Objective: To establish a method for detecting illegal addition of hormone in anti rhinitis gel products. Twenty-two products from online sales were tested. Exposure risks and regulatory suggestions were proposed from the monitoring results. Methods: Forty Illegal hormone additives in the sample were extracted with acetonitrile, separated by high performance liquid chromatography, detected by tandem mass spectrometry and quantified by matrix external standard method. The test methodology was evaluated and samples were determined. Results: The method showed a good linear relationship with 40 illegal hormone additives, and met the methodological requirements of precision, repeatability and recovery. Twenty-two samples were tested, and the total positive rate was 45.5% (10/22). Two in seven of medical device samples were tested positive, involving the illegal addition of beclomethasone dipropionate and clobetasopronate. Eight in fifteen hygienic samples were tested positive, including the illegal addition of clobetasopronate and budesonide. Conclusion: According to the monitoring results, there might be a systematic exposure of illegal hormone addition within the related online products, and may cause the systematic risks. It is necessary to strengthen the supervision and rectification of the rhinitis treatment and related products sold online. Meanwhile, since three kinds of hormone drugs were detected, supervision of hormone APIs should also be strengthened.
GUO Jian-bo, WANG Jian-shan, LIN Fang, NAN Guan-jun, WANG Song, ZHANG Xiao-fei, LI Tao, LIU Hai-jing
. Detection and investigation of hormone additives in external used gel products on market*[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(12)
: 2127
-2136
.
DOI: 10.16155/j.0254-1793.2023.12.19
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