1. The meaning of Chinese medicine extractionChinese medicine extraction refers to the process of dissolving the effective ingredients in Chinese medicinal materials, separating and purifying them to obtain effective monomers. Second, the value of traditional Chinese medicine extractionThe composition of traditional Chinese medicine is very complicated. There are not only many effective ingredients, but also invalid and toxic ingredients. Using modern science and technology to extract the effective ingredients of traditional Chinese medicine to the maximum extent can improve the internal quality and clinical treatment effect of traditional Chinese medicine preparations, and maximize the effect of traditional Chinese medicine. 3. Introduction to extraction methods>>>>Traditional methodsTraditional extraction methods for traditional Chinese medicine treatment include water decocting, dipping, and percolation , Improved gelatin method, reflux method, solvent extraction method, steam distillation method and sublimation method, etc. Traditional methods of traditional Chinese medicine extraction have many disadvantages:There is a lot of loss of active ingredients, especially water-insoluble ingredients;In the extraction process, organic solvents are possible and effective. The effect of the ingredients makes it lose its original effective use;The non-effective ingredients cannot be removed to the maximum, and the concentration rate is not high enough;In addition to the active ingredients, the extracts often contain more impurities Many, there are still a small amount of fat-soluble components, which is disadvantageous to the refining;High temperature operation will cause a large amount of thermally sensitive active components to decompose. >>>>Modern methodsIn recent years, the high and new technology used in the extraction and separation of traditional Chinese medicines include supercritical fluid extraction, membrane separation technology, superfine grinding technology, and traditional Chinese medicine flocculation separation technology. , Semi-bionic extraction method, ultrasonic extraction method, cyclone extraction method, pressure countercurrent extraction method, enzymatic method, macroporous resin adsorption method, ultrafiltration method, molecular distillation method, etc. Compared with traditional methods, modern methods of traditional Chinese medicine extraction have the following advantages:Chinese medicine extrac Phenibut Suppliers ts have high purity, simple operation and energy saving;High extraction efficiency, The production cycle is short, it is easy to find new active ingredients in natural plants, there is little loss of volatile components or physiologically active substances, no solvent residues, and high product quality. Four. Uses of Chinese medicine extractsOne is to make Chinese patent medicines. At present, most Chinese medicine products use original medicinal materials or primary extracts as medicine;2 It is in the field of health food. Domestic health food has continued the model of Chinese patent medicine for a long time, and has low requirements for ingredients or markers;The third is functional food and daily cosmetics. Five. Market spaceData from Cyberlan shows that the domestic plant extraction industry has grown from more than 5 billion in 2005 to more than 20 years of accumulation and development. More than 16 billion yuan in 2013; companies engaged in plant extraction have grown from more than 200 in 2005 to more than 3,000 now. VI. Current problems in the Chinese medicine extraction industry>>>>CaseOn May 19, 2015, the State Food and Drug Administration issued a notice , Pointed out that Guilin Xingda illegally changed the ginkgo biloba extraction production process and purchased ginkgo biloba extract produced by the illegal process from unqualified companies. The notice stated that 24 pharmaceutical companies across the country have been found to have purchased Guilin Xingda’s ginkgo biloba extract. Six listed companies, Qianyuan Pharmaceutical, Fangsheng Pharmaceutical, Yunnan Baiyao, Kang Enbei, Haiwang Biological, and Lansen Pharmaceutical, have been successively registered. Into this storm. >>>>Summary of problems1. In terms of production, some Chinese medicine extraction companies buy inferior medicinal materials as raw materials, and the production process does not meet the standard. Some Chinese patent medicine companies do not have extraction Ability, relying on commissioned processing or purchasing illegal extracts to produce drugs, quality is difficult to guarantee;2. In terms of industry attributes, the existing drug regulatory laws and regulations do not specify the regulatory attributes of traditional Chinese medicine extracts, leading to the production of traditional Chinese medicine extracts , The use situation is not clear, Phenibut powder wholesale and it is outside the whole-process supervision system of drug quality;3. In terms of industry supervision, the relevant management system is not perfect, especially in terms of corporate responsibility, regulatory responsibility and qualitative punishment. Loopholes, insufficient supervision and punishment. Seven. Policies and related influences>>>>PoliciesIn response to the outstanding problems in the extraction of Chinese medicine, the State Food and Drug Administration issued a The “Notice on Strengthening the Supervision and Administration of Extraction and Extracts in the Production of Traditional Chinese Medicines” (Food and Drug Administration and Pharmaceutical Huajian [2014] No. 135) was issued this month, which clarified the requirements for the management of extraction and extracts of traditional Chinese medicine and stipulated the transition period. All provinces (autonomous regions, municipalities) Food and Drug Administration should stop approving the entrusted processing of extraction of traditional Chinese medicines. For the entrusted processing of extraction of traditional Chinese medicines that have been approved, pharmaceutical manufacturers must stop entrusting processing from January 1, 2016 extract. For proprietary Chinese medicine manufacturers that do not have the ability to pre-process and extract traditional Chinese medicines, starting from January 1, 2016, they will stop the production of corresponding Chinese medicines. If they do not stop production within the time limit, the Food and Drug Administration will Seriously investigate and deal with it. Starting from January 1, 2016, the Chinese patent medicine national drug standard prescription items have been downloaded, and the Chinese medicine extracts with a separate national drug standard have been filed and managed. In the 2015 edition of the Chinese Pharmacopoeia, there are 47 varieties including clove basil oil, star anise oil, and total saponins of ginseng stems and leaves under a catalog of “plant oils and extracts” in the 2015 edition of the Chinese Pharmacopoeia. In the category of traditional Chinese medicine extracts, record management shall be implemented in accordance with the “Implementation Rules for the Record Management of Traditional Chinese Medicine Extracts”. Click “Read the original text” at the bottom of the article to view China Phenibut the full text of the “Detailed Rules for the Administration of Chinese Medicine Extract Records”>>>>ImpactChina’s plant extract production 80% is used for export and 20% is used for domestic digestion, of which a small part comes from the commissioned extraction of Chinese patent medicine manufacturers. From January to June 2014, my country’s plant extracts were 31,000 tons. Judging from the total amount of plant extracts in the country and the proportion of commissioned extraction of traditional Chinese medicines, the ban on commissioned processing of traditional Chinese medicine extracts should not have a significant impact on the proprietary Chinese medicine industry. Big. Eight. Development SuggestionsAlthough some Chinese medicine extracts can be purchased, considering that the current plant extraction industry is still far from the national requirements, some industry professionals suggest that The better way is to build extraction workshops by pharmaceutical companies. That is, according to the enterprise’s own production needs, production is carried out, the extraction and production process of Chinese medicine is standardized, the control of the production process of Chinese medicine is emphasized, strict quality control standards are established, and product standardization is promoted. In this way, not only can the uniformity of product batch quality be ensured, but it is also conducive to product quality improvement and avoiding quality risks. Attach:47 kinds of plant oils and extracts included in the 2015 edition of the Chinese PharmacopoeiaClove basil oil, star anise oil, ginseng stems and leaves Total saponins, ginseng total saponins, notoginseng triol saponins, notoginseng total saponins, rhubarb extract, rhubarb liquid extract, hawthorn leaf extract, patchouli oil, salvia total phenolic acid extract, tanshinone extract, buffalo horn concentrate Powder, licorice extract, licorice flow extract, northern bean root extract, angelica flow extract, cinnamon oil, breviscapine, polygala extract, forsythia extract, vitex oil, cyclovitamin boxwood D, turpentine oil , Acanthopanax senticosus extract, bergenin, tumefaciens extract, green grass extract, tea oil, balsam, ginger flow extract, andrographolide, turmeric oil, eucalyptus oil, asiaticoside, Motherwort extract, zhebei extract, scutellaria baicalensis extract, sapengin, ginkgo biloba extract, sesame oil, castor oil, red oil, peppermint oil, menthol, belladonna extract, belladonna extract . 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