The development of new Chinese medicines is an inevitable requirement for the reform of Chinese pharmaceuticals and multi-path administration, and it is also an objective requirement for the clinical research of traditional Chinese medicine. In recent years, a large number of new Chinese medicines have been widely used in the clinical practice of various departments, which not only facilitates patients but also greatly promotes the industrialization of traditional Chinese medicines, especially in recent years when the State Administration of Food and Drugs stipulates the quality standards for drug testing (GCP). Under the guidance of the new Chinese medicine, the development of new drugs has become more standardized and has become one of the important signs of the development and progress of Chinese medicine. However, we should also be soberly aware that there are still some misunderstandings and deviations in the implementation and operation of the guiding ideology, test methods and models, and experimental schemes for the development of new Chinese medicines. Therefore, although a large amount of manpower and resources are devoted to the development of new drugs each year, many new drugs are put into production and clinical applications every year. However, few Chinese patent medicines that have truly been recognized as having good curative effects have resulted in great waste of resources and obstruction. The progress of clinical research in Chinese medicine.
Deviation and misunderstanding of guiding ideology
Deviations and misunderstandings in the development of traditional Chinese medicines and new drugs are mainly reflected in the devourers of the research and development targets. If there are new drugs that are targeted at certain diseases such as hepatitis B and diabetes, it is hoped that these can be made through certain proprietary Chinese medicines. All the problems of the disease can be solved. This is obviously unrealistic. It does not conform to the efficacy of Chinese medicine, but also violates the characteristics of traditional Chinese medicine. Naturally, it is difficult to achieve the desired therapeutic effect.
The primary reason for the deviation of the guiding ideology is the lack of correct understanding of the effectiveness of the development of Chinese medicine by the developer. Practice has proved that Chinese medicine can play a role in many aspects of the disease, but its most definitive effect is still reflected in the symptoms and signs of modern medicine that are used to improve and eliminate diseases. Because the "certificate" is the most important basis for TCM differentiation, Chinese patent medicine is no different, such as wood Qixiangqiqi pills qi inflation, Sixiao pills and stomach digestion, are all on the "certificate" and set, medicine refers to, for Strong, effective, so long-term trust by doctors and patients, still used in clinical practice. Abnormality of some lesions and objective indicators in the course of disease may also have certain and good effects, but these are often uncertain, so when setting targets for new Chinese medicines, these can only be subordinated. Or take into account.
Secondly, the researcher does not know the main effects of therapeutic effects, synergy, attenuating effects, and corrective actions of Chinese medicine treatment diseases, nor does it explicitly require that the developed drug should play a leading treatment, adjuvant treatment, or after-treatment. Different roles and goals, this will naturally affect the accuracy of the establishment of the governing law and the selection of drugs by the group.
Second, ignore the basic rules of drug use. There is no doubt that new Chinese medicines are aimed at modern medical diseases. The problems that each disease should solve are by no means one, and there are often several or multiple treatment links. For example, chronic hepatitis B may have hypochondriac pain and bloating. There are several therapeutic links such as low fever, low food, fatigue, insomnia, jaundice, and bleeding that require us to resolve. We can address one or the other, but we must also focus on two or more links. If the different treatment links, priorities, and priorities of the disease are not clear, blindness in the development of new drug development plans will be difficult to avoid.
Blind and one-sided use of prescription drugs
The prescription of the prescription is the most critical or even decisive factor in the success or failure of the development of traditional Chinese medicines. The requirements for the use of new medicines are of course accurate and targeted. They must conform to the theoretical guidance of Chinese medicines and prescriptions, and conform to the principle of compatibility between officials and ministers. It is necessary to embody the experience of the researcher and the development of the modern scientific achievements. It must integrate the concept of modern science; it must embody the macro-control of the disease, but also reflect the specific targets of certain aspects of the disease. Only in this way can we ensure The curative effect is obtained, at the same time, it is also ensured that it is non-toxic, and the safety of the use of the drug is guaranteed.
In contrast to the basic requirements for the above-mentioned group prescriptions, there has been more general blindness and one-sidedness in the development of traditional Chinese medicine in the formulation of traditional Chinese medicines in the past ten years. The main manifestation is that in the selection of certain Chinese medicines, only attention is paid to their effects and they are ignored. Toxic and other adverse reactions to organ tissue. If the use of peach kernel to treat liver cirrhosis, ignoring the toxicity of its contained benzaldehyde, hydrocyanic acid on the liver; with Chuanxiong qi to relieve pain, it ignores the side effects of Chuanxiong destroy liver cells, the use of harmful Treatment of hepatic diabetes mellitus application of trichosanthin, only pay attention to the therapeutic effect of thirst thirst on diabetes, but ignore the hepatotoxicity of trichosanthin, anti-hepatitis inflammation after use; use fleece-flower root treatment of fatty liver, only pay attention to The efficacy of lipid-lowering effect of Polygonum multiflorum has neglected the toxic effects of destroying liver tissues. However, liver damage may be aggravated when used for a long time. It is counterproductive; treatment of high blood pressure ignores side reactions caused by water and sodium retention caused by licorice, which can increase blood pressure. Make blood pressure higher and so on.
The blindness of the prescription medication is also reflected in the violation of the basic rules of the development of the disease, such as liver injury should have used immunosuppressive drugs, and some in the liver and reduce the enzyme added Ganoderma lucidum, wolfberry and other immune boosting tonic Traditional Chinese medicines increase the level of ALT and increase the severity of liver damage after use. All these are due to lack of knowledge and experience of the developer.
Stylization and visualization of implementation rules
At present, the procedures and data requirements for clinical trials of new TCM drugs appear to be rigorous, reasonable, and feasible. However, in many cases, these rules and requirements are too stylized and visualized, and sometimes even become a hidden rule. The requested information is also often based on textual designation, such as the etiology and pathogenesis of the indications in traditional Chinese medicine theory that must be available in the bid-winning data, the analysis of the companions and ministers of the other side, the analysis of traditional Chinese medicine and the review of modern pharmacology, etc. It seems that it is not an exaggeration to pass the approval service for the new drug trials and it cannot substantially improve the quality of new drug development. Frequently, the developers also asked the relevant personnel to write about the phenomenon of related materials. This is actually a kind of text decoration and falsification.
As for the case of failure in the execution and operation of the clinical trial scheme, it is almost impossible to see a case, how the authenticity of the line of figures is, and whether or not there is a digital game, it is also difficult to avoid the embarrassment of people because we often cannot have information on these clinical trials. Make an accurate decision. It is precisely for this reason that some well-known experts and even clinical people are often unable to enter this rule and develop new drugs due to factors such as human and financial resources, and the group that enters new drug development may be lacking in theoretical foundation. Non-experienced mediocre groups waste a lot of manpower and material resources, and they cannot receive the desired curative effect when they are put into clinical use. Some of them are quickly eliminated. This is precisely the fundamental reason why the new Chinese medicines are mixed.
In addition, due to the drive of interests, there is a great deal of arbitrariness in the application of new drug development in traditional Chinese medicine, which makes it difficult to ensure the quality of new drug development, and at the same time, it also causes imbalances in the variety of new drugs between different types of diseases.
Problems to be Paid Attention to in the Development of New Chinese Drugs
For the development of traditional Chinese medicines and new drugs, we must first clarify the role of traditional Chinese medicine in the field of certain diseases and the positioning of curative effects, and distinguish the different targets that a new drug should play for the leading role, supporting role, and aftereffect of a certain disease. The design of technical routes and test plans can be targeted, scientific and practical. Secondly, it must be clear that there may be many links in certain diseases, and the content of traditional Chinese medicines in crude drugs is low, and it is sometimes impossible to solve all problems. Therefore, it must be targeted to ensure efficacy. Such as liver cirrhosis, can develop gallbladder retinoic acid, diuretic drugs, hemostatic drugs, blood circulation medicine, respectively, to solve the patient's jaundice, ascites, gums and liver fibrosis and other issues, according to the disease, can be used first, Or several kinds of application at the same time, the idea of ​​this link drug application is applicable to the development of new Chinese medicine.
The key to determining the quality and efficacy of new Chinese medicines is the use of prescriptions, and the deciding factors in determining the level of medication used by the group are related clinical experts. The relevant national authorities should organize well-known experts at home and abroad to collaboratively research and discuss collectively, jointly draft new drug prescriptions for each disease, and then discuss with pharmacologists to determine drug dosage forms, and then proceed to enter the development of new drugs. The track will maximally change the arbitrariness of the current research and development of new drugs, and at the same time solve the problem of unbalanced development among various diseases of traditional Chinese medicines.