The first child diarrhea-removing Chinese medicine protection variety was born

The first child diarrhea-removing Chinese medicine protection variety was born

July 29, 2016 Source: New Kangjie

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On July 22, CFDA announced that it has approved the approval of nine Chinese medicine varieties as the first Chinese medicine secondary protection variety. The protection period is seven years from the date of the announcement, and one Chinese medicine protection variety is given to extend the protection period. The same type of production enterprise shall declare the same variety protection according to the "Regulations on the Protection of Chinese Medicine Varieties" and relevant regulations. If it is not declared within the time limit, production shall be stopped; if production continues, the State Food and Drug Administration will suspend the validity of its approval number and The relevant provisions of Article 23 of the Regulations on the Protection of Chinese Medicine Varieties shall be investigated and punished.

The specific announcement is as follows:

Announcement of the Protection of Traditional Chinese Medicines by the General Administration (No. 7) (No. 125 of 2016)

According to the Regulations on the Protection of Traditional Chinese Medicine Varieties, the State Food and Drug Administration approved Tianjin Tianshili Zhijiao Pharmaceutical Co., Ltd. for injection of Danshen polyphenolic acid, Qingdao Huarentai Pharmaceutical Co., Ltd. Puyuan Hewei Capsule, Hefei Huarun Deer Medicine Industry Co., Ltd. Children's Diarrhea Stop Granules, Xiangyu Pharmaceutical Co., Ltd. Puqi Panyankang Granules, Harbin Zhenbao Pharmaceutical Co., Ltd. Injection Xuesaitong (freeze-dried), Shandong Hanfang Pharmaceutical Co., Ltd. Compound Huangbai Liquid Coating Agent, Shanghai Huanghai Pharmaceutical Co., Ltd. Fuzheng Huayu Capsule, Gansu Pu'an Pharmaceutical Co., Ltd. Xuanfei Zhiyu Mixture, Kunming Pharmaceutical Group Co., Ltd. Injection Xuesaitong (freeze-dried), Qinghua Deren Xi'an Xingfu Pharmaceutical Co., Ltd. Nine Chinese medicine varieties were listed as the first Chinese medicine secondary protection variety, and the protection period was seven years from the date of the announcement. The same type of production enterprise shall declare the same variety protection according to the "Regulations on the Protection of Chinese Medicine Varieties" and relevant regulations. If it is not declared within the time limit, production shall be stopped; if production continues, the State Food and Drug Administration will suspend the validity of its approval number and The relevant provisions of Article 23 of the Regulations on the Protection of Chinese Medicine Varieties shall be investigated and punished.

Special announcement.

It is understood that the state encourages the development of clinically effective Chinese medicine varieties, and implements a hierarchical protection system for Chinese medicine varieties with stable quality and curative effect. The protected Chinese medicine varieties are divided into first and second grades. The protection period of traditional Chinese medicine protection varieties: the first-grade protection varieties of traditional Chinese medicine are 30 years, 20 years and 10 years respectively. The second-grade protection of Chinese medicine is seven years.

The above nine varieties are all secondary protection varieties of traditional Chinese medicine. According to the historical announcement, there are currently 317 traditional Chinese medicine protection varieties in China, of which only 14 are used for children, and more than one cough and lung medicine.

It is worth noting that in this announcement, Hefei Huarun Shenlu Pharmaceutical Co., Ltd. is the first child-protective Chinese medicine for diarrhea. As we all know, although children's medicine is called "one of the next gold mines" in the industry, at present, the number of enterprises producing children's medicine is small, and the varieties of children's medicines are mostly concentrated in the use of colds and cough medicines. less. The Chinese patent medicine improved by the traditional Chinese medicine prescription is one of the key directions of children's medicine.

Taking the 999 diarrhea granules as an example, as the national medical insurance B variety under the China Resources Sanjiu, it is one of the existing and less child-specific varieties in China. At present, the favorable policies in the field of children's medicine in China are frequently introduced, and children's medicines with good quality of medicines have an advantage in the market.

When the 999 diarrhea granules were on the market, they passed the authoritative verification of the pediatric diarrhea field of the Chinese Medical Association. After 1489 large samples and 15 well-known top three hospitals, 999 diarrhea granules were used to treat children with acute diarrhea. The efficacy and safety are better than montmorillonite. Academician Li Lianda, an academician of the Chinese Academy of Engineering and a pharmacologist of Chinese medicine, once commented: "The 999 diarrhea granules are strictly rigorous, with little medicinal taste, good clinical research, and are very useful drugs for pediatrics."

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