CN110538147A - Invert sugar injection and preparation process thereof - Google Patents
Invert sugar injection and preparation process thereof Download PDFInfo
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- CN110538147A CN110538147A CN201910950631.2A CN201910950631A CN110538147A CN 110538147 A CN110538147 A CN 110538147A CN 201910950631 A CN201910950631 A CN 201910950631A CN 110538147 A CN110538147 A CN 110538147A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/02—Nutrients, e.g. vitamins, minerals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/21—Pharmaceuticals, e.g. medicaments, artificial body parts
Abstract
The invention provides an invert sugar injection and a preparation process thereof, wherein the invert sugar injection comprises the following components: in the water for injection, anhydrous glucose and fructose were added. The method comprises the steps of pumping water for injection into a thick preparation tank, sequentially adding anhydrous glucose and fructose according to the prescription amount, stirring and dissolving, adding activated carbon, stirring, adsorbing and decarburizing; adding the medicinal liquid into a diluting preparation tank, supplementing water for injection to full volume, and adjusting pH value; and (6) filling, sterilizing and packaging. The invention provides a new proportioning component of invert sugar injection and proportioning proportion. The invert sugar injection has better treatment effect. The present invention provides a new production preparation process of invert sugar injection. The production and preparation process has good sterilization effect.
Description
Technical Field
the present invention relates to an injection and its preparation process. Belongs to the field of injection medicine production.
Background
the invert sugar injection is a sterilized aqueous solution consisting of fructose and glucose in equal amounts, and is suitable for the fluid replacement therapy of patients needing non-oral water or energy supplement or used as a diluent of other medicines. The human preparation proportion of the invert sugar injection has not been better, so that the prior invert sugar injection has low drug effect and needs to be further improved in treatment effect.
In the production process of injection, aseptic production is always the key of injection production, and multiple times of sterilization are carried out in the process of producing injection so as to control the total number of bacteria within the qualified number.
The same is true of the production process of invert sugar injection, which must control the total bacterial count. The existing control method mainly comprises the steps of carrying out once activated carbon adsorption, degerming and impurity removal in a thick preparation tank after the preparation pharmaceutical industry is finished in a high-cleanness production environment area. Then filtering and decarburizing to finish sterilization. Depending on the mode, to achieve better sterilization, a sufficient amount of activated carbon must be added, and the activated carbon must be stirred and mixed in the concentration tank for a sufficient time to achieve better bacteria adsorption.
However, when the amount of the activated carbon in the concentration tank is too large and the adsorption time is too long, the active ingredients in the pharmaceutical industry in the concentration tank can be adsorbed, so that the amount of the active ingredients in the final product is reduced, and if the amount of the activated carbon is too large, new pollution is caused to the liquid medicine, and the procedure and cost for later-stage decarburization are increased. Therefore, in the production process of the existing invert sugar injection, the consumption of the activated carbon must be controlled, the sterilization effect and the consumption of the activated carbon are balanced, the sterilization requirement is properly reduced, the bacteria quantity can reach the standard within the specified control quantity, and the bacteria quantity is not further controlled.
For the invert sugar injection, the lower the number of bacteria contained in the invert sugar injection, the safer the invert sugar injection is theoretically injected into human blood, the faster the bacteria grow, and the unknown bacteria can grow in various complicated environments, so that if the number of bacteria packaged in the liquid medicine at the early stage is lower, the number of bacteria growing in the liquid medicine at a later stage in a period of time in stock is certainly lower. In the production period of the liquid medicine, it is very important to effectively sterilize the liquid.
Therefore, in the existing production mode of invert sugar injection, the aim of better controlling the bacterial quantity is to improve the medicine effect loss and increase the filtration cost, which belongs to the problem contradiction which is difficult to solve.
Disclosure of Invention
In order to solve the problems, the invention provides an invert sugar injection and a preparation process thereof. Wherein, the invert sugar injection comprises the following components: in the water for injection, anhydrous glucose and fructose were added.
The invert sugar injection is prepared by adding 10% HCL into water for injection.
The invert sugar injection is prepared from the following components in parts by weight: 250 parts of water for injection, 12.5 parts of fructose and 12.5 parts of anhydrous glucose.
The preparation process of the invert sugar injection provided by the invention is completed by the following steps,
(1) Adding water for injection into a concentration tank, sequentially adding anhydrous glucose and fructose according to the formula amount, stirring for dissolving, adding activated carbon, and stirring for adsorption;
(2) Removing carbon;
(3) Injecting the liquid medicine into a diluting preparation tank, repeatedly flushing the concentrating preparation tank with injection water, and injecting the flushing water into the diluting preparation tank;
(4) Supplementing water for injection to full volume in the diluting preparation tank, and adjusting the pH value;
(5) Circulating to make the liquid medicine uniform, and taking the intermediate to monitor the pH value of the liquid medicine;
(6) filtering the liquid medicine until the visible foreign matters are qualified, and sampling and measuring the PH value;
(7) Filling, sterilizing and packaging.
The preparation process of the invert sugar injection comprises the following specific steps:
Injecting water for injection into the thick preparation tank, specifically, adding 60% of the total amount of the water for injection into the thick preparation tank;
The active carbon is added, specifically, the diluted ligand volume is 0.02% (W/V) active carbon, and the stirring is carried out for about 15 minutes.
The decarbonization is specifically carried out by filtering through a titanium rod;
The pH value is adjusted by 10% HCL to be: 4.7 to 5.3;
Filtering the liquid medicine until the visible foreign matters are qualified, specifically, filtering the liquid medicine through a 0.22-micrometer microporous filter until the visible foreign matters are qualified;
And specifically, carrying out constant-temperature sterilization on the mixture by using superheated water bath at the temperature of 121 ℃ for 10 minutes.
The preparation process of the invert sugar injection comprises the following steps of: (1) preparing ingredients: anhydrous glucose and fructose; (2) carrying out ultrasonic sterilization: adding injection water with more than 5 times volume of the ingredients into an ultrasonic tank, putting the ingredients into the ultrasonic tank, performing ultrasonic oscillation for 8-10 minutes to perform primary sterilization, and dissolving the ingredients into the injection water; (3) and introducing the sterilized and dissolved ingredients into a concentration tank.
The preparation process of the invert sugar injection comprises the following specific steps of: the sound intensity is 1-5W/cm2, the frequency is 30-40KHz, and the bottom of the ultrasonic tank generates 10.5 μm amplitude; the ultrasonic output power is 45-55w, the ultrasonic wave is pulse wave, and the pulse width is 8-12 ms.
The preparation process of the invert sugar injection comprises the following steps of supplementing injection water to the full amount in a diluting preparation tank, and then carrying out reflux water shearing sterilization in the diluting preparation tank; the reflux water shearing sterilization is specifically that the liquid in the blending tank is stirred and repeatedly rotated for 20-25 minutes.
The preparation process of the invert sugar injection comprises the following steps of stirring the liquid in the diluting and blending tank to rotate repeatedly, wherein the liquid in the diluting and blending tank is stirred to rotate for 1 to 3 minutes from one direction, then the liquid in the diluting and blending tank is stirred to rotate for 1 to 3 minutes from the other direction, the rotation is repeated, and the rotation direction is changed every 1 to 3 minutes to generate high shear force;
the stirring method for stirring the liquid in the diluting preparation tank to rotate repeatedly comprises the following steps: the water outlets of a plurality of first group of reflux pumps are arranged on the outer wall of the diluting preparation tank in a clockwise direction and from the tangential direction of the inner circle of the diluting preparation tank, the water inlets of the first group of reflux pumps are arranged at the bottom of the diluting preparation tank, and the arranged first group of reflux pumps complete the stirring of the clockwise rotation in the diluting preparation tank;
The water outlets of a plurality of second groups of reflux pumps are arranged on the outer wall of the diluting preparation tank in the anticlockwise direction and from the tangential direction of the inner circle of the diluting preparation tank, the water inlets of the second groups of reflux pumps are arranged at the bottom of the diluting preparation tank, and the arranged second groups of reflux pumps complete the stirring of the anticlockwise rotation in the diluting preparation tank;
The first group of reflux pumps and the second group of reflux pumps are repeatedly and alternately started to enable the liquid in the diluting preparation tank to repeatedly rotate to generate high shearing force;
The water outlet parameters of the water outlet are as follows: the flow rate is more than 50L/min, and the flow speed is 2-3.5 m/s.
The preparation process of the invert sugar injection comprises the following steps of continuously and repeatedly rotating and stirring liquid in a diluting tank in the filling process; stirring the liquid in the diluting and blending tank for 3-5 minutes, then reversely stirring the liquid in the diluting and blending tank for 3-5 minutes, repeatedly rotating in the way, and converting the rotating direction every 3-5 minutes to generate high shearing force;
until the liquid medicine in the diluting preparation tank is canned.
has the advantages that:
The invention provides a new proportioning component of invert sugar injection and proportioning proportion. The invert sugar injection has better treatment effect.
The present invention provides a new production preparation process of invert sugar injection.
the production and preparation process has good sterilization effect.
under the condition of not adding more active carbon for adsorption sterilization, ultrasonic sterilization, sterilization by the shearing force of boiling water in the concentrated preparation tank, sterilization by the shearing force of reflux water in the diluted preparation tank and multiple sterilization steps are facilitated, so that the total amount of bacteria in the liquid medicine is better reduced. Or under the condition of keeping the total amount of bacteria in the existing liquid medicine unchanged and qualified products, the invention can reduce the dosage of the active carbon and reduce the adsorption time of the active carbon so as to keep the effective components of the liquid medicine.
Detailed Description
the invention is firstly dissolved, then concentrated, diluted and finally canned.
The invention carries out ultrasonic sterilization during dissolution, then carries out concentrated preparation boiling sterilization, then carries out water flow sterilization in a diluting preparation tank, and finally carries out canning, and simultaneously carries out water flow sterilization.
The first embodiment is as follows: the composition of unit dose of the product
| Composition (I) | dosage of | Is added in excess | function of | Execution criteria |
| Anhydrous glucose | 12.5g | is free of | Active substance | 2010 version two parts 927 page of Chinese pharmacopoeia |
| Fructose | 12.5g | Is free of | active substance | Page 1204 of the second part of the Chinese pharmacopoeia 2010 edition |
| Dilute hydrochloric acid | proper amount of | is free of | pH regulator | page 1215 of 2010 version of Chinese pharmacopoeia |
| Water for injection | 250ml | is free of | Solvent(s) | second 500 pages of Chinese pharmacopoeia 2010 edition |
Example two: a total of 1750L of 250ml invert sugar injection was prepared.
| Composition (I) | Dosage (Kg) | Is added in excess | Function of | Execution criteria |
| anhydrous glucose | 87.5 | is free of | Active substance | 2010 version two parts 927 page of Chinese pharmacopoeia |
| fructose | 87.5 | is free of | Active substance | Page 1204 of the second part of the Chinese pharmacopoeia 2010 edition |
| Dilute hydrochloric acid | Proper amount of | is free of | pH value regulator | page 1215 of 2010 version of Chinese pharmacopoeia |
| Water for injection | 1750L | Is free of | Solvent(s) | second 500 pages of Chinese pharmacopoeia 2010 edition |
Example three:
1. Concentration and preparation: 60 percent of the total amount of water for injection is added into a thick preparation tank, and anhydrous glucose and fructose are added according to the prescription amount in turn and stirred for dissolution.
2. Adding diluted product 0.02% (W/V) active carbon, stirring for about 15 min, filtering with titanium rod to remove carbon, adding flush water into the diluted tank, adding injection water to full volume, and circulating to make the liquid medicine uniform.
3. Diluting and preparing: adding water for injection to nearly full dose, adjusting the pH value with 10% HCL: 4.7-5.3, adding water to full amount, and circulating uniformly. After the content and the pH value of the semi-finished product are detected to be qualified, the liquid medicine is filtered by a 0.22 mu m microporous filter until the visible foreign matters are qualified.
4. And (6) filling and sealing. Sterilizing with superheated water bath at 121 deg.C for 10 min. And (6) inspecting and packaging by using a lamp.
example four:
1. Preparing ingredients: anhydrous glucose and fructose.
2. Carrying out ultrasonic sterilization: adding 100L of water for injection into an ultrasonic tank, putting half of the ingredients into the ultrasonic tank, and carrying out ultrasonic oscillation for 8-10 minutes to carry out primary sterilization, wherein the ultrasonic oscillation parameters are as follows: the sound intensity is 1-5Wcm2, the frequency is 30-40KHz, and the bottom of the ultrasonic tank generates 10.5 mu m amplitude; the ultrasonic output power is 45-55w, the ultrasonic wave is pulse wave, and the pulse width is 8-12 ms.
Dissolving the ingredients in water for injection while performing a first sterilization; and introducing the sterilized and dissolved ingredients into a concentration tank.
the other half of the batch was again sterilized and dissolved in the ultrasonic tank using the above procedure, and then introduced into the concentration tank as well. And the ultrasonic tank is flushed with water for injection, and the flushing water is led into the thickening tank.
3. 60% of the total amount of water for injection is added into the concentration tank.
4. Adding 0.02% (W/V) of activated carbon in diluted ligand volume, and stirring for about 15 minutes. Filtering with titanium rod to remove carbon.
5. pumping the medicinal liquid into diluting preparation tank, repeatedly flushing the concentrating preparation tank with water for injection, pumping into diluting preparation tank,
6. supplementing water for injection to full volume in the diluting preparation tank, and then carrying out reflux water shearing sterilization in the diluting preparation tank; the reflux water shearing sterilization is specifically that the liquid in the blending tank is stirred and repeatedly rotated for 20-25 minutes. Specifically, the liquid in the diluting and blending tank is stirred for 1-3 minutes, then the liquid in the diluting and blending tank is stirred for 1-3 minutes from the reverse direction, the rotation is repeated, and the rotation direction is changed every 1-3 minutes to generate high shearing force.
The stirring method for stirring the liquid in the diluting preparation tank to rotate repeatedly comprises the following steps: the water outlets of a plurality of first group of reflux pumps are arranged on the outer wall of the diluting preparation tank in a clockwise direction and from the tangential direction of the inner circle of the diluting preparation tank, the water inlets of the first group of reflux pumps are arranged at the bottom of the diluting preparation tank, and the arranged first group of reflux pumps complete the stirring of the clockwise rotation in the diluting preparation tank;
The water outlets of a plurality of second groups of reflux pumps are arranged on the outer wall of the diluting preparation tank in the anticlockwise direction and from the tangential direction of the inner circle of the diluting preparation tank, the water inlets of the second groups of reflux pumps are arranged at the bottom of the diluting preparation tank, and the arranged second groups of reflux pumps complete the stirring of the anticlockwise rotation in the diluting preparation tank;
the first set of reflux pump and the second set of reflux pump are alternately started repeatedly to make the liquid in the diluting preparation tank rotate repeatedly to generate high shearing force. The water outlet parameters of the water outlet are as follows: the flow rate is more than 50L/min, and the flow speed is 2-3.5 m/s.
7. The pH was adjusted with 10% HCL to: 4.7 to 5.3;
8. Circularly homogenizing the liquid medicine, and taking an intermediate to monitor the pH value of the liquid medicine;
9. Filtering the liquid medicine through a 0.22 mu m microporous filter until the visible foreign matters are qualified. Then, the pH was measured by sampling.
10. Filling, and continuously rotating and stirring the liquid in the diluting preparation tank repeatedly in the filling process; specifically, the liquid in the stirring and diluting tank rotates for 1-3 minutes, then the liquid in the stirring and diluting tank rotates for 1-3 minutes from the reverse direction, the rotation is repeated, the rotation direction is changed once every 1-3 minutes, high shear force is generated, and the stirring mode is the same as the reflux water shearing sterilization mode. Until the liquid medicine in the diluting preparation tank is canned.
11. Sterilizing with superheated water bath at 121 deg.C for 10 min. And (6) packaging.
The stirring device for stirring the liquid in the diluting preparation tank to rotate repeatedly is as follows: set up two sets of backwash pumps on the tank is joined in marriage to the rare, and first set of backwash pump is used for stirring the interior liquid clockwise rotation of tank is joined in marriage to the rare, and the second set of backwash pump is used for stirring the interior liquid anticlockwise rotation of tank is joined in marriage to the rare.
the delivery port of first set of backwash pump sets up on the tank outer wall of rare matching with clockwise and from the circle tangential direction in the rare matching jar, for example, first set of backwash pump sets up 5 delivery ports, evenly from the top down distributes on the tank outer wall of rare matching. When the 5 water outlets spray liquid into the diluting preparation tank at a high speed along the tangential direction, the liquid medicine in the diluting preparation tank is stirred to rotate clockwise.
The water inlet of the first set of reflux pump is arranged at the bottom of the diluting preparation tank, and the liquid medicine is sucked from the bottom of the diluting preparation tank. Therefore, the liquid medicine is circulated by the first group of reflux pumps.
The water outlet of the second group of reflux pumps is arranged on the outer wall of the diluting preparation tank in the anticlockwise direction and in the tangential direction of the inner circle of the diluting preparation tank, and the first group of reflux pumps is referred to by other structures. The second group of reflux pumps agitates the liquid medicine in the diluting preparation tank to rotate anticlockwise.
The first set of reflux pump and the second set of reflux pump are alternately started repeatedly to make the liquid in the diluting preparation tank rotate repeatedly to generate high shearing force.
In the embodiment of the invention, various ingredients are firstly put into the ultrasonic tank for dissolution, and then ultrasonic sterilization is carried out. The ultrasonic wave is composed of a series of longitudinal waves with alternate density and is transmitted to the periphery through a liquid medium. When the sound energy is high enough, the attractive force among liquid phase molecules is broken in a loose half period to form a cavitation nucleus, the service life of the cavitation nucleus is about 0.1 mu S, the cavitation nucleus can generate local high-temperature and high-pressure environments of about 4000K and 100MPa at the moment of explosion, and generates microjet with strong impact at the speed of about 110m/S, the action of the microjet can form strong mechanical stirring effect among interfaces, and the effect can break through the limit of laminar boundary, so that the chemical reaction process and the transfer process among the interfaces are strengthened.
Ultrasonic waves are sound waves with a frequency greater than 20kHz and are mechanical vibrations that propagate in a medium. Due to the high frequency and short wavelength, the ultrasonic wave can cause cavitation and a series of special effects such as mechanical effect, thermal effect, chemical effect and biological effect besides the characteristics of good directivity, high power, strong penetrating power and the like. The sterilization effect of the ultrasonic wave is mainly due to the cavitation effect generated by the ultrasonic wave, so that the contents of the microbial cells are strongly vibrated, and the destruction effect on the microbes is achieved. The cavitation is a cavitation phenomenon that when ultrasonic waves act in a medium and the intensity of the ultrasonic waves exceeds a certain air threshold value, tiny bubble nuclei in liquid are activated under the action of the ultrasonic waves and show a series of dynamic processes such as oscillation, growth, shrinkage and collapse of the bubble nuclei. At the moment of adiabatic shrinkage and collapse, the air bubbles have a high temperature of 5000 ℃ or higher and a temperature change rate of 109K/s, and generate strong shock waves of 108N/m 2. The ultrasonic cavitation effect is utilized to generate local instantaneous high temperature, temperature alternation change, local instantaneous high pressure and pressure change in the liquid, so that certain bacteria in the liquid are killed, viruses are inactivated, and even cell walls of a few microorganisms with small volume are damaged.
In this example, the ultrasonic sterilization effect is as follows:
| Duration of sterilization | Output power | Frequency of ultrasonic waves | Sterilizing effect |
| 1 minute | 50w | 30KHz | 8％ |
| 3 minutes | 50w | 30KHz | 14％ |
| 5 minutes | 50w | 30KHz | 17％ |
| 7 minutes | 50w | 30KHz | 21.5％ |
| 9 minutes | 50w | 30KHz | 22.5％ |
| 10 minutes | 50w | 30KHz | 23.3％ |
| 13 minutes | 50w | 30KHz | 24.0％ |
| 15 minutes | 50w | 30KHz | 24.4％ |
in the ultrasonic sterilization test, the sterilization time affects the final sterilization effect, and a longer sterilization time brings a better sterilization effect, and when the sterilization time is 5 minutes or more, the sterilization effect is greatly increased, but when the sterilization time exceeds a certain time, the sterilization effect is not increased in proportion to 13 minutes or more, so that the sterilization time within 5 to 10 minutes is considered to be most significant. The invention takes 5-10 minutes of ultrasonic sterilization time in the implementation, and balances the use cost and time of ultrasonic sound and sterilization.
The diluting preparation tank adopts a rotary injection water sterilization mode.
The volume of the ultrasonic tank is the minimum and is less than 1000L, so that ultrasonic oscillation can be utilized, but the volumes of the concentration tank and the diluting tank are too large, and the cost is too high due to the adoption of ultrasonic oscillation.
Because the high-speed circulating water flow for injection prevents bacteria from adhering to the wall surface of the container, and the circulating water flow for injection has uncertain turbulence, molecules of water for injection are squeezed to each other to generate shearing force, and the shearing force has destructive effect on cells. Thereby achieving a certain effect.
But the shearing force sterilization of the injection water flow which is beneficial to high-speed circulation is not suitable for too long time, and the canning is completed within 16 hours because the canning time of the liquid medicine prepared by the liquid medicine person of the invention is not suitable for too long time. Therefore, the time of each step of the process must be strictly controlled, secondly, the shearing force sterilization effect of the injection water is limited, and when the circulation time exceeds 30 minutes, the sterilization effect is reduced, and the extension time becomes meaningless. Therefore, the water shearing force sterilization cycle time for injection is 20-25 minutes.
In the canning process, the liquid in the diluting preparation tank is continuously and repeatedly rotated and stirred until the liquid medicine in the diluting preparation tank is canned. Further inhibiting bacterial growth during this period.
The invert sugar injection has feasible preparation process, and the three-batch sample amplification production result shows that the invert sugar injection has good preparation process reproducibility.
Stability studies show that: an accelerated test for 6 months shows that the pH value of the product is slightly reduced, 5-HMF is in an increasing trend, each batch is within the limit of quality standard, the content of partial components of the product is slightly increased to about 3-4% due to certain permeability of the packaging material, and other indexes all meet the standard specification of the product; the long-term test for 18 months proves that the product has no obvious change in appearance and pH value, the detection result of 5-HMF is slightly increased compared with that of 0, the absorbance is between 0.05 and 0.06 and is far lower than the standard limit, and all content indexes are within the specified content limit range. Therefore, the product has stable quality and controllable quality.
Clinical research shows that compared with glucose injection, the invert sugar injection only contains half of glucose, has smaller influence on fluctuation of blood sugar and insulin level, is suitable for non-diabetic patients and diabetic patients to supplement energy, can obviously reduce metabolic burden of organisms, and is beneficial to returning and treating diseases.
The invert sugar injection has good effectiveness and higher safety when being used clinically. Has wide application space in clinic, and has great social and economic benefits in researching and developing the variety.
The foregoing is illustrative of the present invention and does not represent the scope of the invention.
Claims (10)
1. An invert sugar injection is characterized in that anhydrous glucose and fructose are added into water for injection.
2. The invert sugar injection of claim 1 which is further characterized by the addition of 10% HCl to the water for injection.
3. The invert sugar injection as claimed in claim 1, which is prepared from the following components in parts by weight: 250 parts of water for injection, 12.5 parts of fructose and 12.5 parts of anhydrous glucose.
4. A preparation process of invert sugar injection is characterized by comprising the following steps,
(1) Adding water for injection into a concentration tank, sequentially adding anhydrous glucose and fructose according to the formula amount, stirring for dissolving, adding activated carbon, and stirring for adsorption;
(2) Removing carbon;
(3) injecting the liquid medicine into a diluting preparation tank, repeatedly flushing the concentrating preparation tank with injection water, and injecting the flushing water into the diluting preparation tank;
(4) Supplementing water for injection to full volume in the diluting preparation tank, and adjusting the pH value;
(5) Circulating to make the liquid medicine uniform, and taking the intermediate to monitor the pH value of the liquid medicine;
(6) filtering the liquid medicine until the visible foreign matters are qualified, and sampling and measuring the PH value;
(7) filling, sterilizing and packaging.
5. the process for preparing an invert sugar injection as claimed in claim 4, which is characterized in that:
Injecting water for injection into the thick preparation tank, specifically, adding 60% of the total amount of the water for injection into the thick preparation tank;
The active carbon is added, specifically, the diluted ligand volume is 0.02% (W/V) active carbon, and the stirring is carried out for about 15 minutes.
the decarbonization is specifically carried out by filtering through a titanium rod;
The pH value is adjusted by 10% HCL to be: 4.7 to 5.3;
Filtering the liquid medicine until the visible foreign matters are qualified, specifically, filtering the liquid medicine through a 0.22-micrometer microporous filter until the visible foreign matters are qualified;
And specifically, carrying out constant-temperature sterilization on the mixture by using superheated water bath at the temperature of 121 ℃ for 10 minutes.
6. The process for preparing an invert sugar injection according to claim 4,
the method is characterized in that anhydrous glucose and fructose are sequentially added according to the prescription amount and stirred for dissolution, and the method also comprises the following steps of putting the anhydrous glucose and the fructose into an ultrasonic tank for sterilization and dissolution, wherein the steps are as follows: (1) preparing ingredients: anhydrous glucose and fructose; (2) carrying out ultrasonic sterilization: adding injection water with more than 5 times volume of the ingredients into an ultrasonic tank, putting the ingredients into the ultrasonic tank, performing ultrasonic oscillation for 8-10 minutes to perform primary sterilization, and dissolving the ingredients into the injection water; (3) and introducing the sterilized and dissolved ingredients into a concentration tank.
7. the process according to claim 6, wherein the ultrasonic oscillation parameters are: the sound intensity is 1-5W/cm2, the frequency is 30-40KHz, and the bottom of the ultrasonic tank generates 10.5 μm amplitude; the ultrasonic output power is 45-55w, the ultrasonic wave is pulse wave, and the pulse width is 8-12 ms.
8. The process for preparing an invert sugar injection as claimed in claim 4, wherein the dilution tank is filled with injection water to full volume and then is sterilized by shearing with reflux water; the reflux water shearing sterilization is specifically that the liquid in the blending tank is stirred and repeatedly rotated for 20-25 minutes.
9. The process for preparing an invert sugar injection as claimed in claim 8, wherein the agitation of the liquid in the dilution tank is repeated by rotating the liquid in the dilution tank from one direction for 1 to 3 minutes, then from the other direction for 1 to 3 minutes, and then repeating the rotation, and the rotation direction is changed every 1 to 3 minutes to generate high shear force;
The stirring method for stirring the liquid in the diluting preparation tank to rotate repeatedly comprises the following steps: the water outlets of a plurality of first group of reflux pumps are arranged on the outer wall of the diluting preparation tank in a clockwise direction and from the tangential direction of the inner circle of the diluting preparation tank, the water inlets of the first group of reflux pumps are arranged at the bottom of the diluting preparation tank, and the arranged first group of reflux pumps complete the stirring of the clockwise rotation in the diluting preparation tank;
The water outlets of a plurality of second groups of reflux pumps are arranged on the outer wall of the diluting preparation tank in the anticlockwise direction and from the tangential direction of the inner circle of the diluting preparation tank, the water inlets of the second groups of reflux pumps are arranged at the bottom of the diluting preparation tank, and the arranged second groups of reflux pumps complete the stirring of the anticlockwise rotation in the diluting preparation tank;
the first group of reflux pumps and the second group of reflux pumps are repeatedly and alternately started to enable the liquid in the diluting preparation tank to repeatedly rotate to generate high shearing force;
The water outlet parameters of the water outlet are as follows: the flow rate is more than 50L/min, and the flow speed is 2-3.5 m/s.
10. The process for preparing an invert sugar injection as claimed in claim 4, wherein the repeated rotary agitation of the liquid in the dilution tank is continued during the filling; stirring the liquid in the diluting and blending tank for 3-5 minutes, then reversely stirring the liquid in the diluting and blending tank for 3-5 minutes, repeatedly rotating in the way, and converting the rotating direction every 3-5 minutes to generate high shearing force;
until the liquid medicine in the diluting preparation tank is canned.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910950631.2A CN110538147A (en) | 2019-10-08 | 2019-10-08 | Invert sugar injection and preparation process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910950631.2A CN110538147A (en) | 2019-10-08 | 2019-10-08 | Invert sugar injection and preparation process thereof |
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| Publication Number | Publication Date |
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| CN110538147A true CN110538147A (en) | 2019-12-06 |
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| CN201910950631.2A Withdrawn CN110538147A (en) | 2019-10-08 | 2019-10-08 | Invert sugar injection and preparation process thereof |
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| CN (1) | CN110538147A (en) |
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2019
- 2019-10-08 CN CN201910950631.2A patent/CN110538147A/en not_active Withdrawn
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Application publication date: 20191206 |