ตำรามาตรฐานยาสมุนไพรไทย
Thai Herbal Pharmacopoeia
สำนักยาและวัตถุเสพติด กรมวิทยาศาสตร์การแพทย์ กระทรวงสาธารณสุข
Bureau of Drug and Narcotic, Department of Medical Sciences, Ministry of Public Health
สำนักยาและวัตถุเสพติด กรมวิทยาศาสตร์การแพทย์ กระทรวงสาธารณสุข
Bureau of Drug and Narcotic, Department of Medical Sciences, Ministry of Public Health(Tinospora crispa (L.) Hook.f. & Thomson)
(Nelumbo nucifera Gaertn.)
(Centella asiatica (L.) Urb.)
(Centella Dry Extract)
(Centella Cream)
(Mesua ferrea L.)
(Piper sarmentosum Roxb.)
(Piper sarmentosum Roxb.)
(Pterocarpus santalinus L. f.)
(Santalum album L.)
(Senna tora (L.) Roxb.)
(Senna alata (L.) Roxb.)
(Senna Alata Tea)
(Piper retrofractum Vahl)
(Myristica fragrans Houtt)
(Andrographis paniculata (Burm. f.) Nees)
(Andrographis Capsules)
(Allium ascalonicum L.)
(Ocimum tenuiflorum L.)
(Curcuma longa L.)
(Turmeric Capsules)
(Turmeric Dry Extract)
(Turmeric Dry Extract Capsules)
(Arcangelisia flava (L.) Merr.)
(Curcuma sp.)
Harrisonia perforata (Blanco) Merr.
(Aristolochia pierrei Lecomte)
(Zingiber officinale Roscoe)
(Ginger Capsules)
(Ginger Tea)
(Cassia fistula L.)
(Nardostachys jatamansi (D. Don) DC.)
(Angelica sinensis (Oliv.) Diels)
Artemisia annua L.
(Ligusticum sinense Oliv. cv. Chuanxiong)
(Neopicrorhiza scrophulariiflora Pennell)
(Atractylodes lancea (Thunb.) DC.)
(Aucklandia lappa Decne)
(Terminalia chebula Retz.)
(Angelica dahurica (Hoffm.) Benth. & Hook. f. ex Franch. & Sav. var. dahurica)
(Kaempferia parviflora Wall. ex Baker)
(Hibiscus sabdariffa L.)
(Roselle Tea)
(Allium sativum L.)
(Zingiber zerumbet (L.) Sm.)
(Wurfbainia testacea (Ridl.) Škorničk.& A. D. Poulsen)
(Cannabis sativa L.)
(Myristica fragrans Houtt)
(Dracaena cochinchinensis (Lour.) S. C. Chen)
(Ficus racemosa L.)
(Hyptis suaveolens (L.) Poit.)
Clerodendrum indicum (L.) Kuntze
(Phyllanthus emblica L.)
(Citrus hystrix DC.)
(Citrus hystrix DC.)
(Areca catechu L.)
(Momordica charantia L.)
Moringa oleifera Lam.
(Aegle marmelos (L.) Corrêa)
(Solanum trilobatum L.)
(Morus alba L.)
Gynostemma pentaphyllum(Thunb.)
Makino
(Clinacanthus nutans (Burm. f.) Lindau)
(Cissus quadrangularis L.)
(Mimusops elengi L.)
(Zingiber montanum (J. König) Link. ex A. Dietr.)
(Piper betle L.)
(Capsicum annuum L.)
(Capsicum Oleoresin)
(Capsicum Gel)
(Piper nigrum L.)
(Piper nigrum L.)
(Eurycoma longifolia Jack)
(Thunbergia laurifolia Lindl.)
(Piper wallichii (Miq.) Hand.-Mazz.)
Senna garrettiana (Craib) H. S. Irwin & Barneby
(Terminalia bellirica (Gaertn.) Roxb.)
(Terminalia chebula Retz.)
(Caesalpinia bonduc (L.) H. Roxb.)
(Tarlmounia elliptica (DC.) H. Rob., S. C. Keeley, Skvaria & R. Chan)
(Hog Creeper Vine Dry Extract Capsiles)
(Hog Creeper Vine Dry Extract)
(Brachypterum scandens (Roxb.) Miq.)
(Lepidium sativum L.)
(Nigella sativa L.)
(Cuminum cyminum L.)
(Foeniculum vulgare Mill.)
(Plantago ovata Forssk.)
(Pimpinella anisum L.)
(Carum carvi L.)
(Anethum graveolens L.)
(Trachyspermum ammi (L.) Sprague)
Albizia procera (Roxb.) Benth.
(Acorus calamus L.)
(Tiliacora triandra (Colebr.) Diels)
Cyanthillium cinereum (L.) H. Rob.
(Orthosiphon aristatus (Blume) Miq.)
Murdannia loriformis (Hassk.) R. S. Rao & Kammathy
(Capparis micracantha DC.)
(Chrysopogon zizanioides (L.) Roberty)
(Cyperus rotundus L.)
(Cannabis sativa L.)
(Syzygium aromaticum (L.) Merr. & L. M. Perry)
(Boesenbergia rotunda (L.) Mansf.)
(Acanthus ebracteatus Vahl)
(Acanthus ilicifolius L.)
(Kaempferia galanga L.)
(Curcuma comosa Roxb.)
Betula alnoides Buch.-Ham. ex D. Don
Cannabis sativa L.
Carthamus tinctorius L
Mitragyna speciosa (Korth.) Havil
Mallotus repandus (Rottler) Müll. Arg
Azadirachta indica A. Juss. var. siamensis Valeton
Azadirachta indica A. Juss. var. siamensis Valeton
Punica granatum L.
Rhinacanthus nasutus (L.) Kurz
Baliospermum solanifolium (Burm.) Suresh
Curcuma aeruginosa Roxb
Boesenbergia kingii Mood & L. M. Prince
Senegalia rugata (Lam.) Britton & Rose
Acacia concinna (Willd.) DC.
Senegalia rugata (Lam.) Britton & Rose
Acacia concinna (Willd.) DC.
Senna alexandriana Mill. var. alexandriana
Cassia acutifolia Delile, Cassia angustifolia Vahl
Butea superba Roxb. ex Willd.
[Plaso superba (Roxb. ex Willd.) Kuntze, Rudolphia superba (Roxb. ex Willd.) Poir.
Pueraria candollei Graham
ex Benth. var. mirifica (Airy Shaw & Suvat.) Niyomdham
Streblus asper Lour.
Suregada multiflora (A. Juss.) Baill. (Gelonium
multiflorum A. Juss.
Plumbago zeylanica L.
Plumbago indica L.
Biancaea sappan (L.) Tod.
Ziziphus attopensis Pierre
Streblus asper Lour.
Justicia gendarussa Burm. f.
Enhalus acoroides (L. f.) Royle
Bridelia ovata Decne.
Tamarindus indica L.
Citrus × aurantiifolia (Christm.) Swingle
Garcinia mangostana L.
Blumea balsamifera (L.) DC
Persicaria odorata (Lour.) Soják
Zingiber montanum (J. König) Link ex A. Dietr.
Mammea siamensis (Miq.) T. Anderson
Citrus maxima (Burm.) Merr.
Citrus × aurantium L. ‘Som Sa'
Punica granatum L.
Rhinacanthus nasutus (L.) Kurz
Kratom Dry Extract is prepared from the powdered Kratom by extraction with water. It contains not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of mitragynine (C23H30N2O4); the labelled amount of mitragynine is not less than 10.0 per cent, calculated on dried basis.
Description Brownish yellow powder.
Packaging and storage Kratom 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 mitragynine; (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 (Fig. 1).
Loss on drying Not more than 6.0 per cent w/w after drying at 105° to constant weight, use 1 g (Appendix 4.15).
Assay Carry out the determination as described in the “Liquid Chromatography” (Appendix 3.5).
Diluent Prepare a mixture of 8 volumes of methanol and 2 volumes of a 0.1 per cent v/v solution of glacial acetic acid.
Buffer solution Dissolve 1.54 g of ammonium acetate in 500 mL of water, adjust with glacial acetic acid to pH 6.0, and dilute to 1000.0 mL.
Mobile phase Prepare a mixture of 65 volumes of acetonitrile and 35 volumes of Buffer solution.
Standard preparations Dissolve a suitable quantity of Mitragynine RS in sufficient Diluent to obtain a stock solution having a known concentration of about 100 μg of mitragynine per mL. Dilute the solution quantitatively and stepwise with the same solvent to obtain six solutions of 10, 20, 40, 60, 80, and 100 μg of mitragynine per mL. Filter through a membrane having a 0.45-µm porosity.
Assay preparation Transfer about 25 mg of Kratom Dry Extract, in fine powder and accurately weighed, to a 50-mL volumetric flask and add 35 mL of Diluent. Sonicate for 30 minutes, allow to cool to room temperature, and adjust to volume with the same solvent. Centrifuge the resulting solution at 3218 × g (5000 rpm) for 5 minutes. Use the supernatant and filter through a membrane having a 0.45-µm porosity.
Chromatographic system The chromatographic procedure may be carried out using (a) a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilane chemically bonded to porous silica or ceramic microparticles (5 µm), (b) Mobile phase at a flow rate of 1.0 mL per minute, and (c) an ultraviolet photometer set at 225 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 response as directed under Procedure and Calculation: the relative standard deviation for replicate injections is not more than 2.0 per cent. The symmetry factor for mitragynine peak is not more than 1.5.
Procedure and Calculation Separately inject about 20 μL of Standard preparations into the chromatograph, record the chromatograms, and measure the responses for the mitragynine peaks. Plot the readings and draw the standard curve of best fit: the curve shows the correlation coefficient of not less than 0.995. Inject about 20 µL of Assay preparation into the chromatograph, record the chromatogram, and measure the response for the mitragynine peak. By reference to the standard curve, calculate the content of mitragynine (C23H30N2O4) in the portion of the Extract taken.
Other requirements Complies with the requirements described under “Extracts” (Appendix 1.16H).
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