echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > The quality management system of Chinese herbal pieces is in urgent need of construction

    The quality management system of Chinese herbal pieces is in urgent need of construction

    • Last Update: 2017-06-12
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    [market analysis of China Pharmaceutical network] Chinese herbal pieces are one of the characteristics of traditional Chinese medicine They are widely used in the production of preparations and proprietary Chinese medicine Quality and safety are closely related to the prescription or clinical effect of preparations Therefore, whether the quality of Chinese herbal pieces is qualified has always been highly concerned by the pharmaceutical industry However, in the current situation, the quality of Chinese herbal pieces is not optimistic (picture source: Baidu picture) for a long time, Chinese herbal medicine, Chinese herbal pieces and Chinese patent medicine constitute the three pillars of Chinese medicine industry As the essential material foundation for clinical application of traditional Chinese medicine, the quality of Chinese herbal pieces is directly related to the safety of drug use and industrial production, and also determines the healthy development of Chinese medicine in China With China's pharmaceutical industry entering a critical period of transformation in 2013, in recent years, the market capacity of Chinese Herbal Pieces industry has been increasing, and Chinese Herbal Pieces industry has entered a new period of rapid development But just as the industry is facing a good development, Chinese herbal pieces have also encountered severe challenges Recently, the 2016 annual drug inspection report issued by the State Food and Drug Administration confirmed the existing problems of Chinese herbal pieces Ding Jianhua, director of the Department of pharmaceutical and chemical supervision of the State Food and drug administration, revealed at the report conference that 172 GMP (drug production quality management standard) certificates were withdrawn in 2016 Among them, 81 pieces of traditional Chinese medicine were involved, accounting for 47.6% In fact, in order to rectify the market of Chinese herbal pieces, the State Food and drug administration has carried out special actions in 2013, exposed the problems of Chinese herbal medicine, interviewed the heads of the municipal governments where 17 Chinese herbal medicine professional markets are located, and signed the letter of responsibility for the management of Chinese herbal medicine professional market with them However, the unqualified Chinese herbal pieces still exist today It is one of the characteristics of traditional Chinese medicine that the pieces of traditional Chinese medicine are not qualified due to the omission of multiple processes They are widely used in the production of preparations and finished drugs Quality safety is closely related to the prescription or clinical effect of preparations Therefore, whether the pieces of traditional Chinese Medicine are qualified has always been highly concerned by the pharmaceutical industry For the long-term problems of Chinese herbal pieces and the problems disclosed in the 2016 annual drug inspection report, Shi lichen, head of Beijing Dingchen medical management consulting center, said in an interview with the reporter of China national economic news that the reasons for the disqualification of Chinese herbal pieces may come from many aspects First of all, in planting, today's medicinal materials mainly rely on large-scale artificial planting, compared with wild medicinal materials, the efficacy is naturally inferior The effect of "orange growing in Huainan, orange growing in Huaibei, orange growing in Huaibei" is deeply influenced by the planting area, which is closely related to the local natural climate and geographical environment, especially the soil composition; Secondly, on the issue of pesticide residues, some growers, in order to achieve high-yield, do not hesitate to sacrifice the efficacy of medicinal materials, over fertilization and pesticide application, which will not only reduce the efficacy, but also change the functionality of medicinal materials As the saying goes, "Artemisia capillaris in March, Artemisia annua in April, and firewood in May and June" Therefore, the harvesting season of medicinal materials will indirectly affect the efficacy of medicinal materials Because in the process of plant growth and development, roots, stems and leaves have different functions If they are not picked in time, the effect of medicinal materials will not be good In addition to the above reasons, Shi lichen believes that the processing process of traditional Chinese medicine plays a crucial role in whether the quality of Chinese herbal pieces is up to the standard The poor and irregular processing process will not only affect the quality of Chinese herbal pieces, but may even endanger the life of patients In addition, at present, there is no unified processing standard of Chinese Herbal Pieces in China, and each enterprise can only produce according to the local processing standard Therefore, there are different standards of Chinese herbal pieces, and the quality of Chinese herbal pieces cannot be unified Packaging and storage are the key to ensure the quality of Chinese Herbal Pieces in the process of transportation and circulation In the process of storage, due to the influence of temperature, humidity, time and other factors, the content of effective components in Chinese herbal pieces will be reduced or can not be used directly In addition, the weak technology and the shortage of talents are more prominent problems in the development of traditional Chinese medicine In our country, some people who are engaged in traditional Chinese medicine have no professional title, have not received professional training or study, especially in rural drug-related units In addition, the reporter learned that chemical pigment dyeing is also critical to the quality of Chinese herbal pieces In order to pursue profits and reduce losses, some illegal traders do not hesitate to sell inferior medicinal materials, rotten and deteriorated medicinal materials or extracted effective ingredient medicinal materials better through chemical dye and pigment dyeing; in order to increase the weight of medicinal materials, some medicinal material dealers even add non-medical ingredients to the pieces of Chinese Medicine to increase the weight of the pieces of Chinese medicine At present, with the improvement of people's living standards and health awareness, more and more people are willing to take conservative treatment Therefore, patients are more focused on traditional Chinese medicine treatment or health care, which puts forward higher requirements for the quality of traditional Chinese medicine "The quality problems of Chinese herbal pieces not only affect the therapeutic effect of clinicians, but also cause adverse consequences to patients and even lead to poisoning, which cannot be ignored." Lichen told reporters At present, it is urgent to standardize the quality of Chinese herbal pieces Some experts in the industry have proposed that we should establish a planting base of traditional Chinese medicine in line with the requirements of gap as soon as possible, actively carry out the planting, development and production of green herbal medicine, and timely apply fertilizer and medicine, all on the premise of ensuring the drug properties of herbal medicine; Secondly, we should establish a relatively unified quality standard of Chinese herbal pieces to make local enterprises close to the national standards and further improve the qualification rate of Chinese herbal pieces At the same time, we should not only establish the qualitative standard of effective ingredients, but also establish the quantitative standard of effective ingredients For the unqualified Chinese Herbal Pieces Market, we should not sell them; Moreover, it is necessary to further strengthen the training of employees to improve the quality of the whole line of employees For the lack of TCM professionals, the relevant departments should pay attention to it, and ensure that the practitioners have a smooth way to learn professional knowledge, so as to ensure that the practitioners can continuously improve their technical level, so as to lay a solid foundation for the quality of TCM However, in his opinion, what should be done to ensure the quality of Chinese herbal pieces is to call on relevant departments to strengthen the construction of quality management system of Chinese herbal pieces, strengthen the quality management of the selection, processing, warehousing and other links of Chinese herbal medicine, so as to achieve the basis, so as to further improve the quality and safety of Chinese herbal pieces In addition, in the process of strengthening the management of processing links, the processing and cutting of Chinese herbal medicines should be carried out in strict accordance with the standards At the same time, the corresponding departments should also test the processing of enterprise herbal medicines from time to time to ensure the safety of the quality of Chinese herbal medicines He believes that in the process of ensuring the quality and safety of Chinese herbal pieces, when necessary, a third-party organization can be established to test and prove the safety of Chinese herbal pieces by the third party, which can also reduce the work of relevant regulatory departments As long as the relevant departments negotiate with the third party, they will know the relevant situation of Chinese herbal pieces; In the aspect of personnel training, Shi lichen believes that we should train professionals who have a certain understanding of the characteristics of traditional Chinese medicine to ensure the quality of traditional Chinese medicine planting and production At the same time, cultivate technical personnel in the storage, use and storage of traditional Chinese medicine industry.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.