ISO 23959-2021 pdf free download – Traditional Chinese medicine — Glehnia littoralis root.
5.2Macroscopic characteristics
a) The root is slender-cylindrical. The top section of the root is slender, the greater portion of the
middle section of the root is thick and the end section of the root becomes slender again towardsthe distal end (see Figure 1,A and B).
b)The top section of the root is often marked with remnants of yellowish-brown rhizome base.c)The root is 9 cm to 45 cm long, 0,2 cm to 1,5 cm in diameter.
d) The outer surface is pale yellowish-white to yellowish-brown and somewhat rough. There are fine
longitudinal wrinkles and grooves and brownish-yellow punctiform protuberance scars of rootletsacross the surface of the root.
e) The bark (or cortex) section of the root’s fracture is yellowish-white and the xylem section of the
root’s fracture is brown.
fThe texture is hard and fragile, and the root is easily broken.
g)The odour of the root is distinctively fragrant and the taste is slightly sweet.5.3 Microscopic characteristics
5.3.1Transverse section characteristics
a)Cortex consists of several rows of parenchyma cells.
b)Phloem is broad and has cleft.Phloem rays and groups of sieve tubes in the inner part are encrusted
with densely arranged secretory canals.Secretory canals are 20 um to 65 um in diameter andcontain yellowish-brown secretions.Each secretory canal is surrounded by 5 to 8 secretory cells.c)Cambium is prominent and in a ring.
d) Xylem rays are broad and their width is 2 to 5 column cells. Vessels occur singly and are scatteredor arranged in a V-shape configuration.
e)Parenchyma cells contain gelatinous starch masses.5.3.2 Powder characteristics
a) The colour of the powder is yellowish-white.
b)Fragments of secretory canals containing yellowish-brown secretion are found frequently.
c)Yellowish-brown secretion and gelatinous starch masses are found frequently and their shape isirregular.
d) Vessel elements appear singly or in groups. The reticulate wall of the vessel elements is thick and
the pits of the reticulate wall are long and wide.
e)Parenchyma cells are sub-rectangular and abundant.5.4 Moisture
The content of moisture should not be more than 13,0%%.5.5 Total ash
The content of total ash should not be more than 6,0 %.
5.6Acid-insoluble ash
The content of acid-insoluble ash should not be more than 1,5%.5.7 Thin-layer chromatogram identification
The identification of Glehnia littoralis root with thin-layer chromatogram (TLC) shall present spot(s])of marker compound(s) such as falcarinol and other spots obtained from the test solution, referencestandard solution and reference drug solution in the same positions with the same colour after evenlyspraying the chromogenic agent.
5.8 Marker compounds
The content of marker compounds (e.g. polyacetylenes such as falcarinol) should be determined.5.9 Heavy metals
The content of heavy metals such as lead, arsenic, cadmium and mercury should be determined.5.10 Pesticide residues
The content of pesticide residues such as benzex,dichloro-diphenyl-trichloroethane (DDT) andquintozene should be determined.
5.11 Sulfur dioxide residue
The content of sulfur dioxide residue should be determined.6Sampling
Sampling of Glehnia littoralis root shall be in accordance with the World Health Organization’s Qualitycontrol methods for herbal materials,”General advice on sampling’.
a)From a batch of five containers or packaging units, take a sample from each one.b)From a batch of between 6 and 50 units, take a sample from five units.
c) From a batch of over 50 units, sample 10 %,rounding up the number of units to the nearest multiple
of 10.For example, a batch of 51 units would be sampled as 60 units; i.e. take samples from sixpackages.
d) From each selected container or package, take three original samples from the top, middle and
bottom of the container or package. The three original samples should then be combined into apooled sample that should be carefully mixed.
e)The average sample is obtained by quartering. Take some of the pooled sample, adequately mixed,
place into an even, square-shaped heap, and divide this diagonally into four equal parts. Take twodiagonally opposite parts and imix carefully.ISO 23959 pdf download.