽样量计算框架，有助于提高抽样工作的科学性、规范性和可复核性。

Abstract

Objective: To investigate the formation logic of finished product sampling quantity for traditional Chinese patent medicine preparations under the framework of the Chinese Pharmacopoeia (2025 Edition), and to establish a calculation model applicable to regulatory sampling and inspection practice. Methods: Based on the monographs and general chapters of traditional Chinese patent medicine preparations in the Chinese Pharmacopoeia (2025 Edition), together with statistical data on sampling quantities, the sample consumption characteristics of inspection items for different dosage forms were analyzed. The formation basis of the “total quantity” and “double quantity” was clarified, and a calculation model for sampling quantity was established. Results: The finished product sampling quantity of traditional Chinese patent medicine preparations is not a fixed empirical value, but a cumulative result of statutory inspection item consumption, further adjusted by parallel tests, reinspection, retained samples, minimum package conversion, and operational loss. Considerable differences were observed among dosage forms. Tablets and capsules mainly relied on cumulative unit dosage numbers, pills were characterized by mixed conversion between mass units and dosage units, while liquid preparations were primarily based on cumulative volume with consideration of transfer losses. Conclusion: The determination of sampling quantity for finished traditional Chinese patent medicine preparations should shift from empirical judgment to an item-driven calculation model based on pharmacopoeial quality standards. Establishing a unified calculation framework is conducive to improving the scientific validity, standardization, and traceability of sampling practice.

关键词

中国药典2025年版 / 中成药制剂 / 成品抽样 / 抽样量计算 / 质量标准

Key words

Chinese Pharmacopoeia (2025 Edition) / Traditional Chinese patent medicine preparations / Finished product sampling / Sampling quantity calculation / Quality standard

参考文献

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[7] 国家市场监督管理总局. 药品质量抽查检验管理办法[Z]. 北京: 国家市场监督管理总局 , 2023.

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基金资助

《〈中国药典〉中药制剂检验用样品量标准化研究》(SXSGGGLYB2531)