Monagas Maria, Brendler Thomas, Brinckmann Josef, Dentali Steven, Gafner Stefan, Giancaspro Gabriel, Johnson Holly, Kababick James, Ma Cuiying, Oketch-Rabah Hellen, Pais Pilar, Sarma Nandu, Marles Robin
United States Pharmacopeia (USP). Dietary Supplements and Herbal Medicines, Rockville, MD, United States.
United States Pharmacopeia (USP). Botanical Dietary Supplements and Herbal Medicines Expert Committee, Rockville, MD, United States.
Front Pharmacol. 2022 Sep 30;13:981978. doi: 10.3389/fphar.2022.981978. eCollection 2022.
Dietary supplement current good manufacturing practice (cGMP) requires establishment of quality parameters for each component used in the manufacture of a dietary supplement to ensure that specifications for the identity, purity, strength, composition, and limits on contaminants are met. Compliance with botanical extract ingredient specifications is assured by using scientifically valid methods of analysis, the results of which are reported on certificates of analysis (CoAs). However, CoAs routinely include additional data that are not amenable to verification through methods of analysis. Such descriptive information may include Plant to Extract ratios, which are ratios of the quantity of botanical article used in the manufacture of the extract to the quantity of extract obtained Plant to Extract ratios can be misleading when their meaning is not clearly understood. Plant to Extract ratios do not completely describe botanical extracts because other important factors influence the make-up of final extracts, such as the quality of the raw starting material (as can defined by pharmacopeial standards), extraction solvent(s) used, duration and temperature of extraction, and percentage and type of excipients present. Other important qualitative descriptions may include constituent "fingerprinting." Despite these issues, Plant to Extract ratios are often used as a measure of extract strength for dosage calculations. This article defines and clarifies the meaning of Plant to Extract ratios and their proper use in describing and labeling botanical extract ingredients and finished products containing them.
膳食补充剂现行良好生产规范（cGMP）要求为膳食补充剂生产中使用的每种成分确定质量参数，以确保符合身份、纯度、强度、成分以及污染物限量的规格要求。通过使用科学有效的分析方法来确保符合植物提取物成分规格，分析结果会在分析证书（CoA）上报告。然而，CoA通常包含一些无法通过分析方法进行验证的额外数据。此类描述性信息可能包括植物与提取物的比例，即用于提取物生产的植物原料数量与所获得的提取物数量之比。如果对其含义理解不清，植物与提取物的比例可能会产生误导。植物与提取物的比例并不能完全描述植物提取物，因为其他重要因素会影响最终提取物的组成，例如起始原料的质量（可由药典标准定义）、使用的提取溶剂、提取的持续时间和温度以及辅料的百分比和类型。其他重要的定性描述可能包括成分“指纹图谱”。尽管存在这些问题，植物与提取物的比例仍经常被用作剂量计算中提取物强度的衡量标准。本文定义并阐明了植物与提取物比例的含义及其在描述和标注植物提取物成分以及含有这些成分的成品时的正确用法。
