Case report
Anorectic sibutramine detected in a Chinese herbal drug for weight loss

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Abstract

In the presented case, a young healthy woman had ordered a Chinese herbal medicine, called “LiDa Dai Dai Hua Jiao Nang”, via internet. She took this product for approximately 1 week, but on the second day she developed severe headache, vertigo and sensation of numbness. After discontinuing medication, symptoms disappeared within 2 days. For identification of the ingredients, a urine sample as well as a sample of the “LiDa” capsule were analysed by GC–MS and HPLC-DAD. One major ingredient was detected in urine as well as in the “LiDa” capsule and was identified as sibutramine. Quantification by HPLC-DAD yielded 27.4 mg sibutramine base, which is approximately two times the amount of the highest authorized single dose available on the pharmaceutical market in Germany. This case demonstrates a common problem with herbal medicines, where adulterations with synthetic therapeutic substances can lead to severe side effects and/or potentially fatal interactions with conventional medicines.

Introduction

Worldwide traditional herbal medicines are gaining popularity as a source of complementary and alternative remedies. In contrast to conventional pharmaceuticals, herbal medicines are generally presumed as safe, harmless and without side effects, because of their natural origin.

Common problems affecting the safety of herbal medicines include contamination [1], adulteration [2], toxicity [3], lack of standardization, incorrect preparation or dosage and inappropriate labeling. According to the source of the plant materials, herbal medicines can contain excessive or even banned pesticides, heavy metals and microbial contaminants. The presence of these contaminants as well as adulteration with conventional pharmaceuticals can lead to acute or chronic toxicity, severe side effects and drug interactions [4], [5]. Over the past several years, there have been many reports on adulterations of traditional herbal medicines by synthetic therapeutic substances [6], [7], [8], [9], [10].

Section snippets

Case report

In the presented case, a 20-year-old healthy woman had purchased a Chinese herbal medicine, called “LiDa Dai Dai Hua Jiao Nang” (Kunming Dali Industry and Trade Co. Ltd.), via the Internet to support weight reduction. She took one capsule per day over a period of 6 days. On the second day she developed severe headache, vertigo and numbness. After discontinuing medication, symptoms disappeared within 2 days. Twenty-four hours after the last intake of the “LiDa” capsule, she went to her family

Methods

The urine sample was prepared using a standard GC–MS-based systematic toxicological analysis procedure including acidic hydrolysis and acetylation [11]. For analysis of the “LiDa” capsule an aliquot of 10 mg each was suspended in 1 mL methanol and 1 mL HPLC mobile phase, respectively. After centrifugation and separation of the liquid phase, an aliquot of 1 μL methanolic solution was analyzed by GC–MS after dilution 1:50 (v/v), and an aliquot of 10 μL HPLC mobile phase solution by HPLC-DAD [11], [12].

Results and discussion

Sibutramine, a synthetic noradrenaline, dopamine and serotonin reuptake inhibitor, which is only available on prescription, was detected in urine as well as in the “LiDa” capsule, even though only powders of Chinese medical plants were declared as ingredients. Quantification yielded 27.4 mg sibutramine base per capsule, which is approximately two times the amount of the highest authorized single dose (capsules with 12.55 mg sibutramine base) available on the pharmaceutical market in Germany.

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