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          Centella Cream is Centella Dry Extract in a suitable hydrophilic cream base.   It contains not less than 90.0 per cent and not more than 110.0 per cent of the labelled amounts of asiaticoside (C₄₈H₇₈O₁₉) and madecassoside (C₄₈H₇₈O₂₀).

Strength available  7 per cent w/w of centella dry extract (about 0.2 per cent w/w of asiaticoside).

Dose  Topical, to the wound, one to three times a day.

Contra-indication  It is contra-indicated in patients hypersensitive to herbal drugs belonging to Family Umbelliferae.

Warning   

          1. Contact with eyes should be avoided.

          2. It may cause allergic contact dermatitis.

Precaution  Treatment with Centella Cream should be discontinued if there is no response after two weeks.

Packaging and storage  Centella Cream shall be kept in collapsible tubes or in tightly closed containers, protected from light, and stored at a temperature not exceeding 30°.

Labelling  The label on the container states (1) the amounts of asiaticoside and  madecassoside; (2) the expiration date.

Identification   

          A. The chromatogram of the Assay preparation shows several peaks, two of which correspond to those of the Standard preparation as obtained in the Assay.

          B.  Carry out the test as described in the “Thin-Layer Chromatography” (Appendix 3.1), using silica gel G as the coating substance and a mixture of 60 volumes of chloroform,  28 volumes of methanol and 4 volume of water as the mobile phase and allowing the solvent front to ascend 8 cm above the line of application.  Apply separately to the plate as bands of 8 mm, 15 µL each of the following three solutions.  For solution (A), transfer 6 g of the sample to a 125-mL Erlenmeyer flask.  Add 25.0 mL of methanol, shake well and sonicate for about 30 minutes.  Transfer the solution to a 50-mL volumetric flask, dilute with methanol to volume and mix.  Centrifuge the resulting solution at 13,684×g (12,000 rpm) at ‒20° for 15 minutes.  Pass a portion of the supernatant through a filter having a 0.45 µm or finer porosity.  Solution (B) contains 0.1 mg per mL of asiaticoside in methanol and solution (C) contains 0.1 mg per mL of madecassoside in methanol.  After removal of the plate, allow it to dry in air.  Spray the plate with anisaldehyde TS and heat at 105° for 5 minutes.  The chromatogram obtained from solution (A) shows a greenish blue band and a violet band corresponding to the asiaticoside and the madecassoside bands from solutions (B) and (C), respectively.  Several other bands of different colours are observed.

Microbial limit  Complies with the requirements for Category 1B in the “Limits for Microbial Contamination” (Appendix 10.5).

Assay  Carry out the determination as described in the “Liquid Chromatography”  (Appendix 3.5).

          Mobile phase A, Mobile phase B, Standard preparation, Chromatographic system, and Procedure   Proceed as directed in the Assay under Centella Dry Extract.

          Assay preparation  Transfer an accurately weighed quantity of Centella Cream, containing about 5 mg of asiaticoside, to a 125-mL Erlenmeyer flask.  Add 25.0 mL of methanol, shake well and sonicate for about 30 minutes.  Quantitatively transfer the solution to a 50-mL volumetric flask, dilute with methanol to volume and mix.  Centrifuge the resulting solution at 13,684×g (12,000 rpm) at –20° for 15 minutes.  Pass a portion of the clear solution through a filter having a 0.45 µm or finer porosity. 

          Calculation  Calculate the contents of C₄₈H₇₈O₁₉ and C₄₈H₇₈O₂₀ in the portion of the Cream taken, using the declared contents of C₄₈H₇₈O₁₉ and C₄₈H₇₈O₂₀ in asiaticoside and madecassoside, respectively.

Other requirements  Complies with the requirements described under “Topical Preparations” (Appendix 1.16H).