Medical network - March 13, a few days ago, the state administration of traditional Chinese medicine to the industry of traditional Chinese medicine sent a gift - the catalogue of ancient classic square selection range and selection principles (hereinafter referred to as "principles"), to solicit opinions from the public.
▍ the catalogue of ancient classic square selection range and selection principles
According to information from the state administration of traditional Chinese medicine, the directory is a classic formulation of the square directory, in order to promote the ancient and the state food and drug supervision bureau jointly entrust China academy of traditional Chinese medicine research work, under the terms of the supplementary provisions of the Chinese traditional medicine registration management related.
Basis in January 2008, the Chinese medicine registration management supplementary provisions in article 7: "comes from the ancient classic square compound preparations of Chinese medicine, is still widely used, curative effect, has obvious characteristic and advantages of medical books are written in the qing dynasty and the qing dynasty before the prescription". The selection range is defined as: published 1911 years ago the ancient medical books.
According to the overall requirements of "the principle", a forthcoming classic square directory is not only the selection scope of requirements, general also requires "there are more ancient records and the basis of evidence in the modern literature have more clinical and experimental research reports; get the doctor of traditional Chinese medicine clinical further refining, authoritative experts widely recognized; widely collected in all kinds of teaching material of Chinese medicine, etc."
A forthcoming classic square directory you need to follow the following principles:
(1) health demand oriented, around the advantages of traditional Chinese medicine disease to choose formula, attending to juggle has listed the conditions of the Chinese patent medicine involve less; Prescription don't contain the law of the People's Republic of China pharmacopoeia 2015 edition contains toxic medicinal materials; Prescription does not involve in the national key protected wild animal drug varieties directory of varieties under grade 1 protection.
(2) prescription ZhongYaoWei are according to the 2015 edition of pharmacopoeia of the statutory standards; Prescription is suitable for industrialized production, as medicinal properties is good; Dosing way consistent with the recorded in ancient medical books; Do not contain in the prescription of the eighteenth and nineteenth fear such as compatibility taboo.
(3), in principle, prescription applicable scope does not include emergency and critical care, infectious diseases, and do not involve the special drugs such as pregnant women, infants and young children, the crowd; But is found to have curative effect, the outstanding features of prescriptions, discretion on, so as to adapt to clinical demand.
(4) domestic unlisted varieties.
At the same time, this also is on the basis of the traditional Chinese medicine of the People's Republic of China law article 30 "production meets the conditions prescribed by the state from ancient classic square compound preparations of Chinese medicine, when applying for drug approval number, can only provide non-clinical safety study materials".
▍ key is how to define the Chinese medicine classic square
Because in ancient China is the world's most advanced, countries, medical also more developed, the accumulation of a large number of medical texts. According to statistics, in the history of our country has written nearly 100000 prescriptions.
Public information, at present, our country academic circles generally will be the history of ancient Chinese medicine huangdi neijing, "difficult", "theory of typhoid miscellaneous disease", "huang di" as the four great classics of traditional Chinese medicine, which recorded the numerous prescriptions. In addition, there are other prescriptions of TCM treating multi-purpose.
In January 2008, the state food and drug administration issued the supplementary provisions of the Chinese traditional medicine registration management for the first time in the context of official clear "classic party without clinical".
However, over the past eight years, check total bureau of national food and drug supervision and management of data, can be found that rare exemptions clinical listed Chinese medicine case directly. The biggest problem is that nobody knows what is classic, classic party list, what are the follow-up policy how to implement it. According to the literal understanding, in the qing dynasty and the former formula is classic, but the number of large, miscellaneous, some effect is not very good, even there is a big toxicity.
"Classic party of examination and approval shall be issued corresponding implementing rules, can't say who has taken a Cuban side it became a new drug, how should the market regulation, there are a series of problems. In addition, the previous list of laws and regulations have stipulated in feed by the competent department of traditional Chinese medicine under the state council in conjunction with the state food and drug administration specific scope, but never take it out." Bao-yan liu, a researcher at the Chinese chief of traditional Chinese medicine academy of sciences, said.
▍ classic square directory will reference "pharmacology" directory?
In the industry to classic square directory behind the continuous attention, it is also the traditional Chinese medicine (TCM) how inheritance and innovation is more and more attention.
Once one of the direction of traditional Chinese medicine (TCM) innovation and modernization of Chinese medicine of traditional Chinese medicine injection, after suffering a crisis of confidence, traditional Chinese medicine (TCM) innovation is more difficult. At present, the number of TCM injections were included in key monitoring varieties. After the traditional Chinese medicine has hampered innovation through inheriting classic square also can yet be regarded as a kind of choice. Therefore, in the positive push the process of making the classical square directory.
Although the national related department to actively promote classic square directory related work, also has obtained certain achievements, but the list has been haven't released, lead to enterprise can't develop without authorization.
"Pharmacology" is China's national higher colleges and universities of Chinese medicine for teaching in the new century classic materials, is also a specialized students' compulsory teaching material of Chinese medicine. According to the principle of "general requirements of the principle of" were widely included in all kinds of teaching material of Chinese medicine ", the author sorts through prescriptions in "pharmacology" directory reading found that in addition to medicinal broth of dosage form be focus on pharmaceutical enterprise, in addition to medicinal broth of proprietary Chinese medicine are relatively easy to scale, industrialization production.
The current "pharmacology" directory has some pills and individual medicinal broth has become our country traditional hot varieties on the market. Such as benefit of liuwei dihuang pill (rehmannia pill), pill, qi chrysanthemum rehmannia pill, begin to understand agent when palace bezoar bolus (bezoar bolus), bezoar sedative bolus, four grinding, such as soup, the leading enterprises have become some varieties or well-known varieties.
In the national market to the retail price, which is expected to more than 2 billion yuan, liuwei dihuang pill Beijing tongrentang, wan west pharmaceutical, nine cheese market scale in the 3-500 million yuan. Ann palace bezoar bolus national market scale also has more than 1 billion yuan, which is dominated by Beijing tongrentang, the size of the market more than 600 million yuan, guangzhou in the pharmaceutical industry the varieties in one hundred million yuan of above; Bezoar sedative bolus of the size of the market also is expected to more than 500 million yuan, including Beijing tongrentang market size is close to 400 million yuan; Four grinding soup is one of the leading varieties, listed companies in hunan Hansen pharmaceutical market scale is controlled in 600 million yuan. In spite of this, the author preliminary estimate now classical prescriptions in sales of proprietary Chinese medicine market in China is in ten billion yuan of less than, at more than $6000 of the nation's proprietary Chinese medicine sales in the market share is still very low.
Visible through the above analysis, the famous pharmaceutical enterprises in our country has a first mover advantage in classic square marketization, such as old Beijing tongrentang, guangzhou in the pharmaceutical industry is one of the leading manufacturers more classical prescriptions, these enterprises after the classic square directory has a good market experience, in the market.
However, as a classic formula doesn't require clinical importance will be proprietary Chinese medicine production enterprises, and vigorously support of national policy, some modern high degree of marketization of proprietary Chinese medicine production enterprises in classical prescriptions directory products will also unwilling to lag behind, will grasp the "overtaking corner" in the field of opportunity, result how? We can see.
In any case, the author thinks that in our country after official announcement on classic square directory, China's traditional Chinese medicine industry will usher in a new development opportunity, classic type of proprietary Chinese medicine prescriptions market share is a big probability event will be greatly increased.
Add: "pharmacology" classical prescriptions in the directory
Nourish the agent
Ephedra soup, ephedra and licorice, ephedra, almond and Yi soup soup, tsing lung soup, three kink, canopy, guizhi soup, soup guizhi plus puerarin soup, cassia twig and apricot soup, cassia twig and laurel decoction, cassia twig and peony soup, taste notopterygium soup, nine notopterygium soup, sweet Sue powder, sweet Onions fish soup, flavored Sue scattered, small qinglong decoction, shoot dry ephedra soup, check syndromes is boiling grass powder, gold powder, radix bupleuri drinks, fructus forsythiae and sang ju Yin, ephedra, almond, licorice gypsum soup, the male and the soup, chai ge solution muscle, muscle chai ge solution soup, soup cohosh puerarin, bamboo liu Bang soup, soup disease spread, jing disease prevention, storage, and Sue drinks, ephedra asarum aconite decoction, ephedra monkshood licorice soup, reengineering, add and subtract luxuriant soup, worship seven flavor drink
Flooded with agent
Large bearing gas, small bearing gas soup, soup and stomach gas bearing, compound bearing gas soup, soup rhubarb peony blood soup, drink soup, clear bowel, appendix appendix 淸 clear soup, soup, appendix big chest, rhubarb soup soup, lateral root of aconite wenpi decoction, pockmarked kernel pill (spleen about pill), five kernel pill, dhi sichuan Fried, ten jujube soup, accused of salivary Dan, Huang Longshang, new Huang Longshang
The settlement agent
Little soup of radix bupleuri, radix bupleuri definite orange soup, major bupleurum decoction, seven things decoction, artemisia Qin qing bravery of the original soup, drink and radix bupleuri da qing spleen drink, drink and four inverse scattering, radix bupleuri, liver powder, acid-insoluble ash scattered, easy dispersion, flavored peony xiaoyao powder, black xiaoyao powder, heart pain s, this decoction soup, ginger, licorice xie xie heart soup soup, rhizoma coptidis decoction
Heat agent
White tiger decoction, white tiger and ginseng soup, white tiger plus guizhi soup, white tiger and rhizoma atractylodis, bamboo leaves gypsum soup soup, soup, soup 淸 palace 淸 camp, horn when when (paeonia lactiflora), rhinoceros, Dan god spot soup, huanglian jiedu decoction, diarrhea, gardenia golden flower heart soup soup, 淸 sickness disease, cool diaphragm, lifeline five disinfection disinfection alive XianFang drink, drink, drink, four wonderful yong red powder, blessed are lotus seed soup, drink and gentian purging liver soup, xie pills for green, angelica dragon group, left pills for gold, e, f, sweet even nine, reed stem soup, soup, white powder, platycodon draba nemorosa jujube lung soup, 淸 stomach, diarrhea yellow powder, herself frying, radix scutellariae, radix puerariae radix scutellariae, rhizoma coptidis decoction, peony soup soup annua turtle shell, Chinese bulbul soup, soup, qing bone powder, radix gentianae macrophyllae six when turtle shell powder, angelica
Prompting fashionistas agent
淸 collaterals, Chinese mosla herb powder, new on the Chinese mosla herb drinks, children are scattered, yi yuan, jasper, chicken Sue scattered, bolus of the dew, 淸 heat yiqi decoction, yiqi 淸 chief of soup
Temperature in the agent
Principle of pills, pills in aconite, cassia twig, ginseng soup, soup in tracey, astragalus, angelica chienchung chienchung soup soup, to build the inverse soup, soup, soup of evodia rutaecarpa, four pulse four inverse soup and four inverse ginseng soup, Bai Tong soup, with soup, and back to shenyang emergency Xing, hui Yang emergency four inverse soup soup, angelica, angelica four inverse of evodia rutaecarpa ginger, huangqi guizhi wuwu tang, Yang and soup, antiphlogistic tablet
Tonic agent
Sijunzi decoction, and different work loose, 6 gentleman soup, sweet sand 6 gentleman, yuan bao soup, soup and three scattered, 7 atractylodes atractylodes scattered, fill in beneficial gas soup, soup YangYi stomach soup, litres, RMB for frying, scattered, yupinfeng powder, and the pulse with peach siwu soup, siwu soup, soup, glue YiShang, st the soup, angelica blood tonic soup, soup of spleen-invigorating, eight Jane soup scattered (8), perfect great repair soup, ginseng keep bolus, Tarzan rock powder, main grass soup, add and subtract the complex pulse soup, liuwei dihuang pill (rehmannia pill), pill, qi chrysanthemum rehmannia pill, wheat flavour rehmannia pill, have pills for gas, left, left to drink pills, greatly tonifying Yin, tiger hidden pills, pills for consistent decoct, kidney, flavored kidney gas, ten pills for repair, right, right to drinks, rehmannia YinZi (radix rehmanniae drink), two fairy tortoise deer glue, qibao beards Dan
Shibuya fixing agent
Oysters are scattered, nine fairy, reality have dirty soup (pure Yang reality keep dirty soup), peach blossom soup, four gods pill, up solid essence bolus, mantis egg-case, indentation springs pill, solid salt soup, solid when the pill, easy
Sedative agents
Cinnabar sedative bolus, magnetic bushing Dan zhu pill, heavenly Kings, cedar seed in yangxin pill, Kong Sheng pillow Dan, zizyphus jujube kernel soup, gansu wheat jujube soup
Begin to understand agent
Ann palace bezoar bolus (bezoar bolus), bezoar 淸 heart pill, purple snow, infantile rejuvenation, treasure Dan Dan, marched away, the bow pill pills (men), acid-insoluble ash scallions Bai Guizhi soup, fructus scallions soup, white liquor fructus scallions white magnolia bark, pinellia pinellia soup soup, Jin Lingzi temperature in magnolia bark, yanhusuo soup, soup, good bolus, tiantai medicine powder (powder), four grind soup, orange nuclear pill, warm, antiasthmatic soup, Fried liver anti-asthma, small, big pinellia pinellia soup soup, soup inula generation of ochre and soup, orange peel bamboo RuShang, clove persimmon soup
Richard blood thinner
Peach pit gas bearing, blood stasis soup, soup big rhubarb ordinary worm pill, blood mansion by mark soup, : huoxue soup, diaphragmatic stasis soup, lower abdomen each stasis soup, body pain by stasis soup, styrax pill (hard ng pill), bolted pills and drugs
Facilitating agent
Fill five soup, Yang also recover huoxue soup, seven mile away and warm the soup, temperature by biochemical soup, soup, had come loose, loose effect best, salvia miltiorrhiza, cassia twig tuckahoe pills, turtle shell decoct pill, ten ashes scattered, four pills, coughing up blood, field thistle YinZi, sophora japonica, loess soup
For agent
Rhizoma ligustici wallichii tea, chrysanthemum tea powder scattered, big radix gentianae macrophyllae soup, small adjustable, adjustable Dan, Dan is scattered, antispasmodic, yuzhen SAN, disperse like the wind, scattered LingJiao teng teng soup, drink and town liver extinguish wind, gastrodia elata, uncaria drink soup, build Ling soup, big wind beads, three compound vein, ejiao when chicken soup
For drying agent
Apricot Sue spread, SangXing soup, 淸 dry save lung soup, soup, toughening liquid bearing gas soup, radix ophiopogonis, benefit stomach soup, soup tastes, Joan jade cream soup, Yin qing lung soup, lily solid jintang, lung soup of donkey-hide gelatin
Clearing damp agent
Flat stomach, not in gold upright scattered, Chai Ping soup, ageratum upright, and soup, artemisia capillaris soup, gardenia skin parker soup, herba artemisiae four inverse soup, eight are scattered, five spray powder, three kernel soup, bud PiaoXia lingya dew, radix scutellariae talc soup, soup disinfection Dan came pain, even drink piao, angelica soup came pain (soup) xuan bi soup, two and three clever pill, four wonderful pill, five three, three four, three stomach soup, Yin Chen Wuling scattered, grifola soup, astragalus root soup, five skins, lingya guangxi sweet soup, liquorice qian jiang tuckahoe large-headed atractylodes soup, really Wu Shang, monkshood soup, spleen, Bi Xie distinguish dispersion (Bi Xie 淸 drink), Bi Xie distinguish wet soup, drinks, notopterygium wins Juan three bi bi soup, living by parasitic soup, soup
expectorant
Two Chen Shang, guide sputum soup, polyester soup, jinshui six gentleman decoction, wendan tang, ten wendan tang, tuckahoe pills (cure phlegm tuckahoe pills), 淸 gas phlegm pill, pure gold decrease internal heat soup, small chest soup, soup of radix bupleuri chest, roll phlegm pill (chlorite schist roll phlegm pill), fritillaria snakegourd fruit powder, three five Jiang Xinshang, cold xiao pill, the third kiss soup, pinellia epilepsy atractylodes rhizoma gastrodiae decoction, pill
Xiaoshi agent
Insurance and pills, pills acid-insoluble ash lead lag, combination pills for betel nut, stomach pill, definite, acid-insoluble ash and arouse the new pill (no pill), flower of kudzuvine solution soup
Insect repellents
Plum pill, branded hatched from soup, even MeiAn hatched from the soup
Chung puke
Melon, and three saint and emergency dilute stripping away |
