The 2020 edition of Chinese Pharmacopoeia revised and improved the quality standard of Chinese herbal pieces according to the problems existing in the quality standard of Chinese herbal pieces, and improved the quality standard of Chinese herbal pieces.

According to clinical needs, the 2020 version of Chinese Pharmacopoeia may consider appropriately increasing the quality standards for Chinese Herbal Pieces commonly used in China. Its selection principles are as follows: 1) it is indeed widely used in clinical practice and in the form of traditional pieces; 2) The source is clear. More than two-thirds of the provinces and municipalities directly under the central government have adopted the processing specifications for decoction pieces, and the corresponding Chinese herbal medicine standards have been included in the 2015 edition of Chinese pharmacoeia; 3) The processing technology is clear, and the processing method is scientific and reasonable.

Sort out all pieces of traditional Chinese medicine contained in the 2020 edition of Chinese Pharmacopoeia, and comprehensively standardize the names of pieces of traditional Chinese medicine. Although the names of individual pieces of traditional Chinese medicine are not standardized, they should be handled according to the clinical practice (for example, some pieces of traditional Chinese medicine should be added with "piece" after the name of the medicine)

According to the requirements of the newly established state drug administration, the national pharmacopoeia committee has entrusted relevant industry associations to organize relevant manufacturers, universities and scientific research institutes of herbal pieces to comprehensively sort out and coordinate the processing methods of herbal pieces, and carry out the work of formulating a unified "national standard for the processing of herbal pieces".

Further improve the basic quality control indicators (properties, moisture, ash, impurities, extracts) of traditional Chinese medicine decoction pieces according to the characteristics of traditional Chinese medicine clinical decoction. In view of the continuous development of producing areas for direct processing of Chinese herbal pieces and mechanical cutting of Chinese herbal pieces, the 2020 version of Chinese pharmacoeia, on the premise of ensuring the quality of Chinese herbal pieces, improves and standardizes the specifications and properties of producing areas for processing of Chinese herbal pieces and mechanical cutting of Chinese herbal pieces. However, some special-shaped pieces, such as longitudinal slices, oblique slices, etc., and freeze-dried pieces, are not included in the revision.

Traditional Chinese medicine pieces are processed products of traditional Chinese medicine, which are easy to be adulterated in the processing process; At the same time, some pieces of traditional Chinese medicine have lost their original properties, which increases the difficulty of on-site identification in the market. Therefore, the decoction pieces of traditional Chinese medicine have been the hardest hit areas of the quality problems of traditional Chinese medicine in recent years.

In view of the problems existing in the identification of Chinese herbal medicines, the 2020 edition of Chinese Pharmacopoeia focuses on the following work: 1) according to the changes in the microscopic characteristics of cultivated medicinal materials, on the basis of the revision of the standards of Chinese herbal medicines, the relevant standards of Chinese herbal medicines should be improved accordingly; 2) To study the changes of components before and after the processing of decoction pieces, and improve the specific methods such as TLC identification and characteristic spectrum identification; 3) For the precious and easy to mix pieces of traditional Chinese medicine, and the pieces of traditional Chinese medicine that are seriously adulterated, dyed and weight increased in the market, efforts should be made to study and establish the identification formula of the characteristic mapLaw, through exclusive identification methods, to curb counterfeits. 4) Focus on the study of "toxicity", "different treatment of raw and cooked" and other specific identification indicators of Chinese herbal pieces that are different from Chinese herbal medicines.

Establish and improve the safety testing methods for Chinese herbal pieces. According to the "guiding principles for the limit of harmful residues of traditional Chinese medicine" in the Chinese Pharmacopoeia, formulate the limit standards for heavy metals, harmful elements and pesticide residues in Chinese herbal pieces, and include them in the corresponding determination methods of the general rules. Continue to carry out research on mycotoxins in moldy decoction pieces, formulate corresponding limit standards for the varieties of traditional Chinese medicine decoction pieces that are easy to detect mycotoxins, and include the varieties under the determination of "mycotoxins" in the general rules.

According to the research results of the processing of Chinese herbal pieces, research and establish content determination methods that meet the characteristics of Chinese herbal pieces, focus on the key quality indicators of Chinese herbal pieces that are different from Chinese herbal medicines, such as "toxicity" and "different treatment of health and maturity", and establish the content determination of relevant index components; According to the characteristics of the overall components of traditional Chinese medicine, the fingerprint and multi-component content determination were studied and the standards were established to improve the control methods of the effectiveness of traditional Chinese medicine.

The quality standards of Chinese Materia Medica (including Chinese medicinal materials, Chinese herbal pieces, extracts and Chinese patent medicines) are an overall standard system, not an isolated test item. Taking traditional Chinese medicine as an example, its quality standard is composed of name, source, character, identification, inspection, extract, fingerprint / characteristic spectrum, content determination, etc. all the contents listed in the standard must comply with the regulations before it can be listed as a traditional Chinese medicine. Each content set in the quality standard system has its own purpose and significance for the quality control of traditional Chinese medicine and the safety and effectiveness of clinical medication, such as:

"Source" refers to the species (species), medicinal parts and processing methods of plants and animals (minerals) used in Chinese medicinal materials.

"Character" refers to the characteristics of traditional Chinese medicine that can be perceived or measured by human senses, such as shape, shape, size, fracture or section characteristics, smell, etc., and also includes some traditional empirical identification, that is, the "shape" and "smell" of traditional Chinese medicine often referred to by old Chinese medicine or traditional Chinese medicine workers.

"Identification" is a test item to identify the authenticity of traditional Chinese medicine, including microscopic identification, physical and chemical identification and DNA molecular identification. With the continuous emergence of chaotic varieties of traditional Chinese medicine, the re marketing of extracted medicinal materials, and the continuous emergence of illegal phenomena such as artificial doping, dyeing and counterfeiting, the physical and chemical identification of traditional Chinese medicine, especially the chromatographic identification, plays a more important role in the identification of traditional Chinese medicine. DNA molecular identification is an effective method for species identification. It is mainly used for the identification of animal drugs that do not have an effective identification method at present, as well as some precious or complex source and many counterfeit plant drugs.

"Inspection" refers to the detection of non medicinal parts, exogenous impurities, moisture, exogenous and endogenous toxic and harmful substances of traditional Chinese medicine, and it is the detection content to ensure the purity and safety of traditional Chinese medicine.

"Extract" refers to the yield of total extract obtained by extracting with corresponding solvents according to the chemical properties and solubility of the main components contained in traditional Chinese medicine. It controls the content of chemical components contained in traditional Chinese medicine to a certain extent and complements "content determination".

"Fingerprint and characteristic spectrum" is a detection method developed in recent 20 years for the whole or main characteristic components of traditional Chinese medicine. With the deepening of people's understanding of "the whole components of traditional Chinese medicine play a role", fingerprint plays an increasingly important role in the control of the whole components of traditional Chinese medicine, and is an effective method to ensure the quality and efficacy consistency of traditional Chinese medicine. In essence, the characteristic atlas belongs to the content of "identification", which is mainly used for the identification of traditional Chinese medicine and its decoction pieces that are difficult to identify by TLC or have complex sources and many counterfeit products.

"Content determination" is the quantitative control of the main pharmacodynamic components or index components in traditional Chinese medicine. It is the most important indicator to ensure the effectiveness of traditional Chinese medicine, and it is also an important indicator to evaluate the quality of traditional Chinese medicine. Because Chinese herbal medicine is a complex system with complex chemical components and extensive functions, it is very difficult to completely clarify the efficacy substances or pharmacodynamic substances of Chinese herbal medicine. The quality standard or quality control of Chinese medicinal materials is to ensure the relative consistency of the quality of Chinese medicinal materials, that is, to ensure the relative consistency of the components and contents of each batch of medicinal materials. A large number of studies, especially in the recent 20 years, have shown that there is a correlation between the contents of secondary metabolites in most plants. Generally speaking, the contents of various components in high-quality medicinal materials are high; On the contrary, the contents of various components in inferior medicinal materials are low; Therefore, controlling the content of several main components also relatively controls the content of other components. Therefore, Chinese Pharmacopoeia establishes the content determination of pharmacodynamic or effective components for Chinese medicinal materials with definite pharmacodynamic or effective components; For the Chinese medicinal materials whose efficacy or effective components have not been determined, the content determination of the index components shall be established. With the improvement and perfection of the Chinese pharmacopoeia standard, the establishment of multi-component content determination, combined with fingerprint, and the construction of the overall component quality control system of traditional Chinese medicine have become the development direction of the quality standard of traditional Chinese medicine.

Historically, most of the botanical and animal Chinese medicinal materials originated from the wild, with a relatively long growth time (animals and perennial plants), and generally contain high content of components. Most of the standards for Chinese medicinal materials and decoction pieces in Chinese Pharmacopoeia are based on samples from wild sources.

With the rapid growth of the demand for medicinal materials and the attention paid by the Chinese government to the protection of wild resources and ecological environment, many commonly used or valuable Chinese medicinal materials have gradually realized artificial cultivation or breeding. The National Pharmacopoeia Committee actively supports the artificial cultivation and breeding of Chinese medicinal materials. In view of the differences between some cultivated medicinal materials and wild medicinal materials in terms of properties and microscopic characteristics, Chinese Pharmacopoeia revised their properties and microscopic characteristics on the premise of ensuring their quality.

However, the current planting or breeding of traditional Chinese medicine generally pays attention to the yield and economic benefits, but does not pay attention to the quality, and there is a chaotic situation of "blooming everywhere". The abuse of chemical fertilizers, pesticides and plant growth regulators has become a common problem in the production of Chinese medicinal materials. The cultivation time of many perennial medicinal materials has been shortened to one or two years. For example, according to traditional experience, the growth time of wild licorice reaching the excavation standard is generally more than five years. At present, licorice is basically cultivated in the first year, transplanted in the spring of the next year, and dug in the autumn. Its growth time is less than two years. This situation also exists in a number of Chinese medicinal materials such as Astragalus membranaceus and Sophora flavescens, which are used as medicine by roots or rhizomes. A batch of Chinese medicinal materials such as Codonopsis pilosula, Angelica sinensis and Ligusticum chuanxiong were sown in the spring and dug in the autumn. Their growth time was less than 1 year; Some Chinese medicinal materials such as Dendrobium candidum and Dendrobium candidum are cultivated in greenhouses or even in artificial climate chambers. The growth conditions do not change day and night, temperature difference, etc., and the content of secondary metabolites is very low. Therefore, the current cultivated Chinese medicinal materials generally have the problems of low content of active ingredients, high residues of pesticides and plant growth regulators.

In recent years, some manufacturers and trade associations have reported to the national pharmacopoeia committee that the content limit of some Chinese medicinal materials in Chinese Pharmacopoeia has been set too high, and the cultivated medicinal materials are difficult to meet the requirements. The National Pharmacopoeia Committee attached great importance to this. It organized Pharmacopoeia members to conduct a serious and careful investigation on the original files, literature and cultivation status. It was found that most of the medicinal materials were caused by too short cultivation growth period and excessive use of chemical fertilizers and growth regulators, which was essentially a decline in the quality of cultivated Chinese medicinal materials. The national pharmacopoeia committee has always adhered to the concept of "drugs are for disease prevention and treatment, and standards are for clinical service" to carry out the preparation and revision of Chinese Pharmacopoeia drug standards, insisting that the cultivation of traditional Chinese medicine must improve production efficiency and yield on the premise of ensuring its quality.

In recent years, the continuous development of processing technology in the producing areas of traditional Chinese medicine has improved the quality of traditional Chinese medicine on the whole, especially in preventing the mildew of traditional Chinese medicine and the change of effective components. However, there are also some worrying problems: 1) some unnecessary processing for commercial purposes, including the cutting of some whole grass medicinal materials that are not difficult to dry, and the cutting of roots, rhizomes, stems and trees with small diameter and volume, has virtually increased the price of traditional Chinese medicine; 2) In order to change the medicinal properties or reduce the toxicity of traditional processing methods, fresh slices are used for drying, which affects the medicinal properties or safety of medicinal materials, such as Salvia miltiorrhiza and Angelica sinensis; 3) It is against the GMP management regulations for the production of Chinese herbal pieces to directly process the medicinal materials into Chinese Herbal Pieces in non Chinese Herbal Pieces production enterprises. To this end, the national pharmacopoeia committee will study and formulate relevant guiding principles to guide the processing of traditional Chinese medicine in the origin; At the same time, it emphasizes the coordination and matching with the current regulatory laws and regulations.

Nowadays, the processing of decoction pieces of traditional Chinese medicine is a link facing many problems in the traditional Chinese medicine industry. Its main problems include the following aspects:

1) Traditional Chinese medicine pieces are processed according to the local drug habits, and basically circulate in the province and the city. With the development of society, the Chinese herbal medicine industry has developed rapidly and gradually appeared in the national circulation. Therefore, the Chinese Pharmacopoeia has combed the processing specifications of Chinese herbal medicine in provinces, cities and autonomous regions across the country, included the commonly used Chinese herbal medicine in the Chinese Pharmacopoeia, especially since the 2010 Edition of the Chinese Pharmacopoeia, and formulated and improved the quality standards of most commonly used herbal medicine. However, due to the long-term habit of processing Chinese herbal pieces, the processing methods and processes of Chinese Herbal Pieces in various regions and enterprises are still not unified, resulting in different shapes and qualities of Chinese herbal pieces.

2) Although GMP management has been implemented in the production of Chinese herbal pieces, due to the large number and small scale of Chinese Herbal Pieces production enterprises, many production enterprises have not passed or implemented GMP, but are still producing. Especially in several major drug markets and their surrounding areas, there are still a large number of workshop type family factories. They are sold in the form of "passing the ticket" in GMP enterprises, which has brought great challenges to the quality and market supervision of Chinese herbal pieces.

3) For commercial purposes and economic interests, some manufacturing enterprises arbitrarily change the processing methods and specifications of Chinese herbal pieces, such as prepared rehmannia, jiuhuangjing, Polygonum multiflorum, etc. according to the traditional needs of "nine steaming and nine drying" or "stewing" and "steaming", many enterprises have adopted high-pressure equipment for stewing or steaming to replace the traditional processing methods without relevant research; Oblique section, longitudinal section, cutting section and other specifications continue to appear. Some even squeeze several medicinal materials with a small diameter and then process them into oblique section and longitudinal section, shoddy and deceiving consumers.

4) Illegal activities in the production of Chinese herbal pieces include adulteration, dyeing, weight gain, sulfur fumigation, and the reprocessing of extracted medicinal materials. These phenomena continue despite repeated prohibitions, bringing great harm to people's medication.

To sum up, the problems in the Chinese herbal medicine industry are prominent. In order to make huge profits, some illegal production enterprises have exhausted all means to substitute inferior products for good ones and confuse the false with the true, which has brought great harm to people's health. The state needs to strengthen the supervision of the Chinese herbal medicine industry. By improving the quality standards of Chinese herbal pieces and standardizing the processing methods of Chinese herbal pieces, we can ensure the quality of Chinese herbal pieces and ensure the safety and effectiveness of people's medication.

Chinese Pharmacopoeia (2020 Edition) quality standards for Chinese medicinal materials and Chinese herbal pieces (Part 1)
Source: Modern Chinese medicine, Vol. 20, No. 12, 2018, pp. 1459-1464,
Author: as follows