ISO 23959:2021 pdf download – Traditional Chinese medicine — Glehnia littoralis root.
5.2 Macroscopic 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 towards the 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 rootlets across 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. f) The 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 5.3.1 Transverse 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 μm to 65 μm in diameter and contain 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 scattered or 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 is irregular. d) Vessel elements appear singly or in groups.
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) and quintozene should be determined. 5.11 Sulfur dioxide residue The content of sulfur dioxide residue should be determined. 6 Sampling Sampling of Glehnia littoralis root shall be in accordance with the World Health Organization’s Quality control 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 six packages. 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 a pooled 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 two diagonally opposite parts and mix carefully. f) Repeat the process as necessary until the required quantity, to within ±10 %, is obtained. g) Using the same quartering procedure, divide the average sample into four final samples, taking care that each portion is representative of the bulk material. h) The final samples are tested for the measurement and analyses specified in Table 1. Ground samples shall be used in the measurement and analyses, except the identification of macroscopic characteristics. The test samples shall be finely ground, carefully mixed and sealed.