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ยาแคปซูลสารสกัดแห้งปัญจขันธ์(PANCHA KHAN DRY EXTRACT CAPSULES)

Five-Leaf Ginseng Dry Extract Capsules
Jiaogulan Dry Extract Capsules
Five-Leaf Ginseng Dry Extract Capsules
Category Tonic.

      Five-Leaf Ginseng Capsules are prepared from Five-Leaf Ginseng Dry Extract and contain 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 250 and 300 mg (dry extract).

Dose  250 to 300 mg twice a day before meals.

Packaging and storage  Five-Leaf Ginseng Capsules shall be kept in well-closed containers, protected from light, and stored in a dry place at a temperature not exceeding 30°.

Labelling  The label on the container states (1) the amount of total crude saponins; (2) the expiration date.

Identification The capsule contents comply with the tests for Identification A, B, and C described under Five-Leaf Ginseng Dry Extract.

Loss on drying  Of the capsule contents, not more than 9.0 per cent w/w after drying at 105° to constant weight (Appendix 4.15).

Microbial limit Comply with the requirements for Category 1A 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 Dry Extract Capsules. Transfer about 400 mg, in powder, accurately weighed, to a 100-mL volumetric flask, add 50 mL of water, mix, and adjust to volume. Transfer 10.0 mL of this solution to a separator and extract with three 15-mL portions of 1-butanol.  Combine the 1-butanol extracts, wash with two 10-mL portions of water and discard the washings.  Evaporate the combined 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).

MONOGRAPHS • ยาแคปซูลสารสกัดแห้งปัญจขันธ์(PANCHA KHAN DRY EXTRACT CAPSULES)
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หมายเหตุ / Note : THP 2021 Page 531