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Strictly follow the prescription production to control the raw material of beef and yellow patent medicine
Release time: 2013-01-09 & nbsp & nbsp & nbsp Source: Anonymous

To strengthen beef -containing、Middle Pharmaceuticals of Music and other medicinal materials,A few days ago,The State Food and Drug Administration issued the "Notice on Strengthening the Supervision and Management of Pharmaceuticals in Niuhuang and other medicinal materials (hereinafter referred to as" Notice "),It is clearly specified in the prescription of national drug standards,Drug production enterprises should strictly follow the prescription and production,It is strictly forbidden to replace with other medicinal materials or raw materials without authorization。
 
"Notice" points out,For the prescriptions of beef and cattle in the national drug standard prescription, drugs and other dosage or specifications,Including Agai Niuhuang Wan、Dahuoluo Pill、38 varieties including Pianzi 癀,You can fix the beef in the prescription to cultivate the amount of beef yellow or in vitro cultivating beef and cattle for instead of the feed,But you must not use artificial beef and yellow replacement。and the variety listed in the attachment of the "Notice", and other dosage or specifications of the current drug standards, are artificial beef and yellow,Related production enterprises shall submit supplementary applications before December 31, 2013 in accordance,And the stake sports betting appstake betting appNational Pharmacopoeia Committee is reviewed。
 
Yao Pan, the Food and Drug Administration of Jingmen City, Hubei Province, said in an interview with reporters,State's strengthening supervision of Chinese patent medicines such as beef and yellow, which reflects three & ldquo;,Adjust the macro market,Reduced and sells false and inferior behaviors; the second is to help protect consumers' rights and interests,Modification of related instructions,Makes consumers endangered whether consumers contain beef and yellow in Chinese medicines、The situation of resource shortage of Chinese medicinal materials is clear at a glance; the third is conducive to musk、Niuhuang and other endangered、Resource shortage of Chinese medicinal materials sustainable use,Protect existing resources。
 
Pharmaceutical beef and yellow croaker dragon mixed
 
According to the reporter's understanding,In more than 4,500 Chinese medicines,There are more than 600 types of beef and yellow ingredients。Due to the extremely scarcity of drugs,To solve the problem of shortage of natural beef resources,Medical experts have been looking for beef and yellow alternatives。
 
To strengthen the supervision of alternatives,Since 1972,The regulatory authorities have successively approved 3 Niuhuang generation supplies,、Cow yellow in the body、Creating beef and yellow in vitro。
 
Reporter after checking the relevant information and found out,Artificial beef yellow is beef bile acid、Biliary redin、cholesterol and inorganic salt (magnesium sulfate、Trimite of sulfate and tan phosphate) is raw material,Mixed with starch; cultivating beef and yellow uses living beef bodies,Inserting yellow factor in the gallbladder of cattle with the method of surgery,Make it a beef and cattle; and in vitro cultivating beef and yellow is used as the fresh bile of beef as the mother liquid,Add oxygenic acid、bile acid、Composite bilirubin calcium and calcium。
 
What is worrying is,With the price of natural beef and yellow, the price continues to rise,Drive by interest,Some pharmaceutical manufacturers are produced when producing Chinese medicines containing beef stake betting appand yellow stake betting appvarieties,The varieties that can only be used with natural beef and physical beef yellow are used to replace artificial beef and yellow,Mixed patent fish dragon containing beef and yellow ingredients in the market。
 
SFDA Researcher Chen Xueyu of the Policy Research Office of the Southern Medical Economics Research Institute believes,The information determined during the registration of the drug has legal effect,Non -legal ways must not be changed at will。The quality of Chinese medicinal materials can be changed due to replacing the raw materials of Chinese medicinal materials due to artificial products,Therefore, it must be determined by system science experiments to determine whether it is feasible,Random replacement may cause unpredictable risks。He said,& ldquo; This country restricts artificial beef and yellow,It reflects the country's cautious attitude in replacing Chinese medicinal materials with artificial products。If you want to replace the original Chinese medicinal materials with new raw materials,It should submit a supplementary application to the regulatory authorities,Otherwise, there will be a suspicion of illegal law。& rdquo;
 
In addition,The quality of the artificial beef and yellow itself is also very worrying,The safety of the raw materials of Chinese medicinal materials with unqualified artificial products has received widespread attention。Chen Xueyu pointed out,Artificial Niuhuang belongs to the Chinese medicine and medicine medicine,According to the SFDA website data, it shows,So far only 23 pharmaceutical production approval numbers of artificial bezoar ingredients have been promulgated。At present, many artificial cattle and yellow manufacturers do not have corresponding production qualifications,As a result, the quality of artificial beef yellow on the market is different。
 
For this,Industry insiders call for,The regulatory authorities can start from the perspective of the safety of the masses,Increase the cleanup and rectification of the beef and yellow market。Researcher Zhou Chaofan of the Chinese Institute of Traditional Chinese Medicine has previously suggested,& ldquo; The state responds to the stake betting appstake online sports bettingproduction or sales of three types of cattle and yellow to implement a fixed -point system,Through standardized supply channels for beef and yellow,Strictly prevent falsehood、illegal behavior of the second charging。& rdquo;
 
Supervisor is clear and unambiguous
 
Current,There are about 650 species of Chinese medicines containing beef and yellow in China,Most of them use artificial beef。SFDA has issued 29 artificial beef yellow (raw medicine) drug production license。
 
It is worth mentioning is,Some precious Chinese medicines exist & ldquo; one medicine two sides & rdquo; phenomenon,That is, a recipe uses natural beef and yellow,Another recipe is artificial beef,The same packaging,The instruction manual is the same,But the effect is different,The price is also far away。"Notice" This time clearly stipulates that the use of cattle and yellow、Creating beef and yellow in vitro、Artificial beef and yellow replace beef,and the variety of natural musk with artificial musk,In its manual and label & ldquo; ingredient & rdquo;、Creating beef and yellow in vitro、Artificial beef or artificial musk; involved the manual and label change,To the province (district、City) Food and drug supervision and management department for filing。
 
For the effect of the body of cattle yellow and natural beef and yellow,The two have been identified as equal。The reporter learned,From 2004,All departments of the state have regulated the use of beef and yellow one after another,It is stipulated that 42 types of emergency or severe drug prescriptions can use natural beef and yellow or in vitro breeding beef。After the implementation of the 2010 version of the Pharmacopoeia,The market environment is further purified。
 
From "Notice" for & ldquo; National Drug Standard Prescription Prescription Candidic Clinical Species,You can fix the beef in the prescription to cultivate beef and in vitro cultivating beef and cattle to replace the regulations & rdquo;,Relevant departments to ensure endangered、Encouragement and support for the sustainable use of Chinese medicinal materials in resources。Previous,SFDA has successively formulated relevant measures for strict review approval stake betting appstake betting appand encouraging research and application of substitute supplies。
 
At the same time,The reporter also noticed,sfda encourages & ldquo; Related drug manufacturers continue to carry out alternative research work of endangered or short -lack of medicinal materials,Actively conducts the safety research of substitute supplies,Strengthen clinical monitoring and evaluation,For further improvement of the application and management of substitute products。& rdquo;,Some experts point out,On the one hand, we must insist on cracking down on fake and inferior behaviors; on the other hand,,We must vigorously develop and actively promote excellent efficacy、Mass control、Natural Niuhuang Representatives with low price,At the same time,Guide related drug manufacturers except for clinical acute serious illnesses,Try to use substitutes as much as possible,So as to fundamentally regulate the natural beef and yellow market。