The new Pharmacopoeia has been over for more than a month in the medical industry.

Business News Agency November 9 News New Pharmacopoeia With new quality requirements and higher control standards, China's pharmaceutical quality level has been further improved, and China's drug standards have also begun to surpass the European and American rally.

One of the highlights of the new edition of the Pharmacopoeia is the increase in the number of varieties collected and the adoption of advanced technologies and analytical methods at home and abroad. The new edition of the Pharmacopoeia has formed a full range of pharmaceutical standards systems, including Chinese herbal medicines, Chinese herbal medicines, Chinese patent medicines, chemical medicines, pharmaceutical excipients, and biological products. The long-standing problems of lacking and insufficient national standards for Chinese herbal medicines, Chinese herbal medicines, and commonly used pharmaceutical excipients have been solved. This means that China's Chinese medicine industry has been given full attention and has become more standardized and standardized.

An Haoyi, Chairman of Sichuan Qi Traditional Chinese Medicine Industry Group Analysis: Along with the gradual approach of Chinese Pharmacopoeia standards and foreign quality standards, the intention of the Chinese medicine industry to take the internationalization route is very clear. Prior to this, throughout the country, the entire industry chain construction of traditional Chinese medicine from planting to production, from secondary development to new drug development will become a general trend.

Standards enhance new development trends

In the process of revision of the new edition of the Pharmacopoeia, a number of foreign-funded biological products companies and domestic pharmaceutical leading enterprises were involved. Many of these companies have high-tech advantages. Some people worry that new technical barriers may form.

However, An Haoyi does not think so. He believes that the concentrated development trend of the industry after the new edition of the Pharmacopoeia will become a feast for a few enterprises. The new technical barriers are also considered to be an essential means to raise industrial standards. Only in this way can the Chinese pharmaceutical industry have the possibility of gradually shortening its international distance. In this process, Chinese medicine is the most important thing, and it is also China's "unique cheats" for participating in international competition.

The new pharmacopoeia fully emphasizes the special status of traditional Chinese medicine, insists on embodying the characteristics of traditional Chinese medicine on the basis of comprehensive inheritance of fine traditions, and adjusts the preparation methods of Chinese patent medicines to make them more in line with the clinical practice of “decoction and medicine” in traditional Chinese medicine. At the same time, a special quality control method that conforms to the characteristics of Chinese medicine has been greatly increased.

As a pharmaceutical practitioner who has been practicing for 30 years, An Haoyi can deeply grasp the deep meaning behind these new standards: The new development trend will be presented, and in the short term it will develop into the mainstream of the Chinese medicine industry. Those companies with great technological advantages, great innovation results, good foresight, and strong financial and investment awareness will enjoy this future mainstream feast.

From two perspectives, on the one hand, standards have boosted demand. The more systematic and strict control standards for the decoction pieces make the raw materials quality control of the medicinal materials become the basis for quality control of traditional Chinese medicine. From the perspective of recent changes in the market of medicinal herbs, the Chinese herbal medicine market centered on the four major medicinal material distribution centers in Zhangzhou and Anguo is characterized by uneven quality, mixed sources, and difficult to distinguish advantages and disadvantages, resulting in significant difficulties in quality control of medicinal materials. increase. Due to the inability to meet the "authentic" nature of Chinese medicine, it has restricted the improvement of the quality of Chinese medicine. Therefore, the industrialization and intensification of cultivation of traditional Chinese medicine has become a general trend. On the other hand, innovation is the only way for ethnic medicine to go global.

For the new industrial chain layout

In view of the in-depth prediction of the development of the Chinese medicine industry, An Haoyi led the Chinese medicine industry to establish a higher standard of traditional Chinese medicine industry management line based on the new version of the “Chinese Pharmacopoeia” and the upcoming new version of the GMP, and began its Chinese medicine industry. Chain development layout.

Recently, 蜀Chinese Medicine Industry Group authorized the project department of the group to submit the "Standardized Planting and Deep Processing Project of Salvia miltiorrhiza Medicinal Materials" to the relevant authorities. The main contents of the project include the following aspects:

Standardized Chinese medicine cultivation and traditional Chinese medicine industry are used to determine and evaluate the main components of fingerprints of Salvia miltiorrhiza from different origins. From the results of the measurement, Salvia miltiorrhiza Bunge in Shiquan Township of Sichuan Province and Songlin Town of Guanghan County had higher contents of salvianolic acid B, and other active ingredients such as tanshinone IIA were also relatively high, belonging to the high-quality medicinal materials of Taodi. After field investigation, its natural geographical environment can fully meet the requirements of establishing a GAP-standardized Salvia miltiorrhiza medicine planting base. Therefore, Suizhong intends to divide the construction of the planting base into two phases. In the first phase, it is planned to establish a 2,000 m2 Salvia miltiorrhiza herb cultivation base complying with the GAP regulations in Songlin Town, Guanghan County; and the second phase is to establish the Salvia miltiorrhiza herb cultivation in accordance with GAP specifications in Shiquan Town, Zhongjiang City. Base 3000 acres.

About 70% of the pharmaceutical standards for the new Chinese version of the “Pharmacopoeia” have been improved and improved. At the same time, higher requirements have been placed on the safety and efficiency of medicines.蜀 Before July 2010, the Chinese medicine industry had already completed the revision of the internal control standards of the enterprise according to the Pharmacopoeia. The existing enterprise internal control standards in Yanzhong not only highlight the quality requirements of the new edition of the Pharmacopoeia, but also have some typical features:

High, higher than the national standard input of effective pharmaceutical ingredients, to ensure the high quality and efficiency of drugs;

Fine, fine control of all aspects of production, fine control of various indicators of pharmaceutical parameters;

Yan, internal control standards supporting a strict standard implementation management system, training in place, responsibility to the people, so that the standard can be implemented smoothly and in place;

In detail, the internal control standards of Suizhong pay attention to detail management, and all the finer points of production are under control.

New, innovative equipment, and innovative technology not only introduce high-precision production equipment at home and abroad, but also pioneer the largest and most sophisticated equipment in China to adapt to the existing production scale. It not only strictly enforces the new Pharmacopoeia standards, but also pioneers the green production of Chinese medicines, attaches importance to the high efficiency and safety of drugs, and uses a new scientific production concept to inherit the essence of Chinese medicine.

In the "Standardized Planting and Deep Processing Project of Salvia miltiorrhiza Medicinal Materials" submitted this time, the content of the deep processing of Chinese medicine follows the above-mentioned internal control standards. Vigorously develop high-purity Salvia miltiorrhiza extracts, extract the effective components of salvia miltiorrhiza, purify and refine, and further increase the added value of Salvia miltiorrhiza products.

Variety Development The existing annual sales of compound Danshen Tablets, Tongmai Granules and Refined Guanxin Granules containing Danshen medicinal materials exceed 10 million yuan. Through the in-depth development of the above varieties, the scientific and technological content of Salvia miltiorrhiza products will be greatly improved, and product quality standards will be increased, new quality control indicators will be added, and the effectiveness and safety of products will be reevaluated to ensure the safety of people's medications. Effective, it is estimated that the new sales revenue will be 200 million yuan. At the same time, the development of new Danshen preparations will enrich existing product structures.

Since 2005, Suizhong has completed the in-depth development of multiple products, and has cooperated with a number of research institutes such as the Institute of Traditional Chinese Medicine of Sichuan Academy of Traditional Chinese Medicine, and has the advantages of combining production, study and research. At present, the systematic quality research on multiple varieties of traditional Chinese medicine such as compound Danshen tablets has been completed. The results of the research have been highly recognized by the Pharmacopoeia Commission Committee on Traditional Chinese Medicine Preparations and have played an important role in improving the quality standard of compound Danshen tablets in China.

Industrial cooperation extends the reach of the industrial chain

蜀 Since 2009, the Chinese medicine industry has continuously strengthened scientific and technological innovation and technological upgrading. In 2009, it achieved sales revenue of 1.8 billion yuan, a year-on-year increase of approximately 50%, of which new products accounted for more than 20% of total sales revenue. At present, the company is developing 8 new drug projects, among which there are 5 new drugs of category 3.1 of chemical drugs, 2 new drugs of category 6 of Chinese medicines, and 1 new drug certificate transfer category. It is estimated that by the end of 2010, there will be 15 new drugs research projects. While strengthening the creation of new drugs, the company plans to introduce more than 10 varieties of Chinese medicine. In order to realize the rapid industrialization of new drugs, the company is now constructing and supporting the new dosage forms, new workshops and other capacity design and transformation. All projects are expected to invest a total of 200 million yuan, of which 75 million yuan will be spent on research and development of new drugs, and 125 million yuan will be invested in fixed assets. After the completion of the project, it is estimated that the new sales revenue will be 1.5 billion yuan and the new profit will be 400 million yuan.

Recently, the Sichuan Yao Traditional Chinese Medicine Industry Group and the local government reached a consensus to jointly carry out the in-depth development of Dangshen Dangshen oral solution and the innovative work of Dangshen Dangshen. According to the relevant person in charge, the Chinese herbal medicine industry will first invest in expanding the production scale, in-depth development of Panax Dangshen oral solution and creating the latest single product marketing strategy. In the later period, a large amount of investment will be invested in the research and development of new products. Following the use of Codonopsis pilosula Oral Liquid, a new type of Codonopsis pilosula preparation with good curative effect and high safety will be developed. In order to ensure the quality and quantity of the original medicine and to protect the authentic medicinal materials, the Codonopsis pilosula GAP planting base will be established in the local area, and the local Codonopsis pilosula plantation processing will be upgraded to standardization and industrialization to further enhance the quality of Codonopsis pilosula source.

In September 2010, at the 2010 International (Luzhou) Chinese Medicine Expo and the 26th National (Luzhou) Chinese Herbal Medicine Trade Fair, the Sichuan Shuo Traditional Chinese Medicine Industry Group and the Zhuozhou City Government established a long-term cooperation project for the development of traditional Chinese medicine industry. An Haoyi, chairman of the Chinese Medicine Industry Group, was hired as a consultant for the development of the Chinese medicine industry in Quzhou, and was awarded a consultancy certificate issued by the president of Cangzhou City.

Luzhou is the largest collection and distribution center for Chinese herbal medicines in China. It ranks first in China’s “Four Pharmaceutical Capitals” and bred more than 400 kinds of medicinal varieties with its unique natural and geographical conditions. Now it has formed the cultivation and processing of Chinese herbal medicines and the logistics trade of Chinese herbal medicines. A complete industrial chain for the production and R&D of Chinese patent medicines. Relying on a number of favorable conditions in the region, the Sichuan Yao Traditional Chinese Medicine Group will establish a large-scale purchase and sales base for Chinese herbal medicines in Zhangzhou. At present, large-scale medicinal material storage warehouses have been completed and it is expected that they will be ready for use next year.

In addition, Suizhong will continue to follow the path of “production and learning” of Sichuan University of Traditional Chinese Medicine and other colleges and universities. On the one hand, it provides practical venues for high graduates of Chinese medicine that are about to graduate, integrates all the knowledge they have learned, and truly links theory with practice. On the other hand, in this process, they establish a pool of talents in Suizhong to absorb more Academic and high-skilled researchers are able to reserve energy for Suizhong to further expand the scale of research and development of new drugs.