Chinese medicine heavy metal and harmful element limit requirements, no longer one-size-fits-all

　　On March 25, the State Pharmacopeia Commission issued the "Publicity of the revised draft of the four general principles 0212 and the general principles 9302 for the four general rules of the Chinese Pharmacopeia"
The author notes that the second public draft of "0212 Herbs and Drink Tablets" deletes the unified limit requirements for five heavy metal elements of medicinal herbs and drink tablets (plants), and the "uniform limit requirements for heavy metals and harmful elements" are revised to "consistency limit guidelines", from 0212 inspection rules into the 9302 guiding principles, and become guidelines for the formulation of limit values
In addition, the National Pharmacopeia Commission simultaneously published 18 kinds of medicinal herbs and drink tablets standard revised public draft For the 2015 and 2020 editions of pharmacopeia varieties standard (plant herbs and drink tablets) to collect "heavy metals and harmful elements" and limit value changes, the 2020 edition of the pharmacophone publicity on the basis of the 2015 edition of the pharmacopoean, the white, tang, Gegen and other 10 varieties The standard has updated the "heavy metal and harmful elements" check item, and the "2015 edition of the pharmacopeia white, danson, licorice and other 8 varieties of standard provisions, cadmium limit value must not exceed 0.3 mg /kg", from 0.3 mg/kg revised to 1 mg/kg, the rest remains unchanged
Industry sources said that the development of medicinal herbs and tablets of heavy metals and harmful elements, pesticide residues, the limit standards, is regarded by the industry as the "Chinese Pharmacopoeia" 2020 edition of the progress, is also a major change From the perspective of the revised draft, there is no one-size-fits-all approach to heavy metals and harmful elements of Chinese medicine, which will allow chinese medicine enterprises to adjust and transition period According to relevant sources, "China Pharmacopoeia" 2020 edition is expected to be implemented by the end of the year, the enterprise has about a year to prepare
At present, there are many Chinese medicine enterprises raised concerns, after the implementation of the new standards, the previous production, listing of drinktablets were detected unqualified enterprises will be punished In this regard, industry sources said, in accordance with the practice implemented in the Chinese Pharmacopeia, the new standards apply to the standard after the implementation of products produced
There are also Chinese medicine enterprises believe that the addition of new inspection projects, the acquisition of new testing equipment, training of technical personnel, the purchase of control products, the cost of testing enterprises will rise significantly In this regard, the industry suggests that Chinese medicine enterprises can cooperate with a number of enterprises, the construction of public laboratories, or commissioned third-party laboratories to carry out bulk testing to reduce the cost of testing, or Chinese medicine enterprises can also through extensive data collection, one-by-one variety analysis of quality risks
From the point of view of testing, it can be expected that with the arrival of new standards, the relevant testing equipment manufacturers will also usher in opportunities At present, there are instrument manufacturers said that in the face of new challenges, the company has established a complete application solution to help the relevant testing institutions and Chinese medicine enterprises to deal with calmly
There are also enterprises said that for chinese medicine heavy metal detection field, the company used digital technology to develop a new type of intelligent detector According to the introduction, the intelligent metal detector can achieve the metal detection technology of the full digital and intelligent, operating the use of highly intelligent, good performance, and easy to use, can help pharmaceutical companies or testing institutions to improve production efficiency, but also according to customer demand for automatic elimination of defective devices, saving labor costs
In general, with the continuous development of the Chinese medicine industry, the quality and safety of Chinese medicine has been paid more and more attention, with the new policy and new standards, Chinese medicine enterprises need to do a good job of long-lasting response programs to standardize production and operation At the same time, the prospects of the relevant testing equipment market is immeasurable, equipment enterprises to seize good business opportunities, but also need to strengthen the updating and upgrading of drug testing equipment, to domestic demand and related standards for research and development direction, and constantly help the development of the industry.