Analysis of some serious defects existing in the production enterprises of TCM decoction pieces
Since the implementation of the "Good Practice for the Quality Management of Pharmaceutical Production (Revised in 2010)" on March 1, 2011, the production quality responsible person and quality authorized person system have been improved. The enterprise has a stable quality management structure, including quality assurance, quality control and quality
Since the implementation of the "Good Practice for the Quality Management of Pharmaceutical Production (Revised in 2010)" on March 1, 2011, the production quality responsible person and quality authorized person system have been improved. The enterprise has a stable quality management structure, including quality assurance, quality control and quality control laboratory, but there are still fewer quality assurance and quality control personnel, and the quality of personnel has decreased with the poor efficiency in recent years.
In recent years, with the large fluctuation of the market price of Chinese herbal medicine, in order to save costs, in addition to the outflow of talents with good quality, new practitioners hired lower-quality personnel, such as those who had no knowledge of Chinese medicine or had not been engaged in Chinese medicine inspection, in the compliance production and management of Chinese herbal medicine pieces, There are some serious defects, and the problems existing in the production enterprises of traditional Chinese medicine decoction pieces in recent years are summarized and analyzed.
A, lack of knowledge of Chinese medicine
The author visited Heze, Bozhou, Anguo, Yulin, West Guangdong, Pearl River Delta more than a dozen traditional Chinese medicine decoction pieces production enterprises, found many counterfeit products in the goods, Examples include Trichosanthin (actually a counterfeit of Hubei Trichosanthes Kirilowii), Thunberg Fritillaria (actually a Hubei fritillaria), Horny medium (actually a variety of counterfeits), Xinjiang comfrey (actually an imported Afghan hardskin comfrey or Himalayan soft skin comfrey), licorice (actually a bitter licorice imported from East Asia), yellow essence (actually a bitter yellow essence), and Sichuan wood fragrance (actually a wood fragrance). In addition, some enterprises will blunt tooth clematis, blunt calyx clematis as Chuanmutong; Some also use the false bulbs of the mountain orchid and the tube orchid as the mountain mushroom; A Guangdong enterprise will be Longshu teng and Guo Gang dragon distinguish; There was once an enterprise that did not know to make the ocean flower, as a trumpet trumpet production, resulting in many poisoning; In addition, Hubei trichosanthes kirilowii instead of trichosanthin also poisoned patients.
There is also a part of the problem is that the decoction does not meet the requirements of pharmacopoeia, such as planting parsnips, red peony is not old enough, flowering cistanche and so on.
The reason for this situation is mainly that the production enterprises of traditional Chinese medicine pieces pay more attention to the cost and are not willing to invest in the quality of personnel, which leads to the quality of many enterprises. More importantly, enterprises only treat Chinese medicine as a business, a business that only knows how to make money, rather than doing drugs, and make money at the same time.
2. Outsourcing intermediate products for subcontracting
Article 7 of the Appendix of GMP Chinese Medicine Decoction Pieces: “ Chinese medicine decoction pieces should be produced in accordance with the variety process regulations. The production conditions of Chinese medicine prepared pieces shall be consistent with the scope of production license, and the intermediate products or finished products of Chinese medicine prepared pieces shall not be purchased for sub-packaging or packaging labels shall be changed. ”
Chinese medicine decoction pieces production enterprises, even some well-known relatively large Chinese medicine decoction pieces production enterprises, there are outsourcing Chinese medicine decoction pieces intermediate products for subcontracting, such as astragalus, licorice, of course, they also carry out risk assessment, in and out of strict quality inspection and assessment, if there is professionalism and risk awareness, the risk is still small.
However, some companies are bold to purchase semi-finished products for subcontracting, but do not know the risk is great, such as lobelia, there is a company is to buy semi-finished products after cutting, the results found that there are about 30% of the collapse bowl (a kind of Chinese medicine also known as snow grass), it is estimated that wild harvesting mixed; Buy a slice of Fritillaria thunberg, because you know in advance that there are counterfeit fritillaria Thunberg, pay special attention, carefully focus on a piece of inspection, only to find the counterfeit. This kind of harm is one of the reasons that lead to the unsafe and ineffective Chinese medicine.
The above serious defects, in addition to the lack of necessary knowledge for the identification of the characteristics of traditional Chinese medicine pieces, there is also the quality detection equipment of the enterprise is relatively primitive, such as biological imaging microscope, the resolution is not high, the imaging image is fuzzy, resulting in the identification of authenticity; Thin layer identification is the same, at present, it is basically manual sample running thin layer plates, because the level of experimentalists is limited, it is not expanded at all, and it is difficult to play the identification significance.
3, doping is serious, failed to process
in accordance with the relevant processing specifications
Here are some examples:
1, white art or white art tablets, mixed with a lot of bad drugs, such as dead seedlings and rotten roots of white art, these white art is very brown after incision, there is a smell, especially the bran fried white art will smell a very obvious smell.
2, Bupleurum, mixed with bupleurum stems, or black heart bupleurum (deteriorated).
3, cicada, covered with mud.
The reason why this is so, is also the enterprise to save cost than quality important inferior root, if clean or pick clean, the yield is low and the cost is high, in the vicious competition market, the survival of the enterprise is difficult. And the result is to prescribe 10 grams of medicine, in fact, only 5 grams is medicine, how effective Chinese medicine?
4. Environmental impact
In recent years, some enterprises are difficult to operate, resulting in QA personnel or technologists began to part-time more, QA part-time administration, calculation of wages, technologists into batch production records, etc., so that the quality of traditional Chinese medicine pieces has declined.
What is more, the overall environment of the enterprise is bad, the punishment of the state on the production of traditional Chinese medicine pieces is also appropriately humane, the intensity of the punishment is relatively low, and it is more incentive for some enterprises to take the edge of the sword, always think that the penalty is less than the profit, especially in remote places, this awareness is more serious.
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