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ยาชงกระชาย (YA CHONG KRACHAI)


Fingerroot Tea
Category Carminative, antiflatulent, tonic.

    Fingerroot Tea contains an amount of powdered Fingerroot equivalent to not less
than 90.0 per cent and not more than 110.0 per cent of the labelled amount of pinostrobin (C16H14O4), and not less than 80.0 per cent of the labelled amount of volatile oil, calculated on the anhydrous basis.

Strengths available 1 and 1.5 g (powder), supplied in a sachet.
Dose One sachet, prepared as an infusion by soaking each with 120 mL of boiling water for
5 minutes, three times a day.
Packaging and storage Fingerroot Tea shall be kept in well-closed containers, protected
from light, and stored at a temperature not exceeding 30°.
Labelling The label on the container states (1) the amount of pinostrobin in mg per sachet;
(2) the amount of volatile oil; (3) the expiration date.
Identification
    A. The tea contents exhibit diagnostic structures of the powdered drug described under
Fingerroot.
    B. The tea contents comply with the tests for Identification A, B, and C described under
Fingerroot.
Water Of the tea contents, not more than 9.0 per cent v/w (Azeotropic Distillation Method,
Appendix 4.12).
Microbial limit Complies with the requirements for Category 2 in the “Limits for Microbial
Contamination” (Appendix 10.5).
Assay

FOR VOLATILE OIL Mix the contents of not less than 20 sachets of Fingerroot Tea and
transfer about 10 g, accurately weighed, to a 500-mL round-bottomed flask. Use 100 mL of
water as the distillation liquid and distil at a rate of 2 to 3 mL per minute for 5 hours. Use
2.0 mL of xylene in the graduated tube (Appendix 7.3H). Calculate the content of volatile oil,
in mL, in the portion of the Tea taken with reference to the anhydrous substance.

FOR PINOSTROBIN Carry out the determination as described in the “Liquid Chromatography”
(Appendix 3.5).
    Mobile phase A Prepare a mixture of equal volumes of methanol and acetonitrile.
    Mobile phase B Use water.
    Standard preparations Dissolve a suitable quantity of pinostrobin, accurately weighed, in
sufficient methanol to obtain a stock solution having a known concentration of about 1 mg of
pinostrobin per mL. Dilute the solution quantitatively and stepwise with the same solvent to
obtain five solutions having known concentrations ranging from 40 to 240 μg per mL.
    Assay preparation Grind the contents of not less than 20 sachets of Fingerroot to fine
powder. Macerate about 100 mg, accurately weighed, in 20.0 mL of methanol for 24 hours.
Pass a portion of the supernatant through a 0.22-µm polyvinylidene fluoride filter.

ดาวน์โหลด / Download
THP 2021 Supplement 2024 • ยาชงกระชาย (YA CHONG KRACHAI)
view 135 ผู้เข้าชม / View
หมายเหตุ / Note : THP 2021 Supple. 2024 pp.44-45