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.
Roselle Tea contains an amount of powdered Roselle equivalent to not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of organic acids, calculated as citric acid on the dried basis.
Strengths available 2, 2.5 and 3 g (powder), supplied in a sachet.
Dose One sachet, containing 2 to 3 g of powdered roselle, prepared as an infusion by soaking each with 120 mL of boiling water for 10 minutes, three times a day after meals.
Contra-indication It is contra-indicated in patients with impaired renal function.
Warning
1. It may cause abdominal discomfort.
2. It may cause diarrhoea due to its laxative effect.
Packaging and storage Roselle 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 organic acids calculated as citric acid; (2) the expiration date.
Identification
A. The tea contents exhibit diagnostic structures of the powdered drug described under Roselle.
B. The tea contents comply with the tests for Identification A, B and C described under Roselle.
Loss on drying Of the tea contents, not more than 12.0 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 Grind the contents of not less than 20 sachets of Roselle Tea to No. 250 powder. Shake about 1 g, accurately weighed, with 100.0 mL of carbon dioxide-free water for 15 minutes and filter. To 50.0 mL of the filtrate, add 100 mL of carbon dioxide free-water. Titrate with 0.1 M sodium hydroxide VS until pH 7.0, determining the end-point potentiometrically (Appendix 6.4). Perform a blank determination, and make any necessary correction. Each mL of 0.1 M sodium hydroxide VS is equivalent to 6.4 mg of citric acid.
Other requirements Complies with the requirements described under “Herbal Teas” (Appendix 1.16H).