Perspective micro powder Chinese medicine

China Pharmaceutical News November 5, 2002

Perspective micro powder Chinese medicine

Micro-powder Chinese medicine began to enter people's field of vision in the mid-1990s. The amount of research literature published has increased geometrically. Its technology has been increasingly valued by Chinese medicine companies and experts. Its huge potential and broad prospects have been Widely optimistic, the words of beauty in various media, too numerous to mention, and even some call it "the revolution in the history of Chinese medicine technology."

Why can micro-powder Chinese medicine attract more people to cheer? What kind of impact does micronized Chinese medicine have on the development of traditional Chinese medicine? At the "Chinese Medicine Micropowder Technology Symposium" organized by the State Administration of Traditional Chinese Medicine, the reporter interviewed experts in traditional Chinese medicine and materials engineering on this hot topic.

Micropowder Chinese medicine is not a "modern" Chinese medicine

"In the 13th section of the Internal Medicine of the Yellow Emperor's Internal Medicine, there is a prescription related to this. In the Song Dynasty, it developed to the peak. One-third of the famous "Spiritual Agents" is such a drug. It has a The name that everyone is familiar with - powder." Professor Gao Yimin, a professor at the School of Chinese Medicine of Capital Medical University, a member of the Seventh Committee of the National Pharmacopoeia Committee, and the deputy director of the Chinese Medicine Committee, unveiled the "modern" veil that was once immersed in Chinese medicine. .

"Pill, powder, cream, Dan" is a traditional dosage form of traditional Chinese medicine. Medical scientists in various periods in history have used powder to treat diseases. In addition to general diseases, powders are widely used in acute, severe, surgical, and pediatric applications. Yinqiao San, Chuanxi Tea Dispersion, Ruyi Golden Powder, Shengji San, Wuyi San have been circulating for a long time. It has been stipulated in the 2000 edition of the "Guidelines for the Preparation of Chinese Pharmacopoeia" that the powder refers to the mixing of one or more medicinal materials into a powdery preparation. What is the relationship between powder and micro-powder Chinese medicine?

"Micro-powder Chinese medicine is a very fine powder. This is the relationship between micro-powder Chinese medicine and powder." Professor Gao Yimin said. In other words, in ancient times, the medicinal materials were pressed into powder by using mills, stone mills, hoes, etc., but nowadays it is only made to be made finer by modern machinery, and it is possible to make it scale production. "Micropowder Chinese medicine can not be counted as a new drug, nor is it a newly created dosage form. It is a reform of traditional Chinese medicine preparation technology, not a new preparation."

Micro-powder Chinese medicine reflects the characteristics of traditional Chinese medicine

Some scholars have asserted that the emergence of micro-powder Chinese medicine may be the modern preparation method of traditional Chinese medicine that is easily accepted by the Chinese medicine industry.

Professor Zhang Wengao of Shandong University of Traditional Chinese Medicine used “original flavor” to describe micro-powder traditional Chinese medicine, that is, to maintain the basic medicinal properties of traditional Chinese medicine (four gas, five flavors, returning to the classics, efficacy); to maintain the characteristics of traditional Chinese medicine that “one traditional Chinese medicine is a small compound” Constantly, the practicability of traditional Chinese medicine and the characteristics of multi-site and multi-target comprehensive adjustment remain unchanged. Although the micro-crushing technology breaks the cell membrane or cell wall of the traditional Chinese medicine, it does not change the physical and chemical properties of the drug, and does not affect the taste and function of the traditional Chinese medicine. Micro-powder Chinese medicine should be said to be indispensable in embodying the characteristics of traditional Chinese medicine.

Micropowder Chinese medicine is the inevitable development of traditional Chinese medicine

At the project demonstration meeting on the establishment of the National Traditional Chinese Medicine Resource Sustainable Development System and the National Key Chinese Medicine Resources Survey, the questions raised by the experts were revuded: the demand for natural medicines has tripled in the past 10 years. The excessive and disorderly development of traditional Chinese medicine resources has led to the very common Chinese herbal medicine resources such as licorice and ephedra, which have not met the demand. In the long run, the Chinese medicine industry will face the embarrassing situation that no medicine is available. In the era of Song, Jin and Yuan, where a large amount of powder was prevalent in history, it was also an era in which medicines were in short supply. After the Ming and Qing Dynasties, the drug source increased, and the cutting technology was improved. With the application and development of the pieces, and because of the taste and drug effects, the powder was gradually reduced.

The advantage of micro-powder traditional Chinese medicine zui is to save medicine. It is not difficult to see from more than 90 academic papers published so far that the dosage of micro-powder traditional Chinese medicine is generally only 1/3 of the current clinical prescription, and some can reach 1/5. Compared with the soup medicine head fried 30%, the second fried 15%, the third fried is less than 50% utilization rate, it can be described as "high efficiency". Professor Peng Jieshou of the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, etc., applied ultra-fine pulverization and mixing equipment, and processed traditional Chinese medicine prescriptions and some single-flavored traditional Chinese medicines, after traditional processing and drying and sterilization, processed into ultrafine powder without any excipients. Do not do any extraction, use water to make up the suit. After more than 400 clinical trials of more than 100 kinds of internal, external, maternal and pediatric common diseases, it was found that it can reduce the amount of medicine by 30%~80%, reduce the volume of medication by 50%~70%, save medicines and save medical expenses. Improve the efficacy and ease of use. Some large pharmaceutical companies such as Tongrentang, Shanghai Traditional Chinese Medicine No.1, Shandong Lunan Pharmaceutical have applied the micro-grinding technology of traditional Chinese medicine to pharmaceuticals, with the aim of reducing costs and improving quality.

Moreover, finer micronized Chinese medicines have technically solved various disadvantages of powders. Professor Zhuang Xiangjiu believes that the release amount and release rate of the active ingredients of the Chinese medicine of the micro-powder and the amount of the active ingredient absorbed by the human body per unit time are higher than those of the powder, and the released active ingredients of the medicine are more. Because the particles are smaller, the adhesion to the intestinal wall is strengthened, and the retention time of the Chinese medicine particles in the intestine will increase, which is also beneficial for drug absorption. Therefore, directly taking the micro-powder Chinese medicine will obviously make the body absorb more comprehensive ingredients, increase the absorption intensity, and increase the absorption, thereby significantly improving the bioavailability. After the Chinese medicine compound is pulverized, the active ingredients are homogenized and can be uniformly absorbed by the human body. Due to the high cell wall breaking rate, the extraction rate can be significantly improved when industrially used for extracting active ingredients of drugs. After the Chinese medicine compound is pulverized, the average particle size is generally below 20 microns, and its particle size is lower than the oral particle sensory threshold. No roughness when taken. Micro-powder Chinese medicine drink tablets do not need to add auxiliary materials, capsules can be directly pharmaceutical. It is easy to swallow, carry, and not easy to deteriorate, and is also conducive to preservation and transportation.

Micro-powder Chinese medicine requires interdisciplinary collaboration

The development of micronized Chinese medicine has good prospects, but also has certain problems. It can be seen at the symposium that the related concepts and terminology are more turbulent. There are more than 20 kinds of similar titles such as “micro-powder traditional Chinese medicine, ultra-fine powder, ultra-fine powder, and cell-level micro-powder Chinese medicine”. The research and application of micronized Chinese medicine involves many departments in different fields such as powder engineering technology and related mechanical equipment manufacturing units, Chinese medicine medical, scientific research, teaching institutions and pharmaceutical companies. In scientific research, it also involves powder engineering, Chinese medicine identification, In the pharmaceutical engineering, pharmacology, toxicology, pharmacokinetics and clinical aspects, most of them are currently in the exploration stage of lack of coordination and cooperation, lacking overall planning and coordination. In addition, the lack of authoritative quality standards and process specifications has become one of the important factors restricting the research and application of micronized Chinese medicine. At the same time, due to the weak clinical application research, how to determine the dosage of micro-powder traditional Chinese medicine in different dosage forms and different methods of administration, there is no standard to rely on, and there is no reliable research results for reference, which is to restrict the clinical application of micro-powder Chinese medicine. The key issue. Due to recent economic benefits, most hospitals (including Chinese medicine hospitals at all levels) also lack the enthusiasm for applying micronized Chinese medicine.

Professor Gao Yimin pointed out that based on the experience of drug review for many years, he can follow the “Chinese medicine formula granules” approved by the State Drug Administration, and name it “Chinese medicine formula micro powder” to deal with the dosage form according to the technological revolution. Conduct research according to the requirements of the current Pharmacopoeia, and do not go offside to avoid confusion in research.

Professor Zhang Wengao proposed: According to the technical requirements of the research on the quality standard of Chinese medicine formula granules promulgated by the State Drug Administration, the organization of domestic research on the quality standard of traditional Chinese medicine formula micro powder, in order to regulate the production behavior and ensure the quality of Chinese medicine formula micropowder. Drawing on and referring to the methods and lessons of the trial production, clinical trial and comparative research of traditional Chinese medicine formula granules, under the leadership of the State Drug Administration, the pilot research and development, trial production, clinical trial and comparative study of Chinese medicine formula micro powder were gradually piloted.

Dr. Gai Guosheng from the Powder Engineering Research Department of Tsinghua University believes that science can be used to bring in the spirit of teamwork, and people from different industries and different professions work closely together to absorb the original processing in the fields of materials and chemicals. The lessons learned from the transplantation of mature technology into traditional Chinese medicine preparations, in the process of micro-particles of Chinese medicine, try to minimize detours.

Whether it is due to the scarcity of traditional Chinese medicine resources, the improvement of traditional industries, or the pressure of international competition, traditional Chinese medicine micropowder technology will be one of the important and feasible means of TCM innovation in the early 21st century. Traditional Chinese medicine micropowder technology has been paid attention to by China's drug regulatory authorities and the Chinese medicine community, and the research and application process of micronized Chinese medicine will be beneficial to the healthy development of Chinese medicine and better for the benefit of mankind.

Related links: The Chinese medicine powder stipulated by the Chinese Pharmacopoeia is “very fine powder”, which means that it can pass all the No. 8 sieve and No. 9 sieve (the average diameter of the sieve hole is 75±4.1 μm), and it contains energy. Pass 95% powder. The finer traditional Chinese medicine powder prepared by the new technology of modern powder engineering is called Chinese medicine micro powder, and the Chinese herbal medicine which is pulverized into such a fine state is called micro powder Chinese medicine.

The general concept in modern powder engineering is that the particle size of the powder is less than 100 microns and greater than 1 micron, which is "micron". At present, most of the micropowder traditional Chinese medicine is in the micron range. Therefore, some people call it "micro powder Chinese medicine."

Note: Because there are no unified standards for related terms and concepts, this article refers to the more commonly used terms and concepts, and does not use standard applications.