CN115060632A - Colostrum quality automatic control device in elemene oral emulsion production process - Google Patents

Abstract

The invention belongs to the technical field of production process control, and discloses an automatic control device for colostrum quality in the production process of elemene oral milk. The device comprises an emulsifying tank, a high shearing machine arranged at the top of the emulsifying tank, an automatic accurate quantitative sampling system connected with the side surface of the emulsifying tank, an automatic time controller connected with the automatic accurate quantitative sampling system, a particle size distribution detector, an online detection and analysis system connected with the particle size distribution detector, and a control center connected with the device. The device realizes accurate online detection analysis control of key process steps of elemene oral emulsion colostrum, breaks through the inherent blind quality control parameter of 'emulsification for 30 minutes', greatly improves the one-time yield of the elemene oral emulsion, improves the product quality uniformity and stability, is also beneficial to reducing the corrosion and loss of an imported high-value instrument high-pressure homogenizer and prolongs the service life of equipment.

Description

An automatic control device for colostrum quality in the production process of elemene oral milk

technical field

The invention belongs to the technical field of production process control, and in particular relates to an automatic control device for colostrum quality in the production process of liposome antitumor drug elemene oral milk.

Background technique

Elemene oral milk is a liposome formulation made of elemene, soybean phospholipid and cholesterol. It is mainly used for the treatment of esophageal cancer and gastric cancer in clinic. In 2012, "Elemene Liposome Series Targeted Anticancer Natural Drug Industrialization Technology and Its Application" won the second prize of National Science and Technology Progress Award. In recent years, elemene oral milk has been widely recognized by clinical medical workers and patients, and product sales have increased year by year.

The industrial production of elemene oral emulsion liposome is mainly prepared by injection method, that is, the oil phase is injected into the water phase, and a milky suspension (MLV) is formed under the action of a high shear machine. This process step is also referred to as colostrum, and then homogenized. Quality, filling and sterilization. In the industrial production process of elemene oral emulsion, homogenization is usually considered as the key process step. The key process parameters such as mass temperature have a great influence on the key quality attributes of liposomes. At the same time, it is briefly described that the homogeneity of the starting material and the composition and content of lipids have a certain influence on the key quality attributes of liposomes. Through many years of research data, it is found that colostrum is also a key process step for liposome production, especially for elemene oral milk. The colostrum process of elemene oral milk is to emulsify for 30 minutes at a fixed speed of high shear machine. The key material soybean phospholipid is derived from natural plant soybean, and its composition is very complex, including phosphatidylcholine, phosphatidylglycerol, phosphatidyl Ethanolamine, phosphatidylserine, phosphatidic acid, sphingomyelin, lysophosphatidylcholine, lysophosphatidylethanolamine, etc. Therefore, different batches of soybean phospholipids have different phospholipid head groups and different conversion factors, and the colostrum process is an oil phase In the process of transforming from the water phase into a milky suspension, the phase transition time varies with the soybean phospholipid phospholipid head group in the colostrum process, so the index of elemene orally taking the milk colostrum for 30 minutes cannot effectively control the milkiness. quality of the suspension. If the colostrum is insufficient at 30 minutes, it may lead to incomplete encapsulation of elemene in the colostrum, because elemene is an effective anti-tumor component extracted and isolated from the traditional Chinese medicine Wen Zezhu oil. Strong fat-soluble, volatile and corrosive, it is easy to corrode the sealing rubber ring and metal particles of the homogenizer during homogenization, and the encapsulation rate after homogenization is low, and the product stability is not good; if the colostrum is too sufficient, MLV is prone to occur. The secondary particle size increases, and the homogenizer is blocked when it exceeds the upper limit of the homogenizer. In the actual production process, many blockages have occurred, resulting in the lockup of the homogenizer.

SUMMARY OF THE INVENTION

In order to overcome the deficiencies of the prior art, the present invention provides an automatic control device for colostrum quality in the production process of elemene oral milk, which can realize online automatic sampling, detection analysis and control, and improves the primary product of elemene oral milk. rate and stabilize the product quality of elemene.

The above object of the present invention is achieved through the following technical solutions: an automatic control device for colostrum quality in the production process of elemene oral milk, comprising an emulsifying tank, a high shearing machine, an automatic precise quantitative sampling system, an automatic time controller, Particle size distribution detector, online detection and analysis system, and control center; the emulsification tank is provided with a high shear head, and the high shear head is connected to the high shear machine located on the top of the emulsification tank; the automatic precise quantitative sampling system includes electric four-way control Valve, quantitative sampling tube, pneumatic control valve, solenoid valve, electric four-way control valve, one end of which is connected to the side of the emulsification tank, one end is connected to the solenoid valve B, one end is connected to the pneumatic control valve, and the last end is connected to the quantitative sampling tube. The lower end of the quantitative sampling tube is provided with Solenoid valve A and pneumatic control valve are connected with clean compressed air pipeline and solenoid valve C. Solenoid valve A is connected with particle size distribution detector, which is also connected with drain pipe and online detection and analysis system; solenoid valve C is connected automatically at the time The controller, the electric four-way control valve, the solenoid valve A, the solenoid valve B, the online detection and analysis system are connected to the control center, the time automatic controller is connected to the control center and is connected to the main circuit together with the high shear machine, and the control center is connected to the feedback control circuit .

Preferably, the volume of the quantitative sampling tube is 5ml.

Preferably, the particle size distribution detector is a laser particle size distribution detector based on the principle of laser diffraction.

Compared with the prior art, the beneficial effects of the present invention are as follows: 1. The particle size distribution detector adopts laser diffraction raw material laser particle size distribution detector, compared with dynamic light scattering (DLS) detector, static light scattering (SLS) detector, Coulter counters, optical microscopes, etc., laser particle size distribution detectors have the characteristics of sub-micron level, high precision of large particles, and fast detection speed. 2. The device realizes accurate online detection, analysis and control of the key process steps of elemene oral milk "colostrum", breaks the inherent blind quality control parameter "emulsification for 30 minutes", and greatly improves the one-time yield of elemene oral milk. , The uniformity and stability of product quality are improved, and it also helps to reduce the corrosion and loss of the high-pressure homogenizer imported high-value instruments, and prolong the service life of the equipment.

Description of drawings

The present invention will be further described below with reference to the accompanying drawings and specific embodiments

1 is a schematic structural diagram of an automatic control device for colostrum quality in the production process of elemene oral milk of the present invention.

1. Emulsifying tank; 101. High shear head; 2. High shear machine; 3. Electric four-way control valve; 4. Quantitative sampling pipe; 5. Pneumatic control valve; 6. Clean compressed air pipeline; 7 . Solenoid valve A; 8. Solenoid valve B; 9. Solenoid valve C; 10. Particle size distribution detector; 11. On-line detection and analysis system; 12. Automatic time controller; 13. Control center; 14. Drain pipe; 15 . Main circuit; 16. Feedback control circuit.

Detailed ways

The present invention is described in detail below through specific embodiments, but the protection scope of the present invention is not limited. Unless otherwise specified, the experimental methods used in the present invention are all conventional methods, and the experimental equipment, materials, reagents, etc. used can be obtained from commercial sources.

Example 1

An automatic control device for colostrum quality in the production process of elemene oral milk, comprising an emulsifying tank 1, a high shearing machine 2, an automatic precise quantitative sampling system, an automatic time controller 12, a particle size distribution detector 10, and an online detection and analysis system 11. The control center 13; the emulsification tank 1 is used to carry out colostrum, and the emulsification tank 1 is provided with a rotatable fan-shaped high shear head 101 for uniformly mixing the oil phase and the water phase, and the high shear head 101 is connected to the emulsification tank. The high shear machine 2 on the top of the tank 1 provides kinetic energy to the high shear head 101; the automatic precise quantitative sampling system includes an electric four-way control valve 3, a quantitative sampling pipe 4, a pneumatic control valve 5, a solenoid valve, and an electric four-way control valve 3 One end is connected to the side of the emulsification tank 1 to discharge the emulsion, one end is connected to the solenoid valve B8, one end is connected to the pneumatic control valve 5, and the last end is connected to the quantitative sampling tube 4 that can add emulsion, and the lower end of the quantitative sampling tube 4 is provided with a control emulsion The solenoid valve A7 for sample circulation, the pneumatic control valve 5 is connected to the clean compressed air pipeline 6 and the solenoid valve C9. The time automatic controller 12 controls the opening and closing of the pneumatic control valve 5 by controlling the solenoid valve C9. When the pneumatic control valve 5 is opened The air in the clean compressed air pipeline 6 is released to blow the emulsion into the quantitative sampling tube 4; the solenoid valve A7 is connected to the particle size distribution detector 10, and the particle size distribution detector 10 detects the emulsion sample in the quantitative sampling tube 4 when the solenoid valve A7 is opened. Particle size; the particle size distribution detector 10 is also connected with a drain pipe 14 for discharging the detected emulsion samples and an online detection and analysis system 11 for detecting and analyzing the transmission data of the particle size distribution detector 10; electric four-way control valve 3, solenoid valve A7, The solenoid valve B8 and the online detection and analysis system 11 are connected to the control center 13, and the time automatic controller 12 is connected to the control center 13 and is connected to the main circuit 15 together with the high shear machine 2. The main circuit 15 is the high shear machine 2, and the time automatic control The device 12 and the control center 13 provide electrical energy, and the control center 13 is also connected to the feedback control circuit 16 for its transmission of control signals, the capacity of the quantitative sampling tube 4 is 5ml, and the particle size distribution detector 10 is based on the principle of laser diffraction. Distribution detector 10.

The above-mentioned embodiments are only preferred embodiments of the present invention, rather than all possible embodiments of the present invention. For those skilled in the art, any obvious changes made to it without departing from the principle and spirit of the present invention should be considered to be included in the protection scope of the claims of the present invention.

Claims (3)

1. an automatic control device for colostrum quality in an elemene oral milk production process, is characterized in that, comprises emulsifying tank (1), high shearing machine (2), automatic precise quantitative sampling system, time automatic controller (12 ), a particle size distribution detector (10), an online detection and analysis system (11), and a control center (13); the emulsification tank (1) is provided with a high shear head (101), which is connected to the high shear head (101). The high shearing machine (2) is located on the top of the emulsification tank (1); the automatic precise quantitative sampling system includes an electric four-way control valve (3), a quantitative sampling pipe (4), a pneumatic control valve (5), a solenoid valve, and an electric four-way control valve (4). One end of the control valve (3) is connected to the side of the emulsification tank (1), one end is connected to the solenoid valve B (8), one end is connected to the pneumatic control valve (5), and the last end is connected to the quantitative sampling pipe (4), the quantitative sampling pipe (4) The lower end is provided with a solenoid valve A (7), the pneumatic control valve (5) is connected with a clean compressed air pipeline (6) and a solenoid valve C (9), and the solenoid valve A (7) is connected with a particle size distribution detector (10). The distribution detector (10) is also connected with a drain pipe (14) and an online detection and analysis system (11); the solenoid valve C (9) is connected to an automatic time controller (12), an electric four-way control valve (3), and a solenoid valve A (7), solenoid valve B (8), on-line detection and analysis system (11) are connected to the control center (13), and the time automatic controller (12) is connected to the control center (13) and together with the high shearing machine (2) The main circuit (15) is connected, and the control center (13) is connected to the feedback control circuit (16). 2. The automatic control device for colostrum quality in the production process of elemene oral milk according to claim 1, wherein the capacity of the quantitative sampling tube (4) is 5ml. 3. colostrum quality automatic control device in the production process of elemene oral milk according to claim 1, is characterized in that, described particle size distribution detector (10) is the laser particle size distribution detector (10) based on laser diffraction principle ).

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