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       Five-Leaf Ginseng Capsules contain an amount of powdered Five-Leaf Ginseng equivalent to not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of total crude saponins, calculated on the dried basis. 

Strengths available 500 mg (powder).

Dose One to two capsules three times a day, before meals

Warning
       1. Caution should be exercised if it is to be used in pregnant or nursing women.
       2. It may cause mild adverse effects including nausea/vomiting, abdominal tension, diarrhoea or constipation, dizziness, blurred vision and tinnitus.

Precaution Because its bioactive components can inhibit platelet aggregation, lower blood glucose level and enhance immune system function; therefore, caution should be exercised when it is to be used concomitantly with antiplatelets, anticoagulants,  antihyperglycemic agents, or immunomodulators.

Additional information The safety data of the Five-Leaf Ginseng powder have not yet been established.

Packaging and storage Five-Leaf Ginseng Capsules shall be kept in well-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 equivalent amount of total crude saponins; (2) the expiration date.

Identification
       A. The capsule contents exhibit diagnostic structures of the powdered drug described under Five-Leaf Ginseng.
       B. The capsule contents comply with the tests for Identification A, B and C described under Five-Leaf Ginseng.

Loss on drying Of the capsule contents, not more than 8.0 per cent w/w after drying 5 g at 105° to constant weight (Appendix 4.15).

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

Assay Weigh and mix the contents of not less than 20 capsules of Five-Leaf Ginseng Capsules. Place about 500 mg, accurately weighed, in a 250-mL round-bottomed flask, reflux with 50 mL of water for 2 hours, and filter. Wash the marc with two 20-mL portions of hot water. Combine the washings and the filtrate, transfer to a 100-mL volumetric flask and adjust to volume. Transfer 20.0 mL of this solution to a separator and extract with three 10-mL portions of 1-butanol. Combine the 1-butanol extracts, wash with two 10-mL portions of water and discard the washings. Evaporate the 1-butanol extract to dryness and dry the residue at 105° to constant weight. Weigh the residue and calculate the content of total crude saponins on the dried basis.

Other requirements Comply with the requirements described under “Capsules” (Appendix 1.16H).