Medical network - on March 17, the state administration of traditional Chinese medicine office released on March 8th "ancient classic square directory for a selection range and the selection principle of" for advice and means on July 1, 2017 implementation of the law of the People's Republic of China law of Chinese medicine in the 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. The specific measures for the administration of traditional Chinese medicine by the pharmaceutical supervisory and administrative department under the state council in conjunction with the competent departments to formulate" the corresponding ancient classic square directory finally have the selection range and the selection principle.
Ancient classic square selection to seven
According to the catalogue of ancient classic square make selection range and selection principles, in line with the selection range and the selection principle of ancient classic square will be at 7 o 'clock at the same time satisfy the following:
1. To the ancient sources, published 1911 years ago the ancient medical books;
2. Sufficient literatures: 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; Various widely collected in the textbooks of Chinese medicine;
3. Indications to differentiation: 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; In principle the prescription applicable scope does not include emergency and critical care, infectious diseases, do not involve the special drugs such as pregnant women, infants and young children, the crowd; But to have curative effect, the outstanding features of prescriptions, discretionary included, to adapt to clinical demand;
4. Prescription medicine to safe and legal standard: do not contain in the prescription 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; 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;
5. Delivery system may not be changed: give medicine way consistent with the recorded in ancient medical books;
6. No compatibility taboo: does not contain in the prescription of the eighteenth and nineteenth fear such as compatibility taboo;
7. New drugs: domestic unlisted varieties.
From the point of view of project, to complete the above product selection, first of all, there must be 1911 years ago in ancient medical books published by the formula of the prescriptions database, the database market is blank for the time being. Formula of prescriptions in ancient medical books, want to be with the domestic listed proprietary Chinese medicine formula do cross analysis, screening is not listed on the domestic formula formula in ancient medical books, again with the "pharmacopoeia of the People's Republic of China medicine yinpian do cross analysis, remove contain big poisonous herbs and varieties of wildlife under special state protection of medicinal materials directory varieties under grade 1 protection of medicinal materials of party, the party have to look at the current literature research, choose the research indications shall not include emergency and critical care, infectious diseases, and do not involve the special drugs such as pregnant women, infants and young children, the party to mark of the crowd.
Above all, Chinese traditional medicine prescription, medicinal herbs and other information at present mainly books, the Internet mainly by scanning version of books rather than form can do further processing of the database, the lack of the database will increase the difficulty of the screening.
Again meets the "naming rules change"
As of March 15, 2017, salty reach data V3.2 found that has been listed on the proprietary Chinese medicine products approval number 58221, corresponding to 9011 product name.
Because of proprietary Chinese medicine often tongfang listed, so the judgment formula formula whether in ancient medical books are on the market is very difficult. According to the notice in the 2017 edition, panax notoginseng saponins injection preparations include blood flux injection, blood clots injection, injection of blood flux (lyophilization), for injection via blood clots (lyophilization); "Lamp injection preparation including lamp" asarum injection, lamps, injection, injection with lamps,; Dropping pill "ginkgo biloba oral preparations" include ginkgo biloba, gingko leaf capsule, ginkgo biloba, ginkgo biloba oral liquid (granular), ginkgo leaf, ginkgo biloba, ginkgo biloba extract drops, ginkgo biloba extract, dropping pill YinXingTong ester, YinXingTong ester capsules, YinXingTong ester particles, YinXingTong ester, YinXingTong ester dispersible tablets, apricot ling dispersible tablets, ginkgo armillaria oral solution.
Thus it can be seen that due to previous naming is not standard, proprietary Chinese medicine exclusive products very much.
In view of this, on January 9, 2017 CFDA issued general name "open for proprietary Chinese medicine technical guidelines" (draft). According to the draft, the name contains "hypoglycemic, antihypertensive, lipid, diminishing inflammation, cancer," such as possible to the patients to suggest about the pharmacology, anatomy, physiology, pathology and therapeutics, "treasure" "spirit" "fine" "strong" "quick fix" exaggerated, boast, unrealistic, contain "drive" praise "secret" and other names of the pharmaceuticals will be renamed.
Health-care products relating to the above product name: ginseng and astragalus hypoglycemic tablets (capsules, granules), gold stilbene reducing sugar pill (tablets, capsules, granules), stilbene vermiculite hypoglycemic tablets (capsules) stilbene hypoglycemic capsule, bezoar, day step-down pills (tablets, capsules), qinggan hypotention capsule, clear brain antihypertension tablet, capsule, granule, Jane chrysanthemum step-down tablet, Ann palace step-down pills, mountain green tea tablets (capsules), lipid, aperient demonstrated capsule, lipid-lowering pills, lipid-lowering spirit tablet (particles), lipid-lowering tong capsule of arteries and veins, clear lung inflammation pill, jianwei anti-inflammatory particles, anti-inflammatory cholagogue (capsules, granules), anti-inflammatory cholagogue soft capsule, anti-inflammatory plaster, kang fu anti-inflammatory bolt, eliminate cancer injection, eliminate cancer pill (tablets, capsules, granules), infantile treasure bolus, infantile taikang particles, boa, powder, pills bezoar riches, sweet, sweet capsule, army treasure bolus, blood particles (mixture), heart treasure treasure bolus, dysmenorrhea treasure grain, sweet ophthalmic, ma yinglong sweet eye ointment, loose bone capsule (particles), ruyi pills for treasures, treasures, compound fritillary bulb tablets (capsules), up solid essence bolus, powerful become pipagao in (honey) smelting, puissant loquat (capsules, granules), powerful computer tablets (capsules) of eucommia ulmoides, gastrodia elata forcefully pill (capsule), available bezoar bolus, available kyushin pills, available heartache dropping pill, available toothache tincture.
Tables may be required to name the products
(source: salty reach data V3.2 domestically listed as remit 】 【 varieties database)
In 2000, the national drug standards into preparation of Chinese medicines, 1 ~ 20 copies issued after execution, discovered some variety name tongfang different name and doesn't conform to the principle of naming problems, affects the execution of the national drug standards, the national pharmacopoeia committee after the audit, a total of 11 products have been renamed, such as "lipid-lowering ling capsule" renamed "fat vein kang capsule" "oral liquid of compound panax notoginseng" renamed "qi kang oral liquid".
Proprietary Chinese medicine named standardization is expected to drive the standardization of prescription combination, related with the composition of product will be in the same product name, many exclusive products will no longer exclusive, bidding price will face competition. For larger market has formed their own brand products such as ma yinglong sweet eye ointment, jinshui bao capsule, etc., and changed its name in addition to increasing the cost of production, still need to face the costs of marketing investment, let consumers to know the product name. The author thinks that "oil jings" class represents formulations product name meaning is not big, also do not belong to exaggerate, boast, unrealistic, lower the possibility of "wind" has been renamed.
Conclusion the < < <
Under the condition of current information, it is very difficult to filter out in the catalogue of ancient classic square selection range and selection principles formulated by the standard of specific prescriptions directory.
Advantages of traditional Chinese medicine disease often in chronic diseases, often proprietary Chinese medicine of the cluster is already on the market advantages of traditional Chinese medicine disease to plant, the selection rules require both have listed the conditions of the Chinese patent medicine involve less, but ruled out most of the indications, has been gradually found indications and modern western medicine there are more basic impossible in the ancient records and the basis of evidence, many constraints restrict each other's will be hard pressed to meet all the conditions lead to target.
According to the law of the People's Republic of China law of traditional Chinese medicine, the ancient classic square non-enterprise specific directory as the dominant, but by the competent department of traditional Chinese medicine under the state council in conjunction with the pharmaceutical supervisory and administrative department under the state council, the might as well in countries such as formal catalogue published do further planning. |
