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ยาแคปซูลใบมะขามแขก (MAKHAM KHAEK CAPSULES, BAI)

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

     Alexandrian Senna Leaf Capsules contain 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 450 mg (powder).
Dose Three to four capsules, equivalent to about 20 to 30 mg of sennoside B, 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 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 equivalent amount of hydroxyanthracene
glycosides as sennoside B; (2) the expiration date.
Identification
     A. The capsule contents exhibit diagnostic structures of the powdered drug described
under Alexandrian Senna Leaf.
    B. The capsule contents comply with the tests for Identification A and B described under
Alexandrian Senna Leaf.
Loss on drying Of the capsule contents, not more than 8.0 per cent w/w after drying 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 (Note Carry out the determination protected from light.) Remove, as completely as
possible, the contents of not less than 20 Alexandrian Senna Leaf Capsules, and grind 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 capsules 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 capsules taken.
Other requirements Comply with the requirements described under “Capsules”
(Appendix 1.16H).

 

 

ดาวน์โหลด / Download
THP 2021 Supplement 2024 • ยาแคปซูลใบมะขามแขก (MAKHAM KHAEK CAPSULES, BAI)
view 303 ผู้เข้าชม / View
หมายเหตุ / Note : THP 2021 Supple. 2024 pp.67-68