彩乐乐网

Hello, welcome to Mingke Looking for Instrument Network

彩乐乐网 | Help Center | About Us | Mingke Official Website

Recently Viewed

彩53彩票网 万人炸金花 新橙彩票 电子游戏 360彩票 中国福彩网 一定牛彩票网 精选四肖三码 白小姐四肖必选一肖四不像 六肖中特精选

withBroswerStore(function(broswerStore){ var box=$('box_widgets_1154');; broswerStore.get('history',function(v){ v=JSON.decode(v); if(!v||!v.length)return; var html=''; var template = '
'; template+='
'; template+= ''; template+= ''; template+= '
'; template+= '
{viewTime}
'; template+='{goodsName}

'; var max=Math.min(v.length,3); if(v.length>1) v.reverse(); v.each(function(goods,index){ var vt = ($time() - goods['viewTime']); vt = Math.round(vt/(60*1000))+'分钟前浏览过:'; if(vt.toInt()>=60){ vt = Math.round(vt.toInt()/60)+'小时前浏览过:'; if(vt.toInt()>23){ vt = Math.round(vt.toInt()/24)+'天前浏览过:'; if(vt.toInt()>3){ vt = new Date(goods['viewTime']).toLocaleString()+'浏览过:'; } } }; if(!!!vt.toInt()){vt='刚才浏览了:'} goods['viewTime'] = vt; if(index

Establish TCM Biological Standards to Promote TCM Quality Consistency

Release Date: 2019-03-19

A few days ago, the State Council issued the "Outline of Strategic Planning for the Development of Traditional Chinese Medicine", which has been upgraded to the national strategy. The "Outline" states that by 2020, the Chinese medicine industry will become one of the important pillars of the national economy. At present, the first and most important thing is to establish a detailed Chinese medicine quality standard system.

As an innovative direction of the internationalization research of Chinese medicine, the quality control of biopotential analysis methods for compound botanicals has received the attention of FDA, EMA and other institutions and written into the research and development guidelines, and the sponsors are encouraged to apply them widely in the research.

Member of the Third Pharmacopoeia Committee, Mr. Guo Dianwu, Chief Scientist of Hangzhou Minsheng Pharmaceutical Co., Ltd., degraded the hot topics such as the consistency evaluation of Chinese medicine quality and the research on biological potency.

Q: What is a biological standard?

The biological standard (biological potency) is based on the biological effect of the drug, using the whole animal, isolated tissues, organs, microorganisms and cells and related biological factors to establish a corresponding pharmacological model to evaluate the effectiveness or safety of the drug to achieve control Or the basic purpose of evaluating drug quality.

For traditional Chinese medicines and preparations with complex ingredients and various pharmacological effects, currently only a few ingredients can be controlled, and the quality cannot be fully controlled or the efficacy can be reflected. Therefore, it is very necessary to establish an effective biological standard (evaluation methods and indicators) method, especially for multi-component and multi-target natural medicines, to find one or several main targets, and to set up for the main targets Pharmacological model. At the same time, chemical standards cannot be excluded, but a single standard cannot be used to control clinical safety and effectiveness, as well as the consistency of quality of different batches from different manufacturers.

Q: What kind of Chinese medicines or indications can be used to establish a quality system by bioavailability analysis?

Theoretically, biological standards (biological potency) can be applied to all Chinese medicines, especially those with complicated structures, unclear medicinal substances, or physical and chemical measurements that cannot reflect their clinical biological activity. The earliest application of the biological titer determination method was in the field of antibiotics, which used the bactericidal power of antibiotics as the standard for measuring the titer. The measurement of insulin titer by the mouse blood glucose method has the advantages of saving animals, simple equipment, and easy operation. It was later included in the British Pharmacopoeia (1980 edition). In the field of traditional Chinese medicine in China, the biological potency of bacteriostatic agents such as isatis root and honeysuckle can be determined by establishing a dose-response curve for sensitive strains, and measuring the skin weight potency of traditional Chinese medicine by different companies based on its dose-effect relationship. Among them, the quality standards of medicine varieties.

For "toxic" Chinese medicines, biological standards can be used to control their safety. Aconite as a representative can be used to establish a toxic value measurement method based on the minimum lethal dose test, which provides an objective for the quality control and reasonable use of aconite Chinese medicines. Accurate technical support.

In the "National Symposium on Resources and Ecological Planting of Traditional Chinese Medicine" recently held in Kunming, Wang Guoqiang, the director of the State Administration of Traditional Chinese Medicine, bluntly stated that Chinese medicine may be ruined by traditional Chinese medicine. The statement "Traditional Chinese Medicine is destroyed by Chinese medicine" provides a warning to everyone that the quality of Chinese medicinal materials should attract everyone's attention.

Question: Aiming at the recent concern that "Chinese medicine may be ruined in Chinese medicine" caused by the decline in the quality of Chinese medicinal materials, can the biological titer test method establish a titer label on Chinese medicine decoction pieces?

Authentic medicinal materials and their product specifications and grades have been an important standard for the evaluation of the quality of medicinal materials by traditional Chinese medicine. Using biological titer technology, the study found that the biological titer of rhubarb medicinal materials with different product specifications had significant differences. However, the biological potency of some medicinal materials has nothing to do with the current classification of commodity specifications. At present, there are many medicinal product grades that cannot effectively reflect the quality of medicinal materials. Therefore, some experts have proposed that the concept of biological titer grades makes the quality standards of medicinal materials directly concerned with clinical efficacy and provides a reference for clinical rational drug use.

With the development of modern science and technology, botanical medicine is more and more popular and concerned by governments of various countries. The United States Congress passed the "Plant Medicine Approval Law in the United States" in 1997 and began to allow natural compound blends of traditional medicines to enter the US market as medicines. The US botanical market is growing at a rate of 20% per year. At the same time, the botanical drug market in other developed countries is also expanding. The United Kingdom has increased by about 70% since 1987; France has increased by about 50%. These data indicate that botanical drugs are gradually being recognized and accepted worldwide and are setting off a wave of botanical drug development in the global pharmaceutical industry. >>> Life Science Instruments

Q: What benefits and challenges can the establishment of biological standards bring to the international declaration of Chinese medicine varieties?

At present, Diao Xinxuekang and Tasly's Danshen capsules have been approved by the European Union for the registration of traditional medicines in the European Union; nine compound Chinese medicine products have been applied for Investigational New Drug (IND) in the US Meeting, PIND) phase, in which Fufang Danshen Diwan has completed phase III clinical research, Lianhua Qingwen Capsule has started phase II clinical research, and Shenmin Jiangzhi Tablet of Hangzhou Minsheng Pharmaceutical Research Institute has also completed its biological standard. Research has been submitted to the CFDA for clinical approval.

At the same time, there are many challenges in the successful development of international research. As an innovative direction of the internationalization research of Chinese medicine, the biopotential analysis method used for the quality control of compound botanicals has received the attention of FDA, EMA and other institutions and written into the research and development guidelines, which encourages the sponsors to apply it widely in the research. Biovalency analysis is based on pharmacology, biostatistics as a tool, and the use of specific experimental designs, using organisms under certain conditions to compare the specific response produced by the test product to the corresponding standard or reference product (measureable, quantifiable Physiological indicators or biological characteristics), a quantitative method to determine the biological activity (pharmacological efficacy, vitality or virulence) of a drug.

Question: What are the misunderstandings in the biological evaluation of Chinese medicine quality?

The biological evaluation of the quality of traditional Chinese medicine is closely related to clinical efficacy and safety, but it does not replace or reduce chemical and conventional testing methods. In practice, the analytical properties of biological evaluation of traditional Chinese medicine are often ignored, which is not equivalent to the analysis of the pharmacological effects of traditional Chinese medicines. In addition, the characteristics of biological evaluation itself will be ignored, and the methodological quality of physical and chemical tests will require the biological evaluation methods of Chinese medicine. It is undeniable that the methodological quality evaluation indicators of biological evaluation standards such as specificity, accuracy, precision, linear range, Detection limits and durability are not as good as physical and chemical tests.

Processing......
Ranch