According to the report from May 26th, the lack of standards in the process of planting, processing and storage of Chinese herbal medicines will be improved for a long time, especially the sulphur smoking process will be written into the national standard.
The "Notice on Further Improving the Quality Supervision of Chinese Medicinal Materials" issued by the SFDA recently revealed that after the State Bureau is in the process of formulating limits for sulfur dioxide residue in Chinese herbal medicines and Chinese medicine decoction pieces, the reporter learned from related departments that the National Pharmacopoeia Commission and other departments are now in full swing. Promote standards development.
SO2 limit standards are missing
Because of corrosion resistance, mildew resistance, and insect repellent, medicinal herbs sulfur fumigation method has been applied for a long time in the process of storage, conservation and processing of Chinese medicinal materials. As for the sulfur-smoke technology, the country has relevant legal restrictions. In the “Approval of Sulfur Fumigation of Chinese Medicinal Materials†issued by the SFDA in 2004, it was stipulated that some Chinese herbal medicines and Chinese Herbal Medicine pieces that are in circulation in the market should be bleached by fumigation or soaking with sulfur. Article 49 and Article 75 of the Drug Administration Law (that is, according to the inferior drug) are investigated and dealt with; and the Chinese version of the Chinese Pharmacopoeia has already eliminated the sulphur smoking process of Chinese medicinal materials such as yam and pueraria; The 2010 edition of the Pharmacopoeia included the sulfur dioxide detection method in the appendix.
From the current relevant regulations, it can be seen that although there are sulfur dioxide detection methods, there are no specific regulations for the limit of sulfur dioxide. In fact, in recent years, the variety and scope of sulphur-cured medicinal herbs have been expanded, and fumigation links have been advanced. According to modern medical research, sulfur dioxide and sulfite can destroy vitamin B1, and long-term use will lead to gastrointestinal dysfunction, damage to the liver, and harm the human digestive system.
At present, many major countries in the world of botanical medicine have increased the limits for sulfur dioxide in Chinese herbal medicines, of which the most significant one is in Korea. From January 7, 2009, South Korea stipulates that the residual sulfur dioxide in 267 kinds of Chinese herbal medicines such as Pueraria must be less than 30 ug·kg-1. Compared with the previously implemented standards, the sulfur dioxide residue limits in 72 Chinese herbal medicines are from 200, The 500, 1000, and 1500 mg kg-1 were all revised to 30 ug kg-1, and the maximum standard was increased by 50 times. At the same time, 60 new Chinese herbal medicines were tested for sulfur dioxide residue, and the maximum limits for 23 heavy metals (including lead and arsenic) derived from rocks and minerals traditional medicines were stipulated.
In response, an industry source familiar with the export of Chinese herbal medicines stated that the standard requirements of South Korea have already exceeded the basic characteristics of medicinal materials and do not meet actual requirements. China's sulfur dioxide limit standards will not fully meet the standards of Japan and South Korea.
Duan Jinyi, vice president of Nanjing University of Traditional Chinese Medicine, previously stated that China should classify and treat different materials according to the extensiveness of the use of medicinal materials and Chinese herbal medicines, such as formula dispensing, pharmaceutical industry raw materials, health food, and dietary raw materials. Refer to the World Health Organization's daily sulfur dioxide intake (0-0.7mg·kg-1) per person, China's food sulfur limit standards and relevant international standards, and formulate sulfur dioxide limit standards suitable for Chinese herbal medicines and decoction pieces. .
Sulfur-free herbs are sought after
Although South Korea's stringent SO2 limit standards are suspected of setting up technical barriers to trade, it is a fact that foreign countries have increasingly stricter standards for sulfur content in traditional plant medicines, pesticide residue, and heavy metals. Therefore, in recent years, China's export of green plant drugs has also begun to heat up.
In the Canton Fair Medical Insurance Center held in May, many exhibitors of Chinese herbal medicines took sulfur-free as a highlight of publicity, such as the non-vulcanized treatment technology promoted by Chengdu Tongling Herbal Pieces Select Co., Ltd.: using pure hot air in the processing of fresh herbs. Drying; strictly in accordance with the GMP management specifications production and processing; the use of vacuum or nitrogen packaging technology; the use of low-temperature cold storage of traditional Chinese medicine products, effectively solve the problem of drying and storage of Chinese herbal medicines.
This type of product is also highly sought after by international buyers. The Chinese herbal medicines that are sold to Hong Kong in China are also classified into sulfur-free and sulfur-containing specifications, and the prices are quite different. Zhang Guoquan, director of the Baiyin Codonopsis Industrial Cooperative in Gansu Province, Wuyuan County, Gansu Province, specializes in non-sulphur Chinese angelica, and the price difference between sulfur-free and sulphur-containing medicinal herbs currently on the market is at least 20% to 30%.
At present, the growth rate of demand for green plant drugs in the global market is maintained at more than 20% every year. Due to the huge price contrast between herbs and people’s increasing demand for green plant drugs, many pharmaceutical and pesticide companies have taken the initiative to switch to non-sulfur processing technologies.
"The establishment of sulfur dioxide residue standards for Chinese herbal medicines and decoction pieces will generally improve the quality of Chinese herbal medicine decoction pieces and, to a certain extent, facilitate the export of medicinal materials," said Liu Zhanglin, deputy director of the China Chamber of Commerce for the Import and Export of Medicines and Health Products. “The formulation of the sulfur dioxide limit standard will also release a favorable signal for the pace of the development of other standards such as heavy metals and pesticide residues in Chinese medicine.â€
Process and warehousing ushered in the test
"Sulfur fumigation is mainly to prevent mildew and insect infestation during the storage and storage phase. After canceling or limiting sulphur fumigation, the key is to explore new suitable replacement technologies in the main processes of inactivation, dehydration, drying and compression vacuum packaging. According to Zhou Ronghan, chief expert of the national Chinese herbal medicine GAP expert group.
According to the reporter's understanding, for the quality control problems in the circulation of Chinese herbal medicines, the technologies such as primary processing and low-temperature drying have gradually been applied. However, at this stage, various solutions have not been widely promoted in China and are only applied in some enterprises. Some people in the industry are concerned that the current elimination of sulphur fumigation is likely to lead to the use of other unsatisfactory additives.
Therefore, the most important issue at the present stage is to address the traditional and realistic nature of sulphur smoked medicinal herbs, to regulate the sulphur smoke process and to control the degree of sulphur smoke, and to formulate limit standards. Duan Jinlu suggested that with the advancement of science and technology, it is also necessary to create a standardized sulfur-smoke mechanical device so that the fumigation process can be controlled; and the suitability of the modern non-destructive processing drying technology (microwave drying technology, infrared drying technology, etc.) New types of fumigants and alternative maintenance technologies have been explored to find safer, more effective and feasible alternative technologies that can replace the sulphur fumigation process.
At present, many medicine production bases in China are located in remote areas and have poor storage conditions. For medicine farmers, smoked herbs with sulfur is more for preservation. On the other hand, hot selling of sulfur-free medicinal materials also puts new tests on traditional drying techniques and storage conditions.
Therefore, the CEO of a large-scale TCM decoction piece stated that while improving the maintenance technology, the establishment of a standardized storage facility for Chinese herbal medicines is imminent. It can learn from the management and circulation experience of Japanese herbal medicines, and strengthen the hardware facilities in terms of storage, logistics, and testing. Completely eliminate the sulphur fumigation process. According to the reporter's understanding, this is precisely one of the considerations for the country to formulate sulfur limit standards.
The "Notice on Further Improving the Quality Supervision of Chinese Medicinal Materials" issued by the SFDA recently revealed that after the State Bureau is in the process of formulating limits for sulfur dioxide residue in Chinese herbal medicines and Chinese medicine decoction pieces, the reporter learned from related departments that the National Pharmacopoeia Commission and other departments are now in full swing. Promote standards development.
SO2 limit standards are missing
Because of corrosion resistance, mildew resistance, and insect repellent, medicinal herbs sulfur fumigation method has been applied for a long time in the process of storage, conservation and processing of Chinese medicinal materials. As for the sulfur-smoke technology, the country has relevant legal restrictions. In the “Approval of Sulfur Fumigation of Chinese Medicinal Materials†issued by the SFDA in 2004, it was stipulated that some Chinese herbal medicines and Chinese Herbal Medicine pieces that are in circulation in the market should be bleached by fumigation or soaking with sulfur. Article 49 and Article 75 of the Drug Administration Law (that is, according to the inferior drug) are investigated and dealt with; and the Chinese version of the Chinese Pharmacopoeia has already eliminated the sulphur smoking process of Chinese medicinal materials such as yam and pueraria; The 2010 edition of the Pharmacopoeia included the sulfur dioxide detection method in the appendix.
From the current relevant regulations, it can be seen that although there are sulfur dioxide detection methods, there are no specific regulations for the limit of sulfur dioxide. In fact, in recent years, the variety and scope of sulphur-cured medicinal herbs have been expanded, and fumigation links have been advanced. According to modern medical research, sulfur dioxide and sulfite can destroy vitamin B1, and long-term use will lead to gastrointestinal dysfunction, damage to the liver, and harm the human digestive system.
At present, many major countries in the world of botanical medicine have increased the limits for sulfur dioxide in Chinese herbal medicines, of which the most significant one is in Korea. From January 7, 2009, South Korea stipulates that the residual sulfur dioxide in 267 kinds of Chinese herbal medicines such as Pueraria must be less than 30 ug·kg-1. Compared with the previously implemented standards, the sulfur dioxide residue limits in 72 Chinese herbal medicines are from 200, The 500, 1000, and 1500 mg kg-1 were all revised to 30 ug kg-1, and the maximum standard was increased by 50 times. At the same time, 60 new Chinese herbal medicines were tested for sulfur dioxide residue, and the maximum limits for 23 heavy metals (including lead and arsenic) derived from rocks and minerals traditional medicines were stipulated.
In response, an industry source familiar with the export of Chinese herbal medicines stated that the standard requirements of South Korea have already exceeded the basic characteristics of medicinal materials and do not meet actual requirements. China's sulfur dioxide limit standards will not fully meet the standards of Japan and South Korea.
Duan Jinyi, vice president of Nanjing University of Traditional Chinese Medicine, previously stated that China should classify and treat different materials according to the extensiveness of the use of medicinal materials and Chinese herbal medicines, such as formula dispensing, pharmaceutical industry raw materials, health food, and dietary raw materials. Refer to the World Health Organization's daily sulfur dioxide intake (0-0.7mg·kg-1) per person, China's food sulfur limit standards and relevant international standards, and formulate sulfur dioxide limit standards suitable for Chinese herbal medicines and decoction pieces. .
Sulfur-free herbs are sought after
Although South Korea's stringent SO2 limit standards are suspected of setting up technical barriers to trade, it is a fact that foreign countries have increasingly stricter standards for sulfur content in traditional plant medicines, pesticide residue, and heavy metals. Therefore, in recent years, China's export of green plant drugs has also begun to heat up.
In the Canton Fair Medical Insurance Center held in May, many exhibitors of Chinese herbal medicines took sulfur-free as a highlight of publicity, such as the non-vulcanized treatment technology promoted by Chengdu Tongling Herbal Pieces Select Co., Ltd.: using pure hot air in the processing of fresh herbs. Drying; strictly in accordance with the GMP management specifications production and processing; the use of vacuum or nitrogen packaging technology; the use of low-temperature cold storage of traditional Chinese medicine products, effectively solve the problem of drying and storage of Chinese herbal medicines.
This type of product is also highly sought after by international buyers. The Chinese herbal medicines that are sold to Hong Kong in China are also classified into sulfur-free and sulfur-containing specifications, and the prices are quite different. Zhang Guoquan, director of the Baiyin Codonopsis Industrial Cooperative in Gansu Province, Wuyuan County, Gansu Province, specializes in non-sulphur Chinese angelica, and the price difference between sulfur-free and sulphur-containing medicinal herbs currently on the market is at least 20% to 30%.
At present, the growth rate of demand for green plant drugs in the global market is maintained at more than 20% every year. Due to the huge price contrast between herbs and people’s increasing demand for green plant drugs, many pharmaceutical and pesticide companies have taken the initiative to switch to non-sulfur processing technologies.
"The establishment of sulfur dioxide residue standards for Chinese herbal medicines and decoction pieces will generally improve the quality of Chinese herbal medicine decoction pieces and, to a certain extent, facilitate the export of medicinal materials," said Liu Zhanglin, deputy director of the China Chamber of Commerce for the Import and Export of Medicines and Health Products. “The formulation of the sulfur dioxide limit standard will also release a favorable signal for the pace of the development of other standards such as heavy metals and pesticide residues in Chinese medicine.â€
Process and warehousing ushered in the test
"Sulfur fumigation is mainly to prevent mildew and insect infestation during the storage and storage phase. After canceling or limiting sulphur fumigation, the key is to explore new suitable replacement technologies in the main processes of inactivation, dehydration, drying and compression vacuum packaging. According to Zhou Ronghan, chief expert of the national Chinese herbal medicine GAP expert group.
According to the reporter's understanding, for the quality control problems in the circulation of Chinese herbal medicines, the technologies such as primary processing and low-temperature drying have gradually been applied. However, at this stage, various solutions have not been widely promoted in China and are only applied in some enterprises. Some people in the industry are concerned that the current elimination of sulphur fumigation is likely to lead to the use of other unsatisfactory additives.
Therefore, the most important issue at the present stage is to address the traditional and realistic nature of sulphur smoked medicinal herbs, to regulate the sulphur smoke process and to control the degree of sulphur smoke, and to formulate limit standards. Duan Jinlu suggested that with the advancement of science and technology, it is also necessary to create a standardized sulfur-smoke mechanical device so that the fumigation process can be controlled; and the suitability of the modern non-destructive processing drying technology (microwave drying technology, infrared drying technology, etc.) New types of fumigants and alternative maintenance technologies have been explored to find safer, more effective and feasible alternative technologies that can replace the sulphur fumigation process.
At present, many medicine production bases in China are located in remote areas and have poor storage conditions. For medicine farmers, smoked herbs with sulfur is more for preservation. On the other hand, hot selling of sulfur-free medicinal materials also puts new tests on traditional drying techniques and storage conditions.
Therefore, the CEO of a large-scale TCM decoction piece stated that while improving the maintenance technology, the establishment of a standardized storage facility for Chinese herbal medicines is imminent. It can learn from the management and circulation experience of Japanese herbal medicines, and strengthen the hardware facilities in terms of storage, logistics, and testing. Completely eliminate the sulphur fumigation process. According to the reporter's understanding, this is precisely one of the considerations for the country to formulate sulfur limit standards.
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