Automatic decocting and aseptic packaging principl

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Abstract: This paper introduces the current situation of automatic decocting and aseptic packaging of traditional Chinese medicine at home and abroad. By analyzing the decocting mechanism of traditional Chinese medicine and combining modern electromechanical manufacturing technology, an integrated machine for automatic decocting and aseptic packaging of traditional Chinese medicine is designed, and the process flow, working principle and structure of each component of the machine are analyzed in detail, which lays a good foundation for further application and promotion

1. Overview

Chinese traditional medicine has a long history and has made great contributions to human health for thousands of years. With the deepening of the research on traditional Chinese medicine, he attracts more people to see traditional Chinese medicine with his unique charm. In China, almost every hospital has a traditional Chinese medicine clinic. People usually turn to traditional Chinese medicine for difficult and miscellaneous diseases. The patient takes the prescription home and decocts it after dispensing it according to the prescription of the traditional Chinese medicine doctor in the traditional Chinese medicine pharmacy. The traditional decocting method of traditional Chinese medicine is very particular, and has a great impact on the curative effect of traditional Chinese medicine. However, it is difficult to grasp the boiling process and heat. From the appliance to the heat, it is fried first and then taken. The boiling takes time, and it is very inconvenient to take and carry, which is extremely detrimental to the development and promotion of traditional Chinese medicine. How to realize the modernization of traditional Chinese medicine today, when a convenient, hygienic and efficient lifestyle has become the goal of people? How to realize the Chinese people's long cherished wish to let traditional Chinese medicine rush out of the country to the world? This is an urgent task before us. The development of traditional Chinese medicine decocting and aseptic packaging machine meets the needs of people's fast-paced life, is a good way to solve this problem, and has important practical significance

the data test-bed of traditional Chinese medicine and its automatic friction and wear testing machine series also has its own characteristics in computer-controlled operation. The research on equipment is mainly concentrated in the surrounding countries and regions of our country. Japan is a country with the longest history, the widest range, the highest level and the largest number of practitioners of traditional Chinese medicine

the research on the basis of traditional Chinese medicine and its equipment in Korea is also very active. Its focus is to improve the modernization level of the developed traditional Chinese medicine through the basic research work of traditional Chinese medicine, so as to obtain economic profits. In particular, some achievements have been made in the research on the decoction method of traditional Chinese medicine. After learning from the preparation methods of traditional Chinese medicine and prescriptions in China, South Korea took the lead in developing the decoction equipment and sterile packaging machine of traditional Chinese medicine in the world. In recent years, a small amount of it has been exported to China, which has been immediately welcomed by many large and medium-sized city hospitals, with a high utilization rate and a promising market prospect

therefore, Chinese medical equipment manufacturers began to research and imitate this equipment. Through investigation and research, we found that there are many problems in the current domestic equipment: blindly copying foreign equipment, the decoction process of traditional Chinese medicine often has an impact on the drug properties, the automatic control is not ideal, and the performance of sterile packaging is unstable

looking at the research status at home and abroad, we believe that it is necessary to conduct in-depth research on the boiling mechanism of traditional Chinese medicine in theory, integrate theory with practice, learn from foreign advanced technology, and learn from the experience and lessons of domestic enterprises, so as to design an integrated, miniaturized and automated traditional Chinese medicine boiling equipment and its sterile packaging machine to meet the needs of the domestic market. See Figure 1 for the process diagram of the all-in-one traditional Chinese medicine and sterile packaging machine

1 - safety valve; 2 - electric extrusion rod; 3 - pressure transmission display alarm; 4 - filter barrel; 5 - boiling pot; 6 - temperature transmission display alarm; 7 - solenoid valve; 8 - electric heater; 9 - horizontal cutting; 10 - horizontal seal; 11 - longitudinal sealing and traction; 12 - left and right packaging film rollers; 13 - flow regulating valve; 14 - liquid level transmission alarm; 15 - cleaning solenoid valve of packaging machine; 16 - liquid medicine container; 17 - exhaust port; 18 - tank cleaning solenoid valve; 19 - pressure relief solenoid valve

2. Process description

before starting up, sterilize the whole equipment piping system with steam for 30min; The equipment cavity is sprayed with H2O2 water mist for sterilization for 25min; The second is soaking. Before decocting the medicine, soak the medicine in clear water for 30min to soften it, and then heat it for decocting. You can't directly decoct it in boiling water, otherwise the protein in the medicine will soon solidify, affecting the decocting of the effective components in the traditional Chinese medicine

open the head of the decocting pot and add Chinese medicine and water into the decocting pot 5; Before turning on the power supply, set the temperature controller and liquid discharge timer on the PLC (usually in the state of 120 ~ 125 ℃, the time is set to 1H; turn on the power supply to keep the temperature at 120 ~ 125 ℃, and the pressure is about 1.5 ~ 1.7bar (Note: in fact, there may be errors of ± 10 ℃ and ± 0.5bar, because of the influence of different medicinal materials, different boiling capacity and the thickness of manually made internal heating plate); When discharging the medicine liquid, the solenoid valve 7 automatically opens to release 0.5bar of steam. (in order to better discharge the liquid medicine). In order to prevent overheating, the safety valve 1 on the head will automatically bleed after the pressure exceeds 2bar; After the above process, the solenoid valve 7 automatically opens, and the liquid medicine flows through the pipeline to the liquid medicine container 16 under its own pressure. At the same time, the electric extrusion rod 2 rotates until it stops, and slowly locks to ensure that all the liquid medicine flows out; Then, the liquid level transmission alarm 14 starts the automatic bag packing of the packaging machine; The sterile packaging area is full of sterile hot air and irradiated by ultraviolet light, so as to ensure that the filling and sealing of liquid medicine are carried out in a sterile state

3. Decocting pot

decocting pot refers to the apparatus for decocting traditional Chinese medicine. Choosing different containers as decocting apparatus has a great impact on the quality of liquid medicine, so it is required that the heat transfer speed of decocting apparatus is moderate and inert. Shi Zhen said, "decocting medicine should avoid copper and iron, and silver and earthen pots should be used.". Containers made of copper, iron, aluminum and tin have unstable chemical properties. Polyphenols such as tannins, flavonoids, coumarin, anthraquinone, etc. contained in the drugs to be decocted are very easy to combine with the metal ions released by the decocting instruments or be catalyzed by them to oxidize, which will deepen the color of the liquid medicine or produce peculiar smell. Cinnabar, etc. can react with copper, iron, aluminum, etc. to produce toxic free mercury. Aluminum reacts with organic acids, and the generated organic aluminum enters the human body with the drug solution, and accumulates in liver, kidney and brain tissues, which is harmful to health, such as inducing or aggravating Alzheimer's disease. Therefore, in practical work, ceramic products (such as casseroles) are often used as medicine decocting appliances, and stainless steel pots are also used (the heat transfer speed is too fast, and the crude ground and other decoction pieces are easy to stick to the pot, so it is necessary to stir frequently when decocting medicine). After repeated experiments and research, we choose stainless steel shell lined with ceramics, and make full use of the advantages of these two materials to make a boiling pot. In the sealed state, it is controlled by PLC, and the drug ingredients are fully fried at one time by boiling and the steam generated by it

4. Research on the mechanical structure of traditional Chinese medicine liquid packaging machine

traditional Chinese medicine liquid packaging machine must comply with the national GMP (GMP is the abbreviation of good manufacturing practice. The full name is good practice in the manufacturing and quality control of drugs) certification system. Specifically:

(1) simple structure, smooth surface, easy to clean. The equipment containing materials shall be sealed as far as possible to avoid exposure. The inner wall in direct contact with materials shall be smooth, flat, free of dead corners, easy to clean and corrosion resistant

(2) the inner surface of the equipment in direct contact with the material shall be made of materials that do not react with it, release particles and adsorb materials. Equipment and containers for producing sterile drugs should be made of high-quality low-carbon stainless steel

(3) the transmission parts of the equipment shall be well sealed to prevent the pollution of raw materials, semi-finished products, finished products, packaging containers and materials in case of leakage of lubricating oil, coolant, etc

(4) the equipment should be cleaned frequently. The equipment that is inconvenient to move should have local cleaning facilities, and the equipment that needs sterilization should also have local sterilization facilities. Parts that need cleaning and sterilization should be easy to disassemble

(5) dry air in direct contact with drugs should be equipped with purification devices. After purification, the particles and microorganisms contained in the gas shall meet the specified air cleanliness requirements

(6) except for special requirements, foundation bolts should not be set for equipment in the clean room (area)

(7) it should meet the verification requirements and set relevant parameter test points reasonably

(8) in addition to the above requirements, the equipment in the sterile clean room (area) should also meet the needs of disinfection or sterilization

(9) instruments and measuring devices on equipment or machinery should count accurately, and the adjustment and control should be stable and reliable. In case of disqualification or performance failure of the key control counting parts, there should be adjustment or 4. The experimental principle and method display function

(10) simple and reliable operation without errors. In case of product nonconformity, foreign matter mixing or performance failure, it shall have the function of adjustment or display

on the premise of meeting the above basic requirements and equipment functions, we try to simplify the design. The packaging machine adopts double film roll and four sides sealing type continuous bag making. The left and right film coils are configured symmetrically, and are pulled by the longitudinal sealing rollers through their respective guide rollers, and then enter the guide tube to meet. The film is sealed at both edges while being pulled to form two longitudinal sealing seams. After the horizontal sealing roller is closed, the material enters through the feeding pipe. Then, the cutting roll completes the transverse seal cutting

5. Characteristics of packaging sterile area

5.1 aseptic air

the air is filtered by coarse, medium and high efficiency, and heated to about 45e before entering the sterile area of the packaging machine, so that the equipment cavity forms a positive pressure during operation

filters can be selected according to the classification of air filters in China (see Table 1)

because the equivalent diameter of microorganisms is much larger than 0.5 μ m. Therefore, the filtration efficiency of the high-efficiency filter is nearly 100%, and the bacterial concentration at the outlet of the high-efficiency filter is close to 0%

the detection standard of sterility degree of sterile area can refer to the air cleanliness grade of clean workshop in medical industry (see Table 2)

general sterile area requires 100 grades

at the same time, if the traditional Chinese medicine decocting equipment and its sterile packaging machine are placed in a polluted environment, no matter how advanced their own performance is, it is difficult to ensure the product quality, so such equipment also has strict requirements on the site

(1) place the packaging machine in a clean room with aluminum alloy structure

(2) air curtain, air lock and other facilities shall be installed at the entrance and exit of the clean room

(3) positive pressure should be maintained indoors

(4) walls, floors and ceilings should be smooth, seamless and easy to clean

(5) operators should wear work clothes and the fabric fibers should not fall off

(6) the condition of indoor microorganisms should be checked frequently

5.2 ultraviolet rays irradiation sterilization

this equipment is equipped with several 20W ultraviolet light tubes, which are used to sterilize the packaging machine with H2O2 before startup; Sterilize the packaging film when starting up; After shutdown, the internal sterility of the equipment can be maintained

the ultraviolet wavelength is 2500 ~ 2600, and the light wavelength emitted by the ultraviolet lamp is 2537. When using ultraviolet ray for sterilization, the exposed objects need to be exposed for a long time. Dose up to 1000 ~ 3000 μ At WS/cm2, the killing rate of general bacteria reached 99%, but once the irradiation was stopped, there was no sterilization effect. Generally, ultraviolet lamps are accompanied by strong ozone production, which is harmful to human skin and eyes

the following problems should be paid attention to when using ultraviolet lamp for sterilization:

(1) lamp starting time: the efficiency between 100 ~ 3000h is 85% of the rated

(2) ambient temperature: the efficiency is the highest at 20 ℃, and only 60% at 0 ℃

(3) the effect is the best when the environmental relative humidity is 40% - 60%; The sterilization effect decreased at 60% - 70%; At 80%, it even has activation effect

(4) irradiation distance: within 500mm from the lamp tube, intensity and distance

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