On July 6, 2017, in the first six months of 2017, more than 350 batches of Chinese herbal medicines failed to qualify!
Around in the first half of this year, regardless of the food and drug administration for Chinese medicine yinpian inspection notice, only national administration reported a total of nine times, more than 350 batches Chinese medicine yinpian, involved in the large number and check the bulletin strength are rare.
Among the companies that are notified, there are also a number of pharmaceutical companies and well-known pharmaceutical companies, such as tongrentang and kangmei pharmaceutical.
And nothing more than most of the major problems are involved: the content of Chinese medicinal materials or processed products purchased detection problem is outstanding, dyeing, weight problems, batch production record authenticity in doubt.
(1) the batch production records are not true;
(2) suspected foreign purchase and beverage products for distribution and sale;
(3) data reliability problem, the component index is not qualified.
▍ Chinese medicine yinpian HeiBang reason full disclosure frequency
Alas, why?
The problem is much more rapid development
In recent years, as countries increase "medicine proportion", "two votes", scope of implementation, drug bidding basic only at a low price for trends, such as Chinese medicine yinpian due from all sorts of policy control, more and more drug firms in Chinese medicine yinpian, industry as a whole situation is really good and bad are intermingled.
As a result, the growth rate in recent years is one of the highest in the pharmaceutical industry.
According to the ministry data, Chinese medicine yinpian except in 2016, slightly below the medical instruments and equipment manufacturing sector, the main business income in 2015-2016, the pharmaceutical industry growth were the highest in the architectural industry.
The state attaches importance to it and the verification is strengthened
In recent years, the state has strengthened the support of traditional Chinese medicine, and the supervision has been strengthened. Chinese medicine yinpian in traditional Chinese medicine (TCM) industry middle link, which forms a connecting link between the preceding and once the quality problem not only affects directly taking the effects of the slices, the drug effect of downstream of the proprietary Chinese medicine industry.
Since 2016, the quality verification announcement of traditional Chinese medicine has been the focus of food and drug administration at all levels.
Once checked, it is difficult to find qualified products, including well-known traditional Chinese medicines such as tongrentang, which has always been reputable.
According to the analysis of the disqualified project, it is not only the dyeing weight gain, but also the fake medicine. And more of a variety of a certain component index is unqualified, unexpectedly still have the character (film type) not qualified.
At present, the supervision mode of Chinese traditional medicine industry is rapidly changing; Start extensive verification, just as "the word is more than lost", the more the spot check, so the detection of the problem natural also the more!
Check the standard problem, the heavy component, light processing
According to the relevant experts in the Chinese medicine industry, the current verification standards of Chinese traditional Chinese medicine refer to the laws of Chinese pharmacopoeia in 2015.
As the testing standards for the Chinese medicine yinpian completely according to the chemical composition and content of western medicine such as quality standard requirements, and standard is very strict, ignoring the Yin and Yang five lines of Chinese medicine, sexual flavour to the; The influence of the processing process on the Chinese medicine is ignored.
Industry experts for such as the pharmacopoeia in the content of ephedrine to evaluate the quality of ephedra, but in the practical application of ephedra stems are sweating nourish, ephedra root is anti-perspirant convergence, the function of the different parts with ephedrine not drugs.
In addition, the university of TCM firing is a q, some processing is used to increase efficiency, have a plenty of to detoxify, have a plenty of to change to the, but did not reflect current pharmacopoeia changes after processing.
As the first dust poison, the liver and kidney damage, but by the traditional processing methods, with black beans water soaked, nine steamed JiuZhi again, no poison, makes the role of nourishing liver and kidney, ufa enhanced; It is different from the process of raw ephedrine and yellow and yellow, and it has a great effect on sweating. Also like ginger, ginger, ginger, angelica head, angelica, angelica, the active ingredients are the same, the effect is completely different.
Therefore, in the current "only theory" situation, the majority of Chinese traditional Chinese medicine is not qualified because of the content of the content.
In fact, there are many online has different voice or question for verification standards, such as the senior Chinese medicine people ridicule pharmacopoeia: the composition as a Chinese medicine yinpian standard is a dead end ", "Chinese traditional medicine quality standards, westernized road impassability, etc.
▍ open the right way for the future development of Chinese medicine yinpian
The improvement and establishment of the traceability system
CFDA earlier this year, the ministry of commerce and other seven ministries and commissions on the promotion of the construction of important product information tracing system guidelines "(hereinafter referred to as" guidelines "), including the establishment and perfection of the Chinese medicinal materials traceability system as the most important content:
Gradually increasing the trace species of Chinese medicinal herbs; Gradually expand coverage to cover the major Chinese medicinal materials wholesale markets; We will improve the coverage of the production and operation of Chinese medicinal materials, the production and operation of Chinese medicines, the production and operation of Chinese medicines, medical institutions and pharmacies.
We will strengthen the circulation traceability system of Chinese medicinal herbs, upgrade and transform the central platform for the circulation of Chinese medicinal materials, and promote the sharing of information sharing between different drug traceability systems.
We will vigorously develop the medicinal herbs
Chinese medicine is the basic substance of the development of TCM. The development of traditional Chinese medicine needs to be cut from the source, so that the production of medicinal materials is concentrated in the dominant areas of the region. The procurement of medicinal materials is collected from the market and the high-quality traditional Chinese medicine agricultural enterprises in the daodiao region, and the standardization, scale and modern green production of the authentic medicine of the dais.
Regional division of Chinese Taoist medicine and its representative herbs: