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    Home > Medical News > Latest Medical News > The new drug code is about to be introduced Chinese medicine enterprise problems come.

    The new drug code is about to be introduced Chinese medicine enterprise problems come.

    • Last Update: 2020-08-01
    • Source: Internet
    • Author: User
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    Pharmaceutical companies will be a history to dandelion as an example, this flavor editing drug in the 2015 edition of the Pharmacopeia, is to detect the "coffee acid" ingredient content as the main object.
    coffee acid sacin meets the pharmacopeia standard of 0.020%.
    was judged to be "qualified" and not enough to be "incompetent".
    dandelion production area is relatively wide, generally produced in the southern region of Gansu, dandelion herbs "coffee acid" content is very high, to meet the pharmacopeia standard is no problem.
    and Shandong Province, Henan, Hubei and other production areas of dandelion, coffee acid content is slightly lower, between qualified and unqualified, often by the pharmaceutical factory return rate is higher.
    therefore there is a difference in price, the general Gansu Minnan dandelion market price is more than 14 yuan kg, Shanshan Two Provinces, Henan, Hubei and other real estate dandelion medicinal market prices more floating between 7 to 9 yuan Kg.
    this makes the two provinces of Shanshan, Henan, Hubei and other places dandelion acquisition, business psychology is very unbalanced.
    but soldiers will block, water to cover, so many years, these origin of the acquisition of vendors and market merchants, in order to allow their acquisition of dandelion herbs to meet the national pharmacopeia standards, painstaking research, on the "research" out of a "earth experience."
    such as those after the acquisition of dry to eight or nine percent dry dandelion bag stacked in one place, by smouldering heat or summer through the summer storage fermentation method, in order to improve the dandelion "coffee acid" content, and the effect is excellent.
    But as things stand, the days of speculation on this approach may soon be over.
    on September 2, 2019, the Pharmacopeia Commission issued the 2020 edition of the pharmacopeia corresponding variety inspection item "revised for comments public draft", in which the above-mentioned easy to let people get "qualified" standard dandelion coffee acid inspection items, has been replaced by chrysanthemum acid inspection items.
    of course, this is not to say that after this revision, Gansu Minnan origin of dandelion medicinal materials are still the best quality, Shanxi Province, Henan, Hubei and other places of dandelion medicinal materials in the future composition content is still difficult to qualify.
    but the result of this revision, perhaps for Shanshan, Henan, Hubei and other places of dandelion herbs, is a good start and opportunity.
    in the original "coffee acid" check item was removed, if the dandelion "daisy acid" ingredient content is also very high in Shanshan, Henan, Hubei and other places, then, these origin of dandelion herbs, or will be the same as the dandelion herbs in southern Gansu, from then on the ingredientcontent is fully in line with the pharmacopeia "pass", no longer rely on "smouldering stack fermentation" and other speculative means.
    some Road real estate or abandoned in June 2018, the author has published an article "Analysis: Chinese herbal medicine Road real estate "death" and "extinction"! The article mentions some varieties of Chinese herbal medicine, although the growth area belongs to the historically recognized traditional Road real estate, but due to the impact of the current pharmacopeia inspection items, the composition content and pharmacopeia requirements of the gap is very large, and eventually abandoned by the medicinal farmers, resulting in the origin of this variety was gradually abandoned.
    with the implementation of the 2020 edition of the Pharmacopeia, a similar situation may occur.
    first of all, the 2020 edition of the Pharmacopoeia opinion draft has been proposed for 544 kinds of medicinal materials to increase agricultural residues, heavy metals inspection items.
    but the sources of heavy metal pollution are different, mostly related to the natural ecological environment in the area where medicinal materials grow.
    second, soil, water, air pollution, may lead to the growth of the region of the heavy metal content of medicinal materials exceeded the standard.
    again, according to the relevant data analysis, some provinces in southwest China have higher soil arsenic content.
    relatively speaking, some of the individual Chinese herbal medicine varieties grown in these provinces with strong absorption and concentration of heavy metals may contain high arsenic content.
    from the point of view of the procurement of production enterprises, where the new drug code 544 agricultural residues, heavy metals must be checked varieties, if the medicinal material slot real estate more, then, they will deliberately avoid the origin.
    and went to other provinces to buy the flavored herbs.
    for such a long time, some or certain varieties of medicinal herbs in these sources will be given high levels of arsenic to meet pharmacopeia standards, and the drug farmers will abandon cultivation and phase-out, even if the origin of these herbs will disappear from this.
    of course, the corresponding not optimistic problems not only in the southwest region, for mining, farmland pesticide spraying serious, heavy industrial cities more waste water, waste slag emissions are very large, water, air, soil pollution is more serious in the Central Plains region or some northern regions, if the future of the production of a heavy metal substance absorption, enrichment of strong varieties of medicinal herbs, belong to the new drug code 544 kinds of "must be inspected" within the scope of the pharmaceutical, after detection and heavy metal, i.e.
    pharmaceutical enterprises procurement direction change The author believes that, with the implementation of the 2020 edition of the Pharmacopoeia, the agricultural residues inspection items also affect many Chinese medicine production enterprises, especially to change the direction of their raw material procurement.
    such as yellow cypress, Du Zhong, cinnamon, thick, chubby and other bark herbs, as well as flowers, roots, seed fruits and other varieties, these herbs are grown in the field head, or directly planted in farmland, and some are grown in the mountains, under the forest, the head of the desert slope.
    grow in the field head, or planted in the field of medicinal herbs, because with the crops adjacent or for the old, after years by pesticide spraying, agricultural residue coefficient naturally increased, pharmaceutical enterprises when procurement is inevitable in the heart of the heart, encountered by the new drug code into 544 kinds of mandatory agricultural residues, heavy metals varieties, this environment grows of medicinal herbs, natural can not become the first choice for pharmaceutical enterprises procurement.
    grow or grow in mountainous areas, under the forest, beachhead wasteland, because these places never sprayed pesticides, even heavy metal pollution sources are not in contact, almost in the wild or imitation of wild natural exile growth, this source of medicinal herbs, often heavy metals, agricultural residues will not exceed the standard, natural will be sought after and favored by pharmaceutical companies.
    with the gradual improvement of pharmacopeia standards and the tightening of the regulatory level, the most popular chinese medicine raw materials for the future manufacturers are those that have now entered into the management norms of GAP planting base, agricultural cooperatives or related planting alliances output.
    in addition, similar varieties or the same varieties, wild herbs will be more preferred by pharmaceutical companies.
    because the growth environment of wild herbs is relatively special, agricultural residues, heavy metal pollution probability is relatively small, such varieties will naturally become the target of production enterprises in the future.
    in fact, for the Chinese herbal medicine agricultural residues, heavy metals over the standard phenomenon, has attracted the attention of the Government and related departments.
    October 20, 2019, the State Council also gave concise prevention and control measures in Article 7 of Chapter III of the Opinions of the State Council of the CPC Central Committee on Promoting the Innovation and Development of Chinese Medicine, both as "Subregionaland, sub-species, improve pesticide residues of Chinese herbal medicines, and limit standards of heavy metals..."
    the future, Chinese medicine pesticide residues, heavy metals must be Chinese medicine enterprises must understand and solve the problem, in accordance with the requirements of the upcoming introduction of a new drug code, if this indicator is not up to standard, waiting for their outcome only one - by the market elimination.
    original title: The new drug code is about to be issued, Chinese medicine enterprises are difficult.
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