ISO 9109:2024

International
Standard
ISO 9109
First edition
Traditional Chinese medicine —
2024-01
Rehmannia glutinosa root
Médecine traditionnelle chinoise — Racine de Rehmannia
glutinosa
Reference number
© ISO 2024
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . . 2
5 Requirements . 2
5.1 General characteristics .2
5.2 Morphological characteristics .3
5.3 Microscopic characteristics .3
5.4 Moisture .3
5.5 Total ash .3
5.6 Acid-insoluble ash .4
5.7 Water-soluble extractives .4
5.8 Thin-layer chromatogram (TLC) identification .4
5.9 Content of marker compounds .4
5.10 Heavy metals .4
5.11 Pesticide residues .4
5.12 Sulfur dioxide residues . .4
5.13 Grading .4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification .4
7.2 Determination of moisture .4
7.3 Determination of total ash .4
7.4 Determination of acid-insoluble ash .5
7.5 Determination of water-soluble extractives .5
7.6 Thin-layer chromatogram (TLC) identification .5
7.7 Determination of marker compounds .5
7.8 Determination of heavy metals .5
7.9 Determination of pesticide residues .5
7.10 Determination of sulfur dioxideresidues .5
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 6
Annex A (informative) Identification of catalpol . 7
Annex B (informative) Identification of verbascoside . 9
Annex C (informative) Determination of catalpol content .11
Annex D (informative) Determination of rehmannioside D content . 14
Annex E (informative) Example of traditional grading of Rehmannia glutinosa root. 17
Annex F (informative) National and regional requirements for Rehmannia glutinosa root.18
Bibliography .20

iii
Foreword
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iv
Introduction
Rehmannia glutinosa root, dried root of Rehmannia glutinosa Libosch. (Fam. Scrophulariaceae), is one of the
most commonly used herbs in traditional Chinese medicine. It has a long history of use in East and Southeast
Asian countries for relieving heat and cooling the blood, and for nourishing yin and body fluid, meaning
promoting overall health and body fluid circulation.
Clinically, Rehmannia glutinosa root is used for the prevention and treatment of diabetes, inflammation,
cancer and other diseases. At present, Rehmannia glutinosa root and its processed products occupy a huge
share of the international market. The international trading amount of Rehmannia glutinosa root ranks in
the top ten of Chinese materia medica in countries including China, the Republic of Korea, Japan, Viet Nam
and Malaysia. However, many problems can affect the quality of Rehmannia glutinosa root, such as different
quality requirements among different countries and regions, different preparation methods, and different
packaging, transportation and storage conditions. Therefore, the establishment of an International
Standard is necessary to meet the quality requirements of Rehmannia glutinosa root, supporting its clinical
effectiveness and safety.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.4, 5.5 and 5.6 in their national standards. Examples of national and regional values are given in Annex F.

v
International Standard ISO 9109:2024(en)
Traditional Chinese medicine — Rehmannia glutinosa root
1 Scope
This document specifies the requirements and test methods for dried Rehmannia glutinosa root that is
derived from Rehmannia glutinosa Libosch.
Fresh Rehmannia glutinosa Libosch. and processed Rehmannia glutinosa Libosch. are excluded.
This document is applicable to Rehmannia glutinosa root that is sold and used as a natural medicine in
international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces
derived from this plant.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use
ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas
chromatography
ISO 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration
ISO 23193, Traditional Chinese medicine — Lycium barbarum and Lycium chinense fruit
ISO 23723, Traditional Chinese medicine — General requirements for herbal raw material and materia medica
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
root
main underground part of Rehmannia glutinosa Libosch.

3.2
root weight
average weight of final samples of root, calculated by sampling no less than 1 000 g from each batch
randomly, weighing the roots one by one, and then calculating the average weight of the roots
[SOURCE: ISO 20409:2017, 3.2, modified — details on how to calculate root weight have been added.]
Note 1 to entry: Final samples may be packed in different materials meeting conditions for specific tests (e.g. moisture
or total ash).
4 Description
Rehmannia glutinosa root is the dried root of Rehmannia glutinosa Libosch. (Fam. Scrophulariaceae), as
shown in Figure 1.
a) Plant of Rehmannia glutinosa Libosch. b) Dried root
Key
1 flower 4 length
2 leaf 5 diameter
3 root
Figure 1 — Structure of Rehmannia glutinosa Libosch.
5 Requirements
5.1 General characteristics
The following requirements shall be met before sampling:
a) Rehmannia glutinosa root shall be clean and free of foreign matter.
b) The presence of living insects, mouldy root and external contaminants which are visible to the naked
eye shall not be permitted.
5.2 Morphological characteristics
a) The roots are an irregular mass or oblong, swollen in the centre, slightly tapering at both ends; some are
small, slat-shaped, slightly compressed or twisted, with an irregular transverse flexure.
b) The external surface is brownish-black or brownish-grey.
c) The root is 6 cm to 12 cm in length and 2 cm to 6 cm in diameter, measured at the base of the root.
d) The texture is soft and thick, but libriform, not easily broken.
e) The fracture is brownish-yellow to black or jet-black, shiny, with viscosity.
f) The odour is slight and the taste is slightly sweet.
5.3 Microscopic characteristics
The powder is dark brown. Cork cells are brownish. Parenchymatous cells are sub-rounded, containing a
sub-rounded nuclei-like substance. Secretory cells are similar to parenchymatous cells in shape, containing
orange-yellow or orange-red oil droplets. Bordered pitted and reticulated vessels, shown in Figure 2, are up
to about 92 μm in diameter.
Key
1 cork cells
2 parenchymatous cells
3 secretory cells
4 bordered pitted and re
...