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ยาชงใบมะขามแขก (YA CHONG MA KHAM KHAEK, BAI)

Alexandria Senna Leaf, Indian Senna Leaf, Senna Leaf
Sennae Alexandrianae Folium
Alexandrian Senna Leaf Tea
Category Laxative.

      Alexandrian Senna Leaf Tea contains an amount of powdered Alexandrian Senna Leaf
equivalent to not less than 90.0 per cent and not more than 110.0 per cent of the labelled
amount of hydroxyanthracene glycosides, calculated as sennoside B.
Strength available 2.5 g (powder), supplied in a sachet.
Dose One sachet, prepared as an infusion by soaking each with 200 mL of hot water for
10 minutes, once at bedtime.
Contra-indication It is contra-indicated in patients with intestinal obstruction, undiagnosed
abdominal symptoms, appendicitis and in children under the age of 10 years.
Warning It may cause abdominal pain.
Precaution It should not be used in nursing mothers.
Packaging and storage Alexandrian Senna Leaf Tea shall be kept in well-closed containers,
protected from light, and stored in a dry place at a temperature not exceeding 30º.
Labelling The label on the container states (1) the equivalent amount of hydroxyanthracene
glycosides, as sennoside B; (2) the expiration date.
Identification
    A. The tea contents exhibit diagnostic structures of the powdered drug described under
Alexandrian Senna Leaf.
    B. The tea contents comply with the tests for Identification A and B described under
Alexandrian Senna Leaf.
Loss on drying Of the tea contents, not more than 8.0 per cent w/w after drying at 105º to
constant weight (Appendix 4.15).
Microbial limit Complies with the requirements for Category 2 in the “Limits for Microbial
Contamination” (Appendix 10.5).
Assay (Note Carry out the determination protected from light.) Grind the contents
of not less than 20 sachets of Alexandrian Senna Leaf Tea to fine powder. Place about 150 mg,
accurately weighed, in a 100-mL round-bottomed flask. Add 30.0 mL of water, mix, weigh,
and place in a water-bath. Heat under a reflux condenser for 15 minutes. Allow to cool,
weigh, and adjust to the original weight with water. Centrifuge the resulting solution
at 2683 × g (4000 rpm) for 5 minutes and transfer 20.0 mL of the supernatant liquid to
a 150-mL separator. Add 0.1 mL of dilute hydrochloric acid and shake with three 15-mL
portions of chloroform. Allow to separate and discard the chloroform layer. Add 100 mg of
sodium hydrogen carbonate and shake for 3 minutes. Centrifuge and transfer 10.0 mL of the
supernatant liquid to a 100-mL round-bottomed flask with a ground-glass neck. Add 20 mL
of iron
(III) chloride TS and mix. Place the flask in a water-bath so that the water level is above
that of the liquid in the flask, and heat under a reflux condenser for 20 minutes. Add 3 mL
of hydrochloric acid and heat for a further 20 minutes, with frequent shaking, to dissolve the
precipitate. Cool, transfer the mixture to a separator, and shake with three 25-mL portions of
ether previously used to rinse the flask. Combine the three ether layers and wash with two
15-mL portions of water. Transfer the combined ether layers to a 100-mL volumetric flask

and dilute to volume with ether. Evaporate 10.0 mL carefully to dryness and dissolve the
residue in 10.0 mL of a 0.5 per cent w/v solution of magnesium acetate in methanol. Measure
the absorbance of Assay preparation at 515 nm using methanol as the blank. Calculate the
percentage content of hydroxyanthracene glycosides, calculated as sennoside B, in the
portion of the Tea taken, utilizing the specific absorbance of sennoside B to be 240, by the
expression:
                                                              1.25 × A/W,
where A is the absorbance of the Assay preparation at 515 nm and W is the weight, in g,
of the portion of the Tea taken.
Other requirements Complies with the requirements described under “Herbal Teas”
(Appendix 1.16H).

ดาวน์โหลด / Download
THP 2021 Supplement 2024 • ยาชงใบมะขามแขก (YA CHONG MA KHAM KHAEK, BAI)
view 138 ผู้เข้าชม / View
หมายเหตุ / Note : THP 2021 Supple. 2024 pp.69-70