ตำรามาตรฐานยาสมุนไพรไทย
Thai Herbal Pharmacopoeia
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.
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).