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1、Breakthrough of TCM injectio nsRecently, microblogging Beijing Chaoyang Hospital,will prohibit any admi nistrative measures in the hospital of TCM injecti ons existe nee and use of once aga in raised theabolishme ntofTraditi onalChin eseMedic ineInjecti ons hot. In deed, in 2006 the Houttu ynia inje
2、ctio n eve nt once let the com mun ity medic ine lose con fide nee inthe development of injection, injury events in previous years aga in TCM injecti ons in to the cusp, the safety ofTCM injecti ons has bee n widely questi on ed, the in dustry isdebati ng the fate of traditi onal Chin ese medic ine
3、injecti on, but it is undeni able that in rece nt years Chin ese medic ineinjectio n in cli nical drugs play an importa ntrole inn atio nal policies such as the new vers ion of GMP, Chin esePharmacopoeiaformulatio ntraditi onal Chin ese medic ine positive role in promot ing. Chin ese medici ne injec
4、tio nfor theproducti onofinjection, regulators have athus solv ing traditi onaldrug safe and effectiveiingredient in question is the most important, or elsetraditi onal Chin ese medici ne injecti ons will escape the fateof being eliminated.Breakthrough of TCM injectionsIn vited guests:Henan Li ng Ru
5、i Pharmaceutical Co., Ltd.Marketing ProductManagerWuYanbi ngPKUMan ageme ntCon sult ingSenior Part ner Shi Liche nmedici ne Shin eway Pharmaceutical Group Limited, Vice Preside nt Chen ZhongReduce adverse reacti ons is thekey Medical observers: Regardless of microblogging rumors by admi nistrative m
6、ea ns of prohibit ing the use of traditional Chinese medicine injections, the truth, in your opinion, constrained by administrativemeans oftraditi onal Chin ese medic ineinjecti onpractice feasible?Reas ons for this practice?Wu Yanbing: I think it is notfeasible. Traditi onalChin ese medici neinject
7、io n adversereacti onsarein evitable,sinceit is to getproductsapprovedbythe state,mustbe a marketdema nd.Problem now is that some manu facturers do not strictly in accordanee with the standardsof production,coupledwith the quality of traditi onal Chin ese medici ne injectio n itself is relatively di
8、fficult to mon itori ng, detecti on, escrow, their problems are caused by particulate impurities, while the pharmaceutical ingredients and no problem. Chen Zhong: Obviously, this administrationand the means topractice is uncon sci on able. Because they are biasedagainst traditionalChinese medicinein
9、jections,in fact,have any adverse drug reactions, especially more than 80% of the county hospitals, health cli nics and so can not do without On it, the reason for prohibiting the use of reasonis that they are traditionalChinese medicineinjecti ons are biased, i n fact, any drug has side effects, bu
10、t not so to completelynegate medicine injection,andtraditi onalChin ese medici ne injectio n adverse reacti onrate is less tha n Western medici ne injecti ons. fact, adverse reactions highest incideneeof antibiotic drugs, Top Ten perpetrators are more than a decade of clinical use eve n cen turies o
11、ld an tibiotics. they not only failed because a mistake was uprooted , but has been more intensiveand comprehensive pharmacological research,drug safetyhasimproved significantly.Shi Lichen: Iwould th inkthatthe useof admi nistrativemeans notabad idea. TCM injections Abolition of from traditional Chi
12、n esemedici neinjectio nproducti onbeg inninghasbee n discussed more, now TCM injecti ons freque ntly more cases, i ndicati ng that Chin ese medic ine injecti ons as usageexpa ndedSecurity problems have becomein creas in glyprominent, gen eric drug side effects occurprimary risk is that the hospital
13、, such as pharmaceuticals death row cases are basically the patient s family hospital, which caused the normal operation of the hospital too much in stability.Medical observers: As we all know, afew years ago Chin ese medici ne injectio n freque nt quality problems, criticized you thi nk why there i
14、s this problem?Chen Zhong: puerari n, Houttu ynia, Acan thopa nax, SHLA few years ago, a group of prestigious series of traditi onalChin ese medici ne injecti onsin to a securitygate , many people began to question the safety of TCM injecti ons, adverse effects on societyrecog nize theexistenee of e
15、rrors, adverse reactions can not equate to quality problems, not to magnify, wouldlike the mediaand society to in still kno wledgeof adversereacti on s, letevery one know that adverse drug reacti ons are n atural attributes, regardless of Wester n medic ine, what dosage, there adverse reacti ons adv
16、erse eve nts after furtherin vestigatio n, media coverage must be objective, realistic,do notescalate.Wu Yanbing: This ismainly becauseChin esemedici neinjectio nprocess inthe producti onprocess,containsa numberof particles,impurities, ofcourse,does notrule outsome ofthein dividualsthemselves agains
17、t this formulation is more difficult to accept the fact, Chinese medicineinjectionpurificationin creas in gly refin ed, and now many En terprises in quality control figuring out ways to do better in the process. Shi Liche n: traditi onal Chin ese medici ne injecti ons of the chemical compositi on is
18、 very complex, eve n if the sin gle herb is no excepti on, and the medic ine of the producti on process also seems to be rather rough, which led to a lot of unknown substances enter the body granular, so Chin ese medic ine injecti ontoxicitiescase also moreurge nt state of traditi onal Chin ese medi
19、ci ne injecti ons re-evaluation of a genuinescientific<&It; ChinesePharmacopoeia > > .2015 years preparati on outl ine for the safety of TCM injections controlpoints from thepolicy level to stre ngthe n the sig nal has bee n give n, this will lead to the national level of Chinese medicine m
20、ore careful use of injecti ons would lead to regulate the use of this dosage form products into the period. Medical observers:Experts believe that, as the results ofexplorati on of moder n medic ine,traditi onalChin esemedici ne injecti ons has its own value for cli nical treatme nt has played a hug
21、e role. How do you see this problem?Wu Yanbing: of course has its own value, because traditi onal Chin ese medici ne injecti ons cli nical dema nd, the curre nt large volume of TCM injecti ons in clude Xueshua ntong Danhong injecti on, Shuxue ning, salescanbe see n from its large market dema nd, but
22、 Quality con trol is more difficult, so the priority is to solve quality con trol, as well as extracti on of residues and other impurities and other issues. Shi Liche n: Since there is certa inly a n eed for its existenee,but both from a technicallevel ortoxicities case perspective, the developme nt
23、 of traditi onalChin ese medici neinjectio nand producti on there aremany imperfecti ons, but there are many un resolved issues,So, I think that is not the abolitionof the problem, buthow to en sure toxicity un der the premise of safety factor is reduced to regulate the use of issue.Policies to boos
24、tthe healthy development of the Medical observers: TCM injectionsre-evaluation has been carried out, inadditi on to other policies such as the new GMP Chin ese medic ineinjecti onproducti on,quality con trol and putforward new requireme ntsfor the impleme ntatio nofthese policies has achieved what r
25、esults? Shi Lichen: From thecurre ntsituatio n,thetraditi onalChin esemedici neinjecti onsstatus not muchimproveme nt,inadditionto China, other countries,there is no medicineinjectio n,while traditi onalChin ese medici ne injecti onswithoutbeing internationalmedical system and medicalmonitoringsyste
26、m approved, so if TCM injections alsoexist and use, there should be a real substantial clinical data to support, strengthenR & D and productiontech no logy level if it can not solve this problem, as the n atio naldrug safetyaware ness,traditi onalChin esemedici ne injecti ons to really will face
27、 the aboliti on of the problem. Chen Zhong: In fact, with the accelerated process of moder ni zati on of Chin ese medic ine, more and moremoder ntech niq ues, adva needequipme ntandin strume nts used for the producti on of traditi onal Chin ese medici neinjecti ons.In dustry-lead ingproducti oncompa
28、 nies such as: Shin eway have used computer con trol automatic producti on line for herbal extracts, the dyn amic coun tercurre ntextracti on,supercritical fluid extracti on,macroporous resin compositi on applied to the producti on process, etc., widely used in the preparati on of producti on fully
29、en closed con trolled preparati on tech niq ues, pott ing lin kageinjectio nwash ingdryi ngproducti onli ne, thewholecon trolledwater bath sterilizati on, EDI reverseosmosis water and other tech ni cal equipme nt, producti onof the whole process of program-c on trolled,automated,ensuring quality con
30、trol of Chinese medicine injections stable in quality con trol using Fin gerpri nting tech no logy,in dividualen terpriseshave usednear-in fraredOn li nedetecti ontech no logy,Chin ese medici neinjecti onsfromraw materials, in termediatestofini shed theen tireproducti onprocessofreal-timecon troland
31、feedback.Medicalobservers:Itis worthmen tio ningthat theadditi onof esse ntialdrugs over from theprevioussituati on,varietiesoftraditi onalChin esemedici neinjecti on drug additi ons foun dati on is still much con cer n in the directory and procureme nt focus, this phe nomenon illustrates the proble
32、m?Shi Liche n: Nati onalandprov in cial releva nt directory in 2013 are to stre ngthe n the protecti on of traditi onalChin esemedici ne,Chin esemedic ine which has in creased the amount of the actual medical, but because three or fewer hospitals above the basic n eed to do primary treatme nt with h
33、erbal medic in es, traditi onalChin ese medici neinjecti onsCustomary usewestern medici ne doctors, there was not only convenientbut also with drug habits, so the directory Adde ndum to in crease procureme nt of TCM injecti ons are subservie nt to the choice of medicalinstitutions,because in order t
34、oin crease the use of traditi onalChin ese medic ine healthcare system. Wu Yanbing: For the current base drug additi ons, the first con siderati ons is the product of cli ni cal n eeds and market dema nd. Taking Jia ngsu Prov ince as an example, can be the first three years of clinical use to compar
35、e the situati on, if that is not a product into 520 , inthe province of medicineisvery large, it shows thatthemarket n eedsthis product,en terthe local grouptocon sider drugadditi ons,secondcon sideratio nsarebus in esses,noton ly tocon siderthe degree oflocalsupport to en terprises, the dema nd for
36、 its products in the market, degree, En terprises should also con sider the contribution of the local financial and other aspects. Medical observers:Curre ntly,2015 Edition & It ;&It;Chin ese Pharmacopoeia > ;& gt; still un der developme nt, and the preparati on of outl ine has explicitly proposed
37、 to further stre ngthe n high-risk the safety of TCM injecti ons con trol whether this will give the developme nt of traditi onalChin ese medic ineinjecti onto bring aboutcha nge? Why? Shi Liche n:willcerta inlyhave atreme ndous impact, if pharmaceutical compa nies can not solve the traditionalChine
38、se medicineinjection safetyissues and the use of the activeingredientobviousquesti on, the n, traditi onal Chin ese medic ine injecti on will stre ngthe n the role of n ati onal regulators and the public aware nessof drug safety in the con text of improv inggradually withdraw from the market. Wu Yan
39、bing: Of course, i n short, the sta ndard is to enhance its esse nee,to its dregs. Adoption of a standard, first reflected in the quality of products, followed by the en terprise hardware and software facilities up to sta ndard, compa nies will face the problemof existenee, so I think enterprises th
40、roughGMP, quality standards,is to improve the industryconcen trati onin one directi on.If the bus in ess processmore and more adva need, more reliable, more complete hardware facilities, software facilities more complete, the n left to would be good bus in ess and products.Medicalobservers:the futur
41、e, the development of traditionalChin esemedic ineinjecti ons will show what kind ofsituati on? TCM injecti ons compa nies how to conform with the trend to develop?Wu Yan bi ng: Future market TCMinjecti onshave greater dema nd, a nu mber of adversereactions,side effects of very large productswill be
42、elim in ated. For bus in esses,First,en terprisesshouldenhance the hardware and software, the market dema nd and the state adapt to the developme nt trend, and sec on dly, traditi onal Chin ese medici ne injectio n products currently limited to domestic sales, if you want to go abroad, but also graduallyimprove product quality.Chen Zhong: Admittedly, the current Chinese medicine injectio nmanu facturerun eve n,in dividuale
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