Production Technology in Chinese Patent Medicine Preparations

Oct 12, 2022

For the preparation process of traditional Chinese medicine, the selection and processing of raw materials are very important to the quality of production and its testing, and the raw materials are directly related to the safety of Chinese patent medicine preparations. Therefore, the production of pharmaceutical companies should pay more attention to the quality of preparations, and regard improving the quality as an important task. The control of the quality of traditional Chinese medicine requires enterprises to implement strict quality control in the entire production process from raw materials to final product formation. So how to effectively implement the production process of traditional Chinese medicine preparations?


There are two commonly used methods for the production of traditional Chinese medicine:


1. Retaining its shape or the original properties of the drug is the preliminary processing of the drug;


2. In-depth production makes it into capsules, sugar tablets and other products;


The preparation process of decoction pieces is similar to that of oral solid preparations. The extraction and separation technology in the production process of Chinese patent medicine preparations is different from that of Western medicine preparations. The production process of traditional Chinese medicine preparations is more advanced in drug extraction and separation technology, compared to traditional extraction and separation technology. The current technology It has been greatly improved, and the production efficiency has been greatly improved in the application of modern technology, and the quality of its products has also been guaranteed.


1. Clean system


The effect of net preparation is to extract the medicinal components of the medicinal materials, remove the non-medicinal parts and impurities so that the medicinal materials can reach the required level and standard, and at the same time, it is convenient for cutting, processing, and preparation. Different types of medicinal materials use different purification processes, which can be carried out by selection, wind selection, water selection, shearing, and cutting.

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2. Cannon fire


Boilering is a method of processing medicinal materials after washing and cutting them into fire, water or a combination of water and fire. The effect makes some changes in the medicinal properties, efficacy, trend, meridian return and physical and chemical aspects, which can detoxify, inhibit bias, and enhance the curative effect.


3. Cutting


Cutting refers to cutting the net medicinal materials into slices, blocks, segments, etc. for production, but it is necessary to comprehensively consider the origin, processing methods and extraction techniques of medicinal materials. The purpose is to improve the quality by means of gunfire and so on.

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4. Crush


Crushing is a method of extracting some relatively hard and difficult-to-cut medicinal materials into powder, and some more expensive medicinal materials can be directly used as medicine after being crushed.

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For drug pulverization, the characteristics of the preparation need to be considered, and attention should be paid to the pulverization particle size, disposal rate, temperature, method, etc., to ensure that it is used in the subsequent process requirements. Pulverization methods are diverse, such as: dry pulverization, wet pulverization, low temperature pulverization and micropowder pulverization.


5. Extract


Extraction specifically refers to transferring the soluble substances in the medicinal materials into the solvent by using a certain solvent and using a certain method, and the solvent enters the medicinal materials' cell tissues and dissolves its effective components. This is the process of transferring the medicinal materials to the liquid phase for mass transfer. Principle basis. Extraction is divided into continuous extraction, ultrasonic extraction, etc. The solvent used for extraction can be water or other organic solvents.


6. Separation and refining


Sometimes some more ineffective components are extracted, which directly leads to the high rate of concentrated paste. Appropriate separation and purification can be carried out before concentration in order to improve the purity. For the production process of traditional Chinese medicine tablets, there are sedimentation, centrifugation, filtration and separation methods, and purification by water extraction and alcohol precipitation, acid-base method, etc.


7. Concentrate


The general method of concentration is to extract part of the solvent in the liquid to obtain a higher concentration. Conventionally, evaporation is achieved, and there are also methods for concentrating the liquid through reverse osmosis and ultrafiltration. In actual production, boiling evaporation is used to concentrate the liquid medicine.

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8. Sterilization


In the production of proprietary Chinese medicines, some traditional Chinese medicines are directly used as medicines after being crushed, and some bacteria will be produced during the crushing process. After the implementation of GMP2010, most enterprises began to pay attention to the problem of bacterial treatment of drug quality. The commonly used sterilization methods mainly include:


A. Dry heat sterilization: weak penetration, uneven temperature, and high sterilization temperature, not suitable for rubber, plastic and most drugs.


B. Moist heat sterilization: steam has strong specific heat and strong penetrating power, which can easily lead to protein denaturation, but it is reliable and easy to operate. One of the most widely used methods in formulation production. But the disadvantage is that it takes a long time, and the heat dissipation is slow.


C. Radiation sterilization: It is used for sterilization of Chinese medicinal materials, but the cost of this type of sterilization equipment is high, and some products will reduce the effect after sterilization, produce toxic or heat-generating substances, and the solution is not as stable as the solid, so attention should be paid to safety protection and radiation residues.


D. Microwave sterilization: This method can kill microorganisms and spores, and is suitable for liquid and solid to have a drying effect on solid materials. At present, the research on microwave sterilization equipment is still insufficient. Finding a safe, cost-effective device for solids sterilization is a common problem faced by the industry.


The existing sterilization equipment has problems such as long sterilization time, high temperature, high energy consumption, complex equipment and high cost, and there are uncertainties in the impact on the chemical composition of traditional Chinese medicine. Obvious defects, can not guarantee the quality of medicinal materials or preparations. Problems such as these can be achieved by improving existing equipment or innovating new equipment, so as to achieve the purpose of economy, efficiency and safety, and at the same time, it can save energy and protect the environment and improve the quality of finished products. It is believed that it will have an important positive impact on the pharmaceutical industry.


If you have any questions about more TCM production process and want to cooperate with us, send an Email to contact us:wallence.suen@wecistanche.com

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