สารสกัดแห้งฟ้าทะลาย (FA THALAI DRY EXTRACT) -

ตำรามาตรฐานยาสมุนไพรไทย

Thai Herbal Pharmacopoeia

สำนักยาและวัตถุเสพติด กรมวิทยาศาสตร์การแพทย์ กระทรวงสาธารณสุข

Bureau of Drug and Narcotic, Department of Medical Sciences, Ministry of Public Health

สารสกัดแห้งฟ้าทะลาย (FA THALAI DRY EXTRACT)

สารสกัดแห้งฟ้าทะลายโจร (FA THALAI CHON DRY EXTRACT)

Andrographis Dry Extract
Category Antipyretic, anti-inflammatory in laryngitis.

Andrographis Dry Extract is prepared from the powdered Andrographis Herb by extraction with ethanol. It contains not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of andrographolide (C₂₀H₃₀O₅); the labelled amount of andrographolide is not less than 4.5 per cent, calculated on the dried basis.

Description Brownish green powder.

Packaging and storage Andrographis Dry Extract shall be kept in tightly closed containers, protected from light, and stored in a cool and dry place.

Labelling The label on the container states (1) the amount of andrographolide; (2) the expiration date.

Identification The chromatogram of the Assay preparation shows several peaks, one of which corresponds to that of the Standard preparation, as obtained in the Assay.

Loss on drying Not more than 5.0 per cent w/w after drying at 105° to constant weight (Appendix 4.15). Use 2.0 g.

Assay Carry out the determination as described in the “Liquid Chromatography” (Appendix 3.5).
Mobile phase Prepare a mixture of equal volumes of methanol and water.
Standard preparation Transfer about 5 mg of Andrographolide RS, accurately weighed, to a 25-mL volumetric flask, add 2 mL of methanol, and sonicate for 5 minutes. Dissolve and dilute with Mobile phase to volume to obtain a stock solution having a known concentration of about 200 µg of andrographolide per mL. Dilute this solution quantitatively and stepwise with Mobile phase to obtain seven solutions having known concentrations of 10, 20, 40, 60, 80, 100, and 140 µg per mL. Filter through a nylon membrane having a 0.45-µm porosity.
Assay preparation Transfer an accurately weighed quantity of Andrographis Dry Extract, containing about 10 mg of andrographolide, to a 100-mL volumetric flask. Add 10 mL of methanol and sonicate for 5 minutes. Add 60 mL of Mobile phase, sonicate for 15 minutes, and stand for 30 minutes. Dilute with Mobile phase to volume, mix, and filter through a nylon membrane having a 0.45-µm porosity.
Chromatographic system The chromatographic procedure may be carried out using (a) a stainless steel column (15 cm × 4.6 mm) packed with octadecylsilane chemically bonded to porous silica or ceramic microparticles (5 µm), equipped with a similarly packed guard column, (b) Mobile phase at a flow rate of 1.0 mL per minute, and (c) an ultraviolet photometer set at 224 nm.
To determine the suitability of the chromatographic system, chromatograph Standard preparation having a known concentration of 60 µg per mL, and record the peak responses as directed under Procedure: the symmetry factor for the andrographolide peak is not more than 2.0 and the relative standard deviation for replicate injections is not more than 2.0 per cent.
Procedure and Calculation Separately inject about 20 µL each of Standard preparations into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Plot the readings and draw the standard curve of best fit. The curve shows the correlation coefficient of not less than 0.999. Inject about 20 µL of Assay preparation into the chromatograph, record the chromatograms, and measure the response for the major peak. By reference to the standard curve, calculate the content of andrographolide (C₂₀H₃₀O₅) in the portion of the Extract taken.

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

THP 2021 Supplement 2023 • สารสกัดแห้งฟ้าทะลาย (FA THALAI DRY EXTRACT)

1,273 ผู้เข้าชม / View

หมายเหตุ / Note : THP 2021 Supplement 2023 p. 11-12

ตำรามาตรฐานยาสมุนไพรไทย

Thai Herbal Pharmacopoeia

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