Jin Bu Huan Anodyne Tablets, a mislabelled and misclassified medicine
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Abstract'Jin Bu Huan Anodyne Tablets' was recently reported to cause life-threatening bradycardia with rapid onset and central nervous system and respiratory depression in three unrelated children in Colorado, USA. A proprietary 'medicinal' preparation, 'Jin Bu Huan Anodyne Tablets', is on sale in local pharmacies and Chinese emporia and is labelled as containing 'Polygala Chinensis L. Alkaloids 30% Starch 70%'. Thin-layer and high-pressure liquid chromatography and chirality determination confirmed that the tablets contain l-tetrahydropalmatine (L-THP) 25.16 mg/tablet and no other alkaloids. L-THP, however, is not found in P. chinensis (Polygalaceae) but in Stephania species (Menispermaceae). This chemical, though available in plants, is registered under Rotundinum as a fine pharmaceutical in Part 2 of the Pharmacopoeia of the People's Republic of China (1990 edition). Based on the purity, quantity and potency of L-THP in Jin Bu Huan Anodyne Tablets, health authorities should reclassify this proprietary preparation to ensure proper supervision and consumer safety.
All Author(s) ListBut P.P.H., Choi K.L.
Journal nameJOURNAL OF THE HONG KONG MEDICAL ASSOCIATION
Year1994
Month12
Day1
Volume Number46
Issue Number4
PublisherScientific Communications International Ltd.
Place of PublicationHong Kong
Pages302 - 305
ISSN1010-8424
LanguagesEnglish-United Kingdom
Keywordsadverse effects, control measures, Jin Bu Huan, tetrahydropalmatine, traditional Chinese medicine

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