ISO 23190:2021 pdf free download – Traditional Chinese medicine一 Determination of aristolochic acids in natural products by high-performance liquid chromatography (HPLC).
Aristolochic acids, a class of chemical compounds with renal toxicity, carcinogenic and mutagenic toxicity, are widely distributed in over 350 species of plant from around the world, many of which have been used as natural products to treat gout, arthritis, rheumatism and acute inflammation of the skin; some species from North America have been used to treat snake bites. Clinical practice and research have confirmed that long-term use of natural products containing aristolochic acids can cause chronic renal failure and renal tubules, and natural products containing aristolochic acids have been prohibited and restricted to use in clinics in many counties. Aristolochic acid toxicity is of great concern worldwide.
Safety and efficacy are basic requirements for the use of natural medicines. Although many natural products containing aristolochic acids have been strictly controlled in clinics, some are still used as raw herbal materials or to produce manufactured products such as asarum, Kaempfer dutchmanspipe root, Herba Aristolochiae mollissimae, German birthwort, American snakeroot and Indian Aristolochia tagala. In addition, some prohibited plant medicines are easily confused or misused during manufacturing, which can cause large safety concerns in the application of natural products.
This document is beneficial for effectively supervising and reducing the toxic side effects of naturalmedicine-derived products and ensuring their safety and efficacy in clinical use.
The high-performance liquid chromatography (H PLC) method is applied in organizations in such places as Europe, China, the United States of America, Japan and the Republic of Korea for the determination of aristolochic acid I, both qualitatively and quantitatively. The HPLC method is recommended internationally for the qualitative determination of aristolochic acid I in natural products.
B.3 Reference solution
Reference solution of aristolochic acid I (0,1 ug/ml) is prepared by dilution of the stock solution of aristolochic acid I with methanol or 80 % methanol.
B.4 Test solution I
Weigh 100 g of crude drug to grind and pass it through an 80-mesh or finer sieve. Weigh accurately 0,5 g of the powdered crude drug in a conical flask with stopper. Add accurately 25 ml of 70 % methanol or 80 % methanol and weigh. Ultrasonicate (powder, 250 W; frequency, 40 kHz) for 40 minutes, cool, weigh again, make up the loss of weight with 70 % methanol or 80 % methanol, mix well and filter through a membrane filter (normal pore size 0,45 iim) using the successive filtrate as the test solution.
B.5 Test solution II
Grind approximately 10 g to 100 g of the extract, bolus, powder, pellet and tablet to fine powder, weigh an appropriate amount (equivalent to 0,5 g of aristolochic acid-containing raw herbal material) in a conical flask with stopper. Add accurately an appropriate amount of 70 % methanol or 80 % methanol with a 50:1 material:methanol ratio and weigh. Ultrasonicate (powder, 250 W; frequency, 40 kHz) for 40 minutes, cool and then filter. Evaporate the filtrate to dryness, dissolve the residue in an appropriate amount of 70 % methanol or 80 % methanol to prepare a solution containing 20 mg aristolochic acid- containing crude drug per ml and filter through a membrane filter (normal pore size 0,45 1Am) using the successive filtrate as the test solution.
B.6 Real sample analysis
Inject 1 i.tl of standard solution into the column of LC-MC system to record the retention time, UV spectrum, ion with mass charge ratio (m/z) of 366 or the ion pair of 324,3 0 to 265,25. Afterwards, inject 1 iii to 2 p.1 of test solution into the LC-MS system to record the retention time, UV spectrum, ion with mass charge ratio (m/z) or the ion pair. Then compare the retention times, UV spectrums, ion with mass charge ratio (m/z) or the ion pair of standard and test sample to determine whether aristolochic acid lis present in the test sample.