康生丹四代新药,化学名—三合皂甙分类引述

刘君 原创 | 2009-06-25 20:32 | 收藏 | 投票

                             康生丹四代新药,化学名—三合皂甙分类引述



  新药的类别是从药政管理角度划分,以便于新药的研究和审批,而不完全从药物的药理作用角度考虑。目前我国对子新药的分类,是将新药分成中药、天然药物和化学药品及生物制品三大部分,又按照各自不同的成熟程度再分类。

  1 .中药、天然药物分类

  ( l )未在国内上市销售的中药、天然药物中提取的有效成分及其制剂。

  ( 2 )未在国内上市销售的来源于植物、动物、矿物等药用物质制成的制剂。

  ( 3 )中药材的代用品。

  ( 4 )未在国内上市销售的中药材新的药用部位制成的制剂。

  ( 5 )未在国内上市销售的中药、天然药物中提取的有效部位制成的制剂。

  ( 6 )未在国内上市销售的中药、天然药物制成的复方制剂。

   ( 7 )未在国内上市销售的中药、天然药物制成的注射剂。

  ( 8 )改变国内已上市销售药品给药途径的制剂。

  ( 9 )改变国内已上市销售药品剂型的制剂。

  ( 10 )改变国内已上市销售药品工艺的制剂。

  ( 11 )已有国家标准的中成药和天然药物制剂。

  2 .化学药品分类

  ( 1 )未在国内外上市销售的药品 ① 通过合成或者半合成的方法制得的原料药及其制剂; ② 天然物质中提取或者通过发酵提取的新的有效单体及其制剂; ③ 用拆分或者合成等方法制得的已知药物中的光学异构体及其制剂; ④ 由已上市销售的多组分药物制备为较少组分的药物; ⑤ 新的复方制剂。

  ( 2 )改变给药途径且尚未在国内外上市销售的制剂。

  ( 3 )已在国外上市销售但尚未在国内上市销售的药品 ① 已在国外上市销售的原料药及其制剂; ② 已在国外上市销售的复方制剂; ③ 改变给药途径并已在国外上市销售的制剂。

  ( 4 )改变已上市销售盐类药物的酸根、碱基(或者金属元素),但不改变其药理作用的原料药及其制剂。

  ( 5 )改变国内已上市销售药品的剂型,但不改变给药途径的制剂。

  ( 6 )已有国家药品标准的原料药或者制剂。

  3 .生物制品分类

  ( l )未在国内外上市销售的生物制品。

  ( 2 )单克隆抗体。

  ( 3 )基因治疗、体细胞治疗及其制品。

  ( 4 )变态反应原制品。

  ( 5 )由人的、动物的组织或者体液提取的,或者通过发酵制备的具有生物活性的多组份制品。

  ( 6 )由已上市销售生物制品组成新的复方制品。

  ( 7 )已在国外上市销售但尚未在国内上市销售的生物制品。

  ( 8 )含未经批准菌种制备的微生态制品。

  ( 9 )与已上市销售制品结构不完全相同且国内外均未上市销售的制品(包括氨基酸位点突变、缺失,因表达系统不同而产生、消除或者改变翻译后修饰,对产物进行化学修饰等)。

  ( 10 )与已上市销售制品制备方法不同的制品(例如采用不同表达体系、宿主细胞等)。

  ( 11 )首次采用 DNA 重组技术制备的制品(例如以重组技术替代合成技术、生物组织提取或者发酵技术等)。

  ( 12 )国内外尚未上市销售的由非注射途径改为注射途径给药,或者由局部用药改为全身给药的制品。

  ( 13 )改变已上市销售制品的剂型但不改变给药途径的生物制品。

  ( 14 )改变给药途径的生物制品(不包括上述 12 项)。(巧)已有国家药品标准的生物制品。

      因此,依据以上的分类,康生丹四代新药,化学名—三合皂甙分类为∶

  1 中药、天然药物分类  (l)未在国内上市销售的中药、天然药物中提取的有效成分及其制剂。

  2 .化学药品分类  (1) 未在国内外上市销售的药品  ② 天然物质中提取或者通过发酵提取的新的有效单体及其制剂;

  所以,康生丹四代新药,化学名—三合皂甙分类为中药、天然药物分类—化学提取药品—天然有效成分单体及其制剂;属于完全创新的新药。而研制根本与宗旨是以T细胞无序保护诱导激活免疫记忆来增加CD4改变HIV细胞生理状态入核并生物性破解、抑制病毒毒斑的形成,从前期阻断细胞基因编程记忆,全面科学杀灭HIV。以上观点在刘君主任2000年申报国家专利局发明专利时已在专利公报中提及;而国内外提出艾滋病T细胞研究开始于2003以后,以及2005才确认提出。而现在国外的研究才证实艾滋病病毒池来源于T细胞的记忆功能。而刘主任坦诚的宣示∶康生丹一代、二代、三代、四代〔已诞生〕以及未来诞生的五代,都是围绕T细胞无序免疫诱导激活记忆核心来改变细胞基因编程前期入核阻断HIV而提升T细胞、CD4以及生物性破解、抑制病毒毒斑的形成来达到药理发挥作用的。

  临床的初步结果也显示了非常乐观的药理与疗效∶患者体重明显增加、并发症迅速控制、生命体证恢复、CD4正常、HIV检测LPD;期待未来的药理实验揭示其核心作用并不断证明之而最终造福患者。

     

Dan Kang Sheng four generations of new drugs, chemical name - San categories quoted saponins
The category of new drugs from the perspective of药政管理divided in order to facilitate the research and approval of new drugs, and not entirely from the perspective of the pharmacological effects of drugs to consider. At present, the classification of China's pair of new drugs, new drugs is divided into traditional Chinese medicine, natural medicine, and chemical and biological products in three and in accordance with the maturity of the different re-sorting.
1. Chinese medicine, natural medicine Category
(L) is not listed in the domestic sales of Chinese medicine, natural medicine to extract the active ingredients and its preparation.
(2) is not sold in the domestic market comes from plants, animals, minerals and other preparations made from medicinal substances.
(3) Chinese herbal substitutes.
(4) not listed in the domestic sales of new Chinese herbal medicinal preparation made from the site.
(5) is not listed in the domestic sales of Chinese medicine, natural medicine effective in the extraction of parts of the preparations made.
(6) is not listed in the domestic sales of Chinese medicine, natural medicine made of compound preparation.
  (7) is not listed in the domestic sales of Chinese medicine, natural medicine, injections made.
(8) changes in domestic sales of drugs have been listed on the preparation route of administration.
(9) changes in domestic sales of pharmaceutical dosage forms have been listed on the preparations.
(10) changes in domestic sales of drugs have been listed on the preparation process.
(11) has been the national standard of proprietary Chinese medicines and natural pharmaceutical preparations.
2. Chemical classification
(1) is not listed at home and abroad through the sale of drugs ① synthesis methods or semi-synthetic drug obtained and its preparation; ② natural material extracted or extracted through the fermentation of new and effective monomer and its preparation; ③ with demolition synthesis methods such as sub-system or a known drug of optical isomers and their agents; ④ have been listed by the multi-component drug sales less prepared for the component drugs; ⑤ new compound preparation.
(2) to change the route of administration and not yet listed in the sales agents at home and abroad.
(3) sales in foreign markets but not yet sold in the domestic market has been ① drugs sold in foreign markets and raw materials preparation; ② sale in foreign agents of the compound; ③ to change the route of administration and sales in foreign markets agents.
(4) changes in the sale of drugs, radical salts, the base (or metal elements), but does not change the pharmacological effects of the drug and its preparations.
(5) changes in domestic sales of pharmaceutical products have been listed on form, but does not change the route of administration of the agents.
(6) have been the standard drugs or drug formulations.
3. Biological Products Category
(L) is not listed in the domestic and international sales of biological products.
(2) monoclonal antibodies.
(3) gene therapy, somatic cell therapy and its products.
(4) the original allergy products.
(5) from human and animal body fluids or extracts of the organizations, or through fermentation with the biological activity of the preparation of multi-component products.
(6) from the sale of biological products have been listed on the compound to form a new product.
(7) has been marketed abroad but not yet sold in the domestic market of biological products.
(8) strains containing unapproved products microecological prepared.
(9) sales of products listed with the same structure and were not listed on domestic and international sales of products (including the amino acid point mutation, deletion, due to difference in the expression system, the elimination of post-translational modification or change of products, such as chemical modification ).
(10) with the sale of products of products of different preparation methods (such as the use of different expression systems, host cell, etc.).
(11) for the first time the use of recombinant DNA technology to prepare the products (for example, an alternative to recombinant synthesis, biological tissue extract or fermentation technology, etc.).
(12) has not yet been listed for sale at home and abroad by means of non-injection drug delivery means be re-injected, or replaced by the local administration of systemic drug delivery products.
(13) changes in products have been listed for sale but does not change the form of route of administration of biological products.
(14) to change the route of administration of biological products (excluding the above-mentioned 12). (Clever) has national standards for biological products drugs.
     Therefore, based on the above classification, Kang Sheng Dan four generations of new drugs, chemical name -三合saponins classified as:
1 Chinese medicine, natural medicine Category (l) is not listed in the domestic sales of Chinese medicine, natural medicine to extract the active ingredients and its preparation.
2. Chemical classification (1) not listed in the sales of drugs at home and abroad ② natural material extracted or extracted through the fermentation of new and effective monomer and its preparation;
Therefore, Kang Sheng Dan four generations of new drugs, chemical name -三合saponins classified as Chinese medicine, natural medicine Category - chemical extraction of drugs - natural active ingredients and its preparation monomer; are totally innovative new drugs. Developed with the aim of the fundamental disorder is the protection of T cells induced by activation of immune memory to increase the CD4 cell changes in HIV to the physiological state of nuclear and bio-hacking, drugs inhibit virus plaque formation, blocking cell gene from the pre-programming memory, comprehensive scientific to kill HIV. Liu, director of the points mentioned above in the declaration of national patent offices in 2000 when the patent has been mentioned in the Patent Gazette; and AIDS at home and abroad to T-cell research began in 2003 after, as well as the confirmation made before 2005. Study abroad is now confirmed from the HIV pool of memory T cells. And frank declaration刘主任: Kang Sheng Dan generation, second generation, three generations, four generations have been born 〔〕 and the future birth of the Five Dynasties, around the T cells are induced by activation of the immune disorder to change the core memory cell gene pre-programmed into the nuclear waste off HIV and enhance T cells, CD4 and biological break and suppress the formation of plaque virus drugs to achieve the pharmacological role.
Preliminary clinical results also show a very optimistic about the pharmacology and efficacy: patients with a marked increase in body weight, rapid control of complications, permit the resumption of life, CD4 normal, HIV testing LPD; look forward to the future pharmacological experiments reveal the central role and continue to prove themselves the ultimate benefit of patients.
   

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