CN111494314B - Ambroxol hydrochloride oral solution and preparation method thereof - Google Patents
Ambroxol hydrochloride oral solution and preparation method thereof Download PDFInfo
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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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/10—Expectorants
Abstract
The invention discloses an ambroxol hydrochloride oral solution and a preparation method thereof, and relates to the technical field of phlegm-eliminating medicines. The technical key points are as follows: an ambroxol hydrochloride oral solution comprises the following raw material components: ambroxol hydrochloride: 2-5 parts by weight; sorbitol: 150-250 parts by weight; benzoic acid: 0.5-1 weight part; AK sugar: 0.5-1.5 weight parts; calcium disodium edetate: 0.05-1 weight part; lemon essence: 0.1-0.5 weight parts; mint water: 0.05-0.2 weight parts; purifying water: adding to 1000 parts by volume; when the unit of the parts by weight is g, the unit of the parts by volume is mL, and the ambroxol hydrochloride oral solution prepared by the formula has the advantages of high safety and good stability.
Description
Technical Field
The invention relates to the technical field of phlegm eliminating medicines, in particular to an ambroxol hydrochloride oral solution and a preparation method thereof.
Background
The ambroxol hydrochloride mainly acts on respiratory tract secretory cells, regulates the secretion of mucoid and serous substances, increases the serous secretion, can also crack polysaccharide fibers of acidic glycoprotein in sputum, inhibits the synthesis of acidic protein in mucous glands and goblet cells, reduces the viscosity of the sputum, and makes the sputum thin and easy to discharge. Meanwhile, the medicine can also increase the movement frequency and strength of respiratory tract cilia, and promote sputum discharge and respiratory tract self-cleaning. The ambroxol hydrochloride has the advantages of small adverse reaction, quick response and the like.
Ambroxol hydrochloride was first marketed in Japan in 1984, developed by the company Boehrin, Germany, in parts by weight of erIn, and is a relatively new sputum-dissolving agent. At present, the ambroxol hydrochloride sold on the market comprises tablets, capsules, syrup, small-needle injections and freeze-dried powder injections, and is the first choice for eliminating phlegm. In recent years, researches show that the ambroxol hydrochloride has the protection effects on the respiratory system such as antioxidation, reduction of release of inflammatory transmitters and the like, so that the market of the ambroxol hydrochloride is still in the rising stage of being yet to be developed and short of supply.
The Chinese patent application with publication number CN101152181A discloses a liquid composition containing loratadine and ambroxol hydrochloride, wherein the active ingredients are loratadine and ambroxol hydrochloride, the liquid composition further comprises a pharmaceutically acceptable stabilizer, a pH regulator, a preservative, a flavoring agent and a metal ion complexing agent, the flavoring agent adopts sodium chloride, an aromatic and a sweetening agent, and the sweetening agent adopts saccharin sodium. The saccharin sodium is an organic chemical synthesis product, has no nutritive value to human bodies except the sweet feeling caused by taste sense, influences the normal secretion of digestive enzymes in intestines and stomach and reduces the absorption capacity of small intestines when being eaten more, and the safety of the saccharin sodium is widely disputed all the time.
Therefore, a new solution is needed to solve the above problems.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide an ambroxol hydrochloride oral solution which has the advantages of high safety and good stability.
The invention aims at providing a preparation method of ambroxol hydrochloride oral solution, which has the advantages of simplicity, feasibility and suitability for large-scale production.
In order to achieve the first purpose, the invention provides the following technical scheme:
an ambroxol hydrochloride oral solution comprises the following raw material components:
ambroxol hydrochloride: 2-5 parts by weight;
sorbitol: 150-250 parts by weight;
benzoic acid: 0.5-1 weight part;
AK sugar: 0.5-1.5 weight parts;
sucralose: 0.1-0.3 weight parts;
calcium disodium edetate: 0.05-1 weight part;
lemon essence: 0.1-0.5 weight parts;
mint water: 0.05-0.2 weight parts;
purifying water: adding to 1000 parts by volume;
when the unit of the parts by weight is g, the unit of the parts by volume is mL.
By adopting the technical scheme, the sorbitol and the benzoic acid play a role in preservation, so that the stability of the oral solution can be improved, and the sorbitol can also be used as a sweetening agent to improve the taste of the oral solution; AK sugar, sucralose and peppermint water are used as flavoring agents to improve and shield the bad smell of ambroxol hydrochloride and improve the taste of oral solution.
The stability of the common ambroxol hydrochloride oral solution is poor under the standing condition, the color of the solution gradually turns yellow along with the prolonging of the standing time, the impurity content gradually increases, and the change of the solution is accelerated under the high-temperature condition, so that the use safety risk of the solution is greatly increased, and the quality guarantee period of the ambroxol hydrochloride oral solution is shortened. According to the invention, a certain amount of calcium disodium edetate is added into the formula system, so that the storage stability of ambroxol hydrochloride can be obviously improved.
Further preferably, the feed comprises the following raw material components:
ambroxol hydrochloride: 3 parts by weight;
sorbitol: 200 parts by weight;
benzoic acid: 0.7 part by weight;
AK sugar: 1 part by weight;
sucralose: 0.2 part by weight;
calcium disodium edetate: 0.08 parts by weight;
lemon essence: 0.3 part by weight;
mint water: 0.1 part by weight;
purifying water: adding to 1000 parts by volume;
when the unit of the parts by weight is g, the unit of the parts by volume is mL.
By adopting the technical scheme, the ambroxol hydrochloride oral solution prepared from the raw material components in the ratio has good stability and excellent effect.
Further preferably, the feed comprises the following raw material components:
Ambroxol hydrochloride: 2-5 parts by weight;
sorbitol: 150-250 parts by weight;
benzoic acid: 0.5-1 weight part;
AK sugar: 0.5-1.5 weight parts;
sucralose: 0.1-0.3 weight parts;
calcium disodium edetate: 0.05-1 weight part;
EDTA-2 Na: 0.02-0.05 weight parts;
lemon essence: 0.1-0.5 weight parts;
mint water: 0.05-0.2 weight parts;
purifying water: adding to 1000 parts by volume;
when the unit of the parts by weight is g, the unit of the parts by volume is mL.
By adopting the technical scheme, the EDTA-2Na is an important chelating agent, can chelate metal ions in the solution, can prevent the ambroxol hydrochloride oral solution from discoloring, deteriorating, becoming turbid and the like, and can greatly improve the storage stability of the oral solution when being matched with the calcium disodium edentate.
The AK sugar and the sucralose are compounded to replace saccharin sodium with controversial safety, and the AK sugar and the sucralose act together with other components in the formula, so that the safety and the stability of the oral solution are greatly improved.
Further preferably, the feed comprises the following raw material components:
ambroxol hydrochloride: 3 parts by weight;
sorbitol: 200 parts by weight;
benzoic acid: 0.7 part by weight;
AK sugar: 1 part by weight;
sucralose: 0.2 part by weight;
Calcium disodium edetate: 0.08 part by weight;
EDTA-2 Na: 0.04 parts by weight
Lemon essence: 0.3 part by weight;
mint water: 0.1 part by weight;
purifying water: adding to 1000 parts by volume;
when the unit of the parts by weight is g, the unit of the parts by volume is mL.
By adopting the technical scheme, the ambroxol hydrochloride oral solution prepared from the raw material components in the ratio has the best stability and the optimal effect.
More preferably, the ambroxol hydrochloride is prepared by the following preparation method:
adding ambroxol into water with the volume 10-30 times of the weight of the ambroxol, heating to 145 ℃ for complete dissolution, then cooling to 25-30 ℃, preserving the heat, adding 0.1mol/L hydrochloric acid solution, stirring for 4-6h, filtering while hot, drying at 40-60 ℃, recrystallizing the dried solid with water and decolorizing with activated carbon to obtain the ambroxol.
By adopting the technical scheme, compared with the common methods such as column chromatography, recrystallization, preparative thin-layer chromatography and the like, the preparation method of ambroxol hydrochloride is simpler and easier to operate, is suitable for large-scale production and use, and has high yield.
In order to achieve the second purpose, the invention provides the following technical scheme:
a preparation method of ambroxol hydrochloride oral solution comprises the following steps:
s1, adding hot purified water with the temperature of 70-80 ℃ and the preparation amount of 60-80% into a preparation tank, adding ambroxol hydrochloride, and stirring for dissolving;
s2, adding sorbitol and benzoic acid, heating to 95-105 ℃, stirring to dissolve, keeping the temperature for 2-3min, and cooling to 45-55 ℃;
s3, adding calcium disodium edetate, AK sugar, sucralose, lemon essence and peppermint water, and stirring for dissolving;
s4, adding the rest purified water to a preparation amount, and stirring for 10-20min to make it uniform;
s5, filtering the liquid medicine obtained in the step S4 for 2-3 times by a polyether sulfone filter core;
s6, sampling to obtain QC test intermediate with qualified main medicine content, pH value and relative density, and filling the liquid medicine into a liquid storage tank;
and S7, filtering the liquid medicine in the liquid storage tank by a polyether sulfone filter element until the visible foreign matters are qualified, inputting the liquid medicine into a liquid storage container for filling, and recovering the filtered liquid medicine into the liquid storage tank after counting.
By adopting the technical scheme, the method has the advantages of simple and feasible process, less high-temperature condition, no high-pressure condition, energy conservation and controllable key factors, and the ambroxol hydrochloride oral solution prepared by the preparation method has high stability and long storage time.
More preferably, in step S5, the pore size of the filter membrane of the polyethersulfone filter element is 0.45 μm, and in step S7, the pore size of the filter membrane of the polyethersulfone filter element is 0.22 μm.
By adopting the technical scheme, the polyether sulfone filter element is a hydrophilic sterile-grade folding filter element, has the microporosity accounting for more than eighty percent of the area of the filter membrane and a unique micropore geometric shape, has large flux, filters a crude product by adopting the polyether sulfone filter element with the pore diameter of the filter membrane, can filter most of crude impurities, and obtains an oral solution with good finished product quality and composite requirements.
In summary, compared with the prior art, the invention has the following beneficial effects:
(1) the AK sugar and the sucralose are compounded to replace saccharin sodium with controversial safety, and the AK sugar and the sucralose act together with other components in the formula, so that the safety and the stability of the oral solution are greatly improved;
(2) according to the invention, a certain amount of calcium disodium edetate is added into the formula system, so that the storage stability of ambroxol hydrochloride can be obviously improved;
(3) according to the invention, EDTA-2Na and edetate calcium sodium are compounded in the formula system, so that the situations of discoloration, deterioration, turbidity change and the like of the ambroxol hydrochloride oral solution can be prevented, and the storage stability of the ambroxol hydrochloride oral solution can be greatly improved.
Drawings
FIG. 1 is a flow chart of the process for preparing the oral solution of ambroxol hydrochloride in example 1.
Detailed Description
The invention is described in detail below with reference to the figures and examples.
Example 1: an ambroxol hydrochloride oral solution comprises the following raw materials: ambroxol hydrochloride: 2g of the total weight of the mixture; 150g of sorbitol; 0.5g of benzoic acid; AK sugar 0.5 g; 0.05g of calcium disodium edetate; 0.1g of lemon essence; 0.05g of peppermint water; purified water was added to 1000 parts by volume.
The preparation method of ambroxol hydrochloride in the embodiment comprises the following steps:
adding ambroxol into water with the volume 30 times of the weight of the ambroxol, heating to 100 ℃ to completely dissolve the ambroxol, then cooling to 25 ℃, preserving the temperature, adding 0.1mol/L hydrochloric acid solution, stirring for 6 hours, filtering while hot, drying at 40 ℃, recrystallizing the dried solid with water and decoloring with activated carbon to obtain the ambroxol hydrochloride, wherein the hydrochloric acid solution is the same as the ambroxol in molar weight, and the yield is 98.6%.
The preparation method of the ambroxol hydrochloride oral solution comprises the following steps:
s1, adding 70% of hot purified water with the temperature of 70 ℃ and the preparation amount into a preparation tank, adding ambroxol hydrochloride, and stirring for dissolving;
s2, adding sorbitol and benzoic acid, heating to 100 ℃, stirring to dissolve, keeping the temperature for 2min, and cooling to 47 ℃;
S3, adding calcium disodium edentate, AK sugar, lemon essence and peppermint water, stirring and dissolving;
s4, adding the rest purified water to a preparation amount, and stirring for 15min to make it uniform;
s5, filtering the liquid medicine obtained in the step S4 for 3 times by a 0.45 mu m polyethersulfone filter core;
s6, sampling to test the main drug content, pH value and relative density of the intermediate by QC, and filling the liquid medicine into a liquid storage tank;
and S7, filtering the liquid medicine in the liquid storage tank by a 0.22 mu m polyethersulfone filter element until no visible foreign matters are qualified, inputting the liquid medicine into a liquid storage container for filling, and recovering the filtered liquid medicine into the liquid storage tank after counting.
The stirring speed in this example was 60 r/min.
Example 2: the difference between the ambroxol hydrochloride oral solution and the embodiment 1 is that the oral solution has different raw material component dosage, and comprises the following specific components: 5g of ambroxol hydrochloride; 250g of sorbitol; 1g of benzoic acid; AK sugar 1.5 g; 1g of calcium disodium edetate; 0.5g of lemon essence; 0.2g of peppermint water; purified water was added to 1000 parts by volume.
Example 3: the difference between the ambroxol hydrochloride oral solution and the embodiment 1 is that the oral solution has different raw material component dosage, and comprises the following specific components: 3g of ambroxol hydrochloride; 200g of sorbitol; benzoic acid 0.7 g; AK sugar 1 g; 0.08g of calcium disodium edetate; 0.3g of lemon essence; 0.1g of peppermint water; purified water was added to 1000 parts by volume.
Example 4: an ambroxol hydrochloride oral solution is different from the embodiment 1 in that EDTA-2Na0.02g is also added in the step S2, and the step S2 is specifically set as follows: adding EDTA-2Na, sorbitol and benzoic acid, heating to 100 deg.C, stirring for dissolving, maintaining the temperature for 2min, and cooling to 47 deg.C.
0.3g of sucralose is also added in the step S3, and the step S3 is specifically set as follows: adding calcium disodium edentate, AK sugar, sucralose, lemon essence and peppermint water, and stirring for dissolving.
Example 5: an ambroxol hydrochloride oral solution, which is different from the embodiment 4 in that EDTA-2Na is replaced by 0.04g from 0.02 g.
Example 6: the difference between the ambroxol hydrochloride oral solution and the embodiment 1 is that the preparation conditions of the ambroxol hydrochloride are different, and the specific preparation steps are as follows:
adding ambroxol into water with the volume of 25 times that of the ambroxol, heating to 140 ℃ to completely dissolve the ambroxol, then cooling to 30 ℃, preserving the temperature, adding 0.1mol/L hydrochloric acid solution, stirring for 4 hours, filtering while hot, drying at 60 ℃, recrystallizing the dried solid with water and decoloring with activated carbon to obtain the ambroxol hydrochloride with the yield of 99%.
Example 7: the difference between the ambroxol hydrochloride oral solution and the embodiment 1 is that the preparation conditions of the ambroxol hydrochloride oral solution are different, and the preparation steps are as follows:
s1, adding 70% of hot purified water with the temperature of 70 ℃ and the preparation amount into a preparation tank, adding ambroxol hydrochloride, and stirring for dissolving;
s2, adding sorbitol and benzoic acid, heating to 100 ℃, stirring to dissolve, keeping the temperature for 3min, and cooling to 50 ℃;
s3, adding calcium disodium edetate, AK sugar, sucralose, lemon essence and peppermint water, stirring and dissolving;
s4, adding the rest purified water to a preparation amount, and stirring for 15min to make the mixture uniform;
s5, filtering the liquid medicine obtained in the step S4 for 3 times by a 0.45 mu m polyethersulfone filter core;
s6, sampling to obtain QC test intermediate with qualified main medicine content, pH value and relative density, and filling the liquid medicine into a liquid storage tank;
and S7, filtering the liquid medicine in the liquid storage tank by a 0.22 mu m polyethersulfone filter element until the visible foreign matters are qualified, inputting the liquid medicine into a liquid storage container for filling, and recovering the filtered liquid medicine into the liquid storage tank after counting.
Comparative example 1: except for the difference from example 1, this comparative example does not include calcium sodium edetate, and the raw materials and amounts thereof are the same as in example 1.
Comparative example 2: except that calcium disodium edetate was added together with sorbitol and benzoic acid in step S2.
Comparative example 3: the difference from example 1 is that in this comparative example ambroxol hydrochloride is salified and recrystallized according to the method described in CN 102557967: dissolving ambroxol in acetone, adding concentrated hydrochloric acid to form salt, stirring for 4 hours, filtering to obtain a crude product, and recrystallizing the crude product with water to obtain the yield of 90%.
Performance testing
The ambroxol hydrochloride oral solutions prepared in examples 1 to 7 and comparative examples 1 to 2 were used as test samples, and the color changes of the solutions were measured for 0 day, 10 days and 30 days at a temperature of 60 ℃ and the results are shown in Table 1. The color change of the resulting film after standing at 40 ℃ and 75% relative humidity for 0 day and 60 days was measured, and the results are shown in Table 2.
As can be seen from the test data in tables 1 and 2, the color change is small and the stability is highest in examples 4 and 5 because EDTA-2Na and calcium disodium edetate are compounded under the condition of 60 ℃ and the acceleration condition. In contrast, in comparative example 1, no calcium disodium edetate was added, and in comparative example 2, the calcium disodium edetate was added after heating at 100 ℃, so that the color change of both samples was large, and the stability was the worst.
TABLE 160 ℃ test results
TABLE 2 test results under accelerated conditions
The above description is only a preferred embodiment of the present invention, and the protection scope of the present invention is not limited to the above embodiments, and all technical solutions belonging to the idea of the present invention belong to the protection scope of the present invention. It should be noted that modifications and embellishments within the scope of the invention may occur to those skilled in the art without departing from the principle of the invention, and are considered to be within the scope of the invention.
Claims (4)
1. The ambroxol hydrochloride oral solution is characterized by comprising the following raw material components:
ambroxol hydrochloride: 2-5 parts by weight;
sorbitol: 150-250 parts by weight;
benzoic acid: 0.5-1 weight part;
AK sugar: 0.5-1.5 weight parts;
sucralose: 0.1-0.3 weight parts;
calcium disodium edetate: 0.05-1 weight part;
EDTA-2 Na: 0.02-0.05 weight parts;
lemon essence: 0.1-0.5 weight parts;
mint water: 0.05-0.2 weight parts;
purifying water: adding to 1000 parts by volume;
when the unit of the weight part is g, the unit of the volume part is mL;
the ambroxol hydrochloride oral solution is prepared by the following preparation steps:
s1, adding hot purified water with the temperature of 70-80 ℃ and the preparation amount of 60-80% into a preparation tank, adding ambroxol hydrochloride, and stirring for dissolving;
S2, adding EDTA-2Na, sorbitol and benzoic acid, heating to 95-105 deg.C, stirring to dissolve, maintaining the temperature for 2-3min, and cooling to 45-55 deg.C;
s3, adding calcium disodium edetate, AK sugar, sucralose, lemon essence and peppermint water, stirring and dissolving;
s4, adding the rest purified water to a preparation amount, and stirring for 10-20min to make it uniform;
s5, filtering the liquid medicine obtained in the step S4 for 2-3 times by a polyether sulfone filter core;
s6, sampling to obtain QC test intermediate with qualified main medicine content, pH value and relative density, and filling the liquid medicine into a liquid storage tank;
s7, filtering the liquid medicine in the liquid storage tank by a polyether sulfone filter element until the visible foreign matters are qualified, inputting the liquid medicine into the liquid storage tank for filling, counting the filtered liquid medicine and recovering the liquid medicine into the liquid storage tank
2. The ambroxol hydrochloride oral solution of claim 1, which is characterized by comprising the following raw material components:
ambroxol hydrochloride: 3 parts by weight;
sorbitol: 200 parts by weight;
benzoic acid: 0.7 part by weight;
AK sugar: 1 part by weight;
sucralose: 0.2 part by weight;
calcium disodium edetate: 0.08 parts by weight;
EDTA-2 Na: 0.04 parts by weight
Lemon essence: 0.3 part by weight;
mint water: 0.1 part by weight;
purifying water: adding to 1000 parts by volume;
When the unit of the weight part is g, the unit of the volume part is mL.
3. Ambroxol hydrochloride oral solution according to any one of claims 1-2, characterized in that it is obtained by the following preparation method:
adding ambroxol into water with the volume 10-30 times of the weight of the ambroxol, heating to 145 ℃ for complete dissolution, then cooling to 25-30 ℃, preserving the heat, adding 0.1mol/L hydrochloric acid solution, stirring for 4-6h, filtering while hot, drying at 40-60 ℃, recrystallizing the dried solid with water and decolorizing with activated carbon to obtain the ambroxol.
4. The ambroxol hydrochloride oral solution according to claim 1, wherein in step S5, the pore size of the filter membrane of the polyethersulfone filter element is 0.45 μm, and in step S7, the pore size of the filter membrane of the polyethersulfone filter element is 0.22 μm.
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