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      Senna Alata Capsules contain an amount of powdered Senna Alata Leaf equivalent to not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of hydroxyanthracene derivatives, calculated as rhein-8-glucoside.

Strength available 500 mg (powder).

Dose Six to twelve capsules once a day at bedtime.

Contra-indication It is contra-indicated in patients with symptoms of gastro-intestinal obstruction or abdominal pain with unknown etiology.

Warning
1. It should be used with caution in children, or in patients with inflammatory bowel disease.
2. It may cause mild abdominal discomfort such as colic or cramps. Excessive doses may produce nephritis.
3. Prolonged use should be avoided since it may result in diarrhea with excessive loss of water and electrolytes, particularly potassium.

Packaging and storage Senna Alata Capsules shall be kept in well-closed containers, protected from light, and stored at a temperature not exceeding 30°.

Labelling The label on the container states (1) the equivalent amount of hydroxyanthracene derivatives, calculated as rhein-8-glucoside; (2) the expiration date.

Identification
A. The capsule contents exhibit diagnostic structures of the powdered drug described
under Senna Alata Leaf.
B. The capsule contents comply with the tests for Identification A and B described
under Senna Alata Leaf.

Loss on drying Of the capsule contents, not more than 11.0 per cent w/w after drying at
105° for 5 hours (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 Senna Alata Capsules.
Grind to fine powder and transfer about 150 mg, accurately weighed, to 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 and transfer 20.0 mL of the supernatant liquid to a 150-mL separator.  Add 0.1 mL of 2 M hydrochloric acid and shake with three 15-mL portions of chloroform.  Allow to separate and discard the chloroform layer. Add 100 mg of sodium hydrogencarbonate and shake for 3 minutes.  Centrifuge and transfer 10.0 mL of the supernatant liquid to a 100-mL round-bottomed flask. Add 20 mL of a 10.5 per cent w/v solution of iron(III) chloride and mix.  Heat for 20 minutes under a reflux condenser in a water-bath with its water level above that of the liquid in the flask, add 1 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 ether layers and wash with two 15-mL portions of water.  Transfer the ether layers to a 100-mL volumetric flask and dilute with ether to volume.  Evaporate 25.0 mL carefully to dryness at a low temperature 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 this solution at the maximum at about 515 nm (Appendix 2.2), using the magnesium acetate solution as the blank.  Calculate the quantity, in mg, of rhein-8-glucoside in the portion of the Capsules taken by the formula:

(446.37/284.22) (1200A/440),

in which 446.37 and 284.22 are the molecular weights of rhein-8-glucoside and rhein, respectively, A is the absorbance of the solution at 515 nm and 440 is the specific absorbance.

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