Affecting more than a thousand production enterprises 260 billion Chinese medicine tablets market is facing quality pressure.

With the implementation of the new edition of the Pharmacopoeia and the special rectification of Chinese medicine tablets around the country, Chinese medicine tablets production enterprises will face great pressure to improve the quality of Chinese medicine tabletsrecently, Shandong, Gansu, Hubei and other places issued a series of drug quality announcementsOn July 9,, Gansu Provincial Drug Administration announced a notice of drug sampling, announced that 10 batches of drugs produced by 7 enterprises did not meet the requirements, all of which were Chinese herbal medicines (drink tablets)July 8, Shandong Province Drug Administration issued the 4th issue of 2020 drug quality sampling notice, a total of 15 production enterprises (preparation units) of 14 varieties of a total of 16 batches of drug sampling does not meet the standard requirements, including 10 kinds of Chinese medicine drink tabletsOn July 6,, the Hubei Provincial Drug Administration issued the 2nd issue of the drug quality announcement for 2020in this drug quality sampling, found that 65 batches did not meet the standard requirements, including 61 kinds of Chinese herbal medicine (drink tablets)01 Drugs unqualified disaster areas from these drug quality sampling reports are not difficult to see, Chinese herbal medicine (drinking tablets) do not meet the standard requirements of the majority of the situationfor a long time, Chinese herbal medicine (drinking tablets) are the domestic drug unqualified disaster areapublic data show that in 2019 in all provinces of the country, the quality of Chinese herbal medicine (drinking tablets) sampling, 5865 batches of Chinese herbal medicine (drinking tablets) in 1858 batches of non-conformity, accounting for 31.68 percentand in recent years, the national policy level has also been strengthening the regulation and supervision of Chinese medicine tabletspublished in 2013 "Notice on strict Chinese medicine drink tablets and the pilot research and management of Chinese medicine formula particles" and in 2015 issued "Notice on further strengthening the supervision of the production and operation of Chinese medicine tablets", and in 2018 published the "Programme of Work on the Centralization of the Quality of Chinese Medicine Tablets", and a one-year nationwide focus on the quality of Chinese medicine tabletswith the implementation of the new version of the Drug Administration Law, the efforts of the chinese medicine tablets are also increasingFebruary this year, the State Drug Administration issued the "Special Work Programme on The Special Treatment of Chinese Medicine Tablets", which put forward the overall objectives and requirements for the implementation of the special rectification work of Chinese medicine tablets nationwide;According to the incomplete statistics of E drug managers, Jiangsu, Hunan, Hubei, Jiangxi, Anhui, Fujian and so on have been in jiangsu, Hunan, Hubei, Jiangxi, Anhui, Fujian and so on for the implementation of the new version of the Drug Administration Law, the introduction of the corresponding Special Treatment work programme for Chinese medicine tablets, taking Fujian as an example, the province on July 6 issued the "Notice on the issuance of Chinese medicine drink tablets special rectification work programme", to carry out a year and a half of Chinese medicine drink tablets special rectification actionthe province proposed to focus on the inspection of Chinese medicine drink tablets illegal channels to buy Chinese medicine tablets, the use of unqualified Chinese medicine, Chinese medicine tablets, the implementation of GMP requirements, the implementation of the relevant obligations of the listing permit holdersfor Chinese medicine tablet slicing enterprises, in the last 3 years to withdraw the GSP certificate or illegal filing of drug business enterprises;and with the State Drug Administration, the State Health and Health Commission issued the 2020 edition of the "Pharmacopoeia of the People's Republic of China" (hereinafter referred to as the "Pharmacopoeia"), "Pharmacopoeia" for Chinese medicine farmers and other issues made more clear requirements, such as methamidophos and other 33 banned pesticides may not be detected (not over quantitative limits) written into the general rules of medicinal herbs and drinking tabletsindustry insiders said that the implementation of the new version of the Pharmacopoeia, with the national Special Treatment of Chinese Medicine tablets to carry out, for Chinese medicine tablets production enterprises, will usher in more clear and strict requirements02 Quality unqualified mainly exists these 9 major problems Although the quality of Chinese medicine tablets frequently, but the Chinese medicine drink tablets industry still maintains a high-speed growth trend, the National Bureau of Statistics data show that in 2018 China's Chinese medicine tablet processing market reached 263.7 billion yuan, Chinese medicine tablets processing enterprises more than 1000but can not avoid the problem is that most production enterprises are small in size, production varieties, there are no shortage of enterprises to carry out workshop-style production, the production process is relatively simpleindustry insiders said that although Chinese medicine tablet production enterprises should obtain GMP (drug production quality management practices) certificate, but many enterprises in order to obtain the certificate, in order to reduce costs, still in accordance with the original production process, in the actual production to abandon the GMP standardfor Chinese medicine tablets sampling quality is not qualified in the common several major problems, a few days ago, Shandong Provincial Drug Administration gave nine non-compliant tips1Traits: recorded appearance, odor, taste, solubility and physical constants, non-compliance may involve the deviation of the medicinal species, defects in the preparation process, improper storage, etc2Loading: indicators that reflect the weight or capacity of the drug, non-compliance will lead to insufficient dose of clinical administration3Total ash determination: test the purity of Chinese medicine4Content determination: Related to the efficacy of the drug, the content of the active ingredients in raw materials and preparations is determined by prescribed test methods 5 Dissolved degree: affecting the absorption and biological utilization of drugs, the degree of dissolution is not in accordance with the regulations caused by a variety of factors, such as improper control of the production process 6 Identification: used to identify and study the authenticity, safety and efficacy of drugs according to the characteristics of different drugs include empirical identification, micro-identification and physical and chemical identification, physical and chemical identification includes physical, chemical, spectral, chromatography and other identification methods Aflatoxin Test: Control of toxin content in Chinese herbs and beverage tablets Chinese medicine in the storage, preparation, transport process, if not properly preserved, may be affected by moisture mold and pollution of aflatoxin 8 Visible foreign bodies: in injections, eye preparations, insoluble substances that can be observed under specified visual conditions, the particle size or length is usually greater than 50 microns 9 Time limit for the dissolution: the limit of time required for a solid preparation to be completely dissolved or crushed and screened by the prescribed means in the prescribed medium .