IQuality standard of Chinese medicinal materials
      It includes name, Chinese Pinyin, Latin name of medicinal materials, source, character, identification, inspection, extract, content determination, processing, nature, taste and meridian tropism, function and indications, usage and dosage, attention and storage, etc. the technical requirements of the relevant items are as follows:
      ; The Chinese name, Chinese pinyin and Latin name of medicinal materials shall be formulated according to the requirements of the naming principle of traditional Chinese medicine.
      2. the sources include the family name, Chinese name, Latin scientific name, medicinal parts, harvesting season, origin and processing of the original plants (animals). Mineral medicine includes the type, family, ore or rock name, main components and processing place of the mineral. ① The original plants (animals and minerals) shall be identified by relevant units to determine the family name, Chinese name and Latin scientific name of the original plants (animals); Chinese and Latin names of minerals. ② . ③ Harvest season and processing in origin refer to the best harvest season and processing method in origin that can ensure the quality of medicinal materials.
      3. character refers to the description of the shape, size, color, surface, texture, section, smell and other characteristics of medicinal materials. Except those that must be used fresh according to the description of fresh products, generally complete dried medicinal materials are the main; Breakable medicinal materials must also describe the broken part. .
      4. identification includes empirical identification, microscopic identification (histological section, powder or surface preparation, and microchemistry), general physicochemical identification, chromatographic identification, spectral identification, etc. chromatographic identification should include reference substance or reference medicinal material. The selection method should be specific, sensitive, fast and simple.
      5. the inspection includes impurities, moisture, ash, acid insoluble ash, heavy metals, pesticide residues and related toxic components, which shall be inspected according to the methods specified in Chinese Pharmacopoeia.
    . The limit (amplitude) index of the amount of extract should be formulated according to the measured data, and calculated according to the dry product of medicinal materials.
    7．Chinese medicinal materials. The description of operation steps should be accurate, and the terms and calculation units should be standardized.
    8. processing according to the needs of drug use, reasonable processing technology should be developed, and the amount of auxiliary materials and the quality requirements of processed products should be clear.
      9. functions and indications, usage and dosage, contraindications, precautions and storage are formulated according to the research results of this medicinal material.
      10. refer to Chinese pharmacopoeia for writing format.
    IIQuality standard of Chinese medicinal materialsDrafting instructions
      The purpose is to explain the reasons for formulating each item in the quality standard, and the basis, technical conditions and precautions for specifying the indicators of each item. There should be reasons for explanation, as well as summary of practical work and test data. Specific requirements are as follows:
      1. the name, Chinese pinyin and Latin name of medicinal materials should clarify the reasons and basis for determining the name.
      . The plant and animal medicinal materials introduced or wild to be domesticated should have data comparing with the original plants and animals. ② Reasons for determining the medicinal part and experimental research data. ③ Research data to determine the best harvesting season and processing method of the medicinal material.
      .
      4. identification   The basis for the selection of various identifications shall be described and all test and research data shall be provided, including the microscopic identifications of the microstructure, the easily visible characteristics of the powder and its ink line diagram or micrograph (indicating the magnification), the basis and test results of physical and chemical identifications, the optional conditions and Atlas of chromatographic or spectral identification tests (copy of the original diagram), and the color photos or color scanning diagrams of thin-layer chromatography. The reference substance and Caizhao medicinal material used for chromatographic identification should meet the "technical requirements for the study of reference substance for the quality standard of new Chinese medicine".
      5. check and explain the reasons for each inspection item and its test data, and clarify the significance and basis of determining the limit index of the inspection item.
    6. the test data of the solvent selection basis and the determination method research and the basis for determining the limit index of the extract (at least 20 data of 10 batches of samples should be available).
    . The principle of content determination method should be clarified; Determine the methodological investigation data and relevant spectra of the determination method (including the linear relationship, precision, reproducibility, stability test and recovery test of the determination method); Clarify the significance and basis of determining the content limit (there should be at least 20 data of 10 batches of samples). The reference substance and reference medicinal materials used for content determination should meet the "technical requirements for the study of reference substances for the quality standards of new Chinese medicine".
      8. processing, stating the purpose of processing the drug flavor and the basis for formulating the processing technology.
      9. sexual ambiguity and meridian tropism, function and indications shall meet the requirements of relevant clinical data of "new drug (traditional Chinese Medicine) application data project".
    3、 Latin nomenclature of traditional Chinese Medicine
      Latin names of traditional Chinese medicine can not only further unify the names of traditional Chinese medicine and prevent confusion, but also benefit foreign trade and international academic exchanges. The Latin name of traditional Chinese medicine generally needs to indicate the medicinal part, that is, it consists of the medicinal part name in the front (use the first grid) and the drug name in the back (use the second grid). The drug name is the Latin genus or species name of plants or animals. For example, Rhizoma Coptidis, folium Eriobotryae, Flos Carthami, semen Strychni, calculus bovis, etc., the first letter of each word should be capitalized. The naming of Latin names of traditional Chinese medicine includes the following:
      1. when only one species in a genus is used as medicine, or several species in a genus are used as the same medicine, the generic name is generally used; . For example, Cortex Eucommiae (only one plant species in a genus is used as a medicinal material), Herba Ephedrae (several plant species in a genus are used as the same medicinal material), Pericarpium Granati (species name, idiomatic usage).
      2. there are several varieties in the same genus. If they are used as different medicinal materials, they are named after the genus and species. Such as Radix Angelicae sinensis, Radix Angelicae Pubescentis,   Radix Angelicae dahuricae et al. If the Latin name of a medicinal material has been customarily adopted by the genus name, it is generally not changed, and the medicinal materials of other species of the same genus are named by the genus and species name for differentiation. Such as Herba asari, Herba asari forbesii, etc.
      3. if the medicinal part includes two different parts, the main or most parts shall be used. The column used is in front, and connected with ET (and) or SEU (or), such as rhubarb, Radix et rhzoma Rhei;the main content of rhubarb is as follows:the main content of rhubarb is as follows:the main content of rhubarb is as follows:the main content of rhubarb is as follows:the main content of rhubarb; Or named separately, such as Herba cirsiijaponici, Radix Cirsii japonici, etc. When the medicinal materials contain plants of different genera, they are named after two genera and connected by SEU. Add Herba erodii SEU geranii and concha Meretricis SEU Cyclinae.
      4. if there are adjectives in Latin names to describe the nouns of the preceding medicinal parts, they are listed at the end. Such as amarum in semenarmeniacae and amarum and pantotrichum in comu cervi pantotrichum.
      5. the Latin names of a few traditional Chinese medicines do not add medicinal parts, but are directly named by genus or species names, or common names, which follow customary usage, and some are internationally used names. Such as Poria cocos, Moschus musk, aloe aloe, catechu, Mel honey, Scorpio Scorpio, Eupolyphaga SEU Steleophaga, etc.
      6. mineral medicinal materials generally use the Latin name of the chemical composition contained in the mineral or the Latin name of the original mineral. Such as Glauber salt Natrii sulfas and calamine. .    
    According to the Latin names of crude drugs in foreign Pharmacopoeia, for example, the Japanese Pharmacopoeia puts the drug name in front (using the second grid), while the name of medicinal parts in the back (using the first grid), just contrary to the writing method in China. Such as Coptidis Rhizoma, sennae Folium, etc. However, the nomenclature of medicinal oils is the same as that in China, such as oleum cinnamo Mi of cinnamon oil. It can be seen that there is no uniform international regulation on the Latin names of crude drugs, and some of them belong to customary usage. If there is an international common name, the naming should be as consistent as possible for communication.