สารบัญ

Contents
MENU

ยาชงมะตูม (YA CHONG MATUM)


Bael Fruit Tea
Category Antidiarrheal, stomachic.

       Bael Fruit Tea contains an amount of powdered Bael Fruit equivalent to not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of imperatorin (C16H14O4), calculated on the dried basis.

Strengths available 1 and 2.5 g (powder), supplied in a sachet.

Dose One sachet, prepared as an infusion by soaking each with 120 mL of boiling water for 10 minutes, as needed.

Packaging and storage Bael Fruit Tea 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 imperatorin; (2) the expiration date.

Identification
A. The tea contents exhibit diagnostic structures of the powdered drug described under Bael Fruit.
B. The tea contents comply with the tests for Identification A, B, C, and D described under Bael Fruit.

Loss on drying Of the tea contents, not more than 9.0 per cent w/w after drying at 105° 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 Carry out the determination as described in the “Liquid Chromatography” (Appendix 3.5).
Mobile phase Prepare a mixture of 60 volumes of methanol and 40 volumes of water. Make adjustments if necessary.
Standard preparations Dissolve an accurately weighed quantity of imperatorin in sufficient methanol, dilute quantitatively and stepwise with methanol to obtain a stock solution having a known concentration of about 400 μg per mL. Dilute the solution quantitatively and stepwise with methanol to obtain six solutions having known concentrations of 40, 80, 120, 160, 200, and 240 μg per ml.
Assay preparation Grind the contents of not less than 20 sachets of Bael Fruit Tea to fine powder. Reflux about 1 g, accurately weighed, with 50 mL of n-hexane for 30 minutes, filter and evaporate the filtrate to dryness. Dissolve the residue in sufficient methanol. Transfer quantitatively to a 25-mL volumetric flask, dilute with methanol to volume and mix.
Chromatographic system The chromatographic procedure may be carried out using (a) a stainless steel column (5 cm × 2.1 mm) packed with octadecylsilane chemically bonded to porous silica or ceramic microparticles (1.7 μm), (b) Mobile phase at a flow rate of about 0.5 mL per minute (the retention time is about 1.2 minutes for imperatorin), and (c) an ultraviolet photometer set at 302 nm.

Procedure and Calculation Separately inject about 3 μL each of Standard preparations into the chromatograph, record the chromatograms and measure the responses for the major peaks: the relative standard deviation for the replicate injections is not more than 2.0 per cent. Plot the readings and draw the standard curve of best fit: the curve shows a correlation coefficient of not less than 0.999. Inject about 3 μL of Assay preparation into the chromatograph, record the chromatogram and measure the response for the major peak. By reference to the standard curve, calculate the content of imperatorin (C16H14O4) in the portion of the Tea taken.

Other requirements Complies with the requirements described under “Herbal Teas” (Appendix 1.16H).

MONOGRAPHS • ยาชงมะตูม (YA CHONG MATUM)
view 505 ผู้เข้าชม / View
หมายเหตุ / Note : THP2021 Page 488-489