Introduction: Chinese patent medicine is a unique therapeutic drug in China, and also occupies a part of the drug market in China
In recent years, the national policy strongly supports the development of traditional Chinese medicine, and promotes the healthy development of traditional Chinese medicine industry
On October 25, 2018, the national health and Health Commission issued the catalogue of national essential drugs (2018 Edition)
The number of varieties of Chinese patent medicine (including ethnic medicine) increased from 203 to 268, and 67 varieties of Chinese patent medicine were transferred
This catalogue adjustment focuses on both Chinese and Western medicine, in addition, it also increases the scope of functional indications, covers more clinical symptoms of traditional Chinese medicine, and adds the section of "pediatric medication" in the Chinese patent medicine
However, although the development trend of Chinese patent medicine is good, the standardization of its production and use is gradually highlighted, especially the uneven quality, which needs to be paid more attention
Based on the national and provincial (city) drug quality nonconformity announcement, this report summarizes and analyzes the results of 2018 Chinese patent medicine sampling, aiming to summarize and analyze the problems of Chinese patent medicine quality through macro data for reference
Table of contents 1
2018 drug quality unqualified overview 2
Top 10 enterprises of Chinese patent medicine unqualified quality 3
Distribution of provinces and cities of Chinese patent medicine unqualified quality 4
Top 10 varieties of Chinese patent medicine unqualified quality 5
Top 10 dosage forms of Chinese patent medicine unqualified quality 6
Top 5 inspection items of Chinese patent medicine unqualified quality 7
Inspection basis 8
Summary of sample sources 1
2018 drug quality unqualified overview In the unqualified data of drug quality sampling in 2018, the proportion of various drugs is shown in the figure below
Among the 3268 batches of substandard drugs (excluding 553 batches of counterfeit products), there are 613 batches of Chinese patent medicines, accounting for 18.76%
Compared with 2017, the total number of substandard batches of Chinese patent medicines decreased by 304 batches, accounting for 14.72%
However, when the traditional Chinese medicine, auxiliary materials and drug packaging materials are excluded and only the pharmaceutical preparations are taken into account, the proportion of unqualified batches of traditional Chinese medicine compared with chemical drugs and others is most, accounting for 70.22%
Compared with 2017, the proportion of unqualified batches of traditional Chinese medicine in pharmaceutical preparations has increased from 64.94% to 70.22%
It can be seen that the problem of Chinese patent medicine still needs attention
2
Top 10 enterprises with unqualified quality of Chinese patent medicine In 2018, among the top 10 Chinese patent medicine quality unqualified enterprises, Changchun yinnock Pharmaceutical Co., Ltd
ranked first, with 14 batches in total, of which Zhike ningsou capsule (4 batches unqualified) was the main one, and the other 10 varieties of Chinese patent medicine, such as Kangerxin capsule, dabudu capsule, duanxuexue capsule, Feining capsule, Fufang Danshen tablet, were the rest; Jiangxi Hengkang Pharmaceutical Co., Ltd
was the second, with 13 batches of Chinese patent medicine All of them were Keteling capsules
In addition, compared with the top 10 enterprises in 2017, three enterprises, Changchun yinnock Pharmaceutical Co., Ltd., Hubei nordsong Pharmaceutical Co., Ltd
and Tonghua Zhenlin Pharmaceutical Co., Ltd., have been on the list for two consecutive years, which need to be focused on
In addition, there are many enterprises on the list, which indicates that the quality problems of Chinese patent medicine are more common
Note: due to the juxtaposition, the total number of the above ranking is more than 10.3
Distribution of provinces and cities with substandard quality of Chinese patent medicines in 2018
The announcement of substandard Chinese patent medicines came from the State Drug Administration and 25 provinces and cities
No such announcement was issued in Beijing, Liaoning, Qinghai, Tibet, Shaanxi and Chongqing
According to statistics, Guangdong released the most unqualified Chinese patent medicines, 188 batches, accounting for 30.5%
It is worth noting that in 2017, Guangdong Province was also the region with the largest number of substandard Chinese patent medicines, with a total of 412 batches, accounting for 44.6%
This year, the number and proportion of substandard batches decreased
Hubei took the second place, 112 batches, accounting for 18.2%; Hubei ranked third in 2017, accounting for 7.5%; other provinces and cities were relatively few, less than 100 batches
The specific situation is shown in the following figure: 4
Top 10 unqualified varieties of Chinese patent medicine Among the top 10 non-conforming varieties of Chinese patent medicine, there are 5 varieties in the 2017 national medical insurance catalog (Xinkening capsule, Kaixiong SHUNQI pill, kanggusheng tablet, Niuhuang Jiedu tablet, xueshuanxianmailing capsule)
Among the other 5 varieties, except zhilianing tablet, 4 of them are included in some local medical insurance
Medical insurance drugs are relatively the most popular drugs among the public, which need to be paid attention to
Among the top 10 non-conforming varieties of Chinese patent medicine, Keteling capsule ranks first
There are 20 batches of non-conforming products, including 13 batches from Jiangxi Hengkang Pharmaceutical Co., Ltd., 9 batches from Hubei, 3 batches from Zhejiang, 2 batches from Fujian, Anhui and Guangdong, and 1 batch from Jiangxi and Heilongjiang
Keteling capsule is used for cough and asthma and chronic bronchitis cough
In 2017, it was included in the local supplementary medical insurance by Hubei Province, Ningxia Hui Autonomous Region, Tibet Autonomous Region, Liaoning Province, Hunan Province and Gansu Province
The second place was "Yunzhi Gantai granules", 11 batches, of which 9 batches were from Jiangxi Jiulianshan Pharmaceutical Co., Ltd., 2 batches were from Jilin Tonghua Boxiang Pharmaceutical Co., Ltd., 10 batches from the State Drug Administration and 1 batch from Hubei Province
Yunzhi Gantai granule, as an immunomodulator, is mainly used for the treatment of chronic active hepatitis
In 2017, it was included in the local supplementary medical insurance by Qinghai Province, Heilongjiang Province, Ningxia Hui Autonomous Region and Tibet Autonomous Region
The drug category is tumor drug > tumor adjuvant drug (ZC > zc02)
In the third place is "Xinkening capsule", 9 batches; Harbin Tiandi Pharmaceutical Co., Ltd., Jilin Jiji Pharmaceutical Co., Ltd
and Shaanxi Panlong Pharmaceutical Group Co., Ltd
each have 2 batches of disqualification, Shaanxi Dongtai Pharmaceutical Co., Ltd., Jilin Tonghua Boxiang Pharmaceutical Co., Ltd
and Diaoyutai Pharmaceutical Group Jilin tianqiang Pharmaceutical Co., Ltd
have 1 batch of disqualification
All non conformity notifications are from the State Drug Administration
Xinkoning capsule is used for coronary heart disease, angina pectoris, chest distress, palpitation and vertigo
It is the 2017 version of national medical insurance class B drug
See the following figure for details: 5
Top 10 unqualified dosage forms of Chinese patent medicines refer to many dosage forms, mainly including tablet, capsule, granule, pill, injection, oral liquid, plaster, solution, powder and syrup
It can be seen from the above that the main unqualified dosage forms are mainly taken internally, while the external dosage forms are less, such as 8 batches of plaster
According to statistics, tablets and capsules account for a large proportion, 233 batches of tablets and 182 batches of capsules, and the two dosage forms account for about 65.22% of the total unqualified Chinese patent medicines
This may be related to the mature technology of tablets and capsules and the large market share of Chinese patent medicines, so the probability of being used as sampling samples is also large
6
The top 5 items of unqualified test of Chinese patent medicine are mainly the difference of loading capacity and properties
In addition, there are many batches of unqualified content determination items, up to 61 batches
Content determination is the quantity of effective ingredients specified in national standards, which is the main index to determine whether the drugs meet the requirements of the standards
The unqualified content will directly affect the quality and efficacy of the drugs
7
The inspection basis is mainly based on the Chinese Pharmacopoeia, including the national drug single page standard, the preparation standard of local medical institutions, the standard issued by the Ministry of health, the new drug standardization standard, the supplementary inspection method for drug inspection and the approval document for inspection items, etc
8
Most of the samples were from pharmaceutical companies, pharmacies, health societies and hospitals
Among them, Chinese patent medicine accounts for a large proportion in the preparations of medical institutions developed by the hospital
Therefore, compared with the sources of chemical drugs sampling, the proportion of hospital sources has increased significantly
Summary quality announcement is not only the supervision and supervision of drug development and production enterprises
For consumers, it also plays a guiding role
Through the announcement of drug quality information, the public can understand the quality of drugs, have judgment in selection and use, and enhance self-protection awareness, so as to protect the health rights and interests of the public
According to the statistical results of the unqualified quality data of Chinese patent medicine, although the total batch of unqualified drugs is decreasing, the proportion of unqualified drugs in pharmaceutical preparations is increasing instead of decreasing, which shows that the unqualified phenomenon of Chinese patent medicine is relatively poor compared with the chemical medicine, and more efforts are still needed
In addition, it is worth mentioning that enterprises repeatedly listed need to be highly concerned and supervised
Moreover, the traditional Chinese medicine in the national and local medical insurance should also be paid attention to, and the quality should be guaranteed
Disclaimer: the statistics are only from the official website of drug administration of all provinces and cities
In this report, counterfeit drugs and duplicate data marked by FDA have been eliminated, but there may still be counterfeit drugs not 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
Data source: State Drug Administration official website, provincial (city) drug administration official website, drug intelligence data statement: this view only represents the author, does not represent the position of drug intelligence website, welcome to exchange and supplement in the message area; the copyright belongs to drug intelligence website, not reprinted, and the infringement must be investigated!
