Analysis of TCM pharmaceutical production and production unit process

1. Pretreatment of the medicinal materials

The pretreatment of Chinese medicinal materials includes the removal of non-medicinal parts, the removal of impurities, the cutting of medicinal materials, and the necessary processing of four A part. In Chinese medicinal materials, only the useful parts of them are often used to remove their non-medicinal parts, such as root medicinal materials To the stem, with the stem needs to go to the root, shell, hair and so on, brought into the medicinal materials of impurities need to clean up, medicinal materials in the removal of miscellaneous cleaning After the need to be cut into a certain specification, and to go through the necessary processing process for production use. The pretreatment of Chinese medicine is Chinese medicine Pharmaceutical production is an indispensable link, but in recent years developed a batch of medicinal materials pretreatment equipment whether in performance, use The situation, operation control and other aspects are backward, which is a more prominent problem in the production of traditional Chinese medicine,

2. Extraction, isolation, and purification of the active ingredients of the medicinal materials

It is the goal of modern Chinese medicine to separate and remove the ineffective ingredients in medicinal materials. Taking powder is 100% medicine Material substances into the human digestive tract, taking decoction only accounts for 10%~15% of the total quality of medicinal materials, pills, tablets, hard Capsule agent also is the same, oral liquid, water injection agent and other liquid preparations using water lift alcohol sedimentation or flocculation clarification process is reduced to About 5%~8%, but the active substance purification is still far removed to such a degree from the quality requirements of modern drugs, only Only further breakthroughs in process technology can achieve higher purity, and new extraction, separation and purification technologies are not Broken appear.

In the 1990s, the extraction process of active ingredients of Chinese medicine mainly focused on solving the quality transfer of increasing the extraction process In terms of power and reducing the amount of solvent used, three-stage countercurrent dynamic extraction is an ideal process and equipment.on this basis, At present, it focuses on the efficiency of the solution process, that is, strengthening the extraction rate and improving the extraction rate of the active components, for example, Wall breaking technology (plus enzyme extraction, etc.), ultrasonic extraction, microwave extraction, pressurized extraction, supercritical dioxygen Carbon extraction, etc. The improvement of the purity of the traditional sedimentation, filtration, evaporation and concentration is far from enough Macroporous resin adsorption and separation, supercritical carbon dioxide extraction, membrane separation, etc., until industrial chromatographic separation, molecular distillation technology The comprehensive application of these modern separation technologies provides advanced high technology for the purification of active ingredients or component groups of TCM Methods of industrial separation.

3. Drug product and packaging

Chinese patent medicine from the traditional pill, powder, paste, Dan extended to tablets, hard capsules, soft capsules, oral liquid, water injection, Powder injection and other modern dosage forms, all means of modern drug production (process technology, equipment, clean technology, etc.) are almost all It can be used for Chinese medicine preparations, and sustained release, controlled release, transdermal absorption and targeted drug delivery are the development direction of Chinese medicine preparations. In addition, the progress of packaging technology and packaging materials provides good conditions for improving the quality of Chinese patent medicine. For traditional Chinese medicine What is important is how to use modern pharmaceutical preparations and packaging technology to develop modern Chinese medicine products and achieve large-scale industrialization produce.

TCM pharmaceutical production unit process

1.What is the cell process

The laboratory can easily complete operations such as material transfer, heating or cooling must be used in large production Process and equipment to carry out, thus forming a fluid flow, heat transfer, mass transfer and other batch of production unit process. Last century 2 In the 1910s, Walker summarized the various unit operations from numerous product production processes and studied them separately Theory, equipment, computing design, etc. In the process of Chinese medicine manufacturing, Chinese medicine pretreatment, extraction of active ingredients, Chinese medicine preparation All the industrial production processes of traditional Chinese medicine in agent production and decoction piece production are selected according to the needs of specific products These are combined with various unit operations that we call the TCM pharmaceutical unit processes.

1.Momentum transfer

• Fluid delivery: delivering energy to the fluid; from one to another; changing fluid pressure.
• Settlement: using gravity and centrifugal force to realize the separation of solid-gas and solid-liquid heterogeneous series.
• Filtration: using gravity, centrifugal force as the driving force, by the transition medium to achieve the solid-gas, solid-liquid non-uniform division leave.

2. Heat transfer

• Heating, cooling and condensation: the transfer of heat to the material to achieve its heating, cooling and condensation.
• Evaporation: transfer heat to the liquid to achieve solvent evaporation and concentration of the liquid.

3. Quality transmission

• Exleaching: extract the active ingredients (parts) of the Chinese medicinal materials into the solvent.
• Liquid-liquid extraction: purify the TCM extract with another solvent extraction.
• Distillation: recover the solvent to enrich the extract of medicinal materials.
• Water vapor distillation: to obtain the volatile oil components of the medicinal materials.
• Drying: drying and sterilization of extract, particles, solid preparations and medicinal packaging materials.
• Membrane separation (microfiltration, ultrafiltration, reverse osmosis, nanofiltration): fine filtration of traditional Chinese medicine solution, separation of components, and liquid medicine Of concentrated, microbial, or pyrogenic filtration.
• Supercritical CO2 extraction: separation and purification of lipid-soluble components of traditional Chinese medicine.
• Macroporous adsorption resin adsorption or industrial chromatography separation: separation and purification of Chinese medicine components.

4. Mechanical process

• Crushing: medicinal materials, extract, auxiliary materials crushing.
• Sieve: the particle size grading of powder materials.
• Mix: the mix of different powder materials.
• Granulation: powder granulation, tablet pressing, pill making, etc.

5.thermal process

• Freezing: to obtain a low temperature.
• Air conditioning: air conditioning in the production plant (especially the clean workshop).

2.Classification of the cell processes

The process of TCM production unit distinguishes the momentum, the heat and the mass transfer process according to the objective laws they follow And mechanical process and thermal process five categories. Some of these unit processes have been used for hundreds of years, such as momentum Heat transfer process, etc. Some are developed in recent decades due to the rapid development of modern technology, such as membrane division Separation, supercritical carbon dioxide extraction, macroporous resin adsorption separation, industrial chromatography separation, ultrascopic crushing, etc. The former is called Is a general cell process; and the latter is the emerging unit process.

3.The importance of studying the unit process of TCM pharmaceuticals

The unit process of TCM pharmaceutical is summarized from the industrial production process of a large number of TCM products, with TCM manufacturing Unit operation and equipment of drug characteristics, so familiar with the objective law, special equipment and operation of each TCM pharmaceutical unit process The principle and method, design and calculation are undoubtedly the basis of Chinese medicine, in the pilot research and industrial production The process has become one of the important research content, which we will continue to discuss in the subsequent articles. The next question is such as How to choose these unit processes to form a reasonable production process of specific Chinese medicine products, which is also compared with people on the unit Whether Cheng's research is deep or not is closely related. TCM pharmaceutical unit process and chemical industry unit process have a common side, unit The names and research contents of the process overlap, and all the achievements of the latter in the past hundred years can be made by traditional Chinese medicine pharmacy need. However, the unit process involved in the production of TCM manufacturing has its own emphasis, and some unit processes are in TCM manufacturing The product is frequently used in the production process, some are not; even the same unit process is because of TCM medicine A lot of targeted research is needed, so the study of the personality of the unit process of TCM pharmacy is even more important than the commonness.