Chinese medicine, natural medicine injection standard over

The principle of safety and effectiveness put forward by the “Basic Technical Requirements for Traditional Chinese Medicines and Natural Medicine Injections” is actually the principle of quality standards research. The testing standards for drug standards should be closely related to safety and effectiveness, otherwise their practical significance will be greatly reduced. .

Traditional Chinese medicine injections are new preparations for the development of modern Chinese medicine. In recent years, reports on the adverse reactions of traditional Chinese medicine injections have aroused widespread concern in the society. Some people have even questioned Chinese medicine injections and even proprietary Chinese medicines. Therefore, establishing an evaluation principle for traditional Chinese medicine injections has become an urgent need. Not long ago, the industry's long-awaited "Basic Technical Requirements for Injectables for Traditional Chinese Medicines and Natural Products" (hereinafter referred to as the "Requirements") was finally issued by the State Food and Drug Administration. In the process of interpreting the "Requirements", the author found that the following problems were solved: It may have important implications for the development of traditional Chinese medicines and natural medicine injections.

First of all, “The traditional Chinese medicine theory and experience have limited guidance on the compatibility and compatibility of traditional Chinese medicine and natural medicine injections.” This is the first time in the normative document. Chinese patent medicine is a new development of modern Chinese medicine. For a long time, China's research on traditional Chinese medicine has always been guided by the traditional Chinese medicine theory and experience, while ignoring the differences between traditional Chinese medicine and clinical traditional Chinese medicine (decoction). As we all know, understanding the medicinal properties and dosage of traditional Chinese medicine through decoction and oral administration is the main way of understanding traditional Chinese medicine, and injections have clearly broken through this traditional path. Then, traditional prescription formulas are used to illustrate the principles, methods, prescriptions, and methods of traditional Chinese medicine injections. Suspected metaphysics and far-fetched. For example, the efficacy of Qingkailing oral preparation is detoxification, calming and tranquilizing. It is suitable for hyperthermia caused by fever, irritability, sore throat, red tongue or sputum, moss yellow, and pulse number; it is mostly used for damp-heat type hepatitis and upper respiratory tract infection. The efficacy of Qingkailing injection is detoxification, phlegm and collaterals, and resuscitation. It can be used for fever, faintness, hemiplegia, unconsciousness, and can be used for acute and chronic hepatitis, hepatitis B, upper respiratory tract infections, pneumonia, high fever, and cerebral thrombosis. Obviously, the efficacy and indications of the two types of Qingkailing preparations are quite different. The "Pharmacopoeia Clinical Medication Notes" organized and compiled by the National Pharmacopoeia Committee has the same interpretation of the prescription drug efficacy of the two preparations, but there is a great difference in the determination of the prescription efficacy, that is, "jun, chen, zuo, and qi" of the medicinal taste. The relationship is exactly the same, but the effects of the "total play" are different, beyond the scope of traditional Chinese medicine theory, there are obvious contradictions, and it is unreasonable. "Requirements" according to the actual situation of traditional Chinese medicine injections, put forward the "limited" principle, in line with the actual development of traditional Chinese medicine, in line with the theory of Chinese medicine and the actual development needs.

Second, the "request" has guiding significance for clinical research. The "Requirements" pointed out that if a compound injection prescription contains a prescription for a marketed injection, and its functional indication (indications) is basically the same as that of a listed injection, the efficacy and safety of the compound injection and the listed injection should be compared clinically. Tests, the efficacy or safety of new injections should be significantly better than the injections already on the market. The above requirements recognize the possibility of consistent prescriptions, availability, and safety. For a long time, people think that as long as the prescription is the same, the functional indications are the same, thus ignoring the existence of different technologies. For example, the various oral preparations of Liu Wei Di Huang are converted into the same medicinal dose, and the effects of different technologies on the efficacy are not considered at all, making the research and production specifications of the dosage form become formal. For the same prescription, same dosage form, and the same process, assuming that the medicinal materials are also the same, if the production equipment and the details of the process are different, it will cause differences in efficacy. If the extraction heating time of 5 ton and 1 ton of medicinal materials is different, there will be differences in efficacy, and filtration equipment will also have a greater impact on the indicators such as the amount of production. Many different omissions have made Chinese medicines highly competitive and have been caught in price wars. The "Requirements" addressed this difference and proposed the concept of "obvious superiority." This approach is necessary to promote the use of traditional Chinese medicine injections to achieve success in other formulations.

Finally, the "Requirements" also mentioned that after injections are approved for listing, drug producers should carefully conduct relevant research work to ensure the safety and effectiveness of their clinical use according to their risk control plan when they are listed. Most drugs have risks after they are listed on the market. Many Chinese medicines lack clinical re-examination after they are listed.

In clinical use, the combination of multiple Chinese medicines and Chinese and Western medicines is very common. Therefore, the re-study of postmarketing Chinese medicines is not only for the individual use of the preparations, but also for combined use and extended use (age, dose, etc.) Happening. However, how this kind of research is conducted, there is no clear provision in the "Drug Administration Law" and the current methods. Moreover, the clinical re-study of marketed drugs is different from that of new drugs. There is no standard for the subjects' rights or the subjects' rights to be observed, which are different from those of new drug research subjects, and what principles they should follow. Recently, there have been reports that a woman in a certain place was drowned due to taking Chinese medicine pills. His family members believed that it was improperly explained that the method of “oral administration” in the drug instruction manual was not clear. The first-instance drug company in the court took responsibility for 20% and compensated more than 50,000 yuan. This shows that companies should attach great importance to the risk monitoring of drug listing.

On the one hand, it is difficult for us to tolerate the questioning of traditional Chinese medicines. On the other hand, there is a lack of solutions to the practical problems existing in traditional Chinese medicines. Therefore, timely adjustment policies are very important. The principle of safety and effectiveness proposed by the "Requirements" is actually the principle of quality standards research. That is, the testing items for drug standards should be closely related to safety and effectiveness, otherwise their practical significance will be greatly reduced.