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published in(发表于) 2014/8/14 8:19:11
State Pharmacopoeia Committee: the pharmacopoeia revision cannot be manipulated by one person

State Pharmacopoeia Committee: Pharmacopoeia revision amendments _ cannot be manipulated by one person | Pharmacopoeia news

Legal evening news (reporters Wang TINGTING) national pharmacopoeia Committee Chairman of the Professional Committee of Chinese herbal medicine, Peking University School of Medicine Professor TU p f accepts the legal evening news said in a Xinhua interview, gray felt massive planting in some regions currently Lonicera fulvotomentosa income only in the year 2005 under the Chinese Pharmacopoeia mountain Honeysuckle. Prior to this, it has never been included in the Honeysuckle in the pharmacopoeia.


Tu Pengfei said Pharmacopoeia supplemented or revised standard, required by a number of relevant expert committee consisting of independent review to determine, through several links, programs, is a very careful and serious, the whole process takes three or four years, there is no controlled by an official person or interest group "kidnapped".


Meanwhile said Tu Pengfei, Pharmacopoeia 2005 Edition after the Honeysuckle and Lonicera flower is listed, because not much clinical experience, it was directly from the introduction of the honeysuckle, in the future, after accumulating clinical experience, mountain Honeysuckle will be amended as appropriate. However, traditional medicine and current research data, cannot support merging mountain Honeysuckle and honeysuckle.


  Honeysuckle and Lonicera flower distinguish when it first started?


Hunan provincial Commission for discipline inspection said Lu Qun, Deputy Director of corruption prevention, from the 2005 edition of the pharmacopoeia of honeysuckle as mountain Honeysuckle begins in the South, rather than in 1977. Guangxi has a honeysuckle, also called "Silver Flower", and Pharmacopoeia Committee described this as before 1977, all used to refer to the southern region of honeysuckle. In fact, apart from the County of Guangxi, "mountain honeysuckle, the words" is unprecedented in history.


Tu Pengfei said that according to the textual research of Materia Medica, honeysuckle Lonicera are recorded in the ancient herbal plants of Lonicera flower, are distributed in North and South. Honeysuckle in the 1963 Edition of the pharmacopoeia contains only dried flower buds of Lonicera. 1977 Edition of the pharmacopoeia of surcharged under the criteria of Flos lonicerae in 3 other plant sources, including red, mountain Honeysuckle Lonicera hypoglauca (later renamed "Lonicera") and Mao Huazhu of Lonicera japonica Thunb. Due to the 1977 Edition of the Pharmacopoeia "herbal movement" effect, when drug use disorder, and listed a large number of non-traditional local herbs. The 2005 edition of the pharmacopoeia has broken down the Honeysuckle and Lonicera flower. Gray felt-Lonicera fulvotomentosa massive planting in some regions income only in the year 2005 under the Chinese Pharmacopoeia mountain honeysuckle, previously had never been included in the Pharmacopoeia, is not even recognised by the State pharmacopoeia of medicinal plants.


  Where is the difference between Honeysuckle and Lonicera flower?


Lu Qun, said generations of Materia Medica classics like the Shen Nong's Materia Medica, the compendium of Materia Medica, the Honeysuckle is specifically mentioned. Honeysuckle is a known, its scientific name actually called Honeysuckle flowers, yellow and white, just out of the flower is white, mature flower will turn yellow, hence the "Honeysuckle" name, so both North-South and is called Honeysuckle.


The so-called "Silver Flower" and honeysuckle in the Chinese Pharmacopoeia, whether it's "Meridian", "functions and indications of" or "dosage and usage of" the three important indicators, the Honeysuckle and the so-called "Silver Flower" description is exactly the same. In that case, why southern Honeysuckle changed to "Silver Flower"?


Tu Pengfei said, both in terms of characteristics, chemical composition and other disparities, especially in terms of chemical composition differences, high content of flavonoids of Flos lonicerae, Lonicera flower saponins content is high.


Containing mainly flavonoids of Flos lonicerae, iridoid glycosides, organic acids, and volatile oil constituents, while higher levels of flavonoids, saponins are very low.


Mountain Honeysuckle main saponins, iridoid glycosides, flavonoids, organic acids, volatile oil constituents and saponin content and low levels of flavonoids. Including saponins as valid components, there is a lack of research.


  Luteolin glycosides are unique to Honeysuckle?


Lu Qun, Luteolin glycosides of Chinese Pharmacopoeia as a honeysuckle's main active ingredient, has upended the conventional wisdom. In fact, the so-called "Silver Flower" and the physical benefits of chlorogenic acid in Flos lonicerae.


If Luteolin glycosides is the main active ingredient, "mountain Honeysuckle" better content of leaves and vines and honeysuckle, or even a higher content of peanut hulls, then why not just leaves, vines and peanut shell? Therefore, this so called standard Luteolin glycosides is tailor-made for Lonicera japonica in the North.


Main active ingredient is the contents of chlorogenic acid in Flos lonicerae, not Luteolin glycosides. If we say that "Silver Flower" and "Honeysuckle" what's the difference, from the content of active ingredients, is much higher than in the South North.


Tu p f believes that flavonoids Luteolin glycosides in Flos lonicerae by one of typical ingredients and active ingredients, has antibacterial, anti-inflammatory, antioxidant, and many other effects; the organic acid compounds in Flos lonicerae chlorogenic acid one of the typical ingredients and active ingredients. In order to effectively control the quality, the quality of Flos lonicerae in the Chinese Pharmacopoeia standards while containing the active ingredient content determination of chlorogenic acid and Luteolin glycosides. Luteolin glycosides is not the endemic species of honeysuckle, also contain several varieties of honeysuckle in the mountains, only content is low.


  Pharmacopoeia revision was kidnapped by corporate interests?


Lu Qun, said, "the State food and Drug Administration for the interest group endorsements, giving tens of millions of people, causing major economic losses. "Lu Qun said in a reported Twitter, amendments to the Chinese Pharmacopoeia 2005 Edition," Southern Honeysuckle "was renamed as" Honeysuckle "is the pharmacopoeia revision was kidnapped by corporate interests, former head of its State food and Drug Administration SHAO Ming is behind State directed farce.


Tu Pengfei said that as amendments of the Pharmacopoeia, Tu p f Lu Qun quote is without foundation. Introduce TU p f, Pharmacopoeia supplemented or revised standard, required by a number of relevant expert committee consisting of independent reviews to determine, requiring feedback, Pharmacopoeia, members discussed the project, scientific research, the drafting of standards, testing, resubmit for review by members of the pharmacopoeia discuss such links and procedures.


Tu p f think pharmacopoeias pharmacopoeia of supplemented or revised standard layout for Committee members, Institute for drug control, as well as throughout the community for public comment. Comment then entered the Pharmacopoeia Committee to discuss the project phase, research institutes or institutes from all over, the Pharmacopoeia Committee expert will participate in the discussions, experts can speak freely in a discussion process, is to discuss the project is scientific and rational, ease of quality control, and so on into consideration. Tu p f told reporters that during the course of this discussion have repeatedly failed to pass the project situation, not every discussion project can be approved.


After passing the project will also conduct scientific research. Such as medicinal herbs, their chemical composition, pharmacologic actions and so on, according to the index to the active ingredients of quality analysis, also to prepare for the drafting of standards.


After preparation, the drafting of standards will be carried out. Standards review to complete and pass the drug test, and then resubmit the Pharmacopeial discussion.


Tu Pengfei said that this process is a very careful and serious, the whole process takes three or four years. Among them, a person controls or is protected by a kidnapped of space there is little of interest.


 Silver Flower name prices?


Lu Qun, said China's drug and food markets, demand for Honeysuckle is 20,000 tons a year, southern Honeysuckle was renamed "Silver Flower" before that supply and demand are balanced. After renaming, Flos lonicerae japonicae yield only about 6000 tons. But the market demand is 20,000 tons, and 14,000 tons of honeysuckle gap come from?


Only two possibilities: one is a blatant replaced by mountain Honeysuckle Lonicera japonica, medicine into the food; second, North of Flos lonicerae enterprises cheaply buy "Silver Flower" affixed with a label of honeysuckle, fresh enterprise to sell to pharmaceutical companies. Market surveillance is the responsibility of the State food and drug administration, what is 14,000 tons of gaps in market supervision?


Tu p f responded, 2005 edition of the pharmacopoeia of honeysuckle and honeysuckle after a breakdown, does not affect the sales of mountain Yin hua. Until 2013, media "sulfur fumigation mountain Honeysuckle incident", mountain Honeysuckle markets and prices are subject to certain impact.


There are many reasons for price differences, not because Pharmacopoeia "was renamed" cause.


  Why pharmacopoeias to include mountain Honeysuckle and honeysuckle, the efficacy of instructions will be the same?


Lu Qun said that so-called "Silver Flower" and honeysuckle in the Chinese Pharmacopoeia, whether it's "Meridian", "functions and indications of" or "dosage and usage of" the three important indicators, the Honeysuckle and the so-called "Silver Flower" description is exactly the same.


Tu p f said, because China Pharmacopoeia containing of herbs and pieces of sex flavor owned by, and function attending and usage dosage are is principle of, clinical doctor according to its medication experience and prescription compatibility for reasonable application, and as proprietary Chinese medicines of prescription, its function attending of played and dosage is through reasonable group party, and by strictly of efficacy learn, and HIV science evaluation and clinical test for determines.


The 2005 edition of the pharmacopoeia of Flos lonicerae, Lonicera flower breakdown, the main considerations of honeysuckle mass as raw material for traditional Chinese medicine injections, and high mountain Silver Flower saponins, General saponins with hemolysis, if mountain Honeysuckle and honeysuckle mingle with, there is a potential security risk.


 After the breakdown, ingredients in recipes as will the Honeysuckle Lonicera flower instead?


Lu Qun told the media to provide an China Southern Honeysuckle resource conservation Association open letter to Prime Minister Li keqiang, the first of which was questioned whether the Chinese Pharmacopoeia, with slight "difference" disaggregated mountain Honeysuckle and Honeysuckle is without foundation.


Skeptics say the Chinese Pharmacopoeia in Flos lonicerae and Lonicera flower on the description of the drug, a verbatim, full description of Flos lonicerae and Lonicera flower has no difference.


Said Tu Pengfei, honeysuckle, mountain flowers have their appropriate uses of silver, Silver Flower cannot be used as a raw material for injection, but still more than more than 500 Chinese patent medicines approved by the food and drug administration, State (more than 30 varieties) used prescriptions. In recent years, silver mountain flowers begin to use as raw materials of health food, new proprietary Chinese medicines are also used by some mountain Silver flower.


According to the State food and drug administration regulations, approved drugs listed shall not change its source of prescription medicine and, therefore, if Honeysuckle in the prescription of proprietary Chinese medicines, and cannot be replaced by mountain honeysuckle, too, if it's mountain Honeysuckle or Honeysuckle instead.


Text/reporter-Ting


(Original title: the pharmacopoeia revision cannot be manipulated by one person)

14:50 August 14, 2014 Legal evening news


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