Asiasarum Root-Asiasari Radix-Asiasarum sieboldii-Asiasarum heterotropoides (aristolochic acid)

Asiasarum Root

Asiasari Radix

Asiasarum Root is the root with rhizome of Asiasarum sieboldii F. Maekawa or Asiasarum heterotropoides F. Maekawa var. mandshuricum F. Maekawa (Aristolochiaceae).

Description:

Asiasarum Root is a nearly cylindrical rhizome with numerous thin and long roots, externally light brown to dark brown. The root, about 15 cm in length, about 0.1 cm in diameter, with shallow longitudinal wrinkles on the surface, and brittle. The rhizome, 2 . 4 cm in length, 0.2 . 0.3 cm in diameter, often branched, with longitudinal wrinkles on the surface; internode short; each node has several scars of petiole and peduncle, and several thin and long roots.
Odor, characteristic; taste, acrid, with some sensation of numbness on the tongue.

Purity:

(1) Terrestrial part.When perform the test of foreign matter, any terrestrial parts are not found.
(2) Arsenic. Prepare the test solution with 0.40 g of pulverized Asiasarum Root according to Method 4, and perform the test (not more than 5 ppm).
(3) Foreign matter <5.01>.The amount of foreign matter other than terrestrial part contained in Asiasarum Root is not more than 1.0z.
(4) Aristolochic acid I.To exactly 2.0 g of pulverized Asiasarum Root add exactly 50 mL of diluted methanol (3 in 4), shake for 15 minutes, filter, and use the filtrate as the sample solution. Separately, dissolve exactly 1.0 mg of aristolochic acid I for crude drugs purity test in diluted methanol (3 in 4) to make exactly 100 mL. Pipet 1 mL of this solution, add diluted methanol (3 in 4) to make exactly 25 mL, and use this solution as the standard solution. Perform the test with exactly 20 μL each of the sample solution and standard solution as directed under Liquid Chromatography, according to the following conditions: the sample solution shows no peak at the retention time corresponding to aristolochic acid I from the standard solution. If the sample solution shows such a peak, repeat the test under different conditions to confirm that the peak in question is not aristolochic acid I.
Operating conditions.
Detector: An ultraviolet or visible absorption photometer (wavelength: 400 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 25 cm in length, packed with octadecylsilanized silicagel for liquid chromatography (5 μm in particle diameter).
Column temperature: A constant temperature of about 400C.
Mobile phase: A mixture of a solution prepared by dissolving 7.8 g of sodium dihydrogen phosphate dihydrate and 2 mL of phosphoric acid in water to make 1000 mL and acetonitrile (11:9).
Flow rate: Adjust the flow rate so that the retention time of aristolochic acid I is about 15 minutes.
System suitability.
Test for required detectability: Measure exactly 1 mL of the standard solution, and add diluted methanol (3 in 4) to make exactly 10 mL. Confirm that the ratio, S/N, of the signal (S) and noise (N) of aristolochic acid I obtained from 20 μL of this solution is not less than 3. In this case, S means the peak height on the chromatogram not including noise obtained by drawing an average line of the detector output, and N is 1/2 of the difference between the maximum and minimum output signals of the baseline around the peak in the range of 20 times the width at half-height of the peak.
System repeatability: When the test is repeated 6 times with 20 μL of the standard solution under the above operating conditions, the relative standard deviation of the peak
area of aristolochic acid I is not more than 5.0z.
(5) Total BHC's and total DDT's. Not more than 0.2 ppm, respectively.

Total ash:

Not more than 10.0z.

Acid-insoluble ash:

Not more than 3.0z.

Essential oil content:

Perform the test with 30.0 g of pulverized Asiasarum Root: the volume of essential oil is not less than 0.6 mL.
Containers and storage:
Containers.Well-closed containers.

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