Defoaming agent composition as well as preparation method and application thereof

By using a defoamer composition containing simethicone oil, a stable thickener, a surfactant and natural products in biopharmaceuticals, the existing defoamer has been solved, and the problems of poor biocompatibility, poor defoaming effect, insufficient stability and poor environmental performance in biopharmaceuticals are achieved, and an efficient, stable and environmentally friendly defoaming effect is achieved, improving the cell culture environment.

CN119633455APending Publication Date: 2025-03-18BIO-LINK PHARM APPL SYST (JIANGSU) CO LTD
View PDF 0 Cites 0 Cited by

Patent Information

Application Number
CN202411819640.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-10
Publication Date
2025-03-18

AI Technical Summary

Technical Problem

In the biopharmaceutical process, existing defoamers have problems such as poor biocompatibility, unsatisfactory defoaming effect, insufficient stability and poor environmental protection performance, which affect production efficiency and product quality.

Method used

A defoamer composition is provided, including simethicone oil, a stabilizing thickener, a surfactant and natural products, to form an efficient, stable and environmentally friendly defoamer emulsion through specific proportioning and preparation methods.

Benefits of technology

The defoamer composition has good defoaming performance, can quickly and effectively eliminate foam during cell culture, improve the cell growth environment, and is non-toxic and harmless to the human body. It is suitable for various cell culture processes.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure BDA0005182793880000121
    Figure BDA0005182793880000121
Patent Text Reader

Abstract

The invention provides a defoaming agent composition as well as a preparation method and application thereof. The defoaming agent composition comprises the following components in percentage by mass: 2-5% of simethicone, 0.5-1.5% of a stable thickener, 0.8-6% of a surfactant, 0.5-1.5% of a natural product and the balance of pharmaceutical water, wherein the sum of the components is not more than 100%. The preparation method of the defoaming agent composition comprises the following steps: weighing a proper amount of thickening agent, dissolving the thickening agent in pharmaceutical water, and uniformly stirring to form a stabilizer solution; weighing a proper amount of a surfactant, dissolving the surfactant in pharmaceutical water, and uniformly stirring to form a surfactant solution; mixing the stabilizer solution with the surfactant solution, adding a proper amount of a natural product, and stirring at room temperature for a first preset time to form a uniform water-phase mixture; and adding 30% simethicone emulsion into the water-phase mixture, and cooling the obtained mixture to room temperature to obtain the defoaming agent emulsion. The problem of foam generated in the cell culture process can be solved, and the cell culture efficiency and quality are improved.
Need to check novelty before this filing date? Find Prior Art

Description

Technical Field

[0001] The present invention relates to the field of biomedical technology, and in particular to a defoamer composition, a preparation method and an application thereof. Background Art

[0002] In the biopharmaceutical process, a large amount of foam is often generated in the fermentation and reaction stages. These foams can cause many problems, such as reducing production efficiency, affecting product quality, and interfering with the process. Traditional defoamers may have poor defoaming effects, adverse effects on bioactive ingredients, poor biocompatibility, or insufficient environmental protection in biopharmaceutical applications. Therefore, it is necessary to develop new defoamer formulas to meet the complex requirements of biopharmaceuticals.

[0003] Prior art;

[0004] Chemical defoamers: Some traditional chemical defoamers can quickly defoam, but they may inhibit or destroy the active ingredients in biopharmaceuticals, and some chemical residues do not meet the strict quality acceptance standards for drug production.

[0005] Natural oil defoamers: Defoamers based on animal and plant oils have good biocompatibility, but their defoaming efficiency is relatively low and their stability is poor under complex pharmaceutical process conditions such as high temperature and high pressure.

[0006] Silicone defoamers: In some cases, they are incompatible with the pharmaceutical system and have poor dispersibility, and may affect the stability of the drug after long-term use at high concentrations.

[0007] Problems and defects of existing technologies:

[0008] 1. Poor biocompatibility

[0009] Some chemical defoamers contain substances that are harmful to biologically active ingredients. For example, some fluorine-containing and chlorine-containing organic compound defoamers may chemically react with active ingredients such as proteins and enzymes in biopharmaceuticals, changing their structure and function, thereby affecting the quality and efficacy of the drugs.

[0010] 2. The defoaming effect is not ideal

[0011] Natural oil defoamers, such as vegetable oils, are safer but have a slow defoaming speed. In the fermentation process of biopharmaceuticals, when the foam is generated quickly, it is difficult for such defoamers to quickly control the growth of foam, causing the foam to overflow the reaction vessel and affect the production process.

[0012] Some silicone defoamers may be unevenly dispersed in high-concentration or complex pharmaceutical systems, resulting in poor local defoaming effects and failure to effectively suppress the generation of foam.

[0013] 3. Insufficient stability

[0014] Under the complex process conditions of high temperature, high pressure, high shear force, etc. in biopharmaceuticals, the stability of many defoamers will be affected. For example, the molecular structure of some non-ionic surfactant defoamers may change under high temperature environment, which will reduce their defoaming performance.

[0015] Some defoamers may experience stratification and precipitation during long-term storage, which will affect their effectiveness.

[0016] 4. Poor environmental performance

[0017] Some traditional defoamers contain ingredients that are difficult to degrade. After being used in the pharmaceutical process, the disposal of their waste will cause environmental pollution. For example, some defoamers containing complex organic structures such as benzene rings are difficult to be decomposed by microorganisms in the natural environment and do not meet environmental protection requirements.

[0018] 5. Interference with pharmaceutical process

[0019] Some defoamers will remain in the pharmaceutical system and interact with other ingredients in the drug, interfering with subsequent separation, purification and other processes. For example, defoamer residues may change the rheological properties of the drug and affect the efficiency and effectiveness of operations such as filtration and centrifugation.

[0020] Therefore, it is particularly important to develop an efficient, non-toxic defoamer emulsion that does not affect the composition of the culture medium. Summary of the invention

[0021] In view of the above situation, the present invention provides a defoaming agent composition and a preparation method and application thereof to solve the technical problems raised by the background technology.

[0022] The technical solution of the present invention is:

[0023] A defoamer composition comprises the following components by mass fraction:

[0024] 2-5% simethicone, 0.5-1.5% stable thickener, 0.8-6% surfactant, 0.5-1.5% natural product, the sum of the mass fractions of the above components does not exceed 100%, and the remainder is pharmaceutical water.

[0025] The defoamer composition proposed by the present invention has the following beneficial effects:

[0026] (1) Simethicone defoamer emulsion has good defoaming performance, which can effectively eliminate foam in the cell culture process and improve the growth environment of cells;

[0027] (2) The stability enhancer, surfactant, and emulsifier in the emulsion can work synergistically to improve the stability and dispersibility of the emulsion and ensure the uniform distribution of the defoamer during the cell culture process;

[0028] (3) The natural non-toxic products added to the emulsion that can increase cell expression can promote cell growth and expression, and improve the efficiency and quality of cell culture;

[0029] (4) The defoamer emulsion of the present invention is non-toxic and harmless to the human body, has no negative impact on cells, and is suitable for various cell culture processes.

[0030] Preferably, the stabilizing thickener is any one or more combinations of sodium alginate or sodium carboxymethyl cellulose.

[0031] Preferably, the simethicone is an emulsion containing 30% simethicone.

[0032] Preferably, the natural product is vitamin E.

[0033] Preferably, the surfactant is any one or more of Tween 80, Span 80, Tween 60 and Span 60.

[0034] Preferably, the ratio of the content of Tween 80 to that of Span 80 in the surfactant is 1:(1.5-4.5);

[0035] The ratio of the Tween 60 and the Span 60 in the surfactant is 1:(1.5-4.5).

[0036] A method for preparing a defoamer composition comprises the following steps:

[0037] Weigh an appropriate amount of thickener and dissolve it in pharmaceutical water, stirring evenly to form a stabilizer solution;

[0038] Weigh an appropriate amount of surfactant and dissolve it in pharmaceutical water, stirring evenly to form a surfactant solution;

[0039] mixing the stabilizer solution with the surfactant solution, adding an appropriate amount of the natural product, and stirring at room temperature for a first preset time to form a uniform aqueous phase mixture;

[0040] Adding 30% simethicone emulsion to the aqueous phase mixture, and stirring at 70-80° C. for a second preset time;

[0041] After the obtained mixture is cooled to room temperature, it is filtered and sterilized to obtain the final simethicone defoamer emulsion for cell culture.

[0042] Preferably, the first preset time is 1-2 hours, and the second preset time is 1-2 hours.

[0043] In addition, the present invention also provides an application of the defoamer composition, specifically applying the defoamer composition in a biological cell culture process. DETAILED DESCRIPTION

[0044] In order to facilitate understanding of the present invention, the present invention will be described more fully below with reference to various embodiments, but the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present invention more thorough and comprehensive.

[0045] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used herein in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more related listed items.

[0046] The embodiment of the present invention provides a defoamer composition, which comprises the following components by mass fraction:

[0047] 2-5% simethicone, 0.5-1.5% stable thickener, 0.8-6% surfactant, 0.5-1.5% natural product, the sum of the mass fractions of the above components does not exceed 100%, and the remainder is pharmaceutical water.

[0048] The stable thickener is any one or more combinations of sodium alginate or sodium carboxymethyl cellulose.

[0049] The natural product is vitamin E, and the simethicone is an emulsion containing 30% simethicone.

[0050] The defoaming time of the defoamer composition is no more than 4 seconds.

[0051] The surfactant is any one or more of Tween 80, Span 80, Tween 60 and Span 60.

[0052] The ratio of the content of Tween 80 to that of Span 80 in the surfactant is 1:(1.5-4.5);

[0053] The ratio of the Tween 60 and the Span 60 in the surfactant is 1:(1.5-4.5).

[0054] Among them, simethicone is a highly effective and versatile silicone defoamer, particularly suitable for use as a defoamer in aqueous systems, such as bio-fermentation. They are typically used to control and suppress foam, designed for medical and pharmaceutical applications, and meet quality and safety standards as well as specific legal and regulatory requirements.

[0055] The adsorption of surfactants at the liquid / liquid interface is an important factor in the emulsification process. Its main mechanism of action is to reduce the liquid / liquid interfacial tension and reduce the thermodynamic instability of the system caused by the increase in interfacial area caused by emulsification. In the field of biopharmaceuticals, it is very important to select surfactants with good cell compatibility to ensure that the defoamer does not have a negative impact on cells or biological reaction processes.

[0056] Stabilizers are a type of additive that can shape food and maintain a stable shape and texture. In the defoamer formula, stabilizers help maintain the stability of the defoamer and prevent it from decomposing or deteriorating during storage and use.

[0057] The embodiment of the present invention also provides a method for preparing a defoamer composition, comprising the following steps:

[0058] Weigh an appropriate amount of thickener and dissolve it in pharmaceutical water, stirring evenly to form a stabilizer solution;

[0059] Weigh an appropriate amount of surfactant and dissolve it in pharmaceutical water, stirring evenly to form a surfactant solution;

[0060] mixing the stabilizer solution with the surfactant solution, adding an appropriate amount of the natural product, and stirring at room temperature for a first preset time to form a uniform aqueous phase mixture;

[0061] Adding 30% simethicone emulsion to the aqueous phase mixture, and stirring at 70-80° C. for a second preset time;

[0062] After the obtained mixture is cooled to room temperature, it is filtered and sterilized to obtain the final simethicone defoamer emulsion for cell culture.

[0063] The method for preparing the defoamer composition is as follows: wherein the first preset time is 1-2 hours, the second preset time is 1-2 hours, and the stirring speed for the first preset time and the second preset time is 300-500 rpm.

[0064] The following is a further description of the embodiments of the present invention in multiple embodiments. The embodiments of the present invention are not limited to the following specific embodiments. Within the scope of the unchanged main rights, appropriate changes can be made to the implementation.

[0065] Example 1

[0066] A defoamer composition comprises the following components by mass fraction:

[0067] 30% simethicone emulsion, content: 10%, which can be understood as 3% simethicone content;

[0068] Stable thickener, content: 1%;

[0069] Surfactant, content: 3%;

[0070] Natural product, content: 1%;

[0071] The remainder is pharmaceutical water.

[0072] The stable thickener is sodium carboxymethyl cellulose.

[0073] The natural product is vitamin E, and the simethicone is an emulsion containing 30% simethicone.

[0074] The surfactant is a combination of Tween 80 and Span 80.

[0075] The ratio of the Tween 80 to the Span 80 in the surfactant is 1:3.

[0076] The preparation method of the above defoamer composition comprises the following steps:

[0077] (1) Weigh an appropriate amount of thickener and dissolve it in pharmaceutical water, and stir evenly to form a stabilizer solution;

[0078] Specifically, 6 g of a stabilizing thickener (such as sodium carboxymethyl cellulose) is weighed into a beaker, and an appropriate amount of pharmaceutical water is added, and stirred until the solid is completely dissolved to obtain a stabilizer solution.

[0079] (2) weighing an appropriate amount of surfactant and dissolving it in pharmaceutical water, and stirring evenly to form a surfactant solution;

[0080] Specifically, take another beaker, weigh an appropriate amount of surfactant (such as 18 g of Span 80 and 6 g of Tween 80) into it, then add an appropriate amount of pharmaceutical water, stir and dissolve to obtain a mixed solution.

[0081] (3) mixing the stabilizer solution with the surfactant solution, adding an appropriate amount of the natural product, and stirring at room temperature for a first preset time to form a uniform aqueous phase mixture;

[0082] Specifically, the stabilizer solution is transferred to the mixed solution, and a natural non-toxic product (such as vitamin E) is added, and the mixture is stirred at room temperature for about 1.5 hours, and then mixed evenly to obtain an aqueous phase mixture.

[0083] (4) adding 30% simethicone emulsion to the aqueous phase mixture and stirring at 70-80° C. for a second preset time;

[0084] Specifically, 120 g of 30% simethicone emulsion and an appropriate amount of pharmaceutical water were weighed, added to the above aqueous phase mixture, and stirred at 70-80° C. for 1.5 h (same speed as above) to obtain an oil-in-water mixed emulsion.

[0085] Among them, 30% simethicone accounts for 10%, and 1.2L of defoaming agent is approximately equal to 1200g. 120g of 30% simethicone emulsion, converted into simethicone, is 120*0.3=36g, accounting for the total defoaming agent: 36g / 1200=3%, which is within the range of 2% to 5%; 6g of thickener, 6g / 1200g=0.5%.

[0086] (5) After the obtained mixture is cooled to room temperature, it is filtered and sterilized to obtain the final simethicone defoamer emulsion for cell culture.

[0087] Specifically, after cooling to room temperature, the emulsion is filtered and sterilized to obtain a final 3% defoaming agent emulsion for cell culture.

[0088] This embodiment also provides the use of the defoamer composition prepared above in cosmetics.

[0089] Example 2

[0090] This embodiment provides a defoamer composition, which includes the following components by mass fraction:

[0091] 30% simethicone emulsion, content: 10%;

[0092] Stable thickener, content: 1%;

[0093] Surfactant, content: 3%;

[0094] Natural product, content: 1%;

[0095] The remainder is pharmaceutical water.

[0096] The stable thickener is sodium alginate.

[0097] The natural product is vitamin E, and the simethicone is an emulsion containing 30% simethicone.

[0098] The surfactant is a combination of Tween 60 and Span 60.

[0099] The ratio of Tween 60 to Span 60 in the surfactant is 1:3.

[0100] The difference between this embodiment and embodiment 1 is that the stabilizing thickener in this embodiment is sodium alginate, the surfactant is a combination of Tween 60 and Span 60, and the ratio of the content of Tween 60 to Span 60 in the surfactant is 1:3.

[0101] Example 3

[0102] This embodiment provides a defoamer composition, which includes the following components by mass fraction:

[0103] 30% simethicone emulsion, content: 10%;

[0104] Stable thickener, content: 1%;

[0105] Surfactant, content: 3%;

[0106] Natural product, content: 1%;

[0107] The remainder is pharmaceutical water.

[0108] The stable thickener is sodium carboxymethyl cellulose.

[0109] The natural product is vitamin E, and the simethicone is an emulsion containing 30% simethicone.

[0110] The surfactant is a combination of Tween 80, Span 80, Tween 60 and Span 60.

[0111] The ratio of the content of Tween 80 and Tween 60 to that of Span 80 and Span 60 in the surfactant is 1:3.

[0112] The difference between this embodiment and embodiment 1 is that the surfactant described in this embodiment is a combination of Tween 80, Span 80, Tween 60 and Span 60, and the ratio of the content of Tween 80 and Tween 60 to Span 80 and Span 60 in the surfactant is 1:3.

[0113] Example 4

[0114] This embodiment provides a defoamer composition, which includes the following components by mass fraction:

[0115] 30% simethicone emulsion, content: 10%;

[0116] Stable thickener, content: 1%;

[0117] Surfactant, content: 3%;

[0118] Natural product, content: 1%;

[0119] The remainder is pharmaceutical water.

[0120] The stable thickener is sodium carboxymethyl cellulose.

[0121] The natural product is vitamin E, and the simethicone is an emulsion containing 30% simethicone.

[0122] The surfactant is a combination of Tween 80 and Span 80.

[0123] The ratio of Tween 80 to Span 80 in the surfactant is 1:2.

[0124] The difference between this embodiment and embodiment 1 is that the ratio of Tween 80 to Span 80 in the surfactant of this embodiment is 1:2.

[0125] Example 5

[0126] This embodiment provides a defoamer composition, which includes the following components by mass fraction:

[0127] 30% simethicone emulsion, content: 10%;

[0128] Stable thickener, content: 1%;

[0129] Surfactant, content: 3%;

[0130] Natural product, content: 1%;

[0131] The remainder is pharmaceutical water.

[0132] The stable thickeners are sodium carboxymethyl cellulose and sodium alginate.

[0133] The natural product is vitamin E, and the simethicone is an emulsion containing 30% simethicone.

[0134] The surfactant is a combination of Tween 60 and Span 60.

[0135] The ratio of Tween 60 to Span 60 in the surfactant is 1:3.

[0136] The difference between this embodiment and embodiment 1 is that the stabilizing thickeners in this embodiment are sodium carboxymethyl cellulose and sodium alginate, and the surfactants are Tween 60 and Span 60.

[0137] Example 6

[0138] This embodiment provides a defoamer composition, which includes the following components by mass fraction:

[0139] 30% simethicone emulsion, content: 7%;

[0140] Stable thickener, content: 0.5%;

[0141] Surfactant, content: 0.8%;

[0142] Natural product, content: 1%;

[0143] The remainder is pharmaceutical water.

[0144] The stable thickener is sodium carboxymethyl cellulose.

[0145] The natural product is vitamin E, and the simethicone is an emulsion containing 30% simethicone.

[0146] The surfactant is a combination of Tween 80 and Span 80.

[0147] The ratio of the Tween 80 to the Span 80 in the surfactant is 1:3.

[0148] The difference between this embodiment and embodiment 1 is that: in this embodiment, 30% simethicone, content: 7%; stable thickener, content: 0.5%; surfactant, content: 0.8%.

[0149] Example 7

[0150] This embodiment provides a defoamer composition, which includes the following components by mass fraction:

[0151] 30% simethicone emulsion, content: 13%;

[0152] Stable thickener, content: 1.5%;

[0153] Surfactant, content: 6%;

[0154] Natural product, content: 1%;

[0155] The remainder is pharmaceutical water.

[0156] The stable thickener is sodium carboxymethyl cellulose.

[0157] The natural product is vitamin E, and the simethicone is an emulsion containing 30% simethicone.

[0158] The surfactant is a combination of Tween 80 and Span 80.

[0159] The ratio of the Tween 80 to the Span 80 in the surfactant is 1:3.

[0160] The difference between this embodiment and embodiment 1 is that: in this embodiment, 30% simethicone, content: 13%; stable thickener, content: 1.5%; surfactant, content: 6%.

[0161] Example 8

[0162] This embodiment provides a defoamer composition, which includes the following components by mass fraction:

[0163] 30% simethicone emulsion, content: 10%;

[0164] Stable thickener, content: 1.2%;

[0165] Surfactant, content: 4%;

[0166] Natural product, content: 1.5%;

[0167] The remainder is pharmaceutical water.

[0168] The stable thickener is sodium carboxymethyl cellulose.

[0169] The natural product is vitamin E, and the simethicone is an emulsion containing 30% simethicone.

[0170] The surfactant is a combination of Tween 80 and Span 80.

[0171] The ratio of the Tween 80 to the Span 80 in the surfactant is 1:3.

[0172] The difference between this embodiment and embodiment 1 is that: the content of the stabilizing thickener in this embodiment is 1.2%; the content of the surfactant is 4%; the content of the natural product is 1.5%.

[0173] Example 9

[0174] This embodiment provides a defoamer composition, which includes the following components by mass fraction:

[0175] 30% simethicone emulsion, content: 10%;

[0176] Stable thickener, content: 0.8%;

[0177] Surfactant, content: 3%;

[0178] Natural product, content: 0.5%;

[0179] The remainder is pharmaceutical water.

[0180] The stable thickener is sodium carboxymethyl cellulose.

[0181] The natural product is vitamin E, and the simethicone is an emulsion containing 30% simethicone.

[0182] The surfactant is a combination of Tween 80 and Span 80.

[0183] The ratio of the Tween 80 to the Span 80 in the surfactant is 1:3.

[0184] The difference between this embodiment and embodiment 1 is that the content of the stable thickener in this embodiment is 0.8%; the content of the natural product is 0.5%.

[0185] Example 10

[0186] This embodiment provides a defoamer composition, which includes the following components by mass fraction:

[0187] A defoamer composition comprises the following components by mass fraction:

[0188] 30% simethicone emulsion, content: 10%;

[0189] Stable thickener, content: 1.2%;

[0190] Surfactant, content: 3%;

[0191] Natural product, content: 1.2%;

[0192] The remainder is pharmaceutical water.

[0193] The stable thickener is sodium carboxymethyl cellulose.

[0194] The natural product is vitamin E, and the simethicone is an emulsion containing 30% simethicone.

[0195] The surfactant is a combination of Tween 80 and Span 80.

[0196] The ratio of the Tween 80 to the Span 80 in the surfactant is 1:3.

[0197] The difference between this embodiment and embodiment 1 is that the content of the stable thickener in this embodiment is 1.2%; the content of the natural product is 1.2%.

[0198] Table 1 compares the test results of the above embodiments:

[0199] Table 1: Comparison of results of Examples 1-10

[0200]

[0201] At the same time, the defoaming performance of the defoaming agent composition obtained in the above examples was tested according to the Pharmacopoeia standard (USP) to obtain the actual defoaming time.

[0202] As shown in Table 1, in Example 1, the defoaming time is 4s;

[0203] Example 2, defoaming time 4.03s;

[0204] Example 3, defoaming time 4.21s;

[0205] Example 4, defoaming time 4.33s;

[0206] Example 5, defoaming time 4.32s;

[0207] Example 6, defoaming time 4.58s;

[0208] Example 7, defoaming time 4.65s;

[0209] Example 8, defoaming time 4.85s;

[0210] Example 9, defoaming time 4.65s;

[0211] Example 10, defoaming time 4.29s.

[0212] As can be seen from Table 1, according to the experimental data of Examples 1-10 of the present invention, Example 1 has the best defoaming performance and the shortest actual defoaming time.

[0213] In summary, according to the defoamer composition provided by the present invention, its preparation method and application, the defoamer composition comprises 30% simethicone, a stabilizing thickener, a surfactant, a natural product and other ingredients. The defoamer emulsion of the present invention has simethicone as the main ingredient, and is added with auxiliary ingredients such as a surfactant and a stabilizer, aiming to solve the foam problem generated during cell culture and improve the efficiency and quality of cell culture.

[0214] (1) The present invention provides a simethicone defoamer emulsion for cell culture, which has good defoaming performance and can effectively eliminate foam in the cell culture process and improve the growth environment of cells;

[0215] (2) The stability enhancer, surfactant, and emulsifier in the emulsion can work synergistically to improve the stability and dispersibility of the emulsion and ensure the uniform distribution of the defoamer during the cell culture process;

[0216] (3) The natural non-toxic products added to the emulsion that can increase cell expression can promote cell growth and expression, and improve the efficiency and quality of cell culture;

[0217] (4) The defoamer emulsion of the present invention is non-toxic and harmless to the human body, has no negative impact on cells, and is suitable for various cell culture processes.

[0218] (5) Ingredient selection: Based on the silicone matrix, a new type of biocompatible polymer component is used as the main defoaming component. It can effectively reduce the surface tension of the foam without affecting the biological activity. At the same time, it is matched with a special surfactant to enhance the dispersibility and stability of the defoaming agent in the pharmaceutical system.

[0219] (6) Ratio optimization: Through a large number of experiments, the optimal ratio of each component is determined so that the defoamer can play a good defoaming performance under different biopharmaceutical process conditions. For example, in the fermentation process, for different microbial species and fermentation parameters, the newly formulated defoamer can quickly eliminate foam without adversely affecting the fermentation product.

[0220] (7) Environmentally friendly design: Select biodegradable raw materials to ensure environmental friendliness during use and subsequent processing, in line with the development trend of green pharmaceutical manufacturing.

[0221] The above-mentioned embodiments only express several implementation methods of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the scope of the patent of the present invention. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A defoamer composition, characterized in that The following components are included by mass fraction: 2-5% simethicone, 0.5-1.5% stable thickener, 0.8-6% surfactant, 0.5-1.5% natural product, the sum of the mass fractions of the above components does not exceed 100%, and the remainder is pharmaceutical water.

2. The defoamer composition according to claim 1, characterized in that The stable thickener is any one or more combinations of sodium alginate or sodium carboxymethyl cellulose.

3. The defoamer composition according to claim 1, characterized in that The simethicone is an emulsion containing 30% simethicone.

4. The defoamer composition according to claim 1, characterized in that The natural product is vitamin E.

5. The defoamer composition according to claim 1, characterized in that The surfactant is any one or more of Tween 80, Span 80, Tween 60 and Span 60.

6. The defoamer composition according to claim 6, characterized in that The ratio of the content of Tween 80 to that of Span 80 in the surfactant is 1:(1.5-4.5); The ratio of the Tween 60 and the Span 60 in the surfactant is 1:(1.5-4.5).

7. The method for preparing the defoamer composition according to any one of claims 1 to 6, characterized in that: The following steps are involved: Weigh an appropriate amount of thickener and dissolve it in pharmaceutical water, stirring evenly to form a stabilizer solution; Weigh an appropriate amount of surfactant and dissolve it in pharmaceutical water, stirring evenly to form a surfactant solution; mixing the stabilizer solution with the surfactant solution, adding an appropriate amount of the natural product, and stirring at room temperature for a first preset time to form a uniform aqueous phase mixture; Adding 30% simethicone emulsion to the aqueous phase mixture, and stirring at 70-80° C. for a second preset time; After the obtained mixture is cooled to room temperature, it is filtered and sterilized to obtain the final simethicone defoamer emulsion for cell culture.

8. The method for preparing the defoamer composition according to claim 7, characterized in that: The first preset time is 1-2 hours, and the second preset time is 1-2 hours.

9. The use of the defoamer composition according to claim 1, characterized in that: The defoamer composition is applied in a biological cell culture process.