[Explanation] Chinese patent medicines have always been closely related to the clinical use of Chinese medicine. However, due to the complexity of the ingredients and the relative limitations of quality standards, individual Chinese patent medicines have quality problems. Therefore, the importance of drug inspectors is self-evident.
In late April, the reporter came to the Chinese Patent Medicine Inspection Laboratory of Gansu Provincial Institute of Drug Control and met Yao Shixia, the deputy director of the Laboratory.
She told reporters that compared with chemical drug inspection, the pre-treatment process of Chinese patent medicine extraction is complicated, with many influencing factors, and inspection is more time-consuming.
[Concurrent] Yao Shixia, Deputy Director of the Research Office of Chinese Patent Medicines, Gansu Institute of Drug Control
Just like our common astragalus medicinal material, according to the current pharmacopoeia inspection, it starts with sample preparation, and basically it takes two or three days to prepare the sample before it can be tested on the machine.
[Explanation] When a proprietary Chinese medicine is held in our hands, it may seem ordinary or even inconspicuous, but in fact, these pills condense many aspects of process design, quality, and safety control.
Yao Shixia, who has been engaged in inspections for more than 10 years, said that proprietary Chinese medicines focus on the inspection of index components that affect the quality of medicines.
[Concurrent] Yao Shixia, Deputy Director of the Research Office of Chinese Patent Medicines, Gansu Institute of Drug Control
For example, licorice, we have identified hundreds of compounds.
(Some ingredients) may have nothing to do with curative effect, so at present, index ingredients related to curative effect or quality stability are selected as its quality control indicators.
[Explanation] Inspector Liu Dongsheng in a white coat is operating the machine and doing liquid chromatography related tests.
In his opinion, with the aid of a machine, an "electrocardiogram" of the indicator components can be "drawn", and the quality of the medicines can be seen at a glance.
[Concurrent] Liu Dongsheng, Inspector of the Chinese Patent Medicine Inspection Laboratory, Gansu Institute of Drug Control
(Previously) In liquid chromatography, manual injection is usually done. After this is done, wait a long time before injecting and repeating the injection. It takes a lot of time to do this.
Now, equipped with an autosampler, the sample injection is more accurate, the time is more controllable, hands are liberated, and the data is more accurate.
[Explanation] Zhu Xujiang, director of the research office, said that the purpose of testing is to urge companies to produce qualified and even better quality drugs to ensure the safety of people's medication.
[Concurrent] Zhu Xujiang, Director of the Research Office of Chinese Patent Medicines, Gansu Institute of Drug Control
We undertake more tasks issued by the Pharmacopoeia Commission.
As in previous years, we have undertaken dozens of types as a whole. Its purpose is mainly to reserve for the upgrade of the Pharmacopoeia. After the (standard) is improved, the quality of medicines can be more comprehensively controlled. (There are also problems with enterprises and products, such as We have also undertaken the technical problems, quality standards, and the set up issues, in order to solve the problems of the enterprise, improve the quality of our products, and be able to get out of Gansu.
Ai Qinglong, Shi Jingjing, Yang Yanmin reports from Lanzhou, Gansu
Editor in charge: [Lu Yan]