[exposure table] 2017 annual analysis report on unqualified drug quality data

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According to the announcement database of drug quality nonconformity and relevant information on the official website of each provincial food and drug administration, the author sorts out and analyzes the data of drug quality nonconformity in 2017, and forms the annual analysis report of drug quality nonconformity data in 2017 Please refer to it and read it If there are any omissions or deficiencies, please leave a message directly on the website Contents: 1 Introduction to unqualified drugs 2 Top 20 of unqualified drugs 3 Top 20 of unqualified drugs 4 Top 10 of unqualified drugs 5 Distribution of unqualified drugs in provinces 6 Analysis of counterfeit drugs 7 Summary 1 Introduction to unqualified drugs In order to ensure the safety of drug use by the public, the drug regulatory authorities and inspection agencies of each province (city) have carried out quality sampling inspection on drug production, operation and use units of the whole province (city) in accordance with laws and regulations and drug sampling inspection plan, and published the result report The author of Yaozhi summarized and analyzed the notice of unqualified drug quality sampling in all provinces (cities) in 2017, and formed the annual analysis report of unqualified drug quality data in 2017 for reference The unqualified drugs involved in this report are divided into seven types: Chinese herbal medicine (medicinal materials and their pieces), Chinese patent medicine, chemical medicine, biological medicine, drug packaging materials, auxiliary materials and other seven types, a total of 4106 batches, excluding 654 batches of counterfeit products Unqualified drugs are mainly concentrated in traditional Chinese medicine, Chinese patent medicine and chemical medicine Among them, 2618 batches of medicinal materials were unqualified, accounting for 64%; 917 batches of Chinese patent medicines were unqualified, accounting for 22%; 493 batches of chemical drugs were unqualified, accounting for 12% The proportion of unqualified drugs is the highest in the sampling 2 Top 20 enterprises with unqualified drug quality 2.1 According to the statistics of batch quantity of unqualified drugs based on the enterprise, 9 enterprises with Chinese Herbal Pieces accounted for 45% of the top 20 enterprises with unqualified drug quality, especially 6 enterprises with Chinese Herbal Pieces in the top 10 of the list The details are shown in the figure below Because it is calculated by batch, there will be different batches of the same variety of non-conforming products For example, among the 41 batches of non-conforming products announced by Sichuan Sanxingdui Pharmaceutical Co., Ltd., "Yankening tablet" has 28 batches 2.2 According to the statistics of the number of unqualified drug varieties based on the enterprise, there are 16 Chinese Herbal Pieces enterprises in the top 20 enterprises with unqualified drug quality, accounting for 80% Among them, Zhangshu Qingren Herbal Pieces Co., Ltd ranked first, up 18 places compared with 2016 The details are shown in the following figure: 2.3 There are some differences between the charts obtained by batch and by variety analysis, because the same variety of drugs may have n batches of products But generally speaking, most of the top 20 Chinese herbal medicine enterprises exist in two charts at the same time, and occupy a large proportion in the ranking Compared with the ranking table in 2016, the number of traditional Chinese medicine enterprises increased significantly, and ranked first It can be seen that the quality of traditional Chinese medicine is a major problem in the current national drug quality management and monitoring 3 According to statistics, the number of safflower is the largest among the top 20 unqualified drug varieties, 113 (calculated by unqualified batches, the same below); alum ranks the second, 86; Dilong 85, the third In 2017, the new herbal medicines were alum, woodlouse worm, Amomum villosum, ginseng, Pueraria lobata, oenopsis, Radix Codonopsis, borneol, Rhizoma Bletillae, chrysanthemum, Ge Gen, cortex Amari and vinegar myrrh See the figure below for details: Among the top 20 unqualified varieties of Chinese patent medicine, there are 19 "duzhongping tablets" (calculated by unqualified batches, the same below), ranking the second, mainly from Tonghua Zhenlin Pharmaceutical Co., Ltd.; 18 "chenxianglu Bailu tablets", ranking the third, mainly from Guangxi hengtuojituanrensheng Pharmaceutical Co., Ltd.; the most unqualified "Yankening tablets", 37 in total, ranking the third 1、 Among them, Sichuan Sanxingdui Pharmaceutical Co., Ltd accounts for 28 All of the above three enterprises are ranked in the top 20 (by batch) of drug quality unqualified enterprises See the figure below for details: in view of the relatively small total number of chemical unqualified drugs, only the top 10 drugs are listed, with 170 batches of unqualified drugs, accounting for about 34% of the total number of chemical unqualified drugs "Chloramphenicol eye drops" topped the list, with 41 batches in total, and Guangdong Hongying Technology Co., Ltd accounted for 23 batches See the figure below for details: Note: the total number of the above rankings may exceed 10 or 20 due to the juxtaposition 4 The top 10 drug quality inspection items of the unqualified drug quality inspection items mainly include property, identification, inspection, extract, characteristic or fingerprint, content determination and processing determination Among them, the most prominent problems are the properties and inspection items, with 1625 batches (accounting for about 35%); the inspection items specifically include water, ash, related substances, visible foreign matters, relative density, sulfur dioxide / solvent residues, heavy metals, disintegration time limit, loading difference, etc., with 1749 batches (accounting for about 38%) not meeting the requirements Statistics of the identified unqualified items are as follows: Note: (1) properties: record the appearance, texture, section, odor, taste, solubility and physical constants of the drug (2) Content determination: it refers to the quantity of effective ingredients specified in national standards contained in drugs Content determination is the main index to determine whether a drug meets the requirements of the standard If the content does not meet the requirements, the quality and efficacy of the drug will be directly affected (3) Ash: inorganic matter, residue after calcination (4) Identification: including experience identification, microscopic identification and physical and chemical identification The cross section, surface and powder identification in microscopic identification refer to the characteristics observed under the microscope after certain preparation Physical and chemical identification includes physical, chemical, spectral and chromatographic methods (5) Related substances refer to impurities introduced in the production and storage of specific drugs (6) Water content: refers to the water content of drugs The moisture inspection is mainly to check whether the moisture content in the drug conforms to the standard If the water content does not meet the requirements, the quality and efficacy of the drug may be affected (7) Sulfur dioxide residue: sulfur fumigation is a traditional method of crude processing of traditional Chinese medicinal materials used by pharmaceutical farmers in China After sulfur fumigation, volatile sulfur dioxide remains in Chinese medicinal materials and decoction pieces, and excessive residue of sulfur-containing substances will damage health (8) Filling quantity difference: it is one of the uniformity testing indexes of pharmaceutical preparations, which is common in capsule, powder injection and other dosage forms It mainly checks whether the weight uniformity of several minimum unit drugs is within the error range specified in the standard The difference of loading capacity is one of the means to determine whether the drugs meet the standard (9) Heavy metal: metal impurity that can react with thioacetamide or sodium sulfide to develop color under experimental conditions, represented by lead (10) Extract: water, ethanol or other suitable solvents, targeted to determine the soluble substances in medicinal materials and preparations 5 Province distribution of unqualified drugs according to the further research of the author of Yaozhi, unqualified drugs (including drugs and medicinal materials, the same below) are found in all provinces of the country, including Guangdong, Inner Mongolia, Fujian and Jiangsu provinces, where the number of unqualified drugs is more than 200 batches In addition, 821 batches of drugs (including medicinal materials) were found unqualified by the general administration The quantity distribution of substandard drugs in each province is as follows: 6 Compared with the spot check in 2016 (1300 batches of counterfeit drugs), the production of counterfeit drugs has improved significantly, but it still exists Among them, Bozhou Haomen traditional Chinese medicine Yinpian Co., Ltd., Anhui jinfurong traditional Chinese medicine Yinpian Co., Ltd., Anhui Mengshi traditional Chinese medicine Yinpian Factory Co., Ltd., Anhui Jishun traditional Chinese medicine Yinpian Co., Ltd and other enterprises have been counterfeited by lawbreakers (see the figure below for details) Counterfeiting seriously affects the reputation of enterprises, so the relevant departments of the state should increase efforts to crack down on counterfeit drugs and purify the pharmaceutical market 7 By summarizing the statistical data, we found that the quality problems of traditional Chinese medicine are very prominent Among them, the number of unqualified Chinese herbal medicines accounted for 64% of the total, and the proportion of Chinese Herbal Pieces enterprises also increased significantly compared with 2016 On the one hand, it shows that the state has strengthened the supervision of the quality of medicinal materials On the other hand, the basic reasons for the results are that the quality problems of Chinese herbal medicines are not well understood, the control is not strict, the phenomenon of selling fake and inferior Chinese herbal medicines (pieces of Chinese herbal medicines) in violation of laws and regulations and the imperfection of drug standards It can be seen that the quality and safety problems of traditional Chinese medicine need to be solved Drug quality is directly related to people's health and life safety, and it is a livelihood issue that the state attaches great importance to As a potential economic resource, original technological resource, excellent cultural resource and important ecological resource, the improvement of the quality of traditional Chinese medicine is necessary, necessary and has a way to follow As long as we strive to improve and perfect, I believe that the quality of drugs will be greatly improved The unqualified data report of drug quality has been collected manually and processed by a large number of procedures for one year Due to the different data structure and scattered data of the issued documents in each province, the relevant software is specially used for statistical analysis to avoid human errors and erroneous conclusions This analysis report is hard to come by We love and cherish it You are welcome to pay attention to the intelligence data, the most comprehensive and professional medical database in China, and provide relevant suggestions Disclaimer: the statistics are only from the official website of food and Drug Administration of each province The small edition of Yaozhi has eliminated the counterfeit drugs and duplicate data marked by the food and drug administration, but there may still be counterfeit drugs that have not been found by relevant departments Due to the continuous update of official website data, there will be slight deviation in the statistical results for reference only Appendix: tips on drug safety consumption (1) The food and Drug Administration reminds consumers to purchase drugs in legal and regular medical institutions and pharmacies and ask for relevant documents for preservation; when purchasing drugs, they should pay attention to check whether the relevant marks of the outer packaging, such as the production date, validity period, manufacturer, approval number, are complete and within the validity period; when necessary, they can log in the relevant website to check the drug registration phase Relevant information: after purchasing the drugs, keep the drugs according to the storage conditions indicated in the instructions, and take the drugs according to the doctor's orders or usage, paying special attention to the adverse reactions, taboos, precautions and other contents in the instructions (2) Drug information inquiry way  CFDA website  drug intelligence data related website statement: the 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