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ยาชงขิง (YA CHONG KHING)


Ginger Tea
Category Carminative, antiflatulant, anti-emetic.

     Ginger Tea contains an amount of powdered Ginger equivalent to not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of gingerols, gingerdiones and shogaols, and not less than 90.0 per cent of the labelled amount of volatile oil, calculated on the anhydrous basis.

Strengths available 1, 2 and 3 g (powder), supplied in a sachet.

Dose Carminative, antiflatulent, antidyspepsia: one sachet, containing 1 to 3 g of powdered ginger, prepared as an infusion by soaking each with 150 mL of boiling water for 10 minutes, twice a day.
          Prophylaxis of nausea and vomiting associated with motion sickness: one sachet, containing 1 to 2 g of powdered ginger, prepared as an infusion by soaking each with 150 mL of boiling water for 10 minutes, at least 30 minutes to 1 hour before travelling or as needed.
          Prevention of postoperative nausea and vomiting: one sachet, containing 1 g of powdered ginger, prepared as an infusion by soaking each with 150 mL of boiling water for 10 minutes, at least 1 hour before operation.

Warning
          1. It is not recommended in children under 6 years of age.
          2. It may cause gastro-intestinal disturbances and irritation in mouth and throat.
          3. Caution should be exercised when it is to be used concomitantly with anticoagulants and antiplatelets.
          4. It should not be used in patients with bile duct obstruction except under medical supervision.

Packaging and storage Ginger Tea shall be kept in well-closed containers, protected from light.

Labelling The label on the container states (1) the amounts of gingerols, gingerdiones and shogaols; (2) the amount of volatile oil; (3) the expiration date; (4) “If you are pregnant or nursing, consult a qualified health care professional before using”.

Identification
      A. The tea contents exhibit diagnostic structures of the powdered drug described under Ginger.
      B. The tea contents comply with the tests for Identification A, B and C described under Ginger Capsules.

Water Of the tea contents, not more than 11.0 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 Ginger Tea and transfer about 20 g, accurately weighed, to a 500-mL round-bottomed flask. Use 250 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 anhydrous substance.
       
FOR GINGEROLS, GINGERDIONES AND SHOGAOLS  Carry out the determination as described in the “Liquid Chromatography” (Appendix 3.5).
        Mobile phase A, Mobile phase B, System suitability solution, Standard preparation, Chromatographic procedure, and Procedure  Proceed as directed in the Assay under Ginger Capsules.
        Assay preparation Grind the contents of not less than 20 sachets of Ginger Tea to fine powder. Transfer about 2 g of the powdered ginger, accurately weighed, to a glass-stoppered conical flask. Add 50 mL of ethanol, insert a stopper into the flask, macerate for 24 hours, shaking frequently during the first 8 hours, and then allowing to stand for 16 hours. Filter.
        Calculation Calculate the percentage of the labelled amount of gingerols, gingerdiones, and shogaols in the portion of the Tea taken by the expression:

(ru/rs) × C × (V/D) × (W/L) × 100,

in which ru is the sum of the peak responses for gingerols, gingerdiones, and shogaols from Assay preparation, rs is the peak response of capsaicin from Standard preparation, C is the concentration, in mg per mL, of Capsaicin RS in Standard preparation, V is the final volume, in mL, of Assay preparation, D is the weight, in mg, of the portion of the tea taken, W is the average weight, in mg, of the tea content, and L is the labelled amount, in mg per sachet, of gingerols, gingerdiones and shogaols.
(Note Calculate the sum of the peak responses due to gingerols and gingerdiones occurring at about the following retention times relative to 1.0 for capsaicin: 0.8 for 6-gingerol, 1.5 for 8-gingerol A, 2.2 for 8-gingerol B, 2.5 for 6-gingerdiol, 2.6 for 6-gingerdione, 3.4 for 10-gingerol, and 5.2 for 8-gingerdione and calculate the sum of the peak responses due to shogaols, occurring at about the following retention times, relative to 1.0 for capsaicin: 1.9 for 6-shogaol, 4.2 for 8-shogaol, and 5.8 for 10-shogaol).

Other requirements Complies with the requirements described under “Herbal Teas” (Appendix 1.16H).

MONOGRAPHS • ยาชงขิง (YA CHONG KHING)
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หมายเหตุ / Note : THP2021 Page 221-222