Definition of classical formulas: It refers to the TCM compound preparation derived from ancient classical formulas, prescriptions which are still widely used, have definite curative effect, obvious characteristics and advantages, and are recorded in medical books in the Qing Dynasty and before.
Features and strengths of classical formulas: 1. It is still widely used, has clear curative effect, obvious characteristics and advantages; 2. There are many records and medical case evidence in ancient time, and many clinical and experimental research reports in modern literatures, so classical formulas have been further improved by TCM clinical practice and widely recognized by authoritative experts; 3. It is basically consistent with the material base of the decoction, and more time-saving, suitable for carrying and storage; 4. Using advanced technology and quality control technology for extraction, concentration, drying, granulation into granules to provide controllable quality and safe medication; 5. Classical formulas can only provide non-clinical safety research data and directly apply for production.
Technical difficulties of classical formulas: 1. The medicinal materials are uniformly used to prepare qualified Chinese medicine decoction pieces, which are consistent with ancient medical records. Due to different medical records of different dynasties, the names of prescription and medicinal materials of each hospital are different. All Chinese herbal pieces used in the production of classical formulas need to be processed in a unified and standardized way by the manufacturers themselves, producing decoction pieces which are consistent with the original ancient medical records and meet the modern standards. 2. Classical formulas adopt modern preparation technology to make them in line with modern application. They are different from the original prescriptions recorded in ancient medical books, so it is necessary to establish standards of fingerprint/characteristic spectrum, so as to ensure the effectiveness and quality consistency of classical formulas compared with original prescriptions to the greatest extent; 3. There are many kinds of classical formulas, so we need to design a reasonable preparation process for different kinds of Chinese medicine; 4. The heat sensitive components are easy to be destroyed and volatile components are easy to be lost when heated for a long time. Therefore, the extraction and preparation technology of medicinal materials containing volatile oil are very important; 5. In order to reduce the dosage, it is necessary to use the appropriate method and the least adjuvants to prepare stable products.
Key technologies of the center's technology platform: 1. Solving the key technical problems in the production of classical formulas, using advanced modern production equipment, analytical equipment and core technologies, carrying out systematic and targeted research on extraction technology, concentrated drying technology, preparation molding technology, quality analysis technology of classical formulas, mastering the production and evaluation techniques of different properties and varieties of classical formulas, and effectively solving the key technical problems in the production of classical formulas; 2. Establishing fingerprint/characteristic spectrum of each classical formula, strengthening the specific identification of classical formulas, so as to ensure the effectiveness and quality consistency between batches of classical formulas to the greatest extent; 3. Establishing a quality assurance system covering the whole industrial chain from raw materials to production to use, and establishing standards, including standards for TCM materials, Chinese herb pieces, decoction, intermediate and finished products; 4. The whole research process is compared with the standard decoction. According to the indications of each product, screens the types and dosages of adjuvants on the basis of ensuring the quality of the classical formula preparation, and selects the best pharmaceutical formulation, and sets the quality standard for classical formulas according to average value of all batches of standard decoction.