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          Ginger Capsules contain 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 250 and 500 mg (powder).

Dose  Carminative, antiflatulent: 2 to 4 g a day.

    Prophylaxis of nausea and vomiting associated with motion sickness: 1 to 2 g at least 30 minutes to 1 hour before travelling or as needed.

    Prevention of postoperative nausea and vomiting: 1 g at 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 Capsules shall be kept in tightly closed containers, protected from light, and stored in a dry place and at a temperature not exceeding 30°.

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 capsule contents exhibit diagnostic structures of the powdered drug described under Ginger.

          B. The retention times of the major peaks in the chromatogram of the Assay preparation correspond to that of the Standard preparation, as obtained in the Assay

          C. Carry out the test as described in the “Thin-Layer Chromatography” (Appendix 3.1), using silica gel GF254 as the coating substance and a mixture of 2 volumes of n-hexane and 3 volumes of diethyl ether as the mobile phase and allowing the solvent front to ascend 10 cm above the line of application. Apply separately to the plate, as bands of 5 mm, 10 μL of solution (A) and 5 μL each of solutions (B) and (C). For solution (A), shake a quantity of the capsule contents, containing 20 mg of 6-gingerol and 10 mg of 6-shogaol, with 10 mL of methanol and sonicate for 5 minutes and filter. Solution (B) contains 2 mg per mL of 6-gingerol in methanol and solution (C) contains 1 mg per mL of 6-shogaol in methanol. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254 nm), marking the quenching bands. Spray the plate with vanillin-sulfuric acid TS and heat 105° for 10 minutes. The chromatogram obtained from solution (A) shows two violet bands corresponding to the 6-gingerol and 6-shogaol bands from solutions (B) and (C), respectively. Several other bands of different colours are observed

Water Of the capsule contents, not more than 11.0 per cent v/w (Azeotropic Distillation Method, Appendix 4.12).

Microbial limit Comply with the requirements for Category 4 in the “Limits for Microbial Contamination” (Appendix 10.5).

Assay

          FOR VOLATILE OIL Remove the contents of not less than 20 Ginger Capsules, mix 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 Capsules 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 Prepare a mixture of 55 volumes of acetonitrile, 44 volumes of phosphoric acid (1 in 1000), and 1 volume of methanol.

          Mobile phase B Use acetonitrile.

          System suitability solution Reconstitute the content of 1 vial of Ginger Constituent Mixture RS containing 80 μg of 6-gingerol and 150 μg of 6-shogaol in 1 mL of Standard preparation.

          Standard preparation Dissolve an accurately weighed quantity of Capsaicin RS in methanol to obtain a solution having a known concentration of about 100 μg per mL of capsaicin.

          Assay preparation Weigh and mix the contents of not less than 20 Ginger Capsules. 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.

          Chromatographic procedure The chromatographic procedure may be carried out using (a) a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilane chemically bonded to porous silica or ceramic microparticles (5 μm), (b) Mobile phase A at a flow rate of 1.0 mL per minute for not less than seven times the retention time of capsaicin (the retention time is about 10 minutes for capsaicin.), and (c) an ultraviolet photometer set at 282 nm. After each chromatographic run, wash the column as follows.

          To determine the suitability of the chromatographic system, chromatograph Standard preparation and record the peak response as directed under Procedure: the relative standard deviation for replicate injections is not more than 2.5 per cent. Chromatograph System suitability solution and record the peak response as directed under Procedure: the relative retention times are about 0.8 for 6-gingerol, 1.0 for capsaicin and 1.9 for 6-shogaol. The resolution factor, R, between the 6-gingerol and the capsaicin peaks is not less than 3.0 and the resolution factor, R, between the capsaicin and the 6-shogaol peaks is not less than 10.0. The symmetry factors for 6-gingerol, 6-shogaol and capsaicin peaks are not more than 2.0.

Procedure Separately inject equal volumes (about 25 μL) of Standard preparation and Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.

Calculation Calculate the percentage of the labelled amount of gingerols, gingerdiones, and shogaols in the portion of the Capsules taken by the expression:

(r_u/r_s) × C × (V/D) × (W/L) × 100,

in which r_u is the sum of the peak responses for gingerols, gingerdiones, and shogaols from Assay preparation, r_s 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 capsules taken, W is the average weight, in mg, of the capsule content, and L is the labelled amount, in mg per capsule, 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 Comply with the requirements described under “Capsules” (Appendix 1.16H).