Traditional Chinese medicine decoction pieces are frequently found to be unqualified. How should pharmaceutical companies ensure quality and safety?

Recently, the Yunnan Provincial Food and Drug Administration issued the third phase of the 2021 drug quality announcement
.
The announcement showed that 21 batches of drugs from 13 drug manufacturers were found to be unqualified
.
Frequently found unqualified pieces of Chinese herbal medicines in random inspections (picture source: Pharmaceutical Network) Specifically, there are 3 unqualified proprietary Chinese medicines, namely Dragon Blood Capsules, Banlangen Granules, and Ganoderma Tonic Pills
.
In addition, there are 18 batches of Chinese medicine decoction pieces, including Atractylodes, Acanthopanax, Baiji, Poria, Epimedium, Vinegar Tortoiseshell, Dandelion, Licorice (Licorice Tablets), Dilong, Vinegar Myrrh, Hawthorn Powder, Black snake and so on
.
From the point of view of unqualified items, they are mainly [Properties], [Inspection], [Assay] and so on
.
In addition to the above-mentioned Chinese herbal medicine pieces, there are actually many places that have also released a large number of Chinese herbal medicine pieces that have failed to pass the random inspection
.
According to the 2020 Annual Report on Statistics of Drug Supervision and Administration released by the State Food and Drug Administration in April this year, the total unqualified rate of national drug sampling inspections in 2020 is 0.
57%.
Among them, the unqualified rate of Chinese medicine decoction pieces is the highest, reaching 1.
97%, which is obviously high.
For Chinese patent medicines and chemicals
.
In this regard, the industry believes that the quality and safety of TCM decoction pieces has been very prominent
.
It is understood that the lack of standardization and uniformity in the quality standards of Chinese herbal medicines in the past led to frequent chaos of Chinese herbal medicines, and it became a "severe disaster area" for random inspections of unqualified medicines
.
Therefore, in response to the above situation, in order to further do a good job in the filing of the specifications for the processing of Chinese herbal medicines, the state has issued a series of documents and regulations in recent years to regulate the high-quality development of the industry
.
Among them, the State Food and Drug Administration clearly stated in the notice on the filing procedures and requirements of the provincial-level Chinese herbal medicine processing specifications that there are situations in which the provincial-level Chinese herbal medicine processing specifications do not meet the current laws, regulations and related technical requirements.
Once discovered, the State Drug Administration will order the relevant provincial drug regulatory authority to cancel or correct it
.
At present, under the impetus of the national policy, all localities are also beginning to improve the quality control system of local Chinese herbal medicine pieces, and revise relevant Chinese herbal medicine pieces processing norms. .
Relevant manufacturing companies are constantly helping the Chinese herbal medicine industry to develop in a high-quality direction by continuously improving the supervision of production quality and improving the independent inspection and testing capabilities of Chinese herbal medicines
.
It is reported that in order to improve the ability of independent pesticide residue inspection and inspection efficiency and accuracy, some Chinese herbal medicine enterprises have established a Chinese medicine joint laboratory through the united instrument technology giant, and have carried out methodological explorations on more than 100 commonly used plant Chinese medicines.
A set of detection methods and procedures have been formed, and through optimization of the methods, a detection method for pesticide residues in traditional Chinese medicines from simple substrates to high pigment content has also been established
.
From the above point of view, the industry analysis believes that all pharmaceutical companies need to further strengthen self-discipline, and strictly follow the requirements of the new version of the pharmacopoeia to do a good job in the inspection of each link of planting, production, processing, and circulation, and promote the overall quality of the Chinese medicine decoction industry.
Promote
.
In addition, it should be noted that whether the pharmaceutical technology is advanced or not will directly affect the quality and output of the medicine
.
Therefore, relevant companies also need to accelerate the standardization of pharmaceutical production to further ensure the safety of production links and ensure the quality of pharmaceuticals
.
It is worth mentioning that if Chinese herbal medicine enterprises want to promote the standardization of pharmaceutical production, they cannot do without the help of pharmaceutical equipment
.
You should know that Chinese herbal medicine is a Chinese herbal medicine product processed through a certain process
.
Therefore, in the context of the domestic vigorously boosting the development of the traditional Chinese medicine decoction pieces industry in a high-quality direction, relevant pharmaceutical equipment companies will also usher in huge development opportunities
.
However, in this context, the industry has also pointed out that if Chinese medicine pharmaceutical equipment companies want to seize the opportunity, they must pay attention to and strengthen the modernization research of related pharmaceutical equipment, and design and develop various types and specifications according to the technical requirements of processing technology.
Processing machinery, especially machinery and automation complete sets of equipment that can provide a quantitative basis for the specifications of the processing technology of decoction pieces
.
According to the author's understanding, in fact, many enterprises have developed various kinds of decoction pieces machinery for different purposes, which are playing an increasingly important role in improving the production efficiency of traditional Chinese medicine decoction pieces and improving the quality of medicines
.
For example, a company said that the automatic frying machine developed and produced by it adopts electromagnetic heating technology and intelligent temperature compensation technology, and realizes that the microcomputer programming device can control the temperature in sections according to the process requirements of frying raw materials. .
In addition, the user-friendly computer system can also compile the processing technology, temperature, stirring speed and other process requirements of the drug into the computer system according to the processing requirements of different varieties, and then process the medicinal materials according to the requirements to realize the entire pharmaceutical industry.
The process is standardized and automated
.
In general, if we want to promote the development of Chinese medicine decoction pieces, we need to be equipped first
.
At present, many related equipment in China still have problems such as high energy consumption, high pollution, and low efficiency, which severely restrict the sustainable development of the Chinese medicine industry, as well as quality and safety
.
Therefore, pharmaceutical equipment companies also need to continue to carry out technological innovation, while promoting the high-quality development of traditional Chinese medicine decoction pieces, continuously improve their own competitiveness
.