Policies to help break through the raw materials for endangered animals and plants

Business News Agency August 12 News Last month, ST Golden Flower was officially starred for its improved business performance. This made people think again about this company, which has two types of new drugs, which are based on artificial tiger bones. Later, on the 2015 edition of the Pharmacopoeia, in principle, the news that Chinese proprietary Chinese medicines, which are based on wild endangered plants and animals, will no longer be reintroduced will continue to spread in the industry and be reprinted by many media.

Under the premise of protecting wild and endangered animal and plant resources, the 2010 edition of the Pharmacopoeia has guided related companies to develop alternatives for the development of related raw materials for Chinese medicine, and included some substitutes such as artificial bezoar and artificial musk into pharmacopoeia. With the maturation of traditional Chinese medicine substitutes, whether there will be more alternative materials will be collected in the Pharmacopoeia, many drug companies are quite concerned about this.

Related research expansion

The replacement of natural products by artificial products, artificial synthesis, etc. is an important way to ease the dependence on valuable resources that are commonly used. There is a great deal of room and potential for research on alternatives. The varieties that have been systematically researched so far are mainly precious and rare Chinese medicinal materials, such as rhinoceros, tiger bone, antelope horn, musk, pangolin, bear bile, and bezoar.

In order to restore the production of traditional tiger bone medicines, research on artificial tiger bones began in 1990. After 21 years of development, the artificial tiger bone market is gradually opening up.

As two important new drugs for ST Golden Flower, Artificial Tiger Bone Powder and Jintiange Capsules made of it as raw materials were awarded a new drug certificate issued by the State Food and Drug Administration in June 2003; Jinhua Pharmaceutical began to fully promote the quality standards of artificial tiger bone powder and Jintiange capsule trials and phase IV clinical trials of capsules. It has achieved good results and began to rapidly open the musculoskeletal drug market.

Relevant data show that in 2009, Jintiange Capsule ranked first in the market share of the musculoskeletal system in the musculoskeletal system, with a market share of 6.15%. In 2008, the market share of the product was only ranked seventh and was 3.21%. , With the 6.59% of the top ranked Xiaotong plaster, 5.58% of Tongjitang Xianlinggufen capsules are far from one another. In fact, since 2007, the cumulative growth of Jintiange capsules has reached 15 times, which no matter what company has to be said to be a miracle. Some analysts pointed out that under the social background that China has completely banned the use of tiger bone medicine and accelerated population aging, the artificial tiger bone industry will become the hope for the development of ST Golden Flower.

In addition to the development of artificial tiger bones, research on artificial bezoar, artificial musk, artificial horns, and buffalo horns in place of rhino horns is quite mature. Rhinoceros, for example, is the main drug for the name “Rhinoceros Dioscorea”. Since the drug relies mainly on imports, the drug source is scarce and the price is expensive. It has not been able to meet clinical needs for a long time. In addition, Rhinoceros is listed as an internationally endangered animal and regulations prohibit medicinal use. This brings difficulties to clinical medication. In order to seek alternatives to rhinoceros, it is widely accepted that buffalo horns and yellow horns are used instead of rhinoceros, and they have been adopted and applied clinically.

Pharmacopoeia cautiously included

According to insiders, although the 2015 edition of the Pharmacopoeia will in principle no longer re-accelerate the use of proprietary Chinese medicines that are endangered by wild animals and plants as a raw material, preliminary guidelines have not yet been formed. However, after alternatives such as artificial bezoar and other valuable Chinese herbal medicines were collected into the pharmacopoeia, related companies were rather anxious and were eager to know whether there would be more wild and endangered animal and plant substitutes to be included in the next step. The next step for companies should be How to seek a breakthrough.

In fact, in the 2010 edition of the Pharmacopoeia, the six “non-commercial” principles have been identified, that is, the more varieties the better, but do not reduce the requirements, do not break the rules, the quality standards can not meet the requirements of the species; Protection of movements and plants; not including keels; containing people in white, Placenta, Wuling fat; not containing fresh living things; prescription drug sources are unclear or basic work is weak The variety is not included in principle.

The 2010 edition of the Pharmacopoeia has made it clear that the resources of endangered wild animals are no longer newly added, and actively promotes the development of the shortage of medicinal materials for artificial breeding, such as in vitro use of bovine, artificial musk, artificial tiger substitutes for medicinal materials.

Due to the fact that the natural bezoars on the market are mainly derived from individual diseased cattle, the yield is minimal. In order to solve the deficiency of the source of the bezoar, artificial breeding of bezoars is currently used. This is similar to the artificial cultivation of stones for cattle: surgical implantation of plastics and other nuclear bodies. It will take yellow in 1 year or so. According to the reporter's understanding, at present, only five kinds of Chinese patent medicine products such as Pien Tze Huang, Ba Bao Dan and Xinnaojing are allowed to use natural musk, and the endangered wild animal protection label is to be put on the packaging. Other Chinese musk-containing proprietary Chinese medicines can only be artificially used. Musk replaces natural musk.

However, compared with artificial bezoar and artificial musk, artificial tiger bone was not so lucky. Current artificial bezoar and artificial musk have been included in the Pharmacopoeia, laying the foundation for their raw material market.

Even so, artificial bezoar and other substitutes in the market still have some inherent deficiencies. Some industry experts pointed out that the formula of artificial bezoar must be improved. This adds resistance to the artificial tiger bones entering the Pharmacopoeia. "Because it is contrary to the international spirit of protecting wild and endangered animals, artificial tiger bones, artificial leopard bones, etc. are difficult to enter into pharmacopoeia," Zhou Chaofan, an advisor to the State Pharmacopoeia Commission, said.

In fact, there is still a great deal of controversy about wild endangered animals and plants such as bear bile and tiger bone. Zhou Chaofan stated that because the Chinese pharmacopoeia is to be included in the UNESCO bibliography, in order to avoid disputes as much as possible, the current pharmacopoeia is only Some of the two types of protected species are included, such as pangolins and antelope horns. One category is absolutely excluded. Therefore, under the premise that the current policy is more cautious on alternatives, as related companies, as soon as possible to improve formula research and development of related alternatives, it may be possible to find a way to break through faster and more accurately.