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BELLADONNA LEAF EXTRACT TABLETS


Category Anticholinergic.

       Belladonna Leaf Extract Tablets contain not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of the alkaloids of belladonna leaf.

Strength available 15 mg.

Dose 15 mg (equivalent to approximately 0.2 mg of atropine) three or four times a day, 30 minutes to 1 hour before meals and at bedtime, the dosage being adjusted as needed and tolerated.

Other relevant information
       1. It may impair mental and/or physical abilities required for the performance of potentially hazardous tasks, patients should observe caution while driving or performing other tasks requiring alertness.
       2. Transient stinging, dryness of mouth, blurred vision, photophobia with or without corneal staining, tachycardia, headaches, allergic reactions, and somnolence may appear during uses.

Packaging and storage Belladonna Leaf Extract Tablets shall be kept in tightly closed containers, protected from light, and stored at a temperature not exceeding 25°.

Identification Macerate a quantity of powdered Tablets, equivalent to about 5 mg of the alkaloids of belladonna extract, with 20 mL of water, and transfer to separator. Render the solution alkaline with ammonia TS, and extract the alkaloids with 50 mL of chloroform. Filter the chloroform layer, divide it into two equal portions, and evaporate to dryness: the residue complies with the following test.
       A. To one portion of the dry residue add 2 drops of nitric acid, evaporate on a water-bath to dryness, and add a few drops of ethanolic potassium hydroxide TS: a violet colour is produced.
       B. Dissolve the other portion of the residue in 1 mL of diluted hydrochloric acid (1 in 120), and add gold chloride TS, dropwise with shaking, until a definite precipitate separates. Slowly heat until the precipitate dissolves, and allow the solution to cool: a lustreless precipitate is produced.

Assay Carry out the determination as described in the “Gas Chromatography” (Appendix 3.4).
         pH 9.5 phosphate buffer, Diluent, Internal standard preparation, Standard preparation, Extraction blank, Standard curve, Chromatographic system, and System suitability Proceed as directed in the Assay under Belladonna Leaf.
       Assay preparation Weigh and finely powder not less than 20 Belladonna Leaf Extract Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 600 µg of atropine and scopolamine, to a 60-mL separator, add 10.0 mL of Diluent, and shake vigorously to dissolve as much as possible of the sample. Proceed as directed for Assay preparation in the Assay under Belladonna Leaf Extract, beginning with “add 1.0 mL of Internal standard solution”.
       Procedure Proceed as directed for Procedure in the Assay under Belladonna Leaf Extract. Record from the Standard curves the quantities, in mg, of atropine and scopolamine in the weight of sample taken. Add the quantity, in mg, of atropine and scopolamine, to obtain the weight, in mg, of alkaloids in the portion of the Tablets taken.

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

TP SUPPLEMENT 2022 • BELLADONNA LEAF EXTRACT TABLETS
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