中药首次获得美国FDA批复
时间：2015-12-29 00:08:06
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SHIJIAZHUANG, Dec. 25 (Xinhua) -- A listed Chinese herbal medicine maker1 on Thursday said its compound flu formula has received approval from the U.S. Food and Drug Administration (FDA) for clinical tests.
The decision has paved the way for Chinese herbal medicine to enter the U.S. market.
The Shenzhen-listed Yiling
Pharmaceutical2 said that its wholly owned subsidiary in the U.S. received the approval for trials for its Lianhuaqingwen capsule, a compound herbal medicine for treating the common cold and
influenza3 virus.
Chinese herbal medicine gets FDA clinical test approval
Chinese therapists have adopted
prescriptions4 from ancient records on herbal medicine and used modern research on viruses and bacteria in developing the medicine.
The Western medical circle has long questioned the efficacy and safety of Chinese herbal medicine due to the complex herbal ingredients and pharmacology of traditional Chinese medicine.
When the influenza type A H1N1 virus broke out in 2009, nine Chinese hospitals that participated in international exchanges for treating the
epidemic5 used the medicine in clinical treatment, which tested its efficacy and safety. The hospitals' records of using the drug during the epidemic have been recognized by the World Health Organization.
The Chinese medicine has shown effectiveness in treating flu symptoms including fever, nasal
congestion6, cough and muscle soreness in clinical tests.
As one of the top-selling anti-influenza drugs in China, the capsule is available in 120,00
pharmacies7 around China and is also available in Hungary, Canada and Indonesia.
The company based in Shijiazhuang, capital of north China's Hebei Province, said getting an FDA certificate would further enhance the herbal medicine's
standing8 in the international market.
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