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.
Ginger Tea contains an amount of powdered Ginger equivalent to not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of gingerols, gingerdiones and shogaols, and not less than 90.0 per cent of the labelled amount of volatile oil, calculated on the anhydrous basis.
Strengths available 1, 2 and 3 g (powder), supplied in a sachet.
Dose Carminative, antiflatulent, antidyspepsia: one sachet, containing 1 to 3 g of powdered ginger, prepared as an infusion by soaking each with 150 mL of boiling water for 10 minutes, twice a day.
Prophylaxis of nausea and vomiting associated with motion sickness: one sachet, containing 1 to 2 g of powdered ginger, prepared as an infusion by soaking each with 150 mL of boiling water for 10 minutes, at least 30 minutes to 1 hour before travelling or as needed.
Prevention of postoperative nausea and vomiting: one sachet, containing 1 g of powdered ginger, prepared as an infusion by soaking each with 150 mL of boiling water for 10 minutes, at least 1 hour before operation.
Warning
1. It is not recommended in children under 6 years of age.
2. It may cause gastro-intestinal disturbances and irritation in mouth and throat.
3. Caution should be exercised when it is to be used concomitantly with anticoagulants and antiplatelets.
4. It should not be used in patients with bile duct obstruction except under medical supervision.
Packaging and storage Ginger Tea shall be kept in well-closed containers, protected from light.
Labelling The label on the container states (1) the amounts of gingerols, gingerdiones and shogaols; (2) the amount of volatile oil; (3) the expiration date; (4) “If you are pregnant or nursing, consult a qualified health care professional before using”.
Identification
A. The tea contents exhibit diagnostic structures of the powdered drug described under Ginger.
B. The tea contents comply with the tests for Identification A, B and C described under Ginger Capsules.
Water Of the tea contents, not more than 11.0 per cent v/w (Azeotropic Distillation Method, Appendix 4.12).
Microbial limit Complies with the requirements for Category 2 in the “Limits for Microbial Contamination” (Appendix 10.5).
Assay
FOR VOLATILE OIL Mix the contents of not less than 20 sachets of Ginger Tea and transfer about 20 g, accurately weighed, to a 500-mL round-bottomed flask. Use 250 mL of water as the distillation liquid and distil at a rate of 2 to 3 mL per minute for 5 hours. Use 2.0 mL of xylene in the graduated tube (Appendix 7.3H). Calculate the content of volatile oil, in mL, in the portion of the Tea taken with reference to anhydrous substance.
FOR GINGEROLS, GINGERDIONES AND SHOGAOLS Carry out the determination as described in the “Liquid Chromatography” (Appendix 3.5).
Mobile phase A, Mobile phase B, System suitability solution, Standard preparation, Chromatographic procedure, and Procedure Proceed as directed in the Assay under Ginger Capsules.
Assay preparation Grind the contents of not less than 20 sachets of Ginger Tea to fine powder. Transfer about 2 g of the powdered ginger, accurately weighed, to a glass-stoppered conical flask. Add 50 mL of ethanol, insert a stopper into the flask, macerate for 24 hours, shaking frequently during the first 8 hours, and then allowing to stand for 16 hours. Filter.
Calculation Calculate the percentage of the labelled amount of gingerols, gingerdiones, and shogaols in the portion of the Tea taken by the expression:
(ru/rs) × C × (V/D) × (W/L) × 100,
in which ru is the sum of the peak responses for gingerols, gingerdiones, and shogaols from Assay preparation, rs is the peak response of capsaicin from Standard preparation, C is the concentration, in mg per mL, of Capsaicin RS in Standard preparation, V is the final volume, in mL, of Assay preparation, D is the weight, in mg, of the portion of the tea taken, W is the average weight, in mg, of the tea content, and L is the labelled amount, in mg per sachet, of gingerols, gingerdiones and shogaols.
(Note Calculate the sum of the peak responses due to gingerols and gingerdiones occurring at about the following retention times relative to 1.0 for capsaicin: 0.8 for 6-gingerol, 1.5 for 8-gingerol A, 2.2 for 8-gingerol B, 2.5 for 6-gingerdiol, 2.6 for 6-gingerdione, 3.4 for 10-gingerol, and 5.2 for 8-gingerdione and calculate the sum of the peak responses due to shogaols, occurring at about the following retention times, relative to 1.0 for capsaicin: 1.9 for 6-shogaol, 4.2 for 8-shogaol, and 5.8 for 10-shogaol).
Other requirements Complies with the requirements described under “Herbal Teas” (Appendix 1.16H).