In the research and development of new Chinese medicines, the higher gold content is 6.1 new medicines, Chinese medicines and natural medicine compound preparations that have not been marketed at home and abroad. The bad news is that of the 37 new drug applications for Chinese medicine in the 17 years of new drug registration, only 5 were approved. The good news is that these 5 are all 6.1 new drugs.
Although there were some policies to support the development of Chinese medicine in 2017, which gave Chinese medicine a slight upward trend, it still did not change the difficult state of the modernization of Chinese medicine.
It's too hard, and there are hardships to tell. . . For example, the content of medicinal materials in different sources, different origins, and different harvesting periods, and the paste yield rate are very different, process stability cannot be guaranteed, quality control cannot be solved, and the phenomenon of blending in production is basically common. Need for policy liberalization.
The problem of ointment yield that you asked me the day before yesterday is actually very complicated. Take a product as an example. A certain medicine from Gansu and Sichuan has different origins from the same base source. The different harvesting periods are very surprised. The real data on the ointment yield is ours. No real data on production is available, and these data are top secret for every company. But we probably know that the fluctuation is large. It is not only the problem of medicinal materials, but also the process. There is a lot of pressure on the production of large varieties of medicinal materials every year. Our large varieties are restricted by the scale of production, and the production is in short supply throughout the year. Therefore, it is impossible to use low-temperature vacuum drying or oven drying in the research stage. It is a fluidized bed one-step granulation or spray drying. Regardless of the process, there will be many problems in large-scale production, because polysaccharides and tanning will cause adhesion, and different paste rates will lead to the collapse of the capsule. The solution is risky, so Japan always uses intermediates as raw materials for independent preparation. China emphasizes that compound medicinal materials are used as the unit, and intermediates are not allowed.
However, basically every company will have this kind of deployment problem. The stricter the quality control, the more it is needed, otherwise there will be risks with so many indicators. The company has been investigating for a long time, and we didn't admit it to death in production. We can't do anything with them. Several other GMP production qualifications have also visited, and the situation is basically the same. Small-scale and pilot-scale research are relatively easy, but there are not many large-scale production equipment in China, and they are uneven, and various problems are common after amplification. It's not that if the company doesn't work hard to solve it, you will find that it is too difficult if you make a new drug. Regulations are needed to support the relaxation of policies. Not to mention doing three batches of pilot trials, our large-scale production has been restarted more than a dozen times, and there will still be many process problems.
The difficulty of Chinese medicine is so great that it is hopeless. First, the academics do not pay attention because they cannot publish articles. Second, they do not have interdisciplinary capabilities. Third, they do not have equipment funds. This leads to a mismatch between research and practice.
Today, the 2020 version of the pharmacopoeia dry goods are released:
1. To improve the ability of TCM standards to deal with quality issues, that is, to solve the problem that certain TCM standards face the "no use" problem in the complex and changeable regulatory process. To achieve the established standards that can effectively solve the quality problems of traditional Chinese medicine, it is necessary to establish innovative thinking, start from a holistic view, and adopt technical means such as traditional Chinese medicine fingerprints that can evaluate the quality of traditional Chinese medicines, so that quality problems can be discovered and resolved in time.
2. Comprehensively improve the safety testing capabilities and levels of traditional Chinese medicines. Chinese herbal medicines and decoction pieces are fully loaded with heavy metals and harmful elements, pesticide residues, mycotoxins and other exogenous hazardous substances testing and their limit standards, and gradually promote the establishment of exogenous Chinese patent medicines. Testing standards for harmful substances; continue to carry out research on the determination methods and limit standards of pesticide residues, plant hormones, mycotoxins and other exogenous harmful substances.
3. Focus on improving the detection ability and level that can characterize the effectiveness of traditional Chinese medicine, promote the application of fingerprint and characteristic map, multi-component content determination and other detection technologies for the overall control of traditional Chinese medicine components in traditional Chinese medicine standards, and further improve fingerprint and characteristic map detection technology and evaluation Methodological research; strengthen the research and collection of control extracts of traditional Chinese medicines and reference substances, and strengthen the research of multi-component quantitative analysis techniques that use alternative reference substances as controls, including multi-component content with internal standards or self-internal standards and control extracts as controls To solve problems such as lack or instability of reference materials, reduce the cost of testing, and provide guarantee for the improvement and implementation of standards; for expensive and easy-to-mix Chinese herbal medicines and decoction pieces, continue to carry out genetic material-based DNA molecular identification research to solve current problems The problem of morphology and chemical identification is difficult to solve; focus on the research of biological effect methods that can directly reflect the clinical efficacy of traditional Chinese medicine, and explore the applicability of biological activity detection methods in the quality inspection of traditional Chinese medicine.
4. Standardize and improve the testing methods, processes, limits, result judgments and formulation specifications and other expressions and terms; standardize and coordinate the relative consistency of the same series of product quality control, testing methods, indicators and limits. Standardize and unify the terminology of traditional Chinese medicine, highlight the characteristics of syndrome differentiation, standardize the expression of functions and indications, the arrangement of primary and secondary symptoms, and thoroughly solve problems such as inaccurate descriptions, inconsistencies, and broad indications.
5. Actively advocate green standards and economic standards, promote the use of low-toxicity, less pollution, resource saving, environmental protection, simple and practical detection methods, and completely stop the use of toxic reagents such as benzene and replace them all.
The good news is that the application of new technologies will lag behind, but will not be absent. Fully establish the limit of pesticide residues and heavy metal residues, ICP-MS has fully replaced atomic spectrophotometry, and GC is fully popularized; promote internal standard method, one test and multiple evaluation, European Pharmacopoeia, American Pharmacopoeia natural medicine has long been internal standard method, Chinese Pharmacopoeia There are only a handful of internal standard methods, it can be said that there is basically no; the establishment of fingerprints, reflecting the comprehensiveness, except for Tasly’s compound Danshen dripping pills and other large varieties of well-known companies, basically not much can be done at present; discuss biological activity detection methods Applicability is another technology that will lag behind by 20 years.
Finally, let me talk about my consistent point of view. What is the problem with Chinese medicine? The biggest market has spawned the best technology, just like the rise of China's computer technology, the rise of China's communication technology, and the rise of China's artificial intelligence. The problem we talked about today is just the minutiae, and it lies in the market. The problem of Chinese medicine is that it cannot make a lot of money. Large varieties cannot occupy foreign markets like western medicine and chemical drugs. The sales volume is tens of billions. At present, hundreds of millions of Chinese medicines are large varieties. Make enough money, or let investors see the hope of making big money, and other things will be solved naturally.
Post time: Feb-17-2022